FrancophonIA/ELRC3.0 huggingface dataset:
English: The PK data demonstrate that ELOCTA has a prolonged circulating half-life.
Slovenian: Farmakokinetični podatki kažejo, da ima zdravilo ELOCTA podaljšan cirkulirajoči razpolovni čas.
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 7 time points up to 120 hours (5 days) post-dose.
Slovenian: Farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa zaporedno v 7 časovnih točkah do 120 ur (5 dni) po odmerjanju.
English: In patients with haemophilia A, factor VIII is missing or not working properly.
Slovenian: Bolnikom s hemofilijo A faktor VIII manjka ali ne dela pravilno.
English: Do not push the solution through the needle.
Slovenian: Raztopine ne potiskajte skozi iglo.
English: The pharmacokinetic parameters from the chromogenic assay data were similar to those derived for the one-stage assay.
Slovenian: Farmakokinetični parametri iz podatkov kromogenega preskusa so bili podobni tistim, izpeljanim iz enostopenjskega strjevalnega preskusa.
English: Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids.
Slovenian: Efmoroktokog alfa (rekombinantni humani koagulacijski faktor VIII, fuzijska beljakovina Fc (rFVIIIFc)) ima 1.890 aminokislin.
English: Upon activation of the clotting cascade, factor VIII is converted to activated factor VIII and released from von Willebrand factor.
Slovenian: Po aktiviranju kaskade strjevanja se faktor VIII pretvori v aktivirani faktor VIII in sprosti od von Willebrandovega faktorja.
English: Individualised prophylaxis: 25 to 65 IU/kg every 3 to 5 days.
Slovenian: Individualizirana profilaksa: 25 do 65 i.e./kg vsake 3 do 5 dni.
English: Haemophilia A is an X-linked hereditary disorder of blood coagulation due to decreased levels of functional factor VIII and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na kromosom X vezana dedna motnja strjevanja krvi zaradi znižanih ravni funkcionalnega faktorja VIII in povzroči krvavitev v sklepe, mišice ali notranje organe, bodisi spontano ali kot posledica nezgode ali kirurške poškodbe.
English: Each vial of ELOCTA contains nominally 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 or 6000 IU efmoroctocog alfa.
Slovenian: Ena viala zdravila ELOCTA vsebuje nominalno 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 ali 6000 i.e. efmoroktokoga alfa.
English: One IU of recombinant factor VIII Fc activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Slovenian: Ena i.e. aktivnosti rekombinantnega faktorja VIII Fc ustreza količini faktorja VIII v enem mililitru normalne humane plazme.
English: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Slovenian: Pri bolnikih z visokimi ravnmi zaviralcev morda zdravljenje s faktorjem VIII ne bo učinkovito, zato bodo potrebni drugi načini zdravljenja.
English: ELOCTA 250 ELOCTA 500 ELOCTA 750 ELOCTA 1000 ELOCTA 1500 ELOCTA 2000 ELOCTA 3000 ELOCTA 4000
Slovenian: ELOCTA 250 ELOCTA 500 ELOCTA 750 ELOCTA 1000 ELOCTA 1500 ELOCTA 2000 ELOCTA 3000 ELOCTA 4000 ELOCTA 5000 ELOCTA 6000
English: Always use this medicine exactly as your doctor has told you (see section 7).
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika (glejte poglavje 7).
English: Do not use the solution if cloudy or contains visible particles.
Slovenian: Raztopine ne uporabljajte, če je motna ali vsebuje vidne delce.
English: Sodium chloride
Slovenian: Prašek saharoza natrijev klorid
English: Frequencies have been evaluated 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).
Slovenian: < 1/10); občasni (≥ 1/1.000 do < 1/100); redki (≥ 1/10.000 do < 1/1.000); zelo redki (< 1/10.000); neznana
English: Hold the vial adapter in its protective cap and place it squarely over the top of the vial.
Slovenian: Nastavek za vialo v zaščitnem ovoju držite in ga položite pravokotno na vrh viale.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerjanje zdravila in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja VIII, mesta in obsega krvavitve ter od bolnikovega kliničnega stanja.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: Vodenje teh bolnikov mora voditi zdravniki z izkušnjami v zdravljenju bolnikov s hemofilijo in tistih z zaviralci faktorja VIII.
