FrancophonIA/ELRC3.0 huggingface dataset:
English: PRAC concluded that these adverse reactions could be causally associated with Zinbryta.
Croatian: PRAC je zaključio da ove nuspojave mogu biti uzročno povezane s lijekom Zinbryta.
English: • The PRAC considered the procedure under Article 20 of Regulation (EC) No 726/2004 resulting from pharmacovigilance data for Zinbryta, in particular the need for provisional measures in accordance with Article 20(3) of Regulation (EC) No 726/2004, taking into account the grounds set out in Articles 116 and 117 of Directive 2001/83/EC.
Croatian: Uredbe (EZ) br. 726/2004 koji je proizašao iz podataka o farmakovigilanciji za lijek Zinbryta, posebno u pogledu potrebe donošenja privremenih mjera u skladu s člankom 20. stavkom 3. Uredbe (EZ) br. 726/2004, uzimajući u obzir osnove utvrđene u člancima 116. i 117.
English: Autoimmune haemolytic anemia is already known to be related to daclizumab beta treatment.
Croatian: Već je poznato da je autoimuna hemolitička anemija povezana s liječenjem daklizumabom beta.
English: Daclizumab beta is hypothesized to exert its activity in MS through immunomodulatory mechanisms.
Croatian: Za daklizumab beta pretpostavlja se da djeluje na MS kroz imunomodulatorne mehanizme.
English: It was noted that there are ongoing clinical studies for which the MAH informed PRAC that the treatment with daclizumab beta is to be stopped.
Croatian: Navedeno je da se provode klinička ispitivanja za koja je nositelj odobrenja za stavljanje u promet izvijestio PRAC da je potrebno prekinuti liječenje daklizumabom beta.
English: Administration of acute corticosteroids and/or plasmapheresis did not improve the clinical situation, brain biopsies were obtained, which showed an unexpected finding of massive inflammation with eosinophilic granulocytes (unexpected in MS patients).
Croatian: Primjena akutnih kortikosteroida ili plazmafereze nije poboljšala kliničku situaciju, provedene su biopsije mozga, koje su pokazale neočekivani nalaz jake upale s eozinofilnim granulocitima (neočekivano kod bolesnika s MS-om).
English: Daclizumab beta is a humanised IgG1 monoclonal antibody that modulates IL-2 signalling by blocking CD25-dependent, high affinity IL-2 receptor signalling, resulting in higher levels of IL-2 available for signalling through the intermediate-affinity IL-2 receptor.
Croatian: Daklizumab beta je humanizirano IgG1 monoklonalno antitijelo koje modulira signaliziranje IL-2 blokiranjem signaliziranja putem IL-2 receptora visokog afiniteta ovisnog o CD25, što dovodi do viših razina IL-2 na raspolaganju za signaliziranje putem IL-2 receptora intermedijarnog afiniteta.
English: • The PRAC recommended to suspend the use and the marketing authorisation for Zinbryta, and to recall all the batches of the medicinal product from the market up to the level of pharmacies and hospitals.
Croatian: • PRAC je preporučio obustavu uporabe i odobrenja za stavljanje u promet za lijek Zinbryta te opoziv svih serija lijeka s tržišta do razine ljekarni i bolnica.
English: Some of these patients did not improve despite treatment with corticosteroids and/or plasmapheresis in these patients brain biopsies were obtained, which showed an unexpected finding of massive inflammation with eosinophilic granulocytes.
Croatian: Kod nekih od ovih bolesnika nije došlo do poboljšanja unatoč liječenju kortikosteroidima ili plasmafereza je provedena u biopsijama mozga ovih bolesnika, koja je pokazala neočekivani nalaz jake upale s eozinofilnim granulocitima.
English: Daclizumab beta binds to the alpha-subunit (CD25) of the high-affinity interleukin-2 (IL-2) receptor.
Croatian: Daklizumab beta se veže na alfa-subunit (CD25) receptora interleukina-2 (IL-2) visokog afiniteta.
