FrancophonIA/ELRC3.0 huggingface dataset:
English: Pulmonary embolism, Hypoxia, Dysphoniaa
Croatian: Poremećaji metabolizma i prehrane anoreksija hipomagnezijemija hiponatrijemija dehidracija
English: • Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and topotecan 0.75 mg/m2 IV over 30 minutes on days 1-3 (q3w)
Croatian: tijekom 30 minuta od 1. do 3. dana (svaka 3 tjedna) • paklitaksel u dozi od 175 mg/m i.v. tijekom 3 sata 1. dana i topotekan u dozi od 0,75 mg/m i.v.
English: Median PFS (months) Hazard Ratio (95% CI)
Croatian: Medijan PFS (mjeseci) Omjer hazarda (95% CI)
English: The main secondary efficacy endpoint was progression-free survival (PFS).Results are presented in Table 22.
Croatian: Glavna sekundarna mjera ishoda za djelotvornost bilo je preživljenje bez progresije bolesti (PFS).
English: Pulmonary hypertensiona, Nasal septum perforationa
Croatian: perforacija nosnog septumaa
English: Erlotinib + Avastin N = 75#
Croatian: Erlotinib + Avastin
English: IRC Assessment
Croatian: Procjena neovisnog povjerenstva
English: A total of 452 patients were randomised to receive either:
Croatian: Ukupno je randomizirano 484 bolesnica s mjerljivom bolešću u omjeru 1:1 da primaju:
English: Tumour-associated haemorrhage (see section 4.4)
Croatian: Krvarenje povezano s tumorom (vidjeti dio 4.4)
English: Avastin is a medicine used for the treatment of adult patients with advanced cancer in the large bowel, i.e., in the colon or rectum.
Croatian: Avastin je lijek koji se koristi za liječenje odraslih bolesnika s uznapredovalim rakom debelog crijeva,
English: Hypertension a,b
Croatian: hemoptiza a,b plućna embolija,
English: AVF3694g
Croatian: • Ispitivanje AVF3694g (kapecitabin)
English: CP (n = 154)
Croatian: (n = 154)
English: Asthenia, Fatigue, Pyrexia, Pain, Mucosal inflammation
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, umor, pireksija, bol, upala sluznice letargija
English: Arm 1
Croatian: PRILOG I.
English: Paclitaxel 175 mg/m2 IV over 3 hours on Day 1 and cisplatin 50 mg/m2 IV on Day 1 plus bevacizumab 15 mg/kg IV on Day 1 (q3w)
Croatian: tijekom 30 minuta od 1. do 3. dana plus bevacizumab u dozi od 15 mg/kg i.v. 1. dana (svaka 3 tjedna)
English: The median age was 46.0 years (range: 20−83) in the Chemo alone group and 48.0 years
Croatian: Medijan dobi bio je 46,0 godina (raspon: 20-83) u skupini koja je primala samo kemoterapiju, a 48,0 godina (raspon: 22-85) u skupini koja je primala kemoterapiju+Avastin; 9,3% bolesnica u skupini koja je primala samo kemoterapiju i 7,5% bolesnica u skupini koja je primala kemoterapiju+Avastin bilo je starije od 65 godina.
English: Median OS (months) Hazard Ratio (95% CI) p-value
Croatian: Medijan OS (mjeseci) Omjer hazarda (95% CI) p-vrijednost
English: • fever,
Croatian: ● proljev,
English: No trials have been conducted to investigate the pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion.
Croatian: S obzirom na to da jetra nije glavni organ metaboliziranja i izlučivanja bevacizumaba, nisu provedena ispitivanja farmakokinetike bevacizumaba u bolesnika s oštećenjem jetrene funkcije.
English: 7.5 mg/kg q 3 weeks
Croatian: 7,5 mg/kg svaka 3 tjedna
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/4 ml
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA
English: Median (months) Hazard ratio (95% CI) p-value
Croatian: Medijan (mjeseci) Omjer hazarda (95% CI) p-vrijednost
English: PFS subgroup analyses by disease stage and debulking status are summarised in Table 17.
Croatian: Analize preživljenja bez progresije bolesti po podskupinama prema stadiju bolesti i statusu smanjenja tumorske mase sažeti su u Tablici 17. Ti rezultati pokazuju robusnost analize preživljenja bez progresije bolesti koja je prikazana u Tablici 16.
