País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 250 mg
Pharmacor Pty Ltd
Mycophenolate mofetil
Capsule
Excipient Ingredients: magnesium stearate; croscarmellose sodium; pregelatinised maize starch; povidone; titanium dioxide; indigo carmine; purified water; iron oxide yellow; iron oxide red; Gelatin; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
One carton contains 100 capsules (10 strips of 10 capsules)
(S4) Prescription Only Medicine
Alcept 250 is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Alcept 250 is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.
Visual Identification: Capsule with Blue cap, Brown body imprinted 266 on body in black; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2011-11-21
Page 1 of 5 ALCEPT 250 CMI (V-06) ALCEPT 250 (MYCOPHENOLATE MOFETIL CAPSULES 250 MG) _contains the active ingredient mycophenolate mofetil _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ALCEPT 250. 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 ALCEPT 250 against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ALCEPT 250 IS USED FOR ALCEPT 250 contains the active ingredient mycophenolate mofetil. ALCEPT 250 belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent rejection of transplanted organs and work by stopping your immune system from reacting to the transplanted organ. There are many different types of medicines used to prevent rejection of a transplanted organ. ALCEPT 250 may be used together with other medicines known as cyclosporine and corticosteroids. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ALCEPT 250 HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed ALCEPT 250 for another reason. ALCEPT 250 is not addictive. This medicine is only available with a doctor’s prescription. BEFORE YOU TAKE OR ARE GIVEN ALCEPT 250 _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE ALCEPT 250 IF: 1. YOU HAVE AN ALLERGY TO: ALCEPT 250 or any of the ingredients listed at the end of the leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the body rash, itching, hives on the skin. 2. YOU ARE PREGNANT ALCEPT 250 is harmful to an unborn baby when taken by a pregnant woman. There have been cases of miscarriage and severe birth defects reported when patients have taken ALCE Leia o documento completo
ALCEPT 250 PI (V-06) Page 1 of 33 AUSTRALIAN PRODUCT INFORMATION ALCEPT 250 (MYCOPHENOLATE MOFETIL) CAPSULES 1. NAME OF THE MEDICINE Mycophenolate Mofetil 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ALCEPT 250 MG CAPSULES: Each capsules contains 250 mg mycophenolate mofetil For the full list of excipients, see section 6.1 - list of excipients . 3. PHARMACEUTICAL FORM Capsules, hard. ALCEPT 250 MG CAPSULES: The capsules are oblong, size “1” blue colored cap, brown colored body hard gelatin capsule imprinted with “266” on body with black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALCEPT 250 mg capsule is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. ALCEPT 250 mg capsule is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE The initial dose of mycophenolate mofetil should be given as soon as clinically feasible following transplantation. Intravenous administration is recommended in those patients unable to take oral medication. However, oral administration should be initiated as soon as possible. ADULTS _RENAL TRANSPLANTATION _ The recommended dose in renal transplant patients is 1 g administered orally or intravenously twice daily (2 g daily dose). ALCEPT 250 PI (V-06) Page 2 of 33 _CARDIAC TRANSPLANTATION _ The recommended dose in cardiac transplant patients is 1.5 g administered orally or intravenously twice daily (3 g daily dose). _HEPATIC TRANSPLANTATION _ The recommended dose in hepatic transplant patients is 1 g administered intravenously twice daily (2 g daily dose) followed by 1.5 g administered orally twice daily (3 g daily dose) _OTHER TRANSPLANTS _ The recommended dose in other transplants is 2 to 3g per day depending on the level of immunosuppression required. _PAEDIATRICS (2 TO 18 YEARS) _ The recommended dose for renal transplant patients is 600 mg/m 2 of mycophenolate mofetil (MMF) administered orall Leia o documento completo