FrancophonIA/ELRC3.0 huggingface dataset:
English: To complement the answer, the batch release protocols for two batches were provided revealing consistent germ-count-based target formulation.
Croatian: Kako bi zaključio odgovor, dostavljeni su protokoli za izdavanje serija za dvije serije koji su otkrili konzistentnu ciljnu formulaciju temeljenu na broju bakterija.
English: • This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Croatian: • Ovaj postupak upućivanja pokrenut je zbog zabrinutosti vezane uz cjelokupnu učinkovitost cjepiva.
English: Ceva Sante Animale B.V.
Croatian: Nizozemska Ceva Sante Animale B.V.
English: A sentence is included in section 5 Immunological properties of the Summary of Product Characteristics to reflect the lack of data from field trials.
Croatian: U dio 5. Imunološka svojstva sažetka opisa svojstava VMP-a uvrštena je rečenica kako bi se prikazao manjak podataka iz terenskih ispitivanja.
English: Belgium Ceva Santé Animale S.A/N.V.
Croatian: Ceva Santé Animale S.A/N.V.
English: Scientific conclusions and grounds for the granting of the marketing authorisation for Coglapix suspension for injection for pigs
Croatian: Znanstveni zaključci i razlozi za izdavanje odobrenja za stavljanje u promet VMP-a Coglapix suspenzije za injekciju za svinje
English: Poland Ceva Animal Health Polska Sp. z o.o.
Croatian: Ceva Animal Health Polska Sp. z o.o. ul.
English: The marketing authorisation holder (MAH), Ceva-Phylaxia Veterinary Biologicals Co. Ltd., submitted an application for mutual recognition of the marketing authorisation granted by Hungary in accordance with Article 32 of Directive 2001/82/EC.
Croatian: Ltd., dostavio je prijavu za međusobno priznavanje odobrenja za stavljanje VMP-a u promet koje je izdala Mađarska u skladu sa člankom 32. Direktive 2001/82/EZ.
English: Vaccination of pigs reduces the clinical signs and lung lesions associated with the disease, thus reducing the need for antimicrobial treatment and increasing the range of available prophylactic treatment possibilities against pneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Croatian: Cijepljenjem svinja smanjuju se klinički znakovi i lezije pluća povezane s bolesti, stoga se smanjuje potreba za antimikrobnim terapijama i povećava se raspon dostupnih mogućnosti profilaktičkih terapija protiv pneumonije uzrokovane bakterijom A. pleuropneumoniae serotipova 1 i 2.
English: The MAH conducted 2 studies to evaluate the onset of immunity and 4 studies to evaluate the duration of immunity, using appropriate challenge strains for both A. pleuropneumoniae serotypes (1 and 2) included in the vaccine.
Croatian: Nositelj odobrenja proveo je 2 ispitivanja sa ciljem nastupanja imunosti i 4 ispitivanja kako bi se ocijenilo trajanje imunosti, primjenom odgovarajućih testiranih sojeva za oba serotipa (1 i 2) bakterije A. pleuropneumoniae uključenih u cjepivo.
English: Slovakia Ceva Animal Health Slovakia, s.r.o.
Croatian: Slovačka Ceva Animal Health Slovakia, s.r.o.
English: The MAH presented the results of all the laboratory studies to support the efficacy claims.
Croatian: Nositelj odobrenja dostavio je rezultate laboratorijskih ispitivanja kako bi podržao tvrdnje o djelotvornosti.
English: Amendments in the relevant sections of the Summary of Product Characteristics and package leaflet
Croatian: Izmjene i dopune relevantnih dijelova sažetka opisa značajki proizvoda i naputka u pakiranju
English: The vaccine contains inactivated Actinobacillus pleuropneumoniae bacteria.
Croatian: Ovo cijepivo sadrži inaktiviranu Actinobacillus pleuropneumoniae bakteriju.
English: In particular, the MAH was requested to provide evidence that the reduction of lung lesions and clinical signs would result in reduced weight losses in vaccinated animals as compared to controls.
Croatian: Posebice, od nositelja odobrenja je zatraženo da dostavi dokaze kako bi smanjenje u lezijama pluća i kliničkim znakovima utjecalo na smanjenje gubitka tjelesne težine u cijepljenih životnija u usporedbi s kontrolama.
