Intratect 100 g/l, solution for infusion (vial of 10 ml contains 1g)
Country: Malta
Language: English
Source: Medicines Authority
Patient Information leaflet
(PIL)
01-05-2023
Summary of Product characteristics
(SPC)
28-05-2023
Active ingredient:
ALBUMIN, HUMAN
Available from:
Biotest Pharma GmbH Landsteinerstrasse 5, 63303 Dreieich, Germany
ATC code:
J06BA02
INN (International Name):
ALBUMIN, HUMAN 10 % (W/V)
Pharmaceutical form:
SOLUTION FOR INFUSION
Composition:
ALBUMIN, HUMAN 10 % (W/V)
Prescription type:
POM
Therapeutic area:
IMMUNE SERA AND IMMUNOGLOBULINS
Authorization status:
Authorised
Authorization date:
2013-09-24
Patient Information leaflet
Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
INTRATECT 100 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 100 g/L is and what it is used for
2.
What you need to know before you use Intratect 100 g/L
3.
How to use Intratect 100 g/L
4.
Possible side effects
5.
How to store Intratect 100 g/L
6.
Contents of the pack and other information
1. WHAT INTRATECT 100 G/L IS AND WHAT IT IS USED FOR
Intratect 100 g/L 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 100 g/L 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 100 g/L can restore normal
values when blood levels of
Immunoglobulin G (IgG) are low.
INTRATECT 100 G/L IS USED IN ADULTS, CHILDREN, AND ADOLESCENTS (0–18
YEARS) WHO DO NOT HAVE
SUFFICIENT ANTIBODIES (REPLACEMENT THERAPY) IN CASES OF:
•
Patients who are born with a lack of antibodies (primary
immunodeficiency syndromes, PID)
•
Acquired lack of antibodies (secondary immunodeficiency syndrome, SID)
in patients who
suffer from severe or recurrent infections and ineffective
antimicrobial treatment with either
proven specific antibody failure or low IgG level (< 4 g/L)
INTRATECT 100 G/L IS ALSO USED IN ADULTS, CHILDREN, AND ADOLESCENTS
(0–18 YEARS) TO TREAT
INFLAMMATORY DISORDERS (IMMUNOMODULATION)
Read the complete document
Summary of Product characteristics
PAGE 1 OF 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Intratect 100 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 100 mg (purity of at least 96% 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 vial of 50 mL contains: 5 g of human normal immunoglobulin
Each vial of 100 mL contains: 10 g of human normal immunoglobulin
Each vial of 200 mL contains: 20 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 1800 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 100 g/L has a pH of 5.0–5.6 and an osmolality of 280–380
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 polyradiculoneuropath
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