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HSA Product

DEXMEDETOMIDINE FRESENIUS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML

Product approved by Health Sciences Authority (SG)

Basic Information

DEXMEDETOMIDINE FRESENIUS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML

INJECTION

Regulatory Information

SIN16908P

December 12, 2023

Prescription Only

Therapeutic

INTRAVENOUS

January 24, 2024

June 3, 2025

XN05CM18

Company Information

FRESENIUS KABI (SINGAPORE) PTE LTD

FRESENIUS KABI (SINGAPORE) PTE LTD

Active Ingredients

Detailed Information

Contraindications

**9 Contraindications** Hypersensitivity to the active substance or to any of the excipients in the formulation. Advanced heart block (grade 2 or 3) unless paced. Uncontrolled hypotension. Acute cerebrovascular conditions.

Indication Information

**7 Indications** **Intensive Care Unit Sedation** Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Dexmedetomidine should be administered by continuous infusion not to exceed 24 hours. Dexmedetomidine has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue dexmedetomidine prior to extubation. **Procedural Sedation** Dexmedetomidine is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.

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