BL-Contrast Betamethasone Sodium Phosphate, Betamethasone Acetate, Lidocaine, Iohexol, Povidine Iodine, Isopropyl Alcohol Betamethasone Sodium Phosphate and Betamethasone Acetate Betamethasone Sodium Phosphate and Betamethasone Acetate SODIUM PHOSPHATE, DIBASIC, ANHYDROUS SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE EDETATE DISODIUM BENZALKONIUM CHLORIDE WATER BETAMETHASONE SODIUM PHOSPHATE BETAMETHASONE BETAMETHASONE ACETATE BETAMETHASONE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE SODIUM CHLORIDE WATER SODIUM HYDROXIDE HYDROCHLORIC ACID LIDOCAINE HYDROCHLORIDE LIDOCAINE LIDOCAINE HYDROCHLORIDE ANHYDROUS OMNIPAQUE Iohexol TROMETHAMINE EDETATE CALCIUM DISODIUM HYDROCHLORIC ACID SODIUM HYDROXIDE IOHEXOL IOHEXOL IODINE colorless to pale yellow Povidine Iodine Povidine Iodine CITRIC ACID ACETATE GLYCERIN POLYSORBATE 80 SODIUM CITRATE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS WATER POVIDONE-IODINE IODINE Isopropyl Alcohol Isopropyl Alcohol WATER ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL

11.1 Chemical Characteristics OMNIPAQUE (iohexol) injection is a nonionic, x-ray or radiographic contrast medium for intrathecal, intravenous, oral, rectal and body cavity use. OMNIPAQUE oral solution is for oral use only. OMNIPAQUE injection and OMNIPAQUE oral solution are both provided as sterile, pyrogen-free and gluten-free solutions. OMNIPAQUE injection and OMNIPAQUE oral solution are colorless to pale yellow solutions. The chemical name of iohexol is Bis(2,3-dihydroxypropyl)-5-[ N -(2,3-dihydroxypropyl)-acetamido]-2,4,6- triiodoisophthalamide with a molecular weight of 821.14 (iodine content 46.36%). Iohexol has the following structural formula: OMNIPAQUE injection is available in five strengths: OMNIPAQUE 140 mg iodine/mL (302 mg of iohexol/mL): Each mL contains 140 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE 180 mg iodine/mL (388 mg of iohexol/mL): Each mL contains 180 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE 240 mg iodine/mL (518 mg of iohexol/mL): Each mL contains 240 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE 300 mg iodine/mL (647 mg of iohexol/mL): Each mL contains 300 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE 350 mg iodine/mL (755 mg of iohexol/mL): Each mL contains 350 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE oral solution is available in two strengths: OMNIPAQUE oral solution 9 mg iodine/mL (19 mg of iohexol/mL): Each mL contains 9 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium OMNIPAQUE oral solution 12 mg iodine/mL (26 mg of iohexol/mL): Each mL contains 12 mg organically bound iodine, 1.21 mg tromethamine and 0.1 mg edetate calcium disodium The pH is adjusted between 6.8 and 7.7 with hydrochloric acid or sodium hydroxide. OMNIPAQUE injection and OMNIPAQUE oral solution are sterilized by autoclaving and contain no preservatives. Chemical Structure 11.2 Physical Characteristics OMNIPAQUE injection and OMNIPAQUE oral solution have the following physical properties: Presentation Concentration (mg iodine/mL) Osmolality By vapor-pressure osmometry. (mOsmol/kg water) Absolute Viscosity (cP) Specific Gravity 20°C 37°C 37°C OMNIPAQUE 140 140 322 2.3 1.5 1.164 OMNIPAQUE 180 180 408 3.1 2.0 1.209 OMNIPAQUE 240 240 520 5.8 3.4 1.280 OMNIPAQUE 300 300 672 11.8 6.3 1.349 OMNIPAQUE 350 350 844 20.4 10.4 1.406 OMNIPAQUE oral solution 9 9 38 1.1 0.8 1.011 OMNIPAQUE oral solution 12 12 45 1.1 0.8 1.014 OMNIPAQUE 140, OMNIPAQUE 180, OMNIPAQUE 240, OMNIPAQUE 300, and OMNIPAQUE 350 have osmolalities from approximately 1.1 to 3.0 times that of plasma (285 mOsmol/kg water) or cerebrospinal fluid (301 mOsmol/kg water) as shown in the above table and are hypertonic under conditions of use. OMNIPAQUE oral solution 9 and OMNIPAQUE oral solution 12 are hypotonic under conditions of use (see table above). DESCRIPTION Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is a sterile aqueous suspension containing 3 mg per milliliter betamethasone, as betamethasone sodium phosphate, and 3 mg per milliliter betamethasone acetate. Inactive ingredients per mL: 7.1 mg dibasic sodium phosphate anhydrous; 3.4 mg monobasic sodium phosphate monohydrate; 0.1 mg edetate disodium; and 0.2 mg benzalkonium chloride as a preservative. The pH is adjusted to between 6.8 and 7.2. The formula for betamethasone sodium phosphate is C 22 H 28 FNa 2 O 8 P and it has a molecular weight of 516.40. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-(disodium phosphate). The formula for betamethasone acetate is C 24 H 31 FO 6 and it has a molecular weight of 434.50. Chemically, it is 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 21-acetate. The chemical structures for betamethasone sodium phosphate and betamethasone acetate are as follows: Betamethasone sodium phosphate is a white to practically white, odorless powder, and is hygroscopic. It is freely soluble in water and in methanol, but is practically insoluble in acetone and in chloroform. Betamethasone acetate is a white to creamy white, odorless powder that sinters and resolidifies at about 165ºC, and remelts at about 200ºC to 220ºC with decomposition. It is practically insoluble in water, but freely soluble in acetone, and is soluble in alcohol and in chloroform. image description image description DESCRIPTION Lidocaine hydrochloride injection, USP is sterile, nonpyrogenic, aqueous solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Lidocaine hydrochloride injection, USP contains lidocaine hydrochloride, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular weight 270.8. Lidocaine hydrochloride (C 14 H 22 N 2 O • HCl) has the following structural formula: Lidocaine hydrochloride injection, USP is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. The pH of the solution is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Lidocaine Hydrochloride Chemical Structure

OMNIPAQUE (iohexol) injection is a radiographic contrast agent indicated for intrathecal, intravascular, oral, rectal, intraarticular and body cavity use. OMNIPAQUE oral solution is indicated for oral use only in conjunction with OMNIPAQUE injection administered intravenously for computed tomography (CT) of the abdomen ( 1 ). 1.1 Intrathecal Administration Adults OMNIPAQUE 180, 240, and 300 Myelography (lumbar, thoracic, cervical, total columnar) Computerized Tomography (CT) (myelography, cisternography, ventriculography) Pediatrics OMNIPAQUE 180 Myelography (lumbar, thoracic, cervical, total columnar) CT (myelography, cisternography) 1.2 Intravascular Administration Adults OMNIPAQUE 140 Intra-arterial digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels OMNIPAQUE 240 CT head imaging Peripheral venography (phlebography) OMNIPAQUE 300 Aortography including studies of the aortic arch, abdominal aorta and its branches CT head and body imaging Cerebral arteriography Peripheral venography (phlebography) Peripheral arteriography Excretory urography OMNIPAQUE 350 Angiocardiography (ventriculography, selective coronary arteriography) Aortography including studies of the aortic root, aortic arch, ascending aorta, abdominal aorta and its branches CT head and body imaging Intravenous digital subtraction angiography of the head, neck, abdominal, renal and peripheral vessels Peripheral arteriography Excretory urography Pediatrics OMNIPAQUE 240 CT head and body imaging OMNIPAQUE 300 