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Review Zinecard Safety Reports submitted to FDA

Total Zinecard reports: 4.
Zinecard FDA safety alerts: No.
   Reported hospitalizations: 3.
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FDA Reported Zinecard Side Effects:
Zinecard Usage.
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Zinecard Side Effects Report #5637696-2
Health Professional from UNITED STATES reported ZINECARD problem on Feb 06, 2008. Male patient, 76 years of age, weighting 238.1 lb, was diagnosed with extravasation and was treated with ZINECARD. After drug was administered, patient experienced the following problems/side effects: arthralgia, aspartate aminotransferase increased, blood creatinine increased, blood glucose increased, blood sodium decreased, blood urea increased, bursitis, catheter site cellulitis, catheter site erythema. ZINECARD dosage: 2000 MG ONCE IV. During the same period patient was treated with TOTECT, ADRIAMYCIN PFS, HEXADROL, ALOXI, CASODEX, NASALIDE, LOPID. Patient was hospitalized. Patient recovered.

Zinecard Side Effects Report #5603795-4
ZINECARD problem was reported by a Health Professional from UNITED STATES on Jan 07, 2008. Male patient, weighting 238.1 lb, was diagnosed with extravasation and was treated with ZINECARD. After drug was administered, patient experienced the following problems/side effects: catheter site erythema, dehydration. ZINECARD dosage: 2000 MG ONCE IV. During the same period patient was treated with TOTECT. Patient was hospitalized. Patient recovered.

Zinecard Side Effects Report #5608647-1
Health Professional from UNITED STATES reported ZINECARD problem on Jan 22, 2008. Male patient, weighting 238.1 lb, was diagnosed with extravasation and was treated with ZINECARD. After drug was administered, patient experienced the following problems/side effects: dehydration. ZINECARD dosage: unknown. During the same period patient was treated with DEXRAZOXANE. Patient was hospitalized. Patient recovered.

Zinecard Side Effects Report #5513888-8
ZINECARD problem was reported by a Pharmacist from UNITED STATES on Nov 09, 2007. Female patient, weighting 169.6 lb, was diagnosed with cardiotoxicity, prophylaxis and was treated with ZINECARD. After drug was administered, patient experienced the following problems/side effects: infusion related reaction, sensation of pressure. ZINECARD dosage: 600MG/M2 EVERY 3 WEEKS IV. During the same period patient was treated with ADRIAMYCIN PFS, CYTOXAN, ALOXI, DECADRON. Patient recovered.


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