CellCept 500 mg powder for concentrate for solution forinfusion

Immunosuppressants.

CellCept 500 mg powder for concentrate for solution for infusion is used to prevent your body rejecting a transplanted kidney or liver. CellCept 500 mg powder for concentrate for solution for infusion is used together with other medicines known as ciclosporin and corticosteroids.

CellCept should not be given to you:

• If you are allergic (hypersensitive) to mycophenolate mofetil, mycophenolic acid, polysorbate 80 or any of the other ingredients of CellCept. Tell your doctor if this applies to you.
• If you are breastfeeding.

Take special care with CellCept:
You should inform your doctor immediately:

• If you experience any evidence of infection (e.g. fever, sore throat), unexpected bruising and/or bleeding.
• If you have or ever have had any problems with your digestive system, e.g., stomach ulcers.
• If you are planning to become pregnant, or if you fall pregnant while taking CellCept.

CellCept reduces your body?s defence mechanism. Because of this, there is an increased risk of skin cancer. Therefore you should limit your exposure to sunlight and UV light by wearing appropriate protective clothing and using a sunscreen with high protection factor.

Taking other medicines:
Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those not prescribed.

If you answer yes to any of the following questions talk to your doctor before you start to take CellCept:

• Are you taking any medicines containing: azathioprine or other immunosuppressive agents (which are sometimes given to patients after a transplant operation), cholestyramine (used to treat patients with high blood cholesterol), rifampicin (antibiotic), phosphate binders (used in patients with chronic renal failure to reduce the absorption of phosphate) or any other medicines (including those you can buy without a prescription) that your doctor does not know about?
• Do you need to receive vaccines (live vaccines)? Your doctor will have to advise you what is indicated for you.

Pregnancy and breast feeding:

Use of CellCept during pregnancy may cause miscarriage or damage to your unborn baby (abnormal development of ears for example).

If you plan to become pregnant, discuss with your doctor alternative medicines to best prevent rejection of your transplanted organ. In certain situations, you and your doctor may decide that the benefits of taking CellCept for your health are more important than the possible risks to your unborn baby.

If you become pregnant while taking CellCept, do not stop taking it, but tell your doctor about your pregnancy as soon as possible.

Do not take CellCept if you are:

• Breast-feeding
• Pregnant (unless your doctor clearly tells you)

Tell your doctor straight away if:

• You think you may be pregnant
• You are breast-feeding
• You plan to start a family in the near future

You must always use an effective method of birth control:

• Before you start taking CellCept
• During your entire treatment with CellCept
• For 6 weeks after you stop taking CellCept

You should talk to your doctor about the most suitable methods for birth control for you based on your individual situation.

Women who are capable of becoming pregnant must have a negative pregnancy test BEFORE starting treatment with CellCept.

You are a woman who is not capable of becoming pregnant if any of the following applies to you:

• You are post-menopausal, i.e. at least 50 years old and your last period was more than a year ago (if your periods have stopped because you have had treatment for cancer, then there is still a chance you could become pregnant).
• Your fallopian tubes and both ovaries have been removed (bilateral salpingo-oophorectomy).
• Your uterus has been surgically removed (hysterectomy).
• You have premature failure of the ovaries, confirmed by a specialist gynaecologist.
• You have been diagnosed with one of the following rare conditions that some patients are born with that make pregnancy impossible: the XY genotype, Turner?s syndrome or uterine agenesis.
• You are a child/teenager who has not started having periods, and cannot become pregnant.

Driving and using machines:
CellCept has not been shown to impair your ability to drive or operate machinery.

You will be given the intravenous infusion solution as your doctor has prescribed. The usual way to administer CellCept is as follows:

Kidney Transplant

The first dose should be given within 24 hours after the transplant operation. The recommended dose in renal transplant patients is 1 g administered twice daily (2 g daily dose).

Liver Transplant

The first dose of IV CellCept will be given as soon as possible following the transplant operation and will be continued for at least 4 days. The recommended daily dose of CellCept 500 mg powder for concentrate for solution for infusion in liver transplant patients is 1 g administered twice daily (2 g daily dose). Oral administration of CellCept will be initiated as soon as you can tolerate oral medication. The recommended dose of oral CellCept in liver transplant patients is 1.5 g administered twice daily (3 g daily dose).

Method and route of administration

CellCept 500 mg powder for concentrate for solution for infusion does not contain an antibacterial preservative; therefore, reconstitution and dilution of the product must be performed under aseptic conditions.

