FrancophonIA/ELRC3.0 huggingface dataset:
English: SPECIAL STORAGE CONDITIONS Keep the blister in the outer carton.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Pretisni omot shranjujte v zunanji ovojnini.
English: On the day of, or the day following administration of spinosad at a dose of 45-70 mg/kg bodyweight, the observed incidence of vomiting in the field trial was 5.6%, 4.2% and 3.6% after the first, second and third monthly treatments respectively.
Slovenian: Na dan dajanja spinosada v odmerku 45-70 mg/kg telesne mase ali naslednji dan so v terenski študiji opazili 5,6 % pojavnost bruhanja po zdravljenju prvi mesec, 4,2 % po zdravljenju drugi mesec in 3,6 % po zdravljenju tretji mesec.
English: If a dose is missed, administer the veterinary medicinal product with the next offering of food and resume a monthly dosing schedule.
Slovenian: Če odmerek izpustite, dajte zdravilo za uporabo v veterinarski medicini z naslednjim obrokom hrane in nato ponovno vzpostavite režim mesečnega odmerjanja.
English: The frequency of adverse reactions is defined using the following convention:
Slovenian: Najpogostejši neželeni učinek je v skupini naveden prvi, po naslednjem dogovoru:
English: Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Slovenian: Z laboratorijskimi študijami na podganah in kuncih niso bili dokazani teratogeni in fetotoksični učinki ter toksični učinki na mater.
English: Comfortis 1620 mg chewable tablets for dogs spinosad
Slovenian: Comfortis 1620 mg žvečljive tablete za pse
English: The residual insecticidal properties of the product persist for up to 4 weeks after a single administration.
Slovenian: Rezidualne insekticidne lastnosti zdravila se ohranijo še do 4 tedne po enkratnem dajanju.
English: If a dose is missed, administer the product with the next offering of food and resume a monthly dosing schedule.
Slovenian: Če odmerek izpustite, dajte zdravilo z naslednjim obrokom hrane in nato ponovno vzpostavite režim mesečnega odmerjanja.
English: Approximately 90% of spinosad is comprised of spinosyns A and D. Of that 90%, the ratio of spinosyn A to A+D is 0.85 when calculated as spinosyn A/spinosyn A+D.
Slovenian: Približno 90 % spinosada sestavljata spinosina A in D. Od teh 90 % je razmerje spinosina A in spinosina A in D 0,85, če se izračuna kot spinosin A/spinosin A in D. Doslednost te številke v farmakokinetičnih in drugih študijah kaže na primerljivost absorpcije, presnove in izločanja dveh glavnih spinosinov.
English: − very rare (less than 1 animal in 10,000 animals, including isolated reports).
Slovenian: - zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere)
English: In dogs, at doses up to 100 mg/kg bodyweight per day for 10 days, the only clinical symptom of overdose was vomiting, which occurred usually within 2.5 hours of dosing.
Slovenian: Pri dnevnih odmerkih do 100 mg/kg telesne mase, ki so jih psi dobivali 10 dni, je bil edini klinični znak prevelikega odmerjanja bruhanje, ki se je običajno pojavilo v roku 2,5 ure od dajanja zdravila.
English: On the day of, or the day following administration of spinosad at a dose of 50-75 mg/kg bodyweight, the observed incidence of vomiting in the global field trial was between 6% and 11% in the first three months of treatment.
Slovenian: Na dan dajanja spinosada v odmerku 50-75 mg/kg telesne mase ali naslednji dan so v terenski študiji opazili pojavnost bruhanja med 6 % in 11 % v prvih treh mesecih zdravljenja.
English: After a single acute overdose corresponding to 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Slovenian: Pri enkratnem akutnem prevelikem odmerjanju, pri katerem je odmerek 1,6-krat večji od največjega priporočenega odmerka spinosada, se je pri približno polovici mačk pojavilo bruhanje; redko so se pojavili tudi depresija, nemirna hoja/sopenje in močna driska.
