PROPOFOL injection, emulsion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

PROPOFOL (UNII: YI7VU623SF) (PROPOFOL - UNII:YI7VU623SF)

Tilgjengelig fra:

Actavis Pharma, Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Propofol Injectable Emulsion is an intravenous general anesthetic and sedation drug indicated for: 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 Pediatric Use (8.4 )]. Propofol Injectable Emulsion is not indicated for use in Pediatric ICU sedation since the safety of this regimen has not been established [see Pediatric Use (8.4 )]. Propofol Injectable Emulsion is contraindicated in patients with a known hypersensitivity to propofol or any of Propofol Injectable Emulsion components. Propofol Injectable Emulsion is contraindicated in patients with a history of anaphylaxis

Produkt oppsummering:

Propofol Injectable Emulsion, USP is available as follows: NDC Code Strength 0591-2136-95 200 mg in a 20 mL vial (10 mg per mL) 20 mL ready-to-use single-dose infusion vial in packages of twenty five. 0591-2136-51 500 mg in a 50 mL vial (10 mg per mL) 50 mL ready-to-use single-dose infusion vial in packages of twenty. 0591-2136-68 1,000 mg in a 100 mL vial (10 mg per mL) 100 mL ready-to-use single-dose infusion vial in packages of ten. Store between 4 to 25°C (40°F to 77°F). Do not freeze. Shake well before use. Do not use if there is evidence of excessive creaming or aggregation, if large droplets are visible, or if there are other forms of phase separation indicating that the stability of the product has been compromised. Slight creaming, which should disappear after shaking, may be visible upon prolonged standing.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

PROPOFOL- PROPOFOL INJECTION, EMULSION
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
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: (1)
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 (1)
MAC sedation in the pediatric population is not recommended. 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/mL), 500 mg per 50 mL (10
mg/mL), and 1,000 mg per
100 mL (10 mg/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