SUPRANE- desflurane liquid

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Baxter Healthcare Corporation

INN (Միջազգային անվանումը):

DESFLURANE

Կազմը:

DESFLURANE 240 mL in 240 mL

Կառավարման երթուղին:

RESPIRATORY (INHALATION)

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

SUPRANE is indicated as an inhalation agent for induction of anesthesia for inpatient and outpatient surgery in adults. SUPRANE 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. SUPRANE 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 SUPRANE, and tracheal intubation, SUPRANE is indicated for maintenance of anesthesia in infants and children. SUPRANE 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 Precautions (5.3) and Clinical Studies (14.5) ]. The use of SUPRANE is contraindicated in the following conditions: Risk Summary There are no adequate and well-controlled studies in pregnant women

Ապրանքի ամփոփագիր:

SUPRANE (desflurane, USP) is available in an amber-colored glass bottle or an aluminum bottle containing 240 mL of desflurane as follows: NDC Container Unit(s) 10019-641-60 Amber-colored Glass 1 10019-641-24 6 10019-641-64 Aluminum Bottle 1 10019-641-34 6 Occupational Caution There is no specific work exposure limit established for SUPRANE. 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 SUPRANE 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 2-3% in inspired air before individuals would likely experience dizziness or other physiologic effects. Store at room temperature, 15°-30°C (59°-86°F). SUPRANE has been demonstrated to be stable for the period defined by the expiration dating on the label. The bottle should be recapped after each use of SUPRANE.

Լիազորման կարգավիճակը:

New Drug Application

Ապրանքի հատկությունները

SUPRANE- DESFLURANE LIQUID
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPRANE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUPRANE.
SUPRANE (DESFLURANE) LIQUID, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1992
RECENT MAJOR CHANGES
Contraindications (4) 11/2022
INDICATIONS AND USAGE
SUPRANE, a general anesthetic, is an inhalation agent indicated:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions; Malignant Hyperthermia (5.1) 11/2022
for induction and/or maintenance of anesthesia in adults (1.1)
for maintenance of anesthesia in pediatric patients following
induction with agents other than
SUPRANE and intubation.
SUPRANE 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
SUPRANE. (2)
The administration of general anesthesia must be individualized based
on the patient’s response,
including cardiovascular and pulmonary changes. (2)
SUPRANE 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)
Liquid (volatile): 100% (3)
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)
Malignant Hyperthermia: Malignant hyperthermia may occur, especially
in individua