국가: 이스라엘
언어: 영어
출처: Ministry of Health
OXYTETRACYCLINE HYDROCHLORIDE
COMEX LTD
J01AA06
SPRAY
OXYTETRACYCLINE HYDROCHLORIDE 32.1 MG/ML
TOPICAL
Required
NORBROOK LABORATORIES LIMITED, NORTHERN IRELAND
OXYTETRACYCLINE
OXYTETRACYCLINE
For the treatment of foot rot and topical infections caused by Oxytetracycline-sensitive organisms in sheep.
2020-06-30
_THIS LEAFLET HAS BEEN REVIEWED AND APPROVED BY THE MOH: 6.2010 _ _ _ _SUMMARY OF PRODUCT CHARACTERISTICS _ _VETERINARIAN PRESCRIPTION ONLY MEDICINE _ _FOR ANIMAL USE ONLY _ 1. NAME FORM AND STRENGTH OF THE VETERINARY MEDICIN Alamycin Aerosol Veterinary, topical spray 2. ACTIVE INGREDIENTS Oxytetracycline Hydrochloride 32.1 Mg/Ml Each 140g aerosol can contain: Oxytetracycline Hydrochloride 5 gr (3.6% w/w) For a full list of excipients, see section 13 “further information” 3. INDICATIONS FOR USE Oxytrycycline in indicated for the treatment in wide range of gram positive and gram negative bacterial pathogens. Alamycin Aerosol is indicated for the treatment of foot rot and topical infections caused by organisms sensitive to oxytetracycline in sheep. THERAPEUTIC GROUP: Tetracyclin antibiotic 4. CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active substance. 5. ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) None known. Side effects can be reported to the Ministry of Health by clicking on the link "Reporting adverse events due to drug treatment" found on the home page of the Ministry of Health website (www.health.gov.il) which refers to the online form for reporting adverse events, or by entering the link: _https://sideeffects.health.gov.il/_ _ _ 6. TARGET SPECIES: Sheep 7. AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE For Topical use. Foot rot: Before spraying, the infected area should be cleaned and hooves should be pared. 8. HOW TO USE THE PREPARATION: Holding the can upright, spray at a distance of 15-20 cm away for a few seconds or until the area is covered. Treated sheep should be allowed to stand on dry ground for one hour before returning to pasture. 9. WITHDRAWAL PERIOD Meat: 0 days. Milk: 0 days. In the case of forced slaughter, the treated area should be removed and not used for human consumption. 10. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: • Special precautions for use in animals: Keep away from the animal eyes. For external use only. • Special precautions to be t 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Alamycin Aerosol 3.58% w/w cutaneous spray, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ACTIVE SUBSTANCE _ Each 140g aerosol can contains 5g Oxytetracycline Hydrochloride (equivalent to 3.58% w/w). _EXCIPIENTS _ Patent Blue V (E 131) 0.33% w/w as a marker dye For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Cutaneous spray solution A blue opaque solution. 4. CLINICAL PARTICULARS 4.1 _TARGET SPECIES_ : Cattle, sheep and pigs 4.2 _INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES:_ Alamycin Aerosol is indicated for the treatment of foot rot in sheep and topical infections caused by organisms sensitive to oxytetracycline in cattle, sheep and pigs. 4.3 _CONTRAINDICATIONS:_ None. 4.4 _SPECIAL WARNINGS FOR EACH TARGET SPECIES:_ None. 4.5 _SPECIAL PRECAUTIONS FOR USE:_ SPECIAL PRECAUTIONS FOR USE IN ANIMALS: Keep away from the animal’s eyes SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO THE ANIMALS: Keep away from eyes. Avoid contact with skin. Avoid inhaling vapours. Wash hands after use. Do not spray on a naked flame or any incandescent material. Highly flammable. Must be used in a well ventilated area. Do not smoke when using this product. 4.6 _ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS):_ None. 4.7 _USE DURING PREGNANCY, LACTATION OR LAY:_ The product can be safely administered to pregnant and lactating animals. 4.8 _INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION:_ None. 4.9 _AMOUNT TO BE ADMINISTERED AND ADMINISTRATION ROUTE:_ For the treatment of foot rot, the hooves should be cleaned and pared prior to administration. Wounds should be cleaned prior to administration. Shake the can before use. Spray for a few seconds or until the lesion is adequately covered. Treated sheep should be allowed to stand on dry ground for one hour before returning to pasture. 4.10 _OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES) (IF NECESSARY):_ Not applicable. 4. 전체 문서 읽기