FrancophonIA/ELRC3.0 huggingface dataset:
English: Dafiro HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT je lijek koji sadrži tri djelatne tvari, amlodipin, valsartan i hidroklorotiazid.
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Dafiro HCT which combines the three substances in a single tablet.
Croatian: CHMP je zaključio kako je izglednije da će se bolesnici koji već uzimaju tri djelatne tvari pridržavati liječenja ako im se propiše Dafiro HCT koja objedinjuje tri djelatne tvari u jednoj tableti.
English: The most common side effects with Dafiro HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Croatian: Najčešće nuspojave lijeka Dafiro HCT (koje se mogu javiti u 1 do 10 osoba na 100 osoba) su hipokalemija (mala koncentracija kalija u krvi), vrtoglavica, glavobolja, hipotenzija (niski krvi tlak), dispepsija (žgaravica), polakiurija (abnormalno često uriniranje), iscrpljenost (umor) i edem (zadržavanje tekućine).
English: The daily dose of Dafiro HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Croatian: Dnevna doza lijeka Dafiro HCT ne smije premašiti 10 mg amlodipina, 320 mg valsartana i 25 mg hidroklorotiazida.
English: The CHMP therefore decided that Dafiro HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Stoga je CHMP odlučio da koristi od lijeka Dafiro HCT nadmašuju s njim povezane rizike te je preporučilo davanje odobrebha za stavljanje lijeka u promet.
English: For all doses, Dafiro HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken separately.
Croatian: U slučaju svih doza, lijek Dafiro HCT udovoljio je zahtjevima kako bi se dokazalo da je usporediva s kombinacijom individualnih djelatnih tvari koje se uzimaju zasebno.
English: Dafiro HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Dafiro HCT.
Croatian: Dafiro HCT se ne smije primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatne tvari, na druge sulfonamide, derivate dihidropiridina ili bilo koju drugu pomoćnu tvar u lijeku Dafiro HCT.
English: Dafiro HCT must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Croatian: Dafiro HCT se također ne smije primjenjivati u kombinaciji s lijekovima koji sadrže aliskiren (koriste se također za liječenje esencijalne hipertenzije) u bolesnika s dijabetesom tipa 2 ili u bolesnika s umjerenim do ozbiljnim oštećenjem bubrega.
English: What is the risk associated with Dafiro HCT?
Croatian: Koji su rizici povezani s lijekom Dafiro HCT?
English: Dafiro HCT is used to treat essential hypertension (high blood pressure) in adults whose blood pressure is already adequately controlled with a combination of amlodipine, valsartan and hydrochlorothiazide.
Croatian: Dafiro HCT se primjenjuje za liječenje esencijalne hipertenzije (visokog krvnog tlaka) u odraslih bolesnika čiji je krvni tlak već odgovarajuće kontroliran kombinacijom amlodipina, valsartana i hidroklorotiazida. „Esencijalno” znači da hipertenzija nema očiti uzrok.
English: Why has Dafiro HCT been approved?
Croatian: Zašto je Dafiro HCT odobren?
English: Other information about Dafiro HCT
Croatian: Druge informacije o lijeku Dafiro
English: For the full list of all side effects reported with Dafiro HCT, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Dafiro HCT potražite u uputi o lijeku.
English: What is Dafiro HCT?
Croatian: Što je Dafiro HCT?
English: What benefit has Dafiro HCT shown during the studies?
Croatian: Koje koristi lijeka Dafiro HCT su dokazane u ispitivanjima?
English: Finally, Dafiro HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Croatian: Naposljetku, Dafiro HCT ne smije se koristiti u bolesnika s hipokalemijom (niskim razinama kalija u krvi), hiponatremijom (niskim razinama natrija u krvi) i hiperkalcemijom
English: What is Dafiro HCT used for?
Croatian: Za što se Dafiro HCT koristi?
English: How does Dafiro HCT work?
