FrancophonIA/ELRC3.0 huggingface dataset:
English: Zynteglo in patients 12 years and older with transfusion-dependent β thalassaemia (TDT) who do not have a β0/β0 genotype, the MAH should conduct and submit the results of a study based on data from a product registry (REG501) and use data on patients treated with transfusions and/or HLA-matched allogenic HSCT treated patients from an established European registry as a comparator group.
Croatian: Neintervencijsko ispitivanje sigurnosti i djelotvornosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet: Kako bi se dodatno utvrdio karakter i kontekst dugotrajne sigurnosti i djelotvornosti lijeka Zynteglo u bolesnika u dobi od 12 i više godina s β-talasemijom ovisnom o transfuziji koji nemaju β0/β0 genotip, nositelj odobrenja treba provesti i dostaviti rezultate ispitivanja na osnovu podataka iz registra liječenih bolesnika (REG-501) te koristeći podatke o bolesnicima liječenim transfuzijama i/ili bolesnicima liječenih alogenim HSCT-om s podudarnim sustavom HLA antigena iz uspostavljenog europskog registra kao skupine komparatora.
English: o The Summary of Product Characteristics o Guide for healthcare professionals o Guide for handling and method of administration
Croatian: • Edukacijski materijal za liječnike treba sadržavati: o Sažetak opisa svojstava lijeka o Vodič za zdravstvene radnike o Vodič za rukovanje i način primjene
English: AUC0-24h was measured on Day 1 and informed the dose for Day 3; the median (min, max) estimated daily AUC was
Croatian: AUC0-24 h je mjeren 1. dana i što je dalo informaciju za dozu koja se primjenjivala 3. dan; medijan (min, maks) dnevno procijenjenog AUC-a bio je 4417,0 (3030; 9087) μM*min (N=31).
English: Adverse reactions attributed to myeloablative conditioning
Croatian: Tablica 2 Nuspojave pripisane mijeloablativnom kondicioniranju Klasifikacija organskih sustava
English: • dry lips
Croatian: • suhe usne
English: Bag ID:
Croatian: ID vrećice:
English: Table 2
Croatian: • druga bol
English: • dizziness, tiredness
Croatian: • omaglica, umor
English: Citrate toxicity, Contusion, Procedural pain
Croatian: Ozljede, trovanja i proceduralne komplikacije toksičnost citrata, kontuzija, bol povezana s procedurom
English: Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion (autologous CD34+ cells encoding βA-T87Q-globin gene)
Croatian: Zynteglo 1,2-20 × 106 stanica/ml disperzija za infuziju (autologne CD34+ stanice s genom koji kodira βA-T87Q-globin)
English: Keep infusion bag(s) in the metal cassette(s).
Croatian: Infuzijske vrećice čuvati u metalnoj kazeti.
English: A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene with a strength of 1.2-20 × 106
Croatian: Obogaćena stanična populacija genetski modificiranih autolognih CD34+ stanica koja sadrži hematopoetske matične stanice transducirane lentivirusnim vektorom s genom koji kodira βA-T87Qglobin s jačinom od 1,2-20 × 106 stanica/ml.
English: • Access the medicinal product infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products.
Croatian: • Spojite infuzijski sustav s infuzijskom vrećicom i primijenite infuziju sukladno standardnim postupcima primjene stanične terapije na predviđenom mjestu primjene.
English: ≥100 × 109/L were 52 (20, 268) days and 63 (20, 1231) days, respectively.
Croatian: Medijan (minimalno, maksimalno) vremena do postizanja broja trombocita od ≥50 × 109/l i ≥100 × 109/l neovisnog o potpornoj terapiji iznosilo je 52 (20, 268) dana odnosno 63 (20, 1231) dana.
English: • Confirm that Zynteglo is printed on the infusion bag(s).
Croatian: • Provjerite da je naziv Zynteglo otisnut na infuzijskoj vrećici(ama).
English: bluebird bio (Netherlands) B.V. Stadsplateau 7
Croatian: bluebird bio (Netherlands) B.V.
English: • stomach pain, upset stomach, constipation, diarrhoea
Croatian: • želučani bolovi, želučane tegobe, zatvor, proljev
English: Zynteglo 1.2-20 × 106 cells/mL dispersion for infusion (autologous CD34+ cells encoding βA-T87Q-globin gene) For intravenous use.
