FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1 Cytokine release syndrome management algorithm
Croatian: Tablica 1 Algoritam zbrinjavanja sindroma otpuštanja citokina
English: As appropriate, prophylactic antibiotics should be administered and surveillance testing should be employed prior to and during treatment with Kymriah.
Croatian: Prema potrebi trebaju se primijeniti profilaktički antibiotici te napraviti nadzorne kulture prije te tijekom liječenja lijekom Kymriah.
English: Duration of remission (DOR)7
Croatian: Trajanje remisije (DOR)
English: The timing of thaw of Kymriah and of infusion should be coordinated.
Croatian: Vrijeme odmrzavanja lijeka Kymriah i vrijeme infuzije mora biti usklađeno.
English: Sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion and to rinse it after infusion.
Croatian: Otopina natrijevog klorida 9 mg/mL (0,9%) za injekciju mora se upotrijebiti za pripremu (punjenje) cijevi seta prije infuzije te za njihovo ispiranje nakon infuzije.
English: Relapsed disease2
Croatian: Recidivirajuća bolest2
English: Key baseline information for enrolled and infused patients is presented in Table 3.
Croatian: Ključne informacije s početka ispitivanja za uključene i infundirane bolesnike su prikazane u Tablici
English: The most common non-haematological adverse reactions were cytokine release syndrome (58%), infections (54%), pyrexia (35%), diarrhoea (32%), nausea (29%), hypotension (26%) and fatigue
Croatian: Najčešće nehematološke nuspojave bile su sindrom otpuštanja citokina (58%), infekcije (54%), pireksija (35%), proljev (32%), mučnina (29%), hipotenzija (26%) i umor (26%).
English: The pivotal study (B2202) is a multicentre, single-arm phase II study in paediatric and young adult patients with r/r B-cell acute lymphoblastic leukaemia.
Croatian: Pivotalno ispitivanje (B2202) multicentrično je ispitivanje faze II s jednom skupinom u pedijatrijskih i mladih odraslih bolesnika s r/r akutnom limfoblastičnom leukemijom B-stanica.
English: Enrolled N=165 n (%)
Croatian: Uključeni N=165 n (%)
English: Lymphodepleting chemotherapy may be omitted if a patient's white blood cell (WBC) count is ≤1,000 cells/µL within 1 week prior to Kymriah infusion.
Croatian: Kemoterapija za limfocitnu depleciju može se izostaviti ako je broj bolesnikovih leukocita ≤1000 stanica/µL unutar 1 tjedna prije infuzije lijeka Kymriah.
English: Infused N=75 n (%)
Croatian: Infundirani N=75 n (%)
English: Pruritus Erythema Night sweats Petechiae Hyperhidrosis
Croatian: Noćno znojenje Petehije Hiperhidroza
English: Mouth haemorrhage Stomatitis
Croatian: Krvarenje u ustima Stomatitis
English: • Thirst
Croatian: • Žeđ
English: Infections are known to complicate the course and management of concurrent cytokine release syndrome.
Croatian: Infekcije mogu zakomplicirati tijek i zbrinjavanje istodobnog sindroma otpuštanja citokina.
English: - For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T cells (non-weight based).
Croatian: - Za bolesnike iznad 50 kg: 0,1 do 2,5 x 10
English: Preparation for infusion
Croatian: Priprema za infuziju
English: Kymriah contains sodium, dimethylsulfoxide (DMSO) and dextran 40.
Croatian: Kymriah sadrži natrij, dimetilsulfoksid (DMSO) i dekstran 40.
English: Hypogammaglobulinaemia
Croatian: Hipogamaglobulinemija
English: Efficacy was established through the primary endpoint of overall remission rate (ORR) within 3 months post infusion, as determined by Independent Review Committee (IRC) assessment, duration of remission (DOR) and the proportion of patients who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) with minimal residual disease (MRD) <0.01% by flow cytometry (MRD-negative).
Croatian: Independent Review Committee, IRC), trajanja remisije (engl. duration of remission, DOR) i udjela bolesnika koji su postigli potpunu remisiju (engl. complete remission, CR) ili potpunu remisiju s nepotpunim oporavkom krvne slike (CRi) uz minimalnu rezidualnu bolest (engl. minimal residual disease, MRD) <0,01% pomoću protočne citometrije (MRD-negativan).
English: Sterile sodium chloride 9 mg/mL (0.9%) solution for injection should be used to prime the tubing prior to infusion as well as rinse it afterwards.
Croatian: Sterilna otopina natrijevog klorida 9 mg/mL (0,9%) za injekciju mora se upotrijebiti za pripremu (punjenje) cijevi seta prije infuzije te za njihovo ispiranje nakon infuzije.
English: Abdominal distension Ascites
Croatian: Distenzija abdomena Ascites
English: • Fast heart beat
Croatian: • Ubrzani otkucaji srca
English: Non-responding patients (NR) N=11
Croatian: Bolesnici bez odgovora (NR)
English: The majority of patients tested positive for pre-dose anti-mCAR19 antibodies in paediatric and young adult ALL (B2202 and B2205J, 84.6%) and adult DLBCL (C2201, 91.4%).
Croatian: Većina bolesnika kod pedijatrijskog ALL-a i ALL-a mladih odraslih bolesnika (B2202 i B2205J, 84,6%) te kod DLBCL-a u odraslih (C2201, 91,4%) imala je pozitivan nalaz anti-mCAR19 protutijela prije doziranja.
English: Histiocytosis haematophagic Pancytopenia
Croatian: Hematofagna histiocitoza Pancitopenija
English: Final report: December 2023
Croatian: Završno izvješće: prosinac
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (25 mg/m2 intravenous daily for 3 days) and cyclophosphamide (250 mg/m2
Croatian: Preporučeni kemoterapijski protokol za limfocitnu depleciju je: - fludarabin (25 mg/m intravenski dnevno tijekom 3 dana) i ciklofosfamid (250 mg/m intravenski dnevno tijekom 3 dana počevši s prvom dozom fludarabina).
English: Nominal one-sided exact p-value based on H0: ORR ≤20% vs. Ha: ORR >20% CR (complete remission) was defined as <5% of blasts in the bone marrow, circulating blasts in blood should be <1%, no evidence of extramedullary disease, and full recovery of peripheral blood counts (platelets >100,000/μL and absolute neutrophil counts [ANC] >1,000/μL) without blood transfusion.
Croatian: CR (potpuna remisija) bio je definiran kao <5% blasta u koštanoj srži, cirkulirajući blasti u krvi trebaju biti <1%, bez dokaza ekstramedularne bolesti i potpuni oporavak periferne krvne slike (trombociti >100 000/μL i apsolutni broj neutrofila [ABN] >1000/μL) bez transfuzije krvi.
English: Kymriah is an immunocellular therapy containing tisagenlecleucel, autologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD19 chimeric antigen receptor (CAR).
Croatian: Kymriah je terapija imunosnim stanicama koja sadrži tisagenlekleucel, autologne T-stanice genetički modificirane ex vivo koristeći lentivirusni vektor koji kodira anti-CD19 kimerični antigenski receptor (engl. chimeric antigen receptor, CAR).
English: How Kymriah is given
Croatian: Kako se daje Kymriah
English: The recommended lymphodepleting chemotherapy regimen is: - Fludarabine (30 mg/m2 intravenous daily for 4 days) and cyclophosphamide (500 mg/m2
Croatian: Preporučeni kemoterapijski protokol za limfocitnu depleciju je: - fludarabin (30 mg/m intravenski dnevno tijekom 4 dana) i ciklofosfamid (500 mg/m intravenski dnevno tijekom 2 dana počevši s prvom dozom fludarabina).
English: Sodium and potassium content
Croatian: Sadržaj natrija i kalija
English: Acute kidney injury includes acute kidney injury, anuria, azotaemia, blood creatinine increased, renal failure, renal tubular dysfunction and renal tubular necrosis.
Croatian: Akutna ozljeda bubrega uključuje akutnu ozljedu bubrega, anuriju, azotemiju, povišeni kreatinin u krvi, zatajivanje bubrega, disfunkciju bubrežnih kanalića i nekrozu bubrežnih kanalića.
