Страна: Кипър
Език: гръцки
Източник: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QJ01CA04
AMOXICILLIN TRIHYDRATE EQUIVALENT TO AMOXICILLIN 150MG/ML
GRANTED
KELA N.V.
SUSPENSION FOR INJECTION
N. A. CHANCE TRADING CO
Withdrawal period: PIGS; Distributor: ANTIBACTERIALS FOR SYSTEMIC USE
ΠΑΡΑΡΤΗΜΑ Ι: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT AMOXY-KEL 15 _150 mg amoxicillin/ml_ _suspension for injection_ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Amoxycillin trihydrate equivalent with 150 mg amoxycillin anhydrous. EXCIPIENTS: Butylhydroxytoluene 1 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. 4. CLINICAL PARTICULARS 4.1 TARGET ANIMAL SPECIES Pigs 4.2 INDICATIONS FOR USE IN THE SPECIFIED TARGET ANIMAL SPECIES For the treatment of infections caused by amoxycillin-sensitive Gram-positive and Gram- negative pathogens and taking into account the antibiotic’s ability to reach the site of the infection in effective concentrations based on its pharmacokinetic properties. 4.3 CONTRAINDICATIONS Hypersensitivity to penicillins and cephalosporins. Do not administer to ruminants, horses, lagomorphs and rodents such as rabbits, guinea pigs, hamsters or gerbils. Do not administer to animals suffering from serious renal failure associated with anuria or oliguria. 4.4 SPECIAL WARNINGS FOR EACH ANIMAL SPECIES FOR WHICH THE VETERINARY MEDICINAL PRODUCT IS INTENDED None 4.5 SPECIAL SAFETY PRECAUTIONS FOR USE SPECIAL SAFETY PRECAUTIONS FOR USE IN ANIMALS The sensitivity of the target pathogens to amoxycillin can change over time. An antibiogram may be necessary for treatment. SPECIAL SAFETY MEASURES FOR THOSE ADMINISTERING THE MEDICINAL PRODUCT TO THE ANIMALS Penicillins and cephalosporins can cause hypersensitivity (allergies) after injection, inhalation, intake or skin contact. Hypersensitivity to penicillins may lead to cross- 1/11 reactions against cephalosporins and vice versa. Allergic reactions to these products can occasionally be serious. Do not use this product in case of known sensitivity, or when you are advised not to use these products. Be careful when using this product and take all recommended precautions to prevent exposure to the prod Прочетете целия документ