Baytril One 100 mg/ml
Country: Portugal
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
06-07-2013
Summary of Product characteristics
(SPC)
06-07-2013
Active ingredient:
enrofloxacin 100 mg/ml
Available from:
Bayer HealthCare
ATC code:
QJ01MA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
enrofloxacin
Therapeutic area:
Cattle Food, Pigs
Authorization date:
2011-12-21
Patient Information leaflet
_[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
Read the complete document
Summary of Product characteristics
_[Version 8, 10/2012] _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
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
Read the complete document
