Sandimmun 250mg/5ml concentrate for solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ciclosporin

Available from:

Novartis Pharmaceuticals UK Ltd

ATC code:

L04AD01

INN (International Name):

Ciclosporin

Dosage:

50mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020200; GTIN: 5013054190028

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDIMMUN
® CONCENTRATE FOR SOLUTION FOR INFUSION 50 MG/ML
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 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 and
ethanol”

Summary of Product characteristics

OBJECT 1
SANDIMMUN CONCENTRATE FOR SOLUTION FOR
INFUSION 50MG/ML
Summary of Product Characteristics Updated 09-May-2016 | Novartis
Pharmaceuticals UK Ltd
1. Name of the medicinal product
SANDIMMUN
®
Concentrate for Solution for Infusion 50mg/ml.
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.
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 recommend that patients be
switched to oral therapy as soon as
possible.
For reference the initial oral dose of Sandimmun or Sandimmun Neoral
is 10 to 15 mg/kg given in 2
divided doses which should be initiated within 12 hours before
surgery. This dose