Angiocardiography (ventriculography) Excretory urography CT head and body imaging OMNIPAQUE 350 Angiocardiography (ventriculography, pulmonary arteriography, venography, and studies of the collateral arteries) Aortography including the aortic root, aortic arch, ascending and descending aorta 1.3 Oral or Rectal Administration Adults OMNIPAQUE 350 Oral radiographic examination of the gastrointestinal tract Pediatrics OMNIPAQUE 180, 240 and 300 Oral and rectal radiographic examination of the gastrointestinal tract 1.4 Oral Administration in Conjunction with Intravenous Administration Diluted OMNIPAQUE Injection Adults OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 300 administered intravenously CT of the abdomen Pediatrics OMNIPAQUE 240, 300 and 350 diluted and administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously CT of the abdomen OMNIPAQUE Oral Solution Adults OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 300 administered intravenously CT of the abdomen Pediatrics OMNIPAQUE oral solution 9 and 12 administered orally in conjunction with OMNIPAQUE 240 or OMNIPAQUE 300 administered intravenously CT of the abdomen 1.5 Intraarticular Administration Adults OMNIPAQUE 240, 300, and 350 Arthrography 1.6 Body Cavity Administration Adults OMNIPAQUE 240 Endoscopic retrograde pancreatography (ERP) and cholangiopancreatography (ERCP) Herniography Hysterosalpingography OMNIPAQUE 300 Hysterosalpingography Pediatrics OMNIPAQUE 240, 300 and 350 diluted Voiding cystourethrography (VCU) INDICATIONS AND USAGE When oral therapy is not feasible, the intramuscular use of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as follows: Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic Diseases Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine Disorders Congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Hydrocortisone or cortisone is the drug of choice in primary or secondary adrenocortical insufficiency. Synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance. Gastrointestinal Diseases To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis. Hematologic Disorders Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia. Miscellaneous Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy. Neoplastic Diseases For palliative management of leukemias and lymphomas. Nervous System Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor or craniotomy. Ophthalmic Diseases Sympathetic ophthalmia, temporal arteritis, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal Diseases To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus. Respiratory Diseases Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus. The intra-articular or soft tissue administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis. The intralesional administration of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may also be useful in cystic tumors of an aponeurosis or tendon (ganglia). INDICATIONS AND USAGE Lidocaine hydrochloride injection is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. For use as an first aid antiseptic pre-operative skin preperation Uses For first aid to decrease germs in minor cuts scrapes burns For preparation of the skin prior to injection

The concentration and volume required will depend on the indication, size and condition of the patient, and the equipment and imaging technique used. For CT of the head and body, OMNIPAQUE may be used with an automated contrast injection system or contrast media management system cleared for use with OMNIPAQUE. See full prescribing information for complete dosing information ( 2 ). 2.1 Important Dosage and Administration Instructions OMNIPAQUE 140, 180, 240, 300 and 350 are indicated for intravascular, oral, rectal, intraarticular, and body cavity administration. OMNIPAQUE 180, 240, and 300 are indicated for intrathecal administration [see Boxed Warning , Contraindications (4) , and Warnings and Precautions (5.1) ]. Use sterile technique for all handling and administration of OMNIPAQUE for intravascular, intrathecal, intraarticular, and body cavity administration. OMNIPAQUE oral solution 9 and 12 are indicated for oral use only [see Contraindications (4) and Warnings and Precautions (5.2) ]. Do not use if tamper-evident ring is broken or missing. OMNIPAQUE injection may be administered at either body (37°C, 98.6°F) or room temperature (20° to 25°C, 68° to 77°F). Inspect OMNIPAQUE injection for particulate matter or discoloration before administration, whenever solution and container permit. Do not administer if OMNIPAQUE injection contains particulate matter or is discolored. Do not mix OMNIPAQUE injection with, or inject in intravenous lines containing, other drugs or total nutritional admixtures. Use the lowest dose necessary to obtain adequate visualization. Individualize the volume, strength, and rate of administration of OMNIPAQUE injection. Consider factors such as age, body weight, vessel size, blood flow rate within the vessel, anticipated pathology, degree and extent of opacification required, structures or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. Avoid extravasation when administering OMNIPAQUE injection intravascularly, especially in patients with severe arterial or venous disease [see Warnings and Precautions (5.6) ] . Hydrate patients before and after intravascular administration of OMNIPAQUE injection [see Warnings and Precautions (5.4) ]. Each bottle of OMNIPAQUE injection and oral solution is intended for one procedure only. Discard any unused portion. 2.2 Intrathecal Dosage and Administration Rate of injection: Injection should be made slowly over 1 to 2 minutes Repeat procedures: If sequential or repeat examinations are required, a suitable interval of time between administrations should be observed to allow for normal clearance of the drug from the body; at least 48 hours should be allowed before repeat examination; however, whenever possible, 5 days to 7 days is recommended. If computerized tomographic (CT) myelography follows myelography, delay imaging several hours to allow the degree of contrast to decrease. TABLE 1 - INTRATHECAL ADULTS The usual recommended total doses for use in lumbar, thoracic, cervical, and total columnar myelography in adults are 1,200 mg iodine to 3,100 mg iodine (see below). STUDY TYPE INJECTION TYPE CONCENTRATION (mg iodine/mL) VOLUME (mL) * A total dose of 3,100 mg iodine or a concentration of 300 mg iodine/mL should not be exceeded in adults. LUMBAR MYELOGRAPHY LUMBAR OMNIPAQUE 180 OMNIPAQUE 240 10 to 17 7 to 12.5 THORACIC MYELOGRAPHY LUMBAR CERVICAL OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10 CERVICAL MYELOGRAPHY LUMBAR OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10 CERVICAL MYELOGRAPHY C1-2 OMNIPAQUE 180 OMNIPAQUE 240 OMNIPAQUE 300 7 to 10 6 to 12.5 4 to 10 TOTAL COLUMNAR MYELOGRAPHY LUMBAR OMNIPAQUE 240 OMNIPAQUE 300 6 to 12.5 6 to 10 TABLE 2 – INTRATHECAL PEDIATRICS The usual recommended total doses for lumbar, thoracic, cervical, and/or total columnar myelography by lumbar puncture in children are 360 mg iodine to 2700 mg iodine (see below). Actual volumes administered depend largely on patient age and the following guidelines are recommended. AGE STUDY TYPE INJECTION TYPE CONCENTRATION (mg iodine/mL) VOLUME (mL) *A total dose of 2,700 mg iodine or a concentration of 180 mg iodine/mL should not be exceeded in a single myelographic examination in pediatrics. 