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Abelcet Safety Reports submitted to FDA

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Total Abelcet reports: 24.
Abelcet FDA safety alerts: No.
Reported deaths: 8    Reported hospitalizations: 7.
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FDA Reported Abelcet Side Effects: tachycardia, hypertension, pyrexia, therapeutic product contamination, tachypnoea, renal failure acute, tremor, respiratory distress, mucormycosis, hepatic lesion, ventricular extrasystoles.
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Abelcet Side Effects Report #5223525-8
Health Professional from UNITED STATES reported ABELCET problem on Jan 10, 2007. Female patient, 25 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: heart rate increased, pyrexia, respiratory distress, tremor. ABELCET dosage: 400 MG;. Patient recovered.

Abelcet Side Effects Report #5223526-X
ABELCET problem was reported by a Health Professional from UNITED STATES on Jan 10, 2007. Female patient, 38 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, hypothermia, pyrexia, respiratory distress, tremor, wheezing. ABELCET dosage: 270 MG;. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5289164-8
Pharmacist from UNITED STATES reported ABELCET problem on Feb 16, 2006. Male patient, 42 years of age, weighting 194.0 lb, was diagnosed with aspiration tracheal, fungal infection, cytomegalovirus infection and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: renal impairment. ABELCET dosage: 400 MG;QD;IV. During the same period patient was treated with GANCICLOVIR, CRIXIVAN, ATIVAN, NEUMEGA, INSULIN, PROSTAT. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5257164-X
ABELCET problem was reported by a Physician from ITALY on Feb 15, 2007. Male patient, 76 years of age, was diagnosed with bronchopulmonary aspergillosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: anaemia, condition aggravated. ABELCET dosage: 300 MG; QD; IV. During the same period patient was treated with LEVOFLOXACIN, MEROPENEM. Patient recovered.

Abelcet Side Effects Report #5339262-5
Health Professional from UNITED STATES reported ABELCET problem on May 10, 2007. Female patient, 60 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: chills, hypertension, pyrexia, rash, tachycardia. ABELCET dosage: 100 MG;QD;IV. During the same period patient was treated with AMIKACIN, MEROPENEM, NORADRENALINE, PANTOPRAZOLE, OCTREOTIDE ACETATE. Patient recovered.

Abelcet Side Effects Report #5339915-9
ABELCET problem was reported by a Health Professional from UNITED STATES on May 16, 2007. Male patient, 66 years of age, was diagnosed with zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: bacterial sepsis, multi-organ failure. ABELCET dosage: 7.5 MG/KG/QD;IV. During the same period patient was treated with MYCOPHENOLATE MOFETIL, TACROLIMUS, PREDNISONE, EPOGEN. Patient died.

Abelcet Side Effects Report #5339916-0
Health Professional from UNITED STATES reported ABELCET problem on May 16, 2007. Female patient, 48 years of age, was diagnosed with zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: acidosis. ABELCET dosage: 7.5 MG/KG;QD;IV. During the same period patient was treated with MYCOPHENOLATE MOFETIL, TACROLIMUS, PREDNISONE, EPOGEN. Patient died.

Abelcet Side Effects Report #5339917-2
ABELCET problem was reported by a Health Professional from UNITED STATES on May 16, 2007. Female patient, 39 years of age, was diagnosed with zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: respiratory failure. ABELCET dosage: 5 MG/KG;IV. During the same period patient was treated with CYCLOSPORINE, PREDNISONE, EPOGEN. Patient died.

Abelcet Side Effects Report #5377862-7
Pharmacist from UNITED STATES reported ABELCET problem on June 14, 2007. Female patient, child .1 years of age, weighting 5.31 lb, was diagnosed with fungal sepsis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: organ failure, renal failure acute, renal impairment, sepsis. ABELCET dosage: unknown. During the same period patient was treated with DOBUTAMINE, DOPAMINE, FUROSEMIDE, ALBUMIN, HYDROCORTISONE, DEXAMETHASONE, FENTANYL. Patient was hospitalized. Patient died on 06/20/2007.

Abelcet Side Effects Report #5052079-4
ABELCET problem was reported by a Consumer or non-health professional from UNITED KINGDOM on June 26, 2006. Male patient, 16 years of age, was diagnosed with mucormycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. ABELCET dosage: unknown. During the same period patient was treated with INSULIN. Patient died.

Abelcet Side Effects Report #5052641-9
Health Professional from UNITED KINGDOM reported ABELCET problem on June 26, 2006. Female patient, 15 years of age, was diagnosed with mucormycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood glucose increased. ABELCET dosage: unknown. During the same period patient was treated with INSULIN. Patient died.

