Intratect 1g/20ml solution for infusion vials

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Normal immunoglobulin human

Beszerezhető a:

Biotest (UK) Ltd

ATC-kód:

J06BA02

INN (nemzetközi neve):

Normal immunoglobulin human

Adagolás:

50mg/1ml

Gyógyszerészeti forma:

Solution for infusion

Az alkalmazás módja:

Intravenous

Osztály:

No Controlled Drug Status

Recept típusa:

Caution - AMP level prescribing advised

Termék összefoglaló:

BNF: 14050100; GTIN: 04036124000011

Betegtájékoztató

Intratect 50 g/l solution for infusion
Package leaflet
1
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 an infusion solution. 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)

Hypogammaglobulinemia and repeated bacterial infections in patients
with chronic lymphocytic
leukaemia, in whom prophylactic antibiotics have failed

Hypogammaglobulinaemia and repeated bacterial infections in plateau
phase multiple myeloma
patients who have failed to respond to pneumococcal immunisation

Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation
(HSCT)

Congenital

Termékjellemzők

OBJECT 1
INTRATECT
Summary of Product Characteristics Updated 14-Jul-2016 | Biotest (UK)
Ltd
1. Name of the medicinal product
Intratect 50 g/l, solution for infusion
2. Qualitative and quantitative composition
Human normal immunoglobulin (IVIg)
One ml contains:
Human normal immunoglobulin 50 mg (purity of at least 96% IgG)
Each vial of 20 ml contains: 1 g
Each vial of 50 ml contains: 2.5 g
Each vial of 100 ml contains: 5 g
Each vial of 200 ml contains: 10 g
Distribution of the IgG subclasses (approx. values):
IgG1
IgG2
IgG3
IgG4
57%
37%
3%
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.
4. Clinical particulars
4.1 Therapeutic indications
Replacement therapy in adults, and children and adolescents (0-18
years) in:
- Primary immunodeficiency syndromes with impaired antibody production
(see section 4.4).
- Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic
leukaemia, in whom prophylactic antibiotics have failed.
- Hypogammaglobulinaemia and recurrent bacterial infections in plateau
phase multiple myeloma patients
who have failed to respond to pneumococcal immunisation.
- Hypogammaglobulinaemia in patients after allogeneic haematopoietic
stem cell transplantation (HSCT).
- Congenital AIDS with recurrent bacterial infections.
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 platelet count.
- Guillain Barré syndrome.
- Kawasaki disease.
4.2 Posology and method of administration
Replacement therapy should be initiated and monitored under the
supervision of a physician experienced
in the treatment of immunodeficiency.
Posology
The dose and dose regimen is dependent on the indication.
In replacement therapy the dose may need to be in