Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, United Kingdom
Butec 5 microgram/hour transdermal patch.
Butec 10 microgram/hour transdermal patch.
Butec 20 microgram/hour transdermal patch.
| Pharmaceutical Form |
|---|
|
Transdermal patch. Beige coloured patch with rounded corners. Butec 5 microgram/hour is a square patch marked Butec 5 μg/h. Butec 10 microgram/hour is a rectangular patch marked Butec 10 μg/h. Butec 20 microgram/hour is a square patch marked Butec 20 μg/h. |
Each 5 microgram/hour transdermal patch contains 5 mg of buprenorphine in a 6.25 cm² area releasing a nominal 5 micrograms of buprenorphine per hour over a period of 7 days.
Each 10 microgram/hour transdermal patch contains 10 mg of buprenorphine in a 12.5 cm² area releasing a nominal 10 micrograms of buprenorphine per hour over a period of 7 days.
Each 20 microgram/hour transdermal patch contains 20 mg of buprenorphine in a 25 cm² area releasing a nominal 20 micrograms of buprenorphine per hour over a period of 7 days.
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] (Oleyl oleate) Adhesive matrix (without buprenorphine): Poly[acrylic acid-co-butylacrylate-co-(2-ethylhexyl) acrylate-co-vinylacetate] (5:15:75:5), not cross-linked (DuroTak 387-2051) 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) (to be removed before applying the patch): Poly(Ethyleneterephthalate) – foil, siliconised, coated on one side with aluminium |
Sealed child resistant sachet, composed of identical top and bottom layers of heat-sealable laminate, comprising (from outside to inside) paper, PET, polyethylene-based copolymer, aluminium and poly(acrylic acid-co-ethylene).
Pack Sizes: 1, 2, 3, 4, 5, 8, 10 and 12 transdermal patches.
Not all pack sizes may be marketed.
Qdem Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0AB, United Kingdom
PL 40431/0024
PL 40431/0025
PL 40431/0026
18/06/2015
| Drug | Countries | |
|---|---|---|
| BUTEC | United Kingdom |
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