FrancophonIA/ELRC3.0 huggingface dataset:
English: • Carefully remove the needle protection cap from the needle and throw it away.
Slovenian: • Z igle nežno odstranite zaščitno zaporko in jo zavrzite.
English: • After cleaning, do not touch the rubber stopper or allow it to touch any surface.
Slovenian: • Po čiščenju se gumijastega zamaška več ne dotikajte in ne dovolite, da se dotakne kakšne druge površine.
English: If more than 12 hours have passed since the dose was to have been given, the missed dose should NOT be administered and the next dose should be administered per the usual dosing schedule.
Slovenian: Če mine več kot 12 ur od takrat, ko bi bilo treba odmerek dati, se izpuščenega odmerka NE sme dati; naslednji odmerek se da po običajnem urniku odmerjanja.
English: If needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis.
Slovenian: Po potrebi se lahko za korekcijo hemostaze razmisli o uporabi koncentrata von Willebrandovega faktorja.
English: This was followed by daily subcutaneous injections of 10 mg caplacizumab or placebo after completion of each plasma exchange for the duration of the daily plasma exchange period and for 30 days thereafter.
Slovenian: Temu je sledilo dnevno subkutano injiciranje 10 mg kaplacizumaba ali placeba vsakokrat po izvedeni izmenjavi plazme, kar se je nadaljevalo celotno obdobje dnevne izmenjave plazme in še 30 dni zatem.
English: • Put the vial and the attached adapter into the supplied disposal container.
Slovenian: • Vialo in priključen nastavek odložite v vsebnik za odpadke, ki so vam ga dali.
English: Do not shake it.
Slovenian: Ne stresajte je.
English: • While keeping it vertical, slowly pull the plunger to transfer all the solution into the syringe.
Slovenian: • Držite jo vertikalno in počasi vlecite za bat, da vso raztopino prenesete v injekcijsko brizgo.
English: First dose Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
Slovenian: Prvi odmerek Intravenska injekcija 10 mg kaplacizumaba pred izmenjavo plazme.
English: The intravenous bolus injection of Cablivi given at the start of the treatment must be administered by a health care professional.
Slovenian: Intravensko bolusno injekcijo zdravila Cablivi na začetku zdravljenja mora dati zdravstveni delavec.
English: The pharmacologic effect of caplacizumab on target disposition was measured using von Willebrand factor antigen and factor VIII clotting activity (factor VIII:C) as biomarkers.
Slovenian: Farmakološki učinek kaplacizumaba na razpoložljivost tarčnega mesta so izmerili z antigenom von Willebrandovega faktorja in aktivnostjo strjevanja faktorja VIII (faktor VIII:C) kot biomarkerjema.
English: Pre-filled syringe (type I glass cartridge closed with a bromobutyl rubber stopper) with 1 mL of water for injections.
Slovenian: Napolnjena injekcijska brizga (vložek iz stekla tipa I, zaprt z zamaškom iz bromobutilne gume) z 1 ml vode za injekcije.
English: 1 vial with powder 1 syringe with solvent 1 sterile vial adapter 1 sterile needle 2 alcohol swabs
Slovenian: 1 viala s praškom 1 brizga z vehiklom 1 sterilen nastavek za vialo 1 sterilna igla 2 alkoholni blazinici
English: It also affects the disposition of von Willebrand factor, leading to transient reductions of total von Willebrand factor antigen levels and to concomitant reduction of factor VIII:C levels during treatment.
Slovenian: Vpliva tudi na razpoložljivost von Willebrand faktorja, kar povzroči prehodno znižanje skupne ravni antigena von Willebrandovega faktorja in sočasno znižanje ravni faktorja VIII:C med zdravljenjem.
English: Contact your doctor or nurse if this happens.
Slovenian: V tem primeru se posvetujte z zdravnikom ali medicinsko sestro.
English: Subsequent doses are to be administered via subcutaneous injection in the abdomen.
Slovenian: Naslednje odmerke se da v obliki subkutane injekcije v trebuh.
English: Increased risk of bleeding
Slovenian: Zvečano tveganje za krvavitve.
English: • Take the vial with the attached adapter.
Slovenian: • Vzemite vialo s priključenim nastavkom.
English: • Hold the syringe at eye level with the needle pointing upwards.
Slovenian: • Injekcijsko brizgo držite v višini oči tako, da gleda igla navzgor.
English: How to use Cablivi
Slovenian: Kako uporabljati zdravilo Cablivi
English: Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
Slovenian: Dnevno subkutano dajanje 10 mg kaplacizumaba po vsaki končani izmenjavi plazme za trajanje dnevnega zdravljenja z izmenjavo plazme, čemur mu sledijo dnevne subkutane injekcije 10 mg kaplacizumaba še 30 dni po prenehanju dnevnega zdravljenja z izmenjavo plazme.
English: As such, caplacizumab prevents the ultralarge von Willebrand factor-mediated platelet adhesion, which is characteristic of aTTP.
Slovenian: Tako kaplacizumab preprečuje z von Willebrandovim faktorjem posredovano ultra veliko adhezijo trombocitov, ki je značilna za aTPP.
English: Cablivi should only be restarted upon the advice of a physician experienced in the management of thrombotic microangiopathies.
Slovenian: Zdravljenje z zdravilom Cablivi se sme nadaljevati šele po nasvetu zdravnika z izkušnjami v obravnavi trombotičnih mikroangiopatij.
English: • Do not touch the syringe tip or allow it to touch the surface.
Slovenian: • Ne dotikajte se konice injekcijske brizge in ne dovolite, da se dotakne površine.
English: The solvent should be added slowly and mixed gently to avoid foaming of the solution.
Slovenian: Vehikel dodajajte počasi in ga nežno mešajte, da se raztopina ne speni.
English: • water for injections in a pre-filled syringe to dissolve the powder After dissolving the powder in the solvent, the solution is clear, colourless or slightly yellowish.
Slovenian: • voda za injiciranje v napolnjeni injekcijski brizgi, s katero se prašek raztopi Ko se prašek v vehiklu raztopi, dobimo bistro, brezbarvno do nekoliko rumenkasto raztopino.
English: Cablivi may be stored at room temperature (not above 25 °C) for a single period of up to 2 months.
Slovenian: Zdravilo Cablivi je dovoljeno za enkratno največ 2-mesečno obdobje shranjevati pri sobni temperaturi (do 25 °C).
English: The first injection of Cablivi into your vein must be given by a healthcare professional.
Slovenian: Prvo injekcijo zdravila Cablivi v veno vam mora dati zdravstveni delavec.
English: Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies) is to be accompanied by close clinical monitoring.
Slovenian: Zaradi možnega zvečanega tveganja za krvavitev je treba pri uporabi zdravila Cablivi pri bolnikih s koagulopatijo kot osnovno boleznijo (npr. hemofilijo, drugimi pomanjkanji koagulacijskih faktorjev) izvajati natančno klinično spremljanje.
English: No data on re-treatment with caplacizumab are available.
Slovenian: Ni podatkov o ponovljenem zdravljenju s kaplacizumabom.
English: • Select a suitable place (‘injection site') on your belly for injection under your skin.Avoid the area around the belly button.
Slovenian: • Izberite primerno mesto ("mesto injiciranja") na trebuhu za injiciranje pod kožo.
English: See section 4.4 for special considerations in patients with severe hepatic impairment.
Slovenian: Za posebne pomisleke pri bolnikih s hudo okvaro jeter glejte poglavje 4.4.
English: For both intravenous and subcutaneuous administration,reconstitute the powder contained in the vial using the vial adapter and all solvent in the pre-filled syringe.
Slovenian: Za intravensko in subkutano dajanje s pomočjo nastavka za vialo rekonstituirajte prašek v viali z vso količino vehikla v napolnjeni injekcijski brizgi.
English: Disconnect the filled syringe from the adapter by holding the adapter in one hand and gently turning the syringe counter-clockwise.
Slovenian: Napolnjeno injekcijsko brizgo ločite od nastavka tako, da nastavek držite v eni roki in injekcijsko brizgo nežno obračate v levo.
