Xylazine

Mule deer (Odocoileus hemionus), sika deer (Cervus nippon), and white-tailed deer (Odocoileus virginianus)

To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine.

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

Fallow deer (Dama dama)

To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine.

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

Elk (Cervus canadensis)

To produce sedation, as an analgesic, and as a preanesthetic to local anesthesia. To produce sedation, accompanied by a shorter period of analgesia. May be used to calm and facilitate handling of fractious animals for diagnostic procedures, for minor surgical procedures, for therapeutic medication for sedation and relief of pain following injury or surgery, and as a preanesthetic to local anesthetic. At the recommended dosages, can be used in conjunction with local anesthetics, such as procaine or lidocaine.

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.

Not for use in horses intended for food.

Chanazine®

To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.

Chanazine®

To produce sedation, as an analgesic, and as a preanesthetic to local or general anesthesia.

Chanazine®

XYLAMED 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. Horses: XYLAMED has been used successfully as follows: 1. Diagnostic procedures-oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. 2. Orthopedic procedures, such as application of casting materials and splints. 3. Dental procedures. 4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. 5. To calm and facilitate handling of fractious animals. 6. Therapeutic medication for sedation and relief of pain following injury or surgery. 7. Major surgical procedures: a. When used as a preanesthetic to general anesthesia. b. When used in conjunction with local anesthetics. Cervidae: XYLAMED may be used for the following: 1. To calm and facilitate handling of fractious animals. 2. Diagnostic procedures. 3. Minor surgical procedures. 4. Therapeutic medication for sedation and relief of pain following injury or surgery. 5. As a preanesthetic to local anesthesia. XYLAMED at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.

XylaMed™

INDICATIONS Xylazine (xylazine injection) 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. Horses: Xylazine (xylazine injection) has been used successfully as follows: 1. Diagnostic procedures-oral and ophthalmic examinations, abdominal palpation, rectal palpation, vaginal examination, catheterization of the bladder and radiographic examinations. 2. Orthopedic procedures, such as application of casting materials and splints. 3. Dental procedures. 4. Minor surgical procedures of short duration such as debridement, removal of cutaneous neoplasms and suturing of lacerations. 5. To calm and facilitate handling of fractious animals. 6. Therapeutic medication for sedation and relief of pain following injury or surgery. 7. Major surgical procedures: a. When used as a preanesthetic to general anesthesia. b. When used in conjunction with local anesthetics. Cervidae: Xylazine (xylazine injection) may be used for the following: 1. To calm and facilitate handling of fractious animals. 2. Diagnostic procedures. 3. Minor surgical procedures. 4. Therapeutic medication for sedation and relief of pain following injury or surgery. 5. As a preanesthetic to local anesthesia. Xylazine at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine.

FDA application 200-529

INDICATIONS: Anased® Equine Injection should be used in horses when it is desirable to produce a state of sedation. It has been successfully used when conducting various diagnostic, orthopedic and dental procedures of short duration. It may also be used as a preanesthetic to local or general anesthesia.

Anased Equine Injection(xylazine injection)100 mg/mL

INDICATIONS: Rompun (xylazine injection) 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.

Rompun® (xylazine injection) 100 mg/mL

PHARMACOLOGY: Rompun, a non-narcotic compound, is a sedative and analgesic as well as 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, 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 Rompun the respiratory rate is reduced as in natural sleep. Following treatment with Rompun 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 Rompun (xylazine injection), the incidence is less than when it is administered intravenously. Intravenous administration of Rompun (xylazine injection) causes a transient rise in blood pressure, followed by a slight decrease. Rompun has no effect on blood clotting time or other hematologic parameters.

Rompun® (xylazine injection) 100 mg/mL

CLINICAL PHARMACOLOGY: Xylazine Injection is pharmacologically classified as a non-narcotic sedative. The drug causes sedation by acting upon alpha-adrenergic receptors in the brain to prevent the release of norepinephrine. Xylazine Injection also produces muscle relaxation by inhibiting the intraneural transmission of impulses in the central nervous system. Deep sedation develops in the horse within 10 to 15 minutes after intramuscular injection, and within 3 to 5 minutes following intravenous administration. Deep sedation lasts 15 to 20 minutes, while a sleep-like state, the depth of which is dose-dependent, is usually maintained for 1 to 2 hours following intramuscular administration of the drug at the recommended dosage. Recovery is complete with 30-40 minutes following intravenous injection. In animals under the influence of Xylazine Injection, the respiratory and pulse rates are reduced as in a natural sleep. The intramuscular injection of Xylazine produces only negligible effects on the cardiovascular and respiratory systems. However, intravenous administration in the horse may cause transient changes in the conductivity of the cardiac muscle, evidenced by partial AV blocks, bradycardia, decreased cardiac output and a rise in arterial blood pressure. These actions are transient and can be counteracted to a large degree by the administration of atropine prior to or following Xylazine Injection. Xylazine Injection has no effect on blood clotting time or other hematologic parameters.

