FrancophonIA/ELRC3.0 huggingface dataset:
English: How is Tovanor Breezhaler used?
Croatian: Kako se Tovanor Breezhaler koristi?
English: What benefits of Tovanor Breezhaler have been shown in studies?
Croatian: Koje su koristi od lijeka Tovanor Breezhaler utvrđene u ispitivanjima?
English: Tovanor Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Croatian: U dvama ispitivanjima kojima je bilo obuhvaćeno ukupno 1 888 osoba oboljelih od KOPB-a utvrđeno je da je lijek Tovanor Breezhaler učinkovitiji od placeba (prividnog liječenja) pri ublažavanju simptoma KOPB-a.
English: The full EPAR for Parsabiv can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Parsabiv nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: In some circumstances, it can be given by injection into a vein.
Croatian: U određenim okolnostima može se dati injekcijom u venu.
English: What is Parsabiv and what is it used for?
Croatian: Što je Parsabiv i za što se koristi?
English: The main measure of effectiveness was a reduction in parathyroid hormone by more than 30% after at least 20 weeks of treatment.
Croatian: Glavno mjerilo učinkovitosti bilo je smanjenje razine paratireoidnog hormona za više od 30 % nakon barem 20 tjedana liječenja.
English: What measures are being taken to ensure the safe and effective use of Parsabiv?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Parsabiv?
English: In all three studies, Parsabiv was given for 26 weeks.
Croatian: U sva tri ispitivanja lijek Parsabiv primjenjivan je 26 tjedana.
English: Other information about Parsabiv
Croatian: Ostale informacije o lijeku Parsabiv
English: It is not intended to provide practical advice on how to use Parsabiv.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Parsabiv.
English: In the first two studies, Parsabiv was effective in 75% (380 out of 509) of patients compared with 9% (46 out of 514) of patients given placebo.
Croatian: U prvim dvama ispitivanjima lijek Parsabiv bio je učinkovit u 75 % (380 od 509) bolesnika, u usporedbi s 9 % (46 od 514) bolesnika koji su primali placebo.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Parsabiv'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 Parsabiv nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What are the risks associated with Parsabiv?
Croatian: Koji su rizici povezani s lijekom Parsabiv?
English: This is a summary of the European public assessment report (EPAR) for Parsabiv.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Parsabiv.
English: Treatment is started at a dose of 5 mg three times a week and the dose is then adjusted according to the patient's parathyroid hormone level or calcium level.
Croatian: Liječenje započinje dozom od 5 mg tri puta tjedno, a zatim se doza prilagođava sukladno razini paratireoidnog hormona ili razini kalcija u bolesnika.
English: Parsabiv is available as a solution for injection.
Croatian: Lijek Parsabiv dostupan je kao otopina za injekciju.
English: In the third study, Parsabiv was found to be at least as effective as cinacalcet: in 68% (232 out of 340) patients given Parsabiv compared with 58% (198 out of 343) patients given cinacalcet.
Croatian: U trećem ispitivanju, lijek Parsabiv bio je barem jednako učinkovit kao i sinakalcet: u 68% (232 od 340) bolesnika koji su primali lijek Parsabiv, u usporedbi s 58 % (198 od 343) bolesnika koji su primali sinakalcet.
English: The most common side effects with Parsabiv (which may affect more than 1 in 10 people) are low calcium level in the blood, muscle spasm, diarrhoea, nausea (feeling sick) and vomiting.
Croatian: Najčešće su nuspojave lijeka Parsabiv (koje se mogu javiti u više od 1 na 10 osoba) niska razina kalcija u krvi, grčevi u mišićima, proljev, mučnina i povraćanje.
English: Parsabiv etelcalcetide
Croatian: Parsabiv etelkalcetid
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Parsabiv 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 Parsabiv nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The active substance in Parsabiv, etelcalcetide, is a calcimimetic.
Croatian: Djelatna tvar u lijeku Parsabiv, etelkalcetid, jest kalcimimetik.
English: It contains the active substance etelcalcetide.
Croatian: Sadrži djelatnu tvar etelkalcetid.
English: Parsabiv can only be obtained with a prescription.
Croatian: Parsabiv se izdaje samo na recept.
English: Why is Parsabiv approved?
Croatian: Zašto je lijek Parsabiv odobren?
English: For more information about treatment with Parsabiv, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Parsabiv pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Parsabiv must not be started if the patient's blood calcium level is below the normal range.
Croatian: Liječenje lijekom Parsabiv ne smije se započeti ako je razina kalcija u krvi bolesnika niža od normalnih vrijednosti.
English: The first two studies compared Parsabiv with placebo (a dummy treatment), and the third study compared it with cinacalcet, another calcimimetic medicine.
