FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: In a double-blind placebo-controlled trial designed to assess the efficacy and safety of riluzole in Japanese patients, 204 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 18 months.
Slovenian: V dvojno slepem, s placebom kontroliranem preskušanju za oceno učinkovitosti in varnosti riluzola pri japonskih bolnikih so 204 bolnike randomizirali na riluzol 100 mg/dan (50 mg dvakrat na dan) ali placebo in jih spremljali 18 mesecev.
English: In phase III clinical studies conducted in ALS patients treated with riluzole, the most commonly reported adverse reactions were asthenia, nausea and abnormal liver function tests.
Slovenian: V kliničnih študijah III faze opravljenih pri bolnikih z ALS, so bili najpogostejši z riluzolom povezani neželeni učinki astenija, navzeja in nenormalni testi jetrnih funkcij.
English: Tablets are packaged in opaque pvc/aluminium blister cards.
Slovenian: Tablete so pakirane v neprosojne pretisne omote iz PVC in aluminija.
English: Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Slovenian: Zdravilo Riluzol Zentiva je na voljo v pakiranjih s 28, 56, 98, 112 ali 168 tabletami in ga jemljemo z zaužitjem.
English: Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Slovenian: Zdravilo Riluzol Zentiva je kontraindicirano med nosečnostjo (glejte poglavji 4.3 in 5.3).
English: In a single toxicity study, the absence of corpora lutea was noted at a higher incidence in the ovary of treated compared to control female rats.
Slovenian: V eni sami študiji toksičnosti so pri podganjih samicah v skupini, ki je prejela zdravilo pogosteje ugotavljali odsotnost corpora lutea kot v primerjalni skupini.
English: Glucuronides accounted for more than 85% of the metabolites in the urine.
Slovenian: Več kot 85 % presnovkov v urinu je glukuronidov.
English: Common side effects (may affect up to 1 in 10 people) of Riluzole Zentiva are: dizziness numbness or tingling of the mouth vomiting sleepiness increase in heart beat diarrhoea headache abdominal pain pain
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) zdravila Riluzol Zentiva so: omotica odrevenelost ali mravljinčavost ust bruhanje zaspanost pospešen srčni utrip driska glavobol bolečine v trebuhu bolečine
English: Not known
Slovenian: Pogostost neznana
English: There is no significant difference in pharmacokinetic parameters between patients with moderate or severe chronic renal insufficiency (creatinine clearance between 10 and 50 ml.min-1) and healthy volunteers after a single oral dose of 50 mg riluzole.
Slovenian: Po enkratnem peroralnem odmerku 50 mg riluzola ni značilnih razlik v farmakokinetičnih parametrih med bolniki z zmerno ali hudo ledvično odpovedjo (očistek kreatinina med 10 in 50 ml.min-1) in zdravimi prostovoljci.
English: Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
Slovenian: V posameznih primerih so opazili nevrološke in psihiatrične simptome, akutno toksično encefalopatijo s stuporjem, komo in methemoglobinemijo.
English: Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Slovenian: O dodatnih informacijah o ALS in o razlogu, zakaj ste dobili to zdravilo, se prosimo posvetujte s svojim zdravnikom.
English: Tracheostomy-free survival in patients treated with riluzole did not differ significantly from placebo.
Slovenian: Preživetje brez traheostomije se pri bolnikih, zdravljenih z riluzolom, ni značilno razlikovalo od tistega pri bolnikih, ki so dobivali placebo.
English: How to store Riluzole Zentiva Contents of the pack and other information
Slovenian: Shranjevanje zdravila Riluzol Zentiva Vsebina pakiranja in dodatne informacije
English: IMPORTANT Tell your doctor immediately if you experience any fever (increase in temperature) because Riluzole Zentiva may cause a decrease in the number of white blood cells.
Slovenian: - če imate vročino (zvišanje telesne temperature), saj zdravilo Riluzol Zentiva lahko povzroči znižanje števila belih krvnih celic.
