Source: Medicines and Medical Devices Safety Authority (NZ) Revision Year: 2022 Publisher: Distributed on behalf of Mundipharma New Zealand Limited by: Pharmaco (N.Z.) Ltd, Fisher Crescent, Mt Wellington, Auckland 1060 Ph: (09) 377-3336 Toll Free [Medical Enquiries]: 0800 773 310
NORSPAN 5mg Patch.
NORSPAN 10mg Patch.
NORSPAN 20mg Patch.
| Pharmaceutical Form |
|---|
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NORSPAN patch is either rectangular (10 micrograms/hr) or square (5 and 20 micrograms/hr) beige coloured matrix patch with rounded corners, marked with the trade name and consisting of a protective liner and functional layers. Proceeding from the outer surface towards the surface adhering to the skin, the layers are (1) a beige-coloured web backing layer of polyester material; (2) an adhesive matrix rim without buprenorphine; (3) a separating layer (“foil”) consisting of polyethylene terephthalate over the adhesive matrix; (4) the buprenorphine-containing adhesive matrix; and (5) a release liner. Before use the release liner covering the adhesive layer is removed and discarded. Figure 1. Cross section drawing of NORSPAN patch: NORSPAN patch is available in three different strengths: 5 micrograms per hour, 10 micrograms per hour and 20 micrograms per hour. The composition of all three strengths is identical except for patch size. The proportion of buprenorphine in the adhesive matrix is the same in each strength (10% by weight). The amount of buprenorphine released from each system per hour is proportional to the surface area of the patch. The skin is the limiting barrier to diffusion from the system into the bloodstream. |
NORSPAN patch 5:
Each square patch releases buprenorphine 5 micrograms per hour over 7 days.
The area containing the active substance: 6.25 cm².
Total buprenorphine content: 5mg.
NORSPAN patch 10:
Each rectangular patch releases buprenorphine 10 micrograms per hour over 7 days.
The area containing the active substance: 12.5 cm².
Total buprenorphine content: 10mg.
NORSPAN patch 20:
Each square patch releases buprenorphine 20 micrograms per hour over 7 days.
The area containing the active substance: 25 cm².
Total buprenorphine content: 20mg.
For 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 |
|---|
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Inert ingredients: Levulinic acid |
NORSPAN patch is supplied a heat-sealed aluminium/anionic methacrylate laminate pouch. Each carton contains two individually packaged patches.
Distributed on behalf of Mundipharma New Zealand Limited by: Pharmaco (N.Z.) Ltd, Fisher Crescent, Mt Wellington, Auckland 1060
Ph: (09) 377-3336
Toll Free [Medical Enquiries]: 0800 773 310
Date of first approval: 16 November 2006
| Drug | Countries | |
|---|---|---|
| NORSPAN | Austria, Australia, Germany, Ecuador, Estonia, Finland, Hong Kong, Japan, Lithuania, New Zealand |
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