English: More information concerning these immune-mediated events had been requested to the MAH to be submitted in the third PSUR.
Croatian: Od nositelja odobrenja za stavljanje u promet zatraženo je da u trećem PSUR-u dostavi više informacija koje se odnose na ove imunološki posredovane događaje.
English: Grounds for PRAC recommendation
Croatian: Razlozi za preporuku PRAC-a Budući da:
English: This effect is probably mediated through excess of IL-2 produced by activated T cells that cannot bind to high affinity IL-2 receptors, but is available to bind to intermediate IL-2 receptors.
Croatian: T stanice, koji se ne može vezati na IL-2 receptore visokog afiniteta, ali je dostupan za vezanje na IL-2 receptore intermedijarnog afiniteta.
English: The doctor may decide to stop treatment if the condition does not improve after 28 weeks.
Croatian: Liječnik može odlučiti prekinuti liječenje ako se stanje ne popravi nakon 28 tjedana.
English: Further information on Ilumetri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Ilumetri nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose is one 100 mg injection, followed by a further dose after 4 weeks and then an injection every 12 weeks.
Croatian: Preporučena doza je 100 mg u jednoj injekciji, nakon koje se po isteku četiri tjedna daje nova doza, a nakon toga jedna injekcija svakih 12 tjedana.
English: Patients do not experience many side effects.
Croatian: Bolesnici nemaju mnogo nuspojava.
English: What measures are being taken to ensure the safe and effective use of Ilumetri?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Ilumetri?
English: After training, patients may inject Ilumetri themselves if the doctor considers it appropriate.
Croatian: Nakon obuke bolesnici mogu sami ubrizgavati lijek Ilumetri ako to liječnik smatra primjerenim.
English: Information on the use of Ilumetri in the long term is limited and studies are ongoing.
Croatian: Informacije o dugoročnoj upotrebi lijeka Ilumetri ograničene su, a ispitivanja su u tijeku.
English: What is Ilumetri and what is it used for?
Croatian: Što je Ilumetri i za što se primjenjuje?
English: The dose may be increased to 200 mg in certain patients, for example patients badly affected by the disease or with bodyweight over 90 kg.
Croatian: Doza se može povećati na 200 mg u određenih bolesnika, na primjer u bolesnika u kojih su simptomi vrlo ozbiljni ili koji imaju više od 90 kg.
English: Other information about Ilumetri
Croatian: Ostale informacije o lijeku Ilumetri
English: Interleukin 23 is a substance that controls the growth and maturation of some types of T cells.
Croatian: Interleukin 23 je tvar koja upravlja rastom i sazrijevanjem nekih vrsta T-stanica.
English: Headache, gastroenteritis (diarrhoea and vomiting), nausea (feeling sick), diarrhoea, pain at the site of the injection and back pain may affect up to 1 in 10 people.
Croatian: Glavobolja, gastroenteritis (proljev i povraćanje), mučnina (slabost), proljev, bol na mjestu injekcije i bol u leđima mogu se javiti u manje od 1 do 10 osoba.
English: The most common side effects with Ilumetri are upper respiratory tract (nose and throat) infections (which may affect more than 1 in 10 people).
Croatian: Najčešće nuspojave lijeka Ilumetri su upale gornjih dišnih putova (nos i grlo) (mogu se javiti u više od 1 na 10 osoba).
English: Ilumetri must not be used in patients who have a serious ongoing infection such as tuberculosis.
Croatian: Ilumetri se ne smije primjenjivati u bolesnika koji u vrijeme primjene imaju ozbiljne infekcije, na primjer tuberkulozu.
English: Side effects reported with Ilumetri are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Ilumetri pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: These T cells, which are part of the immune system (the body's natural defences), are involved in causing inflammation that is linked to the development of plaque psoriasis.
