CISATRACURIUM BESYLATE- cisatracurium besylate injection

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Jiangsu Hengrui Medicine Co., Ltd.

INN (mednarodno ime):

CISATRACURIUM BESYLATE

Sestava:

CISATRACURIUM 2 mg in 1 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 have been reported [see Warnings and Precautions ( 5.4)] . The use of 10 mL cisatracurium multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [see Warnings and

Povzetek izdelek:

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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

CISATRACURIUM BESYLATE- CISATRACURIUM BESYLATE INJECTION
JIANGSU HENGRUI MEDICINE CO., LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CISATRACURIUM BESYLATE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CISATRACURIUM BESYLATE INJECTION.
CISATRACURIUM BESYLATE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1995
RECENT MAJOR CHANGES
Dosage and Administration ( 2.1)
7/2018
Warnings and Precautions, Residual Paralysis ( 5.1)
7/2018
Warnings and Precautions, Risk of Death Due to Medication Errors (
5.5)
7/2018
INDICATIONS AND USAGE
Cisatracurium Besylate Injection is a nondepolarizing neuromuscular
blocker indicated:
as an adjunct to general anesthesia to facilitate tracheal intubation
in adults and in pediatric patients 1 month to 12 years
of age ( 1)
to provide skeletal muscle relaxation during surgery in adults and in
pediatric patients 2 to 12 years of age as a bolus or
infusion maintenance ( 1)
for mechanical ventilation in the ICU in adults ( 1)
Limitations of Use:
Cisatracurium Besylate Injection is not recommended for rapid sequence
endotracheal intubation due to the time required
for its onset of action ( 1)
DOSAGE AND ADMINISTRATION
Administer intravenously only by or under the supervision of
experienced clinicians familiar with drug’s actions and
possible complications ( 2.1)
Use only if personnel and facilities for resuscitation and life
support, and a cisatracurium besylate injection antagonist
are immediately available ( 2.1)
Use a peripheral nerve stimulator to determine adequacy of blockade
(e.g., need for additional doses), minimize risk of
overdosage or underdosage, assess extent of recovery from blockade,
potentially limit exposure to toxic metabolites
through dose titration, and facilitate more rapid reversal of
cisatracurium besylate injection-induced paralysis ( 2.1)
See the Full Prescribing Information for:
Dosage and administration instructions in adults, pediatric patients,
geriatric pati