FrancophonIA/ELRC3.0 huggingface dataset:
English: How to store Riluzole Zentiva Contents of the pack and other information
Croatian: Kako čuvati Riluzole Zentiva Sadržaj pakiranja i druge informacije
English: Please consult your doctor for more information about ALS and the reason why this medicine has been prescribed for you.
Croatian: Upitajte svog liječnika za više informacija o ALS-u i razlozima zašto
English: In this study, the efficacy was assessed on inability to walk alone, loss of upper limb function, tracheostomy, need for artificial ventilation, gastric tube feeding or death.
Croatian: U ovom je ispitivanju ocijenjena djelotvornost lijeka prema nemogućnosti samostalnog hoda, gubitku funkcije gornjih ekstremiteta, traheotomiji, potrebi za umjetnom ventilacijom, hranjenju putem želučane sonde ili smrti.
English: Film-coated tablet The tablets are capsule-shaped, white and engraved with “RPR 202” on one side.
Croatian: Filmom obložena tableta Tablete su u obliku kapsula, bijele, s utisnutom oznakom "RPR 202" na jednoj strani.
English: Tests on the major active metabolite of riluzole gave positive results in two in vitro tests.
Croatian: Od testova provedenih s glavnim aktivnim metabolitom riluzola, dva su testa in vitro dala pozitivne rezultate.
English: The AUC of riluzole after a single oral dose of 50 mg increases by about 1.7 fold in patients with mild chronic liver insufficiency and by about 3 fold in patients with moderate chronic liver insufficiency.
Croatian: AUC riluzola nakon jednokratne oralne doze od 50 mg povećava se približno 1,7 puta u bolesnika s blagom kroničnom insuficijencijom jetre, a približno 3 puta u bolesnika s umjerenom kroničnom insuficijencijom jetre.
English: The overall urinary excretion accounts for about 90% of the dose.
Croatian: Mokraćom se ukupno izluči oko 90% doze.
English: Riluzole is proposed to act by inhibiting glutamate processes.
Croatian: Riluzol vjerojatno djeluje tako da inhibira procese povezane s glutamatom.
English: Clinical experience with riluzole in pregnant women is lacking.
Croatian: Nema kliničkog iskustva s primjenom riluzola u trudnica.
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.
Croatian: diklofenak, diazepam, nicergolin, klomipramin, imipramin, fluvoksamin, fenacetin, teofilin, amitriptilin i kinoloni) mogu potencijalno smanjiti brzinu eliminacije riluzola, dok induktori CYP1A2 (npr. dim cigareta, hrana pripremljena na žaru, rifampicin i omeprazol) mogu povećati brzinu eliminacije riluzola.
English: What Riluzole Zentiva looks like and content of the pack
Croatian: Kako Riluzole Zentiva izgleda i sadržaj pakiranja
English: The tablets are film-coated, capsule-shaped and white.
Croatian: Tablete su obložene filmom, bijele boje, u obliku kapsula.
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.
Croatian: Primarni metabolički put za riluzol je početna oksidacija pomoću citokroma P450 1A2, pri kojoj nastaje N-hidroksiriluzol (RPR112512), najvažniji aktivni metabolit riluzola.
English: Riluzole should be discontinued if the ALT levels increase to 5 times the ULN.
Croatian: Primjena riluzola mora se obustaviti ako se razine ALT-a povise 5 puta iznad GGN.
English: Hepatic disease or baseline transaminases greater than 3 times the upper limit of normal.
Croatian: Bolest jetre ili početna vrijednost transaminaza više od 3 puta iznad gornje granice normalnih vrijednosti.
English: The active substance in Riluzole Zentiva is riluzole which acts on the nervous system.
Croatian: Djelatna tvar u lijeku Riluzole Zentiva je riluzol koji djeluje na živčani sustav.
English: The report of a febrile illness should prompt physicians to check white blood cell counts and to discontinue riluzole in case of neutropenia (see section 4.8).
Croatian: Prijava febrilne bolesti treba potaknuti liječnika da provjeri broj bijelih krvnih stanica i obustavi primjenu riluzola u slučaju neutropenije (vidjeti dio 4.8).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ALUMINIUM BLISTER
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP PVC/ALUMINIJSKI BLISTER
English: Safety and efficacy of Riluzole Zentiva has only been studied in ALS.
Croatian: Sigurnost primjene i djelotvornost lijeka Riluzole Zentiva ispitana je samo u ALS-u.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIŠTENOG LIJEKA ILI
English: Do not use this medicine after the expiry date which is stated on the carton and the blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza "Rok valjanosti".
