Enroxil 100 mg/ml Solution for Injection
País: Irlanda
Língua: inglês
Origem: HMA (Heads of Medicines Agencies)
Características técnicas
(SPC)
13-03-2012
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Ingredientes ativos:
enrofloxacin 100 mg/ml
Disponível em:
Cyton Biosciences Ltd
Código ATC:
QJ01MA90
Forma farmacêutica:
Solution for injection
Grupo terapêutico:
Fluoroquinolones
Área terapêutica:
Cattle Food, Pigs Food
Data de autorização:
2011-01-12
Características técnicas
Revised: December 2011
AN: 00172/2011
Page 1 of 5
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 a 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 respiratory and alimentary tract diseases of bacterial or
mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia)
and secondary bacterial infections subsequent to viral conditions (e.g. viral
pneumonia).
Pigs: Treatment of respiratory and alimentary tract diseases of bacterial or
mycoplasmal origin (pasteurellosis, mycoplasmosis, coli-bacillosis) and multifactorial
diseases such as enzootic pneumonia.
4.3
CONTRAINDICATIONS
Do not use for prophylaxis.
Do not use in case of resistance against quinolones.
Do not use in case of disturbances in growth of cartilages and/or during injury of
locomotory system particularly on functionally loaded joints or due to body weight
loaded joints.
Do not use in case of hypersensitivity to the active substance, or to any of the
excipients.
Revised: December 2011
AN: 00172/2011
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cattle: Not more than 10 ml should be administered at one subcutaneous injection site.
Calves: Not more t
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