FORCYL swine 160 mg/ml solution for injection for pigs

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:

2012-08-31

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 swine 160 mg/ml solution for injection for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE (S):
Marbofloxacin ............................ 160 mg
EXCIPIENT (S):
Benzyl alcohol (E 1519) ………………... 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
Pigs (fattening pigs, weaned piglets, sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In fattening pigs:
- Treatment of respiratory tract infections caused by susceptible
strains of _Actinobacillus pleuropneumoniae_ and _Pasteurella _
_multocida_.
In weaned piglets:
- Treatment of intestinal infections caused by susceptible strains of
_E. coli_.
In post-partum sows:
- Treatment of metritis mastitis agalactia syndrome (form of
postpartum dysgalactiae syndrome, PPDS) caused by susceptible
strains of _E. coli_.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones
or to any of the excipients.
To limit development of resistance, do not use fluoroquinolones as
prophylaxis or metaphylaxis to prevent diarrhoea at
weaning.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
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.
Health Products Regulatory Authority
27 September 2019
CRN009282
Page 2 of 4
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 p