FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use solutions containing visible particles or that are cloudy.
Croatian: Nemojte koristiti otopine u kojima su vidljive čestice ili koje su mutne.
English: KOGENATE Bayer can be used in children of all ages.
Croatian: Primjena u djece i adolescenata KOGENATE Bayer se može koristiti u djece svih dobi.
English: In this case, this medicine expires at the end of this 12-month period or the expiration date on the product vial, whichever is earlier.
Croatian: Rok valjanosti lijeka u tom slučaju ističe nakon tog perioda od 12 mjeseci ili nakon datuma isteka roka valjanosti navedenog na bočici s lijekom, ovisno o tome koji nastupi ranije.
English: The analysis demonstrated that the frequency of inhibitor development is much lower in PTPs compared to PUPs.
Croatian: Analiza je pokazala da je učestalost razvoja inhibitora u prethodno liječenih bolesnika znatno niža u odnosu na prethodno neliječene bolesnike.
English: Information submitted by the lead authors of the SIPPET study during the course of the referral was also taken into consideration by PRAC in reaching its conclusion.
Croatian: PRAC je u donošenju zaključka također uzeo u obzir informacije koje su vodeći autori ispitivanja SIPPET dostavili tijekom upućivanja.
English: KOGENATE Bayer should be reconstituted and administered with the components provided with each package.
Croatian: KOGENATE Bayer treba pripremiti i primijeniti pomoću pribora priloženog u pakiranju.
English: Your doctor will tell you, how often and at what intervals this medicine is to be administered.
Croatian: Liječnik će Vam reći potrebnu učestalost i vremenske razmake primjene ovog lijeka.
English: Peel off the paper cover on the vial adapter plastic housing.
Croatian: Uklonite papirnati pokrov s plastičnog kućišta nastavka za bočicu.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially “sodium free”.
Croatian: Lijek sadrži manje od 1 mmol natrija (23 mg) po bočici, tj. zanemarive količine natrija.
English: This product is for single use only.
Croatian: Ovaj je lijek namijenjen samo za jednokratnu primjenu.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - FOR VIAL ADAPTER
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKO PAKIRANJE - ZA NASTAVAK ZA BOČICU
English: Fill the syringe by drawing the plunger out slowly and smoothly.
Croatian: Napunite štrcaljku polaganim i ravnomjernim izvlačenjem klipa.
English: If you have any questions about this medicine and compatible separate filters, contact your doctor.
Croatian: Ako imate dodatnih pitanja o lijeku KOGENATE Bayer i kompatibilnim zasebnim filterima, obratite se svom liječniku.
English: Note the new expiry date on the top of the carton.
Croatian: Na kutiji naznačite novi datum roka valjanosti.
English: It is recommended that every time that you use KOGENATE Bayer, the name and batch number of the product are documented.
Croatian: Dokumentiranje Preporučuje se da se pri svakoj primjeni lijeka KOGENATE Bayer zabilježe naziv i broj serije lijeka.
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with KOGENATE Bayer.
Croatian: Detaljne upute za pripremu i primjenu lijeka navedene su u uputi o lijeku koja se isporučuje uz KOGENATE Bayer.
English: • The PRAC considered the totality of the data submitted with regards to the risk of inhibitor development for the classes of recombinant and plasma derived FVIII products, in previously untreated patients (PUPs).
Croatian: • PRAC je pregledao sve dostavljene podatke u pogledu rizika od razvoja inhibitora u prethodno neliječenih bolesnika za razrede lijekova s rekombinantnim faktorom VIII i faktorom VIII dobivenim iz plazme.
English: Inject the diluent by slowly pushing down on the plunger rod (G).
Croatian: Polagano ubrizgavajte otapalo potiskivanjem klipa (G).
English: B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: In May 2016, an open-label, randomised controlled trial aimed at addressing the incidence of inhibitors between the two classes (pdFVIII vs. rFVIII products) was published in the New England Journal of Medicine1.
Croatian: U svibnju 2016. u časopisu New England Journal of Medicine1 objavljeno je otvoreno randomizirano kontrolirano ispitivanje koje se bavilo incidencijom inhibitora u dvama razredima lijekova (s faktorom VIII dobivenim iz plazme u odnosu na lijekove s rekombinantnim faktorom VIII).
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: Točno praćenje nadomjesnog liječenja analizom koagulacije (aktivnosti faktora VIII u plazmi) nužno je pogotovo u slučaju opsežnih kirurških zahvata.
English: How KOGENATE Bayer is prepared for adminsitration
Croatian: Kako se KOGENATE Bayer priprema za primjenu
English: Hold the vial on end above the vial adapter and syringe (I).
Croatian: 11. Primite bočicu za kraj iznad nastavka i štrcaljke (I).
English: In view of the above, the PRAC concluded that the benefit-risk balance of Factor VIII products indicated for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency), remains favourable subject to the changes to the product information agreed (section 4.4, 4.8 and 5.1 of the SmPC).
Croatian: S obzirom na sve prethodno navedeno, PRAC je zaključio da omjer koristi i rizika za lijekove s faktorom VIII koji su indicirani za liječenje i profilaksu krvarenja u bolesnika s hemofilijom A (prirođeni nedostatak faktora VIII) ostaje povoljan pod uvjetom da se u informacije u lijeku unesu dogovorene izmjene (dijelovi 4.4., 4.8. i 5.1. sažetka opisa svojstava lijeka).
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) in the prefilled syringe and the integrated transfer system (Bio-Set).
Croatian: Prašak KOGENATE Bayer smije se pripremati samo otapalom (2,5 ml (za 250 IU, 500 IU i 1000 IU) ili 5 ml (za 2000 IU i 3000 IU) vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću integriranog sustava za prijenos (Bio-Set).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use, single dose administration only.
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu u venu, primjena samo jedne doze.
English: Gently rotate the vial until all powder is dissolved.
Croatian: Polagano okrećite bočicu dok se sav prašak ne otopi.
English: Invert vial/syringe and transfer the solution into syringe by drawing the plunger out slowly and smoothly (H).
Croatian: Preokrenite bočicu/štrcaljku te prenesite otopinu u štrcaljku polaganim i ravnomjernim povlačenjem klipa (H).
English: Experience regarding fertility or the use of KOGENATE Bayer during pregnancy and breast-feeding is not available.
Croatian: Nisu dostupni podaci o uzimanju lijeka KOGENATE Bayer tijekom trudnoće i dojenja, kao niti iskustvo u pogledu plodnosti.
English: Each pack of KOGENATE Bayer contains a vial and a pre-filled syringe with a separate plunger rod, as well as a vial adapter, a venipuncture set (for injection into a vein), two alcohol swabs, two dry swabs and two plasters.
Croatian: Svako pakiranje lijeka KOGENATE Bayer 250 IU sadrži bočicu i napunjenu štrcaljku s odvojenim potisnim klipom, kao i nastavak za bočicu, set za venepunkciju (za ubrizgavanje u venu), dva tupfera natopljena alkoholom, dva suha tupfera i dva flastera.
English: • one venipuncture set
Croatian: • jedan set za venepunkciju
English: Special populations Paediatric population
Croatian: Posebne populacije
English: • With regards to sections 4.8 and 5.1 of the SmPC, the PRAC noted that several FVIII products currently include reference to data from study results which do not allow for a definite conclusion on the inhibitor risk for individual products.
Croatian: • U pogledu dijelova 4.8. i 5.1. sažetka opisa svojstava lijeka, PRAC je primijetio da se za nekoliko lijekova s faktorom VIII trenutačno navodi upućivanje na podatke iz rezultata ispitivanja koja ne omogućuju donošenje konačnog zaključka o riziku od inhibitora za pojedine lijekove.
English: This medicinal product contains less than 1 mmol (23 mg) sodium per vial and is therefore considered essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Medical devices for reconstitution and administration are provided with each package of this medicine.
Croatian: Svako pakiranje ovog lijeka sadrži medicinske proizvode za pripremu i primjenu.
English: • whether you have inhibitors and how high the inhibitor titre is
Croatian: • prisutnost inhibitora te visina titra inhibitora
English: It found that patients treated with rFVIII products had an 87% higher incidence of all inhibitors than those treated with pdFVIII (which contained VWF) (hazard ratio, 1.87; 95% CI, 1.17 to 2.96).
Croatian: Ispitivanje je pokazalo da je incidencija svih inhibitora bila veća za 87 % u bolesnika liječenih lijekovima s rekombinantnim faktorom VIII u odnosu na one liječene lijekovima s faktorom VIII dobivenim iz plazme (koji su sadržavali VWF) (omjer rizika 1,87; 95 % CI, 1,17 do 2,96).
English: The infusion rate should be calculated based on the clearance and the desired FVIII level.
Croatian: Brzinu infuzije potrebno je izračunati prema klirensu te željenoj razini faktora VIII.
English: If the factor VIII level in your plasma fails to reach expected levels, or if bleeding is not controlled after apparently adequate dose, you may have developed factor VIII inhibitors.
