DESFLURANE liquid

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DESFLURANE (UNII: CRS35BZ94Q) (DESFLURANE - UNII:CRS35BZ94Q)

Доступна з:

Sandoz Inc.

ІПН (Міжнародна Ім'я):

DESFLURANE

Склад:

DESFLURANE 240 mL in 240 mL

Адміністрація маршрут:

RESPIRATORY (INHALATION)

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. Desflurane, USP, Liquid for Inhalation is contraindicated as an inhalation agent for the induction of anesthesia in pediatric patients because of a high incidence of moderate to severe upper airway adverse events. Desflurane, USP, Liquid for Inhalation is indicated as an inhalation agent for maintenance of anesthesia for inpatient and outpatient surgery in adults and in pediatric patients. After induction of anesthesia with agents other than Desflurane, USP, Liquid for Inhalation, and tracheal intubation, Desflurane, USP, Liquid for Inhalation is indicated for maintenance of anesthesia in infants and children. Desflurane, USP, Liquid for Inhalation is not approved for maintenance of anesthesia in non-intubated children due to an increased incidence of respiratory adverse reactions, including coughing, laryngospasm, and secretions [See Warnings and Preca

Огляд продуктів:

Desflurane, USP, Liquid for Inhalation, NDC 0781-6172-22, is available in amber-colored glass bottle containing 240 mL desflurane, USP. Each individual bottle is supplied in a carton of 6, NDC 0781-6172-86. Occupational Caution There is no specific work exposure limit established for Desflurane, USP, Liquid for Inhalation. However, the National Institute for Occupational Safety and Health Administration (NIOSH) recommends that no worker should be exposed at ceiling concentrations greater than 2 ppm of any halogenated anesthetic agent over a sampling period not to exceed one hour. Principle routes of exposure include: Skin contact – May cause skin irritation. In case of contact, immediately flush skin with plenty of water. Remove contaminated clothing and shoes. Seek medical attention if irritation develops. Eye contact – May cause eye irritation. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Seek medical attention if irritation develops. Ingestion – No specific hazards other than therapeutic effects. Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. If large quantities of this material are swallowed, seek medical attention immediately. Inhalation – If individuals smell vapors, or experience dizziness or headaches, they should be moved to an area with fresh air. Individuals could also experience the following: Cardiovascular effects: may include fluctuations in heart rate, changes in blood pressure, chest pain. Respiratory effects: may include shortness of breath, bronchospasms, laryngospasms, respiratory depression. Gastrointestinal effects: may include nausea, upset stomach, loss of appetite. Nervous System effects: may include ataxia, tremor, disturbance of speech, lethargy, headache, dizziness, blurred vision. The predicted effects of acute overexposure by inhalation of Desflurane, USP, Liquid for Inhalation include headache, dizziness or (in extreme cases) unconsciousness [See Overdosage (10)] . There are no documented adverse effects of chronic exposure to halogenated anesthetic vapors ( W aste A nesthetic G ases or WAGs) in the workplace. Although results of some epidemiological studies suggest a link between exposure to halogenated anesthetics and increased health problems (particularly spontaneous abortion), the relationship is not conclusive. Since exposure to WAGs is one possible factor in the findings for these studies, operating room personnel, and pregnant women in particular, should minimize exposure. Precautions include adequate general ventilation in the operating room, the use of a well-designed and well-maintained scavenging system; work practices to minimize leaks and spills while the anesthetic agent is in use, and routine equipment maintenance to minimize leaks. Consistent with clinical data, concentrations would need to reach 2% to 3% in inspired air before individuals would likely experience dizziness or other physiologic effects. Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] . Desflurane, USP, Liquid for Inhalation has been demonstrated to be stable for the period defined by the expiration dating on the label. Preserve in tight, light-resistant container. Replace the cap securely after each use.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DESFLURANE- DESFLURANE LIQUID
SANDOZ INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DESFLURANE, LIQUID FOR
INHALATION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DESFLURANE, LIQUID
FOR INHALATION.
DESFLURANE, LIQUID FOR INHALATION USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Contraindications (4) 11/2022
Warnings and Precautions; Malignant Hyperthermia (5.1) 11/2022
INDICATIONS AND USAGE
Desflurane, USP, Liquid for Inhalation, a general anesthetic, is an
inhalation agent indicated:
for induction and/or maintenance of anesthesia in adults ( 1.1)
for maintenance of anesthesia in pediatric patients following
induction with agents other than
Desflurane, USP, Liquid for Inhalation and intubation.
DOSAGE AND ADMINISTRATION
Desflurane, USP, Liquid for Inhalation should be administered only by
persons trained in the
administration of general anesthesia. It should only be administered
using a vaporizer specifically
designed and designated for use with desflurane. ( 2)
The administration of general anesthesia must be individualized based
on the patient’s response,
including cardiovascular and pulmonary changes. ( 2)
Desflurane, USP, Liquid for Inhalation should not be used as the sole
agent for anesthetic induction in
patients with coronary artery disease or where increases in heart rate
or blood pressure are
undesirable. ( 2.6)
For dosing considerations in patients with intracranial space
occupying lesions, see Full Prescribing
Information. ( 2.7)
DOSAGE FORMS AND STRENGTHS
Liquid (volatile): 100% ( 3)
CONTRAINDICATIONS
Patients with known or suspected genetic susceptibility to malignant
hyperthermia ( 4)
Patients in whom general anesthesia is contraindicated ( 4)
Induction of anesthesia in pediatric patients ( 4)
Patients with known sensitivity to halogenated agents ( 4)
Patients with a history of moderate to severe hepatic dysfunction
following anesthesia with halogenated
agents and not otherwise explained. ( 4)
WARNINGS