Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
tacrolimus monohydrate, Quantity: 5.1 mg (Equivalent: tacrolimus, Qty 5 mg)
Pharmacor Pty Ltd
tacrolimus monohydrate
Capsule
Excipient Ingredients: dichloromethane; lactose; magnesium stearate; croscarmellose sodium; ethanol absolute; hypromellose; titanium dioxide; purified water; iron oxide red; Gelatin; sodium lauryl sulfate
Oral
50's [1x(5x10's)], 50's [5x(1x10'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 '4' greyish red cap/body HGC printed with '5 mg' on cap and 'Tacro' on body with white ink; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-04-29
__________________________________________________________________________________________________ TACROLIMUS APOTEX CMI Version 06 1 TACROLIMUS APOTEX CAPSULES _Tacrolimus monohydrate _ CONSUMER MEDICINE INFORMATION _FOR _ _A _ _COPY _ _OF _ _A _ _LARGE _ _PRINT _ _LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET_ _ _ _ This leaflet answers some common questions about TACROLIMUS APOTEX 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 TACROLIMUS APOTEX against the benefits this medicine is expected to have for you. If you have any concerns about using TACROLIMUS APOTEX ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again._ _ WHAT TACROLIMUS APOTEX 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. TACROLIMUS APOTEX stops this attack; it is very important to take TACROLIMUS APOTEX 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 APOTEX. TACROLIMUS APOTEX contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed TACROLIMUS APOTEX for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE TACROLIMUS APOTEX _WHEN YOU MUST NOT USE IT _ Do not use TACROLIMUS APOTEX if you have an allergy to: Any medicine containing tacrolimus or other macrolides (thes Lue koko asiakirja
___________________________________________________________________________________ TACROLIMUS APOTEX PI Version 05 Page 1 of 22 AUSTRALIAN PRODUCT INFORMATION TACROLIMUS APOTEX (TACROLIMUS MONOHYDRATE) CAPSULES 1 NAME OF THE MEDICINE Tacrolimus (as monohydrate). 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 0.5 mg, 1 mg or 5 mg tacrolimus. EXCIPIENTS WITH KNOWN EFFECT Lactose, gelatin (contains sulfites). For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TACROLIMUS APOTEX CAPSULES 0.5 MG: White to off white powder filled in size ‘5’ yellow cap/yellow coloured body HGC printed with “0.5 mg” on cap and “Tacro” on body with red ink. TACROLIMUS APOTEX CAPSULES 1 MG: White to off white powder filled in size ‘5’ white cap/white coloured body HGC printed with “1 mg” on cap and “Tacro” on body with red ink. TACROLIMUS APOTEX CAPSULES 5 MG: White to off white powder filled in size ‘4’ greyish red cap/ greyish red coloured body HGC printed with “5 mg” on cap and “Tacro” on body with white ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children. 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 dose of Tacrolimus APOTEX be administered as two divided doses, in the morning and in the evening. Tacrolimus APOTEX capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximum absorption (Refer to section 5.2 PHARMACOKINETIC PROPERTIES - Lue koko asiakirja