Pays: Australie
Langue: anglais
Source: Department of Health (Therapeutic Goods Administration)
tacrolimus, Quantity: 5 mg
Astellas Pharma Australia Pty Ltd
Capsule, hard
Excipient Ingredients: lactose monohydrate; hypromellose; iron oxide red; Gelatin; magnesium stearate; titanium dioxide; croscarmellose sodium; propylene glycol; butan-1-ol; isopropyl alcohol; ethanol; Shellac; strong ammonia solution; sulfuric acid
Oral
50 capsules
(S4) Prescription Only Medicine
Prograf is indicated for use as an adjunct to liver, kidney, heart or lung allograft transplantation in adults and children.
Visual Identification: Greyish-red hard gelatin capsule with 5mg and [f] 657 printed in white; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Licence status A
1997-08-25
PROGRAF ® ; ADVAGRAF ® XL PROGRAF® and Advagraf® XL 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 PROGRAF OR ADVAGRAF XL? PROGRAF or ADVAGRAF XL contains the active ingredient tacrolimus. PROGRAF or ADVAGRAF XL 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 PROGRAF or ADVAGRAF XL? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE PROGRAF OR ADVAGRAF XL? Do not use if you have ever had an allergic reaction to PROGRAF or ADVAGRAF XL, macrolide antibiotics, or any of the ingredients listed at the end of the CMI. ADVAGRAF XL and PROGRAF are not interchangeable. For more information, see Section 2. What should I know before I use PROGRAF or ADVAGRAF XL? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with PROGRAF or ADVAGRAF XL and affect how it works. Tell your doctor or 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 See Section 3. What if I am taking other medicines? in the full CMI for information. 4. HOW DO I USE PROGRAF OR ADVAGRAF XL? • PROGRAF capsules should be taken in two doses (e.g. morning and evening) each day. • ADVAGRAF XL should be taken once a day in the morning. • PROGRAF or ADVAGRAF XL capsules should be taken at least 1 hour before or 2 to 3 hours after a meal preferably with water and not with grapefruit juice. • More instructions can be found in Section 4. How do I use PROGRAF or ADVAGRAF XL? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING PROGRAF OR ADVAGRAF XL? THINGS YOU SHOULD DO • Tell your doctor if you become pregnant while taking PROGRAF or ADVAGRAF XL. • PROGRAF or ADVAGRAF XL suppresses your immune system by lowering your body's immune defence Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION PROGRAF ® (TACROLIMUS) CAPSULES AND CONCENTRATED INJECTION ADVAGRAF ® 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 Excipients with known effect: sugars as lactose and soya bean products. For the full list of excipients, see Section 6.1 List of excipients. ADVAGRAF 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 Excipients with known effect: sugars as lactose and soya bean products. For the full list of excipients, see Section 6.1 List of excipients. PROGRAF CONCENTRATED INJECTION Each 1 mL of Concentrated Injection contains 5 mg tacrolimus. Contains: Contains alcohol as 95% v/v 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. PROGRAF capsules 5 mg: greyish-red, hard gelatine capsules with _'_5 mg_'_ and _'_[f]657_'_ printed in white. 2 ADVAGRAF XL PROLONGED-RELEASE CAPSULES Prolonged release capsule Supplied as: ADVAGRAF 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”. ADVAGRAF XL 1 mg prolonged-release capsules: oblong capsules with a white cap imprinted with “1 mg” and an orange body imprinted with “ 677”. ADVAGRAF XL 3 mg prolonged-release capsules: oblong capsules with an orange cap imprinted with “3 mg” and an orange Lire le document complet