Држава: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 500 mg
Alphapharm Pty Ltd
Mycophenolate mofetil
Tablet, film coated
Excipient Ingredients: croscarmellose sodium; microcrystalline cellulose; pregelatinised maize starch; magnesium stearate; povidone; sodium lauryl sulfate; silicon dioxide; titanium dioxide; purified talc; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350
Oral
150, 50
(S4) Prescription Only Medicine
Ceptolate (Mycophenolate mofetil) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Ceptolate (Mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 square metres, receiving allogeneic renal transplants.
Visual Identification: A light pink film coated, oval, biconvex, bevelled edge tablet debossed with "MYLAN" on one side of the tablet and "472" on the other side.; Container Type: Blister Pack; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2011-09-23
CEPTOLATE _mycophenolate mofetil_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CEPTOLATE. 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 CEPTOLATE against the benefits they expect it will have 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 CEPTOLATE IS USED FOR CEPTOLATE contains the active ingredient mycophenolate mofetil. CEPTOLATE belongs to a group of medicines called immunosuppressants. Immunosuppressants are used to prevent the rejection of a transplanted organ 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. CEPTOLATE may be used together with other medicines known as ciclosporin and corticosteroids. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed it for another reason. CEPTOLATE is not addictive. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE CEPTOLATE _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CEPTOLATE IF: 1. YOU HAVE AN ALLERGY TO: • any medicine containing mycophenolate mofetil • any of the ingredients listed at the end of this 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 or hives on the skin 2. YOU ARE PREGNANT • CEPTOLATE 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 CEPTOLATE during pregnancy YOU MUST TELL YOUR DOCTOR IF YOU ARE PREGNANT OR PLAN TO BECOME PRE Прочитајте комплетан документ
AUSTRALIAN PRODUCT INFORMATION CEPTOLATE _Mycophenolate mofetil _ 1 NAME OF THE MEDICINE Mycophenolate mofetil 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CEPTOLATE 250 mg capsules contain 250 mg of mycophenolate mofetil (MMF). CEPTOLATE 500 mg tablets contain 500 mg of mycophenolate mofetil. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM CEPTOLATE 250 mg capsules - caramel opaque cap/lavender opaque body, hard shell gelatin capsule filled with white to off-white powder. The capsule is axially printed with “MYLAN” over “2250” in black ink on both the cap and body. CEPTOLATE 500 mg tablets - light pink film coated, oval, biconvex, bevelled edge tablet debossed with “MYLAN” on one side of the tablet and “472” on the other side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CEPTOLATE (mycophenolate mofetil) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. CEPTOLATE (mycophenolate mofetil) is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of (≥ 1.25 m 2 ) receiving allogeneic renal transplants (see section 4.2 Dose and Method of Administration). 4.2 DOSE AND METHOD OF ADMINISTRATION The initial dose of MMF 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. PLEASE NOTE THAT CEPTOLATE MYCOPHENOLATE MOFETIL IN NOT AVAILABLE IN THE INTRAVENOUS DOSAGE FORM. ADULTS Renal Transplantation The recommended dose in renal transplant patients is 1 g administered orally twice daily (2 g daily dose). Cardiac Transplantation The recommended dose in cardiac transplant patients is 1.5 g administrated orally twice daily (3 g daily dose). Hepatic Transplantation The recommended dose in hepatic transplant patients is 1.5 g administered orally twice daily (3 g daily dose). Other Transpl Прочитајте комплетан документ