English: Riluzole Zentiva is not recommended for use in patients with impaired renal function, as studies at repeated doses have not been conducted in this population (see section 4.4).
Croatian: Ne preporučuje se primjena lijeka Riluzole Zentiva u bolesnika s oštećenjem funkcije bubrega jer u ovoj populaciji nisu provedena ispitivanja s primjenom ponovljenih doza (vidjeti dio 4.4).
English: A clinical study conducted to evaluate the pharmacokinetics of riluzole and its metabolite N-hydroxyriluzole following repeated oral administration twice daily for 8 days in 16 healthy Japanese and 16 Caucasian adult males showed in the Japanese group a lower exposure of riluzole (Cmax 0.85 [90% CI 0.68-1.08] and AUC inf. 0.88 [90% CI 0.69-1.13]) and similar exposure to the metabolite.
Croatian: N-hidroksiriluzola nakon oralne primjene ponovljenih doza dva puta na dan tijekom 8 dana u 16 zdravih odraslih Japanaca i 16 zdravih odraslih muškaraca bijelaca pokazalo je manju izloženost riluzolu u skupini s japanskim ispitanicima (Cmax 0,85 [90% CI 0,68-1,08] i AUCinf. 0,88 [90% CI
English: If you forget to take Riluzole Zentiva
Croatian: Ako ste zaboravili uzeti Riluzole Zentiva
English: Riluzole Zentiva is contraindicated in pregnancy (see sections 4.3 and 5.3).
Croatian: Riluzole Zentiva je kontraindiciran u trudnoći (vidjeti dijelove 4.3 i 5.3).
English: ALT levels should be measured more frequently in patients who develop elevated ALT levels.
Croatian: ALT treba određivati češće u bolesnika u kojih se razine ALT-a povise.
English: Anaphylactoid reaction, angioedema
Croatian: Anafilaktoidna reakcija, angioedem
English: In patients treated with riluzole 100 mg/day, survival was significantly higher compared to patients who received placebo.
Croatian: U bolesnika liječenih riluzolom u dozi od 100 mg na dan preživljenje je bilo značajno dulje nego u bolesnika koji su dobivali placebo.
English: Clinical trials have demonstrated that Riluzole Zentiva extends survival for patients with ALS (see section 5.1).
Croatian: Klinička ispitivanja pokazala su da Riluzole Zentiva produljuje preživljenje u bolesnika s ALS-om (vidjeti dio 5.1).
English: Riluzole Zentiva is available in a pack of 28, 56, 98, 112 or 168 tablets to be taken orally.
Croatian: Riluzole Zentiva je dostupan u pakiranju od 28, 56, 98, 112 ili 168 tableta koje se uzimaju kroz usta.
English: Headache, dizziness, oral paraesthesia, somnolence
Croatian: Glavobolja, omaglica, parestezija usta, somnolencija
English: What Riluzole Zentiva is and what it is used for What Riluzole Zentiva is
Croatian: Što je Riluzole Zentiva i za što se koristi Što je Riluzole Zentiva
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Uputa je zadnji puta revidiranau {MM/GGGG}.
English: No studies on the effects on the ability to drive and use machines have been performed.
Croatian: Nisu provedena ispitivanja o djelovanju lijeka na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Farmakokinetika riluzola ispitana je u zdravih muških dobrovoljaca nakon oralne primjene jedne doze od 25 do 300 mg te nakon oralne primjene višekratnih doza od 25 do 100 mg dva puta na dan.
English: Each film-coated tablet contains 50 mg of riluzole.
Croatian: Jedna filmom obložena tableta sadrži 50 mg riluzola.
English: Not known
Croatian: Manje često Nepoznato
English: In lactating rats, 14C-riluzole was detected in milk.
Croatian: 14C-riluzol otkriven je u mlijeku ženki štakora u laktaciji.
English: Riluzole Zentiva is indicated to extend life or the time to mechanical ventilation for patients with amyotrophic lateral sclerosis (ALS).
Croatian: Riluzole Zentiva je indiciran za produljenje života ili vremena do uvođenja mehaničke ventilacije u bolesnika s amiotrofičnom lateralnom sklerozom (ALS).
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
Croatian: bolesnika (n=20) u kliničkim ispitivanjima kojima je ALT porastao više od 5 puta iznad GGN liječenje je prekinuto, a razine enzima su se u većini slučajeva vratile na manje od 2 puta iznad GGN u roku od 2 do 4 mjeseca (vidjeti dio 4.4).
