UBIFLOX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS (SOWS)
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-07-2016
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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, Porcine
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 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 the 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).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 15/07/2016_
_CRN 7022059_
_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. Fluoroquinolones
should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond
po
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