Croatian: Te T-stanice, koje čine dio imunosnog sustava (prirodnog obrambenog mehanizma tijela) pridonose nastanku upale koja je povezana sa stvaranjem plak psorijaze.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ilumetri have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Ilumetri nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: The European Medicines Agency decided that Ilumetri's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Ilumetri nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: As for all medicines, data on the use of Ilumetri are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Ilumetri kontinuirano se prate.
English: The active substance in Ilumetri, tildrakizumab, is a monoclonal antibody (a type of protein) which is designed to attach to interleukin 23 and block its activity.
Croatian: Djelatna tvar lijeka Ilumetri, tildrakizumab, monoklonsko je protutijelo (vrsta bjelančevine) osmišljeno da se veže na interleukin 23 i onemogućuje njegovo djelovanje.
English: An overview of Ilumetri and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Ilumetri i zašto je odobren u EU-u
English: What are the risks associated with Ilumetri?
Croatian: Koji su rizici povezani s lijekom Ilumetri?
English: It is used in adults with moderate to severe disease for whom treatments applied to the skin are not suitable.
Croatian: Koristi se u odraslih osoba s umjerenom do teškom bolešću u kojih nije prikladno liječenje primjenom na kožu.
English: The second study involving 1,090 patients compared Ilumetri with placebo and with etanercept (another psoriasis medicine).
Croatian: U drugom ispitivanju u kojem je sudjelovalo 1090 bolesnika uspoređivao se lijek Ilumetri s placebom i etanerceptom (drugi lijek protiv psorijaze).
English: Why is Ilumetri authorised in the EU?
Croatian: Zašto je lijek Ilumetri odobren u EU-u?
English: By blocking the action of interleukin 23, Ilumetri reduces inflammation and symptoms associated with the disease.
Croatian: Ilumetri onemogućuje djelovanje interleukina 23 i tako smanjuje upalu i simptome povezane s tom bolešću.
English: The first study involving 771 patients compared Ilumetri with placebo (a dummy treatment).
Croatian: U prvom je ispitivanju sudjelovao 771 bolesnik, a uspoređivao se lijek Ilumetri s placebom (prividnim liječenjem).
English: Ilumetri is effective in treating psoriasis and some patients can experience total clearing of their psoriasis.
Croatian: Ilumetri je djelotvoran u liječenju psorijaze, a u nekih bolesnika može doći do potpunog nestanka psorijaze.
English: How does Ilumetri work?
Croatian: Kako djeluje Ilumetri?
English: For more information about using Ilumetri, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Ilumetri pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: Ilumetri can only be obtained with a prescription and should be used under the supervision of a doctor experienced in diagnosing and treating plaque psoriasis.
Croatian: Lijek Ilumetri izdaje se samo na liječnički recept i namijenjen je za primjenu pod nadzorom liječnika s iskustvom u dijagnosticiranju i liječenju plak psorijaze.
English: Two main studies involving adults found Ilumetri effective for treating moderate to severe plaque psoriasis in patients for whom treatments applied to the skin did not work well enough.
Croatian: U dvama glavnim ispitivanjima koja su obuhvatila odrasle osobe utvrđeno je da je lijek Ilumetri djelotvoran u liječenju umjerene do teške plak psorijaze u bolesnika koji nisu dovoljno dobro reagirali na lijekove koji se primjenjuju na kožu.
English: Ilumetri is a medicine that acts on the immune system and is used to treat plaque psoriasis, a disease causing red, scaly patches on the skin.
Croatian: Ilumetri je lijek koji djeluje na imunosni sustav, a primjenjuje se u liječenju osoba s plak psorijazom, bolešću koja na koži uzrokuje crvenkasta žarišta koja se ljušte.
English: What benefits of Ilumetri have been shown in studies?
Croatian: Koje su koristi od lijeka Ilumetri utvrđene u ispitivanjima?
English: Ilumetri is available as a solution in pre-filled syringes for injection under the skin.