English: Step 13 - After administration
Slovenian: 13. korak - Po dajanju
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1305/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/18/1305/001 EU/1/18/1305/003
English: • With the syringe still connected to the vial adapter, gently swirl the vial with connected syringe until the powder is dissolved.
Slovenian: • Z injekcijsko brizgo povezano z nastavkom za vialo nežno obračajte vialo s priključeno injekcijsko brizgo, dokler se prašek ne raztopi.
English: • bleeding from eye
Slovenian: • krvavitev iz očesa
English: • Prepare a clean flat surface for placing the kit package.
Slovenian: • Pripravite čisto ravno površino, na katero položite pakiranje s kompletom.
English: • Use the second alcohol pad to clean the injection site you have chosen.
Slovenian: • Za očiščenje izbranega mesta injiciranje uporabite drugo alkoholno blazinico.
English: In animal toxicology studies, no impact of caplacizumab on male and female fertility parameters was observed (see section 5.3).
Slovenian: V študijah toksičnost pri živalih niso opazili vpliva kaplacizumaba na parametre plodnosti pri samcih in samicah (glejte poglavje 5.3).
English: Dyspnoea, Haemoptysis*
Slovenian: dispneja, hemoptiza*
English: The other ingredients are sucrose, citric acid anhydrous, trisodium citrate dihydrate and polysorbate 80.
Slovenian: - Druge sestavine so saharoza, brezvodna citronska kislina, trinatrijev citrat dihidrat in polisorbat 80.
English: Step 10 - Attach the needle
Slovenian: 10. korak - Priključitev igle
English: Gingival bleeding* Haematemesis*, haematochezia*, melaena*, upper gastrointestinal haemorrhage*, haemorrhoidal haemorrhage*, rectal haemorrhage *, abdominal wall haematoma*
Slovenian: hematemeza*, hematohezija, melena*, krvavitev iz zgornjih prebavil*, hemoroidna krvavitev*, krvavitev iz rektuma*, hematom trebušne stene*
English: An overdose is unlikely since one vial contains only a single dose.
Slovenian: Če ste uporabili večji odmerek zdravila Cablivi, kot bi smeli Ni verjetno, da bi uporabili večji odmerek, ker vsebuje ena viala samo en odmerek.
English: • pre-filled syringe The pre-filled syringe contains 1 mL water for injections.
Slovenian: • napolnjena injekcijska brizga Napolnjena injekcijska brizga vsebuje 1 ml vode za injekcije.
English: Close monitoring for signs and symptoms of bleeding is recommended.
Slovenian: Priporoča se natančno spremljanje glede znakov in simptomov krvavitve (glejte poglavje 4.4).
English: An embryo-foetal development study was conducted in guinea pigs, with no reported signs of toxicity.
Slovenian: V študiji razvoja zarodka in plodu, ki so jo opravili pri morskih prašičkih, niso opazili znakov toksičnosti.
English: Select a different injection site from the one you used on the previous day to help the skin to recover after the injection.'
Slovenian: Vsak dan izberite drugo mesto injiciranja, da si koža po injiciranju opomore.
English: Step 6 - Connect syringe with adapter and vial
Slovenian: 6. korak - Injekcijsko brizgo povežite z nastavkom in vialo
English: Tell your doctor if you are breastfeeding.
Slovenian: Zdravniku povejte, če dojite.
English: LIST OF EXCIPIENTS Excipients: sucrose, citric acid anhydrous, trisodium citrate dihydrate, polysorbate 80.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: saharoza, brezvodna citronska kislina, trinatrijev citrat dihidrat, polisorbat 80.
English: Cablivi can be intravenously administered by connecting the prepared syringe to standard Luer locks of IV lines or using a suitable needle.
Slovenian: Zdravilo Cablivi se lahko uporabi intravensko s priključitvijo pripravljene injekcijske brizge na standardni priključek Luer lock na i.v.
English: • Hold the adapter with the attached vial with one hand.
Slovenian: • V eni roki držite nastavek s priključeno vialo.
English: • Remove the plastic flip-off cap from the vial.
