Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
TACROLIMUS
Ascend Laboratories Sdn Bhd
TACROLIMUS
50 Capsules; 100 Capsules
Alkem Laboratories Limited
_CONSUMER MEDICINE INFORMATION LEAFLET (RIMUP) _ TRANSGRAF _Tacrolimus Capsule _ (0.5 mg, 1 mg, 5 mg) 1 WHAT IS IN THIS LEAFLET 1. What _Transgraf _ is used for 2. How _Transgraf _ works _3._ _ _ Before you use _Transgraf _ _4._ _ _ How to use _Transgraf _ _5._ _ _ While you are using _Transgraf _ 6. Side effects _7._ _ _ Storage and disposal of _Transgraf _ 8. Product description 9. Manufacturer and Product registration holder 10. Date of revision WHAT _TRANSGRAF _IS USED FOR _Transgraf _ is used to control your body’s immune response enabling your body to accept the transplanted liver or kidney. _Transgraf _ is often used in combination with other medicines that also suppress the immune system. You may also be given _Transgraf _ 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. or pharmacist for advice before taking any medicine. - _Transgraf _ contains lactose. If you have been old by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. _-Before you start to use it _ - You will need to take _Transgraf _ every day as long as you need immunosuppression to prevent rejection of your transplanted organ. You should keep in regular contact with your doctor. - Whilst you are taking _Transgraf _ your doctor may want to carry out a number of tests (including blood, urine, heart function, visual and neurological tests) from time to time. This is quite normal and will help your doctor to decide on the most appropriate dose of _Transgraf _ for you. - Please avoid taking any herbal remedies, e.g. St. John’s wort (Hypericum perforatum) or any other herbal products _Transgraf _ blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking _Transgraf _ which may require an increase or decrease in _Transgraf _ dose. In particular, you should tell your doctor if you are taking or Preberite celoten dokument
TRANSGRAF CAPSULE ( 0.5/1/5 MG) TACROLIMUS CAPSULES USP NAME AND STRENGTH OF ACTIVE SUBSTANCE Tacrolimus Monohydrate COMPOSITION: 1. TRANSGRAF CAPSULE 0.5 MG Each Hard gelatin capsule contains : Tacrolimus USP (as Monohydrate) equivalent to Tacrolimus .....0.5mg Colour : Titanium Dioxide and Yellow Iron Oxide 2. TRANSGRAF CAPSULE 1 MG Each hard gelatin capsule contains : Tacrolius USP (as Monohydrate) equivalent to Tacrolimus ...........1mg Colour : Titanium Dioxide 3. TRANSGRAF CAPSULES 5 MG Each hard gelatin capsule contains : Tacrolimus USP (as Monohydrate) equivalent to Tacrolimus ........5mg Colour : Titanium Dioxide, Red iron oxide PRODUCT DESCRIPTION TRANSGRAF CAPSULE 0.5 MG White to off white powder filled in size "5" yellow coloured cap/yellow coloured body hard gelatin capsules printed with "0.5 mg" on cap and "Tacro" on body with red ink. TRANSGRAF CAPSULE 1 MG White to off white powder filled in size "5" white coloured cap/white coloured body hard gelatin capsules printed with "1 mg" on cap and "Tacro" on body with red ink. TRANSGRAF CAPSULES 5 MG White to off white powder filled in size "4" greyish red coloured cap/greyish red coloured body hard gelatin capsules printed with "5 mg" on cap and "Tacro" on body with white ink. PHARMACODYNAMICS Pharmacotherapeutic group: Calcineurin inhibitors, ATC code: L04AD02 Mechanism of action and pharmacodynamic effects At the molecular level, the effects of tacrolimus appear to be mediated by binding to a cytosolic protein (FKBP12) which is responsible for the intracellular accumulation of the compound. The FKBP12-tacrolimus complex specifically and competitively binds to and inhibits calcineurin, leading to a calcium-dependent inhibition of T-cell signal transduction pathways, thereby preventing transcription of a discrete set of lymphokine genes. Tacrolimus is a highly potent immunosuppressive agent and has proven activity in both in vitro and in vivo experiments. In particular, tacrolimus inhibits the formation of cytotoxic lymphocytes, which are mainly respons Preberite celoten dokument