CELLCEPT mycophenolate mofetil 200mg/mL suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mycophenolate mofetil, Quantity: 200 mg/mL

Available from:

Roche Products Pty Ltd

Pharmaceutical form:

Suspension

Composition:

Excipient Ingredients: citric acid; xanthan gum; aspartame; methyl hydroxybenzoate; purified water; silicon dioxide; sorbitol; lecithin; sodium citrate dihydrate; Flavour

Administration route:

Oral

Units in package:

225mL bottle

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

CellCept is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. CellCept is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

Product summary:

Visual Identification: White to off-white powder blend. Reconstituted suspension is white to off-white.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2000-03-14

Patient Information leaflet

CELLCEPT
®
_mycophenolate mofetil_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about CellCept. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking CellCept
against the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CELLCEPT IS USED
FOR
CellCept contains the active
ingredient mycophenolate mofetil.
CellCept belongs to a group of
medicines called
immunosuppressants.
Immunosuppressants are used to
prevent the rejection of a
transplanted organ and work by
stopping your immune system from
reacting to the transplanted organ.
There are many different types of
medicines used to prevent rejection
of a transplanted organ.
CellCept may be used together with
other medicines known as
cyclosporin and corticosteroids.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY CELLCEPT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
CellCept for another reason.
CellCept is not addictive.
This medicine is only available with
a doctor’s prescription.
BEFORE YOU TAKE OR ARE
GIVEN CELLCEPT
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE CELLCEPT IF:
1.
YOU HAVE AN ALLERGY TO:
•
CellCept or any of the ingredients
listed at the end of this leaflet.
•
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin
CELLCEPT IV SOLUTION SHOULD NOT BE
GIVEN IF YOU HAVE AN ALLERGY TO
POLYSORBATE 80.
2.
YOU ARE PREGNANT
•
CellCept is harmful to an unborn
baby when taken by a pregnant
woman.
•
There have been cases of
miscarriage and severe birth
defects reported when patients
have taken CellCept during
pregnancy.
•
You must tell your d

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
CELLCEPT
® (MYCOPHENOLATE MOFETIL)
CellCept 20211130
1
1.
NAME OF THE MEDICINE
Mycophenolate mofetil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CellCept 250 mg capsules contain 250 mg mycophenolate mofetil.
CellCept 500 mg tablets contain 500 mg mycophenolate mofetil.
CellCept 500 mg powder for concentrate for solution for infusion
contains 500mg mycophenolate
mofetil (as hydrochloride salt).
CellCept 1 g/5 ml powder for oral suspension contains 1 g
mycophenolate mofetil per 5 mL when
reconstituted.
For the full list of excipients, see section 6.1. List of excipients.
3.
PHARMACEUTICAL FORM
CELLCEPT 250MG CAPSULES
Capsules, hard.
CellCept capsules: oblong, blue/brown, branded with black "CellCept
250" on the capsule cap and
"Roche" name on the capsule body.
CELLCEPT 500 MG TABLETS
Film coated tablets.
CellCept tablets: lavender coloured caplet-shaped tablet, engraved
with "CellCept 500" on one side and
"Roche" name on the other.
CELLCEPT 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
Powder for concentrate for solution for infusion.
Sterile lyophilised white to off-white powder 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. Reconstitution and
dilution with 5% glucose intravenous infusion as recommended yields a
slightly yellow solution of
mycophenolate mofetil, 6 mg/mL.
CELLCEPT 1 G/5 ML POWDER FOR ORAL SUSPENSION.
Powder for oral suspension
White to off-white powder for oral suspension
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CellCept is indicated for the prophylaxis of solid organ rejection in
adults receiving allogeneic organ
transplants.
CellCept is indicated for the prophylaxis of organ rejection in
paediatric patients (2 to 18 years)
receiving allogeneic renal transplants.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The initial dose of CellCept should be given as soon as clinically
feasible following trans