- Approval Id
- c7a15f565183dc0a
- Drug Name
- DEXMEDETOMIDINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML
- Product Name
- DEXMEDETOMIDINE KALCEKS CONCENTRATE FOR SOLUTION FOR INFUSION 100MCG/ML
- Approval Number
- SIN16554P
- Approval Date
- 2022-07-19
- Registrant
- GOLDPLUS UNIVERSAL PTE LTD
- Licence Holder
- GOLDPLUS UNIVERSAL PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION CONCENTRATE
- Dosage
- **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_.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **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.
- Contraindications
- **4.3 Contraindications**
None
- Atc Code
- N05CM18
- Atc Item Name
- dexmedetomidine
- Pharma Manufacturer Name
- GOLDPLUS UNIVERSAL PTE LTD
- Company Detail Path
- /organization/goldplus-universal-pte-ltd