Slovenian: • Z viale odstranite plastično snemljivo zaporko.
English: Avoid foaming.
Slovenian: Preprečite penjenje.
English: By doing so, Cablivi reduces the risk of experiencing another episode of aTTP soon after the first.
Slovenian: Na ta način zdravilo Cablivi zmanjša tveganje, da bi se ponovila še ena epizoda trombotične trombocitopenične purpure (acquired thrombotic thrombocytopenic purpura, aTTP) kmalu po prvi.
English: • Turn the whole - vial, adapter and syringe - upside down.
Slovenian: • Vse - vialo, nastavek in injekcijsko brizgo - obrnite na glavo.
English: Each vial contains 10 mg caplacizumab.
Slovenian: Ena viala vsebuje 10 mg kaplacizumaba.
English: Target disposition
Slovenian: Razpoložljivost tarčnega mesta
English: No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Slovenian: Pri bolnikih z okvaro jeter odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora epistaksa*
English: Injury, Poisoning And Procedural Complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih subarahnoidna krvavitev*
English: • Gently lock the syringe onto the vial by turning it clockwise until resistance is felt.
Slovenian: • Nežno zaklenite injekcijsko brizgo na vialo z obračanjem v desno, dokler ne začutite upora.
English: • Check the solution for particles.
Slovenian: • Preverite, ali so v raztopini delci.
English: • Without removing the needle cap, attach the needle to the syringe by turning clockwise until resistance is felt.
Slovenian: • Ne odstranite zaporke z igle in iglo priključite na injekcijsko brizgo z obračanjem v desno, dokler ne začutite upora.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Slovenian: Okvara ledvic Pri bolnikih z okvaro ledvic odmerka ni treba prilagajati (glejte poglavje 5.2).
English: Step 9 - Prepare the syringe for administration
Slovenian: 9. korak - Priprava brizge na dajanje
English: Number of days in ICU
Slovenian: Število dni na oddelku za intenzivno nego
English: Read the package leaflet before use Intravenous and subcutaneous use For single use only
Slovenian: intravenska in subkutana uporaba Samo za enkratno uporabo.
English: • multidose packs each containing 7 vials with caplacizumab powder, 7 pre-filled syringes with solvent, 7 vial adapters, 7 needles and 14 alcohol swabs.
Slovenian: • večodmernem pakiranju, ki vsako vsebuje 7 vial s praškom, 7 napolnjenih injekcijskih brizg z vehiklom, 7 nastavkov za vialo, 7 igel in 14 alkoholnih blazinic.
English: • single packs each containing 1 vial with caplacizumab powder, 1 pre-filled syringe with solvent, 1 vial adapter, 1 needle and 2 alcohol swabs
Slovenian: • enoodmernem pakiranju, ki vsebuje 1 vialo s praškom kaplacizumaba, 1 napolnjeno injekcijsko brizgo z vehiklom, 1 nastavek za vialo, 1 iglo in 2 alkoholni blazinici
English: Eye Haemorrhage*
Slovenian: Očesne bolezni krvavitev v očesu*
English: Step 7 - Prepare the solution
Slovenian: 7. korak - Priprava raztopine
English: Step 12 - Administration
Slovenian: 12. korak - Dajanje
English: Each vial of powder contains 10 mg of caplacizumab*.
Slovenian: Ena viala s praškom vsebuje 10 mg kaplacizumaba*.
English: Step 5 - Prepare the syringe
Slovenian: 5. korak - Priprava injekcijske brizge
English: NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection
Slovenian: IME ZDRAVILA Cablivi 10 mg prašek in vehikel za raztopino za injiciranje
English: In the setting of concomitant use of oral anticoagulants or high dose heparin Due to a potential increased risk of bleeding, initiation or continuation of treatment with oral anticoagulants or high dose heparin requires a benefit/risk assessment and close clinical monitoring.
Slovenian: Zaradi možnega zvečanega tveganja za krvavitve je potrebno pri uvedbi ali nadaljevanju zdravljenja s peroralnimi antikoagulanti ali velikimi odmerki heparina opraviti oceno koristi/tveganja in uvesti natančno klinično spremljanje.
