Instanyl
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
19-10-2023
Valmisteyhteenveto
(SPC)
19-10-2023
Julkisesta arviointikertomuksesta
(PAR)
23-07-2019
Aktiivinen ainesosa:
Fentanyl citrate
Saatavilla:
Takeda Pharma A/S
ATC-koodi:
N02AB03
INN (Kansainvälinen yleisnimi):
fentanyl
Terapeuttinen ryhmä:
Analgesics
Terapeuttinen alue:
Pain; Cancer
Käyttöaiheet:
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Tuoteyhteenveto:
Revision: 36
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2009-07-20
Pakkausseloste
89
B. PACKAGE LEAFLET
90
PACKAGE LEAFLET: INFORMATION FOR THE USER
INSTANYL 50 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION
INSTANYL 100 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION
INSTANYL 200 MICROGRAMS/DOSE NASAL SPRAY, SOLUTION
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, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Instanyl is and what it is used for
2.
What you need to know before you use Instanyl
3.
How to use Instanyl
4.
Possible side effects
5.
How to store Instanyl
6.
Contents of the pack and other information
1.
WHAT INSTANYL IS AND WHAT IT IS USED FOR
Instanyl contains the active substance fentanyl and belongs to a group
of strong painkillers called
opioids. Opioids act by blocking the pain signals to the brain.
Instanyl acts rapidly and is used for relieving breakthrough pain in
adult cancer patients already treated
with opioids for their usual pain. Breakthrough pain is an additional
sudden pain that occurs despite
you having taken your usual opioid pain relieving medicines.
2.
WHAT
YOU NEED TO KNOW BEFORE YOU USE INSTANYL
DO NOT USE INSTANYL
-
if you are allergic to fentanyl or any of the other ingredients of
this medicine (listed in
section 6).
-
if you are not regularly using a prescribed opioid medicine (e.g
codeine, fentanyl,
hydromorphone, morphine, oxycodone, pethidine), every day on a regular
schedule, for at least
a week, to control your persistent pain. If you have not been using
these medicines you must not
use Instanyl, because it may increase the risk that breathing could
become dangerously slow
and/or shall
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Instanyl 50 micrograms/dose nasal spray, solution
Instanyl 100 micrograms/dose nasal spray, solution
Instanyl 200 micrograms/dose nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Instanyl 50 micrograms/dose nasal spray, solution
Each ml of solution contains fentanyl citrate equivalent to 500
micrograms fentanyl.
1 dose (100 microlitres) contains 50 micrograms fentanyl.
Instanyl 100 micrograms/dose nasal spray, solution
Each ml of solution contains fentanyl citrate equivalent to 1,000
micrograms fentanyl.
1 dose (100 microlitres) contains 100 micrograms fentanyl.
Instanyl 200 micrograms/dose nasal spray, solution
Each ml of solution contains fentanyl citrate equivalent to 2,000
micrograms fentanyl.
1 dose (100 microlitres) contains 200 micrograms fentanyl.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution (nasal spray)
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Instanyl is indicated for the management of breakthrough pain in
adults already receiving maintenance
opioid therapy for chronic cancer pain. Breakthrough pain is a
transitory exacerbation of pain that
occurs on a background of otherwise controlled persistent pain.
Patients receiving maintenance opioid therapy are those who are taking
at least 60 mg of oral
morphine daily, at least 25 micrograms of transdermal fentanyl per
hour, at least 30 mg oxycodone
daily, at least 8 mg of oral hydromorphone daily or an equianalgesic
dose of another opioid for a week
or longer.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated by and remain under the supervision of a
physician experienced in the
management of opioid therapy in cancer patients. Physicians should
keep in mind the potential of
abuse, misuse, addiction and overdose of fentanyl (see section 4.4).
Posology
Patients should be individually titrated to a dose that provides
adequate analgesia with tolerable
adverse
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