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

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

MARBOFLOXACIN

Commercializzato da:

Krka, d.d., Novo mesto

Codice ATC:

QJ01MA93

INN (Nome Internazionale):

MARBOFLOXACIN

Dosaggio:

100 Mg/Ml

Forma farmaceutica:

Solution for Injection

Tipo di ricetta:

POM: Prescription Only Medicine as defined in relevant national legislation

Gruppo terapeutico:

Cattle, Pigs

Area terapeutica:

marbofloxacin

Indicazioni terapeutiche:

Antibacterial

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2012-08-17

Scheda tecnica

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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