Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Cloprostenol
Virbac
QG02AD90
Cloprostenol
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Prostaglandin
Authorized
2006-02-09
Revised: June 2020 AN: 00694/2019 Page 1 of 5 THE SPC/QRDSUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclix 250 microgram/ml solution for injection for cattle 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml solution for injection contains: ACTIVE SUBSTANCE(S): Cloprostenol sodium 263 micrograms (corresponding to 250 micrograms cloprostenol) EXCIPIENT(S): Benzyl alcohol (E1519) 20 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for Injection Colourless solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cows 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Induction of luteolysis allowing resumption of oestrus and ovulation in cyclic females when used during dioestrus, synchronisation of oestrus (within 2 to 5 days) in groups of cyclic females treated simultaneously, treatment of suboestrus and uterine disorders related to a functioning or persistent corpus luteum (endometritis, pyometra), treatment of ovarian luteal cysts, induction of abortion until day 150 of pregnancy, expulsion of mummified foetuses, induction of parturition. 4.3 CONTRAINDICATIONS Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use in animals with spastic diseases of the respiratory or gastrointestinal tract. Revised: June 2020 AN: 00694/2019 Page 2 of 5 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS As with parenteral administration of any substance, basic aseptic rules should be observed. The injection site must be thoroughly cleaned and disinfected in order to reduce the risk of infection with anaerobic bacteria. SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS People with known hypersensitivity to benzyl alcohol should avoid contact with the product. Do not eat, drink or smoke while handling the product. Direct contact with skin or mucous membranes of the user should be avoided. Pr Read the complete document