English: Risk factors for severe cytokine release syndrome in paediatric and young adult B-cell ALL patients are: high pre-infusion tumour burden, uncontrolled or accelerating tumour burden following lymphodepleting chemotherapy, active infection and early onset of fever or cytokine release syndrome following Kymriah infusion.
Croatian: B-stanica su: visoko tumorsko opterećenje prije infuzije, nekontrolirano ili ubrzavajuće tumorsko opterećenje nakon kemoterapije za limfocitnu depleciju, aktivna infekcija i rana pojava vrućice ili sindroma otpuštanja citokina nakon infuzije lijeka Kymriah.
English: How you are given Kymriah
Croatian: Kako Vam se daje Kymriah
English: Overall response rate (ORR) (CR+PR)1, n (%) 95% CI
Croatian: Ukupna stopa odgovora (ORR) (CR+PR)
English: Cytokine release syndrome Hypogammaglobulinaemiab)
Croatian: Sindrom otpuštanja citokina Hipogamaglobulinemija b)
English: Worsening respiratory distress, including pulmonary infiltrates, increasing oxygen requirement including high-flow oxygen and/or need for mechanical ventilation Rapid clinical deterioration
Croatian: Sindrom otpuštanja citokina koji zahtijeva umjerenu do agresivnu intervenciju - jedno ili više od sljedećeg: hemodinamska nestabilnost usprkos infuzijskim otopinama i vazopresorskoj potpori pogoršanje respiratornog distresa, uključujući plućne infiltrate, povećana potreba za kisikom uključujući visoko protočni kisik i/ili potrebu za mehaničkom ventilacijom brzo kliničko pogoršanje
English: Cough includes cough, productive cough and upper-airway cough syndrome.
Croatian: Kašalj uključuje kašalj, produktivni kašalj i sindrom kašlja u gornjim dišnim putevima.
English: A summary of cellular kinetic parameters of tisagenlecleucel in DLBCL patients is provided in Table 8 below.
Croatian: Sažetak parametara kinetike stanica tisagenlekleucela u bolesnika s DLBCL-om naveden je u Tablici 8 u nastavku.
English: Kymriah should not be used in children and adolescents below 18 years of age to treat DLBCL.
Croatian: Kymriah se ne smije primjenjivati u djece i adolescenata mlađih od 18 godina za liječenje difuznog B-velikostaničnog limfoma zato što se Kymriah nije proučavao u toj dobnoj skupini.
English: The most common (>25%) Grade 3 and 4 haematological laboratory abnormalities were lymphocyte count decreased (95%), neutrophil count decreased (81%), white blood cell count decreased (77%), haemoglobin decreased (59%) and platelet count decreased (55%).
Croatian: Najčešća (>25%) laboratorijska odstupanja 3. i 4. stupnja bila su sniženi broj limfocita (95%), sniženi broj neutrofila (81%), sniženi broj leukocita (77%), sniženi hemoglobin (59%) i sniženi broj trombocita (55%).
English: Male
Croatian: Muški
English: • Muscle and joint aches, muscle spasms, back pain
Croatian: • Bolovi u mišićima i zglobovima, mišićni grčevi, bol u leđima
English: Prolonged cytopenias Cytopenias are very common with Kymriah therapy.
Croatian: Citopenije su vrlo česte uz terapiju lijekom Kymriah.
English: After thawing, the product should be kept at room temperature (20°C-25°C) and infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Croatian: Nakon odmrzavanja, lijek se mora držati na sobnoj temperaturi (20°C-25°C) i infundirati u roku od 30 minuta kako bi se održala maksimalna vijabilnost lijeka, uključujući i moguće prekide tijekom infuzije.
English: Cytokine release syndrome
Croatian: Sindrom otpuštanja citokina
English: The most common Grade 3 and 4 haematological laboratory abnormalities were white blood cells decreased (99%), neutrophils decreased (95%), lymphocytes decreased (95%), platelets decreased (77%) and haemoglobin decreased (53%).
Croatian: Najčešća laboratorijska odstupanja 3. i 4. stupnja bila su snižene razine leukocita (99%), snižene razine neutrofila (95%), snižene razine limfocita (95%), snižene razine trombocita (77%) i sniženi hemoglobin (53%).
