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Medicinal Products

Product class: Medicinal product with marketing authorization
Medicinal product class: Human medicine
Name of medicinal product: DEXMEDETOMIDINE KALCEKS
Active substances:
Dexmedetomidine
Estonian, English, Latin
ATC code: N05CM18
Dosage form: concentrate for solution for infusion
Strength: 100mcg 1ml
Legal status for supply*: Subject to medicinal prescription
Summary of product characteristics (SPC):  (last updated October 18, 2023)
Package information leaflet (PIL): EST  (last updated October 18, 2023)
Labelling:  (last updated October 18, 2023)
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
Marketing authorization holder: Kalceks AS 
Marketing authorization number: 980519 
Marketing authorization issued on: March 5, 2019 
Marketing authorization expires on: February 26, 2025 
Marketing authorization procedure type: Decentralised 
Assessment report:  (last updated March 5, 2019) 
Description Additional condition
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Package code Name of medicinal product Dosage form Package Legal status Reimbursements Reference price Last imported PƤritolumaa Additional information
1769788  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 2ml 5TK  Prescription           
1769799  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 2ml 25TK  Prescription      12.06.2024     
1821068  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 4ml 1TK  Prescription           
1821079  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 4ml 4TK  Prescription      17.05.2024     
1821080  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 10ml 1TK  Prescription           
1821091  DEXMEDETOMIDINE KALCEKS  concentrate for solution for infusion  100mcg 1ml 10ml 4TK  Prescription           
Legal status for supply – medicinal product on medical prescription or not subject to medical prescription

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