English: ALS is a form of motor neurone disease where attacks of the nerve cells responsible for sending instructions to the muscles lead to weakness, muscle waste and paralysis.
Slovenian: ALS je ena od bolezni motoričnega nevrona, kjer pride do propada živčnih celic, ki so odgovorne za pošiljanje navodil mišicam.
English: In patients (n=20) from clinical studies with increases in ALT to more than 5 times the ULN, treatment was discontinued and the levels returned to less than 2 times the ULN within 2 to 4 months in most cases (see section
Slovenian: sodelujočih v kliničnih študijah, z zvišano ALT več kot 5 kratno ULN je bilo zdravljenje prekinjeno in v večini primerov so se koncentracije znižale na manj kot 2 kratno ULN v 2 do 4 mesecih (glejte poglavje 4.4).
English: What Riluzole Zentiva looks like and content of the pack
Slovenian: Izgled zdravila Riluzol Zentiva in vsebina pakiranja
English: Riluzole Zentiva is not recommended for use paediatric population, due to a lack of data on the safety and efficacy of riluzole in any neurodegenerative diseases occurring in children or adolescents.
Slovenian: Pediatrična populacija Zaradi pomanjkanja podatkov o varnosti in učinkovitosti riluzola, pri katerikoli nevrodegenerativni bolezni otrok in mladostnikov, uporaba zdravila Riluzol Zentiva pri pediatrični populaciji ni priporočljiva.
English: Uncommon side effects (may affect up to 1 in 100 people) of Riluzole Zentiva are: anaemia allergic reactions inflammation of the pancreas (pancreatitis).
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) zdravila Riluzol Zentiva so: - slabokrvnost - alergijske reakcije - vnetje trebušne slinavke (pankreatitis).
English: Anaphylactoid reaction, angioedema
Slovenian: Bolezni imunskega sistema anafilaktoidna reakcija, angioedem
English: Česká republika
Slovenian: Češka republika
English: Riluzole Zentiva is contraindicated in breast-feeding women (see sections 4.3 and 5.3).
Slovenian: Dojenje Zdravilo Riluzol Zentiva je kontraindicirano pri ženskah, ki dojijo (glejte poglavji 4.3 in 5.3).
English: Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Slovenian: Če se raven ALT zviša na 5-kratno vrednost ULN, je treba uporabo riluzola prekiniti.
English: ALT should be measured every month during the first 3 months of treatment, every 3 months during the remainder of the first year, and periodically thereafter.
Slovenian: Zaradi tveganja za hepatitis je treba pred začetkom zdravljenja z riluzolom in med zdravljenjem z njim določati serumske transaminaze, vključno z ALT. ALT je treba prve 3 mesece zdravljenja določiti vsak mesec, preostanek prvega leta na 3 mesece, pozneje pa v rednih presledkih.
English: LIST OF EXCIPIENTS PHARMACEUTICAL FORM AND CONTENTS
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA
English: Each package contains 28, 56, 98, 112 or 168 tablets.
Slovenian: Eno pakiranje vsebuje 28, 56, 98, 112 ali 168 tablet Na trgu morda ni vseh navedenih pakiranj.
English: In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Slovenian: Pri brejih podganah je ugotovljeno prehajanje 14C-riluzola prek placente v plod.
English: The other ingredients are:
Slovenian: - Pomožne snovi v tabletah so:
English: - Keep this leaflet.
Slovenian: (glejte poglavje
English: The pharmacokinetics of riluzole have been evaluated in healthy male volunteers after single oral administration of 25 to 300 mg and after multiple-dose oral administration of 25 to 100 mg bid.
Slovenian: Farmakokinetiko riluzola so ovrednotili pri zdravih moških prostovoljcih po enkratni peroralni uporabi odmerkov od 25 do 300 mg in po večkratni peroralni uporabi odmerkov od 25 do 100 mg dvakrat na dan. Koncentracija v plazmi narašča linearno z odmerkom in farmakokinetični profil je neodvisen od odmerka.
