Intratect 100 g/L, solution for infusion

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Human plasma protein

Disponível em:

Biotest Pharma GmbH

Código ATC:

J06BA; J06BA02

DCI (Denominação Comum Internacional):

Human plasma protein

Dosagem:

100 gram(s)/litre

Forma farmacêutica:

Solution for infusion

Tipo de prescrição:

Product subject to prescription which may not be renewed (A)

Área terapêutica:

Immunoglobulins, normal human; immunoglobulins, normal human, for intravascular adm.

Status de autorização:

Marketed

Data de autorização:

2013-02-15

Folheto informativo - Bula

Intratect 100 g/L, solution for infusion
Package leaflet
1
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 T

Características técnicas

Health Products Regulatory Authority
10 July 2023
CRN00DNZZ
Page 1 of 10
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
* 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 inflammator