Dexmedetomidin EQL Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Beipackzettel, Nebenwirkungen, Wirkung, Anwendungsgebiete - Dexmedetomidin EQL Pharma 100 Mikrogramm/ml Konzentrat zur Herstellung einer Infusionslösung

Zusammenfassung des Risikomanagement-Plans gemäß § 34

Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the

Medicinal Products Act(2)

Administrative Information:

Wirkstoff	Dexmedetomidinhydrochlorid
ATC-Code	N05CM18
Darreichungsform	Konzentrat zur Herstellung einer Infusionslösung
Art der Anwendung	intravenöse Anwendung
Inhaber der Zulassung	EQL Pharma AB Stortorget 1 222 23 LUND Schweden
Zulassungsnummer	7009619.00.00
Datum der Zulassung	03.11.2023
Verkaufsabgrenzung	verschreibungspflichtig
Version und Datum des Risikomanagement-Plans	0.2 / 13.10.2022
Datum der Genehmigung des RMPs	03.11.2023

Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass dieses Arzneimittel so sicher wie möglich angewendet wird.

Weitere Informationen zu RMP-Zusammenfassungen finden Sie(nur auf Englisch verfügbar).

Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bundfinden können.

Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 29. Dezember 2023 veröffentlicht.

Part VI: Summary of the risk management plan

Summary of risk management plan for Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion

This is a summary of the risk management plan (RMP) for Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion. The RMP details important risks of Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion, how these risks can be minimised, and how more information will be obtained about Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion's risks and uncertainties (missing information).

Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion's summary of product characteristics (SmPC) and its package leaflet give essential information to healthcare professionals and patients on how Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion should be used.

I. The medicine and what it is used for

Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion is authorised 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 (see SmPC for the full indication). It contains dexmedetomidine as the active substance and it is given by infusion.

II. Risks associated with the medicine and activities to minimise or further characterise the risks

Important risks of Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion together with measures to minimise such risks and the proposed studies for learning more about Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion's risks, are outlined below.

Measures to minimise the risks identified for medicinal products can be:

Specific information, such as warnings, precautions, and advice on correct use, in the package leaflet and SmPC addressed to patients and healthcare professionals;
Important advice on the medicine's packaging;
The authorised pack size — the amount of medicine in a pack is chosen so to ensure that the medicine is used correctly;
The medicine's legal status — the way a medicine is supplied to the patient (e.g. with or without prescription) can help to minimise its risks.

Together, these measures constitute routine risk minimisation measures.

In addition to these measures, information about adverse reactions is collected continuously and regularly analysed so that immediate action can be taken as necessary. These measures constitute routine pharmacovigilance activities.

II.A List of important risks and missing information

Important risks of Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion are risks that need special risk management activities to further investigate or minimise the risk, so that the medicinal product can be safely administered. Important risks can be regarded as identified or potential. Identified risks are concerns for which there is sufficient proof of a link with the use of Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion. Potential risks are concerns for which an association with the use of this medicine is possible based on available data, but this association has not been established yet and needs further evaluation. Missing information refers to information on the safety of the medicinal product that is currently missing and needs to be collected (e.g. on the long-term use of the medicine);

List of important risks and missing information
Important identified risks	Atrioventricular block Cardiac arrest Bradycardia Hypotension Hypertension Hyperglycaemia Withdrawal syndrome
Important potential risks	Cortisol suppression Convulsions Hypothermia Torsade de pointes/QT prolongation Overdose Off-label use Increased mortality in younger ICU patients Rhabdomyolysis
Missing information	Pregnancy

II. B Summary of important risks

The safety information in the proposed Product Information is aligned to the reference medicinal product.

II. C Post-authorisation development plan

II.C.l Studies which are conditions of the marketing authorisation

There are no studies which are conditions of the marketing authorisation or specific obligation of Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion.

II.C.2 Other studies in post-authorisation development plan

There are no studies required for Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion.

EU Risk Management Plan for Dexmedetomidine EQL Pharma, 100 micrograms/ml concentrate for solution for infusion

EMA/164014/2018 Rev.2.0.1 accompanying GVP Module V Rev.2

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