JSC Kalceks launches Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion
JSC Kalceks starts production and commercialization of Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion.
Product has been registered via decentralized registration procedure involving European Union countries. First sales are expected in Czech Republic, Slovakia, Lithuania and Estonia following by other EU countries.
Dexmedetomidine Kalceks contains an active substance dexmedetomidine which belongs to a medicine group called psycholeptics. It is used to provide sedation (a state of calm, drowsiness or sleep) for adult patients in hospital intensive care settings or awake sedation during different diagnostic or surgical procedures.
Dexmedetomidine is a selective alpha‑2 receptor agonist with a broad range of pharmacological properties. It has a sympatholytic effect through decrease of the release of noradrenaline in sympathetic nerve endings. The sedative effects are mediated through decreased firing of locus coeruleus, the predominant noradrenergic nucleus, situated in the brainstem.
Dexmedetomidine Kalceks 100 micrograms/ml concentrate for solution for infusion has two indications:
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.
Dexmedetomidine 100 micrograms/ml concentrate for solution for infusion is a first new product that Kalceks launches this year. In total 8 new products is planned to launch during this year.