Marbocyl 2 % w/v Solution for Injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Marbofloxacin

Tilgjengelig fra:

Vetoquinol Ireland Limited

ATC-kode:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosering :

20 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

marbofloxacin

Indikasjoner:

Antibacterial

Autorisasjon status:

Authorised

Autorisasjon dato:

1998-09-18

Preparatomtale

Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 2 %w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Marbofloxacin
20.0
mg
EXCIPIENTS
Metacresol
2.0
mg
Monothioglycerol
0.5
mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A yellow-greenish to yellow-brownish solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pre- ruminating and ruminating calves and pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Calves
Marbofloxacin 2% is indicated in the treatment of respiratory
infections caused by susceptible strains of organisms.
In Pigs
Marbofloxacin 2% is indicated in the treatment of respiratory
infections caused by susceptible strains of organisms and in the
treatment of Metritis Mastitis Agalactia (MMA) syndrome caused by
susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active
ingredient.
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
Health Products Regulatory Authority
28 August 2019
CRN00987J
Page 2 of 4
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the potential for cross
resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO ANIMALS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERI