FrancophonIA/ELRC3.0 huggingface dataset:
English: Parareg is a medicine containing the active substance cinacalcet.
Slovenian: Parareg je zdravilo, ki vsebuje zdravilno učinkovino cinakalcet.
English: The results of the additional studies supported the use of Parareg for hypercalcaemia in patients with primary hyperparathyroidism.
Slovenian: Rezultati dodatnih študij so podprli uporabo zdravila Parareg pri zdravljenju hiperkalciemije pri bolnikih s primarnim hiperparatiroidizmom.
English: For the full list of all side effects reported with Parareg, see the Package Leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Parareg, glejte navodilo za uporabo.
English: Parareg is used in patients with serious kidney disease who need dialysis to clear their blood of waste products.
Slovenian: Zdravilo Parareg se uporablja pri bolnikih s hudim obolenjem ledvic, ki za očiščenje odpadnih snovi iz krvi potrebujejo dializo.
English: Parareg has been studied in three main studies involving 1,136 dialysis patients with serious kidney disease.
Slovenian: Zdravilo Parareg so preučevali v treh glavnih študijah, ki so vključevale 1136 dializnih bolnikov s hudim obolenjem ledvic.
English: Why has Parareg been approved?
Slovenian: Zakaj je bilo zdravilo Parareg odobreno?
English: Once a maintenance dose has been established, calcium levels should be measured monthly and PTH levels should be measured every one to three months.
Slovenian: Ko je vzdrževalni odmerek določen, je treba ravni kalcija meriti enkrat na mesec, ravni paratiroidnega hormona pa vsakih en do tri mesece.
English: The dose is adjusted every two to four weeks, according the patient's PTH levels, up to a maximum of 180 mg once a day.
Slovenian: Odmerek se prilagodi vsake dva do štiri tedne v skladu z bolnikovimi ravnmi paratiroidnega hormona do maksimalno 180 mg enkrat dnevno.
English: Parareg brought about a 42% reduction in PTH levels compared with an increase of 8% in patients taking placebo.
Slovenian: Zdravilo Parareg je zmanjšalo ravni paratiroidnega hormona za 42 % v primerjavi s povečanjem za 8 % pri bolnikih, ki so jemali placebo.
English: ‘Secondary' means that the hyperparathyroidism is caused by another condition.
Slovenian: „Sekundarni“ pomeni, da hiperparatiroidizem nastane kot posledica drugega bolezenskega stanja.
English: The main measure of effectiveness was the number of patients who had a reduction in blood calcium levels of more than 1 mg per decilitre by the time a maintenance dose had been found (between two and 16 weeks after the start of the study).
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, pri katerih so se ravni kalcija v krvi zmanjšale za več kot 1 mg na deciliter do trenutka, ko so zdravniki uspeli ugotoviti vzdrževalni odmerek (med drugim im 16. tednom po začetku študije).
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the recommended starting dose of Parareg for adults is 30 mg twice a day.
Slovenian: Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom je priporočeni začetni odmerek zdravila Parareg za odrasle 30 mg dvakrat dnevno.
English: The main measure of effectiveness was the number of patients who had a PTH level below 250 micrograms per litre at the end of the study.
Slovenian: Glavno merilo učinkovitosti je bilo število bolnikov, ki so imeli ob koncu študije raven paratiroidnega hormona pod 250 mikrogramov na liter.
English: The active substance in Parareg, cinacalcet, is a calcimimetic agent.
Slovenian: Zdravilna učinkovina v zdravilu Parareg, cinakalcet, je kalcimimetično sredstvo.
English: • to reduce hypercalcaemia (high blood calcium levels) in patients with parathyroid carcinoma (cancer of the parathyroid glands), or in patients with primary hyperparathyroidism who cannot have their parathyroid glands removed or when the doctor thinks that removal of the parathyroid glands is not appropriate.
