FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Glybera, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Glybera nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: What is Glybera?
Croatian: Što je Glybera?
English: Glybera has been studied in 27 patients with lipoprotein lipase deficiency on a low-fat diet.
Croatian: Lijek Glybera ispitivan je u 27 bolesnika s deficijencijom lipoproteinske lipaze na prehrani s niskim sadržajem masnoća.
English: For more information on the dose of Glybera to be given, see the summary of product characteristics (also part of the EPAR).
Croatian: Za dodatne informacije o doziranju lijeka Glybera pogledajte sažetak opisa svojstava lijeka (također dio EPAR-a).
English: Why has Glybera been approved?
Croatian: Zašto je lijek Glybera odobren?
English: What is Glybera used for?
Croatian: Za što se Glybera koristi?
English: What benefit has Glybera shown during the studies?
Croatian: Koje su koristi lijeka Glybera utvrđene u ispitivanjima?
English: How is Glybera used?
Croatian: Kako se Glybera koristi?
English: For the full list of all side effects reported with Glybera, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Glybera potražite u uputi o lijeku.
English: How does Glybera work?
Croatian: Kako djeluje Glybera?
English: How has Glybera been studied?
Croatian: Kako je Glybera ispitivan?
English: Blister (unit-dose)
Croatian: Blister (jedinična doza)
English: MA (EU) number (Invented) name Strength
Croatian: (Zaštićeno) ime Jačina
English: This increases the ability of the immune system to kill cancer cells.
Croatian: Tako povećava sposobnost imunosnog sustava da ubije stanice raka.
English: Patients whose cancer clearly expressed PD-1 seem to show most benefit, but as other patients also responded, further study to clarify patient groups most likely to benefit from the medicine is needed.
Croatian: Čini se da su bolesnici čiji je rak jasno izrazio PD-1 pokazali najviše koristi, no budući da su drugi bolesnici također odgovorili, potrebna su daljnja ispitivanja kako bi se pojasnilo za koju grupu bolesnika je najizglednije da će imati koristi od lijeka.
English: It is used in patients whose disease has spread locally or to other parts of the body and who have previously been treated with other cancer medicines (chemotherapy).
Croatian: Koristi se u bolesnika čija se bolest proširila lokalno ili u druge dijelove tijela te koji su prethodno liječeni drugim antitumorskim lijekom (kemoterapija).
English: When it attaches to PD-1, nivolumab blocks the receptor and prevents it from switching off these immune cells.
Croatian: Vezujući se na PD-1, nivolumab inhibira receptor i sprječava isključivanje ovih imunosnih stanica.
English: Treatment with Nivolumab BMS was compared with another cancer medicine, docetaxel, and the main measure of effectiveness was overall survival (how long patients lived).
Croatian: Terapija lijekom Nivolumab BMS uspoređena je s drugim lijekom protiv raka, doketakselom, a glavna mjera djelotvornosti bilo je cjelokupno preživljenje (koliko su dugo bolesnici živjeli).
English: This is a summary of the European public assessment report (EPAR) for Nivolumab BMS.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Nivolumab BMS.
English: Nivolumab BMS is also commonly associated with side effects related to the activity of the immune system on body organs.
Croatian: Nivolumab BMS se također često povezuje s nuspojavama povezanima s aktivnošću imunosnog sustava na tjelesne organe.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Nivolumab BMS's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Nivolumab BMS nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The antigen to which nivolumab has been designed to attach is a receptor called ‘programmed cell death-1' (PD-1), which switches off the activity of certain cells of the immune system (the body's natural defences) called T cells.
Croatian: Protutjelo za koji je novolumab dizajniran da se vezuje je receptor naziva "programirana stanična smrt-1" (PD-1), koji isključuje djelovanje određenih stanica imunosnog sustava (prirodne obrane tijela) naziva T stanice.
English: The medicine is available as a concentrate for making up a solution for infusion (drip) into a vein.
