Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
tilmicosin phosphate (UNII: SMH7U1S683) (tilmicosin - UNII:XL4103X2E3)
Elanco US Inc.
SUBCUTANEOUS
PRESCRIPTION
Micotil is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida and Histophilus somni and for the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica . Micotil is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica . Do not use in automatically powered syringes, single-use syringes, or other delivery devices not specified in the labeling. Do not administer intravenously to cattle or sheep. Intravenous injection in cattle or sheep will be fatal. Do not use in lambs less than 15 kg body weight. Do not administer to animals other than cattle or sheep. Injection of tilmicosin has been shown to be fatal in swine and non-human primates. Death following exposure to tilmicosin injection has been reported to FDA/CVM in goats, rabbits, pheasants, pigs, dogs, deer, cats, alpacas and horses
Micotil (tilmicosin injection) is supplied in 250 mL multi-dose amber glass bottles in a non-removable polymer protector. Manufactured for: Elanco US, Inc. Greenfield, IN 46140, USA Revised: 09/2021 Micotil, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2022 Elanco or its affiliates YL231214A
New Animal Drug Application
MICOTIL 300- TILMICOSIN PHOSPHATE INJECTION ELANCO US INC. ---------- APPROVED BY FDA UNDER NADA # 140-929 _MICOTIL_™ _300_ _(TILMICOSIN INJECTION)_ 300 MG TILMICOSIN, USP AS TILMICOSIN PHOSPHATE PER ML FOR SUBCUTANEOUS USE IN CATTLE AND SHEEP ONLY SOLO PARA USO SUBCUTÁNEO EN GANADO VACUNO Y OVINO CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. HUMAN WARNINGS: NOT FOR HUMAN USE. INJECTION OF THIS DRUG IN HUMANS HAS BEEN ASSOCIATED WITH FATALITIES. KEEP OUT OF REACH OF CHILDREN. ADMINISTER ONLY WITH A TUBE-FED SAFETY SYRINGE. DO NOT USE IN AUTOMATICALLY POWERED SYRINGES, SINGLE-USE SYRINGES, OR OTHER DELIVERY DEVICES. EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION. IN CASE OF HUMAN INJECTION, CONSULT A PHYSICIAN IMMEDIATELY AND APPLY ICE OR COLD PACK TO INJECTION SITE WHILE AVOIDING DIRECT CONTACT WITH THE SKIN. EMERGENCY MEDICAL TELEPHONE NUMBERS ARE 1-800-722-0987 OR 1-800-428-4441. AVOID CONTACT WITH SKIN, EYES, OR MUCOUS MEMBRANES. NOTE TO THE PHYSICIAN: THE CARDIOVASCULAR SYSTEM IS THE TARGET OF TOXICITY AND SHOULD BE MONITORED CLOSELY. CARDIOVASCULAR TOXICITY MAY BE DUE TO CALCIUM CHANNEL BLOCKADE. IN DOGS, ADMINISTRATION OF INTRAVENOUS CALCIUM OFFSET MICOTIL-INDUCED TACHYCARDIA AND NEGATIVE INOTROPY (DECREASED CONTRACTILITY). DOBUTAMINE PARTIALLY OFFSET THE NEGATIVE INOTROPIC EFFECTS INDUCED BY MICOTIL IN DOGS. SS-ADRENERGIC ANTAGONISTS, SUCH AS PROPRANOLOL, EXACERBATED THE NEGATIVE INOTROPY OF MICOTIL IN DOGS. EPINEPHRINE POTENTIATED LETHALITY OF MICOTIL IN PIGS. THIS ANTIBIOTIC PERSISTS IN TISSUES FOR SEVERAL DAYS. ADVERTENCIAS PARA EL SER HUMANO: ESTE PRODUCTO NO ES PARA USO HUMANO. LA INYECCIÓN DE ESTE MEDICAMENTO AL SER HUMANO SE HA ASOCIADO CON MUERTES. MANTENGA FUERA DEL ALCANCE DE LOS NIÑOS. UTILICE ÚNICAMENTE CON UNA JERINGA DE SEGURIDAD CON TUBO. NO USE EN JERINGAS OPERADAS AUTOMÁTICAMENTE, JERINGAS DE UN SOLO USO U OTROS DISPOSITIVOS DE APLICACIÓN. PROCEDA CON EXTREMA CAUTELA PARA EVITAR LA AUTOINYECCIÓN ACCIDENTAL. EN CASO DE I Pročitajte cijeli dokument