Synulox Palatable Tablets 50 mg

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Amoxicillin, Clavulanic Acid

Fáanlegur frá:

Zoetis UK Limited

ATC númer:

QJ01CR02

INN (Alþjóðlegt nafn):

Amoxicillin, Clavulanic Acid

Lyfjaform:

Tablet

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cats, Dogs

Lækningarsvæði:

Antimicrobial

Leyfisstaða:

Authorized

Leyfisdagur:

1990-08-20

Vara einkenni

Revised: March 2022
AN: 01525/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
SYNULOX PALATABLE TABLETS 50 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredients:_
mg per tablet
Amoxicillin
40.0
(as Amoxicillin Trihydrate)
45.9
Clavulanic acid
10.0
(as Potassium Clavulanate)
11.9
For the full list of all other excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
(Circular pink scored tablets).
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats and dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product has been shown to be effective in treating a wide range of
diseases
of cats and dogs including: Skin disease (including deep and
superficial
pyodermas); soft tissue infections (abscesses and anal sacculitis);
dental
infections (e.g. gingivitis); urinary tract infections; respiratory
disease (involving
upper and lower respiratory tract); enteritis.
4.3
CONTRAINDICATIONS
The product should not be given to rabbits, guinea pigs, hamsters or
gerbils.
Caution is advised in their use in any other very small herbivores.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: March 2022
AN: 01525/2021
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Inappropriate use of the product may increase the prevalence of
bacteria resistant to amoxicillin/clavulanic acid.
In animals with hepatic and renal failure, the dosing regimen should
be carefully evaluated.
Use of the product should be based on susceptibility testing and take
into account official and local antimicrobial policies. Narrow
spectrum
antibacterial therapy should be used for first line treatment where
susceptibility testing suggests likely efficacy of this approach.
ii)
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy)
following injection, inhalation, ingestion or skin contact.
Hypersensitivity to penicillins may lead to cross-