FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Croatian: Ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): Kako bi se ispitali potencijalni učinci nakupljanja PEG-a u koroidnom spletu mozga i drugim tkivima/organima, nositelj odobrenja treba ispitivanje sigurnosti nakon davanja odobrenja u skladu s dogovorenim planom ispitivanja provesti i dostaviti rezultate.
English: The product is for single use only.
Croatian: Lijek je samo za jednokratnu uporabu.
English: Individual PK with 12 post-infusion samples.
Croatian: Pojedinačna farmakokinetika sa 12 uzoraka nakon infuzije.
English: If a patient is to receive more than one vial of ADYNOVI, the contents of multiple vials may be drawn into the same syringe.
Croatian: Ako bolesnik treba primiti više od jedne bočice lijeka ADYNOVI, sadržaj više bočica može se uvući u jednu štrcaljku.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Croatian: Naročito u slučaju većih kirurških zahvata neophodno je precizno praćenje nadomjesne terapije uz pomoć ispitivanja koagulacije (aktivnosti faktora VIII u plazmi).
English: What you need to know before you use ADYNOVI
Croatian: Što morate znati prije nego počnete primjenjivati ADYNOVI
English: Discard any unused solution appropriately.
Croatian: Neiskorištenu otopinu zbrinite na odgovarajući način.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se u postotku (u odnosu na normalnu ljudsku plazmu) ili bolje u međunarodnim jedinicama (u odnosu na međunarodne standarde za faktor VIII u plazmi).
English: Verify that the solvent transfer is complete.
Croatian: Provjerite da je prijenos otapala završen.
English: Pharmacokinetic parameters calculated from 39 subjects less than 18 years of age (intent-to-treat analysis) are available for 14 children (2 to less than 6 years), 17 older children (6 to less than 12 years) and 8 adolescent subjects (12 to < 18 years of age).
Croatian: Farmakokinetički parametri izračunati na 39 ispitanika mlađih od 18 godina (analiza populacije s namjerom liječenja) dostupni su za 14 djece (2 do manje od 6 godina), 17 starije djece (6 do manje od 12 godina) i 8 adolescenata (12 do <18 godina).
English: Your doctor will calculate your dose of ADYNOVI depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Croatian: Vaš će liječnik izračunavati Vašu dozu lijeka ADYNOVI ovisno o Vašem stanju i tjelesnoj težini i ovisno o tomu koristi li se za sprječavanje ili liječenje krvarenja.
English: The frequency of administration will depend on how well ADYNOVI is working for you.
Croatian: Učestalost primjene ovisit će o tome koliko dobro lijek ADYNOVI djeluje kod Vas.
English: Catheter-related complications in treatment
Croatian: Komplikacije povezane s kateterom u liječenju
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Croatian: Ako se pojavi bilo koji od navedenih simptoma, odmah prekinite primjenu injekcije i obratite se svom liječniku.
English: For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Croatian: Za bolesnike koji su primali raniju terapiju s faktorom VIII (više od 150 dana liječenja) inhibitorna antitijela (vidjeti dio 2) mogu se stvarati manje često (manje od 1 na 100 bolesnika).
English: Repeat injections every 12 to 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Croatian: Ponoviti injekcije svakih 12 do 24 sata tijekom 3-4 dana ili dulje do prestanka boli i akutne onesposobljenosti.
English: Haemophilia A occurs only rarely in women.
Croatian: Hemofilija A javlja se samo rijetko u žena.
English: Of the 70 bleeding episodes observed during the paediatric study, 82.9% were controlled with 1 infusion and 91.4% were controlled with 1 or 2 infusions.
Croatian: Od 70 epizoda krvarenja zabilježenih tijekom pedijatrijskog ispitivanja, 82,9% kontrolirana su 1 infuzijom, a 91,4% kontrolirana su sa 1 ili 2 infuzije.
English: The safety, efficacy, and pharmacokinetics of ADYNOVI were evaluated in a pivotal multicenter, open-label, prospective clinical trial that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined haemostatic efficacy in the treatment of bleeding episodes.