Croatian: Lijek je dostupan kao koncentrat za otopinu za infuziju (drip) u venu.
English: What measures are being taken to ensure the safe and effective use of Nivolumab BMS?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Nivolumab BMS?
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in certain cells in the body.
Croatian: Monoklonsko protutijelo je protutijelo (tip proteina) koji je dizajniran za prepoznavanje i vezanje na specifičnu strukturu (naziva antigen) koji se nalazi u određenim stanicama u tijelu.
English: The most common side effects with Nivolumab BMS (which may affect more than 1 in 10 people) are tiredness, decreased appetite, and nausea (feeling sick), which are mostly mild or moderate in severity.
Croatian: Najčešće nuspojave lijeka Nivolumab BMS (mogu se javiti u više od 1 na 10 osoba) su iscrpljenost, smanjeni apetit i mučnina (osjećaj slabosti), a većina kojih je bila blaga do umjerena u svojoj
English: The average survival among 135 patients given Nivolumab BMS was around 9 months, whereas among the 137 patients given docetaxel it was 6 months.
Croatian: Prosječno prežovljenje među 135 bolesnika koji su primili lijek Nivolumab BMS iznosilo je otprilike 9 mjeseci, dok je u slučaju 137 bolesnika preživljenje bilo 6 mjeseci.
English: The company will also provide an alert card for patients with information on the risks of the medicine, as well as instructions on when to contact their doctor if they experience symptoms of side effects.
Croatian: Tvrtka će također dostaviti karticu s upozorenjima za bolesnike s informacijama o rizicima lijeka kao i uputama o tome kada treba kontaktirati liječnika ako se uoče simptomi.
English: The medicine was associated with improved survival over docetaxel in patients with advanced, previously treated squamous NSCLC, a patient group who have few treatment options.
Croatian: Lijek je povezan s poboljšanim preživljenjem u odnosu na doketaksel u bolesnika s uznapredovanim, prethodno liječenim skvamoznim NSCLC-om, grupi bolesnika koja je imala nekoliko opcija za liječenje.
English: A risk management plan has been developed to ensure that Nivolumab BMS is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Nivolumab BMS.
English: The recommended dose is 3 mg of nivolumab per kilogram body weight given into a vein over 60 minutes, every two weeks for as long as the patient continues to benefit from it. Doses may need to be delayed or treatment stopped altogether if the patient develops certain severe side effects.
Croatian: Preporučena doza je 3 mg nivolumaba po kilogramu tjelesne težine u venu tijekom razdoblja od 60 minuta svaka dva tjedna tako dugo dok bolesnik ima korist od lijeka.
English: In addition, the company that markets Nivolumab BMS will provide educational packs for doctors who are expected to prescribe the medicine, containing information on how it should be used and how to manage side effects, particularly side effects related to the activity of the immune system.
Croatian: Nadalje, tvrtka koja stavlja lijek Nivolumab BMS u promet dostavit će edukacijske pakete za liječnike za koje se očekuje da će propisivati lijek koji će sadržati informacije o načinu primjene lijeka i upravljanju nuspojavama, posebice nuspojavama povezanima s djelovanjem na imunosni sustav.
English: Supportive information was also provided from another study indicating that Nivolumab BMS could produce a response in patients whose disease had progressed despite several previous treatments.
Croatian: Informacije koje govore u prilog ovom lijeku dostavljene su i iz drugih ispitivanja i ukazuju da Nivolumab BMS može proizvesti odgovor u bolesnika čija je bolest uznapredovala usprkos nekoliko prethodnih terapija.
English: The active substance in Nivolumab BMS is a monoclonal antibody.
Croatian: Djelatna tvar lijeka Nivolumab BMS je monoklonalno protutijelo.
English: It is not intended to provide practical advice on how to use Nivolumab BMS.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Nivolumab BMS
English: Nivolumab BMS is a cancer medicine used to treat adults with a type of lung cancer called squamous non-small cell lung cancer (NSCLC).