Croatian: U prvim dvama ispitivanjima lijek Parsabiv uspoređen je s placebom (prividno liječenje), a u trećem ispitivanju uspoređen je s sinakalcetom, drugim kalcimimetikom.
English: Parsabiv is a medicine used to reduce the levels of parathyroid hormone in adults who have high levels of this hormone because of their long-term kidney disease (secondary hyperparathyroidism).
Croatian: Parsabiv je lijek koji se primjenjuje za smanjenje razine paratireoidnog hormona u odraslih osoba koje imaju visoke razine tog hormona zbog dugotrajne bolesti bubrega (sekundarni hiperparatireoidizam).
English: High levels of parathyroid hormone can cause loss of calcium from the bones, bone pain and fractures, and heart and circulation problems.
Croatian: Visoke razine paratireoidnog hormona mogu uzrokovati smanjenje kalcija u kostima, bol u kostima i prijelome te probleme sa srcem i cirkulacijom.
English: Parsabiv has been investigated in three main studies involving 1,706 patients on haemodialysis who had long-term kidney disease and secondary hyperparathyroidism.
Croatian: Lijek Parsabiv ispitivan je u okviru triju glavnih ispitivanja koja su uključivala 1706 bolesnika na hemodijalizi koji su imali dugotrajnu bolest bubrega i sekundarni hiperparatireoidizam.
English: Parsabiv is used in patients on haemodialysis (a technique for removing waste products from the blood using a blood filtration machine).
Croatian: Lijek Parsabiv primjenjuje se u bolesnika koji primaju terapiju hemodijalizom (tehnika za uklanjanje otpadnih proizvoda iz krvi s pomoću uređaja za filtriranje krvi).
English: This means that it mimics the action of calcium on these cells and in this way, it reduces the parathyroid hormone levels in the blood.
Croatian: To znači da oponaša djelovanje kalcija u tim stanicama i na taj način smanjuje razinu paratireoidnog hormona u krvi.
English: For practical information about using Parsabiv, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Parsabiv bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Reduced parathyroid hormone decreases the levels of calcium in the blood.
Croatian: Smanjena razina paratireoidnog hormona snižava razinu kalcija u krvi.
English: When cells in the parathyroid gland detect high levels of calcium in the blood, they reduce the amount of parathyroid hormone entering the blood.
Croatian: Kada stanice u paratireoidnoj žlijezdi otkriju visoke razine kalcija u krvi, smanjuju količinu paratireoidnog hormona koja ulazi u krv.
English: The medicine has been found effective for reducing parathyroid hormone in the blood in patients with kidney disease being treated with haemodialysis and its side effects are those expected of a calcimimetic substance.
Croatian: Lijek se pokazao učinkovitim za smanjivanje razine paratireoidnog hormona u krvi bolesnika s bolesti bubrega koji se liječe hemodijalizom, a nuspojave lijeka one su koje se mogu očekivati kod primjene kalcimimetika.
English: How does Parsabiv work?
Croatian: Kako djeluje Parsabiv?
English: How is Parsabiv used?
Croatian: Kako se Parsabiv koristi?
English: What benefits of Parsabiv have been shown in studies?
Croatian: Koje su koristi lijeka Parsabiv dokazane u ispitivanjima?
English: For the full list of Parsabiv's side effects and restrictions, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja zabilježenih pri primjeni lijeka Parsabiv potražite u uputi o lijeku.
English: It is given at the end of a haemodialysis session into the line that leads back from the dialysis machine to the patient's vein.
Croatian: Primjenjuje se na kraju terapije hemodijalize kroz cjevčicu koja spaja uređaj za hemodijalizu s venom bolesnika.
English: Parathyroid hormone is produced by the parathyroid glands in the neck and regulates calcium and phosphate levels.
Croatian: Paratireoidni hormon, koji regulira razinu kalcija i fosfata, stvaraju paratireoidne žlijezde u vratu.
English: You may need further blood tests.
Croatian: Možda su potrebne dodatne krvne pretrage.
English: This leaflet was last revised in {mm/yyyy}
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}
English: What CONTROLOC Control is and what it is used for
Croatian: Što je CONTROLOC Control i za što se koristi
English: Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Croatian: Datum posljednje obnove odobrenja:: 21. veljače 2014.
English: CONTROLOC Control may stop certain other medicines from working properly.
Croatian: CONTROLOC Control može zaustaviti djelovanje nekih drugih lijekova.
English: CONTROLOC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Croatian: Control se ne preporučuje za primjenu u djece i adolescenata u dobi ispod 18 godina jer nema dovoljno podataka o sigurnosti i djelotvornosti.
