Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
dirlotapide
Zoetis Belgium SA
QA08AB91
dirlotapide
Dogs
Antiobesity preparations, excl. diet products
As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight-management programme that also includes appropriate dietary changes and exercise practice.
Revision: 7
Withdrawn
2007-04-13
15 B. PACKAGE LEAFLET Medicinal product no longer authorised 16 PACKAGE LEAFLET FOR: SLENTROL 5 MG/ML ORAL SOLUTION FOR DOGS 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium Manufacturer responsible for batch release: Pfizer Service Company Hoge Wei 10 1930 Zaventem Belgium Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve Belgium 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Slentrol 5 mg/ml oral solution for dogs Dirlotapide 3. STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT Dirlotapide 5 mg/ml is a colourless to pale yellow solution. 4. INDICATION As an aid in the management of overweight and obesity in adult dogs. Your veterinary surgeon will identify a target weight and explain how Slentrol should be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice. 5. CONTRAINDICATIONS Do not use in dogs in the growth phase. Do not use during pregnancy or lactation. Do not use in dogs with impaired liver function. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism. Do not use in cats due to the risk of development of hepatic lipidosis. 6. ADVERSE REACTIONS Some dogs may show one or more vomiting events, sometimes accompanied by signs of tiredness, disinterest in food or diarrhoea, which reoccur occasionally during the course of treatment. These signs typically started during the first month of treatment (about 30% of dogs showed at least one Medicinal product no longer authorised 17 vomiting event and up to 12% showed any of the other signs) and decreased continuously during the course of treatment. Some dogs (less than 10%) experienced repeated vomiting (i.e. mo Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Slentrol_ _5 mg/ml oral solution for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains: ACTIVE SUBSTANCE: Dirlotapide 5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution. A colourless to pale yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES As an aid in the management of overweight and obesity in adult dogs. To be used as part of an overall weight management programme which also includes appropriate dietary changes and exercise practice. 4.3 CONTRAINDICATIONS Do not use in dogs in the growth phase. Do not use during pregnancy or lactation. Do not use in dogs with impaired liver function. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs in which overweight or obesity is caused by a concomitant systemic disease such as hypothyroidism or hyperadrenocorticism. Do not use in cats due to the risk of development of hepatic lipidosis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES In clinical trials, treated dogs rapidly regained weight following cessation of treatment when diet was not restricted. In order to avoid this rebound weight gain, it is necessary to feed the dogs to maintenance energy requirements. Thus, during treatment or at the end of treatment at the latest, an appropriate feeding and exercise regimen should be implemented in order to ensure long term maintenance of the bodyweight. Medicinal product no longer authorised 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals The liver function of dogs suspected of suffering from a liver disease or dysfunction should be evaluated before commencing treatment with the veterinary medicinal product. Any clinical indication of liver disease or dysfunction during treatment should be investigated through the evaluation of liver function Lesen Sie das vollständige Dokument