FrancophonIA/ELRC3.0 huggingface dataset:
English: ● A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution.
Slovenian: ● Za injiciranje do 1 ml raztopine zdravila Hemlibra je treba uporabiti 1-ml brizgo.
English: The total amount time outside cold storage and at room temperature should not exceed 7 days.
Slovenian: Skupni čas, ko zdravilo ni shranjeno na hladnem in je na sobni temperaturi, ne sme preseči 7 dni.
English: Ask your healthcare provider if you have any questions.
Slovenian: Če imate kakšna vprašanja, se posvetujte z zdravnikom.
English: ABR (95% CI) % reduction (RR), p-value % patients with 0 bleeds (95% CI)
Slovenian: ABR (95-% IZ) % zmanjšanje (RR), vrednost p % bolnikov z 0 krvavitvami (95-% IZ)
English: HAVEN 1 health-related outcomes
Slovenian: Zdravstveni izidi v študiji HAVEN 1
English: Patient's bodyweight of 40 kg, under a maintenance dose regimen of 3 mg/kg every two weeks:
Slovenian: Bolnik s telesno maso 40 kg s shemo vzdrževalnega odmerka 3 mg/kg na dva tedna:
English: Table 9 HAVEN 1: Change in Haem-A-QoL Physical Health and Total score with Hemlibra prophylaxis versus no prophylaxis in patients ≥ 18 years with factor VIII inhibitors
Slovenian: Študija HAVEN 1: Sprememba ocene telesnega zdravja in celotne ocene na lestvici Haem-A-QoL med bolniki, ki so prejemali profilakso z zdravilom Hemlibra, v primerjavi z bolniki, ki niso prejemali profilakse, starimi ≥ 18 let z inhibitorji faktorja VIII
English: *Cavernous sinus thrombosis
Slovenian: *tromboza kavernoznega sinusa občasni
English: ● Discard vials that have been kept at room temperature for more than 7 days or have been in temperatures above 30°C.
Slovenian: ● Viale, ki so bile shranjene na sobni temperaturi več kot 7 dni, ali na temperaturi nad 30 °C,
English: One patient resumed Hemlibra following resolution of TMA without recurrence.
Slovenian: Ko je TMA izzvenela, je en bolnik nadaljeval zdravljenje z zdravilom Hemlibra brez ponovitve.
English: Table 2 Summary of adverse drug reactions from pooled HAVEN clinical trials with Hemlibra
Slovenian: Povzetek neželenih učinkov iz vseh kliničnih preskušanj HAVEN zdravila
English: ● Transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip, and
Slovenian: ● Igla za prenos: iz nerjavnega jekla z Luer-lock nastavkom, debelina 18 G, dolžina 35 mm (1½″), po možnosti s poltopo konico, in
English: ● Do not detach the injection needle.
Slovenian: ● Igle za injiciranje ne snemite.
English: ● Keep your finger pressed down on the syringe plunger.
Slovenian: ● S prstom še naprej tiščite bat brizge.
English: ● With the needle pointing upwards, push on the plunger to inject the air from the syringe above the medicine.
Slovenian: ● Medtem, ko igla gleda navzgor, potisnite bat in iztisnite zrak iz brizge nad zdravilo.
English: ● Only use the syringes, vial adapters, and injection needles that your healthcare provider prescribes.
Slovenian: ● Uporabljajte samo brizge, adapterje za viale in igle za injiciranje, ki vam jih predpiše zdravnik.
English: - Activated partial thromboplastin time (aPTT) - Bethesda assays (clotting-based) for FVIII inhibitor titers - One-stage, aPTT-based, single-factor assays - aPTT-based activated protein C resistance (APC-R) - Activated clotting time (ACT)
Slovenian: - Neodzivnost na aktivirani protein C na podlagi aPTČ (APC-R) - Aktivirani čas strjevanja (ACT)
English: Step 3.
Slovenian: 3. korak.
English: Arm C: No Prophylaxis (N = 18)
Slovenian: Skupina C: Brez profilakse (n = 18)
English: ● Only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes.
