Sodium Chloride Injection, USP
Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED The available sizes of each injection in VIAFLEX plastic containers are shown below: Code Size (mL) NDC Product Name 2B1313 500 0338-0043-03 0.45% Sodium Chloride Injection, USP 2B1314 1000 0338-0043-04 2B1300 25 Quad Pack 0338-0049-10 0.9% Sodium Chloride Injection, USP 50 2B1306 Single Pack 0338-0049-41 2B1301 Quad Pack 0338-049-11 2B1308 Multi Pack 0338-0049-31 100 2B1307 Single Pack 0338-0049-48 2B1302 Quad Pack 0338-0049-18 2B1309 Multi Pack 0338-0049-38 2B1321 150 0338-0049-01 2B1322 250 0338-0049-02 2B1323 500 0338-0049-03 2B1324 1000 0338-0049-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.; PRINCIPAL DISPLAY PANEL: LIQUIVIDA HYDRATION KIT NDC 49836-032-05 Rx Only LIQU IV IDA TM HYDRATION KIT Kit Contains: 1 Sodium Chloride , USP 0.9% IV Bag (500mL) 1 Sterile IV Administration Set 1 Sterile IV Start Kit 1 Sterile Safety IV Catheter Jelco † ViaValve † (22 gauge x 1") 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Dose 1 ONE NEEDLE, ONE SYRINGE, ONLY ONE TIME. Safe Injection Practices Coalition www.ONEandONLYcampaign.org Members of One & Only Campaign LIQU IV IDA TM HYDRATION KIT DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-032-05 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Sodium Chloride , USP 0.9% IV Bag (500mL)* (Baxter Healthcare Corp.) Sterile IV Administration Set* (Dynarex) Sterile IV Start Kit* (Covidien TM ) Sterile Safety IV Catheter Jelco † ViaValve † (22 gauge x 1")* (Smiths Medical) Sterile Nitrile Powder-Free Gloves* (Dynarex)- Size 7.5 † All trademarks and registered trademarks noted herein are the property of their respective owners. * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING : KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONALASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE For Single use Only. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 11/2018 This product is not eligible for Medicare or Medicaid reimbursement . LIQUIVIDA HYDRATION KIT LIQUIVIDA HYDRATION KIT
- HOW SUPPLIED The available sizes of each injection in VIAFLEX plastic containers are shown below: Code Size (mL) NDC Product Name 2B1313 500 0338-0043-03 0.45% Sodium Chloride Injection, USP 2B1314 1000 0338-0043-04 2B1300 25 Quad Pack 0338-0049-10 0.9% Sodium Chloride Injection, USP 50 2B1306 Single Pack 0338-0049-41 2B1301 Quad Pack 0338-049-11 2B1308 Multi Pack 0338-0049-31 100 2B1307 Single Pack 0338-0049-48 2B1302 Quad Pack 0338-0049-18 2B1309 Multi Pack 0338-0049-38 2B1321 150 0338-0049-01 2B1322 250 0338-0049-02 2B1323 500 0338-0049-03 2B1324 1000 0338-0049-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.
- PRINCIPAL DISPLAY PANEL: LIQUIVIDA HYDRATION KIT NDC 49836-032-05 Rx Only LIQU IV IDA TM HYDRATION KIT Kit Contains: 1 Sodium Chloride , USP 0.9% IV Bag (500mL) 1 Sterile IV Administration Set 1 Sterile IV Start Kit 1 Sterile Safety IV Catheter Jelco † ViaValve † (22 gauge x 1") 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Dose 1 ONE NEEDLE, ONE SYRINGE, ONLY ONE TIME. Safe Injection Practices Coalition www.ONEandONLYcampaign.org Members of One & Only Campaign LIQU IV IDA TM HYDRATION KIT DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-032-05 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: Sodium Chloride , USP 0.9% IV Bag (500mL)* (Baxter Healthcare Corp.) Sterile IV Administration Set* (Dynarex) Sterile IV Start Kit* (Covidien TM ) Sterile Safety IV Catheter Jelco † ViaValve † (22 gauge x 1")* (Smiths Medical) Sterile Nitrile Powder-Free Gloves* (Dynarex)- Size 7.5 † All trademarks and registered trademarks noted herein are the property of their respective owners. * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING : KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONALASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 15°-30°C (59°-86°F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE For Single use Only. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 11/2018 This product is not eligible for Medicare or Medicaid reimbursement . LIQUIVIDA HYDRATION KIT LIQUIVIDA HYDRATION KIT
Overview
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. The nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity, and ionic concentration are shown below: 0.45% Sodium Chloride Injection, USP contains 4.5 g/L Sodium Chloride, USP (NaCl) and is hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77 mEq/L sodium and 77 mEq/L chloride. 0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride, USP (NaCl) with an osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and 154 mEq/L chloride. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2- ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Indications & Usage
Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures. USE For the preparation of the patient's skin prior to an injection
Dosage & Administration
Important Administration Instructions Sodium Chloride Injection, USP is intended for intravenous administration using sterile equipment. Do not connect flexible plastic containers in series in order to avoid air embolism due to possible residual air contained in the primary container. Set the vent to the closed position on a vented intravenous administration set to prevent air embolism. Use a dedicated line without any connections to avoid air embolism. Do not pressurize intravenous solutions contained in flexible plastic containers to increase flow rates in order to avoid air embolism due to incomplete evacuation of residual air in the container. Prior to infusion, visually inspect the solution for particulate matter and discoloration. The solution should be clear and there should be no precipitates. Do not administer unless solution is clear, and container is undamaged. Do not mix or administer 0.45% Sodium Chloride Injection, USP through the same administration set with whole blood or cellular blood components. Dosing Information The choice of product, dosage, volume, rate, and duration of administration is dependent upon the age, weight and clinical condition of the patient and concomitant therapy, and administration should be determined by a physician experienced in intravenous fluid therapy. Introduction of Additives Additives may be incompatible. Evaluate all additions to the plastic container for compatibility and stability of the resulting preparation. Consult with a pharmacist, if available. If, in the informed judgment of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. After addition, if there is a discoloration and/or the appearance of precipitates, insoluble complexes or crystals, do not use. Do not store solutions containing additives. Discard any unused portion.
