Gammanorm Solution for Injection 165mg/ml (12ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN NORMAL, IMMUNOGLOBULIN

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

J06BA01

INN (International Name):

HUMAN NORMAL IMMUNOGLOBULIN 165 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HUMAN NORMAL IMMUNOGLOBULIN 165 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Authorised

Authorization date:

2011-05-16

Patient Information leaflet

Page 1 of 8
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 BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
−
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 only. Do not pass it on to
others. It
may harm them, even if their signs of illness are the same as yours.
−
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gammanorm is and what it is used for
2.
What do you need to know before you use Gammanorm
3.
How to use Gammanorm
4.
Possible side effects
5.
How to store Gammanorm
6.
Contents of the pack and other information
_ _
1.
WHAT GAMMANORM IS AND WHAT IT IS USED FOR
Gammanorm is an immunoglobulin solution 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, children and
adolescents (0-
18 years) in:
•
Patients who are born with a reduced ability or inability to produce
immunoglobulins (primary immunodeficiencies).
•
Patients with chronic lymphocytic leukaemia, a certain kind of blood
cancer
that leads to a lack of antibodies and to recurrent infections, when
antibiotics
have failed or may not be given.
•
Patients with multiple myeloma, another kind of blood cancer that
leads to a
lack of antibodies and to recurrent infections
•
Patients with lack of antibodies before and after a haematopoietic
stem cell
transplantation
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GAMMANORM
DO NOT USE GAMMANORM:
-
if you are allergic to human normal immunoglobulin or any of the other
ingredients of this medicine (listed in section 6).
-
Intravascularl

Summary of Product characteristics

SUMMARY OF THE PRODUCT CHARACTERISTICS
1
N
AME OF THE
M
EDICINAL
P
RODUCT
Gammanorm, 165 mg/ml, solution for injection
2
Q
UALITATIVE AND
Q
UANTITATIVE
C
OMPOSITION
Human normal immunoglobulin (SCIg/IMIg)
One ml contains:
Human normal immunoglobulin
……………………………..
165 mg
(purity of at least 95% IgG)
Each vial of 6 ml contains: 1 g of human normal immunoglobulin.
Each vial of 10 ml contains: 1.65 g of human normal immunoglobulin.
Each vial of 12 ml contains: 2 g of human normal immunoglobulin.
Each vial of 20 ml contains: 3.3 g of human normal immunoglobulin.
Each vial of 24 ml contains: 4 g of human normal immunoglobulin.
Each vial of 48 ml contains: 8 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG
1
……….. 59%
IgG
2
……….. 36%
IgG
3
……….. 4.9%
IgG
4
…………0.5%
The maximum IgA content is 82.5 micrograms/ml
Produced from the plasma of human donors.
Excipient(s) with known effects:
For vial of 6 ml:
This medicinal product contains less than 1 mmol (23 mg) sodium per
vial that is to
say essentially ‘sodium-free’.
For vials of 10 ml, 12 ml, 20 ml, 24 ml and 48 ml:
This medicinal product contains
25 mg (1.1 mmol) sodium per vial of 10 ml,
30 mg (1.30 mmol) sodium per vial of 12 ml,
50 mg (2.17 mmol) sodium per vial of 20 ml,
60 mg (2.61 mmol) sodium per vial of 24 ml,
120 mg (5.22 mmol) sodium per vial of 48 ml.
For the full list of excipients, see section 6.1.
3
P
HARMACEUTICAL
F
ORM
Solution for injection.
The liquid preparation is clear or slightly opalescent and colourless
or pale yellow or
light-brown.
4
C
LINICAL
P
ARTICULARS
4.1
THERAPEUTIC INDICATIONS
Indications for subcutaneous administration (SCIg)
Replacement therapy in adults, children and adolescents (0-18 years)
in:
•
Primary immunodeficiency syndromes such with impaired antibody
production
(see section 4.4)
•
Hypogammaglobulinaemia and recurrent bacterial infections in patients
with
chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics
have
fa