Simulect 10mg powder and solvent for solution for injection or infusion

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Simulect 10 mg powder and solvent for solution for injection or infusion

Basiliximab

Read all of this leaflet carefully before you are given this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor, nurse or pharmacist. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist. In this leaflet: 1. What Simulect is and what it is used for 2. Before you are given Simulect 3. How Simulect is given to you 4. Possible side effects 5. How to store Simulect 6. Further information What Simulect Is And What It Is Used For

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents and children who are having a kidney transplant. Immunosuppressants reduce the body’s response to anything that it sees as "foreign" – which includes transplanted organs. The body’s immune system thinks a transplanted organ is a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack transplanted organs.

You will only be given two doses of Simulect. These will be given in hospital, around the time of your transplant operation. Simulect is given to stop your body from rejecting the new organ during the first 4 to 6 weeks after the transplant operation, when rejection is most likely. You will be given other medicines to help protect your new kidney during this time, such as ciclosporin and corticosteroids and after you leave hospital.

Before You Are Given Simulect

Follow your doctor’s instructions carefully. If you are unsure about anything, ask your doctor, nurse or pharmacist.

You must not be given Simulect if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6 under "What Simulect contains". Tell your doctor if you suspect you may have had an allergic reaction to any of these ingredients in the past. if you are pregnant or breast-feeding. Take special care with Simulect if you have previously received a transplant that failed after only a short time or, if you have previously been in the operating theatre for a transplantation that in the end was not performed.

In this situation, you may have received Simulect. Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.

Using other medicines

Please tell your doctor, nurse or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.

Older patients (aged 65 years and over)

Simulect can be given to older patients, but the information available is limited. Your doctor may discuss this with you before you are given Simulect.

Children and adolescents (aged 1 to 17 years)

Simulect can be given to children and adolescents. The dose for children who weigh less than 35 kg will be smaller than the dose usually given to adults.

Pregnancy and breast-feeding

It is very important to tell your doctor before your transplant if you are pregnant or you think that you may be pregnant. You must not be given Simulect if you are pregnant. You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last dose of Simulect. If you become pregnant during this time, despite the use of contraceptive measures, you should tell your doctor immediately.

You should also tell your doctor if you are breast-feeding. Simulect may harm your baby. You must not breast-feed after being given Simulect or up to 4 months after the second dose.

Ask your doctor, nurse or pharmacist for advice before taking any medicine while you are pregnant or breast-feeding.

Driving and using machines

There is no evidence to indicate that Simulect has an effect on your ability to drive a car or use machines.

How Simulect Is Given To You

You will only be given Simulect if you are receiving a new kidney. Simulect is given twice, in hospital, either slowly through a needle in your vein as an infusion lasting 20–30 minutes or as an intravenous injection using a syringe.

If you have experienced a severe allergic reaction to Simulect or if you had complications after your surgery such as graft loss, the second dose of Simulect should not be given to you.

The first dose is given just before the transplant operation, and the second dose 4 days after the operation.

Usual dose for children and adolescents (aged 1 to 17 years) For children and adolescents who weigh less than 35 kg, the dose of Simulect given in each infusion or injection is 10 mg. For children and adolescents who weigh 35 kg or more, the dose of Simulect given in each infusion or injection is 20 mg. Usual dose for adults

The usual dose for adults is 20 mg in each infusion or injection.

If you are given too much Simulect

An overdose of Simulect is not likely to cause side effects straight away, but it may weaken your immune system for longer. Your doctor will watch out for any effects on your immune system and treat them if necessary.

Possible Side Effects

Like all medicines, Simulect can cause side effects, although not everybody gets them.

Tell your doctor or nurse as soon as possible if you get any unexpected symptoms while you are being given Simulect, or during the 8 weeks afterwards, even if you do not think that they are related to the medicine.

Sudden severe allergic reactions have been reported in patients treated with Simulect. If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness, light headedness, shortness of breath, wheezing or trouble breathing or flu-like symptoms, tell your doctor or nurse immediately.

In children, the most commonly reported side effects were constipation, excessive growth of normal hair, runny or blocked nose, fever, high blood pressure, and various kinds of infections.

In adults, the most commonly reported side effects were constipation, nausea, diarrhoea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anaemia, changes in blood chemistry (e.g. potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various kinds of infections.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

How To Store Simulect

Store in a refrigerator (2°C - 8°C).

Keep out of the reach and sight of children.

Further Information What Simulect contains The active substance is basiliximab. Each vial contains 10 mg of basiliximab. The other ingredients are: potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine. What Simulect looks like and contents of the pack

Simulect comes as a white powder in a colourless glass vial containing 10 mg of basiliximab. It is supplied in a pack with a colourless glass ampoule containing 5 ml sterile water for injections. 2.5 ml of the sterile water is used to dissolve the powder before it is given to you.

Simulect is also available in vials with 20 mg basiliximab.

Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex RH12 5AB United Kingdom Manufacturer Novartis Pharma S.A.S. 26, rue de la Chapelle F-68333 Huningue France

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

United Kingdom Novartis Pharmaceuticals UK Ltd. Tel:+44 1276 698370

This leaflet was last approved in 10 / 2008

Simulect 10mg powder and solvent for solution for injection or infusion

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