MARBOCYL 10%
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
06-02-2012
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Active ingredient:
marbofloxacin 100 mg/ml
Available from:
Vetoquinol S.A.
Pharmaceutical form:
Solution for injection
Therapeutic area:
CATTLE, SOWS CATTLE, SOWS cattle
Authorization date:
2010-12-22
Summary of Product characteristics
MARBOCYL 10%
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 10%, solution for injection for cattle and swine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marbofloxacin .................................................100.0 mg
_Disodium edetate. ..........................................0.1 mg_
_Thioglycerol ........ _ .........................................._1.0 mg _
_m-cresol ........................................................2.0 mg _
_ _
Excipient to. ................................................... 1 ml
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1
TARGET SPECIES
CATTLE & SOWS
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
IN CATTLE
Treatment of respiratory infections caused by_ _sensitive strains of _Pasteurella multocida, _
_Mannheimia (Pasteurella) haemolytica and Mycoplasma bovis._
Treatment of acute mastitis caused by _E. coli _strains sensitive to marbofloxacin during the
lactation period.
IN SOWS
Treatment of Metritis Mastitis Agalactia Syndrome caused by_ bacterial _strains sensitive to
marbofloxacin._ _
4.3
CONTRA-INDICATIONS
Bacterial infections with resistance to other fluoroquinolones (cross resistance).
Do not administer to an animal previously found to be hypersensitive to marbofloxacin or
other quinolone
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Fluoroquinolones should be reserved for the treatment of clinical conditions which have
responded poorly, or are
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