MARBOCYL BOLUS 50 MG TABLET
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
04-11-2016
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Active ingredient:
MARBOFLOXACIN
Available from:
Vetoquinol Ireland Limited
ATC code:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosage:
50 Milligram
Pharmaceutical form:
Bolus
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Marbofloxacin
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
1999-08-23
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocyl Bolus 50 mg Tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Tablet.
Off white bolus shaped convex tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle (neonatal calves).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbocyl bolus is indicated in the treatment of neonatal gastroenteritis caused by _Escherichia coli_, in calves of 25-50 kg.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the recommended duration of treatment (3 days)
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin
50.00 mg
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 19/10/2016_
_CRN 7023455_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
When administration is carried out using an applicator, care should be taken to avoid soft tissue injury.
Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be
reserved for the treatment of clinical conditions which have responded poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on susceptibility testing. 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 resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
People with known hypersensitivity to fluoroquinolone
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