País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
tacrolimus, Quantity: 1 mg
Accord Healthcare Pty Ltd
Tacrolimus
Capsule, hard
Excipient Ingredients: hypromellose; Gelatin; ethanol absolute; lactose; titanium dioxide; purified water; magnesium stearate; methyl chloride; croscarmellose sodium; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
10 capsules in blister pack, 100 capsules in blister pack, 50 capsules in blister pack
(S4) Prescription Only Medicine
Indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children
Visual Identification: White / White hard gelatin capsules, size "4" imprinted with "TCR" on cap & "ABZ 1" on body containing white to off white granular powder.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2015-05-27
TACROLIMUS ACT CONSUMER MEDICINE INFORMATION Version: 1.0 -2015- Page: 1 of 4 TACROLIMUS ACT (TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG) _Tacrolimus (as monohydrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tacrolimus ACT. 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 Tacrolimus ACT against the benefits this medicine is expected to have for you. If you have any concerns about using Tacrolimus ACT ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT TACROLIMUS ACT 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. Tacrolimus ACT stops this attack; it is very important to take Tacrolimus ACT 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 Tacrolimus ACT. Tacrolimus ACT contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed Tacrolimus ACT for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU TAKE TACROLIMUS ACT _WHEN YOU MUST NOT USE IT _ Do not use Tacrolimus ACT if • you have an allergy to tacrolimus, other macrolides (these are antibiotics of the erythromycin family - trade names are Eryc, EES, Klacid, Zithromax, Rulide and Biaxsig) or any of the ingredients contained in the capsules. See ‘Product Leia o documento completo
Tacrolimus ACT (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version 1.0 -2015- Page 1 of 21 PRODUCT INFORMATION TACROLIMUS ACT (TACROLIMUS CAPSULES 0.5 MG, 1 MG AND 5 MG) NAME OF THE MEDICINE Tacrolimus (as monohydrate) _[3S-_ _[3R*[E(1S*,3S*,4S*)],4S*,5R*,8S*,9E,12R*,14R*,15S*,16R*,18S*,19S*,26aR*]]-_ _5,6,8,11,12,13,14,15,16,17,18,19,24,25,26,26a_ -hexadecahydro-5,19-dihydroxy-3-[2- (4-hydroxy- 3-methoxycyclohexyl)-1-methylethenyl]-14,16-dimethoxy-4,10,12,18- tetramethyl-8-(2-propenyl)-15,19-epoxy-3H-pyrido [2,1-c] [1,4]oxaazacyclotricosine- 1,7,20,21(4H,23H)-tetrone, monohydrate. Molecular Formula: C 44 H 69 NO 12 .H 2 O Molecular Weight: 822.03. CAS 109581-93-3 DESCRIPTION Tacrolimus appears as white crystals or a crystalline powder, very soluble in methanol, and chloroform, freely soluble in acetone and ethanol and practically insoluble in hexane and water. Tacrolimus is obtained by fermentation as a single enantiomer but exists in tautomeric equilibration in aqueous solution. Tacrolimus ACT capsules also contain hypromellose, croscarmellose sodium, lactose anhydrous and magnesium stearate. The capsule shell contains gelatin, water-purified and titanium dioxide and a dye (iron oxide yellow (E172) for 0.5 mg capsules and iron oxide red (E172) for 5 mg capsules). The capsules also have a trace of TekPrint SW-9008 black ink (ARPING Number: 2328), which contains shellac, propylene glycol, ammonia, iron oxide black and potassium hydroxide. PHARMACOLOGY Tacrolimus ACT (Tacrolimus Capsules 0.5 mg, 1 mg and 5 mg) Version 1.0 -2015- Page 2 of 21 Tacrolimus 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 primarily responsible for graft rejection. Tacrolimus suppresses T-cell activation and T-helper-cell-dependent B-cell proliferation, as well as the formation of lymphokines such as interleukins-2 and -3 and gamma-interferon and the expression of the interleukin-2 receptor Leia o documento completo