FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment usually lasts between 5 and 14 days, depending on the type of infection.
Croatian: Liječenje obično traje između 5 i 14 dana, ovisno o vrsti infekcije.
English: The full EPAR for Zavicefta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Zavicefta nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • infections caused by Gram-negative bacteria (types of bacteria) when other treatments might not work.
Croatian: • infekcija uzrokovanih Gram-negativnim bakterijama (vrste bakterija) kada druge terapije možda ne djeluju.
English: One of the main measures of effectiveness was based on eliminating the disease-causing bacteria.
Croatian: Jedno od glavnih mjerila djelotvornosti temeljilo se na uklanjanju bakterija koje uzrokuju bolest.
English: Zavicefta is an antibiotic used in adults to treat the following infections:
Croatian: Zavicefta je antibiotik koji se koristi u odraslih osoba za liječenje sljedećih infekcija:
English: What is Zavicefta and what is it used for?
Croatian: Što je Zavicefta i za što se koristi?
English: Zavicefta ceftazidime / avibactam
Croatian: Zavicefta ceftazidim/avibaktam
English: It is not intended to provide practical advice on how to use Zavicefta.
Croatian: Svrha sažetka nije davati praktične savjete o načinu korištenja lijeka Zavicefta.
English: This causes weakness in the bacterial cell walls which then become prone to collapse, ultimately leading to the death of the bacteria.
Croatian: To uzrokuje slabost bakterijskih staničnih stijenki koje zatim postaju podložne kolapsu, što naposljetku rezultira smrću bakterija.
English: It works by interfering with the production of certain molecules that bacteria need to build their protective cell walls.
Croatian: Djeluje tako da ometa stvaranje određenih molekula koje su potrebne bakterijama za izgradnju njihovih zaštitnih staničnih stijenki.
English: Other information about Zavicefta
Croatian: Ostale informacije o lijeku Zavicefta
English: This is a summary of the European public assessment report (EPAR) for Zavicefta.
Croatian: Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Zavicefta.
English: What measures are being taken to ensure the safe and effective use of Zavicefta?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zavicefta?
English: A study of Zavicefta in patients with hospital-acquired pneumonia has not yet been completed.
Croatian: Ispitivanje lijeka Zavicefta u bolesnika s bolničkom pneumonijom još nije dovršeno.
English: Why is Zavicefta approved?
Croatian: Zašto je Zavicefta odobren?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Zavicefta's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Zavicefta nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za korištenje u Europskoj uniji.
English: • infections of the lungs that are 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: • infekcija pluća do kojih je došlo u bolnici (bolnička pneumonija), uključujući pneumoniju povezanu s mehaničkom ventilacijom (pneumonija uzrokovana mehaničkom ventilacijom, odnosno uređajem koji bolesnicima olakšava disanje);
English: By blocking the action of these enzymes, avibactam allows ceftazidime to act against bacteria that would otherwise be resistant.
Croatian: Onemogućivanjem djelovanja tih enzima, avibaktam omogućuje ceftazidimu da djeluje protiv bakterija koje bi u suprotnom bile rezistentne.
English: • complicated (difficult to treat) infections of the tissues and organs within the belly (intra-abdominal infections);
Croatian: • kompliciranih infekcija (koje je teško liječiti) tkiva i organa u trbuhu (intraabdominalnih infekcija);
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zavicefta have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza koje zdravstveni djelatnici i bolesnici trebaju poštovati radi sigurne i učinkovite upotrebe lijeka Zavicefta također se nalaze u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: What are the risks associated with Zavicefta?
Croatian: Koji su rizici povezani s lijekom Zavicefta?
English: Due to the design of this study, this evidence of Zavicefta's benefits is not as strong as for the other studies; however these results support Zavicefta's activity when combined with the other studies.
Croatian: Zbog načina na koji je osmišljeno ovo ispitivanje, dokazi u prilog koristi od lijeka Zavicefta nisu toliko snažni kao kod drugih ispitivanja, no ti rezultati idu u prilog pozitivnom djelovanju lijeka Zavicefta kada se kombiniraju s drugim ispitivanjima.
English: The benefits of Zavicefta have been shown in four main studies.
Croatian: Koristi od lijeka Zavicefta utvrđene su u četirima glavnim ispitivanjima.
English: Ceftazidime is an antibiotic called a cephalosporin, which belongs to the wider group ‘beta-lactams'.
Croatian: Ceftazidim je antibiotik koji se naziva cefalosporin i koji pripada široj skupini „beta-laktamaza”.
