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Dokument190
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SPIROVET 600 000 IU/ml solution for injection for cattle and pigs [BG, CZ, EE, HU, IE, LT, LV, PL,
PT, SI, SK, UK]
SPIRAMYCINE CEVA 600 000 IU/ml, solution for injection for cattle and pigs [FR]
SPIROCIN 600 000 IU/ml, solution for injection for cattle and pigs [DK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains :
ACTIVE SUBSTANCE:
Spiramycin..................................................600 000 IU
EXCIPIENT:
Benzyl alcohol (E 1519) ...............................41.6 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs (sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by spiramycin susceptible bacteria.
CATTLE (ADULTS):
Treatment of:
- Respiratory diseases,
- Mastitis,
- Metritis,
- Interdigital necrobacillosis (foul in the foot).
SOWS:
Treatment of mastitis.
4.3
CONTRAINDICATIONS
Do not use in animals known for their hypersensitivity to spiramycin or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In cattle, do not administer more than 15 ml per injection site.
In sows, do not administer more than 7 ml per injection site.
Due to the likely variability (time, geographical) in the occurrence of resistance of bact
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