FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/11/713/001 20 tablets EU/1/11/713/002 30 tablets EU/1/11/713/003 50 tablets EU/1/11/713/004 60 tablets EU/1/11/713/005 100 tablets EU/1/11/713/006 120 tablets EU/1/11/713/007 200 tablets
Croatian: EU/1/11/713/001 20 tableta EU/1/11/713/002 30 tableta EU/1/11/713/003 50 tableta EU/1/11/713/004 60 tableta EU/1/11/713/005 100 tableta EU/1/11/713/006 120 tableta EU/1/11/713/007 200 tableta
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 250 mg film-coated tablets in tablet containers
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 250 mg
English: Levetiracetam Actavis 500 mg film-coated tablets
Croatian: Levetiracetam Actavis 500 mg filmom obložene tablete
English: Silica colloidal anhydrous Magnesium stearate Polyvinyl alcohol - part. hydrolyzed Macrogol 4000
Croatian: Levetiracetam Actavis 1,000 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label of 500 mg film-coated tablets in tablet containers
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Naljepnica na spremnicima s filmom obloženim tabletama od 500 mg
English: EU/1/11/713/021 20 tablets EU/1/11/713/022 30 tablets EU/1/11/713/023 50 tablets EU/1/11/713/024 60 tablets EU/1/11/713/025 100 tablets EU/1/11/713/026 120 tablets EU/1/11/713/027 200 tablets
Croatian: EU/1/11/713/021 20 tableta EU/1/11/713/022 30 tableta EU/1/11/713/023 50 tableta EU/1/11/713/024 60 tableta EU/1/11/713/025 100 tableta EU/1/11/713/026 120 tableta EU/1/11/713/027 200 tableta
English: Levetiracetam Actavis 1,000 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Actavis 1000 mg filmom obložene tablete levetiracetam
English: EU/1/11/713/011 20 tablets EU/1/11/713/012 30 tablets EU/1/11/713/013 50 tablets EU/1/11/713/014 60 tablets EU/1/11/713/015 100 tablets EU/1/11/713/016 120 tablets EU/1/11/713/017 200 tablets
Croatian: EU/1/11/713/011 20 tableta EU/1/11/713/012 30 tableta EU/1/11/713/013 50 tableta EU/1/11/713/014 60 tableta EU/1/11/713/015 100 tableta EU/1/11/713/016 120 tableta EU/1/11/713/017 200 tableta
English: EU/1/11/713/031 20 tablets EU/1/11/713/032 30 tablets EU/1/11/713/033 50 tablets EU/1/11/713/034 60 tablets EU/1/11/713/035 100 tablets EU/1/11/713/036 120 tablets EU/1/11/713/037 200 tablets
Croatian: EU/1/11/713/031 20 tableta EU/1/11/713/032 30 tableta EU/1/11/713/033 50 tableta EU/1/11/713/034 60 tableta EU/1/11/713/035 100 tableta EU/1/11/713/036 120 tableta EU/1/11/713/037 200 tableta
English: Description of selected adverse reactions
Croatian: Opći poremećaji i reakcije na mjestu primjene
English: in the treatment of primary generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Croatian: • u liječenju primarno generaliziranih toničko-kloničkih napadaja u odraslih i adolescenata od 12.
English: Levetiracetam Actavis 500 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Actavis 500 mg filmom obložene tablete levetiracetam
English: Serum Creatinine (mg/dl)
Croatian: Maximum Recommended Human Dose, izraženom u mg/m2).
English: България Актавис ЕАД
Croatian: Varvara Atena
English: Titanium dioxide (E171) Indigo carmine (E132) Sunset yellow (E110) Iron oxide red (E172)
Croatian: Levetiracetam Actavis 750 mg filmom obložene tablete krospovidon povidon silicijev dioksid, koloidni, bezvodni magnezijev stearat polivinilni alkohol - djelomično hidroliziran makrogol 4000 talk titanijev dioksid (E171) indigo carmine (E132) sunset yellow (E110) crveni željezov oksid (E172)
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Croatian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan (2) (4)
English: Levetiracetam Actavis 750 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Actavis 750 mg filmom obložene tablete levetiracetam
English: Choreoathetosis, dyskinesia, hyperkinesia, gait disturbance, encephalopathy
Croatian: Koreoatetoza, diskinezija, hiperkinezija,
English: Levetiracetam Actavis 250 mg film-coated tablets Levetiracetam
Croatian: Levetiracetam Actavis 250 mg filmom obložene tablete levetiracetam
English: Levetiracetam Actavis 250 mg film-coated tablets
Croatian: Levetiracetam Actavis 250 mg filmom obložene tablete
English: This will be checked by your doctor.