English: These enzymes enable bacteria to break down beta-lactam antibiotics such as ceftazidime, making them resistant to the antibiotic's action.
Croatian: Ti enzimi omogućuju bakterijama da razgrade beta-laktam antibiotike poput ceftazidima, što ih čini rezistentnima na djelovanje antibiotika.
English: The company that makes Zavicefta is carrying out a study to compare the effectiveness and safety of Zavicefta with meropenem (another antibiotic) for the treatment of hospital-acquired pneumonia.
Croatian: Tvrtka koja proizvodi lijek Zavicefta provodi ispitivanje u kojem se uspoređuje djelotvornost i sigurnost lijeka Zavicefta s meropenemom (drugim antibiotikom) u liječenju bolničke pneumonije.
English: However, the CHMP considered that the data already available supported Zavicefta's activity in hospital-acquired pneumonia and for the treatment of infections due to aerobic Gram-negative organisms in adult patients when other treatments might not work.
Croatian: Međutim, CHMP je zaključio da podaci koji su trenutačno dostupni idu u prilog primjeni lijeka Zavicefta u liječenju bolničke pneumonije i infekcija uzrokovanih aerobnim Gram-negativnim organizmima u odraslih bolesnika kada druge terapije možda ne djeluju.
English: Zavicefta can only be obtained with a prescription, and prescribers should take into account official guidance on the use of antibiotics.
Croatian: Lijek Zavicefta izdaje se samo na recept, a liječnici koji propisuju terapiju trebaju uzeti u obzir službene upute o primjeni antibiotika.
English: The most common side effects with Zavicefta (which affected more than 5 in 100 people) are nausea (feeling sick), diarrhoea and a positive result in a Coombs test (a sign of the development of antibodies that attack red blood cells).
Croatian: Najčešće su nuspojave lijeka Zavicefta (zabilježene u više od 5 na 100 osoba) mučnina (osjećaj slabosti), proljev i pozitivan nalaz Coombsovog testa (pokazatelj razvoja protutijela koja napadaju crvene krvne stanice).
English: In two studies, the effects of the combination of Zavicefta and metronidazole (another antibiotic) were compared with those of the antibiotic meropenem in 1490 patients with complicated intra-abdominal infection.
Croatian: U dva ispitivanja, djelovanje kombinacije lijeka Zavicefta i metronidazola (drugi antibiotik) uspoređeno je s djelovanjem antibiotika meropenema u 1490 bolesnika s kompliciranim intraabdominalnim infekcijama.
English: Zavicefta must not be used in patients who are hypersensitive (allergic) to the active substances in Zavicefta or any of the other ingredients, or in those who are hypersensitive to other cephalosporin antibiotics or have ever had a severe allergic reaction to another beta-lactam antibiotic.
Croatian: Lijek Zavicefta ne smije se primjenjivati u bolesnika koji su preosjetljivi (alergični) na djelatne tvari u lijeku Zavicefta ili neki drugi sastojak lijeka ili u bolesnika koji su preosjetljivi na druge antibiotike koji sadrže cefalosporin ili koji su u prošlosti imali tešku alergijsku reakciju na neki drugi beta-laktam antibiotik.
English: For more information about treatment with Zavicefta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom Zavicefta pročitajte u uputi o lijeku (također dio EPAR-a), ili se obratite svom liječniku ili ljekarniku.
English: A third study looked at 332 patients with complicated intra-abdominal or urinary tract infections caused by Gram-negative bacteria that were resistant to ceftazidime (could not be killed by ceftazidime).
Croatian: U trećem ispitivanju promatralo se 332 bolesnika s kompliciranim intraabdominalnim infekcijama ili infekcijama mokraćnog sustava uzrokovanim Gram-negativnim bakterijama koje su rezistentne na ceftazidim (ceftazidim ih ne ubija).
English: The CHMP considered that the studies on Zavicefta show that is effective at treating complicated intra-abdominal and urinary tract infections.
Croatian: CHMP je zaključio da su ispitivanja pokazala da je lijek Zavicefta djelotvoran u liječenju kompliciranih intraabdominalnih infekcija i infekcija mokraćnog sustava.
English: Both studies showed that Zavicefta in combination with metronidazole was at least as effective as meropenem at curing the infection.
Croatian: U oba je ispitivanja utvrđeno da je lijek Zavicefta u kombinaciji s metronidazolom barem jednako djelotvoran kao meropenem u izliječenju infekcije.
