Refacto and spontaneous haematoma Patient Reports February 12, 2012

Refacto Side Effects Report #5151902-2
Refacto side effect was reported by a Consumer or non-health professional from FINLAND on Oct 23, 2006. Male patient, child 12 years of age, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: arthralgia, coagulation factor viii level decreased, factor viii inhibition, insomnia, retroperitoneal haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5912557-X
Refacto side effect was reported by a Health Professional from FRANCE on Oct 01, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5914111-2
Refacto side effect was reported by a Health Professional from FRANCE on Oct 01, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5933023-1
Refacto side effect was reported by a Health Professional from FRANCE on Oct 21, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.


Refacto Side Effects Report #5933024-3
Refacto side effect was reported by a Health Professional from FRANCE on Oct 21, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5948806-1
Refacto side effect was reported by a Health Professional from FRANCE on Nov 05, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #5995701-8
Refacto side effect was reported by a Health Professional from FRANCE on Dec 05, 2008. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #6061717-9
Refacto side effect was reported by a Health Professional from FRANCE on Jan 26, 2009. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.

Refacto Side Effects Report #6115590-0
Refacto side effect was reported by a Health Professional from FRANCE on Mar 10, 2009. Male patient, weighting 22.05 lb, was diagnosed with factor viii deficiency and was treated with Refacto. After drug was administered, patient experienced the following side effects: coagulation factor viii level decreased, factor viii inhibition, haemarthrosis, infusion site haematoma, spontaneous haematoma. Refacto dosage: unknown. Patient was hospitalized. Patient recovered.