English: In cats, after a single acute overdose of 1.6 times the maximum label dose, spinosad caused vomiting in approximately half of the cats, and depression, pacing/panting and severe diarrhoea on rare occasions.
Slovenian: Pri mačkah se je pri enkratnem akutnem prevelikem odmerjanju, pri katerem je odmerek 1,6-krat večji od največjega priporočenega odmerka spinosada, pri približno polovici pojavilo bruhanje; redko so se pojavili tudi depresija, nemirna hoja/sopenje in močna driska.
English: In dogs, spinosyns A and D are rapidly absorbed and extensively distributed after oral administration.
Slovenian: Pri psih se po peroralni uporabi spinosina A in D hitro absorbirata in obsežno porazdelita.
English: In dogs lethargy, anorexia and diarrhoea were uncommon and muscle tremor, ataxia and seizures were rare.
Slovenian: Pri psih so se občasno pojavili letargija, anoreksija in driska ter redko tresenje mišic, ataksija in konvulzije.
English: The primary faecal and urinary metabolites in both the rat and the cat were identified as the glutathione conjugates of the parent compounds and N-demethylated spinosyns A and D. Excretion is primarily via the faeces, and also to a lesser extent in the urine.
Slovenian: Glavne presnovke v blatu in urinu pri podganah in mačkah so opredelili kot glutationske konjugate starševskih spojin in N-demetilirana spinosina A in D. Glavna pot izločanja je z blatom, v manjši meri pa tudi z urinom.
English: Marketing authorisation holder:
Slovenian: Datum podaljšanja dovoljenja za promet:
English: If the dog or cat does not accept the tablets directly they may be administered with food, or directly by opening the animal's mouth and placing the tablet onto the back of the tongue.
Slovenian: se jih lahko daje s hrano ali neposredno v gobec živali, na koren jezika.
English: In cats, spinosyns A and D are equally rapidly absorbed and extensively distributed after oral administration.
Slovenian: Pri mačkah se po peroralni uporabi spinosina A in D enakomerno hitro absorbirata in obsežno porazdelita.
English: In cats, at doses of 75 to 100 mg/kg bodyweight per day for 5 days, given monthly for a period of six months, the most commonly observed clinical sign was vomiting.
Slovenian: Pri dnevnih odmerkih od 75 do 100 mg/kg telesne mase, ki so jih mačke prejemale 5 dni vsak mesec v šestmesečnem obdobju, je bil najpogostejši klinični znak bruhanje.
English: The tablets are speckled tan to brown, round, flat and chewable.
Slovenian: Lisaste svetlorjave do rjave, okrogle, ploščate in žvečljive tablete.
English: In dogs, the incidence of vomiting on the day of, or the day after, dosing has been observed to increase as a function of dose.
Slovenian: Pri psih so opazili, da pojav bruhanja na dan dajanja zdravila ali dan po dajanju narašča z odmerkom.
