Rx Item-Zinecard 250Mg Vial By Pfizer Pharma Inj

ZINECARD- dexrazoxane hydrochloride injection, powder, lyophilized, for solution
Pharmacia and Upjohn Company


INDICATIONS AND USAGE
ZINECARD is indicated for reducing the incidence and severity of cardiomyopathy associated with doxorubicin administration in women with metastatic breast cancer who have received a cumulative doxorubicin dose of 300 mg/m2 and who will continue to receive doxorubicin therapy to maintain tumor control. Do not use with the initiation of doxorubicin therapy [see Warnings and Precautions (5.2)].
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dose
Administer ZINECARD Injection via intravenous infusion over 15 minutes. DO NOT ADMINISTER VIA AN INTRAVENOUS PUSH.
The recommended dosage ratio of ZINECARD to doxorubicin is 10:1 (e.g., 500 mg/m2 ZINECARD to 50 mg/m2 doxorubicin). Do not administer doxorubicin before ZINECARD. Administer doxorubicin within 30 minutes after the completion of ZINECARD infusion.
Preparation and Administration
Preparation and Handling of Infusion Solution
Reconstitute ZINECARD with Sterile Water for Injection, USP. Reconstitute with 25 mL for a ZINECARD 250 mg vial and 50 mL for a ZINECARD 500 mg vial to give a concentration of 10 mg/mL. Dilute the reconstituted solution further with Lactated Ringer's Injection, USP to a concentration of 1.3 to 3.0 mg/mL in intravenous infusion bags for intravenous infusion
DOSAGE FORMS AND STRENGTHS
ZINECARD (dexrazoxane for injection) is available in 250 mg or 500 mg single dose vials as sterile, pyrogen-free lyophilizates.
DESCRIPTION
ZINECARD (dexrazoxane for injection), a cardioprotective agent for use in conjunction with doxorubicin, is a sterile, pyrogen-free lyophilizate intended for intravenous administration.
Chemically, dexrazoxane is (S)-4,4′-(1-methyl-1,2-ethanediyl)bis-2,6-piperazinedione.
Mechanism of Action
The mechanism by which ZINECARD exerts its cytoprotective activity is not fully understood. Dexrazoxane is a cyclic derivative of EDTA that penetrates cell membranes. Results of laboratory studies suggest that dexrazoxane is converted intracellularly to a ring-opened chelating agent that interferes with iron-mediated free radical generation thought to be responsible, in part, for anthracycline-induced cardiomyopathy.
HOW SUPPLIED/STORAGE AND HANDLING
ZINECARD (dexrazoxane for injection) is available in the following strengths as sterile, pyrogen-free lyophilizates.
NDC 0013-8717-62
250 mg single dose vial with a red flip-top seal, packaged in single vial packs.
NDC 0013-8727-89
500 mg single dose vial with a blue flip-top seal, packaged in single vial packs.
Store at 25�C (77�F); excursions permitted to 15� to 30�C (59� to 86�F) [see USP Controlled Room Temperature].

RX ITEM-Zinecard 250Mg Vial By Pfizer Ph
NDC 00013-8717-62 UPC/GTIN No.3-00138-71762-8 Mfg.Part No.871762

Zinecard 250Mg Vial By Pfizer Pharma Inj
BRAND: ZINECARD NDC: 00013-8717-62,13871762 UPC: 3-00138-71762-8,300138717628

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