Croatian: Zynteglo 1,2-20 × 106 stanica/ml disperzija za infuziju (autologne CD34+ stanice s genom koji kodira βA-T87Q-globin) Samo za intravensku primjenu.
English: • bone or muscle pain
Croatian: • bol u kostima ili mišićima
English: Zynteglo has not been studied in patients with hepatic impairment.
Croatian: Zynteglo nije ispitivan u bolesnika s oštećenjem bubrežne funkcije.
English: Confirm that Zynteglo is printed on the infusion bag(s).
Croatian: Provjerite da je naziv Zynteglo otisnut na infuzijskoj vrećici(ama).
English: Transfusion reaction, Skin abrasion
Croatian: Ozljede, trovanja i proceduralne komplikacije reakcija na transfuziju, abrazija kože
English: Zynteglo is a genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells transduced with lentiviral vector encoding the βA-T87Q-globin gene.
Croatian: Zynteglo je obogaćena stanična populacija genetski modificiranih autolognih CD34+ stanica koja sadrži hematopoetske matične stanice transducirane lentivirusnim vektorom s genom koji kodira βA-T87Q-globin.
English: • sweat gland disorder
Croatian: • poremećaj znojnih žlijezda
English: Petechiae, Ecchymosis, Pain of skin, Palpable purpura, Petechiae, Pruritus generalised, Purpura, Sweat gland disorder, Urticaria, Dry skin
Croatian: generalizirani svrbež, purpura, poremećaj znojnih žlijezda, urtikarija, suha koža
English: Study HGB-205
Croatian: Ispitivanje HGB-205
English: Deutschland bluebird bio (Germany) GmbH Tel: +49 (0) 893 803 7456 (0800 181 0702)
Croatian: Tel: +49 (0) 893 803 7456 (0800 181 0702)
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva osip, hiperhidroza
English: Confirm that patient identity matches the unique patient information located on the infusion bag(s) and metal cassette(s) prior to infusion.
Croatian: Prije infuzije provjerite da identitet bolesnika odgovara jedinstvenim informacijama o bolesniku koje su navedene na infuzijskoj(im) vrećici(ama) i metalnoj(im) kazeti(ama).
English: Zynteglo must not be administered to women who are breast-feeding.
Croatian: Zynteglo se ne smije primjenjivati u dojilja.
English: Delayed platelet engraftment
Croatian: Tablični popis nuspojava
English: Hypoxia, Epistaxis
Croatian: prsišta i sredoprsja hipoksija, epistaksa
English: Study HGB-204
Croatian: Ispitivanje HGB-204
English: HGB-207 and HGB-212 are ongoing Phase 3 open-label, single-arm 24-month studies that are planned to include approximately 39 adults, adolescents, and children with TDT (N=23, HGB-207;
Croatian: HGB-207 i HGB-212 su otvorena ispitivanja faze 3 koja su u tijeku, s trajanjem od 24 mjeseca i s jednom skupinom u koje se planira uključiti oko 39 odraslih, adolescenata i djece s TDT-om (N = 23, HGB-207; N = 16, HGB-212), od kojih 29 ima ne-β0/β0 genotip (N = 23, HGB-207; N = 6, HGB-212) i 10 imaju β0/β0 genotip u HGB-212.
English: A genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem cells (HSC) transduced with lentiviral vector (LVV) encoding the βA-T87Q-globin gene.
Croatian: Obogaćena stanična populacija genetski modificiranih autolognih CD34+ stanica koja sadrži hematopoetske matične stanice (engl. haematopoietic stem cells, HSC) transducirane lentivirusnim vektorom (LVV) s genom koji kodira βA-T87Q-globin.
English: Pyrexia, Influenza like illness, Chest discomfort, Chest pain, Injection site reaction, Catheter site haemorrhage, Catheter site bruise, Injection site bruising, Fatigue, Non-cardiac chest pain, Catheter site pain, Injection site pain, Puncture site pain, Pain
Croatian: nelagoda u prsištu, bol u prsištu, reakcija na mjestu primjene injekcije, krvarenje na mjestu postavljanja katetera, modrica na mjestu postavljanja katetera, modrica na mjestu primjene injekcije, umor, bol u prsima koja nije kardijalnog podrijetla, bol na mjestu postavljanja katetera, bol na mjestu primjene injekcije, bol na mjestu uboda, bol
English: See Method of Administration below and section 6.6 for details on Zynteglo administration and handling.
