产品特点
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1. NAM E OF THE VETERINARY M EDICINAL PRODUCT
MARBOCYL BOLUS 50 mg tablets for calves
2. QUALITATIVE AND QUANTITATIVE COM POSITION
Marbofloxacin ...................................................
50.00 mg
Excipient QSP ...................................................
1500 mg
For a full list of excipients, see section 6.1.
3. PHARM ACEUTICAL FORM
Tablet
Off white bolus shaped convex tablet.
4. CLINICAL PARTICULARS
4.1
TARGET SPECIES
Calves
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
In neonatal calves:
Treatment of gastroenteritis caused by sensitive strains of _Escherichia coli_ K99+.
4.3
CONTRAINDICATIONS
Bacterial infections with resistance to other fluoroquinolones (cross resistance)
Do not administer to an animal previously found to be hypersensitive to marbofloxacine or
other quinolone, or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Refer to statements under Sections 4.3 and 4.5.
4.5
SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Fluoroquinolones should be reserved for the treatment of clinical conditions which have
responded poorly, or are expected to respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing
official and local antimicrobial policies should be taken into account whe n the product is
used.
Use of the product deviating from the instructions given in the SPC may increase the
prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness
of treatment with other quinolones due to the potential for cross resistanc
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