País: Hongria
Idioma: anglès
Font: HMA (Heads of Medicines Agencies)
ketoprofen 300 mg
Laboratorios Dr. Esteve S.A.
QM01AE03
Oral solution
ketoprofen
Cattle Food, Pigs Food
2011-11-16
_MINISTERIO DE SANIDAD, _ _POLÍTICA SOCIAL _ _E IGUALDAD_ Agencia Española de Medicamentos y Productos Sanitarios Repeat Use Assessment Report - addendum DINALGEN 300 mg/ml solution for injection for cattle and pigs ES/V/0136/001/E/001 Date: 14/04/2011 Page 1 of 9 LABELLING _ _ _ _ PARTICULARS TO APPEAR ON THE OUTER PACKAGE 500 ML 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 300 mg/ml oral solution for cattle and pigs (All countries except UK, IE, ES, DK and FI) DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs (UK and IE) DINALGEN CONCENTRADO 300 mg/ml oral solution for cattle and pigs (ES) DINALGEN (DK) DINALGEN VET 300 mg/ml oral solution for cattle and pigs (FI) Ketoprofen 2. STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each ml contains 300 mg of Ketoprofen. 3. PHARMACEUTICAL FORM Oral solution. 4. PACKAGE SIZE 100 ml 500 ml. 5. TARGET SPECIES Fattening Cattle and Pigs 6. INDICATION(S) 7. METHOD AND ROUTE(S) OF ADMINISTRATION Oral use, administer in drinking water. 8. WITHDRAWAL PERIOD _MINISTERIO DE SANIDAD, _ _POLÍTICA SOCIAL _ _E IGUALDAD_ Agencia Española de Medicamentos y Productos Sanitarios Repeat Use Assessment Report - addendum DINALGEN 300 mg/ml solution for injection for cattle and pigs ES/V/0136/001/E/001 Date: 14/04/2011 Page 2 of 9 Meat and offal: 24 hours 9. SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use. 10. EXPIRY DATEShelf life after first opening the container: 3 months Shelf life after Llegiu el document complet
Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS (SPC) 1. NAME OF THE VETERINARY MEDICINAL PRODUCT DINALGEN 300 mg/ml oral solution for cattle and pigs (All countries except UK, IE, ES, DK and FI) DINALGEN 300 mg/ml oral solution for use in drinking water for cattle and pigs. (UK and IE) DINALGEN CONCENTRADO 300 mg/ml oral solution for cattle and pigs (ES) DINALGEN (DK) DINALGEN VET 300 mg/ml oral solution for cattle and pigs (FI) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml of the product contains: Ketoprofen 300 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution for use in drinking water. Clear yellowish solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Fattening Cattle and Pigs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Fattening Cattle and Pigs: Treatment for the reduction of pyrexia and dyspnoea associated with respiratory disease in combination with appropriate anti-infective therapy. 4.3 CONTRAINDICATIONS Do not administer to suckling calves. Do not administer to fasting animals or animals with limited access to feed. Do not use in animals where there is the possibility of gastrointestinal alterations, ulceration or bleeding in order not to aggravate their situation. Page 1 of 7 Do not use in dehydrated or hypovolemic or hypotensive animal due to the potential risk of increased renal toxicity. Do not administer to swine fattened at extensive or semi-extensive production farms with Llegiu el document complet