FrancophonIA/ELRC3.0 huggingface dataset:
English: Using SonoVue to measure blood flow in large blood vessels improved the quality of the scan when testing the cerebral arteries (in the head), the carotids (in the neck) and the portal vein (leading to the liver), but not the renal arteries (leading to the kidneys).
Croatian: Primjenom lijeka SonoVue za mjerenje protoka krvi u velikim krvnim žilama poboljšana je kvaliteta slike kod testiranja cerebralnih arterija (u glavi), karotida (u vratu) i portalne vene (koja vodi do jetra), ali ne i renalnih arterija (koje vode do bubrega).
English: SonoVue has been shown to be effective in improving ultrasound scans of the heart in adults and the bladder in children, and in measurements of blood flow.
Croatian: Dokazana je djelotvornost lijeka SonoVue u poboljšanju ultrazvučnih slika srca u odraslih i mokraćnog mjehura u djece te kod mjerenja protoka krvi.
English: For practical information about using SonoVue, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka SonoVue bolesnici trebaju pročitati u uputi o lijeku, odnosno trebaju se obratiti svojem liječniku ili ljekarniku.
English: For the smaller vessels, SonoVue led to better quality scans when looking at the blood flow in breast and liver lesions.
Croatian: Kod manjih krvnih žila SonoVue je omogućio bolju kvalitetu slike kod promatranja protoka krvi u lezijama grudi i jetra.
English: What benefits of SonoVue have been shown in studies?
Croatian: Koje su koristi lijeka SonoVue dokazane u ispitivanjima?
English: No side effects attributable to the medicine have been reported in children given SonoVue into the bladder.
Croatian: Nisu zabilježene nikakve nuspojave koje bi se mogle povezati s lijekom u djece kojima je SonoVue dan u mjehur.
English: How does SonoVue work?
Croatian: Kako djeluje SonoVue?
English: How is SonoVue used?
Croatian: Kako se lijek SonoVue koristi?
English: For the full list of all side effects reported with SonoVue, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka SonoVue potražite u uputi o lijeku.
English: They may also be given a repeat dose after one hour.
Croatian: Njima se može također dati ponovljena doza nakon jednog sata.
English: It must not be used in patients with the following conditions:
Croatian: Ne smije se primjenjivati u bolesnika sa sljedećim stanjima:
English: This summary was last updated in 10-2016.
Croatian: Ovaj sažetak je posljednji put ažuriran: 10.2016.
English: This means that it is similar to a reference medicine, containing the same active substance but in a different concentration.
Croatian: To znači da je sličan referentom lijeku koji sadrži istu djelatnu tvar, ali u drugoj koncentraciji.
English: • deficiency in the enzyme NADPH reductase.
Croatian: • nedostatak enzima NADPH reduktaze.
English: A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.
Croatian: Doza se može ponoviti jedan sat nakon prve doze ako se simptomi nastave ili se ponovno pojave ili ako razina methemoglobina u krvi ostane viša od normalne.
English: The usual dose for adults and children aged above three months is 1 to 2 mg per kilogram (kg) body weight.
Croatian: Uobičajena doza za odrasle i djecu stariju od tri mjeseca iznosi 1 do 2 mg po kilogramu (kg) tjelesne težine.
English: • glucose-6-phosphate dehydrogenase deficiency (G6PD),
Croatian: • nedostatak glukoza-6-fosfat dehidrogenaze (G6PD)
English: The dose in children aged three months or less is 0.3 to 0.5 mg/kg.
Croatian: Doza za djecu u dobi od tri mjeseca ili mlađu iznosi 0,3 do 0,5 mg/kg.
English: It can only be obtained with a prescription and must be given by a healthcare professional.
Croatian: Lijek se izdaje samo na recept i mora ga primjenjivati zdravstveni radnik.