English: Study II enrolled a total of 71 previously treated male paediatric patients <12 years of age with severe haemophilia A. Of the 71 enrolled subjects, 69 received at least 1 dose of ELOCTA and were evaluable for efficacy (35 were <6 years of age and 34 were 6 to <12 years of age).
Slovenian: Pediatrična populacija V študijo II je bilo skupaj vključenih 71 predhodno zdravljenih pediatričnih bolnikov starosti < 12 let moškega spola s hudo hemofilijo A. Med 71 vključenimi osebami jih je 69 prejelo vsaj 1 odmerek zdravila ELOCTA in je bilo pri njih mogoče oceniti učinkovitost (35 jih je bilo starih < 6 let in 34 jih je bilo starih
English: No fertility studies have been conducted in animals with ELOCTA.
Slovenian: Študij plodnosti pri živalih z zdravilom ELOCTA niso izvedli.
English: Signs of allergic reactions may include generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure.
Slovenian: Znaki alergijskih reakcij lahko vključujejo generalizirano srbenje, koprivnico, stiskanje v prsnem košu, težave z dihanjem in nizek krvni tlak.
English: Remove the clear plastic protective cover from the needle.
Slovenian: Z igle odstranite brezbarvno zaščitno plastično kapico.
English: Treatment of bleeding
Slovenian: Zdravljenje krvavitve
English: Median total time on study II+III was 3.4 years and median no of exposure days was 332.
Slovenian: Mediani skupni čas v študiji II+III je bil 3,4 leta in mediano število dni izpostavljenosti je bilo 332.
English: During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting or chromogenic assays) is advised to guide the dose to be administered and the frequency of repeated injections.
Slovenian: Spremljanje zdravljenja Tekom zdravljenja se priporoča ustrezno določanje ravni faktorja VIII (s pomočjo enostopenjskih strjevalnih ali kromogenih preskusov), kar je vodilo za odmerjanje zdravila in pogostnost ponovljenih injiciranj.
English: Study I enrolled 165 previously treated male patients (12 to 65 years of age) with severe haemophilia A. Subjects on prophylaxis regimens prior to entering the study were assigned to the individualised prophylaxis arm.
Slovenian: V študijo I je bilo vključenih 165 predhodno zdravljenih bolnikov moškega spola (starih 12 do 65 let) s hudo hemofilijo A. Osebe, ki so bile pred vstopom v študijo na profilaktičnem režimu, so bile dodeljene v individualiziran profilaktični krak.
English: ELOCTA should be administered using the infusion set (E) provided in this pack.
Slovenian: Zdravilo ELOCTA dajte z uporabo infuzijskega kompleta (E), priloženega v pakiranju.
English: Solvent: water for injections, a clear, colourless solution.
Slovenian: Vehikel: voda za injekcije, bistra, brezbarvna raztopina.
English: If you stop using ELOCTA
Slovenian: Če ste prenehali uporabljati zdravilo ELOCTA
English: The number of units of recombinant factor VIII Fc administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Slovenian: Število danih enot rekombinantnega faktorja VIII Fc je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard WHO za zdravila s faktorjem VIII.
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.
Slovenian: Tvorba nevtralizirajočih protiteles (inhibitorjev) proti faktorju VIII je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti inhibitorji so običajno IgG imunoglobulini, usmerjeni proti prokoagulacijski aktivnosti faktorja VIII, ki so količinsko opredeljeni v enotah Bethesda (BU - Bethesda
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip.
Slovenian: Opomba: Če raztopine ne boste uporabili takoj, morate pokrovček injekcijske brizge skrbno namestiti nazaj na konico injekcijske brizge.
English: Allergic type hypersensitivity reactions are possible with ELOCTA.
Slovenian: Z zdravilom ELOCTA so možne preobčutljivostne reakcije alergijskega tipa.
English: Median total time on Study I+III was 4.2 years and median no of exposure days was 309.
Slovenian: Mediani skupni čas v študiji I+III je bil 4,2 leti in mediano število dni izpostavljenosti je bilo 309.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL)
Slovenian: Potrebno število enot = telesna masa (kg) x želeni dvig faktorja VIII (%) (i.e./dl) x 0,5 (i.e./kg na i.e./dl)
English: If you forget to use ELOCTA
Slovenian: Če ste pozabili uporabiti zdravilo ELOCTA
English: After reconstitution, if the product is not used within 6 hours, it must be discarded.
