FrancophonIA/ELRC3.0 huggingface dataset:
English: Additionally, Amoxil should no longer be used in several other indications (treatment of bronchitis, acute lung disease, urethritis (inflammation of the urethra, the tube that carries urine from the bladder out of the body), gonococcal infections, male genital infections, gonorrhoea (a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae), enteritis (inflammation of the small intestine) with bacteraemia and intra-abdominal infections such as peritonitis, cholecystitis and acute cholangitis, and serious infections caused by Haemophilus influenzae).
Croatian: Nadalje, Amoxil se više ne smije koristiti u nekoliko drugih indikacija (liječenje bronhitisa, akutne plućne bolesti, uretritisa (upale uretre, cijevi koja prenosi urin iz mjehura izvan tijela), gonokokalnih infekcija, muških genitalnih infekcija, gonoreje (spolno prenosive bolesti uzrokovane bakterijom naziva Neisseria gonorrhoeae), enteritisa (upale tankog crijeva) s bakteremijom i intra-abdominalnih infekcija poput peritonitisa, kolecistitisa i akutnog kolangitisa te ozbiljnih infekcija uzrokovanih bakterijom Haemophilus influenzae).
English: It contains the active substance amoxicillin which belongs to the ‘beta-lactam' family (the family that includes penicillins).
Croatian: Sadrži djelatnu tvar amoksicilin koja se ubraja u obitelj „beta laktama” (obitelj koja uključuje peniciline).
English: The CHMP agreed that the oral (to be taken by mouth) formulations of Amoxil (such as capsules, tablets and suspensions) can be used in adults and children for the treatment of the following bacterial infections:
Croatian: CHMP je suglasan da se oralne formulacije lijeka Amoxil (poput kapsula, tableta i suspenzija) mogu koristiti u odraslih osoba i djece za liječenje sljedećih bakterijskih infekcija:
English: The injectable formulations can also be used for the treatment and prevention of endocarditis.
Croatian: Formulacije koje se mogu ubrizgavati mogu se također koristiti za terapiju i prevenciju endokarditisa.
English: The recommended dose of Amoxil varies depending on the infection it is used to treat, the way it is given, and the age and weight of the patient.
Croatian: Preporučena doza lijeka Amoxil varira ovisno o infekciji za čije se liječenje koristi, načinu primjene i dobi te težini bolesnika.
English: This has led to divergences across Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Croatian: To je rezultiralo divergencijom među državama članicama s obzirom na način primjene lijeka, što je vidljivo u razlikama među sažecima opisa svojstava lijeka, etiketama i uputama o lijeku u državama u kojima se lijek stavlja u promet.
English: Amoxil is also available as a solution for injection or infusion (drip) into a vein, and as a solution for injection into a muscle.
Croatian: Amoxil je također dostupan kao otopina za injekciju ili infuziju (drip) u venu, te kao otopina za injekciju u mišić.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there was a need to harmonise the prescribing information for Amoxil in the European Union (EU).
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da postoji potreba za usklađivanjem informacija za propisivanje za lijek Amoxil u Europskoj uniji (EU).
English: Additionally, Amoxil must not be used in patients who have had severe allergic reactions to another type of beta-lactam antibiotic (e.g. a cephalosporin, carbapenem or monobactam).
Croatian: Nadalje, Amoxil se ne smije koristiti u bolesnika koji imaju teške alergijske reakcije na drugi tip beta laktam antibiotika (primjerice cefalosporin, karbapenem ili monobaktam).
English: Having harmonised the indications, the CHMP also harmonised the recommendations on how to use Amoxil.
Croatian: Nakon usklađivanja indikacija, CHMP je također uskladio preporuke o načinu primjene lijeka Amoxil.
English: The CHMP agreed that Amoxil must not be used in patients who are hypersensitive (allergic) to amoxicillin or any other ingredients of Amoxil, and to any of the penicillins.
Croatian: CHMP je suglasan da se Amoxil ne smije koristiti u bolesnika koji su preosjetljivi (alergični) na amoksicilin ili na bilo koji drugi sastojak lijeka Amoxil, kao i na bilo koji penicilin.
English: Oral Amoxil can also be used for the prevention of endocarditis (infection of the inner lining of the heart).
Croatian: Amoxil za oralnu uporabu može se također koristiti kao prevencija endokarditisa (upale unutarnje ovojnice srca).
