Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution for infusion

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Dexmedetomidine hydrochloride

Disponible depuis:

EVER Valinject GmbH

Code ATC:

N05CM; N05CM18

DCI (Dénomination commune internationale):

Dexmedetomidine hydrochloride

Dosage:

100 microgram(s)/millilitre

forme pharmaceutique:

Concentrate for solution for infusion

Type d'ordonnance:

Product subject to prescription which may not be renewed (A)

Domaine thérapeutique:

Other hypnotics and sedatives; dexmedetomidine

Statut de autorisation:

Marketed

Date de l'autorisation:

2018-07-06

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
[NATIONALLY APPROVED NAME] 100 MICROGRAMS/ML CONCENTRATE FOR SOLUTION
FOR INFUSION
DEXMEDETOMIDINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Nationally approved name] is and what it is used for
2.
What you need to know before you are given [Nationally approved name]
3.
How [Nationally approved name] will be given
4.
Possible side effects
5.
How to store [Nationally approved name]
6.
Contents of the pack and other information
1. WHAT [NATIONALLY APPROVED NAME] IS AND WHAT IT IS USED FOR
[Nationally approved name] contains an active substance called
dexmedetomidine, which belongs to a
medicine group called sedatives. 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.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN [NATIONALLY APPROVED
NAME]
YOU MUST NOT BE GIVEN [NATIONALLY APPROVED NAME]:
-
if you are allergic to dexmedetomidine or any of the other ingredients
of this medicine (listed in
section 6).
-
if you have some disorders of heart rhythm (heart block grade 2 or 3).
-
if you have very low blood pressure which does not respond to
treatment.
-
if you have recently had a stroke or other serious condition affecting
blood supply to the brain.
WARNINGS AND PRECAUTIONS
Before you are given this medicine, tell your doctor or nurse if any
of the following apply as [Nationally
approved name] should be used cautiously:
-
if you have an abnormally slow heart rate (either due to illness or
high levels of physical fitness)
as
it may increase the risk for cardiac arrest
-
if you have low

Résumé des caractéristiques du produit

Health Products Regulatory Authority
24 July 2023
CRN00D57X
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexmedetomidine EVER Pharma 100 micrograms/ml concentrate for solution
for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml of concentrate contains dexmedetomidine hydrochloride
equivalent to 100 micrograms dexmedetomidine.
Each 2 ml ampoule contains 200 micrograms of dexmedetomidine.
Each 4 ml ampoule contains 400 micrograms of dexmedetomidine.
Each 10 ml ampoule contains 1000 micrograms of dexmedetomidine.
Each 2 ml vial contains 200 micrograms of dexmedetomidine.
Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Each 10 ml vial contains 1000 micrograms of dexmedetomidine.
The concentration of the final solution after dilution should be
either 4 micrograms/ml or 8 micrograms/ml.
Excipient with known effect:
Each ml of concentrate contains less than 1 mmol (approximately 3.5
mg) sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Concentrate for solution for infusion (sterile concentrate).
The concentrate is a clear, colourless solution, pH 4.5 - 7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
1. 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).
2. For sedation of non-intubated adult patients prior to and/or during
diagnostic or surgical procedures requiring sedation, i.e.
procedural/awake sedation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
INDICATION 1. 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 hospital use only. Dexmedetomidine EVER Pharma should be
administered by healthcare professionals skilled in the
management of patients requiring intensive care.
Patients already intubated and sedate