Gammanorm 8g/48ml solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Normal immunoglobulin human

Available from:

Octapharma Ltd

ATC code:

J06BA01

INN (International Name):

Normal immunoglobulin human

Dosage:

165mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Caution - AMP level prescribing advised

Product summary:

BNF: 14050100; GTIN: 5060237670730

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
GAMMANORM, 165 MG/ML, SOLUTION FOR INJECTION
Human normal immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
−
Keep this leaflet. You may need to read it again.
−
If you have any further questions, ask your doctor or pharmacist.
−
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
−
If any of the side effects gets serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Gammanorm is and what it is used for
2.
Before you use Gammanorm
3.
How to use Gammanorm
4.
Possible side effects
5.
How to store Gammanorm
6.
Further information
1.
WHAT GAMMANORM IS AND WHAT IT IS USED FOR
Gammanorm is an immunoglobulin and contains antibodies against
bacteria and
viruses. Antibodies protect the body and increase its resistance to
infections. The
purpose of this treatment is to attain normal antibody levels.
Gammanorm is used as replacement therapy in adults and children to
treat primary
immunodeficiency syndromes such as:
-
congenital agammaglobulinaemia and hypogammaglobulinaemia
-
common variable immunodeficiency (CVID)
-
severe combined immunodeficiency
-
IgG subclass deficiencies with recurrent infections
-
myeloma or chronic lymphatic leukaemia with severe secondary
hypogammaglobulinaemia and recurrent infections.
2.
BEFORE YOU USE GAMMANORM
DO NOT USE GAMMANORM
-
if you are hypersensitive to human normal immunoglobulin or any of the
other
ingredients of Gammanorm.
-
intravenously (Gammanorm must not be administered into a vein).
Page 1 of 7
Gammanorm, 165 mg/ml, solution for injection - Human normal
immunoglobulin
-
intramuscularly (into a muscle) by yourself. Gammanorm must not be
given into a
muscle if you have any bleeding disorders.
TAKE SPECIAL CARE WITH GAMMANORM
-
Tell your doctor if you have any other illnesses.
-
If Gammanorm is accidentally administered into a blood

Summary of Product characteristics

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