Reneval 100 mg/ml Solution for Injection for cattle and pigs
Land: Italien
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Produktets egenskaber
(SPC)
21-08-2013
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Aktiv bestanddel:
enrofloxacin 100 mg/ml
Tilgængelig fra:
Pfizer Limited
ATC-kode:
QM01AC06
Lægemiddelform:
Solution for injection
Terapeutisk gruppe:
meloxicam
Terapeutisk område:
Cattle, Pigs
Autorisation dato:
2011-12-21
Produktets egenskaber
AN: 01749/2010
Issued: February 2012
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Reneval 100 mg/ml Solution for Injection for cattle and pigs.
Reneval (DK)
Reneval vet. 100 mg/ml Solution for Injection for cattle and pigs. (FI, SE)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of solution contains:
Active substance
Enrofloxacin
100.0 mg
Excipients
n-Butanol
30.0 mg
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
Clear light yellow solution free from particulate matter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Cattle _
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal
origin (e.g. _pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia _and_ _
_salmonellosis_) and secondary bacterial infections subsequent to viral
infections (e.g. viral pneumonia) where clinical experience, supported where
possible by sensitivity testing of the causal organism, indicates enrofloxacin as
the drug of choice.
AN: 01749/2010
Issued: February 2012
Page 2 of 8
Treatment of local signs (inflammation, milk quality and yield) associated with
peracute/acute mastitis in lactating dairy cattle caused by E. coli, where herd
history and previous sensitivity testing indicate enrofloxacin as the drug of
choice.
_ _
_Pigs _
_ _
Diseases of the respiratory and alimentary tract of bacterial or mycoplasmal
origin (e.g. _pasteurello
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