AnaSed ® Injection

(xylazine injection) 100 mg/mL

Sedative and Analgesic for Use in Horses and Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer and Elk)

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

Do not use in Cervidae less than 15 days before or during the hunting season.

AnaSed^® is supplied in 50 mL multiple-dose vials as a sterile solution.

EACH mL CONTAINS: Xylazine hydrochloride equivalent to 100 mg of base activity, methylparaben 0.9 mg, propylparaben 0.1 mg, sodium citrate dihydrate 5.0 mg and water for injection. pH adjusted with citric acid and sodium citrate.

Xylazine should be used in horses and Cervidae (Fallow Deer, Mule Deer, Sika Deer, White-Tailed Deer and Elk) when it is desirable to produce a state of sedation accompanied by a shorter period of analgesia.

1. Dosage
   Horses:
   Intravenous — 0.5 mL/100 lb body weight (0.5 mg/lb or 1.1 mg/kg).
   Intramuscular — 1.0 mL/100 lb body weight (1 mg/lb or 2.2 mg/kg).
   Cervidae:
   Administer intramuscularly, by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder.
   Fallow Deer (Dama dama) — 2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb or 4.4 to 8.8 mg/kg).
   Mule Deer (Odocoileus hemionus) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
   Sika Deer (Cervus nippon) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
   White-Tailed Deer (Odocoileus virginianus) — 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb or 2.2 to 4.4 mg/kg).
   Elk (Cervus canadensis) — 0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb or 0.55 to 1.1 mg/kg).
   Following injection of xylazine, the animal should be allowed to rest quietly until the full effect has been reached.
   These dosages produce sedation which is usually maintained for 1 to 2 hours, and analgesia which lasts for 15 to 30 minutes.
2. Preanesthetic to Local Anesthesia
   Xylazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.
3. Preanesthetic to General Anesthesia
   Xylazine at the recommended dosage rates produces an additive effect to central nervous system depressants such as pentobarbital sodium, thiopental sodium and thiamylal sodium. Therefore, the dosage of such compounds should be reduced and administered to the desired effect. In general, only 1/3 to 1/2 of the calculated dosage of the barbiturates will be needed to produce a surgical plane of anesthesia. Post-anesthetic or emergence excitement has not been observed in animals preanesthetized with xylazine.

Xylazine has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, glyceryl guaiacolate and methoxyflurane anesthesia.

This drug should not be administered to domestic food-producing animals.

Do not use in horses intended for human consumption.

Avoid accidental administration to humans. Should such exposure occur, notify a physician immediately. Artificial respiration may be indicated.

In Cervidae, occasional capture-associated deaths occur. Clinical trials reveal a mortality rate of approximately 3.5% attendant with the administration of xylazine.

Careful consideration should be given before administering to horses and Cervidae with significantly depressed respiration, severe pathologic heart disease, advanced liver or kidney disease, severe endotoxic or traumatic shock and stress conditions such as extreme heat, cold, high altitude or fatigue.

Do not use xylazine in conjunction with tranquilizers.

Analgesic effect is variable, and depth should be carefully assayed prior to surgical/clinical procedures. Variability of analgesia occurs most frequently at the distal extremities of horses and Cervidae. In spite of sedation, the practitioner and handlers should proceed with caution since defense reactions may not be diminished.

Xylazine in horses and Cervidae used at recommended dosage levels may occasionally cause slight muscle tremors, bradycardia with partial A-V heart block and a reduced respiratory rate. Movement in response to sharp auditory stimuli may be observed. In horses, sweating, rarely profuse, has been reported following administration. In Cervidae, salivation, various vocalizations (bellowing, bleating, groaning, grunting, snoring) on expiration, audible grinding of molar teeth, protruding tongue and elevated temperatures have also been noted in some cases.

Xylazine, a non-narcotic compound, is a sedative and analgesic as well as a muscle relaxant. Its sedative and analgesic activity is related to central nervous system depression. Its muscle-relaxant effect is based on inhibition of the intraneural transmission of impulses in the central nervous system. The principal pharmacological activities develop within 10 to 15 minutes after intramuscular injection in horses and Cervidae, and within 3 to 5 minutes following intravenous administration in horses.

A sleeplike state, the depth of which is dose-dependent, is usually maintained for 1 to 2 hours, while analgesia lasts from 15 to 30 minutes. The centrally acting muscle-relaxant effect causes relaxation of the skeletal musculature complementing sedation and analgesia.

In horses and Cervidae under the influence of xylazine, the respiratory rate is reduced as in natural sleep. Following treatment with xylazine, the heart rate is decreased and a transient change in the conductivity of the cardiac muscle may occur, as evidenced by a partial atrioventricular block. This resembles the atrioventricular block often observed in normal horses.^1,2,3,4 Although a partial A-V block may occasionally occur following intramuscular injection of xylazine, the incidence is less than when it is administered intravenously. Intravenous administration of xylazine causes a transient rise in blood pressure, followed by a slight decrease.

Xylazine has no effect on blood clotting time or other hematologic parameters.

Xylazine has been tested in horses at 5 times the recommended dose, and at doses above the recommended range in Cervidae. However, doses of this magnitude may produce convulsions and long periods of sedation in horses and muscle tremors and long periods of sedation in Cervidae.

Protect from heat. Do not store over 30° C (86° F).

NDC 59399-111-50 50 mL vial

NADA # 139-236, Approved by FDA

1. Detweiler, D. K.: The Diagnosis and Significance of Cardiac Arrhythmias in Progress in Equine Practice. Edited by E. J. Catcott and J. F. Smithcors. American Veterinary Publications, Inc., Santa Barbara, California and Wheaton, Illinois, (1966), 280-281.
2. Glazier, D. B.: Atrioventricular Heart Block. Irish Vet. J., Vol. 12 (1958): 194-198.
3. Holmes, J. R., Alps, B. J.: Observations on Partial Atrioventricular Heart Block in the Horse. Can. Vet. J., Vol. 7, No. 12, (1966), 280-290.
4. Smetzer, D. L, Smith, C. R., Senta, T: Second Degree Atrioventricular Block in the Horse. Am. J. Vet. Res., Vol. 30, No. 6, (1969), 933-946.

AKORN
Distributed by:
Akorn Operating Company LLC
Gurnee, IL 60031
XYA0N Rev. 06/22
U.S. Pat. No. 4,614,798

Principal Display Panel Text for Container Label:

NDC 59399-111-50

AnaSed^®

INJECTION

(xylazine injection) 100 mg/mL

Sedative and Analgesic

For Horses and Cervidae

50 mL

CAUTION: Federal law restricts this drug to use

by or on the order of a licensed veterinarian.

Do not use in Cervidae less than 15 days

before or during the hunting season.

NADA #139-236, Approved by FDA

Principal Display Panel Text for Carton Label:

NDC 59399-111-50

AnaSed^®

INJECTION

(xylazine injection) 100 mg/mL

Sedative and Analgesic

For Horses and Cervidae

50 mL

CAUTION: Federal law restricts this drug

to use by or on the order of a

licensed veterinarian.

Do not use in Cervidae less than 15 days

before or during the hunting season.

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NADA #139-236, Approved by FDA