0 up to 3 mos. LUMBAR, THORACIC, CERVICAL AND/OR TOTAL COLUMNAR MYELOGRAPHY LUMBAR PUNCTURE OMNIPAQUE 180 2 to 4 3 up to 36 mos. OMNIPAQUE 180 4 to 8 3 up to 7 yrs. OMNIPAQUE 180 5 to 10 7 up to 13 yrs. OMNIPAQUE 180 5 to 12 13 to 18 yrs. OMNIPAQUE 180 6 to 15 2.3 Intravascular Dosage and Administration Intra-arterial Procedures TABLE 3 ANGIOCARDIOGRAPHIC PROCEDURES PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 350 VENTRICULOGRAPHY The recommended single dose is 40 mL (Range of 30 mL to 60 mL) May be combined with selective coronary arteriography SELECTIVE CORONARY ARTERIOGRAPHY The recommended single dose is 5 mL (Range of 3 mL to 14 mL) Doses may be repeated as necessary. Maximum volume with multiple injections should not exceed 250 mL. Pediatrics OMNIPAQUE 300 VENTRICULOGRAPHY The recommended single dose is 1.75 mL/kg (Range of 1.5 mL/kg to 2 mL/kg) May be repeated as necessary Maximum dose with multiple injections should not exceed 6 mL/kg up to a total volume of 291 mL. OMNIPAQUE 350 VENTRICULOGRAPHY Recommended single dose is 1.25 mL/kg (Range of 1 mL/kg to 1.5 mL/kg). May be repeated as necessary Maximum dose with multiple injections should not exceed 5 mL/kg up to a total volume of 250 mL. PULMONARY ANGIOGRAPHY (PULMONARY ARTERIOGRAPHY AND/OR PULMONARY VENOGRAPHY) The recommended single dose is 1 mL/kg. TABLE 4 AORTOGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 300 and 350 AORTOGRAPHY AND SELECTIVE VISCERAL ARTERIOGRAPHY The recommended single dose is: 50 mL to 80 mL for the aorta (aortic arch, ascending aorta) 30 mL to 60 mL for abdominal aorta and its branches (celiac, mesenteric, hepatic and splenic arteries) 5 mL to 15 mL for renal arteries Injections may be repeated if indicated, but the total volume should not exceed: 290 mL of OMNIPAQUE 300 250 mL of OMNIPAQUE 350 OMNIPAQUE 350 AORTIC ROOT AND ARCH STUDY WHEN USED ALONE The recommended single dose is 50 mL (Range of 20 mL to 75 mL) Pediatrics OMNIPAQUE 350 AORTOGRAPHY (AORTIC ROOT, AORTIC ARCH, AND DESCENDING AORTA) The recommended single dose is 1 mL/kg. May be repeated as necessary Maximum dose should not exceed 5 mL/kg up to a total volume of 250 mL. TABLE 5 CEREBRAL ARTERIOGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 300 Single dose for cerebral arteriography is as follows: Common carotid artery (6 mL to 12 mL) Internal carotid artery (8 mL to 10 mL) External carotid artery (6 mL to 9 mL) Vertebral artery (6 mL to 10 mL) TABLE 6 INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY HEAD, NECK, ABDOMINAL, RENAL AND PERIPHERAL VESSELS PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Mechanical or hand injection can be used to administer one or more bolus intra-arterial injections of OMNIPAQUE 140. Adults OMNIPAQUE 140 ARTERIES VOLUME/INJECTION (mL) RATE OF INJECTION (mL/sec) Aorta 20 to 45 8 to 20 Carotid 5 to 10 3 to 6 Femoral 9 to 20 3 to 6 Vertebral 4 to 10 2 to 8 Renal 6 to 12 3 to 6 Other branches of aorta (includes subclavian, axillary, innominate and iliac) 8 to 25 3 to 10 TABLE 7 PERIPHERAL ARTERIOGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 300 and 350 The recommended dose for use in peripheral angiography is as follows: Aortofemoral runoffs: 30 mL to 90 mL of OMNIPAQUE 300 20 mL to 70 mL of OMNIPAQUE 350 Selective arteriograms: 10 mL to 60 mL of OMNIPAQUE 300 10 mL to 30 mL of OMNIPAQUE 350 Intravenous Procedures TABLE 8 PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY) PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 240 and 300 The recommended dose (per leg) is: 20 mL to 150 mL of OMNIPAQUE 240 40 mL to 100 mL of OMNIPAQUE 300 TABLE 9 EXCRETORY UROGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 300 and 350 The recommended dose is: 0.6 mL/kg to 1.2 mL/kg body weight Pediatrics OMNIPAQUE 300 Dose ranging from 0.5 mL/kg to 3 mL/kg of body weight: The usual dose for children is 1 mL/kg to 1.5 mL/kg. The total administered dose should not exceed 3 mL/kg. TABLE 10 DIGITAL SUBTRACTION ANGIOGRAPHY HEAD, NECK, ABDOMINAL, RENAL AND PERIPHERAL VESSELS PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) RATE OF INJECTION (mL/sec) Adults OMNIPAQUE 350 The usual dose for the intravenous digital technique is 30 mL to 50 mL. Frequently three or more doses may be required, up to a total volume not to exceed 250 mL 7.5 mL/second to 30 mL/second using a pressure injector TABLE 11 CT SCANNING OF THE HEAD AND BODY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME OMNIPAQUE may be used with an automated contrast injection system or contrast management system cleared for use with OMNIPAQUE [see Dosage and Administration (2.8)]. See device labeling for device indications, additional information, and instructions for use. (mL) Adults OMNIPAQUE 240, 300 and 350 Head and body imaging by rapid injection CT Imaging – Head: 70 mL to 150 mL of OMNIPAQUE 300 80 mL of OMNIPAQUE 350 CT Imaging – Body: 50 mL to 200 mL of OMNIPAQUE 300 60 mL to 100 mL of OMNIPAQUE 350 Head imaging by infusion CT Imaging – Head: 120 mL to 250 mL of OMNIPAQUE 240 Pediatrics OMNIPAQUE 240 and 300 CT Imaging – Head and Body: 1 mL/kg to 2 mL/kg (with maximum = 3 mL/kg) Maximum single dose = 116 mL 2.4 Oral or Rectal Dosage and Administration Oral and Rectal Administration – Undiluted OMNIPAQUE Injection for Radiographic Examination of the Gastrointestinal (GI) Tract TABLE 12 DOSING FOR RADIOGRAPHIC EXAMINATION OF THE GI TRACT PATIENT POPULATION CONCENTRATION (mg iodine/mL) ORAL VOLUME (mL) RECTAL VOLUME When given rectally, larger volumes may be used. (mL) Adults OMNIPAQUE 350 The recommended dose is 50 mL to 100 mL - Pediatrics OMNIPAQUE 180, 240 and 300 The recommended dose is 5 mL to 100 mL The recommended dose is 5 mL to 100 mL Less than 3 months old OMNIPAQUE 180 5 mL to 30 mL - Three months to 3 years OMNIPAQUE 180, 240 and 300 Up to 60 mL - Four years to 10 years OMNIPAQUE 180, 240 and 300 Up to 80 mL - Greater than 10 years Up to 100 mL - 2.5 Oral Dosage and Administration in Conjunction with Intravenous Administration See Table 16 for concurrent intravenous dosing. Oral Administration of Diluted OMNIPAQUE Injection in Conjunction with Intravenous Administration of OMNIPAQUE Injection for CT of the Abdomen TABLE 13 DOSING OF DILUTED Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure. OMNIPAQUE INJECTION FOR ORAL ADMINISTRATION PATIENT POPULATION ORAL CONCENTRATION (mg iodine/mL) ORAL VOLUME (mL) ADMINISTRATION INSTRUCTIONS Adults OMNIPAQUE 240, 300 and 350 DILUTED to 6 to 12 mg iodine/mL (See Table 14 below) Recommended oral dose is: 500 mL to 1,000 mL Smaller administered volumes can be given if the iodine concentration in final diluted product is increased (See Table 14 below) The oral dosage may be given all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Pediatrics OMNIPAQUE 240, 300 and 350 DILUTED to 9 to 21 mg iodine/mL (See Table 14 below) Recommended oral dose is: 180 mL to 750 mL Do not exceed an oral dose of 5 grams iodine for patients less than 3 years old. Do not exceed an oral dose of 10 grams iodine for patients 3 to 18 years old. Smaller administered volumes can be given if the iodine concentration in final diluted product is increased (See Table 14 below) The oral dosage may be given all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. TABLE 14 PROCEDURE FOR PREPARATION OF DILUTED OMNIPAQUE