מדינה: הממלכה המאוחדת
שפה: אנגלית
מקור: VMD (Veterinary Medicines Directorate)
Lactulose
Dechra Regulatory BV
QA06AD11
Lactulose
Syrup
POM-V - Prescription Only Medicine – Veterinarian
Cats, Dogs
Gastrointestinal laxative
Authorized
2019-05-22
Unlimited renewal: May 2023 AN: 00095/2023 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Laxatract 667 mg/ml syrup for dogs and cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Lactulose 667.0 mg (as lactulose, liquid) EXCIPIENT: Benzyl alcohol (E1519) 2.0 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Syrup. Clear, viscous liquid, colourless or pale brownish-yellow. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the treatment of constipation (e.g. due to intestinal atony after surgery, hairballs, massive intestinal contents). For the symptomatic treatment of disease conditions which require facilitated defecation (e.g. partial obstructions due to for example tumours and fractures, rectal diverticulum, proctitis and poisoning). 4.3 CONTRAINDICATIONS Do not use in animals with total gastro-intestinal obstruction, digestive perforation or risk of digestive perforation. Do not use in cases of hypersensitivity to the active substance or to the excipient. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Issued: May 2019 AN: 01575/2017 Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Lactulose solution contains some free lactose and galactose, and may alter the insulin requirements in diabetic patients. Use with caution in animals with pre-existing fluid and electrolyte imbalances, since lactulose may exacerbate these conditions, if diarrhoea occurs. Special precautions to be taken by the person administering the veterinary medicinal product to animals This veterinary medicinal product may cause flatulence and diarrhoea. Accidental ingestion should be avoided, especially by a child. To avoid accidental ingestion, the veterinary medicinal product must be used and kept out of reach of children. Always replace the cap after use. This veterinary medicinal product contains benzyl alcohol. This preservative may cause קרא את המסמך השלם