English: Reductions in red blood cell parameters and/or alterations in liver parameters were noted inconsistently in subacute and chronic toxicity studies in rats and monkeys.
Slovenian: Občasno so v subakutnih in kroničnih študijah toksičnosti pri podganah in opicah opažali zmanjšanje parametrov eritrocitov in/ali spremembe jetrnih parametrov.
English: What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
Slovenian: Kaj je zdravilo Riluzol Zentiva in za kaj ga uporabljamo Kaj je zdravilo Riluzol Zentiva
English: Riluzole Zentiva 50 mg film-coated tablets
Slovenian: Riluzol Zentiva 50 mg filmsko obložene tablete
English: With multiple dose administration (10 day-treatment at 50 mg riluzole bid), unchanged riluzole accumulates in plasma by about 2 fold and steady-state is reached in less than 5 days.
Slovenian: Ob uporabi z večkratnim odmerjanjem (10-dnevno zdravljenje s 50 mg riluzola dvakrat na dan) se nespremenjeni riluzol kopiči v plazmi do približno 2-krat višjih koncentracij od tistih pri posamičnem odmerjanju.
English: How to take Riluzole Zentiva
Slovenian: Kako jemati zdravilo Riluzol Zentiva
English: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Slovenian: Jedro: brezvodni kalcijev hidrogenfosfat, mikrokristalna celuloza, brezvodni koloidni silicijev dioksid, magnezijev stearat, premreženi natrijev karmelozat;
English: In a trial, 155 patients were randomised to riluzole 100 mg/day (50 mg twice daily) or placebo and were followed-up for 12 to 21 months.
Slovenian: V preskušanju so od 12 do 21 mesecev spremljali 155 bolnikov, randomiziranih na 100 mg riluzola/dan (50 mg dvakrat na dan) ali na placebo.
English: What you need to know before you take Riluzole Zentiva Do not take Riluzole Zentiva if you are allergic to riluzole or any of the other ingredients of this medicine (listed in section if you have any liver disease or increased blood levels of some enzymes of the liver (transaminases),
Slovenian: - če ste alergični na riluzol ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če imate katero od bolezni jeter ali zvišanje krvnih koncentracij določenih jetrnih encimov
English: Dibasic calcium phosphate, anhydrous Micro crystalline cellulose Colloidal silica, anhydrous Magnesium stearate Croscarmellose sodium
Slovenian: Jedro brezvodni kalcijev hidrogenfosfat mikrokristalna celuloza brezvodni koloidni silicijev dioksid magnezijev stearat premreženi natrijev karmelozat
English: This leaflet was last approved in {MM/YYYY}.
Slovenian: Navodilo je bilo nazadnje revidirano dne
English: Inhibitors of CYP 1A2 (e.g. caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine, fluvoxamine, phenacetin, theophylline, amitriptyline and quinolones) could potentially decrease the rate of riluzole elimination, while inducers of CYP 1A2 (e.g. cigarette smoke, charcoal-broiled food, rifampicin and omeprazole) could increase the rate of riluzole elimination.
Slovenian: amitriptilin in kinoloni) bi potencialno lahko upočasnili eliminacijo riluzola, induktorji CYP 1A2 (npr. cigaretni dim, nad ogljem pečena hrana, rifampicin in omeprazol) pa bi jo lahko pospešili.
English: Abnormal liver function tests
Slovenian: žolčnika in žolčevodov nenormalni testi jetrnih funkcij hepatitis
English: If respiratory symptoms develop such as dry cough and/or dyspnoea, chest radiography should be performed, and in case of findings suggestive of interstitial lung disease (e.g. bilateral diffuse lung opacities), riluzole should be discontinued immediately.
Slovenian: Če se pojavijo simptomi na dihalih, npr. suh kašelj in/ali dispneja, je treba narediti rentgenogram prsnih organov.
