ULTIVA- remifentanil hydrochloride injection, powder, lyophilized, for solution

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Remifentanil Hydrochloride (UNII: 5V444H5WIC) (Remifentanil - UNII:P10582JYYK)

Tilgjengelig fra:

Mylan Institutional LLC

INN (International Name):

Remifentanil Hydrochloride

Sammensetning:

Remifentanil 1 mg in 1 mL

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

ULTIVA is indicated for intravenous (IV) administration: ULTIVA is contraindicated: Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. Available data with remifentanil hydrochloride in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. In animal reproduction studies, reduced fetal rat body weight and pup weights were reported at 2.2 times a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours. There were no malformations noted when remifentanil was administered via bolus injection to pregnant rats or rabbits during organogenesis at doses approximately 5 times and approximately equal, respectively, to a human intravenous infusion of an induction dose of 1 mcg/kg with a maintenance dose of 2 mcg/kg/min for a surgical procedure lasting 3 hours [see Data ]. The estimated background risk of major birth defects and miscarriage

Produkt oppsummering:

ULTIVA (remifentanil hydrochloride) for Injection, for intravenous use, is supplied as follows: 67457-198-03 3 mL Single-Dose Vial 1 mg lyophilized powder Box of 10 67457-198-05 5 mL Single-Dose Vial 2 mg lyophilized powder Box of 10 67457-198-10 10 mL Single-Dose Vial 5 mg lyophilized powder Box of 10 ULTIVA should be stored at 2° to 25°C (36° to 77°F). Discard unused portion. © 2021 Viatris Inc. ULTIVA is a registered trademark of Glaxo Group Limited, a GSK Company, licensed to the Viatris Companies. Diprivan® is a registered trademark of Fresenius Kabi USA, LLC. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A. Manufactured by: Hospira, Inc. Lake Forest, IL 60045 U.S.A. Revised: 6/2021 MI:ULTIIJ:R7

Autorisasjon status:

New Drug Application

Preparatomtale

ULTIVA- REMIFENTANIL HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ULTIVA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ULTIVA.
ULTIVA (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._
ULTIVA EXPOSES USERS TO RISKS OF ADDICTION, ABUSE, AND MISUSE, WHICH
CAN LEAD TO
OVERDOSE AND DEATH. (5.1)
INDICATIONS AND USAGE
ULTIVA is an opioid agonist indicated for intravenous administration:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
For injection: 1 mg, 2 mg, and 5 mg for intravenous administration
after reconstitution and dilution (3)
CONTRAINDICATIONS
ULTIVA is contraindicated:
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WARNINGS AND PRECAUTIONS
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®
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)
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)
For epidural or intrathecal administration due to the presence of
glycine in the formulation. (4)
In patients wit