ELDEPRYL Tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Eldepryl 5 mg Tablets.
Qualitative and quantitative composition
Selegiline hydrochloride 5 mg. For the full list of excipients, see section 6.1.
Pharmaceutical form
Tablets for oral administration.
Therapeutic indications
Selegiline is indicated for the treatment of Parkinsons disease, or symptomatic parkinsonism. It may be used alone in early Parkinsons disease for symptomatic relief to delay the need for levodopa (with ...
Posology and method of administration
Posology 10 mg daily either alone or as an adjunct to levodopa or levodopa/peripheral decarboxylase inhibitor. When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage ...
Contraindications
Eldepryl is contra-indicated in patients with known hypersensitivity (including severe dizziness or hypotension) to selegiline or any of the excipients listed in section 6.1. Eldepryl is contra-indicated ...
Special warnings and precautions for use
The precise dose at which selegiline becomes a non-selective inhibitor of all MAO has not been determined, but with doses higher than 10 mg/day there is a theoretical risk of hypertension after ingestion ...
Interaction with other medicinal products and other forms of interaction
Association contra-indicated (see section 4.3) Sympathomimetics Because of the risk of hypertension, co-administration of selegiline and sympathomimetics is contraindicated. Pethidine, tramadol, buprenorphine ...
Pregnancy and lactation
Selegiline is indicated for the treatment of Parkinsons disease which, in most cases, is a disease occurring after childbearing age. The available safety data concerning the use during pregnancy and lactation ...
Effects on ability to drive and use machines
Even when used correctly, this medicine may cause dizziness or can affect reaction capacity to the extent that driving or operating machinery is affected and therefore patients should be advised not to ...
Undesirable effects
The following undesirable effects have been reported with selegiline during clinical trials and/or post-marketing use. They are listed below as MedDRA preferred term by system organ class and frequency. ...
Overdose
Selegiline is rapidly metabolised and the metabolites rapidly excreted. In cases of suspected overdosage the patient should be kept under observation for 24 to 48 hours. No overdosage cases are known. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Monoamine oxidase B inhibitors <b>ATC-code:</b> N04BD01 Selegiline is a selective MAO-B-inhibitor which prevents dopamine breakdown in the brain. It also inhibits the ...
Pharmacokinetic properties
Absorption Selegiline HCl is readily absorbed from the gastrointestinal tract. The maximal concentrations are reached in 0.5-0.75h after oral administration in fasting state. The bioavailability is low; ...
Preclinical safety data
Selegiline has not been sufficiently tested for reproductive toxicity. Studies with selegiline revealed no evidence of mutagenic or carcinogenic effects. The only safety concerns for human use derived ...
List of excipients
Mannitol Maize starch Microcrystalline cellulose Povidone Magnesium stearate
Incompatibilities
No other incompatibilities noted.
Shelf life
<u>Bottle:</u> 36 months. <u>Blister:</u> 36 months.
Special precautions for storage
<u>HDPE bottle:</u> Do not store above 25°C. Keep the container tightly closed. <u>Blister Pack:</u> Do not store above 25°C. Store in the original package.
Nature and contents of container
a) White HDPE bottle with LDPE snap cap: 100 tablets. b) AI/AI blister packs: 30, 50, 60 and 100 tablets. c) White HDPE bottle with HDPE screw cap: 100 tablets.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Orion Corporation, Orionintie 1, FIN-02200, Espoo, Finland
Marketing authorization number(s)
PL 27925/0004
Date of first authorization / renewal of the authorization
Date of first authorization: 01 July 1993 Date of latest renewal: July 2007
Date of revision of the text
January 2021
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