English: Zavicefta alone (for urinary tract infection) or in combination with metronidazole (for intra-abdominal infection) provided similar results to a number of alternative antibiotics in curing the infection: 91% of patients (140 out of 154) were cured after treatment with Zavicefta compared with 91% (135 out of 148) after treatment with the best alternative antibiotic.
Croatian: Primjena lijeka Zavicefta kao monoterapija (za infekciju mokraćnog sustava) ili u kombinaciji s metronidazolom (za intraabdominalne infekcije) dala je slične rezultate u izliječenju infekcije kao i brojni alternativni antibiotici: 91 % bolesnika (140 od 154) bilo je izliječeno nakon liječenja lijekom Zavicefta u usporedbi s 91 % (135 od 148) nakon liječenja najboljim alternativnim antibiotikom.
English: Avibactam blocks the action of bacterial enzymes called beta-lactamases.
Croatian: Avibaktam onemogućuje djelovanje bakterijskih enzima koji se nazivaju beta-laktamaze.
English: In addition, disease-causing bacteria were eliminated in 82% (126 out of 154) of patients after treatment with Zavicefta compared with 63% (94 out of 148) after treatment with the best alternative antibiotic.
Croatian: Osim toga, bakterije koje uzrokuju bolest uklonjene su u 82 % bolesnika (126 od 154) nakon liječenja lijekom Zavicefta u usporedbi s 63 % (94 od 148) nakon liječenja najboljim alternativnim antibiotikom.
English: In a fourth study, 1,020 patients with complicated urinary tract infections (including pyelonephritis) caused by Gram-negative bacteria were treated with Zavicefta or the antibiotic doripenem.
Croatian: U četvrtom je ispitivanju 1 020 bolesnika s kompliciranim infekcijama mokraćnog sustava (uključujući pijelonefritis) uzrokovanim Gram-negativnim bakterijama liječeno lijekom Zavicefta ili antibiotikom doripenemom.
English: Doses may need to be reduced and/or given less often in patients with severely reduced kidney function.
Croatian: Bolesnicima s teškim oštećenjem funkcije bubrega dozu će možda trebati smanjiti i/ili je rjeđe davati.
English: Zavicefta was at least as effective as doripenem: 77% of patients (304 out of 393) treated with Zavicefta showed a response compared with 71% of patients (296 out of 417) treated with doripenem.
Croatian: Lijek Zavicefta pokazao se barem jednako djelotvornim kao doripenem: 77 % bolesnika (304 od 393) pozitivno je odgovorilo na liječenje lijekom Zavicefta u usporedbi sa 71 % bolesnika (296 od 417) liječenih doripenemom.
English: For practical information about using Zavicefta, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka Zavicefta pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: What benefits of Zavicefta have been shown in studies?
Croatian: Koje su koristi lijeka Zavicefta utvrđene u ispitivanjima?
English: Regarding Zavicefta's safety profile, side effects were those that can be expected for ceftazidime and a betalactamase inhibitor.
Croatian: U pogledu sigurnosnog profila lijeka Zavicefta, primijećene nuspojave mogu se očekivati kod ceftazidima i inhibitora beta-laktamaze.
English: Zavicefta is available as a powder to be made up into a solution for infusion (drip) into a vein.
Croatian: Lijek Zavicefta dostupan je u obliku praška od kojeg se priprema otopina za intravensku infuziju (drip).
English: In the second study, 94% of patients (166 out of 177) treated with Zavicefta and metronidazole were cured, compared with 94% (173 out of 184) of patients treated with meropenem.
Croatian: U drugom je ispitivanju bilo izliječeno 94 % bolesnika (166 od 177) liječenih lijekom Zavicefta i metronidazolom u usporedbi s 94 % (173 od 184) bolesnika liječenih meropenemom.
English: In the first study, one of the patient groups studied showed 92% of patients (376 out of 410) treated with Zavicefta and metronidazole were cured, compared with 93% (385 out of 416) of patients treated with meropenem.
Croatian: U prvom ispitivanju, u jednoj od ispitivanih skupina bolesnika 92 % bolesnika (376 od 410) liječenih lijekom Zavicefta i metronidazolom bilo je izliječeno u usporedbi s 93 % (385 od 416) bolesnika liječenih meropenemom.
English: How does Zavicefta work?
Croatian: Kako djeluje Zavicefta?
English: How is Zavicefta used?
Croatian: Kako se Zavicefta koristi?
English: The active substances in Zavicefta are ceftazidime and avibactam.
