Ubiflox 20 mg/ml Solution for Injection for Cattle and Pigs

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Marbofloxacin

Inapatikana kutoka:

Krka d.d., Novo Mesto

ATC kanuni:

QJ01MA93

INN (Jina la Kimataifa):

Marbofloxacin

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cattle, Pigs

Eneo la matibabu:

Antimicrobial

Idhini hali ya:

Expired

Idhini ya tarehe:

2011-10-10

Tabia za bidhaa

Revised: July 2016
AN: 00912/2015
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox 20 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin
20 mg
EXCIPIENTS:
Metacresol
2 mg
Disodium edetate
0.10 mg
Monothioglycerol
0.50 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 (pre-ruminant calves up to 100 kg b.w).
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE (PRE-RUMINANT CALVES UP TO 100 KG B.W)
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella _
_multocida, Mannheimia haemolytica _and_ Mycoplasma bovis._
FATTENING PIGS
Treatment of respiratory infections caused by sensitive strains of
_Actinobacillus _
_pleuropneumoniae, Mycoplasma hyopneumoniae, Pasteurella multocida._
4.3
CONTRAINDICATIONS
Do not administer in animals with known hypersensitivity to
marbofloxacin or any
other quinolone or to any of the excipients.
Revised: July 2016
AN: 00912/2015
Page 2 of 5
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.
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
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 treatment with
other
quinolones due to