Slovenian: ● Uporabljajte samo brizge, igle za prenos in igle za injiciranje, ki vam jih predpiše zdravnik.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mg/1 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 mg/1 ml
English: Hemlibra 1.5 mg/kg weekly (N = 48)
Slovenian: 1,5 mg/kg zdravila Hemlibra na teden (n = 48)
English: Dose up-titration to 3 mg/kg once weekly was allowed after 24 weeks on Hemlibra prophylaxis for patients who experienced two or more qualified bleeds (i.e. spontaneous and verified clinically significant bleeds occurring at steady state).
Slovenian: Hemlibra je bilo za bolnike, ki so imeli dve kvalificirani krvavitvi ali več (tj.spontana in preverjena klinično pomembna krvavitev, ki se je pojavila v stanju dinamičnega ravnovesja) dovoljeno povečanje odmerka na 3 mg/kg enkrat na teden.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/0.4 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 mg/0,4 ml
English: Difference in adjusted means (95% CI)
Slovenian: Razlika korigiranih povprečij (95-% IZ)
English: When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
Slovenian: Za spremljanje bolnikovih ostalih testov hemostaze, na katere emicizumab ne vpliva, glejte poglavje 4.4.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg/1mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 mg/1 ml
English: ● Put your used needles and syringes in a sharps disposal container right away after use.
Slovenian: ● Uporabljene igle in brizge takoj po uporabi zavrzite v vsebnik za ostre odpadke.
English: Instructions for Use Hemlibra Injection Single-Dose Vial(s)
Slovenian: Navodila za uporabo Hemlibra Injekcija Viala/viale z enkratnim odmerkom
English: Emicizumab increases coagulation potential, therefore the FVIIa or FVIII dose required to achieve hemostasis may be lower than when used without Hemlibra prophylaxis.
Slovenian: Emicizumab poveča koagulacijski potencial, zato so lahko odmerki rFVIIa ali FVIII,
English: No adequate or well-controlled drug-drug interaction studies have been conducted with emicizumab.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Z emicizumabom ni bilo izvedenih ustreznih ali dobro kontroliranih študij medsebojnega delovanja zdravil.
English: Step B. Remove transfer needle
Slovenian: Korak B. Snemite iglo za prenos
English: Following intravenous administration of 0.25 mg/kg in healthy subjects, the total clearance of emicizumab was 3.26 mL/kg/day (i.e. 0.228 L/d for a 70-kg adult) and the mean terminal half-life was 26.7 days.
Slovenian: 3,26 ml/kg/dan (to je 0,228 l/d pri 70 kg težkem odraslem) in povprečni končni razpolovni čas
English: Each vial contains 30 mg emicizumab in 1 mL of solution for injection.
Slovenian: Ena viala vsebuje 30 mg emicizumaba v 1 ml raztopine za injiciranje.
English: ● You must inject Hemlibra only under the skin.
Slovenian: ● Zdravilo Hemlibra morate injicirati le podkožno.
English: Step 4.
Slovenian: 4. korak.
English: One patient resumed Hemlibra following resolution of TMA and continued to be treated safely.
Slovenian: Ko je TMA izzvenela, je en bolnik ponovno začel zdravljenje z zdravilom Hemlibra in ga varno nadaljeval.
English: METHOD OF ADMINISTRATION Do not shake.
Slovenian: POSTOPEK UPORABE Ne pretresajte
English: Do not use if the expiry date has passed.
Slovenian: Če je rok uporabnosti že potekel, omenjenega ne uporabite.
English: Warning on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and information that single-factor assays utilizing chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific consideration for factor VIII chromogenic activity assays;
Slovenian: Opozorilo, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in informacije, da emicizumab ne vpliva na teste za določanje posameznih faktorjev z uporabo kromogenih ali imunskih metod in se lahko uporablja za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII; Kontaktni podatki zdravnika, ki je bolniku predpisal emicizumab; Izobraževalno gradivo za bolnike/skrbnike mora vsebovati:
English: ● HEMLIBRA Instructions for Use
Slovenian: ● Navodilo za uporabo
English: Step 13.
