FrancophonIA/ELRC3.0 huggingface dataset:
English: In a second US field study looking at effects on epilepsy and involving 151 dogs, Pexion treatment for 12 weeks at a fixed dose of 30 mg/kg bodyweight twice daily resulted in 21% of dogs (21 out of 99) being free of generalised seizures compared to 8% of dogs (4 out of 52) given a dummy treatment.
Croatian: U drugom terenskom ispitivanju učinaka na epilepsiju provedenom u SAD-u na 151 psu, rezultat liječenja fiksnom dozom VMP-a Pexion od 30 mg/kg tjelesne težine dvaput dnevno tijekom 12 tjedana bio je 21 % (21 od 99) pasa bez generaliziranih napadaja, u usporedbi s 8 % (4 od 52) pasa koji su primili placebo.
English: For epilepsy, treatment with Pexion should be started at a dose of 10 mg per kg bodyweight twice a day.
Croatian: Liječenje epilepsije VMP-om Pexion treba započeti dozom od 10 mg po kilogramu tjelesne težine dvaput dnevno.
English: In an EU field study looking at effects on noise phobia, the effectiveness of 3 days' treatment with Pexion, at a dose of 30 mg/kg bodyweight twice daily, was investigated during New Year's Eve fireworks in dogs diagnosed with noise phobia.
Croatian: U terenskom ispitivanju učinaka na akustofobiju provedenom u EU-u, ispitivana je učinkovitost trodnevnog liječenja VMP-om Pexion u dozi od 30 mg/kg tjelesne težine dvaput dnevno tijekom novogodišnjeg vatrometa u pasa s dijagnosticiranom akustofobijom.
English: For the full list of side effects and restrictions of Pexion, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja VMP-a Pexion potražite u uputi o VMP-u.
English: What benefits of Pexion have been shown in studies?
Croatian: Koje su koristi VMP-a Pexion utvrđene u ispitivanjima?
English: For noise phobia, the most common side effects with Pexion (which may affect more than 1 in 10 dogs) are short-lived ataxia, increased appetite, and lethargy (lack of energy).
Croatian: Najčešće nuspojave (mogu se javiti u više od 1 na 10 pasa) pri liječenju akustofobije VMP-om Pexion su kratkoročna ataksija, povećanje apetita i letargija (manjak energije).
English: For noise phobia, treatment with Pexion is given at a dose of 30 mg per kg bodyweight twice a day, starting 2 days before an expected noise event and continuing through it.
Croatian: Liječenje akustofobije VMP-om Pexion primjenjuje se u dozi od 30 mg po kilogramu tjelesne težine dvaput dnevno, dva dana prije očekivanog bučnog događaja te tijekom događaja.
English: How is Pexion used?
Croatian: Kako se Pexion primjenjuje?
English: Pexion contains the active substance imepitoin.
Croatian: VMP Pexion sadržava djelatnu tvar imepitoin.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 January 2017
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27. siječnja 2017.
English: What consequences does this withdrawal have for patients in clinical trials?
Croatian: Koje posljedice ima ovo povlačenje za pacijente u kliničkim ispitivanjima?
English: What was the recommendation of the CHMP at that time?
Croatian: Kakva je bila preporuka CHMP-a u tom trenutku?
English: This means that it was intended to be highly similar to a biological medicine (the ‘reference medicine') already authorised in the European Union.
Croatian: To znači da je bilo planirano da bude vrlo sličan biološkom lijeku („referentnom lijeku”) koji je već odobren u Europskoj uniji (EU).
English: An inspection of the site will therefore be needed before the medicine can be approved.
Croatian: Stoga je potrebno provesti inspekciju lokacije kako bi se lijek mogao odobriti.
English: The other concern was the lack of a certificate of Good Manufacturing Practice (GMP) for the medicine's manufacturing site.
Croatian: Drugi razlog za zabrinutost bio je nepostojanje certifikata dobre proizvođačke prakse (GMP) za lokaciju na kojoj se proizvodi lijek.
English: granulocyte-colony-stimulating factor (G-CSF).
