Enroxil Max 100 mg/ml Solution for Injection for Cattle

País: Reino Unido

Língua: inglês

Origem: VMD (Veterinary Medicines Directorate)

Ingredientes ativos:

Enrofloxacin

Disponível em:

Krka d.d., Novo Mesto

Código ATC:

QJ01MA90

DCI (Denominação Comum Internacional):

Enrofloxacin

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapêutico:

Cattle

Área terapêutica:

Antimicrobial

Status de autorização:

Authorized

Data de autorização:

2007-08-01

Características técnicas

Revised: January 2013
AN: 01156/2012
Page 1 of 5 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:
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
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.
Revised: January 2013
AN: 01156/2012
Page 2 of 5
4.4 SPECIAL WARNING FOR EACH TARGET SPECIES
None.
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
when the product is used.
Fluoroquinolones
should
be
reserved
for
the
treatment
of
clinical
conditions which have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testing.
Use of the product