Dexmedetomidine EVER Valinject 100 micrograms/ml concentrate for solution for infusion - 2ml amp

Šalis: Malta

kalba: anglų

Šaltinis: Malta Medicines Authority

Prieinama:

EVER Valinject GmbH Oberburgau 3 4866 Unterach am Attersee , Austria

ATC kodas:

N05CM18

INN (Tarptautinis Pavadinimas):

DEXMEDETOMIDINE 100 µg/ml

Vaisto forma:

CONCENTRATE FOR SOLUTION FOR INFUSION

Sudėtis:

DEXMEDETOMIDINE 100 µg/ml

Recepto tipas:

POM

Gydymo sritis:

PSYCHOLEPTICS

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2022-12-09

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXMEDETOMIDINE EVER VALINJECT 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 Dexmedetomidine EVER Valinject is and what it is used for
2.
What you need to know before you are given Dexmedetomidine EVER
Valinject
3.
How Dexmedetomidine EVER Valinject will be given
4.
Possible side effects
5.
How to store Dexmedetomidine EVER Valinject
6.
Contents of the pack and other information
1. WHAT DEXMEDETOMIDINE EVER VALINJECT IS AND WHAT IT IS USED FOR
Dexmedetomidine EVER Valinject 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 DEXMEDETOMIDINE EVER
VALINJECT
YOU MUST NOT BE GIVEN DEXMEDETOMIDINE EVER VALINJECT:
-
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
Dexmedetomidine EVER Valinject 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 ri

Prekės savybės

Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Dexmedetomidine EVER Valinject 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.
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
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.
Page 2 of 17
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 Valinject should be
administered by healthcare
professionals skilled in the management of patients requiring
intensive care.
Patients already intubated and sedated may switch to dexmedetomidine
with an initial infusion rate of 0.7
micrograms/kg/h which may then be adjusted stepwise within the dose
range 0.2 to 1.4 micrograms/k