English: Titanium dioxide (E171)
Croatian: hipromeloza makrogol 6000 titanijev dioksid (E171)
English: Package leaflet: Information for the user Riluzole Zentiva 50 mg film-coated tablets riluzole
Croatian: Uputa o lijeku: Informacije za korisnika Riluzole Zentiva 50 mg filmom obložene tablete riluzol
English: Riluzole should be prescribed with care in patients with a history of abnormal liver function, or in patients with slightly elevated serum transaminases (ALT/SGPT; AST/SGOT up to 3 times the upper limit of the normal range (ULN)), bilirubin and/or gamma-glutamyl transferase (GGT) levels.
Croatian: Oštećenje jetre Riluzol treba propisivati uz oprez bolesnicima s anamnezom poremećaja funkcije jetre kao i bolesnicima s blago povišenim vrijednostima serumskih transaminaza (ALT/SGPT ili AST/SGOT do 3 puta iznad gornje granice normalnih vrijednosti (GGN)), razina bilirubina i/ili gamaglutamiltransferaza (GGT).
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.
Croatian: Samo u jednom ispitivanju toksičnosti primijećena je veća incidencija odsutnosti žutih tijela u jajnicima ženki štakora kojima je primijenjen lijek u usporedbi s kontrolnom skupinom.
English: The active substance is riluzole.
Croatian: Djelatna tvar je riluzol.
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.
Croatian: U kliničkim ispitivanjima faze III provedenima u bolesnika s ALS-om liječenih riluzolom najčešće prijavljene nuspojave bile su astenija, mučnina i odstupanja od normalnih vrijednosti testova funkcije jetre.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Croatian: DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO ROK VALJANOSTI
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.
Croatian: U dvostruko slijepom, placebom kontroliranom ispitivanju za procjenu djelotvornosti i sigurnosti primjene riluzola u japanskih bolesnika, 204 bolesnika je randomizirano u skupinu koja je primala riluzol u dozi od 100 mg na dan (50 mg dva puta na dan) ili u skupinu koja je primala placebo te su praćeni tijekom 18 mjeseci.
English: Baseline elevations of several liver function tests (especially elevated bilirubin) should preclude the use of riluzole (see section 4.8).
Croatian: Povišene vrijednosti nekoliko parametara pretraga funkcije jetre prije početka liječenja (osobito povišen bilirubin) isključuju primjenu riluzola (vidjeti dio 4.8).
English: There is no experience with dose reduction or rechallenge in patients who have developed an increase of ALT to 5 times ULN.
Croatian: Nema iskustva sa smanjivanjem doze niti ponovnim uvođenjem lijeka u bolesnika u kojih je ALT porastao 5 puta iznad GGN.
English: Riluzole Zentiva is used in patients with amyotrophic lateral sclerosis (ALS).
Croatian: Riluzole Zentiva se koristi u bolesnika koji boluju od amiotrofične lateralne skleroze (ALS).
English: Because of the risk of hepatitis, serum transaminases, including ALT, should be measured before and during therapy with riluzole.
Croatian: Zbog rizika od hepatitisa, prije i tijekom liječenja riluzolom treba određivati vrijednosti serumskih transaminaza, uključujući ALT.
English: Cases of interstitial lung disease have been reported in patients treated with riluzole, some of them were severe (see section 4.8).
Croatian: U bolesnika liječenih riluzolom prijavljeni su slučajevi intersticijske bolesti pluća, od kojih su neki bili teški (vidjeti dio 4.8).
English: It is not known whether riluzole is excreted in human milk.
Croatian: Nije poznato izlučuje li se riluzol u majčino mlijeko u ljudi.
English: In vitro studies using human liver microsomal preparations suggest that CYP 1A2 is the principal isozyme involved in the initial oxidative metabolism of riluzole.
Croatian: Istraživanja in vitro s preparatima mikrosoma ljudske jetre ukazuju na to da je CYP1A2 glavni izoenzim uključen u početni oksidativni metabolizam riluzola.
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.
Croatian: Kod primjene višekratnih doza (10 dana liječenja s 50 mg riluzola dva puta na dan), nepromijenjeni se riluzol kumulira u plazmi približno dvostruko više, a stanje dinamičke ravnoteže postiže se za manje od 5 dana.
English: In the pregnant rat, the transfer of 14C-riluzole across the placenta to the foetus has been detected.
Croatian: U skotnih ženki štakora otkriven je prijenos 14C-riluzola kroz placentu u plod.