Anased Equine Injection(xylazine injection)100 mg/mL

CONTRAINDICATIONS: Anased® Equine Injection should not be used in conjunction with neuroleptics or tranquilizers.

Anased Equine Injection(xylazine injection)100 mg/mL

WARNINGS Human Safety: Not for human use. Keep out of reach of children. • Strictly avoid self-injection, oral intake and any contact with skin, eyes or mucosa. • In the case of accidental contact wash exposed skin or eyes abundantly with water. If symptoms occur, seek medical advice. • In the case of accidental oral intake or self-injection, seek the advice of a physician and show the package insert but DO NOT DRIVE. • If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure. • Users with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product. • Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated. Note to physician: Xylazine is an alpha2-adrenergic agonist with sedative, some analgesic and muscle relaxant properties. Symptoms after absorption may include dose-dependent respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycemia. Ventricular arrhythmias have also been reported. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users or to obtain a copy of the SDS for this product, contact Bimeda, Inc. at 1-888-524-6332. Animal safety: This drug should not be administered to domestic food-producing animals. Not for use in horses intended for human consumption. In Cervidae, occasional capture-associated deaths occur. Clinical trials reveal a mortality rate of approximately 3.5% attendant with the administration of xylazine.

FDA application 200-529

Not for use in humans. Keep out of reach of children. Avoid skin, eye or mucosal contact. Use caution while handling and using filled syringes. Absorption of the active ingredients is possible following exposure via the skin, eye or mucosa. In case of accidental eye exposure, flush eyes with water for 15 minutes, remove contact lenses then continue to flush. In case of accidental skin exposure, wash with soap and water and remove contaminated clothing. If symptoms occur, seek the advice of a physician. In case of accidental oral intake or self-injection, seek medical advice immediately and show the package insert to the physician. DO NOT DRIVE as sedation, loss of consciousness, and changes in blood pressure may occur. Persons with cardiovascular disease (for example, hypertension or ischemic heart disease) should take special precautions to avoid any exposure to this product. Pregnant women should exercise special caution to avoid exposure. Uterine contractions and decreased fetal blood pressure may occur after accidental systemic exposure. Persons with known hypersensitivity to any of the ingredients should avoid contact with Anased® Equine Injection. Caution should be exercised when handling sedated animals. Handling or any other sudden stimuli, including noise, may cause a defense reaction in an animal that appears to be heavily sedated.

Anased Equine Injection(xylazine injection)100 mg/mL

ADVERSE REACTIONS: The deep sedation produced by Anased® Equine Injection is characterized by lowering of the head, drooping of the eyelids and lower lip and a marked reluctance to move. Most horses given Anased® Equine Injection sweat around the ears and poll region and may seem particularly sensitive to sharp auditory stimuli during the recovery period. The respiratory and pulse rate are reduced as in natural sleep. Transient changes in the conductivity of the cardiac muscle (resulting in partial AV blocks), bradycardia, decreased cardiac output and a rise in arterial blood pressure may occur following intravenous administration.

Anased Equine Injection(xylazine injection)100 mg/mL

SIDE EFFECTS: Rompun (xylazine injection), 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.

Rompun® (xylazine injection) 100 mg/mL

SIDE EFFECTS Xylazine (xylazine injection) 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.

FDA application 200-529

Mule deer (Odocoileus hemionus), sika deer (Cervus nippon), and white-tailed deer (Odocoileus virginianus)

Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder 1 to 2 milligrams per pound.

Intravenous, Intramuscular

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

Fallow deer (Dama dama)

Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder 2 to 4 milligrams per pound.

Intravenous, Intramuscular

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

Elk (Cervus canadensis)

Administer intramuscularly, by hand syringe, or by syringe dart, in the heavy muscles of the croup or shoulder 0.25 to 0.5 milligrams per pound of body weight.

Intravenous, Intramuscular

Do not use in domestic food-producing animals. Do not use in Cervidae less than 15 days before or during the hunting season.

Chanazine®

0.5 milligrams per pound intravenously or 1.0 milligrams per pound intramuscularly.

Intramuscular, Intravenous

Do not use in horses intended for human consumption.

Xylazine HCl Injection

Horses:

Intravenously-0.5 mL/100 lbs body weight (0.5 mg/lb) Intramuscularly-1.0 mL/100 lbs body weight (1.0 mg/lb) Following injection of XYLAMED, 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: XYLAMED at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine. 3. Preanesthetic to General Anesthesia: XYLAMED 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 ½ 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 XYLAMED. XylaMed™ has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, glyceryl guaiacolate, and methoxyflurane anesthesia.

