FrancophonIA/ELRC3.0 huggingface dataset:
English: Of those treated with Vabomere, overall 60% (21 out of 35) of patients were cured, compared with 32% (6 out of 19) of patients receiving best available antibiotic treatment.
Croatian: Od bolesnika liječenih lijekom Vabomere, ukupno 60 % (21 od 35) njih je izliječeno, u usporedbi s 32 % bolesnika (6 od 19) koji su primali najbolje dostupno antibiotsko liječenje.
English: An overview of Vabomere and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Vabomere i zašto je odobren u EU-u
English: This action weakens the bacterial cell walls which can then collapse, ultimately causing the bacteria to die.
Croatian: To djelovanje slabi bakterijske stanične stijenke koje se stoga mogu urušiti, što na kraju dovodi do smrti bakterije.
English: However, the Agency recognised that Vabomere cannot deal with all types of bacteria resistant to meropenem.
Croatian: Međutim, Agencija razumije da Vabomere ne može djelovati na sve vrste bakterija otpornih na meropenem.
English: The Agency decided that Vabomere's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Agencija je zaključila da koristi od lijeka Vabomere nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: • lung infections caught in hospital (hospital-acquired pneumonia), including ventilator-associated pneumonia (pneumonia caught from a ventilator, which is a machine that helps a patient to breathe).
Croatian: • plućnih infekcija nastalih u bolnici (bolnička pneumonija), uključujući pneumoniju uzrokovanu ventilatorom (pneumonija prenesena ventilatorom, odnosno uređajem koji bolesnicima olakšava disanje)
English: It works by interfering with the activity of certain proteins that bacteria need to build their cell walls.
Croatian: Djeluje tako da ometa djelovanje određenih bjelančevina koje su potrebne bakterijama za izgradnju njihovih staničnih stijenki.
English: These enzymes break down beta-lactam antibiotics such as meropenem and stop them from working.
Croatian: Ti enzimi razlažu beta-laktamske antibiotike kao što je meropenem te sprječavaju njihovo djelovanje.
English: The most common side effects with Vabomere (which may affect up to 1 in 10 people) are headache, diarrhoea, inflammation of the vein around the infusion site and nausea (feeling sick).
Croatian: Najčešće nuspojave povezane s lijekom Vabomere (koje se mogu pojaviti u do 1 na 10 osoba) su glavobolja, proljev, upala vena oko mjesta primjene infuzije te mučnina (slabost).
English: Vabomere can only be obtained with a prescription.
Croatian: Vabomere se izdaje samo na liječnički recept.
English: Vaborbactam allows meropenem to work in many such infections by blocking certain beta-lactamases.
Croatian: Vaborbactam omogućuje meropenemu da djeluje u mnogim takvim infekcijama, onemogućujući djelovanje određenih beta-laktamaza.
English: Vaborbactam is a beta-lactamase inhibitor, which means that it blocks the action of bacterial enzymes called beta-lactamases.
Croatian: Vaborbaktam je inhibitor beta-laktamaze, što znači da onemogućuje djelovanje bakterijskih enzima naziva beta-laktamaze.
English: The second study involved patients with complicated urinary tract infection (including kidney infection), complicated intra-abdominal infections, lung infections caught in hospital and bacteraemia.
Croatian: U drugom su ispitivanju sudjelovali bolesnici s kompliciranom infekcijom urinarnog trakta (uključujući infekciju bubrega), kompliciranim intraabdominalnim infekcijama, bolničkim plućnim infekcijama i s bakterijemijom.
English: Vabomere must not be used in patients who are hypersensitive (allergic) to any carbapenem antibiotic or in patients who have had a severe allergic reaction to the broader class of beta-lactam antibiotics (such as penicillins and cephalosporins).
Croatian: Vabomere se nije primjenjivao u bolesnika koji su preosjetljivi (alergični) na bilo koji karbapenem ili u bolesnika koji su imali ozbiljne alergijske reakcije na širi razred beta-laktamskih antibiotika (kao što su penicilini i cefalosporini).
English: The first study, involving patients with complicated urinary tract infection (including kidney infection), compared Vabomere with a combination of piperacillin (another beta-lactam antibiotic) and tazobactam (a beta-lactamase inhibitor).
Croatian: U prvom ispitivanju, u kojem su sudjelovali bolesnici s kompliciranom infekcijom urinarnog trakta (uključujući infekciju bubrega), lijek Vabomere uspoređen je s kombinacijom piperacilina (drugi beta-laktamski antibiotik) i tazobaktama (inhibitor beta-laktamaze).
English: Meropenem belongs to the carbapenem class of antibiotics, which belongs to the wider group of antibiotics known as beta-lactams.
Croatian: Meropenem spada u karbapenemske antibiotike, koji pripadaju u širu skupinu antibiotika poznatih kao betalaktami.
English: Vabomere contains the active substances meropenem and vaborbactam.
Croatian: Vabomere sadrži djelatne tvari meropenem i vaborbaktam.
English: What benefits of Vabomere have been shown in studies?
Croatian: Koje su koristi od lijeka Vabomere utvrđene u ispitivanjima?
English: How is Vabomere used?
Croatian: Kako djeluje Vabomere?
English: • complicated (difficult-to-treat) infections of the urinary tract, including kidneys;
Croatian: • kompliciranih infekcija (koje je teško liječiti) urinarnog trakta, uključujući bubrege
English: No special concerns about side effects have been raised by the addition of vaborbactam to meropenem.
Croatian: Dodavanjem vaborbaktama meropenemu nisu utvrđene nikakve posebne zabrinutosti u pogledu nuspojava.
English: For the full list of side effects of Vabomere, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Vabomere potražite u uputi o lijeku.
English: This will help you remember to take it.
Croatian: To će Vam pomoći da se sjetite uzeti ih.
English: • if you drink alcohol to excess (either every day or from time to time)
Croatian: • ako prekomjerno pijete alkohol (bilo svaki dan ili povremeno)
English: It is important that you follow your doctor's instructions carefully.
Croatian: Iznimno je važno da pažljivo slijedite upute liječnika.
English: A risk to newborns/infants cannot be excluded.
Croatian: Rizik za novorođenče/dojenče ne može se isključiti.
English: • If you forget to take a dose, take it as soon as you remember.
Croatian: • Ako ste zaboravili uzeti dozu, uzmite ju čim se sjetite.
English: • It is best to take your tablet with a meal.
Croatian: • Najbolje je tabletu uzeti uz obrok.
English: Component of a multipack, can not be sold separately.
Croatian: Sastavni dio višestrukog pakiranja, ne može se prodavati pojedinačno.
English: See bone fracture section below for additional information.
Croatian: Vidjeti odjeljak frakture kostiju ispod za dodatne informacije.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Croatian: Mora se izbjegavati konzumiranje alkohola i lijekova koji sadrže alkohol.
English: As an underlying mechanism has not been established, risk factors, apart from general risk factors, for amputation are unknown.
Croatian: Budući da osnovni mehanizam još nije ustanovljen, faktori rizika, osim općih faktora rizika, za amputacije nisu poznati.
English: • if you have a severe infection
Croatian: • ako imate tešku infekciju
English: Multiple dose study: Data are restricted to one study.
Croatian: Ispitivanje ponovljenih doza: Podaci su ograničeni na jedno ispitivanje.
English: However, if it is nearly time for the next dose, skip the missed dose.
Croatian: Međutim, ako je blizu vremena za sljedeću dozu, preskočite propuštenu dozu.
English: ATC code: A10BD16.
Croatian: ATK oznaka: A10BD16.
English: • medicines that contain alcohol.
Croatian: • lijekove koji sadrže alkohol.
English: • The dose of Vokanamet is one tablet twice a day.
Croatian: • Početna doza lijeka Vokanamet je jedna tableta dva puta na dan.
English: Balanitis or balanoposthitis**, h
Croatian: Balanitis ili balanopostitis**, h
English: What Vokanamet is and what it is used for
Croatian: Što je Vokanamet i za što se koristi
English: • Swallow the tablet whole with at least a half glass of water.
Croatian: Uzimanje ovog lijeka • Progutajte tabletu cijelu s najmanje pola čaše vode.
English: See section “Vokanamet with alcohol”.
Croatian: Pogledajte dio “Vokanamet s alkoholom”.
English: The mean Vd ranged between 63- 276 litres.
Croatian: Srednji Vd bio je u rasponu od 63 - 276 litara.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 April 2014
Croatian: Datum prvog odobrenja: 23. travnja 2014.
