Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Ibandronate sodium injection is supplied as a kit containing: a 3 mg/3 mL (1 mg/mL) single-dose prefilled syringe. a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment. 3 mg per 3 mL (1 mg/mL): 3 mL Single-Dose Prefilled Syringes, Packaged in a carton with 1 needle NDC 55150-191-83 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe Label Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL) Sterile. For Intravenous Use Only. Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520 P1433245 Code: TS/DRUGS/13/2010 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe Blister Label Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL)* PHARMACIST: Dispense the enclosed Medication Guide to each patient. Sterile. For Intravenous Use Only. Single-Dose Prefilled Syringe, Discard unused portion. Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL) eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe Blister Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe-Carton Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL)* PHARMACIST: Dispense the enclosed Each Carton Contains: Medication Guide to each patient. 1 Single-Dose Prefilled Syringe, 1 Needle Sterile. For Intravenous Use Only. Discard unused portion. eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe-Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Ibandronate sodium injection is supplied as a kit containing: a 3 mg/3 mL (1 mg/mL) single-dose prefilled syringe. a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment. 3 mg per 3 mL (1 mg/mL): 3 mL Single-Dose Prefilled Syringes, Packaged in a carton with 1 needle NDC 55150-191-83 16.2 Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe Label Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL) Sterile. For Intravenous Use Only. Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520 P1433245 Code: TS/DRUGS/13/2010 PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe Blister Label Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL)* PHARMACIST: Dispense the enclosed Medication Guide to each patient. Sterile. For Intravenous Use Only. Single-Dose Prefilled Syringe, Discard unused portion. Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL) eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe Blister Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg/mL) - Prefilled Syringe-Carton Rx only NDC 55150-191-83 Ibandronate Sodium Injection 3 mg per 3 mL (1 mg/mL)* PHARMACIST: Dispense the enclosed Each Carton Contains: Medication Guide to each patient. 1 Single-Dose Prefilled Syringe, 1 Needle Sterile. For Intravenous Use Only. Discard unused portion. eugia PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 3 mg per 3 mL (1 mg / mL) - Prefilled Syringe-Carton
Overview
Ibandronate sodium is a nitrogen-containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The chemical name for ibandronate sodium is 3-( N -methyl- N -pentyl)amino-1-hydroxypropane-1,1-diphosphonic acid, monosodium salt, monohydrate with the molecular formula C 9 H 22 NO 7 P 2 Na•H 2 O and a molecular weight of 359.24. Ibandronate sodium is a white to almost white powder. It is freely soluble in water and practically insoluble in organic solvents. Ibandronate sodium has the following structural formula: Ibandronate sodium injection is intended for intravenous administration only. Ibandronate sodium injection is available as a sterile, clear, colorless, ready-to-use solution free from visible particles in a prefilled syringe that delivers 3.375 mg of ibandronate monosodium salt monohydrate in 3 mL of solution, equivalent to a dose of 3 mg ibandronate free acid. Inactive ingredients include glacial acetic acid (1.53 mg), sodium acetate trihydrate (0.612 mg), sodium chloride (25.8 mg) and water (q.s. to 3 mL). Glacial acetic acid and sodium acetate trihydrate are used to adjust pH. Ibandronate Sodium Chemical Structure
Indications & Usage
Ibandronate sodium injection is a bisphosphonate indicated for the treatment of osteoporosis in postmenopausal women. (1.1) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.2) 1.1 Treatment of Postmenopausal Osteoporosis Ibandronate sodium injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [ see Clinical Studies (14) ] . 1.2 Important Limitations of Use The safety and effectiveness of ibandronate sodium injection for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture re-evaluated periodically.
Dosage & Administration
3 mg every 3 months administered intravenously over a period of 15 to 30 seconds (2.2) Dosing Instructions: Only administer intravenously by a health care professional. (2.1) Do not mix with calcium-containing solutions or other intravenously administered drugs. (2.1) Do not administer more frequently than once every 3 months. (2.2) Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate 2.1 Important Administration Instructions Ibandronate sodium injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [ see Warnings and Precautions (5.4) ] . Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [ see Warnings and Precautions (5.2) ] . Visually inspect the liquid in the prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration. Administer only with the enclosed needle. Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Prefilled syringes are single-dose only. 2.2 Dosage Information The recommended dose of ibandronate sodium injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months. 2.3 Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose obtain a serum creatinine [ see Warnings and Precautions (5.3) ] . Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of ibandronate sodium injection. 2.4 Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate [ see Warnings and Precautions (5.1) ] . 2.5 Dosing After Missed Dose If the dose is missed, administer as soon as it can be re-scheduled. Thereafter, ibandronate sodium injection should be scheduled every 3 months from the date of the last injection. 2.6 Dosage Modifications in Patients with Renal Impairment Do not administer to patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [ see Warnings and Precautions (5.3) and CLINICAL PHARMACOLOGY (12.3) ] . No dose adjustment is necessary for patients with mild or moderate renal impairment (creatinine clearance greater than or equal to 30 mL/min) [see CLINICAL PHARMACOLOGY (12.3) ] .
Warnings & Precautions
Hypocalcemia can worsen. Correct hypocalcemia prior to use. Adequately supplement patients with calcium and vitamin D (5.1) Anaphylaxis , including fatal events, has been reported. (5.2) Renal Toxicity may be greater in patients with underlying renal impairment. Do not administer ibandronate sodium injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Monitor serum creatinine prior to each dose. (5.3) Tissue Damage with Inappropriate Drug Administration can occur. Do not administer ibandronate sodium injection intra-arterially or paravenously. (5.4) Osteonecrosis of the jaw (ONJ) has been reported. (5.5) Severe Bone, Joint, and/or Muscle Pain may occur, consider discontinuing use if symptoms occur. (5.6) Atypical Fractures Including Femoral Fractures have been reported. Patients with new thigh or groin pain should be evaluated to rule out a femoral fracture. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered. (5.7) 5.1 Hypocalcemia and Mineral Metabolism Ibandronate sodium injection may cause a decrease in serum calcium values. Treat hypocalcemia, hypovitaminosis D, and other disturbances of bone and mineral metabolism before starting ibandronate sodium injection therapy. Adequate intake of calcium and vitamin D is important in all patients. It is recommended that patients receive supplemental calcium and vitamin D if dietary intake is inadequate. 5.2 Anaphylactic Reaction Cases of anaphylaxis, including fatal events, have been reported in patients treated with ibandronate sodium injection. Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment. 5.3 Renal Impairment Treatment with intravenous bisphosphonates has been associated with renal toxicity manifested as deterioration in renal function and acute renal failure. Although no cases of acute renal failure were observed in controlled clinical trials in which intravenous ibandronate was administered as a 15- to 30-second bolus, acute renal failure has been reported postmarketing. Do not administer ibandronate sodium injection to patients with severe renal impairment (creatinine clearance less than 30 mL/min). Obtain serum creatinine prior to each ibandronate sodium injection. After ibandronate sodium injection, assess renal function, as clinically appropriate, in patients with concomitant diseases or taking medications that have the potential for adverse effects on the kidney. Ibandronate sodium injection should be withheld in patients with renal deterioration. 5.4 Tissue Damage Related to Inappropriate Drug Administration Ibandronate sodium injection must only be administered intravenously. Care must be taken not to administer ibandronate sodium injection intra-arterially or paravenously as this could lead to tissue damage. Do not administer ibandronate sodium injection by any other route of administration. The safety and efficacy of ibandronate sodium injection following non-intravenous routes of administration have not been established. 5.5 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including ibandronate sodium injection. Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. Consider a dental examination with appropriate preventive dentistry prior to treatment with bisphosphonates in patients with a history of concomitant risk factors (e.g., cancer, chemotherapy, angiogenesis inhibitors, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy). Concomitant administration of drugs associated with ONJ may increase the risk of developing ONJ. The risk of ONJ may increase with duration of exposure to bisphosphonates. While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. The clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment [ see Adverse Reactions (6.1) ]. 5.6 Musculoskeletal Pain Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking ibandronate and other bisphosphonates [ see Adverse Reactions (6.2) ]. The time to onset of symptoms varied from one day to several months after starting the drug. Most patients had relief of symptoms after stopping the bisphosphonate. A subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. Discontinue ibandronate if severe symptoms develop. 5.7 Atypical Fractures Including Femoral Fractures Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported during treatment with bisphosphonates, including ibandronate sodium in patients with osteoporosis. Atypical femur and other fractures most commonly occur with minimal or no trauma to the affected area. These fractures occurred anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are traverse or short oblique in orientation without evidence of comminution. Atypical fractures of other bones have also been reported. They may be bilateral. These fractures can also occur in osteoporotic patients who have not been treated with bisphosphonates. Concomitant treatment with glucocorticoids may also induce these fractures. Prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs was reported by patients. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Bony pain in other locations should also be considered for evaluation of atypical fracture. Patients presenting with an atypical fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Risk/benefit of continuing bisphosphonate therapy should be re-evaluated in these patients and interruption of bisphosphonate therapy should be considered.
Contraindications
Ibandronate sodium injection is contraindicated in patients with the following conditions: Hypocalcemia [ see Warnings and Precautions (5.1) ] Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported [ see Warnings and Precautions (5.2), Adverse Reactions (6.2) ] Hypocalcemia (4) Hypersensitivity to ibandronate sodium injection (4)
Adverse Reactions
The following clinically significant adverse drug reactions are described elsewhere in the labeling: Hypocalcemia and Mineral Metabolism [ see Warnings and Precautions (5.1) ] Anaphylactic Reaction [ see Warnings and Precautions (5.2) ] Renal Impairment [ see Warnings and Precautions (5.3) ] Tissue Damage Related to Inappropriate Drug Administration [ see Warnings and Precautions (5.4) ] Osteonecrosis of the Jaw [ see Warnings and Precautions (5.5) ] Musculoskeletal Pain [ see Warnings and Precautions (5.6) ] Atypical Fractures Including Femoral Fractures [see Warnings and Precautions (5.7)] The most frequently reported adverse reactions (>5%) are arthralgia, back pain, and abdominal pain. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 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. Quarterly Intravenous Injection – In a 1-year, double-blind, multicenter study comparing ibandronate sodium injection administered intravenously as 3 mg every 3 months to ibandronate 2.5 mg daily oral tablet in women with postmenopausal osteoporosis, the overall safety and tolerability profiles of the two dosing regimens were similar. The incidence of serious adverse reactions was 8% in the ibandronate 2.5 mg daily group and 7.5% in the ibandronate sodium injection 3 mg once every 3 months group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 6.7% in the ibandronate 2.5 mg daily group and 8.5% in the ibandronate sodium injection 3 mg every 3 months group. Table 1 lists the adverse reactions reported in greater than 2% of patients. Table 1 Adverse Reactions With an Incidence of at Least 2% in Patients Treated with Ibandronate Sodium Injection (3 mg once every 3 months) or Ibandronate Daily Oral Tablet (2.5 mg) * Combination of abdominal pain and abdominal pain upper † Combination of influenza-like illness and acute phase reaction ‡ Combination of rash, rash pruritic, rash macular, dermatitis, dermatitis allergic, exanthema, erythema, rash papular, rash generalized, dermatitis medicamentosa, rash erythematous Body System/Adverse Reaction Ibandronate 2.5 mg Daily (Oral) % (n = 465) Ibandronate Sodium Injection 3 mg every 3 months (Intravenous) % (n = 469) Infections and Infestations Influenza 8 5 Nasopharyngitis 6 3 Cystitis 3 2 Gastroenteritis 3 2 Urinary Tract Infection 3 3 Bronchitis 3 2 Upper Respiratory Tract Infection 3 1 Gastrointestinal Disorders Abdominal Pain* 6 5 Dyspepsia 4 4 Nausea 4 2 Constipation 4 3 Diarrhea 2 3 Gastritis 2 2 Musculoskeletal and Connective Tissue Disorders Arthralgia 9 10 Back Pain 8 7 Localized Osteoarthritis 2 2 Pain in Extremity 2 3 Myalgia 1 3 Nervous System Disorders Dizziness 3 2 Headache 3 4 Psychiatric Disorders Insomnia 3 1 Depression 2 1 General Disorders and Administration Site Conditions Influenza-like Illness † 1 5 Fatigue 1 3 Skin and Subcutaneous Tissue Disorders Rash ‡ 3 2 Acute Phase Reaction-like Events Symptoms consistent with acute phase reaction (APR) have been reported with intravenous bisphosphonate use. The overall incidence of patients with APR-like events was higher in the intravenous treatment group (4% in the ibandronate 2.5 mg daily oral tablet group vs. 10% in the ibandronate sodium injection 3 mg once every 3 months group). These incidence rates are based upon reporting of any of 33 potential APR-like symptoms within 3 days of an intravenous dose and lasting 7 days or less. In most cases, no specific treatment was required and the symptoms subsided within 24 to 48 hours. Injection Site Reactions Local reactions at the injection site, such as redness or swelling, were observed at a higher incidence in patients treated with ibandronate sodium injection 3 mg every 3 months (1.7%; 8/469) than in patients treated with placebo injections (0.2%; 1/465). In most cases, the reaction was of mild to