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DEXMEDETOMIDINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML [SIN16554P]
Active ingredients: DEXMEDETOMIDINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML
Last updated 26 October 2025
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Product Info
DEXMEDETOMIDINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML
[SIN16554P]
Product information
Active Ingredient and Strength | DEXMEDETOMIDINE HYDROCHLORIDE EQV DEXMEDETOMIDINE - 100 MCG/ML |
Dosage Form | INFUSION, SOLUTION CONCENTRATE |
Manufacturer and Country | HBM PHARMA S.R.O. - SLOVAK REPUBLIC |
Registration Number | SIN16554P |
Licence Holder | GOLDPLUS UNIVERSAL PTE LTD |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | N05CM18 |
4.1 Therapeutic indications
Intensive Care Unit sedation
Dexmedetomidine is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. This medicinal product 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 adult patients prior to and/or during surgical and other procedures.
4.2 Posology and method of administration
Dosing guidelines
Dosing should be individualized and titrated to desired clinical response.
This medicinal product is not indicated for infusions lasting longer than 24 hours.
This medicinal product should be administered using a controlled infusion device.
Posology
Dosage adjustment
Due to possible pharmacodynamic interactions, a reduction in dosage of dexmedetomidine or other concomitant anaesthetics, sedatives, hypnotics or opioids may be required when co-administered (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Dosage reductions may need to be considered for adult patients with hepatic impairment, and geriatric patients (see sections 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Method of administration
This medicine must be administered only as a diluted intravenous infusion using a controlled infusion device.
For instructions on dilution of the medicinal product before administration, see section 6.7 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
4.3 Contraindications
None