Octacillin 697 mg/g Powder for use in drinking water for Chickens
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
25-08-2013
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Active ingredient:
(13C) urea 9 µ
Available from:
Eurovet Animal Health
ATC code:
QJ01CA
Pharmaceutical form:
Powder and solvent for oral solution
Therapeutic group:
Penicillins with extended spectrum
Therapeutic area:
Chicken Non Food
Authorization date:
2011-09-02
Summary of Product characteristics
Revised: July 2011
An: 00487/2010
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Octacillin 697 mg/g powder for use in drinking water for chickens
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
Amoxicillin (as Amoxicillin trihydrate Ph. Eur.)
697 mg/g
For a 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
Chickens (excluding laying birds producing eggs for human consumption).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections in chickens caused by bacteria susceptible to amoxicillin.
Not effective against beta-lactamase producing organisms.
_ _
4.3
CONTRA-INDICATIONS
Do not use in known cases of hypersensitivity to penicillin or other substances of the beta-
lactam group.
Do not use in rabbits, guinea pigs, hamsters, gerbils or any other small herbivores.
4.4
SPECIAL WARNING FOR EACH TARGET SPECIES.
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and it should take into account
official and local antimicrobial policies.
Inappropriate use of the product may increase the prevalence of bacteria resistance to
amoxicilline and may decrease its effectiveness.
Revised: July 2011
An: 00487/2010
Page 2 of 5
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection,
inhalation,
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