Croatian: Sigurnost, djelotvornost i farmakokinetika lijeka ADYNOVI procijenjene su u pivotalnom multicentričnom, otvorenom, prospektivnom kliničkom ispitivanju u kojem je uspoređivana djelotvornost profilaktičkog režima liječenja uz doziranje dva puta tjedno s liječenjem kod krvarenja i utvrđena hemostatska djelotvornost u liječenju epizoda krvarenja.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijekova koji sadrže ljudski koagulacijski faktor VIII (rDNK) s drugim lijekovima.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom povećava se razina faktora VIII u plazmi i tako omogućuje privremena korekcija nedostatka faktora te korekcija sklonosti krvarenju.
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Croatian: Tablica 1 Vodič za doziranje kod epizoda krvarenja i kirurških zahvata Stupanj krvarenja/vrsta kirurškog zahvata
English: Haemophilia A is a X-chromosomal linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Croatian: Hemofilija A spolno je vezani nasljedni X-kromosomski poremećaj koagulacije krvi zbog smanjene razine faktora VIII:C te dovodi do obilnog krvarenja u zglobovima, mišićima ili unutrašnjim organima, bilo spontano ili uzrokovano slučajnom ili kirurškom traumom.
English: Population PK model with 3 post-infusion samples based on randomized drawing schedule.
Croatian: Populacijski farmakokinetički model sa 3 uzorka nakon infuzije na temelju randomiziranog rasporeda vađenja krvi.
English: The safety of ADYNOVI was evaluated in 243 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVI in 3 completed multi-center, prospective, open label clinical studies and 2 ongoing clinical studies.
Croatian: Sigurnost lijeka ADYNOVI procjenjivana je u 243 prethodno liječena bolesnika s teškom hemofilijom A (faktor VIII manji od 1% od normalnog) koji su primili najmanje jednu dozu lijeka ADYNOVI u 3 dovršena multicentrična, prospektivna, otvorena klinička ispitivanja i 2 klinička ispitivanja u tijeku.
English: Of the 518 bleeding episodes, 96.1% were rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in their response to treatment with ADYNOVI.
Croatian: Od 518 epizoda krvarenja, 96,1% bilo je ocijenjeno odlično (potpuno olakšanje bolova i prestanak objektivnih znakova krvarenja nakon pojedinačne infuzije) ili dobro (definitivno olakšanje boli i/ili poboljšanje znakova krvarenja nakon jedne infuzije) u njihovom odgovoru na liječenje lijekom ADYNOVI.
English: ADYNOVI has no influence on the ability to drive and use machines.
Croatian: ADYNOVI ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The vacuum will draw the solvent into the powder vial.
Croatian: Vakuum će uvući otapalo u bočicu s praškom.
English: Driving and using machines ADYNOVI has no influence on your ability to drive or to use machines.
Croatian: Upravljanje vozilima i strojevima ADYNOVI ne utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
English: Clean rubber stoppers with an alcohol wipe and allow to dry prior to use.
Croatian: Očistite gumene čepove alkoholnom maramicom i pričekajte da se osuše prije upotrebe.
English: The pharmacokinetics (PK) of ADYNOVI were evaluated in a crossover study with octocog alfa in 26 subjects (18 adults and 8 adolescents) and in 22 subjects (16 adults and 6 adolescents) after 6 months of treatment with ADYNOVI.
Croatian: Farmakokinetika (PK) lijeka ADYNOVI procijenjena je u ukriženom ispitivanju oktokoga alfa u 26 ispitanika (18 odraslih i 8 adolescenata) i u 22 ispitanika (16 odraslih i 6 adolescenata) nakon 6 mjeseci liječenja lijekom ADYNOVI.
English: If you forget to use ADYNOVI
Croatian: Ako ste zaboravili primijeniti ADYNOVI
English: Prophylactic treatment
Croatian: Profilaktičko liječenje
English: Be sure that the powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Croatian: Pobrinite se da je prašak u potpunosti otopljen, inače sva rekonstituirana otopina neće proći kroz filtar uređaja.
English: Do not use this medicine after the expiry date, which is stated on the label and carton after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji iza oznake „EXP”.
