Gamunex 10% 5g/50ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Normal immunoglobulin human

Available from:

Grifols UK Ltd

INN (International Name):

Normal immunoglobulin human

Dosage:

100mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 14050100; GTIN: 4250414900144

Summary of Product characteristics

OBJECT 1
GAMUNEX 10%
Summary of Product Characteristics Updated 03-Nov-2014 | Grifols UK
Ltd
1. Name of the medicinal product
_Gamunex 10%,_
100 mg/ml, solution for infusion
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One ml contains:
human normal immunoglobulin
...............................................................................100
mg
(purity of at least 98% IgG)
One vial of 10 ml contains: 1 g
One vial of 50 ml contains: 5 g
One vial of 100 ml contains: 10 g
One vial of 200 ml contains: 20 g
Distribution of the IgG subclasses (average values):
IgG1 .................... 62.8%
IgG2 .................... 29.7%
IgG3 ...................... 4.8%
IgG4 ................ ....2.7%
1 ml _Gamunex 10%_ contains 100 mg protein with an IgG content of at
least 98% (IgA content: mean: 59
micrograms/ml; max.: 84 micrograms/ml; results from 5 different
batches).
Produced from plasma of human donors.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0-18
years):
- Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4).
- Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic
leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma patients
who have failed to respond to pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
- Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior to surgery to
correct the platelet count.
- Guillain Barré syndrome.
- Kawasaki disease.
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
4.2 Posology and