국가: 오스트레일리아
언어: 영어
출처: Department of Health (Therapeutic Goods Administration)
tacrolimus monohydrate, Quantity: 5.112 mg (Equivalent: tacrolimus, Qty 5 mg)
Arrotex Pharmaceuticals Pty Ltd
tacrolimus monohydrate
Capsule, hard
Excipient Ingredients: hypromellose; lactose monohydrate; croscarmellose sodium; magnesium stearate; Gelatin; purified water; sodium lauryl sulfate; brilliant blue FCF; phloxine B; titanium dioxide; quinoline yellow; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; ethanol absolute
Oral
100 capsule, 50 capsule
(S4) Prescription Only Medicine
Adjunct to liver, kidney, lung or heart allograft transplantation in adults and children.
Visual Identification: No 4 hard gelatin capsules with teal opaque body and cap, printed "SAL" on cap and "722" on body in black ink; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
2011-08-18
TACROGRAF CAPSULES _Tacrolimus (as monohydrate) _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about TACROGRAF 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 TACROGRAF against the benefits this medicine is expected to have for you. If you have any concerns about using TACROGRAF ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT TACROGRAF 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 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. TACROGRAF stops this attack; it is very important to take TACROGRAF 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 TACROGRAF. TACROGRAF is an immunosuppressive agent. Your doctor may have prescribed TACROGRAF for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you. BEFORE YOU USE TACROGRAF _When you must not use it _ Do not use TACROGRAF if you have an allergy to TACROGRAF, other macrolides (these are antibiotics of the erythromycin family - trade names are Eryc, EES, Klacid, Zithromax, Rulide and Biaxsig) or any of the ingredients contained in the capsules. See Product Description at the end of this leaflet for a list of ingredients. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongu 전체 문서 읽기
1 AUSTRALIAN PI – TACROGRAF (TACROLIMUS AS MONOHYDRATE) CAPSULES 1 NAME OF THE MEDICINE Tacrolimus (as monohydrate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION TACROGRAF 0.5mg hard gelatin capsules contain tacrolimus monohydrate equivalent to tacrolimus 0.5mg. TACROGRAF 1mg hard gelatin capsules contain tacrolimus monohydrate equivalent to tacrolimus 1mg. TACROGRAF 5mg hard gelatin capsules contain tacrolimus monohydrate equivalent to tacrolimus 5mg. TACROGRAF capsules contain sugars as lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TACROGRAF 0.5mg hard gelatin capsules have a red opaque cap and red opaque body, printed SAL on cap and 720 on body in black ink. TACROGRAF 1mg hard gelatin capsules have a green opaque cap and green opaque body, printed SAL on cap and 721 on body in black ink. TACROGRAF 5mg hard gelatin capsules have a teal opaque cap and teal opaque body, printed SAL on cap and 722 on body in black ink. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS TACROGRAF capsules are indicated for use as an adjunct to liver, kidney, lung or heart allograft transplantation in adults and children. 2 4.2 D OSE AND METHOD OF ADMINISTRATION The dosage recommendations given below for oral and intravenous administration 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 be taken in two divided doses, in the morning and in the evening. The capsules should generally be taken on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal to achieve maximal absorption (See SECTION 5.2 – PHARMACOKINETIC PROPERTIES - ABSORPTION). The capsules should be swallowed with fluid, preferably water. Oral administration of tacrolimus should commence as soon as practicable. In some liver transplantation patients, t 전체 문서 읽기