Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Tacrolimus monohydrate 5.11mg equivalent to 5 mg tacrolimus
Sandoz New Zealand Limited
Tacrolimus monohydrate 5.11 mg (= 5 mg tacrolimus)
5 mg
Capsule
Active: Tacrolimus monohydrate 5.11mg equivalent to 5 mg tacrolimus Excipient: Croscarmellose sodium Hypromellose Lactose monohydrate Magnesium stearate Opaque orange G3ICS000767
Blister pack, PVC/PE/PVdC/Al, 50 capsules, 50 capsules
Prescription
Prescription
Lek Pharmaceuticals d.d.
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 kidneys) transplantation, that has either failed conventional immunosuppressive agents, or where such agents are producing intolerable side effects.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al, 50 capsules - 50 capsules - 24 months from date of manufacture stored at or below 30°C 12 months opened stored at or below 25°C. (opened pouch, but still packed in blisters)
2010-03-01
Tacrolimus Sandoz® CMI v1.0 1 TACROLIMUS SANDOZ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING TACROLIMUS SANDOZ? Tacrolimus Sandoz contains the active ingredient tacrolimus monohydrate. Tacrolimus Sandoz is used so that your new liver, kidney, lung or heart will not be attacked or rejected by your body. For more information, see Section 1. Why am I using Tacrolimus Sandoz? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE TACROLIMUS SANDOZ? Do not use if you have ever had an allergic reaction to Tacrolimus Sandoz, macrolide antibiotics, or any of the ingredients listed at the end of the CMI. Tacrolimus Sandoz and Tacrolimus XR Sandoz are not interchangeable. For more information, see Section 2. What should I know before I use Tacrolimus Sandoz? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Tacrolimus Sandoz and affect how it works. Tell your doctor of pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE TACROLIMUS SANDOZ? • Tacrolimus Sandoz capsules should be taken in two doses (e.g. morning or evening) each day. • Tacrolimus Sandoz capsules should be taken at least 1 hour before or 2 to 3 hours after a meal preferably with water and not grapefruit juice. More instructions can be found in Section 4. How do I use Tacrolimus Sandoz? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING TACROLIMUS SANDOZ? THINGS YOU SHOULD DO • Tell your doctor if you become pregnant while taking Tacrolimus Sandoz. • Tacrolimus Sandoz suppresses your immune system by lowering your body’s immune defence system. This increases your risk of skin cancer and other cancers while taking Tacrolimu Leggi il documento completo
240130-Tacrolimus Sandoz-ds-v1.0 Page 1 of 23 NEW ZEALAND DATA SHEET TACROLIMUS SANDOZ CAPSULES (TACROLIMUS) 1. PRODUCT NAME Tacrolimus 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tacrolimus Sandoz 0.5 mg: Each capsule contains tacrolimus 0.5 mg (as monohydrate). Tacrolimus Sandoz 0.75 mg: Each capsule contains tacrolimus 0.75 mg (as monohydrate). Tacrolimus Sandoz 1 mg: Each capsule contains tacrolimus 1 mg (as monohydrate). Tacrolimus Sandoz 2 mg: Each capsule contains tacrolimus 2 mg (as monohydrate). Tacrolimus Sandoz 5 mg: Each capsule contains tacrolimus 5 mg (as monohydrate). For the full list of excipients, see Section 6.1. 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 New Zealand. _ 4. CLINICAL PARTICULARS 4.1. T HERAPEUTIC INDICATIONS 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. 4.2. D OSE AND METHOD OF ADMINISTRATION DOSAGE _ADULTS _ The dosage recommendations given below for oral administration should act as a guideline. Tacrolimus doses should be adjusted accordi Leggi il documento completo