Enroxil Max 100 mg/ml solution for injection for cattle

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Enrofloxacin

Tillgänglig från:

Krka, d.d., Novo mesto

ATC-kod:

QJ01MA90

INN (International namn):

Enrofloxacin

Dos:

100 milligram(s)/millilitre

Läkemedelsform:

Solution for injection

Receptbelagda typ:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk grupp:

Cattle

Terapiområde:

enrofloxacin

Terapeutiska indikationer:

Antibacterial

Bemyndigande status:

Authorised

Tillstånd datum:

2008-09-19

Produktens egenskaper

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
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4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FO