Croatian: To će provjeriti Vaš liječnik.
English: 2304 Orth an der Donau AUSTRIA
Croatian: 2304 Orth an der Donau AUSTRIJA
English: [hours],
Croatian: [sati],
English: EXP: Use immediately or within 3 hours after reconstitution.
Croatian: EXP: Koristiti odmah nakon ili unutar 3 sata od rekonstitucije.
English: Uferstrasse 15
Croatian: Uferstraße 15
English: This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein.
Croatian: Taj se učinak odmah javlja i poznato je da uvelike ovisi o razini polimerizacije proteina.
English: Filtration does not influence dosage calculations.
Croatian: Filtracija ne utječe na izračun doze.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6
Croatian: Lijek se ne smije miješati s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Minimum Duration of treatment
Croatian: Minimalno trajanje liječenja
English: In case of shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju šoka, potrebno je provesti standardnu medicinsku terapiju šoka.
English: Chemical and physical in-use stability has been demonstrated for 3 hours at 25°C.
Croatian: Kemijska i fizikalna stabilnost lijeka u primjeni dokazana je tijekom 3 sata pri 25 °C.
English: In all three studies, subjects were evaluated in the non-bleeding state.
Croatian: U sva tri ispitivanja ispitanici su ocjenjivani u stanju bez krvarenja.
English: You will be monitored carefully for the possibility of having developed these inhibitors.
Croatian: Bit ćete pod pažljivim praćenjem zbog mogućeg razvoja tih inhibitora.
English: Neutralizing antibodies (Inhibitors)
Croatian: Neutralizirajuća antitijela (inhibitori)
English: Do not infuse any faster than 4 mL per minute.
Croatian: Infuzija ne smije biti brža od 4 ml po minuti.
English: Discard after three hours.
Croatian: Bacite nakon tri sata.
English: Like all medicines, this medicine may cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: In all such cases, it is recommended that a specialised haemophilia centre be contacted.
Croatian: U svim takvim slučajevima, preporučuje se kontaktirati specijalizirani centar za hemofiliju.
English: ATC code: B02BD10
Croatian: ATK oznaka: B02BD10
English: Severe symptoms, including difficulty in breathing and dizziness, require prompt emergency treatment.
Croatian: Teški simptomi, uključujući poteškoće pri disanju i omaglicu, zahtijevaju hitno medicinsko liječenje.
English: If such inhibitors occur, the condition may manifest itself as an inadequate clinical response.
Croatian: Ako se pojave takvi inhibitori, to se stanje može očitovati kao neadekvatan klinički odgovor.
English: Be careful not to touch the clear plastic spike.
Croatian: Pazite da ne dotičete prozirni plastični šiljak.
English: It is used when treatment with another medicine, desmopressin, is not effective or cannot be given.
Croatian: Koristi se kada liječenje drugim lijekom, desmopresinom, nije učinkovito ili se ne može primijeniti.
English: Wash your hands and put on clean exam gloves (the use of gloves is optional).
Croatian: Operite ruke i navucite čiste rukavice za pregled (korištenje rukavica nije obavezno).
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Croatian: S obzirom da su te reakcije prijavljene dobrovoljno iz populacije neodređene veličine, nije uvijek moguće pouzdano procijeniti njihovu učestalost ili utvrditi uzročnu povezanost s izloženosti lijeku.
English: Your doctor will calculate the dose that is most appropriate for you, how often you should receive VEYVONDI and for how long.
Croatian: Vaš će liječnik izračunati dozu lijeka koja Vam najbolje odgovara, koliko često trebate primiti VEYVONDI i koliko dugo.
English: Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel SWITZERLAND
Croatian: Baxalta Manufacturing Sarl Route de Pierre-a-Bot 111 CH-2000 Neuchatel ŠVICARSKA
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Croatian: Kategorije učestalosti definirane su prema sljedećoj konvenciji: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000); vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: - Use the reconstituted product within 3 hours to avoid the risk of microbial contamination because the product does not contain preservatives.
Croatian: - Primijenite rekonstituirani lijek u roku od 3 sata kako bi se izbjegla opasnost od kontaminacije mikroorganizmima jer lijek ne sadrži konzervanse.
English: The rate of administration should be slow enough to ensure the comfort of the patient, up to a maximum of 4 mL/min.
Croatian: Primjena treba biti dovoljno spora da bi se osigurala udobnost bolesnika, do najviše 4 ml/min.
English: - Proceed with the next infusion as scheduled and continue as advised by your doctor.