Slovenian: 13. korak.
English: Step 2.
Slovenian: 2. korak.
English: Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection.
Slovenian: Ena viala vsebuje 60 mg emicizumaba v 0,4 ml raztopine za injiciranje.
English: Arm B: Hemlibra 3 mg/kg every 2 weeks (N = 35)
Slovenian: Skupina B: 3 mg/kg zdravila Hemlibra na 2 tedna (n = 35)
English: ● Do not touch exposed needles or place them on a surface once the cap has been removed.
Slovenian: ● Izpostavljenih igel se po odstranitvi pokrovčka ne dotikajte in jih nikamor ne polagajte.
English: ● Keep the transfer needle, injection needle and syringe dry.
Slovenian: ● Poskrbite, da ostanejo igla za prenos, igla za injiciranje in injekcijska brizga suhe.
English: Information on assays and methods not affected by emicizumab and that may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays;
Slovenian: Informacije o testih in metodah, na katere emicizumab ne vpliva, in se lahko uporabljajo za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII;
English: INFORMATION IN BRAILLE hemlibra 150 mg
Slovenian: PODATKI V BRAILLOVI PISAVI hemlibra 150 mg
English: A doctor qualified to care for patients with haemophilia will start you on treatment with Hemlibra.
Slovenian: Zdravljenje z zdravilom Hemlibra vam bo uvedel zdravnik, usposobljen za vodenje bolnikov s hemofilijo.
English: Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment beyond a maximum of 100 U/kg in the first 24-hours.
Slovenian: Če lečeči zdravnik razmišlja o zdravljenju z aPCC v odmerku, večjem od maksimalnega 100 e./kg v prvih 24 urah, mora skrbno pretehtati tveganje za TMA in trombembolijo v primerjavi s tveganjem za krvavitev.
English: Description of the signs and symptoms of the following safety concerns and reminder of the importance of immediately stopping using Hemlibra and aPCC and notifying their treating physician if symptoms occur : - Destruction of red blood cells (thrombotic microangiopathy) - Blood clots (thromboembolism)
Slovenian: Opis znakov in simptomov spodnjih varnostnih tveganj ter opomnik o pomenu takojšnjega prenehanja uporabe zdravila Hemlibra in aPCC ter obveščanja lečečega zdravnika v primeru pojava simptomov:
English: - Bethesda assays (bovine chromogenic) for FVIII inhibitor titers - Thrombin time (TT) - One-stage, prothrombin time (PT)-based, single-factor assays - Chromogenic-based single-factor assays other than FVIII1
Slovenian: - Trombinski čas (TČ) - Enostopenjska metoda določanja aktivnosti faktorja na podlagi protrombinskega časa (PČ) - Kromogena metoda določanja aktivnosti faktorja razen FVIII1
English: After storage at room temperature, unopened vials may be returned back to the refrigerator.
Slovenian: Po shranjevanju na sobni temperaturi lahko neodprte viale vrnete nazaj v hladilnik.
English: Do not insert the injection needle into vial adapter or use the injection needle to withdraw medicine from vial.
Slovenian: Igle za injiciranje ne vstavljajte v adapter za vialo ali za jemanje zdravila iz viale.
English: Serious thrombotic events were reported from a clinical trial in patients receiving Hemlibra prophylaxis when on average a cumulative amount of >100U/kg/24 hours of aPCC for 24 hours or more was administered (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o resnih primerih trombotičnih dogodkih pri bolnikih, ki so prejemali profilakso z zdravilom Hemlibra in sočasno aPCC, in sicer, kadar so oboje prejemali 24 ur ali več in pri povprečni kumulativni količini aPCC > 100 e./kg/24 ur (glejte poglavje 4.8).
