Gammanorm, 165 mg/mL, solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human normal immunoglobulin

Available from:

Octapharma (IP) SPRL

ATC code:

J06BA; J06BA02

INN (International Name):

Human normal immunoglobulin

Dosage:

165 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

Authorization status:

Marketed

Authorization date:

2007-06-01

Patient Information leaflet

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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 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 sectio

Summary of Product characteristics

Health Products Regulatory Authority
28 January 2021
CRN00C4R3
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gammanorm, 165 mg/mL, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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 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
Health Products Regulatory Authority
28 January 2021
CRN00C4R3
Page 2 of 9
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