Thymoglobuline 25mg powder for solution for infusion

Kraj: Malta

Język: angielski

Źródło: Medicines Authority

Składnik aktywny:

RABBIT IMMUNOGLOBULIN

Dostępny od:

Genzyme Europe BV Paasheuvelweg 25, 1105 BP Amsterdam , Netherlands

Kod ATC:

L04AA04

INN (International Nazwa):

RABBIT IMMUNOGLOBULIN 25 mg

Forma farmaceutyczna:

POWDER FOR SOLUTION FOR INFUSION

Skład:

RABBIT IMMUNOGLOBULIN 25 mg

Typ recepty:

POM

Dziedzina terapeutyczna:

IMMUNOSUPPRESSANTS

Status autoryzacji:

Authorised

Data autoryzacji:

2009-12-11

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
THYMOGLOBULINE
® 25 MG POWDER FOR SOLUTION FOR INFUSION
rabbit anti-human thymocyte immunoglobulin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
• Keep this leaflet. You may need to read it again.
-
• This medicine will be given to you by a doctor or nurse in
hospital.
-
• If you have any further questions, ask your doctor or nurse.
-
• If you get any side effects talk to your doctor or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4
.
WHAT IS IN THIS LEAFLET
1.
What Thymoglobuline is and what it is used for
2.
What you need to know before you are given Thymoglobuline
3.
How Thymoglobuline is given
4.
Possible side effects
5.
How to store Thymoglobuline
6.
Contents of the pack and other information
1.
WHAT THYMOGLOBULINE IS AND WHAT IT IS USED FOR
Thymoglobuline belongs to a group of medicines called
immunosuppressants (anti–rejection
medicines). These medicines can help prevent the rejection of
transplanted organs. They can also be
used to treat other unwanted immune reactions. Thymoglobuline is made
by injecting human thymus
cells into rabbits. It contains immunoglobulins (antibodies) which
attach to and destroy some
of the cells of your immune system in your body. These cells play a
role in the rejection of
transplanted organs or carry out other unwanted immune reactions.
Kidney and Heart Transplantation
Thymoglobuline is used in patients who have had a kidney or heart
transplant, to prevent the rejection
of a kidney or a heart transplant. It is also used to treat the
rejection of a kidney transplant in patients
who are resistant to treatment with corticosteroids. Thymoglobuline is
a type of drug known as an
immunosuppressant (anti-rejection drug) and is usually used in
combination with other
immunosuppressants. When a patient receives an organ, the body’s
natural defence system will try to
get rid of it (reject it). Thymoglobuline modifi

Charakterystyka produktu

Page 1 of 11
1.
NAME OF THE MEDICINAL PRODUCT
Thymoglobuline
25 mg powder for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Rabbit anti-human thymocyte immunoglobulin 25 mg per vial. 1 ml
reconstituted solution contains
5 mg rabbit, anti-human thymocyte immunoglobulin.
Excipient(s) with known effect:
Each 10 ml vial contains 0.171 mmol of sodium, which is 4 mg of
sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Immunosuppression in solid organ transplantation
-
Prevention of graft rejection in renal transplantation
-
Treatment of steroid resistant graft rejection in renal
transplantation
-
Prevention of graft rejection in heart transplantation.
Thymoglobuline is usually used in combination with other
immunosuppressive medicinal products.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Thymoglobuline must always be used under strict medical supervision
and prescribed by physicians
with experience in using immunosuppressive agents.
Posology
The posology depends on the indication, the administration regimen and
the combination with other
immunosuppressive agents.
The following dosage may be used as a reference. Treatment can be
discontinued without gradual
tapering of the dose.
_Immunosuppression in solid organ transplantation _
_ _
Prophylaxis of graft rejection
1 to 1.5 mg/kg/day for 3 to 9 days after transplantation of a kidney,
corresponding to a cumulative
dose of 3 to 13.5 mg/kg.
Page 2 of 11
1 to 2.5 mg/kg/day for 3 to 5 days after transplantation of a heart,
corresponding to a cumulative
dose of 3 to 12.5 mg/kg.
Treatment of steroid resistant graft rejection:
1.5 mg/kg/day for 7 to 14 days after transplantation of a kidney,
corresponding to a cumulative dose
of 10.5 to 21 mg/kg.
_Dose modifications _
For obese patients dosing should be based on ideal weight rather than
actual weight.
Special population
_Paediatric Population _
Currently available data are described in secti