FrancophonIA/ELRC3.0 huggingface dataset:
English: In view of the MAO inhibitory activity of safinamide, the concomitant administration of safinamide and dextromethorphan is not recommended, or if concomitant treatment is necessary, it should be used with caution (see section 4.4).
Slovenian: Zaradi zaviralne aktivnosti safinamida na MAO sočasna uporaba safinamida in dekstrometorfana ni priporočljiva, če pa je sočasno zdravljenje potrebno, ga je treba izvajati previdno (glejte poglavje 4.4).
English: Safinamide should not be administered to patients with ophthalmological history that would put them at increased risk for potential retinal effects (e.g., family history of hereditary retinal disease, or history of uveitis) see sections 4.3 and 5.3.
Slovenian: Safinamida se ne sme dajati bolnikom z oftalmološkimi stanji v anamnezi, ki bi lahko zanje predstavljala povečano tveganje za morebiten pojav učinkov na mrežnico (npr. bolniki z dednimi boleznimi mrežnice v družinski anamnezi ali bolniki z uveitisom v anamnezi), glejte poglavji 4.3 in
English: Patients and carers should be made aware of the behavioural symptoms of ICDs that were observed in patients treated with MAO-inhibitors, including cases of compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying.
Slovenian: Bolnikom in negovalcem je treba povedati, da se lahko pri bolnikih, ki se zdravijo z zaviralci MAO, pojavijo vedenjski simptomi ICD, vključno s kompulzijami, obsesivnimi mislimi, patološkim hazardiranjem, povečanim libidom, hiperseksualnostjo, impulzivnim vedenjem in kompulzivnim trošenjem denarja ali nakupovanjem.
English: Common (may affect up to 1 in 10 people): insomnia, difficulty in performing voluntary movements, feeling sleepy, dizziness, headache, worsening of Parkinson's disease, clouding of the lens of the eye, fall in blood pressure when rising to a standing position, nausea, falling.
Slovenian: Pogosti (pojavijo se lahko pri do 1 od 10 bolnikov): nespečnost, težave pri izvajanju prostovoljnih gibov, občutek zaspanosti, omotica, glavobol, poslabšanje parkinsonove bolezni, zamotnitev očesne leče, upad krvnega tlaka ob vstajanju v pokončen položaj, navzea, padci.
English: Xadago is indicated for the treatment of adult patients with idiopathic Parkinson's disease (PD) as addon therapy to a stable dose of levodopa (L-dopa) alone or in combination with other PD medicinal products in mid-to late-stage fluctuating patients.
Slovenian: Zdravilo Xadago se uporablja za zdravljenje odraslih bolnikov z idiopatsko parkinsonovo boleznijo kot dodatek k stabilnemu odmerku levodope (L-dopa) v monoterapiji ali v kombinaciji z drugimi zdravili za zdravljenje parkinsonove bolezni pri bolnikih s fluktuacijami v srednjem do poznem stadiju.
English: What Xadago contains - The active substance is safinamide.
Slovenian: Kaj vsebuje zdravilo Xadago - Učinkovina je safinamid.
English: There have been reports of medicinal product interactions with the concomitant use of MAO inhibitors and sympathomimetic medicinal products.
Slovenian: Poročali so o medsebojni interakciji zdravil pri sočasni uporabi zaviralcev MAO in simpatikomimetičnih zdravil.
English: The lower dose of 50 mg/day is recommended for patients with moderate hepatic impairment.
Slovenian: Za bolnike z zmerno jetrno okvaro je priporočen nižji odmerek 50 mg/dan.
English: In mid- to late-stage patients experiencing sudden switches between being “ON” and able to move and being “OFF” and having difficulties moving about, Xadago is added to a stable dose of the medicine called levodopa alone or in combination with other medicines for Parkinson's disease.
Slovenian: Pri bolnikih v srednjem do poznem stadiju bolezni, pri katerih prihaja do nenadnih sprememb iz stanja »vklopa«, ko je njihovo gibanje normalno, v stanje »izklopa«, ko imajo pri gibanju težave, je zdravilo Xadago dodano stabilnemu odmerku zdravila, imenovanega levodopa, samega ali v kombinaciji z drugimi zdravili za parkinsonovo bolezen.
