Ionsys
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
06-11-2018
Valmisteyhteenveto
(SPC)
06-11-2018
Julkisesta arviointikertomuksesta
(PAR)
06-11-2018
Aktiivinen ainesosa:
fentanyl hydrochloride
Saatavilla:
Incline Therapeutics Europe Ltd
ATC-koodi:
N02AB03
INN (Kansainvälinen yleisnimi):
fentanyl
Terapeuttinen ryhmä:
Analgesics
Terapeuttinen alue:
Pain, Postoperative
Käyttöaiheet:
Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
Tuoteyhteenveto:
Revision: 2
Valtuutuksen tilan:
Withdrawn
Valtuutus päivämäärä:
2015-11-18
Pakkausseloste
28
B. PACKAGE LEAFLET
Medicinal product no longer authorised
29
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IONSYS 40 MICROGRAMS PER DOSE TRANSDERMAL SYSTEM
FENTANYL
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, please ask your doctor or your
nurse.
•
This medicine 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 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 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.
Contents of the pack and other information
1.
WHAT IONSYS IS AND WHAT IT IS USED FOR
What IONSYS is
IONSYS is a transdermal system (to be applied on intact skin) that
contains a strong analgesic (pain
reliever) medicine called fentanyl.
What IONSYS is used for
IONSYS is used to treat short-term moderate to severe pain in adults
after an operation. IONSYS is
used in hospital only.
How IONSYS works
IONSYS is a small device applied to the skin of your upper arm or
chest. It works by delivering
fentanyl through your skin to relieve your pain.
You must talk to a doctor if you do not feel better or if you feel
worse.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE IONSYS
DO NOT USE IONSYS:
•
if you are allergic
(hypersensitive)
_ _
to fentanyl, or any of the other ingredients of IONSYS (listed
in section 6).
•
if you suffer from severe breathing problems or cystic fibrosis.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before using IONSYS if:
•
you have a severe or persistent lung disease, or any breathing
problems
•
you have a very slow heart rate, low blood pressure, or other serious
heart problem
•
you have problems with your liver or kidneys
•
you ha
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
IONSYS 40 micrograms per dose transdermal system
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each IONSYS system contains fentanyl hydrochloride equivalent to 9.7
mg of fentanyl and delivers
40 micrograms fentanyl per dose, to a maximum of 80 doses (3.2 mg/24
hours).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Transdermal system
IONSYS is composed of an electronic controller and a drug unit with
two hydrogels. The controller is
white with the identifier ‘IONSYS
®’
and has
a digital display, a light window, and a recessed dose
activation button. The drug unit is blue on the side that connects to
the controller and has a red bottom
housing containing the hydrogels, one of which contains the fentanyl.
The assembled IONSYS
product measures 47 mm x 75 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IONSYS is indicated for the management of acute moderate to severe
post-operative pain in adult
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
IONSYS is restricted to hospital use only. Treatment should be
initiated by and remain under the
guidance of a physician experienced in the management of opioid
therapy. Due to the well-known
potential of abuse of fentanyl, physicians should evaluate patients
for a history of drug abuse (see
section 4.4).
Posology
Patients should be titrated to an acceptable level of analgesia prior
to initiating use of IONSYS (see
section 5.1).
IONSYS should only be activated by the patient.
Each dose of IONSYS delivers 40 micrograms of fentanyl over a 10
minute period, to a maximum of
240 micrograms per hour (6 doses each of 10 minutes duration). IONSYS
will operate for 24 hours
after the system is assembled or for 80 doses, whichever comes first,
and then becomes inoperative.
After 24 hours or 80 doses, a new system should be applied if
necessary. Each new system should be
placed on a new skin site. With each new IONSYS application
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