English: Treatment monitoring:
Croatian: Praćenje liječenja:
English: • Do not use after the expiry date stated on the labels and carton.
Croatian: • Ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na naljepnicama i kutiji.
English: Sterilised water for injections
Croatian: Sterilizirana voda za injekcije
English: Administration Steps:
Croatian: Koraci primjene:
English: Therefore no experience regarding the use of ADYNOVI during preganancy and breast-feeding is available.
Croatian: Stoga nije dostupno nikakvo iskustvo s primjenom lijeka ADYNOVI tijekom trudnoće i dojenja.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu za ovaj lijek putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: Intravenous use, after reconstitution.
Croatian: Intravenska primjena, nakon pripreme otopine.
English: In the repeat dose toxicity study in Cynomologous monkey, two animals showed vacuolation in the kidney in the mid dose group (350IU/kg).
Croatian: U ispitivanju toksičnosti ponovljenih doza u majmuna Cynomologous, dvije životinje pokazale su vakuolizaciju na bubrezima u grupi sa srednjom dozom (350 IU/kg).
English: The table presented below is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
Croatian: Tablica u nastavku prikazuje nuspojave prema MedDRA klasifikaciji organskih sustava (organski sustav i preporučeni pojam).
English: The median number of exposure days to ADYNOVI per subject was 103.5 (min-max: 1-278).
Croatian: Medijan broja dana izloženosti lijeku ADYNOVI po ispitaniku bio je 103,5 (min-maks: 1-278).
English: Use only the solvent and the reconstitution device for preparation of the solution that are provided with each package of ADYNOVI.
Croatian: Upotrebljavajte samo otapalo i uređaj za pripremu otopine koji su priloženi u svakom pakiranju lijeka ADYNOVI.
English: There is a rare risk that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ADYNOVI.
Croatian: Postoji mogućnost da dobijete anafilaktičku reakciju (tešku i iznenadnu alergijsku reakciju) na ADYNOVI, ali to je rijetko.
English: A field study has indicated that plasma factor VIII levels can be monitored using either a chromogenic substrate assay or a one stage clotting assay routinely used in clinical laboratories.
Croatian: Ispitivanje na terenu pokazalo je da se razine faktora VIII u plazmi mogu pratiti uz pomoć testa s kromogenim supstratom ili jednostupanjskog testa koagulacije koji se rutinski koriste u kliničkim laboratorijima.
English: In case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Croatian: U slučaju sljedećih događaja krvarenja, aktivnost faktora VIII ne smije pasti ispod zadane razine aktivnosti u plazmi (u % od normalne ili IU/dl) u odgovarajućem razdoblju.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Croatian: Teški simptomi, uključujući poteškoće u disanju i (zamalo) padanje u nesvijest zahtijevaju hitno medicinsko liječenje.
English: The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all Factor VIII medicines.
Croatian: Stvaranje inhibitora (antitijela) poznata je komplikacija koja se može pojaviti tijekom liječenja bilo kojim lijekom koji sadrži faktor VIII.
English: Common side effects (may affect up to 1 in 10 people) Headache, nausea, diarrhoea, rash
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 bolesnika) glavobolja, mučnina, proljev, osip
English: Known allergic reaction to mouse or hamster protein.
Croatian: Poznate alergijske reakcije na proteine miša ili hrčka.
English: Treatment with ADYNOVI will be started and supervised by a doctor who is experienced in the care of patients with haemophilia A.
Croatian: Liječenje lijekom ADYNOVI započet će i nadgledati liječnik koji ima iskustva u liječenju bolesnika s hemofilijom A.
English: Octocog alfa is then covalently conjugated with the PEG reagent.
Croatian: Oktokog alfa se potom kovalentno konjugira s reagensom PEG.
English: The safety of ADYNOVI was evaluated in 38 subjects < 6 years and 34 subjects 6 to < 12 years of age having accumulated a total of 2880 EDs and 2975 EDs respectively.
Croatian: Sigurnost lijeka ADYNOVI procjenjivana je u 38 ispitanika < 6 godina i 34 ispitanika u dobi od 6 do < 12 godina koji su nakupili ukupno 2880 dana izloženosti (DI) odnosno 2975 DI.