English: The full EPAR for Methylthioninium chloride Proveblue can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Croatian: Cjeloviti EPAR za lijek Methylthioninium chloride Proveblue nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The CHMP decided that the medicine's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: Odbor je odlučio da koristi od lijeka nadmašuju s njime povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: It does this by accepting negatively charged electron particles through an enzyme called ‘NADPH methaemoglobinaemia reductase'.
Croatian: Ona to čini prihvaćanjem negativno nabijenih elektronskih čestica putem enzima naziva „NADPH methemoglobinreduktaza”.
English: To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ‘ferrous' form (Fe2+).
Croatian: Da bi prenosio kisik u krvi, hemoglobin treba sadržavati atom željeza u „fero” obliku (Fe2+).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Methylthioninium chloride Proveblue na snazi u Europskoj uniji od 6. svibnja 2011.
English: The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles'), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine), sweating and pain at the site of injection or in a limb.
Croatian: Najčešće nuspojave pri primjeni metiltioninijeva klorida su vrtoglavica, parestezija (neobičan osjećaj poput trnaca), disgeuzija (poremećeni osjet okusa), povraćanje (osjećaj slabosti), obezbojenje kože, kromaturija (abnormalna boja mokraće), znojenje i bol na mjestu injekcije ili u udovima.
English: Methylthioninium chloride Proveblue is available as a solution for injection (5 mg/ml), which is injected slowly into a vein over a period of five minutes.
Croatian: Methylthioninium chloride Proveblue dostupan je kao otopina za injekciju (5 mg/ml) koja se polako ubrizgava u venu tijekom razdoblja od pet minuta.
English: The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.
Croatian: Elektroni se tada prenose u atome željeza u abnormalnom hemoglobinu, čime se ovi pretvaraju u normalni fero oblik.
English: Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on its use from the published literature, which confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.
Croatian: Budući da se metiltioninijev klorid koristi u Europskoj uniji nekoliko desetljeća za liječenje methemoglobinemije, proizvođač je predočio podatke o njegovoj primjeni iz objavljene literature kojima se potvrđuje da je metiltioninijev klorid djelotvoran u liječenju odraslih i djece od methemoglobinemije uzrokovane izlaganjem lijeku ili kemikaliji.
English: Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by the use of certain medicines or chemicals.
Croatian: Methylthioninium chloride Proveblue primjenjuje se u odraslih osoba i djece svih dobi kao protuotrov za liječenje simptoma methemoglobinemije uzrokovane primjenom određenih lijekova ili kemikalija.
English: Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs).
Croatian: Methylthioninium chloride Proveblue ne smije se primjenjivati u osoba koje su preosjetljive (alergične) na metiltioninijev klorid ili na bilo koju drugu tiazinsku boju (skupinu kojoj pripada metiltioninijev klorid).
English: Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ‘ferric' form (Fe3+) seen in methaemoglobinaemia which is less able to transport oxygen.
Croatian: Izloženost određenim lijekovima ili kemikalijama može prouzročiti promjenu željeza u hemoglobinu u „feri” oblik (Fe3+) koji je uočen kod methemoglobinemije, a koji ima slabiju sposobnost prijenosa kisika.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Proveblue 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 Methylthioninium chloride Proveblue nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin (called methaemoglobin) in the blood that is not able to transport oxygen effectively.
Croatian: Methemoglobinemija je stanje u kojem je prisutna prevelika količina abnormalnog oblika hemoglobina (koji se naziva methemeglobin) u krvi koji nije u stanju učinkovito transportirati kisik.
English: • methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning,
Croatian: • methemoglobinemija uzrokovana nitritom tijekom liječenja trovanja cijanidom
English: The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia.
Croatian: Odbor je zaključio kako dugotrajno iskustvo u primjeni djelatne tvari, metiltioninijeva klorida, pokazuje njezinu djelotvornost u liječenju methemoglobinemije.
English: This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) za lijek Methylthioninium chloride Proveblue.
English: The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin.
Croatian: Djelatna tvar u lijeku Methylthioninium chloride Proveblue, metiltioninijev klorid (koji se još naziva metilensko plavilo), ubrzava pretvaranje abnormalnog hemoglobina u normalni hemoglobin.
