UBIFLOX CATTLE 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
25-04-2024
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Active ingredient:
MARBOFLOXACIN
Available from:
Krka, d.d., Novo mesto
ATC code:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosage:
100 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Marbofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2012-08-17
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox Cattle 100 mg/ml solution for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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._
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).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/02/2013_
_CRN 7013946_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinoles should
be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to
other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on susceptibility
testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria
resistant to the fluoroquinolones and may decrease the effectiveness of tre
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