Octacillin 800 mg/g powder for use in drinking water for pigs

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amoxicillin trihydrate

Dostupno od:

Eurovet Animal Health B.V.

ATC koda:

QJ01CA04

INN (International ime):

Amoxicillin trihydrate

Doziranje:

800 milligram(s)/gram

Farmaceutski oblik:

Powder for use in drinking water

Tip recepta:

POM: Prescription Only Medicine as defined in relevant national legislation

Područje terapije:

amoxicillin

Status autorizacije:

Authorised

Datum autorizacije:

2020-06-12

Svojstava lijeka

Health Products Regulatory Authority
14 April 2021
CRN009RSW
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Octacillin 800 mg/g powder for use in drinking water for pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains:
ACTIVE SUBSTANCE:
​
Amoxicillin
​697 mg
​
equivalent to amoxicillin trihydrate
​800 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for use in drinking water
White to pale yellow-white powder
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
​
​
Treatment of infections caused by bacteria sensitive to amoxicillin:
​
Pigs:
​
Pleuropneumonia caused by_ Actinobacillus pleuropneumoniae._
​
​
Meningitis caused by _Streptococcus suis._
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to penicillin and
other substances of the ß-lactam group.
Do not use in rabbits and rodents such as guinea pig, hamster or
gerbil.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official, national and regional antimicrobial policies should be taken
into account when the product is used. Use of the product
should be based on susceptibility testing of the bacteria isolated
from the animal. If this is not possible, therapy should be
based on local (regional, farm level) epidemiological information
about susceptibility of the target bacteria. Use of the product
deviating from the instructions given in the SPC may increase the
prevalence of bacterial resistance to amoxicillin and may
decrease its effectiveness of treatment with amoxicillin, due to the
potential for cross-resistance.
The uptake of medication by pigs can be altered as a consequence of
illness. In case of insufficient uptake of water, pigs should
be treated parenterally. Do not use in animals with serious kidney
malfunction including anuria and oliguria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMIN