DEXMEDETOMIDINE HYDROCHLORIDE injection, solution, concentrate

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO)

Sẵn có từ:

Zydus Lifesciences Limited

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Dexmedetomidine hydrochloride injection is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures. None Pregnancy Category C There are no adequate and well-controlled studies of dexmedetomidine hydrochloride use in pregnant women. In an in vitro human placenta study, placental transfer of dexmedetomidine occurred. In a study in the pregnant rat, placental transfer of dexmedetomidine was observed when radiolabeled dexmedetomidine was administered subcutaneously. Thus, fetal exposure should be expected in humans, and dexmedetomidine hydrochloride should be used during pregnancy only if the potential benefits justify the potential risk to the fetus. Teratogenic effects were not observed in rats following subcutaneous administration of dexmedetomidine during the period of fetal organogenesis (from gestation day 5 to 16) with doses up to 200 mcg/kg (representing a dose approximately equal to the maximum recommended human intravenous dose based on body surface area) o

Tóm tắt sản phẩm:

Dexmedetomidine hydrochloride Injection Dexmedetomidine hydrochloride injection 200 mcg/2 mL (100 mcg/mL) is available in 2 mL clear glass vials. The strength is based on the dexmedetomidine base. Vials are intended for single dose only. Store at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

DEXMEDETOMIDINE HYDROCHLORIDE - DEXMEDETOMIDINE
HYDROCHLORIDE INJECTION, SOLUTION, CONCENTRATE
ZYDUS LIFESCIENCES LIMITED
----------
DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
PRINCIPAL DISPLAY PANEL
200 MCG/2 ML CONTAINER LABEL
NDC 70771-1319-1
Dexmedetomidine
Hydrochloride Injection
200 mcg/2 mL
(100 mcg/mL)
For Intravenous Infusion Use
MUST BE DILUTED
2 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL - 200 MCG/2 ML CARTON LABEL
NDC 70771-1319-7
Dexmedetomidine
Hydrochloride Injection
200 mcg/2 mL
(100 mcg/mL)
For Intravenous Infusion Use
MUST BE DILUTED
25 X 2 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
DEXMEDETOMIDINE HYDROCHLORIDE
dexmedetomidine hydrochloride injection, solution, concentrate
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1319
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
DEXMEDETOMIDINE HYDROCHLORIDE (UNII: 1018WH7F9I) (DEXMEDETOMIDINE -
DEXMEDETOMIDINE
100 ug
Zydus Lifesciences Limited
UNII:67VB76HONO)
DEXMEDETOMIDINE
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
SODIUM CHLORIDE (UNII: 451W47IQ8X)
9 mg in 1 mL
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1319-7
25 in 1 CARTON
06/14/2018
1
NDC:70771-
1319-1
2 mL in 1 VIAL; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206798
06/14/2018
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1319) , MANUFACTURE(70771-1319)
Revised: 10/2022