"TBSF" Human Immunoglobulin for Intravenous Use

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

即購入

公開評価報告書 公開評価報告書 (PAR)
30-11-2017

有効成分:

normal immunoglobulin, Quantity: 60 g/L

から入手可能:

CSL Behring Australia Pty Ltd

INN(国際名):

normal immunoglobulin

医薬品形態:

Injection, solution

構図:

Excipient Ingredients: maltose

投与経路:

Intravenous

パッケージ内のユニット:

50mL, 200mL

クラス:

Medicine Listed (Export Only)

処方タイプ:

(S1) This Schedule is intentionally blank

適応症:

TBSF Human Immunoglobulin for Intravenous Use is indicated for replacement IgG therapy in: * primary immunodeficiency (PID) * symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. TBSF Human Immunoglobulin for Intravenous Use is indicated for immunomodulatory therapy in: * Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count * allogeneic bone marrow transplantation * Kawasaki disease * Guillain-Barre Syndrome (GBS).

製品概要:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

認証ステータス:

Listed (Export Only)

承認日:

2006-03-01