English: While no increased risk of bleeding was observed in clinical trials, concomitant treatment with antiplatelet agents and / or LMWH requires a benefit/risk assessment and close clinical monitoring.
Slovenian: Pri sočasni uporabi protitrombocitnih zdravil in/ali nizkomolekularnega heparina Čeprav v kliničnih preskušanjih niso opazili večjega tveganja za krvavitev, je ob sočasnem zdravljenju s protitrombocitnimi zdravili in/ali nizkomolekularnih heparinom treba opraviti oceno koristi/tveganja in uvesti natančno klinično spremljanje.
English: METHOD AND ROUTE OF ADMINISTRATION For single use only
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Samo za enkratno uporabo.
English: What Cablivi contains
Slovenian: Kaj vsebuje zdravilo Cablivi
English: Citric acid anhydrous Trisodium citrate dihydrate Polysorbate 80
Slovenian: 6.1 Seznam pomožnih snovi prašek saharoza brezvodna citronska kislina trinatrijev citrat dihidrat polisorbat 80
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Ablynx NV
Slovenian: IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM Ablynx NV
English: • Press the plunger down as far as it goes.
Slovenian: • Bat pritisnite do konca navzdol.
English: • Do not touch the syringe tip or allow it to come into contact with any surfaces.
Slovenian: • Konice injekcijske brizge se ne dotikajte in ne dovolite, da se dotakne kakšne druge površine.
English: Step 4 - Attaching the adapter
Slovenian: 4. korak - Priključitev nastavka
English: No formal study with caplacizumab has been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of caplacizumab in these populations are available.
Slovenian: Formalnih študij s kaplacizumabom pri bolnikih s hudo akutno ali kronično okvaro jeter niso izvedli in podatkov glede uporabe kaplacizumaba pri tej populaciji ni. Za uporabo zdravila Cablivi pri tej populaciji je treba opraviti oceno koristi/tveganja in uvesti natančno klinično spremljanje.
English: Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Slovenian: Cablivi 10 mg prašek in vehikel za raztopino za injiciranje kaplacizumab
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON Multipack (without Blue Box) NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA Večodmerno pakiranje (brez modrega okenca) IME ZDRAVILA Cablivi 10 mg prašek in vehikel za raztopino za injiciranje kaplacizumab
English: Pharmacokinetics of caplacizumab appear as non-dose proportional, as characterized by targetmediated disposition.
Slovenian: Kaže, da farmakokinetika kaplacizumaba ni odvisna od odmerka, na kar kaže razpoložljivost zdravila, odvisna od tarčnega mesta.
English: • Take the packed vial adapter and remove the paper cover.
Slovenian: • Z zapakiranega nastavka za vialo odstranite papirnat ovoj.
English: Your doctor may decide that you or your caregiver may inject Cablivi.
Slovenian: Zdravnik se lahko odloči, da si lahko zdravilo Cablivi injicirate sami ali ga vam injicira negovalec.
English: • Remove any air bubbles by tapping the side of the syringe with your finger to make the bubbles rise towards the tip.
Slovenian: • Po strani injekcijske brizge potolcite s prstom, da se morebitni zračni mehurčki dvignejo do konice.
English: 7 vials with powder 7 syringes with solvent 7 sterile vial adapters 7 sterile needles 14 alcohol swabs
Slovenian: 7 vial s praškom 7 brizg z vehiklom 7 sterilnih nastavkov za vialo 7 sterilnih igel
English: • Press down firmly until the adapter snaps into place, with the adapter spike going through the vial stopper.
Slovenian: • Čvrsto pritiskajte navzdol, da se nastavek zaskoči, konica nastavka pa prebode zamašek viale.
English: hypodermic needle (30 gauge) and 2 alcohol swabs.
Slovenian: 7 nastavkov za vialo, 7 hipodermičnih igel (velikosti 30G) in 14 alkoholnih blazinic.
English: STATEMENT OF ACTIVE SUBSTANCE Each vial of powder contains 10 mg caplacizumab.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena viala s praškom vsebuje 10 mg kaplacizumaba.
