Octagam 10% Solution for Infusion 100mg/ml(200ml vial)

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

HUMAN NORMAL, IMMUNOGLOBULIN

Dostępny od:

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

Kod ATC:

J06BA02

INN (International Nazwa):

HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml

Forma farmaceutyczna:

SOLUTION FOR INFUSION

Skład:

HUMAN NORMAL IMMUNOGLOBULIN 100 mg/ml

Typ recepty:

POM

Dziedzina terapeutyczna:

IMMUNE SERA AND IMMUNOGLOBULINS

Status autoryzacji:

Authorised

Data autoryzacji:

2009-08-25

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAGAM 10%, 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. 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 Octagam 10% is and what it is used for
2.
What you need to know before you use Octagam 10%
3.
How to use Octagam 10%
4.
Possible side effects
5.
How to store Octagam 10%
6.
Contents of the pack and other information
1
What Octagam
10% IS
and what it is used for
WHAT OCTAGAM 10%
is
Octagam 10% 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 body and support the immune defence
of your body.
Octagam 10% contains all IgG activities which are present in the
normal population.
Adequate doses of this medicinal product may restore abnormally low
IgG levels to the
normal range.
Octagam 10% has a broad spectrum of antibodies against various
infectious agents.
WHAT OCTAGAM 10%
is USED FOR
Octagam 10% is used as replacement therapy in children, 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
Oc

Charakterystyka produktu

Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
OCTAGAM 10%, solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin (IVIg) 100 mg
(purity of at least 95% IgG)
Each vial of 20 ml contains 2g of human normal immunoglobulin.
Each bottle of 50 ml contains 5g of human normal immunoglobulin.
Each bottle l of 60 ml contains 6g of human normal immunoglobulin.
Each bottle of 100 ml contains 10g of human normal immunoglobulin.
Each bottle of 200 ml contains 20g of human normal immunoglobulin.
Each bottle of 300 ml contains 30g of human normal immunoglobulin.
Distribution of IgG subclasses (approx. values):
IgG
1
ca. 60%
IgG
2
ca. 32%
IgG
3
ca. 7%
IgG
4
ca. 1%
The maximum IgA content is 400 micrograms/ml
Produced from the plasma of human donors.
Excipient(s) with known effect
This medicinal product contains 69 mg sodium per 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 liquid preparation is clear to slightly opalescent and colourless
to slightly yellow. The
pH of the liquid preparation is 4.5 – 5.0, the osmolality is ≥ 240
mosmol/kg.
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
Page 2 of 18
•
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:
•
Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior
to