FrancophonIA/ELRC3.0 huggingface dataset:
English: • amfetamine (used to treat hyperactivity in children and narcolepsy (excessive sleepiness);
Croatian: • amfetamin (koristi se za liječenje hiperaktivnosti kod djece i narkolepsije (pretjerane pospanosti); također je i opojna droga)
English: Driving and using machines It is considered unlikely that Striascan will affect your ability to drive or to use machines.
Croatian: Smatra se da je malo vjerojatno da će Striascan utjecati na Vašu sposobnost upravljanja vozilima i strojevima.
English: If you have any further questions on the use of this medicine, ask your nuclear medicine doctor who supervises the procedure.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku specijalistu nuklearne medicine koji nadgleda postupak.
English: After administration of Striascan, you should urinate frequently in order to eliminate the product from your body.
Croatian: Nakon primjene Striascana trebate što češće mokriti kako bi se lijek izlučio iz Vašeg tijela.
English: What Striascan looks like and contents of the pack Striascan is a colourless solution for injection, supplied in a single amber 15 mL glass vial sealed with a rubber closure and metal overseal.
Croatian: Striascan je bezbojna otopina za injekciju, dostupna u pojedinačnoj bočici od smeđeg stakla od 15 ml zatvorenoj gumenim čepom i metalnim prstenom
English: 80.2% and specificity from 81.3% to 83.9% when the possible DLB patients were included as non-DLB patients.
Croatian: I) u rasponu od 75,0 % do 80,2 %, a specifičnost od 81,3 % do 83,9 % kad su mogući bolesnici s DLT-om bili uključeni kao bolesnici s ne-DLT-om.
English: Formal studies have not been carried out in patients with significant renal or hepatic impairment.
Croatian: Ispitivanja na bolesnicima sa značajnim oštećenjem funkcije bubrega ili jetre nisu provedena.
English: Each 2.5 mL single dose vial contains 185 MBq ioflupane (
Croatian: Jedna jednodozna bočica s 2,5 ml otopine sadrži 185 MBq ioflupana (
English: • Instead use formula feed for your child. Express your breast milk regularly and throw away any breast milk you have expressed.
Croatian: Redovito se izdajajte i sve mlijeko koje ste izdojili bacite.
English: Store in the original lead shielding.
Croatian: Čuvati u originalnom olovnom spremniku.
English: Remaining organs Effective Dose
Croatian: Efektivna doza
English: Striascan 74 MBq /mL solution for injection.
Croatian: Striascan 74 MBq/ml otopina za injekciju
English: Metal Box / Lead Pot - 2.5 mL presentation
Croatian: Metalna kutija / Olovni spremnik - Pakiranje od 2,5 ml
English: The biokinetic model for ioflupane (
Croatian: Biokinetički model ioflupana (
English: Do not use this medicine after the expiry date which is stated on the labels after EXP. Hospital staff will ensure that the product is stored and thrown away correctly and not used after the expiry date stated on the label.
Croatian: Bolničko osoblje osigurat će pravilno čuvanje i zbrinjavanje lijeka te da se lijek ne koristi nakon isteka roka valjanosti navedenog na naljepnici.
English: Metal Box / Lead Pot - 5 mL presentation
Croatian: Metalna kutija / Olovni spremnik - Pakiranje od 5 ml
English: Manufacturer name address CIS bio international F-91192 GIF-SUR-YVETTE CEDEX
Croatian: Naziv i adresa proizvođača CIS bio international F-91192 GIF-SUR-YVETTE CEDEX
English: Striascan contains the active substance ioflupane (
Croatian: Striascan sadrži djelatnu tvar ioflupan (
English: Gallbladder wall Gastrointestinal tract Stomach wall
Croatian: Stijenka žučnog mjehura Probavni sustav
English: Image acquisition
Croatian: Snimanje slike
English: Small intestine wall Colon wall (Upper large intestine wall ) (Lower large intestine wall) Heart wall
Croatian: Stijenka tankog crijeva Stijenka debelog crijeva (Stijenka gornjeg dijela debelog crijeva) (Stijenka završnog dijela debelog crijeva)
English: If you are pregnant, do not use Striascan.
Croatian: Ako ste trudni, ne primajte Striascan jer i dijete može biti izloženo radioaktivnosti.