English: Febrile neutropenia, Leucopenia, Neutropenia a,
Croatian: Poremećaji krvi i limfnog sustava febrilna neutropenija, leukopenija, neutropenija a, trombocitopenija anemija, limfopenija
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription
Croatian: Lijek se izdaje na recept
English: Prior radiation is a risk factor for GI perforation in patients treated for persistent, recurrent or metastatic cervical cancer with Avastin and all patients with GI perforation had a history of prior radiation.
Croatian: recidivirajućeg ili metastatskog karcinoma cerviksa, a sve bolesnice s gastrointestinalnom perforacijom prethodno su bile liječene zračenjem.
English: Hepatobiliary disorders
Croatian: 5-fluorouracil
English: Table 9
Croatian: Tablici 3.
English: Posterior reversible encephalopathy syndrome a,b,c,
Croatian: obiteljski i genetski poremećaji poremećaji fetusa a,c
English: Topotecan+ Paclitaxel vs. Cisplatin+ Paclitaxel
Croatian: Topotekan+paklitaksel naspram
English: The response was maintained for up to 5 years.
Croatian: Taj je rezultat održan tijekom razdoblja do pet godina.
English: This summary was last updated in 04-2017.
Croatian: Ovaj sažetak je posljednji put ažuriran u 04. 2017.
English: PML is a very serious condition that may result in severe disability or death.
Croatian: PML je vrlo ozbiljno stanje koje može dovesti do teškog invaliditeta ili smrti.
English: Patients should read this card carefully and keep it with them.
Croatian: Bolesnici tu karticu trebaju pažljivo pročitati i držati je uza sebe.
English: The full EPAR for Tysabri can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Tysabri nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The pack will also include information about other risks of this medicine for patients.
Croatian: U paketu će se također nalaziti i informacije o drugim rizicima ovog lijeka za bolesnike.
English: Patients should make sure their partner or carer, as well as other doctors treating them, are aware of its content.
Croatian: Bolesnici se moraju pobrinuti da su njihov partner ili skrbnik, kao i drugi liječnici koji ih liječe, upoznati sa sadržajem kartice.
English: Tysabri is given as a one-hour infusion (drip) into a vein once every four weeks.
Croatian: Tysabri se primjenjuje kao intravenska infuzija (drip) jednom svaka četiri tjedna.
English: About 6% of the patients in studies developed long-lasting antibodies against natalizumab, which reduced the medicine's effectiveness.
Croatian: Otprilike 6 % bolesnika uključenih u ispitivanja razvilo je dugotrajna protutijela na natalizumab, što je smanjilo djelotvornost lijeka.
English: This is a summary of the European public assessment report (EPAR) for Tysabri.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Tysabri.
English: Because the infusion can trigger an allergic reaction, the patient must be monitored during the infusion and for one hour afterwards.
Croatian: Infuzija može izazvati alergijsku reakciju zbog čega je potrebno nadzirati bolesnike tijekom i jedan sat nakon primjene lijeka.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Tysabri on 27 June 2006.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Tysabri u promet koje je na snazi na prostoru Europske unije od 27. lipnja 2006.
English: Tysabri can increase the risk of infections, including the brain infection PML.
Croatian: Tysabri može povećati rizik od infekcija, uključujući infekciju mozga PML.
English: It must not be given in combination with other disease-modifying medicines or to patients who have cancer (unless it is a type of skin cancer called basal cell carcinoma).
Croatian: Ne smije ga se davati u kombinaciji s drugim lijekovima za modifikaciju bolesti niti bolesnicima koji imaju rak (osim ako se radi o vrsti raka kože naziva rak bazalnih stanica).
English: If PML is suspected, the doctor must stop treatment until it is certain that the patient does not have the infection.
Croatian: U slučaju sumnje na PML, liječnik mora prekinuti liječenje dok se sa sigurnošću ne utvrdi da bolesnik nema upalu.
English: However, because of its safety risks, it should only be used in patients who have a real need for the medicine either because their disease has failed to respond to at least one other disease-modifying therapy or is rapidly getting worse.
Croatian: Međutim, zbog njegova sigurnosnog rizika, Odbor je zaključio da ga trebaju koristiti samo bolesnici koji imaju stvarnu potrebu za lijekom bilo zato što im bolest nije reagirala na barem jednu drugu terapiju za modificiranje bolesti ili zato što im se stanje naglo pogoršava.
