Amoxibactin 500 mg tablets for dogs

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Amoxicillin

Disponibil de la:

Le Vet Beheer B.V.

Codul ATC:

QJ01CA04

INN (nume internaţional):

Amoxicillin

Dozare:

500 mg/tablet

Forma farmaceutică:

Tablet

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Dogs

Zonă Terapeutică:

amoxicillin

Indicații terapeutice:

Antibiotics

Statutul autorizaţiei:

Authorised

Data de autorizare:

2015-01-16

Caracteristicilor produsului

Health Products Regulatory Authority
24 July 2020
CRN008ZLF
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Amoxibactin 500 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 tablet contains:
ACTIVE SUBSTANCE:
Amoxicillin 500 mg (equivalent to 575 mg amoxicillin trihydrate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White to off white with brown spots, round and convex flavoured tablet
with a cross-shaped break line on one side.
Tablets can be divided into halves and quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of primary and secondary infections of the airways, such as
rhinitis caused by _Pasteurella _spp. and _Streptococcus _
spp.,and bronchopneumonia caused by _Pasteurella _spp., _Escherichia
coli _and Gram-positive cocci.
Treatment of primary infections of the urogenital tract, such as
pyelonephritis and infections of the lower urinary tract caused
by _Escherichia coli, Proteus _spp. and Gram-positive cocci,
endometritis caused by _Escherichia coli, Streptococcus canis _and
_Proteus _spp., and vaginitis as a result of mixed infections.
Treatment of mastitis caused by Gram-positive cocci and _Escherichia
coli_.
Treatment of local skin infections caused by _Streptococcus _spp_._
4.3 CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to penicillins or other
substances of the β-lactam group or to any of the
excipients.
Do not administer to gerbils, guinea pigs, hamsters, rabbits and
chinchillas.
Do not use in animals with serious renal dysfunction accompanied by
anuria or oliguria.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In animals with hepatic and renal dysfunction, the dosing regimen
should be carefully evaluated and the use of the product
based on a risk/benefit evaluation by the veterinary surgeon.
Caution is advised in the use in small herbivores