SELEGOS Tablet (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Selegos 5 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains 5mg of Selegiline hydrochloride. <u>Excipient with known effect:</u> lactose monohydrate. Each 5 mg tablet contains 85 mg lactose monohydrate. For the full list of excipients, see ...
3. Pharmaceutical form
Tablet. Round, white, flat, scored tablets with 7mm diameter.
4.1. 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 ...
4.2. Posology and method of administration
Posology Adults 10mg daily, either alone or as an adjunct to levodopa/peripheral decarboxylase therapy. When selegiline is added to a levodopa regimen it is possible to reduce the levodopa dosage by an ...
4.3. Contraindications
Selegiline is contraindicated in: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Patients receiving treatment with serotonin-agonists (e.g. sumatriptan, naratriptan, ...
4.4. 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 ...
4.5. Interaction with other medicinal products and other forms of interaction
Drugs Association contra-indicated (see section 4.3) Sympathomimetics Because of the risk of hypertension, co-administration of selegiline and sympathomimetics is contraindicated. Pethidine and other opioids ...
4.6. 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 ...
4.7. 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 ...
4.8. 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. ...
4.9. Overdose
Symptoms 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 ...
5.1. 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 ...
5.2. 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; ...
5.3. 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 ...
6.1. List of excipients
Selegos 5 mg tablets also contain lactose monohydrate, povidone, maize starch, talc and magnesium stearate.
6.2. Incompatibilities
No other incompatibilities noted.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C, in the original package, in order to protect from light and moisture.
6.5. Nature and contents of container
Selegos tablets are packed in the following: PVC/PCTFE film-aluminium foil blisters of ten tablets, in packs of 10, 50, 100, 500 and 1000 tablets. Dispensing packs of either screw cap or securitainer type ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
14025
9. Date of first authorization / renewal of the authorization
Date of First Authorization: 26/11/1992 Date of Renewal: 20/03/2009
10. Date of revision of the text
02/05/2019
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