Croatian: faktor stimulacije kolonije granulocita (G-CSF).
English: Filgrastim is very similar to a human protein called
Croatian: Filgrastim je vrlo sličan ljudskom proteinu pod nazivom
English: Because filgrastim is pegylated, its removal from the body is slowed down, allowing the medicine to be given less often.
Croatian: Budući da je filgrastim pegiliran, njegovo uklanjanje iz tijela je usporeno, što omogućava rjeđe davanje lijeka.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Croatian: Više informacija o biosličnim lijekovima potražite u dokumentu s pitanjima i odgovorima ovdje.
English: On 18 January 2017, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zioxtenzo, intended for treating neutropenia in patients taking cancer treatments.
Croatian: Dana 18. siječnja 2017. tvrtka Sandoz GmbH službeno je obavijestila Odbor za lijekove za humanu uporabu (CHMP) kako želi povući svoj zahtjev za odobrenje za stavljanje u promet lijeka Zioxtenzo za liječenje neutropenije u bolesnika koji se liječe od raka.
English: EMEA/H/C/004211
Croatian: EMA/47326/2017 EMEA/H/C/004211
English: In addition, two studies in patients receiving cancer medicines compared the safety and effectiveness of Zioxtenzo and Neulasta.
Croatian: Osim toga, u dvama ispitivanjima na bolesnicima koji su dobivali lijekove za liječenje raka uspoređena je sigurnost i učinkovitost lijekova Zioxtenzo i Neulasta.
English: Zioxtenzo was developed as a ‘biosimilar' medicine.
Croatian: Zioxtenzo je razvijen kao „biosličan” lijek.
English: One concern was that study results were not able to show that the concentrations of pegfilgrastim in blood were the same after taking Zioxtenzo and Neulasta.
Croatian: Jedan od razloga za zabrinutost bio je da rezultati ispitivanja nisu pokazali da su koncentracije pegfilgrastima u krvi iste nakon uzimanja lijeka Zioxtenzo i lijeka Neulasta.
English: What is Zioxtenzo?
Croatian: Što je Zioxtenzo?
English: The company presented results of studies designed to show that Zioxtenzo is highly similar to its reference medicine Neulasta in terms of chemical structure, purity, the way it works and how the body handles the medicine.
Croatian: Tvrtka je predstavila rezultate ispitivanja koja su provedena kako bi se dokazalo da je lijek Zioxtenzo vrlo sličan svojem referentnom lijeku Neulasta u smislu kemijske strukture, čistoće, načina djelovanja i načina na koji tijelo podnosi lijek.
English: Neutropenia is a side effect of certain cytotoxic (cell-killing) cancer treatments and can lead to development of serious infections.
Croatian: Neutropenija je nuspojava određenih citotoksičnih (ubijanje stanica) načina liječenja raka i može uzrokovati nastanak ozbiljnih infekcija.
English: Zioxtenzo was to be used in cancer patients to treat neutropenia (low levels of neutrophils, a type of white blood cell that helps fight infection).
Croatian: Zioxtenzo se trebao primjenjivati u bolesnika oboljelih od raka za liječenje neutropenije (niske razine neutrofila, vrste bijelih krvnih stanica koje pomažu u borbi protiv infekcija).
English: Zioxtenzo was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Croatian: Zioxtenzo se trebao primjenjivati za smanjenje trajanja neutropenije i pojave febrilne neutropenije (neutropenija praćena vrućicom).
English: The active substance in Zioxtenzo, pegfilgrastim, consists of filgrastim that has been 'pegylated' (attached to a chemical called polyethylene glycol).
Croatian: Djelatna tvar lijeka Zioxtenzo, pegfilgrastim, sastoji se od filgrastima koji je „pegiliran” (spojen s kemijskom tvari pod nazivom polietilen glikol).
English: What did the company present to support its application?
Croatian: Što je tvrtka dostavila u prilog svom zahtjevu?
English: In its letter notifying the Agency of the withdrawal of the application, the company stated that it would not be able to provide the additional data required by the CHMP within the timeframe allowed for the procedure.