English: EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
Slovenian: EU/2/10/115/018 (140 mg, 3 tablete) EU/2/10/115/019 (140 mg, 6 tablet) EU/2/10/115/020 (180 mg, 3 tablete) EU/2/10/115/021 (180 mg, 6 tablet) EU/2/10/115/011 (270 mg, 3 tablete) EU/2/10/115/001 (270 mg, 6 tablet) EU/2/10/115/012 (425 mg, 3 tablete) EU/2/10/115/003 (425 mg, 6 tablet) EU/2/10/115/013 (665 mg, 3 tablete) EU/2/10/115/005 (665 mg, 6 tablet) EU/2/10/115/014 (1040 mg, 3 tablete) EU/2/10/115/007 (1040 mg, 6 tablet) EU/2/10/115/015 (1620 mg, 3 tablete) EU/2/10/115/009 (1620 mg, 6 tablet)
English: EU/2/10/115/016 (90 mg, 3 tablets) EU/2/10/115/017 (90 mg, 6 tablets) EU/2/10/115/018 (140 mg, 3 tablets) EU/2/10/115/019 (140 mg, 6 tablets) EU/2/10/115/020 (180 mg, 3 tablets) EU/2/10/115/021 (180 mg, 6 tablets) EU/2/10/115/011 (270 mg, 3 tablets) EU/2/10/115/001 (270 mg, 6 tablets) EU/2/10/115/012 (425 mg, 3 tablets) EU/2/10/115/003 (425 mg, 6 tablets) EU/2/10/115/013 (665 mg, 3 tablets) EU/2/10/115/005 (665 mg, 6 tablets) EU/2/10/115/014 (1040 mg, 3 tablets) EU/2/10/115/007 (1040 mg, 6 tablets) EU/2/10/115/015 (1620 mg, 3 tablets) EU/2/10/115/009 (1620 mg, 6 tablets)
Slovenian: EU/2/10/115/016 (90 mg, 3 tablete) EU/2/10/115/017 (90 mg, 6 tablet) EU/2/10/115/018 (140 mg, 3 tablete) EU/2/10/115/019 (140 mg, 6 tablet) EU/2/10/115/020 (180 mg, 3 tablete) EU/2/10/115/021 (180 mg, 6 tablet) EU/2/10/115/011 (270 mg, 3 tablete) EU/2/10/115/001 (270 mg, 6 tablet) EU/2/10/115/012 (425 mg, 3 tablete) EU/2/10/115/003 (425 mg, 6 tablet) EU/2/10/115/013 (665 mg, 3 tablete) EU/2/10/115/005 (665 mg, 6 tablet) EU/2/10/115/014 (1040 mg, 3 tablete) EU/2/10/115/007 (1040 mg, 6 tablet) EU/2/10/115/015 (1620 mg, 3 tablete) EU/2/10/115/009 (1620 mg, 6 tablet)
English: The veterinary medicinal product should be administered in accordance with the following table to ensure a dose of 45-70 mg/kg bodyweight for dogs:
Slovenian: Zdravilo za uporabo v veterinarski medicini se daje v skladu s spodnjo tabelo, da se zagotovi odmerek 45-70 mg/kg telesne mase pri psih.
English: The mean Tmax for spinosyns A and D ranged from 2-4 hours and the mean elimination half-life ranged from 127.5 to 162.6 hours and 101.3 to 131.9 hours respectively.
Slovenian: 2-4 ure, medtem ko je bil razpon srednjega razpolovnega časa izločanja od 127,5 do 162,6 ur za spinosin A in 101,3 do 131,9 ur za spinosin D. Vrednosti AUC in Cmax so bile višje pri nahranjenih kot pa pri teščih psih in so naraščale približno linearno z naraščanjem stopenj odmerka v nameravanem razponu terapevtskega odmerka.
English: Elanco GmbH Heinz-Lohmann-Str. 4 27472 Cuxhaven Germany
Slovenian: Heinz-Lohmann-Str. 4
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet 1 x 665 mg tablet 1 x 1040 mg tablet 1 x 1620 mg tablet 1 x 1620 mg tablet + 1 x 665 mg tablet 2 x 1620 mg tablets
Slovenian: Število tablet in jakost tablete (mg spinosada) 1 x 90 mg tableta 1 x 140 mg tableta 1 x 180 mg tableta 1 x 270 mg tableta 1 x 425 mg tableta 1 x 665 mg tableta 1 x 1040 mg tableta 1 x 1620 mg tableta 1 x 1620 mg tableta + 1 x 665 mg tableta 2 x 1620 mg tableta
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROSTITEV SERIJE
English: Special warnings for each target species:
Slovenian: POSEBNO(A) OPOZORILO(A) Posebna opozorila za vsako živalsko vrsto:
English: Tan to brown, or speckled with embedded darker particles, round, flat, bevelled edge tablets plain on one side and debossed with a number and a line above on the other side:
Slovenian: Svetlorjave do rjave ali lisaste z vgrajenimi temnejšimi delci, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa, na drugi strani pa z vtisom številke in črto nad njo:
English: Also noted were diffuse hepatocellular hypertrophy in males and females, and this finding correlated with higher pooled mean liver weights.