INJECTION FOR ORAL ADMINISTRATION OMNIPAQUE to be mixed with liquid such as water, carbonated beverage, milk, infant formula, or juice to achieve one liter of oral contrast agent. Final Iodine Concentration of Diluted Contrast Agent (mg iodine/mL) OMNIPAQUE 240 OMNIPAQUE 300 OMNIPAQUE 350 Volume of Contrast Agent (mL) Volume of Liquid (mL) Volume of Contrast Agent (mL) Volume of Liquid (mL) Volume of Contrast Agent (mL) Volume of Liquid (mL) 6 25 975 20 980 17 983 9 38 962 30 970 26 974 12 50 950 40 960 35 965 15 63 937 50 950 43 957 18 75 925 60 940 52 948 21 88 912 70 930 60 940 Oral Administration of OMNIPAQUE Oral Solution in Conjunction with Intravenous Administration of OMNIPAQUE Injection for CT of the Abdomen TABLE 15 DOSING AND ADMINISTRATION OF OMNIPAQUE ORAL SOLUTION PATIENT POPULATION ORAL CONCENTRATION (mg iodine/mL) ORAL VOLUME (mL) ADMINISTRATION INSTRUCTIONS Adults OMNIPAQUE oral solution 9 and 12 The recommended oral dose is: 500 mL to 1,000 mL The oral dosage may be given all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. Pediatrics OMNIPAQUE oral solution 9 and 12 The recommended oral dose is: 180 mL to 750 mL Do not exceed an oral dose of 5 grams iodine for patients less than 3 years old. Do not exceed an oral dose of 10 grams iodine for patients 3 to 18 years old. The oral dosage may be given all at once or over a period of up to 45 minutes if there is difficulty in consuming the required volume. TABLE 16 INTRAVENOUS ADMINISTRATION OF OMNIPAQUE INJECTION FOR CT OF THE ABDOMEN IN CONJUNCTION WITH ORALLY ADMINISTERED DILUTED OMNIPAQUE INJECTION OR OMNIPAQUE ORAL SOLUTION PATIENT POPULATION INTRAVENOUS CONCENTRATION (mg iodine/mL) INTRAVENOUS VOLUME OMNIPAQUE may be used with an automated contrast injection system or contrast management system cleared for use with OMNIPAQUE [see Dosage and Administration (2.8)]. See device labeling for device indications, additional information, and instructions for use. (mL) ADMINISTRATION INSTRUCTIONS Adults OMNIPAQUE 300 The recommended dose is: 100 mL to 150 mL Administer up to 40 minutes AFTER consumption of the oral dose Pediatrics OMNIPAQUE 240 and 300 The recommended dose is: 2 mL/kg with a range of 1 mL/kg to 2 mL/kg (maximum 3 mL/kg) Administer up to 60 minutes AFTER consumption of the oral dose 2.6 Intraarticular Dosage and Administration TABLE 17 ARTHROGRAPHY PATIENT POPULATION LOCATION CONCENTRATION (mg iodine/mL) VOLUME (mL) DOUBLE CONTRAST/SINGLE CONTRAST Adults Knee Passive or active manipulation is used to disperse the medium throughout the joint space. OMNIPAQUE 240 5 to 15 Lower volumes recommended for double-contrast examinations; higher volumes recommended for single-contrast examinations. OMNIPAQUE 300 5 to 15 OMNIPAQUE 350 5 to 10 Adults Shoulder OMNIPAQUE 240 3 OMNIPAQUE 300 10 Adults Temporomandibular OMNIPAQUE 300 0.5 to 1 2.7 Body Cavity Dosage and Administration Body Cavity Administration - Undiluted OMNIPAQUE Injection TABLE 18 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY (ERP) ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ECRP) PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 240 10 mL to 50 mL but may vary depending on individual anatomy and/or disease state. TABLE 19 HYSTEROSALPINGOGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 240 and 300 15 mL to 20 mL but may vary depending on individual anatomy and/or disease state. TABLE 20 HERNIOGRAPHY PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Adults OMNIPAQUE 240 50 mL but may vary depending on individual anatomy and/or disease state. Body Cavity Administration - Diluted OMNIPAQUE Injection TABLE 21 VOIDING CYSTOURETHROGRAPHY (VCU) (CAN BE PERFORMED IN CONJUNCTION WITH EXCRETORY UROGRAPHY) PATIENT POPULATION CONCENTRATION (mg iodine/mL) VOLUME (mL) Pediatrics The concentration may vary depending upon the patient's size and age and with the technique and equipment used. OMNIPAQUE injection may be diluted with Sterile Water for Injection. (See Table 22 below). OMNIPAQUE injection may be diluted, utilizing aseptic technique, with Sterile Water for Injection to a concentration of 50 mg iodine/mL to 100 mg iodine/mL for voiding cystourethrography. Range: 50 mL to 300 mL of DILUTED OMNIPAQUE at a concentration of 100 mg iodine/mL 50 mL to 600 mL of DILUTED OMNIPAQUE at a concentration of 50 mg iodine/mL. TABLE 22 PROCEDURE FOR PREPARATION OF DILUTED Dilutions of OMNIPAQUE should be prepared just prior to use and any unused portion discarded after the procedure. OMNIPAQUE INJECTION FOR VCU Final Iodine Concentration of Diluted Contrast Agent (mg iodine/mL) Volume of OMNIPAQUE 240 (mL) Volume of Sterile Water for Injection (mL) Volume of OMNIPAQUE 300 (mL) Volume of Sterile Water for Injection (mL) Volume of OMNIPAQUE 350 (mL) Volume of Sterile Water for Injection (mL) 100 100 140 100 200 100 250 90 167 233 289 80 200 275 338 70 243 330 400 60 300 400 483 50 380 500 600 2.8 Instructions for Use with an Automated Contrast Injection System or Contrast Management System for CT of the Head and Body OMNIPAQUE may be used with an automated contrast injection system cleared for use with contrast media. See above Important Dosage and Administration Instructions for OMNIPAQUE (2.1) . See device labeling for information on device indications, instructions for use, and techniques to help assure safe use. OMNIPAQUE 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles may be used with a contrast media management system cleared for use with OMNIPAQUE 300 mg iodine/mL and 350 mg iodine/mL in 150 mL bottles. See device labeling for information on device indications, instructions for use, and techniques to help assure safe use. Use sterile technique for penetrating the container closure of OMNIPAQUE 300 and 350 and transferring OMNIPAQUE solution. The container closure may be penetrated only one time with a suitable sterile component of the contrast media management system cleared for use with OMNIPAQUE 300 and 350 in 150 mL bottles. Once the OMNIPAQUE 300 and 350 Injection is punctured, do not remove the bottle from the work area during the entire period of use. Maximum use time is 4 hours after initial puncture. Each bottle is for one procedure only. Discard unused portion. DOSAGE AND ADMINISTRATION Benzyl alcohol as a preservative has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight. Solutions used for further dilution of this product should be preservative-free when used in the neonate, especially the premature infant. The initial dosage of parenterally administered Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may vary from 0.25 to 9 mg per day depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administrations in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages. It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 30 mg of betamethasone for a week followed by 12 mg every other day for 1 month are recommended (see PRECAUTIONS, Neuro-psychiatric section). In pediatric patients, the initial dose of betamethasone may vary depending on the specific disease entity being treated. The range of initial doses is 0.02 to 0.3 mg/kg/day in three or four divided doses (0.6 to 9 mg/m 2 bsa/day). For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids: Cortisone, 25 Triamcinolone, 4 Hydrocortisone, 20 Paramethasone, 2 Prednisolone, 5 Betamethasone, 0.75 Prednisone, 5 Dexamethasone, 0.75 Methylprednisolone, 