Ursodeoxycholic Acid(Destolit) generic is a biliary agent, prescribed for gallstones. It helps to dissolve the stone by reducing the amount of cholesterol released by. There are no age restrictions on the use of Ursofalk 250mg hard capsules in the treatment of PBC and for the dissolution of radiolucent gallstones. There are no age restrictions on the use of Ursofalk 250mg/5ml suspension in the treatment of PBC and for the dissolution of radiolucent gallstones. The role for the medical management of gallstone disease has decreased since the introduction of laparoscopic cholecystectomy. Cholecystectomy remains the preferred. Ursofalk 2. 50mg/5ml Suspension - Summary of Product Characteristics (SPC)Ursofalk 2. Suspension. 5ml (= 1 cup) of Ursofalk Suspension contains 2. UDCA) as the active ingredient. The suspension also contains 1. For a full list of excipients, see section 6. Oral suspension. Appearance: white, homogenous oral suspension with small air bubbles and an odour of lemon. Ursofalk 2. 50mg/5ml Suspension is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder. Paediatric population. Hepatobiliary disorders associated with cystic fibrosis in children aged 1 month to 1. There are no age restrictions on the use of Ursofalk 2. PBC and for the dissolution of radiolucent gallstones. There are no adequate data on the efficacy and safety in this population. Hepatobiliary disorders associated with cystic fibrosis Paediatric population. Children with cystic fibrosis aged 1 month to. Very rarely, children under 1. In this case, a commercially available single- use syringe should be used. Studies in animals have shown reproductive toxicity during the early phase of gestation (see section 5. Ursofalk suspension must not be used during pregnancy unless clearly necessary. Women of childbearing potential should be treated only if they use reliable contraception: non- hormonal or low- oestrogen oral contraceptive measures are recommended. However, in patients taking Ursofalk 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. Breastfeeding According to few documented cases of breastfeeding women milk levels of UDCA are very low and probably no adverse reactions are to be expected in breastfed infants. UDCA has no or negligible influence on the ability to drive and use machines. The evaluation of undesirable effects is based on the following frequency data. Very common: (. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting scheme: United Kingdom. Yellow Card Scheme. Website: www. mhra. Diarrhoea may occur in cases of overdose. There is evidence that treatment with UDCA can decrease bile duct proliferation, halt progression of histological damage and even reverse hepatobiliary changes if given at early stage of CFAHD. Treatment with UDCA should be started as soon as the diagnosis of CFAHD is made in order to optimise treatment effectiveness. UDCA occurs naturally in the body. In vitro and in vivo genetic toxicology tests with UDCA were negative. The tests with UDCA revealed no relevant evidence of a mutagenic effect.
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