Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Tacrolimus 5mg
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
Tacrolimus 5 mg
5 mg
Modified release capsule
Active: Tacrolimus 5mg Excipient: Ethanol Ethylcellulose Gelatin Hypromellose Opacode S-1-15083 red (trace, see TT70-) Iron oxide red Iron oxide yellow Lactose monohydrate Magnesium stearate Sodium laurilsulfate Titanium dioxide
Blister pack, PVC/PVDC/Alu, 30 capsules, 30 capsules
Prescription
Prescription
Astellas Pharma Tech Co Limited
Primary immunosuppression in liver, kidney, pancreas, kidney-pancreas, lung or heart allograft recipients and rescue use in liver, kidney or other solid organ (heart, lung, pancreas or kidney-pancreas) transplantation, that has either failed conventional immunosuppressive agents, or where such agents are producing intolerable side effects.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Alu, 30 capsules - 30 capsules - 36 months from date of manufacture stored at or below 25°C
2009-01-08
_ _ 1 PROGRAF XL(130927)DDS DATA SHEET NAME OF MEDICINE PROGRAF-XL Tacrolimus PROGRAF-XL 0.5 mg, 1 mg, 5 mg Prolonged-release Capsules Molecular Formula: C 44 H 69 NO 12 .H 2 0 Molecular Weight: 822.05 PRESENTATION PROGRAF-XL 0.5 mg prolonged-release capsules: oblong capsules with a light yellow cap imprinted with “0.5 mg” and an orange body imprinted with “ 647”. PROGRAF-XL 1 mg prolonged-release capsules: oblong capsules with a white cap imprinted with “1 mg” and an orange body imprinted with “ 677”. PROGRAF-XL 5 mg prolonged-release capsules: oblong capsules with a greyish red cap imprinted with “5 mg” and an orange body imprinted with “ 687”. PROGRAF-XL prolonged-release capsules contain hypromellose, ethylcellulose, lactose and magnesium stearate. The capsule shells contain gelatin, titanium dioxide, iron oxide yellow CI77492, iron oxide red CI77491 and sodium lauryl sulfate. The capsules also have a trace of printing ink, Opacode S-1-15083 red, which contains shellac, soya lecithin, simethicone and iron oxide red CI77491. PROGRAF-XL prolonged-release capsules are supplied as blister strips each containing 10 capsules packed within a protective aluminium wrapper. The capsules should be stored below 25°C. After opening the aluminium wrapper, PROGRAF-XL capsules are stable for 12 months when stored at room temperature. The blister strips should be kept in a dry place and the capsules should be left in the blister until required for use. _ _ 2 PROGRAF XL(130927)DDS USES ACTIONS Tacrolimus is an immunosuppressant. It is a macrolide lactone with potent_ in vitro_ and_ in _ _vivo_ immunosuppressive activity. Studies suggest that tacrolimus inhibits the formation of cytotoxic lymphocytes which are regarded as being Aqra d-dokument sħiħ