Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs

Země: Velká Británie

Jazyk: angličtina

Zdroj: VMD (Veterinary Medicines Directorate)

Aktivní složka:

Amoxicillin, Clavulanic Acid

Dostupné s:

Norbrook Laboratories Limited

ATC kód:

QJ01CR02

INN (Mezinárodní Name):

Amoxicillin, Clavulanic Acid

Léková forma:

Chewable tablet

Druh předpisu:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutické skupiny:

Cats, Dogs

Terapeutické oblasti:

Antimicrobial

Stav Autorizace:

Expired

Datum autorizace:

2014-03-05

Charakteristika produktu

Revised: August 2017
AN: 00727/2016
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Noroclav 75 mg Chewable Flavoured Tablets for Cats and Dogs (IE [RMS],
AT,UK).
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.
Revised: August 2017
AN: 00727/2016
Page 2 of 7
4.3
CONTRAINDICATIONS
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
te