FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substances in Zerbaxa, ceftolozane and tazobactam, work in different ways.
Croatian: Djelatne tvari u lijeku Zerbaxa, ceftolozan i tazobaktam, djeluju na različite načine.
English: As for all medicines, data on the use of Zerbaxa are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Zerbaxa kontinuirano se prate.
English: For more information about using Zerbaxa, see the package leaflet or contact your doctor or pharmacist.
Croatian: Za više informacija o primjeni lijeka Zerbaxa pročitajte uputu o lijeku odnosno obratite se liječniku ili ljekarniku.
English: Both medicines cured 94% of patients (353 out of 375 given Zerbaxa and 375 out of 399 given meropenem).
Croatian: Primjenom obaju lijekova izliječeno je 94 % bolesnika (353 od 375 onih koju su primali lijek Zerbaxa te 375 od 399 onih koji su primali meropenem).
English: The Agency also noted that tazobactam is not active against some classes of beta-lactamase that can cause problems of resistance.
Croatian: Agencija je primijetila i da tazobaktam ne djeluje protiv nekih razreda enzima beta-laktamaze koji mogu prouzročiti problem otpornosti na lijek.
English: By blocking the action of these enzymes, tazobactam allows ceftolozane to act against bacteria that would otherwise be resistant to ceftolozone.
Croatian: Onemogućivanjem djelovanja tih enzima tazobaktam omogućuje ceftolozanu da djeluje protiv bakterija koje bi u suprotnom bile otporne na ceftolozan.
English: An overview of Zerbaxa and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Zerbaxa i zašto je odobren u EU-u
English: Zerbaxa successfully treated the infection in about 85% of the cases where it was given (288 of 340), compared with 75% (266 of 353) of those given another antibiotic called levofloxacin.
Croatian: Lijekom Zerbaxa uspješno je izliječena infekcija u otprilike 85 % bolesnika koji su ga primili (288 od 340), u odnosu na 75 % bolesnika (266 od 353) koji su primili drugi antibiotik naziva levofloksacin.
English: Why is Zerbaxa authorised in the EU?
Croatian: Zašto je lijek Zerbaxa odobren u EU-u?
English: Zerbaxa is available for infusion (drip) into a vein and can only be obtained with a prescription.
Croatian: Lijek Zerbaxa dostupan je za infuziju (ukapavanje) u venu i izdaje se samo na recept.
English: It found Zerbaxa to be at least as effective as meropenem: the infection had resolved in 54% of patients (197 out of 362) after 7 to 14 days of treatment with Zerbaxa compared with 53% of patients (194 out of 362) on meropenem.
Croatian: Utvrđeno je da je lijek Zerbaxa barem jednako učinkovit kao i meropenem; infekcija je izliječena u 54 % bolesnika (197 od 362) nakon 7 do 14 dana liječenja lijekom Zerbaxa, u usporedbi s 53 % bolesnika (194 od 362) koji su primali meropenem.
English: What are the risks associated with Zerbaxa?
Croatian: Koji su rizici povezani s lijekom Zerbaxa?
English: These enzymes enable bacteria to break down beta-lactam antibiotics like ceftolozane, making the bacteria resistant to the antibiotic's action.
Croatian: Ti enzimi omogućuju bakterijama da razgrade beta-laktamske antibiotike kao što je ceftolozan, što bakterije čini otpornima na djelovanje antibiotika.
English: • complicated infections of the urinary tract (structures that carry urine, such as the bladder);
Croatian: • kompliciranih infekcija mokraćnog sustava (organa koji prenose mokraću, kao što je mjehur);
English: Ceftolozane is a type of antibiotic called a cephalosporin, which belongs to the wider group of antibiotics called betalactams.
Croatian: Ceftolozan je vrsta antibiotika naziva cefalosporin koji pripada široj skupini antibiotika naziva beta-laktami.
English: How does Zerbaxa work?
Croatian: Kako djeluje Zerbaxa?
English: What benefits of Zerbaxa have been shown in studies?
Croatian: Koje su koristi od lijeka Zerbaxa utvrđene u ispitivanjima?
English: Zerbaxa has been shown to be at least as effective as other antibiotics in curing infections in three main studies.
Croatian: U trima glavnim ispitivanjima utvrđeno je da je u liječenju infekcija lijek Zerbaxa barem jednako učinkovit kao i ostali antibiotici.
English: Zerbaxa contains the active substances ceftolozane and tazobactam.
Croatian: Zerbaxa sadrži djelatne tvari ceftolozan i tazobaktam.
