FrancophonIA/ELRC3.0 huggingface dataset:
English: The most serious side effect seen in some patients treated with Lojuxta is abnormally raised liver enzyme levels.
Croatian: Najozbiljnija nuspojava uočena kod nekih bolesnika liječenih lijekom Lojuxta je neuobičajeno povišenje razine jetrenih enzima.
English: What are the risks associated with Lojuxta?
Croatian: Koji su rizici povezani s lijekom Lojuxta?
English: The active substance in Lojuxta, lomitapide, blocks the action of a substance in the body called ‘microsomal triglyceride transfer protein', which is present in the cells of the liver and the gut.
Croatian: Djelatna tvar u lijeku Lojuxta, lomitapid, blokira djelovanje tvari u organizmu zvane „mikrosomalni protein za prijenos triglicerida” koji je prisutan u stanicama jetre i želuca.
English: The CHMP considered that the medicine's effect in reducing LDL cholesterol levels was a benefit for patients with homozygous familial hypercholesterolaemia, who have an unmet medical need.
Croatian: CHMP je smatrao da učinak lijeka u smanjenju LDL kolesterola predstavlja dobrobit za bolesnike s homozigotnom obiteljskom hiperkolesterolemijom koji nisu liječeni na odgovarajući način.
English: Why is Lojuxta approved?
Croatian: Zašto je lijek Lojuxta odobren?
English: Microsomal triglyceride transfer protein is involved in assembling fatty substances such as cholesterol and triglyceride into larger particles called lipoproteins, which are then released into the blood stream.
Croatian: Uključen je u skupljanje masnih tvari poput kolesterola i triglicerida u veće čestice zvane lipoproteini koje se potom otpuštaju u krvotok.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lojuxta, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Lojuxta nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: All patients were given Lojuxta together with other medicines for reducing the level of fats in the blood.
Croatian: Svi bolesnici koji su primili lijek Lojuxta skupa s drugim lijekovima za smanjivanje razine masnoća u krvi.
English: Lojuxta can only be obtained with a prescription.
Croatian: Lojuxta se izdaje samo na liječnički recept.
English: For practical information about using Lojuxta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Lojuxta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: The full EPAR for Lojuxta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Lojuxta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports Više informacija o liječenju lijekom Lojuxta pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: What information is still awaited for Lojuxta?
Croatian: Koje se još informacije očekuju o lijeku Lojuxta?
English: How is Lojuxta used?
Croatian: Kako se Lojuxta koristi?
English: Patients with moderately or severely reduced liver function must not take Lojuxta.
Croatian: Bolesnici s blago do snažno oslabljenom funkcijom jetre ne smiju uzimati lijek Lojuxta.
English: How does Lojuxta work?
Croatian: Kako Lojuxta djeluje?
English: What benefits of Lojuxta have been shown in studies?
Croatian: Koje su koristi lijeka Lojuxta dokazane ispitivanjima?
English: For the full list of side effects, see the package leaflet.
Croatian: Potpuni popis nuspojava potražite u uputi o lijeku.
English: The maximum daily dose is 100 micrograms.
Croatian: Maksimalna dnevna doza je 100 mikrograma.
English: What is Natpar and what is it used for?
Croatian: Što je Natpar i za što se koristi?
English: The usual recommended starting dose is 50 micrograms once a day.
Croatian: Uobičajena preporučena početna doza iznosi 50 mikrograma jednom dnevno.
English: The proportion of patients taking placebo (a dummy treatment) who achieved the same was 2.5% (1 out of 40 patients).
Croatian: Udio bolesnika koji su primali placebo (prividno liječenje) i postigli jednaki učinak bio je 2,5 % (1 od 40 bolesnika).
English: This means that there is more evidence to come about the medicine, which the company is required to provide.
Croatian: To znači da se očekuju dodatni podaci o lijeku koje tvrtka mora dostaviti.
English: Because of the limited data available, Natpar has been given ‘conditional approval'.
Croatian: Budući da su dostupni ograničeni podaci, Natpar je dobio „uvjetno odobrenje“.
English: What measures are being taken to ensure the safe and effective use of Natpar?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Natpar?
English: What are the risks associated with Natpar?
Croatian: Koji su rizici povezani s lijekom Natpar?
English: Why is Natpar approved?
Croatian: Zašto je lijek Natpar odobren?
