Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TACROLIMUS
Astellas Pharma Malaysia Sdn Bhd
TACROLIMUS
50capsule Capsules
ASTELLAS IRELAND CO., LTD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ ADVAGRAF ® PROLONGED-RELEASE HARD CAPSULES Tacrolimus (0.5 mg, 1 mg, 5 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Advagraf _ is used for 2. How _Advagraf _works 3. Before you use _Advagraf_ 4. How to use _Advagraf_ 5. While you are using it 6. Side effects 7. Storage and Disposal of_ Advagraf_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _ADVAGRAF_ IS USED FOR Following your organ transplant (liver, kidney), Advagraf is used to control your body’s immune response, enabling your body to accept the transplanted organ. You may also be given Advagraf for an ongoing rejection of your transplanted liver or kidney, when any previous treatment you were taking was unable to control this immune response after your transplantation. Advagraf is used in adults. HOW _ADVAGRAF_ WORKS Advagraf contains an active ingredient called tacrolimus. It belongs to a group of medicines called immunosuppressants. Advagraf reduces your body’s own defense mechanism to stop you rejecting your transplanted organ. BEFORE YOU USE _ADVAGRAF_ _- When you must not use it _ If you are allergic (hypersensitive) to: - tacrolimus or any of the other ingredients of Advagraf. - macrolide antibiotics (e.g. _erythromycin, clarithromycin, _ _josamycin)._ _- Before you start to use it _ Talk to your doctor or pharmacist before taking Advagraf. - If you have liver problems or have had a disease which may have affected your liver, please tell your doctor as this may affect the dose of Advagraf that you receive. - If you have an alteration of the electrical activity of your heart called QT prolongation. - If you have diarrhoea for more than one day, please tell your doctor, because it might be necessary to adapt the dose of Advagraf that you receive. - If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Advagraf passes into breast milk. Therefore, Olvassa el a teljes dokumentumot
NAME OF THE MEDICINAL PRODUCT ADVAGRAF® 0.5 mg prolonged-release hard capsules ADVAGRAF® 1 mg prolonged-release hard capsules ADVAGRAF® 5 mg prolonged-release hard capsules QUALITATIVE AND QUANTITATIVE COMPOSITION Prolonged-release hard capsule containing 0.5 mg, 1 mg and 5 mg tacrolimus on anhydrous basis (as 0.51 mg, 1.02 mg and 5.10 mg tacrolimus as monohydrate). PRODUCT DESCRIPTION Advagraf 0.5 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “0.5 mg” on the light yellow capsule cap and “ 647” on the orange capsule body, containing white powder. Advagraf 0.5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant. Packs of 50 prolonged-release capsules are available. Advagraf 1 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder. Advagraf 1 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant. Packs of 50 prolonged-release capsules are available. Advagraf 5 mg prolonged-release hard capsules are hard gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder. Advagraf 5 mg is supplied in blisters containing 10 capsules within a protective foil wrapper, including a desiccant. Packs of 50 prolonged-release hard capsules are available. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of kidney or liver allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult patients. POSOLOGY AND METHOD OF ADMINISTRATION Advagraf is a once-a-day oral formulation of tacrolimus. Advagraf therapy requires careful monitoring by adequately qualified and equipped personnel. This medicinal product should only be prescribed, and changes in im Olvassa el a teljes dokumentumot