SIMULECT 20 mg
Simulect belongs to a group of medicines called immunosuppressants. Is given in hospital to adults, adolescents and children who have undergone renal transplantation. Immunosuppressants reduce the body's response to anything that it sees as "foreign", which includes transplanted organs. Body's immune system recognizes the transplanted organ as 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. They 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, when the likelihood of rejection is greatest. You will be given other medicines, such as ciclosporin and corticosteroids to help protect your new kidney during this period and after you leave hospital.
2. BEFORE YOU ARE GIVEN SIMULECT
Carefully follow your doctor's instructions. If you are not sure, ask your doctor, nurse or pharmacist.
Should 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". Tell your doctor if you think you may have had an allergic reaction to any of these ingredients in the past.
- If you are pregnant or breastfeeding.
Take special care with Simulect
- If you have previously received a transplant that has failed after a short period of time or,
if you have previously been in the operating theater for a transplantation that in the end has not been made. In these cases, you may have received Simulect. Your doctor will check this for you and discuss with you the possibility of repeated treatment with Simulect.
If you need to be vaccinated first consult your doctor.
Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In elderly patients (aged 65 years and over)
Simulect can be administered to the elderly, but the information available is limited. Your doctor will 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 weighing less than 35 kg will be smaller than the dose which is usually administered to adults.
Pregnancy and lactation
It is important to tell your doctor before your transplant if you are pregnant or think you may be pregnant. You should not apply Simulect, if you are pregnant. You must use adequate contraception during treatment and up to 4 months after receiving the last dose of Simulect. If, despite the use of contraceptive measures become pregnant during this period, you should inform your doctor immediately.
It is also necessary to inform your doctor if you are breastfeeding. Simulect, can harm your child. Should not breast-feed after being given Simulect or up to 4 months after the second dose.
Ask your doctor, nurse or pharmacist before taking any medicine while pregnant or breast-feeding.
Driving and using machines
There is no evidence to indicate that Simulect has an effect on your ability to drive and use machines.
3. HOW YOU WILL BE GIVEN SIMULECT?
Simulect will be given only if you get 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 had a severe allergic reaction to Simulect or complications after surgery such as graft loss, the second dose of Simulect you will not be made.
The first dose will be given just before the transplant operation, and the second four days after surgery.
Usual dose for adults
The usual adult dose is 20 mg in each infusion or injection.
Usual dose for children and adolescents (aged 1 to 17 years)
- For children and adolescents weighing 35 kg or more, the dose of Simulect, given in each infusion or injection is 20 mg.
- For children and adolescents weighing less than 35 kg, the dose of Simulect, given in each infusion or injection is 10 mg.
If you receive more than you should Simulect
Not expected overdose of Simulect can cause side effects straight away, but it may weaken your immune system for a long period of time. Your doctor will monitor you for any effects on your immune system and treat them if necessary.
4. 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 taking Simulect, or during the 8 weeks afterwards, even if you think you may be drug-related.
Sudden severe allergic reactions in patients treated with Simulect. Tell your doctor or nurse 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, fainting, shortness of breath, sneezing, wheezing or difficulty breathing, severe reduction in the amount of urine or fever and flu-like symptoms.
In adults, the most commonly reported side effects were constipation, nausea, diarrhea, weight increase, headache, pain, swelling of hands, ankles or feet, high blood pressure, anemia, changes in blood chemistry (eg. Potassium, cholesterol , phosphate, creatinine), surgical wound complications, and various kinds of infections.
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.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or nurse.
5. HOW TO STORE SIMULECT?
Store in a refrigerator (2 ° C - 8 ° C). Keep out of the reach and sight of children.
6. FURTHER INFORMATION
- The active substance is basiliximab. Each vial contains 20 mg 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 is in the form of powder in a colorless glass vial containing 20 mg of basiliximab. Supplied in a pack with a colorless glass ampoule containing 5 ml sterile water for injections. This solvent is used to dissolve the powder before it is given to you.
Simulect is also available in vials with 10 mg basiliximab.