English: potassium, magnesium)
Croatian: jetrenih enzima, bilirubina, kreatinina)
English: Dosage in adult DLBCL patients - 0.6 to 6 x 108 CAR-positive viable T cells (non-weight based).
Croatian: Doziranje kod odraslih bolesnika s DLBCL-om - 0,6 do 6 x 10
English: Hypoxia Dyspnoean)
Croatian: Hipoksija Dispneja n)
English: Once Kymriah has been thawed and is at room temperature (20°C -25°C), it should be infused within 30 minutes to maintain maximum product viability, including any interruption during the infusion.
Croatian: Jednom kad se Kymriah odmrzne i postigne sobnu temperaturu (20°C-25°C), trebao bi se infundirati unutar 30 minuta kako bi se sačuvala najveća moguća vijabilnost lijeka, uključujući bilo kakve prekide tijekom infuzije.
English: Sex - n (%)
Croatian: Spol - n (%)
English: Neurological adverse reactions
Croatian: Neurološke nuspojave
English: Batch:
Croatian: Serija:
English: Cellular kinetics in paediatric and young adult B-cell ALL patients
Croatian: Kinetika stanica u pedijatrijskih i mladih odraslih bolesnika s ALL-om B-stanica
English: Deliriumc) Anxiety Sleep disorderd)
Croatian: Tjeskoba Poremećaj spavanja d)
English: • Changes in blood test results that report on how the liver and kidneys are working (high levels of: liver enzymes, bilirubin, creatinine)
Croatian: • Promjene u rezultatima krvnih pretraga koje ukazuju na rad jetre i bubrega (visoke razine:
English: Final CSR: August 2023
Croatian: Završno izvješće o kliničkom ispitivanju: kolovoz 2023.
English: Medicines given before Kymriah treatment
Croatian: Nakon što primite lijek Kymriah
English: Back pain Myalgia Arthralgia
Croatian: Bol u leđima Mijalgija Artralgija
English: Kymriah was given as a single-dose (0.6-6.0 x 108 CAR-positive viable T cells) intravenous infusion in a qualified Kymriah treatment centre in an inpatient and outpatient setting.
Croatian: CAR-pozitivnih vijabilnih T-stanica) kao intravenska infuzija u kvalificiranom centru za liječenje lijekom Kymriah u bolničkom i u ambulantnom okruženju.
English: 1-3 infusion bags containing a total of 1.2 x 106 to 6 x 108 CAR-positive viable T cells.
Croatian: 1-3 vrećice za infuziju sadrže ukupno 1,2 x 10
English: Prior bone marrow transplant
Croatian: Prethodna transplantacija koštane srži
English: Vomiting Constipation Abdominal paino)
Croatian: Mučnina Povraćanje Konstipacija Bol u abdomenu o)
English: Epistaxis Lung infiltration
Croatian: Epistaksa Infiltracija pluća
English: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma.
Croatian: Aktivna leukemija ili limfom središnjeg živčanog sustava (SŽS) Postoji ograničeno iskustvo s primjenom lijeka Kymriah u bolesnika s aktivnom leukemijom SŽS-a i aktivnim limfomom SŽS-a.
English: Each ethylene vinyl acetate (EVA) infusion bag of Kymriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells) (see section 4.2).
Croatian: Jedna vrećica za infuziju lijeka Kymriah od etilenvinilacetata (EVA) sadrži disperziju stanica tisagenlekleucela, autolognih T-stanica koje su genetički modificirane da eksprimiraju anti-CD19 kimerični antigenski receptor (CAR-pozitivne vijabilne T-stanice), u koncentraciji koja se može razlikovati od serije do serije (vidjeti dio 4.2).
English: Median [min;max], n 170 [17.8; 617], 80 28.8 [13.9; 376], 11 ‡A total of 5 patients had an early Tmax (<1 days), the next lowest Tmax occurs at 5.7 days.
Croatian: Medijan [min; max], n 170 [17,8; 617], 80 28,8 [13,9; 376], 11 Ukupno 5 bolesnika imalo je rani Tmax (<1 dana), sljedeći najniži Tmax javlja se nakon 5,7 dana.