English: Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete ovaj lijek, te tijekom liječenja:
English: You may already be taking one or more of these to treat your type 2 diabetes.
Croatian: Možda već uzimate jedan ili više od tih lijekova za liječenje šećerne bolesti tipa 2.
English: In both cases, treatment with Vokanamet may be restarted once the patient's condition has stabilised.
Croatian: U oba slučaja, liječenje Vokanametom može se ponovno započeti nakon što se bolesnikovo stanje stabiliziralo.
English: • if you have or have recently had heart failure.
Croatian: • ako imate ili ste nedavno imali zatajenje srca.
English: Do not store above 30°C.
Croatian: Nemojte čuvati na temperaturi iznad 30°C.
English: No metabolites have been identified in humans.
Croatian: U ljudi nisu identificirani metaboliti.
English: This will lower your chance of having an upset stomach.
Croatian: To će umanjiti mogućnost za nadraženost želuca.
English: What you need to know before you take Vokanamet
Croatian: Što morate znati prije nego počnete uzimati Vokanamet
English: For further detail, it may be advisable to contact the specific manufacturer of the 1,5-AG assay.
Croatian: Za detalje, može se preporučiti obraćanje specifičnom proizvođaču 1,5-AG testa.
English: Placebo-controlled studies
Croatian: Placebom-kontrolirana ispitivanja
English: The safety and efficacy of Vokanamet in children under 18 years of age have not been established.
Croatian: Sigurnost i djelotvornost lijeka Vokanamet u djece u dobi ispod 18 godina nisu ustanovljene.
English: • Try to take it at the same times each day.
Croatian: • Nastojte tablete uzeti svaki dan u isto vrijeme.
English: • if you have recently had a heart attack or have severe blood circulation problems, such as ‘shock' or breathing difficulties
Croatian: • ako ste nedavno imali srčani udar ili imate teške probleme s cirkulacijom krvi, poput ‘šoka“ ili poteškoća s disanjem
English: • It is important to check your feet regularly and adhere to any other advice regarding foot care and adequate hydration given by your health care professional.
Croatian: • važno je da redovito provjeravate svoja stopala, te da se držite bilo kojeg drugog savjeta vezanog uz njegu stopala i primjerenu hidrataciju kojeg ste dobili od svog zdravstvenog radnika.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 hours.
Croatian: Nakon oralne doze, prividno poluvrijeme eliminacije je približno 6,5 sati.
English: In controlled clinical trials, Cmax did not exceed 5 μg/mL, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima, Cmax nisu prešle 5 μg/ml, čak i pri maksimalnim dozama.
English: The blood peak is lower than the plasma peak and appears at approximately the same time.
Croatian: Vršna razina u krvi je niža nego vršna razina u plazmi, a pojavljuju se u približno isto vrijeme.
English: Active controlled studies
Croatian: Aktivno-kontrolirana ispitivanja
English: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Croatian: Zabilježeni farmakokinetički i farmakodinamički odgovori bili su u skladu s onim nađenim u odraslih ispitanika.
English: • if you are allergic to canagliflozin, metformin or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na kanagliflozin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: What Vokanamet looks like and contents of the pack
Croatian: Kako Vokanamet izgleda i sadržaj pakiranja
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Croatian: Nakon oralne doze, neapsorbirana frakcija koja se pojavila u fecesu bila je 20-30%.
English: A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital malformations.
Croatian: Ograničeni podaci proizašli iz upotrebe metformina u trudnica ne ukazuju na povećani rizik kongenitalnih malformacija.
English: Experience in New York Heart Association (NYHA) class III is limited, and there is no experience in clinical studies with canagliflozin in NYHA class IV.
Croatian: Iskustvo s klasifikacijom New York Heart Associaton (NYHA) III je ograničeno, a nema iskustva u kliničkim ispitivanjima s kanagliflozinom u klasifikaciji NYHA IV.
English: • The strength of Vokanamet that you will take varies depending on your condition and the amount of canagliflozin and metformin needed to control your blood sugar.
Croatian: • Jačina lijeka Vokanamet koju uzimate varira ovisno o Vašem stanju i količini kanagliflozina i metformina, potrebnoj za kontrolu šećera u Vašoj krvi.
English: • Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Croatian: • Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari (vidjeti dio 6.1);
English: Taste disturbance
Croatian: Poremećaj okusa
English: This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
Croatian: To je bilo praćeno postojanim smanjenjem koncentracije mokraćne kiseline u serumu za približno 20%.