English: In a main 24-week study involving 124 patients, 54.8% (46 out of 84) of the patients who received Natpar achieved and maintained acceptable blood calcium levels while reducing their doses of calcium and vitamin D supplements by at least 50%.
Croatian: U glavnom ispitivanju u trajanju od 24 tjedna koje je uključivalo 124 bolesnika, 54,8 % (46 od 84) bolesnika koji su primali Natpar dosegli su i održali prihvatljivu razinu kalcija u krvi, a smanjili su doze dodatno uzimanog kalcija i vitamina D za najmanje 50 %.
English: As a result, patients have low levels of calcium which can cause problems in bones, muscles, heart, kidneys and other parts of the body.
Croatian: Posljedično tome, bolesnici imaju niske razine kalcija što može prouzročiti teškoće u kostima, mišićima, srcu, bubrezima i drugim dijelovima tijela.
English: The full EPAR for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjelovito EPAR za lijek Natpar nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Natpar parathyroid hormone
Croatian: Natpar paratiroidni hormon
English: It is not intended to provide practical advice on how to use Natpar.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Natpar.
English: Because the number of patients with hypoparathyroidism is low, the disease is considered ‘rare', and Natpar was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 December 2013.
Croatian: Budući da je broj bolesnika s hipoparatiroidizmom nizak, ta se bolest smatra „rijetkom” te je Natpar dobio status „lijeka za liječenje rijetkih bolesti” od 18. prosinca 2013.
English: The company that markets Natpar will set-up a registry and collect long-term data on patients treated with Natpar, including its effects on bones, kidneys and patients' quality of life.
Croatian: Tvrtka koja stavlja na tržište lijek Natpar osnovat će registar i prikupljati dugoročne podatke o bolesnicima liječenim lijekom Natpar, uključujući njegove učinke na kosti, bubrege i kvalitetu života bolesnika.
English: Regarding safety, the risk of calcium levels becoming too high or too low is considered important and further data are needed to better understand the consequences of wide fluctuations in blood calcium level after the medicine is given once a day.
Croatian: S obzirom na sigurnost primjene, rizik da razine kalcija postanu previsoke ili preniske smatra se važnim, pa su potrebni dodatni podaci kako bi se više saznalo o posljedicama velikih promjena u razinama kalcija u krvi nakon primjene lijeka jednom dnevno.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Natpar can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Povjerenstva za lijekove za rijetke i teške bolesti o lijeku Natpar možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: The most common side effects with Natpar (which may affect more than 1 in 10 people) are too high or too low blood calcium levels, which can lead to headache, diarrhoea, vomiting, paraesthesia (unusual sensations like pins and needles), hypoaesthesia (reduced sense of touch) and high calcium levels in the urine.
Croatian: Najčešće nuspojave uz Natpar (koje se mogu javiti u više od 1 na 10 osoba) jesu previsoke ili preniske razine kalcija u krvi, što može dovesti do glavobolje, proljeva, povraćanja, parestezije (neobični osjeti poput trnaca i bockanja), hipoestezija (smanjeni osjet dodira) i visoke razine kalcija u mokraći.
English: Natpar must not be used in patients who are having or have had radiation therapy to the bones, who have bone cancer or cancer that has spread to the bones and are at increased risk of developing a bone cancer called osteosarcoma.
Croatian: Natpar ne smiju primjenjivati bolesnici koji primaju ili su primali terapiju zračenja kostiju, koji imaju rak kostiju ili rak koji se proširio na kosti, i imaju povećani rizik od razvoja raka kostiju koji se naziva osteosarkom.
English: This is a summary of the European public assessment report (EPAR) for Natpar.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije o lijeku (EPAR) za lijek Natpar.
English: Natpar is available as a powder and a liquid that are mixed together to make a solution for injection.
Croatian: Natpar je dostupan u obliku praška i tekućine koji se zajedno miješaju kako bi se dobila otopina za injekciju.
English: In patients with this condition, the parathyroid glands in the neck do not produce enough parathyroid hormone which controls the level of calcium in the blood.
Croatian: U bolesnika s tim stanjem paratiroidne žlijezde u vratu ne proizvode dovoljno paratiroidnog hormona koji kontrolira razinu kalcija u krvi.
English: Patients can inject Natpar themselves once they have been trained.