Croatian: U svom dopisu kojim obavještava Agenciju o povlačenju zahtjeva tvrtka je navela da unutar predviđenog vremenskog roka ne može dostaviti dodatne podatke koje CHMP traži.
English: It was to be available as a solution for injection under the skin.
Croatian: Lijek je trebao biti dostupan u obliku otopine za potkožnu injekciju.
English: What was Zioxtenzo expected to be used for?
Croatian: Za što se Zioxtenzo trebao koristiti?
English: Based on the review of the data, at the time of the withdrawal, the CHMP had two main concerns and was of the provisional opinion that Zioxtenzo could not have been approved as a biosimilar of Neulasta.
Croatian: Na temelju pregledanih podataka, u trenutku povlačenja CHMP je smatrao da postoje dva glavna razloga za zabrinutost te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Zioxtenzo kao biosličan lijek lijeku Neulasta.
English: The reference medicine for Zioxtenzo is Neulasta.
Croatian: Referentni lijek za lijek Zioxtenzo je Neulasta.
English: Zioxtenzo is a medicine that contains the active substance pegfilgrastim.
Croatian: Zioxtenzo je lijek koji sadrži djelatnu tvar pegfilgrastim.
English: At the time of the withdrawal, the company had not demonstrated that Zioxtenzo is highly similar to Neulasta and an inspection to confirm that it was being manufactured according to GMP standards had not yet taken place.
Croatian: U trenutku povlačenja, tvrtka nije dokazala da je lijek Zioxtenzo vrlo sličan lijeku Neulasta, niti je provedena inspekcija kojom bi se potvrdilo da se lijek proizvodi u skladu sa standardima GMP-a.
English: The company informed the CHMP that there is no impact of the withdrawal of Zioxtenzo on ongoing clinical trials and there are no compassionate use programmes for Zioxtenzo.
Croatian: Tvrtka je obavijestila CHMP da povlačenje lijeka Zioxtenzo ne utječe na klinička ispitivanja koja su u tijeku te da nema programa milosrdnog davanja lijeka Zioxtenzo.
English: It encourages the bone marrow to produce more neutrophils and improves the patient's ability to fight off infections.
Croatian: On potiče koštanu srž na stvaranje više neutrofila te poboljšava sposobnost bolesnika da se zaštiti od infekcija.
English: How does Zioxtenzo work?
Croatian: Kako djeluje Zioxtenzo?
English: 30 June 2024
Croatian: 30. lipnja 2024.
English: These types of symptoms occur in greater than 1 out of every 10 patients.
Croatian: Ti se simptomi pojave u više od 1 na svakih 10 bolesnika.
English: It has not been tested in other types of shock.
Croatian: Nije ispitan pri drugim vrstama šoka.
English: If this occurs, hospital staff will monitor your vital signs and you will be provided with supportive care.
Croatian: Ako se to dogodi, bolničko osoblje pratit će Vaše vitalne znakove i pružiti potpornu skrb.
English: Final concentration (ng/mL)
Croatian: Konačna koncentracija (ng/ml)
English: The dose depends on your body weight.
Croatian: Doza ovisi o Vašoj tjelesnoj težini.
English: You will only be given this medicine if the possible benefit is greater than the possible risks.
Croatian: Ovaj lijek primit ćete samo ako je moguća korist veća od mogućih rizika.
English: Osmolarity: 130 to 170 mOsm/kg
Croatian: Osmolalnost: od 130 do 170 mOsm/kg
English: Use of this medicine during pregnancy should be avoided if possible.
Croatian: Ako je moguće, upotrebu ovog lijeka tijekom trudnoće treba izbjegavati.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Croatian: JEDINSTVENI IDENTIFIKATOR - PODATCI ČITLJIVI LJUDSKIM OKOM PC: {broj}
English: There are no data available on the potential effects on fertility in humans.
Croatian: Nema dostupnih podataka o mogućim učincima na plodnost u ljudi.