English: Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.
Croatian: Methemoglobinemiju mogu prouzročiti tvari poput nekih antibiotika, sredstava za lokalnu anesteziju, nitrata u pitkoj vodi te pesticida.
English: The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.
Croatian: Referentni lijek za Methylthioninium chloride Proveblue je injekcija metiltioninijeva klorida USP 1% w/v.
English: • methaemoglobinaemia caused by chlorate poisoning,
Croatian: • methemoglobinemija uzrokovana trovanjem kloratom
English: For more information about treatment with Methylthioninium chloride Proveblue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Methylthioninium chloride Proveblue pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: What measures are being taken to ensure the safe and effective use of Methylthioninium chloride Proveblue?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Methylthioninium chloride Proveblue?
English: For practical information about using Methylthioninium chloride Proveblue, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Methylthioninium chloride Proveblue bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Other information about Methylthioninium chloride Proveblue
Croatian: Ostale informacije o lijeku Methylthioninium chloride Proveblue
English: What is Methylthioninium chloride Proveblue and what is it used for?
Croatian: Što je Methylthioninium chloride Proveblue i za što se koristi?
English: It is not intended to provide practical advice on how to use Methylthioninium chloride Proveblue
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Methylthioninium chloride Proveblue.
English: Methylthioninium chloride Proveblue is a ‘hybrid medicine'.
Croatian: Methylthioninium chloride Proveblue je „hibridni lijek ”.
English: Methylthioninium chloride Proveblue methylthioninium chloride
Croatian: Methylthioninium chloride Proveblue metiltioninijev klorid
English: What are the risks associated with Methylthioninium chloride Proveblue?
Croatian: Koji su rizici povezani s lijekom Methylthioninium chloride Proveblue?
English: For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Methylthioninium chloride Proveblue potražite u uputi o lijeku.
English: Why is Methylthioninium chloride Proveblue approved?
Croatian: Zašto je lijek Methylthioninium chloride Proveblue odobren?
English: Methylthioninium chloride Proveblue contains the active substance methylthioninium chloride.
Croatian: Methylthioninium chloride Proveblue sadrži djelatnu tvar metiltioninijev klorid.
English: How is Methylthioninium chloride Proveblue used?
Croatian: Kako se Methylthioninium chloride Proveblue koristi?
English: What benefits of Methylthioninium chloride Proveblue have been shown in studies?
Croatian: Koje su koristi lijeka Methylthioninium chloride Proveblue utvrđene u ispitivanjima?
English: Your doctor will decide whether or not you should be given this medicine.
Croatian: Vaš će liječnik odlučiti trebate li ili ne trebate primiti ovaj lijek.
English: It is important to tell your doctor if you are pregnant, think you may be pregnant, or are planning to have a baby.
Croatian: Važno je napomenuti liječniku ako ste trudni, mislite da biste mogli biti trudni ili ako planirate imati dijete.
English: The current information on subsequent doses/administration of the product, including for example slower initial rate of administration, should remain unchanged]
Croatian: Postojeće informacije o sljedećim dozama/primjeni proizvoda, uključujući npr. sporiju početnu primjenu, trebaju ostati neizmijenjene.]
English: [All references to the recommendation for an initial test dose before the administration of the first dose to a new patient should be removed in section 4.2 and in any other sections of the SmPC where applicable.
Croatian: [Sve reference na preporučenu početnu testnu dozu prije davanja prve doze novom pacijentu treba ukloniti iz odjeljka 4.2 i svih ostalih odjeljaka dokumenta SmPC ako je primjenjivo.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Croatian: Podaci o lijeku mogu naknadno biti ažurirani od strane nadležnih tijela zemlje članice, u suradnji s referentnom zemljom članicom i u skladu sa procedurama opisanim u odjeljku 4, dijela III, Direktive 2001/83/EC.
English: {invented name} has not been tested in pregnant women.
Croatian: {zaštićeni naziv} nije ispitivan na trudnicama.
