Thymoglobuline 25mg powder and solvent for solution for infusion vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Antithymocyte immunoglobulin (rabbit)

Tersedia dari:

Sanofi

Kode ATC:

L04AA04

INN (Nama Internasional):

Antithymocyte immunoglobulin (rabbit)

Dosis:

25mg

Bentuk farmasi:

Powder and solvent for solution for infusion

Rute administrasi :

Intravenous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 08020200; GTIN: 5030045000111

Selebaran informasi

MEASURE BAR SHOULD BE 150MM AT 100% SCALE
Customer
Description
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Proof By
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WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
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Process Black
Keyline (does not print)
Genzyme UK (Suffolk)
624236
GI266305
266x305mm
UK/ROI/MT
English
louise.heel
2
18/01/2016
626972
102x30mm
50 gsm
THYMO 5MG/ML Leaflet
8.5pt
Folded:
N/A
[e-mail]
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PACKAGE LEAFLET: INFORMATION FOR THE USER 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 pharmacist 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
so

Karakteristik produk

OBJECT 1
THYMOGLOBULINE 25 MG POWDER FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 03-Oct-2016 | SANOFI
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.
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.
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 section 4.8 and