SOFTIFLOX 5 MG FLAVOURED CHEWABLE TABLETS FOR CATS
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
14-06-2024
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Virkt innihaldsefni:
MARBOFLOXACIN
Fáanlegur frá:
Norbrook Laboratories Limited
ATC númer:
QJ01MA93
INN (Alþjóðlegt nafn):
MARBOFLOXACIN
Skammtar:
5 mg/tablet
Lyfjaform:
Tablets
Gerð lyfseðils:
POM
Meðferðarhópur:
Canine, Feline
Lækningarsvæði:
Marbofloxacin
Ábendingar:
Antibacterial
Leyfisstaða:
Authorised
Leyfisdagur:
2013-03-22
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Softiflox 5 mg flavoured chewable tablets for cats and dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Chewable Tablet contains:
Active Substance:
Marbofloxacin
5.0 mg
Excipients :
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
Light brown round convex tablet with breakline.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs: Indicated for the treatment of skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis,
furunculosis, cellulitis) caused by susceptible strains of organisms, urinary tract infections associated or not with
prostatitis caused by susceptible strains of organisms and respiratory infections, caused by susceptible strains of
organisms.
In cats: Indicated for the treatment of skin and soft tissue infections (wounds, abscesses phlegmons) and upper
respiratory tract infections caused by susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the
excipients.
Do not use in dogs and cats with central nervous system (CNS) disorders, such as epilepsy, as fluoroquinolones could
potentially cause seizures in predisposed animals
Do not use in dogs aged less than 12 months or less than 18 months for exceptionally large breeds of dogs, such as
Great Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer growth period as the fluoroquinolones have been
shown to induce erosion of the articular cartilage in juvenile dogs. Not recommended for use in cats aged less than 16
weeks.
IRISH MEDICINES BOARD
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