20 mg powder and solvent <\/p>\n\n\n\n
for solution for injection or infusion basiliximab Simulect belongs to a group of medicines called immunosuppressive medicines.\u00a0It is given to adults, adolescents, and children who have a kidney transplant and are in hospital.\u00a0Immunosuppressive drugs reduce the body’s reactions to what it considers ‘foreign’, e.g.\u00a0transplanted organs.\u00a0The body’s immune system perceives a transplanted organ as a foreign body and therefore tries to repel it.\u00a0Select works by stopping the immune cells that attack transplanted organs.<\/p>\n\n\n\n You only get two\u00a0doses\u00a0of Simulect.\u00a0These are given in hospitals, in connection with the transplant.\u00a0Simulect 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.\u00a0You will also receive other medicines that help protect the new kidney during this period and after you leave the hospital, e.g.\u00a0ciclosporin and\u00a0corticosteroids. <\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n <\/p>\n\n\n\n Follow your doctor’s instructions carefully.\u00a0If you are not sure, talk to your doctor, nurse, or\u00a0pharmacist.<\/p>\n\n\n\n You must not be given Simulect<\/strong><\/p>\n\n\n\n Talk to your doctor, nurse, or pharmacist before giving Simulect:<\/p>\n\n\n\n In these situations, you may have received Simulect. Your doctor will check this and discuss the possibility of repeated Simulect treatment with you.<\/p>\n\n\n\n If you need to be vaccinated, you must first ask your doctor for advice.<\/p>\n\n\n\n Other medicines and Simulect<\/strong><\/p>\n\n\n\n Tell your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n Elderly patients (65 years and older)<\/strong><\/p>\n\n\n\n Select can be given to elderly patients, but available information is limited.\u00a0Your doctor may discuss this with you before you receive Simulect.<\/p>\n\n\n\n Children and adolescents (1\u201317 years)<\/strong><\/p>\n\n\n\n Select can be given to children and adolescents.\u00a0Dose\u00a0one for children weighing less than 35 kg is lower than that usually given to adults.<\/p>\n\n\n\n You must tell your doctor before the transplant if you are or think you may be pregnant.\u00a0You must not be given Simulect if you are pregnant.\u00a0You must use adequate contraception to prevent pregnancy during treatment and up to 4 months after receiving the last\u00a0dose\u00a0of Simulect.\u00a0If you become pregnant during this time despite the use of contraceptives, you should inform your doctor immediately.<\/p>\n\n\n\n You should also tell your doctor if you are breastfeeding.\u00a0Simulect can harm the baby.\u00a0You must not breastfeed after being given Simulect or for up to 4 months after the second\u00a0dose.<\/p>\n\n\n\n If you are pregnant or breastfeeding, ask your doctor, nurse, or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n There is no indication that Simulect would affect your ability to drive or use machines.<\/a><\/p>\n\n\n\n This medicine contains less than 1 mmol (23 mg)\u00a0sodium\u00a0per\u00a0vial, ie essentially ‘sodium-free’.<\/p>\n\n\n\n This medicine contains less than 1 mmol (39 mg)\u00a0potassium\u00a0per\u00a0vial, ie essentially ‘potassium-free’. Simulect is only given to patients who get a new kidney.\u00a0Simulect is given twice in hospital.\u00a0The treatment is given either as a slow\u00a0infusion\u00a0into a vein for 20-30 minutes or as an\u00a0intravenous\u00a0injection\u00a0with a\u00a0syringe.<\/p>\n\n\n\n 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.<\/p>\n\n\n\n The first dose is given immediately before the transplant operation and the second dose is given 4 days after the operation.<\/p>\n\n\n\n The usual\u00a0dose\u00a0for adults<\/strong><\/p>\n\n\n\n The usual\u00a0dose\u00a0for adults is 20 mg in each\u00a0infusion\u00a0or\u00a0injection.<\/p>\n\n\n\n The usual\u00a0dose\u00a0for children and adolescents (1-17 years)<\/strong><\/p>\n\n\n\n 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.<\/a><\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Tell your doctor or nurse as soon as possible if you experience unexpected symptoms<\/strong>\u00a0during treatment with Simulect or for 8 weeks afterward, even if you do not suspect that they may be related to Simulect.<\/p>\n\n\n\n Sudden severe allergic reactions have been reported in patients treated with Simulect.\u00a0If you notice sudden signs of\u00a0allergy\u00a0such as rash,\u00a0itching\u00a0or\u00a0hives\u00a0on 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.<\/p>\n\n\n\n In adults, the most common\u00a0side effects\u00a0are constipation, nausea, diarrhea, weight gain, headache, pain, swelling of the hands, ankles, or feet, high\u00a0blood pressure,\u00a0anemia, changes in e.g.\u00a0potassium,\u00a0cholesterol,\u00a0phosphate,\u00a0or creatinine in the blood, wound complications after surgery and various types of\u00a0infections.<\/p>\n\n\n\n In children, the most common\u00a0side effects\u00a0are constipation, heavy hair growth, runny or stuffy nose, fever, high\u00a0blood pressure,\u00a0and various types of\u00a0infection.<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Do not use this medicine after the expiry date which is stated on the carton and the label after EXP.\u00a0The expiration date is the last day of the specified month.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat Simulect is and what it is used for<\/h2>\n\n\n\n
<\/p>\n\n\n\n3.<\/h2>\n\n\n\n
What you need to know before you receive Simulect<\/h2>\n\n\n\n
Warnings and cautions<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
Driving and using machines<\/h2>\n\n\n\n
Select contains sodium and potassium<\/h2>\n\n\n\n
<\/p>\n\n\n\nHow Simulect is given<\/h2>\n\n\n\n
If you get more Simulect than you should<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
How to store Simulect<\/h2>\n\n\n\n