English: Treatment with {invented name} should be confined to second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Croatian: Liječenje lijekom {zaštićeni naziv} treba svesti na drugo i treće tromjesečje ako se procijeni da korist premašuje potencijalni rizik i za majku i za fetus.
English: If you become pregnant during treatment, you must ask your doctor for advice.
Croatian: Ako ostanete trudni tijekom liječenja, morate se posavjetovati sa svojim liječnikom.
English: Iron deficiency anaemia occurring in the first trimester of pregnancy can in many cases be treated with oral iron.
Croatian: Anemija uzrokovana nedostatkom željeza u prvom tromjesečju trudnoće može se u mnogim slučajevima liječiti peroralnim pripravcima željeza.
English: How {invented name} is given
Croatian: Kako se primjenjuje {zaštićeni naziv}
English: • Known serious hypersensitivity to other parenteral iron products.
Croatian: • Poznata ozbiljna preosjetljivost na druge parenteralne pripravke željeza.
English: If hypersensitivity reactions or signs of intolerance occur during administration, the treatment must be stopped immediately.
Croatian: Ako se prilikom primjene pojave reakcije preosjetljivosti ili znakovi nepodnošljivosti lijeka, liječenje se mora odmah prekinuti.
English: There are no adequate and well-controlled trials of {invented name} in pregnant women.
Croatian: Nema podataka o odgovarajućim i dobro kontroliranim ispitivanjima <lijeka> {zaštićeni naziv} u trudnica.
English: - if you have experienced serious allergic (hypersensitive) reactions to other injectable iron preparations.
Croatian: Ako ste imali ozbiljne alergijske reakcije (reakcije preosjetljivosti) na druge injekcijske pripravke željeza.
English: Talk to your doctor or nurse before receiving {invented name}: - if you have a history of medicine allergy - if you have systemic lupus erythematosus - if you have rheumatoid arthritis - if you have severe asthma, eczema or other allergies
Croatian: Obratite se svom liječniku ili medicinskoj sestri prije nego primite {zaštićeni naziv}: - ako ste nekada imali alergiju na bilo koji lijek - ako imate sistemski lupus erythematosus - ako imate reumatoidni artritis - ako imate tešku astmu, ekcem ili druge alergije
English: If you are breast-feeding, ask your doctor for advice before you are given {invented name}.
Croatian: Ako dojite, upitajte svog liječnika za savjet prije nego primite {zaštićeni naziv}.
English: You must not receive {invented name}: - if you are allergic (hypersensitive) to the product or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti {zaštićeni naziv}: - Ako ste alergični (preosjetljivi) na lijek ili bilo koji drugi sastojak ovog lijeka (naveden u dijelu
English: Additional treatment with antihistamines and/or corticosteroids should be given as appropriate.
Croatian: Po potrebi, moguće je primijeniti i dodatno liječenje antihistaminicima i/ili kortikosteroidima.
English: Monitor carefully patients for signs and symptoms of hypersensitivity reactions during and following each administration of {invented name}.
Croatian: Pažljivo nadgledajte bolesnike ne biste li uočili znakove i simptome reakcija preosjetljivosti tijekom i nakon svake primjene <lijeka> {zaštićeni naziv}.
English: A careful risk/benefit evaluation is therefore required before use during pregnancy and {invented name} should not be used during pregnancy unless clearly necessary (see section
Croatian: Prije primjene tijekom trudnoće potrebna je pažljiva procjena omjera rizika i koristi, a {zaštićeni naziv} se ne smije primjenjivati tijekom trudnoće ako to nije prijeko potrebno (pogledajte dio 4.4).
English: There is also an increased risk of hypersensitivity reactions to parenteral iron complexes in patients with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis).
Croatian: Povećan je rizik i od reakcija preosjetljivosti na komplekse parenteralnog željeza kod bolesnika s imunološkim ili upalnim stanjima (npr. sistemski eritemski lupus, reumatoidni artritis).
English: You will be observed for at least 30 minutes by your doctor or nurse after each administration.