English: • Bacterial meningitis (infection of the membranes around the brain and spine);
Croatian: • bakterijski meningitis (infekcija membrana oko mozga i kralježnice);
English: • Helicobacter pylori eradication;
Croatian: • eradikacija bakterije Helicobacter pylori;
English: • Acute cystitis;
Croatian: • akutni cistitis;
English: • Asymptomatic bacteriuria (bacteria detected in the urine) in pregnancy;
Croatian: • asimptomatična bakteriurija (prisutnost bakterija u urinu) u trudnoći;
English: • Acute pyelonephritis;
Croatian: • akutni pijelonefritis;
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets should be harmonised across the EU.
Croatian: U svjetlu dostavljenih podataka i znanstvene rasprave unutar Odbora, mišljenje je CHMP-a da se sažetci opisa svojstava lijekova, etikete i upute za lijekove moraju uskladiti na razini EU-a.
English: On 22 July 2013, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Amoxil in the EU.
Croatian: Europska je komisija uputila predmet CHMP-u s ciljem usklađivanja odobrenja za stavljanje u promet lijeka Amoxil u EU-u.
English: • Acute otitis media (infection of the middle ear);
Croatian: • akutna otitis media (upala srednjeg uha);
English: • Acute exacerbations of chronic bronchitis;
Croatian: • akutne egzacerbacije kroničnog bronhitisa;
English: On 25 June 2015, the European Medicines Agency completed a review of Amoxil.
Croatian: Europska agencija za lijekove završila je pregled lijeka Amoxil.
English: • Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections,
Croatian: • ozbiljne infekcije uha, nosa i grla (poput mastoiditisa, peritonzilarnih infekcija, epiglotitisa i sinusitisa kada su popraćeni ozbiljnim sistemskim znakovima i simptomima);
English: • Severe dental abscess with spreading cellulitis;
Croatian: • ozbiljan dentalni apsces s celulitisom;
English: • Dental abscess with spreading cellulitis (inflammation of the deep skin tissue);
Croatian: • dentalni apsces s celulitisom (upala dubokog kožnog tkiva);
English: • Acute streptococcal tonsillitis and pharyngitis (infections of the tonsils and throat);
Croatian: • akutni streptokokalni tinzilitis i faringilitis (upale mandula i grla);
English: • Acute exacerbations (flare-ups) of chronic bronchitis (inflammation of the airways in the lungs);
Croatian: • akutne egzacerbacije (pogoršanje) kroničnog bronhitisa (upale zračnih putova u plućima);
English: • Acute bacterial sinusitis (infection of the sinuses);
Croatian: • akutni bakterijski sinusitis (upala sinusa);
English: Amoxil was identified as needing harmonisation by the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh).
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) utvrdila je potrebu za usklađivanjem lijeka Amoxil.
English: • Acute pyelonephritis (kidney infection);
Croatian: • akutni pijelonefritis (upala bubrega);
English: • Community acquired pneumonia;
Croatian: • izvanbolnička upala pluća;
English: • Community acquired pneumonia (infection of the lungs acquired outside the hospital);
Croatian: • zarazna upala pluća (izvanbolnička upala pluća);
English: • Acute cystitis (infection of the bladder);
Croatian: • akutni cistitis (upala mjehura);
English: EU/2/02/035/007 SevoFlo 100% Inhalation vapour, liquid
Croatian: EU/2/02/035/007 SevoFlo 100% Para inhalata,
English: Dogs and cats.
Croatian: Psi i mačke Primjena udisanjem
English: 1 bottle Not applicable.
Croatian: 1 bočica
English: Inhalation use Bottle (polyethylene naphthalate) with Quik-Fil (II) closure
Croatian: Bočica od polietilen naftalata (PEN) od 250 ml s Quik-Fil zatvaračem250 ml
English: Withdrawal period
Croatian: tekućina
English: Further information on Giapreza can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
Croatian: Više informacija o lijeku Giapreza dostupno je na internetskim stranicama Agencije: https://www.ema.europa.eu/en/medicines/human/EPAR/giapreza
English: Giapreza (angiotensin II)
Croatian: Giapreza (angiotenzin II)
English: The rise in blood pressure is expected to help prevent organ damage and reduce the number of deaths from this condition.
Croatian: Očekuje se da će povišenje krvnog tlaka pomoći u sprječavanju oštećenja organa i smanjiti broj smrtnih slučajeva koji su posljedica tog stanja.
