Sedaconda 100% V/V inhalation vapour, liquid

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Isoflurane

Dostupné s:

Sedana Medical AB

ATC kód:

N01AB06

INN (Mezinárodní Name):

Isoflurane

Dávkování:

100 percent volume/volume

Léková forma:

Inhalation vapour, liquid

Terapeutické oblasti:

isoflurane

Datum autorizace:

2021-11-19

Informace pro uživatele

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SEDACONDA
100%
V/V
INHALATION VAPOUR, LIQUID
isoflurane
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sedaconda is and what it is used for
2.
What you need to know before you receive Sedaconda
3.
How you receive Sedaconda
4.
Possible side effects
5.
How to store Sedaconda
6.
Contents of the pack and other information
1.
WHAT SEDACONDA IS AND WHAT IT IS USED FOR
Sedaconda contains an active substance called isoflurane which belongs
to a medicine group
called anesthetics. It is used to provide sedation (a state of calm,
drowsiness or sleep) for adult patients
who are in need of mechanical ventilation (a treatment with a special
machine that helps patients to
breathe) during intensive care.
2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SEDACONDA
YOU WILL NOT BE GIVEN SEDACONDA
−
If you are allergic to isoflurane or other halogenated anaesthetics.
−
If you, or anyone in your family, have ever experienced a rapid rise
in body temperature during
sedation or anaesthesia (a rare condition known as malignant
hyperthermia). For more information
see section “Possible side effects”.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before receiving Sedaconda if:
-
You have ever had QT prolongation (abnormal reading on an
electrocardiogram) or torsade de
pointes (life-threatening irregular heartbeat). Isoflurane has
sometimes been known to cause these.
-
You have a mitochondrial disease. Mitochondrial diseases are a group
of rare genetic conditions
that occur when mitochondria (small structures in the cells) fail to
produce enough energy for the
body to function properly.
-
You hav

Charakteristika produktu

Health Products Regulatory Authority
16 November 2022
CRN00D8C7
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sedaconda 100% V/V inhalation vapour, liquid
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Isoflurane 100% V/V
3 PHARMACEUTICAL FORM
Inhalation vapour, liquid
Clear and colourless liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sedaconda is indicated for sedation of mechanically ventilated adult
patients during intensive care.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sedaconda should only be administered by medical staff familiar with
the management of mechanically ventilated patients, the
delivery device Sedaconda ACD (Anaesthetic Conserving Device) and the
pharmacodynamics of isoflurane.
Isoflurane should only be administered in an adequately equipped
environment by personnel who are trained in handling
volatile anaesthetic agents (see section 6.6).
Sedaconda should only be delivered via the Sedaconda ACD, as the
efficacy and safety of inhaled isoflurane sedation have only
been established via the Sedaconda ACD. Sedaconda should only be used
in intubated or tracheotomised patients with a
protected airway.
During sedation, clinical assessment of sedation depth with a
validated clinical sedation scale, such as the Richmond
Agitation-Sedation Scale (RASS), should be used to guide dose.
Equipment should be available for measurement of the
delivered and end-tidal concentration of isoflurane.
Priming and bolus doses should never be performed manually, see the
Instructions for Use (IFU) delivered together with the
Sedaconda ACD.
Posology
_Priming_
When initiating the treatment, the anaesthetic agent line of the
Sedaconda ACD must be primed with a volume of 1.2 mL.
_Starting dose and dose titration_
Recommended initial syringe pump rate is 3 mL/hour. Adjustments of
pump rate should be done in steps of 0.5‑1.0 mL/hour.
To increase sedation quickly, a programmed bolus of 0.3‑0.5 mL can
be given via the pump. Other sedatives can normally be
stopped once treatment with