FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking the receptors to which angiotensin II normally attaches, valsartan stops the hormone having an effect, allowing the blood vessels to widen and blood pressure to reduce.
Croatian: Blokirajući receptore na koje se angiotenzin II normalno vezuje, valsartan zaustavlja djelovanje hormona te omogućuje širenje krvnih žila.
English: The most common side effects with Exforge 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 Exforge 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 CHMP therefore decided that Exforge 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 Exforge HCT nadmašuju s njim povezane rizike te je preporučilo davanje odobrebha za stavljanje lijeka u promet.
English: The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Croatian: Dnevna doza lijeka Exforge HCT ne smije premašiti 10 mg amlodipina, 320 mg valsartana i 25 mg hidroklorotiazida.
English: For all doses, Exforge HCT also met requirements to prove that it was comparable to the combinations of the individual active substances taken seperately.
Croatian: U slučaju svih doza, lijek Exforge HCT udovoljio je zahtjevima kako bi se dokazalo da je usporediva s kombinacijom individualnih djelatnih tvari koje se uzimaju zasebno.
English: Other information about Exforge HCT
Croatian: Druge informacije o lijeku Exforge HCT
English: Finally, Exforge 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, Exforge HCT ne smije se koristiti u bolesnika s hipokalemijom (niskim razinama kalija u krvi), hiponatremijom (niskim razinama natrija u krvi) i hiperkalcemijom (visokim razinama kalcija u krvi) koji ne odgovaraju na liječenje i u bolesnika s hiperurikemijom (visokim razinama mokraćne kiseline) koja uzrokuje simptome.
English: It must also not be used in patients who have liver or bile problems (such as jaundice), severe kidney problems, anuria (a condition in which a patient cannot make or pass urine) or in patients undergoing dialysis (a blood clearance technique).
Croatian: Ne smije primjenjivati u bolesnika koji imaju oštećenje jetre ili probleme sa žući (poput žutice), ozbiljnog oštećenje bubrega, anuriju (stanje u kojem bolesnik ne može proizvoditi urin ili eliminirati urin) ili u bolesnika koji se podvrgavaju dijalizi (tehnici čišćenja krvi).
English: Exforge 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 Exforge HCT.
Croatian: Exforge 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 Exforge HCT.
English: Exforge 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: Exforge 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: Exforge 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: Exforge 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: What is the risk associated with Exforge HCT?
Croatian: Koji su rizici povezani s lijekom Exforge HCT?
English: By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and helps the blood vessel walls to relax and widen, thereby reducing blood pressure.
Croatian: Smanjivanjem dotoka kalcija u stanice, amlodipin sprječava kontrakciju stanica te pomaže pri opuštanju krvnih žila.
English: What benefit has Exforge HCT shown during the studies?
Croatian: Koje koristi lijeka Exforge HCT su dokazane u ispitivanjima?
English: For the full list of all side effects reported with Exforge HCT, see the package leaflet.
Croatian: Potpuni popis nuspojava koje su zabilježene s lijekom Exforge HCT potražite u uputi o lijeku.
English: Why has Exforge HCT been approved?
Croatian: Zašto je Exforge HCT odobren?
English: What is Exforge HCT?
Croatian: Što je Exforge HCT?
English: How has Exforge HCT been studied?
Croatian: Kako je Exforge HCT ispitivan?
English: What is Exforge HCT used for?
Croatian: Za što se Exforge HCT koristi?
English: How is Exforge HCT used?
Croatian: Kako Exforge HCT djeluje?
English: It is a hybrid medicine.
Croatian: To je hibridni lijek.
English: In adults, the total recommended daily dose is from 3 to 6.5 tablets, and in children from 1.5 to 4 tablets.
Croatian: U odraslih ukupna preporučena dnevna doza iznosi od 3 do 6,5 tableta, a u djece od 1,5 do 4 tablete.
English: Cuprior should be taken on an empty stomach, at least one hour before or two hours after meals.
Croatian: Cuprior treba uzimati na prazan želudac, najmanje jedan sat prije obroka ili dva sata poslije obroka.
English: The tablets are taken in 2 to 4 divided doses.
Croatian: Tablete se uzimaju podijeljene u 2 do 4 doze.
English: Cuprior trientine
Croatian: Cuprior trientin
English: Cuprior is available as 150 mg tablets.
Croatian: Lijek Cuprior dostupan je u obliku tableta od 150 mg.
English: This means that it is similar to a ‘reference medicine' (in this case Trientine Dihydrochloride 300 mg capsules) also containing trientine.
Croatian: To znači da je sličan referentnom lijeku (u ovom slučaju trientin dihidrokloridu u kapsulama od 300 mg) koji također sadrži trientin.
