SUPRANE- desflurane liquid

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Desflurane (UNII: CRS35BZ94Q) (Desflurane - UNII:CRS35BZ94Q)

Saatavilla:

General Injectables & Vaccines, Inc

INN (Kansainvälinen yleisnimi):

Desflurane

Koostumus:

Desflurane 240 mL in 240 mL

Antoreitti:

RESPIRATORY (INHALATION)

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

1.1 Induction of Anesthesia 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. 1.2 Maintenance of Anesthesia 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)]. SUPRANE (desflurane, USP) is indicated as an inhalation agent for induction of anesthesia f

Tuoteyhteenveto:

SUPRANE (desflurane, USP) is available in an amber-colored glass bottle or an aluminum bottle containing 240 mL of desflurane as follows: 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 individual 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 (desflurane, USP) 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 (desflurane, USP).

Valtuutuksen tilan:

New Drug Application

Valmisteyhteenveto

SUPRANE- DESFLURANE LIQUID
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUPRANE (DESFLURANE,
USP) SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
SUPRANE (DESFLURANE, USP).
SUPRANE (DESFLURANE, USP) VOLATILE LIQUID FOR INHALATION
INITIAL U.S. APPROVAL: 1992
INDICATIONS AND USAGE
Suprane is an inhalation agent indicated: (1)
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.
DOSAGE AND ADMINISTRATION
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)
Patients with intracranial space occupying lesions (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, 5.5)
Patients with a history of moderate to severe hepatic dysfunction
following anesthesia with ahlogenated
agents and not otherwise explained. (4, 5.5)
WARNINGS AND PRECAUTIONS
Malignant hyperthermia may occur. (5.1)
Perioperative hyperkalemia may occur. Patients with latent or overt
neuromuscular disease, particularly
with Duchenne muscular dystrophy, appear to be most vulnerable. (5.2)
SUPRANE may cause sensitivity hepatitis in patients sensitized by
previou