Slovenian: Če rekonstituiranega zdravila ne uporabite v 6 urah, ga morate zavreči.
English: Perioperative management (surgical prophylaxis): A total of 48 major surgical procedures were performed and assessed in 34 subjects in Study I and Study III.
Slovenian: Perioperativno obvladovanje (kirurška profilaksa): V študiji I in študiji III je bilo opravljenih in ocenjenih skupaj 48 večjih kirurških posegov pri 34 osebah.
English: ELOCTA increases factor VIII level in the blood and temporarily corrects the bleeding tendency.
Slovenian: Zdravilo ELOCTA veča ravni faktorja VIII v krvi in začasno popravi nagnjenost h krvavitvam.
English: After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration.
Slovenian: Po pripravi lahko zdravilo ELOCTA do 6 ur pred dajanjem shranjujete pri sobni temperaturi.
English: Open the infusion set package and remove the cap at the end of the tubing.
Slovenian: Odprite pakiranje z infuzijskim kompletom in odstranite kapico na koncu cevke.
English: Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the tourniquet.
Slovenian: Iglo infuzijskega kompleta vstavite v veno po navodilih zdravnika ali medicinske sestre in odstranite zažemko.
English: Pharmacokinetic parameters of ELOCTA were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 120 hours (5 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 72 hours (3 days) post-dose).
Slovenian: Farmakokinetične parametre zdravila ELOCTA so za mladostnike določili v študiji I (farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa ocenjeni v več časovnih točkah do 120 ur (5 dni) po odmerjanju), za otroke pa so jih določili v študiji II (farmakokinetični vzorci so bili odvzeti pred odmerjanjem, nato pa ocenjeni v več časovnih točkah do 72 ur (3 dni) po odmerjanju).
English: Median dose to maintain haemostasis during surgery was 60.6 IU/kg (min 38, max 158).
Slovenian: Mediana odmerka za ohranitev hemostaze med kirurškim posegom je bila 60,6 i.e./kg (najmanj 38, največ 158).
English: Recording of batch number
Slovenian: Beleženje številke serije
English: Method of administration ELOCTA is for intravenous use.
Slovenian: Zdravilo ELOCTA je za intravensko uporabo.
English: Treatment with ELOCTA will be started by a doctor who is experienced in the care of patients with haemophilia.
Slovenian: Zdravljenje z zdravilom ELOCTA bo uvedel zdravnik, ki ima izkušnje pri zdravljenju bolnikov s hemofilijo.
English: Excipient with known effect 0.6 mmol (or 14 mg) sodium per vial.
Slovenian: 0,6 mmol (ali 14 mg) natrija na vialo.
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of the aPTT reagent and the reference standard used in the assay.
Slovenian: Pri uporabi enofaznih koagulacijskih preiskav in vitro na osnovi tromboplastinskega časa (aPTT) za določanje aktivnosti faktorja VIII v krvnih vzorcih bolnikov, lahko na rezultate aktivnosti faktorja VIII v plazmi bistveno vplivata vrsta uporabljenega reagenta aPTT in referenčni standard.
English: If needed apply a tourniquet and prepare the injection site by wiping the skin well with the other alcohol swab provided in the pack.
Slovenian: Po potrebi namestite zažemko in pripravite mesto injiciranja tako, da kožo dobro obrišete z drugim alkoholnim zložencem iz pakiranja.
English: Instructions for preparation and administration
Slovenian: Navodila za pripravo in dajanje
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay against an in-house standard that is referenced to the WHO factor VIII standard.
Slovenian: Jakost (mednarodne enote) je določena s pomočjo kromogenega preskusa po Evropski farmakopeji v primerjavi z internim standardom, ki temelji na standardu WHO za faktor VIII.
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Slovenian: Če potrebujete centralni venski kateter (CVK), morate upoštevati zaplete, povezane s CVK, vključno z lokalnimi okužbami, prisotnostjo bakterij v krvi in trombozo na mestu katetrizacije.