English: Tazobactam blocks the action of bacterial enzymes called beta-lactamases.
Croatian: Tazobaktam onemogućuje djelovanje bakterijskih enzima beta-laktamaza.
English: For the full list of side effects of Zerbaxa, see the package leaflet.
Croatian: Potpuni popis zabilježenih nuspojava povezanih s lijekom Zerbaxa potražite u uputi o lijeku.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/15/1037/001 Pemetrexed Sandoz 100 mg Powder for concentrate for solution for infusion
Croatian: Unutarnje pakiranje Veličina pakiranja
English: The doctor may have to adjust or
Croatian: Liječnik će možda
English: It will also provide a final analysis from the main study on how long patients who have been treated with the medicine survive.
Croatian: Također će dostaviti završnu analizu provedenu na temelju glavnog ispitivanja o tome koliko su dugo preživjeli bolesnici liječeni lijekom.
English: In addition, panobinostat works in a different way to existing treatments.
Croatian: Nadalje, panobinostat djeluje na način koji se razlikuje od postojećih terapija.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom delay the dose in patients who experience severe side effects.
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom morati prilagoditi ili odgoditi dozu u bolesnika koji imaju ozbiljne nuspojave.
English: Patients are given the medicine for 8 cycles, and further 8 cycles of treatment are recommended in those that benefit.
Croatian: Bolesnici primaju lijek u 8 ciklusa, a daljnjih 8 ciklusa preporuča se za one bolesnike koji su imali koristi od terapije.
English: Although the side effects were of concern and could not be justified in patients who could be given less toxic treatments, the CHMP considered that they were acceptable in this previously treated subgroup in view of the lack of alternatives, and could be managed.
Croatian: Iako su nuspojave pobudile zabrinutost i ne mogu se opravdati u bolesnika koji bi mogli primati manje toksičnu terapiju, CHMP je zaključio da su nuspojave prihvatljive u ovoj prethodno liječenoj podgrupi s obzirom na manjak alternativa, te da se nuspojavama može upravljati.
English: This is a summary of the European public assessment report (EPAR) for Farydak.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) za lijek Farydak.
English: The recommended starting dose of Farydak is 20 mg, taken on days 1, 3, 5, 8, 10 and 12 of the cycle.
Croatian: Preporučena početna doza lijeka doza Farydak je 20 mg jednom na dan 1., 3., 5., 8., 10. i 12. dana svakog ciklusa.
English: This is expected to stop the cancer cells from multiplying and to activate processes that kill the cell, thereby slowing down the growth of the cancer.
Croatian: Smatra se da bi to moglo spriječiti stanice raka od umnožavanja i aktivirati procese koji ubijaju stanice, te stoga usporiti rast stanica raka.
English: Other information about Farydak
Croatian: Ostale informacije o lijeku Farydak
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered the increase in progression free survival to be clinically significant although it noted that a benefit in overall survival had not yet been shown.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je kako je povećanje preživljenja bez progresije bolesti od kliničkog značaja iako je naglašeno da koristi za cjelokupno preživljenje još uvijek nisu dokazane.
English: What is Farydak and what is it used for?
Croatian: Što je Farydak i za što se koristi?
English: This means that for patients who have previously received at least two previous treatments, including bortezomib and immunomodulatory agents, who have limited treatment options and therefore a high unmet medical need, it offers a new alternative.
Croatian: To znači da u slučaju bolesnika koji su prethodno primili najmanje dvije terapije, uključujući bortezomib i imunomodulatore, a koji imaju ograničene opcije terapije i stoga visoku nezadovoljenu medicinsku potrebu, on nudi novu alternativu.
English: Because the number of patients with multiple myeloma is low, the disease is considered ‘rare', and Farydak was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 November 2012.
Croatian: Budući da je broj bolesnika s multiplim mijelomom nizak, dotična se bolest smatra „rijetkom” te se Farydak označava kao lijek za liječenje rijetkih bolesti od 8. studenog 2012.
English: In addition, the company that markets Farydak will provide educational materials for patients, including a patient card, to help them take the medicine correctly.
Croatian: Nadalje, tvrtka koja stavlja lijek Farydak u promet dostavit će edukacijske materijale za bolesnike, uključujući karticu bolesnika, kako bi im pomogla pri ispravnoj primjeni lijeka.
English: The main measure of effectiveness was the average length of time before the patient's disease got worse again (progression-free survival), which was 12 months in patients given Farydak, compared with around 8 months in those given placebo.
