GAMMABULIN Solution for Injection 0.8g/5ml %w/v
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN
Available from:
Baxter Healthcare Limited
Dosage:
0.8g/5ml %w/v
Pharmaceutical form:
Solution for Injection
Authorization date:
1999-08-14
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gammabulin S/D 160 mg/ml Solution for injection, 5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human Normal Immunoglobulin (SC/IMIg).
1 ml solution contains:
human protein 160 mg
(of which at least 90 % are immunoglobulin)
Distribution of IgG subclasses:
Maximum IgA content: 4.8 mg/ml.
1 vial of 5 ml contains 800 mg human protein (of which at least 90 % are immunoglobulin).
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection
The product is a clear or slightly opalescent, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Replacement therapy in patients with primary or secondary immunodeficiency.
o
Congenital agammagloculinaemia and hypogammaglobulinaemia.
o
Common variable immunodeficiency.
o
Severe combined immunodeficiency.
o
IgG subclass deficiencies with or without concomitant IgA deficiency.
o
Specific antibody deficiencies.
Replacement therapy in secondary immunodeficiency disorders such as hypogammaglobulinaemia or low levels if IgG
due to low grade B-cell tumours.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy: human normal immunoglobulin i.m. may prevent serious infection in patients with
immunoglobulin deficiency. The dosage should be adjusted to maintain an approximate level of 2g/I of circulating
IgG.
IgG1 45-75 %
IgG2 20-45 %
IgG3
3-10 %
IgG4
2-8 %
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 16/08/2006_
_CRN 2026744_
_page number: 1_
The usual posology consists of 0.66 ml/kg body weight (100 mg/kg) given every 3 to 4 weeks, with a double dose
given at onset of therapy.
4.2.1 POSOLOGY
The dose and dosage regimen is dependent on the indication.
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