ENROXIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
12-06-2015
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Ingredient activ:
ENROFLOXACIN
Disponibil de la:
Krka, d.d., Novo mesto
Codul ATC:
QJ01MA90
INN (nume internaţional):
ENROFLOXACIN
Dozare:
100 Mg/Ml
Forma farmaceutică:
Solution for Injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Bovine
Zonă Terapeutică:
Enrofloxacin
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2008-09-19
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enroxil Max 100 mg/ml solution for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of bovine respiratory disease associated with _Mannheimia haemolytica_, _Pasteurella multocida_, _Histophilus_
_somni _and _Mycoplasma _spp. where clinical experience, supported where possible by sensitivity testing of the causal
organism, indicates enrofloxacin as the drug of choice.
Treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating
dairy cattle caused by _E. coli_, where herd history and previous sensitivity testing indicate enrofloxacin as the drug of
choice.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis.
Do not administer in case of hypersensitivity to the active substance or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCE
Enrofloxacin
100 mg
EXCIPIENTS
Benzyl alcohol (E1519)
20 mg
Butyl alcohol
30 mg
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 28/05/2015_
_CRN 7020775_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Normal sterile precautions should be taken.
The safety of the product has not been established in calves when administered by the intravenous route and use of this
route of administration in calves is therefore not recommended.
Official and local antimicrobial policies should be taken into account w
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