MICOTIL 300- tilmicosin phosphate injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

tilmicosin phosphate (UNII: SMH7U1S683) (tilmicosin - UNII:XL4103X2E3)

זמין מ:

Elanco US Inc.

מסלול נתינה (של תרופות):

SUBCUTANEOUS

סוג מרשם:

PRESCRIPTION

סממני תרפויטית:

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

leaflet_short:

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

מצב אישור:

New Animal Drug Application

מאפייני מוצר

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