Warnings & Precautions
WARNINGS Hypersensitivity Hypersensitivity and infusion reactions, including hypotension, pyrexia, tremor, chills, urticaria, rash,and pruritus have been reported with 0.9% Sodium Chloride Injection, USP and may occur with 0.45% Sodium Chloride Injection, USP. Stop the infusion immediately if signs or symptoms of a hypersensitivity reaction develop, such as tachycardia, chest pain, dyspnea and flushing. Appropriate therapeutic countermeasures must be instituted as clinically indicated. Electrolyte Imbalances Fluid Overload Depending on the volume and rate of infusion, and the patient’s underlying clinical condition, the intravenous administration of Sodium Chloride Injection, USP can cause fluid disturbances such as overhydration/hypervolemia and congested states, including pulmonary congestion and edema. Avoid 0.9% Sodium Chloride Injection, USP in patients with or at risk for fluid and/or solute overloading. If use cannot be avoided, monitor fluid balance, electrolyte concentrations, and acid base balance, as needed and especially during prolonged use. Hyponatremia Sodium Chloride Injection, USP may cause hyponatremia. Hyponatremia can lead to acute hyponatremic encephalopathy characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with brain edema are at particular risk of severe, irreversible and life-threatening brain injury. The risk of hospital-acquired hyponatremia is increased in patients with cardiac or pulmonary failure, and in patients with non-osmotic vasopressin release (including SIADH) treated with high volume of Sodium Chloride Injection, USP. The risk for hyponatremia is increased in pediatric patients, elderly patients, postoperative patients, those with psychogenic polydipsia, and in patients treated with medications that increase the risk of hyponatremia (such as diuretics, certain antiepileptic and psychotropic medications). See DRUG INTERACTIONS . Patients at increased risk for developing complications of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in particular pre-menopausal women), patients with hypoxemia, and patients with underlying central nervous system disease. Avoid Sodium Chloride Injection, USP in patients with or at risk for hyponatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hyponatremia is potentially dangerous with risk of serious neurologic complications. Brain adaptations reducing risk of cerebral edema make the brain vulnerable to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS). To avoid complications, monitor serum sodium and chloride concentrations, fluid status, acid-base balance, and signs of neurologic complications. Hypernatremia Hypernatremia may occur with Sodium Chloride Injection, USP. Conditions that may increase the risk of hypernatremia, fluid overload and edema (central and peripheral), include patients with: primary hyperaldosteronism; secondary hyperaldosteronism associated with, for example, hypertension, congestive heart failure, liver disease (including cirrhosis), renal disease (including renal artery stenosis, nephrosclerosis); and pre-eclampsia. Certain medications, such as corticosteroids or corticotropin, may also increase risk of sodium and fluid retention, see DRUG INTERACTIONS . Avoid Sodium Chloride Injection, USP in patients with, or at risk for, hypernatremia. If use cannot be avoided, monitor serum sodium concentrations. Rapid correction of hypernatremia is potentially dangerous with risk of serious neurologic complications. Excessively rapid correction of hypernatremia is also associated with a risk for serious neurologic complications such as osmotic demyelination syndrome (ODS) with risk of seizures and cerebral edema. WARNINGS For external use only Flammable, keep away from fire or flame Do not use with electrocautery procedures Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction occurs, stop use and seek medical help right away. Do not use on patients allergic to chlorhexidine gluconate or any other ingredients in this product for lumbar puncture or in contact with the meninges on open skin wounds or as a general skin cleanser under occlusive patch When using this product keep out of eyes, ears, mouth and mucous membranes. May causer serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
Post-Marketing Adverse Reactions The following adverse reactions have been identified during post approval use of Sodium Chloride Injection, USP. 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. The following adverse reactions have been reported in the post-marketing experience during use of Sodium Chloride Injection, USP and include the following: General disorders and administration site conditions : Infusion site erythema, injection site streaking, burning sensation, and infusion site urticaria Hypersensitivity reactions : Hypotension, pyrexia, tremor, chills, urticaria, rash, and pruritus. Metabolism and nutrition disorders : Hypernatremia*, hyponatremia, hyperchloremic metabolic acidosis. Nervous System Disorders : Hyponatremic encephalopathy * Adverse reaction of hyponatremia is only related to 0.9% Sodium Chloride Injection, USP If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.
Storage & Handling
OTHER INFORMATION Store between 68-77°F (20-25°C) Avoid freezing and excessive heat above 104°F (40°C) For hospital and professional use only For Questions: Call 1-800-999-6423 M-F (9:00 am - 5:00 pm EST) Professional Disposables International, Inc Orangeburg, NY 10962-1376 USA www.pdihc.com Revised 8/2019
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