Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
monensin (as monensin sodium)
Elanco GmbH
QA16QA06
monensin
Cattle (cows and heifers)
Drugs for prevention and/or treatment of acetonemia
For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis.
Revision: 9
Authorised
2013-01-28
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: KEXXTONE 32.4G CONTINUOUS-RELEASE INTRARUMINAL DEVICE FOR CATTLE 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany Manufacturer responsible for batch release: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue France 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Kexxtone 32.4g continuous-release intraruminal device for cattle monensin 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Monensin 32.4 g (equivalent to 35.2 g monensin sodium) A cylindrical orange polypropylene intraruminal device uniquely identified with a number, fitted with wings, consisting of a core which presents as a stack of 12 subunits. 4. INDICATION(S) For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis. 5. CONTRAINDICATIONS Do not use in animals weighing less than 300 kg bodyweight. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 6. ADVERSE REACTIONS In rare cases, digestive signs (e.g. diarrhoea, ruminant stomach disorder) have been observed. In very rare cases, oesophagus obstruction has been observed. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports). 16 If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon. 7. TARGET SPECIES Cattle (dairy cows and heifers) 8. DO Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Kexxtone 32.4g continuous-release intraruminal device for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Monensin 32.4 g (equivalent to 35.2 g monensin sodium) Each intraruminal device contains 12 subunits each containing 2.7 g monensin (equivalent to 2.9 g monensin sodium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Continuous-release intraruminal device. A cylindrical orange polypropylene intraruminal device uniquely identified with a number, fitted with wings, consisting of a core which presents as a stack of 12 subunits. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (dairy cows and heifers) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the reduction in the incidence of ketosis in the peri-parturient dairy cow/heifer which is expected to develop ketosis. 4.3 CONTRAINDICATIONS Do not use in animals weighing less than 300 kg bodyweight. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Identification of animals for treatment should be at veterinary discretion. Risk factors may include a history of energy-deficiency-related diseases, high body condition score and parity. In the event of early regurgitation, identify the animal by matching the animal ID number with the number on the intraruminal device and re-administer an undamaged intraruminal device (See section 4.5). 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Hold treated cattle in a confined area for 1 hour after administration to observe for failure to swallow or regurgitation. If this occurs re-administer the intraruminal device if undamaged. If damaged, 3 administer a new intraruminal device. Recheck cattle for up to 4 days after dosing to observe for signs of an intraruminal device lodging in the oesophagus. Signs of lodging may include bloat which may be followed by coughing, droolin Прочетете целия документ