MARBOSYVA 100 mg/ml solution for injection for cattle and pigs.
Kraj: Węgry
Język: angielski
Źródło: HMA (Heads of Medicines Agencies)
Ulotka dla pacjenta
(PIL)
02-09-2013
Charakterystyka produktu
(SPC)
02-09-2013
Składnik aktywny:
marbofloxacin 100 mg
Dostępny od:
Laboratorios Syva SA
Kod ATC:
QJ01MA93
Grupa terapeutyczna:
marbofloxacin
Dziedzina terapeutyczna:
Cattle Food, Pigs Females, Pigs Food
Data autoryzacji:
2012-10-24
Ulotka dla pacjenta
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
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Charakterystyka produktu
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
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