Enrotril injection

Name of product: Enrotril inj.  Product-licence holder (name and address): Korea Thumb Vet. Co., Ltd.  470-15 Sunhwa ro(740-1 Shinheung-dong), Iksan-si, Jeollabuk-do, South Korea.  Product-licence number: 34-188  Approval date: 17. Apr. 2013.  Dosage form: pale yellow injectable solution.  Composition: Each 1ml contains 1)   Enrofloxacin                                                        50mg 2)   Potassium Hydroxide                                             q.s. 3)   Butyl Alcohol                                                         q.s. 4)   Water for injection                                                 q.s.  Indications Treatment of bacterial disease sensitive to Enrofloxacin. 1) Cattle: Colibacillosis (diarrhea, sepsis, and E.coli), Mycoplasma bovis, Salmonellosis(Salmonella typhimurium), Pasteurella pneumonia (Pasteurella multocida, Pasteurella haemolytic). 2) Swine: Colibacillosis (diarrhea, enterotoxemia, and E.coli), Mycoplasmal pneumonia (Mycoplasma hyopneumonia, Salmonellosis( Salmonella typhimurium, Salmonella derby), Pasteurella pneumonia( Pasteurella multocida), Actinobacillus pleuropneumoniae. 3) Sheep and Goat: infectious disease causing by Campylobacter spp, E-coli, Haemophilus spp, Mycoplasma spp, Pasteurella multocida, Salmonella spp.  Dosage and administration 1) Swine (I.M) a. Bacterial disease: 0.5mL/10kg/day for 3days. (2.5mg/kg bw/day as Enrofloxacin) b. Severe respiratory, digestive disease: 1mL/10kg/day for 3~5 days. (5mg/kg bw/day as Enrofloxacin) c. Salmonellosis: 1mL/10kg/day for 5 days. (5mg/kg bw/day as Enrofloxacin) 2) Cattle (S.C) a. Bacterial disease: 0.5mL/10kg/day for 3days. (2.5mg/kg bw/day as Enrofloxacin) b. Severe respiratory, digestive disease: 1mL/10kg/day for 3~5 days. (5mg/kg bw/day as Enrofloxacin) c. Salmonellosis: 1mL/10kg/day for 5 days. (5mg/kg bw/day as Enrofloxacin) 3) Sheep and Goat (S.C)   a. Bacterial disease: 0.5mL/10kg/day for 3days. (2.5mg/kg.bw/day as Enrofloxacin) b. Severe respiratory, digestive disease: 1mL/10kg/day for 3~5 days. (5mg/kg bw/day as Enrofloxacin)  Shelf life: 24 months from manufacturing date.   Storage conditions: Store in room temperature away from direct sunlight.   Precautions: 1)   Do not use for animals undergoing hypersensitivity or shock reactions. 2)   Do not administer for animals with hepatic dysfunction or kidney disorder. 3)   Dysarthrosis(lameness, some pain and achondroplasia) may occur in young animal. 4)   Gastroenteric trouble(vomit, loss of appetite, diarrhea and stomachache) may occur. 5)   Central nervous system disorder (dizziness, anxiety, pain, depression, ataxia and    seizure)may occur. Do not use for animal having central nervous system disorder. 6)   Hypersensitivity reactions, crystalluria may occur. 7)   Wash immediately when the solution contact to skin or eyes, and then see the doctor as     soon as possible because Butyl Alcohol is moderate epispastic. 8)   Butyl p-oxybenzoate methyl, Butyl p-oxybenzoate Propyl and Sodium bisulfite can occur hypersensitive reaction. 9)   In case of excessive administration (more than 10 times), vomit or anorexia may occur. 10)    In case of excessive administration(more than 15mg/kg) for cat, mydriasis and retinal degeneration can occur. 11)   Any inquiries about the product, please contact the manufacturer. 12)   It can be used for ruminant such as sheep and goat only exportable products. 13)   Do not use in lactation period of sheep and goat.   Withdrawal period : Cattle - 20 days(milk: 4 days), Swine, Sheep, Goat- 20 days.