Ifosfamide And Mesna Kit
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ifosfamide injection is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
History
There is currently no drug history available for this drug.
Other Information
Ifosfamide injection, single-dose vials for administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide, USP. The 1 gram vial also contains 69 mg monobasic sodium phosphate monohydrate, USP, 21.3 mg dibasic sodium phosphate anhydrous, USP and water for injection, USP, qs. The 3 gram vial also contains 207 mg monobasic sodium phosphate monohydrate, USP, 63.9 mg dibasic sodium phosphate anhydrous, USP and water for injection, USP, qs. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifosfamide is 3-(2-chloroethyl)- 2-[(2-chloroethyl)amino] tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide. Its structural formula is:
C7H15Cl2N2O2P M.W. 261.1
Sources
Ifosfamide And Mesna Kit Manufacturers
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Teva Parenteral Medicines, Inc
![Ifosfamide And Mesna Kit [Teva Parenteral Medicines, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ifosfamide And Mesna Kit | Teva Parenteral Medicines, Inc
Ifosfamide injection should be administered intravenously at a dose of 1.2 grams per m2 per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.
In order to prevent bladder toxicity, ifosfamide injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. Mesna should be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of ifosfamide injection in patients with hepatic or renal impairment have not been conducted [see Use in Specific Populations (8.6, 8.7)].
Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
5% dextrose injection, USP
0.9% sodium chloride injection, USP
Lactated ringer’s injections, USP
Sterile water for injection, USP
Because essentially identical stability results were obtained for sterile water admixtures as for the other admixtures (5% dextrose injection, 0.9% sodium chloride injection, and lactated ringer’s injection), the use of large volume parenteral glass bottles, viaflex bags or PAB™ bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% dextrose injection, 0.45% sodium chloride injection, or 5% dextrose and 0.9% sodium chloride injection) is also acceptable.
Constituted or constituted and further diluted solutions of ifosfamide injection should be refrigerated and used within 24 hours. Benzyl-alcohol-containing solutions can reduce the stability of ifosfamide.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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