UBIFLOX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS (SOWS)

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

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.
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