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Median age was 64 years (range: 22-89 years).
Croatian: Medijan dobi bio je 64 godine (raspon: 22-89 godina).
English: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co. Meath Ireland
Croatian: Millmount Healthcare Limited Block 7, City North Business Campus Stamullen, Co.
English: Submission of study results:
Croatian: Podnošenje rezultata ispitivanja:
English: A risk to the suckling child cannot be excluded.
Croatian: Ne može se isključiti rizik za dojenče.
English: While not all of these symptoms lead to life-threatening complications, your doctor should be told about them immediately.
Croatian: Iako svi ovi simptomi ne dovode do komplikacija koje ugrožavaju život, o njima treba odmah obavijestiti liječnika.
English: Primary efficacy endpoints: MAP response at hour 3 (mITT population and subgroups)
Croatian: Tablica 3: Mjere primarnih ishoda djelotvornosti: MAP odgovor u 3. satu (mITT populacija i podskupine)
English: The effect on MAP was sustained for at least the first three hours of treatment.
Croatian: Učinak na MAP održan je barem prva tri sata liječenja.
English: 38/58 patients mITT=modified intent-to-treat population
Croatian: 38/58 bolesnika mITT = modificirana populacija planirana za liječenje
English: The effect on blood pressure is sustained for at least the first three hours of continuous intravenous infusion.
Croatian: Učinak na krvni tlak održi se najmanje prva tri sata kontinuirane intravenske infuzije.
English: Very common side effects (may affect more than 1 in 10 people) are: - Too high blood pressure
Croatian: Vrlo česte nuspojave (mogu se pojaviti u više od 1 na 10 osoba): - previše visok krvni tlak
English: Animal studies are insufficient with respect to reproductive toxicity.
Croatian: Ispitivanja na životinjama u pogledu reproduktivne toksičnosti nedostatna su.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba odmah upotrijebiti.
English: 91% of subjects had septic shock; the remaining subjects had other forms of distributive shock such as neurogenic shock.
Croatian: Septički šok imalo je 91 % ispitanika; preostali ispitanici imali su druge oblike distributivnog šoka, kao što je neurogeni šok.
English: GIAPREZA is titrated to effect for each individual patient.
Croatian: GIAPREZA se titrira do učinka za svakog pojedinog bolesnika.
English: No treatment related adverse effects were observed.
Croatian: Nisu zabilježeni štetni učinci povezani s liječenjem.
English: The median duration of treatment in clinical trials was 48 hours (range: 3.5 to 168 hours).
Croatian: Medijan trajanja liječenja u kliničkim ispitivanjima bio je 48 sati (raspon: od 3,5 do 168 sati).
English: However, if you have side effects or think you have been given too much GIAPREZA, tell your doctor or nurse straight away.
Croatian: Međutim, ako imate nuspojave ili mislite da ste dobili previše lijeka GIAPREZA, odmah to javite svom liječniku ili medicinskoj sestri.
English: Overdose may result in severe hypertension.
Croatian: Predoziranje može rezultirati teškom hipertenzijom.
English: 114/163 patients
Croatian: 114/163 bolesnika
English: In the ATHOS-3 trial, the median time to increase blood pressure was approximately 5 minutes.
Croatian: U ispitivanju ATHOS-3 medijan vremena do povišenja krvnog tlaka bio je približno 5 minuta.
English: The effect of GIAPREZA on morbidity and mortality has not been determined in appropriate studies.
Croatian: Učinak lijeka GIAPREZA na morbiditet i smrtnost nije utvrđen u odgovarajućim ispitivanjima.
English: Your doctor should be told if you are using, have recently used, or might use any other medicines.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
English: One patient in each arm discontinued treatment as a result.
Croatian: Kao rezultat toga, u svakoj je skupini jedan bolesnik prekinuo liječenje.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8 °C or 25 °C.
Croatian: Ako se lijek ne upotrijebi odmah, vrijeme i uvjeti čuvanja prije uporabe odgovornost su korisnika i ne bi trebali biti dulji od 24 sata pri 2 - 8 °C ili 25 °C.
