Transtec 35micrograms/hour transdermal patches

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Buprenorphine

Dostępny od:

Grunenthal Ltd

Kod ATC:

N02AE01

INN (International Nazwa):

Buprenorphine

Dawkowanie:

35microgram/1hour

Forma farmaceutyczna:

Transdermal patch

Droga podania:

Transdermal

Klasa:

Schedule 3 (CD No Register)

Typ recepty:

Caution - AMP level prescribing advised

Podsumowanie produktu:

BNF: 04070200; GTIN: 5012854067080

Ulotka dla pacjenta

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
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 strong pain relievers (opioids);
-
if you suffer from a disease in which you have or may have great
difficulty breathing
-
if you are taking monoamine oxidase (MAO) inhibitors (certain
medicines used to treat depression) or
you have taken this type of medicine i

Charakterystyka produktu

OBJECT 1
TRANSTEC 35 MICROGRAMS TRANSDERMAL PATCH
Summary of Product Characteristics Updated 24-Apr-2015 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
TRANSTEC 35
®
micrograms/h transdermal patch
TRANSTEC 52.5
®
micrograms/h transdermal patch
TRANSTEC 70
®
micrograms/h transdermal patch
2. Qualitative and quantitative composition
TRANSTEC 35 micrograms/h transdermal patch:
One transdermal patch contains 20 mg buprenorphine.
Area containing the active substance: 25 cm
2
Nominal release rate: 35 micrograms of buprenorphine per hour (over a
period of 96 hours).
TRANSTEC 52.5 micrograms/h transdermal patch:
One transdermal patch contains 30 mg buprenorphine.
Area containing the active substance: 37.5 cm
2
Nominal release rate: 52.5 micrograms of buprenorphine per hour (over
a period of 96 hours).
TRANSTEC 70 micrograms/h transdermal patch:
One transdermal patch contains 40 mg buprenorphine.
Area containing the active substance: 50 cm
2
Nominal release rate: 70 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 35 µg/h, buprenorphinum 20 mg
TRANSTEC 52.5 µg/h, buprenorphinum 30 mg
TRANSTEC 70 µg/h, buprenorphinum 40 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