alfaxalone

For induction of anesthesia followed by maintenance with an inhalant anesthetic

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Maintenance of general anesthesia following induction

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Induction of general anesthesia.

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

For induction of anesthesia followed by maintenance with an inhalant anesthetic

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Maintenance of general anesthesia following induction

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Induction of general anesthesia

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

ALFAXAN MULTIDOSE IDX is indicated as a sedative and anesthetic in multiple minor species*. More specifically, ALFAXAN MULTIDOSE IDX is indicated for the following: For sedation and anesthesia in captive reptiles, excluding any food‑producing species** For sedation and anesthesia in captive amphibians, excluding any food‑producing species** For sedation and anesthesia in ornamental fish, including species used in research such as the zebrafish For sedation and anesthesia in captive species and pet birds in the orders Psittaciformes, Passeriformes, and Columbiformes, excluding any food‑producing species** For sedation and anesthesia in non‑human primates For sedation and anesthesia in captive rodents For sedation and anesthesia in captive mustelids For sedation and anesthesia in captive marsupials For induction of anesthesia and immobilization in captive minor species ungulates, excluding any food‑producing species** Use only when there is reasonable certainty that the treated animal will not be consumed by humans or food‑producing animals. * The term “minor species” means animals other than humans that are not major species. “Major species” means cattle, horses, swine, chickens, turkeys, dogs and cats. ** As used on this label, a “food‑producing minor species” is considered to be a minor species of which some members are bred, cultured, farmed, ranched, hunted, caught, trapped or otherwise harvested for the purpose of having the animals or edible products of the animals commercially distributed for consumption by humans or food‑producing animals in the United States.

ALFAXAN MULTIDOSE IDX

ALFAXAN MULTIDOSE is indicated for the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in cats and dogs.

ALFAXAN MULTIDOSE

ALFAXAN MULTIDOSE is a reformulation of previously approved, single-use ALFAXAN (NADA 141-342) which contained no antimicrobial preservative. The bioequivalence of ALFAXAN (unpreserved) and ALFAXAN MULTIDOSE following administration of 5 mg/kg IV was demonstrated in a two sequence, two period crossover study in 24 cats (see EFFECTIVENESS). The bioequivalence of ALFAXAN (unpreserved) and ALFAXAN MULTIDOSE following administration of 3 mg/kg IV was demonstrated in a two sequence, two period crossover study in 24 dogs (see EFFECTIVENESS).

ALFAXAN MULTIDOSE

ALFAXAN MULTIDOSE IDX is contraindicated in animals with a known sensitivity to ALFAXAN MULTIDOSE IDX or its components, or when general anesthesia and/or sedation are contraindicated. Do not use in any minor species animal that may become eligible for consumption by humans or food‑producing animals.

ALFAXAN MULTIDOSE IDX

ALFAXAN MULTIDOSE is contraindicated in cats and dogs with a known sensitivity to ALFAXAN MULTIDOSE or its components, or when general anesthesia and/or sedation are contraindicated.

ALFAXAN MULTIDOSE

Animal safety: When using ALFAXAN MULTIDOSE, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. Rapid bolus administration or anesthetic overdose may cause cardiorespiratory depression, including hypotension, apnea, hypoxia, or death. Arrhythmias may occur secondary to apnea and hypoxia. In cases of anesthetic overdose, stop ALFAXAN MULTIDOSE administration and administer treatment as indicated by the patient’s clinical signs. Cardiovascular depression should be treated with plasma expanders, pressor agents, anti-arrhythmic agents or other techniques as appropriate for the treatments of the clinical signs. Human safety: Not for human use. Keep out of the reach of children. ALFAXAN MULTIDOSE should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting. Exercise caution to avoid accidental self-injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression should be treated by artificial ventilation and oxygen. Avoid contact of this product with skin, eyes, and clothes. In case of contact, eyes and skin should be liberally flushed with water for 15 minutes. Consult a physician if irritation persists. In the case of accidental human ingestion, seek medical advice immediately and show the package insert or the label to the physician. Note to physician: This product contains an injectable anesthetic.

