TILMOVET AC ORAL SOLUTION- tilmicosin phosphate concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TILMICOSIN PHOSPHATE (UNII: SMH7U1S683) (TILMICOSIN - UNII:XL4103X2E3)

Available from:

Huvepharma, Inc.

Administration route:

Oral

Prescription type:

PRESCRIPTION

Therapeutic indications:

For the control of swine respiratory disease associated with Pasteurella multocida and Haemophilus parasuis in groups of swine in buildings where a respiratory disease outbreak is diagnosed. For the control of swine respiratory disease associated with Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings where a respiratory disease outbreak is diagnosed. Lot No. Exp. Date FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. SEE BOXED WARNING AND ENCLOSED PRODUCT INFORMATION (INCLUDING NOTE TO THE PHYSICIAN). Wear overalls, impervious gloves and eye protection when mixing and handling the product. Wash hands after handling the product. Wash affected parts if skin contact occurs. If accidental eye contact occurs, immediately rinse thoroughly with water. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Huvepharma, Inc. at 1-877

Product summary:

Tilmovet AC (tilmicosin phosphate) is provided in a 960 ml white-colored plastic bottle sealed with a plastic screw cap.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

TILMOVET AC ORAL SOLUTION- TILMICOSIN PHOSPHATE CONCENTRATE
HUVEPHARMA, INC.
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TILMOVET AC
(TILMICOSIN PHOSPHATE)
250 MG/ML TILMICOSIN
FRONT PANEL
960 ML
TILMOVET® AC
(TILMICOSIN PHOSPHATE)
250 MG/ML TILMICOSIN
Aqueous concentrate for oral use in drinking water.
For swine only.
Macrolide Antibiotic.
Do not inject this product. Injection of tilmicosin has been shown to
be fatal in swine and
non-human primates, and may be fatal in horses and goats.
WARNING
Exposure to tilmicosin in humans has been associated with chest pain,
increased
heart rate, dizziness,
headache, and nausea. Death has been reported following ingestion or
injection of
tilmicosin.
Avoid ingestion. Avoid direct skin and eye contact. In case of human
exposure, call
1-877-994-4883 and
consult a physician immediately.
NOTE TO THE PHYSICIAN:
The cardiovascular system is the target of toxicity and should be
monitored closely.
The primary cardiac
effects are tachycardia and decreased contractility. Cardiovascular
toxicity may be
due to calcium channel
blockade.
See User Safety Warnings for additional information.
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
READ ENCLOSED PRODUCT INFORMATION CAREFULLY FOR COMPLETE DETAILS.
INDICATIONS:
For the control of swine respiratory disease associated with
_Pasteurella multocida_ and
_Haemophilus parasuis_ in groups of swine in buildings where a
respiratory disease
outbreak is diagnosed.
For the control of swine respiratory disease associated with
_Mycoplasma_
_hyopneumoniae_ in the presence of
Porcine Reproductive and Respiratory Syndrome Virus (PRRSV) in groups
of swine in
buildings where a
respiratory disease outbreak is diagnosed.
LOT NO.
EXP. DATE
DOSAGE AND ADMINISTRATION:
Must be diluted before administration to animals. Include in the
drinking water to provide
a concentration of
200 mg tilmicosin per liter (200 ppm). One 960 ml bottle is sufficient
to medicate 1200
liters (320 gallons)
of drinking water for pigs. The medicated water should be admin