English: After 3 hours, 70% of patients treated with Giapreza in addition to standard treatments had their average arterial blood pressure rise to above 75 mmHg (an acceptable level) or by at least 10 mmHg, compared with 23% of patients treated with placebo (a dummy treatment) and standard treatments.
Croatian: Nakon tri sata kod 70 % bolesnika koji su uz standardnu terapiju primili lijek Giapreza prosječni arterijski krvni tlak porastao je iznad 75 mmHg (prihvatljiva razina) ili se povisio za najmanje 10 mmHg, u usporedbi s 23 % bolesnika liječenih placebom (prividnim liječenjem) i standardnom terapijom.
English: What is Giapreza and what is it used for?
Croatian: Što je Giapreza i za što se koristi?
English: What measures are being taken to ensure the safe and effective use of Giapreza?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Giapreza?
English: The medicine should be prescribed by a physician experienced in the treatment of shock and is for use in a hospital setting.
Croatian: Lijek treba propisati liječnik s iskustvom u liječenju šoka, a primjenjuje se u bolničkim uvjetima.
English: Giapreza (angiotensin II) EMA/370784/2019
Croatian: Giapreza (angiotenzin II) EMA/370784/2019
English: It is given as a continuous infusion (‘drip') into a vein.
Croatian: Daje se kontinuiranom intravenskom infuzijom (ukapavanjem).
English: Giapreza is a medicine used in adults with dangerously low blood pressure (a condition known as shock).
Croatian: Giapreza je lijek koji se primjenjuje u odraslih osoba s opasno niskim krvnim tlakom (stanje poznato kao šok).
English: The company that markets Giapreza will carry out a study to further investigate the effectiveness and safety of Giapreza, including whether the medicine could prevent damage to organs and affect how long patients live.
Croatian: Tvrtka koja stavlja lijek Giapreza u promet provest će ispitivanje kako bi dodatno istražila učinkovitost i sigurnost lijeka Giapreza, uključujući i to može li lijek spriječiti oštećenje organa i djelovati na dužinu životnog vijeka bolesnika.
English: The active substance in Giapreza, angiotensin II, is the same as a hormone that the body produces.
Croatian: Djelatna tvar lijeka Giapreza, angiotenzin II, jednaka je hormonu koje tijelo samo proizvodi.
English: Angiotensin II increases blood pressure by narrowing blood vessels and releasing another hormone (aldosterone) that increases the volume of blood circulating in the body.
Croatian: Angiotenzin II povisuje krvni tlak sužavanjem krvnih žila i oslobađanjem drugog hormona (aldosteron) koji povećava volumen krvi koja kruži u tijelu.
English: The side effects of Giapreza were similar to those of standard treatments and were considered manageable.
Croatian: Nuspojave lijeka Giapreza bile su slične onima standardnih terapija i mogle su se kontrolirati.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Giapreza 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 Giapreza nalaze se također u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The dose depends on the patient's weight and should be adjusted according to the patient's blood pressure.
Croatian: Doza ovisi o tjelesnoj težini bolesnika i trebala bi se prilagoditi njegovu krvnom tlaku.
English: The European Medicines Agency therefore decided that Giapreza's benefits are greater than its risks and that it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da koristi od lijeka Giapreza nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Giapreza are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Giapreza pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The most common side effects with Giapreza (which may affect more than 1 in 10 people) are thromboembolic events (problems due to clots in blood vessels) and short-lived high blood pressure.
Croatian: Najčešće su nuspojave lijeka Giapreza (mogu se javiti u više od 1 na 10 osoba) tromboembolijski događaji (problemi zbog krvnih ugrušaka u krvnim žilama) i kratkotrajni visoki krvni tlak.
English: Other information about Giapreza
Croatian: Ostale informacije o lijeku Giapreza
English: As for all medicines, data on the use of Giapreza are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Giapreza kontinuirano se prate.
English: Why is Giapreza authorised in the EU?
Croatian: Zašto je lijek Giapreza odobren u EU-u?
English: An overview of Giapreza and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Giapreza i zašto je odobren u EU-u
English: A main study involving 344 patients in shock has shown that Giapreza is effective at raising blood pressure when other treatments have not worked.
Croatian: U glavnom ispitivanju koje je obuhvaćalo 344 bolesnika u stanju šoka pokazalo se da je lijek Giapreza učinkovit u povišenju krvnog tlaka kada druge vrste terapija nisu djelovale.
English: What are the risks associated with Giapreza?
Croatian: Koji su rizici povezani s lijekom Giapreza?
English: The main study showed that adding Giapreza to standard treatment was effective in increasing average blood pressure in patients in shock.
Croatian: U glavnom je ispitivanju utvrđeno da je uzimanje lijeka Giapreza uz standardnu terapiju učinkovito u povišenju prosječnog krvnog tlaka kod pacijenata u stanju šoka.
English: For more information about using Giapreza, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Giapreza pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: How does Giapreza work?
Croatian: Kako djeluje Giapreza?
English: For the full list of side effects and restrictions with Giapreza, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja povezanih s lijekom Giapreza potražite u uputi o lijeku.
English: What benefits of Giapreza have been shown in studies?
Croatian: Koje su koristi od lijeka Giapreza utvrđene u ispitivanjima?
English: It is used when other treatments for raising blood pressure have not worked and contains the active substance angiotensin II.
Croatian: Lijek sadrži djelatnu tvar angiotenzin II i primjenjuje se ako druge vrste terapija za povišenje krvnog tlaka nisu djelovale.
English: Children (< 18 years)
Croatian: Djeca (<18 godina)
English: The reason for this time-dependency is not completely understood.
Croatian: Razlog za ovu ovisnost o vremenu nije u potpunosti razumljiv.
English: - if you have or have ever had liver problems.
Croatian: - ako imate ili ste ikada imali tegobe s jetrom.
English: See Table 5 and 6 for results from both studies.
Croatian: Vidjeti tablice 5 i 6 za rezultate iz oba ispitivanja.
English: Taking this medicine - Swallow the tablet whole with some water.
Croatian: Uzimanje ovog lijeka - Progutajte cijelu tabletu s malo vode.
English: 1 Includes other less common species or species unknown
Croatian: 1 Obuhvaća ostale rjeđe vrste ili nepoznate vrste
English: a: FLU/ITZ (1899); FLU (316).
Croatian: FLU/ITZ (1899); FLU (316).
English: Currently available data are described in sections 5.1 and 5.2, but no recommendation on a posology can be made.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 5.1 i 5.2, međutim, nije moguće dati preporuku o doziranju.
English: - Tablets may be taken with or without food.
Croatian: - Tablete se mogu uzeti s hranom ili bez nje.
English: Therefore, follow the specific dosage recommendations for each formulation.
Croatian: Stoga je potrebno pridržavati se preporuka o doziranju za svaku formulaciju.
English: Carcinogenicity studies did not reveal special hazards for humans.
Croatian: Ispitivanja kancerogenosti nisu otkrila poseban rizik za ljude.
English: This is because small amounts may pass into breast milk.
Croatian: To je zato što male količine lijeka mogu prijeći u majčino mlijeko.
English: The length of treatment may depend on the type of infection that you have and may be individually adapted for you by your doctor.
Croatian: Trajanje liječenja može ovisiti o vrsti infekcije koju imate i Vaš Vam ga liječnik može prilagoditi.
English: Each dose may be taken without regard to food intake.
Croatian: Svaka se doza može uzeti bez obzira na uzimanje hrane.
English: psychotic disorder, depression
Croatian: psihotični poremećaj, depresija
English: Please make sure you tell your doctor about all the medicines you are taking (prescribed or non-prescribed).
Croatian: Svakako obavijestite svog liječnika o svim lijekovima koje uzimate (na recept ili bez recepta).
English: This medicine works by killing or stopping the growth of some types of fungi that can cause infections.
Croatian: Ovaj lijek djeluje tako što ubija ili zaustavlja rast nekih vrsta gljivica koje mogu uzrokovati infekcije.
English: The principle mechanism of resistance is the acquisition of substitutions in the target protein, CYP51.
Croatian: Glavni mehanizam rezistencije je stjecanje supstitucija u ciljnom proteinu, CYP51.
English: § See section 4.4.
Croatian: § Vidjeti dio 4.4.
English: Children Posaconazole Accord should not be used in children (17 years of age and younger).
Croatian: Posakonazol Accord se ne smije primjenjivati u djece (u dobi od 17 godina i mlađe).
English: The tablets should be swallowed whole with water and should not be crushed, chewed, or broken.
Croatian: Tablete treba progutati cijele s vodom i ne smiju se drobiti, žvakati niti lomiti.
English: 08039 Barcelona, Spain
Croatian: 08039 Barcelona, Španjolska
English: Recommended dose is shown in Table 1.
