Dexmedetomidine Hydrochloride (Page 7 of 7)
16 HOW SUPPLIED/STORAGE AND HANDLING
Dexmedetomidine Hydrochloride Injection is clear and colorless, and is available in a 100 mcg/mL strength in clear glass, multiple-dose vials as follows:
NDC No. | Strength | Package |
44567-600-04 | 400 mcg/4 mL | 4 vials/carton |
44567-601-04 | 1000 mcg/10 mL | 4 vials/carton |
Dexmedetomidine Hydrochloride Injection is available in single-dose, single-port, ready-to-use flexible plastic infusion bags in a foil laminate overwrap as follows:
NDC No. | Strength | Package |
44567-602-24 | 200 mcg/50 mL | 24 bags/carton |
44567-603-24 | 400 mcg/100 mL | 24 bags/carton |
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. It is recommended that the infusion bags be kept in the overwrap until ready to use. PROTECT INFUSION BAGS FROM FREEZING.
17 PATIENT COUNSELING INFORMATION
Advise patients, their families, or caregivers to report to their health care provider symptoms that occur within 48 hours after the administration of Dexmedetomidine HCl Injection such as:
- •
- Nervousness, agitation, and headaches which may be associated with an infusion lasting for more than 6 hours
- •
- Weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness
Important Potential Adverse Reactions Following Drug Discontinuation
Advise the patient, their families, or caregivers to contact their health care provider if they develop any of the following symptoms within 48 hours of receiving Dexmedetomidine HCl Injection: weakness, confusion, excessive sweating, weight loss, abdominal pain, salt cravings, diarrhea, constipation, dizziness or light-headedness.
Manufactured for:
WG Critical Care, LLC
Paramus, NJ 07652
Vials made in Finland
Bags made in Switzerland
U.S. Patent Numbers 9,649,296 and 9,717,796
PRINCIPAL DISPLAY PANEL
NDC 44567-600-04
Dexmedetomidine HCl Injection
400 mcg/4 mL (100 mcg/mL)
Rx only WG Critical Care
PRINCIPAL DISPLAY PANEL
NDC 44567-601-04
Dexmedetomidine HCl Injection
1000 mcg/10 mL (100 mcg/mL)
Rx only WG Critical Care
Package/Label Display Panel
NDC 44567-602-24 Rx only
Dexmedetomidine
HCl in 5% Dextrose Injection
200 mcg/50 mL (4 mcg/mL)
For Intravenous Use Only
Package/Label Display Panel
NDC 44567-603-24 Rx only
Dexmedetomidine
HCl in 5% Dextrose Injection
400 mcg/100 mL (4 mcg/mL)
For Intravenous Use Only
DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection, solution, concentrate | |||||||||||||||||
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DEXMEDETOMIDINE HYDROCHLORIDE dexmedetomidine hydrochloride injection, solution, concentrate | |||||||||||||||||
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DEXMEDETOMIDINE HYDROCHLORIDE IN DEXTROSE dexmedetomidine hydrochloride injection | |||||||||||||||||
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DEXMEDETOMIDINE HYDROCHLORIDE IN DEXTROSE dexmedetomidine hydrochloride injection | |||||||||||||||||
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Labeler — WG Critical Care, LLC (829274633) |
Revised: 12/2021 WG Critical Care, LLC
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