FrancophonIA/ELRC3.0 huggingface dataset:
English: Within the following table, adverse reactionsare ranked under the MedDRA frequency classification:
Croatian: Unutar sljedeće tablice nuspojave su razvrstane prema MedDRA klasifikaciji učestalosti:
English: Do not take PANTOZOL 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 PANTOZOL 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: PANTOZOL 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: PANTOZOL 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: PANTOZOL Control should not be used during breast-feeding.
Croatian: Pantozol Control ne smije se koristiti tijekom dojenja.
English: If you forget to take PANTOZOL Control
Croatian: Ako ste zaboravili uzeti PANTOZOL Control
English: Sleep disorders Depression (and all aggravations)
Croatian: Psihijatrijski poremećaji poremećaji sna depresija (i pogoršanje iste)
English: To avoid this interference, PANTOZOL 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: Do not take PANTOZOL 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: Ne mojte uzimati PANTOZOL Control: - ako ste alergični na pantoprazol ili bilo koji sastojak ovog lijeka (navedeno u dijelu 6) - ako uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir (za liječenje infekcije
English: Within each frequency grouping adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake grupe učestalosti, nuspojave su poredane u padajućem nizu prema stupnju ozbiljnosti.
English: Other medicines and PANTOZOL Control
Croatian: Drugi lijekovi i PANTOZOL Control
English: However, you may take PANTOZOL Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Croatian: Ako je potrebno, PANTOZOL Control možete uzimati s antacidima (npr. megaldrat, alginatna kiselina, natrijev bikarbonat, aluminijev hidroksid, magnezijev karbonat ili kombinacije navedenih).
English: What PANTOZOL 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: Kako PANTOZOL Control izgleda i sadržaj pakiranja Želučanootporne tablete su žute, ovalne, bikonveksne, filmom obložene tablete sa smeđom oznakom "P20" na jednoj strani.
English: Liver enzymes increased (transaminases, γ-GT)
Croatian: Poremećaji jetre i žuči povišenje jetrenih enzima (transaminaze, γ-GT)
English: Disorientation (and all aggravations)
Croatian: dezorijentiran ost (i pogoršanje istog)
English: PANTOZOL 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: Talk to your doctor before taking PANTOZOL Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to PANTOZOL
Croatian: - ako ste stariji od 55 godina i svakodnevno uzimate lijekove za probavne smetnje koji se izdaju bez recepta - ako ste stariji od 55 godina i imate bilo kakve nove ili nedavno promijenjene simptome refluksa - ako ste imali čir na želucu ili operaciju želuca - ako imate probleme s jetrom ili žuticu (žutilo kože ili očiju) - ako redovno posjećujete liječnika zbog neke ozbiljne bolesti ili stanja - ako ste naručeni na endoskopiju ili C-urea izdisajni test. - ako ste ikad imali kožnu reakciju nakon terapije s lijekom sličnim lijeku PANTOZOL
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni matrijal potrebno je zbrinuti u sukladno nacionalnim propisima.
English: If you take more PANTOZOL Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Croatian: Obavijestite liječnika ili ljekarnika ako ste uzeli više od preporučene doze.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Croatian: Odmah obavijestite svog liječnika, prije ili nakon uzimanja ovog lijeka, ako primijetite neki od sljedećih simptoma koji može biti znak druge, ozbiljnije bolesti: - nenamjeran gubitak težine (koji nije vezan uz dijetu ili program tjelovježbe) - povraćanje, osobito ako se ponavlja - povraćanje krvi, što možete primijetiti u obliku tamnih zrnaca veličine zrna kave - krv u stolici, koja može biti crna ili poput katrana - teškoće pri gutanju ili bol pri gutanju - bljedoća ili osjećaj slabosti (anemija) - bol u prsnom košu - bol u trbuhu - težak i/ili stalan proljev, jer je ovaj lijek povezan sa malim porastom zaraznog proljeva - ako dobijete osip na koži, posebice na područjima izloženima suncu obavijestite svojeg liječnika što je prije moguće, jer ćete možda morati prekinuti liječenje lijekom PANTOZOL Control.
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTOZOL 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 PANTOZOL Control, ali ovaj lijek nije namijenjen trenutnom olakšanju simptoma.
English: You must not use PANTOZOL Control if you are taking HIV protease inhibitors.
Croatian: Control ako uzimate inhibitore HIV proteaze.
English: How to store PANTOZOL Control
Croatian: Kako čuvati PANTOZOL Control
English: You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTOZOL Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Croatian: - metotreksat (koristi se za liječenje reumatoidnog artritisa, psorijaze ili raka) - ako uzimate metotreksat liječnik će možda preporučiti da privremeno prekinete uzimati PANTOZOL
English: How to take PANTOZOL Control
Croatian: Kako uzimati PANTOZOL Control
English: Remember to also mention any other ill-effects like pain in your joints Your doctor may decide that you need some tests.