English: ELOCTA is comprised of recombinant B-domain deleted human coagulation factor VIII covalently linked to the Fc domain of human immunoglobulin G1.
Slovenian: Zdravilo ELOCTA je sestavljeno iz rekombinantne B-domene zbrisanega humanega koagulacijskega faktorja VIII, kovalentno vezanega na domeno Fc humanega imunoglobulina G1.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ELOCTA in one or more subsets of the paediatric population in the treatment of hereditary Factor VIII deficiency (see section 4.2 for information on paediatric use).
Slovenian: ELOCTA za eno ali več podskupin pediatrične populacije za zdravljenje dednega pomanjkanja faktorja VIII (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje se mora uvesti pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
English: The dose may be adjusted by your doctor in the range of 25 to 65 IU per kg of body weight.
Slovenian: Odmerek lahko zdravnik prilagaja v razponu od 25 do 65 i.e. na kg telesne mase.
English: After this time, the prepared ELOCTA should be discarded.
Slovenian: Po poteku tega časa morate pripravljeno zdravilo ELOCTA zavreči.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem se zveča plazemska raven faktorja VIII in s tem omogoči začasna poprava pomanjkanja faktorja in nagnjenosti h krvavitvam.
English: ELOCTA is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia A (inherited bleeding disorder caused by factor VIII deficiency).
Slovenian: Zdravilo ELOCTA se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih vseh starostnih skupin s hemofilijo A (dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII).
English: Place the vial on a clean flat surface.
Slovenian: Vialo položite na čisto ravno površino.
English: Minor surgery including tooth extraction
Slovenian: vključno z izruvanjem zoba
English: The prepared product should be injected intravenously over several minutes.
Slovenian: Pripravljeno zdravilo injicirajte intravensko nekaj minut.
English: If you are not sure what to do, ask your doctor or pharmacist.
Slovenian: Če niste prepričani, kako ravnati, se posvetujte z zdravnikom ali farmacevtom.
English: Intravenous use, after reconstitution.
Slovenian: intravenska uporaba po rekonstituciji
English: ELOCTA (efmoroctocog alfa) is a fully recombinant fusion protein with extended half-life.
Slovenian: Zdravilo ELOCTA (efmoroktokog alfa) je povsem rekombinantna fuzijska beljakovina s podaljšanim razpolovnim časom.
English: In a placental transfer study, ELOCTA has been shown to cross the placenta in small amounts in mice.
Slovenian: V študiji prehajanja skozi posteljico se je pokazalo, da pri miših zdravilo ELOCTA v majhnih količinah prehaja skozi posteljico.
English: ELOCTA should be injected intravenously over several minutes.
Slovenian: Zdravilo ELOCTA se injicira intravensko nekaj minut.
English: If this happens you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Slovenian: Če pride do tega, zdravilo pri vas ali vašem otroku ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: What ELOCTA looks like and contents of the pack
Slovenian: Izgled zdravila ELOCTA in vsebina pakiranja
English: How to use ELOCTA
Slovenian: Kako uporabljati zdravilo ELOCTA
English: Repeat injection every 24 hours, for at least 1 day, until healing is achieved.
Slovenian: Injiciranje ponavljajte vsaj 1 dan vsakih 24 ur, dokler se ne zaceli.
English: Solvent for ELOCTA water for injections
Slovenian: vehikel za zdravilo ELOCTA voda za injekcije
English: On-demand treatment
Slovenian: Zdravljenje na zahtevo
English: Contents of the pack and other information Instructions for preparation and administration
Slovenian: Shranjevanje zdravila ELOCTA Vsebina pakiranja in dodatne informacije Navodila za pripravo in dajanje
English: Table 1: Guide to ELOCTA dosing for treatment of bleeding episodes and surgery Degree of haemorrhage /
Slovenian: Preglednica 1: Vodilo za odmerjanje zdravila ELOCTA za zdravljenje krvavitev in pri kirurških posegih
English: Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid has reached the infusion set needle.
Slovenian: Ves zrak iz cevke infuzijskega kompleta odstranite s počasnim pritiskanjem na bat, da tekočina doseže iglo infuzijskega kompleta.
English: After storage at room temperature, the product must not be put back in the refrigerator.