Croatian: Ako razina faktora VIII u plazmi ne dosegne očekivane vrijednosti ili se naizgled odgovarajućom dozom ne uspije zaustaviti krvarenje, postoji mogućnost da su se razvili inhibitori faktora VIII.
English: Whether there are significant differences in the risk of inhibitor development between different types of FVIII replacement product remains an area of uncertainty.
Croatian: I dalje nije sigurno postoje li značajne razlike u pogledu rizika od razvoja inhibitora između različitih vrsta lijekova za zamjensku terapiju faktorom VIII.
English: Overall, the PRAC maintains its conclusions that standardised information on the frequency for FVIII products in PUP and PTP should be reflected in section 4.8 of the SmPC, unless another frequency range for a specific medicinal product is demonstrated by robust clinical studies for which the results would be summarised in section 5.1.
Croatian: Ukupno gledano, PRAC ostaje pri zaključku da je u dijelu 4.8. sažetka opisa svojstava lijeka potrebno navesti standardizirane informacije o učestalosti za lijekove s faktorom VIII u prethodno neliječenih bolesnika i prethodno liječenih bolesnika, osim ako se za određeni lijek ne dokaže drugi raspon učestalosti u pouzdanim kliničkim ispitivanjima, sa sažetcima rezultata navedenima u dijelu
English: Besides, as the evidence suggests that all human FVIII products carry a risk of inhibitor development, within the frequency of ‘very common' and ‘uncommon', for PUPs and PTPs respectively, the PRAC recommended that the product information of these products should be aligned with these frequencies unless justified by product specific data.
Croatian: Osim toga, budući da dokazi ukazuju na to da kod svih lijekova s ljudskim faktorom VIII postoji rizik od razvoja inhibitora unutar raspona učestalosti „vrlo često” u prethodno neliječenih bolesnika i „manje često” u prethodno liječenih bolesnika, PRAC je preporučio da se informacije o lijeku za te lijekove usklade s tim učestalostima, osim ako to nije opravdano s obzirom na podatke specifične za lijek.
English: Based on the current evidence from the SIPPET study, as well as data from the individual clinical trials and observational studies included in the MAH responses, and the views expressed by the experts of the ad-hoc expert meeting, the PRAC agreed that the current evidence does not provide clear and consistent evidence of any statistically and clinically meaningful differences in inhibitor risk between rFVIII and pdFVIII products.
Croatian: Na temelju postojećih dokaza iz ispitivanja SIPPET, kao i podataka iz pojedinih kliničkih i opservacijskih ispitivanja koji su navedeni u odgovorima nositelja odobrenja za stavljanje u promet, te stajališta stručnjaka iznesenih na ad hoc sastanku stručne skupine, PRAC je donio zaključak da postojeći dokazi ne dokazuju na jasan i dosljedan način postojanje statistički i klinički značajne razlike u pogledu rizika od inhibitora između lijekova s rekombinantnim faktorom VIII i lijekova s faktorom VIII dobivenim iz plazme.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Croatian: Ti inhibitori su obično IgG imunoglobulini koji djeluju protiv prokoagulacijske aktivnosti faktora VIII, a njihova količina se određuje u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: The referral focuses on the risk of inhibitor development in PUPs.
Croatian: Upućivanje je usmjereno na rizik od razvoja inhibitora u prethodno neliječenih bolesnika.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Croatian: 11. IME I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG 51368 Leverkusen Njemačka
English: • The PRAC noted that the SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products in total.
Croatian: • PRAC je napomenuo da ispitivanje SIPPET nije osmišljeno za procjenu rizika od razvoja inhibitora kod pojedinih lijekova te je ukupno uključivalo ograničen broj lijekova s faktorom VIII.
English: Do not refrigerate after reconstitution.
Croatian: Nakon pripreme za primjenu nemojte držati u hladnjaku.
English: 1 pre-filled syringe with 2.5 mL or 5 mL water for injections with separate plunger rod.
Croatian: 1 bočica s praškom za otopinu za injekciju 1 štrcaljka napunjena s 2,5 ml ili 5 ml vode za injekciju i odvojenim potisnim klipom 1 nastavak za bočicu
English: Only the provided components (powder vial with Bio-Set system, pre-filled syringe containing solvent and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Croatian: Za pripremu za primjenu i injiciranje smiju se koristiti samo priložene komponente (bočica praška sa sustavom Bio-Set, napunjena štrcaljka koja sadrži otapalo i set za venepunkciju) jer zbog adsorpcije ljudskog rekombinantnog koagulacijskog faktora VIII u unutrašnje površine određene infuzijske opreme liječenje može biti neuspješno.