Croatian: Pojedinosti o primjeni i rukovanju lijekom Zynteglo pogledajte u dijelu Način primjene u nastavku i u dijelu 6.6.
English: Bag ID
Croatian: ID
English: HGB-204 and HGB-205 were Phase 1/2 open-label, single-arm 24-month studies that included 22 patients with TDT treated with Zynteglo (N=18, HGB-204; N=4, HGB-205), of whom 14 had a non-β0/β0 genotype (N=10, HGB-204; N=4, HGB-205) and 8 had a β0/β0 genotype in HGB-204.
Croatian: Ispitivanja su imala jednu skupinu koja je uključivala 22 bolesnika s TDT-om liječena Zynteglom (N=18, HGB-204; N=4, HGB-205), od kojih je 14 imalo ne-β0/β0 genotip (N = 10, HGB-204; N = 4, HGB-205), 8 je imalo β0/β0 genotip u HGB-204.
English: Study HGB-207
Croatian: HGB-207
English: Hypoxia, Dyspnoea, Pleural effusion, Rales, Upper-airway cough syndrome, Cough, Laryngeal pain, Hiccups
Croatian: prsišta i sredoprsja epistaksa, upala ždrijela hipoksija, dispneja, pleuralni izljev, hroptanje, sindrom kašlja povezanog s gornjim dišnim putevima, kašalj, laringealna bol, štucanje
English: If you get any side effects, talk to your doctor or nurse.
Croatian: Ako primijetite bilo koju nuspojavu, obavijestite liječnika ili medicinsku sestru.
English: The Summary of Product Characteristics (SmPC) for the iron chelator and the myeloablative conditioning agent must be consulted for the recommendations regarding co-administration with CYP3A substrates.
Croatian: Za preporuke o istodobnoj primjeni s CYP3A supstratima mora se konzultirati Sažetak opisa svojstava lijeka za kelator željeza i lijek za mijeloablativno kondicioniranje.
English: Engraftment failure as measured by neutrophil engraftment
Croatian: Neuspjeh prihvaćanja transplantata mjeren na temelju oporavka stvaranja neutrofila
English: Name (Last, First):
Croatian: Ime i prezime:
English: Figure 1 Median total haemoglobin over time in non-β0/β0 TDT patients treated with Zynteglo who have achieved transfusion independence (Studies HGB-204,
Croatian: Slika 1 Medijan ukupnog hemoglobina tijekom vremena u bolesnika s ne-β0/β0 genotipom i TDT-om, koji su liječeni lijekom Zynteglo i postigli su neovisnost o transfuziji (ispitivanja HGB-204, HGB-205, HGB-207, LTF-303)
English: Additional studies with human CD34+ HSCs administered to immunodeficient, myeloablated mice demonstrated no toxicity, tumorigenicity or genotoxicity.
Croatian: mijeloabliranih miševa pokazala su da nema toksičnosti, tumorogeničnosti ili genotoksičnosti.
English: The medicinal product contains genetically-modified cells.
Croatian: Lijek sadrži genetski modificirane stanice.
English: Hypocalcaemia, Hypokalaemia, Metabolic acidosis, Fluid overload, Fluid retention, Hypomagnesaemia, Hyponatraemia, Hypophosphataemia
Croatian: metabolička acidoza, preopterećenje tekućinom, zadržavanje tekućine,
English: Common side effects (may affect up to 1 in 10 people)
Croatian: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba):
English: Vomiting, Lip swelling, Abdominal pain, Abdominal pain upper, Paraesthesia oral
Croatian: Poremećaji probavnog sustava mučnina povraćanje, otjecanje usana, bol u abdomenu, bol u gornjem abdomenu, oralna parestezija
English: Cardiac flutter
Croatian: Srčani poremećaji undulacija srca
English: Anal haemorrhage, Gastritis, Gastrointestinal inflammation, Abdominal distension, Abdominal pain upper, Anal fissure, Dyspepsia, Dysphagia, Oesophagitis, Haemorrhoids, Proctalgia.