Croatian: Kako Dafiro HCT djeluje?
English: How has Dafiro HCT been studied?
Croatian: Kako je Dafiro HCT ispitivan?
English: 28 April 2014 EMA/276477/2014
Croatian: 28. travnja 2014. EMA/276477/2014
English: • Patients who have any questions should speak to their doctor or pharmacist.
Croatian: • Bolesnici koji imaju bilo kakva pitanja trebaju se obratiti svojem liječniku ili ljekarniku.
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Croatian: Farmaceutski oblici i odobrene indikacije, jačine i doze razlikuju se u različitim državama EU-a.
English: If you are being treated for this purpose, please contact your doctor to discuss alternative treatment.
Croatian: Ako se liječite zbog te dijagnoze, molimo da se obratite svom liječniku kako biste raspravili alternativno liječenje.
English: The review of methysergide was initiated on 24 May 2012 at the request of the French medicines agency ANSM under Article 31 of Directive 2001/83/EC following concerns about serious cases of fibrosis identified by the French agency.
Croatian: Pregled podataka o metizergidu započeo je 24. svibnja 2012. na zahtjev francuske agencije za lijekove ANSM u skladu s člankom 31. Direktive 2001/83/EZ zbog bojazni o ozbiljnim slučajevima fibroze koje je utvrdila francuska agencija.
English: However, there were no data to support this use and Methysergide should therefore no longer be used in carcinoid disease.
Croatian: Međutim, ne postoje podaci koji bi poduprli ovu uporabu i metizergid se stoga ne smije više koristiti kod karcinoidne bolesti.
English: The symptoms of fibrosis often take some time to appear and without screening the diagnosis may come too late to prevent severe (and potentially life-threatening) damage to organs .
Croatian: Simptomima fibroze često treba neko vrijeme da se pojave i bez probira dijagnoza može doći prekasno da bi se spriječilo teško (i po život opasno) oštećenje organa.
English: In the EU, medicines containing methysergide have been authorised by national procedures and have been marketed under various trade names.
Croatian: Na području EU-a, lijekovi koji sadrže metizergid odobreni su nacionalnim postupcima i stavljeni u promet pod različitim trgovačkim imenima.
English: The CHMP opinion was sent to the European Commission, which endorsed it and issued a final legally binding decision on 28 April 2014.
Croatian: Mišljenje CHMP-a poslano je Europskoj komisiji koja ga je potvrdila i izdala konačnu, pravno obvezujuću odluku 28. travnja 2014.
English: • Your doctor will also regularly re-assess the need for you to continue treatment with methysergide by seeing if your symptoms return after periodic breaks in treatment.
Croatian: • Vaš liječnik će također redovito provjeravati Vašu potrebu za nastavkom liječenja metizergidom praćenjem povratka Vaših simptoma nakon periodičkih prekida u liječenju.
English: • If you are using methysergide to prevent migraines and cluster headaches, your doctor will check on a regular basis whether you are developing any signs or symptoms of fibrosis.
Croatian: • Ako koristite metizergid za sprječavanje migrena i cluster glavobolja, Vaš liječnik će redovito provjeravati razvijate li znakove ili simptome fibroze.
English: • Following the review of methysergide-containing medicines, methysergide should now only be used for:
Croatian: • Nakon procjene podataka o lijekovima koji sadrže metizergid zaključeno je da se metizergid sada smije koristiti samo za:
English: The prescribing information for physicians and information in the patients' information leaflet has been updated.
Croatian: Informacije o propisivanju za liječnike i informacije u Uputi o lijeku za bolesnike ažurirane su.
English: This examination should include a re-assessment of the benefit-risk balance in the individual patient.
Croatian: Ovaj pregled treba uključivati ponovnu procjenu omjera koristi i rizika u pojedinog bolesnika.
English: Screening investigations may include heart ultrasound, abdominal MRI and lung function tests.