English: Marketing Authorisation Holder Bayer AG 51368 Leverkusen Germany
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Bayer AG 51368 Leverkusen Njemačka
English: If the expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay should be performed to determine if a factor VIII inhibitor is present.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili se odgovarajućom dozom ne zaustavi krvarenje, potrebno je obaviti test da bi se utvrdila prisutnost inhibitora faktora VIII.
English: 3000 IU) solvent (clear glass cylinder type 1 with latex-free grey bromobutyl rubber blend stopper)
Croatian: 3000 IU) otapala (cilindar od prozirnog stakla tipa 1 sa sivim gumenim čepom od bromobutila)
English: Use in children and adolescents
Croatian: I DOHVATA DJECE
English: Remove tourniquet!
Croatian: Uklonite povesku!
English: Remove the protective cap from the vial (A) and wipe the rubber stopper on the vial with a alcohol swab and allow it to air dry before use.
Croatian: Uklonite zaštitni čep s bočice (A) te očistite gumeni čep sterilnom blazinicom (ili antiseptičkim sprejem).
English: Driving and using machines No effects on ability to drive or use machines have been observed.
Croatian: Nije zabilježen utjecaj lijeka na sposobnost upravljanja vozilima i rada sa strojevima.
English: For calculation of mL/hour, multiply infusion rate in IU/h/kg by kg bw/concentration of solution (IU/mL).
Croatian: Da biste izračunali brzinu izraženu u ml/h, brzinu infuzije izraženu u IU/h/kg pomnožite s tjelesnom težinom/koncentracija otopine (IU/ml).
English: Reconstitute the desired amount of product, repeating steps 2 - 9, using a new syringe and connect it to the venipuncture set.
Croatian: Pripremite željenu količinu lijeka prema postupku iz koraka od 2 do 9.
English: KOGENATE Bayer powder should only be reconstituted with the supplied solvent (2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 3000 IU) water for injections) in the prefilled syringe and the vial adapter.
Croatian: Prašak KOGENATE Bayer smije se pripremati samo otapalom (2,5 ml (za 250 IU, 500 IU i 1000 IU) ili 5 ml (za 2000 IU i 3000 IU) vode za injekcije) priloženim u napunjenoj štrcaljki i pomoću nastavka za bočicu.
English: Connect the plunger rod to the syringe by screwing it into the rubber stopper (E).
Croatian: Umetnite potisni klip u štrcaljku zavrtanjem u gumeni čep (E).
English: Attach the syringe to the venipuncture set by screwing it clockwise and ensure that no blood enters the syringe (J).
Croatian: Pričvrstite štrcaljku na set za venepunkciju zavrtanjem u smjeru kretanja kazaljke na satu te provjerite da u štrcaljku ne ulazi krv (J).
English: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Parenteralne lijekove treba vizualno pregledati prije primjene na prisutnost čestica i promjenu boje.
English: As the evidence suggests that all human FVIII products carry a risk of inhibitor development, within the frequency of ‘very common' and ‘uncommon' for PUPs and PTPs respectively, the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Croatian: Budući da dokazi ukazuju na to da kod svih lijekova s ljudskim faktorom VIII postoji rizik od razvoja inhibitora unutar raspona učestalosti „vrlo često” u prethodno neliječenih bolesnika i „manje često” u prethodno liječenih bolesnika, PRAC preporučuje da se sažetci opisa svojstava lijeka usklade s tim učestalostima, osim ako to nije opravdano s obzirom na podatke specifične za lijek.
English: Hold a pad firmly over the injection site on your outstretched arm for approximately 2 minutes.
Croatian: Otprilike 2 minute na ispruženoj ruci čvrsto držite tupfer na mjestu injiciranja.
English: MARKETING AUTHORISATION HOLDER Bayer AG 51368 Leverkusen Germany
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet Bayer AG 51368 Leverkusen Njemačka
English: Holding the syringe by the barrel, snap the syringe cap off the tip (D).
Croatian: Štrcaljku primite za tijelo te uklonite poklopac s vrha (D).
English: Gently screw the syringe on to the powder vial (B).
Croatian: Oprezno pričvrstite štrcaljku zavrtanjem na bočicu s praškom (B).
