Baytril Flavour Tablets 250 mg

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Enrofloxacin

Saatavilla:

Bayer plc

ATC-koodi:

QJ01MA90

INN (Kansainvälinen yleisnimi):

Enrofloxacin

Valtuutuksen tilan:

Expired

Valmisteyhteenveto

Issued 23/02/2010 – AN 01747/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Flavour Tablets 250 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
ACTIVE CONSTITUENTS
MG PER TABLET
Enrofloxacin
250.0
2.2
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Artificial Beef Flavour Irradiated
70.0
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Tablet.
Light brown to brown, slightly marbled tablets for oral administration
to dogs.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in dogs in the treatment of bacterial
infections of the
alimentary, respiratory and urogenital tracts, skin, secondary wound
infections
and otitis externa where clinical experience, supported where possible
by
sensitivity testing of the causal organism, indicates enrofloxacin as
the drug of
choice.
4.3
CONTRAINDICATIONS
Not for use in dogs less than 1 year of age or in exceptionally large
breeds of
dog with a longer growth period under 18 months of age, as articular
cartilage
may be affected during the period of rapid growth.
Baytril Flavour Tablets 250 mg should not be used for prophylaxis.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Please see point 4.3.
4.5
SPECIAL PRECAUTIONS FOR USE
I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not exceed the recommended dose.
1/4
Issued 23/02/2010 – AN 01747/2008
II)
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
MEDICINAL PRODUCT TO ANIMALS
None.
III)
OTHER PRECAUTIONS
None.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In dogs enrofloxacin may affect articular cartilage during the period
of rapid
growth.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
The product may be used safely in pregnant and lactating animals.
4.8
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
None known
4.9
AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE
The dosage rate of enrofloxacin is 5 mg/kg given orally once daily or
as a
divided dose twice