Enroxil 50 mg/ml; 100 mg/ml
Negara: Jerman
Bahasa: Inggris
Sumber: HMA (Heads of Medicines Agencies)
Karakteristik produk
(SPC)
13-03-2012
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Bahan aktif:
enrofloxacin 50 mg/ml
Tersedia dari:
Cyton Biosciences Ltd
Kode ATC:
QJ01MA90
Bentuk farmasi:
Solution for injection
Kelompok Terapi:
Fluoroquinolones
Area terapi:
Cattle Young, Dogs, Pigs Food
Tanggal Otorisasi:
2011-01-12
Karakteristik produk
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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