Ubiflox 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)
03-10-2013
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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
Authorization date:
2011-03-23
Summary of Product characteristics
Revised: September 2012
AN: 01598/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERSITICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox 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,_ _Mycoplasma bovis_ and _Histophilus somni_.
Treatment of acute mastitis caused by _Escherichia coli_ strains sensitive to
marbofloxacin during the lactation period.
SOWS
Treatment of Metritis Mastitis Agalactia Syndrome (postpartum dysgalactiae
syndrome, PDS) caused by bacterial strains sensitive to marbofloxacin.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active substance or to
any of the excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Revised: September 2012
AN: 01598/2011
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FO
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