Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Tacrolimus 0.5mg
Research Associates Ltd
Tacrolimus 0.5 mg
0.5 mg
Capsule
Active: Tacrolimus 0.5mg Excipient: Croscarmellose sodium Gelatin Hypromellose Iron oxide yellow Lactose monohydrate Magnesium stearate Purified water Titanium dioxide
Blister pack, PVC/PVdC, in Al pillows/Si gel, 100 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, in Al pillows/Si gel - 100 capsules - 36 months unopened stored at or below 25°C 12 months opened stored at or below 25°C
2000-04-17
PROGRAF ® 1 PROGRAF ® _CAPSULES, CONCENTRATED INJECTION _ _Tacrolimus _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROGRAF Capsules and PROGRAF Concentrated Injection. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PROGRAF against the benefits this medicine is expected to have for you. If you have any concerns about using PROGRAF ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT PROGRAF IS USED FOR You have been given a new transplanted liver or kidney, lung or heart from another person because your own was no longer healthy. Your body recognises that this new organ is different from your organs and will try to reject it by attacking it in the same way that it would attack germs that enter your body. This could make you become ill again. PROGRAF stops this attack; it is very important to take PROGRAF given to you by your doctor regularly so that your new liver, kidney, lung or heart will not be attacked or rejected. If you have been taking other medicines for this purpose, but are still feeling unwell, your doctor may change your treatment and begin giving you PROGRAF. PROGRAF contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed PROGRAF for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE PROGRAF _WHEN YOU MUST NOT USE IT _ Do not use PROGRAF if • you have an allergy to tacrolimus, other macrolides (these are antibiotics of the erythromycin Read the complete document
1 PROGRAF(130927)DDS DATA SHEET NAME OF MEDICINE PROGRAF ® Tacrolimus PROGRAF 0.5mg 1 mg, 5 mg Capsules PROGRAF 5mg/mL Concentrated Injection Molecular Formula: C 44 H 69 NO 12 .H 2 0 Molecular Weight: 822.05 PRESENTATION CAPSULES PROGRAF capsules 0.5mg: light yellow, hard gelatine capsules with ‘0.5mg’ and ‘[f]607 printed in red. Each capsule contains 0.5 mg tacrolimus. PROGRAF capsules 1mg: white, hard gelatin capsules with '1 mg' and '[f]617' printed in red. Each capsule contains 1 mg tacrolimus. PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with '5 mg' and '[f]657' printed in white. Each capsule contains 5 mg tacrolimus. PROGRAF capsules are supplied as blister strips each containing 10 capsules packed within a protective aluminium wrapper. The 1 mg and 5 mg capsules should be stored below 30°C and the 0.5 mg capsules below 25°C. After opening the aluminium wrapper, Prograf 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. CONCENTRATED INJECTION PROGRAF concentrate for infusion 5 mg/mL: colourless, clear, sterile liquid in transparent glass ampoules. Each mL of concentrate for infusion contains 5 mg tacrolimus together with PEG-60 hydrogenated castor oil and ethanol. 2 PROGRAF(130927)DDS PROGRAF concentrate for infusion should be protected from light and stored below 25°C. Once an ampoule is opened, the contents should be used immediately. Following reconstitution in either 5% w/v glucose solution in polyethylene or glass containers or in 0.9% Sodium Chloride Injection in polyethylene containers, the resulting infusion mixture is stable for 24 hours. USES ACTIONS Tacrolimus is an immunosuppressan Read the complete document