CellCept 500mg powder for solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Mycophenolate mofetil hydrochloride

Available from:

Roche Products Ltd

ATC code:

L04AA06

INN (International Name):

Mycophenolate mofetil hydrochloride

Dosage:

500mg

Pharmaceutical form:

Powder for solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08020100; GTIN: 5000471005110

Patient Information leaflet

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uk-ie-mt-pil-cellcept-clean-180312-500mg-sol-inf
PACKAGE LEAFLET: INFORMATION FOR THE USER
CELLCEPT 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
(mycophenolate mofetil)
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 nurse.
•
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 nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What CellCept is and what it is used for
2.
What you need to know before you have CellCept
3.
How you have CellCept
4.
Possible side effects
5.
How to store CellCept
6.
Contents of the pack and other information
7.
Making up the medicine
1.
WHAT CELLCEPT IS AND WHAT IT IS USED FOR
The full name of your medicine is CellCept 500 mg powder for
concentrate for solution for infusion.
•
In this leaflet the shorter name CellCept is used.
CellCept contains mycophenolate mofetil.
•
This belongs to a group of medicines called “immunosuppressants”.
CellCept is used to prevent your body rejecting a transplanted organ.
•
A kidney or liver.
CellCept should be used together with other medicines:
•
Ciclosporin and corticosteroids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CELLCEPT
WARNING
Mycophenolate causes birth defects and miscarriage. If you are a woman
who could become pregnant,
you must provide a negative pregnancy test before starting treatment
and must follow the
contraception advice given to you by your doctor.
Your doctor will speak to you and give you written information,
particularly on the effects of
mycophenolate on unborn babies. Read the information carefully and
follow the instructions.
If you do not fully understand these instructions, please ask your
doctor to

Summary of Product characteristics

OBJECT 1
CELLCEPT 500MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 16-Mar-2018 | Roche
Products Limited
1. Name of the medicinal product
CellCept 500 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains the equivalent of 500 mg mycophenolate mofetil (as
hydrochloride salt).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion.
CellCept 500 mg powder for concentrate for solution for infusion must
be reconstituted and further
diluted with glucose intravenous infusion 5% prior to administration
to the patient (see section 6.6).
4. Clinical particulars
4.1 Therapeutic indications
CellCept 500 mg powder for concentrate for solution for infusion is
indicated in combination with
ciclosporin and corticosteroids for the prophylaxis of acute
transplant rejection in patients receiving
allogeneic renal or hepatic transplants.
4.2 Posology and method of administration
Treatment with CellCept should be initiated and maintained by
appropriately qualified transplant
specialists.
CAUTION: CELLCEPT I.V. SOLUTION MUST NOT BE ADMINISTERED BY RAPID OR
BOLUS INTRAVENOUS INJECTION.
Posology
CellCept 500 mg powder for concentrate for solution for infusion is an
alternative dosage form to
CellCept oral forms (capsules, tablets and powder for oral suspension)
that may be administered for up to
14 days. The initial dose of CellCept 500 mg powder for concentrate
for solution for infusion should be
given within 24 hours following transplantation.
_Renal transplant_
The recommended dose in renal transplant patients is 1 g administered
twice daily (2 g daily dose).
_Hepatic transplant_
The recommended dose of CellCept for infusion in hepatic transplant
patients is 1 g administered twice
daily (2 g daily dose). IV CellCept should continue for the first 4
days following hepatic transplant, with
oral CellCept initiated as soon after this as it can be tolerated. The
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