KELACYL 100 mg/ml
Country: Portugal
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:
KELA ALBORATORIES N.V.
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
Kelacyl PIL – D210– January 2012
LABELLING AND PACKAGE LEAFLET
A. LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
CARTON BOX
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kelacyl 100 mg/ml, solution for injection for cattle and pigs (BG, CY, CZ, DE, EL, FR, HU, IE, IT,
LT, PL, PT, RO, SK, UK)
Kelbomar 100 mg/ml, solution for injection for cattle and pigs (BE, NL and LU)
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)
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
PIGS (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
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Summary of Product characteristics
Page 1 of 6
Kelacyl SPC - D210 – January 2013
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Kelacyl 100 mg/ml, solution for injection for cattle and pigs (BG, CY, CZ, DE, EL, FR, HU, IE, IT, LT, PL,
PT, RO, SK, UK)
Kelbomar 100 mg/ml, solution for injection for cattle and pigs (BE, NL and LU)
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 resistanc e).
Do not use in animals with known hypersensitivity to the active substance or to any other quinolone or to
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