Gammaplex 10%100 mg/ml solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Human normal immunoglobulin

Available from:

Bio Products Laboratory Limited

ATC code:

J06BA; J06BA02

INN (International Name):

Human normal immunoglobulin

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:

2018-07-06

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
GAMMAPLEX 10%
100 MG/ML SOLUTION FOR INFUSION
human normal immunoglobulin
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Gammaplex 10% is and what it is used for
2.
What you need to know before you use Gammaplex 10%
3.
How to use Gammaplex 10%
4.
Possible side effects
5.
How to store Gammaplex 10%
6.
Contents of the pack and other information
1.
WHAT GAMMAPLEX 10% IS AND WHAT IT IS USED FOR
WHAT GAMMAPLEX 10% IS
Gammaplex 10% contains the active substance human normal
immunoglobulin. The immunoglobulin
contains antibodies which help to fight infection. Immunoglobulin is
obtained from blood plasma
from screened donors.
WHAT GAMMAPLEX 10% IS USED FOR
This medicine is used to treat patients who do not have sufficient
antibodies (proteins which protect
you against infection).
Gammaplex 10% is used to treat patients who require antibody
replacement because they were
born with or have developed a lack of antibodies during life (primary
antibody deficiencies).
Gammaplex 10% is also used to treat antibody deficiencies as a result
of another illness such as:
–
chronic lymphocytic leukaemia (cancer of the blood where too many
white blood cells are
produced) and where antibiotics are not preventing infections
–
some other bone marrow

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick identification of new safety
information. Healthcareprofessionals are asked to report any suspected
adverse reactions. See section 4.8 for how to
report adverse reactions.
1 NAME OF THE MEDICINAL PRODUCT
Gammaplex 10%
100 mg/ml solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg).
One ml contains 100 mg human normal immunoglobulin (purity of at least
98% IgG).
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.
Distribution of the IgG subclasses (approx. values):
IgG1 ……… 63%
IgG2 ……… 31%
IgG3 ……… 5%
IgG4 ……… 1%
The maximum IgA content is <20 micrograms/ml.
Produced from the plasma of human donors.
For the 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 (see section 6.6).
The pH of the solution is 4.9 – 5.2, the osmolality is not less than
240 mOsmol/kg and typically 280 mOsmol/kg.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:
•
Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4)
•
Hypogammaglobulinaemia and recurrent bacterial infections in patients
with chronic lymphocytic leukaemia, in
whom prophylactic antibiotics have failed
•
Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma patients who have
failed to respond to pneumococcal immunisation
•
Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation (HSCT)
•
Congenital AIDS with recurrent bacterial infections
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