Croatian: - Nastavite sa sljedećom Infuzijom prema rasporedu, onako kako Vam je preporučio liječnik.
English: You can have an allergic reaction to VEYVONDI.
Croatian: Možete imati alergijsku reakciju na VEYVONDI.
English: In the 2 spontaneous post-marketing cases reported, the symptoms resolved and the patients fully recovered in 20 minutes to 4 hours upon stopping the infusion.
Croatian: U prijavljena 2 spontana slučaja nakon stavljanja lijeka u promet, simptomi su se povukli, a pacijenti u potpunosti oporavili u 20 minuta do 4 sata nakon prekida infuzije.
English: Patients should be closely monitored and carefully observed for any symptoms throughout the infusion period.
Croatian: Bolesnike je potrebno pomno pratiti i pažljivo promatrati radi bilo kakvih simptoma tijekom razdoblja infuzije.
English: Healthcare professionals should balance the potential risks and only prescribe VEYVONDI if needed
Croatian: Zdravstveni radnici trebaju odvagnuti potencijalne rizike i VEYVONDI propisati samo ako je to potrebno.
English: Lack of VWF increases the tendency to bleed.
Croatian: Nedostatak VWF-a povećava sklonosti krvarenju.
English: VEYVONDI should not be used in the treatment of Haemophilia A.
Croatian: VEYVONDI se ne smije koristiti u liječenju hemofilije A.
English: Check that all the solvent has transferred.
Croatian: Provjerite da se otapalo potpuno prenijelo.
English: Do not dispose of these supplies in ordinary household trash.
Croatian: Te predmete ne bacajte u običan kućni otpad.
English: If you forget to use VEYVONDI - Do not infuse a double dose to make up for a forgotten dose.
Croatian: Ako ste zaboravili primijeniti VEYVONDI - Nemojte infuzijom davati dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Dosing guidance should be done based on the IR.
Croatian: Smjernice za doziranje trebaju se temeljiti na IR-u.
English: If you use VEYVONDI at home, your doctor will make sure that you are shown how to infuse it and how much to use.
Croatian: Ako VEYVONDI primjenjujete kod kuće, Vaš liječnik će se pobrinuti da Vam se objasni kako ćete si davati infuziju i u kojoj količini.
English: Patients developing inhibitors
Croatian: Bolesnici koji razviju inhibitore
English: Disconnect the empty syringe.
Croatian: Odvojite praznu štrcaljku.
English: Image example
Croatian: Primjer slike
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doza koja se temelji na tjelesnoj težini može zahtijevati prilagodbu u bolesnika s premalenom ili prekomjernom težinom.
English: Subsequent infusions:
Croatian: Naknadne infuzije:
English: In a human ex vivo placenta perfusion model, it has been demonstrated that VEYVONDI does not cross the human placenta barrier.
Croatian: Na modelu perfuzije ljudske placente ex vivo pokazano je da VEYVONDI ne prelazi barijeru ljudske placente.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: Start of treatment
Croatian: Početak liječenja
English: AUC0inf/Dose e
Croatian: AUC0inf/Doza e
English: Trehalose dihydrate Mannitol
Croatian: Trehaloza dihidrat Manitol
English: If you previously had problems with blood clots or vessel occlusion (thromboembolic complications), tell your doctor immediately.
Croatian: Ako ste ranije imali problema s krvnim ugršcima ili začepljenom žilom (tromboembolijske komplikacije), odmah obavijestite liječnika.
English: No investigations on carcinogenicity, fertility impairment and fetal development have been conducted.
Croatian: Nisu provedena nikakva istraživanja kancerogenosti, oštećenja plodnosti i fetalnog razvoja.
English: In addition, one post-marketing case of DVT has been reported spontaneously for an elderly patient.
Croatian: Nadalje, nakon stavljanja lijeka u promet zabilježena je jedna spontana prijava DVT-a za starijeg pacijenta.
English: Table 5 Pharmacokinetic Assessment of VWF:RCo f
Croatian: Tablica 5 Farmakokinetička procjena VWF:RCo f
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 to 8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne upotrijebi odmah, vrijeme i uvjeti čuvanja rekostituiranog lijeka prije primjene odgovornost su korisnika i normalno ne smiju biti dulji od 24 sata pri 2 do 8 °C, osim ako je rekonstitucija provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: The filter included in the Mix2Vial device removes those particles completely.
Croatian: Filtar koji je dio uređaja Mix2Vial potpuno uklanja te čestice.
English: Administered intravenously, VEYVONDI binds to endogenous factor VIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Croatian: Primijenjen intravenski, VEYVONDI se veže na endogeni faktor VIII (koji bolesnik normalno stvara), a stabilizacijom tog faktora izbjegava se njegova brza degradacija.
