Transtec 35 micrograms/h Transdermal Patch

Land: Maleisië

Taal: Engels

Bron: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Werkstoffen:

Buprenorphine

Beschikbaar vanaf:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Algemene Internationale Benaming):

Buprenorphine

Eenheden in pakket:

8sachet Sachets; 4sachet Sachets

Geproduceerd door:

LTS LOHMANN THERAPIE-SYSTEM AG

Productkenmerken

_TRANSTEC®_ TRANSDERMAL PATCH
1.
NAME OF THE MEDICINAL PRODUCTS
_TRANSTEC®_
35 micrograms/h transdermal patch
_TRANSTEC®_
52.5 micrograms/h transdermal patch
_TRANSTEC®_
70 micrograms/h transdermal patch
2.
Q
UALITATIVE AND QUANTITATIVE COMPOSITION
_TRANSTEC®_
35 micrograms/h transdermal patch:
One transdermal patch contains 20 mg buprenorphine.
Area containing the active substance: 25 cm²
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 cm²
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 cm²
Nominal release rate: 70 micrograms of buprenorphine per hour (over a
period of 96 hours).
For a full list of excipients, see section 6.1.
3.
P
HARMACEUTICAL FORM
Transdermal patch
Skin coloured transdermal patch with rounded corners marked:
_TRANSTEC®_
35 µg/h, buprenorphine 20 mg
_TRANSTEC®_
52.5 µg/h, buprenorphine 30 mg
_TRANSTEC®_
70 µg/h, buprenorphine 40 mg
4.
C
LINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Moderate to severe cancer pain and severe pain which does not respond
to non-opioid analge-
sics.
_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®_
Transdermal Patch 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®_
Transdermal Patch 35 micrograms/h,
_TRANSTEC®_
Trans-
dermal Patch 52.5 micrograms/h and
_TRANSTEC®_
Transdermal Patch 70 micrograms/h.
_Initial dose selection_
: patien