English: GIAPREZA should not be used in children or adolescents under 18 years of age as it has not been studied in these age groups.
Croatian: Lijek GIAPREZA ne smije se primjenjivati u djece ili adolescenata mlađih od 18 godina jer nije ispitan u tim dobnim skupinama.
English: What GIAPREZA is and what it is used for
Croatian: Što je GIAPREZA i za što se koristi
English: - If you have any further questions, ask your doctor.
Croatian: - Ako imate dodatnih pitanja, obratite se liječniku.
English: The maximum dose after the first 3 hours will be 40 ng per kilogram each minute.
Croatian: Maksimalna doza nakon prva 3 sata bit će 40 ng po kilogramu svake minute.
English: As a part of your treatment, you may be given medicine to prevent the formation of blood clots.
Croatian: Kao dio liječenja, može Vam se dati lijek za sprječavanje stvaranja krvnih ugrušaka.
English: Patients were not necessarily on maximum doses of other vasopressors at the time of randomisation.
Croatian: Bolesnici nisu nužno primali maksimalne doze drugih vazopresora u vrijeme randomizacije.
English: Other medicines and GIAPREZA
Croatian: Drugi lijekovi i GIAPREZA
English: It is first diluted and then given as a drip (infusion) into a vein, supplying a specified dose each minute.
Croatian: Najprije se razrijedi i zatim daje kao infuzija (ukapavanje) u venu, čime se svake minute primjenjuje određena doza.
English: Use during pregnancy should be avoided if possible and the potential benefit to the patient weighed against any possible risk to the foetus.
Croatian: Ako je moguće, treba izbjegavati uporabu tijekom trudnoće, a moguću korist za bolesnicu treba usporediti s mogućim rizikom za fetus.
English: You will be monitored closely to make sure that your blood pressure is at the right level.
Croatian: Bit ćete pomno nadzirani kako bi se osiguralo da je Vaš krvni tlak na odgovarajućoj razini.
English: Dilute before use.
Croatian: Razrijedite prije uporabe.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Croatian: DATUM PRVOG ODOBRENJA / DATUM OBNOVE ODOBRENJA
English: GIAPREZA is used in an emergency setting to increase blood pressure to normal levels in adult patients with seriously low blood pressure who do not respond to fluids or other medicines that raise blood pressure.
Croatian: GIAPREZA se koristi u hitnim slučajevima kako bi se krvni tlak povisio do normalne razine u odraslih bolesnika s ozbiljno niskim krvnim tlakom koji ne reagiraju na tekućine ili druge lijekove koji povisuju krvni tlak.
English: The diluted solution should be used immediately.
Croatian: Razrijeđena otopina mora se upotrijebiti odmah.
English: OTHER La Jolla Pharmaceutical
Croatian: DRUGO La Jolla Pharmaceutical
English: Patients with cardiogenic shock were excluded (see section 4.4).
Croatian: Bolesnici s kardiogenim šokom bili su isključeni (vidjeti dio 4.4).
English: The safety and efficacy of GIAPREZA in children less than 18 years old has not yet been established.
Croatian: Sigurnost i djelotvornost lijeka GIAPREZA u djece mlađe od 18 godina nisu još utvrđene.
English: Peripheral ischaemia
Croatian: Periferna ishemija
English: The adverse reactions described in this section were identified in the pivotal clinical study (N = 163 treated with GIAPREZA).
Croatian: Nuspojave opisane u ovom dijelu utvrđene su u ključnom kliničkom ispitivanju (N = 163 osobe liječene lijekom GIAPREZA).
English: Hypertensive effects are expected to be brief because the half-life of angiotensin II is less than one minute.
Croatian: Očekuje se da će hipertenzivni učinci biti kratki jer je poluvijek angiotenzina II kraći od jedne minute.
English: The solution is a clear, colourless solution free of any visible particles.
Croatian: Otopina je bistra, bezbojna otopina bez vidljivih čestica.
