BOFLOX, 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
03-02-2016
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Ingredient activ:
MARBOFLOXACIN
Disponibil de la:
Industrial Veterinaria, S.A.
Codul ATC:
QJ01MA93
INN (nume internaţional):
MARBOFLOXACIN
Dozare:
100 Mg/Ml
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine, Porcine
Zonă Terapeutică:
Marbofloxacin
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2013-05-17
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Boflox, 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Disodium edetate
0.10 mg
Monothioglycerol
1 mg
Metacresol
2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Yellow greenish to yellow brownish, clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- treatment of respiratory infections caused by strains of _Histophilus somni_, _Mannheimia haemolytica_, _Mycoplasma_
_bovis, Pasteurella multocida _susceptible to marbofloxacin.
- treatment of acute mastitis caused by strains of _Escherichia coli _susceptible to marbofloxacin during the lactation
period.
In pigs:
- treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis Mastitis Agalactia syndrome), caused by bacterial
strains susceptible to marbofloxacin.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/01/2016_
_CRN 7020663_
_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
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