Marbonor 100 mg/ml Solution for Injection for cattle and pig

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Marbofloxacin

Mevcut itibaren:

Norbrook Laboratories Limited

ATC kodu:

QJ01MA93

INN (International Adı):

Marbofloxacin

Doz:

100 milligram(s)/millilitre

Farmasötik formu:

Solution for injection

Reçete türü:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapötik grubu:

Cattle, Pigs

Terapötik alanı:

marbofloxacin

Terapötik endikasyonlar:

Antibacterial

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2013-02-22

Ürün özellikleri

Health Products Regulatory Authority
22 November 2017
CRN000VF0
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbonor 100 mg/ml Solution for Injection for cattle and pig
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin 100.0 mg
EXCIPIENTS:
Monothioglycerol 1.0 mg
Metacresol 2.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow to amber 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 susceptible strains of
_Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Mycoplasma bovis_.
Treatment of acute mastitis caused by _Escherichia coli _strains
susceptible to
marbofloxacin during the lactation period.
SOWS
Treatment of Metritis Mastitis Agalactia Syndrome (postpartum
dysgalactia
syndrome, PDS) caused by bacterial strains susceptible to
marbofloxacin.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
Do not use in cases of hypersensitivity to the active substance or to
any of the
excipients.
Health Products Regulatory Authority
22 November 2017
CRN000VF0
Page 2 of 6
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 upon susceptibility testing. Use of the product deviating from
the instructions
given in the SPC may increase the prevalence of bacteria r