Croatian: Ilumetri je dostupan u obliku otopine u napunjenoj štrcaljki za potkožnu injekciju.
English: After 12 weeks, 64% and 62% of patients given 100 mg and 200 mg Ilumetri respectively had at least a 75% improvement in disease severity compared with 6% of those given placebo.
Croatian: Nakon 12 tjedana 64 % i 62 % bolesnika koji su primali dozu od 100 mg i 200 mg lijeka Ilumetri doživjeli su najmanje 75 % poboljšanja u ozbiljnosti bolesti u odnosu na 6 % bolesnika koji su primali placebo.
English: For the full list of side effects and restrictions with Ilumetri, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja vezanih uz primjenu lijeka Ilumetri potražite u uputi o lijeku.
English: After 12 weeks, 61% and 66% of patients given 100 mg and 200 mg Ilumetri respectively had at least 75% improvement in severity compared with 48% of those given etanercept and 6% given placebo.
Croatian: Nakon 12 tjedana 61 % i 66 % bolesnika koji su primali dozu od 100 mg i 200 mg lijeka Ilumetri doživjeli su najmanje 75 % poboljšanja u ozbiljnosti bolesti u odnosu na 48 % bolesnika koji su primali etanercept i 6 % bolesnika koji su primali placebo.
English: Of those given Ilumetri, 55% (for 100 mg) and 59% (for 200 mg) had almost complete skin clearance compared with 48% given etanercept and 5% given placebo.
Croatian: U bolesnika koji su primali Ilumetri 55 % (doza od 100 mg) i 59 % (doza od 200 mg) došlo je do potpunog čišćenja kože u odnosu na 48 % bolesnika koji su primali etanercept i 5 % bolesnika koji su primali placebo.
English: How is Ilumetri used?
Croatian: Kako se Ilumetri primjenjuje?
English: Additionally, 58% of those given 100 mg and 59% of those given 200 mg had almost complete skin clearance compared with 7% given placebo.
Croatian: Nadalje, u 58 % bolesnika koji su primali dozu od 100 mg i 59 % bolesnika koji su primali dozu od 100 mg došlo je do potpunog čišćenja kože u odnosu na 7 % bolesnika koji su primali placebo.
English: The potential risk for humans is still unknown.
Croatian: Potencijalni rizik za ljude još uvijek je nepoznat.
English: Opsumit should be taken every day at about the same time.
Croatian: Opsumit je potrebno uzeti svaki dan otprilike u isto vrijeme.
English: The advice of a hepatologist is recommended.
Croatian: Preporučuje se zatražiti savjet hepatologa.
English: The uncertainties of such modelling should be considered.
Croatian: Treba uzeti u obzir nepouzdanost takvog modeliranja.
English: Ask your pharmacist how to throw away medicines you no longer require.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne koristite.
English: ATC code: C02KX04.
Croatian: ATK oznaka: C02KX04.
English: Caution is recommended in this population.
Croatian: Preporučuje se oprez u ovoj populaciji.
English: It is best to take the tablet at the same time each day.
Croatian: Najbolje je uzeti tabletu u isto vrijeme svaki dan.
English: The safety margins for fertility were 18 for male and 44 for female rats.
Croatian: Sigurnosne granice za plodnost bile su 18 za mužjake i 44 za ženke štakora.
English: No data are available.
Croatian: Nema raspoloživih podataka.
English: What Opsumit is and what it is used for
Croatian: Što je Opsumit i za što se koristi
English: Date of latest renewal: 23 August 2018
Croatian: Datum posljednje obnove odobrenja: 23 Kolovoz 2018
English: These changes are not considered clinically relevant.
Croatian: Te se promjene ne smatraju klinički značajnim.
English: Tubular dilatation was fully reversible.
Croatian: Dilatacija tubula bila je u potpunosti reverzibilna.
English: Signs that your liver may not be working properly include:
Croatian: Znakovi da Vaša jetra ne radi normalno mogu uključivati:
English: Due to the species-specific sensitivity and the safety margin, this finding is considered not relevant for humans.