English: Your doctor may decide to perform regular blood tests to monitor your levels of magnesium.
Croatian: Vaš liječnik može odlučiti da je potrebno provoditi redovite krvne pretrage kako bi se nadzirala razina magnezija u krvi.
English: The most commonly reported adverse reactions are diarrhoea and headache, both occurring in approximately 1% of patients.
Croatian: Najčešće prijavljene nuspojave su proljev i glavobolja, koje se javljaju u otprilike 1% bolesnika.
English: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: If possible take your medicine and this leaflet with you
Croatian: Ako je moguće ponesite lijek i ovu Uputu sa sobom.
English: Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
Croatian: halucinacije; konfuzija (posebno u predisponiran ih bolesnika, kao i pogoršanje tih simptoma ako su već bili prisutni)
English: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Croatian: Uvijek uzmite ovaj lijek točno onako kako je opisano u ovoj uputi ili kako Vam je rekao liječnik ili ljekarnik.
English: If you take CONTROLOC Control for longer periods, this may cause additional risks, such as:
Croatian: Uzimanje lijeka Controloc Control tijekom duljih razdoblja može izazvati dodatne rizike, kao što su:
English: CONTROLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Croatian: CONTROLOC Control 20 mg želučanootporne tablete se ne smiju žvakati ni lomiti, već ih se mora progutati cijele s tekućinom prije obroka.
English: What you need to know before you take CONTROLOC Control
Croatian: Što morate znati prije nego počnete uzimati CONTROLOC Control
English: What CONTROLOC Control is and what it is used for What you need to know before you take CONTROLOC Control How to take CONTROLOC Control Possible side effects
Croatian: Što je CONTROLOC Control i za što se koristi Što morate znati prije nego počnete uzimati CONTROLOC Control Kako uzimati CONTROLOC Control Moguće nuspojave
English: CONTROLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Croatian: Control je dostupan u Al/Al blisterima sa ili bez kartonskog pojačanja.
English: How to store CONTROLOC Control Contents of the pack and other information
Croatian: Kako čuvati CONTROLOC Control Sadržaj pakiranja i druge informacije
English: { mm/yyyy}
Croatian: {MM/GGGG}
English: CONTROLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Croatian: Control ne smiju koristiti djeca i mladi u dobi do 18 godina jer ne postoje podaci o sigurnosti primjene u ovoj mlađoj dobnoj skupini.
English: What CONTROLOC Control contains - The active substance is pantoprazole.
Croatian: Što CONTROLOC Control sadrži - Djelatna tvar je pantoprazol.
English: However adverse reactions such as dizziness and visual disturbances may occur (see section 4.8).
Croatian: Međutim, mogu se pojaviti nuspojave poput omaglice i poremećaja vida (vidjeti dio 4.8).
English: Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%.
Croatian: Opservacijska ispitivanja ukazuju da inhibitori protonske pumpe mogu povećati ukupni rizik od prijeloma za 10-40%.
English: Stevens-Johnson syndrome; Lyell syndrome;
Croatian: StevensJohnsonov sindrom;
English: CONTROLOC Control has no or negligible influence on the ability to drive and use machines.
Croatian: Control ne utječe ili neznatno utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
Croatian: Pogledajte dio 4. - Obavezno se obratite liječniku ako se ne osjećate bolje ili ako se osjećate lošije nakon 2 tjedna.
English: Disorientation (and all aggravations)
Croatian: dezorijentiranost (i pogoršanje istog)
English: Detailed information on this medicine is available on the European Medicines Agency web site: http:// www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: If you take more CONTROLOC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Croatian: Control nego što ste trebali Obavijestite liječnika ili ljekarnika ako ste uzeli više od preporučene doze.
English: Other medicines and CONTROLOC Control
Croatian: Drugi lijekovi i CONTROLOC Control
English: Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation.
Croatian: Prodiranje kroz placentu je ispitano na štakorima i otkriveno je da se povećava s napredovanjem gestacije.
English: Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets
Croatian: Al/Al blisteri sa ili bez kartonskog pojačanja koji sadrže 7 ili 14 želučanootpornih tableta.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Croatian: Za sve dodatne informacije ovom lijeku obratite se lokalnom predstavniku nositelja odobrenja za stavljanje gotovog lijeka u promet.
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping CONTROLOC Control.
Croatian: Ako nastupe lezije, posebice na suncem izloženim područjima kože, te ako su popraćene artralgijom, bolesnik treba odmah potražiti medicinsku pomoć, a zdravstveni radnik treba razmotriti prekid liječenja lijekom CONTROLOC Control.
English: CONTROLOC Control should not be used during breast-feeding.
