Instanyl 100microgramsdose nasal spray

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Fentanyl citrate

Beschikbaar vanaf:

Takeda UK Ltd

ATC-code:

N02AB03

INN (Algemene Internationale Benaming):

Fentanyl citrate

Dosering:

100microgram/1dose

farmaceutische vorm:

Spray

Toedieningsweg:

Nasal

klasse:

Schedule 2 (CD)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04070200; GTIN: 7038319035010 7038319035027 5060065110316

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
INSTANYL 50 MICROGRAMS NASAL SPRAY, SOLUTION IN SINGLE-DOSE CONTAINER
INSTANYL 100 MICROGRAMS NASAL SPRAY, SOLUTION IN SINGLE-DOSE CONTAINER
INSTANYL 200 MICROGRAMS NASAL SPRAY, SOLUTION IN SINGLE-DOSE CONTAINER
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 very fast 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 hypersensitive (allergic) to fentanyl or any of the other
ingredients of Instanyl;
-
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 da

Productkenmerken

OBJECT 1
INSTANYL 50 MCG NASAL SPRAY, SOLUTION IN SINGLE-
DOSE CONTAINER
Summary of Product Characteristics Updated 25-May-2018 | Takeda UK Ltd
1. Name of the medicinal product
Instanyl 50 micrograms nasal spray, solution in single-dose container
Instanyl 100 micrograms nasal spray, solution in single-dose container
Instanyl 200 micrograms nasal spray, solution in single-dose container
2. Qualitative and quantitative composition
Instanyl 50 micrograms nasal spray, solution in single-dose container
Each single-dose container contains one dose (100 microlitres) of
fentanyl citrate equivalent to 50
micrograms fentanyl.
Instanyl 100 micrograms nasal spray, solution in single-dose container
Each single-dose container contains one dose (100 microlitres) of
fentanyl citrate equivalent to 100
micrograms fentanyl.
Instanyl 200 micrograms nasal spray, solution in single-dose container
Each single-dose container contains one dose (100 microlitres) of
fentanyl citrate equivalent to 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
of fentanyl.
Posology
Patients s