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RELETRANS Transdermal patch (2021)

Active ingredients: Buprenorphine

Product Name and Form

Reletrans 5 microgram/hour transdermal patch.

Pharmaceutical form

Transdermal patch.

The product is composed of a drug containing transdermal patch integrated with an oversized pale yellowish-brown cover patch without any active substance. The shape of the transdermal patch is rectangular with rounded edges. The transdermal patch contains the following imprint:

'Buprenorphinum 5 µg/h'

Qualitative and Quantitative Composition

Each transdermal patch contains 5 mg of buprenorphine per 6.25 cm², releasing 5 micrograms of buprenorphine per hour.

For the full list of excipients, see section 6.1.

Chemical substance
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

Release liner (to be removed before applying the patch):

Poly (ethylene terephthalate) foil, siliconized

Adhesive matrix (containing buprenorphine):

Levulinic acid
Oleyl oleate
Povidone K90
Poly [acrylic acid-co-butylacrylate-co-(2-ethylhexyl)acrylate-co-vinylacetate] (5:15:75:5)

Separating film (between the adhesive matrices with and without buprenorphine):

Poly (ethylene terephthalate) foil

Adhesive matrix (without buprenorphine):

Acrylate adhesive

Backing layer (printed):

Polyurethane backing foil
Printing ink

Pack sizes and Marketing

Each transdermal patch is individually packed in a child resistant sachet made of PET/Alu/PE.

Carton containing 1, 2, 3, 4, 5, 8, 10, 12 or 20 transdermal patches.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom

Date of first authorisation: 10 February 2016
Last renewal date: 10 November 2020

Marketing authorization number:

PL 04416/1406