Opiodur 25micrograms/hour transdermal patches

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Fentanyl

Beschikbaar vanaf:

Pfizer Ltd

ATC-code:

N02AB03

INN (Algemene Internationale Benaming):

Fentanyl

Dosering:

25microgram/1hour

farmaceutische vorm:

Transdermal patch

Toedieningsweg:

Transdermal

klasse:

Schedule 2 (CD)

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04070200; GTIN: 5013457011029

Productkenmerken

OPIODUR 25 MICROGRAMS/HOUR TRANSDERMAL PATCH
Summary of Product Characteristics Updated 03-Aug-2016 | Pfizer
Limited
1. Name of the medicinal product
Opiodur 25 micrograms/hour transdermal patch
2. Qualitative and quantitative composition
Each Opiodur 25 micrograms/ hour transdermal patch contains 2.75 mg of
fentanyl in a patch size of
10cm
2
, releasing 25 micrograms of fentanyl per hour.
Excipients(s) with known effect:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Transdermal Patch
Opiodur transdermal patch is a rectangular, tan coloured patch placed
between two oversized, transparent
protective layers which must be removed prior to the patch
application.
The patches will be imprinted:
“Fentanyl 25 μg/h“ in red ink
4. Clinical particulars
4.1 Therapeutic indications
ADULTS
This product is indicated in severe chronic pain which can be
adequately managed only with opioid
analgesics.
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
It is not possible to ensure the interchangeability of different
fentanyl containing transdermal patch
product in individual patients. Therefore, it should be emphasised
that patients should not be changed
from one fentanyl containing product to another without specific
counselling on the change from their
healthcare professionals.
Initial dose selection
The appropriate initiating dose of fentanyl should be based on the
patient's current opioid use. It is
recommended that fentanyl be used in patients who have demonstrated
opioid tolerance. Other factors to
be considered are the current general condition and medical status of
the patient, including body size, age,
and extent of debilitation as well as degree of opioid tolerance.
ADULTS
Opioid-tolerant patients
To convert opioid-tolerant patients from oral or parenteral opioids to
fentanyl refer to _Equianalgesic _
_potency conversion_ below. The dosage may subsequently be titrated
upwards or downwards, if