Quiflor S 100 mg/ml solution for injection
Country: Hungary
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
04-07-2013
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Active ingredient:
marbofloxacin 100 mg/ml
Available from:
Miklich Laboratorios S.L
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle
Authorization date:
2011-03-23
Summary of Product characteristics
Revised: January 2013
AN: 01322/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quiflor S100 mg/ml Solution for Injection for Cattle (United Kingdom, Austria,
Belgium, Germany, Denmark, Greece, France, Italy Ireland, Netherlands,
Portugal)
Quiflor Single Dose 100 mg/ml Solution for Injection for Cattle (Spain)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin 100 mg
EXCIPIENTS:
Disodium edetate 0.10 mg
Monothioglycerol
1 mg
Metacresol
2 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow to brownish yellow solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections caused by sensitive strains of _Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Histophilus somni_.
This product should only be used based on susceptibility testing.
4.3 CONTRAINDICATIONS
Do not administer in animals with known hypersensitivity to marbofloxacin or
any other quinolone or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Revised: January 2013
AN: 01322/2012
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
Official and local antimicrobial policies should be taken into accoun
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