Croatian: Sjetite se spomenuti i bilo koje druge štetne učinke poput boli u zglobovima.
English: HIV-infection) at the same time as pantoprazole, ask your doctor for specific advice.
Croatian: (za liječenje infekcije HIV-om), posavjetujte se s liječnikom.
English: PANTOZOL Control is indicated for short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Croatian: Control je indiciran za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, regurgitacija kiseline) u odraslih.
English: PANTOZOL Control 20 mg gastro-resistant tablets Pantoprazole
Croatian: PANTOZOL Control 20 mg želučanootporne tablete pantoprazol
English: PANTOZOL Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Croatian: Control se koristi za kratkotrajno liječenje simptoma refluksa (npr. žgaravica, vraćanje kiseline iz želuca u usta) u odraslih.
English: PANTOZOL Control 20 mg gastro-resistant tablets
Croatian: PANTOZOL Control 20 mg želučanootporne tablete
English: Control - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Croatian: Control koji smanjuje želučanu kiselinu - ako morate napraviti određenu krvnu pretragu (kromogranin A). - ako istodobno s pantoprazolom uzimate inhibitore HIV proteaze kao što su atazanavir i nelfinavir
English: Agranulocytosis Thrombocytopenia; Leukopenia,
Croatian: Poremećaji krvi i limfnog sustava agranulocitoza trombocitopen ija; leukopenija, pancitopenija
English: Subacute cutaneous lupus erythematosus (see section
Croatian: Lyellov sindrom; erythema multiforme; fotoosjetljivost subakutni kožni lupus eritematodes (pogledajte dio
English: - warfarin and phenprocoumon (used to thin blood and prevent clots).
Croatian: Pogledajte 'Ne uzimajte PANTOZOL Control'. - ketokonazol (koristi se za gljivične infekcije) - varfarin i fenprokumon (koristi se za razrjeđivanje krvi i sprečavanje ugrušaka).
English: - You should not take PANTOZOL Control tablets for more than 4 weeks without consulting a doctor.
Croatian: Control tablete dulje od 4 tjedna bez savjetovanja s liječnikom.
English: Pancytopenia
Croatian: PANTOZOL
English: Stop taking PANTOZOL Control when you are completely symptom-free.
Croatian: Control kada nastupi potpuno povlačenje simptoma.
English: Asthenia, fatigue and malaise
Croatian: Trudnoća i dojenje
English: - Frequency not known: hallucination, confusion (especially in patients with a history of these symptoms); decreased level of sodium in blood; decreased level of magnesium in blood, rash, possibly with pain in the joints;
Croatian: Nepoznata učestalost: halucinacije, smetenost (pogotovo kod bolesnika koji su već imali te simptome), smanjenje razine natrija u krvi; smanjenje razine magnezija u krvi; osip, moguće praćen boli u zglobovima; osjećaj bockanja, peckanja, trnaca i mravinjanja, žarenja ili utrnulosti, upala debelog crijeva koja uzrokuje ustrajan vodenasti proljev.
English: Headache; Dizziness
Croatian: glavobolja; omaglica poremećaji okusa parestezija
English: Subacute cutaneous lupus erythematosus (SCLE)
Croatian: Poremećaji živčanog sustava polipi fundusnih žlijezda (dobroćudni)
English: Calcium stearate
Croatian: Nemojte uzimati PANTOZOL
English: feeling of tingling, prickling, pins and needles, burning sensation or numbness, inflammation in the large bowel, that causes persistent watery diarrhoea.
Croatian: Opći poremećaji i reakcije na mjestu primjene astenija, umor i malaksalost povišenje tjelesne temperature; periferni edem
English: EMA/455635/2016
Croatian: EMA/455635/2016 EMEA/H/C/002752
English: The full EPAR for Aerivio Spiromax can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Aerivio Spiromax nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Two medicines are bioequivalent when they produce the same levels of the active substance in the body.
Croatian: Dva su lijeka bioekvivalentna ako proizvode iste razine djelatne
English: Since Aerivio Spiromax is only available in one high strength (containing 50 micrograms of salmeterol and 500 micrograms of fluticasone propionate), should a lower strength become appropriate, patients should be switched to an alternative combination of salmeterol and fluticasone propionate containing a lower
Croatian: Budući da je Aerivio Spiromax dostupan samo u jednoj jačoj dozi (koja sadrži 50 mikrograma salmeterola i 500 mikrograma flutikazonpropionata), ako manja doza bude dovoljna, bolesnike treba prebaciti na drugi kombinirani lijek koji sadrži salmeterol i manju dozu flutikazonpropionata.