4 These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. If coadministration of a local anesthetic is desired, Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension may be mixed with 1% or 2% lidocaine hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc., should be avoided, since these compounds may cause flocculation of the steroid. The required dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is first withdrawn from the vial into the syringe. The local anesthetic is then drawn in, and the syringe shaken briefly. Do not inject local anesthetics into the vial of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension. Bursitis, Tenosynovitis, Peritendinitis In acute subdeltoid, subacromial, olecranon, and prepatellar bursitis, one intrabursal injection of 1 mL Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension can relieve pain and restore full range of movement. Several intrabursal injections of corticosteroids are usually required in recurrent acute bursitis and in acute exacerbations of chronic bursitis. Partial relief of pain and some increase in mobility can be expected in both conditions after one or two injections. Chronic bursitis may be treated with reduced dosage once the acute condition is controlled. In tenosynovitis and tendinitis, three or four local injections at intervals of 1 to 2 weeks between injections are given in most cases. Injections should be made into the affected tendon sheaths rather than into the tendons themselves. In ganglions of joint capsules and tendon sheaths, injection of 0.5 mL directly into the ganglion cysts has produced marked reduction in the size of the lesions. Rheumatoid Arthritis and Osteoarthritis Following intra-articular administration of 0.5 to 2 mL of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, relief of pain, soreness, and stiffness may be experienced. Duration of relief varies widely in both diseases. Intra-articular Injection of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is well tolerated in joints and periarticular tissues. There is virtually no pain on injection, and the “secondary flare” that sometimes occurs a few hours after intra-articular injection of corticosteroids has not been reported with Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension. Using sterile technique, a 20- to 24-gauge needle on an empty syringe is inserted into the synovial cavity and a few drops of synovial fluid are withdrawn to confirm that the needle is in the joint. The aspirating syringe is replaced by a syringe containing Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension and injection is then made into the joint. Recommended Doses for Intra-articular Injection Size of Joint Location Dose (mL) Very Large Hip 1 - 2 Large Knee, ankle, shoulder 1 Medium Elbow, wrist 0.5 - 1 Small (metacarpophalangeal, interphalangeal) (sternoclavicular) Hand, chest 0.25 to 0.5 A portion of the administered dose of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is absorbed systemically following intra-articular injection. In patients being treated concomitantly with oral or parenteral corticosteroids, especially those receiving large doses, the systemic absorption of the drug should be considered in determining intra-articular dosage. Dermatologic Conditions In intralesional treatment, 0.2 mL/cm 2 of Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is injected intradermally (not subcutaneously) using a tuberculin syringe with a 25-gauge, 1/2-inch needle. Care should be taken to deposit a uniform depot of medication intradermally. A total of no more than 1 mL at weekly intervals is recommended. Disorders of the Foot A tuberculin syringe with a 25-gauge, 3/4-inch needle is suitable for most injections into the foot. The following doses are recommended at intervals of 3 days to a week. Diagnosis Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension Dose (mL) Bursitis under heloma durum or heloma molle 0.25 to 0.5 under calcaneal spur 0.5 over hallux rigidus or digiti quinti varus 0.5 Tenosynovitis, periostitis of cuboid 0.5 Acute gouty arthritis 0.5 to 1 DOSAGE AND ADMINISTRATION Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of lidocaine hydrochloride injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine hydrochloride injection is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease. The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of lidocaine hydrochloride injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of lidocaine hydrochloride injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine hydrochloride is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected. Epidural Anesthesia For epidural anesthesia the following dosage form of lidocaine hydrochloride injection is recommended: 1% without epinephrine 30 mL single dose vials Although this solution is intended specifically for epidural anesthesia, it may also be used for infiltration and peripheral nerve block, provided it is employed as a single dose unit. This solution contains no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2 to 3 mL of the indicated concentration per dermatome). Caudal and Lumbar Epidural Block As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of lidocaine hydrochloride injection through the catheter should be avoided, and, when feasible, fractional doses should be administered. In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter. Directions Povidone iodine: Tear at notch, remove applicator, use only once. As a first aid antiseptic clean affected area apply 1 to 3 times daily may be covered with a sterile bandage, if bandaged let dry. For preoperative patient skin preparation clean area apply to operative site prior to surgery using the applicator Directions apply to skin as needed discard after single use

OMNIPAQUE 140 and OMNIPAQUE 350 are contraindicated for intrathecal use [ see Warnings and Precautions (5.1) ] OMNIPAQUE oral solution 9 and 12 are contraindicated for parenteral administration [ see Warnings and Precautions (5.2) ] OMNIPAQUE body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy or suspected pregnancy, menstruation or when menstruation is imminent, within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract including the external genitalia, and when reproductive tract neoplasia is known or suspected because of the risk of peritoneal spread of neoplasm. OMNIPAQUE injection 140 and 350 are contraindicated for intrathecal use ( 4 ) OMNIPAQUE oral solution 9 and 12 are contraindicated for parenteral use ( 4 ) OMNIPAQUE body cavity 240 and 300 for hysterosalpingography is contraindicated during pregnancy (or suspected pregnancy), menstruation (or when menstruation is imminent), within 6 months after termination of pregnancy, within 30 days after conization or curettage, when signs of infection are present in any portion of the genital tract, including the external genitalia, and when reproductive tract neoplasia is known or suspected. ( 4 ) CONTRAINDICATIONS Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension is contraindicated in patients who are hypersensitive to any components of this product (see DESCRIPTION ). Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura. CONTRAINDICATIONS Lidocaine hydrochloride is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Risks Associated with Inadvertent Parenteral Administration [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.4) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.5) ] Thromboembolic Events [see Warnings and Precautions (5.6) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.9) ] Severe Cutaneous Adverse Reactions [ see Warnings and Precautions (5.12) ] Most common adverse reactions (incidence ≥ 1.0%) in adult patients after OMNIPAQUE administration. ( 6.1 ) Intrathecal: Headaches, Pain including backache, neckache, stiffness and neuralgia, nausea, vomiting and dizziness Intravascular: Pain, vision abnormalities (including blurred vision and photomas), headache, taste perversion, arrhythmias including premature ventricular contractions (PVCs) and premature atrial contractions (PACs), angina/chest pain, nausea Oral: Diarrhea, nausea, vomiting, abdominal pain, flatulence, headache Body Cavity: Pain, swelling and heat sensation Post-marketing adverse reactions ( 6.2 ): Hypersensitivity and manifestations like rash, pruritus, urticaria, and dyspnea, in addition chest pain, and swelling. To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Intrathecal Administration Adults TABLE 23 ADVERSE REACTIONS – INTRATHECAL ADMINISTRATION In controlled clinical studies involving 1531 patients using OMNIPAQUE the following adverse reactions were reported: System Organ Class Adverse Reaction Incidence Nervous System Headaches 18% Musculoskeletal and Connective Tissue Pain including backache, neckache, stiffness and neuralgia 8% Gastrointestinal System Nausea 6% Vomiting 3% Nervous System Dizziness 2% Other Reactions Feeling of heaviness, hypotension, hypertonia, sensation of heat, sweating, vertigo, loss of appetite, drowsiness, hypertension, photophobia, tinnitus, neuralgia, paresthesia, difficulty in micturition, and neurological changes <0.1% Pediatric Patients TABLE 24 ADVERSE REACTIONS – INTRATHECAL ADMINISTRATION In clinical studies involving 152 patients for pediatric myelography by lumbar puncture, adverse events following the use of OMNIPAQUE 180 were generally similar to those reported in adults. Procedure System Organ Class Adverse Reaction Incidence Myelography by Lumbar Puncture Nervous System Headache 9% Gastrointestinal System Vomiting 6% Musculoskeletal and Connective Tissue Backache 1.3% Other Reactions All were transient and mild with no clinical sequelae. Fever <0.7% Hives Stomachache Visual Hallucination Neurological Changes Intravascular Administration Immediately following intravascular injection of contrast medium, a transient sensation of mild warmth is not unusual. Warmth is less frequent with OMNIPAQUE than with ionic contrast media. Adults In controlled clinical studies involving 1485 patients, the following adverse reactions occurred (Table 25). TABLE 25 ADVERSE REACTIONS – INTRAVASCULAR ADMINISTRATION System Organ Class Adverse Reaction Incidence Cardiovascular System Arrhythmias including PVCs and PACs 2% Hypotension 0.7% Others including cardiac failure, asystole, bradycardia, tachycardia, and vasovagal reaction ≤ 0.3% Nervous System Vertigo (including dizziness and lightheadedness) 0.5% Pain 3% Vision Abnormalities (including blurred vision and photomas) 2% Taste Perversion 1% Other Reactions Anxiety, fever, motor and speech dysfunction, convulsion, paresthesia, somnolence, stiff neck, hemiparesis, syncope, shivering, transient ischemic attack, cerebral infarction, and nystagmus Individual incidence of 0.3% or less Respiratory System Dyspnea, rhinitis, coughing, and laryngitis Individual incidence of 0.2% or less Gastrointestinal System Nausea 2% Vomiting 0.7% Others including diarrhea, dyspepsia, cramp, and dry mouth Individual incidence of less than 0.1%. Skin and Subcutaneous Tissues Urticaria 0.3% Purpura 0.1% Abscess 0.1% Pruritus 0.1% Pediatric Patients In controlled clinical studies involving 391 patients for pediatric angiocardiography, urography, and CT head imaging, adverse reactions following the use of OMNIPAQUE 240, 300, and 350 were generally similar in quality and frequency to those reported in adults (Table 26). TABLE 26 ADVERSE REACTIONS – INTRAVASCULAR ADMINISTRATION System Organ Class Adverse Reaction Incidence Cardiovascular System Ventricular Tachycardia 0.5% 2:1 Heart Block 0.5% Hypertension 0.3% Anemia 0.3% General Disorders and Administration Site Conditions Pain 0.8% Fever 0.5% Nervous System Convulsion 0.3% Taste Abnormality 0.5% Respiratory System Congestion 0.3% Apnea 0.3% Gastrointestinal System Nausea 1% Vomiting 2% Endocrine System Hypoglycemia 0.3% Skin and Subcutaneous Tissue Rash 0.3% Oral Administration for Examination of the Gastrointestinal Tract Adults Nausea, vomiting, and diarrhea have been most frequently reported following orally administered undiluted OMNIPAQUE for radiographic examination of the gastrointestinal tract. In controlled clinical studies involving 54 adult patients for oral radiographic examination of the gastrointestinal tract using undiluted OMNIPAQUE 350 the following adverse reactions were reported (Table 27). TABLE 27 ADVERSE REACTIONS – ORAL ADMINISTRATION OF UNDILUTED OMNIPAQUE 350 System Organ Class Adverse Reaction Incidence Gastrointestinal System Diarrhea 42% Nausea 15% Vomiting 11% Abdominal Pain 7% Flatulence 2% Nervous System Headache 2% Pediatrics Patients (Oral and Rectal Administration) In clinical studies involving 58 pediatric patients, the adverse reactions were found to mostly affect the gastrointestinal system with diarrhea (36%), vomiting (9%), nausea (5%) and abdominal pain (2%). However, fever (5%), hypotension (2%) and urticaria (2%) were also reported. Oral Administration for CT of the Abdomen in Conjunction with Intravenous Administration Adults In a controlled clinical study involving 44 adult patients receiving oral administration of diluted OMNIPAQUE (4-9 mg iodine/mL) in conjunction with intravenously injected OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting. Pediatric Patients In clinical studies involving 69 pediatric patients receiving oral administration of diluted OMNIPAQUE (9-29 mg iodine/mL) in conjunction with intravenously administered OMNIPAQUE 240 and OMNIPAQUE 300 for CT examination of the abdomen, adverse reactions were limited to a single report of vomiting (1.4%). Body Cavity Use Adults Arthrography : In controlled clinical studies involving 285 adult patients for various body cavity examinations using OMNIPAQUE 240, 300 and 350, the most frequent adverse reactions were administration site reactions: pain 26% and swelling 22%, were exclusively reported for arthrography and were generally related to the procedure rather than the contrast medium. Patients also experienced heat (7%). All other adverse reaction occurred at a rate less than or equal to 1%. Pediatric Patients No adverse reactions associated with the use of OMNIPAQUE for VCU procedures were reported in 51 pediatric patients studied. 