Synulox Palatable Tablets 50 mg

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Amoxicillin, Clavulanic Acid

Διαθέσιμο από:

Zoetis UK Limited

Φαρμακολογική κατηγορία (ATC):

QJ01CR02

INN (Διεθνής Όνομα):

Amoxicillin, Clavulanic Acid

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Cats, Dogs

Θεραπευτική περιοχή:

Antimicrobial

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

1990-08-20

Αρχείο Π.Χ.Π.

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-