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 USA Inc

INN（国际名称）:

HUMAN IMMUNOGLOBULIN G

组成:

HUMAN IMMUNOGLOBULIN G 100 mg in 1 mL

给药途径:

Intravenous

疗效迹象:

Octagam 10% is indicated for the treatment of chronic immune thrombocytopenic purpura to rapidly raise platelet counts to control or prevent bleeding in adults. Octagam 10% is indicated for the treatment of dermatomyositis in adults. - Octagam 10% is contraindicated in patients who have a history of severe systemic hypersensitivity reactions, such as anaphylaxis, to human immunoglobulin. - Octagam 10% contains trace amounts of IgA (average 106 µg/mL in a 10% solution). It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity . Risk Summary No human data are available to indicate the presence or absence of drug-associated risk. Animal reproduction studies have not been conducted with Octagam 10%. It is not known whether Octagam 10% can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Immune globulins cross the placenta from maternal circulation increasingly after 30 weeks of gestation. Octagam 10% should be given t

產品總結:

Octagam 10% is supplied in 2 g, 5 g, 10 g, 20 g or 30 g single use bottles. Octagam 10% is not supplied with an infusion set. If a filtered infusion set is used (not mandatory), choose a filter size of 0.2 – 200 microns. Components used in the packaging of Octagam 10% are not made with natural rubber latex. Store Octagam 10% for 36 months at +2°C to + 8°C (36°F to 46°F) from the date of manufacture. Within this shelf-life, the product may be stored up to 9 months at ≤ +25°C (77°F). After storage at ≤ +25°C (77°F) the product must be used or discarded. Do not use after expiration date. Do not freeze. Do not use frozen product. Dispose of any unused product or waste material in accordance with local requirements.

授权状态:

Biologic Licensing Application

产品特点

OCTAGAM IMMUNE GLOBULIN (HUMAN)- IMMUNE GLOBULIN SOLUTION
OCTAPHARMA USA INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OCTAGAM 10% SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OCTAGAM 10%.
OCTAGAM 10% [IMMUNE GLOBULIN INTRAVENOUS (HUMAN)]
LIQUID SOLUTION FOR INTRAVENOUS ADMINISTRATION
INITIAL U.S. APPROVAL: 2014
WARNING: THROMBOSIS, RENAL DYSFUNCTION AND ACUTE RENAL FAILURE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
• THROMBOSIS MAY OCCUR WITH IMMUNE GLOBULIN INTRAVENOUS (IGIV)
PRODUCTS, INCLUDING
OCTAGAM 10%. RISK FACTORS MAY INCLUDE: ADVANCED AGE, PROLONGED
IMMOBILIZATION,
HYPERCOAGULABLE CONDITIONS, HISTORY OF VENOUS OR ARTERIAL THROMBOSIS,
USE OF ESTROGENS,
INDWELLING VASCULAR CATHETERS, HYPERVISCOSITY, AND CARDIOVASCULAR RISK
FACTORS.
• RENAL DYSFUNCTION, ACUTE RENAL FAILURE, OSMOTIC NEPHROPATHY, AND
DEATH MAY OCCUR
WITH THE ADMINISTRATION OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN) (IGIV)
PRODUCTS IN
PREDISPOSED PATIENTS. RENAL DYSFUNCTION AND ACUTE RENAL FAILURE OCCUR
MORE COMMONLY
IN PATIENTS RECEIVING IGIV PRODUCTS CONTAINING SUCROSE. OCTAGAM 10%
DOES NOT CONTAIN
SUCROSE.
• FOR PATIENTS AT RISK OF THROMBOSIS, RENAL DYSFUNCTION OR RENAL
FAILURE, ADMINISTER
OCTAGAM 10% AT THE MINIMUM INFUSION RATE PRACTICABLE. ENSURE ADEQUATE
HYDRATION IN
PATIENTS BEFORE ADMINISTRATION. MONITOR FOR SIGNS AND SYMPTOMS OF
THROMBOSIS AND
ASSESS BLOOD VISCOSITY IN PATIENTS AT RISK FOR HYPERVISCOSITY
RECENT MAJOR CHANGES
Indications and Usage ( 1.2 ) 06/2021
Dosage and Administration ( 2.1 ) 06/2021
INDICATIONS AND USAGE
Octagam 10% is an immune globulin intravenous (human) liquid
preparation indicated for the treatment
of:
• Chronic immune thrombocytopenic purpura (ITP) in adults ( 1.1 )
• Dermatomyositis (DM) in adults ( 1.2 ).
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY.
INDICATION
DOSE
INITIAL INFUSION
RATE
MAINTENANCE INFUSION
RATE (IF TOLERATED)
Chronic ITP
2 g/kg divided in equal doses given over 2
cons