Animal NDC 49480-001-01 Alfaxan

Alfaxalone

Animal NDC Product Code 49480-001-01

Field Name Field Value
Animal NDC Code 49480-001-01
Proprietary Name Alfaxan What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Alfaxalone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Jurox Pty. Limited
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Alfaxalone
Inactive Ingredient(s)
  • HYDROXYPROPYLBETADEX (0.58-0.68 MS) (1I96OHX6EK)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • POTASSIUM PHOSPHATE, MONOBASIC (4J9FJ0HL51)
  • HYDROCHLORIC ACID (QTT17582CB)
  • HYDROXYPROPYLBETADEX (0.58-0.68 MS) (1I96OHX6EK)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • POTASSIUM PHOSPHATE, MONOBASIC (4J9FJ0HL51)
  • HYDROCHLORIC ACID (QTT17582CB)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141342 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Alfaxan Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Cats

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 ALFAXAN induction dose in the field study was reduced by 10 - 43%, depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN 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 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. The actual induction dose should be based on patient response.ALFAXAN Induction Dose Guidelines: CATS PreanestheticAverage ALFAXAN induction dose (and range) in mg/kgNumber of catsNo preanesthetic4.0 (2.2-9.7)33Opioid + phenothiazine3.2 (1.1-10.8)96Benzodiazepine + phenothiazine3.6 (1.5-7.1)23Benzodiazepine + opioid + phenothiazine2.3 (1.2-5.0)26Alpha2-adrenergic agonist with/without phenothiazine3.6 (1.1-5.0)15Alpha2-adrenergic agonist + phenothiazine with/without benzodiazepine or opioid2.9 (1.0-3.9)11Additional doses of ALFAXAN 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 and intubation, anesthesia may be maintained using intermittent ALFAXAN 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 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.ALFAXAN Maintenance Dose Guidelines: CATS Dose and DurationPreanesthetized CatsUnpreanesthetized CatsMaintenance anesthesia doses1.1 - 1.3 mg/kg1.4 - 1.5 mg/kgMean duration of anesthesia7-8 minutes3 - 5 minutesIn the field study, recovery times (extubation to head lift) following ALFAXAN 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, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

Dogs

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 ALFAXAN induction dose in the field study was reduced by 23 - 50% depending on the combination of preanesthetics (dose sparing effect). Dose sparing of ALFAXAN 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 against the response of the patient. In the field study, the use of a preanesthetic appeared to decrease the occurrence of apnea following ALFAXAN induction in dogs.In dogs, ALFAXAN 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. The actual induction dose should be based on patient response.ALFAXAN Induction Dose Guidelines: DOGSPreanestheticAverage ALFAXAN induction dose (and range) in mg/kgNumber of dogsNo preanesthetic2.2 (1.5 - 4.5)17Benzodiazepine + opioid + acepromazine1.7 (0.9 - 3.5)39Opioid + acepromazine1.6 (0.6 - 3.5)80Alpha2-agonist1.1 (0.21 - 2.00)9Additional doses of ALFAXAN 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 and intubation, anesthesia may be maintained using intermittent ALFAXAN 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 (alfaxalone) 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.ALFAXAN Maintenance Dose Guidelines: DOGSDose and DurationPreanesthetized DogsUnpreanesthetized DogsMaintenance anesthesia doses1.2 - 1.4 mg/kg1.5 - 2.2 mg/kgMean duration of anesthesia6 - 8 minutes6 - 8 minutesIn the field study, recovery times (extubation to head lift) following ALFAXAN 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, similar to a maintenance dose, may be required to facilitate the transition to inhalant maintenance anesthesia.

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