Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 250 mg
Arrotex Pharmaceuticals Pty Ltd
Mycophenolate mofetil
Capsule
Excipient Ingredients: croscarmellose sodium; magnesium stearate; indigo carmine; purified water; titanium dioxide; Gelatin; iron oxide red; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
100 capsules, 300 capsules
(S4) Prescription Only Medicine
Mycophenolate mofetil is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.,Mycophenolate mofetil is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.
Visual Identification: Opaque blue cap and opaque pink body in Size 1 capsule containing white to off white powder. "M250" and "APO" are imprinted on capsules in black ink.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2011-11-08
APO-MYCOPHENOLATE CAPSULES 1 APO-MYCOPHENOLATE CAPSULES _Contains the active ingredient mycophenolate mofetil _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about mycophenolate mofetil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Mycophenolate. It contains the active ingredient mycophenolate mofetil. It is used for: • the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants • the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ Mycophenolate mofetil 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. Mycophenolate mofetil may be used together with other medicines such as cyclosporin and co Прочитать полный документ
1 AUSTRALIAN PRODUCT INFORMATION APO-MYCOPHENOLATE (MYCOPHENOLATE MOFETIL) CAPSULES 1 NAME OF THE MEDICINE Mycophenolate mofetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 250 mg mycophenolate mofetil as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT May contain traces of sulfites For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 250 MG CAPSULES: Opaque blue cap and opaque pink body in Size 1 capsules containing white to off white powder. "M250" and "APO" are imprinted on capsules in black ink. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mycophenolate mofetil is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Mycophenolate mofetil 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 APO-Mycophenolate capsules are intended for oral 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. Note: Alternative preparations will be required for IV administration and dosages requiring an oral suspension. ADULTS _RENAL TRANSPLANTATION _ The recommended dose in renal transplant patients is 1 g administered orally or intravenously twice daily (2 g daily dose). _ _ _ _ _CARDIAC TRANSPLANTATION_ 2 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 immunosup Прочитать полный документ