MARBOCYL 10 % SOLUTION FOR INJECTION

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

MARBOFLOXACIN

MAH:

Vetoquinol Ireland Limited

ATC_code:

QJ01MA93

INN:

MARBOFLOXACIN

dosage:

10 %w/v

pharmaceutical_form:

Solution for Injection

prescription_type:

POM

therapeutic_group:

Bovine, Porcine

therapeutic_area:

Marbofloxacin

therapeutic_indication:

Antibacterial

authorization_status:

Authorised

authorization_date:

1997-10-31

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 10% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow to green/brown solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Cattle
Marbofloxacin 10% injection is indicated in the treatment of respiratory infections caused by susceptible strains of
organisms. It is also indicated in the treatment of acute _E.coli _mastitis.
In Pigs
Marbofloxacin 10% injection is indicated in the treatment of Metritis Mastitis Agalactia syndrome caused by
susceptible strains of organisms
4.3 CONTRAINDICATIONS
None known
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known
Active Substance:
Marbofloxacin
100 mg
Excipients:
m-Cresol
2.0 mg
Monothioglycerol
1.0 mg
Disodium Edetate
0.1 mg
Excipient Q.S.
1
ml
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/10/2016_
_CRN 7023455_
_page number: 1_
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
fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potent