English: How Striascan is stored
Croatian: Kako se čuva Striascan
English: Each mL of solution contains 74 MBq of ioflupane (
Croatian: Jedan ml otopine sadrži 74 MBq ioflupana (
English: Tell your doctor if any of these apply to you.
Croatian: Ako se bilo što od navedenog odnosi na Vas, recite to liječniku.
English: Oesophagus
Croatian: Striascan
English: Each 5 mL single dose vial contains 370 MBq ioflupane (
Croatian: Jedna jednodozna bočica s 5 ml otopine sadrži 370 MBq ioflupana (
English: What Striascan contains - The active substance is ioflupane (
Croatian: Sadržaj pakiranja i druge informacije Što Striascan sadrži - Djelatna tvar je ioflupan (
English: MedDRA Body system SOCs
Croatian: MedDRA klasifikacija organskih sustava
English: Pack size: 1 vial containing 2.5 mL or 5 mL of solution.
Croatian: Pakiranje: 1 bočica s 2,5 ml ili 5 ml otopine.
English: Ear and labyrinth disorders Vertigo
Croatian: Poremećaji uha i labirinta Vrtoglavica
English: I) you are given is passed into breast milk.
Croatian: I) u majčino mlijeko.
English: Ioflupane (
Croatian: Ioflupan (
English: Name and address of the manufacturer(s) responsible for batch release CIS BIO International
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet
English: - If you get any side effects, talk to your nuclear medicine doctor.
Croatian: - Ako primijetite bilo koju nuspojavu, potrebno je obavijestitili liječnika specijalista nuklearne medicine.
English: Any ioflupane (
Croatian: Uz ioflupan (
English: Dyspnea
Croatian: Dojka
English: Bone surfaces Brain
Croatian: Nadbubrežne žlijezde Površina kosti
English: The frequency of side effects is:
Croatian: I) su primijećene sljedeće nuspojave:
English: Common
Croatian: Jednjak
English: LABELLING AND PACKAGE LEAFLET
Croatian: Kako Striascan izgleda i sadržaj pakiranja
English: I) in determining probable DLB from non-DLB ranged from 75.0% to 80.2% and specificity from 88.6% to 91.4%.
Croatian: do 80,2 %, a specifičnosti od 88,6 % do 91,4 %.
English: Contact your nuclear medicine doctor if you have any questions.
Croatian: Ako imate bilo kakvih pitanja obratite se liječniku specijalistu nuklearne medicine.
English: Renal impairment / Hepatic impairment
Croatian: Oštećenje funkcije bubrega / Oštećenje funkcije jetre
English: The full EPAR for Zometa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zometa nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zometa on 20 March 2001.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Zometa na snazi u Europskoj uniji od 20. ožujka 2001.
English: The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes.
Croatian: Uobičajena doza lijeka Zometa je jedna infuzija od 4 mg tijekom najmanje 15 minuta.
English: What measures are being taken to ensure the safe and effective use of Zometa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zometa?
English: Zoledronic acid
Croatian: Zometa zoledronatna kiselina
English: Other information about Zometa
Croatian: Ostale informacije o lijeku Zometa
English: This is a summary of the European public assessment report (EPAR) for Zometa.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zometa.
English: It is available as a powder (4mg) and solvent, and as a concentrate (4mg/5ml), both of which are made up into a solution for infusion (drip into a vein), and as a pre-prepared solution for infusion (4mg/100ml).
Croatian: Lijek je dostupan kao prašak (4mg) i otapalo, te kao koncentrat (4mg/5ml), oboje se koriste za pripremu otopine za infuziju (drip u venu), kao i prethodno pripremljenu otopinu za infuziju (4mg/100ml).
English: Looking at the results of the two studies together, 88% of the patients receiving Zometa had normal calcium levels within 10 days after treatment, compared with 70% of those receiving pamidronate.
Croatian: Promatrajući rezultate dva ispitivanja zajedno, 88% bolesnika koji su primili lijek Zometa imalo je normalne razine kalcija unutar 10 dana nakon terapije, u usporedbi sa 70% onih koji su primili pamidronat.
English: In the first two studies of patients with bone metastases, the number of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%).
Croatian: U prva dva ispitivanja provedena na bolesnicima s metastazama kostiju, broj bolesnika koji je razvio nove skeletalne poremećaje bio je manji s lijekom Zometa (33 do 38%) u odnosu na placebo (44%).
English: Zometa has also been compared with pamidronate in two main studies involving a total of 287 adults with hypercalcaemia caused by tumours.
Croatian: Zometa je također uspoređen s pamidronatom u dva glavna ispitivanja koja su obuhvatila ukupno 287 odraslih osoba s hiperkalkemijom uzrokovanom tumorima.
English: What is the risk associated with Zometa?
Croatian: Koji su rizici povezani s lijekom Zometa?
English: A risk management plan has been developed to ensure that Zometa is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Zometa.
English: Osteonecrosis of the jaw (damage to the bones of the jaw, which could lead to pain, sores in the mouth or loosening of teeth) has been reported uncommonly (seen in between 1 and 10 patients in 1,000).
Croatian: Osteonekroza čeljusti (oštećenje kosti čeljusti, koje može rezultirati s boli, bolnim ustima ili gubljenjem zubi) se javlja rijetko (kod između 1 i 10 bolesnika na 10 000).
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Zometa.
Croatian: Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Zometa.
English: The main measure of effectiveness was the number of patients who developed at least one new ‘skeletal event' over 13 months.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika kod kojih je zabilježen najmanje jedan novi "skeletalni poremećaj" tijekom 13 mjeseci.
English: This included any bone complications needing treatment with radiotherapy or surgery, any fractures or any spinal compression.
Croatian: To je uključivalo bilo kakve komplikacije kostiju koje su zahtijevale liječenje s radioterapijom ili kirurškim zahvatom, bilo kakve frakture ili kompresije kralježnice.
English: In the third study, Zometa was as effective as pamidronate: 44% of the patients receiving Zometa had at least one skeletal event, compared with 46% of those receiving pamidronate.
Croatian: U trećem ispitivanju, Zometa je bio djelotvoran kao pamidronat: 44% bolesnika koji su primili lijek Zometa imalo je najmanje jedan skeletalni poremećaj, u usporedbi sa 46% onih koji su primili pamidronat.
English: For more information about treatment with Zometa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zometa pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: In patients with hypercalcaemia, Zometa was more effective than pamidronate.
Croatian: U bolesnika s hiperkalkemijom, lijek Zometa je bio djelotvorniji od pamidronata.
English: The main measure of effectiveness was the number of patients whose calcium levels had returned to normal within 10 days after treatment.
Croatian: Glavna mjera djelotvornosti bio je broj bolesnika čije su se razine kalcija vratile u normalne vrijednosti 10 dana nakon terapije.
English: Zometa has been studied in over 3,000 adults with bone metastases in three main studies looking at its ability to prevent bone damage.
Croatian: Lijek Zometa ispitan je u više od 3 000 odraslih osoba s metastazama u kostima, u tri glavna ispitivanja koja su istražila njegovu sposobnost sprječavanja oštećenja kostiju.
English: Why has Zometa been approved?
Croatian: Zašto je lijek Zometa odobren?
English: What is Zometa?
Croatian: Što je Zometa?
English: Zometa must only be used by a doctor who has experience in the use of this type of medicine given into a vein.
Croatian: Lijek Zometa smije primjenjivati samo liječnik koji ima iskustva u liječenju ovim tipom lijeka koji se primjenjuje u venu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zometa, 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 Zometa nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: In addition, the company that markets Zometa will provide a card to inform patients about the risk of osteonecrosis of the jaw and to instruct them to contact their doctor if they experience symptoms.
Croatian: Nadalje, proizvođač lijeka Zometa bolesnicima će dostaviti karticu s informacijama o riziku osteonekroze čeljusti i uputama da se obrate svom liječniku ako iskuse takve simptome.
English: Zometa was compared with placebo (a dummy treatment) in two of the studies, and with pamidronate (another bisphosphonate) in the third.
Croatian: Zometa je uspoređen s placebom (prividnim liječenjem) u dva ispitivanja, i s pamidronatom (drugim bifosfonatom) u trećem ispitivanju.
English: Zometa can also be used to treat the hypercalcaemia caused by tumours.
Croatian: Zometa se može također koristiti za liječenje hiperkalkemije koju uzrokuju tumori.
English: Zometa must not be used in people who are hypersensitive (allergic) to zoledronic acid, other bisphosphonates or any of the other ingredients.
Croatian: Zometa se ne smije upotrebljavati kod osoba koje su preosjetljive (alergične) na bifosfonate ili na bilo koji drugi sastojak.
