SPECTRON 100 mg/ml solution for use in drinking water for chickens and turkeys

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Enrofloxacin

Dostopno od:

Laboratorios Hipra S.A.

Koda artikla:

QJ01MA90

INN (mednarodno ime):

Enrofloxacin

Odmerek:

100 milligram(s)/millilitre

Farmacevtska oblika:

Oral solution

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Chickens, Turkeys

Terapevtsko območje:

enrofloxacin

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

2010-11-19

Lastnosti izdelka

Health Products Regulatory Authority
19 July 2018
CRN000YRP
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
SPECTRON 100 mg/ml solution for use in drinking water for chickens and
turkeys
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin................................ 100 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for use in drinking water.Slightly yellowish clear solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens and Turkeys.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by the following bacteria susceptible
to enrofloxacin:
CHICKENS
_Mycoplasma gallisepticum, _
_Mycoplasma synoviae, _
_Avibacterium paragallinarum, _
_Pasteurella multocida._
TURKEYS
_Mycoplasma gallisepticum, _
_Mycoplasma synoviae, _
_Pasteurella multocida._
Health Products Regulatory Authority
19 July 2018
CRN000YRP
Page 2 of 7
4.3 CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use when resistance/ cross-resistance to (fluoro)quinolones is
known to occur
in the flock intended for treatment.
Do not use in case of known hypersensitivity to the active substance,
to other
(fluoro)quinolones, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of _Mycoplasma_ spp. infections may not eradicate the
organism.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Before use, header tanks should be emptied, thoroughly cleaned and
then filled with
a known volume of clean water before adding the required amount of the
veterinary
medicinal product. The resulting mixture should be stirred.
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
susceptibi