English: The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Slovenian: Celotni volumen zdravila Hemlibra, ki ga je treba injicirati subkutano, se izračuna takole: celotna količina (mg) emicizumaba, ki jo je treba uporabiti ÷ koncentracija v viali (mg/ml) = celotni volumen zdravila Hemlibra (ml), ki ga je treba injicirati Pri pripravi celotnega potrebnega volumna se v isti injekcijski brizgi ne sme kombinirati različnih koncentracij (30 mg/ml in 150 mg/ml) zdravila Hemlibra.
English: Hemlibra 150 mg/mL solution for injection
Slovenian: Hemlibra 150 mg/ml raztopina za injiciranje
English: ● 1 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL or
Slovenian: ● 1-ml brizga: prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,01 ml ali
English: Hemlibra is a colourless to slightly yellow solution.
Slovenian: Zdravilo Hemlibra je brezbarvna do rumenkasta raztopina.
English: ● Maintenance dose (from week 5 on) example: 60 kg x 6 mg/kg = 360 mg of emicizumab needed for the maintenance dose.
Slovenian: ● Vzdrževalni odmerek (od 5. tedna naprej): 60 kg x 6 mg/kg = 360 mg emicizumaba, potrebnega za vzdrževalni odmerek.
English: INFORMATION IN BRAILLE hemlibra 60 mg
Slovenian: PODATKI V BRAILLOVI PISAVI hemlibra 60 mg
English: Step D. Transfer medicine into syringe
Slovenian: Korak D. V injekcijsko brizgo prenesite zdravilo
English: ● Do not inject into areas that could be irritated by a belt or waistband.
Slovenian: ● Ne injicirajte v predele, ki jih lahko draži pas oblačil.
English: Keep the vial in the outer carton in order to protect from light
Slovenian: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo
English: Rate ratio and confidence interval (CI) comes from negative binomial regression (NBR) model and pvalue from Stratified Wald test, comparing ABR between specified arms.
Slovenian: Razmerje deležev in interval zaupanja (IZ) so dobljeni na podlagi modela z negativno binomsko regresijo (NBR), vrednost p pa s stratificiranim Waldovim testom s primerjavo ABR med opredeljenima skupinama.
English: Each vial contains 150 mg emicizumab in 1 mL of solution for injection.
Slovenian: Ena viala vsebuje 150 mg emicizumaba v 1 ml raztopine za injiciranje.
English: Other side effects when using Hemlibra
Slovenian: Drugi neželeni učinki med uporabo zdravila Hemlibra:
English: Attach injection needle to syringe
Slovenian: Namestite iglo za injiciranje na brizgo
English: Primary analysis efficacy results of Hemlibra prophylaxis every four weeks with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 8.
Slovenian: Preglednica 8 prikazuje rezultati primarne analize učinkovitosti profilakse z zdravilom Hemlibra na štiri tedne, kar zadeva delež zdravljenih krvavitev, vseh krvavitev, zdravljenih spontanih krvavitev, zdravljenih krvavitev v sklepe in zdravljenih krvavitev v tarčne sklepe (glejte preglednico 8).
English: Table 13 HAVEN 2: Change from baseline to week 25 in the Physical Health score of patients (< 12 years of age) following treatment with Hemlibra prophylaxis as reported by patients and caregivers
Slovenian: 25. tedna pri bolnikih, < 12 let, po profilaksi z zdravilom Hemlibra, kot so jo ocenili bolniki in skrbniki
English: Do not touch, fan or blow on the cleaned area before your injection.
Slovenian: Očiščenega predela se pred injiciranjem ne dotikajte, ne sušite ga z ventilatorjem in ne pihajte vanj.
English: Syringes
Slovenian: Brizge
English: Step C. Attach a new transfer needle to syringe
Slovenian: Korak C. Na brizgo namestite novo iglo za prenos
English: ● A syringe, a transfer needle (or vial adapter), and an injection needle are needed to draw up the Hemlibra solution from the vial into the syringe and to inject it under the skin.
