CISATRACURIUM BESYLATE injection

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)

Beszerezhető a:

Zydus Lifesciences Limited

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Cisatracurium besylate injection is indicated: - as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age - to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU - to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to cisatracurium besylate have been reported [see Warnings and Precautions (5.4)] . Risk Summary There are no adequate and well-controlled studies of cisatracurium besylate in pregnant women. Animal studies conducted in rats administered cisatracurium besylate during organogen

Termék összefoglaló:

Cisatracurium besylate injection USP is a clear solution supplied as follows: Storage Refrigerate cisatracurium besylate injection USP at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Protect from light. DO NOT FREEZE. Upon removal from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection USP within 21 days, even if re-refrigerated.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CISATRACURIUM BESYLATE - CISATRACURIUM BESYLATE INJECTION
ZYDUS LIFESCIENCES LIMITED
----------
CISATRACURIUM BESYLATE INJECTION
PRINCIPAL DISPLAY PANEL – CONTAINER LABEL (10 MG/5 ML)
NDC 72785-0008-1
CISATRACURIUM BESYLATE INJECTION, USP
10 MG/5 ML*
(2 MG/ML)
WARNING: Paralyzing Agent
For Intravenous Injection
Preservative free
5 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL – CONTAINER LABEL (200 MG/20 ML)
NDC 72785-0009-1
CISATRACURIUM BESYLATE INJECTION, USP
200 MG/20 ML*
(10 MG/ML)
WARNING: Paralyzing Agent
For ICU use only.
For Intravenous Injection
Preservative free
20 mL Single-Dose Vial
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL – CARTON LABEL (10 MG/5 ML)
NDC 72785-0008-6
CISATRACURIUM BESYLATE INJECTION, USP
10 MG/5 ML*
(2 MG/ML)
WARNING: Paralyzing Agent
For Intravenous Injection
Preservative free
10 x 5 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
PRINCIPAL DISPLAY PANEL – CARTON LABEL (200 MG/20 ML)
NDC 72785-0009-6
CISATRACURIUM BESYLATE INJECTION, USP
200 MG/20 ML*
(10 MG/ML)
WARNING: Paralyzing Agent
For ICU use only.
For Intravenous Injection
Preservative free
10 x 20 mL Single-Dose Vials
Rx only
Zydus Pharmaceuticals
CISATRACURIUM BESYLATE
cisatracurium besylate injection
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:72785-0008
ROUTE OF ADMINISTRATION
INTRAVENOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM -
UNII:QX62KLI41N)
CISATRACURIUM
2 mg
in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
BENZENESULFONIC ACID (UNII: 685928Z18A)
WATER (UNII: 059QF0KO0R)
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:72785-
0008-6
10 in 1 CARTON
02/12/2020
1
NDC:72785-
0008-1
5 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
ANDA212171
02/12/2020
CISATRACURIUM BESYLATE