Gammanorm 3.3g/20ml solution for injection vials

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Normal immunoglobulin human

Dostępny od:

Octapharma Ltd

INN (International Nazwa):

Normal immunoglobulin human

Dawkowanie:

165mg/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Subcutaneous

Klasa:

No Controlled Drug Status

Typ recepty:

Caution - AMP level prescribing advised

Podsumowanie produktu:

BNF: 14050100; GTIN: 5060237670266 5060237670426

Charakterystyka produktu

OBJECT 1
GAMMANORM
Summary of Product Characteristics Updated 22-Jun-2017 | Octapharma
Limited
1. Name of the medicinal product
GAMMANORM, 165 mg/ml, solution for injection
2. Qualitative and quantitative composition
Human normal immunoglobulin (SC/IMIg)
Human normal immunoglobulin 165 mg/ml*
*corresponding to human protein content of which at least 95 % is IgG.
One vial of 6 ml contains: 1 g* of human normal immunoglobulin.
One vial of 10 ml contains: 1.65 g * of human normal immunoglobulin.
One vial of 12 ml contains: 2 g* of human normal immunoglobulin.
One vial of 20 ml contains: 3.3 g * of human normal immunoglobulin.
One vial of 24 ml contains: 4 g* of human normal immunoglobulin.
One vial of 48 ml contains: 8 g* of human normal immunoglobulin.
Distribution of IgG subclasses:
IgG
1
59%
IgG
2
36%
IgG
3
4.9%
IgG
4
0.5%
IgA
max. 82.5 microgram/ml
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection
The liquid preparation is clear or slightly opalescent and colourless
or pale-yellow or light-brown.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults and children in primary immunodeficiency
syndromes such as:
- congenital agammaglobulinaemia and hypogammaglobulinaemia
- common variable immunodeficiency (CVID)
- severe combined immunodeficiency
- IgG subclass deficiencies with recurrent infections
Replacement therapy in myeloma or chronic lymphatic leukaemia with
severe secondary
hypogammaglobulinaemia and recurrent infections.
4.2 Posology and method of administration
POSOLOGY
REPLACEMENT THERAPY
The treatment should be initiated and monitored under the supervision
of a physician experienced in the
treatment of immunodeficiency.
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 guidance.
The dosage regimen using the subcutaneous route should achieve a
sustained level of IgG. A loading dose
of at least 0.2-0.5 g/kg may be required. Afte