Slovenian: Pri samcih in samicah so opazili tudi difuzno hipertrofijo jetrnih celic, kar je bilo povezano s povečano maso jeter.
English: The safety of spinosad in pregnant cats (queens) has not been evaluated.
Slovenian: Pri brejih mačkah varnost spinosada ni bila ocenjena.
English: Number of tablets and strength (mg spinosad) 1 x 90 mg tablet 1 x 140 mg tablet 1 x 180 mg tablet 1 x 270 mg tablet 1 x 425 mg tablet †Cats over 8.5 kg: give the appropriate combination of tablets.
Slovenian: Število tablet in jakost tablete (mg spinosada) 1 x 90 mg tableta 1 x 140 mg tableta 1 x 180 mg tableta 1 x 270 mg tableta 1 x 425 mg tableta
English: In cats, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Slovenian: Pri mačkaj je neželeni učinek, ki so ga pogosto opazili, bruhanje, ki se pojavi v prvih 48 urah po dajanju zdravila in ga najverjetneje povzroči lokalni učinek na tanko črevo.
English: Faecal excretion accounted for the vast majority of metabolites in cats.
Slovenian: Velika večina presnovkov se je pri mačkah izločila z blatom.
English: In dogs, a commonly observed adverse reaction is vomiting, which occurs in the first 48 hours after dosing and is most likely caused by a local effect on the small intestines.
Slovenian: Pri psih je neželeni učinek, ki so ga pogosto opazili, bruhanje, ki se pojavi v prvih 48 urah po dajanju zdravila in ga najverjetneje povzroči lokalni učinek na tanko črevo.
English: INDICATION(S) For the treatment and prevention of flea infestations.
Slovenian: Zdravljenje in preprečevanje infestacij z bolhami.
English: Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number underlined as listed below on the other:
Slovenian: Svetlorjave do rjave ali lisaste, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa, na drugi strani pa z vtisom številke, kot je navedeno spodaj:
English: Comfortis 90 mg spinosad 90 mg Comfortis 140 mg spinosad 140 mg Comfortis 180 mg spinosad 180 mg Comfortis 270 mg spinosad 270 mg Comfortis 425 mg spinosad 425 mg Comfortis 665 mg spinosad 665 mg Comfortis 1040 mg spinosad 1040 mg Comfortis 1620 mg spinosad 1620 mg
Slovenian: Comfortis 90 mg 90 mg spinosada Comfortis 140 mg 140 mg spinosada Comfortis 180 mg 180 mg spinosada Comfortis 270 mg 270 mg spinosada Comfortis 425 mg 425 mg spinosada Comfortis 665 mg 665 mg spinosada Comfortis 1040 mg 1040 mg spinosada Comfortis 1620 mg 1620 mg spinosada
English: Comfortis 90 mg chewable tablets for dogs and cats Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs
Slovenian: Comfortis 90 mg žvečljive tablete za pse in mačke Comfortis 140 mg žvečljive tablete za pse in mačke Comfortis 180 mg žvečljive tablete za pse in mačke Comfortis 270 mg žvečljive tablete za pse in mačke Comfortis 425 mg žvečljive tablete za pse in mačke Comfortis 665 mg žvečljive tablete za pse
English: Bioavailability was shown to be approximately 100%, with maximum plasma concentrations attained approximately 4-12 hours post treatment, and with half-lives of spinosyn A and spinosyn D ranging between 5 days and 20 days in cats dosed at 50-100 mg spinosad/kg bodyweight.
Slovenian: Ugotovljeno je bilo, da je biološka razpoložljivost približno 100 %, največja plazemska koncentracija pa se je pojavila v 4-12 urah po zdravljenju.
