SIMULECT 10 mg POWDER AND SOLVENT FOR SOLUTION FOR INJECTION OR SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the User

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

basiliximab

Read all of this leaflet carefully before you start receiving 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, nurse or pharmacist.
• If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Simulect and what is it used for
2. What you need to know before you receive Simulect
3. How Simulect is given
4. Possible side effects
5. Storage of Simulect
6. Contents of the pack and further information

1. What is Simulect and what is it used for

Simulect belongs to a group of medicines called immunosuppressants. It is given in hospital to adults, adolescents and children who are going to have a kidney transplant. Immunosuppressants reduce your body's response to things it recognises as 'foreign' - including transplanted organs. Your immune system recognises a transplanted organ as a foreign body and will try to reject it. Simulect works by stopping the immune cells that attack the transplanted organ.

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

2. What you need to know before you receive Simulect

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

You must not receive Simulect

• if you are allergic (hypersensitive) to basiliximab or any of the other ingredients of Simulect listed in section 6.
• if you are pregnant or breast-feeding.

Warnings and precautions

Tell your doctor, nurse or pharmacist before you start receiving Simulect:

• if you have previously received a transplant that your body rejected after a short period of time, or
• if you have previously been in an operating theatre for a transplant that was not carried out in the end.

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

If you need to receive a vaccine, consult your doctor first.

Other medicines and Simulect

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines.

Elderly (65 years or over)

Simulect can be given to elderly people, however, the information available is limited. Your doctor will discuss this with you before giving you Simulect.

Children and adolescents (from 1 to 17 years)

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

Pregnancy and breast-feeding

It is very important that you inform your doctor before your transplant if you are pregnant or think you might be pregnant. You must not receive Simulect if you are pregnant. You must use an effective method of contraception to prevent pregnancy during treatment and for 4 months after receiving the last dose of Simulect. You must inform your doctor immediately if you become pregnant during this time, even if you are using contraception.

You must also inform your doctor if you are breast-feeding. Simulect may harm your baby. You must not breast-feed after receiving Simulect or for 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 suggest that Simulect affects your ability to drive or use machines.

Simulect contains sodium and potassium

This medicine contains less than 23 mg of sodium (1 mmol) per vial; this is essentially 'sodium-free'. This medicine contains less than 39 mg (1 mmol) of potassium per vial, and is therefore considered to be 'potassium-free'.

3. How Simulect is given

You will only be given Simulect if you are going to receive a new kidney. Simulect is given twice, in hospital, either as a slow infusion into a vein over 20-30 minutes or as an intravenous injection using a syringe.

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

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

Normal dose for children and adolescents (from 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.

Normal dose for adults

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

If you receive too much Simulect

An overdose of Simulect is unlikely to cause immediate side effects, however, it may prolong the time during which the activity of your immune system is reduced. Your doctor will monitor you to see if this has any consequences for your immune system and will treat them if necessary.

4. Possible side effects

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

Tell your doctor or nurse as soon as possible if you notice any unexpected symptomswhile you are receiving Simulect, or during the 8 weeks following, even if you do not think they are related to the medicine.

Severe unexpected allergic reactions have been reported in patients treated with Simulect. Tell your doctor or nurse immediately if you notice any unexpected symptoms of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, rapid heartbeat, dizziness, fainting, difficulty breathing, sneezing, wheezing or difficulty breathing, significant decrease in urine production or flu-like symptoms.

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. Storage of Simulect

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C - 8°C).

6. Contents of the pack and 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 hydrogen phosphate anhydrous; sodium chloride; sucrose; mannitol (E421); glycine.

What Simulect looks like and contents of the pack

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

Simulect is also presented in vials with 20 mg of basiliximab.

Marketing Authorisation Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Manufacturer

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Farmacéutica S.A.

Ronda de Santa Maria, 158

08210 Barberà del Vallès, Barcelona

Spain

You can get more information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION

This information is intended only for healthcare professionals:

Simulect must not be administered unless it is certain that the patient will receive the graft and concomitant immunosuppression.

To prepare the solution for infusion or injection, add the 5 ml of water for injections from the ampoule to the vial containing the Simulect powder, using aseptic techniques. Gently swirl the vial to dissolve the powder, avoiding the formation of foam. It is recommended that the clear to opalescent solution is used immediately after reconstitution. Reconstituted products must be inspected visually for particulate matter and discolouration prior to administration. Do not use if particulate matter or discolouration is present. After reconstitution, the physical and chemical stability has been demonstrated for 24 hours at 2°C - 8°C or for 4 hours at room temperature. The reconstituted solution should be discarded if not used within this time. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user.

Reconstituted Simulect is administered as an intravenous infusion over 20 to 30 minutes or as a bolus injection. The reconstituted solution is isotonic. For infusion, the reconstituted solution must be diluted to a volume of 50 ml or more with 50 mg/ml (5%) sodium chloride solution or glucose solution. The first dose must be administered during the 2 hours before the transplant operation, and the second dose 4 days after the transplant. The second dose must not be administered if severe hypersensitivity reactions to Simulect or graft loss occur.

Since no data are available on the compatibility of Simulect with other intravenous substances, Simulect must not be mixed with other medicinal products or substances and must always be administered through a separate infusion line.

Compatibility has been verified with the following infusion equipment:

Infusion bag

• Baxter minibag NaCl 0.9%

Infusion equipment

• Luer Lock, H. Noolens
• Intravenous administration set with sterile vent, Abbott
• Infusion set, Codan
• Infusomat, Braun
• Infusionsgerät R 87 plus, Ohmeda
• Lifecare 5000 Plumset Microdrip, Abbott
• Basic set with vent, Baxter
• Flashball device, Baxter
• Primary administration set with vent, Imed

Do not use after the expiry date stated on the packaging.

Store in a refrigerator (2°C - 8°C).

Disposal of unused medicine and all materials that have been in contact with it should be done in accordance with local regulations.