MATRIFEN Transdermal patch Ref.[7247] Active ingredients: Fentanyl

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF

Product name and form

Matrifen, 12 micrograms/hour Transdermal patch.
Matrifen, 25 micrograms/hour Transdermal patch.
Matrifen, 50 micrograms/hour Transdermal patch.
Matrifen, 75 micrograms/hour Transdermal patch.
Matrifen, 100 micrograms/hour Transdermal patch.

Pharmaceutical Form

Transdermal patch.

Rectangular, translucent patch on a removable protective film. The protective film is larger than the patch.

Patches are marked with a coloured imprint stating the trade name and strength:

Matrifen 12 micrograms/hour patch: brown imprint.
Matrifen 25 micrograms/hour patch: red imprint.
Matrifen 50 micrograms/hour patch: green imprint.
Matrifen 75 micrograms/hour patch: light blue imprint.
Matrifen 100 micrograms/hour patch: grey imprint.

Qualitative and quantitative composition

Matrifen 12 micrograms/hour: Each transdermal patch contains 1.38 mg fentanyl in a patch of 4.2 cm² and releases fentanyl 12 micrograms/hour.

Matrifen 25 micrograms/hour: Each transdermal patch contains 2.75 mg fentanyl in a patch of 8.4 cm² and releases fentanyl 25 micrograms/hour.

Matrifen 50 micrograms/hour: Each transdermal patch contains 5.50 mg fentanyl in a patch of 16.8 cm² and releases fentanyl 50 micrograms/hour.

Matrifen 75 micrograms/hour: Each transdermal patch contains 8.25 mg fentanyl in a patch of 25.2 cm² and releases fentanyl 75 micrograms/hour.

Matrifen 100 micrograms/hour: Each transdermal patch contains 11.0 mg fentanyl in a patch of 33.6 cm² and releases fentanyl 100 micrograms/hour.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fentanyl

Fentanyl is a potent µ-opioid analgesic with rapid onset of analgesia and short duration of action. Its primary therapeutic actions are analgesia and sedation and is approximately 100-fold more potent than morphine as an analgesic. Secondary effects of fentanyl on central nervous system (CNS), respiratory and gastro-intestinal function are typical of opioid analgesics and are considered to be class effects.

List of Excipients

Dipropylene glycol
Hydroxypropyl cellulose
Dimeticone
Silicone adhesives (amine resistant)
Release membrane, ethylenvinylacetate (EVA)
Backing film, polyethylene terephthalate film (PET)
Removable protective film, fluoropolymercoated polyester film
Printing ink

Pack sizes and marketing

Each patch is packed in a heat-sealed sachet made of paper, aluminium and acrylonitrile-methyl acrylate-butadiene (AMAB) or made of paper, aluminium, polyethylene terephthalate (PET), polyethylene (PE) and cyclic olefin copolymer (LAS Pol A).

Pack sizes: 1, 2, 3, 4, 5, 8, 10, 16, and 20 patches.

Not all pack sizes may be marketed.

Marketing authorization holder

Takeda UK Limited, Building 3, Glory Park, Glory Park Avenue, Wooburn Green, BUCKS, HP10 0DF

Marketing authorization dates and numbers

12 microgram/hour: PL 16189/0014
25 microgram/hour: PL 16189/0015
50 microgram/hour: PL 16189/0016
75 microgram/hour: PL 16189/0017
100 microgram/hour: PL 16189/0018

16.09.2005 / 16.09.2010

Drugs

Drug Countries
MATRIFEN Austria, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Lithuania, Malta, Poland, United Kingdom

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