MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
Country: Ungverjaland
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
Upplýsingar fylgiseðill
(PIL)
02-09-2013
Vara einkenni
(SPC)
02-09-2013
Virkt innihaldsefni:
marbofloxacin 100 mg
Fáanlegur frá:
Laboratorios Syva SA
ATC númer:
QJ01MA93
Meðferðarhópur:
marbofloxacin
Lækningarsvæði:
Cattle Food, Pigs Females, Pigs Food
Leyfisdagur:
2012-10-24
Upplýsingar fylgiseðill
1
_[Version 7.3.2, 10/2011] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marboquinol 100 mg/ml solution for injection for cattle and pigs (sows)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Metacresol
2 mg
Monothioglycerol
1 mg
Disodium edetate
0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, yellowish solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs (sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Treatment of respiratory infections caused by susceptible strains of _Histophilus somni, Mannheimia _
_haemolytica,_ _Pasteurella multocida_ and _ Mycoplasma bovis_.
- Treatment of acute forms of mastitis induced by marbofloxacin-susceptible _Escherichia coli_ strains,
during lactation.
In pigs (sows):
- Treatment of Postpartum Dysgalactiae Syndrome, PDS (Metritis Mastitis Agalactia Syndrome)
caused by marbofloxacin-susceptible bacterial strains.
4.3
CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance
Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or
to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
3
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be rese
Lestu allt skjalið
Vara einkenni
1
_[Version 7.3.2, 10/2011] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marboquinol 100 mg/ml solution for injection for cattle and pigs (sows)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Metacresol
2 mg
Monothioglycerol
1 mg
Disodium edetate
0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, yellowish solution
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs (sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Treatment of respiratory infections caused by susceptible strains of _Histophilus somni, Mannheimia _
_haemolytica,_ _Pasteurella multocida_ and _ Mycoplasma bovis_.
- Treatment of acute forms of mastitis induced by marbofloxacin-susceptible _Escherichia coli_ strains,
during lactation.
In pigs (sows):
- Treatment of Postpartum Dysgalactiae Syndrome, PDS (Metritis Mastitis Agalactia Syndrome)
caused by marbofloxacin-susceptible bacterial strains.
4.3
CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance
Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or
to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
3
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when the product is used.
Fluoroquinolones should be rese
Lestu allt skjalið