English: Finally, a third study, still ongoing, has shown the average number of MS attacks per year falling from 1.99 to 0.22 in Tysabri-treated patients (regardless of which disease-modifying treatment they had previously used),.
Croatian: Konačno, treće ispitivanje koje još traje pokazalo je smanjenje prosječnog broja napada multiple skleroze s 1,99 na 0,22 u bolesnika koji su primali lijek Tysabri (bez obzira na vrstu prethodnog liječenja za modifikaciju bolesti).
English: What measures are being taken to ensure the safe and effective use of Tysabri?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tysabri?
English: What is Tysabri and what is it used for?
Croatian: Što je Tysabri i za što se koristi?
English: The most common side effects seen in studies with Tysabri (seen in between 1 and 10 patients in 100) were urinary tract infection (infection of the structures that carry urine), nasopharyngitis (inflammation of the nose and throat), urticaria (itchy rash), headache, dizziness, vomiting, nausea (feeling sick), joint pain, rigors (shaking chills), fever and tiredness.
Croatian: Najčešće su nuspojave lijeka Tysabri zabilježene u ispitivanjima (uočene u 1 do 10 na 100 bolesnika) upala mokraćnog sustava (upala organa koji prenose urin), nazofaringitis (upala nosa i grla), urtikarija (osip praćen svrbežom), glavobolja, omaglica, povraćanje, mučnina (slabost), bol u zglobovima, tresavica (zimica), vrućica i umor.
English: Other information about Tysabri
Croatian: Ostale informacije o lijeku Tysabri
English: This scanner will enable the doctor to check for changes in the brain or spinal cord linked to MS or to the brain infection called progressive multifocal leukoencephalopathy (PML), which has been associated with Tysabri and other MS medicines.
Croatian: Njime liječnik može ispitati prisutnost promjena u mozgu ili leđnoj moždini povezanih s multiplom sklerozom ili infekcijom mozga koja se naziva progresivna multifokalna leukoencefalopatija (PML), povezana s lijekom Tysabri i drugim lijekovima za liječenje multiple skleroze.
English: A second study showed that adding Tysabri to treatment with another medicine, interferon beta-1a, was more effective than adding placebo, reducing the risk of disability getting worse and the number of relapses.
Croatian: Drugo je ispitivanje pokazalo da je dodavanje lijeka Tysabri terapiji drugim lijekom, interferonom beta1a, djelotvornije od dodavanja placeba za smanjenje pogoršanja rizika od invalidnosti i broja relapsa.
English: It is not intended to provide practical advice on how to use Tysabri.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Tysabri.
English: The active substance in Tysabri, natalizumab, is a monoclonal antibody which targets a protein called ‘α4β1 integrin' found on the surface of white blood cells involved in inflammation.
Croatian: Djelatna tvar u lijeku Tysabri, natalizumab, monoklonsko je protutijelo koje djeluje na bjelančevinu naziva „α4β1 integrin” koja se nalazi na površini bijelih krvnih stanica uključenih u upalu.
English: Patients should receive this information when starting Tysabri, when continuing treatment for longer than 2 years, and when stopping treatment, as the risk of PML persists for 6 months after stopping treatment.
Croatian: Bolesnici te informacije trebaju primiti prije početka terapije lijekom Tysabri, kad nastavljaju terapiju duže od dvije godine i kad prekidaju terapiju jer rizik od razvoja PML-a postoji još šest mjeseci nakon prekida terapije.
English: In a study comparing Tysabri with placebo (a dummy treatment), the number of MS attacks in Tysabritreated patients fell by about 68% after a year, compared with the patients who received placebo.
Croatian: U ispitivanju u kojem je lijek Tysabri uspoređen s placebom (prividnim liječenjem), broj napada multiple skleroze u bolesnika koji su primali Tysabri smanjio se za oko 68 % nakon godinu dana u usporedbi s bolesnicima koji su primali placebo.
English: Tysabri was effective at reducing the number of relapses and the worsening of disability (as measured with the Expanded Disability Status Scale).
Croatian: Tysabri je bio učinkovit u smanjenju broja relapsa i pogoršanja invalidnosti mjereno prema ljestvici EDSS (Expanded Disability Status Scale).
English: It contains the active substance natalizumab.
Croatian: Sadrži djelatnu tvar natalizumab.