English: Tiendweg 8 c, 2670 AB Naaldwijk The Netherlands
Croatian: Tiendweg 8 c, 2670
English: The strains belong to the serotype 1 or serotype 2 groups.
Croatian: Sojevi se ubrajaju u grupe serotipa 1 ili serotipa
English: Onset of immunity is 21 days following second vaccination.
Croatian: Imunost nastupa 21 dan nakon drugog cijepljenja.
English: Annex III
Croatian: Prilog III
English: The amended sections of the Summary of Product Characteristics and package leaflet of the reference Member State are set out in Annex III.
Croatian: Izmijenjeni sažetak opisa svojstava VMP-a i uputa o VMP-u države članice sudionice u postupku navedeni su u Prilogu III.
English: However, the MAH confirmed that a re-test was carried out according to the finished product specifications agreed during the MRP and the vaccine batches were found to conform to them.
Croatian: No, nositelj odobrenja potvrdio je da je provedeno ponovno testiranje u skladu sa specifikacijama završnog proizvoda, koje su usuglašene tijekom MRP-a. te da je utvrđeno da serije cjepiva odgovaraju ovim specifikacijama.
English: Overall summary of the scientific evaluation of Coglapix suspension for injection for pigs (see Annex I)
Croatian: Cjelokupan sažetak znanstvene ocjene VMP-a Coglapix suspenzije za injekciju za svinje (pogledajte Prilog I)
English: Therefore the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to clearly reflect this conclusion.
Croatian: Stoga, relevantni dijelovi sažetka opisa svojstava VMP-a i upute o VMP-u treba izmijeniti kako bi jasno prikazivali ove zaključke.
English: Grounds for the granting of the marketing authorisations for Coglapix suspension for injection for pigs
Croatian: Razlozi za izdavanje odobrenja za stavljanje u promet VMP-a Coglapix suspenzija za injekciju svinja
English: This referral was raised due to concerns regarding the overall efficacy of the vaccine.
Croatian: Ovaj postupak upućivanja pokrenut je zbog zabrinutosti vezane uz cjelokupnu učinkovitost cjepiva.
English: Hungary CEVA-Phylaxia Veterinary Biologicals Co. Ltd
Croatian: Mađarska CEVA-Phylaxia Veterinary
English: Coglapix is intended for active immunisation of pigs against pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2.
Croatian: Coglapix je namijenjen za aktivnu imunozaciju svinja protiv pleuropneumonije uzrokovane bakterijom A. pleuropneumoniae serotipovima 1 i 2.
English: Vaccinated pigs develop active immunity against disease caused by serotype 1 or 2 of Actinobacillus pleuropneumoniae.
Croatian: Cijepljene svinje razvijaju aktivan imunitet protiv bolesti prouzročene serotipom 1 ili 2 Actinobacillus pleuropneumoniae.
English: The vaccine contains five, formaldehyde-inactivated strains of Actinobacillus pleuropneumoniae.
Croatian: Cjepivo sadrži pet sojeva s inaktiviranim formaldehidom bakterije Actinobacillus pleuropneumoniae.
English: 1130 Brussel
Croatian: Metrologielaan 6 1130 Brussel Belgija
English: The concern related to the overall efficacy of the vaccine have been assessed and it is concluded that Coglapix is expected to be efficacious in immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Croatian: Iznijeta je zabrinutost povezana s cjelokupnom djelotvornosti cjepiva te je zaključeno da se za Coglapix očekuje da će biti djelotvoran u imunizaciji svinja kao pomoć za kontroliranje pleuropneumonije povezane s A. pleuropneumoniae serotopovima 1 i 2, smanjujući kliničke znakove i lezije pluća povezane s bolesti.
English: Szállás u. 5.
Croatian: Ltd Szállás u.
English: Therefore, the relevant sections of the Summary of Product Characteristics and package leaflet should be amended in order to reflect this (see Annex III).
Croatian: Stoga, relevantni dijelovi sažetka opisa svojstava VMP-a i upute o lijeku treba nadopuniti kao bi se ovo prikazalo (pogledajte Prilog III.).