6.2 Post-marketing Experience The following additional reactions listed by indication have been identified during post-approval use of OMNIPAQUE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General Immune System Disorders: Hypersensitivity reactions, anaphylactic or anaphylactoid reactions, anaphylactic or anaphylactoid shock including life-threatening or fatal anaphylaxis General Disorders and Administration Site Conditions: Pyrexia, chills, pain and discomfort, asthenia, administration site conditions including extravasation Intrathecal Administration Nervous System Disorders: Meningism, aseptic meningitis, seizures or status epilepticus, disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Musculoskeletal and Connective Tissue Disorders: Pain, muscle spasms or spasticity Psychiatric Disorders: Confusional state, agitation, anxiety Eye Disorders: Transient visual impairment including cortical blindness Renal Reactions: Acute kidney injury Intravascular Administration Cardiovascular Disorders: Severe cardiac complications (including cardiac arrest, cardiopulmonary arrest), shock, peripheral vasodilatation, palpitations, vasospasm including spasm of coronary arteries, myocardial infarction, syncope, cyanosis, pallor, flushing, chest pain Hemodynamic Reactions: Vasospasm and thrombophlebitis following intravenous injection Blood and Lymphatic System Disorders: Neutropenia Nervous System Disorders: Disorientation, coma, depressed or loss of consciousness, transient contrast-induced toxic encephalopathy (including amnesia, hallucination, paralysis, paresis, speech disorder, aphasia, dysarthria), restlessness, tremors, hypoesthesia Psychiatric Disorders: Confusional state, agitation Eye Disorders: Eye irritation or itchiness, periorbital edema, ocular or conjunctival hyperemia, lacrimation Renal Reactions: Acute kidney injury, toxic nephropathy (CIN), transient proteinuria, oliguria or anuria, increased serum creatinine Gastrointestinal Disorders: Abdominal pain, pancreatitis aggravated, salivary gland enlargement Endocrine Reactions: Hyperthyroidism, hypothyroidism Respiratory; Thoracic, and Mediastinal Disorders: Respiratory distress, respiratory failure, pulmonary edema, bronchospasm, laryngospasm, throat irritation, throat tightness, laryngeal edema, wheezing, chest discomfort, asthmatic attack Skin and Subcutaneous Tissue Disorders: Contrast media reactions range from mild (e.g., pleomorphic rashes, drug eruption, erythema and skin discoloration, blisters, hyperhidrosis, angioedema, localized areas of edema) to severe: [e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), bullous or exfoliative dermatitis, acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)] Oral Administration Gastrointestinal Disorders: Dysphagia, abdominal pain Body Cavity Administration Gastrointestinal Disorders: Pancreatitis Musculoskeletal and Connective Tissue Disorders: Arthritis (arthrography) Hysterosalpingography : Injection of OMNIPAQUE for hysterosalpingography is associated with immediate, transient pain. Monitor injection pressure and volume instilled to minimize pain and to avoid disruptive distention of the uterus and fallopian tubes. Fluoroscopic monitoring is recommended. Nervous system : Pain (49%), somnolence and fever each with an individual incidence of 3%. Gastrointestinal system : Nausea (3%) ADVERSE REACTIONS (listed alphabetically, under each subsection) Allergic Reactions Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. Dermatologic Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria. Endocrine Decreased carbohydrate and glucose tolerance, development of cushingoid state, glucosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients. Fluid and Electrolyte Disturbances Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention. Gastrointestinal Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis. Metabolic Negative nitrogen balance due to protein catabolism. Musculoskeletal Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intralesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures. Neurologic/Psychiatric Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo. Arachnoiditis, meningitis, paraparesis/paraplegia, and sensory disturbances have occurred after intrathecal administration (see WARNINGS, Neurologic section). Ophthalmic Exophthalmos, glaucoma, increased intraocular pressure, posterior subcapsular cataracts, rare instances of blindness associated with periocular injections, vision blurred. Other Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, malaise, moon face, weight gain. ADVERSE REACTIONS Systemic Adverse experiences following the administration of lidocaine hydrochloride are similar in nature to those observed with other amide local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption or inadvertent intravascular injection, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central Nervous System CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest. The excitatory manifestations may be very brief or may not occur at all, in which case the first manifestation of toxicity may be drowsiness merging into unconsciousness and respiratory arrest. Drowsiness following the administration of lidocaine hydrochloride is usually an early sign of a high blood level of the drug and may occur as a consequence of rapid absorption. Cardiovascular System Cardiovascular manifestations are usually depressant and are characterized by bradycardia, hypotension, and cardiovascular collapse, which may lead to cardiac arrest. Allergic Allergic reactions are characterized by cutaneous lesions, urticaria, edema or anaphylactoid reactions. Allergic reactions may occur as a result of sensitivity to local anesthetic agents. Allergic reactions, including anaphylactic reactions, may occur as a result of sensitivity to lidocaine, but are infrequent. If allergic reactions do occur, they should be managed by conventional means. The detection of sensitivity by skin testing is of doubtful value. There have been no reports of cross sensitivity between lidocaine hydrochloride and procainamide or between lidocaine hydrochloride and quinidine. Neurologic The incidences of adverse reactions associated with the use of local anesthetics may be related to the total dose of local anesthetic administered and are also dependent upon the particular drug used, the route of administration and the physical status of the patient. In a prospective review of 10,440 patients who received lidocaine hydrochloride for spinal anesthesia, the incidences of adverse reactions were reported to be about 3 percent each for positional headaches, hypotension and backache; 2 percent for shivering; and less than 1 percent each for peripheral nerve symptoms, nausea, respiratory inadequacy and double vision. Many of these observations may be related to local anesthetic techniques, with or without a contribution from the local anesthetic. In the practice of caudal or lumbar epidural block, occasional unintentional penetration of the subarachnoid space by the catheter may occur. Subsequent adverse effects may depend partially on the amount of drug administered subdurally. These may include spinal block of varying magnitude (including total spinal block), hypotension secondary to spinal block, loss of bladder and bowel control, and loss of perineal sensation and sexual function. Persistent motor, sensory and/or autonomic (sphincter control) deficit of some lower spinal segments with slow recovery (several months) or incomplete recovery have been reported in rare instances when caudal or lumbar epidural block has been attempted. Backache and headache have also been noted following use of these anesthetic procedures. There have been reported cases of permanent injury to extraocular muscles requiring surgical repair following retrobulbar administration. Hematologic Methemoglobinemia.

