Negara: Inggris
Bahasa: Inggris
Sumber: VMD (Veterinary Medicines Directorate)
Dinoprost
Zoetis UK Limited
QG02AD01
Dinoprost
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Horses, Pigs
Prostaglandin
Authorized
2005-10-07
Revised: April 2021 AN: 01269/2020 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Lutalyse 5 mg/ml Solution for Injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Dinoprost (as Dinoprost Trometamol) 5 mg EXCIPIENTS: Benzyl Alcohol (E1519). 16.5 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear and colourless solution 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, horses and pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Lutalyse is indicated for its luteolytic and/or oxytocic effects in cattle, horses and pigs. The indications for use are: CATTLE 1. To more effectively control the time of oestrus in cycling cows. 2. To treat cows which have a functional corpus luteum, but do not express behavioural oestrus (sub-oestrus or silent heat). 3. To induce abortion. 4. To induce parturition. 5. For treatment of chronic metritis and pyometra. 6. For controlled breeding in normally-cycling dairy cows: - oestrus synchronisation - ovulation synchronisation in combination with GnRH or GnRH analogues as part of fixed time artificial insemination protocols. Revised: April 2021 AN: 01269/2020 Page 2 of 10 MARES 1. To more effectively control the time of oestrus in cycling mares. 2. To treat mares which have a functional corpus luteum but do not express behavioural oestrus. 3. To induce abortion. PIGS 1. Induction of parturition 2. To reduce the weaning to oestrus interval (WOI) and the weaning to fertile service interval (WFSI) in sows in herds with reproductive problems. 4.3 CONTRAINDICATIONS Contra-indicated in animals suffering from either acute or sub-acute disorders of the vascular system, gastro-intestinal tract or respiratory system. Contra- indicated when abortion or parturition is not intended. Do not administer by the intravenous route. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES CATTLE: Localized post injection bacterial infections that may become generalized hav Baca dokumen lengkapnya