Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
basiliximab
Novartis Europharm Limited
L04AC02
basiliximab
Immunosuppressants
Graft Rejection; Kidney Transplantation
Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years).It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.
Revision: 28
Authorised
1998-10-09
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE LABEL 1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Simulect Water for injections 2. METHOD OF ADMINISTRATION See package leaflet 3. EXPIRY DATE EXP 4. BATCH NUMBER Lot 5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 ml 6. OTHER 34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX FOR PACK CONTAINING 1 POWDER VIAL AND 1 SOLVENT AMPOULE 1. NAME OF THE MEDICINAL PRODUCT Simulect 10 mg powder and solvent for solution for injection or infusion basiliximab 2. STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 10 mg of basiliximab. 3. LIST OF EXCIPIENTS It also contains potassium dihydrogen phosphate; disodium phosphate, anhydrous; sodium chloride; sucrose; mannitol (E421); glycine. The solvent ampoule contains 5 ml water for injections. 4. PHARMACEUTICAL FORM AND CONTENTS Powder and solvent for solution for injection or infusion 1 vial with 10 mg powder 1 ampoule with 5 ml solvent 5. METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use. Intravenous use 6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE SIGHT AND REACH OF CHILDREN Keep out of the sight and reach of children. 7. OTHER SPECIAL WARNING(S), IF NECESSARY 8. EXPIRY DATE EXP Use immediately after reconstitution (chemically and physically stable at 2°C - 8°C for 24 hours or at room temperature for 4 hours). 35 9. SPECIAL STORAGE CONDITIONS Store in a refrigerator. 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Novartis Europharm Limited Vista Building Elm Park, Merrion Road Dublin 4 Ireland 12. MARKETING AUTHORISATION NUMBER(S) EU/1/98/084/002 13. BATCH NUMBER Lot 14. GENERAL CLASSIFICATION FOR SUPPLY 15. INSTRUCTIONS ON USE Please open here. 16. INFORMATION IN BRAILLE Justification for not including Braille accepted. 17. UNIQUE IDENTIFIER – 2D BARCODE_ _ 2D Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Simulect 20 mg powder and solvent for solution for injection or infusion Simulect 20 mg powder for solution for injection or infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg basiliximab*. One ml of the reconstituted solution contains 4 mg basiliximab. * recombinant murine/human chimeric monoclonal antibody directed against the interleukin-2 receptor -chain (CD25 antigen) produced in a mouse myeloma cell line by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Simulect 20 mg powder and solvent for solution for injection or infusion Powder and solvent for solution for injection or infusion White powder Simulect 20 mg powder for solution for injection or infusion Powder for solution for injection or infusion White powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Simulect is indicated for the prophylaxis of acute organ rejection in _de novo_ allogeneic renal transplantation in adult and paediatric patients (1-17 years) (see section 4.2). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Simulect should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Simulect should be administered under qualified medical supervision. Simulect MUST NOT be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression. Simulect is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression. It can be used in a ciclosporin for microemulsion- and corticosteroid-based triple i Прочетете целия документ