Twinox 40 mg/10 mg Tablets for Cats and Dogs

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Amoxicillin, Clavulanic Acid

MAH:

Virbac

ATC_code:

QJ01CR02

INN:

Amoxicillin, Clavulanic Acid

pharmaceutical_form:

Tablet

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Cats, Dogs

therapeutic_area:

Antimicrobial

authorization_status:

Expired

authorization_date:

2015-06-24

SPC

Issued: June 2015
AN: 01327/2013
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Twinox 40 mg/10 mg tablets for dogs and cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCES
Amoxicillin (as amoxicillin trihydrate)
40 mg
Clavulanic acid (as potassium clavulanate)10 mg
EXCIPIENTS
Erythrosine (E127)
0.05 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Pale pink, rounded, one side scored, uncoated and divisible tablet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Dogs:
Treatment of infections caused by micro-organisms sensitive to the
combination
amoxicillin/clavulanic acid, especially:
- dermatitis (superficial and deep pyoderma) caused by _Staphylococcus
_
_(pseud)intermedius_.
- urinary tract infections caused by _E. coli_ and _Staphylococcus_
spp.
- respiratory tract infections caused by _Streptococcus_ spp.
- enteritis caused by _E. coli_.
Cats:
Treatment of infections caused by micro-organisms sensitive to the
combination
amoxicillin/clavulanic acid, especially:
- dermatitis (superficial and deep pyoderma) caused by _Staphylococcus
_
_(pseud)intermedius_.
- urinary tract infections caused by _E. coli_
- respiratory tract infections caused by _Streptococcus_ spp.
- enteritis caused by _E. coli_.
Issued: June 2015
AN: 01327/2013
Page 2 of 6
4.3
CONTRAINDICATIONS
- Do not use in animals with known hypersensitivity to penicillin or
other substances
of the
beta-lactam group or to any of the excipients.
- Do not use in case of serious dysfunction of the kidneys accompanied
by anuria
and oliguria.
- Do not use in rabbits, guinea pigs, hamsters, chinchillas or
gerbils.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5
SPECIAL PRECAUTIONS FOR USE
i) Special precautions for use in animals
-
Do not use in known cases of resistance to the combination.
-
Official, national and regional antimicrobial policies with respect to
the use o