Enroxil Max 100 mg/ml solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle

Therapeutic area:

enrofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2008-09-19

Summary of Product characteristics

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