Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
CISATRACURIUM BESYLATE (UNII: 80YS8O1MBS) (CISATRACURIUM - UNII:QX62KLI41N)
Sandoz Inc
INTRAVENOUS
PRESCRIPTION DRUG
Cisatracurium besylate injection is indicated: Limitations of Use Cisatracurium besylate injection is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action. Risk Summary The 10 mL cisatracurium besylate multiple-dose vials contain the preservative benzyl alcohol. Therefore, if cisatracurium besylate is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL cisatracurium besylate single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely. However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] . There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug associated risk of major birth defects, miscarria
Cisatracurium besylate injection, USP 2 mg cisatracurium per mL, is supplied as under: 0781-3152-95 10 mL Multiple-Dose Vial Pack of 10’s Contains 0.9% w/v benzyl alcohol [see Warnings and Precautions (5.2)] Storage Cisatracurium besylate injection, USP should be refrigerated at 2° to 8°C (36° to 46°F) in the carton to preserve potency. Protect from light. DO NOT FREEZE. Upon removal of the unused vial from refrigeration to room temperature storage conditions (25°C/77°F), use cisatracurium besylate injection within 21 days, even if re-refrigerated.
Abbreviated New Drug Application
CISATRACURIUM BESYLATE- CISATRACURIUM BESYLATE INJECTION SANDOZ INC ---------- 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 INDICATIONS AND USAGE Cisatracurium besylate is a nondepolarizing neuromuscular blocker indicated: • • • Limitations of Use Cisatracurium besylate is not recommended for rapid sequence endotracheal intubation due to the time required for its onset of action (1) DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Injection: • CONTRAINDICATIONS • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SANDOZ INC., AT 1-800-525-8747 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • USE IN SPECIFIC POPULATIONS • 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) Store cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) 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 antagonist are immediately available (2.1) Use a peripheral nerve stimulator to determine adequacy of blockade (e.g., need for additional doses), minimize risk o Lugege kogu dokumenti