Gamunex® 10%, 100 mg/ml, solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Immunoglobulin human normal

Available from:

Grifols Deutschland GmbH

ATC code:

J06BA; J06BA02

INN (International Name):

Immunoglobulin human normal

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for infusion

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:

Not marketed

Authorization date:

2006-08-11

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 _Gamunex_
_®_
_ 10%_ is and what it is used for
2. What you need to know before you use _Gamunex_
_®_
_ 10%_
3. How to use _Gamunex_
_®_
_ 10%_
4. Possible side effects
5. How to store _Gamunex_
_®_
_ 10%_
6. Contents of the pack and other information
1. WHAT _GAMUNEX_
_®_
_ 10%_ IS AND WHAT IT IS USED FOR
WHAT _GAMUNEX_
_®_
_ 10%_ IS
_Gamunex_
_®_
_ 10%_ contains human normal immunoglobulin (antibodies) as highly
purified protein extracted from human plasma (part of the blood of
donors). This medicine
belongs to the group of medicines called intravenous immunoglobulins.
These are used to treat conditions where the body’s defence system
against disease is not working properly.
WHAT _GAMUNEX_
_®_
_ 10%_ IS USED FOR
Treatment of adults, children and adolescents (0-18 years) who do not
have sufficient antibodies (replacement therapy) such as:
- Patients with primary immunodeficiency syndromes (PID), an inborn
lack of antibodies
-
Patients with acquired immunodeficiency (SID) with severe or recurrent
infections, ineffective antimicrobial treatment and either proven
specific antibody failure or serum IgG
level of <4 g/l
Treatment of susceptible adults, children and adolescents (0-18 years)
who have been exposed to measles or are at risk of measles exposure
and in whom active vaccination
against measles is not indicated or not advised.
Treatment of adults, children and adolescents (0-18 years) with
cert

Summary of Product characteristics

Health Products Regulatory Authority
16 September 2022
CRN00CYZ5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gamunex® 10%, 100 mg/ml, solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
human normal immunoglobulin
............................................................................100
mg
(purity of at least 98% IgG)
Each vial of 10 ml contains: 1 g of human normal immunoglobulin
Each vial of 50 ml contains: 5 g of human normal immunoglobulin
Each vial of 100 ml contains: 10 g of human normal immunoglobulin
Each vial of 200 ml contains: 20 g of human normal immunoglobulin
Each vial of 400 ml contains: 40 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG1 .................... 62.8%
IgG2 .................... 29.7%
IgG3 ...................... 4.8%
IgG4 ....................2.7%
Minimum level of anti-measles IgG is 9 IU/ml.
The maximum IgA content is 84 micrograms/ml.
Produced from the plasma of human donors.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
The solution is clear or slightly opalescent and colourless or pale
yellow.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Replacement therapy in adults, children and adolescents (0-18 years)
in:

Primary immunodeficiency syndromes (PID) with impaired antibody
production

Secondary immunodeficiencies (SID) in patients who suffer from severe
or recurrent infections, ineffective
antimicrobial treatment and either PROVEN SPECIFIC ANTIBODY FAILURE
(PSAF)* or serum IgG level of <4 g/l
*PSAF = failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal polysaccharide and polypeptide antigen
vaccines
Measles pre-/post exposure prophylaxis for susceptible adults,
children and adolescents (0-18 years) in whom active
immunisation is contraindicated or not advised.
Consideration should also be given to official recommendations on
intravenous human immunoglobulin use in measles
pre-/post exposur