Norotril Max 100 mg/ml Solution for Injection for Cattle

Nazione: Regno Unito

Lingua: inglese

Fonte: VMD (Veterinary Medicines Directorate)

Principio attivo:

Enrofloxacin

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QJ01MA90

INN (Nome Internazionale):

Enrofloxacin

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

POM-V - Prescription Only Medicine – Veterinarian

Gruppo terapeutico:

Cattle

Area terapeutica:

Antimicrobial

Stato dell'autorizzazione:

Expired

Data dell'autorizzazione:

2010-11-25

Scheda tecnica

Revised: October 2015
AN: 01468/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Norotril 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
Revised: October 2015
AN: 01468/2014
Page 2 of 6
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.
4.5
SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Normal sterile precautions should be taken.
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 deviating fro