English: How to store Cablivi
Slovenian: Shranjevanje zdravila Cablivi
English: Do not touch the adapter itself.
Slovenian: Nastavka se ne dotikajte.
English: Injection site haemorrhage*, injection site pruritus, injection site erythema, injection site reaction
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, utrujenost krvavitev na mestu injiciranja*, pruritus na mestu injiciranja, eritem na mestu injiciranja, reakcija na mestu injiciranja
English: • bruise
Slovenian: • modrice
English: Willebrand factor antigen, and consequently factor VIII:C, were noted in cynomolgus monkeys and, to a lesser extent for factor VIII:C, in guinea pigs.
Slovenian: Nadalje so opazili s farmakologijo povezano znižanje ravni antigena von Willebrandovega faktorja ter posledično faktorja VIII:C pri opicah cynomolgus, kot tudi pri morskih prašičkih, pri katerih je do znižanja ravni faktorja VIII:C prišlo v manjši meri.
English: • If you get any side effects, talk to your doctor or pharmacist.
Slovenian: • Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom ali farmacevtom.
English: Target-bound caplacizumab is assumed to be catabolised within the liver, whereas unbound caplacizumab is assumed to be renally cleared.
Slovenian: Predvideva se, da se kaplacizumab, vezan na tarčno mesto, v jetrih katabolizira, za nevezan kaplacizumab pa se predvideva ledvični očistek.
English: Step 8 - Draw up solution
Slovenian: 8. korak - Izvlek raztopine
English: Cerebral infarction
Slovenian: Bolezni živčevja glavobol možganska kap
English: Subarachnoid haemorrhage*
Slovenian: Bolezni sečil hematurija*
English: • bleeding from the stomach
Slovenian: • krvavitev v želodcu
English: • powder vial The active substance is caplacizumab.
Slovenian: • viala s praškom - Učinkovina je kaplacizumab.
English: Each pre-filled syringe of solvent contains 1 mL of water for injections.
Slovenian: Ena napolnjena injekcijska brizga z vehiklom vsebuje 1 ml vode za injekcije.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON Multipack (contains Blue Box) NAME OF THE MEDICINAL PRODUCT Cablivi 10 mg powder and solvent for solution for injection caplacizumab
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA Večodmerno pakiranje (vsebuje modro okence) IME ZDRAVILA Cablivi 10 mg prašek in vehikel za raztopino za injiciranje kaplacizumab
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA prašek in vehikel za raztopino za injiciranje Bel liofiliziran prašek.
English: There are no data on the use of caplacizumab in breastfeeding women.
Slovenian: Podatkov o uporabi kaplacizumaba pri doječih ženskah ni. Ni znano, ali se kaplacizumab izloča v materino mleko.
English: Place the syringe on the clean flat surface.
Slovenian: Injekcijsko brizgo položite na čisto ravno površino.
English: • Pull out the needle at the same angle you inserted it. Do not rub the injection site.
Slovenian: • Iglo izvlecite pod enakim kotom, kot ste jo vstavili.
English: Because von Willebrand factor acts as a carrier for factor VIII, reduced von Willebrand factor antigen levels resulted in a similar reduction in factor VIII:C levels.
Slovenian: Ker deluje von Willebrandov faktor kot nosilec za faktor VIII, so znižane ravni antigena von Willebrandovega faktorja povzročile podobno znižanje ravni faktorja VIII:C. Znižane ravni antigena von Willebrandovega faktorja in FVIII:C so bile prehodne in so se po prekinitvi zdravljenja vrnile na izhodiščne.
English: Marketing Authorisation Holder and Manufacturer Ablynx NV
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Ablynx NV
English: • vomiting blood
Slovenian: • bruhanje krvi
English: • tiredness
Slovenian: • koprivnica
English: • bleeding gums
Slovenian: • izkašljevanje krvi
English: • Place the syringe on the clean flat surface.
Slovenian: • Injekcijsko brizgo položite na čisto ravno površino.
English: Step 3 - Disinfect the rubber stopper
Slovenian: 3. korak - Razkužite gumijast zamašek