Croatian: Bolesnici si mogu sami ubrizgavati
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Natpar 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 Natpar uključene su i u sažetak opisa svojstava lijeka i uputu o lijeku.
English: Other information about Natpar
Croatian: Ostale informacije o lijeku Natpar
English: Natpar is used as an add-on to treatment with calcium and vitamin D supplements when these treatments have not worked well enough.
Croatian: Natpar se primjenjuje kao dodatno liječenje uz nadomjestke kalcija i vitamina D kada te terapije nisu odgovarajuće djelovale.
English: What information is still awaited for Natpar?
Croatian: Koje se još informacije očekuju o lijeku Natpar?
English: While the main study showed that Natpar helps control blood calcium levels while reducing the need for calcium and vitamin D supplements, the study was of short duration and there was no evidence of improvements in patients' quality of life or reductions in long-term problems such as kidney impairment.
Croatian: Glavno je ispitivanje pokazalo da Natpar pomaže u kontroli razina kalcija u krvi te smanjuje potrebu za nadomještanjem kalcija i vitamina D, ali ispitivanje je trajalo kratko i nije pružilo dokaze o poboljšanju kvalitete života bolesnika ili smanjenju dugoročnih tegoba kao što je oštećenje bubrežne funkcije.
English: Therefore, Natpar should only be used in patients who are not adequately controlled with standard treatments alone, who do not have other treatment options.
Croatian: Stoga se Natpar smije primjenjivati samo u bolesnika u kojih liječenje samo standardnim terapijama nije odgovarajuće te koji nemaju druge opcije liječenja.
English: Natpar must also not be used in patients who have unexplained increases in the levels of an enzyme called bone alkaline phosphatase and those who have pseudohypoparathyroidism, a rare disease where the body does not respond adequately to the parathyroid hormone produced by the body.
Croatian: Također, Natpar se ne smije primjenjivati u bolesnika koji imaju neobjašnjena povećanja razine enzima pod nazivom alkalna fosfataza u kostima te onih koji imaju pseudohipoparatiroidizam, rijetku bolest u kojoj tijelo ne reagira na odgovarajući način na paratiroidni hormon koji proizvodi tijelo.
English: The medicine can only be obtained with a prescription and treatment should be supervised by a healthcare professional experienced in the management of patients with hypoparathyroidism.
Croatian: Lijek se izdaje samo na recept, a liječenje mora nadzirati liječnik s iskustvom u zbrinjavanju bolesnika s hipoparatiroidizmom.
English: How is Natpar used?
Croatian: Kako se Natpar koristi?
English: What benefits of Natpar have been shown in studies?
Croatian: Koje su koristi od lijeka Natpar dokazane u ispitivanjima?
English: How does Natpar work?
Croatian: Kako djeluje Natpar?
English: Since Natpar has been granted a conditional approval, the company that markets Natpar will conduct a further study to confirm the benefits and risks of the medicine and the appropriateness of the once-aday dosing schedule.
Croatian: Budući da je lijek Natpar dobio uvjetno odobrenje, tvrtka koja stavlja na tržište lijek Natpar provest će daljnje ispitivanje kako bi se potvrdile koristi i rizici lijeka te prikladnost doziranja jednom dnevno.
English: Natpar has been shown to help control blood calcium levels in patients with hypoparathyroidism who are receiving calcium and vitamin D supplements.
Croatian: Pokazalo se da Natpar pomaže kontrolirati razine kalcija u krvi u bolesnika s hipoparatiroidizmom koji uzimaju nadomjeske kalcija i vitamina D.
English: and calcium supplements, is then adjusted on the basis of the patient's blood calcium levels.
Croatian: D i kalcija, prilagođavaju na temelju bolesnikovih razina kalcija u krvi.
English: For more information about treatment with Natpar, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Natpar pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
English: Natpar is injected under the skin of the thigh using the Natpar pen.
Croatian: Natpar se ubrizgava pod kožu na bedru pomoću Natpar brizgalice.
English: It replaces the missing hormone in patients with hypoparathyroidism, thus helping to restore calcium levels.
Croatian: On zamjenjuje hormon koji nedostaje u bolesnika s hipoparatiroidizmom, pomažući tako uspostaviti potrebne razine kalcija.
English: Natpar is a hormone replacement medicine for treating adults with under-active parathyroid glands, a condition known as hypoparathyroidism.