Croatian: Djelatne tvari u lijeku Zavicefta su ceftazidim i avibaktam.
English: Zavicefta contains the active substances ceftazidime and avibactam.
Croatian: Lijek Zavicefta sadrži djelatne tvari ceftazidim i avibaktam.
English: For the full list of all side effects with Zavicefta, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Zavicefta potražite u uputi o lijeku.
English: • complicated (difficult to treat) infections of the urinary tract (structures that carry urine), including pyelonephritis (kidney infection);
Croatian: • kompliciranih infekcija (koje je teško liječiti) mokraćnog sustava (strukture koje prenose mokraću),
English: Further information on Kineret can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Kineret možete naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What is Kineret and what is it used for?
Croatian: Što je Kineret i za što se koristi?
English: • cryopyrin-associated periodic syndromes (CAPS).
Croatian: • periodičnih sindroma povezanih s kriopirinom (CAPS).
English: The injection site should be varied with each dose to avoid discomfort.
Croatian: Mjesto ubrizgavanja treba za svaku dozu biti drugačije kako bi se izbjegla neugoda.
English: For Still's disease, three small studies have been carried out.
Croatian: Za Stillovu su bolest provedena tri mala ispitivanja.
English: Results showed a significant and rapid improvement in symptoms, with a fall in average symptom score from 4.5 to 0.8 within 3 days of starting treatment.
Croatian: Rezultati su pokazali značajno i brzo ublažavanje simptoma, pri čemu je prosječni rezultat simptoma pao s 4,5 na 0,8 u roku od tri dana od početka liječenja.
English: Other information about Kineret
Croatian: Ostale informacije o lijeku Kineret
English: This overview was last updated in 04-2018.
Croatian: Pregled informacija posljednji je put ažuriran: 4. 2018.
English: Why is Kineret authorised in the EU?
Croatian: Zašto je lijek Kineret odobren u EU-u?
English: By attaching to the receptors that interleukin 1 would normally attach itself to, anakinra blocks the activity of interleukin 1, helping to relieve the symptoms of these diseases.
Croatian: Spajanjem na receptore na koje bi se interleukin 1 obično spojio, anakinra blokira aktivnost interleukina 1 i pomaže u ublažavanju simptoma bolesti.
English: • signs and symptoms of rheumatoid arthritis (an immune system disease causing inflammation of the joints) in adults.
Croatian: • znakova i simptoma reumatoidnog artritisa (bolesti imunosnog sustava koja uzrokuje upalu zglobova) u odraslih.
English: The improvement was maintained over a follow-up period of up to 60 months.
Croatian: Ublažavanje simptoma održano je tijekom razdoblja praćenja u trajanju do 60 mjeseci.
English: The Agency recommended that Kineret be given marketing authorisation.
Croatian: Agencija je preporučila izdavanje odobrenja za stavljanje lijeka Kineret u promet.
English: However, because of the way the study was designed, the results were considered insufficient to support the use of the medicine on its own.
Croatian: No, s obzirom na način na koji je ispitivanje osmišljeno, zaključeno je da rezultati nisu dostatni kao potpora samostalne primjene lijeka.
English: Side effects reported with Kineret are carefully evaluated and any necessary action is taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Kineret pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: The recommended dose of Kineret for rheumatoid arthritis is 100 mg once a day, given at around the same time each day.
Croatian: Preporučena doza lijeka Kineret za reumatoidni artritis je 100 mg jedanput dnevno i daje se svakog dana u približno isto vrijeme.
English: It blocks the receptors for a chemical messenger in the body called interleukin 1.
Croatian: Blokira receptore kemijskog glasnika u organizmu koji se naziva interleukin 1.
English: Results showed that Kineret was more effective than placebo when used as an add-on to methotrexate.
Croatian: Rezultati su pokazali da je lijek Kineret bio djelotvorniji od placeba kad se primjenjivao kao dodatak metotreksatu.
English: In addition levels of amyloid A, a marker of inflammation were also reduced.
Croatian: Uz to su i smanjene razine amiloida A, markera upale.
English: Given the beneficial effect and the fact that there were no new safety concerns, the Agency also considered that the benefits outweighed the risks in patients with CAPS and Still's disease.
Croatian: S obzirom na blagotvorni učinak i činjenicu da nema novih razloga za zabrinutost u pogledu sigurne primjene, Agencija također smatra da koristi nadmašuju rizike u bolesnika s CAPS-om i Stillovom bolesti.
