Χώρα: Γερμανία
Γλώσσα: Αγγλικά
Πηγή: HMA (Heads of Medicines Agencies)
amoxicillin trihydrate 800 mg/g
Eurovet Animal Health
QJ01CA04
Powder for oral solution
amoxicillin
Chicken Food
2010-02-24
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 Διαβάστε το πλήρες έγγραφο
_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 Διαβάστε το πλήρες έγγραφο