Mycomas 100 mg/ml Solution for use in drinking water

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Enrofloxacin

Tersedia dari:

Univet Limited

Kode ATC:

QJ01MA90

INN (Nama Internasional):

Enrofloxacin

Dosis:

100 milligram(s)/millilitre

Bentuk farmasi:

Solution for use in drinking water

Jenis Resep:

POM: Prescription Only Medicine as defined in relevant national legislation

Kelompok Terapi:

Chickens, Turkeys

Area terapi:

enrofloxacin

Indikasi Terapi:

Antibacterial

Status otorisasi:

Authorised

Tanggal Otorisasi:

2016-10-28

Karakteristik produk

B.1. SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Mycomas 100 mg/ml Solution for use in drinking water
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin ............................................... 100
mg
EXCIPIENTS:
Benzyl Alcohol (E 1519) ............................. 14
mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for use in drinking water.
An aqueous, clear, yellowish 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 _
_ _
_ _
_ _
Enrofloxacin should be used where clinical experience, supported where
possible by
sensitivity testing of the causal organism, indicates enrofloxacin as
the active substance
of choice.
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
cases
of
known
hypersensitivity
to
the
active
substance,
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
product. The
resulting mixture should be stirred.
Before use, header tanks should be inspected at regular intervals for
presence of dust,
algae formation and sedimentation.
Official and local antimicrobial policies should be taken into account
when the product
is