English: The following Table 1 can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća Tablica 1 može se koristiti za usmjeravanje doziranja pri epizodama krvarenja i kirurških zahvata:
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ADYNOVI.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući ADYNOVI.
English: MedDRA Standard System Organ Class
Croatian: MedDRA standardna klasifikacija prema organskim sustavima
English: The median annualised bleed rate (ABR) in the on-demand treatment arm was 41.5 compared to 1.9 while on a twice a week prophylaxis regimen.
Croatian: Medijan anualizirane stope krvarenja (ASK) u skupini liječenoj kod krvarenja iznosio je 41,5 u usporedbi sa 1,9 kod primjene režima profilakse dvaput tjedno.
English: Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar, oktokog alfa kao ishodišnu molekulu ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Rijetko su opaženi preosjetljivost ili alergijske reakcije (koje mogu uključivati angioedem, pečenje i peckanje na mjestu injekcije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsima, trnce, povraćanje i piskanje u plućima) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
Croatian: Koristite antiseptičku tehniku (čisti uvjeti s malim brojem mikroorganizama) i ravnu radnu površinu tijekom postupka rekonstitucije.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena, nisu dostupni podaci o primjeni faktora VIII tijekom trudnoće i dojenja.
English: The PEG moiety is conjugated to octocog alfa to increase the plasma half-life.
Croatian: PEG skupina konjugirana je s oktokogom alfa da bi se povećao poluvijek u plazmi.
English: This should be taken into consideration by patients on a controlled sodium diet.
Croatian: To se mora uzeti u obzir kod bolesnika na dijeti s kontroliranim unosom natrija.
English: Name and batch number of the medicinal product
Croatian: Naziv i serijski broj lijeka
English: If the product is still stored in a refrigerator, take the sealed blister (contains powder and solvent vials preassembled with the system for reconstitution) from the refrigerator and let it reach room temperature (between 15 °C and 25 °C).
Croatian: Ako se proizvod i dalje čuva u hladnjaku, uzmite hermetički zatvoreni blister (sadrži bočice praška i otapala već pričvršćene na sustav za rekonstituciju) iz hladnjaka i pričekajte da postigne sobnu temperaturu (između 15 °C i 25 °C).
English: Instructions for preparation and administration
Croatian: Upute za pripremu i primjenu
English: With one hand holding the powder vial in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the powder vial (Figure 2).
Croatian: Jednom rukom držite bočicu s praškom u sustavu BAXJECT III, drugom rukom čvrsto pritisnite bočicu otapala prema dolje sve dok u potpunosti ne potisnete sustav i otapalo teče u bočicu s praškom (slika 2).
English: A total of 137 male PTPs (12 to 65 years of age) with severe haemophilia A received at least one infusion with ADYNOVI.
Croatian: Ukupno je 137 muških prethodno liječenih bolesnika (u dobi od 12 do 65 godina) s teškom hemofilijom A primalo najmanje jednu infuziju lijeka ADYNOVI.
English: Twenty four out of 65 subjects (37%) experienced no bleeding episodes, 47 out of 65 subjects (72%) experienced no joint bleeding episodes, and 43 out of 65 subjects (66%) experienced no spontaneous bleeding episodes on prophylaxis.
Croatian: Kod režima profilakse, 24 od 65 ispitanika (37%) nije iskusilo epizode krvarenja, 47 od 65 ispitanika (72%) nije iskusilo epizode krvarenja u zglobovima i 43 od 65 ispitanika (66%) nije iskusilo spontane epizode.
English: One hundred eighteen of 120 (98%) prophylaxis subjects remained on the starting recommended regimen without dose adjustment, and 2 subjects increased their dose to 60 IU/kg during prophylaxis due to bleeding in target joints.
Croatian: Od 120 ispitanika koji su primali profilaksu, 118 (98%) ih je ostalo na početnom preporučenom režimu bez prilagodbe doze, a 2 su ispitanika povećala svoju dozu na 60 IU/kg tijekom profilakse zbog krvarenja u ciljanim zglobovima.