English: CAPS are a group of diseases where patients have a defect in the gene that produces a protein called cryopyrin.
Croatian: CAPS predstavlja skupinu bolesti u kojima bolesnici imaju defekt na genu koji proizvodi protein koji se naziva kriopirin.
English: As for all medicines, data on the use of Kineret are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Kineret kontinuirano se prate.
English: After one month of treatment, more patients on Kineret (6 out of 12 patients) achieved remission compared with treatment with DMARD (3 out of 10 patients).
Croatian: Nakon mjesec dana liječenja više je bolesnika koji su primali lijek Kineret (6 od 12 bolesnika) postiglo remisiju u usporedbi s liječenjem DMARD-om (3 od 10 bolesnika).
English: What measures are being taken to ensure the safe use of Kineret?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna primjena lijeka Kineret?
English: What are the risks associated with Kineret?
Croatian: Koji su rizici povezani s lijekom Kineret?
English: The first study included 468 patients, some of whom had taken other medicines for their disease in the past, and who were given either Kineret on its own or placebo.
Croatian: U prvom ispitivanju, koje je uključivalo 468 bolesnika, od kojih su neki uzimali druge lijekove za svoju bolest u prošlosti, bolesnici su primali ili samo lijek Kineret ili placebo.
English: The active substance in Kineret, anakinra, is a copy of a natural human protein called ‘human interleukin 1 receptor antagonist'.
Croatian: Djelatna tvar lijeka Kineret, anakinra, kopija je prirodnog humanog proteina naziva „antagonist receptora humanog interleukina 1”.
English: Kineret received a marketing authorisation valid throughout the European Union on 8 March 2002.
Croatian: Lijek Kineret dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 8. ožujka
English: In the other two studies, Kineret was used as an add-on to existing treatment including methotrexate: one study, which involved 419 patients, used a range of doses of Kineret that depended on the patient's weight, and the other study, which involved 501 patients, used Kineret at a fixed dose of 100 mg once a day.
Croatian: U drugim dvama ispitivanjima, lijek Kineret primijenjen je kao dodatak postojećem liječenje koje je uključivalo metotreksat: u jednom je ispitivanju, koje je obuhvatilo 419 bolesnika, primijenjeno nekoliko doza lijeka Kineret koje su ovisile o tjelesnoj težini bolesnika, a u drugom je ispitivanju, koje je obuhvatilo 501 bolesnika, lijek Kineret primijenjen u fiksnoj dozi od 100 mg jedanput dnevno.
English: Kineret has been studied in three main studies involving a total of 1,388 patients with rheumatoid arthritis.
Croatian: Lijek Kineret uspoređen je u trima glavnim ispitivanjima u kojima je sudjelovalo ukupno 1388 bolesnika s reumatoidnim artritisom.
English: Severe disabilities such as deafness and loss of vision may also occur;
Croatian: Također mogu nastupiti ozbiljna oštećenja poput gubitka sluha i gubitka vida.
English: For CAPS, Kineret has been studied in one main study involving 43 patients with neonatal-onset multisystem inflammatory disease (NOMID/CINCA syndrome, the most severe form of CAPS).
Croatian: Lijek Kineret je za CAPS ispitan u jednom glavnom ispitivanju koje je uključivalo 43 bolesnika s neonatalnom multisistemskom upalnom bolesti (NOMID/sindrom CINCA, najozbiljniji oblik CAPS-a).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kineret 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 Kineret nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: Results showed that certain doses of Kineret were more effective than placebo in reducing the symptoms of the disease, measured by the doctor and the patient using the ‘American College of Rheumatology' score, which includes measurements of the number of painful or tender joints, disease activity, pain, disability and levels of C reactive protein in the blood (a marker of inflammation).
Croatian: Rezultati su pokazali da su određene doze lijeka Kineret bile djelotvornije od placeba u ublažavanju simptoma bolesti, koje su liječnik i bolesnik mjerili s pomoću ljestvice Američkog udruženja za reumatologiju (American College of Rheumatology) što uključuje mjerenje broja bolnih ili osjetljivih zglobova, aktivnosti bolesti, bola, invaliditeta i razina C reaktivnog proteina u krvi (markera upale).
English: Patients were given Kineret at a starting dose of 1 to 2 mg per kg body-weight daily, increased after a month if necessary.
Croatian: Bolesnicima je lijek Kineret dan u početnoj dozi od 1 mg do 2 mg po kilogramu tjelesne težina dnevno, koja je, prema potrebi, povećana nakon mjesec dana.