REMIFENTANIL HYDROCHLORIDE injection, powder, lyophilized, for solution REMIFENTANIL HYDROCHLORIDE- remifentanil hydrochloride

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

REMIFENTANIL HYDROCHLORIDE (UNII: 5V444H5WIC) (REMIFENTANIL - UNII:P10582JYYK)

Tillgänglig från:

Fresenius Kabi USA, LLC

INN (International namn):

REMIFENTANIL HYDROCHLORIDE

Sammansättning:

REMIFENTANIL 1 mg in 1 mL

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Remifentanil hydrochloride (HCl) for injection is indicated for intravenous (IV) administration: - As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures. - For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting. - As an analgesic component of monitored anesthesia care in adult patients. Remifentanil HCl is contraindicated: - For epidural or intrathecal administration due to the presence of glycine in the formulation [see Nonclinical Toxicology (13)] . - In patients with hypersensitivity to remifentanil (e.g., anaphylaxis) [see Adverse Reactions (6.2)] . Risk Summary Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to

Produktsammanfattning:

Remifentanil HCl for injection should be stored at 2° to 25°C (36° to 77°F). Remifentanil HCl for IV use is supplied as follows: Strength Discard unused portion. The container closure is not made with natural rubber latex. The brand names mentioned in this document are the trademarks of their respective owners.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

REMIFENTANIL HYDROCHLORIDE- REMIFENTANIL HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
REMIFENTANIL HYDROCHLORIDE - REMIFENTANIL HYDROCHLORIDE INJECTION,
POWDER,
LYOPHILIZED, FOR SOLUTION
FRESENIUS KABI USA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REMIFENTANIL HYDROCHLORIDE FOR
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
REMIFENTANIL HYDROCHLORIDE
FOR INJECTION.
REMIFENTANIL HYDROCHLORIDE FOR INJECTION,
FOR INTRAVENOUS USE, CII
INITIAL U.S. APPROVAL: 1996
WARNING: ADDICTION, ABUSE, AND MISUSE
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
REMIFENTANIL HYDROCHLORIDE FOR INJECTION EXPOSES USERS TO RISKS OF
ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO OVERDOSE AND DEATH. (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.4)
6/2020
INDICATIONS AND USAGE
Remifentanil hydrochloride for injection is an opioid agonist
indicated for intravenous administration:
As an analgesic agent for use during the induction and maintenance of
general anesthesia for inpatient and outpatient
procedures. (1)
For continuation as an analgesic into the immediate postoperative
period in adult patients under the direct supervision
of an anesthesia practitioner in a postoperative anesthesia care unit
or intensive care setting. (1)
As an analgesic component of monitored anesthesia care in adult
patients. (1)
DOSAGE AND ADMINISTRATION
Monitor patients closely for respiratory depression when initiating
therapy and following dosage increases and adjust
the dosage accordingly. (2.1)
Initial Dosage in Adults: See full prescribing information for
recommended doses in adult patients. (2.2, 2.3)
Initial Dosage in Pediatric Patients: See full prescribing information
for recommended doses in pediatric patients. (2.2)
Geriatric Patients: The starting doses should be decreased by 50% in
elderly patients (> 65 years). (2.6)
DOSAGE FORMS AND STRENGTHS
For injection: 1 mg, 2 mg, and 5 mg for intravenous administration
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