English: Fertility studies in female rats showed reduced number of implantations and corpora lutea at exposures in excess of 3 times the anticipated human exposure.
Slovenian: Študije plodnosti na podganjih samicah so pokazale zmanjšano število implantacij in rumenih telesc pri izpostavljenostih, ki so več kot 3-krat presegle pričakovano izpostavljenost pri človeku.
English: - If you are taking any of the following medicines: - Monoamine oxidase (MAO) inhibitors such as selegiline, rasagiline, moclobemide, phenelzine, isocarboxazid, tranylcypromine (e.g. for treatment of Parkinson's disease or depression, or used for any other condition).
Slovenian: - če jemljete katero od naslednjih zdravil: zaviralci monoaminooksidaze (zaviralci MAO), kot so npr. selegilin, rasagilin, moklobemid, fenelzin, izokarboksazid, tranilcipromin (npr. za zdravljenje parkinsonove bolezni ali depresije oz. uporabljeni za zdravljenje katere koli druge bolezni); petidin (močno protibolečinsko zdravilo).
English: In view of the MAO inhibitory activity of safinamide, concomitant administration of safinamide and sympathomimetics, such as those present in nasal and oral decongestants or cold medicinal products containing ephedrine or pseudoephedrine, requires caution (see section 4.4).
Slovenian: Zaradi zaviralne aktivnosti safinamida na MAO je pri sočasni uporabi safinamida in simpatikomimetičnih zdravil, ki so npr. prisotni v nazalnih in peroralnih dekongestivih ali zdravilih proti prehladu, ki vsebujejo efedrin ali psevdoefedrin, potrebna previdnost (glejte poglavje 4.4).
English: Concomitant treatment with pethidine (see sections 4.4 and 4.5).
Slovenian: Sočasno zdravljenje s petidinom (glejte poglavji 4.4 in 4.5).
English: Use in patients with severe hepatic impairment (see section 4.2).
Slovenian: Uporaba zdravila pri bolnikih s hudo jetrno okvaro (glejte poglavje 4.2).
English: As this may be a class-effect, the concomitant administration of safinamide and pethidine is contraindicated (see section 4.3).
Slovenian: Ker gre morda za razredni učinek, je sočasno dajanje safinamida in petidina kontraindicirano (glejte poglavje 4.3).
English: At least 7 days must elapse between discontinuation of safinamide and initiation of treatment with MAO inhibitors or pethidine (see section 4.3 and 4.5).
Slovenian: Med prekinitvijo zdravljenja s safinamidom in začetkom zdravljenja z zaviralci MAO ali petidinom mora preteči vsaj sedem dni (glejte poglavji 4.3 in 4.5).
English: The principal pathway involves hydrolytic oxidation of the amide moiety leading to the primary metabolite ‘safinamide acid' (NW-1153).
Slovenian: Glavna pot vključuje hidrolitsko oksidacijo amidnega dela molekule, kar ustvari primarni presnovek „safinamidno kislino“ (NW-1153).
English: Male rat fertility is not affected (see section 5.3).
Slovenian: Na plodnost podganjih samcev to ne vpliva (glejte poglavje 5.3).
English: MAO inhibitors and pethidine
Slovenian: Zaviralci MAO in petidin
English: In a pre- and postnatal developmental rat study, pup mortality, absence of milk in the stomach and neonatal hepatotoxicity were observed at dose levels similar to the anticipated clinical exposure.
Slovenian: V študijah prenatalnega in postnatalnega razvoja podgan so pri ravneh odmerkov, podobnih ravnem pri pričakovani klinični izpostavljenosti, opazili smrtnost mladičev, odsotnost mleka v želodcu in neonatalno hepatotoksičnost.
English: Male rats showed minor abnormal morphology and reduced speed of sperm cells at exposures in excess of 1.4 times the anticipated human exposure.
Slovenian: Pri podganjih samcih so opazili nekoliko nenormalno morfologijo in zmanjšanje hitrosti spermijev, vendar brez učinka na plodnost, pri izpostavljenostih, ki so več kot 1,4-krat presegle pričakovano izpostavljenost pri človeku.
English: The recommended starting dose of Xadago is one 50 mg tablet that may be increased to one 100 mg tablet, taken once daily preferably in the morning by mouth with water.