ALFAXAN MULTIDOSE

Animal Safety: Rapid bolus administration or anesthetic overdose may cause cardiorespiratory depression, including hypotension, apnea, hypoxia, or death. Arrhythmias may occur secondary to apnea and hypoxia. In cases of anesthetic overdose, stop ALFAXAN MULTIDOSE IDX administration and administer treatment as indicated by the patient’s clinical signs. Cardiovascular depression should be treated with plasma expanders, pressor agents, anti-arrhythmic agents or other techniques as appropriate for the treatments of the clinical signs. Human safety: Not for human use. Keep out of the reach of children. ALFAXAN MULTIDOSE IDX should be managed to prevent the risk of diversion, through such measures as restriction of access and the use of drug accountability procedures appropriate to the clinical setting. Exercise caution to avoid accidental self‑injection. Overdose is likely to cause cardiorespiratory depression (such as hypotension, bradycardia and/ or apnea). Remove the individual from the source of exposure and seek medical attention. Respiratory depression should be treated by artificial ventilation and oxygen. Avoid contact of this product with skin, eyes, and clothes. In case of contact, eyes and skin should be liberally flushed with water for 15 minutes. Consult a physician if irritation persists. In the case of accidental human ingestion, seek medical advice immediately and show the package insert or the label to the physician. 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 call 1-888-963-8471. Note to physician: This product contains an injectable anesthetic.

ALFAXAN MULTIDOSE IDX

Adverse Reactions in Cat Field Study Adverse Reaction Number of Catsa = 207 Hypotension (≤90 mm Hg) 92 Tachycardia (≥ 180 bpm) 61 Apnea (≥ 30 seconds) 32 (of 202) Hypertension (> 165 mm Hg) 23 Bradypnea (RR< 10 breaths/min) 16 Apnea (≥ 60 seconds) 12 (of 202) Bradycardia (≤90 beats/min) 10 Hypothermia (<97°F) 10 Hypoxia (SpO2 <85%) 4 Emesis 1 Unacceptable Anesthesia Quality 1 aEach cat may have experienced more than one adverse reaction Additional adverse reactions for cats included vocalization, paddling, and muscle tremors. One cat that experienced tachycardia and hypoxia during anesthesia was euthanized 3 days later due to carcinoma involving the liver, pancreas and common bile duct. The relationship of the original tachycardia during anesthesia and the carcinoma is unknown. Adverse Reactions in Dog Field Study Adverse Reaction Number of Dogsa = 182 Bradypnea (RR< 10 breaths/min) 89 Apnea (≥ 30 seconds) 55 (of 137) Hypertension (> 165 mm Hg) 54 Tachycardia (≥ 180 bpm) 49 Apnea (≥ 60 seconds) 34 (of 137) Hypotension (≤70 mm Hg) 32 Hypothermia (<97°F) 28 Bradycardia (≤70 beats/min) 24 Hypoxia (SpO2 <85%) 4 Lack of Effectiveness 3 Unacceptable Anesthesia Quality 1 Emesis 1 aEach dog may have experienced more than one adverse reaction Additional adverse reactions for dogs included vocalization, paddling, and muscle tremors. To report adverse reactions or to obtain a copy of the SDS for this product call 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

ALFAXAN MULTIDOSE

Specific adverse reactions described in the referenced literature are listed in the Dosage and Administration section of the product insert. To report adverse reactions or to obtain a copy of the SDS for this product call 1‑844‑253‑2926. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1‑888‑FDA‑VETS or online at http://www.fda.gov/reportanimalae.

ALFAXAN MULTIDOSE IDX

Specific adverse reactions described in the referenced literature are listed in the Dosage and Administration section of the product insert.

ALFAXAN MULTIDOSE IDX

Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Additional low doses of ALFAXAN, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

Intravenous

Administer by intravenous injection only. Federal law restricts this drug to use by or on the order of a licensed veterinarian. When using ALFAXAN, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available.

