Sevoflurane (Page 5 of 5)

HOW SUPPLIED

Sevoflurane, USP, Volatile Liquid for Inhalation, is packaged in amber colored bottles containing 250 mL Sevoflurane, USP, NDC # 66794-022-25.

SAFETY AND HANDLING

Occupational Caution

There is no specific work exposure limit established for sevoflurane. However, the National Institute for Occupational Safety and Health has recommended an 8 hour time-weighted average limit of 2 ppm for halogenated anesthetic agents in general (0.5 ppm when coupled with exposure to N 2 O) (see ADVERSE REACTIONS).

Storage

Store at controlled room temperature, 15° — 30°C (59° — 86°F). See USP.

ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.

In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss; however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in pregnant women, neonates and young children who require procedures against the potential risks suggested by the nonclinical data (see WARNINGS — Pediatric Neurotoxicity, PRECAUTIONS — Pregnancy, PRECAUTIONS — Pediatric Use).

Manufactured by:

Piramal Critical Care, Inc.

3950 Schelden Circle

Bethlehem, PA 18017

(888) 822-8431

Last Revised: May 2022

© 2022 Piramal Critical Care, Inc.

label
(click image for full-size original)

SEVOFLURANE
sevoflurane liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66794-022
Route of Administration RESPIRATORY (INHALATION) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SEVOFLURANE (SEVOFLURANE) SEVOFLURANE 1 mL in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66794-022-25 250 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077867 10/01/2020
Labeler — Piramal Critical Care Inc (805600439)
Establishment
Name Address ID/FEI Operations
Piramal Critical Care Inc 805600439 analysis (66794-022), api manufacture (66794-022), label (66794-022), manufacture (66794-022), pack (66794-022)

Revised: 06/2022 Piramal Critical Care Inc

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