국가: 사이프러스
언어: 그리스어
출처: Κυπριακή Δημοκρατία, Υπουργείο Γεωργίας, Αγροτικής Ανάπτυξης και Περιβάλλοντος, Κτηνιατρικές Υπηρεσίες
GRANTED
QJ01FA90
TYLOSIN 200 MG/ML
GRANTED
BIMEDA ANIMAL HEALTH LIMITED
SOLUTION FOR INJECTION
PANCHRIS FEEDS (VETERINARY) LTD
Withdrawal period: PIGS; Distributor: ANTIBACTERIALS FOR SYSTEMIC USE
ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bilosin 200mg/ml Solution for Injection for pigs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active Substance Tylosin 200.00mg Excipients Qualitative composition of excipients and other constituents Benzyl Alcohol Propylene Glycol Water for Injections A clear yellow solution for injection. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Pigs 3.2 INDICATIONS FOR USE, FOR EACH TARGET SPECIES For the treatment in pigs of diseases involving organisms sensitive to tylosin, such as swine erysipelas (_Erysipelothrix rhusiopathiae_), _vibrionic dysentery_ and pneumonia (_Mycoplasma hyopneumoniae_). 3.3 CONTRAINDICATIONS Do not use in cases of hypersensitive to the active substance or to any of the excipients. 3.4 SPECIAL WARNINGS None. 3.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR SAFE USE IN THE TARGET SPECIES: Not applicable SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek medical attention immediately. In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water. Wash hands after use. Tylosin 1/12 may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided. If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the physician this warning. Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent m 전체 문서 읽기