Durogesic DTrans 12 mcg/hr Transdermal Patch
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
Fentanyl
Available from:
Janssen-Cilag Ltd
ATC code:
N02A B03
INN (International Name):
Fentanyl
Dosage:
2.1 mg
Pharmaceutical form:
Transdermal patch
Administration route:
Transdermal use
Units in package:
Five pouches
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
Janssen Pharmaceutica NV
Therapeutic group:
Phenylpiperidine derivatives
Therapeutic indications:
In Adults: is indicated in the management of chronic intractable pain due to cancer; in the management of chronic intractable pain In Children:is indicated in long term management of severe chronic pain in children receiving opioid therapy from 2 years of age.
Authorization status:
Authorised
Authorization date:
2005-10-28
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
DUROGESIC
®
_DTRANS_
®
TRANSDERMAL PATCH
FENTANYL
Durogesic and DTrans are registered trademarks
IMPORTANT THINGS YOU NEED
TO KNOW ABOUT DUROGESIC DTRANS TRANSDERMAL
PATCHES
• These patches contain a strong pain killer
• Ensure that old patches are
removed before applying a new one
• Patches must not be cut
• Do not expose the patches to a heat source (such as a
hot water bottle)
• If you develop a fever tell your doctor immediately
• Follow the dosage instructions carefully and only change
your patch every
3 DAYS (72 HOURS)
• If your breathing becomes shallow and weak take
the patch off and seek
medical help
THE REST OF THIS LEAFLET INCLUDES
MORE DETAIL AND OTHER IMPORTANT
INFORMATION ON THE SAFE AND EFFECTIVE USE OF THIS MEDICINE.
• Keep this leaflet. You may need to read it again
• If you have
any further questions, ask your doctor, nurse or pharmacist
• 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 side effects and
they become serious or if you notice any side
effects not listed in this leaflet, please
tell your doctor, nurse or pharmacist
IN THIS LEAFLET
1. What Durogesic DTrans patches are and what they are used for
2. Before you use Durogesic DTrans patches
3. How to use Durogesic DTrans patches
4. Possible side effects
5. How to store Durogesic DTrans patches
6. Further information
1. WHAT DUROGESIC DTRANS PATCHES ARE AND WHAT THEY ARE USED
FOR
The name
of your medicine is Durogesic DTrans transdermal patch. It is called
‘Durogesic DTrans patch’ or just ‘patch’ in this leaflet.
The patches help relieve pain
Read the complete document
Summary of Product characteristics
Durogesic DTrans 12 mcg/hr Transdermal Patch
Summary of Product Characteristics Updated 23Jul2015 | JanssenCilag Ltd
1. Name of the medicinal product
Durogesic
®
DTrans
®
12 mcg/hr Transdermal Patch
2. Qualitative and quantitative composition
Each Durogesic DTrans 12 patch contains fentanyl 2.1 mg.
Release rate approximately 12 µg/h; active surface area 5.25 cm
2
.
For excipients, see 6.1
3. Pharmaceutical form
Transdermal patch.
Each patch is marked:
Durogesic
12 µg fentanyl/h
Orange printing ink
4. Clinical particulars
4.1 Therapeutic indications
Adults:
Durogesic DTrans is indicated
in the management of chronic intractable pain due to cancer
in the management of chronic intractable pain
Children:
long term management of severe chronic pain in children receiving opioid therapy from 2 years of age.
4.2 Posology and method of administration
For transdermal use.
Durogesic DTrans should be applied to nonirritated and nonirradiated skin on a flat surface of the torso or upper arm. In
young children, the upper back is the preferred location to apply the patch, to minimise the potential of the child
removing the patch. A nonhairy area should be selected. If this is not possible, hair at the application site should be
clipped (not shaved) prior to application. If the site of Durogesic DTrans application requires to be cleansed prior to
application of the patch, this should be done with water. Soaps, oils, lotions or any other agent that might irritate the
skin or alter its characteristics should not be used. The skin should be completely dry before the patch is applied.
Patches should be inspected prior to use. Patches that are cut, divided, or damaged in any way should not be used.
The Durogesic DTrans patch should be removed from the protective
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