20 mg powder and solvent
for solution for injection or infusion basiliximab
What Simulect is and what it is used for
Simulect belongs to a group of medicines called immunosuppressive medicines. It is given to adults, adolescents, and children who have a kidney transplant and are in hospital. Immunosuppressive drugs reduce the body’s reactions to what it considers ‘foreign’, e.g. transplanted organs. The body’s immune system perceives a transplanted organ as a foreign body and therefore tries to repel it. Select works by stopping the immune cells that attack transplanted organs.
You only get two doses of Simulect. These are given in hospitals, in connection with the transplant. Simulect is given to prevent the body from rejecting the new organ during the first 4 to 6 weeks after the transplant when the risk of a rejection reaction is greatest. You will also receive other medicines that help protect the new kidney during this period and after you leave the hospital, e.g. ciclosporin and corticosteroids.
3.
What you need to know before you receive Simulect
Follow your doctor’s instructions carefully. If you are not sure, talk to 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 “Contents of contents”). Tell your doctor if you think you have had an allergic reaction to any of these substances before.
- if you are pregnant or breastfeeding.
Warnings and cautions
Talk to your doctor, nurse, or pharmacist before giving Simulect:
- if you have previously undergone a transplant that failed shortly afterward, or,
- if you have previously been to an operating room to undergo a transplant that was not performed in the end.
In these situations, you may have received Simulect. Your doctor will check this and discuss the possibility of repeated Simulect treatment with you.
If you need to be vaccinated, you must first ask your doctor for advice.
Other medicines and Simulect
Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Elderly patients (65 years and older)
Select can be given to elderly patients, but available information is limited. Your doctor may discuss this with you before you receive Simulect.
Children and adolescents (1–17 years)
Select can be given to children and adolescents. Dose one for children weighing less than 35 kg is lower than that usually given to adults.
Pregnancy and breastfeeding
You must tell your doctor before the transplant if you are or think 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 contraceptives, you should inform your doctor immediately.
You should also tell your doctor if you are breastfeeding. Simulect can harm the baby. You must not breastfeed after being given Simulect or for up to 4 months after the second dose.
If you are pregnant or breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking any medicine.
Driving and using machines
There is no indication that Simulect would affect your ability to drive or use machines.
Select contains sodium and potassium
This medicine contains less than 1 mmol (23 mg) sodium per vial, ie essentially ‘sodium-free’.
This medicine contains less than 1 mmol (39 mg) potassium per vial, ie essentially ‘potassium-free’.
How Simulect is given
Simulect is only given to patients who get a new kidney. Simulect is given twice in hospital. The treatment is given either as a slow infusion into a vein for 20-30 minutes or as an intravenous injection with a syringe.
If you have had a severe allergic reaction to Simulect or if you have had complications after your operation, e.g. transplant loss, the second Simulect dose should not be given to you.
The first dose is given immediately before the transplant operation and the second dose is given 4 days after the operation.
The usual dose for adults
The usual dose for adults is 20 mg in each infusion or injection.
The usual dose for children and adolescents (1-17 years)
- For children and adolescents weighing 35 kg or more, 20 mg Simulect is given in each infusion or injection.
- For children and adolescents weighing less than 35 kg, Simulect 10 mg is given in each infusion or injection.
If you get more Simulect than you should
Overdose with Simulect probably has no immediate effect, but may weaken your immune system for a long time. Your doctor is vigilant for any side effects on the immune system and treats them as needed.
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 experience unexpected symptoms during treatment with Simulect or for 8 weeks afterward, even if you do not suspect that they may be related to Simulect.
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, rapid heartbeat, dizziness, intoxication, shortness of breath, sneezing, wheezing or difficulty breathing, greatly reduced urine production or fever and flu symptoms, tell your doctor or nurse immediately.
In adults, the most common side effects are constipation, nausea, diarrhea, weight gain, headache, pain, swelling of the hands, ankles, or feet, high blood pressure, anemia, changes in e.g. potassium, cholesterol, phosphate, or creatinine in the blood, wound complications after surgery and various types of infections.
In children, the most common side effects are constipation, heavy hair growth, runny or stuffy nose, fever, high blood pressure, and various types of infection.
How to store 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 the label after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Contents of the packaging and other information
Content declaration
- The active substance is basiliximab. Each vial contains 20 mg of basiliximab.
- The other ingredients are potassium dihydrogen phosphate, anhydrous disodium phosphate, sodium chloride, sucrose, mannitol (E421), and glycine.
What the medicine looks like and the contents of the pack
Simulect is supplied as a white powder in a colorless glass vial containing 20 mg basiliximab. It comes in a package together with a colorless glass ampoule containing 5 ml of sterile water for injections. This diluent is used to dissolve the powder before it is given.
Simulect is also available in vials containing 10 mg basiliximab.
Marketing Authorisation Holder
Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland
Manufacturer
Novartis Pharmacéutica SA
Gran Via de Les Corts Catalanes, 764
08013 Barcelona
Spain
Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany
Contact the representative of the marketing authorization holder to find out more about this medicine:
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