Instruction for use: Simulect

Dosage form: Lyophilizate for the preparation of a solution for intravenous administration

Active substance: Basiliximabum

ATX

L04AC02 Basiliximab

Pharmacological group:

Immunodepressants

The nosological classification (ICD-10)

T86.1 Kidney transplant death and rejection: Reaction of acute rejection of a transplanted kidney; Refractory tissue rejection in patients after allogeneic kidney transplantation

Z94.0 Presence of transplanted kidney: Allogeneic kidney transplantation; Allogeneic kidney transplant; Kidney allograft; Allotransplantation of the kidney; Kidney Transplantation

Composition

Lyophilizate for the preparation of a solution for intravenous administration 1 vial.

active substance: Basiliximab 20 mg

Auxiliary substances: sodium hydrophosphate anhydrous - 0.992 mg; Sodium chloride - 1,608 mg; Potassium dihydrogen phosphate - 7.212 mg; Sucrose - 20 mg; Glycine - 40 mg; Mannitol - 80 mg

Is supplied complete with a solvent: water for injection - 5 ml

Pharmachologic effect

Mode of action - immunosuppressive.

Dosing and Administration

IV.

For adults, the recommended dose is 40 mg, divided into 2 injections of 20 mg.

For children and adolescents (aged 1 to 17 years) with a body weight of less than 35 kg, the recommended total dose is 20 mg divided into 2 injections of 10 mg; If the body weight is 35 kg or more, the preparation of Simulect® is prescribed in a total dose of 40 mg divided into 2 injections of 20 mg.

There is limited information on the use of the preparation of Simulect® in elderly patients (65 years and older). There is no data that would indicate the need for a change in the dosing regimen compared to the recommendations for younger patients.

The first administration is performed 2 hours before the transplantation operation. The introduction of the preparation Simulect® is possible only in the case of absolute certainty that the transplantation will be performed and the patient will be prescribed basic immunosuppressive therapy.

The second administration of 20 mg of Simulect® is carried out 4 days after the operation. From the introduction of the second dose should be refrained in case of loss (rejection) of the transplant or the development of reactions of hypersensitivity to the introduction of the first dose.

Recommendations for the preparation of solution for injection or infusion

Solution for injection or infusion is prepared in aseptic conditions.

In a vial containing 20 mg of lyophilizate for the preparation of a solution for injection, add 5 ml of water for injection from the enclosed ampoule. It is necessary to shake the bottle gently before dissolving the powder. The prepared solution should be transparent or slightly opalescent, colorless, should not contain visible inclusions. It is desirable to use the solution immediately after preparation, but it is possible to store not more than 4 hours at a temperature (20-22 ° C) or not more than 24 hours at a temperature of 2-8 ° C.

If the solution has not been used under the appropriate storage conditions for the specified time, it should be destroyed.

The resulting solution of Simulect® is isotonic and can be administered as a bolus injection. To prepare a solution for infusion, the resulting solution is adjusted to a volume of at least 50 ml with a 0.9% solution of sodium chloride or 5% glucose solution. Duration of infusion is 20-30 minutes.

The preparation of Simulect® should be administered with a separate system and not mixed with other preparations for IV administration.

The compatibility of the solution with the following infusion systems was tested and established: Baxter minibag NaCl infusion bag 0,9%; Systems for infusions Luer Lock ™, N. Noolens; Sterile vented i.v. Set, Abbott; Infusion set, Codan; Infusomat ™, Braun; Infusiongerat R 87 plus, Ohmeda; Lifecare 5000 ™ Plumset Microdrip, Abbott; Vented basic set, Baxter; Flashball device, Baxter; Vented primary administration set, Imed.

Compatibility with other commercial systems was not tested.

Release Form

Lyophilizate for the preparation of a solution for intravenous administration, 20 mg. 1 fl. Colorless glass with 1 amp. Solvent (5 ml of water for injection), packed in a cardboard box.

Manufacturer

Novartis Pharma AG, Switzerland.

Produced

Novartis Pharma Stein AG, Switzerland.

Lichtstraße, 35, 4056, Basel, Switzerland.

Novartis Pharma AG, Switzerland.

Manufactured by Novartis Pharma Stein AG, Switzerland.

Lichtstrasse 35, 4056 Basel, Switzerland.

For more information about the product, contact:

115035, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Simulect

At a temperature of 2-8 ° C. After cooking - 24 h (at a temperature of 2-8 ° C) and 4 h (at a temperature of 15-25 ° C)

Keep out of the reach of children.

Shelf life of the drug Simulect

3 years.

Do not use after the expiry date printed on the package.