EXELON Transdermal patch (2018)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Exelon 4.6 mg/24 h transdermal patch. Exelon 9.5 mg/24 h transdermal patch. Exelon 13.3 mg/24 h transdermal patch.
Qualitative and quantitative composition
<u>Exelon 4.6 mg/24 h transdermal patch:</u> Each transdermal patch releases 4.6 mg of rivastigmine per 24 hours. Each transdermal patch of 5 cm² contains 9 mg of rivastigmine. <u>Exelon 9.5 mg/24 h transdermal ...
Pharmaceutical form
Transdermal patch. Exelon 4.6 mg/24 h transdermal patch: Each transdermal patch is a thin, matrix-type transdermal patch consisting of three layers. The outside of the backing layer is beige and labelled ...
Therapeutic indications
Symptomatic treatment of mild to moderately severe Alzheimers dementia.
Posology and method of administration
Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimers dementia. Diagnosis should be made according to current guidelines. Similar to any treatment ...
Contraindications
Hypersensitivity to the active substance rivastigmine, to other carbamate derivatives or to any of the excipients listed in section 6.1. Previous history of application site reactions suggestive of allergic ...
Special warnings and precautions for use
The incidence and severity of adverse reactions generally increase with increasing doses, particularly at dose changes. If treatment is interrupted for more than three days, it should be re-initiated with ...
Interaction with other medicinal products and other forms of interaction
No specific interaction studies have been performed with Exelon transdermal patches. As a cholinesterase inhibitor, rivastigmine may exaggerate the effects of succinylcholine-type muscle relaxants during ...
Pregnancy and lactation
Pregnancy In pregnant animals, rivastigmine and/or metabolites crossed the placenta. It is not known if this occurs in humans. No clinical data on exposed pregnancies are available. In peri/postnatal studies ...
Effects on ability to drive and use machines
Alzheimers disease may cause gradual impairment of driving performance or compromise the ability to use machines. Furthermore, rivastigmine may induce syncope or delirium. As a consequence, rivastigmine ...
Undesirable effects
Summary of the safety profile Application site skin reactions (usually mild to moderate application site erythema), are the most frequent adverse reactions observed with the use of Exelon transdermal patch. ...
Overdose
Symptoms Most cases of accidental overdose of oral rivastigmine have not been associated with any clinical signs or symptoms and almost all of the patients concerned continued rivastigmine treatment 24 ...
Pharmacodynamic properties
Pharmacotherapeutic group: psychoanaleptics, anticholinesterases ATC code: N06DA03 Rivastigmine is an acetyl- and butyrylcholinesterase inhibitor of the carbamate type, thought to facilitate cholinergic ...
Pharmacokinetic properties
Absorption Absorption of rivastigmine from Exelon transdermal patches is slow. After the first dose, detectable plasma concentrations are observed after a lag time of 0.5-1 hour. C<sub>max</sub> is reached ...
Preclinical safety data
Oral and topical repeated-dose toxicity studies in mice, rats, rabbits, dogs and minipigs revealed only effects associated with an exaggerated pharmacological action. No target organ toxicity was observed. ...
List of excipients
Backing layer: Polyethylene terephthalate film, lacquered Medicinal product matrix: Alpha-tocopherol Poly(butylmethacrylate, methylmethacrylate) Acrylic copolymer Adhesive matrix: Alpha-tocopherol Silicone ...
Incompatibilities
To prevent interference with the adhesive properties of the transdermal patch, no cream, lotion or powder should be applied to the skin area where the medicinal product is to be applied.
Shelf life
2 years.
Special precautions for storage
Do not store above 25°C. Keep the transdermal patch in the sachet until use.
Nature and contents of container
Each child-resistant sachet is made of a paper/polyester/aluminium/polyacrylonitrile multilaminated material. One sachet contains one transdermal patch. Exelon 4.6 mg/24 h transdermal patch: Available ...
Special precautions for disposal and other handling
Used transdermal patches should be folded in half, with the adhesive side inwards, placed in the original sachet and discarded safely and out of the reach and sight of children. Any used or unused transdermal ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
<u>Exelon 4.6 mg/24 h transdermal patch:</u> EU/1/98/066/019-022 EU/1/98/066/031-032 <u>Exelon 9.5 mg/24 h transdermal patch:</u> EU/1/98/066/023-026 EU/1/98/066/033-034 <u>Exelon 13.3 mg/24 h transdermal ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 May 1998 Date of latest renewal: 20 May 2008
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