English: The two active substances in Aerivio Spiromax are well known and are present in several medicines used to treat asthma and COPD, either alone or in combination with other medicines.
Croatian: Dvije djelatne tvari lijeka Aerivio Spiromax dobro su poznate i prisutne u nekoliko lijekova koji se koriste za liječenje astme i KOPB-a, samostalno ili u kombinaciji s drugim lijekovima.
English: This means that Aerivio Spiromax is similar to a ‘reference medicine' called Seretide Diskus (also known as Seretide Accuhaler), which contains the same active substances.
Croatian: To znači da je Aerivio Spiromax sličan „referentnom lijeku” Seretide Diskus (poznatom i kao Seretide Accuhaler) koji sadrži iste djelatne tvari.
English: Aerivio Spiromax is a ‘hybrid medicine'.
Croatian: Aerivio Spiromax je „hibridni lijek”.
English: When it attaches to these receptors in the airways, it causes the muscles to relax, which keeps the airways open and helps with the patient's breathing.
Croatian: Prilikom spajanja na ove receptore u dišnim putovima, uzrokuje opuštanje mišića, što održava dišne putove otvorenima i pomaže bolesniku pri
English: This is a summary of the European public assessment report (EPAR) for Aerivio Spiromax.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aerivio Spiromax.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aerivio Spiromax 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 Aerivio Spiromax nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Because Aerivio Spiromax is a hybrid medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Aerivio Spiromax hibridni lijek te je bioekvivalentan referentnom lijeku, smatra se da su njegove koristi i rizici isti kao i oni referentnog lijeka.
English: In asthma, Aerivio Spiromax can be used in patients whose disease is not adequately controlled despite treatment with a combination of a beta-2 agonist and a lower dose of inhaled corticosteroid, or those whose asthma is already controlled with a long-acting beta-2 agonist and a high-dose of inhaled
Croatian: Aerivio Spiromax može se koristiti za liječenje bolesnika u kojih astma nije odgovarajuće kontrolirana primjenom kombiniranog lijeka koji sadrži beta-2 agonist i inhalacijski kortikosteroid manje jačine, ili bolesnika u kojih je astma već kontrolirana primjenom dugodjelujućeg beta-2 agonista i visoke doze
English: Aerivio Spiromax is available as an inhalation powder in a portable inhaler device.
Croatian: Aerivio Spiromax dostupan je kao prašak za inhalaciju u prijenosnom inhalatoru.
English: What measures are being taken to ensure the safe and effective use of Aerivio Spiromax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Aerivio Spiromax?
English: However, Aerivio Spiromax is available only as a single high strength, whereas the reference medicine is available in three strengths, the same high strength and two lower strengths.
Croatian: Međutim, Aerivio Spiromax dostupan je samo u jednoj jačoj dozi, dok je referentni lijek dostupan u tri doze, odnosno u dozi iste jačine i dvjema slabijim dozama.
English: Other information about Aerivio Spiromax
Croatian: Ostale informacije o lijeku Aerivio Spiromax
English: The Committee recommended that Aerivio Spiromax be approved for use in the EU.
Croatian: Odbor je preporučio davanje odobrenja za stavljanje lijeka Aerivio Spiromax u promet u EU-u.
English: Aerivio Spiromax is a medicine used for the regular treatment of adults with severe asthma and for the relief of symptoms of chronic obstructive pulmonary disease (COPD, a long-term disease in which the airways and air sacs inside the lungs become damaged or blocked, leading to difficulty in breathing).
Croatian: Aerivio Spiromax je lijek koji se koristi za redovito liječenje odraslih osoba s teškom astmom i za simptomatsko liječenje bolesnika s kroničnom opstruktivnom plućnom bolesti (KOPB je dugotrajna bolest kod koje su dišni putovi i zračne vrećice u plućima oštećeni ili začepljeni što dovodi do teškoća u disanju).
English: It is not intended to provide practical advice on how to use Aerivio Spiromax.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Aerivio Spiromax.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Aerivio Spiromax has been shown to have comparable quality and to be bioequivalent to Seretide Diskus.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je lijek Aerivio Spiromax dokazao usporedivu kakvoću te da je bioekvivalentan lijeku Seretide Diskus.
English: What is Aerivio Spiromax and what is it used for?
Croatian: Što je Aerivio Spiromax i za što se koristi?
English: For more information about treatment with Aerivio Spiromax, read the package leaflet (also part of the EPAR) or contact your
Croatian: Više informacija o liječenju lijekom Aerivio Spiromax pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: In COPD, Aerivio Spiromax is used in adults who have had exacerbations (flare-ups) of the disease in the past and have significant symptoms despite regular treatment.