Croatian: Pretrage prilikom probira mogu uključivati ultrazvuk srca, MRI abdomena i ispitivanja rada pluća.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP), which conducted the review, noted that these recommendations were necessary due to the reports of fibrosis seen with methysergide and other medicines of the same class (ergot derivatives).
Croatian: Povjerenstvo za humane lijekove Europske agencije za lijekove (CHMP) koje je provelo procjenu zabilježilo je da su te preporuke bile nužne zbog izvješća o fibrozi uočenoj s metizergidom i drugim lijekovima iste klase (derivatima ergota).
English: The CHMP recommendations were sent to the European Commission, which has endorsed them and issued a final legally-binding decision that is valid throughout the EU.
Croatian: Preporuke CHMP-a poslane su Europskoj komisiji koja ih je potvrdila i izdala konačnu, pravno obvezujuću odluku koja vrijedi diljem EU-a.
English: The mechanism by which methysergide could cause fibrosis through serotoninergic-receptor activation is widely described in the literature.
Croatian: Mehanizam putem kojeg bi metizergid mogao uzrokovati fibrozu aktivacijom serotoninergičnih receptora detaljno je opisan u literaturi.
English: Regarding the benefits, the Committee noted that there is some evidence of a clinically relevant effect of methysergide when used for prevention in patients who regularly get migraines and cluster headaches and for whom treatment options are limited.
Croatian: Što se tiče koristi, Povjerenstvo je primijetilo da postoje određeni dokazi o klinički značajnom učinku metizergida kad se koristi za sprječavanje u bolesnika koji redovito dobivaju migrene i cluster glavobolje i za koje su opcije liječenja ograničene.
English: Methysergide is a medicine that belongs to the class ‘ergot alkaloids' that has been used in the EU for preventing migraines (with or without aura) and other types of throbbing headaches.
Croatian: Metizergid je lijek koji pripada klasi „alkaloida ergota” koji se koriste u EU za sprječavanje migrena (s aurom ili bez nje) i drugih vrsta pulsirajućih glavobolja.
English: The Agency's recommendations are based on available data on the benefits and risks of methysergide, from clinical studies, post-marketing safety reports and the scientific literature.
Croatian: Preporuke Agencije temelje se na svim dostupnim podacima o koristima i rizicima metizergida uključujući i podatke iz kliničkih ispitivanja, izvješća iz ispitivanja nakon stavljanja lijeka u promet i objavljene literature.
English: Treatment must be stopped if a patient develops symptoms suggestive of fibrosis unless an alternative cause is confirmed.
Croatian: Terapiju treba prekinuti ako bolesnik razvije simptome koji ukazuju na fibrozu osim ako se ne potvrdi alternativni uzrok.
English: Based on these data a potential causal association between methysergide and fibrosis seems likely.
Croatian: Na temelju ovih podataka, moguća uzročna veza između metizergida i fibroze postaje moguća.
English: • Methysergide-containing medicines may cause a potentially serious condition known as fibrosis, in which scar tissue accumulates in some of the body's organs.
Croatian: • Lijekovi koji sadrže metizergid mogu uzrokovati potencijalno ozbiljno stanje poznato kao fibroza kod kojeg se ožiljci tkiva akumuliraju u nekim od tjelesnih organa.
English: Previous treatment must have included treatment with medicines of other classes for at least 4 months at the maximum tolerated dose;
Croatian: Prethodne terapije moraju uključivati terapije lijekovima druge klase tijekom najmanje 4 mjeseca pri maksimalnoj toleriranoj dozi;
English: Previous treatment must have included treatment with medicines of at least 2 classes for a minimum of 2 months.
Croatian: Prethodna terapija morala je uključivati liječenje lijekovima od barem 2 klase tijekom najmanje 2 mjeseca.
English: • During treatment with methysergide, a treatment-free period of at least 4 weeks must be allowed between treatment courses at least every 6 months.