Slovenian: ● Za odvzem raztopine zdravila Hemlibra iz viale v brizgo in za injiciranje pod kožo potrebujete injekcijsko brizgo, iglo za prenos (ali adapter za vialo) in iglo za injiciranje.
English: ABR (95% CI) a % reduction (RR), p-value % patients with zero bleeds (95% CI)
Slovenian: ABR (95-% IZ) % zmanjšanje (RR), vrednost p % bolnikov, ki niso imeli nobene krvavitve (95-% IZ)
English: Management in the perioperative setting
Slovenian: Vodenje v primeru operacije
English: Following multiple subcutaneous administrations of 3 mg/kg once weekly for the first 4 weeks in haemophilia A patients, mean (±SD) trough plasma concentrations of emicizumab achieved 52.6±13.6 µg/mL at Week 5.
Slovenian: Po večkratni subkutani uporabi 3 mg/kg enkrat na teden v prvih 4 tednih pri bolnikih s hemofilijo A je povprečna (± std. odklon) najmanjša koncentracija emicizumaba v plazmi pred naslednjim odmerkom
English: In the intra-patient analysis, Hemlibra weekly prophylaxis resulted in a clinical meaningful reduction (98 %) in treated bleed rate in 18 paediatric patients who had at least 12 weeks of Hemlibra prophylaxis compared to their bleed rate collected in the NIS prior to enrolment (Table 12).
Slovenian: (98 %) delež zdravljenih krvavitev pri 18 pediatričnih bolnikih, ki so imeli vsaj 12 tednov profilakse z zdravilom Hemlibra, v primerjavi z njihovim deležem krvavitev, evidentiranih v neintervencijski študiji pred vključitvijo v to študijo (preglednica 12).
English: * Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells For the full list of excipients, see section 6.1
Slovenian: * Emicizumab je humanizirano monoklonsko protitelo - spremenjeni imunoglobulin G4 (IgG4),
English: NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection
Slovenian: Hemlibra 30 mg/ml raztopina za injiciranje Hemlibra 150 mg/ml raztopina za injiciranje
English: ● Patient alert card
Slovenian: ● Vodnik za zdravstvene delavce ● Opozorilno kartico za bolnika
English: You will need to recap the transfer needle after transferring the medicine.
Slovenian: Potem, ko boste izvlekli zdravilo, boste morali iglo za prenos znova pokriti s pokrovčkom.
English: All bleeds = bleeds treated and not treated with bypassing agents.
Slovenian: Vse krvavitve = krvavitve, ki so bile in ki niso bile zdravljene z obvodnimi zdravili.
English: ● Maintenance dose (from week 5 on) example: 16 kg x 1.5 mg/kg = 24 mg of emicizumab needed for the maintenance dose.
Slovenian: ● Primer vzdrževalnega odmerka (od 5. tedna naprej): 16 kg x 1,5 mg/kg = 24 mg emicizumaba, potrebnega za vzdrževalni odmerek
English: After storage at room temperature unopened vials may be returned to the refrigerator.
Slovenian: Po shranjevanju na sobni temperaturi lahko neodprte viale daste nazaj v hladilnik.
English: How Hemlibra works
Slovenian: Kako deluje zdravilo Hemlibra
English: Patients with mild and moderate hepatic impairment were included in clinical trials.
Slovenian: V klinična preskušanja so bili vključeni bolniki z blago in zmerno okvaro jeter.
English: Serious and potentially life-threatening side effects can occur when aPCC is used in patients who are also receiving Hemlibra: Potentially serious side effects of using aPCC while receiving Hemlibra
Slovenian: Med uporabo aPCC se lahko pri bolnikih, ki prejemajo tudi zdravilo Hemlibra, pojavijo resni neželeni učinki, ki so lahko življenjsko ogrožajoči.
English: Hemlibra 30 mg/mL solution for injection
Slovenian: Hemlibra 30 mg/ml raztopina za injiciranje
English: Myalgia
Slovenian: VIALA
English: A syringe, a transfer needle (or vial adapter) and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously.