moderate severity. Daily Oral Tablet - The safety of ibandronate 2.5 mg once daily in the treatment and prevention of postmenopausal osteoporosis was assessed in 3577 patients aged 41 to 82 years. The duration of the trials was 2 to 3 years, with 1134 patients exposed to placebo and 1140 exposed to ibandronate 2.5 mg. Patients with pre-existing gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs, proton pump inhibitors and H 2 antagonists were included in these clinical trials. All patients received 500 mg calcium plus 400 international units vitamin D supplementation daily. The incidence of all-cause mortality was 1% in the placebo group and 1.2% in the ibandronate 2.5 mg daily group. The incidence of serious adverse reactions was 20% in the placebo group and 23% in the ibandronate 2.5 mg daily oral tablet group. The percentage of patients who withdrew from treatment due to adverse reactions was approximately 17% in both the placebo group and the ibandronate 2.5 mg daily oral tablet group. Table 2 lists adverse reactions from the Treatment and Prevention Studies reported in greater than or equal to 2% of patients and in more patients treated with ibandronate 2.5 mg daily oral tablet than patients treated with placebo. Table 2 Adverse Reactions Occurring at an Incidence greater than or equal to 2% and in More Patients Treated with Ibandronate 2.5 mg Daily Oral Tablet than in Patients Treated with Placebo in the Osteoporosis Treatment and Prevention Studies Body System Placebo % (n = 1134) Ibandronate 2.5 mg daily % (n = 1140) Body as a Whole Back Pain 12 14 Pain in Extremity 6 8 Asthenia 2 4 Allergic Reaction 2 3 Digestive System Dyspepsia 10 12 Diarrhea 5 7 Tooth Disorder 2 4 Vomiting 2 3 Gastritis 2 2 Musculoskeletal System Myalgia 5 6 Joint Disorder 3 4 Arthritis 3 3 Nervous System Headache 6 7 Dizziness 3 4 Vertigo 3 3 Respiratory System Upper Respiratory Infection 33 34 Bronchitis 7 10 Pneumonia 4 6 Pharyngitis 2 3 Urogenital System Urinary Tract Infection 4 6 Gastrointestinal Adverse Reactions The incidence of selected gastrointestinal adverse reactions in the placebo and ibandronate 2.5 mg daily groups were: dyspepsia (10% vs. 12%), diarrhea (5% vs. 7%), and abdominal pain (5% vs. 6%). Musculoskeletal Adverse Reactions The incidence of selected musculoskeletal adverse reactions in the placebo and ibandronate 2.5 mg daily groups were: back pain (12% vs. 14%), arthralgia (14% vs. 14%) and myalgia (5% vs. 6%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ibandronate sodium injection or bisphosphonate products. 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. Hypersensitivity : Allergic reactions including anaphylaxis with fatalities, angioedema, asthma exacerbation, bronchospasm, rash, Stevens-Johnson syndrome, erythema multiforme, and dermatitis bullous [ see Contraindications (4) , Warnings and Precautions (5.2) ] . Hypocalcemia : Hypocalcemia [ see Warnings and Precautions (5.1) ]. Renal Toxicity : Acute renal failure [ see Warnings and Precautions (5.3) ]. Osteonecrosis of the Jaw : Osteonecrosis of the jaw and other oro-facial sites, including the external auditory canal [ see Warnings and Precautions (5.5) ]. Musculoskeletal : Bone, joint, or muscle pain, described as severe or incapacitating, have been reported rarely [see Warnings and Precautions (5.6)] ; low-energy femoral shaft and subtrochanteric fractures, and atypical fractures of other bones [see Warnings and Precautions (5.7)] . Eye Inflammation : Iritis and uveitis. In some cases with other bisphosphonates, these events did not resolve until the bisphosphonate was discontinued.
Drug Interactions
7.1 Melphalan/Prednisolone Intravenous ibandronate (6 mg) did not interact with intravenous melphalan (10 mg/m 2 ) or oral prednisolone (60 mg/m 2 ). [ See Clinical Pharmacology (12.3) ] 7.2 Tamoxifen There was no interaction between oral 30 mg tamoxifen and intravenous 2 mg ibandronate. [ see Clinical Pharmacology (12.3) ] 7.3 Bone Imaging Agents Bisphosphonates are known to interfere with the use of bone-imaging agents. Specific studies with ibandronate have not been performed.
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