Desflurane (Page 10 of 10)

16.2 Storage

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Desflurane, USP, Liquid for Inhalation has been demonstrated to be stable for the period defined by the expiration dating on the label. Preserve in tight, light-resistant container. Replace the cap securely after each use.

17 PATIENT COUNSELING INFORMATION

Anesthesia providers need to obtain the following information from patients prior to administration of anesthesia:

  • Medications they are taking, including herbal supplements
  • Drug allergies, including allergic reactions to anesthetic agents (including hepatic sensitivity)
  • Any history of severe reactions to prior administration of anesthetic
  • If the patient or a member of the patient’s family has a history of malignant hyperthermia or if the patient has a history of Duchenne muscular dystrophy or other latent neuromuscular disease

Anesthesia providers should inform patients of the risks associated with desflurane, USP:

  • Post-operative nausea and vomiting and respiratory adverse effects including coughing.
  • There is no information of the effects of desflurane, USP following anesthesia on the ability to operate an automobile or other heavy machinery. However, patients should be advised that the ability to perform such tasks may be impaired after receiving anesthetic agents.

Anesthesia providers should inform parents and caregivers of pediatric patients that emergence from anesthesia in children may evoke a brief state of agitation that may hinder cooperation.

Effect of anesthetic and sedation drugs on early brain development

Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on their developing brains. Discuss with parents and caregivers the benefits, risks, and timing and duration of surgery or procedures requiring anesthetic and sedation drugs [See Warnings and Precautions (5.7)] .

LMA is a trademark of The Laryngeal Mask Company Limited and is used under license.

Manufactured by
Shanghai Hengrui Pharmaceutical Co., Ltd.
Shanghai 200245, China
for Sandoz Inc., Princeton, NJ 08540

Rev. November 2022

SH02AUF08

PACKAGE LABEL — PRINCIPAL DISPLAY PANEL

NDC 0781-6172-22

Desflurane, USP, Liquid for Inhalation

240 mL

Rx Only

for

Sandoz

Container Label

container
(click image for full-size original)
DESFLURANE desflurane liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-6172
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DESFLURANE (DESFLURANE) DESFLURANE 240 mL in 240 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-6172-86 6 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (0781-6172-22)
1 NDC:0781-6172-22 240 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (0781-6172-86)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208234 02/26/2018
Labeler — Sandoz Inc. (005387188)
Registrant — Shanghai Hengrui Pharmaceutical Co., Ltd. (527903636)
Establishment
Name Address ID/FEI Operations
Shanghai Hengrui Pharmaceutical Co., Ltd. 527903636 manufacture (0781-6172), analysis (0781-6172), pack (0781-6172), label (0781-6172)

Revised: 11/2022 Sandoz Inc.

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