English: Slovenia Ceva Santé Animale 10, av. de La
Croatian: Slovenija Ceva Santé Animale 10, av. de La
English: Iceland Ceva Santé Animale 10, av. de La
Croatian: Island Ceva Santé Animale 10, av. de La
English: For the active immunisation of pigs as an aid to control pleuropneumonia caused by Actinobacillus pleuropneumoniae serotypes 1 and 2, by reducing the clinical signs and lung lesions associated with the disease.
Croatian: Za aktivnu imunizaciju svinja kao pomoć pri kontroli pleuropneumonia prouzročene od strane Actinobacillus pleuropneumoniae serotipa 1 i 2, smanjivanjem kliničkih znakova i lezija na plućima povezanih s oboljenjem.
English: Libourne
Croatian: Cipar
English: Coglapix is intended for active immunisation of pigs as an aid to control pleuropneumonia caused by A. pleuropneumoniae serotypes 1 and 2, and reduction of clinical signs and lung lesions associated with the disease has been demonstrated in laboratory studies.
Croatian: Coglapix je namijenjen za aktivnu imunizaciju svinja kao pomoć pri kontroli pleuropneumonije povezane s A. pleuropneumoniae serotopovima 1 i 2, smanjujući kliničke znakove i lezije pluća povezane s bolesti.
English: Lithuania Ceva Santé Animale 10, av. de La
Croatian: Estonija Ceva Santé Animale 10, av. de La
English: Finland Ceva Santé Animale 10, av. de La
Croatian: Austrija Ceva Santé Animale 10, av. de La
English: It can also be used as a maintenance treatment in patients who have received platinum-based chemotherapy.
Croatian: Može se također koristiti kao terapija održavanja u bolesnika koji su primili kemoterapiju na bazi platine.
English: The full EPAR for Pemetrexed Hospira UK Limited can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Pemetrexed Hospira UK Limited nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Croatian: Lijek se izdaje samo na recept i smije se davati samo pod nadzorom liječnika s iskustvom u primjeni kemoterapije.
English: This means that Pemetrexed Hospira UK Limited contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Croatian: To znači da Pemetrexed Hospira UK Limited sadržava istu djelatnu tvar i djeluje na isti način kao i „referentni lijek” koji je već odobren u Europskoj uniji (EU) pod nazivom Alimta.
English: Because Pemetrexed Hospira UK Limited is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Croatian: Budući da je Pemetrexed Hospira UK Limited generički lijek, smatra se da su njegove koristi i rizici isti kao i kod referentnog lijeka.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Hospira UK Limited has been shown to be comparable to Alimta.
Croatian: Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji zaključio je da je u skladu sa zahtjevima EU-a potvrđeno kako je lijek Pemetrexed Hospira UK Limited usporediv s lijekom Alimta.
English: Pemetrexed Hospira UK Limited is a cancer medicine used to treat two types of lung cancer:
Croatian: Pemetrexed Hospira UK Limited je lijek protiv raka koji se koristi za liječenje dva tipa raka pluća:
English: There was no need for ‘bioequivalence' studies to investigate whether Pemetrexed Hospira UK Limited is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Croatian: Nije bilo potrebe za ispitivanjima bioekvivalencije da bi se istražilo apsorbira li se Pemetrexed Hospira UK Limited na sličan način kao referentni lijek radi proizvodnje jednake razine djelatne tvari u krvi.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Alimta, and do not need to be repeated for Pemetrexed Hospira UK Limited.
Croatian: Ispitivanja o koristima i rizicima djelatne tvari pri odobrenim primjenama već su provedena za referentni lijek Alimta te ih ne treba ponavljati za lijek Pemetrexed Hospira UK Limited.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Hospira UK Limited 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 Pemetrexed Hospira UK Limited nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: As for every medicine, the company provided studies on the quality of Pemetrexed Hospira UK Limited.
Croatian: Kao i za svaki lijek, tvrtka je dostavila ispitivanja o kvaliteti lijeka Pemetrexed Hospira UK Limited.
English: The Committee recommended that Pemetrexed Hospira UK Limited be approved for use in the EU.
Croatian: Odbor je preporučio odobrenje lijeka Pemetrexed Hospira UK Limited za korištenje u EU-u.
English: When Pemetrexed Hospira UK Limited is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Croatian: Ako se Pemetrexed Hospira UK Limited primjenjuje s cisplatinom, prije ili nakon doze cisplatina bolesniku također treba dati „antiemetik” (za sprječavanje povraćanja) i tekućinu (za sprječavanje dehidracije).