English: Comfortis 665 mg 665 mg spinosad Comfortis 1040 mg 1040 mg spinosad Comfortis 1620 mg 1620 mg spinosad
Slovenian: Comfortis 270 mg 270 mg spinosada Comfortis 425 mg 425 mg spinosada Comfortis 665 mg 665 mg spinosada Comfortis 1040 mg 1040 mg spinosada Comfortis 1620 mg 1620 mg spinosada
English: − common (more than 1 but less than 10 animals in 100 animals)
Slovenian: - pogosti (pojavijo se pri 1 do 10 živali od 100 živali)
English: − rare (more than 1 but less than 10 animals in 10,000 animals)
Slovenian: - redki (pojavijo se pri 1 do 10 živali od 10.000 živali)
English: Comfortis 90 mg chewable tablets for dogs and cats Comfortis 140 mg chewable tablets for dogs and cats Comfortis 180 mg chewable tablets for dogs and cats Comfortis 270 mg chewable tablets for dogs and cats Comfortis 425 mg chewable tablets for dogs and cats Comfortis 665 mg chewable tablets for dogs Comfortis 1040 mg chewable tablets for dogs Comfortis 1620 mg chewable tablets for dogs
Slovenian: Comfortis 90 mg žvečljive tablete za pse in mačke Comfortis 140 mg žvečljive tablete za pse in mačke Comfortis 180 mg žvečljive tablete za pse in mačke Comfortis 270 mg žvečljive tablete za pse in mačke Comfortis 425 mg žvečljive tablete za pse in mačke Comfortis 665 mg žvečljive tablete za pse Comfortis 1040 mg žvečljive tablete za pse Comfortis 1620 mg žvečljive tablete za pse
English: The primary biliary, faecal and urinary metabolites in both the rat and the dog were identified as the demethylated spinosyns, glutathione conjugates of the parent compounds and Ndemethylated spinosyns A and D. Excretion is primarily via the bile and faeces, and also to a lesser extent in the urine.
Slovenian: Glavne presnovke v žolču, blatu in urinu pri podganah in psih so opredelili kot demetilirane spinosine, glutationske konjugate starševskih spojin in
English: Comfortis 90 mg 90 mg spinosad Comfortis 140 mg 140 mg spinosad Comfortis 180 mg 180 mg spinosad Comfortis 270 mg 270 mg spinosad Comfortis 425 mg 425 mg spinosad
Slovenian: Comfortis 90 mg 90 mg spinosada Comfortis 140 mg 140 mg spinosada Comfortis 180 mg 180 mg spinosada
English: Tan to brown, or speckled, round, flat, bevelled edge tablets, plain on one side and debossed with a number as listed below on the other:
Slovenian: Svetlorjave do rjave ali lisaste, okrogle, ploščate tablete s prirezanimi robovi, na eni strani brez vtisa,
English: − very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
Slovenian: - zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali)
English: − uncommon (more than 1 but less than 10 animals in 1,000 animals)
Slovenian: - občasni (pojavijo se pri 1 do 10 živali od 1.000 živali)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Slovenian: PODATKI NA ZUNANJI OVOJNINI Zunanja kartonska škatla
English: Outer carton
Slovenian: Pretisni omot
English: This effect was also maintained in the long-term.
Slovenian: Ta učinek se je ohranjal tudi dolgoročno.
English: Regarding safety, in overall it was considered acceptable.
Slovenian: Kar zadeva varnost, je bilo ocenjeno, da je ta sprejemljiva.
English: Another study showed maintenance of this effect for 24 months.
Slovenian: Z drugo študijo je bilo dokazano vzdrževanje tega učinka v obdobju 24 mesecev.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xadago on 24 February 2015.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Xadago, veljavno po vsej Evropski uniji, izdala 24. februarja 2015.
English: Treatment should be started at a dose of 50 mg a day and the doctor may increase the dose up to 100 mg a day based on patient's need.
Slovenian: Zdravljenje je treba začeti z odmerkom 50 mg na dan, zdravnik pa lahko odmerek glede na bolnikove potrebe poveča na največ 100 mg.
English: What measures are being taken to ensure the safe and effective use of Xadago?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Xadago?
English: The full EPAR and risk management plan summary for Xadago can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) in povzetek načrta obvladovanja tveganj za zdravilo Xadago sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Xadago.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Xadago.
