Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
mycophenolate mofetil, Quantity: 250 mg
Arrotex Pharmaceuticals Pty Ltd
Mycophenolate mofetil
Capsule, hard
Excipient Ingredients: erythrosine; Gelatin; povidone; microcrystalline cellulose; purified water; sodium lauryl sulfate; titanium dioxide; croscarmellose sodium; magnesium stearate; iron oxide yellow; butan-1-ol; Shellac; industrial methylated spirit; iron oxide black; lecithin; xanthan gum; glyceryl monostearate; benzoic acid; methylcellulose; simethicone; glyceryl distearate; PEG-10 stearate; sorbic acid; dimeticone 5000
Oral
300, 100
(S4) Prescription Only Medicine
Imulate is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants. Imulate is indicated for the prophylaxis of organ rejection in paediatric patients with a body surface area of greater than or equal to 1.25 meters square receiving allogeneic renal transplants (refer DOSAGE and ADMINISTRATION section).
Visual Identification: White to off white blend of Mycophenolate Mofetil filled in size 1 hard gelatin capsules with ivory Cap and ivory body printed 'SAL' on cap & '726' on body in black ink; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2011-04-13
IMULATE – Consumer Medicine Information Page 1 of 4 IMULATE CAPSULES AND TABLETS _mycophenolate mofetil _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Imulate capsules and tablets. 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 Imulate 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 IMULATE IS USED FOR Imulate contains the active ingredient mycophenolate mofetil. Imulate 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. Imulate may be used together with other medicines known as cyclosporin and corticosteroids. Your doctor, however, may have prescribed Imulate for another purpose. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IMULATE HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. Imulate is not addictive. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE IMULATE IF: 1. YOU HAVE HAD AN ALLERGIC REACTION TO IMULATE OR ANY INGREDIENTS LISTED AT THE END OF THIS LEAFLET. 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. THE PACKAGE IS TORN OR SHOWS SIGNS OF TAMPERING. 3. THE EXPIRY DATE (EXP) PRINTED ON THE PACK HAS PASSED. If you take this medicine after the expiry date has passed, it may not work as well. IF YOU ARE NOT SURE IF YOU SHOULD BE TAKING IMULATE, TALK TO YOUR DOCTOR. _BEFORE YOU START TO TAKE IT _ TELL YOUR DOCTOR IF: 1. YOU ARE PREGNANT OR Přečtěte si celý dokument
IMULATE – Product Information Page 1 of 26 PRODUCT INFORMATION IMULATE NAME OF THE MEDICINE mycophenolate mofetil CAS-115007-34-6 Mycophenolate mofetil is the 2-morpholinoethyl ester of mycophenolic acid. The chemical name for mycophenolate mofetil is 2-morpholinoethyl(_E_)-6-(1, 3-dihydro-4-hydroxy-6- methoxy-7-methyl-3-oxo-5-isobenzofuranyl) -4-methyl4-hexenoate. It has an empirical formula of C 23 H 31 NO 7 and a molecular weight of 433.50. DESCRIPTION Mycophenolate mofetil is a white to off-white crystalline powder. It is freely soluble in dimethyl sulfoxide, tetrahydrofuran, acetone, acetonitrile, dichloromethane, and ethyl acetate; soluble in methanol and propylene carbonate; sparingly soluble in anhydrous ethanol; slightly soluble in 2-propanol, diethyl ether, and very slightly soluble in hexane. It is practically insoluble in water (43 µg/mL at pH 7.4); the solubility increases in acidic medium (4.27 mg/mL at pH 3.6). Imulate tablet is available as a mauve-coloured, capsule shaped film-coated tablet containing 500 mg of mycophenolate mofetil with the excipients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, titanium dioxide, macrogol 400, iron oxide red, allura red AC and brilliant blue FCF. Imulate capsule is available as an ivory coloured hard gelatin capsule contains 250 mg mycophenolate mofetil with the excipients: microcrystalline cellulose, croscarmellose sodium, povidone and magnesium stearate. The capsule shell contains gelatin, water – purified, sodium lauryl sulphate, iron oxide yellow, allura red AC, titanium dioxide and Opacode black S-1-8152HV ink (ARTG no. 1560). PHARMACOLOGY MECHANISM OF ACTION Mycophenolic acid (MPA) is a potent, selective, uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH) which inhibits the _de novo_ pathway of IMULATE – Product Information Page 2 of 26 guanosine nucleotide synthesis without incorporation into DNA. Based on Chinese hamster inosine-5’-monophosphate dehydrongenase Přečtěte si celý dokument