SANDIMMUN 50 Mg/Ml Concentrate for Soln for Inf

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

CICLOSPORIN

Inapatikana kutoka:

Novartis Pharmaceuticals UK Ltd

ATC kanuni:

L04AD01

INN (Jina la Kimataifa):

CICLOSPORIN

Kipimo:

50 Mg/Ml

Dawa fomu:

Concentrate for Soln for Inf

Dawa ya aina:

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

Eneo la matibabu:

Calcineurin inhibitors

Idhini hali ya:

Authorised

Idhini ya tarehe:

1984-10-03

Taarifa za kipeperushi

1

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

SANDIMMUN 50 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION 

ciclosporin 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
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 or pharmacist. 
- 
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, 
even if their signs of illness are the same as yours. 
- 
If you get any side effects, talk to your doctor or pharmacist.

This includes any possible side 
effects not listed in this leaflet. 

WHAT IS IN THIS LEAFLET 
1. 
What Sandimmun is and what it is used for 
2. 
What you need to know before Sandimmun is used 
3. 
How Sandimmun is used 
4. 
Possible side effects 
5. 
How to store Sandimmun 
6. 
Contents of the pack and other information 

1. 
WHAT SANDIMMUN IS AND WHAT IT IS USED FOR 

WHAT SANDIMMUN IS 
The name of your medicine is Sandimmun. It contains the active
substance ciclosporin. The 
concentrate is used to prepare a solution which is administered
by intravenous infusion. This belongs 
to a group of medicines known as immunosuppressive agents.
These medicines are used to lower the 
body’s immune reactions. 

WHAT SANDIMMUN IS USED FOR AND HOW IT WORKS 
Sandimmun is used to control the body’s immune
system following an organ transplant, including 
bone marrow and stem cell transplantation. It prevents rejection
of transplanted organs by blocking 
the development of certain cells which would normally attack the
transplanted tissue. 

2. 
WHAT YOU NEED TO KNOW BEFORE SANDIMMUN IS USED 

Sandimmun will only be prescribed for you by a doctor with
experience in transplants. 

Follow all your doctor’s instructions
carefully. They may differ from the general in

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandimmun 50 mg/ml Concentrate for Solution for Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The concentrate for solution for infusion contains 50 mg/ml. Each
ampoule of 1 ml contains 50 mg of ciclosporin. Each
ampoule of 5 ml contains 250 mg of ciclosporin.
Excipients with known effect:
Ethanol: 278 mg/ml. Sandimmun 50 mg/ml concentrate for solution for
infusion contains around 34% v/v ethanol
(27.8% m/v ethanol).
Macrogolglycerol ricinoleate/ Polyoxyl 35 castor oil: 650 mg/ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Solution for Infusion
Clear brown-yellow oleaginous concentrate for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Transplantation indications
_Solid organ transplantation_
Prevention of graft rejection following solid organ transplantation.
Treatment of transplant cellular rejection in patients previously
receiving other immunosuppressive agents.
_Bone marrow transplantation_
Prevention of graft rejection following allogeneic bone marrow and
stem cell transplantation.
Prevention or treatment of graft-versus-host disease (GVHD).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose ranges given for oral administration are intended to serve as
guidelines only.
Sandimmun should only be prescribed by, or in close collaboration
with, a physician with experience of
immunosuppressive therapy and/or organ transplantation.
_Transplantation_
_Solid organ transplantation_
The recommended dose of Sandimmun concentrate for solution for
infusion is approximately one-third of the
corresponding oral dose and it is recommended that patients be
switched to oral therapy as soon as possible.
For reference the initial dose of Sandimmun or Neoral is 10 to 15
mg/kg given in 2 divided doses which should be
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