Slovenian: Za odvzem raztopine zdravila Hemlibra iz viale in njeno subkutano injiciranje so potrebne injekcijska brizga, igla za prenos (ali adapter za vialo) in igla za injiciranje.
English: At the time of the interim analysis, efficacy was evaluated in 59 patients who were < 12 years old and had been receiving weekly Hemlibra prophylaxis for at least 12 weeks, including four patients aged < 2 years old, 17 patients aged 2 to < 6 years, 38 patients aged 6 to < 12 years old.
Slovenian: Rezultati učinkovitosti pri pediatričnih bolnikih v študiji HAVEN 2 (vmesna analiza) Ob času vmesne analize so učinkovitost ocenili pri 59 bolnikih, ki so bili stari < 12 let in so vsaj 12 tednov prejemali profilakso z zdravilom Hemlibra enkrat na teden, vključno s 4 bolniki, starimi
English: Information that they should be given a Patient Alert Card and reminder to carry it at all times and to show it to any healthcare professionals who may treat them; Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and on the importance to show the patient alert card to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Slovenian: Podatki, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in podatki o pomembnosti, da bolnik svojo opozorilno kartico pokaže vsem zdravstvenim delavcem, ki ga zdravijo, in laboratorijskim delavcem, ki izvajajo koagulacijske teste;
English: How Hemlibra is given
Slovenian: Kako se daje zdravilo Hemlibra
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 30 mg/mL solution for injection emicizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Hemlibra 30 mg/ml raztopina za injiciranje emicizumab za subkutano uporabo
English: INCLUDED IN THE BOX:
Slovenian: Škatla vsebuje:
English: Note: Do not use 3 mL LDS syringe for doses up to 1 mL.
Slovenian: Opomba: Za odmerke do 1 ml ne uporabljajte 3-ml brizge z majhnim volumnom mrtvega prostora.
English: Rate ratio, and confidence interval (CI) come from negative binomial regression (NBR) model and p-value from Stratified Wald test, comparing bleed rate between specified arms.
Slovenian: Razmerje deležev in interval zaupanja (IZ) so dobljeni na podlagi modela z negativno binomsko regresijo (NBR), vrednost p pa s stratificiranim Waldovim testom s primerjavo deleža krvavitev med opredeljenima skupinama.
English: Treated bleeds = bleeds treated with FVIII All bleeds = bleeds treated and not treated with FVIII.
Slovenian: Vse krvavitve = krvavitve, ki so bile in ki niso bile zdravljene s FVIII.
English: The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agents (separate comparisons) in patients who had participated in the NIS prior to enrolment (Arms A and C, respectively) (see Table 7).
Slovenian: Študija je ocenila tudi učinkovitost tedenske profilakse z zdravilom Hemlibra v primerjavi s predhodno občasno (po potrebi) oziroma profilaktično uporabo obvodnih zdravil (ločeni primerjavi) pri bolnikih, ki so pred vključitvijo v to študijo sodelovali v neintervencijski študiji (skupini A
English: Before using the medicine, check the solution for particles or discoloration.
Slovenian: Pred uporabo zdravila preverite, da v raztopini ni delcev in da se barva ni spremenila.
English: ● Syringe Note: For injection amount up to 1 mL use a 1 mL syringe.
Slovenian: Opomba: Za injiciranje količine do 1 ml uporabite 1-ml brizgo.
English: ● Throw away any used vial(s), needles, vial or injection needle caps and used syringes in a sharps or puncture-proof container.
Slovenian: ● Vse uporabljene viale, igle, pokrovčke vial ali igel za injiciranje in uporabljene injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
English: Storing Hemlibra vials, needles and syringes:
Slovenian: Shranjevanje vial, igel in brizg zdravila Hemlibra:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 150 mg/mL solution for injection emicizumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Hemlibra 150 mg/ml raztopina za injiciranje emicizumab za subkutano uporabo
English: ● Keep the vials, needles and syringes out of the sight and reach of children.
Slovenian: ● Viale, igle in brizge shranjujte nedosegljive otrokom!