Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
cabergoline
Ceva Santé Animale
QG02CB03
cabergoline
Prolactine inhibitors, Genito urinary system and sex hormones, Other gynecologicals
For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to:reduce milk leakage at drying off;reduce the risk of new intramammary infections during the dry period;reduce discomfort.
Revision: 1
Withdrawn
2015-12-09
Medicinal product no longer authorised 14 B. PACKAGE LEAFLET Medicinal product no longer authorised 15 PACKAGE LEAFLET FOR Velactis 1.12 mg/ml solution for injection 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 and manufacturer responsible for batch release: Ceva Santé Animale 10 av. de La Ballastière 33500 Libourne FRANCE 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle. cabergoline 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each ml contains 1.12 mg of cabergoline. Clear pale yellow solution. 4. INDICATION For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to: - reduce milk leakage at drying off, - reduce the risk of new intramammary infections during the dry period, - reduce discomfort. 5. CONTRAINDICATIONS Do not use in case of hypersensitivity to cabergoline or to any of the excipients. 6. ADVERSE REACTIONS Slight injection site reactions (mostly swellings) were commonly observed after injection of the product and may persist for at least 7 days. The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals) - uncommon (more than 1 but less than 10 animals in 1,000 animals) - rare (more than 1 but less than 10 animals in 10,000 animals) - very rare (less than 1 animal in 10,000 animals, including isolated reports). If you notice any serious effects or any other effects not mentioned in this package leaflet, please inform your veterinary surgeon. Medicinal product no longer authorised 16 7. TARGET SPECIES Cattle (dairy cows) 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION Intramuscular use. The recommended dose is 5.6 mg of cabergoli Pročitajte cijeli dokument
Medicinal product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Velactis 1.12 mg/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Cabergoline ....................................................................... 1.12 mg EXCIPIENTS: For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for injection. Clear pale yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle (dairy cows) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For use in the herd management programme of dairy cows as an aid in the abrupt drying-off by reducing milk production to: - reduce milk leakage at drying off, - reduce the risk of new intramammary infections during the dry period, - reduce discomfort. 4.3 CONTRAINDICATIONS Do not use in case of hypersensitivity to cabergoline or to any of the excipients. 4.4 SPECIAL WARNINGS Velactis should be used as part of a comprehensive mastitis and milk quality control program under veterinarian advice, which might include the need to use intramammary treatment. For cows considered likely to be free of subclinical mastitis at drying off, in which antibiotic use is not justified/permitted, Velactis can be used as a dry cow treatment. The cows should be diagnosed to be free of subclinical mastitis by using suitable criteria such as bacterial examination of milk, somatic cell count or other recognized tests. In a multicentric randomized clinical trial where dairy cows with no intramammary infections at the time of drying-off were administered either Velactis or placebo at the time of drying-off, the incidence of new intramammary infections within 7 days after subsequent calving was significantly lower among udder quarters of cows treated with Velactis (20.5%) as compared to placebo (26.0%). The difference in percentage of new intramammary infections during the dry period between Velactis tr Pročitajte cijeli dokument