Quiflor 100 mg/ml solution for injection for cattle and pigs (sows)
Country: Portugal
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, Pigs Females
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 100 mg/ml Solution for Injection for Cattle and Pigs (Sows)
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 and pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
Treatment of respiratory infections caused by sensitive strains of _Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Mycoplasma bovis_.
Treatment of acute mastitis caused by _Escherichia coli_ strains sensitive to
marbofloxacin during the lactation period.
SOWS
Treatment of Metritis Mastitis Agalactia Syndrome caused by bacterial strains
sensitive to marbofloxacin.
The 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.
Revised: January 2013
AN: 01322/2012
Page 2 of 5
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use
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