Sandimmun 50 mg/ml Concentrate for Solution for Infusion

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Ciclosporin

Pieejams no:

Novartis Ireland Limited

ATĶ kods:

L04AD; L04AD01

SNN (starptautisko nepatentēto nosaukumu):

Ciclosporin

Deva:

50 milligram(s)/millilitre

Zāļu forma:

Concentrate for solution for infusion

Receptes veids:

Product subject to prescription which may be renewed (B)

Ārstniecības joma:

Calcineurin inhibitors; ciclosporin

Autorizācija statuss:

Marketed

Autorizācija datums:

1984-10-03

Lietošanas instrukcija

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. See Section 4.
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 information
contained in this leaflet.
DO NOT USE SANDIMMUN:
-
if you are allergic to ciclosporin or any of the other ingredients of
this medicine (listed in
section 6; also see section “Sandimmun contains castor oil

Produkta apraksts

Health Products Regulatory Authority
28 June 2023
CRN00DP1V
Page 1 of 14
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 initiated
within 12 hours before surgery. This dose should be maintained as the
daily dose for 1 to 2 wee