English: The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels).
Croatian: Najčešća nuspojava lijeka Zometa (može se javiti u više od jedne na 10 osoba) je hipofosfatemija (niska razina fosfata u krvi).
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Croatian: To uključuje frakture (lomove kosti), spinalnu kompresiju (u slučaju kada kost pritišće leđnu moždinu), poremećaje kostiju koji zahtijevaju radioterapiju (terapiju zračenjem) ili kirurški zahvat, te hiperkalemiju (visoke koncentracije kalcija u krvi).
English: The CHMP decided that Zometa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Zometa nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Zometa should not be used in pregnant or breastfeeding women.
Croatian: Lijek se ne smije davati trudnicama niti dojiljama.
English: Zometa can be used to prevent bone complications in adults with advanced cancer that is affecting the bone.
Croatian: Zometa se može koristiti za sprječavanje koštanih komplikacija u odraslih osoba s uznapredovalim rakom koji zahvaća kost.
English: The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Croatian: Djelatna tvar u lijeku Zometa, zoledronatna kiselina je bisfosfonat.
English: What is Zometa used for?
Croatian: Za što se Zometa koristi?
English: Zometa is a medicine that contains the active substance zoledronic acid.
Croatian: Zometa je lijek koji sadrži zoledronatnu kiselinu kao djelatnu tvar.
English: What benefit has Zometa shown during the studies?
Croatian: Koje su koristi lijeka Zometa utvrđene u ispitivanjima?
English: How does Zometa work?
Croatian: Kako djeluje Zometa?
English: The reduction of bone loss helps to make bones less likely to break, which is useful in preventing fractures in cancer patients with bone metastases.
Croatian: Smanjenjem gubitka kostiju dolazi do rjeđih prijeloma kostiju, čime se sprječavaju frakture u bolesnika s rakom i metastazama u kostima.
English: How is Zometa used?
Croatian: Kako se Zometa koristi?
English: When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D. A lower dose is recommended for patients with bone metastases (when cancer has spread to the bone) if they have mild to moderate problems with their kidneys.
Croatian: Ako se koristi za sprječavanje komplikacija kostiju, infuzija se može ponoviti svaka tri do četiri tjedna, a bolesnik treba također uzimati dodatke kalcija i vitamina D.
English: By preventing the breakdown of bones, Zometa also helps to reduce the amount of calcium released into the blood.
Croatian: Zometa također doprinosi snižavanju količine kalcija koja se oslobađa u krv time što sprječava razgradnju kostiju.
English: It is not recommended for patients with severe kidney problems.
Croatian: Primjena lijeka Zometa ne preporuča se u bolesnika s ozbiljnim oštećenjem bubrega ili jetre.
English: For the full list of all side effects reported with Zometa, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zometa potražite u uputi o lijeku.
English: The full EPAR for Multaq can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Multaq nalazi se na internetskim stranicama Agencije ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Multaq and what is it used for?
Croatian: Što je Multaq i za što se koristi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Multaq on 26 November 2009.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet lijeka Multaq koje vrijedi na prostoru Europske unije od 26. studenoga 2009.
English: Multaq is available as tablets (400 mg) and the recommended dose is one tablet twice a day, with the morning and evening meals.
Croatian: Multaq je dostupan u obliku tableta (400 mg), a preporučena doza je jedna tableta dvaput na dan, uz jutarnji i večernji obrok.
English: This followed a review of data that became available since its authorisation including data from the PALLAS study.1
Croatian: Nakon toga je slijedio pregled podataka koji su postali dostupni poslije odobrenja lijeka, uključujući podatke iz ispitivanja PALLAS.1
English: Other information about Multaq
Croatian: Ostale informacije o lijeku Multaq
English: This is a summary of the European public assessment report (EPAR) for Multaq.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni(EPAR) lijeka Multaq.
English: It must not be used in patients with permanent atrial fibrillation of unknown duration or lasting for more than six months when the doctor has decided not to try to restore normal rhythm.
Croatian: Ne smiju ga uzimati bolesnici s permanentnom fibrilacijom atrija nepoznatog trajanja ili onom koja traje dulje od šest mjeseci, kada je liječnik odlučio ne pokušavati uspostaviti normalan ritam.
English: It must also not be used in patients with some other heart problems, such as some problems with the electrical activity, very slow heart beats or heart failure.