Slovenian: • za zmanjšanje hiperkalciemije (visokih ravni kalcija v krvi) pri bolnikih s paratiroidnim karcinomom (rakom obščitnic) ali pri bolnikih s primarnim hiperparatiroidizmom, pri katerih odstranitev obščitnic ni možna, ali za katere zdravnik meni, da odstranitev obščitnic zanje ni primerna.
English: Parareg has also been studied in a study involving 46 patients with hypercalcaemia, including 29 with parathyroid carcinoma and 17 with primary hyperparathyroidism who could not have their parathyroid glands removed or in whom surgery to remove the parathyroid glands was not effective.
Slovenian: Zdravilo Parareg so preučevali tudi v študiji, ki je vključevala 46 bolnikov s hiperkalciemijo, od tega 29 bolnikov s paratiroidnim karcinomom in 17 bolnikov s primarnim hiperparatiroidizmom, pri katerih ni bilo mogoče odstraniti obščitnic ali pri katerih kirurška odstranitev obščitnic ni bila učinkovita.
English: In dialysis patients with serious kidney disease, about 40% of the patients taking Parareg had PTH levels below 250 micrograms/l at the end of the study, compared with about 6% of those taking placebo.
Slovenian: Pri dializnih bolnikih s hudim obolenjem ledvic je imelo približno 40 % bolnikov, ki so jemali zdravilo Parareg, ob koncu študije ravni paratiroidnega hormona pod 250 mikrogramov na liter, v primerjavi s 6 % bolnikov, ki so prejemali placebo.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Parareg's benefits are greater than its risks for the treatment of secondary hyperparathyroidism in patients with end-stage renal disease on maintenance dialysis therapy, and for the reduction of hypercalcaemia in patients with parathyroid carcinoma or primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels but in whom parathyroidectomy is not clinically appropriate or is contraindicated.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Parareg večje od z njim povezanih tveganj pri zdravljenju sekundarnega hiperparatiroidizma pri dializnih bolnikih s končno odpovedjo ledvic na vzdrževalnem dializnem zdravljenju in za zmanjšanje hiperkalciemije pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom, pri katerih bi bila kirurška odstranitev obščitnic indicirana na osnovi ravni kalcija v krvi, vendar pa taka odstranitev zanje ni klinično ustrezna ali je kontraindicirana.
English: The most common side effects with Parareg in secondary hyperparathyroidism (seen in more than 1 patient in 10) are nausea (feeling sick) and vomiting.
Slovenian: Najpogostejša neželena učinka zdravila Parareg pri zdravljenju sekundarnega hiperparatiroidizma (opažena pri več kot 1 izmed 10 bolnikov) sta navzeja (slabost) in bruhanje.
English: A further three studies compared the effectiveness of Parareg and placebo in a total of 136 patients with primary hyperparathyroidism over up to a year.
Slovenian: nadaljnjih treh študijah so v času do enega leta primerjali učinkovitost zdravila Parareg z učinkovitostjo placeba pri skupno 136 bolnikih s primarnim hiperparatiroidizmom.
English: Parareg was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Parareg so primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: PTH levels should be assessed at least 12 hours after dosing and one to four weeks after each dose adjustment of Parareg.
Slovenian: Ravni paratiroidnega hormona je treba izmeriti najmanj 12 ur po zaužitju odmerka in en do štiri tedne po vsaki prilagoditvi odmerka zdravila Parareg.
English: In patients with parathyroid carcinoma or primary hyperparathyroidism, the side effects are similar to those seen in patients with long-standing kidney disease - the most frequent side effects are nausea and vomiting.
Slovenian: Pri bolnikih s paratiroidnim karcinomom ali primarnim hiperparatiroidizmom so neželeni učinki podobni tistim, opaženim pri bolnikih z dolgotrajnim obolenjem ledvic: najpogostejša neželena učinka sta navzeja (slabost) in bruhanje.
English: Cinacalcet works by increasing the sensitivity of the calcium-sensing receptors on the parathyroid glands that regulate PTH secretion.
