Durogesic DTrans 100 micrograms/hour Transdermal Patch

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Fentanyl

Saatavilla:

PCO Manufacturing Ltd.

ATC-koodi:

N02AB03

INN (Kansainvälinen yleisnimi):

Fentanyl

Annos:

100 micrograms/hour

Lääkemuoto:

Transdermal patch

Prescription tyyppi:

Product subject to prescription which may not be renewed (A)

Terapeuttinen alue:

fentanyl

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-07-25

Pakkausseloste

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DUROGESIC
® _DTRANS_™
12 MICROGRAMS /HOUR TRANSDERMAL PATCH
25 MICROGRAMS /HOUR TRANSDERMAL PATCH
50 MICROGRAMS /HOUR TRANSDERMAL PATCH
75 MICROGRAMS /HOUR TRANSDERMAL PATCH
100 MICROGRAMS /HOUR TRANSDERMAL PATCH
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, pharmacist or
nurse.
•
This medicine has been prescribed for you (or your child) 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 side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Durogesic DTrans
TM
is and what it is used for
2.
What you need to know before you use Durogesic DTrans
TM
3.
How to use Durogesic DTrans
TM
4.
Possible side effects
5.
How to store Durogesic DTrans
TM
6.
Contents of the pack and other information
1.
WHAT DUROGESIC DTRANS
TM IS AND WHAT IT IS USED FOR
The name of your medicine is Durogesic DTrans
TM
The patches help relieve pain that is very bad and long-lasting:
•
in adults who need continuous pain treatment
•
in children above 2 years of age who are already using opioid
medication and who need continuous pain treatment.
Durogesic DTrans
TM
contains a medicine called fentanyl. It belongs to
a group of strong painkillers called opioids.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE DUROGESIC DTRANS
TM
DO NOT USE DUROGESIC DTRANS
TM IF:
•
You are allergic to fentanyl or any of the other ingredients of this
medicine (listed in section 6)
•
You have pain which lasts only for a short period, such as
sudden pain or pain after having an operation
•
You have breathing difficulties, with slow or shallow breathing
Do not use this medicine if any of the above apply to you or your
child. If you are not

Valmisteyhteenveto

Health Products Regulatory Authority
15 January 2024
CRN00F172
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Durogesic DTrans 100 micrograms/hour Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Durogesic DTrans 100 patch contains fentanyl 16.8 mg.
Release rate of approximately 100 micrograms per hour; active surface
area 42.0 cm
2
.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
_Product imported from Italy, Poland and Greece_
Durogesic is a translucent, rectangular transdermal patch with rounded
corners, marked with the product name, strength and a
border in coloured ink.
The patch has a sticky back so that it can be stuck onto the skin.
Each patch is 42.0 cm
2
and is marked with a border and "Durogesic 100 µg fentanyl/h" in grey
printing ink.
4 CLINICAL PARTICULARS
As per PA22612/004/004
5 PHARMACOLOGICAL PROPERTIES
As per PA22612/004/004
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Polyacrylate adhesive
Polyethylene terephthalate/ethyl vinyl acetate film
Grey printing ink
Siliconised polyester film
6.2 INCOMPATIBILITIES
To prevent interference with the adhesive properties of Durogesic
DTrans, no creams, oils, lotions or powder should be applied
to the skin area when the Durogesic DTrans transdermal patch is
applied.
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
Health Products Regulatory Authority
15 January 2024
CRN00F172
Page 2 of 2
6.4 SPECIAL PRECAUTIONS FOR STORAGE
This medicinal product does not require any special temperature
storage conditions. Store in the original pouch in order to
protect from light.
6.5 NATURE AND CONTENTS OF CONTAINER
Each patch is packed in a heat-sealed pouch made of acrylonitrate
film, polyethylene terephthalate (PET), low density
polyethylene/aluminium foil and adhesive.
Pouches are packed into cardboard cartons (five pouches per carton).
6.6 SPECIAL P