Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Amoxicillin ; Clavulanic acid

Dostupné s:

Norbrook Laboratories Limited

ATC kód:

QJ01CR02

INN (Mezinárodní Name):

Amoxicillin ; Clavulanic acid

Dávkování:

75 mg/tablet

Léková forma:

Chewable tablet

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

amoxicillin and enzyme inhibitor

Terapeutické indikace:

Antibacterial

Stav Autorizace:

Authorised

Datum autorizace:

2014-03-07

Charakteristika produktu

Health Products Regulatory Authority
24 August 2017
CRN000TWG
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredients:
Amoxicillin 60.00 mg
(as Amoxicillin Trihydrate)
Clavulanic acid 15.00 mg
(as Potassium Clavulanate)
Excipients:
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Chewable Tablet.
Pale brown circular tablet with a score line and embossed with
‘75’ on opposing
faces.The tablets can be divided into equal halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of the following infections caused by beta-lactamase
producing strains of
bacteria sensitive to amoxicillin in combination with clavulanic acid:
Skin infections (including superficial and deep pyodermas) caused by
_Staphylococcus_spp.
Urinary tract infections caused by _Staphylococcus _spp. or
_Escherichia coli_.
Respiratory tract infections caused by _Staphylococcus_spp.
Enteritis caused by _Escherichia coli_.
Dental infections (e.g. gingivitis).
It is recommended to carry out suitable tests for sensitivity when
initiating the
treatment. The treatment should only proceed if sensitivity is proven
to the
combination.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
24 August 2017
CRN000TWG
Page 2 of 7
The product should not be given to rabbits, hamsters, guinea pigs or
gerbils. Do not
use in animals with known hypersensitivity to penicillin, other
beta-lactams or any of
the excipients. Do not use in animals with serious dysfunction of the
kidneys
accompanied by anuria or oliguria.
Do not use where resistance to this combination is known to occur.
Do not administer to horses and ruminating animals.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Whenever possible, the product should only be used based on
susceptibility