English: The full EPAR for Cuprior can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Cuprior nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The CHMP noted that trientine has been used for over 30 years to treat patients with Wilson's disease.
Croatian: CHPM je napomenuo da se trientin upotrebljava više od 30 godina za liječenje bolesnika s Wilsonovom bolešću.
English: Cuprior is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Croatian: Cuprior je lijek za liječenje bolesnika u dobi od 5 i više godina s Wilsonovom bolešću, genetskim stanjem u kojem se bakar apsorbiran iz hrane nakuplja u tijelu, posebice u jetri i mozgu te uzrokuje oštećenje.
English: What measures are being taken to ensure the safe and effective use of Cuprior?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Cuprior?
English: The difference between Cuprior and the reference medicine is that Cuprior contains another form of trientine (trientine tetrahydrochloride) and does not need to be stored in a refrigerator.
Croatian: Razlika između lijeka Cuprior i referentnog lijeka jest u tome što Cuprior sadrži drugi oblik trientina (trientin tetrahidroklorid) i ne treba ga čuvati u hladnjaku.
English: Other information about Cuprior
Croatian: Ostale informacije o lijeku Cuprior
English: To take account of this difference, Cuprior is used at lower doses.
Croatian: Kako bi se uskladila ta razlika, Cuprior se uzima u manjim dozama.
English: This is a summary of the European public assessment report (EPAR) for Cuprior.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Cuprior.
English: The company provided data from the published literature, which show that trientine significantly increases copper elimination in the urine.
Croatian: Tvrtka je dostavila podatke objavljene u literaturi koji pokazuju da trientin značajno povećava eliminaciju bakra putem mokraće.
English: Results showed that Cuprior produces higher levels of the active substance in the blood than the reference medicine.
Croatian: Rezultati su pokazali da Cuprior proizvodi više razine djelatne tvari u krvi nego referentni lijek.
English: Since Cuprior is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Cuprior hibridni lijek, smatra se da su njegove koristi i rizici jednaki onima utvrđenima za referentni lijek.
English: It works by attaching to copper in the body and forming a complex that is then eliminated in the urine.
Croatian: Djeluje tako da se veže na bakar u tijelu i stvara kompleks koji se zatim izlučuje u mokraći.
English: What is Cuprior and what is it used for?
Croatian: Što je Cuprior i za što se koristi?
English: Although Cuprior releases more trientine in the body than the reference medicine, this difference can be addressed by lowering the dose, which is in any case adjusted according to patient response and levels of copper in the body.
Croatian: Iako Cuprior oslobađa u tijelu više trientina nego referentni lijek, ta se razlika može uskladiti snižavanjem doze, koja se u svakom slučaju prilagođava na temelju odgovora bolesnika i razina bakra u tijelu.
English: Cuprior is used in patients who cannot take D-penicillamine, another medicine for this condition.
Croatian: Cuprior se primjenjuje u bolesnika koji ne mogu uzimati D-penicilamin, drugi lijek za liječenje te bolesti.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Cuprior'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 lijeka Cuprior nadmašuju s njim povezane rizike te je preporučio 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 Cuprior 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 Cuprior nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the benefits and risks of Cuprior?
Croatian: Koje su koristi i rizici lijeka Cuprior?
English: Doses are adjusted according to patient response and levels of copper in the body.
Croatian: Doze su prilagođene s obzirom na odgovor bolesnika i razine bakra u tijelu.
English: It is not intended to provide practical advice on how to use Cuprior.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Cuprior.
English: Cuprior can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Croatian: Cuprior se izdaje samo na liječnički recept, a liječenje mora započeti liječnik s iskustvom u liječenju Wilsonove bolesti.
English: The company also carried out a study to compare the levels of trientine in the blood after having taken Cuprior with those for the reference medicine.
Croatian: Tvrtka je također provela ispitivanje kako bi usporedila razine trientina u krvi nakon uzimanja lijeka Cuprior s razinama kod referentnog lijeka.
English: For more information about treatment with Cuprior, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Cuprior pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Cuprior contains the active substance trientine.
Croatian: Cuprior sadrži djelatnu tvar trientin.
English: Why is Cuprior approved?
Croatian: Zašto je lijek Cuprior odobren?
English: For practical information about using Cuprior, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Cuprior bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: The active substance in Cuprior, trientine, is a chelating agent.
Croatian: Djelatna tvar lijeka Cuprior, trientin, kelacijsko je sredstvo.
English: How has Cuprior been studied?
Croatian: Kako je Cuprior ispitivan?
English: How is Cuprior used?
Croatian: Kako se lijek Cuprior koristi?
English: How does Cuprior work?
