Refacto and catheter related complication Patient Reports February 12, 2012

Refacto Side Effects Report #4602136-9
Refacto side effect was reported by a Health Professional from on Mar 25, 2004. Male patient, 41 years of age, weighting 218.3 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: catheter related complication, dyspnoea, pyrexia, tachycardia. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5093387-0
Refacto side effect was reported by a Consumer or non-health professional from FINLAND on Aug 15, 2006. Male patient, 13 years of age, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: catheter related complication, coagulation factor viii level decreased, factor viii inhibition, muscle haemorrhage. Refacto dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Refacto Side Effects Report #5097126-9
Refacto side effect was reported by a Consumer or non-health professional from FINLAND on Aug 15, 2006. Male patient, 13 years of age, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: catheter related complication, factor viii inhibition, muscle haemorrhage. Refacto dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.

Refacto Side Effects Report #5801371-1
Refacto side effect was reported by a Physician from GERMANY on June 27, 2008. Male patient, weighting 27.56 lb, was diagnosed with factor viii deficiency, anti factor viii antibody positive and was treated with Refacto. After drug was administered, patient experienced the following side effects: anti factor viii antibody positive, catheter related complication, haemorrhage. Refacto dosage: unknown. During the same period patient was treated with NOVOSEVEN. Patient was hospitalized. Patient recovered.


Refacto Side Effects Report #5826849-6
Refacto side effect was reported by a Physician from GERMANY on July 18, 2008. Male patient, weighting 27.56 lb, was diagnosed with factor viii deficiency, anti factor viii antibody positive and was treated with Refacto. After drug was administered, patient experienced the following side effects: anti factor viii antibody positive, catheter related complication, haemorrhage. Refacto dosage: unknown. During the same period patient was treated with NOVOSEVEN. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5889139-1
Refacto side effect was reported by a Physician from GERMANY on Sept 16, 2008. Male patient, weighting 27.56 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: anti factor viii antibody positive, catheter related complication, haemorrhage. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5900374-6
Refacto side effect was reported by a Physician from GERMANY on Sept 16, 2008. Male patient, weighting 27.56 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: anti factor viii antibody positive, catheter related complication, haemorrhage. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.