Baytril 1nject Porc et Bovin
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
11-03-2012
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Active ingredient:
enrofloxacin 100 mg/ml
Available from:
Bayer Austria GmbH
ATC code:
QJ01MA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
enrofloxacin
Therapeutic area:
Cattle, Pigs
Authorization date:
2012-09-20
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
(Based on the current SPC of the reference product
Baytril RSI 100 mg/ml Injektionslösung für Rinder und Schweine)
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Direct 100 mg/ml Injektionslösung für Rinder und Schweine [AT]
Baytril Inject – Soluzione iniettabile 100mg/ml per bovini e suini [IT]
Baytril XM 100 mg/mL Solution injectable pour bovins et porcs [FR]
Baytril 1nject 100 mg/ml Injektionslösung für Rinder und Schweine [DE]
Baytril Max 100 mg/ml Solution for Injection for Cattle and Pigs[IE, UK]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Enrofloxacin
100 mg
EXCIPIENT(S):
n-Butanol
30 mg
Benzyl alcohol (E 1519)
20 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, yellow solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle, Pig
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
For the treatment of respiratory tract infections caused by enrofloxacin-sensitive _Histophilus _
_somni, Mannheimia haemolytica, Pasteurella multocida _and_ Mycoplasma _spp.
For the treatment of Mastitis caused by enrofloxacin-sensitive _E. coli_.
Pig:
For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive_ Actinobacillus _
_pleuropneumoniae_, _Pasteurella multocida_ and complicated by _Haemophilus parasuis _as secondary
pathogen_ _in pigs._ _
4.3
CONTRAINDICATIONS
Do not use in the presence of documented hypersensitivity to the pharmacologically active ingredient or
to any of the other ingredients. Do
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