Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Ursodeoxycholic acid 250mg; ;
Boucher & Muir (New Zealand) Limited t/a BNM Group
Ursodeoxycholic acid 250 mg
250 mg
Capsule
Active: Ursodeoxycholic acid 250mg Excipient: Capsugel white OP Colloidal silicon dioxide Magnesium stearate Maize starch Pregelatinised maize starch
Blister pack, PVC/PVdC/Al foil, 100 capsules
Prescription
Prescription
ICE SpA
Ursosan is indicated in the treatment of chronic cholestatic liver diseases, including primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). In primary biliary cirrhosis ursodeoxycholic acid improves liver enzymes and IgM and prevents worsening of liver histology in patients with less advanced forms of the disease, i.e. serum bilirubin less that 2 mg/dL and histologic changes in liver confined to the portal regions. Prevention of complications of chronic liver disease has not been established.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/Al foil - 100 capsules - 48 months from date of manufacture stored at or below 25°C
2011-03-23
1 URSOSAN ® 05022019 Consumer Medicine Information URSOSAN ® _URSODEOXYCHOLIC ACID _ Capsules 250 mg WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start taking Ursosan. This leaflet answers some common questions about Ursosan. It does not contain all the available information. The most up-to-date Consumer Medicine Information can be downloaded from www.ebs.tga.gov.au (Australia) or www.medsafe.govt.nz (New Zealand). Reading this leaflet 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 Ursosan against the benefits this medicine is expected to 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 want to read it again. WHAT URSOSAN IS USED FOR Ursosan contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile acid, which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts. Ursosan may be used to treat liver diseases such as primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis. Your doctor may have prescribed this medicine for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN PRESCRIBED FOR YOU. Ursosan is only available with a doctor's prescription. Ursosan is not addictive. 2 URSOSAN ® 05022019 BEFORE YOU TAKE URSOSAN _ _ Ursosan is not suitable for everyone. _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE URSOSAN IF: you are allergic to any medicine containing ursodeoxycholic acid, bile acids or any of the ingredients listed at the end of this leaflet you have a bile duct or gall bladder that is swollen, painful or blocked you have certain types of cholesterol stones or bile pigment stones your doctor advises you that you will have your gall bladder removed. DO NOT TAKE IT AFTER THE EXPIRY DATE PRINTED ON THE PACK. If you take it after t Perskaitykite visą dokumentą
1 URSOSAN ® URSODEOXYCHOLIC ACID CAPSULES 250 MG NEW ZEALAND DATA SHEET 1 URSOSAN URSOSAN 250 mg capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One Ursosan capsule contains ursodeoxycholic acid (UDCA) 250 mg. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ursosan capsules are white hard gelatin capsules, containing a white or almost white powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ursosan is indicated in the treatment of chronic cholestatic liver diseases, including primary biliary cirrhosis (PBC) and primary sclerosing cholangitis (PSC). In primary biliary cirrhosis ursodeoxycholic acid improves liver enzymes and IgM and prevents worsening of liver histology in patients with less advanced forms of the disease, i.e. serum bilirubin less that 2 mg/dL and histologic changes in liver confined to the portal regions. Prevention of complications of chronic liver disease has not been established. 4.2 DOSE AND METHOD OF ADMINISTRATION This product may not be interchangeable with similar products on the New Zealand market. 2 URSOSAN ® URSODEOXYCHOLIC ACID CAPSULES 250 MG DOSE _ADULTS _ The degree of biliary enrichment of UDCA does not depend on the formulation or the number of doses administered per day, but rather the total daily dose. 10 – 15 mg UDCA per kg per day in either a single dose or two to four divided doses are recommended for PBC (primary biliary cirrhosis) and chronic cholestatic liver diseases other than CF (cystic fibrosis). This dose can be approximated as follows: For CF, the general recommended dose is up to 20 mg/kg/day. This dose has been shown to improve histology in PSC patients. _ELDERLY _ In worldwide clinical studies of UDCA, approximately 14% of subjects were over 65 years of age (approximately 3% were over 75 years old). In a subgroup analysis of existing clinical trials, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age-related differences i Perskaitykite visą dokumentą