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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN NORMAL IMMUNOGLOBULIN

Available from:

Octapharma (IP) Limited

ATC code:

J06BA01

INN (International Name):

HUMAN NORMAL IMMUNOGLOBULIN

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

HUMAN NORMAL IMMUNOGLOBULIN 165 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Authorised

Patient Information leaflet

Page 1 of 7
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 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 and recurrent infections 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).
-

Summary of Product characteristics

Page 1 of 11
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.
Excipients with known effects:
This medicinal product contains 4.35 mmol (or 100 mg) sodium per dose
(40 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)
Page 2 of 11

Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic
lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have
failed or are contra-
indicated.

Hypogammaglobulinaemia and recurrent bacterial infections in multiple
myeloma (MM)
patients

Hypogammaglobulinaemia in patients pre- and post- allogenic
haematopoietic stem cell
transplantation (HSCT)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Replacement therapy should be initiated and monitored under the
supervision of a physician
e