Croatian: Kako djeluje Cuprior?
English: What you need to know before you use [product name]
Croatian: Što morate znati prije nego počnete primjenjivati [naziv lijeka]
English: Conventional studies using the currently accepted standards for the evaluation of toxicity to reproduction and development are not available.
Croatian: Konvencionalna ispitivanja sukladna trenutno važećim standardima za procjenu reproduktivne i razvojne toksičnosti nisu dostupna.
English: Hypoparathyroidismh
Croatian: Hipoparatireoidizamh
English: If necessary, <Product name> can be used during pregnancy.
Croatian: <Naziv lijeka> može se primjenjivati tijekom trudnoće, ako je neophodno.
English: A large amount of data on pregnant women indicate neither malformative, nor feto/neonatal toxicity.
Croatian: Opsežni podaci u trudnica ne ukazuju na pojavu malformacija ni feto/neonatalni toksični učinak.
English: Adopted at the 12-15 March 2019 PRAC
Croatian: Usvojeno na sjednici PRAC-a 12. - 15. ožujka 2019.
English: Nivolumab - Hypoparathyroidism (EPITT no 19310)
Croatian: Nivolumab - hipoparatireoidizam (EPITT br. 19310)
English: What you need to know before you use OPDIVO Warnings and precautions
Croatian: Što morate znati prije nego počnete primati OPDIVO
English: Paracetamol - Paracetamol use in pregnancy and child neurodevelopment and effects on the urogenital apparatus (EPITT no 17796)
Croatian: Paracetamol - primjena paracetamola u trudnoći i neurološki razvoj djeteta te učinci na urogenitalni sustav (EPITT br. 17796)
English: You should use the lowest possible dose that reduces your pain and/or your fever and use it for the shortest time possible.
Croatian: Trebate uzeti najnižu moguću dozu koja Vam ublažava bol i/ili snižava vrućicu i uzimati je što je moguće kraće.
English: Special warnings and precautions for use
Croatian: Upozorenja i mjere opreza
English: • Decreased function of the parathyroid gland
Croatian: • Smanjena funkcija doštitne žlijezde
English: Epidemiological studies on neurodevelopment in children exposed to paracetamol in utero show inconclusive results.
Croatian: Epidemiološka ispitivanja neurološkog razvoja djece izložene paracetamolu in utero nisu dala rezultate na temelju kojih se može donijeti konačan zaključak.
English: Problems with your hormone producing glands (including the pituitary, the thyroid, the parathyroid and adrenal glands) that may affect how these glands work.
Croatian: tegobe sa žlijezdama koje proizvode hormone (uključujući hipofizu, štitnjaču, doštitne i nadbubrežne žlijezde), koje mogu utjecati na rad tih žlijezda.
English: Signs and symptoms that these glands are not working properly may include fatigue (extreme tiredness), weight change or headache, decreased blood levels of calcium and visual disturbances.
Croatian: Znakovi i simptomi koji pokazuju da te žlijezde ne rade pravilno mogu uključivati izrazit umor, promjenu tjelesne težine ili glavobolju, snižene razine kalcija u krvi te smetnje vida.
English: New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/157160/2019
Croatian: Novi tekst informacija o lijeku - izvadci iz preporuka PRAC-a vezanih uz signale EMA/PRAC/189292/2019
English: Contact your <doctor><midwife> if the pain and/or fever are not reduced or if you need to take the medicine more often.
Croatian: <primalji> ako nije došlo do ublažavanja boli i/ili snižavanja vrućice ili ako lijek trebate uzimati češće.
English: Other immune-related adverse reactions: […] Cases of Vogt-Koyanagi-Harada syndrome and hypoparathyroidism have been reported post-marketing (see section 4.8).
Croatian: Posebna upozorenja i mjere opreza pri uporabi Ostale imunološki uzrokovane nuspojave: […] Nakon stavljanja lijeka u promet prijavljeni su slučajevi Vogt-Koyanagi-Harada sindroma i hipoparatireoidizma (vidjeti dio 4.8).
English: Frequency: Not known for nivolumab monotherapy / nivolumab in combination with ipilimumab [Table key: h Post-marketing event (also see section 4.4)]
Croatian: Učestalost: Nepoznato za monoterapiju nivolumabom / nivolumab u kombinaciji s ipilimumabom [Legenda uz tablicu: h Događaj zabilježen nakon stavljanja lijeka u promet (vidjeti i dio 4.4.)]
English: If clinically needed, paracetamol can be used during pregnancy however it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.
Croatian: Međutim, potrebno ga je primjenjivati u najnižoj učinkovitoj dozi uz najkraće moguće trajanje liječenja i najmanju moguću učestalost doziranja.
