Marbocyl 10% Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Marbofloxacin

Available from:

Vetoquinol SA

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

1997-02-14

Summary of Product characteristics

Revised: July 2011
AN: 00298/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 10% SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marbofloxacin
10.0g
Monothioglycerol
0.1g
Metacresol
0.2g
Disodium edetate
0.01g
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for Injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle & pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle: 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: Indicated in the treatment of Metritis Mastitis Agalactia
syndrome caused
by susceptible strains of organisms.
4.3
CONTRA-INDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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
Page 1 of 5
Revised: July 2011
AN: 00298/2011
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 the potential for cross resistance.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid
using
this product. Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No severe side-effects are to be expected at doses up to 3 or 5 times
the
recommended dose in cattle and pigs respectively. In particular, no
lesions of the
articular joints are encountered