Gammaraas

Virus Inactivated/ Virus Filtered
GAMMARAAS - Immune Globulin Intravenous (Human), 5% solution.

Product Name
Generic Name: Immune Globulin Intravenous (Human)
Trade Name: GAMMARAAS

Composition 
Each vial contain:
Active ingredient: Plasma (Immune Globulin Intravenous-Human) 5%.
Excipients: Glycine; Sorbital; Sodium Acetate; Glacial Acetic Acid; Hydrochloric acid; 95% Alcohol.

Description
GAMMARAAS is a sterile solution of intact, unmodified human immunoglobulin G intended for intravenous use. The product is made by Cohn's cold ethanol fractionation from large pools of human plasma with Chinese origin, followed by isolation of immunoglobulin from the fraction II + III, diafiltration and concentration of IgG solution by ultrafiltration, It has been virus inactivated during manufacturing process, and virus filtered by nanofiltration. The manufacture and the testing of the product is in accordance with "Biological Products Regulation, China" (2000 edition), GAMMARAAS 5% solution is stabilized with Sorbitol and contains no preservatives. The purity of IgG exceeds 96% and almost 100% of IgG is monomer. Trace of IgA and IgM are present. The distribution of IgG subclasses is similar to that in normal human plasma. The osmolarity is approximately 300 milliosmoles per liter and pH from 3.8 to 4.4 in the solution

Characters
GAMMARAAS is a colorless or pale yellow and clear or slight opalescent liquid preparation.

Clinical Pharmacology
GAMMARAAS contains a broad spectrum of IgG antibodies against bacterial and viral agents that are capable of both opsonization and neutralization.
The level of IgG peaks immediately after infusion. The half life of IgG is 21-25 days.

Indications

1. Primary and secondary immunodeficiency. 
2. Idiopathic thrombocytopenic purpura (ITP). 
3. Kawasaki syndrome (KS)

Contra indications
GAMMARAAS contraindicated in individuals who have an anaphylactic of severe systemic response to immune globulin intravenous or intramuscular preparation, Individuals with selective IgA deficiencies may have a severe reactions

Adverse Reactions
In general, the incidence of adverse reaction is rare. Symptoms reported included headache, palpitation, nausea, and mild fever. These reactions are .often related to the infusion rate and individual difference. Reactions are often: mild and usually will subside by slowing of the infusion rate or interrupting infusion. The infusion may then be resumed Vital signs should be monitored during infusion. If anaphylactic or severe or severe adverse reactions occur, the infusion should be discontinued immediately

Dosage and Administration
GAMMARAAS should be administered intravenous only. If large doses are administered, several vials may be pooled into an I.V. solution container using aseptic technique. Pooled material must be used within 4 hours of initialing pooling. Dilution with I.V. fluids is not recommended

Filtering is not required, however, use of a 5 to 15 Micron filter will not affect the potency

1. Primary and/or secondary immunodeficiency: Monthly dosage: 100 - 200 mg/kg (body weight) is recommended, may be increased to 300 - 400 mg/ kg (body weight). The dosage may be modulated by monitoring clinical response and serum IgG level
2. Idiopathic thrombocytopenic purpura (ITP): Induction: 400 mg/ kg (body weight)/daily for 5 days, Maintenance: 400 mg/ kg (body weight) as a single infusion, once a week is recommended. The regimen may be determined by monitoring clinical response and platelet count
3. Kawasaki syndrome: when Kawasaki syndrome is diagnosed at the day 5 - 10 of the cause of the disease, 2g/kg (body weight) may be given as a single infusion.

Infusion Rate
For the first infusion of GAMMARAAS the initial rate should be at 0.01 - 0.02 ml/kg per minute for the first 30 minutes. If the patient does not experience any discomfort, then the infusion rate may be increased; however, the rate should not exceed 0,08 ml/kg (body weight) per minute.

Precautions

1. Any vial that has been entered should be used promptly. Partially used vial should be discarded and not saved for future use. Do not use if the solution is turbid or has been frozen. Do not use after the expiration date printed on the label
2. It is recommended that infusion of GAMMARAAS should be given infused via a separate intravenous line, without mixing with other intravenous fluids or medications. If dilution is required, GAMMARAAS may be diluted with 5%Dextrose in water. However, caution should be taken in diabetic patients.
3. GAMMARAAS should be administered intravenously only. The rate of infusion specified in infusion Rate should be closely followed, at least until the physician has had sufficient experience with a given patient

Drug Interactions
Non known. It is recommended that infusion of GAMMARASS should be given by a separate line, by itself, without mixing with other intravenous fluids or medications. If dilution is required.

Storage
GAMMARAAS should be stored at 2 - 8° C, protected from light. Do not freeze

"Harus dengan resep dokter"

GAMMARAAS 5%, Box @ 1 vial/2.5 g/50 ml
Reg, No. : DKI0408500143A1

Manufactured by:
Shanghai RAAS Blood Products Co., ltd
Shanghai - China.

Imported by:
P.T. Doxa Manggalya Utama
Jakarta - Indonesia

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