Ülke: İsrail
Dil: İngilizce
Kaynak: Ministry of Health
TACROLIMUS AS MONOHYDRATE
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
L04AD02
CAPSULES PROLONGED RELEASE
TACROLIMUS AS MONOHYDRATE 1 MG
PER OS
Required
ASTELLAS IRELAND CO. LTD, IRELAND
TACROLIMUS
Prophylaxis of transplant rejection in adult kidney or liver allograft recipients.Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult kidney or liver allograft recipient patients.
2019-11-30
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS)-1986 THE MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY ADVAGRAF 5 MG PROLONGED RELEASE CAPSULES ADVAGRAF 3 MG PROLONGED RELEASE CAPSULES ADVAGRAF 1 MG PROLONGED RELEASE CAPSULES ADVAGRAF 0.5 MG PROLONGED RELEASE CAPSULES COMPOSITION: Tacrolimus (as monohydrate) 5 mg Tacrolimus (as monohydrate) 3 mg Tacrolimus (as monohydrate) 1 mg Tacrolimus (as monohydrate) 0.5 mg READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their medical condition appears to be similar. This medicine is not intended for children or adolescents under the age of 18. 1. WHAT IS THE MEDICINE USED FOR? Prevention of graft rejection after a kidney or liver transplant. Treatment of graft rejection after a kidney or liver transplant, when there is resistance to other immunosuppressive drugs. THERAPEUTIC GROUP: immunosuppressant. 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE: • If you are sensitive (allergic) to tacrolimus or to any of the additional ingredients that the medicine contains. • If you are sensitive (allergic) to sirolimus or to antibiotics of the macrolide family (such as erythromycin, clarithromycin, josamycin). SPECIAL WARNINGS FOR USING THE MEDICINE: Prograf and Advagraf contain both the active substance, tacrolimus. However, Advagraf is taken once daily, whereas Prograf is taken twice daily. This is because Advagraf capsules allow for a prolonged release (more slow release over a longer period) of tacrolimus. Advagraf and Prograf are not interchangeable. You must update the doctor or the pharmacist in the following cases: • If you are taking a medicine in the list appearing in the next section (“if you are taking or have recently taken medicines…”). • If you have or Belgenin tamamını okuyun
1 1. NAME OF THE MEDICINAL PRODUCT Advagraf 0.5 mg prolonged-release hard capsules. Advagraf 1 mg prolonged-release hard capsules. Advagraf 3 mg prolonged-release hard capsules. Advagraf 5 mg prolonged-release hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Advagraf 0.5 mg: Each prolonged-release hard capsule contains 0.5 mg tacrolimus (as monohydrate). Advagraf 1 mg: Each prolonged-release hard capsule contains 1 mg tacrolimus (as monohydrate). Advagraf 3 mg: Each prolonged-release hard capsule contains 3 mg tacrolimus (as monohydrate). Advagraf 5 mg: Each prolonged-release hard capsule contains 5 mg tacrolimus (as monohydrate). Excipients with known effect: Advagraf 0.5 mg: Each capsule contains 51.09 mg lactose. Advagraf 1 mg: Each capsule contains 102.17 mg lactose. Advagraf 3 mg: Each capsule contains 306.52 mg lactose. Advagraf 5 mg: Each capsule contains 510.9 mg lactose. The printing ink used to mark the capsule contains trace amounts of soya lecithin (0.48% of total printing ink composition). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release hard capsule. Advagraf 0.5 mg: 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 1 mg: Gelatin capsules imprinted in red with “1 mg” on the white capsule cap and “ 677” on the orange capsule body, containing white powder. Advagraf 3 mg: Gelatin capsules imprinted in red with “3 mg” on the orange capsule cap and “ 637” on the orange capsule body, containing white powder. Advagraf 5 mg: Gelatin capsules imprinted in red with “5 mg” on the greyish red capsule cap and “ 687” on the orange capsule body, containing white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis of transplant rejection in adult kidney or liver allograft recipients. Treatment of allograft rejection resistant to treatment with other immunosuppressive medicinal products in adult k Belgenin tamamını okuyun