Croatian: Zbog osjetljivosti specifične za pojedine vrste i sigurnosne granice, smatra se da ovaj nalaz nije relevantan za ljude.
English: Talk to your doctor, who will decide whether this medicine is suitable for you.
Croatian: Razgovarajte sa svojim liječnikom, koji će odlučiti je li taj lijek prikladan za Vas.
English: What you need to know before you take Opsumit
Croatian: Što morate znati prije nego počnete uzimati Opsumit
English: Patient Card Page 1 (front)
Croatian: Kartica za bolesnika Stranica 1 (prednja strana)
English: • Allergic reactions (swelling around the eyes, face, lips, tongue or throat, itching and/or rash) If you notice any of these signs, tell your doctor immediately.
Croatian: • alergijske reakcije (oticanje oko očiju, lica, usana, jezika ili grla, svrbež i/ili osip) Ako primijetite bilo koji od navedenih znakova, odmah obavijestite svog liječnika.
English: Opsumit can affect other medicines.
Croatian: Opsumit može utjecati na druge lijekove.
English: Your doctor may perform additional tests, and will determine what treatment regimen is most suitable for you.
Croatian: Vaš liječnik može obaviti dodatne pretrage i odrediti koji je režim liječenja najprikladniji za vas.
English: This card contains important safety information you need to be aware of when receiving treatment withOpsumit.
Croatian: Ova kartica sadrži važne sigurnosne informacije koje trebate znati kada se liječite lijekom Opsumit.
English: The film-coated tablets are not breakable and are to be swallowed whole, with water.
Croatian: Filmom obložene tablete nisu lomljive i treba ih progutati cijele, s vodom.
English: Macitentan 10 mg improved quality of life assessed by the SF-36 questionnaire.
Croatian: Macitentan 10 mg poboljšao je kvalitetu života prema procjeni upitnikom SF-36.
English: Do not give this medicine to children and adolescents below 18 years because Opsumit has not been tested in children.
Croatian: Nemojte davati ovaj lijek djeci i adolescentima s nenavršenih 18 godina, jer Opsumit nije ispitan u djece.
English: The relevance of this finding to humans is unknown, but a deterioration of spermatogenesis cannot be excluded.
Croatian: Značaj ovog nalaza za ljude je nepoznat ali nije moguće isključiti poremećaj spermatogeneze.
English: If you forget to take Opsumit, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Croatian: Ako ste zaboravili uzeti Opsumit, uzmite dozu čim se sjetite, a potom nastavite uzimati svoje tablete u uobičajeno vrijeme.
English: If you have taken more tablets than you have been told to take, you may experience headache, nausea, or vomiting.
Croatian: Ako ste uzeli više tableta nego što ste trebali, možete osjetiti glavobolju, mučninu ili povraćanje.
English: In the event of an overdose, standard supportive measures must be taken, as required.
Croatian: U slučaju predoziranja, potrebno je primijeniti standardne suportivne mjere.
English: A risk to the breastfeeding child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: Do not breastfeed while you are taking Opsumit.
Croatian: Nemojte dojiti dok uzimate Opsumit.
English: EOS was declared when the predefined number of primary endpoint events was reached.
Croatian: Dovršetak ispitivanja je proglašen kad je dosegnut prethodno definirani broj događaja primarnih ishoda.
English: Other metabolic pathways yield products without pharmacological activity.
Croatian: Drugi metabolički putevi daju produkte bez farmakološke aktivnosti.
English: White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
Croatian: Bijeli, neprozirni blisteri od PVC/PE/PVdC/aluminija u kutijama koje sadrže 15 ili 30 filmom obloženih tableta.
English: They may be taken with or without food.
Croatian: Mogu se uzimati s hranom ili bez hrane.
English: Macitentan has four primary metabolic pathways.
