Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
tacrolimus monohydrate, Quantity: 0.51 mg (Equivalent: tacrolimus, Qty 0.5 mg)
Pharmacor Pty Ltd
tacrolimus monohydrate
Capsule
Excipient Ingredients: dichloromethane; ethanol absolute; hypromellose; magnesium stearate; croscarmellose sodium; lactose; titanium dioxide; purified water; iron oxide yellow; Gelatin; sodium lauryl sulfate
Oral
100's [10x(1x10's)], 100's [2x(5x10's)]
(S4) Prescription Only Medicine
Tacrolimus is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.
Visual Identification: White to off white powder filled in size '5' yellow cap/body HGC printed with '0.5mg' on cap and 'Tacro' on body with red ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-04-29
__________________________________________________________________________________________________ PHARMACOR TACROLIMUS CMI Version 04 1 PHARMACOR TACROLIMUS CAPSULES _Tacrolimus monohydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET_ _ _ _ This leaflet answers some common questions about PHARMACOR TACROLIMUS Capsules. 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 PHARMACOR TACROLIMUS against the benefits this medicine is expected to have for you. If you have any concerns about using PHARMACOR TACROLIMUS ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again._ _ WHAT PHARMACOR TACROLIMUS 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 other 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. PHARMACOR TACROLIMUS stops this attack; it is very important to take PHARMACOR TACROLIMUS 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 PHARMACOR TACROLIMUS. PHARMACOR TACROLIMUS contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed PHARMACOR TACROLIMUS for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE PHARMACOR TACROLIMUS _WHEN YOU MUST NOT USE IT _ Do not use PHARMACOR TACROLIMUS if you have an allergy to: Any medicine containing tacrolimus or other macrolides (these are antibiotics of the erythromycin f Lue koko asiakirja
___________________________________________________________________________________ PHARMACOR TACROLIMUS PI Version 04 Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION - PHARMACOR TACROLIMUS (TACROLIMUS MONOHYDRATE) CAPSULES 1. NAME OF THE MEDICINE Tacrolimus (as monohydrate) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PHARMACOR TACROLIMUS 0.5 MG: Each capsule contains 0.5 mg tacrolimus. PHARMACOR TACROLIMUS 1 MG: Each capsule contains 1 mg tacrolimus. PHARMACOR TACROLIMUS 5 MG: Each capsule contains 5 mg tacrolimus. Contains Lactose. Gelatin (contains sulfites). For the full list of excipients, see SECTION 6.1 - LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM Capsules. PHARMACOR TACROLIMUS CAPSULES 0.5 MG: White to off white powder filled in size ‘5’ yellow cap/yellow coloured body HCG printed with “0.5mg” on cap and “Tacro” on body with red ink. PHARMACOR TACROLIMUS CAPSULES 1 MG: White to off white powder filled in size ‘5’ white cap/white coloured body HCG printed with “1 mg” on cap and “Tacro” on body with red ink. PHARMACOR TACROLIMUS CAPSULES 5 MG: White to off white powder filled in size ‘4’ greyish red cap/ greyish red coloured body HCG printed with “5 mg” on cap and “Tacro” on body with white ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PHARMACOR TACROLIMUS is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children. ___________________________________________________________________________________ PHARMACOR TACROLIMUS PI Version 04 Page 2 of 24 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The dosage recommendations given below for oral and intravenous administration (intravenous dosage form can be available from other brand/s) should act as a guideline. Tacrolimus doses should be adjusted according to individual patient requirements. If allograft rejection or adverse events occur, alteration in the immunosuppressive regimen should be considered. METHOD OF ADMINISTRATION It is recommended that the oral daily d Lue koko asiakirja