English: Lactic acidosis, Vitamin B12 deficiencya
Croatian: Laktacidoza, deficijencija vitamina B12
English: • if you have severely reduced kidney function
Croatian: • ako imate jako smanjenu funkciju bubrega
English: Tell your doctor as soon as possible if you have any of the following side effects: Hypoglycaemia (very common, may affect more than 1 in 10 people)
Croatian: Što je prije moguće recite svom liječniku ako imate bilo koju od slijedećih nuspojava: Hipoglikemija (vrlo često, može se javiti u više od 1 na 10 osoba)
English: These differences are not considered to be clinically meaningful.
Croatian: Te razlike ne smatraju se klinički značajnim.
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Croatian: U ljudi, neovisno o svom djelovanju na glikemiju, metformin ima povoljne učinke na metabolizam lipida.
English: If any of the above applies to you, talk to your doctor for further instructions.
Croatian: Ako se nešto od navedenog odnosi na Vas, obratite se liječniku za daljnje upute.
English: What Vokanamet contains
Croatian: Što Vokanamet sadrži
English: Vokanamet should not be used to treat this condition.
Croatian: Vokanamet se ne smije uzimati za liječenje ovog stanja.
English: Dosing of canagliflozin should occur at least 1 hour before or 4-6 hours after administration of a bile acid sequestrant to minimise possible interference with their absorption.
Croatian: Doziranje kanagliflozina mora biti barem 1 sat prije ili 4-6 sati nakon primjene sekvestranta žučne kiseline kako bi se na minimum smanjio mogući utjecaj na njihovu apsorpciju.
English: Male and female patients with a history of genital mycotic infections were more likely to develop an infection.
Croatian: Muški i ženski bolesnici s anamnezom genitalnih gljivičnih infekcija su češće razvijali infekciju.
English: These changes are not likely to be clinically relevant.
Croatian: Ove promjene vjerojatno nisu klinički značajne.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Vokanamet before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Vokanamet prije ili u vrijeme injekcije.
English: Other medicines and Vokanamet
Croatian: Drugi lijekovi i Vokanamet
English: The red blood cells most likely represent a secondary compartment of distribution.
Croatian: Eritrociti vrlo vjerojatno predstavljaju drugi odjeljak distribucije.
English: In case of suspected symptoms, the patient should stop taking Vokanamet and seek immediate medical attention.
Croatian: U slučaju sumnje na simptome, bolesnik treba prestati uzimati Vokanamet i odmah potražiti pomoć liječnika.
English: The patient should be informed and more frequent blood glucose monitoring performed, especially at the beginning of treatment with such medicinal products.
Croatian: Bolesnika se o tome mora obavijestiti, te mu češće nadzirati glukozu u krvi, naročito na početku liječenja takvim lijekovima.
English: • Your doctor will prescribe the strength that is right for you.
Croatian: • Liječnik će propisati odgovarajuću jačinu lijeka primjerenog Vama.
English: The racial distribution of patients who received canagliflozin was 72% White, 16% Asian, 4% Black, and 8% other groups.
Croatian: Raspodjela po rasama bolesnika koji su primili kanagliflozin bila je 72% bijelaca, 16% azijata, 4% crnaca i 8% ostalih skupina.
English: Children and adolescents Vokanamet is not recommended for children and adolescents under 18 years.
Croatian: Primjena lijeka Vokanamet se ne preporučuje u djece i adolescenata ispod 18 godina.
English: Metformin is contraindicated.
Croatian: Metformin je kontraindiciran
English: • lower limb amputations (mainly of the toe) especially if you are at high risk of heart disease.
Croatian: • amputacije donjih udova (većinom nožnog prsta) naročito ako imate visoki rizik za bolesti srca.
English: Balanitis or balanoposthitis occurred primarily in uncircumcised male patients.
Croatian: Balanitis ili balanopostitis su se primarno javili u neobrezanih muških bolesnika.
English: • if you have lost a lot of water from your body (dehydration), e.g. due to long-lasting or severe diarrhoea, or if you have vomited several times in a row
Croatian: • ako ste izgubili puno vode iz tijela (dehidracija), npr. radi dugotrajnog ili teškog proljeva ili ako ste povraćali uzastopno nekoliko puta
English: After an oral dose of metformin hydrochloride tablet, Cmax is reached in approximately 2.5 hours (Tmax).
