Panzyga 100mg/ml solution for infusion (5g/50ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

HUMAN NORMAL, IMMUNOGLOBULIN

Available from:

Octapharma (IP) SPRL Alle de la Recherche 65, 1070 (Anderlecht), Belgium

ATC code:

J06BA02

INN (International Name):

HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Authorised

Authorization date:

2016-02-23

Patient Information leaflet

Page 1 of 7
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PACKAGE LEAFLET: INFORMATION FOR THE USER
PANZYGA, 100 MG/ML SOLUTION FOR INFUSION
Human Normal Immunoglobulin (IVIg)
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 defense 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 as replacement therapy in children and adolescents
(0-18 years), and adults in different
groups of patients:
•
Patients with inborn deficiency of antibodies (primary
immunodeficiency syndromes, such as:
congenital
agammaglobulinaemia
and
hypogammaglobulinaemia,
common
variable
immunodeficiency, severe combined immunodeficiencies)
•
Patients with an acquired deficiency of antibodies (secondary
immunodeficiency) due to
specific diseases and/or treatments and experiencing severe or
recurrent infections
Panzyga
can
be
further

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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.
Excipient(s) with known effect
This medicinal product contains 69 mg sodium per vial of 100 ml
equivalent to 3.45% of
the WHO recommended maximum daily intake of 2 g sodium for an adult.
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 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 <4g/l.
*PSAF=failure to mount at least a 2-fold rise in IgG antibody titre to
pneumococcal
polysaccharide and polypeptide antigen vaccines
Immunomodulation in adults, and children and adolescents (0-18 years)
in:
•