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).
Croatian: Vrlo česte nuspojave lijeka Riluzole Zentiva (mogu se javiti u više od 1 na 10 osoba) su: umor mučnina povišene razine nekih jetrenih enzima (transaminaza) u krvi.
English: The median survival time approached 16.5 months versus 13.5 months for riluzole 100 mg/day and placebo, respectively.
Croatian: Medijan vremena preživljenja iznosio je 16,5 mjeseci za riluzol 100 mg na dan, odnosno 13,5 mjeseci za placebo.
English: In a dose-ranging trial, 959 patients with ALS were randomised to one of four treatment groups: riluzole 50, 100, 200 mg/day, or placebo and were followed-up for 18 months.
Croatian: U ispitivanju za određivanje raspona doza, 959 bolesnika s ALS-om randomizirano je u jednu od četiri terapijske skupine: riluzol u dozi od 50, 100 ili 200 mg na dan ili placebo te su praćeni tijekom
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.
Croatian: 100 mg na dan (50 mg dva puta dnevno) ili placebo te su praćeni tijekom 12 do 21 mjeseca.
English: Neurological and psychiatric symptoms, acute toxic encephalopathy with stupor, coma, and methaemoglobinaemia have been observed in isolated cases.
Croatian: U izoliranim slučajevima opaženi su neurološki i psihijatrijski simptomi, akutna toksična encefalopatija uz stupor, koma te methemoglobinemija.
English: There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Croatian: Nema dokaza da Riluzole Zentiva ima terapijski učinak na motoričku funkciju, funkciju pluća,
English: Riluzole Zentiva 50 mg film-coated tablets
Croatian: Riluzole Zentiva 50 mg filmom obložene tablete
English: How to take Riluzole Zentiva
Croatian: Kako uzimati Riluzole Zentiva
English: In vitro studies using human liver preparations demonstrated that cytochrome P450 1A2 is the principal isoenzyme involved in the metabolism of riluzole.
Croatian: Istraživanja in vitro s preparatima ljudske jetre pokazala su da je citokrom P450 1A2 glavni izoenzim uključen u metabolizam riluzola.
English: Name and address of the manufacturers responsible for batch release
Croatian: Nazivi i adrese proizvođača odgovorno za puštanje serije lijeka u promet
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.
Croatian: U ispitivanjima subakutne i kronične toksičnosti u štakora i majmuna povremeno su zabilježeni smanjenje parametara crvenih krvnih stanica i/ili promjene jetrenih parametara.
English: Patients who are pregnant or breast-feeding.
Croatian: Trudnoća i dojenje.
English: How to store Riluzole Zentiva
Croatian: Kako čuvati Riluzole Zentiva
English: Tracheostomy-free survival in patients treated with riluzole did not differ significantly from placebo.
Croatian: Preživljenje bez traheotomije nije se značajno razlikovalo između bolesnika liječenih riluzolom i bolesnika koji su primali placebo.
English: Core: anhydrous dibasic calcium phosphate, micro crystalline cellulose, anhydrous colloidal silica, magnesium stearate, croscarmellose sodium;
Croatian: Jezgra: kalcijev hidrogenfosfat, bezvodni celuloza, mikrokristalična silicijev dioksid, koloidni, bezvodni magnezijev stearat karmelozanatrij, umrežena
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.
Croatian: Nakon oralne primjene jednokratne doze od 50 mg riluzola nema značajne razlike u farmakokinetičkim parametrima između bolesnika s umjerenom ili teškom kroničnom insuficijencijom bubrega (klirens kreatinina između 10 i 50 ml/min) i zdravih dobrovoljaca.
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.
Croatian: ako nastupi neki od sljedećih simptoma: žutilo kože ili bjeloočnica (žutica), svrbež po cijelom tijelu, mučnina ili povraćanje, jer to mogu biti znakovi bolesti jetre (hepatitisa).
English: Riluzole Zentiva 50 mg film-coated tablets riluzole
Croatian: Riluzole Zentiva 50 mg filmom obložene tablete riluzol
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
Croatian: Česte nuspojave lijeka Riluzole Zentiva (mogu se javiti u manje od 1 na 10 osoba) su: omaglica utrnulost ili trnci u ustima povraćanje pospanost ubrzano kucanje srca proljev glavobolja bol u trbuhu bol Manje česte nuspojave lijeka Riluzole Zentiva (mogu se javiti u manje od 1 na 100 osoba) su: anemija alergijske reakcije upala gušterače (pankreatitis).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Croatian: PRILOG II. A. PROIZVOĐAČ(I) ODGOVORAN(ODGOVORNI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: The pharmacokinetic parameters of riluzole after multiple dose administration (4.5 days of treatment at 50 mg riluzole bid) are not affected in the older people (>70 years).