Alfaxan® Multidose

Induction of general anesthesia in cats: Induction dose guidelines are based on data from the field study (see EFFECTIVENESS) and range between 2.2 - 9.7 mg/kg for cats that did not receive a preanesthetic, and between 1.0 - 10.8 mg/kg for cats that received a preanesthetic. The alfaxalone induction dose in the field study was reduced by 10 - 43%, depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN MULTIDOSE will depend on the potency, dose, and time of administration of the various preanesthetics that are used prior to induction. To avoid anesthetic overdose, titrate the administration of ALFAXAN MULTIDOSE against the response of the patient. Anesthesia is usually observed within 60 seconds after the start of injection, and permits intubation within 1 - 2 minutes, irrespective of preanesthetic. The duration of anesthesia from a single induction dose ranges between 15 - 30 minutes in the unpreanesthetized cat. If a preanesthetic is used, anesthetic duration may be longer, depending on the class and dose of preanesthetic. Individual anesthesia times vary. Examples from the field study of average induction doses (and ranges) for cats that received various preanesthetics are presented as dosing guidelines in the table. The table is for guidance only. Draw up the maximum expected target dose and administer to effect. The actual induction dose should be based on patient response. Alfaxalone Induction Dose Guidelines: CATS Preanesthetic Average alfaxalone induction dose (and range) in mg/kg Number of cats No preanesthetic 4.0 (2.2-9.7) 33 Opioid + phenothiazine 3.2 (1.1-10.8) 96 Benzodiazepine + phenothiazine 3.6 (1.5-7.1) 23 Benzodiazepine + opioid + phenothiazine 2.3 (1.2-5.0) 26 Alpha2-adrenergic agonist with/without phenothiazine 3.6 (1.1-5.0) 15 Alpha2-adrenergic agonist + phenothiazine with/without benzodiazepine or opioid 2.9 (1.0-3.9) 11 Additional doses of ALFAXAN MULTIDOSE similar to those used for maintenance (1.1 - 1.5 mg/kg) may be administered to facilitate intubation. Maintenance of general anesthesia in cats: Following induction of anesthesia with ALFAXAN MULTIDOSE and intubation, anesthesia may be maintained using intermittent ALFAXAN MULTIDOSE intravenous boluses or an inhalant anesthetic agent. A maintenance bolus containing 1.1 - 1.3 mg/kg provides an additional 7 - 8 minutes of anesthesia in preanesthetized cats. A dose of 1.4 - 1.5 mg/kg provides an additional 3 - 5 minutes anesthesia in unpreanesthetized cats. Clinical response may vary, and is determined by the dose, rate of administration, and frequency of maintenance injections. ALFAXAN MULTIDOSE maintenance dose sparing is greater in cats that receive a preanesthetic. Examples from the field study of maintenance doses for preanesthetized and unpreanesthetized cats are presented as guidelines in the table. Maintenance dose and frequency should be based on the response of the individual patient. Alfaxalone Maintenance Dose Guidelines: CATS Dose and Duration Preanesthetized Cats Unpreanesthetized Cats Maintenance anesthesia doses 1.1 - 1.3 mg/kg 1.4 - 1.5 mg/kg Mean duration of anesthesia 7-8 minutes 3 - 5 minutes In the field study, recovery times (extubation to head lift) following alfaxalone maintenance anesthesia averaged 15 minutes in cats that did not receive a preanesthetic, and 17 minutes in preanesthetized cats. Inhalant anesthetic maintenance of general anesthesia in cats: Additional low doses of ALFAXAN MULTIDOSE, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

