Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TACROLIMUS
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
TACROLIMUS
50 Capsules; 100 Capsules
Sandoz Private Limited
TACROLIMUS SANDOZ Tacrolimus (0.5mg, 1mg, 5mg) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ WHAT IS IN THIS LEAFLET 1. What Tacrolimus Sandoz is used for 2. How Tacrolimus Sandoz works 3. Before you use Tacrolimus Sandoz 4. How to use Tacrolimus Sandoz 5. While you are using it 6. Side effects 7. Storage and Disposal of Tacrolimus Sandoz 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TACROLIMUS SANDOZ IS USED FOR Tacrolimus Sandoz is used to control your body’s immune response enabling your body to accept the transplanted liver or kidney. Tacrolimus Sandoz is often used in combination with other medicines that also suppress the immune system. You may also be given Tacrolimus Sandoz 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 TACROLIMUS SANDOZ WORKS Tacrolimus Sandoz contains an active ingredient called tacrolimus. It belongs to a group of medicines called immunosuppressants. Tacrolimus Sandoz reduces your body’s own defense mechanism to stop you rejecting your transplanted organ. BEFORE YOU USE _TACROLIMUS SANDOZ_ - _When you must not use it _ • If you are allergic (hypersensitive) to tacrolimus or any of the other ingredients of Tacrolimus Sandoz • 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. Tacrolimus Sandoz is excreted into breast milk. Therefore you should not breast-feed whilst receiving Tacrolimus Sandoz. Tacrolimus Sandoz contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Tacrolimus Sandoz. - _Before you start to use it _ Talk to your doctor or pharmacist before tak Baca dokumen lengkap
1 1. NAME OF THE MEDICINAL PRODUCT Tacrolimus Sandoz 0.5 mg capsule Tacrolimus Sandoz 1 mg capsule Tacrolimus Sandoz 5 mg capsule 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tacrolimus Sandoz 0.5 mg capsule Each capsule contains 0.5 mg tacrolimus (as tacrolimus monohydrate). Excipient(s): Each capsule contains 48.5 mg lactose monohydrate. Tacrolimus Sandoz 1 mg capsule Each capsule contains 1 mg tacrolimus (as tacrolimus monohydrate). Excipient(s): Each capsule contains 47.4 mg lactose monohydrate. Tacrolimus Sandoz 5 mg capsule Each capsule contains 5 mg tacrolimus (as tacrolimus monohydrate). Excipient(s): Each capsule contains 236.9 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Capsules, hard. Tacrolimus Sandoz 0.5 mg capsule White to off-white powder filled in size “4” capsule with white opaque body imprinted with ‘0.5’ in black and ivory opaque cap. Tacrolimus Sandoz 1 mg capsule White to off-white powder filled in size “4” capsule with white opaque body imprinted with ‘1’ in black and light brown opaque cap. Tacrolimus Sandoz 5 mg capsule White to off-white powder filled in size “3” capsule with white opaque body imprinted with ‘5’ in black and Swedish orange opaque cap. 4. CLINICAL PARTICULARS 4.1 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 Tacrolimus Sandoz be used concomitantly with adrenal corticosteroids. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tacrolimus Sandoz 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. The dosage recommendations given below for oral and intravenous administration are intended to act as a guideline. Tacrolimus San Baca dokumen lengkap