Croatian: Nivolumab BMS je antitumorski lijek za liječenje odraslih bolesnika s tipom raka pluća nemalih stanica (NSCLC).
English: The full EPAR and risk management plan summary for Nivolumab BMS can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Nivolumab BMS nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o terapiji lijekom Nivolumab BMS pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: It will also conduct further studies on the long-term benefits of Nivolumab BMS, and try to identify which patients are most likely to benefit from treatment with the medicine.
Croatian: Tvrtka će također provesti daljnja ispitivanja o dugoročnim koristima lijeka Nivolumab BMS i provest će analize kako bi identificirala za koje je bolesnike izglednije da će imati koristi od terapije lijekom.
English: How does Nivolumab BMS work?
Croatian: Kako djeluje Nivolumab BMS?
English: For further information, see the package leaflet.
Croatian: Za dodatne informacije vidjeti uputu o
English: The European Commission granted a marketing authorisation valid throughout the European Union for Nivolumab BMS on 20.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Nivolumab BMS na snazi u
English: Nivolumab BMS can only be obtained with a prescription and treatment must be started and supervised by a doctor experienced in the treatment of cancer.
Croatian: Nivolumab BMS se izdaje samo na liječnički recept te liječenje treba započeti i provoditi liječnik s
English: What benefits of Nivolumab BMS have been shown in studies?
Croatian: Koje su koristi lijeka Nivolumab BMS utvrđene u ispitivanjima?
English: For practical information about using Nivolumab BMS, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Nivolumab BMS bolesnici trebaju pročitati u uputi o lijeku,
English: For the full list of all side effects and restrictions with Nivolumab BMS, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Nivolumab BMS potražite u uputi
English: Most will resolve following appropriate treatment or on stopping Nivolumab BMS.
Croatian: Većina nuspojava će se ukloniti nakon odgovarajuće terapije ili nakon što
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Nivolumab BMS, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Nivolumab BMS have been shown to improve patients' survival in one main study involving 272 patients with previously treated squamous NSCLC that was advanced or had spread throughout the body.
Croatian: U jednom glavnom ispitivanju koje je obuhvatilo 272 bolesnika s prethodno liječenim skvamoznim NSCLC-om, koji je uznapredovao ili se proširio kroz tijelo, utvrđeno je da lijek Nivolumab BMS poboljšava preživljenje bolesnika.
English: EU/1/06/346/001
Croatian: EU/1/06/346/001 Tysabri
English: 300mg Concentrate for solution for infusion
Croatian: 300 mg Koncentrat za otopinu za infuziju
English: Intravenous use Vial (glass) 15 ml (20 mg/ml) 1 vial
Croatian: 15 ml (20 mg/ml)
English: • Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
Croatian: • Simptomatsko liječenje kroničnih patoloških kognitivnih i neurosenzorijskih oštećenja u starijih (isključuje se Alzheimer - ova bolest i ostale demencije)
English: [the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
Croatian: [dole navedene, trenutačno odobrene indikacije treba brisati (točno formuliranje indikacije može varirati od proizvoda do proizvoda)]
English: • Acute retinopathies of vascular origin
Croatian: • Akutne retinopatije vaskularnog porijekla
English: • Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Croatian: • Pomoćno liječenje smanjenja oštrine vida i smetnji u vidnom polju najvjerojatnije vaskularnog porijekla
English: Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Croatian: Prilog III Dopune relevantnih dijelova sažetaka opisa svojstava proizvoda i letaka iz pakovanja
English: All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Croatian: Svako upućivanje na gore navedene indikacije treba brisati iz relevantnih dijelova letaka iz pakovanja.
English: A. Summary of Product Characteristics
Croatian: Sažetak opisa svojstava proizvoda
English: All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Croatian: Svako upućivanje na gore navedene indikacije treba brisati iz ostatka relevantnih dijelova sažetaka opisa svojstava proizvoda.
