Unisol 100 mg/ml Solution for Injection for Cattle and Pigs

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: VMD (Veterinary Medicines Directorate)

מרכיב פעיל:

Enrofloxacin

זמין מ:

Vetpharma Animal Health, S.L

קוד ATC:

QJ01MA90

INN (שם בינלאומי):

Enrofloxacin

טופס פרצבטיות:

Solution for injection

סוג מרשם:

POM-V - Prescription Only Medicine – Veterinarian

קבוצה תרפויטית:

Cattle, Pigs

איזור תרפויטי:

Antimicrobial

מצב אישור:

Authorized

תאריך אישור:

2011-06-03

מאפייני מוצר

Revised: May 2016
AN: 00490/2015
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
UNISOL 100 mg/ml solution for injection for cattle and pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100.0 mg
EXCIPIENTS:
Benzyl alcohol (E1519)
Disodium edetate
7.8 mg
10.0 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Clear slightly yellowish solution
4. CLINICAL PARTICULARS
4.1. TARGET SPECIES
Cattle and pigs.
4.2. INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE
Treatment
Treatment
of
of
infections
infections
of
of
the
the
respiratory
respiratory
tract
tract
caused
caused
by
by
enrofloxacin
enrofloxacin
susceptible
susceptible
strains
strains
of
of
_Pasteurella_
_Pasteurella_
_ _
_ _
_multocida,_
_multocida,_
_ _
_ _
_Mannheimia_
_Mannheimia_
_ _
_ _
_haemolytica_
_haemolytica_
_ _
_ _
and
and
_Mycoplasma_
_Mycoplasma_
_ _
_ _
spp.
spp.
Treatment
Treatment
of
of
acute
acute
severe
severe
mastitis
mastitis
caused
caused
by
by
enrofloxacin
enrofloxacin
susceptible
susceptible
strains
strains
of
of
_Escherichia_
_Escherichia_
_ _
_ _
_coli_
_coli_
.
.
Revised: May 2016
AN: 00490/2015
Page 2 of 8
Treatment
Treatment
of
of
infections
infections
of
of
the
the
alimentary
alimentary
tract
tract
caused
caused
by
by
enrofloxacin
enrofloxacin
susceptible
susceptible
strains
strains
of
of
_Escherichia_
_Escherichia_
_ _
_ _
_coli_
_coli_
.
.
Treatment
Treatment
of
of
septicaemia
septicaemia
caused
caused
by
by
enrofloxacin
enrofloxacin
susceptible
susceptible
strains
strains
of
of
_Escherichia_
_Escherichia_
_ _
_ _
_coli_
_coli_
.
.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible strains of
_Mycoplasma bovis_ in cattle less than 2 years old.
PIGS
Treatment
Treatment
of
of
infections
infections
of
of
the
the
respiratory
respiratory
tract
tract
caused
caused
by
by
enrofloxacin
enrofloxacin
susceptible
susceptible
strains
strains
of
of
_Pasteurella_
_Past