Slovenian: Cinakalcet deluje tako, da poveča občutljivost receptorjev za zaznavanje kalcija, ki se nahajajo na obščitnicah in uravnavajo izločanje paratiroidnega hormona.
English: By increasing the sensitivity of these receptors, cinacalcet leads to a reduction in the production of PTH by the parathyroid glands.
Slovenian: Cinakalcet s povečanjem občutljivosti teh receptorjev zmanjša tvorbo paratiroidnega hormona v obščitnicah.
English: How has Parareg been studied?
Slovenian: Kako je bilo zdravilo Parareg raziskano?
English: What is Parareg used for?
Slovenian: Za kaj se zdravilo Parareg uporablja ?
English: What is Parareg?
Slovenian: Kaj je zdravilo Parareg?
English: The full EPAR for Parareg is available here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Parareg je na voljo tukaj.
English: How does Parareg work?
Slovenian: Kako zdravilo Parareg deluje?
English: How is Parareg used?
Slovenian: Kako se zdravilo Parareg uporablja?
English: In some cases, patients were hospitalised.
Slovenian: V nekaterih primerih so bili bolniki hospitalizirani.
English: This means that the impact of your condition on daily activities, relationships and other factors should be less than it was before.
Slovenian: To pomeni, da bi moral biti vpliv vašega stanja na vsakodnevne dejavnosti, odnose in druge dejavnike manjši kot prej.
English: *NRI: None responder imputation.
Slovenian: *NRI: opredeljeni kot neodzivni (None Responder Imputation).
English: • if you are pregnant or think you may be pregnant.
Slovenian: • če ste noseči ali mislite, da bi lahko bili noseči.
English: *At least one of these adverse reactions was reported as serious
Slovenian: *O vsaj enem od teh neželenih učinkov so poročali, da je bil resen.
English: Apremilast is not genotoxic.
Slovenian: Apremilast ni genotoksičen.
English: Do not take a dose
Slovenian: ne vzemite odmerka
English: Physical function and health-related quality of life
Slovenian: Telesne funkcije in z zdravjem povezana kakovost življenja
English: • allergic reaction
Slovenian: • alergična reakcija,
English: • feeling tired
Slovenian: • občutek utrujenosti,
English: Take the next dose at your regular time.
Slovenian: Naslednji odmerek vzemite ob rednem času.
English: Not known side effects (frequency cannot be estimated from the available data):
Slovenian: Neželeni učinki z neznano pogostnostjo (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti):
English: • rifampicin - an antibiotic used for tuberculosis
Slovenian: • rifampicin - antibiotik, ki se uporablja za tuberkulozo,
English: No re-titration is required after initial titration.
Slovenian: Ponovno titriranje po začetnem titriranju ni potrebno.
English: • The ‘treatment initiation pack' is clearly labelled to make sure you take the correct tablet at the correct time.
Slovenian: • ‘Pakiranje za začetek zdravljenja' je jasno označeno, da boste zagotovo vzeli pravo tableto ob pravem času.
English: • The ‘treatment initiation pack' will also contain enough tablets for another 8 days at the recommended dose (days 7 to 14).
Slovenian: • ‘Pakiranje za začetek zdravljenja' bo vsebovalo tudi dovolj tablet še za nadaljnjih 8 dni ob priporočenem odmerku (7. do 14. dan).
English: You will only ever need to go through this stage of gradually increasing your dose once even if you re-start treatment.
Slovenian: Skozi ta stadij postopnega večanja odmerka boste morali iti samo enkrat, tudi če boste ponovno začeli z zdravljenjem.
English: Apremilast was studied in young and elderly healthy subjects.
Slovenian: Apremilast so proučevali pri mladih in starejših zdravih preskušancih.
English: • You can take the tablets either with or without food.
Slovenian: • Tablete lahko jemljete s hrano ali brez nje.
