CSL Malaysia Intragam P Normal Immunoglobulin (Human) 6% w/v (60 g/L) Solution for Intravenous Use

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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공공 평가 보고서 공공 평가 보고서 (PAR)
23-11-2017

유효 성분:

normal immunoglobulin, Quantity: 3 g

제공처:

CSL Behring Australia Pty Ltd

INN (International Name):

normal immunoglobulin

약제 형태:

Injection, solution

구성:

Excipient Ingredients: human immunoglobulin A; maltose

관리 경로:

Intravenous Infusion

패키지 단위:

50 mL

처방전 유형:

(S1) This Schedule is intentionally blank

치료 징후:

Intragam P is indicated for replacement IgG therapy in: * primary immunodeficiency (PID); * myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections; * congenital or acquired immune deficiency syndrome with with recurrent infections; * congenital or acquired immune deficiency syndrome with recurrent infections. Intragam P 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).

제품 요약:

Visual Identification: A clear or slightly opalescent and colourless or pale yellow liquid.; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2014-01-08