ETOMIDATE injection, solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598)

から入手可能:

Zydus Lifesciences Limited

投与経路:

INTRAVENOUS

処方タイプ:

PRESCRIPTION DRUG

適応症:

Etomidate injection, USP is indicated by intravenous injection for the induction of general anesthesia. When considering use of etomidate injection, USP the usefulness of its hemodynamic properties (see CLINICAL PHARMACOLOGY ) should be weighed against the high frequency of transient skeletal muscle movements (see ADVERSE REACTIONS ). Intravenous etomidate injection, USP is also indicated for the supplementation of subpotent anesthetic agents, such as nitrous oxide in oxygen, during maintenance of anesthesia for short operative procedures such as dilation and curettage or cervical conization. Etomidate is contraindicated in patients who have shown hypersensitivity to it.

製品概要:

Etomidate Injection, USP is supplied in single-dose containers as follows: Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

ETOMIDATE - ETOMIDATE INJECTION, SOLUTION
ZYDUS LIFESCIENCES LIMITED
----------
ETOMIDATE INJECTION, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Vial Label 10 mL
Zydus Pharmaceuticals
NDC 65841-818-07
Etomidate Injection, USP
20 mg/10 mL
(2 mg/mL)
For Intravenous Use
10 mL, Single-Dose Vial
Rx Only
Carton Label 10 mL
Zydus Pharmaceuticals
NDC 65841-818-07
Etomidate injection, USP
20 mg/10 mL
(2 mg/mL)
For Intravenous Use
10 x 10 mL, Single-Dose Vials
Rx Only
Vial Label 20 mL
Zydus Pharmaceuticals
NDC 65841-818-08
Etomidate injection, USP
40 mg/20 mL
(2 mg/mL)
For Intravenous Use
20 mL, Single-Dose Vial
Rx Only
Carton Label 20 mL
Zydus Pharmaceuticals
NDC 65841-818-08
Etomidate injection, USP
40 mg/20 mL
(2 mg/mL)
For Intravenous Use
10 x 20 mL, Single-Dose Vials
Rx Only
ETOMIDATE
etomidate injection, solution
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-818
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
ETOMIDATE (UNII: Z22628B598) (ETOMIDATE - UNII:Z22628B598)
ETOMIDATE
2 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
0.35 mL in 1 mL
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-818-
07
10 in 1 TRAY
04/03/2015
1
10 mL in 1 VIAL; Type 0: Not a Combination
Product
2
NDC:65841-818-
08
10 in 1 TRAY
04/03/2015
2
20 mL in 1 VIAL; Type 0: Not a Combination
Product
Zydus Lifesciences Limited
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA202360
04/03/2015
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
MANUFACTURE(65841-818) , ANALYSIS(65841-818)
Revised: 10/2022