Croatian: • Tijekom liječenja metizergidom, potrebno je omogućiti razdoblje bez terapije od najmanje 4 tjedna između dva ciklusa liječenja barem svakih 6 mjeseci.
English: Patients should also be screened for fibrosis at the start of treatment and should have additional screenings every 6 months.
Croatian: Bolesnike također treba podvrgnuti probiru na fibrozu na početku liječenja i trebaju se podvrgnuti dodatnim probirima svakih 6 mjeseci.
English: • Treatment must not begin until after the patient has been examined for any pre-existing fibrotic conditions.
Croatian: • Liječenje ne smije započeti sve dok se bolesnik ne pregleda na prisutnost već postojećih fibrotičkih stanja.
English: In addition, treatment should only be started and supervised by a specialist doctor with experience in treating migraine and cluster headaches.
Croatian: Osim toga, liječenje smije započeti i nadzirati samo liječnik specijalist s iskustvom u liječenju migrene i cluster glavobolja.
English: Once treatment is started the patient must be examined for occurrence of fibrosis at 6monthly intervals.
Croatian: Kada počne liječenje bolesnika treba pregledati na pojavu fibroze u 6-mjesečnim intervalima.
English: Treatment must be discontinued if symptoms of fibrosis occur.
Croatian: Liječenje treba prekinuti u slučaju pojave simptoma fibroze.
English: Methysergide medicines are now only to be used for preventing severe intractable migraines and cluster headaches (a type of severe, recurring headache on one side of the head, usually around the eye) when standard medicines have failed.
Croatian: Lijekovi koji sadrže metizergid od sada će se koristiti samo za sprječavanje teških intraktabilnih migrena (vrste teških, rekurentnih glavobolja koje zahvaćaju područje jedne strane glave, obično oko oka) kada standardni lijekovi ne djeluju.
English: Your doctor will stop your treatment if fibrosis is suspected.
Croatian: Vaš liječnik prekinut će redovito liječenje u slučaju sumnje na fibrozu.
English: It was also used to treat diarrhoea caused by carcinoid disease.
Croatian: Koristio se također za liječenje proljeva koji uzrokuje karcinoidna bolest.
English: − Prophylactic treatment of severe intractable migraine (with or without aura) with functional disability in adults, when treatment with standard medicines has failed.
Croatian: Profilaktičko liječenje teške intraktabilne migrene (s aurom ili bez nje) s funkcionalnom nestabilnosti kod odraslih bolesnika kada liječenje standardnim lijekovima nije uspješno.
English: As a result of this, the use of these medicines is being restricted to the prevention of severe intractable migraines and cluster headaches when standard medicines have failed.
Croatian: Kao rezultat navedenog, uporaba ovih lijekova ograničena je na prevenciju teških, intraktabilnih migrena i cluster glavobolja kada standardni lijekovi ne pomažu.
English: • Patients should be screened for fibrosis at baseline and at least every 6 months thereafter.
Croatian: • Bolesnike treba podvrgnuti probiru na fibrozu na samom početku te najmanje svakih 6 mjeseci nakon toga.
English: On 20 February 2014, the European Medicines Agency recommended restricting the use of methysergide due to concerns that it could cause fibrosis, a condition in which fibrous (scar) tissue accumulates in the body's organs potentially damaging them.
Croatian: Europska agencija za lijekove preporučila je ograničavanje uporabe metizergida zbog bojazni da bi mogao uzrokovati fibrozu, stanje kod kojeg se vezivno tkivo (ožiljci) nakuplja u organima i oštećuje ih.
English: • Treatment with methysergide should only be started and supervised by specialised physicians with experience in treating migraine and cluster headaches.
Croatian: • Liječenje metizergidom može započeti i nadzirati samo liječnik specijalist s iskustvom u liječenju migrene i cluster glavobolja.
English: Methysergide has also been used for treating diarrhoea caused by carcinoid disease (a slow-growing tumour that commonly affects the gut).