Croatian: Glavna mjera djelotvornosti bilo je prosječno vrijeme preživljenja prije nego što se bolest bolesnika ponovno pogoršala (preživljenje bez progresije), koje je iznosilo 12 mjeseci u bolesnika koji su primili Farydak, u usporedbi s otprilike 8 mjeseci u onih koji su primili placebo.
English: What measures are being taken to ensure the safe and effective use of Farydak?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Farydak?
English: The CHMP therefore decided that Farydak's benefits are greater than its risks in this group and recommended that it be approved for use in the EU.
Croatian: Stoga je CHMP zaključio da koristi lijeka Farydak nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: The full EPAR and risk management plan summary for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR kao i sažetak plana upravljanja rizikom za lijek Farydak nalaze se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Farydak can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Croatian: Sažetak mišljenja Odbora za lijekove za rijetke bolesti za lijek Farydak dostupan je na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: It is given to adults whose disease has come back or got worse after at least two previous treatments, including bortezomib and an immunomodulatory medicine (a medicine that acts on the immune system).
Croatian: Primjenjuje se u odraslih osoba čija se bolest ponovno pojavila ili se pogoršala nakon najmanje dvije prethodne terapije, uključujući bortezomib i imunomodulatorni lijek (lijek koji djeluje na imunosni sustav).
English: When results were analysed just for the group of patients who had previously received at least two previous treatments, including bortezomib and an immunomodulatory medicine (thalidomide, lenalidomide or pomalidomide), the average time until the myeloma got worse was 12.5 months with Farydak, versus 4.7 months with placebo.
Croatian: Nakon što su rezultati analizirani samo za grupu bolesnika koja je prethodno primila najmanje dvije prethodne terapije, uključujući bortezomib i imunomodulatorni lijek (talidomid, lenalidomid ili pomalidomid), prosječno vrijeme do pogoršanja mijeloma iznosilo je 12,5 mjeseci s lijekom Farydak, u odnosu na 4,7 mjeseci s placebom.
English: The benefits of Farydak have been shown in one main study involving 768 patients with multiple myeloma that had come back after previous treatments.
Croatian: Koristi lijeka Farydak dokazane su u jednom glavnom ispitivanju koje je obuhvatilo 768 bolesnika s multiplim mijelomom koji se pogoršao nakon prethodnih terapija.
English: Treatment with Farydak must be started by a doctor experienced in the treatment of cancer and the medicine can only be obtained with a prescription.
Croatian: Terapiju lijekom Farydak treba započeti liječnik s iskustvom u terapiji raka, a lijek se izdaje samo na liječnički recept.
English: A risk management plan has been developed to ensure that Farydak is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka Farydak.
English: What are the risks associated with Farydak?
Croatian: Koji su rizici povezani s lijekom Farydak?
English: Farydak is available as capsules (10, 15 and 20 mg) and it is given in 21-day treatment cycles, together with bortezomib and dexamethasone.
Croatian: Farydak je dostupan u kapsulama (10, 15 i 20 mg) i primjenjuje se u 21-dnevnim terapijskim ciklusima, zajedno s bortezomibom i deksametazonom.
English: Farydak must not be used in women who are breast-feeding.
Croatian: Farydak se ne smije koristiti u žena koje su trudne ili koje doje.
English: It blocks the activity of enzymes called histone deacetylases (HDACs), which are involved in switching the activity of genes on and off within cells.
Croatian: Inhibira djelovanje enzima histonske deacetilaze (HDAC) koji sudjeluju u uključivanju i isključivanju aktivnosti gena unutar stanica.
English: Effects on the heart occurred in between 1 and 2 patients in 10 and included tachycardia (increased heart rate), palpitations, and irregular heart rhythms (atrial fibrillation, sinus tachycardia); more rarely patients had changes in electrical conduction in the heart (prolonged QTc interval).
Croatian: Učinci na srce pojavili su se kod 1 do 2 bolesnika na 10, a obuhvaćali su tahikardiju (ubrzani rad srca), palpitacije i nepravilan srčani ritam (atrijsku fibrilaciju, sinusnu tahikardiju); bolesnici su rjeđe imali promjene električnog provođenja u srcu (produljeni QTc interval).
English: It is not intended to provide practical advice on how to use Farydak.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Farydak.
English: The most significant effects that led to patients having to stop treatment (which happened in about 4 patients in 10) were diarrhoea, weakness and tiredness, and pneumonia (lung infection).
