BOFLOX 100 mg/ml
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-07-2013
Summary of Product characteristics
(SPC)
09-07-2013
Active ingredient:
marbofloxacin 100 mg/ml
Available from:
INDUSTRIAL VETERINARIA S.A.
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle Food, Pigs Food
Authorization date:
2013-01-23
Patient Information leaflet
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LABELLING AND PACKAGE LEAFLET
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A. LABELLING
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PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Boflox, 100 mg/ml solution for injection for cattle and pigs
Marbofloxacin
2.
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Active substance:
Marbofloxacin 100 mg/ml
Excipients:
Disodium edetate
Monothioglycerol
Metacresol
3.
PHARMACEUTICAL FORM
Solution for injection
4.
PACKAGE SIZE
100 ml
250 ml
6 x 100 ml
6 x 250 ml
10 x 100 ml
10 x 250 ml
12 x 100 ml
12 x 250 ml
5.
TARGET SPECIES
Cattle, pigs (sows)
6.
INDICATION(S)
Read the package leaflet before use.
7.
METHOD AND ROUTE(S) OF ADMINISTRATION
Cattle: IM, SC or IV use
Pigs (sows): IM use
Read the package leaflet before use.
8.
WITHDRAWAL PERIOD
CATTLE:
8 mg/kg on a single occasion (IM)
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Meat and offal: 3 days
Milk: 72 hours
2 mg/kg for 3 to 5 days (IV/SC/IM)
Meat and offal: 6 days
Milk: 36 hours
PIG (SOWS):
Meat and offal: 4 days
9.
SPECIAL WARNING(S), IF NECESSARY
Read the package leaflet before use.
10.
EXPIRY DATE
EXP
Shelf-life after first opening the container: 28 days.
Once broached, use by…
11.
SPECIAL STORAGE CONDITIONS
Store in the original package in order to protect from light.
12.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR
WASTE MATERIALS, IF ANY
Dispose of waste material in accordance with local requirements.
13.
THE WORDS “FOR ANIMAL TR
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Summary of Product characteristics
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Boflox, 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Disodium edetate
0.10 mg
Monothioglycerol
1 mg
Metacresol
2 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Yellow greenish to yellow brownish, clear 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 strains of _Histophilus somni_, _Mannheimia _
_haemolytica_, _Mycoplasma bovis, Pasteurella multocida_ susceptible to marbofloxacin._ _
- treatment of acute mastitis caused by strains of _Escherichia coli_ susceptible to marbofloxacin
during the lactation period.
In pigs:
- treatment of Postpartum Dysgalactia Syndrome –PDS-(Metritis Mastitis Agalactia syndrome),
caused by bacterial strains susceptible to marbofloxacin.
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.
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4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account when the p
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