Croatian: Nakon svake primjene lijeka, liječnik ili medicinska sestra nadzirat će Vas tijekom najmanje 30 minuta.
English: Your doctor or nurse will administer {invented name} by {route of administration defined in posology section of SmPC}; the {invented name} will be administered in a structure where immunoallergic events can receive appropriate and prompt treatment.
Croatian: Vaš liječnik ili medicinska sestra primijenit će {zaštićeni naziv} {put primjene naveden u dijelu o doziranju sažetka opisa svojstava lijeka}; {zaštićeni naziv} primjenjivat će se u ustanovama gdje se imunoalergijski događaji mogu liječiti na odgovarajući i brz način.
English: The risk is enhanced for patients with known allergies including drug allergies, including patients with a history of severe asthma, eczema or other atopic allergy.
Croatian: Rizik je povećan za bolesnike s poznatim alergijama, uključujući alergije na lijekove te bolesnika s anamnezom teške astme, ekcema i drugih atopijskih alergija.
English: {Invented name} should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured.
Croatian: {Zaštićeni naziv} se smije davati bolesnicima samo u slučaju da na raspolaganju odmah stoji osoblje izučeno za procjenu i djelovanje u slučaju pojave anafilaktičkih reakcija, u okruženju u kojem je dostupna puna oprema za reanimaciju.
English: • Hypersensitivity to the active substance, to {invented name} or any of its excipients listed in section 6.1.
Croatian: • Preosjetljivost na djelatnu tvar, na {zaštićeni naziv} ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: What you need to know before you receive {invented name} [the wording below should be inserted in the relevant section]
Croatian: Što morate znati prije nego što počnete primati {zaštićeni naziv} [Riječi u nastavku treba unijeti u odgovarajući dio]
English: Facilities for cardio respiratory resuscitation and equipment for handling acute anaphylactic/anaphylactoid reactions should be available, including an injectable 1:1000 adrenaline solution.
Croatian: Na raspolaganju uvijek treba stajati oprema za kardiorespiratornu reanimaciju, kao i oprema za liječenje akutnih anafilaktičkih/anafilaktoidnih reakcija, uključujući otopinu adrenalina u omjeru 1:1000 za injiciranje.
English: Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes.
Croatian: Reakcije preosjetljivosti također su zabilježene nakon prethodnih parenteralnih pripravaka kompleksa željeza koje su prošle bez ikakvih problema.
English: You can also report side effects directly via {the national reporting system listed in Appendix V}*.
Croatian: Nuspojave možete prijaviti izravno putem {nacionalnog sustava za prijavu nuspojava navedenog u Dodatku V*}.
English: Healthcare professionals are asked to report any suspected adverse reactions {via the national reporting system listed in Appendix V*}.
Croatian: Od zdravstvenih djelatnika se traži da prijave svaku sumnju na nuspojavu lijeka putem {nacionalnog sustava prijave nuspojava navedenog u Dodatku V*}.
English: The patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection (see section 4.4).
Croatian: Bolesnika treba nadzirati ne bi li se uočile nuspojave najmanje 30 minuta od primanja svake injekcije <lijeka> {zaštićeni naziv} (pogledajte dio 4.4).
English: [the wording below should be inserted in the relevant section]
Croatian: [Riječi u nastavku treba unijeti u odgovarajući dio]
English: Each patient should be observed for adverse effects for at least 30 minutes following each {invented name} injection.
Croatian: Svakog bolesnika treba nadzirati ne bi li se uočile nuspojave najmanje 30 minuta od primanja svake injekcije <lijeka> {zaštićeni naziv}.
English: This summary of product characteristics, labelling and package leaflet is the outcome of the referral procedure.
Croatian: Napomena: Sažetak opisa svojstava lijeka, označavanje i uputa o lijeku ishod su arbitražnog postupka.
English: See section 4.8 for how to report adverse reactions.
Croatian: Za postupak prijavljivanja nuspojava pogledajte dio 4.8.