Product class: Authorized package
Medicinal product class: For human use
Package code: 1821091
Name of medicinal product: DEXMEDETOMIDINE KALCEKS
Active substances:
Estonian, English, Latin
ATC code: N05CM18
Dosage form: concentrate for solution for infusion
Route of administration: intravenous use
Strengh: 100mcg 1ml
Amount in package: 10ml 4TK
Legal status for supply*: Subject to medicinal prescription
Class of active substance:  
Additional information:  
Indication: For sedation of adult ICU (Intensive Care Unit) patients requiring a sedation level not deeper than arousal in response to verbal stimulation (corresponding to Richmond Agitation-Sedation Scale (RASS) 0 to -3). For sedation of non-intubated adult patients prior to and/or during diagnostic or surgical procedures requiring sedation, i.e. procedural/awake sedation.
Safety features: Yes
Summary of product characteristics (SPC):  (last updated 18 October 2023)
Package information leaflet (PIL): EST  (last updated 18 October 2023)
Labelling:  (last updated 18 October 2023)
Last imported to Estonia: Never imported to Estonia
Marketing authorization holder: Kalceks AS 
Marketing authorization number: 980519 
Marketing authorization issued on: 05 March 2019 
Marketing authorization expires on: 26 February 2025 
Marketing authorization procedure type: Decentralised 
Reference price:   
Under reference price:   
Reference price of daily dose:   
Description Additional condition
Ei ole lubatud väljastada korduvretsepti
Hambaarstil on õigus välja kirjutada Väikseima müügiloleva ravimpakendi suuruses, kuid mitte üle 20 tableti
Entry/Changing date: 26 February 2024
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription