Synulox Palatable Tablets 500 mg

Summary of Product characteristics

                                Revised: March 2022
AN: 01525/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX PALATABLE TABLETS 500 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredients:_
mg per tablet
Amoxicillin
400.0
(as Amoxicillin Trihydrate)
460.0
Clavulanic acid
100.0
(as Potassium Clavulanate)
119.2
Erythrosine Lake (E127)
35.0
For the full list of all other excipients see section 6.1.
3.
PHARMACEUTICAL FORM
SYNULOX Palatable Tablets are presented as circular, pink TABLETS with
a break line on one face and “Synulox” engraved on the other. Each
tablet contains clavulanic acid as potassium clavulanate and
amoxicillin
as Amoxicillin Trihydrate. in a palatable base.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In vitro the product is active against a wide range of clinically
important
aerobic and anaerobic bacteria, including:
_Gram-positive: _Staphylococci (including

-lactamase-producing strains)
Clostridia; Actinomyces; Peptostreptococcus spp; Streptococci;
Enterococci.
_Gram-negative: _Bacteroides spp. (including

-lactamase-producing
strains); _Escherichia coli_ (including

-lactamase-producing strains);
Salmonellae (including

-lactamase-producing strains); _Bordetella _
_bronchiseptia_; Campylobacter spp; _Fusobacterium necrophorum_;
Klebsiellae; Pasteurellae; Proteus spp.
Clinically, amoxicillin has been shown to be effective in treating a
wide
range of diseases of dogs including: skin disease (including deep and
superficial pyoderma); urinary tract infection; respiratory disease
Revised: March 2022
AN: 01525/2021
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involving upper and lower respiratory tract; enteritis; dental
infections
(e.g. gingivitis); soft tissue infections (e.g. abscesses and anal
sacculitis).
Note: The product is not indicated for cases involving Pseudomonas
spp.
4.3
CONTRAINDICATIONS
In common with other penicillins, amoxicillin should not be
administered
orally to rabbits, guinea pigs or gerbils, and shou
                                
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