Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
Cloprostenol sodium
Virbac S.A.
QG02AD90
Cloprostenol sodium
87.5 microgram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Pigs
cloprostenol
Hormone
Authorised
2008-11-28
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclix 87.5 µg/ml solution for injection for pigs. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Cloprostenol 87.5 µg as Cloprostenol sodium 92 µg EXCIPIENTS: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUCT Benzyl alcohol (E1519) 20 mg Citric Acid Monohydrate (as a pH adjuster) Sodium Citrate Sodium Chloride Sodium Hydroxide (as a pH adjuster) Water for injections Colourless solution. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs (sows). 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Induction or synchronisation of farrowing (within 16 to 34 hours) from day 113 of pregnancy onwards (day 1 of pregnancy is the last day of natural or artificial insemination). 3.3 CONTRAINDICATIONS Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use in the case of dystocic parturition (for example due to abnormal position of the foetus or mechanical obstruction). Do not use in animals with spastic diseases of the respiratory or gastrointestinal tract. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS None. 3 3.5 SPECIAL PRECAUTIONS FOR USE Special precautions for safe use in the target species: The veterinary medicinal product should only be used on farms where accurate insemination records are kept. Do not use before day 113 of pregnancy, as this may lead to increased mortality and reduced vitality of new-born piglets. Induction of labour before the 111 th day of gestation may cause mortality in piglets and an increase in the number of sows that require manual assistance. 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 preca Baca dokumen lengkap