Boflox, 100 mg/ml solution for injection for cattle and pigs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Marbofloxacin

Disponible desde:

Industrial Veterinaria S.A.

Código ATC:

QJ01MA93

Designación común internacional (DCI):

Marbofloxacin

Dosis:

100 milligram(s)/millilitre

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Pigs

Área terapéutica:

marbofloxacin

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2013-05-17

Ficha técnica

Health Products Regulatory Authority
25 June 2018
CRN000W0Y
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Boflox, 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml 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.
Yellow greenish to yellow brownish, clear solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- treatment of respiratory infections caused by strains of
_Histophilus somni_,
_Mannheimia haemolytica_, _Mycoplasma bovis, Pasteurella multocida_
susceptible to
marbofloxacin.
- treatment of acute mastitis caused by strains of _Escherichia coli_
susceptible to
marbofloxacin during the lactation period.
In pigs:
- treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis
Mastitis Agalactia
syndrome), caused by bacterial strains susceptible to marbofloxacin.
Health Products Regulatory Authority
25 June 2018
CRN000W0Y
Page 2 of 8
4.3 CONTRAINDICATIONS
Do not use in cases of resistance to other fluoroquinolones (cross
resistance).
Do not use in cases of hypersensitivity to the active substance, to
any other
quinolone or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy data showed that the product has insufficient efficacy
for the treatment
of acute forms of mastitis induced by gram-positive bacteria.
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