Quiflox/Marfloquin 100 mg/ml solution for injection
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
marbofloxacin 100 mg
Available from:
Krka d.d.
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle, Pigs Females
Authorization date:
2011-01-26
Summary of Product characteristics
1.3.1
Marbofloxacin
SPC, Labeling and Package Leaflet
FR
SmPCPIL013708/4
20.09.2010 – Updated: 17.02.2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.3.1
Marbofloxacin
SPC, Labeling and Package Leaflet
FR
SmPCPIL013708/4
20.09.2010 – Updated: 17.02.2011
Page 2 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Quiflox 20 mg/ml solution for injection for cattle (calves) and pigs
Marfloquin 20 mg/ml solution for injection for cattle (calves) and pigs
Quiflox 20 mg/ml solution for injection for cattle (calves) and pigs (Czech Republic, Hungary, Latvia,
Lithuania, Slovak Republic)
Marfloquin 20 mg/ml solution for injection for cattle (calves) and pigs (Austria, Belgium, Denmark,
Finland, France, Germany, Greece, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, United
Kingdom)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin
20 mg
EXCIPIENTS:
Metacresol
2 mg
Disodium edetate
0.10 mg
Monothioglycerol
0.50 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 (calves).
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In pre-ruminant and ruminant calves:
-
treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_,
_Mannheimia haemolytica_, and _Mycoplasma bovis_.
In pigs:
-
treatment of respiratory infections caused by sensitive strains of
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