Marbocyl S
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
04-03-2012
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Active ingredient:
marbofloxacin 100 mg/ml
Available from:
Vetoquinol
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle
Authorization date:
2008-10-19
Summary of Product characteristics
12219 MARB OCY L S Renewal FR/V/0168/01/R/01 SPC D 90
January 2011
1/12
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
The UK, Ireland,
Marbocyl Solo 10% solution for injection for cattle
Spain
Marbocyl Bovinos 100 mg/ml solution for injection for
cattle
Germany, Austria, The Netherlands, Belgium,
Italy, Poland, Portugal, The Slovak Republic, The
Czech Republic, Greece, Luxembourg, France
Marbocyl S 10% solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance :
Marbofloxacin ..................... 100.0 mg
Excipients :
Disodium edetate. ................... 0.1 mg
Thioglycerol ........................... 1.0 mg
metacresol ............................. 2.0 mg
For a full list of excipients, see section 6.1.”
3.
PHARMACEUTICAL FORM
Solution for injection.
Yellow greenish to yellow brownish, clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Histophilus somni_.
4.3
CONTRA-INDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross
resistance).
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local
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