English: • Your treatment will start at a lower dose and will gradually be increased over the first 6 days of treatment.
Slovenian: • Vaše zdravljenje se bo začelo z manjšim odmerkom, ki se bo prvih 6 dni zdravljenja postopoma povečeval.
English: • Take Otezla at about the same time each day, one tablet in the morning and one tablet in the evening.
Slovenian: • Zdravilo Otezla vzemite vsak dan približno ob istem času, eno tableto zjutraj in eno tableto zvečer.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); not known (cannot be estimated from the available data).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Please see additional warning in section 4.4 for patients who are underweight at beginning of treatment.
Slovenian: Oglejte si tudi dodatna opozorila v poglavju 4.4 za bolnike, ki imajo v začetku zdravljenja premajhno telesno maso.
English: Due to the study design the duration of re-treatment was variable, and ranged from 2.6 to 22.1 weeks.
Slovenian: Zaradi zasnove študije je bilo trajanje ponovnega zdravljenja spremenljivo in je trajalo od 2,6 do 22,1 tedna.
English: The mean apparent volume of distribution (Vd) is 87 L, indicative of extravascular distribution.
Slovenian: Povprečni navidezni volumen porazdelitve (Vd) je 87 l, kar kaže na ekstravaskularno porazdelitev.
English: Human plasma protein binding of apremilast is approximately 68%.
Slovenian: Na beljakovine humane plazme se veže približno 68 % apremilasta.
English: • loss of appetite
Slovenian: • izguba apetita,
English: • The active substance is apremilast.
Slovenian: • Učinkovina je apremilast.
English: Approximately one-third of patients had not received prior phototherapy, conventional systemic or biologic therapy.
Slovenian: Približno ena tretjina bolnikov ni prejela predhodne fototerapije, konvencionalne sistemske ali biološke terapije.
English: Most events occurred within the first few weeks of treatment.
Slovenian: Največ dogodkov se je pojavilo v prvih nekaj tednih zdravljenja.
English: Take the medicine pack and this leaflet with you.
Slovenian: Škatlo z zdravilom in to navodilo vzemite s seboj.
English: Concomitant treatment with biologic DMARDs, including TNF blockers, was not allowed.
Slovenian: Sočasno zdravljenje z biološkimi DMARDs, vključno z zaviralci TNF, ni bilo dovoljeno.
English: The safety and efficacy of apremilast in children aged 0 to 17 years have not been established.
Slovenian: Varnost in učinkovitost apremilasta pri otrocih, starih 0 do 17 let, nista bili dokazani.
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: PRILOGA II A. IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA
English: In the event of overdose, symptomatic and supportive care is advised.
Slovenian: V primeru prevelikega odmerjanja se svetuje simptomatska in podporna oskrba.
English: These studies had a similar design through week 32.
Slovenian: Ti študiji sta bili do 32. tedna podobno oblikovani.
English: • if you are allergic to apremilast or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na apremilast ali katero koli sestavino tega zdravila (navedeno v poglavju 6);
English: These GI adverse reactions generally occur within the first 2 weeks of treatment and usually resolve within 4 weeks.
Slovenian: Ti GI neželeni učinki se na splošno pojavljajo v prvih 2 tednih zdravljenja in navadno izzvenijo v 4 tednih.
English: Your doctor will talk to you about how to increase your dose when you first start taking Otezla.
Slovenian: Zdravnik se bo pogovoril z vami o tem, kako boste večali odmerek, ko boste prvič začeli jemati zdravilo Otezla.
English: The median duration of PsA disease was 5 years.
Slovenian: Mediana trajanja bolezni PsA je bila 5 let.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing)
Slovenian: • huda alergijska reakcija (lahko vključuje otekanje obraza, ustnic, ust, jezika ali žrela, ki lahko povzroči oteženo dihanje ali požiranje).
English: Apremilast is associated with an increased risk of psychiatric disorders such as insomnia and depression.