Croatian: Macitentan ima četiri primarna puta metaboličke razgradnje.
English: Do not stop taking Opsumit unless you have agreed this with your doctor.
Croatian: Opsumit osim ako se niste o tome dogovorili sa svojim liječnikom.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: These changes were largely reversible and considered non-adverse adaptations of the liver to increased metabolic demand.
Croatian: Ove su promjene bile uvelike reverzibilne i smatrane su bezopasnim prilagodbama jetre na povećane zahtjeve metabolizma.
English: • The risk of anaemia, hepatotoxicity and teratogenicity and the need for reliable contraception;
Croatian: • Postoji rizik za anemiju, hepatoksičnost i teratogenost te potreba za pouzdanom kontracepcijom;
English: • Do not take Opsumit if you are pregnant or planning to become pregnant.
Croatian: • Nemojte uzimati Opsumit ako ste trudni ili planirate zatrudnjeti.
English: Relative risk reduction (97.5% CI)
Croatian: Smanjenje relativnog rizika (97,5% CI)
English: Carry this card with you at all times and show it to any doctor involved in your medical care.
Croatian: Uvijek nosite ovu karticu sa sobom i pokažite je svakom liječniku koji Vas liječi.
English: If you take more Opsumit than you should
Croatian: Ako uzmete više lijeka Opsumit nego što ste trebali
English: • That Opsumit is teratogenic in animals;
Croatian: • Opsumit je teratogen za životinje;
English: Opsumit is a treatment that you will need to keep on taking to control your PAH.
Croatian: Opsumit je terapija koju trebate nastaviti uzimati kako biste kontrolirali svoj PAH.
English: • if you are allergic to macitentan, soya or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na macitentan, soju ili na bilo koji drugi sastojak ovog lijeka (naveden u dijelu 6).
English: • Influenza (flu)
Croatian: • influenca (gripa)
English: • The need for baseline and:
Croatian: • Potreba za početnim i:
English: Do not take Opsumit:
Croatian: Nemojte uzimati Opsumit:
English: Macitentan is not a substrate for Pgp/MDR-1.
Croatian: Macitentan nije supstrat za P-gp/MDR-1.
English: Maximum plasma concentrations of macitentan are achieved about 8 hours after administration.
Croatian: Maksimalne plazmatske koncentracije macitentana postižu se otprilike 8 sati nakon primjene.
English: Page 6 (back)
Croatian: Stranica 6 (poleđina)
English: Other medicines and Opsumit
Croatian: Drugi lijekovi i Opsumit
English: The active metabolite circulates in human plasma and may contribute to the pharmacological effect.
Croatian: Aktivni metabolit cirkulira u humanoj plazmi i može doprinijeti farmakološkom učinku.
English: The Prescribing Checklist should remind prescribers of the contraindications, warnings and precautions as well as the following key elements:
Croatian: Popis provjere kod propisivanja treba podsjetiti propisivača na kontraindikacije, upozorenja i mjere opreza kao i na sljedeće ključne elemente:
English: Figure 1 Kaplan-Meier estimates of the first morbidity-mortality event in SERAPHIN
Croatian: Slika 1 Kaplan-Meierove procjene prvog događaja morbiditeta-mortaliteta u ispitivanju
English: Moreover, if you are suffering from pulmonary arterial hypertension, the occurrence of a pregnancy can severely deteriorate the symptoms of your disease.
Croatian: Štoviše, ako patite od plućne arterijske hipertenzije, pojava trudnoće može jako pogoršati simptome
English: • if you have liver disease or if you have very high levels of liver enzymes in your blood.
Croatian: • ako bolujete od bolesti jetre ili ako su Vam razine jetrenih enzima u krvi vrlo visoke.
English: After repeated administration, the pharmacokinetics of macitentan are dose-proportional up to and including 30 mg.
Croatian: Nakon ponovljene primjene, farmakokinetika macitentana je proporcionalna dozi do i uključujući 30 mg.