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SPC: NEUPRO 1mg/24h, 3mg/24h Transdermal patch (2019)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Neupro 1 mg/24 h transdermal patch. Neupro 3 mg/24 h transdermal patch.

Qualitative and quantitative composition

Neupro 1 mg/24 h transdermal patch: Each patch releases 1 mg of rotigotine per 24 hours. Each patch of 5 cm 2 contains 2.25 mg of rotigotine. Neupro 3 mg/24 h transdermal patch: Each patch releases 3 mg ...

Pharmaceutical form

Transdermal patch. Thin, matrix-type, square-shaped with rounded edges, consisting of three layers. Neupro 1 mg/24 h transdermal patch: The outside of the backing layer is tan-coloured and imprinted with ...

Therapeutic indications

Neupro is indicated for the symptomatic treatment of moderate to severe idiopathic Restless Legs. Syndrome (RLS) in adults.

Posology and method of administration

Posology The dose recommendations made are in nominal dose. A single daily dose should be initiated at 1 mg/24 h. Depending on the individual patient response, the dose may be increased in weekly increments ...

Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Magnetic resonance imaging or cardioversion (see section 4.4).

Special warnings and precautions for use

Magnetic resonance imaging and cardioversion The backing layer of Neupro contains aluminium. To avoid skin burns, Neupro should be removed if the patient has to undergo magnetic resonance imaging (MRI) ...

Interaction with other medicinal products and other forms of interaction

Because rotigotine is a dopamine agonist, it is assumed that dopamine antagonists, such as neuroleptics (e.g. phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness ...

Fertility, pregnancy and lactation

Women of childbearing potential, contraception in females Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine. Pregnancy There are no ...

Effects on ability to drive and use machines

Rotigotine may have major influence on the ability to drive and use machines. Patients being treated with rotigotine and presenting with somnolence and/or sudden sleep episodes must be informed not to ...

Undesirable effects

Summary of the safety profile Based on the analysis of pooled placebo-controlled clinical trials comprising a total of 748 Neupro- and 214 placebo-treated patients, 65.5% of the patients on Neupro and ...

Overdose

Symptoms The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, ...

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-parkinson drugs, dopamine agonists ATC code: N04BC09 Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinsons disease and Restless ...

Pharmacokinetic properties

Absorption Following application, rotigotine is continuously released from the transdermal patch and absorbed through the skin. Steady-state concentrations are reached after one to two days of patch application ...

Preclinical safety data

In repeated dose and long-term toxicity studies, the major effects were associated with the dopamine agonist related pharmacodynamic effects and the consequent decrease of prolactin secretion. After a ...

List of excipients

Backing layer: Polyester film, siliconized, aluminized, colour coated with a pigment (titanium dioxide (E171), pigment yellow 95, pigment red 166) layer and imprinted (pigment red 144, pigment yellow 95, ...

Incompatibilities

Not applicable.

Shelf life

Shelf life: 30 months.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Peel off sachet in a plastic box: One side is composed of an ethylene copolymer (innermost layer), an aluminium foil, low density polyethylene film and paper; the other side is composed of polyethylene ...

Special precautions for disposal and other handling

After use the patch still contains active substance. After removal, the used patch should be folded in half, adhesive side inwards so that the matrix layer is not exposed, placed in the original sachet ...

Marketing authorization holder

UCB Pharma S.A., Allée de la Recherche 60, B-1070, Bruxelles, Belgium

Marketing authorization number(s)

Neupro 1 mg/24 h transdermal patch: EU/1/05/331/038 EU/1/05/331/040 EU/1/05/331/041 EU/1/05/331/044 EU/1/05/331/056 Neupro 3 mg/24 h transdermal patch: EU/1/05/331/047 EU/1/05/331/049 EU/1/05/331/050 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 15 February 2006 Date of latest renewal: 22 January 2016

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