Gammagard S/DHuman Normal Immunoglobulin for Intravenous Administration Powder and solvent for solution for infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
20-01-2017
Summary of Product characteristics
(SPC)
23-10-2021
Active ingredient:
HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN
Available from:
Baxalta Innovations GmbH
ATC code:
J06BA; J06BA02
INN (International Name):
HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN
Dosage:
0.5 g/30 m gram(s)/millilitre
Pharmaceutical form:
Powder and solvent for solution for infusion
Administration route:
Intravenous use
Units in package:
vials of 5.0 g and 10.0 g
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic group:
immune sera and immunoglobulins: immunoglobulins, normal human, for intravascular administration
Therapeutic area:
Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.
Therapeutic indications:
Primary immunodeficiency syndromes (PID): Congenital agammaglobulinaemia and hypogammaglobulinaemia Common variable immunodeficiencies Severe combined immunodeficiencies Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections Children with congenital AIDS and recurrent infections
Authorization status:
Not marketed
Authorization date:
1998-05-01
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
GAMMAGARD S/D 5.0 G / 10.0 G
POWDER AND SOLVENT FOR SOLUTION FOR INFUSION
Human normal immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet.
WHAT IS IN THIS LEAFLET:
1.
What GAMMAGARD S/D is and what it is used for
2.
What you need to know before you use GAMMAGARD S/D
3.
How to use GAMMAGARD S/D
4.
Possible side effects
5.
How to store GAMMAGARD S/D
6.
Contents of the pack and other information
The information on Gammagard S/D in the following sections applies to
both adults and children.
1.
WHAT GAMMAGARD S/D IS AND WHAT IT IS USED FOR
GAMMAGARD S/D belongs to a class of medications called
immunoglobulins. These medicines
contain human antibodies, which are present in human blood. Antibodies
help your body to fight
infections. Medicines like GAMMAGARD S/D are used if you do not have
enough antibodies in
your blood. These patients tend to get frequent infections. GAMMAGARD
S/D can also be used if
you need additional antibodies to cure certain inflammatory disorders
(autoimmune diseases).
GAMMAGARD S/D IS USED FOR
TREATMENT OF PATIENTS WHO DO NOT HAVE SUFFICIENT ANTIBODIES
(REPLACEMENT THERAPY). THERE ARE
FOUR GROUPS:
1.
Patients with inborn lack of antibodies (primary immunodeficiency
syndromes (PID)) such as:
–
congenital agammaglobulinemia or hypogammaglobulinemia
–
common variable immunodeficiency
–
severe combined immunodeficiencies
–
Wiskott Aldrich syndrome
2.
Patients with a lack of antibody production and recurrent infections
(myeloma or chronic
lymphocytic leukaemia with severe secondary hypogammaglobulinemia)
3.
Children who suffer from inborn AIDS and get frequent infections
4.
Premature children with low bi
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
22 October 2021
CRN00C3Z8
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gammagard S/DHuman Normal Immunoglobulin for Intravenous
Administration Powder and solvent for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
Human Normal Immunoglobulin (IVIg)
QUANTITATIVE COMPOSITION
Human Normal Immunoglobulin for Intravenous Administration, Gammagard
S/D, may be reconstituted with solvent [Water
for Injections] to a 5% (50 mg/mL) solution or a 10% (100 mg/mL)
solution of protein of which at least 90% is gamma globulin.
Maximum immunoglobulin A (IgA) content: not more than 3 microgram per
mL in a 5% solution.
Produced from the plasma of human donors.
Excipients with known effect:
In grams per 100 mL reconstituted product, at 5 %:
Sodium Chloride 0.9
Glucose Monohydrate 1.7
For the full list of excipients, see section 6.1.
IGG SUBCLASSES
Distribution of IgG subclasses:
IgG1 ≥ 56.9%
IgG2 ≥ 16.0%
IgG3 ≥ 3.3%
IgG4 ≥ 0.3%
3 PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
p.H. of reconstituted product is 6.4 – 7.2.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
REPLACEMENT THERAPY
Primary immunodeficiency syndromes (PID):
Congenital agammaglobulinaemia and hypogammaglobulinaemia
Common variable immunodeficiencies
Severe combined immunodeficiencies
Wiskott Aldrich syndrome Myeloma or chronic lymphocytic leukaemia with
severe secondary
hypogammaglobulinaemia and recurrent infections Children with
congenital AIDS and recurrent
infections IMMUNOMODULATORY EFFECTIdiopathic thrombocytopenic purpura
(ITP) in adults or children at high risk
of bleeding or prior to surgery to correct the platelet
count.Allogeneic bone marrow transplantationKawasaki
syndromeGuillain-Barré disease
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under the
supervision of a physician experienced in the treatment of
immunodeficiency.
Health Products Regulatory
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