Prospecto: information for the user

Simulect 20mg powder and solvent for injectable solution or for infusion

basiliximab

Read this prospect carefully before starting to receive this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, nurse or pharmacist.
• If you experience adverse effects, consult your doctor, nurse or pharmacist, even if they are not listed in this prospect. See section4.

1.What Simulect is and for what it is used

2.What you need to know before starting to receive Simulect

3.How to receive Simulect

4.Possible adverse effects

5.Storage of Simulect

6.Contents of the package and additional information

Simulect belongs to a group of medications known as immunosuppressants. It is administered in the hospital to adults, adolescents, and children who are about to undergo a kidney transplant. Immunosuppressants reduce the body's response to elements it recognizes as«foreign»– which include transplanted organs. The body's immune system recognizes a transplanted organ as a foreign body and will attempt to reject it. Simulect works by stopping the immune cells that attack transplanted organs.

You will only receive two doses of Simulect. These will be administered to you in the hospital, around the time of your transplant surgery.Simulect is administered to prevent rejection of the new organ during the first4 to6weeks after transplant surgery, a time when rejection is more likely. During this time and after leaving the hospital, you will be taking other medications that will help protect your new kidney, such as cyclosporine and corticosteroids.

Follow your doctor's instructions carefully. If you have any doubts, consult your doctor, nurse, or pharmacist.

You should not receive Simulect

-if you are allergic (hypersensitive) to basiliximab or to any of the other components of Simulect included in section6 in “Composition of Simulect”. Inform your doctor if you suspect you have had an allergic reaction to any of these components in the past.

-if you are pregnant or breastfeeding.

Warnings and precautions

Consult your doctor, nurse, or pharmacist before starting to receive 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 the operating room for a transplant that was ultimately not performed.

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

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

Other medications and Simulect

Inform your doctor, nurse, or pharmacist if you are using, have used recently, or may need to use any other medication.

Persons aged 65or older

Simulect can be administered to persons aged 65 or older, although the available information is limited. Your doctor will discuss this with you before administering Simulect.

Children and adolescents (1 to 17years)

Simulect can be administered to children and adolescents. The dose for children weighing less than35kgshould be smaller than the usual adult dose.

Pregnancy and lactation

It is very important to inform your doctor before your transplant if you are pregnant or think you may be pregnant. You should not receive Simulect if you are pregnant. You should use an appropriate contraceptive method to prevent pregnancy during treatment and for 4months after receiving the last dose of Simulect. Inform your doctor immediately if you become pregnant during this time, despite using contraceptive measures.

You should also inform your doctorif you are breastfeeding. Simulect may harm your baby. You should not breastfeed after receiving Simulect or for 4months after the second dose.

Consult your doctor, nurse, or pharmacist before using any medication while you are pregnant or breastfeeding.

Driving and operating machinery

There is no evidence to indicate that Simulect affects your ability to drive a vehicle or operate machinery.

Simulect contains sodium and potassium

This medication contains less than 23mg of sodium (1mmol) per vial; this is essentially “sodium-free”.

This medication contains less than 39mg (1mmol) of potassium per vial, so it is considered essentially “potassium-free”.

Simulect will only be administered to you if you are to receive a new kidney. Simulect is administered twice, in the hospital, either slowly administered 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 severe allergic reactions to Simulect or have suffered complications after your operation such as graft loss, you should not be administered the second dose of Simulect.

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

Normal dose for adults

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

Normal dose for children and adolescents (1 to 17 years)

• For children and adolescents weighing 35 kg or more, the dose of Simulect administered per infusion or injection is 20 mg.
• For children and adolescents weighing less than 35 kg , the dose of Simulect administered per infusion or injection is 10 mg.

If you have received too much Simulect

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Inform your doctor or nurse as soon as possible if you observe any unexpected symptomswhile receiving Simulect, or during the 8weeks following, even if you do not believe it is related to the medication.

Severe unexpected allergic reactions have been reported in patients treated with Simulect. Inform your doctor or nurse immediately if you observe unexpected allergy symptoms such as skin rash, itching, or hives, facial swelling, lip, tongue, or other body part swelling, rapid heart rate, dizziness, confusion, shortness of breath, sneezing, rapid breathing, or difficulty breathing, significant decrease in urine production, or fever and symptoms similar to the flu.

The most commonly reported adverse effects in adults were constipation, nausea, diarrhea, weight gain, headache, pain, hand, ankle, and foot inflammation, high blood pressure, anemia, changes in hematological parameters (e.g., potassium, cholesterol, phosphate, creatinine), surgical wound complications, and various types of infections.

The most commonly reported adverse effects in children were constipation, excessive body hair growth, nasal discharge or blocked nose, fever, high blood pressure, and various types of infections.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, nurse, or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and label after CAD/EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Composition of Simulect

• The active ingredient is basiliximab. Each vial contains 20mg of basiliximab.
• The other components aredihydrogen phosphate potassium; anhydrous hydrogen phosphate of sodium; sodium chloride; sucrose; mannitol (E421); glycine.

Appearance of Simulect and contents of the container

Simulect is presented as a white powder in a colourless glass vial containing 20mg of basiliximab. It is presented in a container together with a colourless glass ampoule containing 5ml of sterile water for injection preparations. This solvent is used to dissolve the powder before it is administered.

Simulect is also presented in vials with 10mg of basiliximab.

Marketing authorisation holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible for manufacturing

Novartis Farmacéutica S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

You can request more information about this medicine by contacting the local representative of the marketing authorisation holder:

Last update of this leaflet:

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu

INSTRUCTIONS FOR RECONSTITUTION AND ADMINISTRATION

This information is intended only for healthcare professionals:

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

To prepare the solution for infusion or injectable solution, add the 5ml of water for injection preparations from the ampoule to the vial containing the Simulect powder, using aseptic techniques. Gently shake the vial to dissolve the powder, avoiding foam formation. It is recommended that the colourless, transparent to opalescent solution be used immediately after reconstitution. The reconstituted products should be visually inspected to check for the absence of particles in suspension before administration. Do not use if there are foreign particles present. After reconstitution, physical and chemical stability has been demonstrated in use for 24hours at 2?C‑8?C or for 4hours at room temperature. Discard the reconstituted solution if it is not used within that time. From a microbiological point of view, the product should be used immediately. If not used immediately, the time of use and conditions before use will be the responsibility of the user.

Simulect reconstituted is administered as an intravenous infusion over20 to30minutes or as a bolus injection.The reconstituted solution is isotonic.To administer by infusion, the reconstituted solution should be diluted to a volume of 50ml or more with 50mg/ml (5%) of normal saline solution or glucose.The first dose should be administered during the two hours preceding the transplant operation, and the second dose 4días after the transplant.The second dose should not be administered if severe hypersensitivity reactions to Simulect occur or if the graft is lost.

Since there is no information available on the compatibility of Simulect with other intravenous substances, Simulect should not be mixed with other medications/substances and should be administered through a separate infusion line.

Compatibility with the following infusion equipment has been verified:

Infusion bag

• Baxter minibag NaCl 0.9%

Infusion equipment

• LuerLock®, H. Noolens
• IV administration equipment with sterile vent, Abbott
• Infusion equipment, Codan
• Infusomat®, Braun
• Infusionsgerät R 87 plus, Ohmeda
• Lifecare 5000®?Plumset Microdrip, Abbott
• Basic administration equipment with vent, Baxter
• Flashball, Baxter
• Primary administration equipment with vent, Imed

Do not use once the expiry date on the container has passed.

Store in refrigerator (between 2?C and 8?C).

The disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.