INTRAVENOUS

ALFAXAN MULTIDOSE

Induction of general anesthesia in dogs: Induction dose guidelines are based on data from the field study (see EFFECTIVENESS) and range between 1.5 - 4.5 mg/kg for dogs that did not receive a preanesthetic, and between 0.2 - 3.5 mg/kg for dogs that received a preanesthetic. The alfaxalone induction dose in the field study was reduced by 23 - 50% depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN MULTIDOSE will depend on the potency, dose, and time of administration of the various preanesthetics that are used prior to induction. To avoid anesthetic overdose, titrate the administration of ALFAXAN MULTIDOSE against the response of the patient. In the field study, the use of a preanesthetic appeared to decrease the occurrence of apnea following alfaxalone induction in dogs. In dogs, ALFAXAN MULTIDOSE usually produces recumbence within 60 seconds after the start of injection, and permits intubation within 1 - 2 minutes, irrespective of preanesthetic. The duration of anesthesia from a single induction dose is approximately 5 - 10 minutes in the unpreanesthetized dog. If a preanesthetic is used, anesthetic duration may be longer, depending on the class and dose of preanesthetic. Individual anesthesia times vary. Examples from the field study of average induction doses (and ranges) for dogs that received various preanesthetics are presented as dosing guidelines in the table. The table is for guidance only. Draw up the maximum expected target dose and administer to effect. The actual induction dose should be based on patient response. Alfaxalone Induction Dose Guidelines: DOGS Preanesthetic Average alfaxalone induction dose (and range) in mg/kg Number of dogs No preanesthetic 2.2 (1.5 - 4.5) 17 Benzodiazepine + opioid + acepromazine 1.7 (0.9 - 3.5) 39 Opioid + acepromazine 1.6 (0.6 - 3.5) 80 Alpha2-agonist 1.1 (0.21 - 2.00) 9 Additional doses of ALFAXAN MULTIDOSE similar to those used for maintenance (1.2 - 2.2 mg/kg) may be administered to facilitate intubation. Maintenance of general anesthesia in dogs: Following induction of anesthesia with ALFAXAN MULTIDOSE and intubation, anesthesia may be maintained using intermittent ALFAXAN MULTIDOSE intravenous boluses or an inhalant anesthetic agent. A maintenance bolus containing 1.2 - 1.4 mg/kg provides an additional 6 - 8 minutes anesthesia in preanesthetized dogs. A dose of 1.5 - 2.2 mg/kg provides an additional 6 - 8 minutes of anesthesia in unpreanesthetized dogs. Clinical response may vary, and is determined by the dose, rate of administration, and frequency of maintenance injections. ALFAXAN MULTIDOSE maintenance dose sparing is greater in dogs that receive a preanesthetic. Examples from the field study of maintenance doses for preanesthetized and unpreanesthetized dogs are presented as guidelines in the table. Maintenance dose and frequency should be based on the response of the individual patient. Alfaxalone Maintenance Dose Guidelines: DOGS Dose and Duration Preanesthetized Dogs Unpreanesthetized Dogs Maintenance anesthesia doses 1.2 - 1.4 mg/kg 1.5 - 2.2 mg/kg Mean duration of anesthesia 6 - 8 minutes 6 - 8 minutes In the field study, recovery times (extubation to head lift) following alfaxalone maintenance anesthesia averaged 22 minutes in dogs that did not receive a preanesthetic, and 15 minutes in preanesthetized dogs. Inhalant anesthetic maintenance of general anesthesia in dogs: Additional low doses of ALFAXAN MULTIDOSE, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

INTRAVENOUS

ALFAXAN MULTIDOSE

When administering ALFAXAN MULTIDOSE IDX by intravenous injection administer slowly to effect, titrating administration against the response of the patient. Rapid administration of ALFAXAN MULTIDOSE IDX may be associated with an increased incidence of cardiorespiratory depression or apnea. The use of preanesthetics may reduce the ALFAXAN MULTIDOSE IDX induction dose. The choice and the amount of phenothiazine, alpha₂‑ adrenoreceptor agonist, benzodiazepine or opioid will influence the response of the patient to an induction dose of ALFAXAN MULTIDOSE IDX. When using ALFAXAN MULTIDOSE IDX, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. ALFAXAN MULTIDOSE IDX contains preservatives. Use within 56 days of first puncture. Any unused ALFAXAN MULTIDOSE IDX remaining after 56 days should be discarded. The following tables outline the dosage and administration of ALFAXAN MULTIDOSE IDX for the indicated species by major group. The doses are representative of doses published in the literature. Veterinarians are advised to consult the published literature before use of the product (see List of References at end of product insert).

INTRAMUSCULAR, INTRAPERITONEAL, INTRAVENOUS, SUBCUTANEOUS, TOPICAL

ALFAXAN MULTIDOSE IDX

Administer by intravenous injection only. For induction, administer ALFAXAN MULTIDOSE over approximately 60 seconds or until clinical signs show the onset of anesthesia, titrating administration against the response of the patient. Rapid administration of ALFAXAN MULTIDOSE may be associated with an increased incidence of cardiorespiratory depression or apnea. Apnea can occur following induction or after the administration of maintenance boluses of ALFAXAN MULTIDOSE. The use of preanesthetics may reduce the ALFAXAN MULTIDOSE induction dose. The choice and the amount of phenothiazine, alpha2-adrenoreceptor agonist, benzodiazepine or opioid will influence the response of the patient to an induction dose of ALFAXAN MULTIDOSE. When using ALFAXAN MULTIDOSE, patients should be continuously monitored, and facilities for the maintenance of a patent airway, artificial ventilation, and oxygen supplementation must be immediately available. ALFAXAN MULTIDOSE contains preservatives. Use within 56 days of first puncture. Any unused ALFAXAN MULTIDOSE remaining after 56 days should be discarded. ALFAXAN MULTIDOSE should not be mixed with other therapeutic agents prior to administration.

INTRAVENOUS

ALFAXAN MULTIDOSE