Croatian: Najozbiljnije nuspojave koje su rezultirale prekidom terapije (što se dogodilo u otprilike 4 na 10 bolesnika) bile su proljev, slabost i umor, te pneumonija (upala pluća).
English: Why is Farydak approved?
Croatian: Zašto je lijek Farydak odobren?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Farydak, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana, u sažetku opisa svojstava lijeka kao i u uputi o lijeku za lijek Farydak nalaze se sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: Farydak is a cancer medicine used in combination with two other medicines, bortezomib and dexamethasone, to treat multiple myeloma (a cancer of the bone marrow).
Croatian: Farydak je antitumorski lijek koji se koristi u kombinaciji s dva druga lijeka, bortezomibom i deksametazonom, za liječenje multipla mijeloma (raka koštane srži).
English: The medicine was compared with placebo (a dummy treatment) as an addition to treatment with bortezomib and dexamethasone.
Croatian: Lijek je uspoređen s placebom (prividnim liječenjem) kao dodatak terapiji bortezomibom i deksametazonom.
English: In multiple myeloma, panobinostat is expected to keep genes that suppress the division and growth of the cancer cells switched ‘on'.
Croatian: U slučaju multipla mijeloma, očekuje se da panobinostat zadrži uključenima gene koji sprječavaju dijeljenje i rast stanica raka.
English: The most common side effects with Farydak (which may affect more than 1 in 10 people) are diarrhoea, tiredness, nausea (feeling sick) and vomiting, and effects on the blood such as thrombocytopenia (low levels of blood platelets which are important for blood clotting), anaemia and neutropenia and lymphopenia (low levels of certain white blood cells).
Croatian: Najčešće su nuspojave lijeka Farydak (koje su uočene u više od 1 na 10 bolesnika) proljev, umor, mučnina (osjećaj slabosti) i povraćanje, te učinci na krv kao što su trombocitopenija (nizak broj trombocita u krvi koji su bitni za grušanje krvi), anemija, neutropenija i limfopenija (niske razine određenih bijelih krvnih stanica).
English: For more information about treatment with Farydak, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Farydak pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
English: For further information, see the summary of product characteristics (part of the product information).
Croatian: Dodatne informacije pročitajte u sažetku opisa svojstava lijeka (također dio informacija o lijeku).
English: The active substance in Farydak, panobinostat, is a type of medicine called a histone deacetylase (HDAC) inhibitor.
Croatian: Djelatna tvar lijeka Farydak, panobinostat, tip je inhibitora histonske deacetilaze (HDAC).
English: Farydak contains the active substance panobinostat.
Croatian: Farydak sadrži djelatnu tvar panobinostat.
English: How is Farydak used?
Croatian: Kako se Farydak koristi?
English: How does Farydak work?
Croatian: Kako djeluje Farydak?
English: What benefits of Farydak have been shown in studies?
Croatian: Koje su koristi lijeka Farydak utvrđene u ispitivanjima?
English: For the full list of all side effects reported with Farydak, see the package leaflet.
Croatian: Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Farydak potražite u uputi o lijeku.
English: For practical information about using Farydak, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Farydak pročitajte u uputi o lijeku, odnosno obratite se svojem liječniku ili ljekarniku.
English: Spedra should not be taken by children and adolescents under 18 years of age.
Croatian: Lijek Spedra ne smiju uzimati djeca i adolescenti mlađi od 18 godina.
English: Therefore, M4 accounts for approximately 4% of total pharmacologic activity.
Croatian: Stoga je M4 odgovoran za približno 4% ukupne farmakološke aktivnosti.
English: • trouble sleeping (insomnia)
Croatian: • teškoće sa spavanjem (nesanica)
English: Spedra with drink and alcohol
Croatian: Spedra s pićem i alkoholom
English: Consideration should be given to the following:
Croatian: Pozornost valja obratiti na sljedeće:
English: • If you have had a stroke or heart attack in the last 6 months
Croatian: • ako ste imali moždani udar ili srčani udar u zadnjih 6 mjeseci
English: • sudden decrease or loss of vision in one or both eyes.
Croatian: • iznenadno smanjenje ili gubitak vida na jedno ili oba oka.
English: Spedra is not for women.
Croatian: Spedra nije za žene.
English: You may get more side effects than usual and they may be worse.
Croatian: Možete dobiti više nuspojava nego obično i koje se mogu pogoršati.
English: However, data on subjects older than 70 years are limited.
Croatian: Međutim, podaci za ispitanike starije od 70 godina su ograničeni.
