资料单张
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
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产品特点
_[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.
阅读完整的文件