Clavudale 200 mg / 50 mg Tablets for Dogs

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Amoxicillin, Clavulanic Acid

Dostupno od:

Dechra Limited

ATC koda:

QJ01CR02

INN (International ime):

Amoxicillin, Clavulanic Acid

Farmaceutski oblik:

Tablet

Tip recepta:

POM-V - Prescription Only Medicine – Veterinarian

Terapijska grupa:

Dogs

Područje terapije:

Antimicrobial

Status autorizacije:

Authorized

Datum autorizacije:

2010-01-08

Svojstava lijeka

Revised: October 2020
AN: 00314/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavudale 200 mg/50 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
Active substances:
Amoxicillin (as amoxicillin trihydrate)
200 mg
Clavulanic acid (as potassium clavulanate)
50 mg
Excipient:
Erythrosine (E127)
3.75 mg
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pink, oblong, scored, meat flavoured tablets.
The tablet can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bacterial infections susceptible to amoxicillin
in combination with
clavulanic acid where clinical experience and/or sensitivity testing
indicates the
product as the drug of choice.
Uses include:
Skin infections (including deep and superficial pyodermas) associated
with
Staphylococcus spp. and Streptococcus spp.;
Infections of the oral cavity (mucous membrane) associated with
Clostridium spp.,
Corynebacterium spp., Staphylococcus spp., Streptococcus spp.,
Bacteroides spp.
and Pasteurella spp.;
Urinary tract infections associated with Staphylococcus spp.,
Streptococcus spp.,
Escherichia coli and Proteus mirabilis;
Respiratory tract infections associated with Staphylococcus spp.,
Streptococcus
spp., and Pasteurella spp.
Gastrointestinal infections associated with Escherichia coli and
Proteus mirabilis.
Revised: October 2020
AN: 00314/2020
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in animals with known hypersensitivity to penicillin or
substances of the
β-lactam group or any of the excipients.
Do not use in animals with either oliguria or anuria associated with
renal dysfunction.
Do not use in cases of known resistance to the combination of
amoxicillin and
clavulanic acid.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in ani