Slovenian: Apremilast je povezan s povečanim tveganjem za psihiatrične motnje, kot sta nespečnost in depresivnost.
English: These improvements were maintained at week 24.
Slovenian: Ta izboljšanja so po 24 tednih še vedno trajala.
English: No fertility data is available in humans.
Slovenian: Pri ljudeh podatkov o plodnosti ni na voljo.
English: A risk to the breastfed infant cannot be excluded, therefore apremilast should not be used during breast-feeding.
Slovenian: Tveganja za dojenega otroka ni mogoče izključiti, zato se apremilasta med dojenjem ne sme uporabljati.
English: Long-term experience in open-label extension studies with apremilast was generally comparable to the 52-week studies.
Slovenian: Dolgoročne izkušnje v odprtih podaljšanih študijah z apremilastom so bile na splošno primerljive z 52-tedenskimi študijami.
English: If a patient shows no evidence of therapeutic benefit after 24 weeks, treatment should be reconsidered.
Slovenian: Če bolnik po 24 tednih ne kaže znakov, da mu zdravljenje koristi, je treba ponovno premisliti o zdravljenju.
English: A total of 18% of patients had a history of psoriatic arthritis.
Slovenian: Vsega skupaj je 18 % bolnikov imelo anamnezo psoriatičnega artritisa.
English: Placebo 30 mg twice daily APR*
Slovenian: placebo 30 mg dvakrat na dan APR*
English: What Otezla is and what it is used for
Slovenian: Kaj je zdravilo Otezla in za kaj ga uporabljamo
English: The film-coated tablets should be swallowed whole, and can be taken either with or without food.
Slovenian: Filmsko obložene tablete je treba pogoltniti cele, lahko se jih jemlje s hrano ali brez nje.
English: Genotoxicity studies
Slovenian: Študije genotoksičnosti
English: • You should continue taking Otezla until your doctor tells you to stop.
Slovenian: • Nadaljujte z jemanjem zdravila Otezla, dokler vam zdravnik ne naroči, da ga nehajte jemati.
English: The exposure in elderly subjects (65 to 85 years of age) is about 13% higher in AUC and about 6% higher in Cmax for apremilast than that in young subjects (18 to 55 years of age).
Slovenian: Izpostavljenost pri starejših osebah (starih 65 do 85 let) je okrog 13 % večja v AUC in okrog 6 % večja v Cmax za apremilast kot pri mladih preskušancih (starih 18 do 55 let).
English: An initial titration schedule is required as shown below in Table 1.
Slovenian: Potreben je začetni titracijski načrt, kot je prikazan v preglednici 1 v nadaljevanju.
English: Total Daily Dose
Slovenian: Celotni dnevni odmerek
English: The patient's response to treatment should be evaluated on a regular basis.
Slovenian: Bolnikov odziv na zdravljenje je treba ocenjevati v rednih presledkih.
English: Detailed and updated information on this medicine is available by scanning the QR code on the outer packaging with a smartphone.
Slovenian: Podrobne in posodobljene informacije o tem zdravilu so na voljo, če s pametnim telefonom na zunanji ovojnini skenirate kodo QR.
English: • suicidal ideation or behaviour
Slovenian: • samomorilne misli ali vedenje.
English: Similar response rates were observed across all weight ranges.
Slovenian: Podobne stopnje odzivnosti so ugotavljali v vseh podskupinah.
English: • When you first start taking Otezla, you will receive a ‘treatment initiation pack' which contains all the doses as listed in the table below.
Slovenian: • Ko boste prvič začeli jemati zdravilo Otezla, boste prejeli ‘pakiranje za začetek zdravljenja', ki vsebuje vse odmerke, navedene v preglednici v nadaljevanju.
English: Sun as symbol for morning dose Moon as symbol for evening dose Refer to the wallet card for daily dose
Slovenian: Sonce kot simbol za jutranji odmerek Mesec kot simbol za večerni odmerek Za dnevni odmerek glejte zgibanko.