English: Xadago safinamide
Slovenian: Xadago safinamid
English: Xadago is available as tablets (50 and 100 mg) and can only be obtained with a prescription.
Slovenian: Zdravilo Xadago je na voljo v obliki tablet (50 mg in 100 mg) in se izdaja le na recept.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Xadago's benefits are greater than its risks and recommended that it be approved for use in the EU.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Xadago večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
English: What is Xadago and what is it used for?
Slovenian: Kaj je zdravilo Xadago in za kaj se uporablja?
English: A risk management plan has been developed to ensure that Xadago is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Xadago je bil pripravljen načrt obvladovanja tveganj.
English: Other information about Xadago
Slovenian: Druge informacije o zdravilu Xadago
English: What benefits of Xadago have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Xadago izkazalo v študijah?
English: Xadago was also investigated as an add-on to treatment in 2 studies in patients with early Parkinson's disease without fluctuations, but these studies did not show a clear benefit and the company did not pursue this use as part of the application.
Slovenian: Zdravilo Xadago so kot dodatek k zdravljenju preučevali tudi v dveh študijah z bolniki s Parkinsonovo boleznijo v zgodnji fazi brez nihanj, vendar ti študiji nista izkazali jasne koristi in družba se ni odločila za uveljavljanje te uporabe v okviru te vloge.
English: What are the risks associated with Xadago?
Slovenian: Kakšna tveganja so povezana z zdravilom Xadago?
English: It blocks the enzyme monoamine oxidase type B (which breaks down dopamine), thereby helping to restore dopamine levels in the brain and improving the patient's symptoms.
Slovenian: Safinamid zavira encim monoaminooksidaza tipa B (ki razgrajuje dopamin), s čimer prispeva k ponovni vzpostaviti ustrezne ravni dopamina v možganih in izboljša bolnikove simptome.
English: The most common side effects with Xadago (which may affect up to 1 in 10 people) are insomnia (difficulty sleeping), dyskinesia (difficulty controlling movement), somnolence (sleepiness), dizziness, headache, worsening of existing Parkinson's disease, cataract (clouding of the lens), orthostatic hypotension (drop in blood pressure when standing up), nausea (feeling sick) and falls.
Slovenian: Najpogostejši neželeni učinki zdravila Xadago (ki lahko prizadenejo največ 1 osebo od 10) so nespečnost, diskinezija (težave pri nadzoru gibov), somnolenca (zaspanost), omotica, glavobol, poslabšanje obstoječe Parkinsonove bolezni, katarakta (zameglitev očesne leče), ortostatska hipotenzija (upad krvnega tlaka ob vstajanju v pokončen položaj), navzeja (slabost) in padci.
English: Why is Xadago approved?
Slovenian: Zakaj je bilo zdravilo Xadago odobreno?
English: In patients with Parkinson's disease, certain cells in the brain that produce dopamine die, and as dopamine is involved in controlling movement, the patient's movement worsens over time.
Slovenian: Pri bolnikih s Parkinsonovo boleznijo določene celice v možganih, ki tvorijo dopamin, odmrejo in ker dopamin sodeluje pri nadzoru gibanja, se bolnikova sposobnost gibanja sčasoma poslabša.
English: For more information about treatment with Xadago, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Xadago preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: In both studies, 6 months treatment with Xadago increased the time during the day during which patients were ‘on' and able to move by 30-60 minutes when compared with placebo.
Slovenian: V obeh študijah je 6-mesečno zdravljenje z zdravilom Xadago v primerjavi s placebom za 30 do 60 minut tekom dneva podaljšalo čas „vklopa“, ko so se bolniki lahko gibali.
English: The active substance in Xadago, safinamide, is a ‘monoamine oxidase-B (MAO-B) inhibitor'.
Slovenian: Zdravilna učinkovina zdravila Xadago, safinamid, je zaviralec monoaminooksidaze tipa B (MAO-B).
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xadago, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.