Croatian: Metizergid se također koristio za liječenje proljeva uzrokovanog karcinoidnom bolešću (spororastući tumor koji obično zahvaća trbuh).
English: − Prophylactic treatment of episodic and chronic cluster headache in adults when treatment with standard medicines has failed.
Croatian: Profilaktičko liječenje epizoda kronične cluster glavobolje u odraslih kada liječenje standardnim lijekovima nije uspješno.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease.
Croatian: • Metizergid se više ne smije koristiti za liječenje proljeva uzrokovanog karcinoidnom bolešću.
English: • Methysergide should no longer be used for treating diarrhoea caused by carcinoid disease (a type of slow-growing tumour).
Croatian: • Metizergid se više ne smije koristiti za liječenje proljeva uzrokovanog karcinoidnom bolešću (tip spororastućeg tumora).
English: Adopted at the 8-11 February 2016 PRAC
Croatian: Usvojeno na sjednici PRAC-a 8. - 11. veljače 2016.
English: What you need to know before you take Lysodren Warnings and precautions
Croatian: Što morate znati prije nego počnete uzimati Lysodren Upozorenja i mjere opreza
English: Abdominal pain may be a symptom of the above listed complications.
Croatian: Bol u abdomenu može biti simptom prethodno navedenih komplikacija.
English: (Applicable to bosutinib and ponatinib)
Croatian: (Primjenjivo na bosutinib i ponatinib)
English: You should tell your doctor if any of the following applies to you:
Croatian: Obratite se liječniku ako je bilo što od sljedeće navedenog primjenjivo na vas:
English: Patients should be advised to notify their physician if they experience any of the symptoms associated with the above events.
Croatian: Bolesnike je potrebno savjetovati da obavijeste svog liječnika ako primijete bilo koji od simptoma povezanih s prethodno navedenim događajima.
English: Most bezoars reside in the stomach but bezoars may be encountered elsewhere in the intestinal tract.
Croatian: Većina bezoara nalazi se u želucu, ali mogu se naći i drugdje u probavnom traktu.
English: Some events may result in serious outcomes, such as surgery and/or death.
Croatian: Neki takvi slučajevi mogu rezultirati ozbiljnim ishodima, npr. operacijom i/ili smrću.
English: Talk to your doctor, pharmacist or nurse before taking BRANDNAME DRUG
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete NAZIV LIJEKA
English: (Applicable to imatinib, dasatinib and nilotinib)
Croatian: (Primjenjivo na imatinib, dasatinib i nilotinib)
English: Women should be urged to seek medical advice if they experience gynecological symptoms such as bleeding and/or pelvic pain.
Croatian: Žene je potrebno savjetovati da zatraže medicinski savjet ako primijete ginekološke simptome kao što su krvarenje i/ili bol u zdjelici.
English: What you need to know before you take BRANDNAME DRUG Talk to your doctor, pharmacist or nurse before taking BRANDNAME DRUG - if you have ever had or might now have a hepatitis B infection.
Croatian: Što morate znati prije nego počnete uzimati NAZIV LIJEKA Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete NAZIV LIJEKA - ako ste ikada imali ili možda sada imate infekciju virusom hepatitisa B.
English: Bezoars are retained concretions of undigested food indigestible material (such as vegetable or fruit non-digestible fibers) in the intestinal tract.
Croatian: Bezoari su zadržane nakupine neprobavljene hrane neprobavljivih tvari (kao što su neprobavljiva vlakna povrća ili voća) u probavnom traktu.
English: - If you have gynaecological problems such as bleeding and/or pelvic pain.
Croatian: Ako imate ginekološke probleme kao što su krvarenje i/ili bol u zdjelici.