Croatian: Također ga ne smiju uzimati bolesnici s nekim drugim srčanim tegobama, kao što su neke tegobe s električnom aktivnošću, vrlo spori otkucaji srca ili zatajenje srca.
English: Multaq should only be prescribed after alternative treatment options have been considered.
Croatian: Multaq se smije propisati tek nakon što se razmotre druge mogućnosti liječenja.
English: Multaq can only be obtained with a prescription and treatment with it should be started and monitored under specialist supervision.
Croatian: Multaq se može dobiti samo na recept, a liječenje njime smije se započeti i pratiti samo pod stručnim nadzorom liječnika.
English: Multaq prevented fibrillation for an average of 116 days compared to 53 days with placebo.
Croatian: Multaq je sprječavao fibrilaciju u trajanju od prosječno 116 dana, u usporedbi s 53 dana uz placebo.
English: What are the risks associated with Multaq?
Croatian: Koji su rizici povezani s lijekom Multaq?
English: The company that makes Multaq must ensure that healthcare professionals who prescribe and dispense the medicine in all Member States are given a ‘prescriber guide'.
Croatian: Tvrtka koja proizvodi Multaq mora osigurati da će u svim državama članicama zdravstveni radnici koji propisuju i izdaju ovaj lijek dobiti „vodič za propisivače”.
English: The guide will also include information on: when not to use Multaq; medicines that interact with Multaq; the need to monitor the function of the liver, lung, heart and kidneys before and during treatment; and what advice to give to patients on Multaq treatment.
Croatian: Također, vodič će uključivati informacije o sljedećem: kada se Multaq ne smije primjenjivati, lijekovima koji su u interakciji s lijekom Multaq, potrebu praćenja funkcije jetre, pluća, srca i bubrega prije i tijekom liječenja, te koje savjete dati bolesnicima koji se liječe lijekom Multaq.
English: Atrial fibrillation is when the atria (the upper chambers of the heart) contract irregularly and rapidly, and this abnormality can be short-lasting (paroxysmal) or it can last longer than a few days (persistent).
Croatian: Fibrilacija atrija je poremećaj kod kojega se atrij (gornje komore srca) nepravilno i brzo steže, a ta abnormalnost može biti kratkotrajna (paroksizmalna) ili može trajati dulje od nekoliko dana (perzistentna).
English: Based on the available evidence, the CHMP decided that Multaq's benefits are greater than its risks and recommended that Multaq be given marketing authorisation.
Croatian: Na temelju raspoloživih dokaza, CHMP JE odlučilo je da koristi od lijeka Multaq nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje u promet lijeka Multaq.
English: Multaq was less effective than amiodarone at maintaining normal rhythm: after a year, atrial fibrillation came back or treatment was stopped in 75% of the patients taking Multaq, compared with 59% of the patients receiving amiodarone.
Croatian: Multaq je bio manje učinkovit od amiodarona u održavanju normalnog ritma: nakon godine dana, fibrilacija atrija se vratila ili je liječenje bilo prekinuto u 75 % bolesnika koji su uzimali Multaq, u usporedbi s 59 % bolesnika koji su primali amiodaron.
English: The main measure of effectiveness was how long the treatment prevented an attack of atrial fibrillation or the change in the patients' heart rate after two weeks.
Croatian: Glavna mjera učinkovitosti bilo je razdoblje u kojem je liječenje sprječavalo napadaj fibrilacije atrija ili promjenu srčanog ritma bolesnika nakon dva tjedna.
English: Multaq must not be used in patients who have severe problems with their liver or kidneys.
Croatian: Multaq ne smiju uzimati bolesnici koji imaju teške probleme s jetrom ili bubrezima.
English: Increased flow of charged particles produces the excessive electrical activity that leads to atrial fibrillation and rapid heart rate.
Croatian: Povećani protok nabijenih čestica uzrokuje preveliku električnu aktivnost, koja dovodi do fibrilacije atrija i ubrzanih otkucaja srca.
English: The study was stopped early because of severe cardiovascular events (such as cardiovascular death or hospitalisation and stroke) in some patients taking Multaq.
Croatian: Ispitivanje je brzo prekinuto zbog teških kardiovaskularnih poremećaja (kao što je kardiovaskularna smrt ili hospitalizacija i moždani udar) u nekih bolesnika koji su uzimali Multaq.