MARFLOXIN 20 MG/ML SOLUTION FOR INJECTION FOR CALVES, PIGS, DOGS AND CATS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-11-2016
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Active ingredient:
MARBOFLOXACIN
Available from:
Krka, d.d., Novo mesto
ATC code:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosage:
20 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Canine, Feline, Porcine
Therapeutic area:
Marbofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2011-08-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 20 mg/ml solution for injection for calves, pigs, dogs and cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
20 mg
EXCIPIENTS:
Metacresol
2 mg
Disodium edetate
0.10 mg
Monothioglycerol
0.50 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow to brownish yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Calves (pre-ruminant and ruminant), pigs, dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections due to marbofloxacin susceptible strains of bacteria.
In Calves
Treatment of respiratory infections caused by _Histophilus somni, Mannheimia haemolytica _and _Pasteurella multocida._
In Pigs
Treatment of respiratory infections.
Treatment of Metritis Mastitis Agalactia (MMA) syndrome.
In Dogs
Treatment of infected wounds and abscesses.
Treatment of lower urinary tract infections due to _Escherichia coli _and _Proteus mirabilis._
Prevention of surgical infections due to _Staphylococcus intermedius, Escherichia coli _and _Pseudomonas aeruginosa_.
In Cats
Treatment of infected wounds and abscesses.
Prevention of surgical infections due to _Staphylococcus intermedius, Escherichia coli _and _Pseudomonas aeruginosa_.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/10/2016_
_CRN 7022043_
_page number: 1_
Do not administer in animals with known hypersensitivity to fluoroquinolones, or to any of the excipients of the
product.
In growing pups of lar
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