English: The primary metabolic pathway for riluzole is initial oxidation by cytochrome P450 1A2 producing N-hydroxy-riluzole (RPR112512), the major active metabolite of riluzole.
Slovenian: Primarna presnovna pot riluzola je uvodna oksidacija s citokromom P450 1A2, s čimer nastane N
English: Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Slovenian: V velikem obsegu se presnavlja s citokromom P450 in poznejšo glukuronidacijo.
English: Diarrhoea, abdominal pain, vomiting
Slovenian: Bolezni prebavil navzea diareja, bolečine v trebuhu, bruhanje pankreatitis
English: There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN.
Slovenian: Pri bolnikih, ki so doživeli porast ALT na 5-kratno vrednost ULN, ni izkušenj z zmanjšanjem odmerka ali ponovnim poskusom zdravljenja.
English: You can drive or use any tools or machines, unless you feel dizzy or light headed after taking this medicine.
Slovenian: Če po jemanju zdravila Riluzol Zentiva niste omotični ali vrtoglavi, lahko vozite ali upravljate s kakršnimikoli orodji ali stroji.
English: Titanium dioxide (E171)
Slovenian: Obloga hipromeloza makrogol 6000 titanov dioksid (E 171)
English: The active substance is riluzole.
Slovenian: - Zdravilna učinkovina je riluzol.
English: Riluzole Zentiva 50 mg film-coated tablets riluzole
Slovenian: Riluzol Zentiva 50 mg filmsko obložene tablete riluzol
English: Oral use
Slovenian: NAVODILA ZA UPORABO
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijska bolezen pljuč
English: Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Slovenian: Pri bolnikih z okvarjenim delovanjem ledvic študije s ponavljajočimi odmerki niso bile izvedene (glejte poglavje 4.2).
English: if you are pregnant or breast-feeding.
Slovenian: - če ste noseči ali dojite.
English: Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Slovenian: Navodilo za uporabo Riluzol Zentiva 50 mg filmsko obložene tablete riluzol
English: What Riluzole Zentiva is used for
Slovenian: Za kaj uporabljamo zdravilo Riluzol Zentiva
English: Headache, dizziness, oral paraesthesia, somnolence
Slovenian: Bolezni živčevja glavobol, omotica, peroralna parestezija in somnolenca
English: How to store Riluzole Zentiva
Slovenian: Shranjevanje zdravila Riluzol Zentiva
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Slovenian: PVC/ALUMINIJASTI PRETISNI OMOT
English: The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Slovenian: Mediana časa preživetja bolnikov, ki so dobivali 100 mg riluzola/dan, je bil 16,5 meseca, in tistih, ki so dobivali placebo, 13,5 meseca.
English: Other side effects
Slovenian: DRUGI PODATKI
English: In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Slovenian: da je P450 1A2 glavni izoencim, ki sodeluje v presnovi riluzola.
English: if you experience any of the following symptoms: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick, as this may be signs of liver disease (hepatitis).Your doctor may do regular blood tests while you are taking Riluzole Zentiva to make sure that this does not occur.
Slovenian: Da se bo vaš zdravnik prepričal, da ni prišlo do pojava teh simptomov, vam bo morda med zdravljenjem z zdravilom Riluzol Zentiva opravljal redne preiskave krvi.
English: Nervous system disorders
Slovenian: Okvarjeno delovanje jeter
English: Very common side effects (may affect more than 1 in 10 people) of Riluzole Zentiva are: tiredness feeling sick increased blood levels of some enzymes of the liver (transaminases).
Slovenian: Drugi neželeni učinki Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov) zdravila Riluzol
English: Talk to your doctor before taking Riluzole Zentiva: if you have any liver problems: yellowing of your skin or the white of your eyes (jaundice), itching all over, feeling sick, being sick if your kidneys are not working very well if you have any fever: it may be due to a low number of white blood cells which can cause an increased risk of infection
Slovenian: - če imate vročino: pojavi se lahko zaradi znižanega števila belih krvnih celic, kar lahko poveča tveganje za okužbo
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema anemija huda nevtropenija (glejte poglavje
English: Core
Slovenian: C.