English: There is a low risk that you may experience a hypersensitivity reaction (a severe, sudden allergic reaction) to VEYVONDI.
Croatian: Postoji niska opasnost od pojave reakcije preosjetljivosti (teška i iznenadna alergijska reakcija) na VEYVONDI.
English: The solution should be slowly administered intravenously (see section 4.2) not exceeding 4 mL/min.
Croatian: Otopina se treba polako primijeniti intravenski (vidjeti dio 4.2) ne brže od 4 ml/min.
English: VEYVONDI is a rVWF that contains ultra-large multimers in addition to all of the multimers found in plasma as it is not exposed to proteolysis by ADAMTS13 during the manufacturing process.
Croatian: VEYVONDI je rVWF koji sadrži ultravelike multimere pored svih multimera iz plazme jer nije izložen proteolizi enzimom ADAMTS13 tijekom proizvodnog postupka.
English: Therefore, patients experiencing hypersensitivity or anaphylactic reactions should be tested and evaluated for the presence of an inhibitor.
Croatian: Stoga bolesnike kod kojih se javlja preosjetljivost ili anafilaktičke reakcije treba testirati i procijeniti vezano uz prisutnost inhibitora.
English: - This medicine is for single use only.
Croatian: - Lijek je samo za jednokratnu uporabu.
English: The safety and efficacy of VEYVONDI in children aged 0 to 18 years have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka VEYVONDI u djece dobi od 0 do 18 godina nisu još ustanovljene.
English: However, in these cases the initially reconstituted solution should not be diluted any further.
Croatian: No, u tim slučajevima inicijalno rekonstituirana otopina ne smije se dodatno razrjeđivati.
English: - Do not store above 30°C.
Croatian: - Nemojte čuvati iznad 30 °C.
English: In patients with the disease the blood does not clot normally leading to a prolonged bleeding time.
Croatian: U bolesnika s tom bolešću krv se ne zgrušava normalno što uzrokuje produljeno krvarenje.
English: You might need a higher dose of VEYVONDI, or a higher dose of factor VIII, or even a different medicine to control bleedings.
Croatian: Možda će Vam biti potrebna veća doza lijeka VEYVONDI, ili veća doza faktora VIII, ili čak neki drugi lijek za kontrolu krvarenja.
English: Experience in the treatment of pregnant or breast-feeding women is not available.
Croatian: Nisu dostupna iskustva u liječenju trudnica ili dojilja.
English: Frequency by Subject: Total number of subjects experiencing the AE (related and unrelated) divided by total number of subjects (N) and multiplied by 100.
Croatian: Učestalost po ispitaniku: Ukupan broj ispitanika sa štetnim događajem (povezanim i nepovezanim) podijeljen ukupnim brojem ispitanika (N) i pomnožen brojem 100.
English: A combination with a FVIII product containing VWF would pose an additional risk of thrombotic events.
Croatian: Kombinacija s lijekom FVIII koji sadrži VWF predstavljala bi dodatni rizik trombotskih događaja.
English: If signs and symptoms of severe allergic reactions occur, immediately discontinue administration of VEYVONDI and provide appropriate supportive care.
Croatian: U slučaju pojave znakova i simptoma teške alergijske reakcije, odmah prekinite primjenu lijeka VEYVONDI i pružite odgovarajuće suportivne mjere.
English: The reconstituted product should be inspected visually prior to administration.
Croatian: Rekonstituirani lijek treba vizualno pregledati prije primjene.
English: Doing so may harm the medicine.
Croatian: Na taj se način može naškoditi lijeku.
English: - VEYVONDI produces delayed correction of the associated factor VIII deficiency.
Croatian: - VEYVONDI stvara odgođenu korekciju povezanog nedostatka faktora VIII.
English: The solution in the syringe should not be used if it is cloudy or contains flakes or particles after filtration.
Croatian: Otopina u štrcaljki ne smije se primjenjivati ako je mutna ili sadrži pahuljice ili čestice nakon filtracije.
English: Based on experience from clinical studies, once VWF has been replaced, endogenous FVIII levels will remain normal or near normal as long as VEYVONDI is continued to be administered.
Croatian: Na temelju iskustva iz kliničkih ispitivanja, nakon nadomjestka VWF, razine endogenog FVIII ostat će normalne ili gotovo normalne sve dok se VEYVONDI nastavi primjenjivati.
English: If you feel that VEYVONDI is not working well enough, talk to your doctor.
