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Review Abelcet Safety Reports submitted to FDA

Total Abelcet reports: 20.
Abelcet FDA safety alerts: No.
Reported deaths: 7    Reported hospitalizations: 2.
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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 #5656222-5
Consumer or non-health professional from AUSTRIA reported ABELCET problem on Mar 04, 2008. Female patient was diagnosed with pyrexia and was treated with ABELCET. ABELCET dosage: unknown. Patient died on 02/21/2008.

Abelcet Side Effects Report #5599346-3
ABELCET problem was reported by a Consumer or non-health professional from NETHERLANDS on Jan 03, 2008. Male patient, 36 years of age, was diagnosed with pneumococcal sepsis, zygomycosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: adrenal insufficiency, bradycardia, hyperkalaemia, ventricular fibrillation. ABELCET dosage: 375 MG; QD; IV. During the same period patient was treated with VORICONAZOLE, CASPOFUNGIN, VALGANCICLOVIR, FENTANYL, CYCLOSPORINE, INSULIN, FUROSEMIDE. Patient died on 10/19/2007.

Abelcet Side Effects Report #5538435-6
Physician from UNITED STATES reported ABELCET problem on Nov 21, 2007. Female patient was diagnosed with lung disorder and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hyperthermia, hypothermia. ABELCET dosage: unknown. Patient recovered.

Abelcet Side Effects Report #5574103-2
ABELCET problem was reported by a Pharmacist from PORTUGAL on Dec 10, 2007. Female patient was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: breast cancer, malignant neoplasm progression. ABELCET dosage: unknown. Patient died.

Abelcet Side Effects Report #5598460-6
Pharmacist from UNITED STATES reported ABELCET problem on Dec 21, 2006. Male patient, 70 years of age, was diagnosed with upper respiratory fungal infection and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: convulsion. ABELCET dosage: unknown. Patient recovered.

Abelcet Side Effects Report #5505982-2
ABELCET problem was reported by a Consumer or non-health professional from FRANCE on Oct 18, 2007. Male patient, 63 years of age, was diagnosed with aspergillosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, heart rate increased, infusion related reaction, respiratory rate increased. ABELCET dosage: 400 MG;QD;IV. During the same period patient was treated with TAZOCIN, CIPROFLOXACIN, LINEZOLID, AMIODARONE, LANSOPRAZOLE, COMBIVENT, ZOPICLONE. Patient recovered.

Abelcet Side Effects Report #5506232-3
Physician from NETHERLANDS reported ABELCET problem on Oct 22, 2007. Male patient was diagnosed with aspergillosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: hyperkalaemia. ABELCET dosage: unknown. Patient died.

Abelcet Side Effects Report #5506233-5
ABELCET problem was reported by a Pharmacist from IRELAND on Oct 19, 2007. Male patient, 63 years of age, was diagnosed with candidiasis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: chills, hypertension, hyperventilation, tachycardia. ABELCET dosage: 400 MG;QD;IV. During the same period patient was treated with CEFTRIAXONE, FLUCLOXACILLIN, RIFAMPIN, ENOXAPARIN, LANSOPRAZOLE. Patient recovered.

Abelcet Side Effects Report #5518845-3
Pharmacist from IRELAND reported ABELCET problem on Oct 30, 2007. Male patient, 47 years of age, was diagnosed with candidiasis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: infusion related reaction. ABELCET dosage: 400 MG;QD; IV. During the same period patient was treated with ENOXAPARIN, LANSOPRAZOLE, GENTAMICIN, LINEZOLID. Patient was hospitalized. Patient recovered.

Abelcet Side Effects Report #5485453-2
ABELCET problem was reported by a Pharmacist from UNITED STATES on Sept 27, 2007. Male patient, 63 years of age, was diagnosed with candidiasis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: chills, hypertension, hyperventilation, tachycardia. ABELCET dosage: 400 MG; QD; IV. During the same period patient was treated with CEFTRIAXONE, FLUCLOXACILLIN, RIFAMPIN, ENOXAPARIN, LANSOPRAZOLE. Patient recovered.

Abelcet Side Effects Report #5485455-6
Health Professional from UNITED STATES reported ABELCET problem on Oct 02, 2007. Male patient, 63 years of age, was diagnosed with aspergillosis and was treated with ABELCET. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, heart rate increased, infusion related reaction, respiratory rate increased. ABELCET dosage: 400 MG; QD; IV. During the same period patient was treated with TAZOCIN, CIPROFLOXACIN, LINEZOLID, AMIODARONE, LANSOPRAZOLE, COMBIVENT, ZOPICLONE. Patient recovered.

Abelcet Side Effects Report #5452064-4
ABELCET problem was reported by a Pharmacist from UNITED STATES 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
Pharmacist from UNITED STATES reported ABELCET problem 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
ABELCET problem was reported by a Physician from UNITED STATES 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
Physician from UNITED STATES reported ABELCET problem 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.

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 #5390883-3
Pharmacist from UNITED STATES reported ABELCET problem 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
ABELCET problem was reported by a Pharmacist from UNITED STATES 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 #5390883-3
Pharmacist from UNITED STATES reported ABELCET problem 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
ABELCET problem was reported by a Pharmacist from UNITED STATES 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.


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adrenal insufficiency, bradycardia, hyperkalaemia, ventricular fibrillation, hyperthermia, hypothermia, , was diagnosed with pyrexia and was diagnosed with pneumococcal sepsis, zygomycosis and was diagnosed with lung disorder and