XylaMed™

0.5 milligrams per pound intravenously or 1.0 milligram per pound intramuscularly.

Subcutaneous, Intramuscular, Intravenous

Chanazine®

0.5 milligrams per pound intravenously or 1.0 milligram per pound intramuscularly.

Subcutaneous, Intramuscular, Intravenous

Chanazine®

Administer intramuscularly, by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder. Dosage Range: Fallow Deer (Dama dama)-2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb). Mule Deer (Odocoileus hemionus)-1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Sika Deer (Cervus nippon)-1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). White-Tailed Deer (Odocoileus virginianus)-1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Elk (Cervus canadensis)-0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb). Following injection of XYLAMED 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

XylaMed™

1. Horse Dosage: Intravenously–0.5 mL/100 lbs body weight (0.5 mg/lb) Intramuscularly–1.0 mL/100 lbs body weight (1.0 mg/lb) Following injection of Rompun (xylazine injection), 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: Rompun at the recommended dosages can be used in conjunction with local anesthetics, such as procaine or lidocaine. 3. Preanesthetic to General Anesthesia: Rompun 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 Rompun. Rompun has been used successfully as a preanesthetic agent for pentobarbital sodium, thiopental sodium, thiamylal sodium, nitrous oxide, ether, halothane, glyceryl guaiacolate and methoxyflurane anesthesia. 4. Cervidae Dosage: Administer intramuscularly, either by hand syringe or syringe dart, in the heavy muscles of the croup or shoulder Cervidae Dosage Range: Fallow Deer (Dama dama) - 2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb). Mule Deer (Odocoileus hemionus) - 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Sika Deer (Cervus nippon) - 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). White-Tailed Deer (Odocoileus virginianus) - 1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Elk (Cervus canadensis) - 0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb). Following injection of Rompun 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. Use within 30 days of first puncture and puncture a maximum of 20 times. Any product remaining after 20 punctures or more than 30 days after initial puncture should be discarded.

INTRAMUSCULAR, INTRAVASCULAR

Rompun® (xylazine injection) 100 mg/mL

DOSAGE AND ADMINISTRATION 1. Horse Dosage: Intravenously−0.5 mL/100 lbs body weight (0.5 mg/lb) Intramuscularly−1.0 mL/100 lbs body weight (1.0 mg/lb) Following injection of Xylazine (xylazine injection), 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. 4. Cervidae Dosage: Administer intramuscularly, by either hand syringe or syringe dart, in the heavy muscles of the croup or shoulder. Cervidae Dosage Range: Fallow Deer (Dama dama)−2.0 to 4.0 mL/100 lbs body weight (2.0 to 4.0 mg/lb). Mule Deer (Odocoileus hemionus)−1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Sika Deer (Cervus nippon)−1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). White-Tailed Deer (Odocoileus virginianus)−1.0 to 2.0 mL/100 lbs body weight (1.0 to 2.0 mg/lb). Elk (Cervus canadensis)−0.25 to 0.5 mL/100 lbs body weight (0.25 to 0.5 mg/lb). 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.

INTRAMUSCULAR, INTRAVENOUS

FDA application 200-529

DOSAGE AND ADMINISTRATION: For intravenous or intramuscular administration in horses. The recommended dosage for intravenous (IV) administration is 0.5 mL/100 lbs body weight (0.5 mg/lb). The recommended dosage for intramuscular (IM) administration is 1 mL/100lbs body weight (1 mg/lb). Following the administration of Anased® Equine Injection the horse should be allowed to rest quietly until the full effect has been reached. These dosages produce a state of sedation which is usually maintained for 1 to 2 hours (See Clinical Pharmacology). Preanesthetic to local anesthesia: At the recommended dosages Anased® Equine Injection may be used in conjunction with local anesthetics, such as procaine and lidocaine. Preanesthetic to general anesthesia: At the recommended dosages Anased® Equine Injection produces an additive effect to central nervous system depressants, such as sodium pentobarbital, sodium thiopental and sodium thiamylal. Accordingly, the dosage of such products should be reduced and administered to the desired effect. Generally, 1/3 to 1/2 of the calculated dosage of the barbiturates will be needed to produce a surgical plane of anesthesia. Postanesthetic or emergence excitement has not been observed in horses preanesthetized with Anased® Equine Injection. Anased® Equine Injection has been successfully used as a preanesthetic agent for sodium pentobarbital, sodium thiopental, sodium thiamylal, nitrous oxide, ether, halothane, guaifenesin and methoxyflurane anesthesia.

INTRAVENOUS, INTRAMUSCULAR

Anased Equine Injection(xylazine injection)100 mg/mL