Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany
TRANSTEC 35 micrograms/h transdermal patch.
TRANSTEC 52.5 micrograms/h transdermal patch.
TRANSTEC 70 micrograms/h transdermal patch.
| 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. |
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).
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).
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 the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Buprenorphine |
Buprenorphine is an opioid partial agonist/antagonist which attaches itself to the μ (mu) and κ (kappa) receptors of the brain. Its activity in opioid maintenance treatment is attributed to its slowly reversible link with the μ receptors which, over a prolonged period, minimises the need of illicit opioids for patients with opioid dependence. |
| List of Excipients |
|---|
|
Adhesive matrix (containing buprenorphine): [(Z)-octadec-9-en-1-yl] oleate, povidone K90, 4-oxopentanic acid, poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), cross-linked Adhesive matrix (without buprenorphine): poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5), not cross-linked Separating foil between the adhesive matrices with and without buprenorphine: poly(ethyleneterephthalate) - foil Backing layer: poly(ethyleneterephthalate) – tissue Release liner (on the front covering the adhesive matrix containing buprenorphine): poly(ethyleneterephthalate) – foil, siliconised, coated on one side with aluminium |
Type of container:
Sealed child-resistant sachet, composed of identical top and bottom layers of heat-sealable laminate, comprising (from outside to inside) paper, polyethylene terephthalate, polyethylene, aluminium and poly (acrylic acid-co-ethylene) (= surlyn).
Pack sizes:
Packs containing 3, 4, 5, 6, 8, 10, 11, 12, 16, 18, 20 or 24 individually sealed transdermal patches.
Not all pack sizes may be marketed.
Grünenthal GmbH, Zieglerstrasse 6, 52078 Aachen, Germany
PL 04539/0014
PL 04539/0015
PL 04539/0016
Date of first authorisation: 27 February 2002
Date of first renewal: 10 August 2006
| Drug | Countries | |
|---|---|---|
| TRANSTEC | Austria, Brazil, Germany, Ecuador, Spain, Croatia, Ireland, Mexico, Netherlands, Poland, United Kingdom |
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