Panzyga Solution for Infusion 100mg/ml

Страна: Мальта

Язык: английский

Источник: Medicines Authority

Активный ингредиент:

HUMAN NORMAL IMMUNOGLOBULIN

Доступна с:

Octapharma (IP) Limited

код АТС:

J06BA02

ИНН (Международная Имя):

HUMAN NORMAL IMMUNOGLOBULIN

Фармацевтическая форма:

SOLUTION FOR INFUSION

состав:

HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml

Тип рецепта:

POM

Терапевтические области:

IMMUNE SERA AND IMMUNOGLOBULINS

Статус Авторизация:

Authorised

тонкая брошюра

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANZYGA, 100 MG/ML SOLUTION FOR INFUSION
Human Normal Immunoglobulin (IVIg)
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 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 Panzyga is and what it is used for
2.
What you need to know before you use Panzyga
3.
How to use Panzyga
4.
Possible side effects
5.
How to store Panzyga
6.
Contents of the pack and other information
1.
WHAT PANZYGA IS AND WHAT IT IS USED FOR
WHAT PANZYGA IS
Panzyga is a human normal immunoglobulin (IgG) solution (i.e. solution
of human antibodies) for
intravenous administration (i.e. infusion into a vein).
Immunoglobulins are normal constituents of the
human blood and support the immune defence of your body. Panzyga
contains all IgG which are present
in the human blood of healthy people. Adequate doses of Panzyga may
restore abnormally low IgG
levels to the normal range.
Panzyga has a broad spectrum of antibodies against various infectious
agents.
WHAT PANZYGA IS USED FOR
Panzyga is used for the treatment of children and adults (replacement
therapy). There are 4 groups of
patients where replacement therapy is used:

Patients with inborn deficiency of antibodies (primary
immunodeficiency syndromes, such as:
congenital
agammaglobulinaemia
and
hypogammaglobulinaemia,
common
variable
immunodef

Характеристики продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
This medicinal product is subject to additional monitoring. This will
allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse reactions. See section 4.8 for how to report adverse
reactions.
1
NAME OF THE MEDICINAL PRODUCT
Panzyga, 100 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin………………….100 mg
(Purity of at least 95 % IgG)
Each vial of 10 ml contains: 1 g of human normal immunoglobulin.
Each vial of 25 ml contains: 2.5 g of human normal immunoglobulin.
Each bottle of 50 ml contains: 5 g of human normal immunoglobulin.
Each bottle of 60 ml contains: 6 g of human normal immunoglobulin.
Each bottle of 100 ml contains: 10 g of human normal immunoglobulin.
Each bottle of 200 ml contains: 20 g of human normal immunoglobulin.
Each bottle of 300 ml contains: 30 g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG
1
65 %
IgG
2
28 %
IgG
3
3 %
IgG
4
4 %
The maximum IgA content is 300 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. The pH of the
solution is 4.5 to 5.0, the osmolality is ≥ 240 mosmol/kg.
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4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, and children and adolescents (0-18
years) in:

Primary immunodeficiency (PID) 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 i