Ionsys
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
17-05-2018
Fachinformation
(SPC)
17-05-2018
Öffentlichen Beurteilungsberichts
(PAR)
28-01-2011
Wirkstoff:
fentanyl hydrochloride
Verfügbar ab:
Janssen-Cilag International NV
ATC-Code:
N02AB03
INN (Internationale Bezeichnung):
fentanyl
Therapiegruppe:
Analgesics
Therapiebereich:
Pain, Postoperative
Anwendungsgebiete:
Management of acute moderate to severe post-operative pain for use in a hospital setting only
Produktbesonderheiten:
Revision: 3
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2006-01-24
Gebrauchsinformation
Medicinal product no longer authorised
B.
PACKAGE LEAFLET
22
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
IONSYS 40 MICROGRAMS PER DOSE IONTOPHORETIC TRANSDERMAL SYSTEM
fentanyl
Read all of this leaflet carefully before you start using this
medicine.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask your doctor or your
nurse.
-
This product has been prescribed for you. Do not pass it on to others.
It may harm them, even if
their symptoms are the same as yours.
-
If any of the side-effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or nurse.
IN THIS LEAFLET:
1.
What IONSYS is and what it is used for
2.
Before you use IONSYS
3.
How to use IONSYS
4.
Possible side effects
5.
How to store IONSYS
6.
Further Information
1.
WHAT IONSYS IS AND WHAT IT IS USED FOR
IONSYS is a system that you can operate to control your pain.
IONSYS IS USED IN HOSPITAL ONLY
, to treat pain after an operation. You control your own treatment,
under the guidance of medical staff.
2.
BEFORE YOU USE IONSYS
DO NOT USE IONSYS:
-
IF YOU ARE ALLERGIC
_(hypersensitive) _
to fentanyl, adhesive bandages or tapes, or any of the
ingredients listed below.
TAKE SPECIAL CARE WITH IONSYS
Tell your doctor or nurse
-
If you already have problems with your lungs or trouble breathing
-
If you have problems with your heart, liver or kidneys
-
If you get headaches or have had a head injury
-
If you have any difficulty hearing
-
If you have abnormally slow bowel movements
TAKING OTHER MEDICINES
Some medicines can affect the way IONSYS works, or make it more likely
that you’ll have side
effects.
CHECK WITH YOUR DOCTOR
if you’re taking:
-
any medicine which makes you sleepy or drowsy (such as other
morphine-related painkillers,
antihistamines or tranquillisers)
-
muscle relaxants (these may be prescribed for back pain)
-
ritonavir or other CYP3A4 inhibitors (medicines that help control HIV
infection)
-
antidepressants call
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Fachinformation
Medicinal product no longer authorised
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
IONSYS 40 micrograms per dose iontophoretic transdermal system.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IONSYS system contains 10.8 mg fentanyl hydrochloride equivalent
to 9.7 mg of fentanyl and
delivers 40 micrograms fentanyl per dose, to a maximum of 3.2 mg (80
doses).
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Iontophoretic transdermal system (ITS).
IONSYS is composed of a compact electronic controller and two hydrogel
reservoirs, one of which
contains fentanyl hydrochloride in a gel formulation for needle free,
on-demand delivery. The upper
part of the product is white and contains the identifier ‘IONSYS
™
’.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
IONSYS is indicated for the management of acute moderate to severe
post-operative pain for use in a
hospital setting only.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
IONSYS should be restricted to hospital use only. Due to the well
known potential of abuse of
fentanyl physicians should evaluate patients for a history of drug
abuse (see section 4.4).
Special precautions for disposal should be followed (see section 6.6).
IONSYS should only be activated by the patient.
Before any surgery, the healthcare professional should ensure that the
patient has been properly
informed on how to use IONSYS post-operatively.
IONSYS delivers 40 micrograms per on-demand dose up to a maximum of
240 micrograms (6 doses
each of 10 minutes duration) per hour but not more than a maximum of
80 doses within a 24 hour
period. Patients should be titrated to an acceptable level of
analgesia prior to initiating use of IONSYS.
_ _
The system should only be activated by the patient in response to
pain. IONSYS will operate for 24
hours following completion of the first dose or for 80 doses,
whichever comes first, and then becomes
inoperative. If the patient attempts to initiate a dose
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