Slovenian: Priporočeni začetni odmerek zdravila Xadago je ena 50-miligramska tableta, ki se lahko poveča na eno 100-miligramsko tableto.
English: Ask your doctor for advice prior to driving or using machines.
Slovenian: Pred upravljanjem vozil ali strojev se posvetujete z zdravnikom.
English: Seek medical advice in case of hypertensive crisis (very high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, increase level of enzyme creatine kinase in your blood), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Slovenian: Takoj se posvetujte z zdravnikom v primeru hipertenzivne krize (zelo visok krvni tlak, kolaps), nevroleptičnega malignega sindroma (zmedenost, potenje, mišična rigidnost, hipertermija, zvišanje ravni encima kreatin kinaze v krvi), serotoninskega sindroma (zmedenost, hipertenzija, okorelost mišic, halucinacije) in hipotenzije.
English: Safinamide use in patients with severe hepatic impairment is contraindicated (see section 4.3).
Slovenian: Uporaba safinamida je kontraindicirana pri bolnikih s hudo okvaro jeter (glejte poglavje 4.3).
English: It is recommended to monitor patients when safinamide is taken with medicinal products that are BCRP substrates (e.g., rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide) and to refer to their SmPCs to determine if a dose adjustment is needed.
Slovenian: Ob uporabi safinamida z zdravili, ki so substrati BCRP (npr. rosuvastatin, pitavastatin, pravastatin, ciprofloksacin, metotreksat, topotekan, diklofenak ali gliburid), je priporočljivo spremljati bolnike in se sklicevati na Povzetek glavnih značilnosti zdravila za ta zdravila, se ugotovi, ali je potrebna prilagoditev odmerka.
English: Liver hypertrophy and fatty changes were seen only in rodent livers at exposures similar to humans.
Slovenian: Pri izpostavljenostih, podobnim izpostavljenostim človeka, so opazili jetrno hipertrofijo in maščobne spremembe le v jetrih glodavcev.
English: Safinamide transiently inhibits BCRP in the small intestine (see section 4.5).
Slovenian: Safinamid prehodno zavira BCRP v tankem črevesu (glejte poglavje 4.5).
English: Least Square Difference vs Placebo mITT Population: Study 016/018 - Placebo (n=212), safinamide 50 mg/day (n=217) and 100 mg/day (n=216), and SETTLE - Placebo (n=270), safinamide 50-100 mg/day (n=273).
Slovenian: SE (Standard Error) - standardna napaka, SD (Standard deviation) - standardni odklon, LSM (Least Square Mean) - povprečje, izračunano po metodi najmanjših kvadratov, LS Diff. Least Square Difference vs Placebo - razlika, izračunana po najmanjših kvadratov, v primerjavi s placebom populacija mITT : študija 016/018 - placebo (n = 212), safinamid 50 mg/dan (n = 217) in 100 mg/dan (n = 216) ter SETTLE - placebo (n = 270), safinamid 50-100 mg/dan (n = 273).
English: A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with safinamide.
Slovenian: Pred začetkom zdravljenja s safinamidom je treba razmisliti o obdobju izpiranja, ki ustreza petim razpolovnim časom predhodno uporabljenega SSRI.
English: Somnolence and dizziness may occur during safinamide treatment; you should be cautious about operating hazardous machines or driving, until you are reasonably certain that Xadago does not affect you in any way.
Slovenian: Pri upravljanju z nevarnimi stroji ali vožnji morate biti previdni, dokler ne boste prepričani, da zdravilo Xadago na vas nima nobenega učinka.
English: Dyskinesia occurred early in treatment, was rated “severe”, led to discontinuation in very few patients (approx. 1.5%), and did not require reduction of dose in any patient.
Slovenian: 1,5 %) povzročila prekinitev zdravljenja, pri nobenem bolniku pa zaradi nje ni bilo potrebno zmanjšanje odmerka.