English: Tysabri is a medicine for treating adults with multiple sclerosis (MS) that has failed to respond to another disease-modifying therapy or is rapidly getting worse.
Croatian: Tysabri je lijek za liječenje odraslih s multiplom sklerozom (MS) koji nisu reagirali na drugu terapiju protiv te bolesti ili im se stanje naglo pogoršava.
English: It will also supply all doctors who prescribe Tysabri with an educational pack that includes information on the safety of Tysabri, including information on which patients may be at a higher or lower risk of PML.
Croatian: Također će svim liječnicima koji propisuju lijek Tysabri dostaviti edukativni paket koji uključuje informacije o sigurnoj primjeni lijeka Tysabri, uključujući informacije o tome koji bi bolesnici mogli biti izloženi većem ili manjem riziku od PML-a.
English: Treatment with Tysabri should be started and continuously supervised by a doctor who is experienced in treating diseases of the nervous system and has access to a magnetic resonance imaging (MRI) scanner.
Croatian: Liječenje lijekom Tysabri mora započeti i stalno nadzirati liječnik s iskustvom u liječenju bolesti živčanog sustava, koji ima pristup uređaju za snimanje magnetskom rezonancijom (MRI).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Tysabri's benefits in this restricted population are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) odlučio je da koristi od lijeka Tysabri nadmašuju s njim povezane rizike u ovoj ograničenoj skupini bolesnika te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: The company that markets Tysabri will agree on measures to further enhance the monitoring of patients with each Member State, such as registries and studies of patients receiving Tysabri.
Croatian: Tvrtka koja stavlja na tržište lijek Tysabri pristat će na mjere dodatnog poboljšanja nadzora bolesnika u svim državama članicama, kao što su registri i ispitivanja koja se provode na bolesnicima koji primaju lijek Tysabri.
English: Multiple sclerosis is a disease of the nerves, in which inflammation destroys the protective sheath surrounding the nerve cells.
Croatian: Multipla skleroza bolest je živaca u kojoj upala uništava zaštitnu ovojnicu živčanih stanica.
English: What are the risks associated with Tysabri?
Croatian: Koji su rizici povezani s lijekom Tysabri?
English: In addition, the risk of disability getting worse was reduced by 42% over two years with Tysabri in comparison with placebo.
Croatian: Osim toga, primjenom lijeka Tysabri rizik od pogoršanja invalidnosti smanjen je za 42 % u razdoblju od dvije godine u usporedbi s placebom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tysabri 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 Tysabri nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Patients who receive Tysabri must be given a special alert card that summarises the key safety information about the medicine.
Croatian: Bolesnici koji primaju lijek Tysabri moraju dobiti posebnu karticu s upozorenjima na kojoj su sažete sve ključne informacije o sigurnoj primjeni lijeka.
English: Why is Tysabri approved?
Croatian: Zašto je lijek Tysabri odobren?
English: Tysabri must not be given to patients who have PML or who are at risk of getting an infection, including patients whose immune system is weakened.
Croatian: Lijek Tysabri ne smije se davati bolesnicima s PML-om ili onima koji su izloženi riziku od upale, kao ni bolesnicima s oslabljenim imunosnim sustavom.
English: For more information about treatment with Tysabri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Tysabri pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Tysabri is used in the type of MS known as ‘relapsing-remitting' MS, when the patient has attacks (relapses) in between periods with no symptoms (remissions).
Croatian: Lijek Tysabri upotrebljava se za liječenje bolesnika s vrstom multiple skleroze poznate pod nazivom „relapsno-remitentna”, pri kojoj bolesnik ima napadaje (relapse) između razdoblja bez simptoma (remisija).
English: By attaching to integrin, natalizumab is thought to stop white blood cells from going from the blood to the brain tissue, thereby reducing inflammation and nerve damage caused by MS.
Croatian: Smatra se da vezivanjem na integrin natalizumab sprječava prelazak leukocita iz krvi u tkivo mozga, čime smanjuje upalu i oštećenje živaca uzrokovano multiplom sklerozom.
English: The risk is also higher if the patient used medicines that supress the immune system before starting Tysabri, or if the patient has antibodies against the virus that causes PML.
Croatian: Rizik je također veći u bolesnika koji su prije početka liječenja lijekom Tysabri primali lijekove za supresiju imunosnog sustava ili imaju protutijela na virus koji izaziva PML.