Slovenian: Po shranjevanju pri sobni temperaturi zdravila ne smete shraniti nazaj v hladilnik.
English: The usual dose of ELOCTA is 50 IU per kg of body weight, given every 3 to 5 days.
Slovenian: Običajni odmerek zdravila ELOCTA je 50 i.e. na kg telesne mase, ki se daje vsakih 3 do 5 dni.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Slovenian: Če je potreben centralni venski kateter (CVK), je treba upoštevati možnost lokalnih okužb, bakteriemije in tromboze na mestu katetrizacije.
English: Subjects on on-demand therapy prior to entry either entered the individualised prophylaxis arm or were randomised to the weekly prophylaxis or on-demand arms.
Slovenian: Osebe, ki so bile pred vstopom v študijo zdravljene na zahtevo, so bile dodeljene bodisi v individualiziran profilaktični krak bodisi randomizirane v krak s tedensko profilakso ali krak z zdravljenjem po potrebi.
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Slovenian: Lahko hranite pri sobni temperaturi (do 30 °C) za enkratno obdobje največ 6 mesecev.
English: Hypertension Hot flush Angiopathy2
Slovenian: Žilne bolezni hipertenzija vročinski oblivi angiopatija2
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden
Slovenian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Švedska
English: Powder: sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid.
Slovenian: Prašek: saharoza, natrijev klorid, L-histidin, kalcijev klorid dihidrat, polisorbat 20, natrijev hidroksid, klorovodikova kislina.
English: None of these patients developed inhibitors.
Slovenian: Pri nobenem od njih se niso razvili zaviralci.
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirano zdravilo je treba pred uporabo pregledati s prostim očesom glede delcev in obarvanja.
English: Do not touch the syringe tip or the inside of the cap.
Slovenian: Ne dotikajte se konice brizge ali notranjosti pokrovčka.
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden
Slovenian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Švedska
English: • The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein).
Slovenian: • Učinkovina je efmoroktokog alfa (rekombinantni koagulacijski faktor VIII, fuzijska beljakovina Fc).
English: The haemostatic response was rated by the physicians as excellent in 41 and as good in 3 of 44 major surgeries.
Slovenian: 41 in kot dober pri 3 od 44 večjih posegov.
English: Patients should be informed of the signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Bolnike je treba poučiti o znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, generalizirano urtikarijo, stiskanje v prsnem košu, sopenje, hipotenzijo in anafilakso.
English: For long term prophylaxis, the recommended dose is 50 IU/kg every 3 to 5 days.
Slovenian: Priporočeni odmerek za dolgotrajno profilakso je 50 i.e./kg vsakih 3 do 5 dni.
English: On-demand treatment: Median annual factor consumption was 1039 IU/kg (min 280, max 3571) for 23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min 286, max 913) for 6 patients remaining on on-demand treatment for at least one year in Study III.
Slovenian: Zdravljenje po potrebi: Mediana letna poraba faktorja je bila 1.039 i.e./kg (najmanj 280, največ 3.571) za 23 bolnikov, ki so bili randomizirani v krak za zdravljenje po potrebi v študiji I, in 671 i.e./kg (najmanj 286, največ 913) za 6 bolnikov, ki so nadaljevali z zdravljenjem po potrebi najmanj eno leto v študiji III.
English: You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, low blood pressure, general feeling of being unwell, nausea, restlessness and fast heartbeat, feeling dizzy or loss of consciousness.
Slovenian: Takoj se posvetujte z zdravnikom, če se pojavijo kateri od naslednjih simptomov alergijskih reakcij: oteklost obraza, izpuščaj, generalizirano srbenje, koprivnica, stiskanje v prsnem košu, težave z dihanjem, pekoč občutek in zbadanje na mestu injiciranja, mrzlica, vročinski oblivi, glavobol, nizek krvni tlak, splošno slabo počutje, navzea, nemir in hiter srčni utrip, občutek vrtoglavice ali izguba zavesti.
English: B) 3 mL solvent in pre-filled syringe C) 1 Plunger rod
Slovenian: A) 1 vialo s praškom B) 3 ml vehikla v napolnjeni injekcijski brizgi C) 1 bat
English: ELOCTA contains sodium
Slovenian: Zdravilo ELOCTA vsebuje natrij