Croatian: Poremećaji probavnog sustava stomatitis, povraćanje, mučnina, proljev, krvarenje desni, konstipacija, bol u abdomenu, analna upala analno krvarenje, gastritis, gastrointestinala upala, distenzija abdomena, bol u gornjem dijelu abdomena, analna fisura, dispepsija, disfagija, ezofagitis, hemoroidi, proktalgija, suhe usne
English: Last Name First Name: Date of Birth: DIN:
Croatian: Datum rođenja:
English: Start of Zynteglo treatment
Croatian: Primjena lijeka Zynteglo
English: Expose the sterile port on the infusion bag by tearing off the protective wrap covering the port. Access the infusion bag and infuse per the administration site's standard procedures for administration of cell therapy products.
Croatian: Spojite infuzijski sustav s infuzijskom vrećicom i primijenite infuziju sukladno standardnim postupcima primjene stanične terapije na predviđenom mjestu primjene.
English: Final results: Q4
Croatian: Konačni rezultati:
English: Inspect each infusion bag for any breaches of integrity before thawing and infusion.
Croatian: Svaku infuzijsku vrećicu potrebno je pregledati prije odmrzavanja i infuzije kako bi bili sigurni da je neoštećena.
English: There is no opportunity for germline transmission of the βA-T87Q-globin gene after treatment with
Croatian: Ne postoji prilika za germinativni prijenos gena za βA-T87Q-globin nakon liječenja lijekom Zynteglo, stoga je vjerojatnost da će potomstvo imati opću somatsku ekspresiju gena za βA-T87Q-globin zanemariva.
English: Pyrexia, Fatigue
Croatian: bol, kseroza
English: Dyspnoea
Croatian: parestezija
English: • hiccups
Croatian: • štucanje
English: Hypotension, Haematoma
Croatian: Krvožilni poremećaji hipotenzija, hematom
English: It is unknown whether Zynteglo is excreted in human milk.
Croatian: Dojenje Nije poznato izlučuju li se Zynteglo u majčino mlijeko.
English: Adverse reactions attributed to mobilisation/apheresis System Organ Class (SOC) Very Common (≥10%)
Croatian: Tablica 1 Nuspojave pripisane mobilizaciji/aferezi Klasifikacija organskih sustava
English: Table 5
Croatian: Stadsplateau 7
English: • low blood calcium level
Croatian: • glavobolja • niske razine kalcija u krvi
English: • inflammation in the digestive tract
Croatian: • upala probavnog trakta
English: Abdominal pain
Croatian: Poremećaji probavnog sustava bol u abdomenu
English: C-reactive protein increased, Aspergillus test positive, Blood potassium decreased, Weight decreased, Blood alkaline phosphatase decreased, Blood magnesium decreased, Forced expiratory flow decreased, Protein total decreased, Blood albumin decreased, Reticulocyte count decreased, Reticulocyte percentage decreased
Croatian: snižen kalij u krvi, smanjena težina, snižena alkalna fosfataza u krvi, snižen magnezij u krvi, smanjen forsirani ekspiracijski protok,
English: July 2020
Croatian: Dostavljanje plana ispitivanja: srpanj 2020.