English: Coating
Slovenian: Odmerjanje
English: Inhalation use Blister (alu) 3 inhalers (3 x 30 doses) (multipack)
Slovenian: Za inhaliranje Pretisni omot (alu) 3 inhalatorji (3 x 30 odmerkov) (skupno pakiranje)
English: Strength Pharmaceutical form
Slovenian: Farmacevtska oblika Pot uporabe Stična ovojnina Velikost pakiranja
English: Wash your hands
Slovenian: Umijte si roke
English: Collect all the materials you need
Slovenian: Zberite ves material, ki ga potrebujete
English: Date of first authorisation: 17 september 2018
Slovenian: Datum prve odobritve: 17. september 2018
English: This leaflet was last revised in April 2019 Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano aprila 2019 Drugi viri informacij
English: Do not warm in any other way.
Slovenian: Zdravila ne ogrevajte na noben drug način.
English: • Wash your hands thoroughly with soap and water.
Slovenian: • Roke si temeljito umijte z milom in vodo.
English: You may see 1 or 2 drops of liquid and that is okay.
Slovenian: Morda boste videli 1 ali 2 kapljici tekočine, to je v redu.
English: Air bubbles may be present; there is no need to remove them.
Slovenian: Morda so prisotni zračni mehurčki; teh ni treba odstraniti.
English: Number of patients PASI 75a (%)
Slovenian: Število bolnikov PASI 75a (%)
English: EXP Removal from refrigerator date:
Slovenian: EXP Datum odstranitve iz hladilnika:
English: Maximum concentration was reached at 6.2 days after injection.
Slovenian: Največja koncentracija je bila dosežena 6,2 dneva po injiciranju.
English: Patients were 18 to 82 years old, with a mean age of 45.9.
Slovenian: Bolniki so bili stari od 18 do 82 let s povprečno starostjo 45,9.
English: These include vaccines and immunosuppressants (medicines that affect the immune system).
Slovenian: To vključuje cepiva in imunosupresive (zdravila, ki vplivajo na delovanje imunskega sistema).
English: Your symptoms may return upon discontinuation.
Slovenian: Vaši simptomi se lahko po prekinitvi vrnejo.
English: In humans, during the first few days after birth antibodies may be transferred to the newborns through milk.
Slovenian: Pri ljudeh se v prvih nekaj dneh po rojstvu protitelesa lahko prenesejo v novorojenca prek mleka.
English: **These patients were switched to placebo at week 28.
Slovenian: **Ti bolniki so v 28. tednu prešli na placeb.
English: Look out for infections and allergic reactions
Slovenian: Bodite pozorni na okužbe in alergijske reakcije
English: Quality of Life/Patient-reported Outcomes
Slovenian: Kakovost življenja/izidi zdravljenja, kot jih poročajo bolniki
English: n = number of patients in the full analysis set for which data was available, after imputation when applicable.
Slovenian: n = število bolnikov v celotni množici za analizo, za katero so bili podatki razpoložljivi, po imputaciji, kjer je primerno.
English: Maintenance of Response
Slovenian: Ohranjanje odziva
English: Week 12 (2 doses)*
Slovenian: 12 teden (2 odmerka)*
English: This is because it has not yet been evaluated in this group of patients.
Slovenian: Zdravila namreč v tej skupini bolnikov še niso ocenili.
English: Wait for 30 minutes (if stored in the refrigerator)
Slovenian: Počakajte 30 minut (če je shranjeno v hladilniku)
English: The effects of this medicine in pregnant women are not known.
Slovenian: Učinki tega zdravila na nosečnice niso znani.
English: Important points to know
Slovenian: Pomembne točke za upoštevanje
English: One month after birth, the milk/serum ratio was ≤0.002.
Slovenian: En mesec po rojstvu je bilo razmerje med mlekom in serumom ≤ 0,002.
