RE-COVR (tripelennamine hydrochloride injection)

20 mg per mL

Antihistamine

Horses - For intramuscular injection only

Cattle - For intravenous or intramuscular injection

RE-COVR (tripelennamine hydrochloride injection) Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Approved by FDA under NADA # 006-417

Before using this drug, read package onsert for full prescribing information.

Description

Tripelennamine hydrochloride is a white, crystalline material which is stable, nonhygroscopic, and readily soluble in water. Tripelennamine hydrochloride is characterized by its capacity to antagonize many of the pharmacologic effects of histamine. RE-COVR™ (tripelennamine hydrochloride injection) is supplied as a sterile solution in multiple dose vials containing 20 mg of tripelennamine hydrochloride, USP per mL, and may contain sodium hydroxide for pH adjustment.

RE-COVR (tripelennamine hydrochloride injection) Indications

For use in horses and cattle in conditions in which antihistamine therapy may be expected to lead to alleviation of some signs of disease. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves.

Dosage and Administration

Horses: Administer intramuscularly only at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight). This dose may be repeated in 6-12 hours if necessary.

Cattle: Administer intravenously or intramuscularly at a dose of 0.5 mg per lb of body weight (2.5 mL for each 100 lbs of body weight). This dose may be repeated in 6-12 hours if necessary. The intravenous route of administration may provide a more rapid onset of action. Use aseptic technique to administer RE-COVR™ (tripelennamine hydrochloride injection).

Warm the solution to near body temperature prior to administration. Intramuscular injection should be made into the heavy musculature of the hind leg or cervical area.

While venomous snake bites have been treated with antihistaminic drugs, other conjunctive therapy is required because of toxic reactions associated with the protein complex of venom.

Do not puncture the stopper more than 30 times, use within the 24-month product expiry.

WARNINGS AND PRECAUTIONS:

Withdrawal Periods and Residue Warnings: Cattle: Milk taken during treatment and for 24 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 4 days following the last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdraw period has not been established in the pre-ruminating calves.

USER SAFETY WARNINGS: Not for use in humans. Keep out of reach of children. To obtain a Safety Data Sheet, contact KineticVet at 1-877-786-9882 or www.KineticVet.com.

ANIMAL SAFETY WARNINGS: Administration of tripelennamine hydrochloride may give rise to excitement, ataxia, and convulsions.

Central nervous system stimulation in the form of hyperexcitability, nervousness, and muscle tremors lasting up to 20 minutes have been noted in horses following administration.

Depression of the central nervous system and incoordination may occur when the drug is used at therapeutic dose levels. Disturbances in gastrointestinal function may occur in some instances.

OTHER WARNINGS: Do not use in horses intended for human consumption.

CONTACT INFORMATION: Contact KineticVet at (877) 786-9882 or www.KineticVet.com. To report suspected adverse drug experiences, contact KineticVet at (877) 786-9882. For additional information about reporting adverse drug experiences for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

How Supplied

STORAGE AND HANDLING: Store at 20°C to 25°C (68°F - 77°F), excursions permitted between 15°C to 30°C (59°F and 86°F). Keep from freezing. Protect from light.

Manufactured For:

KineticVet, PO Box 12388, Lexington, KY 40583

Made in USA

www.KineticVet.com

019

T-7476-05

Revision Date: 11-21

CPN: 6128065.0