Deksmedetomidin Kalceks 100 mikrograma/ml koncentrat za otopinu za infuziju

Name	Deksmedetomidin Kalceks 100 mikrograma/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number	HR-H-423779793
Active Substance	deksmedetomidinklorid
Composition	jedan ml koncentrata sadrži 100 mikrograma deksmedetomidina (u obliku deksmedetomidinklorida)
Pharmaceutical Form	koncentrat za otopinu za infuziju
Manufacturer	AS Kalceks, Riga, Latvija
Marketing Authorisation Holder	AS Kalceks, Krustpils iela 71E, Riga, Latvija
Marketing Authorisation Date	11.11.2019
MA Period of Validity	11.11.2024
Classification Number	UP/I-530-09/19-01/151
Registration Number	381-12-01/70-19-05
Prescription	na recept
Type of prescription	ograničeni recept
Distribution	u ljekarni
Advertising to general public	zabranjeno
ATC Code	N05CM18
Medicinal product marketed in the Croatia	Ne
SmPC	download
PL	download
Public Assessment Report	download

Packaging

Packaging description	MA Number for Packaging	Marketing status	Shortage status
5 ampula s 2 ml koncentrata, u kutiji	HR-H-423779793-01	-	-
25 ampula s 2 ml koncentrata, u kutiji	HR-H-423779793-02	-	-
1 bočica s 4 ml koncentrata, u kutiji	HR-H-423779793-03	-	-
4 bočice s 4 ml koncentrata, u kutiji	HR-H-423779793-04	-	-
1 bočica s 10 ml koncentrata, u kutiji	HR-H-423779793-05	-	-
4 bočice s 10 ml koncentrata, u kutiji	HR-H-423779793-06	-	-

Direct Healthcare Professional Communication

Name	Date	Download
Pismo zdravstvenim radnicima o povećanom riziku od smrtnosti u bolesnika u dobi 65 godina i mlađih, vezano uz primjenu lijekova koji sadrže deksmedetomidin na jedinicama intenzivnog liječenja	15.06.2022	EVER Valinject GmbH, AS Kalceks, Mylan Ireland Limited, Pliva Hrvatska d.o.o., Orion Corporation, Accord Healthcare S.L.U.