English: For practical information about using Tysabri, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Tysabri bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The risk of PML increases the longer a patient has been receiving Tysabri, especially in patients treated for more than two years.
Croatian: Što dulje bolesnik prima lijek Tysabri, to je rizik od PML-a veći, posebice u bolesnika koji se njime liječe duže od dvije godine.
English: What benefits of Tysabri have been shown in studies?
Croatian: Koje su koristi od lijeka Tysabri utvrđene u ispitivanjima?
English: How is Tysabri used?
Croatian: Kako se Tysabri koristi?
English: How does Tysabri work?
Croatian: Kako djeluje Tysabri?
English: Studies have shown that Tysabri is effective in treating relapsing-remitting MS.
Croatian: Ispitivanja su pokazala da je lijek Tysabri djelotvoran u smanjenju relapsno-remitentne multiple skleroze.
English: If there is no clear benefit for the patient after six months, the doctor should re-assess the treatment.
Croatian: Liječnik bi trebao preispitati liječenje ako utvrdi da bolesnik nema vidljive koristi od liječenja nakon šest mjeseci.
English: For the full list of all side effects reported with Tysabri, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Tysabri potražite u uputi o lijeku.
English: The wording should be added to or replace existing text as appropriate for each product.
Croatian: Tekst je potrebno dodati ili zamijeniti postojeći tekst kako je prikladno za svaki lijek.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Gdje je to potrebno informacije o lijeku mogu naknadno biti ažurirane od strane nadležnih tijela zemlje članice, u suradnji s referentnom zemljom članicom, i u skladu s postupcima opisanim u Poglavlju 4, Glave III, Direktive 2001/83/EZ.
English: If the current SmPC or package leaflet includes corresponding information in any other sections, it should be deleted in order to avoid repeated or contradictory information.
Croatian: Ako su u trenutno odobrenom SmPC-u ili uputi o lijeku odgovarajuće informacije uključene u drugim dijelovima, potrebno ih je izbrisati kako bi se izbjeglo ponavljanje ili kontradiktorne informacije.
English: • Section 4.4 Special warnings and precautions for use Pneumonia in patients with COPD
Croatian: • Dio 4.4 Posebna upozorenja i mjere opreza pri uporabi Pneumonija u bolesnika s KOPB-om
English: Amendments to relevant sections of the product information
Croatian: Izmjene odgovarajućih dijelova informacija o lijeku
English: • Section 4.8 Undesirable effects
Croatian: • Dio 4.8 Nuspojave
English: The following information should be implemented in the product information of inhaled corticosteroids with a COPD indication.
Croatian: Sljedeće informacije potrebno je uključiti u informacije o lijeku za inhalacijske kortikosteroide koji su indicirani za kroničnu opstruktivnu plućnu bolest (KOPB).
English: These amendments to the relevant sections of the product information are the outcome of the referral procedure.
Croatian: Ove izmjene odgovarajućih dijelova sažetka opisa svojstava lijeka i upute o lijeku ishod su arbitražnog postupka.
English: Tabulated list of adverse reactions “Pneumonia (in COPD patients)” to be listed as “Common” adverse drug reaction in the “Infections and infestations” SOC.
Croatian: Tablični prikaz nuspojava “Pneumonija (u bolesnika s KOPB-om)” treba biti navedena kao „Česta“ nuspojava u klasifikaciji organskih sustava „Infekcije i infestacije“.
English: Summary of product characteristics
Croatian: Sažetak opisa svojstava lijeka
English: Pneumonia (infection of the lung) in COPD patients (common side effect) Tell your doctor if you have any of the following while taking <active substance> they could be symptoms of a lung infection:
Croatian: • Dio 4: Moguće nuspojave Upala pluća (infekcija pluća) u bolesnika s KOPB-om (česta nuspojava) Obavijestite svog liječnika ako se pri primjeni
English: MA (EU) number
Croatian: Broj EU odobrenja
English: (Invented) name
Croatian: Zaštićeno ime
English: 1 vial
Croatian: 1 uložak
English: 31 July 2015
Croatian: 31. srpnja 2015.
English: December 2016 CMDh meeting
Croatian: sastanak CMDh-a u prosincu 2016.
English: 29 March 2017
Croatian: 29. ožujka 2017.
English: 28 January 2017
Croatian: 28. siječnja 2017.