Forcyl 160 mg/ml solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Vetoquinol Ireland Limited

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

160 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

marbofloxacin

Authorization status:

Authorised

Authorization date:

2011-07-22

Summary of Product characteristics

Health Products Regulatory Authority
27 September 2019
CRN009282
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Forcyl 160 mg/ml solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE INGREDIENT(S):
Marbofloxacin............................. 160 mg
EXCIPIENTS:
Benzyl alcohol (E1519)………………... 15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow greenish to yellow brownish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Therapeutic treatment of respiratory infections caused by sensitive
strains of _Pasteurella multocida_ and _Mannheimia _
_haemolytica_.
In lactating cows:
- Treatment of acute mastitis caused bysensitive strains of
_Escherichia coli. _
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones
or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy of the product has not been tested on mastitis caused by
Gram positive bacteria.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when this 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. Wherever possible,
use of the product should only be based on susceptibility
testing.
Use of the product deviating from the instructions given in this 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.
Health Products Regulatory Authority
27 September 2019
CRN009282
Page 2 of 4
SPECIAL PRECAUT