Kelacyl 100 mg/ml, solution for injection for cattle and pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Kela n.v.

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-05-10

Summary of Product characteristics

Health Products Regulatory Authority
02 February 2018
CRN000VTF
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Kelacyl 100 mg/ml, solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
Each ml 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).
Health Products Regulatory Authority
02 February 2018
CRN000VTF
Page 2 of 7
Do not use in cases of hypersensitivity to the active substance,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
Special precautions for use in animals
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, or are expected to respond 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 t