Octacillin, 800 mg/g powder for oral solution for chickens
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Patient Information leaflet
(PIL)
09-07-2013
Summary of Product characteristics
(SPC)
09-07-2013
Active ingredient:
amoxicillin trihydrate 800 mg/g
Available from:
Eurovet Animal Health
ATC code:
QJ01CA04
Pharmaceutical form:
Powder for oral solution
Therapeutic group:
amoxicillin
Therapeutic area:
Chicken Food
Authorization date:
2010-02-24
Patient Information leaflet
PART IB-2
LABELLING
OCTACILLIN
POWDER FOR USE IN DRINKING WATER
FOR CHICKENS
THE FULL TEXT WILL BE PRINTED ON THE SACHET/BAG
FORMAT USED IS REQUIRED BY DUTCH LAW FOR THIS TYPE OF LABELLING
PARTICULARS TO APPEAR ON THE OUTER PACKAGE
=
IMMEDIATE PACKAGE
=
LEAFLET
PLASTIC/ALUMINIUM SACHET
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Octacillin 800
mg/g powder for use in drinking water for chickens
NL: Octacillin 800
mg/g poeder voor gebruik in het drinkwater voor kippen
DE: Octacillin 800
mg/g Pulver zum Eingeben über das Trinkwasser für Hühner
FR: Octacillin 697
mg/g poudre à administrer dans l'eau de boisson des poulets
2.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT
Composition per gram product
Active Substance: Amoxicillin trihydrate 800
mg corresponding to 697 mg amoxicillin
3.
PHARMACEUTICAL FORM
Powder for use in drinking water. White to pale yellow-white powder.
4.
PACKAGE SIZE
100 g, 250 g, 500 g, 1.0 kg.
5.
TARGET SPECIES
Chicken (excluding laying birds producing eggs for human consumption): broiler, pullet,
breeder.
6.
INDICATION(S)
Where clinical disease is present in the flock, treatment and prevention of respiratory or
gastrointestinal disease due to pathogens sensitive to
amoxicillin.
7.
CONTRAINDICATIONS
None known for this target species.
Do not use in lagomorphs and rodents such as rabbits, guinea pigs, hamster and gerbils as this
may cause severe enterotoxaemia.
8.
ADVERSE REACTIONS
None known.
If you
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Summary of Product characteristics
_SPC- OCTACILLIN 24-02-2010 - Day 90 _
PART IB1
SUMMARY OF PRODUCT CHARACTERISTICS
OCTACILLIN
_SPC- OCTACILLIN 24-02-2010 - Day 90 _
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Octacillin 800
mg/g powder for use in drinking water for chickens
NL: Octacillin 800
mg/g poeder voor gebruik in het drinkwater voor kippen
DE: Octacillin 800
mg/g Pulver zum Eingeben über das Trinkwasser für Hühner
FR: Octacillin 697
mg/g poudre à administrer dans l'eau de boisson des poulets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 gram of powder contains:
ACTIVE SUBSTANCE:
Amoxicillin trihydrate 800 mg corresponding to 697
mg amoxicillin
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
Chicken (broiler, pullet, breeder).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Chickens (excluding laying birds producing eggs for human consumption):
Where clinical disease is present in the flock, treatment and prevention of respiratory or
gastrointestinal disease due to pathogens sensitive to
amoxicillin.
4.3 CONTRA-INDICATIONS
None known for this target species.
Do not use in lagomorphs and rodents such as rabbits, guinea pigs, hamster and gerbils as this
may cause severe enterotoxaemia._ _
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
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