Croatian: Preporučene doze prikazane su u Tablici 1. Tablica 1.
English: Dose adjustment of calcium channel blockers may be required.
Croatian: Možda će biti potrebna prilagodba doze blokatora kalcijevih kanala.
English: Do not adapt your dose yourself before consulting your doctor or change your treatment regimen.
Croatian: Nemojte sami sebi prilagođavati dozu ili mijenjati svoj režim liječenja prije savjetovanja s liječnikom.
English: Dose and duration of therapy (See section 5.2)
Croatian: Doza i trajanje terapije (vidjeti dio 5.2)
English: The critical ratio for subjects with Aspergillus infections was ~200.
Croatian: Kritični omjer za ispitanike s infekcijama Aspergillusom bio je ~200.
English: Recommended dose according to indication.
Croatian: Preporučene doze prema indikacijama
English: If this happens, do not drive or use any tools or machines and contact your doctor.
Croatian: Ako se to dogodi, nemojte upravljati vozilima niti raditi sa strojevima i obratite se svom liječniku.
English: These findings are not necessarily indicative of a potential for functional changes in humans.
Croatian: Ovi nalazi ne upućuju nužno na potencijal lijeka za izazivanje funkcionalnih promjena u ljudi.
English: No adverse reactions were noted by the investigator.
Croatian: Ispitivač nije primijetio nikakve nuspojave.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: Prophylaxis in AML and HSCT Study 5615
Croatian: Profilaksa kod AML i HSCT Ispitivanje 5615
English: No data are available for the tablet formulation.
Croatian: Nema dostupnih podataka za formulaciju tablete.
English: Electrocardiogram evaluation
Croatian: Ocjena elektrokardiograma
English: Vincristine toxicity
Croatian: Toksičnost vinkristina
English: Women of childbearing potential have to use effective contraception during treatment.
Croatian: Žene reproduktivne dobi moraju koristiti učinkovitu kontracepciju tijekom liječenja.
English: The pharmacokinetics and safety data from Study 5615 were bridged to the existing data (including efficacy data) with the oral suspension.
Croatian: Podaci o farmakokinetici i sigurnosti dobiveni Ispitivanjem 5615 premošteni su s postojećim podacima (uključujući podatke o djelotvornosti) za oralnu suspenziju.
English: Budapest, 1045, HUNGARY
Croatian: Budimpešta, 1045,
English: Clinical outcomes were compared with those in an external control group derived from a retrospective review of medical records.
Croatian: Klinički ishodi usporedili su se s onima u vanjskoj kontrolnoj skupini oblikovanoj na temelju retrospektivnog pregleda medicinske dokumentacije.
English: Safety data mainly derive from studies with the oral suspension.
Croatian: Podaci o sigurnosti primjene uglavnom potječu iz ispitivanja s oralnom suspenzijom.
English: - Do not crush, chew, break or dissolve the tablet.
Croatian: - Nemojte drobiti, žvakati, lomiti niti otapati tabletu.
English: It is particularly important to try to ensure that maximal plasma levels are achieved in patients infected with Aspergillus (see sections 4.2 and 5.2 on recommended dose regimens).
Croatian: Osobito je važno pokušati osigurati postizanje maksimalnih razina u plazmi bolesnika zaraženih Aspergillus-om (vidjeti dijelove 4.2 i 5.2 o preporučenim režimima doziranja).
English: If you are a woman who could become pregnant you should use effective contraception while you are taking this medicine.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju dok uzimate ovaj lijek.
English: It is used to prevent and treat many different fungal infections.
Croatian: Primjenjuje se za sprječavanje i liječenje velikog broja različitih gljivičnih infekcija.
English: Five of these patients had chromoblastomycosis due to Fonsecaea pedrosoi and 4 had mycetoma, mostly due to Madurella species.
Croatian: Pet od tih bolesnika imalo je kromoblastomikozu prouzročenu uzročnikom Fonsecaea pedrosoi, a četiri su imala micetom, uglavnom prouzročen vrstama roda Madurella.
English: Posaconazole Accord may be taken with or without food (see section 5.2).
Croatian: Posakonazol Accord može se uzeti s hranom ili bez nje (vidjeti dio 5.2).
English: ECOFF values do not equate to clinical breakpoints.
Croatian: ECOFF vrijednosti nisu jednake kliničkim graničnim vrijednostima.