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

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Enrofloxacin

متاح من:

Krka d.d., Novo Mesto

ATC رمز:

QJ01MA90

INN (الاسم الدولي):

Enrofloxacin

الشكل الصيدلاني:

Solution for injection

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Cattle, Pigs

المجال العلاجي:

Antimicrobial

الوضع إذن:

Authorized

تاريخ الترخيص:

2006-03-15

خصائص المنتج

Revised: January 2015
AN: 01130/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ENROXIL 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT(S):
n-butyl alcohol as antimicrobial preservative
30 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution practically free from particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains
of _Pasteurella multocida, Mannheimia haemolytica _and _Mycoplasma
_spp.
Treatment of acute severe mastitis caused by enrofloxacin susceptible
strains of
_Escherichia coli._
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible strains
of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of
_Escherichia coli_.
Treatment of acute mycoplasma-associated arthritis due to enrofloxacin
susceptible
strains of _Mycoplasma bovis _in cattle less than 2 years old.
Pigs:
Treatment of infections of the respiratory tract caused by
enrofloxacin susceptible strains
of _Pasteurella multocida, Mycoplasma _spp. and _Actinobacillus
pleuropneumoniae._
Treatment of infections of the urinary tract caused by enrofloxacin
susceptible strains of
_Escherichia coli._
Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome)
caused by
enrofloxacin susceptible strains of _Escherichia coli _and _Klebsiella
_spp.
Treatment of infections of the alimentary tract caused by enrofloxacin
susceptible strains
of _Escherichia coli_.
Treatment of septicaemia caused by enrofloxacin susceptible strains of
_Escherichia coli_.
Revised: January 2015
AN: 01130/2014
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in cases of resistanc