מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
tacrolimus, Quantity: 0.5 mg
Astellas Pharma Australia Pty Ltd
Tacrolimus
Capsule, modified release
Excipient Ingredients: iron oxide yellow; hypromellose; iron oxide red; titanium dioxide; lactose monohydrate; ethylcellulose; magnesium stearate; sodium lauryl sulfate; Gelatin; hyprolose; butan-1-ol; purified water; industrial methylated spirit; simethicone; lecithin; ethanol; Shellac; strong ammonia solution; sulfuric acid
Oral
50, 30
(S4) Prescription Only Medicine
PROGRAF-XL is indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.
Visual Identification: Oblong, light yellow and orange capsule imprinted with '0.5mg' & '*647'; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2010-03-31
PROGRAF ® _CAPSULES, XL PROLONGED-RELEASE CAPSULES, CONCENTRATED INJECTION_ _Tacrolimus_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PROGRAF Capsules, PROGRAF XL Prolonged- Release Capsules and PROGRAF Concentrated Injection. 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 PROGRAF or PROGRAF XL against the benefits this medicine is expected to have for you. If you have any concerns about using PROGRAF or PROGRAF XL ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT PROGRAF / PROGRAF XL IS USED FOR You have been given a new transplanted liver, 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. PROGRAF or PROGRAF XL stops this attack; it is very important to take PROGRAF or PROGRAF XL 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 PROGRAF or PROGRAF XL. PROGRAF or PROGRAF XL contains the active ingredient tacrolimus, which is an immunosuppressive agent. Your doctor may have prescribed PROGRAF or PROGRAF XL for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE PROGRAF OR PROGRAF XL _WHEN YOU MUST NOT USE IT_ Do not use PROGRAF or PROGRAF XL if you have an allergy to: • any medicine containing tacrolimus or other macrolides (these are antibiotics of the erythromycin family - trade names are Eryc, EES, Klacid, Zi קרא את המסמך השלם
1 AUSTRALIAN PRODUCT INFORMATION PROGRAF ® (TACROLIMUS) CAPSULES AND CONCENTRATED INJECTION PROGRAF ® XL (TACROLIMUS) PROLONGED-RELEASE CAPSULES 1 NAME OF THE MEDICINE Tacrolimus 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PROGRAF CAPSULES Each 0.5 mg capsule contains 0.5 mg tacrolimus Each 1 mg capsule contains 1 mg tacrolimus Each 5 mg capsule contains 5 mg tacrolimus Contains: lactose The printing ink used to mark the capsule contains trace amounts of soya lecithin For the full list of excipients, see Section 6.1 List of excipients. PROGRAF XL PROLONGED-RELEASE CAPSULES Each 0.5 mg prolonged-release capsule contains 0.5 mg tacrolimus Each 1 mg prolonged-release capsule contains 1 mg tacrolimus Each 3 mg prolonged-release capsule contains 3 mg tacrolimus Each 5 mg prolonged-release capsule contains 5 mg tacrolimus Contains: lactose The printing ink used to mark the capsule contains trace amounts of soya lecithin For the full list of excipients, see Section 6.1 List of excipients. PROGRAF CONCENTRATED INJECTION Each mL of Concentrated Injection contains 5 mg tacrolimus. Contains: ethanol For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM PROGRAF CAPSULES Capsule Supplied as: PROGRAF capsules 0.5 mg: light yellow hard gelatine capsules with ‘0.5 mg’ and ‘[f]607’ printed in red. PROGRAF capsules 1 mg: white, hard gelatine capsules with '1 mg' and '[f]617' printed in red. 2 PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with '5 mg' and '[f]657' printed in white. PROGRAF XL PROLONGED-RELEASE CAPSULES Prolonged release capsule Supplied as: PROGRAF XL 0.5 mg prolonged-release capsules: oblong capsules with a light yellow cap imprinted with “0.5 mg” and an orange body imprinted with “ 647”. PROGRAF XL 1 mg prolonged-release capsules: oblong capsules with a white cap imprinted with “1 mg” and an orange body imprinted with “ 677”. PROGRAF XL 3 mg prolonged-release capsules: oblong capsules with an orange cap imprinted with “3 mg” and an oran קרא את המסמך השלם