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Qualitative and quantitative composition 3. Marketing authorisation holder 8. Marketing authorisation number(s) 9. Date of first authorisation/renewal of the authorisation 10, buy ment 50 mg injectable steroids ment. Date of revision of the text. This information is intended for use by health professionals. Urdox 300mg Film-Coated Tablets, Ursodeoxycholic Acid 300mg Film-Coated Tablets. For a full list of excipients, see section 6. Urdox tablets are white. Urdox tablets are indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of small to medium sized radiolucent, cholesterol-rich gall-stones in patients with a functioning gall bladder. Cholesterol stones coated with calcium or stones composed of bile pigments are not dissolved by ursodeoxycholic acid. Urdox has a particular place in the treatment of patients in whom surgery is contraindicated or who are anxious to avoid surgery. Hepatobiliar disorder associated with cystic fibrosis in children aged 6 years to less than 18 years. Urdox tablets are for oral administration. To be taken with a drink of water. Adults and Elderly: 10 – 15mg ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses. Children: Dosage should be related to bodyweight. Adults and Elderly: The usual dose is 6 – 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary. The duration of treatment may be up to two years, depending on the size of the stone(s), and should be continued for three months after the apparent dissolution of the stone(s). Children: Dosage should be related to bodyweight. Children with cystic fibrosis aged 6 year to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase to 30 mg/kg/day if necessary. Ursodeoxycholic acid should not be used in patients: 1. Unsuccessful portoenterostomy or without recovery of good bile flow in children with biliary atresia. Ursodeoxycholic acid should be taken under medical supervision.
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These observations together with in vitro findings could indicate a potential for ursodeoxycholic acid to induce cytochrome P450 3A enzymes. Controlled clinical trials have shown, however, that ursodeoxycholic acid does not have a relevant inductive effect on cytochrome P450 3A enzymes. Oral contraceptives, oestrogenic hormones and blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter-effect to ursodeoxycholic acid used for dissolution of gallstones. There are no adequate data on the use of ursodeoxycholic acid, particularly in the first trimester of pregnancy. Animal studies have provided evidence of a teratogenic effect during the early phase of gestation. Ursodeoxycholic acid must not be used during pregnancy. Treatment should be discontinued immediately if pregnancy occurs and medical advice sought. Women of childbearing potential should be treated only if they are using reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended. However, in patients taking ursodeoxycholic acid for dissolution of gallstones, effective non-hormonal contraception should be used, since hormonal oral contraceptives may increase biliary lithiasis. The possibility of a pregnancy must be excluded before beginning treatment. It is not known whether ursodeoxycholic acid passes into breast milk. Therefore, ursodeoxycholic acid should not be taken during lactation. If treatment with ursodeoxycholic acid is necessary, breastfeeding must be discontinued. No effects on ability to drive and use machines have been observed. The evaluation of undesirable effects is based on the following frequency data: Ursodiol (Actigall) Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis. Ursodiol is used to treat primary biliary cirrhosis, buy ment 50 mg injectable steroids ment. Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified. Ursodiol may also be used for purposes not listed in this medication guide. What is Ursodiol (Actigall) used for? Biliary Cirrhosis Cholelithiasis Gallbladder Disease Gallstone Ileus Cholelithiasis with Obstruction Acute Cholecystitis Cholelithiasis with Acute Cholecystitis Cholelithiasis w/ Acute Cholecystitis and Obstruction Gallbladder Obstruction w/o Calculus Gallbladder Fistula. What is the most important information I should know about Ursodiol (Actigall)? You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder. undefined
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