English: Spedra does not cure your condition.
Croatian: Spedra neće izliječiti Vaše stanje.
English: Spedra can be taken with or without food; if taken with food, it may take longer to work.
Croatian: Spedra se može uzeti s hranom ili bez nje; ako se uzme s hranom trebat će joj duže da počne djelovati.
English: You should not take Spedra more than once a day.
Croatian: Ne smijete uzeti Spedru češće od jednom na dan.
English: There was no effect on the extent of exposure (AUC).
Croatian: Nije bilo učinka na opseg izloženosti (AUC).
English: ATC code: G04BE10.
Croatian: ATK oznaka: G04BE10
English: Drinking alcohol may also decrease your ability to get an erection.
Croatian: Alkoholna pića mogu također smanjiti Vašu sposobnost postizanja erekcije.
English: Problems with your sight or hearing
Croatian: Teškoće s vidom ili sluhom
English: These exposure changes are not considered clinically significant.
Croatian: Ove promjene izloženosti ne smatraju se klinički značajnima.
English: The maximum recommended dosing frequency is once per day.
Croatian: Najveća preporučena učestalost doziranja je jednom na dan.
English: In cases of overdose, standard supportive measures should be adopted as required.
Croatian: U slučajevima predoziranja treba primijeniti standardne potporne mjere prema potrebi.
English: Populations not studied
Croatian: Populacije koje nisu ispitane
English: • spontaneous erection without sexual stimulation
Croatian: • spontana erekcija bez seksualne stimulacije
English: Other medicines and Spedra
Croatian: Drugi lijekovi i Spedra
English: If this happens, do not drive, cycle, use tools or machines.
Croatian: Ako se to dogodi, ne upravljajte vozilima, ne vozite bicikl, ne rukujte alatima ili strojevima.
English: • If you are taking riociguat.
Croatian: • ako uzimate riocigvat.
English: Avanafil is approximately 99% bound to plasma proteins.
Croatian: Avanafil se približno 99% veže na proteine plazme.
English: • If you are allergic to avanafil or any of the other ingredients of this medicine (listed in section 6)
Croatian: • ako ste alergični na avanafil ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: Avanafil has a terminal half-life of approximately 6-17 hours.
Croatian: Avanafil ima poluvijek od približno 6-17 sati.
English: Limited data are available in elder patients aged 70 years or above.
Croatian: Dostupni su ograničeni podaci u starijih bolesnika u dobi od 70 godina i više.
English: • pink or red urine, blood in the urine
Croatian: • ružičasta ili crvena mokraća, krv u mokraći
English: Therefore, avanafil should be administered to such patients only after careful benefit-risk assessment.
Croatian: Stoga avanafil treba primijeniti u takvih bolesnika samo nakon pažljive procjene koristi i rizika.
English: If you take more Spedra than you should
Croatian: Ako uzmete više lijeka Spedra nego što ste trebali
English: You may feel dizzy (especially when standing), have a headache or feel your heart beating in your chest (palpitations).
Croatian: Možete osjetiti omaglicu (osobito kada stojite), imati glavobolju ili osjetiti da Vam lupa srce u prsima (palpitacije).
English: The M16 metabolite was inactive against PDE5.
Croatian: Metabolit M16 je bio neaktivan protiv PDE5.
English: • sudden decrease or loss of hearing (sometimes you may also feel dizzy or have ringing in your ears).
Croatian: • iznenadno slabljenje sluha ili gubitak sluha (katkad možete također osjetiti omaglicu ili čuti zvonjavu u ušima).
English: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex France
Croatian: Sanofi Winthrop Industrie 1, rue de la Vierge Ambares et Lagrave 33565 Carbon-Blanc-Cedex Francuska
English: Avanafil is rapidly absorbed.
Croatian: Avanafil se brzo apsorbira.
English: • feeling unable to keep still
Croatian: • osjećaj da ne možete biti mirni
English: • abnormal extra sound from the heart
Croatian: • neprirodan dodatni zvuk na srcu
English: What Spedra looks like and contents of the pack
Croatian: Kako Spedra izgleda i sadržaj pakiranja
English: This is when you cannot get, or keep a hard, erect penis suitable for sexual activity.
Croatian: To znači da ne možete postići, ili ne možete održati, odgovarajuću ukrućenost penisa za spolnu aktivnost.
English: • If you have low blood pressure or high blood pressure not controlled by medicines
Croatian: • ako imate snižen krvni tlak ili povišen krvni tlak koji ne kontrolirate lijekovima