Dzuveo
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
31-03-2023
Karatteristiċi tal-prodott
(SPC)
31-03-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
18-07-2018
Ingredjent attiv:
sufentanil citrate
Disponibbli minn:
Laboratoire Aguettant
Kodiċi ATC:
N01AH03
INN (Isem Internazzjonali):
sufentanil
Grupp terapewtiku:
Anesthetics
Żona terapewtika:
Pain
Indikazzjonijiet terapewtiċi:
Dzuveo is indicated for the management of acute moderate to severe pain in adult patients.
Sommarju tal-prodott:
Revision: 6
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-06-25
Fuljett ta 'informazzjoni
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
DZUVEO 30
MICROGRAMS SUBLINGUAL TABLET
sufentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Dzuveo is and what it is used for
2.
What you need to know before you use Dzuveo
3.
How to use Dzuveo
4.
Possible side effects
5.
How to store Dzuveo
6.
Contents of the pack and other information
1.
WHAT DZUVEO IS AND WHAT IT IS USED FOR
The active substance of Dzuveo is sufentanil, which belongs to a group
of strong painkillers called
opioids.
Sufentanil is used to treat sudden moderate-to-severe pain in adults
in medically monitored settings
such as a hospital.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DZUVEO
DO NOT USE DZUVEO:
-
if you are allergic to sufentanil or any of the other ingredients of
this medicine (listed in
section 6).
-
If you have a serious lung or breathing problem.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using Dzuveo. Tell your doctor or
nurse before treatment if you:
-
Are suffering from any condition that affects your breathing (such as
asthma, wheezing, or
shortness of breath). As Dzuveo may affect your breathing, your doctor
or nurse will check your
breathing during treatment;
-
Have a head injury or brain tumour;
-
Have problems with your heart and circulation, especially slow heart
rate, irregular heartbeat,
low blood volume or low blood pressure;
-
Have moderate to severe liver problems or severe kidney problems, as
these organs have an
effect on the way in which your body breaks down and eliminates the
medicine; have
abnormally slow bowel movements;
-
Have a disease of the gall bladder or pancreas;
-
Or anyone in your fam
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Dzuveo 30 micrograms sublingual tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains 30 micrograms of sufentanil (as
citrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet.
Blue-coloured flat-faced tablet with round edges and a diameter of 3
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dzuveo is indicated for the management of acute moderate to severe
pain in adult patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Dzuveo is to be administered by a healthcare professional in a
medically monitored setting only. A
medically monitored setting must have equipment and personnel trained
to detect and manage
hypoventilation, and availability of supplemental oxygen and opioid
antagonists, such as naloxone.
Dzuveo should only be prescribed and administered by healthcare
professionals who are experienced
in the management of opioid therapy; particularly opioid adverse
reactions, such as respiratory
depression (see section 4.4).
Posology
Dzuveo is provided in a disposable single-dose applicator, to be
administered by a healthcare provider
as needed by the individual patient, but no more than once every hour,
resulting in a maximum dose of
720 micrograms /day. Patients with a higher pain intensity at one hour
after sufentanil treatment was
initiated required more frequent redosing compared to patients with
lower pain intensity scores at
one
hour.
Dzuveo should not be used beyond 48 hours.
_Elderly_
No specific dose adjustment is required in elderly patients. However,
elderly patients should be
observed closely for adverse reactions of sufentanil (see section
5.2).
_Hepatic or renal impairment_
Sufentanil should be administered with caution to patients with
moderate to severe hepatic or severe
renal impairment (see section 4.4).
_Paediatric population_
The safety and efficacy of sufentanil in children and adolescents
below 18 years have not been
established. No
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