Kesium 625 mg chewable tablets for dogs
Country: Romania
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
09-12-2013
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Active ingredient:
amoxicillin trihydrate 500 mg, clavulanic acid potassium salt 125 mg
Available from:
Sogeval
ATC code:
QJ01CR02
Pharmaceutical form:
Tablet
Therapeutic group:
amoxicillin and enzyme inhibitor
Therapeutic area:
Dogs
Authorization date:
2013-04-24
Summary of Product characteristics
D209 _ Kesium 625 mg
1
VETERINARY MEDICINAL PRODUCT
CZ, DK, DE, IT, FI, SE, AT, BE, NL, LUX :
Kesium 500 mg / 125 mg Chewable tablets for dogs
UK, IE, FR, EL, PL, HU, RO, PT, ES :
Kesium 625 mg Chewable tablets for dogs
PART I B
Pharmaceutical Form
Chewable Tablet
D209 _ Kesium 625 mg
2
TABLE OF CONTENT
SUMMARY OF THE PRODUCT CHARACTERISTICS ............................3
A
– LABELLING ..................................................................... 10
A
– LABELLING – “OUTER PACKAGE” .............................. 11
A
– LABELLING – BLISTER .................................................. 14
B
– PACKAGE LEAFLET....................................................... 16
D209 _ Kesium 625 mg
3
_ _
VETERINARY MEDICINAL PRODUCT
CZ, DK, DE, IT, FI, SE, AT, BE, NL, LUX :
Kesium 500 mg / 125 mg Chewable tablets for dogs
UK, IE, FR, EL, PL, HU, RO, PT, ES :
Kesium 625 mg Chewable tablets for dogs
PART I B
SUMMARY OF THE PRODUCT CHARACTERISTICS
Pharmaceutical Form
Chewable Tablet
D209 _ Kesium 625 mg
4
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CZ, DK, DE, IT, FI, SE, AT, BE, NL, LUX : Kesium 500 mg / 125 mg Chewable tablets for dogs
UK, IE, FR, EL, PL, HU, RO, PT, ES : Kesium 625 mg Chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Amoxicillin (as amoxicillin trihydrate)
500.00 mg
Clavulanic acid (as potassium clavulanate)
125.00 mg
EXCIPIENT (S):
For a full list of excipients, see section 6.1
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