MARBOCYL 2 % W/V SOLUTION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-11-2016
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Active ingredient:
MARBOFLOXACIN
Available from:
Vetoquinol Ireland Limited
ATC code:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosage:
2 %w/v
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Marbofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1998-09-18
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl 2% w/v Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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
HEALTH PRODUCTS REGULATORY AUTHORITY
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_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 the
fluoroquinolone
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