Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Buprenorphine
MUNDIPHARMA PHARMACEUTICALS SDN. BHD.
Buprenorphine
4sachet Sachets; 8sachet Sachets
LTS LOHMANN THERAPIE-SYSTEM AG
_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 Citiți documentul complet