البلد: أستراليا
اللغة: الإنجليزية
المصدر: Department of Health (Therapeutic Goods Administration)
everolimus, Quantity: 1 mg
Pharmacor Pty Ltd
Tablet, uncoated
Excipient Ingredients: lactose; acetone; butylated hydroxytoluene; magnesium stearate; ethanol absolute; lactose monohydrate; crospovidone; hypromellose
Oral
60's, 120's
(S4) Prescription Only Medicine
Everolimus is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see section 4.4 Special warnings and precautions for use).
Visual Identification: White to off white, round shaped tablets debossed with "EVR" on one side and "100" on other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2021-04-21
Everocan 1 EVEROCAN EVEROLIMUS CONSUMER MEDICINE INFORMATION (CMI) SUMMARY 1. WHY AM I USING EVEROLIMUS? Everocan contains the active ingredient everolimus. Everolimus is used to used to treat adult patients who have had kidney, heart or liver transplants. For more information, see Section 1. Why am I using everolimus? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE EVEROLIMUS? Do not use if you have ever had an allergic reaction to everolimus or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use everolimus? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with everolimus and affect how it works. 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 EVEROLIMUS? KIDNEY AND HEART TRANSPLANTATIONS: • The usual starting dose is 0.75 mg EVEROCAN twice daily, taken in the morning and in the evening together with cyclosporine. • The first dose of EVEROCAN will be given as soon as possible after transplantation. LIVER TRANSPLANTATION: • The general recommended daily dose is 1 mg EVEROCAN twice daily, taken in the morning and in the evening, together with tacrolimus. • The first dose of EVEROCAN will be given approximately four weeks after transplantation. More instructions can be found in Section 4. How do I use everolimus? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING EVEROLIMUS? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using everolimus. • Keep all of your doctor's appointments so that your progress can be checked. • Make sure you use a highly effective contraceptive to prevent pregnancy during treatment with EVEROCAN. If you become pregnant while taking this medicine, tell your doctor immediately. THINGS YOU SHOULD NOT DO • Do not take اقرأ الوثيقة كاملة
Everocan (ver 03) Page 1 AUSTRALIAN PRODUCT INFORMATION – EVEROCAN (EVEROLIMUS) TABLETS 1. NAME OF THE MEDICINE Everolimus 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Everolimus is a white to faintly yellow powder practically insoluble in water but soluble in organic solvents such as ethanol and methanol. EVEROCAN 0.25 MG: Each uncoated tablet contains 0.25 mg Everolimus. EVEROCAN 0.5 MG: Each uncoated tablet contains 0.5 mg Everolimus. EVEROCAN 0.75 MG: Each uncoated tablet contains 0.75 mg Everolimus. EVEROCAN 1 MG: Each uncoated tablet contains 1 mg Everolimus. Excipient with known effect: contain lactose For the full list of excipients, see section 6.1 List of excipients . 3. PHARMACEUTICAL FORM Uncoated tablet. EVEROCAN 0.25 MG: White to off white, round shaped tablets debossed with "EVR" on one side and "25" on other side. EVEROCAN 0.5 MG: White to off white, round shaped tablets debossed with "EVR" on one side and "50" on other side. EVEROCAN 0.75 MG: White to off white, round shaped tablets debossed with "EVR" on one side and "75" on other side. EVEROCAN 1 MG: White to off white, round shaped tablets debossed with "EVR" on one side and "100" on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS EVEROCAN is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see section 4.4 Special warnings and precautions for use). Everocan (ver 03) Page 2 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE Treatment with EVEROCAN should only be initiated and maintained by physicians who are experienced in immunosuppressive therapy following organ transplantation. Everolimus should be used in combination with cyclosporin microemulsion and corticosteroids with cyclosporin exposure reduced over time post-transplantation (see section 4.2 Dose and method of administration, _Therapeutic Drug Monitoring_ ). KIDNEY AND HEART TRANSPLANTATION An initial اقرأ الوثيقة كاملة