Gammagard S/D 10g powder and solvent for solution for injection bottles

País: Regne Unit

Idioma: anglès

Font: MHRA (Medicines & Healthcare Products Regulatory Agency)

ingredients actius:

Normal immunoglobulin human

Disponible des:

Takeda UK Ltd

Codi ATC:

J06BA02

Designació comuna internacional (DCI):

Normal immunoglobulin human

Dosis:

10gram

formulario farmacéutico:

Powder and solvent for solution for injection

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Caution - AMP level prescribing advised

Resumen del producto:

BNF: 14050100; GTIN: 00642621049114

Informació per a l'usuari

PMS 293C
PMS 151C
17/011
LE-07-38255 V1
DI GGSD UK
LE07 38255 V1
LE-04-00381
355 x 600
DELITTE D
07/02/17
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e.g. an elderly patient or a patient having problems with your
kidneys.
4. POSSIBLE SIDE EFFECTS
Like all medicines, GAMMAGARD S/D can cause side effects, although not
everybody gets them.
The following side effects may generally occur after treatment with
intravenous human immunoglobulins (medicines
like GAMMAGARD S/D):
• Common or uncommon side effects (which occur in less than 1 in
every 10, but more than 1 in every 1.000 patients)
are chills, headache, fever, vomiting, allergic reactions, nausea,
joint pain, low blood pressure and moderate lower
back pain.
• Rare side effects, which occur less than 1 in every 1.000
patients, are:
- Cases of a sudden fall in blood pressure,
- Eczema-like symptoms (transient cutaneous reactions).
• Very rare side effects, which occur in less than 1 in every 10.000
patients or cannot be estimated from available data,
are
- Isolated cases of allergic reactions (anaphylactic shock), even if
you have shown no reactions to previous infusions,
- Cases of temporary brain fever (reversible aseptic meningitis),
- Isolated cases of temporary reduction of red blood cell count
(reversible haemolytic anaemia/haemolysis),
- Transient increases in liver function values (liver transaminases),
an increase in blood creatinine content and kidney
failure,
- Blood clot formation in the veins (thromboembolic reactions), which
may lead to heart attack, stroke, lung injury
(pulmonary embolism), and deep vein thrombosis.
Below is a list of side effects that some patients reported when
GAMMAGARD S/D was tested in clinical trials and side
effects reported during post-market phase:
• Common side effects (seen in less than 1 in every 10 patients):
- headache,
- flushing,
- nausea, vomiting,
- fatigue, chills, fever,
Uncommon side effects (seen in less than 1 in every 100 patients):
-
anxiety, agitation, abnormal drowsines

Fitxa tècnica

OBJECT 1
GAMMAGARD S/D 10 G POWDER AND SOLVENT FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 08-Dec-2017 | Shire
Pharmaceuticals Limited
1. Name of the medicinal product
GAMMAGARD
1
S/D 10 g powder and solvent for solution for infusion
1
GAMMAGARD is a trademark of Baxalta Incorporated.
2. Qualitative and quantitative composition
Active Ingredient Human normal immunoglobulin G (IgG)
Quantitative Composition Human Normal Immunoglobulin for Intravenous
Administration,
GAMMAGARD S/D, may be reconstituted with solvent [Water for
Injections, Ph. Eur. (EP)] to a 5% (50
mg/mL) solution or a 10 _%_ (100 mg/mL) solution of protein of which
at least 90% is gamma globulin.
GAMMAGARD S/D contains only trace amounts of IgA.
Maximum immunoglobulin A (IgA) content: not more than 3 microgram per
mL in a 5% solution.
Excipients: Human Albumin, Glycine, Sodium Chloride, Glucose
Monohydrate.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
A sterile, purified, lyophilised powder for reconstitution with
solvent prior to intravenous administration
(Lyophilisate for injection).
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in:
Primary immunodeficiency syndromes
such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency
- severe combined immunodeficiency
- Wiskott Aldrich syndrome
Myeloma or chronic lymphocytic leaukaemia with severe secondary
hypogammaglobulinaemia and
recurrent infections
Children with congenital AIDS and recurrent infections
IMMUNOMODULATION:
Idiopathic thrombocytopenic purpura (ITP), in children or adults at
high risk of bleeding or prior to
surgery to correct the platelet count
Guillain-Barré syndrome
Kawasaki disease
Allogeneic bone marrow transplantation
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 respons