Ubiflox 20 mg/ml Solution for Injection for Cattle and Pigs
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
03-10-2013
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Active ingredient:
marbofloxacin 20 mg/ml
Available from:
Miklich Laboratorios S.L
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle, Pigs
Authorization date:
2011-03-23
Summary of Product characteristics
Issued: October 2011
AN: 00043/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox 20 mg/ml solution for injection for cattle and pigs
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 (pre-ruminant calves up to 100 kg b.w).
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE (PRE-RUMINANT CALVES UP TO 100 KG B.W)
Treatment of respiratory infections caused by sensitive strains of _Pasteurella _
_multocida, Mannheimia haemolytica _and_ Mycoplasma bovis. _
_ _
FATTENING PIGS
Treatment of respiratory infections caused by sensitive strains of _Actinobacillus _
_pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida. _
4.3 CONTRAINDICATIONS
Do not administer in animals with known hypersensitivity to marbofloxacin or any
other quinolone or to any of the excipients.
Issued: October 2011
AN: 00043/2010
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
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when
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