English: Warnings and precautions Talk to your doctor before taking Xadago - If you have liver problems - Patients and carers should be made aware that certain compulsive behaviours such as compulsions, obsessive thoughts, pathological gambling, increased libido, hypersexuality, impulsive behaviour and compulsive spending or buying have been reported with other medicines for Parkinson's disease.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Xadago se posvetujte z zdravnikom: - če imate težave z jetri; - bolnikom in negovalcem je treba povedati, da se lahko pri bolnikih, ki se zdravijo z drugimi zdravili za zdravljenje parkinsonove bolezni, pojavijo določene oblike kompulzivnega vedenja, vključno s kompulzijami, obsesivnimi mislimi, patološkim hazardiranjem, povečanim libidom, hiperseksualnostjo, impulzivnim vedenjem in kompulzivnim trošenjem denarja ali nakupovanjem; - pri sočasni uporabi zdravila Xadago in levodope se lahko pojavijo nenadzorovani sunkoviti gibi ali pa se ti poslabšajo;
English: Tabulated list of adverse reactions
Slovenian: Seznam neželenih reakcij v preglednici
English: Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors, such as hypertensive crisis (high blood pressure, collapse), neuroleptic malignant syndrome (confusion, sweating, muscle rigidity, hyperthermia, CPK increase), serotonin syndrome (confusion, hypertension, muscle stiffness, hallucinations), and hypotension.
Slovenian: Znano je, da se resni neželeni učinki pojavljajo ob sočasni uporabi SSRI, SNRI, tricikličnih/tetracikličnih antidepresivov in zaviralcev MAO, in sicer hipertenzivna kriza (visok krvni tlak, kolaps), nevroleptični maligni sindrom (zmedenost, znojenje, mišična rigidnost, hipertermija, zvišanje CPK), serotoninski sindrom (zmedenost, hipertenzija, mišična okorelost, halucinacije) in hipotenzija.
English: ON time without troublesome dyskinesia (hrs) (c) Baseline (b)
Slovenian: Obdobje »vklopa« brez moteče diskinezije (ure) (c) Izhodišče (b)
English: How to take Xadago
Slovenian: Kako jemati zdravilo Xadago
English: Microcrystalline cellulose Crospovidone type A Magnesium stearate Silica, colloidal anhydrous
Slovenian: Jedro tablete mikrokristalna celuloza krospovidon tipa A magnezijev stearat silicijev dioksid (koloidni brezvodni)
English: Xadago should not be used during pregnancy or by women of childbearing potential not practicing adequate contraception.
Slovenian: Zdravila Xadago se ne uporabljate pri nosečnicah in pri ženskah v rodni dobi, ki ne uporabljajo učinkovite kontracepcije.
English: Anaemia, leukopenia, red blood cell abnormality
Slovenian: Bolezni krvi in limfatičnega sistema anemija, levkopenija, nepravilnosti rdečih krvničk eozinofilija, limfopenija
English: UPDRS III (c) Baseline (b)
Slovenian: p-vrednost UPDRS III (c) Izhodišče (b)
English: Decreased appetite, hypertriglyceridaemia, increased appetite, hypercholesterolaemia, hyperglycaemia,
Slovenian: Presnovne in prehranske motnje zmanjšan apetit, hipertrigliceridemija, povečan apetit, hiperholesterolemija, hiperglikemija kaheksija, hiperkaliemija
English: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V. Tlf/Puh/Tel: + 47 815 300 30
Slovenian: Danmark/Norge/Suomi/Finland/Sverige Zambon Sweden, Filial of Zambon Nederland B.V.
English: Zambon Nederland B.V. Tel: + 31 (0)33 450 4370
Slovenian: Tel: + 31 (0)33 450 4370
English: Rare abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder disorientation, illusion, impulsive behaviour, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation
Slovenian: Psihiatrične motnje nespečnost halucinacije, depresija, nenormalne sanje, anksioznost, stanje zmedenosti, čustvena labilnost, povečan libido, psihotične motnje, nemir, motnje spanja kompulzije, delirij, dezorientiranost, iluzija, impulzivno vedenje, izguba libida, obsesivne misli, paranoja, prezgodnja ejakulacija, napadi spanca, socialna fobija, razmišljanje o samomoru
English: Safinamide
Slovenian: safinamid
English: C-safinamide accounted for approximately 30% of the total radioactivity AUC0-24h, indicative of an extensive metabolism.
Slovenian: Študija masnega ravnovesja je pokazala, da je plazemska vrednost AUC0-24 ur nespremenjenega 14C-safinamida znašala približno 30 % skupne radioaktivnosti vrednosti AUC0-24 ur, kar kaže na obsežno presnovo.
