Țară: Malaezia
Limbă: engleză
Sursă: 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)_ PROGRAF ® Tacrolimus (0.5 mg, 1 mg, 5 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Prograf _ is used for 2. How _Prograf _works 3. Before you use _Prograf_ 4. How to use _Prograf_ 5. While you are using it 6. Side effects 7. Storage and Disposal of _Prograf_ 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT _PROGRAF_ IS USED FOR Prograf is used to control your body’s immune response enabling your body to accept the transplanted liver or kidney. Prograf is often used in combination with other medicines that also suppress the immune system. You may also be given Prograf for an ongoing rejection of your transplanted liver or kidney, or if any previous treatment you were taking was unable to control this immune response after your transplantation. HOW _PROGRAF_ WORKS Prograf contains an active ingredient called tacrolimus. It belongs to a group of medicines called immunosuppressants. Prograf reduces your body’s own defence mechanism to stop you rejecting your transplanted organ. BEFORE YOU USE _PROGRAF_ - _When you must not use it _ _- _If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Prograf. _- _If you are allergic (hypersensitive) to macrolide antibiotics (e.g. _erythromycin, clarithromycin, _ _josamycin). _ _Pregnancy and lactation _ 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. Prograf is excreted into breast milk. Therefore, you should not breast-feed whilst receiving Prograf. Prograf contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Prograf. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’. The printing ink used on Prograf capsules 0.5 mg and 1 mg contains soya lecithin. If you are allergic to peanut or soya, talk t Citiți documentul complet
1 TRADEMARK PROGRAF NAME OF PRODUCT Prograf Capsules 0.5 mg, Prograf Capsules 1 mg, Prograf Capsules 5 mg and Prograf Concentrate for Infusion 5 mg/ml QUALITATIVE AND QUANTITATIVE COMPOSITION Hard gelatin capsules containing 0.5 mg,1 mg and 5 mg tacrolimus on anhydrous basis. Concentrate for intravenous infusion containing tacrolimus 5 mg per 1 ml. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Primary immunosuppression in liver and kidney allograft recipients and liver and kidney allograft rejection resistant to conventional immunosuppressive agents. It is recommended that Prograf be used concomitantly with adrenal corticosteroids. Because of the risk of anaphylaxis, Prograf Injection should be reserved for patients unable to take Prograf capsules only. ONLY FOR PROGRAF CAPSULES 0.5 MG AND 1 MG Lupus nephritis (in a case where the effect of steroids is insufficient or administration of steroids is difficult because of their adverse reactions). For lupus nephritis, the efficacy and safety of this product for patients in an acute phase with high disease activity has not been established. POSOLOGY AND METHOD OF ADMINISTRATION Prograf therapy requires careful monitoring by adequately qualified and equipped personnel. The medicinal product should only be prescribed, and changes in immunosuppressive therapy initiated, by physicians experienced in immunosuppressive therapy and the management of transplant patients. For patients with lupus nephritis, this product should be prescribed by physicians experienced in lupus nephritis therapy. The dosage recommendations given below for oral and intravenous administration are intended to act as a guideline. Prograf doses should be adjusted according to individual patient requirements. Dosing should commence orally, if necessary via an intranasal gastric tube. If the clinical condition of the patient does not allow oral therapy, initial intravenous dosing may be necessary. Dosage Level Recommendations Initial dose level recommendation. Primary Immunosuppression Dose Levels – Adu Citiți documentul complet