OCTAGAM IMMUNE GLOBULIN (HUMAN)- immune globulin solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

HUMAN IMMUNOGLOBULIN G (UNII: 66Y330CJHS) (HUMAN IMMUNOGLOBULIN G - UNII:66Y330CJHS)

可用日期:

Octapharma AB

INN（国际名称）:

HUMAN IMMUNOGLOBULIN G

组成:

HUMAN IMMUNOGLOBULIN G 50 mg in 1 mL

给药途径:

Intravenous

疗效迹象:

Octagam is an immune globulin intravenous (human) 5% liquid indicated for treatment of primary humoral immunodeficiency (PI), such as congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome and severe combined immunodeficiencies. Octagam 5% liquid is contraindicated in patients who have acute severe hypersensitivity reactions to human immunoglobulin. Octagam 5% liquid contains trace amounts of IgA (not more than 0.2 mg/ml in a 5% solution). It is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity (See Description [11]). Octagam 5% liquid is contraindicated in patients with acute hypersensitivity reaction to corn. Octagam 5% liquid contains maltose, a disaccharide sugar which is derived from corn. Patients known to have corn allergies should avoid using Octagam 5% liquid. Pregnancy Category C. Animal reproduction studies have not been conducted with Octagam 5% liquid. It is also not known whether O

產品總結:

Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g, 10 g or 25 g single use bottles. Octapharma Pharmazeutika Produktionsges.m.b.H Octapharma AB 67467 – 843 - 01 68209 – 843 - 01 20 ml 1.0 67467 – 843 – 02 68209 – 843 – 02 50 ml 2.5 67467 – 843 – 03 68209 – 843 – 03 100 ml 5.0 67467 – 843 – 04 68209 – 843 – 04 200 ml 10.0 67467 – 843 – 05 500 ml 25.0 Octagam 5% liquid is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), the filter size must be 0.2 – 200 microns. Components used in the packaging of Octagam 5% liquid are latex-free. Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Do not use after expiration date. Do not freeze. Frozen product should not be used. Any unused product or waste material should be disposed of in accordance with local requirements.

授权状态:

Biologic Licensing Application

产品特点

OCTAGAM IMMUNE GLOBULIN (HUMAN)- IMMUNE GLOBULIN SOLUTION
OCTAPHARMA AB
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OCTAGAM, IMMUNE GLOBULIN INTRAVENOUS (HUMAN) 5% LIQUID PREPARATION
INITIAL U.S. APPROVAL: 2004 - THESE
HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OCTAGAM,
IMMUNE GLOBULIN INTRAVENOUS (HUMAN),
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCTAGAM.
INDICATIONS AND USAGE
•Octagam is an immune globulin intravenous (human), 5% liquid,
indicated for treatment of primary humoral
immunodeficiency (PI) (1). (1)
DOSAGE AND ADMINISTRATION
•Intravenous use only (2). (2)
• (2)
INDIC ATIO N DO SE
INITIAL INFUSION RATE MAINTENANCE INFUSION RATE (IF TOLERATED)
PI (2)
300-600mg/kg (2) 0.5mg/kg/min (2)
3.33 mg/kg/min (2)
Every 3-4 weeks (2)
•Ensure that patients with pre-existing renal insufficiency are not
volume depleted; discontinue Octagam 5% liquid if renal
function deteriorates (2.4). (2)
•For patients at risk of renal dysfunction or thrombotic events,
administer Octagam 5% liquid at the minimum infusion rate
practicable (2.4). (2)
DOSAGE FORMS AND STRENGTHS
•Octagam 5% liquid is supplied in 1.0 g, 2.5 g, 5 g , 10 g or 25 g
single use bottles (3, 16) (3)
CONTRAINDICATIONS
•Anaphylactic or severe systemic reactions to human immunoglobulin
(4) (4)
•IgA deficient patients with antibodies against IgA and a history of
hypersensitivity (4) (4)
•Patients with acute hypersensitivity reaction to corn (4) (4)
WARNINGS AND PRECAUTIONS
•IgA deficient patients with antibodies against IgA are at greater
risk of developing severe hypersensitivity and
anaphylactic reactions Epinephrine should be available immediately to
treat any acute severe hypersensitivity reactions.
(5.1) (5)
•Monitor renal function, including blood urea nitrogen and serum
creatinine, and urine output in patients at risk of
developing acute renal failure. (5.2) (5)
•Falsely elevated blood glucose readings may occur during and after
the infusion of Octagam 5% liquid with some
glucometer and test s