English: Yes
Croatian: Da
English: Infusion bag size (mL)
Croatian: Veličina vrećice za infuziju (ml)
English: No
Croatian: Ne
English: These clots may travel through blood vessels to the lungs causing chest pain and difficulty breathing.
Croatian: Ti ugrušci mogu doprijeti kroz krvne žile u pluća uzrokujući bol u prsnom košu i otežano disanje.
English: Pharmacotherapeutic group: Cardiac therapy, other cardiac stimulants, ATC code: C01CX09
Croatian: Farmakoterapijska skupina: Pripravci koji djeluju na srce, ostali srčani stimulatori, ATK oznaka: C01CX09
English: Other side effects are:
Croatian: Ostale nuspojave uključuju:
English: Your doctor may already be giving you other medicines used to increase your blood pressure.
Croatian: Liječnik Vam je možda već propisao druge lijekove za povećanje krvnog tlaka.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i bočici nakon oznake „EXP” (rok valjanosti).
English: Discard the vial and any unused portion of the medicinal product after use.
Croatian: Bočicu i sve neiskorištene dijelove lijeka bacite nakon uporabe.
English: It is metabolised by end terminal cleavage (at both the amino and carboxy termini) in a variety of tissues including erythrocytes, plasma and many of the major organs (ie, intestine, kidney, liver and lung).
Croatian: Metabolizira se cijepanjem na terminalnom kraju (i amino i karboksi terminalnom kraju) u različitim tkivima, uključujući eritrocite, plazmu i mnoge glavne organe (odnosno crijeva, bubrege, jetru i pluća).
English: Peripheral ischaemia a Grouped term to include arterial and venous thrombotic events b Defined as an increase in mean arterial pressure > 100 mmHg
Croatian: Periferna ishemija a Skupni naziv koji obuhvaća arterijske i venske trombotske događaje b Definirano kao povećanje srednje vrijednosti arterijskog tlaka > 100 mmHg
English: 37/158 patients
Croatian: 37/158 bolesnika
English: 4.7 Effects on ability to drive and use machines Not relevant.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima
English: The clinical experience with GIAPREZA is limited to septic or other distributive shock.
Croatian: Kliničko iskustvo s lijekom GIAPREZA ograničeno je na septički ili drugi distributivni šok.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON
Croatian: PODATCI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA
English: Do not exceed 80 ng/kg per minute during the first 3 hours of treatment.
Croatian: Nemojte premašiti dozu od 80 ng/kg u minuti tijekom prva 3 sata liječenja.
English: The use of GIAPREZA is not recommended in other types of shock (e.g.: cardiogenic shock, etc) as patients with non-distributive shocks were excluded from clinical trials (see section 5.1).
Croatian: Primjena lijeka GIAPREZA ne preporučuje se za druge vrste šoka (npr. kardiogeni šok itd.) jer su bolesnici s nedistributivnim šokom isključeni iz kliničkih ispitivanja (vidjeti dio 5.1).
English: 1017CB Amsterdam, Netherlands
Croatian: 1017CB Amsterdam, Nizozemska
English: Diluted solution may be stored at room temperature or under refrigeration.
Croatian: Razrijeđena otopina može se čuvati na sobnoj temperaturi ili u hladnjaku.
English: What GIAPREZA looks like and contents of the pack GIAPREZA is presented as a concentrate for solution for infusion (sterile concentrate).
Croatian: Kako GIAPREZA izgleda i sadržaj pakiranja GIAPREZA se dobiva u obliku koncentrata za otopinu za infuziju (sterilni koncentrat).
English: Peripheral ischaemia may be a consequence of the mechanism of action of GIAPREZA.
Croatian: Periferna ishemija može biti posljedica mehanizma djelovanja lijeka GIAPREZA.
English: 28/52 patients
Croatian: 28/52 bolesnika
English: Pack size of one vial per carton.
Croatian: Veličina pakiranja od jedne bočice po kutiji.
English: Of these, 7 cases corresponded to deep vein thrombosis.
Croatian: Od toga se u 7 slučajeva radilo o dubokoj venskoj trombozi.