ALEVIATE human coagulation factor VIII 250IU / von Willebrand Factor 600IU powder for injection vial with diluent vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Prenos Javno poročilo o oceni (PAR)
15-11-2017

Aktivna sestavina:

Factor VIII, Quantity: 250 IU; Von willebrand factor, Quantity: 600 IU

Dostopno od:

CSL Behring Australia Pty Ltd

INN (mednarodno ime):

Factor VIII,Von willebrand factor

Farmacevtska oblika:

Injection, diluent for

Sestava:

Excipient Ingredients:

Pot uporabe:

Intravenous

Enote v paketu:

Glass vial containing 250 IU FVIII, 500 IU vWF supplied with 1 x 5mL diluent vial

Tip zastaranja:

Not scheduled. Not considered by committee

Terapevtske indikacije:

The prophylaxis and treatment of non-surgical and surgical bleeding in patients with von Willebrand disease when desmopressin (DDAVP) treatment is ineffective or contraindicated. The prophylaxis and treatment of non-surgical and surgical bleeding associated with factor VIII deficiency due to haemophilia A.

Povzetek izdelek:

Visual Identification: Clear and colourless; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status dovoljenje:

Licence status A

Datum dovoljenje:

2010-05-21