Croatian: Ako osjećate da VEYVONDI ne djeluje dovoljno dobro, obratite se svom liječniku.
English: Clb IR at Cmax c
Croatian: IR pri Cmaks c
English: The clinical safety, efficacy and PK data were assessed in 3 completed trials, (070701, 071001 and 071101) which enrolled patients with VWD.
Croatian: Podaci o kliničkoj sigurnosti, djelotvornosti i farmakokinetici procijenjeni su u 3 dovršena ispitivanja, (070701, 071001 i 071101) koja su uključivala bolesnike s VWD-om.
English: Talk to your doctor before using VEYVONDI.
Croatian: Obratite se svom liječniku prije nego primijenite VEYVONDI.
English: Thromboembolic events may occur in case of major overdose.
Croatian: Tromboembolijski događaji mogu se javiti u slučaju velikog predoziranja.
English: VEYVONDI should be administered to pregnant woment only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients.
Croatian: VEYVONDI treba primijeniti u trudnica samo ako je to jasno indicirano, uzevši u obzir da porođaj stvara povećan rizik od događaja krvarenja u tih bolesnica.
English: Take the needle out of the vein and use sterile gauze to put pressure on the infusion site for several minutes.
Croatian: Izvadite iglu iz vene i koristite sterilnu gazu kako biste pritisnuli mjesto infuzije na nekoliko minuta.
English: Type of Surgery
Croatian: Vrsta kirurškog zahvata
English: b[dL/kg/hours],
Croatian: b[dl/kg/sati],
English: Your doctor may adjust the dose according to your laboratory results.
Croatian: Vaš liječnik će možda trebati prilagoditi dozu sukladno laboratorijskim nalazima.
English: Such antibodies may occur in close association with hypersensitivity or anaphylactic reactions.
Croatian: Takva antitijela mogu se javiti u bliskoj povezanosti s preosjetljivošću ili anafilaktičkim reakcijama.
English: In general, the frequency of VEYVONDI dosing for post-operative substitution should range from twice a day to every 48 hours.
Croatian: Općenito, učestalost doziranja lijeka VEYVONDI za postoperativnu nadoknadu treba biti u rasponu od dva puta dnevno do svakih 48 sati.
English: The amount of air should equal the amount of reconstituted VEYVONDI that you will withdraw from the vial.
Croatian: Količina zraka treba biti jednaka količini rekonstituiranog lijeka VEYVONDI koju ćete izvući iz bočice.
English: Sustained increase of FVIII:C was observed by six hours after a single infusion of VEYVONDI.
Croatian: Neprekinuto povećanje FVIII:C uočeno je šest sati nakon jedne infuzije lijeka VEYVONDI.
English: Sodium citrate Glycine
Croatian: Natrijev citrat Glicin
English: Do not use after the expiry date stated on the labels and carton.
Croatian: Nemojte upotrebljavati nakon isteka roka valjanosti navedenog na naljepnicama i kutiji.
English: A bleed could be considered major if red blood cell transfusion is either required or potentially indicated or if bleeding occurs in a critical anatomical site (e.g., intracranial or gastrointestinal haemorrhage).
Croatian: Krvarenje se može smatrati velikim ako je potrebna transfuzija crvenih krvnih stanica ili je potencijalno indicirana ili ako se krvarenje javlja na kritičnim anatomskim mjestima (npr., intrakranijalno ili gastrointestinalno krvarenje).
English: Do not remove butterfly needle until all syringes have been infused and do not touch the Luer port that connects to the syringe.
Croatian: Ne uklanjajte leptir-iglu sve dok infuzijom ne primijenite sve štrcaljke i ne dirajte luer priključak na koji se spaja štrcaljka.
English: Do not remove the Mix2Vial device from the package.
Croatian: Nemojte vaditi uređaj Mix2Vial iz pakiranja.
English: Patients treated with this product may develop hypersensitivity reactions to these non-human mammalian proteins.
Croatian: Bolesnici liječeni ovim lijekom mogu razviti reakcije preosjetljivosti na te proteine sisavaca koji nisu ljudskog podrijetla.
English: 14 The contents of two vials may be drawn into a single syringe.
Croatian: 14 Sadržaj dvije bočice može se uvući u jednu štrcaljku.
English: Within each frequency grouping, undesirable effects are presented in the order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti, nuspojave su navedene prema ozbiljnosti u padajućem nizu.
English: Draw the VEYVONDI into the syringe by pulling plunger back slowly.
Croatian: Uvucite VEYVONDI u štrcaljku povlačeći klip polako unatrag.
English: What VEYVONDI is and what it is used for
Croatian: Što je VEYVONDI i za što se koristi