Intraglobulin F 50mg/mL
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
24-04-2024
Summary of Product characteristics
(SPC)
24-04-2024
Active ingredient:
HUMAN NORMAL, IMMUNOGLOBULIN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
ATC code:
J06BA02
INN (International Name):
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
Pharmaceutical form:
SOLUTION FOR INFUSION
Composition:
HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml
Prescription type:
POM
Therapeutic area:
IMMUNE SERA AND IMMUNOGLOBULINS
Authorization status:
Withdrawn
Authorization date:
2005-10-04
Patient Information leaflet
Intraglobin F / Package insert
1/7
PACKAGE INSERT
INTRAGLOBIN
®
F
50 mg/ml; solution for infusion
ACTIVE SUBSTANCE
Human normal immunoglobulin for intravenous administration
COMPOSITION
1 ml solution contains
− active substance(s):
human plasma protein
50 mg
thereof immunoglobulin
≥ 95 %
− excipient(s):
glucose monohydrate (corresponding to 25 mg glucose), sodium ions (78
µmol),
chloride ions (78 µmol), water for injections.
The distribution of IgG subclasses is defined around 62 % IgG1, 34 %
IgG2, 0.5 % IgG3
and 3.5 % IgG4.
The IgA content is limited to
≤ 2.5 mg/ml.
PHARMACEUTICAL FORM
Solution for infusion.
The solution is clear to slightly opalescent and colourless to pale
yellow.
PRESENTATIONS
Ampoule with 10 ml and 20 ml
Vial with 50 ml, 100 ml and 200 ml
PHARMACOTHERAPEUTIC GROUP
Human normal immunoglobulin for intravenous administration
NAME AND ADDRESS OF AUTHORIZATION HOLDER AND MANUFACTURER
Biotest Pharma GmbH, Landsteinerstrasse 5, D-63303 Dreieich, Germany
Intraglobin F / Package insert
2/7
INDICATIONS
Replacement therapy in:
Primary immunodeficiency syndromes:
− congenital agammaglobulinaemia and hypogammaglobulinaemia
− common variable immunodeficiency
− severe combined immunodeficiencies
Secondary hypogammaglobulinaemia in patients with chronic lymphocytic
leukaemia
and multiple myeloma with recurrent bacterial infections.
Children with congenital AIDS who have repeated bacterial
infections.
Immunomodulation
Idiopathic thrombocytopenic purpura (ITP), in adults or children at
high risk of bleeding
or prior to surgery to correct the platelet count.
Kawasaki disease.
Allogeneic bone marrow transplantation
CONTRA-INDICATIONS
Hypersensitivity to any of the components.
Hypersensitivity to homologous immunoglobulins, especially in very
rare cases of IgA
deficie
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Summary of Product characteristics
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Intraglobin
®
F
50 mg/ml; solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin for intravenous use (IVIg)
Human plasma protein 50 g/l of which at least 95 % is IgG.
The distribution of IgG subclasses is defined around 62 % IgG1, 34 %
IgG2, 0.5 % IgG3 and 3.5 %
IgG4. The IgA content in finished product is limited to
≤ 2.5 mg/ml.
For excipients, see 6.1.
3. PHARMACEUTICAL
FORM
Solution for infusion.
The solution is clear to slightly opalescent and colourless to pale
yellow.
4. CLINICAL
PARTICULARS
4.1 THERAPEUTIC
INDICATIONS
Replacement therapy in:
Primary immunodeficiency syndromes:
− congenital agammaglobulinaemia and hypogammaglobulinaemia
− common variable immunodeficiency
− severe combined immunodeficiencies
Multiple myeloma or chronic lymphocytic
leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.
Children with congenital AIDS and recurrent infections.
Immunomodulation
Idiopathic thrombocytopenic purpura (ITP), in adults or children at
high risk of bleeding or prior to
surgery to correct the platelet count.
Kawasaki disease.
Allogeneic bone marrow transplantation
Page 2 of 8
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The dose and dosage regimen is dependent on the indication.
In replacement therapy the dosage may need to be individualised
for each patient dependent on the
pharmacokinetic and clinical response. The following dosage regimens
are given as a guideline:
Replacement therapy in primary immunodeficiency syndromes
The dosage regimen should achieve a trough level of IgG (measured
before the next infusion) of at
least 4 - 6 g/l. Three to six months are required after
the initiation of therapy for equilibration to
occu
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