FRESENIUS PROPOVEN 2%- propofol emulsion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Fresenius Kabi USA, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Fresenius Propoven 2% (propofol 20 mg/mL) Emulsion 100 mL, to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit (ICU) setting. CAUTION: THERE IS A RISK OF UNINTENTIONAL OVERDOSE WITH THIS UNAPPROVED PRODUCT. Fresenius Propoven 2% Emulsion contains the same active ingredient, propofol, as FDA-approved Diprivan Injectable Emulsion USP 10 mg/mL, but contains double the concentration. BECAUSE OF THIS DIFFERENCE IN CONCENTRATION BETWEEN THIS UNAPPROVED PRODUCT AND THE FDA-APPROVED PRODUCT, THERE IS A RISK OF UNINTENTIONAL OVERDOSE. Fresenius Propoven 2% Emulsion 100mL is not an FDA-approved drug in the United States. However, FDA has issued an EUA permitting the emergency use of Fresenius Propoven 2% Emulsion during the COVID-19 pandemic. The scope of the EUA is limited as follows

Authorization status:

unapproved drug other

Summary of Product characteristics

FRESENIUS PROPOVEN 2% - PROPOFOL EMULSION
FRESENIUS KABI USA, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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FACT SHEET FOR HEALTH CARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) OF FRESENIUS
PROPOVEN 2% EMULSION
The U.S. Food and Drug Administration (FDA) has issued an Emergency
Use Authorization (EUA) to
permit the emergency use of the unapproved product, Fresenius Propoven
2% (propofol 20 mg/mL)
Emulsion 100 mL, to maintain sedation via continuous infusion in
patients greater than 16 years old who
require mechanical ventilation in an intensive care unit (ICU)
setting.
CAUTION: THERE IS A RISK OF UNINTENTIONAL OVERDOSE WITH THIS
UNAPPROVED PRODUCT.
FRESENIUS PROPOVEN 2% EMULSION CONTAINS THE SAME ACTIVE INGREDIENT,
PROPOFOL, AS FDA-
APPROVED DIPRIVAN INJECTABLE EMULSION USP 10 MG/ML, BUT CONTAINS
DOUBLE THE CONCENTRATION.
BECAUSE OF THIS DIFFERENCE IN CONCENTRATION BETWEEN THIS UNAPPROVED
PRODUCT AND THE FDA-APPROVED PRODUCT, THERE IS A RISK OF
UNINTENTIONAL OVERDOSE.
NOTE IMPORTANT DIFFERENCES IN FORMULATION AND LABELING BETWEEN THE
CURRENT U.S. MARKETED FDA-APPROVED DIPRIVAN INJECTABLE EMULSION, USP
10 MG/ML
(DIPRIVAN ) PRODUCTS AND FRESENIUS PROPOVEN 2% EMULSION.
SEE DETAILS BELOW BEFORE ADMINISTERING FRESENIUS PROPOVEN 2%
EMULSION.
Fresenius Propoven 2% Emulsion 100mL is not an FDA-approved drug in
the United States. However,
FDA has issued an EUA permitting the emergency use of Fresenius
Propoven 2% Emulsion during the
COVID-19 pandemic.
The scope of the EUA is limited as follows:
Fresenius Propoven 2% Emulsion will be USED ONLY TO MAINTAIN SEDATION
VIA CONTINUOUS INFUSION
IN PATIENTS GREATER THAN 16 YEARS OLD who require mechanical
ventilation.
Fresenius Propoven 2% Emulsion will be administered only by a licensed
healthcare provider IN AN
ICU SETTING.
Fresenius Propoven 2% Emulsion WILL NOT BE ADMINISTERED TO PREGNANT
WOMEN, unless there are
no FDA-app