Intratect Solution for Infusion 50g/l (2.5g in 50ml)
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
27-06-2023
Summary of Product characteristics
(SPC)
28-05-2023
Active ingredient:
HUMAN NORMAL, IMMUNOGLOBULIN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
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:
2012-04-09
Patient Information leaflet
Intratect, 50 g/L, solution for infusion
Package leaflet
PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
INTRATECT, 50 G/L, 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, pharmacist or
nurse.
•
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 Intratect is and what it is used for
2.
What you need to know before you use Intratect
3.
How to use Intratect
4.
Possible side effects
5.
How to store Intratect
6.
Contents of the pack and other information
1. WHAT INTRATECT IS AND WHAT IT IS USED FOR
Intratect is an extract of human blood which contains antibodies (the
body’s own defensive substances) to
diseases, available in the form of a solution for infusion. The
solution is ready for infusion into a vein (a
“drip”).
Intratect contains human normal immunoglobulin (antibodies) from blood
donated by a broad spectrum
of the population and is likely to contain antibodies to most common
infectious diseases. Adequate doses
of Intratect can restore normal values when blood levels of
Immunoglobulin G are low.
Intratect is used in adults, and children and adolescents (0-18 years)
who do not have sufficient antibodies
(replacement therapy) in cases of:
•
Patients born with lack of antibodies (primary immunodeficiency
syndromes)
•
Patients* suffering from severe or recurrent infections and
ineffective antimicrobial treatment with
lack of antibodies (secondary immunodeficiencies)
*Patients with proven specific antibody failure or IgG level < 4 g/L
Intratect is also used in adults, and children and adolescents (0-18
years) to treat inflammatory disorders
(immunomodulation) such as:
•
Primary immune thrombocytopenia (ITP, where a patie
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Summary of Product characteristics
PAGE 1 OF 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Intratect, 50 g/L, solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1 GENERAL DESCRIPTION
Human normal immunoglobulin (IVIg)
2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL contains:
Human normal immunoglobulin 50 mg (purity of at least 96% IgG)
Each vial of 20 mL contains: 1 g of human normal immunoglobulin
Each vial of 50 mL contains: 2.5 g of human normal immunoglobulin
Each vial of 100 mL contains: 5 g of human normal immunoglobulin
Each vial of 200 mL contains: 10 g of human normal immunoglobulin
Distribution of the IgG subclasses (approx. values):
IgG1 57%
IgG2 37%
IgG3 3%
IgG4 3%
The maximum IgA content is 900 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 to slightly opalescent and colourless to pale
yellow.
Intratect has a pH of 5.0–5.6 and an osmolality of 250–350
mOsmol/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Replacement therapy in adults, 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 <4 g/L
PAGE 2 OF 13
* PSAF= failure to mount at least a 2-fold rise in IgG antibody titre
to pneumococcal
polysaccharide and polypeptide antigen vaccines
Immunomodulation in adults, 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 platelet count
•
Guillain Barré syndrome
•
Kawasaki disease (in conjunction with acetylsalicylic acid; see
section 4.2)
•
Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
•
Multifocal motor neuropathy (MMN)
4.2
POSOLOGY AND METHOD OF A
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