English: DUODOPA (levodopa/carbidopa - intestinal gel)Intussusception (EPITT no 18424)
Croatian: 2. DUODOPA (levodopa/karbidopa - intestinalni gel)intususcepcija (EPITT br. 18424)
English: Possible side effects - Recurrence (reactivation) of Hepatitis B infection when you have had hepatitis B in the past (a liver infection).
Croatian: Moguće nuspojave - Ponovna pojava (ponovna aktivacija) infekcije virusom hepatitisa B ako ste u prošlosti imali hepatitis B (infekciju jetre).
English: Bcr-abl tyrosine kinase inhibitors: GLIVEC (imatinib); SPRYCEL (dasatinib); TASIGNA (nilotinib); BOSULIF (bosutinib); ICLUSIG (ponatinib) - Hepatitis B virus (HBV) reactivation (EPITT no 18405)
Croatian: Inhibitori Bcr-abl tirozin kinaze: GLIVEC (imatinib); SPRYCEL (dasatinib); TASIGNA (nilotinib); BOSULIF (bosutinib); ICLUSIG (ponatinib) - ponovna aktivacija virusa hepatitisa B (HBV) (EPITT br. 18405)
English: A bezoar around the tip of the jejunal tube may function as a lead point for intestinal obstruction or the formation of intussusception.
Croatian: Bezoar oko vrha jejunalne sonde može biti ishodišna točka za intestinalnu opstrukciju ili stvaranje intususcepcije.
English: Adverse Reaction Data Derived From Clinical Trials and Postmarketing Experience Uncommon (> 1/1,000 to < 1/100)
Croatian: Podaci o nuspojavama iz kliničkih ispitivanja i nakon stavljanja lijeka u promet Manje često (≥1/1000 i <1/100)
English: What you need to know before you take BRANDNAME DRUG
Croatian: Što morate znati prije nego počnete uzimati NAZIV LIJEKA
English: Carriers of HBV who require treatment with BRANDNAME DRUG should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy (see section 4.8).
Croatian: Nositelje virusa HBV kojima je potrebno liječenje NAZIV LIJEKA potrebno je pozorno nadzirati radi utvrđivanja eventualnih znakova i simptoma aktivne infekcije HBV-om tijekom terapije te nekoliko mjeseci nakon završetka terapije (vidjeti dio 4.8).
English: • Inflamed pancreas (pancreatitis).
Croatian: • Upala gušterače (pankreatitis).
English: LYSODREN (mitotane) - Sex hormone disturbances and development of ovarian macrocysts (EPITT no 18301)
Croatian: 3. LYSODREN (mitotan) - poremećaji spolnih hormona i razvoj makrocista na jajnicima (EPITT br. 18301)
English: Patients should be tested for HBV infection before initiating treatment with (BRANDNAME DRUG).
Croatian: Bolesnike je potrebno testirati na infekciju HBV-om prije početka liječenja (NAZIV LIJEKA).
English: • Pocket of infection (abscess) - this could happen after the tube is placed in your stomach
Croatian: • Nakupina gnoja izazvana infekcijom (apsces) - to se može dogoditi nakon stavljanja sonde u želudac
English: • Blockage (obstruction), bleeding or ulcer in the gut.
Croatian: • Začepljenje (opstrukcija), krvarenje ili čir na crijevima.
English: Reported complications in the clinical studies, and seen post-marketing, include bezoar, ileus, implant site erosion/ulcer, intestinal haemorrhage, intestinal ischaemia, intestinal obstruction, intestinal perforation, intussusception, pancreatitis, peritonitis, pneumoperitoneum and post-operative wound infection.
Croatian: U kliničkim studijama i nakon stavljanja lijeka u promet zabilježene su komplikacije, koje uključuju bezoar, ileus, eroziju/čir na mjestu ugradnje, intestinalno krvarenje, intestinalnu ishemiju, intestinalnu opstrukciju, intestinalnu perforaciju, intususcepciju, pankreatitis, peritonitis, pneumoperitoneum i infekciju rane nakon operacije.