English: Packaging Content (concentration)
Croatian: Sastav (koncentracija)
English: 2 vials + 2 syringes
Croatian: 2 bočice + 2 štrcaljke
English: 1 vial + 1 syringe
Croatian: 1 bočica + 1 štrcaljka
English: Invented name
Croatian: EMA broj postupka Zaštićeno ime
English: EU Number
Croatian: Doza
English: What is Besponsa and what is it used for?
Croatian: Što je Besponsa i za što se koristi?
English: The main measure of effectiveness was response to treatment.
Croatian: Glavna mjera učinkovitosti bio je odgovor na liječenje.
English: What measures are being taken to ensure the safe and effective use of Besponsa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Besponsa?
English: The infusions are given on days 1, 8 and 15 of a 3 or 4 week treatment cycle.
Croatian: Intravenske infuzije primjenjuju se 1., 8. i 15. dan 3. ili 4. tjedna ciklusa liječenja.
English: The doctor may interrupt treatment or reduce the dose, if the patient develops certain serious side effects.
Croatian: Liječnik može prekinuti terapiju ili smanjiti dozu ako bolesnik razvije određene teške nuspojave.
English: Why is Besponsa approved?
Croatian: Zašto je lijek Besponsa odobren?
English: An analysis of the first 218 patients treated showed that after at least 2 cycles of treatment, 81% (88 out of 109) of patients receiving Besponsa responded to treatment compared with 29% (32 out of 109) of patients receiving other chemotherapy.
Croatian: Analiza prvih 218 liječenih bolesnika pokazala je da je nakon najmanje dva ciklusa liječenja 81 % (88 od 109) bolesnika koji su primali lijek Besponsa pozitivno odgovorilo na liječenje za razliku od 29 % (32 od 109) bolesnika koji su primali drugu kemoterapiju.
English: What are the risks associated with Besponsa?
Croatian: Koji su rizici povezani s lijekom Besponsa?
English: In patients who have a type of chromosome known as Philadelphia-chromosome, treatment with a cancer medicine called a tyrosine kinase inhibitor should have been tried before starting Besponsa.
Croatian: U bolesnika koji imaju vrstu kromosoma poznatu kao Philadelphia kromosom, liječenje lijekom protiv raka pod nazivom inhibitor tirozin kinaze trebalo je biti isprobano prije početka liječenja lijekom Besponsa.
English: This is a summary of the European public assessment report (EPAR) for Besponsa.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Besponsa.
English: Besponsa is given as an infusion (drip) into a vein lasting for at least one hour.
Croatian: Lijek Besponsa primjenjuje se intravenskom infuzijom (drip) u trajanju od najmanje jednog sata.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Besponsa 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 Besponsa nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: It is not intended to provide practical advice on how to use Besponsa.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Besponsa.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti o lijeku Besponsa možete pronaći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: With regard to safety, the side effects with Besponsa are similar to those of other chemotherapy medicines and can usually be managed by dose reduction or treatment interruption.
Croatian: U pogledu sigurnosti, nuspojave lijeka Besponsa slične su onima drugih kemoterapijskih lijekova, što se uobičajeno može riješiti smanjenjem doze ili prekidom liječenja.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Besponsa'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 lijeka Besponsa nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: Besponsa can only be obtained with a prescription, and treatment should be given under the supervision of a doctor who has experience in the use of cancer treatments.
Croatian: Besponsa se izdaje samo na recept i smije se davati samo pod nadzorom liječnika s iskustvom u primjeni lijekova za liječenje raka.
English: Patients whose treatment works well, but who are not going to receive a stem cell transplant, may receive up to a maximum of 6 cycles of treatment.
Croatian: Bolesnici koji dobro reagiraju na liječenje, ali koji neće biti podvrgnuti transplantaciji matičnih stanica, mogu primiti najviše šest ciklusa liječenja.
English: The full EPAR for Besponsa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito europsko javno izvješće o procjeni (EPAR) lijeka Besponsa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What benefits of Besponsa have been shown in studies?
Croatian: Koje su koristi lijeka Besponsa dokazane u ispitivanjima?
English: For more information about treatment with Besponsa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Besponsa pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svojem liječniku ili ljekarniku.
English: Patients in whom Besponsa works well should receive 2 or 3 cycles, after which they can have a stem cell transplant to replace their bone marrow, the only curative treatment.
Croatian: Bolesnici koji dobro reagiraju na liječenje lijekom Besponsa trebali bi primiti dva ili tri ciklusa, nakon čega mogu biti podvrgnuti transplantaciji matičnih stanica kako bi se zamijenila njihova koštana srž, što je jedina ljekovita terapija.