מדינה: ישראל
שפה: עברית
מקור: Ministry of Health
ATIPAMEZOLE HYDROCHLORIDE
ZOETIS ISRAEL HOLDING B.V., ISRAEL
תמיסה להזרקה
ATIPAMEZOLE HYDROCHLORIDE 5 MG/ML
תת-עורי, תוך-שרירי
מרשם נדרש
ORION CORPORATION ORION PHARMA,FINLAND
2014-10-31
_The format of this leaflet was determined by the Ministry _ _of Health and its content was checked and approved by it._ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Antisedan Veterinary 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient: Atipamezole hydrochloride 5 mg/ml For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Clear and colourless solution for Injection. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Elimination of the sedative effects of medetomidine in dogs and cats. See section 4.4 for restrictions. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES When any combination of butorphanol or medetomidine or dexmedetomidine and ketamine have been used, atipamezole should not be used to reverse the effect in dogs. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precaution(s) for use in animals With the exception of those drugs mentioned within the SPC, the concurrent use of drugs affecting the CNS is not recommended. Antisedan should not be administered within 30-40 minutes of the administration of ketamine in cats. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Due to the potent pharmacological activity of atipamezole, skin contact with this product should be avoided and impervious gloves should be worn during administration. Care should be taken to avoid accidental self-injection. If accidental self-injection occurs, seek immediate medical attention showing a copy of the package leaflet. Do not drive. The patient should not be left unattended. In case of accidental spillage, wash the affected area immediately with clean running water. Seek medical attention if irritation persists. In case of accidental ingestion, seek medical advice immediately. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In dogs a transient hypotensive effect has been observed during the first ten minutes post-injection. Vo קרא את המסמך השלם