Zalviso
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
27-09-2022
Fachinformation
(SPC)
27-09-2022
Öffentlichen Beurteilungsberichts
(PAR)
27-09-2022
Wirkstoff:
sufentanil
Verfügbar ab:
FGK Representative Service GmbH
ATC-Code:
N01AH03
INN (Internationale Bezeichnung):
sufentanil
Therapiegruppe:
Anesthetics
Therapiebereich:
Pain, Postoperative
Anwendungsgebiete:
Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.,
Produktbesonderheiten:
Revision: 7
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2015-09-18
Gebrauchsinformation
30
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZALVISO 15 MICROGRAMS SUBLINGUAL TABLETS
sufentanil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Zalviso is and what it is used for
2.
What you need to know before you take Zalviso
3.
How to take Zalviso
4.
Possible side effects
5.
How to store Zalviso
6.
Contents of the pack and other information
1.
WHAT ZALVISO IS AND WHAT IT IS USED FOR
The active substance of Zalviso is sufentanil, which belongs to a
group of strong pain-relieving
medicines called opioids.
Zalviso is used to treat acute moderate to severe pain after an
operation in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZALVISO
DO NOT TAKE ZALVISO:
-
if you are allergic to sufentanil or any of the other ingredients of
this medicine (listed in section
6).
-
if you have severe breathing problems.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before taking Zalviso.
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 Zalviso 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 heart beats, low
blood volume or low blood pressure;
-
have moderate to severe liver or severe kidney problems, as these
organs have an effect on the
way in which your body breaks down and eliminates the medicine;
-
have a history of medicine or alcohol abuse;
-
are regularly using a prescribed opioid medicine (e.g. codeine,
fe
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Zalviso 15 micrograms sublingual tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sublingual tablet contains 15 micrograms sufentanil (as citrate).
Excipient(s) with known effect
Each sublingual tablet contains 0.074 mg sunset yellow FCF Aluminium
Lake (E110).
Each sublingual tablet contains 0.013 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Sublingual tablet.
Zalviso sublingual tablets of 3 mm diameter are orange-coloured
flat-faced tablets with rounded edges.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zalviso is indicated for the management of acute moderate to severe
post-operative pain in adult
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Zalviso is to be administered in a hospital setting only. Zalviso
should only be prescribed by
physicians who are experienced in the management of opioid therapy,
particularly opioid adverse
reactions such as respiratory depression (see section 4.4).
Posology
Zalviso sublingual tablets are to be self-administered by the patient
in response to pain using the
Zalviso administration device. The Zalviso administration device is
designed to deliver a single
sufentanil 15 micrograms sublingual tablet, on a patient-controlled as
needed basis, with a minimum
of 20 minutes (lockout interval) between doses, over a period of up to
72 hours, which is the
maximum recommended treatment duration. See section “Method of
administration”.
_Elderly _
No special population studies were performed using sufentanil
sublingual tablets in elderly patients. In
clinical trials approximately 30 % of enrolled patients were 65 to 75
years of age. The safety and
efficacy in elderly patients was similar to that observed in younger
adults (see section 5.2).
_Hepatic or renal impairment _
Medicinal Product no longer authorised
3
No special population studies were performed using sufentanil
sublingual tablets in hepatic and re
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