GAMMAGARD S/D 0.5 g/30 m Micromol Pdr+Solv for soln for Inf

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN

Available from:

Baxter Healthcare Limited

INN (International Name):

HUMAN PLASMA PROTEIN >90% GAMMA GLOBULIN

Dosage:

0.5 g/30 m Micromol

Pharmaceutical form:

Pdr+Solv for soln for Inf

Prescription type:

Product subject to prescription which may not be renewed (A)

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

The infusion of immunoglobulins like GAMMAGARD S/D may impair the
effect 
of some live virus vaccines such as measles, rubella, mumps and
chicken 
pox.  Therefore, after receiving these medicines you may have to
wait up to 
3 months before receiving your live-attenuated virus vaccine.  You
may have to 
wait for up to 1 year after receiving immunoglobulins before you
receive your 
measles vaccine.
EFFECTS ON BLOOD TESTS
GAMMAGARD S/D contains a wide variety of different antibodies, some 
of which can affect blood tests.  If you have a blood test, please
inform 
the person taking your blood or your doctor that you have received 
GAMMAGARD S/D.
PREGNANCY, BREAST-FEEDING AND FERTILITY
-  If you are pregnant or breast-feeding, think you may be pregnant
or are 
planning to have a baby ask your doctor or pharmacist for advice
before 
taking this medicine.  Your doctor will decide if GAMMAGARD S/D may
be 
used during pregnancy and breast-feeding.
-  No clinical trials have been made with GAMMAGARD S/D in pregnant
or 
breast-feeding women.  
-  If you are breast-feeding, the antibodies of GAMMAGARD S/D can
be 
found in the breast milk.  
DRIVING AND USING MACHINES
There is no information on the effects of GAMMAGARD S/D on the ability
to 
drive or operate a heavy machine.  Patients may experience reactions
(for 
example dizziness or nausea) during the treatment with GAMMAGARD
S/D, 
which might affect the ability to drive and use machines. If this
happens, you 
should wait until the reactions have disappeared.
GAMMAGARD S/D CONTAINS GLUCOSE
Tell your doctor if you are diabetic.  GAMMAGARD S/D contains maximum
of 
0.4g/g  glucose, which could affect your blood sugar level and should
be taken 
into account in patients with diabetes mellitus. GAMMAGARD S/D
contains 
0.85 mg/ml sodium _(up to 9.77g sodium per dose.)_. This needs to be
taken 
into account in patients on low sodium diet. 
3.  HOW GAMMAGARD S/D IS GIVEN
GAMMAGARD S/D is intended for intravenous administration (inf

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gammagard S/D
Human 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: sodium (3.49 mg/ml)
For a full list of excipients see section 6.1.
IGG SUBCLASSES
Distribution of IgG subclasses:
IgG
1
56.9%
IgG
2
16.0%
IgG
3
3.3%
IgG
4
0.3%
3 PHARMACEUTICAL FORM
Powder and solvent for solution for infusion.
p.H. of reconstituted product is 6.4 – 7.2.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/07/2014_
_CRN 2142998_
_page number: 1_
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 EFFECT
Idiopathic thrombocytopenic purpura (ITP) in adults or children at high risk of bleeding or prior to surgery to correct
the platelet count.
Allogeneic bone marrow transplantation
Kawasaki syndrome
Guillain-Barré disease
4.2 POSO