English: Urinary tract infection Bronchopneumonia, furuncle, nasopharyngitis, pyoderma, rhinitis, tooth infection, viral infection
Slovenian: Infekcijske in parazitske bolezni okužba sečil bronhopnevmonija, furunkel, nazofaringitis, pioderma, rinitis, okužba zoba, virusna okužba
English: Male rat fertility was not affected.
Slovenian: Na plodnost podganjih samcev to ni vplivalo.
English: Palpitations, tachycardia, sinus bradycardia, arrhythmia
Slovenian: Srčne bolezni palpitacije, tahikardija, sinusna bradikardija, aritmija miokardni infarkt
English: The following side effects have been reported in patients at a mid- to late-stage of Parkinson's disease (patients taking safinamide as add-on to levodopa alone or in combination with other medicines for Parkinson's disease):
Slovenian: Pri bolnikih s parkinsonovo boleznijo v srednjem do poznem stadiju (bolniki, ki so jemali safinamid kot dodatek levodopi sami ali v kombinaciji z drugimi zdravili za parkinsonovo bolezen), so poročali o naslednjih neželenih učinkih:
English: If you have taken too many Xadago tablets, you may develop raised blood pressure, anxiety, confusion, forgetfulness, sleepiness, lightheadedness; feel sick or be sick; dilated pupils or develop involuntary jerky movements.
Slovenian: Če ste vzeli večji odmerek zdravila Xadago, kot bi smeli Če ste vzeli preveč tablet zdravila Xadago, se lahko pri vas pojavi povečan krvni tlak, anksioznost, zmedenost, pozabljivost, zaspanost, vrtoglavica, občutek siljenja na bruhanje, bruhanje, razširjene zenice ali nehoteni sunkoviti gibi.
English: Each film-coated tablet contains safinamide methansulfonate equivalent to 50 mg safinamide.
Slovenian: Ena filmsko obložena tableta vsebuje safinamid metansulfonat v količini, ki ustreza 50 mg safinamida.
English: +) channels, and modulation of stimulated release of glutamate.
Slovenian: Safinamid je povezan z od stanja odvisnim zaviranjem napetostno odvisnih natrijevih (Na+) kanalčkov na način in modulacijo stimuliranega sproščanja glutamata.
English: Each film-coated tablet contains safinamide methansulfonate equivalent to 100 mg safinamide.
Slovenian: Ena filmsko obložena tableta vsebuje safinamid metansulfonat v količini, ki ustreza 100 mg safinamida.
English: If patients progress from moderate to severe hepatic impairment safinamide should be stopped (see section 4.4).
Slovenian: Če zmerna jetrna okvara pri bolnikih napreduje v hudo, je treba zdravljenje s safinamidom prekiniti (glejte poglavje 4.4).
English: Via Lillo del Duca 10 20091 Bresso (MI) - Italy
Slovenian: 20091 Bresso (MI) - Italija
English: Impulse control disorders; pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments.
Slovenian: Motnje nadzora impulzov; pri bolnikih, ki se zdravijo z dopaminskimi agonisti in/ali drugimi dopaminergičnimi zdravili se lahko pojavi patološko hazardiranje, povečan libido, hiperseksualnost, kompulzivno trošenje denarja ali nakupovanje, prenajedanje in kompulzivno nažiranje.
English: Studies in mid- to late-stage PD patients
Slovenian: Študije pri bolnikih s parkinsonovo boleznijo v srednjem do poznem stadiju
English: Renal impairment No change in dose is required for patients with renal impairment.
Slovenian: Spreminjanje odmerka zdravila pri bolnikih z okvaro ledvic ni potrebno.
English: Contusion, fat embolism, head injury, mouth injury, skeletal injury
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih padec fraktura stopala kontuzija, maščobna embolija, poškodba glave, poškodba ust, poškodba okostja
English: In vivo and in vitro pharmacodynamic drug interactions
Slovenian: Farmakodinamične interakcije med zdravili in vivo in in vitro
English: Some reports of ICDs have also been observed with other MAO-inhibitors.
Slovenian: O primerih motenj nadzora impulzov poročajo tudi v povezavi z drugimi zaviralci MAO.
