XADAGO Film-coated tablet (2021)
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Περιεχόμενα
Name of the medicinal product
Xadago 50 mg film-coated tablets. Xadago 100 mg film-coated tablets.
Qualitative and quantitative composition
<u>Xadago 50 mg film-coated tablets:</u> Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide. <u>Xadago 100 mg film-coated tablets:</u> Each film-coated tablet contains ...
Pharmaceutical form
Film-coated tablet (tablet). <u>Xadago 50 mg film-coated tablets:</u> Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength 50 on one side ...
Therapeutic indications
Xadago is indicated for the treatment of adult patients with idiopathic Parkinsons disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products ...
Posology and method of administration
Posology Treatment with safinamide should be started at 50 mg per day. This daily dose may be increased to 100 mg/day on the basis of individual clinical need. If a dose is missed the next dose should ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients (see section 6.1). Concomitant treatment with other monoamine oxidase (MAO) inhibitors (see sections 4.4 and 4.5). Concomitant treatment ...
Special warnings and precautions for use
General warning In general, safinamide may be used with selective serotonin re-uptake inhibitors (SSRIs) at the lowest effective dose, with caution for serotoninergic symptoms. In particular, the concomitant ...
Interaction with other medicinal products and other forms of interaction
<em>In vivo</em> and <em>in vitro</em> pharmacodynamic drug interactions MAO inhibitors and pethidine Safinamide must not be administered along with other MAO inhibitors (including moclobemide) as there ...
Fertility, pregnancy and lactation
Women of childbearing potential Safinamide should not be given to women of childbearing potential unless adequate contraception is practiced. Pregnancy There are no or limited amount of data from the use ...
Effects on ability to drive and use machines
Somnolence and dizziness may occur during safinamide treatment, therefore patients should be cautioned about using hazardous machines, including motor vehicles, until they are reasonably certain that safinamide ...
Undesirable effects
Summary of the safety profile Dyskinesia was the most common adverse reaction reported in safinamide patients when used in combination with L-dopa alone or in combination with other PD treatments. Serious ...
Overdose
In one patient suspected of consuming more than the daily prescribed dose of 100 mg for one month, symptoms of confusion, sleepiness, forgetfulness and dilated pupils were reported. These symptoms resolved ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-Parkinson-Drugs, monoamine oxidase-B inhibitors ATC code: N04BD03 Mechanism of action Safinamide acts through both dopaminergic and non-dopaminergic mechanisms of action. ...
Pharmacokinetic properties
Absorption Safinamide absorption is rapid after single and multiple oral dosing, reaching T<sub>max</sub> in the time range 1.8-2.8 h after dosing under fasting conditions. Absolute bioavailability is ...
Preclinical safety data
Retinal degeneration was observed in rodents after repeated safinamide dosing resulting in systemic exposure below the anticipated systemic exposure in patients given the maximal therapeutic dose. No retinal ...
List of excipients
<u>Tablet core:</u> Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous <u>Film-coating:</u> Hypromellose Macrogol (6000) Titanium dioxide (E171) Iron oxide red ...
Incompatibilities
Not applicable.
Shelf life
4 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
PVC/PVDC/Aluminium blister packs of 14, 28, 30, 90 and 100 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Zambon S.p.A., Via Lillo del Duca 10, 20091, Bresso (MI) - Italy, Tel: +39 02 665241, Fax: +39 02 66501492, Email: info.zambonspa@zambongroup.com
Marketing authorization number(s)
Xadago 50 mg film-coated tablets: EU/1/14/984/001 EU/1/14/984/002 EU/1/14/984/003 EU/1/14/984/004 EU/1/14/984/005 Xadago 100 mg film-coated tablets: EU/1/14/984/006 EU/1/14/984/007 EU/1/14/984/008 EU/1/14/984/009 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 February 2015 Date of latest renewal: 19 September 2019
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