7.1 Drug-Drug Interactions Metformin In patients with renal impairment, metformin can cause lactic acidosis. Iodinated contrast agents appear to increase the risk of metformin-induced lactic acidosis, possibly as a result of worsening renal function. Stop metformin at the time of, or prior to, OMNIPAQUE administration in patients with an eGFR between 30 and 60 mL/min/1.73 m 2 ; in patients with a history of hepatic impairment, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure, and reinstitute metformin only after renal function is stable. Radioactive Iodine Administration of iodinated contrast agents may interfere with thyroid uptake of radioactive iodine (I-131 and I-123) and decrease therapeutic and diagnostic efficacy in patients with carcinoma of the thyroid. The decrease in efficacy lasts for 6 to 8 weeks. Beta-adrenergic Blocking Agents The use of beta-adrenergic blocking agents lowers the threshold for and increases the severity of contrast reactions and reduces the responsiveness of treatment of hypersensitivity reactions with epinephrine. Because of the risk of hypersensitivity reactions, use caution when administering OMNIPAQUE to patients taking beta-blockers. Drugs that Lower Seizure Threshold Drugs that lower seizure threshold, especially phenothiazine derivatives including those used for their antihistaminic or antinauseant properties, are not recommended for use with intrathecal administration of OMNIPAQUE. CNS Active Drugs Drugs such as monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, CNS stimulants, psychoactive drugs described as analeptics, major tranquilizers, or antipsychotic drugs. Such medications should be discontinued at least 48 hours before myelography, should not be used for the control of nausea or vomiting during or after myelography, and should not be resumed for at least 24 hours post procedure. In non-elective procedures in patients on these drugs, consider prophylactic use of anticonvulsants. 7.2 Drug-Laboratory Test Interactions Effect on Thyroid Tests If iodine-containing isotopes are to be administered for the diagnosis of thyroid disease, the iodine-binding capacity of thyroid tissue may be reduced for up to 2 weeks after contrast medium administration. Thyroid function tests that do not depend on iodine estimation, e.g., T 3 resin uptake or direct thyroxine assays, are not affected. Drug Interactions Aminoglutethimide Aminoglutethimide may lead to a loss of corticosteroid-induced adrenal suppression. Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (ie, amphotericin B, diuretics), patients should be observed closely for development of hypokalemia. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance. Anticholinesterases Concomitant use of anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. Anticoagulants, Oral Coadministration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required. Antitubercular Drugs Serum concentrations of isoniazid may be decreased. Cholestyramine Cholestyramine may increase the clearance of corticosteroids. Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia. Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Hepatic Enzyme Inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin) Drugs which induce hepatic microsomal drug-metabolizing enzyme activity may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Interactions with Strong CYP3A4 Inhibitors Corticosteroids (including betamethasone) are metabolized by CYP3A4. Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects. Coadministration with other strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, ritonavir, cobicistat-containing products) may lead to increased exposures of corticosteroids and therefore the potential for increased risk of systemic corticosteroid side effects. Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects. Nonsteroidal Anti-inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylates may be increased with concurrent use of corticosteroids. Skin Tests Corticosteroids may suppress reactions to skin tests. Vaccines Patients on prolonged corticosteroid therapy may exhibit a diminished response to toxoids and live or inactivated vaccines due to inhibition of antibody response. Corticosteroids may also potentiate the replication of some organisms contained in live attenuated vaccines. Route administration of vaccines or toxoids should be deferred until corticosteroid therapy is discontinued if possible (see WARNINGS, Infections, Vaccination section). Clinically Significant Drug Interactions The administration of local anesthetic solutions containing epinephrine or norepinephrine to patients receiving monoamine oxidase inhibitors or tricyclic antidepressants may produce severe, prolonged hypertension. Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine. Concurrent use of these agents should generally be avoided. In situations when concurrent therapy is necessary, careful patient monitoring is essential. Concurrent administration of vasopressor drugs (for the treatment of hypotension related to obstetric blocks) and ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.

Purpose: Purpose: First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns. For preparation of the skin prior to surgery. Helps reduce bacteria that can potentially cause skin infections. Purpose Antiseptic

Do not use: As a first aid antiseptic for more than 1 week. In the eyes. Over large areas of the body. Do not use with electrocautery procedures

When using this product do not get into eyes apply over large areas of the body in case of deep or puncture wounds, animal bites or serious burns consult a doctor

Stop Use: If irritation and redness develop If condition persists for more than 72 hours, consult a physician. Stop use and ask a doctor if condition persists or gets worse or lasts for more than 72 hours do not use longer than 1 week unless directed by a doctor

Keep Out Of Reach Of Children Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

16.2 Storage and Handling Protect OMNIPAQUE glass vials and bottles and + PLUS PAK™ polymer bottles from light. Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container. OMNIPAQUE Injection 140, 180, 240, 300 and 350 Store at controlled room temperature, 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. May be stored in a contrast media warmer for up to one month at 36° to 38°C (96.8° to 100.4°F). OMNIPAQUE Oral Solution 9 and 12 Store between 0° and 30°C (32° to 86°F). Other information Protect from freezing and avoid excessive heat