Croatian: Natpar je lijek koji nadomješta hormon u odraslih osoba sa smanjenom aktivnosti paratiroidnih žlijezda, stanjem poznatim kao hipoparatiroidizam.
English: For practical information about using Natpar, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Natpar bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The active substance in Natpar, parathyroid hormone, is a copy of the natural hormone produced by the parathyroid glands.
Croatian: Djelatna tvar lijeka Natpar, paratiroidni hormon, kopija je prirodnog hormona koji proizvode paratiroidne žlijezde.
English: The dose of Natpar, as well as the patient's dose of the vitamin D
Croatian: Zatim se doza lijeka Natpar, kao i doze vitamina
English: Natpar replaces the missing parathyroid hormone in patients with hypoparathyroidism.
Croatian: Natpar zamjenjuje paratiroidni hormon koji nedostaje u bolesnika s hipoparatiroidizmom.
English: Natpar contains the active substance parathyroid hormone.
Croatian: Natpar sadrži djelatnu tvar paratiroidni hormon.
English: For the full list of all side effects reported with Natpar, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Natpar potražite u uputi o lijeku.
English: After reconstitution: 24 hours.
Croatian: Nakon rekonstitucije: 24 sata.
English: Elderly population (> 65 years)
Croatian: Starija populacija (> 65 godina)
English: 90% Confidence Interval
Croatian: 90%-tni interval pouzdanosti
English: % of Patients with Response
Croatian: % bolesnika s odgovorom
English: It may harm them,
Croatian: Dobroćudne,
English: Iasibon with food and drink
Croatian: Iasibon s hranom i pićem
English: The dose is determined by the doctor considering the following factors.
Croatian: Dozu određuje liječnik uzimajući u obzir sljedeće faktore.
English: - Water is the only drink that should be taken with Iasibon.
Croatian: - Voda je jedino piće s kojim se Iasibon smije uzimati.
English: These symptoms usually disappear within a couple of hours or days.
Croatian: Ovi simptomi obično nestaju unutar nekoliko sati ili dana.
English: Number of events (per patient)
Croatian: Broj događaja (po bolesniku)
English: There are only very few data available on patients with African origin.
Croatian: Vrlo je malo podataka dostupno za bolesnike afričkog podrijetla.
English: Do not let the tablet dissolve in your mouth
Croatian: Nemojte dopustiti da vam se tableta otapa u ustima.
English: In clinical trials, therapy has continued for up to 96 weeks.
Croatian: U kliničkim ispitivanjima terapija je trajala do 96 tjedana.
English: Repeated treatment may be considered in case of recurrent hypercalcaemia or insufficient efficacy.
Croatian: Ponovljeno liječenje može se razmotriti u slučaju ponavljajuće hiperkalcijemije ili nedovoljne djelotvornosti.
English: 100 ml over 15 minutes
Croatian: 100 ml tijekom 15 minuta
English: UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying the unique identifier included.
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom
English: These measures will help protect the environment
Croatian: Ove će mjere pomoći u očuvanju okoliša.
English: They are available in packs of 3, 6, 9, 28 and 84 tablets.
Croatian: Dostupne su u pakovanjima od 3, 6, 9, 28 i 84 tablete.
English: Many of these patients were also receiving chemotherapy and corticosteroids.
Croatian: Mnogi od tih bolesnika su također primali kemoterapiju i kortikosteroide.
English: • Swallow the tablet whole.
Croatian: • Progutajte tabletu cijelu.
English: The usual dose of Iasibon is one tablet each day.
Croatian: Uobičajena doza lijeka Iasibon je jedna tableta dnevno.
English: If you develop these symptoms, stop taking Iasibon and tell your doctor straight away (see sections 3 and 4).
Croatian: Ako se ovi simptomi pojave, prekinite uzimati lijek Iasibon i odmah se obratite svom liječniku (vidjeti dijelove 3 i 4).
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, za vrijeme skladištenja i uvjete prije uporabe odgovoran je korisnik, a normalno ne bi trebali biti duži od 24 sata na temperaturi od 2 do 8°C, izuzev u slučaju da je rekonstitucija izvršena u kontroliranim i validiranim aseptičkim uvjetima.
English: • rise in body temperature.
Croatian: • porast tjelesne temperature.
