Transtec 52.5 micrograms/h Transdermal Patch

Land: Irland

Språk: engelska

Källa: HPRA (Health Products Regulatory Authority)

Aktiva substanser:

Buprenorphine

Tillgänglig från:

Grünenthal GmbH

ATC-kod:

N02AE; N02AE01

INN (International namn):

Buprenorphine

Dos:

52.5 micrograms/hour

Läkemedelsform:

Transdermal patch

Receptbelagda typ:

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

Terapiområde:

Oripavine derivatives; buprenorphine

Bemyndigande status:

Marketed

Tillstånd datum:

2002-05-03

Bipacksedel

TRANSTEC
® 35 ΜG/H / 52.5 ΜG/H / 70 ΜG/H
TRANSDERMAL PATCH
April 2021
DE/H/0307/001-003
IE Patient information leaflet
- 1 -
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRANSTEC
® 35 MICROGRAMS/H / 52.5 MICROGRAMS/H / 70 MICROGRAMS/H TRANSDERMAL
PATCH
Buprenorphine
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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Transtec is and what it is used for
2.
What you need to know before you use Transtec
3.
How to use Transtec
4.
Possible side effects
5.
How to store Transtec
6.
Further information
TRANSTEC
® 35 ΜG/H / 52.5 ΜG/H / 70 ΜG/H
TRANSDERMAL PATCH
April 2021
DE/H/0307/001-003
IE Patient information leaflet
- 2 -
1.
WHAT TRANSTEC IS AND WHAT IT IS USED FOR
Transtec is an analgesic (a pain-relieving medicine) intended to
relieve moderate to severe cancer pain and
severe pain that has not responded to other types of painkillers.
Transtec acts through the skin. When the
transdermal patch is applied to the skin, the active substance
buprenorphine passes through the skin into the
blood. Buprenorphine is an opioid (strong pain reliever), which
reduces pain by acting on the central nervous
system (specific nerve cells in the spinal cord and in the brain). The
effect of the transdermal patch lasts for
up to four days. Transtec is not suitable for the treatment of acute
(short-lasting) pain.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE TRANSTEC
DO NOT USE TRANSTEC,
-
if you are allergic to buprenorphine or any of the other ingredients
of this medicine (listed in section
6);
-
if you are dependent on stro

Produktens egenskaper

Health Products Regulatory Authority
27 January 2022
CRN00CG72
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Transtec 52.5 micrograms/h Transdermal Patch
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One transdermal patch contains 30 mg buprenorphine.
Area containing the active substance: 37.5 cm²
Nominal release rate: 52.5 micrograms of buprenorphine per hour (over
a period of 96 hours).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Transdermal patch.
Skin coloured transdermal patch with rounded corners marked:
Transtec 52.5 µg/h, buprenorphinum 30 mg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Moderate to severe cancer pain and severe pain which does not respond
to non-opioid analgesics.
Transtec is not suitable for the treatment of acute pain.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Patients over 18 years of age_
The Transtec
®
dosage should be adapted to the condition of the individual patient
(pain intensity, suffering, individual
reaction). The lowest possible dosage providing adequate pain relief
should be given. Three transdermal patch strengths are
available to provide such adaptive treatment: Transtec
®
35 micrograms/h, Transtec
®
52.5 micrograms/h and Transtec
®
70
micrograms/h.
_Initial dose selection_: patients who have previously not received
any analgesics should start with the lowest transdermal patch
strength (Transtec
®
35 micrograms/h). Patients previously given a WHO step-I analgesic
(non-opioid) or a step-II analgesic
(weak opioid) should also begin with Transtec
®
35 micrograms/h. According to the WHO recommendations, the
administration
of a non-opioid analgesic can be continued, depending on the patient's
overall medical condition.
When switching from a step-III analgesic (strong opioid) to Transtec
®
and choosing the initial transdermal patch strength, the
nature of the previous medication, administration and the mean daily
dose should be taken into account in order to avoid the
recurrence of pain. In gener