Enrotril Max 100 mg/ml Solution for Injection for Cattle

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Enrofloxacin

Tilgjengelig fra:

Norbrook Laboratories Limited

ATC-kode:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosering :

100 milligram(s)/millilitre

Legemiddelform:

Solution for injection

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle

Terapeutisk område:

enrofloxacin

Indikasjoner:

Antibacterial

Autorisasjon status:

Authorised

Autorisasjon dato:

2010-09-03

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotril Max 100 mg/ml Solution for Injection for Cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE
Enrofloxacin
100.0 mg
EXCIPIENTS
Benzyl alcohol (E1519)
20.0 mg
Butyl alcohol
30.0 mg
For the full list of excipients, see section 6.1
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
Indicated for
the 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.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis
Do not
use in case of disturbances in growth of cartilage and/or during
injury of locomotory system particularly on
functionally loaded joints or due to body weight loaded joints.
Do not use in cases of resistance against other fluoroquinolones, due
to the potential for cross-resistance.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Do not use in growing horses because of possible deleterious damage on
articular cartilage.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
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