SOFTIFLOX 20 MG FLAVOURED CHEWABLE TABLETS FOR DOG
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
10-06-2024
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Aktivna sestavina:
MARBOFLOXACIN
Dostopno od:
Norbrook Laboratories Limited
Koda artikla:
QJ01MA93
INN (mednarodno ime):
MARBOFLOXACIN
Odmerek:
20 mg/tablet
Farmacevtska oblika:
Tablets
Tip zastaranja:
POM
Terapevtska skupina:
Canine
Terapevtsko območje:
Marbofloxacin
Terapevtske indikacije:
Antibacterial
Status dovoljenje:
Authorised
Datum dovoljenje:
2013-03-22
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Softiflox 20 mg flavoured chewable tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Chewable Tablet contains:
Active Substance:
Marbofloxacin
20.0 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
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbofloxacin is indicated in dogs 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.
Respiratory infections, caused by susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in cats. A 5 mg tablet is available for the treatment of cats.
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 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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/02/2014_
_CRN 7016307_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
(I) SP
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