Bula do remedy Simulect

the package insert of the medicine Simulect.

what For?

Prophylaxis of acute rejection of organs in transplant renal again, to be used concurrently on immunosuppressive treatment with cyclosporine for microemulsão and corticosteroids.

Contraindications

When should I not use?

Simulect is contraindicated to patients with known hypersensitivity to basiliximab or any other component of the formulation. Warnings: Simulect should be prescribed only by physicians experienced in the use of immunosuppressive therapy after organ transplantation. The experience of using Simulect with other drugs immunosuppressants, in addition to cyclosporine to microemulsão and corticosteroids, is limited. In the recommended dose, the Simulect was administered concomitantly with azathioprine in a restricted number of patients, while other patients received mycophenolate mofetil or therapy with antibodies, such as OCT 3 or ATG/ALG, on several occasions after the transplant. Although these patients do not present symptoms of hiperimunossupressão, the concomitant use of Simulect with other drugs immunosuppressants, in addition to cyclosporine to microemulsão and corticosteroids, may increase the potential for hiperimunossupressão. Pregnancy and lactation: no studies have been conducted in pregnant or lactating women. Simulect should not be given to pregnant women, except in cases where the potential benefit to the mother exceeds the potential risk to the fetus. Since Simulect is an antibody imunogloblina G (IgGdn4 1k), you can cross the human placenta and to be excreted in human milk. The women treated with Simulect should not breastfeed in the 8 weeks following the second dose. – Drug interactions and other forms of interaction: since Simulect is an immunoglobulin, it is not foreseen the occurrence of drug metabolic drug-drug. The antibody responses in human antimurínicos (HAMA) in patients treated with Simulect are rare. The use of Simulect does not preclude the subsequent treatment with preparations of antibodies antilinfocitários source murina.

Dosage

How to use?

Adults: the total dose standard is 40 mg, given in two doses of 20 mg. The first dose of 20 mg should be administered in the period of 2 hours prior to transplantation surgery. The second dose of 20 mg should be administered 4 days after transplant. The second dose should not be administered if you are experiencing post-operative complications, such as loss of the graft. Simulect composition can be administered in the form of intravenous infusion during 20 – 30 minutes or as an injection bolus. Children: experience with the use of Simulect in children is limited. The available pharmacokinetic data obtained in children with age equal to or greater than 2 years base the dosage indicated below. In patients with body weight less than 40 kg, the recommended dosage is 20 mg, administered in two doses of 10 mg. In pediatric patients with body weight equal to or greater than 40 kg, the recommended dosage is the adult dose, or a dosage of 40 mg, given in two doses of 20 mg. The first dose should be administered within 2 hours before transplant surgery. The second dose should be administered 4 days after transplant. The second dose should be omitted if you are experiencing post-operative complications, such as loss of the graft. Simulect composition can be administered both under the form of intravenous infusion during 20 – 30 minutes as in the injection bolus. Elderly: the available data on the use of Simulect in the elderly are limited; however, there is no evidence that elderly patients require a different dosage from that used in adult patients.

Side Effects

What are the evils that can cause me?

Simulect does not seem to contribute to increase the considerable panel of adverse effects observed in patients undergoing organ transplantation, as a result of the underlying disease and the concurrent administration of immunosuppressants and other medications. The effects referred to most frequently were constipation, urinary tract infection, pain, nausea, peripheral edema, hypertension, anemia, headaches, and except in cases of hyperkalemia. Not observed syndrome release of cytokines during or after the injection, making it unnecessary to steroid therapy prophylactic.