English: For more information about treatment with Pemetrexed Hospira UK Limited, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Pemetrexed Hospira UK Limited pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Pemetrexed Hospira UK Limited is available as a powder that is made up into a solution for infusion (drip) into a vein.
Croatian: Pemetrexed Hospira UK Limited dostupan je kao prašak koji se koristi za pripremu otopine za infuziju (drip) u venu.
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Hospira UK Limited.
Croatian: Ovo je sažetak europskoga javnog izvješća o procjeni (EPAR) lijeka Pemetrexed Hospira UK Limited.
English: For practical information about using Pemetrexed Hospira UK Limited, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pemetrexed Hospira UK Limited bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: This is because Pemetrexed Hospira UK Limited is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.
Croatian: Razlog tome je činjenica da se Pemetrexed Hospira UK Limited daje intravenskom infuzijom i djelatna tvar odmah ulazi u krvotok.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Hospira UK Limited?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pemetrexed Hospira UK Limited?
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Hospira UK Limited.
Croatian: Kako bi se ublažile nuspojave lijeka, bolesnici tijekom terapije lijekom Pemetrexed Hospira UK Limited trebaju uzimati kortikosteroid (tip lijeka koji smanjuje upalu) i folnu kiselinu (tip vitamina) te primati injekcije vitamina B12.
English: The active substance in Pemetrexed Hospira UK Limited is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Croatian: Djelatna tvar lijeka Pemetrexed Hospira UK Limited citotoksičan je lijek (lijek koji uzrokuje smrt stanica koje se dijele, kao što su stanice raka), a ubraja se u grupu „antimetabolita”.
English: Other information about Pemetrexed Hospira UK Limited
Croatian: Ostale informacije o lijeku Pemetrexed Hospira UK Limited
English: It is not intended to provide practical advice on how to use Pemetrexed Hospira UK Limited.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pemetrexed Hospira UK Limited.
English: What is Pemetrexed Hospira UK Limited and what is it used for?
Croatian: Što je Pemetrexed Hospira UK Limited i za što se koristi?
English: What are the benefits and risks of Pemetrexed Hospira UK Limited?
Croatian: Koje su koristi i rizici lijeka Pemetrexed Hospira UK Limited?
English: Pemetrexed Hospira UK Limited pemetrexed
Croatian: Pemetrexed Hospira UK Limited pemetreksed
English: Why is Pemetrexed Hospira UK Limited approved?
Croatian: Zašto je lijek Pemetrexed Hospira UK Limited odobren?
English: Pemetrexed Hospira UK Limited contains the active substance pemetrexed.
Croatian: Pemetrexed Hospira UK Limited sadrži djelatnu tvar pemetreksed.
English: Therefore, the CHMP's view was that, as for Alimta, the benefit outweighs the identified risk.
Croatian: Stoga je stav CHMP-a kako koristi nadmašuju utvrđene rizike, kao i kod lijeka Alimta.
English: How is Pemetrexed Hospira UK Limited used?
Croatian: Kako se lijek Pemetrexed Hospira UK Limited koristi?
English: How has Pemetrexed Hospira UK Limited been studied?
Croatian: Kako je Pemetrexed Hospira UK Limited ispitan?
English: How does Pemetrexed Hospira UK Limited work?
Croatian: Kako djeluje lijek Pemetrexed Hospira UK Limited?
English: Pharmaceutical Form Route of Administration Packaging
Croatian: Put primjene Unutarnje pakovanje
English: It is given over 1 hour, every 8 hours.
Croatian: Daje se svakih osam sati, a primjena traje jedan sat.
English: Further information on Zerbaxa can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zerbaxa.
Croatian: Više informacija o lijeku Zerbaxa dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/zerbaxa.
English: The dose and duration of treatment depends on the infection being treated and how the infection responds to the medicine.
Croatian: Doza i trajanje liječenja ovise o infekciji koja se liječi i odgovoru na lijek.
English: Regarding safety, side effects were considered to be typical and expected for an antibiotic of this kind.
Croatian: S obzirom na sigurnost, nuspojave se smatraju tipičnima i očekivanima za antibiotik te vrste.
English: The second study involved 993 patients with complicated intra-abdominal infections.
Croatian: U drugom ispitivanju sudjelovalo je 993 bolesnika s kompliciranim intraabdominalnim infekcijama.
