Octagam 50 mg/ml solution for infusion - (500ml)

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 50 mg/ml

Pharmaceutical form:

SOLUTION FOR INFUSION

Composition:

HUMAN NORMAL IMMUNOGLOBULIN 50 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNE SERA AND IMMUNOGLOBULINS

Authorization status:

Authorised

Authorization date:

2018-09-18

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
OCTAGAM 50 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. 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 50 MG/ML IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE OCTAGAM 50 MG/ML
3. HOW TO USE OCTAGAM 50 MG/ML
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE OCTAGAM 50 MG/ML
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1
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WHAT OCTAGAM 50 MG/ML IS AND WHAT IT IS USED FOR
WHAT OCTAGAM 50 MG/ML IS
Octagam 50 mg/ml 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 50 mg/ml
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 50 mg/ml has a broad spectrum of antibodies against various
infectious agents.
WHAT OCTAGAM 50 MG/ML IS USED FOR
Octagam 50 mg/ml 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
spe

Summary of Product characteristics

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SUMMARY OF THE PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Octagam 50 mg/ml solution for infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Human normal immunoglobulin (IVIg)
One ml contains :
Human normal immunoglobulin 50 mg
(purity of at least 95% IgG)
Each vial of 20 ml contains 1g of human normal immunoglobulin.
Each bottle of 50 ml contains 2.5g of human normal immunoglobulin.
Each bottle of 100 ml contains 5g of human normal immunoglobulin.
Each bottle of 200 ml contains 10g of human normal immunoglobulin.
Each bottle of 500 ml contains 25g of human normal immunoglobulin.
Distribution of the IgG subclasses (approx. values):
IgG
1
ca. 60%
IgG2
ca. 32%
IgG3
ca. 7%
IgG4
ca. 1%
The maximum IgA content is 200 micrograms/ml.
Produced from the plasma of human donors.
_Excipient(s) with known effect: _
This medicinal product contains 35 mg sodium per 100 ml, equivalent to
1.75% 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 5.1 – 6.0, 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:
•
Primary immune thrombocytopenia (ITP), in patients at high risk of
bleeding or prior
to surgery to correct the platele