English: Apremilast was used as a monotherapy (34.8%) or in combination with stable doses of small molecule DMARDs (65.2%).
Slovenian: Apremilast so uporabljali kot monoterapijo (34,8 %) ali v kombinaciji s stabilnimi odmerki nizkomolekularnih DMARDs (65,2 %).
English: • Do not stop taking Otezla without talking to your doctor first.
Slovenian: • Ne prenehajte jemati zdravila Otezla, ne da bi se prej posvetovali z zdravnikom.
English: • Do not use this medicine if you notice any damage or signs of tampering to the medicine packaging.
Slovenian: • Ne uporabljajte tega zdravila, če opazite poškodbe ali znake odpiranja ovojnine zdravila.
English: Pregnancy should be excluded before treatment can be initiated.
Slovenian: Preden se lahko uvede zdravljenje, je treba izključiti nosečnost.
English: QR code to be included www.otezla-eu-pil.com
Slovenian: Vsebuje QR kodo www.otezla-eu-pil.com
English: • If you miss a dose of Otezla, take it as soon as you remember.
Slovenian: • Če pozabite vzeti odmerek zdravila Otezla, ga vzemite, takoj ko se spomnite.
English: Before starting treatment with Otezla, inform your doctor if you are suffering from symptoms of worsening depression with suicidal thinking or behaviour, especially if you take any additional medicines since some of those could increase the probability of these side effects.
Slovenian: Pred začetkom zdravljenja z zdravilom Otezla povejte zdravniku, če imate simptome slabšajoče se depresivnosti s samomorilnimi mislimi ali vedenjem, zlasti če jemljete dodatna zdravila, saj nekatera med njimi lahko povečajo verjetnost za te neželene učinke.
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To vključuje zdravila brez recepta in zdravila rastlinskega izvora.
English: If your condition has not improved after six months of treatment, you should talk to your doctor.
Slovenian: Če se vaša bolezen po šestih mesecih zdravljenja ne izboljša, se posvetujte z zdravnikom.
English: Carcinogenicity studies in mice and rats showed no evidence of carcinogenicity related to treatment with apremilast.
Slovenian: Študije kancerogenosti pri miših in podganah niso pokazale znakov kancerogenosti, povezane s terapijo z apremilastom.
English: Day 8 - Day 14
Slovenian: 8. dan - 14. dan
English: During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment.
Slovenian: Med ključnimi preskušanji so opazili največje izboljšanje v prvih 24 tednih zdravljenja.
English: If patients miss a dose, the next dose should be taken as soon as possible.
Slovenian: Če bolnik izpusti odmerek, mora čimprej vzeti naslednji odmerek.
English: None of these patients had overt clinical consequences resulting from weight loss.
Slovenian: Nobeden od teh bolnikov ni imel očitnih kliničnih posledic, ki bi jih povzročila izguba telesne mase.
English: • phenytoin, phenobarbital and carbamazepine - medicines used in the treatment of seizures or epilepsy
Slovenian: • fenitoin, fenobarbital in karbamazepin - zdravila, ki se uporabljajo pri zdravljenju epileptičnih napadov ali epilepsije,
English: Psoriatic arthritis and psoriasis are usually lifelong conditions and there is currently no cure.
Slovenian: Psoriatični artritis in psoriaza sta običajno vseživljenjski bolezni, za kateri trenutno ni zdravila.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 January 2015
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. januar 2015 Datum zadnjega podaljšanja: 23. avgust 2019
English: Psoriasis is an inflammatory disease of the skin, which can cause red, scaly, thick, itchy, painful patches on your skin and can also affect your scalp and nails.
Slovenian: Psoriaza je vnetna bolezen kože, ki lahko povzroča rdeče, luskaste, debele, srbeče, boleče krpe na koži in lahko prizadene tudi lasišče in nohte.