English: Zerbaxa (ceftolozane / tazobactam)
Croatian: Zerbaxa (ceftolozan/tazobaktam)
English: Zerbaxa received a marketing authorisation valid throughout the EU on 18 September 2015.
Croatian: Lijek Zerbaxa dobio je odobrenje za stavljanje u promet koje je na snazi u EU-u od 18. rujna 2015.
English: The most common side effects with Zerbaxa (which may affect up to 1 in 10 people) are nausea (feeling sick), headache, constipation, diarrhoea and fever.
Croatian: Najčešće nuspojave lijeka Zerbaxa (koje se mogu javiti u najviše 1 na 10 osoba) jesu mučnina, glavobolja, zatvor, proljev i groznica.
English: What is Zerbaxa and what is it used for?
Croatian: Što je Zerbaxa i za što se koristi?
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 uzrokuje smrt bakterija.
English: What measures are being taken to ensure the safe and effective use of Zerbaxa?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Zerbaxa?
English: Side effects reported with Zerbaxa are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Zerbaxa pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: • serious kidney infection (acute pyelonephritis);
Croatian: • ozbiljnih bubrežnih infekcija (akutnog pijelonefritisa);
English: Other information about Zerbaxa
Croatian: Ostale informacije o lijeku Zerbaxa
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zerbaxa 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 Zerbaxa nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: Zerbaxa is an antibiotic used to treat adults with:
Croatian: Zerbaxa je antibiotik koji se koristi za liječenje odraslih osoba oboljelih od:
English: • hospital-acquired pneumonia (an infection of the lungs that is caught in the hospital), including ventilator-associated pneumonia (pneumonia in patients using a ventilator, a machine that helps a patient to breathe).
Croatian: • bolničke upale pluća (infekcije pluća dobivene u bolnici), uključujući upalu pluća povezanu s mehaničkom ventilacijom (upala pluća u bolesnika koji se koriste ventilatorom, uređajem koji bolesnicima olakšava disanje).
English: Zerbaxa must not be used in people who are hypersensitive (allergic) to Zerbaxa or any of its 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: Zerbaxa se ne smije koristiti u osoba koje su preosjetljive (alergične) na lijek ili bilo koji njegov sastojak, kao ni u onih koje su preosjetljive na ostale cefalosporinske antibiotike ili su čak imale snažnu alergijsku reakciju na neki drugi beta-laktamski antibiotik.
English: • complicated (difficult to treat) infections of tissues and organs within the belly (intra-abdominal infections);
Croatian: • kompliciranih (teško izlječivih) infekcija trbušnih tkiva i organa (intraabdominalnih infekcija);
English: The third study involved 726 patients who were using a ventilator and who had either hospitalacquired pneumonia or ventilator-associated pneumonia.
Croatian: Trećim ispitivanjem bilo je obuhvaćeno 726 bolesnika koji su se koristili ventilatorom i koji su bolovali od bolničke upale pluća ili upale pluća povezane s mehaničkom ventilacijom.
English: One study involved 1,083 patients who mostly had kidney infection or in some cases a complicated urinary-tract infection.
Croatian: Jednim je ispitivanjem bilo obuhvaćeno 1 083 bolesnika od kojih je većina imala infekciju bubrega ili, u nekim slučajevima, kompliciranu infekciju mokraćnog sustava.
English: The Agency considered that Zerbaxa was effective at curing infections in the patients studied, but acknowledged that only a limited number of patients with complicated urinary tract infections had been included.
Croatian: Agencija je smatrala da su lijekom Zerbaxa učinkovito izliječene infekcije u bolesnika obuhvaćenih ispitivanjima, ali je priznala da je u ispitivanjima sudjelovao tek mali broj bolesnika s kompliciranim infekcijama mokraćnog sustava.
English: It works by interfering with the production of molecules that bacteria need to build their protective cell walls.
Croatian: Djeluje tako da ometa stvaranje molekula koje su potrebne bakterijama za izgradnju zaštitnih staničnih stijenki.
English: The European Medicines Agency decided that Zerbaxa's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Zerbaxa nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Zerbaxa was compared with another antibiotic, meropenem.
Croatian: Lijek Zerbaxa uspoređen je s drugim antibiotikom, meropenemom.