Etomidate (Page 3 of 3)
HOW SUPPLIED
Etomidate Injection, USP 2 mg/ mL is a sterile, nonpyrogenic clear colorless solution supplied in single-dose vials as follows:
NDC No. | Etomidate Injection, USP (2 mg/mL) | Package Factor |
65145-127-10 | 20 mg/10 mL (2 mg/mL) Single-Dose Vial | 10 vials per carton |
65145-128-10 | 40 mg/20 mL (2 mg/mL) Single-Dose Vial | 10 vials per carton |
Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.]
ANIMAL PHARMACOLOGY & OR TOXICOLOGY
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 neonates and young children who require procedures against the potential risks suggested by the nonclinical data (See WARNINGS/Pediatric Neurotoxicity, PRECAUTIONS/Pregnancy, Pediatric Use).
Manufactured by:
Caplin Steriles Limited,
Gummidipoondi – 601 201,
India.
Code: TN/Drugs/TN00003457
August, 2020
CSL/AWC/XXX-XX
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Etomidate Injection, USP 20 mg/10 mL (2 mg/mL)
NDC 65145-127-01
Rx only
For Intravenous Use Only
10 mL Single-Dose Vial
Etomidate Injection 10 mL Carton
NDC 65145-127-10
10 X 10 mL Single-dose Vial
Etomidate Injection, USP 4 0 mg/20 mL (2 mg/mL)
NDC 65145-128-01
Rx only
For Intravenous Use Only
20 mL Single-Dose Vial
Etomidate Injection 20 mL Carton
NDC 65145-128-10
10 X 10 mL Single-dose Vial
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ETOMIDATE etomidate injection, solution | |||||||||||||||||
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Labeler — Caplin Steriles Limited (650744670) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Caplin Steriles Limited | 650744670 | ANALYSIS (65145-127), ANALYSIS (65145-128), MANUFACTURE (65145-127), MANUFACTURE (65145-128), PACK (65145-127), PACK (65145-128) |
Revised: 12/2020 Caplin Steriles Limited
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