Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
tacrolimus monohydrate, Quantity: 0.767 mg (Equivalent: tacrolimus, Qty 0.75 mg)
Sandoz Pty Ltd
lactose monohydrate,tacrolimus monohydrate
Capsule
Excipient Ingredients: hypromellose; croscarmellose sodium; magnesium stearate; Gelatin; titanium dioxide; iron oxide yellow; brilliant blue FCF; lactose monohydrate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
20 capsules, 28 capsules, 60 capsules, 30 capsules, 10 capsules, 14 capsules, 90 capsules, 7 capsules, 50 capsules, 100 capsules
(S4) Prescription Only Medicine
Adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.
Visual Identification: Capsule with light green opaque body and cap imprinted in black 0.75 mg on cap; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-11-25
TACROLIMUS SANDOZ ® 1 TACROLIMUS SANDOZ ® _tacrolimus monohydrate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Tacrolimus Sandoz. 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 this medicine against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT TACROLIMUS SANDOZ 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 Sandoz stops this attack; it is very important to take Tacrolimus Sandoz given to you by your doctor regularly so you’re 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 Sandoz. Tacrolimus Sandoz contains the active ingredient tacrolimus. Tacrolimus belongs to a group of medicines called macrolide lactones, which is an immunosuppressive agent. It is very important to take Tacrolimus Sandoz, given to you by your doctor, regularly so that your new liver, kidney, lung or heart will not be attacked or rejected. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE TACROLIMUS SANDOZ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE THIS MEDICINE IF YOU HAVE AN ALLERGY TO Belgenin tamamını okuyun
201008-Tacrolimus Sandoz-pi Page 1 of 24 AUSTRALIAN PRODUCT INFORMATION TACROLIMUS SANDOZ ® (TACROLIMUS MONOHYDRATE) CAPSULES 1. NAME OF THE MEDICINE Tacrolimus monohydrate 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Tacrolimus Sandoz ® 0.5 mg capsules contains 0.5 mg Tacrolimus (as monohydrate). Each Tacrolimus Sandoz ® 0.75 mg capsules contains 0.75 mg Tacrolimus (as monohydrate). Each Tacrolimus Sandoz ® 1.0 mg capsules contains 1.0 mg Tacrolimus (as monohydrate). Each Tacrolimus Sandoz ® 2.0 mg capsules contains 2.0 mg Tacrolimus (as monohydrate). Each Tacrolimus Sandoz ® 5.0 mg capsules contains 5.0 mg Tacrolimus (as monohydrate). _Excipients with known effect: _ Each tablet contains sugars (as lactose monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Tacrolimus Sandoz 0.5 mg: White to off-white powder filled in size “4” capsule with white coloured opaque body and ivory coloured cap. Tacrolimus Sandoz 0.75 mg: White to off-white powder filled in size “4” capsule with light green opaque body and cap, imprinted in black with 0.75 mg on cap. Tacrolimus Sandoz 1 mg: White to off-white powder filled in size “4” capsule with white coloured opaque body and light brown coloured cap. Tacrolimus Sandoz 2 mg: White to off-white powder filled in size “4” capsule with dark green opaque body and cap, imprinted in black with 2 mg on cap. Tacrolimus Sandoz 5 mg: White to off-white powder filled in size “3” capsule with white coloured opaque body and Swedish orange coloured cap. _Not all strengths may be marketed in Australia. _ _Not all strengths may be marketed in New Zealand. _ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS Adjunct to liver, kidney, lung or heart allograft transplantation in adults and children. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE The dosage recommendations given below for oral administration should act as a guideline. Tacrolimus doses should be adjusted according to individual patient requirements. 20 Belgenin tamamını okuyun