Clavubactin 50/12.5 mg tablets for cats and dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

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Prenos Lastnosti izdelka (SPC)
12-06-2017

Aktivna sestavina:

Amoxicillin ; Clavulanic acid

Dostopno od:

Le Vet Beheer B.V.

Koda artikla:

QJ01CR02

INN (mednarodno ime):

Amoxicillin ; Clavulanic acid

Odmerek:

50, 12.5 mg/tablet

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Dogs, Cats

Terapevtsko območje:

amoxicillin and enzyme inhibitor

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-11-08

Lastnosti izdelka

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Clavubactin 50/12.5 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Tablets.
Yellowish-white to light yellow round tablet with a cross-shaped break
mark on one side.
The tablets can be divided into 4 equal parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in cats and dogs caused by bacteria sensitive
to amoxicillin in combination with clavulanic
acid, particularly:
-
Skin infections (including superficial and deep pyodermas) associated
with Staphylococci (including beta-lactamase
producing strains) and Streptococci.
-
Urinary tract infections associated with Staphylococci (including
beta-lactamase producing strains), Streptococci,
_Escherichia coli_ (including beta-lactamase producing strains),_
Fusobacterium necrophorum_ and_ Proteus_ spp.
-
Respiratory tract infections associated with Staphylococci (including
beta-lactamase producing strains),
Streptococci and Pasteurellae.
-
Gastrointestinal tract infections associated with_ Escherichia coli_
(including beta-lactamase producing strains) and
_Proteus_ spp.
-
Infections of the oral cavity (mucous membrane) associated with
Clostridia, Corynebacteria, Staphylococci
(including beta-lactamase producing strains), Streptococci,_
Bacteroides_ spp. (including beta-lactamase producing
strains),_ Fusobacterium necrophorum_ and Pasteurellae.
Each tablet contains:
ACTIVE SUBSTANCES:
_quantity_
Amoxicillin
(as amoxicillin trihydrate)
50
mg
Clavulanic acid
(as potassium clavulanate)
12.5
mg
EXCIPIENT(S):
Quinoline Yellow E104
0.06
mg
Titanium dioxide E171
0.10
mg
For the full list of excipients, see section 6.1.
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