The content of CellCept 500 mg powder for concentrate for solution for infusion vials must be reconstituted with 14 ml of glucose intravenous infusion 5 % each. A further dilution with glucose intravenous infusion 5 % is required to a final concentration of 6 mg/ml. This means that to prepare a 1 g dose of mycophenolate mofetil the content of 2 reconstituted vials (approx. 2 x 15 ml) must be further diluted into 140 ml glucose intravenous infusion 5 % solution. If the infusion solution is not prepared immediately prior to administration, the commencement of administration of the infusion solution should be within 3 hours from reconstitution and dilution of the medicinal product.

Avoid skin contact with prepared solutions. If such contact occurs, wash thoroughly with soap and water; rinse eyes with plain water.

CellCept 500 mg powder for concentrate for solution for infusion must be given as intravenous infusion. The infusion flow rate should be controlled to equate a 2 hour period of administration.

CellCept IV solution should never be administered by rapid or bolus intravenous injection.

As soon as you are able to tolerate oral medication your doctor will switch you to CellCept capsules, tablets or oral suspension.

The duration of treatment will be decided by your doctor.

If too much CellCept IV solution is given:

If you know that the dose of CellCept IV solution given to you exceeds the dose recommended by the doctor, seek medical advice immediately.

If a dose of CellCept is missed:

If a dose of CellCept is missed, the dose should be administered as soon as possible. Further dosing should continue at the usual time.

Effects when treatment with CellCept is stopped:

Stopping your treatment with CellCept may increase the chance of rejection of your transplanted organ. Do not stop using your medicine unless your doctor tells you to.

If you have any further questions on the use of this product, ask your doctor.

Like all medicines, CellCept can have side effects, although not everybody gets them. Some of the more usual problems are diarrhoea, fewer white cells and/or red cells in your blood, infection and vomiting. Your doctor will do regular blood tests to monitor any changes in the number of your blood cells or changes in the levels of any of the substances carried in your blood, e.g. sugar, fat, cholesterol.

CellCept reduces your body?s own defence mechanisms to stop you rejecting your transplanted kidney or liver. Consequently your body will not be as good as normal at fighting infections. People receiving CellCept 500 mg powder for concentrate for solution for infusion therefore catch more infections than usual, such as infections of the brain, skin, mouth, stomach and intestines, lungs and urinary tract. As can happen in patients taking this type of medicine, a very small number of CellCept patients have developed cancer of the lymphoid tissues and skin.

General unwanted effects affecting your body as a whole could include hypersensitivity (such as anaphylaxis, angioeodema), fever, lethargy, difficulty in sleeping, pains (such as abdominal, chest, joint/muscle, pain on passing urine), headache, flu symptoms and swelling.

Other unwanted effects may include:

Disorders of the skin such as acne, cold sores, shingles, hair loss, rash,itching.

Urinary disorders such as kidney problems or the urgent need to pass urine.

Disorders of the digestive system and mouth such asconstipation, nausea, indigestion, pancreas inflammation, intestinal disorders including bleeding, inflammation of the stomach, liver problems, inflammation of the colon, loss of appetite, flatulence, swelling of the gums and mouth ulcers.

Disorders of the nerves and senses such as convulsions, tremor, depression, drowsiness, numbness, muscle spasms, changes in thinking or mood.

Metabolic, blood and vascular disorders such as weight loss, high blood sugar, bleeding, clots and bruises, change in blood pressure and abnormal heart beat may be seen. Other unwanted effects caused by the intravenous infusion include local inflammation of the veins.

Disorders of the lungs such as pneumonia, bronchitis, shortness of breath, cough, fluid on the lungs/chest cavity, sinus problems.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet during your treatment with CellCept, please tell your doctor or pharmacist.

Keep out of the reach and sight of children.

Do not use the powder for solution for infusion after the expiry date stated on the carton and on the vials (EXP).

Powder for concentrate for solution for infusion: do not store above 30 °C.

Reconstituted solution and the diluted solution: store at 15 ? 30 °C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What CellCept contains

• The active substance is mycophenolate mofetil.
• The other ingredients are:

CellCept 500 mg powder for concentrate for solution for infusion:
Polysorbate 80
citric acid
hydrochloric acid
sodium chloride.

What CellCept looks like and contents of the pack

20 ml type I clear glass vials with grey butyl rubber stopper and aluminium seals with plastic flip-off caps. CellCept 500 mg powder for concentrate for solution for infusion is available in packs containing 4 vials.

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.

Marketing Authorisation Holder

Roche Registration Limited
6 Falcon Way
Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Manufacturing Authorisation holder responsible for batch release
Roche Pharma AG, Emil Barell Str. 1, 79639 Grenzach Wyhlen, Germany.

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

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