English: Only the provided components (powder vial, pre-filled syringe containing solvent, vial adapter and venipuncture set) should be used for reconstitution and injection because treatment failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Croatian: Za pripremu za primjenu i injiciranje smiju se koristiti samo priložene komponente (bočica praška, napunjena štrcaljka s otapalom, nastavak za bočicu i komplet za venepunkciju) jer zbog adsorpcije ljudskog rekombinantnog koagulacijskog faktora VIII na unutrašnje površine određene infuzijske opreme liječenje može biti neuspješno.
English: After reconstitution, the chemical and physical in-use stability has been demonstrated for 3 hours in in vitro studies.
Croatian: U ispitivanjima in vitro pokazano je da kemijska i fizička stabilnost lijeka nakon pripreme za primjenu traje 3 sata.
English: 2 alcohol swabs for single use
Croatian: 2 tupfera natopljena alkoholom za jednokratnu primjenu 2 suha tupfera
English: INSTRUCTIONS ON USE Read package leaflet before use.
Croatian: NAČIN PRIMJENE LIJEKA Prije uporabe pročitati uputu o lijeku.
English: The available data supports a frequency of FVIII inhibitor development within the frequency of ‘very common' and ‘uncommon', for PUPs and PTPs respectively, therefore the PRAC recommends that the SmPCs should be aligned with these frequencies unless justified by product specific data.
Croatian: Dostupni podatci podupiru učestalost razvoja inhibitora faktora VIII unutar raspona učestalosti „vrlo često” u prethodno neliječenih bolesnika i „manje često” u prethodno liječenih bolesnika, stoga PRAC preporučuje da se sažetci opisa svojstava lijeka usklade s tim učestalostima, osim ako to nije opravdano s obzirom na podatke specifične za lijek.
English: Haemorrhage Early haemarthrosis, muscle bleed or oral bleed
Croatian: Početna hemartroza, krvarenje u mišiću ili usnoj šupljini
English: Holding the vial adapter in place, remove the syringe from the vial adapter (the latter should remain attached to the vial).
Croatian: 15. Nastavak za bočicu pridržavajte na mjestu, a štrcaljku odvojite od nastavka za bočicu (nastavak mora ostati pričvršćen za bočicu).
English: Detailed instructions for reconstitution and administration of KOGENATE Bayer using vial with vial adapter:
Croatian: Detaljne upute za pripremu za primjenu i primjenu lijeka KOGENATE Bayer uz primjenu nastavku za bočicu:
English: KOGENATE Bayer 250 IU powder and solvent for solution for injection KOGENATE Bayer 500 IU powder and solvent for solution for injection KOGENATE Bayer 1000 IU powder and solvent for solution for injection KOGENATE Bayer 2000 IU powder and solvent for solution for injection KOGENATE Bayer 3000 IU powder and solvent for solution for injection Recombinant coagulation factor VIII (octocog alfa)
Croatian: KOGENATE Bayer 250 IU prašak i otapalo za otopinu za injekciju KOGENATE Bayer 500 IU prašak i otapalo za otopinu za injekciju KOGENATE Bayer 1000 IU prašak i otapalo za otopinu za injekciju KOGENATE Bayer 2000 IU prašak i otapalo za otopinu za injekciju KOGENATE Bayer 3000 IU prašak i otapalo za otopinu za injekciju rekombinantni koagulacijski faktor VIII (oktokog alfa)
English: During clinical studies, no patient developed clinically relevant antibody titres against the trace amounts of mouse protein and hamster protein present in the preparation.
Croatian: Tijekom kliničkih ispitivanja ni u jednog bolesnika nije zabilježen klinički značajan titar protutijela na bjelančevine miša i bjelančevine hrčka koje su u pripravku prisutne u tragovima.
English: KOGENATE Bayer 250 IU contains (250 IU / 2.5 mL) = 100 IU octocog alfa per mL after reconstitution.
Croatian: KOGENATE Bayer 250 IU sadržava (250 IU / 2,5 ml) = 100 IU oktokoga alfa po ml nakon pripreme za primjenu.
English: The SIPPET study was not designed to evaluate the risk of inhibitor development for individual products, and included a limited number of FVIII products.
Croatian: Ispitivanje SIPPET nije osmišljeno za procjenu rizika od razvoja inhibitora kod pojedinih lijekova te je uključivalo ograničen broj lijekova s faktorom VIII.
English: >), the above frequency for PUPs should not be implemented.
Croatian: >”, ne navodi se prethodno navedena učestalost za prethodno neliječene bolesnike.
English: Use the venipuncture set provided as it contains an in-line filter.
Croatian: Uporabite priloženi komplet za venepunkciju jer je u njega ugrađen filter.