CSL New Zealand MonoFIX-VF Human Coagulation Factor IX 500 IU powder for injection (100 IU/mL)

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Laporan Penilaian Awam (PAR)
30-11-2017

Bahan aktif:

Factor IX, Quantity: 500 IU

Boleh didapati daripada:

CSL Behring Australia Pty Ltd

INN (Nama Antarabangsa):

Factor IX

Borang farmaseutikal:

Injection, diluent for

Komposisi:

Excipient Ingredients: water for injections

Laluan pentadbiran:

Intravenous

Unit dalam pakej:

500 IU

Jenis preskripsi:

(S1) This Schedule is intentionally blank

Tanda-tanda terapeutik:

MonoFIX-VF is indicated for the treatment of haemorrhages, for use in surgery, and as prophylaxis in patients with haemophilia B. MonoFIX-VF is not indicated for the treatment of factor II, VII or X deficiencies because it does not contain therapeutic levels of these coagulation factors. MonoFIX-VF is not indicated for the treatment of haemophilia A patients with factor VIII inhibitors.

Ringkasan produk:

Visual Identification: Clear, colourless solution, free from visible particles; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status kebenaran:

Licence status A

Tarikh kebenaran:

2006-05-02