English: A small air bubble may be apparent: this is normal.
Slovenian: Morda bo viden majhen zračni mehurček, to je normalno.
English: Population PK analysis indicated a 31% higher bioavailability in healthy subjects compared to patients.
Slovenian: Populacijska FK analiza je pokazala 31 % večjo biološko razpoložljivost pri zdravih osebah v primerjavi z bolniki.
English: These 355 patients on placebo were subsequently crossed over to tildrakizumab.
Slovenian: Teh 355 bolnikov, ki so prejemali placebo, je pozneje prešlo na tildrakizumab.
English: Thereafter, resume dosing at the regularly scheduled interval.
Slovenian: Nato z odmerjanjem nadaljujte v rednih načrtovanih intervalih.
English: No data are available on the response to live or inactivated vaccines.
Slovenian: Podatki o odzivu na živa ali inaktivirana cepiva niso razpoložljivi.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 28 weeks.
Slovenian: Pri nekaterih bolnikih z začetnim delnim odzivom se stanje ob nadaljevanju zdravljenja, daljšem kot 28 tednov, lahko izboljša.
English: In patients with certain characteristics (e.g. high disease burden, body weight ≥ 90 kg) 200 mg may provide greater efficacy.
Slovenian: Pri bolnikih z nekaterimi značilnostmi (npr. veliko breme bolezni, telesna masa ≥ 90 kg) morda večjo učinkovitost zagotavlja 200 mg.
English: The safety and efficacy of Ilumetri in combination with other immunosupressive agents, including biologics, or phototherapy has not been evaluated.
Slovenian: Varnosti in učinkovitosti zdravila Ilumetri v kombinaciji z drugimi imunosupresivi, vključno z biološkimi, ali fototerapijo, niso ovrednotili.
English: The liquid should be clear.
Slovenian: Tekočina mora biti bistra.
English: Your doctor will decide for how long you need to take Ilumetri.
Slovenian: Vaš zdravnik se bo odločil, kako dolgo morate uporabljati zdravilo Ilumetri.
English: In this short period, a risk to the newborns/infants cannot be excluded.
Slovenian: Tveganja za dojenega novorojenčka/otroka ne moremo izključiti.
English: Proportion of Patients with PASI 90 response over time up to Week 64 (Full Analysis Set Part 3*)
Slovenian: Delež bolnikov z odzivom PASI 90 glede na čas do 64. tedna (celotna množica za analizo, 3. del*)
English: The clinical significance of these findings is unknown.
Slovenian: Klinična značilnost teh izsledkov ni znana.
English: Pre-treatment evaluation for tuberculosis
Slovenian: Ocena tuberkuloze pred zdravljenjem
English: A total of 15.4% of study patients had a history of psoriatic arthritis.
Slovenian: Skupaj je 15,4 % bolnikov v študiji imelo v anamnezi psoriatični artritis.
English: Stop using Ilumetri and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction (see 4.
Slovenian: Prenehajte uporabljati zdravilo Ilumetri in se takoj povejte zdravniku ali poiščite zdravniško pomoč, če opazite kakršne koli znake, ki kažejo na možno resno okužbo ali alergijsko reakcijo (glejte poglavje 4.
English: Studies in mouse tumor models showed that selective inhibition of IL-23p19 does not increase carcinogenic risk.
Slovenian: Študije na modelih tumorja pri miših kažejo, da selektivno zaviranje IL-23p19 ne poveča kancerogenega tveganja.
English: Very common side effects (may affect more than 1 in 10 people): - Upper respiratory infections
Slovenian: Zelo pogosti neželeni učinki (pojavijo se lahko pri več kot 1 od 10 bolnikov): - okužba zgornjih dihal
English: • Take a carton pack out of the refrigerator and place the original and unopened carton pack on a clean and flat working surface.
Slovenian: • Škatlo vzemite iz hladilnika in položite originalno in zaprto kartonsko pakiranje na čisto in ravno delovno površino.