English: If you take more Iasibon than you should
Croatian: Ako uzmete više lijeka Iasibon nego što ste trebali
English: 500 ml over 1 hour
Croatian: 500 ml tijekom 1 sata
English: • stomach problems such as ‘gastroenteritis' or ‘gastritis'
Croatian: • problemi sa želucem kao “gastroenteritis” ili “gastritis”
English: Your doctor may adjust your dose and duration of intravenous infusion if you have kidney problems.
Croatian: Liječnik Vam može prilagoditi dozu i trajanje intravenske infuzije ako imate problema s bubrezima.
English: Multiple events were therefore counted only once for the purposes of the analysis.
Croatian: Višestruki događaji su se stoga, za potrebe analize, brojali samo jedanput.
English: Attention should also be paid to the possible existence of simultaneous hypomagnesaemia.
Croatian: Potrebno je obratiti pažnju i na moguću pojavu istodobne hipomagnezijemije.
English: - The tablets should be swallowed whole with a full glass of water (180 to 240 ml) while the patient is standing or sitting in an upright position.
Croatian: - Tablete treba progutati cijele uz punu čašu obične vode (180 do 240 ml) dok bolesnik stoji ili sjedi u uspravnom položaju.
English: The analysis of the SMPR was time-adjusted and considered that one or more events occurring in a single 12 week period could be potentially related.
Croatian: Analiza SMPR bila je vremenski usklađena i uzimala je u obzir mogućnost da bi jedan ili više događaja u razdoblju od 12 tjedana mogli biti povezani.
English: If you take too many tablets talk to a doctor or go to hospital straight away.
Croatian: Ako uzmete previše tableta, obratite se svom liječniku ili odmah idite u bolnicu.
English: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi Greece
Croatian: Pharmathen International S.A. Industrial Park Sapes, Street block 5 69300 Sapes, Prefecture of Rodopi
English: • dry mouth, strange taste in your mouth or difficulty swallowing
Croatian: • suha usta, čudan okus u ustima ili otežano gutanje
English: • Take your tablet with a full glass of water only (about 200 mL).
Croatian: • Uzmite tabletu lijeka Iasibon samo uz punu čašu vode (oko 200 ml).
English: Do not take Iasibon with food or any other drinks except plain water as Iasibon is less effective if it is taken with food or drink (see section 3).
Croatian: Nemojte uzimati Iasibon s hranom i nikakvim drugim napitkom osim obične vode jer je Iasibon manje djelotvoran ako se uzima s hranom ili pićem (vidjeti dio 3.).
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Croatian: Posebno, obavijestite svog liječnika ili ljekarnika ako uzimate neke od sljedećih lijekova:
English: Studies in rats have shown reproductive toxicity (see section 5.3).
Croatian: Ispitivanja na štakorima pokazala su reproduktivnu toksičnost (vidjeti dio 5.3).
English: • injury or pain at the injection site
Croatian: • ozljeda ili bol na mjestu injiciranja
English: • increased sensitivity of sound, taste or touch or changes in smell
Croatian: • povećana osjetljivost na zvuk, okus ili dodir ili promjene osjeta mirisa
English: Film-coated tablets 3 film-coated tablets 6 film-coated tablets 9 film-coated tablets 28 film-coated tablets 84 film-coated tablets
Croatian: Filmom obložene tablete 3 filmom obložene tablete 6 filmom obloženih tableta 9 filmom obloženih tableta 28 filmom obloženih tableta 84 filmom obložene tablete
English: * Note albumin-corrected serum calcium concentrations are calculated as follows:
Croatian: * Koncentracije kalcija u serumu korigiranog albuminom se izračunavaju na sljedeći način:
English: • Iasibon is normally given by a doctor or other medical staff who have experience with the treatment of cancer.
Croatian: • Iasibon će Vam obično dati liječnik ili drugi zdravstveni djelatnici koji imaju iskustva u liječenju raka..
English: The highest dose used in clinical trials was 6 mg but this dose does not add any further benefit in terms of efficacy.
Croatian: Najveća doza korištena u kliničkim ispitivanjima iznosila je 6 mg, međutim, ova doza nije dovela do daljnjeg poboljšanja djelotvornosti liječenja.
English: What Iasibon is and what it is used for
Croatian: Što je Iasibon i za što se koristi
English: If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment.
Croatian: U slučaju pojave anafilaktičke ili neke druge teške reakcije preosjetljivosti/alergijske reakcije, odmah prekinite injekciju i započnite s odgovarajućim liječenjem.