CISATRACURIUM BESYLATE injection

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Piramal Healthcare UK Limited

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Cisatracurium besylate injection, USP 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, USP is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Cisatracurium besylate injection, USP is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to Cisatracurium besylate injection, USP 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 cisatracur

Resumen del producto:

Cisatracurium besylate injection, USP is a colorless to slightly yellow or greenish yellow solution supplied as follows: Discard unused portion of the 5 mL and 20 mL single-dose vials                       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.

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

CISATRACURIUM BESYLATE - CISATRACURIUM BESYLATE INJECTION
PIRAMAL HEALTHCARE UK LIMITED
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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 (2.7) 10/2019
INDICATIONS AND USAGE
Cisatracurium besylate injection, USP 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, USP 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, USP 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-induced paralysis (2.1)
See the Full Prescribing Information for:
Dosage and administration instructions in adults, pediatric patients,
geriatric patients, patients with
neuromuscular disease, burns, end-stage renal disease, and patients
undergoing coronary artery
bypass graft surgery with ind