Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
LACTULOSE
Abbott Healthcare Products Ltd
3.335 MG/5ml
Oral Solution
1983-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Duphalac 3.335g/5ml Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Lactulose solution containing 3.335 g of lactulose per 5 ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Oral solution Clear, colourless to pale brownish – yellow viscous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (1) In the treatment of constipation. (2) In the treatment of hepatic encephalopathy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Hepatic Encephalopathy Initially 30 to 50 ml three times daily; dosage should be subsequently adjusted to produce 2 to 3 soft stools daily and an acidic faecal pH. 4.3 CONTRAINDICATIONS 1. Use in patients who require a galactose-free diet. 2. Use in patients with evidence of gastrointestinal obstruction. 3. Hypersensitivity to any of the components of the product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. Long term use of this product is inadvisable except under medical supervision. 2. A dose of 30 ml provides 116 KJ (28 kcals) and is unlikely to adversely affect diabetics. 3. Duphalac should be administered with care to patients who are intolerant to lactose. 4. Use of laxatives in children should be under medical supervision. Constipation Adults: 15 ml twice daily. Children 5-10 years: 10 ml twice daily. Children 2-5 years: 5 ml twice daily. Babies 1-2 years: 2.5 ml- 5 ml twice daily. Babies 1 month-1 year: 2.5 ml twice daily. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 10/05/2011_ _CRN 2099107_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The product should not be taken with enteric coated mesalazine (5-ASA) as সম্পূর্ণ নথি পড়ুন