产品特点
VETERINARY MEDICINAL PRODUCT
XEDEN 200 MG TABLET FOR DOGS
PART I B
SUMMARY OF PRODUCT CHARACTERISTICS
PHARMACEUTICAL FORM
TABLET
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
XEDEN 200 mg tablet for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
One tablet contains:
Enrofloxacin ...........................................................200.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Clover-shaped scored beige tablet
The tablet can be divided into four equal parts.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
- Treatment of lower urinary tract infections (associated or not with prostatitis) and upper
urinary tract infections caused by Escherichia Coli or Proteus mirabilis.
- Treatment of superficial and deep pyoderma.
4.3 CONTRAINDICATIONS
Do not use in young or growing dogs (dogs aged less than 12 months (small breed) or less
than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in
growing puppies.
Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation.
Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients
of the product.
Do not use in case of resistance to quinolones, as there exists almost complete cross
resistance to other quinolones and complete cross resistance to other fluoroquinolones.
Do not use with tetracyclines, phenicols or macrolides because of pote
阅读完整的文件