English: HGB-207 HGB-212
Croatian: HGB-212
English: Manufacturer apceth Biopharma GmbH Haidgraben 5
Croatian: Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari apceth Biopharma GmbH Haidgraben 5
English: • tiredness
Croatian: • žgaravica
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često: mogu se javiti u više od 1 na 10 osoba:
English: PARTICULARS TO APPEAR ON THE LOT INFORMATION SHEET INCLUDED WITH EACH SHIPMENT FOR ONE PATIENT
Croatian: U SVAKU POŠILJKU ZA JEDNOG BOLESNIKA
English: Vaginal haemorrhage
Croatian: • žučni kamenac
English: Infections and infestations
Croatian: Odmrzavanje i primjena
English: Contents of the pack and other information
Croatian: Kako čuvati Zynteglo 6. Sadržaj pakiranja i druge informacije
English: • vomiting
Croatian: • umor
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u ekstremitetu
English: low sodium, low phosphate, decrease in protein, or decrease in albumin
Croatian: sniženi ukupni proteini, snižen albumin u krvi, smanjen broj retikulocita, smanjen postotak retikulocita
English: Febrile neutropenia, Neutropenia, Thrombocytopenia, Leukopenia, Anaemia
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, neutropenija, trombocitopenija, leukopenija, anemija limfopenija, leukocitoza, smanjen broj monocita,
English: • itchy skin
Croatian: • svrbež kože
English: o The need to explain and to ensure that patients understand: - potential risks of treatment with Zynteglo - signs of leukaemia/lymphoma and what action to take - content of patient's guide - the need to carry the patient alert card and show it to every healthcare professional - enrolment in the drug product Registry o Scope of the Registry and how to enrol patients
Croatian: - sadržaj vodiča za bolesnika - potrebu nošenja kartice s upozorenjima za bolesnika i predočavanja kartice svakom zdravstvenom radniku
English: • abnormal liver tests
Croatian: • odstupanja rezultata testova funkcije jetre
English: Protocol submission:
Croatian: Interim izvješće:
English: Nederland bluebird bio (Netherlands) B.V. Tel: +31 (0) 303 100 450
Croatian: Tel: +31 (0) 303 100 450
English: Reproductive system and breast disorders
Croatian: Klasifikacija organskih sustava
English: • inflammation of the gallbladder
Croatian: • upala žučnog mjehura
English: Hypocalcaemia
Croatian: • hemoroidi
English: Cholecystitis, Cholelithiasis, Hepatomegaly, Jaundice, Transaminases increased, Gamma-glutamyltransferase increased
Croatian: povišene transaminaze, povišena gamaglutamiltransferaza
English: • rash
Croatian: • modrice
English: • The Guide for healthcare professionals shall contain the following key elements: o Warnings and precautions of the mobilisation agents and the myeloablative conditioning agent must be considered.
Croatian: • Vodič za rukovanje i način primjere namijenjen zdravstveni radnicima mora sadržavati sljedeće ključne elemente:
English: SOC
Croatian: ND
English: • heartburn
Croatian: • tjeskoba
English: This summary was last updated in 11-2016.
Croatian: Ovaj sažetak posljednji je put ažuriran u studenome 2016.
English: The full EPAR for Caprelsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Caprelsa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The main measure of effectiveness was ‘overall response rate' (ORR) which considers several features of the disease.
Croatian: Kao glavna mjera djelotvornosti uzimala se „ukupna stopa reakcije” (ORR), koja u obzir uzima nekoliko osobina bolesti.
English: The dose for children aged 5 years or older is calculated using the child's weight and height.
Croatian: Doza za djecu od 5 godina starosti ili više računa se prema djetetovoj visini i težini.
English: Caprelsa is available as tablets (100 mg and 300 mg) and the recommended dose for adults is 300 mg once a day, taken at around the same time each day.
Croatian: Lijek Caprelsa dostupan je u obliku tableta (100 mg i 300 mg), a preporučena doza za odrasle je 300 mg jedanput dnevno, koja se uzima otprilike u isto doba svakoga dana.
English: The study involved 331 patients and the main measure of effectiveness was progression-free survival (how long the patients lived without their disease getting worse).
Croatian: Studija je obuhvatila 331 bolesnika, a glavna mjera djelotvornosti bilo je preživljenje bez progresije bolesti (vrijeme koje su bolesnici proživjeli bez pogoršanja bolesti).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Caprelsa on 17 February 2012.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Caprelsa na snazi u Europskoj uniji od 17. veljače 2012.
English: Of the 16 children treated with Caprelsa, 7 (44%) had partial response on the ORR scale, which was comparable to the response rate in adults.
Croatian: Od 16 djece liječenih lijekom Caprelsa, 7 (44 %) ih je imalo djelomičnu reakciju na ljestvici ORR-a, koja se mogla usporediti sa stopom reakcije u odraslih.
English: The Committee noted the potential risk for QTc interval prolongation, and measures were introduced to minimise this risk.
Croatian: Odbor naglašava mogući rizik produljenja intervala QT te su uvedene mjere kojima bi se smanjio taj rizik.
