Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
cloprostenol 87.5 µg/ml
Virbac S.A.
QG02AD90
Injection
cloprostenol
Pigs Females
2011-08-30
1 _[Version 7.2, 12/2008] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclix Porcine solution for injection (87.5 microgram/ml). SPAIN: Cyclix porcino 87.5 µg/ml solucion inyectable THE NETHERLANDS: Cyclix pig 87.5 µg/ml oplossing voor injectie UK/IRELAND: Cyclix porcine 87.5 microgram/ml solution for injection ITALY: Cyclix suini 87.5 µg/ml soluzione iniettabile BELGIUM: Cyclix Porcine PORTUGAL, AUSTRIA, CZECH REPUBLIC, SLOVAKIA, HUNGARY, BULGARIA: to be determined. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 ml solution for injection contains: Cloprostenol sodium ....................................92 micrograms (corresponding to 87.5 micrograms cloprostenol) EXCIPIENTS: Chlorocresol ...............................................1 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 Sows. 4.2 INDICATIONS FOR USE, SPECIFYING THE 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). 4.3 CONTRAINDICATIONS Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use in the case of distocic parturition due to abnormal position of the foetus, mechanical obstruction, etc…. Do not use in animals with spastic diseases of the respiratory or gastrointestinal tract. 4.4 SPECIAL WARNINGS 3 Read the complete document
_[Version 7.2, 12/2008] _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Cyclix Porcine solution for injection (87.5 microgram/ml). SPAIN: Cyclix porcino 87.5 µg/ml solucion inyectable THE NETHERLANDS: Cyclix pig 87.5 µg/ml oplossing voor injectie UK/IRELAND: Cyclix porcine 87.5 microgram/ml solution for injection ITALY: Cyclix suini 87.5 µg/ml soluzione iniettabile BELGIUM: Cyclix Porcine PORTUGAL, AUSTRIA, CZECH REPUBLIC, SLOVAKIA, HUNGARY, BULGARIA: to be determined. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: 1 ml solution for injection contains: Cloprostenol sodium ................................... 92 micrograms (corresponding to 87.5 micrograms cloprostenol) EXCIPIENTS: Chlorocresol............................................... 1 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 Sows. 4.2 INDICATIONS FOR USE, SPECIFYING THE 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). 4.3 CONTRAINDICATIONS Do not use in pregnant animals, for which induction of abortion or parturition is not intended. Do not use in the case of distocic parturition due to abnormal position of the foetus, mechanical obstruction, etc…. Do not use in animals with spastic diseases of the respiratory or gastrointestinal tract. Read the complete document