English: Name and address of the manufacturer responsible for batch release
Slovenian: Ime in naslov izdelovalca biološke učinkovine
English: 95% CI p-value UPDRS II (c) Baseline (b)
Slovenian: p-vrednost UPDRS II (c) Izhodišče (b)
English: 20091 Bresso (MI) - Italy Tel: +39 02 665241
Slovenian: 20091 Bresso (MI) - Italija tel.: +39 02 665241 faks: +39 02 66501492 e-pošta: info.zambonspa@zambongroup.com
English: In vivo and in vitro pharmacokinetic drug interactions
Slovenian: Farmakokinetične interakcije med zdravili in vivo in in vitro
English: No dose adjustment is required in patients with mild hepatic impairment.
Slovenian: Prilagajanje odmerkov zdravila pri bolnikih z blago jetrno okvaro ni potrebno.
English: Arterial spasm, arteriosclerosis, hypertensive crisis
Slovenian: Žilne bolezni ortostatska hipotenzija hipertenzija, hipotenzija, krčne žile spazem arterije, arterioskleroza, hipertenzivna kriza
English: The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g. serotonin syndrome), although rare, that have occurred when SSRIs and dextromethorphan have been used with MAO inhibitors.
Slovenian: Ta previdnostni ukrep je povezan s pojavom resnih neželenih reakcij (npr. serotoninskega sindroma), do katerih je prihajalo, čeprav redko, pri uporabi SSRI in dekstrometorfana skupaj z zaviralci MAO.
English: Safinamide treatment has not been associated with any increase in the appearance of ICDs.
Slovenian: Pri zdravljenju s safinamidom zvišanja pojavnosti motnje nadzora impulzov niso opazili.
English: Erectile dysfunction Benign prostatic hyperplasia, breast disorder, breast pain
Slovenian: Motnje erektilna disfunkcija benigna hiperplazija
English: Orange to copper, round, biconcave, film-coated tablet of 7 mm diameter with metallic gloss, embossed with the strength “50” on one side of the tablet.
Slovenian: Oranžna do bakrena, okrogla, bikonkavna filmsko obložena tableta premera 7 mm s kovinskim sijajem in vtisnjeno jakostjo „50” na eni strani tablete.
English: Orange to copper, round, biconcave, film-coated tablet of 9 mm diameter with metallic gloss, embossed with the strength “100” on one side of the tablet.
Slovenian: Oranžna do bakrena, okrogla, bikonkavna filmsko obložena tableta premera 9 mm s kovinskim sijajem in vtisnjeno jakostjo „100” na eni strani tablete.
English: Xadago 100 mg are orange to copper, round, biconcave film-coated tablets 9 mm diameter with metallic gloss, embossed with “100” on one side of the tablet.
Slovenian: Xadago 100 mg so oranžne do bakrene barve, okrogle, bikonkavne filmsko obložene tablete premera 9 mm s kovinskim sijajem in vtisnjeno jakostjo „100“ na eni strani tablete.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Zambon S.p.A.
English: xadago 100 mg
Slovenian: PODATKI V BRAILLOVI PISAVI xadago 100 mg
English: Alopecia, blister, dermatitis contact, dermatosis, ecchymosis, lichenoid keratosis, night sweats, pain of skin, pigmentation disorder, psoriasis, seborrhoeic dermatitis
Slovenian: Bolezni kože in podkožja hiperhidroza, generalizirani pruritus, preobčutljivostne reakcije na svetlobo, eritem alopecija, mehurji, kontaktni dermatitis, dermatoza, ekhimoza, lihenoidna keratoza, nočno potenje, boleča koža, motnje pigmentiranosti, psoriaza, seboreični dermatitis
English: Xadago 50 mg film-coated tablets
Slovenian: Xadago 50 mg filmsko obložene tablet
English: Xadago 100 mg tablets safinamide
Slovenian: IME ZDRAVILA Xadago 100 mg tablete safinamid
English: Xadago 50 mg tablets safinamide
Slovenian: IME ZDRAVILA Xadago 50 mg tablete safinamid
English: Xadago 50 mg film-coated tablets Xadago 100 mg film-coated tablets
Slovenian: Xadago 50 mg filmsko obložene tablete Xadago 100 filmsko obložene tablete