PROPOFOL INJECTABLE EMULSION injection, emulsion

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

propofol (UNII: YI7VU623SF) (propofol - UNII:YI7VU623SF)

Disponível em:

Dr. Reddy's Laboratories, Inc.

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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

Resumo do produto:

Propofol injectable emulsion, USP is available as follows: Store between 4 to 25°C (40°F to 77°F). Do not freeze. Shake well before use.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

PROPOFOL INJECTABLE EMULSION- PROPOFOL INJECTABLE EMULSION INJECTION,
EMULSION
DR. REDDY'S LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PROPOFOL INJECTABLE
EMULSIONSAFELY 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 (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: (1)
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 2months. (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 via