Clavudale 400 mg/100 mg tablets for dogs

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Amoxicillin trihydrate; potassium clavulanate

Verfügbar ab:

Dechra Regulatory B.V.

ATC-Code:

QJ01CR02

INN (Internationale Bezeichnung):

Amoxicillin trihydrate; potassium clavulanate

Dosierung:

400, 100 mg/tablet

Darreichungsform:

Tablet

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

amoxicillin and enzyme inhibitor

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2011-04-15

Fachinformation

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavudale 400 mg/100 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES:
Amoxicillin (as amoxicillin trihydrate)
400 mg
Clavulanic acid (as potassium clavulanate)
100 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE COMPOSITION IF THAT INFORMATION IS
ESSENTIAL FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUCT
Erythrosine (E127)
7.5 mg
Silica, colloidal anhydrous
-
Magnesium stearate
-
Sodium starch glycolate (Type A)
-
Cellulose, microcrystalline
-
Luctarom 31600z additive (meat flavour)
-
Pink, oblong, scored tablets.
The tablet can be divided into halves.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs.
3.2
INDICATIONS FOR USE FOR EACH 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.,
_Trueperella_
spp.
(previously
_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_
;
2
Respiratory tract infections associated with
_Staphylococcus_
spp.,
_Streptococcus_
spp. and
_Pasteurella_
spp.
Gastrointestinal infections associated with
_Escherichia coli_
and
_Proteus_
_mirabilis_
.
3.3
CONTRAINDICATIONS
Do not use in rabbits, guinea pigs, hamsters and gerbils.
Do not use in cases of hypersensitivity to the active substances,
substances of the β-lactam group or to
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 resista