English: Allergic type hypersensitivity reactions are possible with ADYNOVI.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa na ADYNOVI.
English: A total of 21 major surgical procedures and 5 additional minor surgeries were performed and assessed in 21 unique subjects in the surgery study.
Croatian: U 21 pojedinačnog ispitanika u ispitivanju kirurških zahvata proveden je i ocijenjen ukupno 21 veliki kirurški postupak i 5 dodatnih manjih kirurških postupaka.
English: The mean dose (SD) was 54.3 (6.3) IU/kg and the median frequency of infusions per week was 1.87.
Croatian: Srednja doza (SD) bila je 54,3 (6,3) IU/kg i medijan učestalosti infuzije na tjedan 1,87.
English: Baxalta Innovations GmbH A-1221 Vienna Austria
Croatian: Baxalta Innovations GmbH A-1221 Beč
English: On demand treatment dosing in paediatric patients (12 to 18 years of age) is the same as for adult patients.
Croatian: Doziranje u liječenju kod krvarenja u pedijatrijskih bolesnika (12 do 18 godina) isto je kao i kod liječenja odraslih bolesnika.
English: Of these, 361 bleeding episodes (n=17 subjects) occurred in the on-demand arm and 157 (n=61 subjects) occurred in the prophylaxis arm.
Croatian: Od tih, 361 epizoda krvarenja (n= 17 ispitanika) pojavile su se u skupini liječenoj kod krvarenja i 157 (n= 61 ispitanika) u skupini na profilaksi.
English: The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line.
Croatian: Terapijska aktivnost rurioktokog alfa pegola potječe od oktokoga alfa, koji se proizvodi tehnologijom rekombinantne DNK u stanicama jajnika kineskog hrčka.
English: For major surgeries, the preoperative loading dose ranged from 36 IU/kg to 109 IU/kg (median: 63 IU/kg); and postoperative total dose ranged from 186 IU/kg to 1320 IU/kg (median: 490 IU/kg).
Croatian: Za veće kirurške zahvate, predoperacijska udarna doza bila je u rasponu od 36 IU/kg do 109 IU/kg (medijan: 63 IU/kg); a postoperacijska ukupna doza u rasponu od 186 IU/kg do 1320 IU/kg (medijan: 490 IU/kg).
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava u djece biti jednaki kao u odraslih osoba.
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Croatian: Sljedeća tablica može se koristiti za usmjeravanje doziranja pri epizodama krvarenja i kirurških zahvata.
English: An increase in AUC and a decrease in clearance as compared to the parent molecule, octocog alfa, were also observed.
Croatian: Zabilježen je i porast AUC i smanjenje klirensa u usporedbi s nadređenom molekulom oktokoga alfa.
English: Other medicines and ADYNOVI Tell your doctor if you are using, have recently used or might use any other medicines.
Croatian: Obavijestite svog liječnika ako primjenjujete, nedavno ste primijenili ili biste mogli primijeniti bilo koje druge lijekove.
English: The median total dose for major surgeries was 553 IU/kg (range: 248-1394 IU/kg) and the median total dose of minor surgeries was 106 IU/kg (range: 76132 IU/kg).
Croatian: Medijan ukupne doze za veće kirurške zahvate bio je 553 IU/kg (raspon: 248-1394 IU/kg), a medijan ukupne doze manjih kirurških zahvata bio je 106 IU/kg (raspon: 76-132 IU/kg).
English: The potency (International Units) is determined using the chromogenic assay.
Croatian: Potentnost (IU) je određena korištenjem kromogenog testa.
English: Remove plastic caps from the powder and solvent vials.
Croatian: Skinite plastične zatvarače s bočica s praškom i otapalom.
English: In this case, this medicine expires at the end of this 3-month period or the expiration date printed on the product vial, whichever is earlier.
Croatian: U tom slučaju valjanost lijeka ističe na kraju navedenog tromjesečnog razdoblja ili na datum isteka roka valjanosti otisnutog na bočici lijeka, što god nastupilo prije.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter (engl. central venous access device, CVAD), treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterijemija i tromboza na mjestu postavljenog katetera.