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Review Kogenate Safety Reports submitted to FDA

Total Kogenate reports: 11.
Kogenate FDA safety alerts: No.
Reported deaths: 1    Reported hospitalizations: 7.
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FDA Reported Kogenate Side Effects: factor viii inhibition, human anti-mouse antibody positive, antibody test positive, impaired healing, haematoma, anti factor viii antibody positive, coagulation factor viii level decreased, pyrexia, white blood cell count increased, c-reactive protein increased, wound haemorrhage.
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Kogenate Side Effects Report #5622727-6
Physician from SWEDEN reported KOGENATE problem on Feb 06, 2008. Male patient, 53 years of age, was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant. KOGENATE dosage: unknown. During the same period patient was treated with ATACAND, CYKLOKAPRON, ZANTAC, IMOVANE. Patient was hospitalized. Patient died on 09/16/2007.

Kogenate Side Effects Report #5578843-0
KOGENATE problem was reported by a Health Professional from UNITED KINGDOM on Nov 30, 2007. Male patient, 40 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haemorrhagic diathesis. KOGENATE dosage: unknown. Patient recovered.

Kogenate Side Effects Report #5592753-4
Health Professional from UNITED KINGDOM reported KOGENATE problem on Nov 30, 2007. Male patient, 40 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haemorrhagic diathesis. KOGENATE dosage: unknown. Patient recovered.

Kogenate Side Effects Report #5603924-2
KOGENATE problem was reported by a Consumer or non-health professional from FRANCE on Jan 15, 2008. Male patient, 57 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haematoma. KOGENATE dosage: unknown. During the same period patient was treated with HELIXATE. Patient was hospitalized. Patient recovered.

Kogenate Side Effects Report #5605544-2
Consumer or non-health professional from FRANCE reported KOGENATE problem on Jan 15, 2008. Male patient, 57 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haematoma. KOGENATE dosage: unknown. During the same period patient was treated with HELIXATE. Patient was hospitalized. Patient recovered.

Kogenate Side Effects Report #5553598-4
KOGENATE problem was reported by a Health Professional from UNITED KINGDOM on Nov 30, 2007. Male patient, 40 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haemorrhagic diathesis. KOGENATE dosage: unknown. Patient recovered.

Kogenate Side Effects Report #5524596-1
Physician from NETHERLANDS reported KOGENATE problem on Nov 13, 2007. Male patient, 50 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: hepatic neoplasm malignant. KOGENATE dosage: unknown. Patient recovered.

Kogenate Side Effects Report #5413028-X
KOGENATE problem was reported by a Physician from GERMANY on June 15, 2007. Male patient, 19 years of age, weighting 160.9 lb, was diagnosed with sinus operation and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haematoma, impaired healing. KOGENATE dosage: unknown. Patient was hospitalized. Patient recovered.

Kogenate Side Effects Report #5442978-3
Physician from GERMANY reported KOGENATE problem on Aug 06, 2007. Male patient, 19 years of age, weighting 160.9 lb, was diagnosed with pilonidal sinus repair and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: factor viii inhibition, haematoma, impaired healing, wound haemorrhage. KOGENATE dosage: unknown. Patient was hospitalized. Patient recovered.

Kogenate Side Effects Report #5408008-4
KOGENATE problem was reported by a Consumer or non-health professional from GERMANY on July 18, 2007. Male patient, child 7 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatitis c antibody positive. KOGENATE dosage: unknown. During the same period patient was treated with KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF. Patient was hospitalized. Patient recovered.

Kogenate Side Effects Report #5408008-4
Consumer or non-health professional from GERMANY reported KOGENATE problem on July 18, 2007. Male patient, child 7 years of age, was diagnosed with factor viii deficiency and was treated with KOGENATE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, hepatitis c antibody positive. KOGENATE dosage: unknown. During the same period patient was treated with KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF, KOGENATE SF. Patient was hospitalized. Patient recovered.


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