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SPC, UK: MATRIFEN Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

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, ...

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 ...

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: ...

Therapeutic indications

Adults Matrifen is indicated for management of severe chronic pain that requires continuous long term opioid administration. Children Long term management of severe chronic pain in children from 2 years ...

Posology and method of administration

Posology Matrifen doses should be individualised based upon the status of the patient and should be assessed at regular intervals after application. The lowest effective dose should be used. The patches ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Acute or postoperative pain because there is no opportunity for dose titration during short-term use and because ...

Special warnings and precautions for use

Patients who have experienced serious adverse events should be monitored for at least 24 hours after removal of Matrifen, or more, as clinical symptoms dictate, because serum fentanyl concentrations decline ...

Interaction with other medicinal products and other forms of interaction

Pharmacodynamic-related interactions Centrally-acting medicinal products and alcohol The concomitant use of other central nervous system depressants, (including opioids, sedatives such as benzodiazepines ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of Matrifen in pregnant women. Studies in animals have shown some reproductive toxicity (see section 5.3). The potential risk for humans is unknown, although ...

Effects on ability to drive and use machines

Matrifen may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving or operating machinery. This medicine can impair cognitive function and can ...

Undesirable effects

The safety of transdermal fentanyl was evaluated in 1565 adult and 289 paediatric subjects who participated in 11 clinical trials (1 double-blind, placebo-controlled; 7 open-label, active-controlled; 3 ...

Overdose

Symptoms and signs The manifestations of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression. Treatment For management of respiratory ...

Pharmacodynamic properties

Pharmacotherapeutic group: Analgesics, Opioids, phenylpiperidine derivatives ATC code: N02AB03 Mechanism of action Fentanyl is an opioid analgesic, interacting predominantly with the μ opioid receptor. ...

Pharmacokinetic properties

Absorption The fentanyl transdermal patch provides continuous systemic delivery of fentanyl during the 72-hour application period. Following patch application, the skin under the system absorbs fentanyl, ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. Standard reproductive and developmental toxicity studies have been carried out using parenteral ...

List of excipients

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

Incompatibilities

To prevent interference with the adhesive properties of Matrifen, no creams, oils, lotions or powder should be applied to the skin area when the Matrifen patch is applied.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

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) ...

Special precautions for disposal and other handling

Instructions for disposal: Used patches should be folded so that the adhesive side of the patch adheres to itself and then they should be safely discarded. Any unused medicinal product or waste material ...

Marketing authorization holder

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

Marketing authorization number(s)

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

Date of first authorization / renewal of the authorization

16.09.2005 / 16.09.2010

Date of revision of the text

01.02.2019

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