Octacillin 697 mg/g Powder for Use in Drinking Water for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Amoxicillin

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01CA04

INN (International Name):

Amoxicillin

Pharmaceutical form:

Powder for use in drinking water

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2010-12-20

Summary of Product characteristics

Revised: May 2021
AN: 00220/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Octacillin 697 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
Revised: May 2021
AN: 00220/2020
Page 2 of 6
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 ADMINISTERING THE
V