Baytril One 100 mg/ml Solution for injection
Nazione: Austria
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
Foglio illustrativo
(PIL)
06-07-2013
Scheda tecnica
(SPC)
06-07-2013
Principio attivo:
enrofloxacin 100 mg/ml
Commercializzato da:
Bayer HealthCare
Codice ATC:
QJ01MA90
Forma farmaceutica:
Solution for injection
Gruppo terapeutico:
enrofloxacin
Area terapeutica:
Cattle Food, Pigs
Data dell'autorizzazione:
2011-12-21
Foglio illustrativo
_[Version 8, 10/2012] _
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril One 100 mg/ml solution for injection for cattle and pig (PT, PL, AT)
Baytriluno 100 mg/ml solution for injection for cattle and pig (ES)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE INGREDIENT:
Enrofloxacin
100 mg
EXCIPIENTS:
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., as well as
treatment of colimastitis.
Pigs:
For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive
_Actinobacillus pleuropneumoniae_, _Haemophilus parasuis _and_ Pasteurella multocida_. _ _
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with central nervous system-associated seizure disorders, existing
impairment of cartilage growth or damage to the locomotor apparatus involving joints
subjected to heavy functional stresses or load-bearing joints.
Do not use in case of existing resistance against quinolones as this resistanc
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Scheda tecnica
_[Version 8, 10/2012] _
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ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril One 100 mg/ml solution for injection for cattle and pig (PT, PL, AT)
Baytriluno 100 mg/ml solution for injection for cattle and pig (ES)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE INGREDIENT:
Enrofloxacin
100 mg
EXCIPIENTS:
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., as well as
treatment of colimastitis.
Pigs:
For the treatment of bacterial bronchopneumonia caused by enrofloxacin-sensitive
_Actinobacillus pleuropneumoniae_, _Haemophilus parasuis _and_ Pasteurella multocida_. _ _
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals with central nervous system-associated seizure disorders, existing
impairment of cartilage growth or damage to the locomotor apparatus involving joints
subjected to heavy functional stresses or load-bearing joints.
Do not use in case of existing resistance against quinolones as this resistanc
Leggi il documento completo