English: B. Package Leaflet
Croatian: Letak iz pakovanja
English: Intrarosa prasterone
Croatian: Intrarosa prasteron
English: The medicine has an acceptable safety profile.
Croatian: Lijek ima prihvatljiv sigurnosni profil.
English: The full EPAR for Intrarosa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Intrarosa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (shortterm) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins).
Croatian: Lijek Intrarosa ne smije se primjenjivati u bolesnica sa sljedećim stanjima: genitalno krvarenje nepoznatog uzroka, ustanovljeni rak dojke ili karcinom ovisan o estrogenu ili sumnja na njih, rak dojke u prošlosti, neliječena hiperplazija endometrija (zadebljanje sluznice maternice), akutna (kratkotrajna) bolest jetre, prijašnja bolest jetre ako su pokazatelji funkcije jetre još uvijek abnormalni, prijašnja ili postojeća venska tromboembolija (stvaranje krvnih ugrušaka u venama), trombofilni poremećaji (abnormalno zgrušavanje krvi), aktivna ili nedavna arterijska tromboembolijska bolest (bolest uzrokovana krvnim ugrušcima u arterijama), porfirija (nemogućnost razgradnje kemikalija koje se nazivaju porfirini).
English: What measures are being taken to ensure the safe and effective use of Intrarosa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Intrarosa?
English: Other information about Intrarosa
Croatian: Ostale informacije o lijeku Intrarosa
English: What is Intrarosa and what is it used for?
Croatian: Što je Intrarosa i za što se koristi?
English: This is a summary of the European public assessment report (EPAR) for Intrarosa.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Intrarosa.
English: Intrarosa is available as a 6.5 mg pessary.
Croatian: Lijek Intrarosa dostupan je u obliku pesara od 6,5 mg.
English: The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information.
Croatian: Tvrtka koja stavlja lijek Intrarosa na tržište mora provesti ispitivanje o načinu primjene lijeka u kliničkoj praksi, uključujući i to primjenjuje li se u skladu s informacijama o odobrenom lijeku.
English: In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks.
Croatian: Doza lijeka Intrarosa od 6,5 mg primjenjivala se jedanput na dan tijekom 12 tjedana.
English: Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain).
Croatian: Bolesnice su samostalno ocjenjivale bol tijekom spolnog odnosa na temelju standardne ljestvice u rasponu od 0 (izostanak boli) do 3 (jaka bol).
English: Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA).
Croatian: Lijek Intrarosa sadržava djelatnu tvar prasteron, također poznatu pod nazivom dehidroepiandrosteron (DHEA).
English: Why is Intrarosa approved?
Croatian: Zašto je lijek Intrarosa odobren?
English: The European Medicines Agency therefore considered that Intrarosa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Stoga je Europska agencija za lijekove zaključila da koristi lijeka Intrarosa nadmašuju s njim povezane rizike te je preporučila njegovo odobrenje za primjenu u Europskoj uniji.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intrarosa have also 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 Intrarosa nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Intrarosa?
Croatian: Koji su rizici povezani s lijekom Intrarosa?
English: Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues.
Croatian: Dva ispitivanja koja su obuhvatila 813 žena u postmenopauzi s vulvarnom i vaginalnom atrofijom pokazala su da je liječenje lijekom Intrarosa učinkovitije od placeba (prividno liječenje) u ublažavanju znakova stanjivanja (atrofije) vaginalnih tkiva.
English: It is not intended to provide practical advice on how to use Intrarosa.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Intrarosa.
English: Women should insert the pessary into their vagina, once daily, at bedtime.
Croatian: Žene trebaju umetnuti pesar u vaginu jedanput na dan, prije spavanja.
English: In women with vulvar and vaginal atrophy, the wall of the vagina and surrounding tissues become thinner and can cause symptoms such as dryness, irritation and soreness around the genital area, and painful sexual intercourse.
Croatian: U žena s vulvarnom i vaginalnom atrofijom vaginalni zid i okolna tkiva postaju tanji i mogu prouzročiti simptome kao što su suhoća, nadraženost i bol u genitalnom području, te bolan seksualni odnos.
English: The pain reduced by 1.3 and 1.4 points with Intrarosa compared with 0.9 and 1.1 points with placebo.
Croatian: Pri primjeni lijeka Intrarosa bol je smanjena za 1,3 i 1,4 boda, u usporedbi s 0,9 i 1,1 boda kod placeba.
English: Intrarosa is a medicine used to treat postmenopausal women with moderate to severe symptoms of vulvar and vaginal atrophy.
Croatian: Intrarosa je lijek koji se primjenjuje za liječenje žena u postmenopauzi s umjerenim do ozbiljnim simptomima vulvarne i vaginalne atrofije.
English: For more information about treatment with Intrarosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Intrarosa pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: The effect seen in the placebo group was explained by the lubricant effect of the excipient.
Croatian: Učinak koji je zabilježen u skupini koja je primala placebo objašnjen je lubrikantnim djelovanjem pomoćne tvari.
English: Patients taking Intrarosa had a modest reduction in pain during sexual intercourse, which was similar or better to the effect seen in patients taking placebo.
Croatian: U bolesnica koje su uzimale lijek Intrarosa zabilježeno je blago smanjenje boli tijekom spolnog odnosa, koje je bilo slično ili bolje od zabilježenoga učinka u bolesnica koje su uzimale placebo.
English: Intrarosa has been shown to improve the structure of the vaginal tissues and to have a modest effect on pain during sexual intercourse.
Croatian: Utvrđeno je da lijek Intrarosa poboljšava strukturu vaginalnih tkiva te da ima blag učinak na bol tijekom spolnog odnosa.
English: As a result of increasing oestrogen levels, the number of superficial cells in the tissues in and around the vagina increases thus relieving the symptoms of vaginal atrophy.
Croatian: Kao rezultat povećane razine estrogena, povećava se broj površinskih stanica u tkivima u vagini i vaginalnom području, čime se ublažavaju simptomi vaginalne atrofije.
English: There was also a decrease in the number of parabasal cells (which normally increase with atrophy) of 42% and 47% with Intrarosa compared with 2% and 12% with placebo.
Croatian: Također je došlo do smanjenja broja parabazalnih stanica (koji se kod atrofije uglavnom povećava) za 42 % i 47 % pri primjeni lijeka Intrarosa, u usporedbi s 2 % i 12 % kod placeba.
English: Results showed that the number of superficial cells (which normally falls with atrophy) increased by 6% and 10% with Intrarosa compared with about 1% and 2% with placebo.
Croatian: Rezultati su pokazali da se broj površinskih stanica (koji se kod atrofije uglavnom snižava) povećao za 6 % i 10 % pri primjeni lijeka Intrarosa, u usporedbi s otprilike 1 % i 2 % kod placeba.
English: In addition, Intrarosa treatment was better at increasing acidity in the vagina (which normally becomes less acidic with atrophy), with pH values reducing by 0.9 and 1.0 with Intrarosa and by 0.2 and 0.3 with placebo.
Croatian: Nadalje, liječenje lijekom Intrarosa bolje je djelovalo na povećanje kiselosti vagine (koja kod atrofije uglavnom postaje manje kisela), te se primjenom lijeka Intrarosa pH vrijednost smanjila za 0,9 i 1,0, a kod placeba za 0,2 i 0,3.
English: The most common side effect with Intrarosa (which may affect up to 1 in 10 people) is vaginal discharge.
Croatian: Najčešća je nuspojava lijeka Intrarosa (može se javiti u manje od 1 na 10 osoba) vaginalni iscjedak.
English: What benefits of Intrarosa have been shown in studies?
Croatian: Koje su koristi lijeka Intrarosa utvrđene u ispitivanjima?
English: How is Intrarosa used?
Croatian: Kako se Intrarosa koristi?