Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
propofol (UNII: YI7VU623SF) (propofol - UNII:YI7VU623SF)
Sagent Pharmaceuticals
INTRAVENOUS
PRESCRIPTION DRUG
Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for: - Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age - Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age - Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients - Sedation for Adult Patients in Combination with Regional Anesthesia - Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients Limitations of Use Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months because its safety and effectiveness have not been established in those populations [see Pediatric Use (8.4)] . Safety, effectiveness and dosing guidelines for Propofol Injectable Emulsion have not been established for MAC sedation in the pediatric population; therefore, it is not recommended for this use [see Pediat
Propofol Injectable Emulsion, USP is available as follows: Contains a sulfite. Storage Conditions Store between 4° to 25°C (40° to 77°F). Do not freeze. Shake well before use. Discard unused portion. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
PROPOFOL- PROPOFOL INJECTION, EMULSION SAGENT PHARMACEUTICALS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE PROPOFOL INJECTABLE EMULSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR PROPOFOL INJECTABLE EMULSION. PROPOFOL INJECTABLE EMULSION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1991 INDICATIONS AND USAGE Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for: Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age (1) Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age (1) Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients (1) Sedation for Adult Patients in Combination with Regional Anesthesia (1) Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients (1) Limitations of Use Propofol Injectable Emulsion is not recommended for induction of anesthesia below the age of 3 years or for maintenance of anesthesia below the age of 2 months (1) MAC sedation in the pediatric population is not recommended (1) Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation (1) DOSAGE AND ADMINISTRATION See Full Prescribing Information for detailed dosing instructions (2) DOSAGE FORMS AND STRENGTHS Injectable emulsion: 200 mg per 20 mL (10 mg per mL), 500 mg per 50 mL (10 mg per mL), and 1,000 mg per 100 mL (10 mg per mL) single-dose vials (3) CONTRAINDICATIONS Known hypersensitivity to propofol, egg or soybean (4) WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Serious and sometimes fatal reactions (5.1) Microbial Contamination: Strict aseptic technique must be maintained during handling. Propofol injectable emulsion vials are never to be accessed more than once or used on more than one person. Administration should commence promptly and be completed within 12 hours after the vial has been opened. Discard unused drug product. Do not use if Lire le document complet