Croatian: Controloc Control ne smije se koristiti tijekom dojenja.
English: CONTROLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Croatian: Control sadrži djelatnu tvar pantoprazol, koja blokira „pumpu“ koja proizvodi želučanu kiselinu.
English: To avoid this interference, CONTROLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Croatian: Control potrebno je prekinuti najmanje 5 dana prije mjerenja razine CgA (vidjeti dio 5.1.).
English: - falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate).
Croatian: - smanjenje razine magnezija u krvi (potencijalni simptomi: umor, nevoljno stezanje mišića, dezorijentacija, konvulzije, omaglica, povećan broj otkucaja srca).
English: Other side effects include: - Common (may affect up to 1 in 10 people): Benign polyps in the stomach.
Croatian: Ostale nuspojave uključuju: - Česte nuspojave (mogu se javiti u do 1 na 10 osoba): dobroćudni polipi u želucu.
English: Within the following table, adverse reactions are ranked under the MedDRA frequency classification:
Croatian: Unutar sljedeće tablice nuspojave su razvrstane prema MedDRA klasifikaciji učestalosti:
English: Do not take CONTROLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Croatian: Ne uzimajte CONTROLOC Control s drugim lijekovima koji ograničavaju količinu proizvodnje želučane kiseline, kao što su drugi inhibitor protonske pumpe (omeprazol, lanzoprazol ili rabeprazol) ili H2 antagonist (npr. ranitidin, famotidin).
English: Do not take a double dose to make up for the forgotten dose.
Croatian: Ako ste zaboravili uzeti CONTROLOC Control Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Do not take CONTROLOC Control: - if you are allergic to pantoprazole or to any of the other ingredients of this medicine (listed in section 6) - if you are taking HIV protease inhibitors such as atazanavir; nelfinavir (for the treatment of
Croatian: Nemojte uzimati CONTROLOC Control: - ako ste alergični na pantoprazol ili bilo koji sastojak ovog lijeka (naveden u dijelu 6) - ako uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir (za liječenje infekcije
English: Common Uncommon Rare
Croatian: Manje česte Rijetke
English: However, you may take CONTROLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Croatian: Ako je potrebno, CONTROLOC Control možete uzimati s antacidima (npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili kombinacije navedenih).
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg Germany
Croatian: Lehnitzstrasse 70-98, 16515 Oranienburg
English: Especially medicines containing one of the following active substances: - HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of HIV-infection).
Croatian: Naročito lijekova koji sadrže sljedeće djelatne tvari: - inhibitore HIV proteaze, kao što su atazanavir i nelfinavir (za liječenje infekcije HIV-om).
English: CONTROLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Croatian: Control može smanjiti apsorpciju djelatnih tvari čija bioraspoloživost ovisi o pH želuca (npr. ketokonazol).
English: Pharmacotherapeutic group: Drugs for acid related disorders Proton pump inhibitors, ATC code: A02BC02
Croatian: Inhibitori protonske pumpe, ATK oznaka: A02BC02
English: What CONTROLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Croatian: Control izgleda i sadržaj pakiranja Želučanootporne tablete su žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom oznakom "P20" na jednoj strani.
English: You must not use CONTROLOC Control if you are taking HIV protease inhibitors.
Croatian: Control ako uzimate inhibitore HIV proteaze.
English: Liver enzymes increased (transaminas es, γ-GT)
Croatian: Poremećaji jetre i žuči povišenje jetrenih enzima (transaminaze , γ-GT)
English: - Very rare side effects (may affect up to 1 in 10,000 people): disorientation; reduction in the number of blood platelets, which may cause you to bleed or bruise more than normal; reduction in the number of white blood cells, which may lead to more frequent infections; coexisting abnormal reduction in the number of red and white blood cells, as well as platelets (seen in blood tests).
Croatian: - Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 osoba): dezorijentiranost; smanjenje broja krvnih pločica što može uzrokovati neuobičajena krvarenja i stvaranja modrica; smanjenje broja bijelih krvnih stanica što može dovesti do učestalih infekcija; istovremeno abnormalno smanjenje broja crvenih i bijelih krvnih stanica, te krvnih pločica (vidljivo na krvnim pretragama).
English: HIV-infection) See ‘Other medicines and CONTROLOC Control'.
Croatian: Pogledajte 'Ostali lijekovi i CONTROLOC Control'.
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with CONTROLOC Control, but this medicine is not meant to bring immediate relief.
Croatian: Možete osjetiti olakšanje od simptoma refluksa kiseline ili žgaravice nakon samo jednog dana liječenja s CONTROLOC Control, ali ovaj lijek nije namijenjen trenutnom olakšanju simptoma.