Croatian: Aerivio Spiromax koristi se za liječenje odraslih osoba s KOPB-om s ponavljajućim egzacerbacijama u anamnezi (bolest se pogoršala) koji imaju značajne simptome unatoč redovitom liječenju.
English: What are the benefits and risks of Aerivio Spiromax?
Croatian: Koje su koristi i rizici lijeka Aerivio Spiromax?
English: Studies in people have been limited to tests to determine that Aerivio Spiromax is bioequivalent to the reference medicine, Seretide Diskus.
Croatian: Ispitivanja na ljudima bila su ograničena na utvrđivanje činjenice je li Aerivio Spiromax bioekvivalentan referentnom lijeku Seretide Diskus.
English: Aerivio Spiromax can only be obtained with a prescription.
Croatian: Aerivio Spiromax se izdaje samo na liječnički recept.
English: As Aerivio Spiromax is only available in one high strength, its use in asthma has been restricted to
Croatian: Budući da je Aerivio Spiromax dostupan samo u jednoj jačoj dozi, njegova primjena u liječenju astme ograničena je na bolesnike s teškom astmom.
English: For practical information about using Aerivio Spiromax, patients should read the package leaflet or
Croatian: Praktične informacije o primjeni lijeka Aerivio Spiromax bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: How has Aerivio Spiromax been studied?
Croatian: Kako je Aerivio Spiromax ispitivan?
English: How is Aerivio Spiromax used?
Croatian: Kako se Aerivio Spiromax koristi?
English: EMA/521289/2014 EMEA/H/C/001045
Croatian: EMA/521288/2014 Ema/H/C/001045
English: The agreement rate was 83%.
Croatian: Stopa preklapanja iznosila je 83%.
English: This summary was last updated in 07-2014.
Croatian: Sažetak je posljednji put ažuriran u 07. 2014.
English: The amount of besilesomab injected varies between 0.25 to 1 mg, depending on how much radioactivity is required.
Croatian: Količina ubrizganog besilesomaba varira između 0,25 i 1 mg, ovisno o količini potrebne radioaktivnosti.
English: The full EPAR for Scintimun 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 ocjeni dokumentacije o lijeku (EPAR) za lijek Scintimun nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Scintimun should only be used in hospitals with a nuclear medicine department and should only be handled by authorised staff.
Croatian: Scintimun treba koristiti samo u bolnicama s odjelima nuklearne medicine i njime treba rukovati samo ovlašteno osoblje.
English: What measures are being taken to ensure the safe and effective use of Scintimun?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Scintimun?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Scintimun on 11 January 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Scintimun na snazi u Europskoj uniji od 11. siječnja 2010.
English: Scintimun is for diagnostic use only.
Croatian: Scintimun se koristi samo u dijagnostičke svrhe.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Croatian: Monoklonalno protutijelo je protutijelo (tip protein) koji je dizajniran za prepoznavanje i vezivanje na određene strukture (naziva antigen) u tijelu.
English: The solution is given to the patient as one injection into a vein.
Croatian: Otopina se daje bolesniku kao jedna injekcija u venu.
English: As for all radioactive substances used in medicine, patients should be exposed to the lowest possible dose of Scintimun.
Croatian: Kao i u slučaju svih radioaktivnih tvari koje se koriste u medicinske svrhe, bolesnici se trebaju izlagati najmanjim mogućim dozama lijeka Scintimun.
English: The images will show where besilesomab has accumulated, which the doctor will use to locate the areas of infection or inflammation.
Croatian: Slike prikazuju mjesta gdje se besilesomab akumulirao, što će liječnik iskoristiti za lociranje područja infekcije ili upale.
English: Three to six hours after the injection, the doctor takes a scan of the limbs to locate the areas in the bones affected by osteomyelitis.
Croatian: Tri do šest sati nakon injekcije, liječnik skenira udove kako bi locirao područja u kostima koja su zahvaćena osteomijelitisom.
English: Scintimun is not used on its own, but must be radiolabelled before use.
Croatian: Scintimun se ne koristi samostalno, no mora biti radioaktivno označen prije primjene.
English: This is a summary of the European public assessment report (EPAR) for Scintimun.
Croatian: Ovo je sažetak Europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Scintimun.
English: Radiolabelling is a technique where a substance is labelled with a radioactive compound.
Croatian: Radioaktivno označavanje je tehnika kojom se tvar označava radioaktivnim spojem.
English: Scintimun should not be used to diagnose diabetic foot infection (infection that occurs in the feet of patients with diabetes).
Croatian: Scintimun se ne smije koristiti za dijagnosticiranje infekcije stopala uzrokovane dijabetesom (infekcija koja nastupa u stopalima bolesnika s dijabetesom).