Abelcet Side Effects Report #5092199-1
ABELCET problem was reported by a Physician from UNITED STATES on Aug 18, 2006. Female patient, 59 years of age, was diagnosed with coccidioidomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: catheter related complication, deep vein thrombosis. ABELCET dosage: 5 MG/KG; QD; IV. Patient recovered.

Abelcet Side Effects Report #5110800-0
Pharmacist from UNITED STATES reported ABELCET problem on Sept 11, 2006. Male patient, 36 years of age, weighting 194.0 lb, was diagnosed with meningitis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: extravasation, infusion site erythema, infusion site pain, infusion site swelling. ABELCET dosage: 450 MG; QD; IV. During the same period patient was treated with FLUCONAZOLE. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5123138-2
ABELCET problem was reported by a Pharmacist from UNITED STATES on Sept 25, 2006. Male patient, 36 years of age, weighting 194.0 lb, was diagnosed with meningitis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: catheter related complication, infusion site erythema, infusion site swelling. ABELCET dosage: 450 MG; QD; IV. During the same period patient was treated with FLUCONAZOLE. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5136008-0
Physician from UNITED KINGDOM reported ABELCET problem on Oct 06, 2006. Male patient, 44 years of age, was diagnosed with lung transplant and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: supraventricular tachycardia. ABELCET dosage: 100 MG; INH. Patient recovered.

Abelcet Side Effects Report #5158146-9
ABELCET problem was reported by a Pharmacist from UNITED STATES on Nov 20, 2006. Female patient, 25 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: chills, pyrexia. ABELCET dosage: 400 MG DAILY IV. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5171128-6
Health Professional from UNITED STATES reported ABELCET problem on Dec 06, 2006. Female patient, child 9 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: diarrhoea, renal failure, vomiting. ABELCET dosage: unknown. During the same period patient was treated with AMPHOTERICIN BECTION. Patient recovered.

Abelcet Side Effects Report #5390883-3
ABELCET problem was reported by a Pharmacist from UNITED STATES on July 09, 2007. Male patient, 24 years of age, was diagnosed with meningitis cryptococcal and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hypertension, tachycardia, tachypnoea, therapeutic product contamination. ABELCET dosage: 475 MG;X1;IV. Patient recovered.

Abelcet Side Effects Report #5390884-5
Pharmacist from UNITED STATES reported ABELCET problem on July 09, 2007. Male patient, 52 years of age, was diagnosed with mucormycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hypertension, renal failure, tachycardia, tachypnoea, therapeutic product contamination, ventricular extrasystoles. ABELCET dosage: unknown. Patient recovered.

Abelcet Side Effects Report #5441488-7
ABELCET problem was reported by a Pharmacist from UNITED STATES on Aug 13, 2007. Female patient, 38 years of age, was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, hypothermia, pyrexia, respiratory distress, respiratory rate increased, tremor, wheezing. ABELCET dosage: 270 MG. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5452064-4
Pharmacist from UNITED STATES reported ABELCET problem on Sept 04, 2007. Male patient, 24 years of age, was diagnosed with meningitis cryptococcal and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hypertension, tachycardia, tachypnoea, therapeutic product contamination. ABELCET dosage: 475 MG; X1; IV. Patient recovered.

Abelcet Side Effects Report #5452079-6
ABELCET problem was reported by a Pharmacist from UNITED STATES on Sept 04, 2007. Male patient, 52 years of age, was diagnosed with mucormycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hypertension, tachycardia, tachypnoea, therapeutic product contamination, ventricular extrasystoles. ABELCET dosage: 375 MG; X1; IV, 480 MG; X1; IV, 96 MG; X1; IV, 500 MG; QD; IV. Patient recovered.

Abelcet Side Effects Report #5453477-7
Physician from UNITED STATES reported ABELCET problem on Sept 06, 2007. Male patient, 63 years of age, was diagnosed with zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: acute graft versus host disease in skin, diarrhoea, disease recurrence, hepatic lesion, large intestinal ulcer, mucormycosis, pleuritic pain, pneumonitis. ABELCET dosage: 5 MG/KG; QD; IV. During the same period patient was treated with FLUCONAZOLE, MYCOPHENOLATE MOFETIL, TACROLIMUS. Patient died.

Abelcet Side Effects Report #5453478-9
ABELCET problem was reported by a Physician from UNITED STATES on Sept 06, 2007. Male patient, 46 years of age, was diagnosed with liver disorder, zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: condition aggravated, enterococcal infection, hepatic lesion, impaired gastric emptying, mucormycosis, multi-organ failure, pathogen resistance, renal failure. ABELCET dosage: 5 MG/KG; QD; IV. During the same period patient was treated with CEFTAZIDIME, FLUCONAZOLE, IMIPENEM, CASPOFUNGIN, POSACONAZOLE. Patient died.

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