Croatian: Nakon oralne doze tablete metforminklorida, Cmax dostižu se za otprilike 2,5 sata (Tmax).
English: If no adequate strength of Vokanamet is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Vokanamet, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse events in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Croatian: Dodatne analize sigurnosti (uključujući dugotrajne podatke) iz podataka cijelog programa za kanagliflozin (placebo i aktivno kontrolirana ispitivanja) bila su provedena radi procjene prijavljenih štetnih događaja da bi se prepoznale nuspojave (vidjeti tablicu 1) (vidjeti dijelove 4.2 i 4.4).
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
Croatian: • lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib)
English: However, as precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Croatian: Međutim, kao mjere opreza treba uzeti u obzir pažljivo praćenje bolesnika s većim rizikom za amputacije, te savjetovanje bolesnika o važnosti rutinske preventivne njege stopala i održavanja primjerene hidratacije.
English: Patients with GFR 45 mL/min to < 60 mL/min
Croatian: Bolesnici s GFR 45 ml/min do < 60 ml/min
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING LABEL (multipack)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA (višestruko pakiranje)
English: If a dose is missed, it should be taken as soon as the patient remembers unless it is nearly time for the next dose in which case patients should skip the missed dose and take the medicine at the next regularly scheduled time.
Croatian: U slučaju da propusti dozu, bolesnik ju treba uzeti čim se sjeti, osim ako je blizu vrijeme za uzimanje slijedeće doze, tada bolesnik mora preskočiti propuštenu dozu i uzeti lijek kada je vrijeme za slijedeću redovnu dozu.
English: The pack sizes are cartons of 20, 60, and 180 tablets (3 bottles containing 60 tablets each).
Croatian: Veličine pakiranja su kutije sa 20, 60 i 180 tableta (3 boce, svaka sadrži 60 tableta).
English: In addition, in such patients greater decreases in GFR were reported (see sections 4.2 and 4.8).
Croatian: Dodatno, u takvih bolesnika prijavljena su veća smanjenja GFR (vidjeti dijelove 4.2 i 4.8).
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Croatian: Uočeno je da su umjerena povišenja (uglavnom < 400 ml do 500 ml) u dnevnom volumenu mokraće smanjena kroz nekoliko dana doziranja.
English: • If your doctor has prescribed this medicine along with any medicine for lowering cholesterol such as cholestyramine you should take this medicine at least 1 hour before or 4 hours to
Croatian: • Ako Vam je liječnik propisao ovaj lijek zajedno s bilo kojim od lijekova za snižavanje kolesterola, poput kolestiramina, ovaj lijek morate uzeti najmanje 1 sat prije ili 4 sata do 6 sati nakon lijeka za snižavanje kolesterola.
English: If you are already taking both canagliflozin and metformin as single tablets, Vokanamet can replace them in one tablet.
Croatian: Ako već uzimate i kanagliflozin i metformin u pojedinačnim tabletama, Vokanamet ih može zamijeniti kao jedna tableta.
English: It is important to keep following advice about diet and exercise given by your doctor or nurse.
Croatian: Važno je da slijedite preporuke o dijeti ili vježbanju koje Vam je dao liječnik ili medicinska sestra.
English: As the dose is individually titrated based on glycaemic control, this is of limited clinical relevance.
Croatian: Budući da se doza titrira individualno, temeljeno na kontroli glikemije, klinički značaj je ograničen.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Vokanamet.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Vokanamet.
English: • beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Croatian: • beta-2 agonisti (poput salbutamola ili terbutalina) koji se koriste za liječenje astme.
English: The effect of Vokanamet on fertility in humans has not been studied.
Croatian: Djelovanje lijeka Vokanamet na plodnost u ljudi nije ispitano.
English: Hypoglycaemia has not been seen with metformin hydrochloride doses of up to 85 g; although, lactic acidosis has occurred in such circumstances.
Croatian: Hipoglikemija nije zabilježena s metforminkloridom u dozama do 85 g; iako se u takvim uvjetima pojavila laktacidoza.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Vokanamet in all subsets of the paediatric population in type 2 diabetes (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Vokanamet u svim podskupinama pedijatrijske populacije u dijabetesu tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).