Croatian: U starijih bolesnika (> 70 godina) nema utjecaja na farmakokinetičke parametre riluzola nakon primjene višekratnih doza (4,5 dana liječenja riluzolom u dozi od 50 mg dva puta na dan).
English: Diarrhoea, abdominal pain, vomiting
Croatian: Proljev, bol u abdomenu,
English: What Riluzole Zentiva is used for
Croatian: Za što se koristi Riluzole Zentiva
English: Studies at repeated doses have not been conducted in patients with impaired renal function (see section
Croatian: Ispitivanja s primjenom ponovljenih doza nisu provedena u bolesnika s oštećenjem bubrežne funkcije
English: Unchanged riluzole is the main component in plasma and is extensively metabolised by cytochrome P450 and subsequent glucuronidation.
Croatian: Glavni sastojak u plazmi je nepromijenjeni riluzol, koji se opsežno metabolizira pomoću citokroma
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
Croatian: mučnina, povraćanje ako Vam bubrezi ne rade dobro ako dobijete vrućicu: ona može biti posljedica smanjenog broja bijelih krvnih stanica, što može povećati rizik od infekcije
English: if you are pregnant or breast-feeding.
Croatian: ako ste trudni ili dojite.
English: Tel: + 48 22 375 92 00
Croatian: Zentiva Polska Sp. z o.o. Tel: + 48 22 375 92 00
English: even if their signs of illness are the same as yours.
Croatian: Može im naškoditi, čak i ako su njihovi znakovi bolestijednaki Vašima.
English: INSTRUCTIONS ON USE 16.
Croatian: 15. UPUTE ZA UPORABU 16. PODACI NA BRAILLEOVOM PISMU
English: Manufacturers
Croatian: FARMACEUTSKI
English: Core
Croatian: VAŽNO
English: Inhalation use Blister (alu) 3 inhalers (3 x 30 doses) (multipack)
Croatian: 3 inhalatora (3 x 30 doza) (višekratno pakiranje)
English: Date of first authorisation: 17 september 2018
Croatian: Datum prvog odobrenja: 17 rujna 2018
English: Always use this medicine exactly as your doctor has told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Do not warm in any other way.
Croatian: Nemojte otopinu zagrijavati ni na koji drugi način.
English: This is because it has not yet been evaluated in this group of patients.
Croatian: To je zato što još nije procijenjen u ovoj skupini bolesnika.
English: • Wash your hands thoroughly with soap and water.
Croatian: • Temeljito operite ruke sapunom i vodom.
English: Maximum concentration was reached at 6.2 days after injection.
Croatian: Maksimalna koncentracija postignuta je 6,2 dana nakon injekcije.
English: Most of the following side effects are mild.
Croatian: Većina sljedećih nuspojava su blage.
English: You may see 1 or 2 drops of liquid and that is okay.
Croatian: Možda ugledate jednu ili dvije kapi tekućine, no to je u redu.
English: In this short period, a risk to the newborns/infants cannot be excluded.
Croatian: U tom kratkom razdoblju ne može se isključiti rizik za novorođenče/dojenče.
English: Patients were 18 to 82 years old, with a mean age of 45.9.
Croatian: Bolesnici su bili u dobi od 18 do 82 godine, s prosječnom dobi od 45,9 godina.
English: Week 12 (2 doses)*
Croatian: Tjedan 12 (2 doze)*
English: Your doctor will decide for how long you need to take Ilumetri.
Croatian: Vaš liječnik će odrediti koliko ćete dugo trebati uzimati Ilumetri.
English: However, the physician should ensure appropriate follow-up of patients.
Croatian: Međutim, liječnik mora osigurati odgovarajuće praćenje bolesnika.
English: **These patients were switched to placebo at week 28.
Croatian: **Ovi bolesnici su prešli na placebo u 28. tjednu.
English: - If you currently have an infection or if you have long-term or repeated infections.
Croatian: - ako trenutno imate infekciju ili ste imali dugotrajne ili ponavljajuće infekcije.
English: These include vaccines and immunosuppressants (medicines that affect the immune system).
Croatian: To uključuje cjepiva i imunosupresivne lijekove (lijekove koji utječu na imunološki sustav).