English: Sodium chloride Human albumin solution Dextran 40 for injection Dimethylsulfoxide Sodium gluconate Sodium acetate
Croatian: 6.1 Popis pomoćnih tvari glukoza natrijev klorid otopina ljudskog albumina dekstran 40 za injekciju dimetilsulfoksid natrijev glukonat natrijev acetat kalijev klorid magnezijev klorid natrijev N-acetiltriptofanat natrijev kaprilat aluminij voda za injekcije
English: Immunogenicity
Croatian: Hiperurikemija
English: Following administration of Kymriah, breast-feeding should be discussed with the treating physician.
Croatian: Nakon primjene lijeka Kymriah o dojenju je potrebno razgovarati s liječnikom koji provodi liječenje.
English: • Jaundice
Croatian: • Svrbež
English: Each infusion bag of Kmyriah contains tisagenlecleucel cell dispersion at a batch-dependent concentration of autologous T cells genetically modified to express an anti-CD19 chimeric antigen receptor (CAR-positive viable T cells).
Croatian: Svaka vrećica za infuziju lijeka Kymriah sadrži disperziju stanica tisagenlekleucela, autolognih T-stanica koje su genetički modificirane da eksprimiraju anti-CD19 kimerični antigenski receptor (CAR-pozitivne vijabilne T-stanice), u koncentraciji koja se može razlikovati od serije do serije.
English: Pulmonary oedema Pleural effusion Tachypnoea
Croatian: Plućni edem Pleuralni izljev Tahipneja
English: How to store Kymriah
Croatian: Kako čuvati lijek Kymriah
English: Diarrhoea Nausea
Croatian: Krvožilni poremećaji
English: Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.
Croatian: U novorođenčadi i majki liječenih lijekom Kymriah indicirana je procjena razine imunoglobulina.
English: Cytokine release syndrome, including fatal or life-threatening events, has been frequently observed after Kymriah infusion (see section 4.8).
Croatian: Nakon infuzije lijeka Kymriah učestalo je opažen sindrom otpuštanja citokina, uključujući smrtne slučajeve ili događaje opasne po život (vidjeti dio 4.8).
English: Coughm)
Croatian: Kašalj m)
English: Not estimable.
Croatian: Ne može se procijeniti (NE).
English: Capillary leak syndrome Flushing
Croatian: Sindrom kapilarnog curenja Navale crvenila
English: PR, n (%)
Croatian: 1, n (%)
English: Asthenia
Croatian: Zimica
English: Tabulated list of adverse drug reactions
Croatian: SAŽETAK OPISA SVOJSTAVA LIJEKA
English: Glucose
Croatian: • Žutica
English: Immunoglobulin levels should be assessed in newborns of mothers treated with Kymriah.
Croatian: U novorođenčadi majki liječenih lijekom Kymriah treba procijeniti razinu imunoglobulina.
English: Pyrexia Fatigue Oedemar) Pains) Chills
Croatian: Pireksija Umor Edem r)
English: CR or CRi with MRD negative bone marrow5,6, n (%) 95% CI
Croatian: CR ili CRi s MRD negativnom koštanom srži
English: All patients had leukapheresis starting material collected and cryopreserved prior to or during study entry.
Croatian: Ključne informacije s početka ispitivanja za uključene i infundirane bolesnike su prikazane u Tablici 5. Svim je bolesnicima ishodišni pripravak dobiven leukaferezom prikupljen i krioprezerviran prije ili tijekom uključivanja u ispitivanje.
English: NAME OF THE MEDICINAL PRODUCT Kymriah 1.2 x 106 - 6 x 108 cells dispersion for infusion
Croatian: Kymriah je primijenjen u jednokratnoj dozi (0,6-6,0 x 10
English: What Kymriah looks like and contents of the pack Kymriah is a cell dispersion for infusion.
Croatian: Kymriah je disperzija stanica za infuziju.