English: What is Caprelsa and what is it used for?
Croatian: Što je Caprelsa i za što se koristi?
English: It must not be used in people with a problem called ‘congenital long QTc syndrome' or who have a QTc interval longer than 480 milliseconds.
Croatian: Ne smije se primjenjivati u osoba koje boluju od „kongenitalnog sindroma dugog intervala QT” ili kod kojih je interval QT duži od 480 milisekundi.
English: On average children taking Caprelsa lived for 46 months without their disease getting worse.
Croatian: Djeca koja su uzimala lijek Caprelsa živjeli su u prosjeku 46 mjeseci bez pogoršanja bolesti.
English: This is a summary of the European public assessment report (EPAR) for Caprelsa.
Croatian: Ovaj je dokument sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Caprelsa.
English: By blocking the activity of EGF receptors, the cancer cells no longer receive the messages needed for growth and multiplication.
Croatian: Inhibiranjem djelovanja receptora EGF stanice karcinoma više ne dobivaju poruke koje su potrebne za rast i množenje.
English: Treatment is continued for as long as the patient benefits from it.
Croatian: Liječenje traje onoliko dugo koliko bolesnik ima koristi od liječenja.
English: It is recommended that the doctor checks for RET mutation at the start of Caprelsa treatment.
Croatian: Preporučuje se da liječnik provjeri RET mutaciju na početku liječenja lijekom Caprelsa.
English: What measures are being taken to ensure the safe and effective use of Caprelsa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Caprelsa?
English: Patients who cannot swallow tablets can mix the tablet in plain (non-sparkling) water.
Croatian: Bolesnici koji ne mogu gutati tablete mogu ih pomiješati s običnom (negaziranom) vodom.
English: The medicine is used when the disease is spreading quickly and causes symptoms, and when the cancer cannot be removed by surgery and has progressed or spread to other parts of the body.
Croatian: Lijek se primjenjuje kada se bolest širi brzo i uzrokuje simptome i kada se karcinom ne može odstraniti kirurški te je napredovao ili se proširio na druge dijelove tijela.
English: These enzymes are needed by certain receptors (such as VEGF, EGF and RET receptors) on the surface of cancer cells, where they activate several processes including cell division and the growth of new blood vessels.
Croatian: Određeni receptori (poput receptora VEGF, EGF i RET) na površini stanica karcinoma trebaju te enzime, gdje aktiviraju nekoliko procesa, uključujući diobu stanica i rast novih krvnih žila.
English: Caprelsa has been given ‘conditional approval'.
Croatian: Za lijek Caprelsa izdano je „uvjetno odobrenje”.
English: Caprelsa can affect the electrical activity of the heart including a measurement called QTc interval.
Croatian: Caprelsa može utjecati na električnu aktivnost srca, uključujući mjeru pod nazivom interval QT.
English: This means that it blocks the activity of enzymes known as tyrosine kinases.
Croatian: To znači da inhibira određene enzime poznate pod nazivom tirozin kinaze.
English: This means that there is more evidence to come about the medicine, in particular on the size of the benefit in patients without the RET mutation.
Croatian: To znači da će se dostaviti dodatni dokazi o lijeku, a osobito podaci o koristima za bolesnike bez RET mutacije.
English: On average, patients taking Caprelsa lived for 30.5 months without their disease getting worse, compared with 19.3 months for patients taking placebo.
Croatian: Bolesnici koji su uzimali lijek Caprelsa prosječno su živjeli dulje, i to 30,5 mjeseci u usporedbi sa 19,3 mjeseci u bolesnika koji su uzimali placebo.
English: The most commonly reported side effects with Caprelsa are diarrhoea, rash, nausea (feeling sick), high blood pressure and headache.
Croatian: Nuspojave koje se najčešće povezuju s primjenom lijeka Caprelsa su proljev, osip, mučnina, visok krvni tlak i glavobolja.
English: Patients must be given a patient alert card containing important safety information and they must be informed by their doctor about the risks of Caprelsa.
Croatian: Bolesnicima se mora dati kartica s upozorenjima u kojoj se nalaze važni podaci o sigurnosti, a njihov ih liječnik mora obavijestiti o rizicima primjene lijeka Caprelsa.