English: LIST OF EXCIPIENTS
Croatian: Produljene citopenije
English: MARKETING AUTHORISATION HOLDER
Croatian: NOSITELJ ODOBORENJA ZA STAVLJANJE LIJEKA U PROMET
English: Headachee) Encephalopathyf) Dizziness
Croatian: Encefalopatija f)
English: Thrombocytopenia
Croatian: Hiperglikemija
English: • Nerve pain
Croatian: • Bol u živcima
English: Disease status (%) Primary refractory1
Croatian: Status bolesti (%)
English: Route of administration Packaging
Croatian: Put primjene
English: They should be given appropriate training and should follow the user instructions.
Croatian: Trebaju proći odgovarajuću obuku i slijediti upute za korisnike.
English: All patients were also taking metformin.
Croatian: Svi bolesnici su također uzimali metformin.
English: Nausea occurs mainly at the start of treatment and decreases over time.
Croatian: Mučnina se uglavnom pojavljuje na početku liječenja i s vremenom se smanjuje.
English: The full EPAR for Bydureon can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Bydureon nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Bydureon exenatide
Croatian: Bydureon eksenatid
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bydureon on 17 June 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Bydureon na snazi u Europskoj uniji od 17. lipnja 2011.
English: Bydureon is given by injection under the skin once a week on the same day each week in the abdomen (belly), thigh or back of the upper arm.
Croatian: Bydureon se primjenjuje putem injekcije pod kožu jednom tjedno, istog dana u tjednu, u abdomen (trbuh), bedro ili stražnji dio nadlaktice.
English: Prolonged-release means that the active substance is released slowly after being injected.
Croatian: Produljeno otpuštanje znači da se djelatna tvar otpušta polako nakon injektiranja.
English: This is a summary of the European public assessment report (EPAR) for Bydureon.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Bydureon.
English: This means that it acts in the same way as incretins (hormones produced in the gut) by increasing the amount of insulin released by the pancreas in response to food.
Croatian: To znači da djeluje na isti način kao i inkretini (hormoni koji se proizvode u crijevima) povećavajući razinu inzulina koji se oslobađa u gušterači kao odgovor na unos hrane.
English: What measures are being taken to ensure the safe and effective use of Bydureon?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Bydureon?
English: Adding Bydureon to metformin or pioglitazone does not cause hypoglycaemia.
Croatian: Dodavanje lijeka Bydureon metforminu ili pioglitazonu ne uzrokuje hipoglikemiju.
English: Patients inject themselves using a kit supplied with the medicine.
Croatian: Bolesnici sami sebi daju injekciju pomoću pribora isporučenog s lijekom.
English: This leads to excess glucose in the blood.
Croatian: To dovodi do prekomjerne razine glukoze u krvi.
English: When adding Bydureon to a sulphonylurea, the doctor may need to reduce the dose of the sulphonylurea because there is a risk of hypoglycaemia (low blood sugar levels).
Croatian: Pri dodavanju lijeka Bydureon sulfonilureji, liječnik može smanjiti dozu sulfonilureje jer postoji rizik od hipoglikemije (niske razine šećera u krvi).
English: The Agency therefore decided that Bydureon's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Agencija je stoga zaključila da koristi lijeka Bydureon nadmašuju s njim povezane rizike te je preporučila davanje odobrenja za stavljanje lijeka u promet.
English: Bydureon was effective at controlling blood glucose in six main studies involving nearly 2700 patients with type 2 diabetes.
Croatian: Bydureon je bio djelotvoran u kontroli razine glukoze u krvi u šest glavnih ispitivanja koja su obuhvatila gotovo 2 700 bolesnika s dijabetesom tipa 2.
English: What is Bydureon and what is it used for?
Croatian: Što je Bydureon i za što se koristi?
English: Patients using both Bydureon and insulin should inject the medicines separately.
Croatian: Bolesnici koji uzimaju i Bydureon i inzulin trebaju ubrizgavati lijekove zasebno.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Bydureon 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 Bydureon nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Bydureon.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Bydureon.
English: Other information about Bydureon
Croatian: Ostale informacije o lijeku Bydureon
English: In addition, reactions at the site of injection (itching and redness), low blood sugar levels (when used with a sulphonylurea) and headache occur.
Croatian: Nadalje, javljaju su reakcije na mjestu injektiranja (svrbež i crvenilo), niska razina šećera u krvi (u kombinaciji sa sulfonilurejom) i glavobolja.