FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Slovenian: Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Za preučitev možnih učinkov kopičenja PEG v horoidnem pleksusu možganov in v drugih tkivih oziroma organih mora imetnik dovoljenja za promet z zdravilom v skladu z dogovorjenim protokolom opraviti neintervencijsko študijo o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom in predložiti rezultate te študije.
English: There was one case of persistent anti-drug antibodies concomitant with the confirmed case of factor VIII inhibitors (see Factor VIII inhibitors).
Slovenian: Opisan je bil en primer trajnih protiteles proti zdravilu, sočasno s potrjenim primerom zaviralcev faktorja VIII (glejte Zaviralci faktorja VIII).
English: Perioperative management
Slovenian: Perioperativna uporaba
English: Do not use the equipment without proper training from your doctor or nurse.
Slovenian: Ne uporabljajte pripomočkov, če vas zdravnik ali medicinska sestra nista poučila o njihovi pravilni uporabi.
English: The reconstituted product must be injected into your vein (intravenous (IV) injection).
Slovenian: Pripravljeno zdravilo je treba injicirati v veno (intravenska (i.v.)
English: • Push the plunger rod slowly until all air bubbles are gone.
Slovenian: • Potisni bat potiskajte počasi, dokler ne izginejo vsi zračni mehurčki.
English: Adults/adolescents who had a low bleeding rate of 0-2 bleeding episodes during the last 6 months and had obtained at least 50 doses of Esperoct had the option of being randomised to prophylaxis treatment every 7 days (75 IU/kg every 7 days) or every 4 days (50 IU/kg every 4 days).
Slovenian: Odrasli/mladostniki, ki so imeli nizko stopnjo krvavitev (med 0 in 2 krvavitvama) v zadnjih 6 mesecih in so prejeli vsaj 50 odmerkov zdravila Esperoct, so imeli možnost randomiziranja v profilaktično zdravljenje na 7 dni (75 i.e./kg na 7 dni) ali na 4 dni (50 i.e./kg na 4 dni).
English: The dose in adolescents (12 years and above) is the same as for adults.
Slovenian: Odmerki pri mladostnikih (12 let in več) so enaki kot pri odraslih.
English: • Inject the reconstituted solution as instructed by your doctor or nurse.
Slovenian: • Pripravljeno raztopino injicirajte v skladu z navodili zdravnika ali medicinske sestre.
English: In the case of major surgical interventions in particular, monitoring of the factor VIII substitution therapy by measurement of plasma factor VIII activity is necessary.
Slovenian: Še zlasti pri večjih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z merjenjem aktivnosti faktorja VIII v plazmi.
English: ** Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. *** Preferred terms included in injection site reactions: Injection site reaction, Vessel puncture site haematoma, Infusion site reaction, Injection site erythema, Injection site rash, Vessel puncture site pain, and Injection site swelling.
Slovenian: ** Pogostnost temelji na študijah z vsemi zdravili s faktorjem VIII, ki so vključevale bolnike s hudo hemofilijo A. *** Prednostni izrazi pri reakcijah na mestu injiciranja: reakcija na mestu injiciranja, hematom na mestu preboda žile, reakcija na mestu infundiranja, eritem na mestu injiciranja, izpuščaj na mestu injiciranja, bolečina na mestu preboda žile in otekanje na mestu injiciranja.
English: The mechanism of action of turoctocog alfa pegol is based on the replacement of the deficient or absent factor VIII in patients with haemophilia A. When turoctocog alfa pegol is activated by thrombin at the site of injury, the B-domain containing the PEG moiety and the a3-region are cleaved off, thus generating activated recombinant factor VIII (rFVIIIa) which is similar in structure to native factor VIIIa.
Slovenian: Mehanizem delovanja turoktokog alfa pegola temelji na zamenjavi pomanjkljivega ali manjkajočega faktorja VIII pri bolnikih s hemofilijo A. Ko trombin na mestu poškodbe aktivira turoktokog alfa pegol, se domena B, ki vsebuje PEG, in del a3 odcepita, pri čemer nastane aktivirani rekombinantni faktor VIII (rFVIIIa), ki je po strukturi podoben nativnemu faktorju
English: The mean annual consumption for prophylaxis was 4641 IU/kg.
Slovenian: Povprečna letna poraba za profilakso je bila 4.641 i.e./kg.
English: There is no indication of an increased risk of factor VIII inhibitor development with treatment of Esperoct as compared to other factor VIII products.
Slovenian: Ni znakov, da bi bilo tveganje za pojav zaviralcev faktorja VIII med zdravljenjem z zdravilom Esperoct večje kot med zdravljenjem z drugimi zdravili s faktorjem VIII.
English: • factor VIII inhibitors (antibodies) in patients previously treated with factor VIII.
Slovenian: • zaviralci (protitelesa) faktorja VIII pri bolnikih, ki so bili predhodno zdravljeni s faktorjem VIII
English: In such cases, it is recommended that a specialised haemophilia centre is contacted.
Slovenian: V takšnih primerih je priporočljivo, da se bolnik obrne na specializiran center za hemofilijo.
English: If you forget to use Esperoct
Slovenian: Če ste pozabili uporabiti zdravilo Esperoct
English: Esperoct contains sodium
Slovenian: Zdravilo Esperoct vsebuje natrij
English: In 12 patients above 18 years of age, 1,126 bleedings were treated among patients receiving on-demand treatment with an average treatment dose of 38.1 IU/kg with a mean annual consumption of 1457 IU/kg.
Slovenian: Pri 12 bolnikih, starejših od 18 let, je bilo med prejemniki zdravljenja po potrebi zdravljenih 1.126 krvavitev; povprečni terapevtski odmerek je bil 38,1 i.e./kg in povprečna letna poraba 1.457 i.e./kg.
English: Do not inject a double dose to make up for a forgotten dose.
Slovenian: Ne injicirajte dvojnega odmerka, če ste pozabili injicirati prejšnji odmerek.
English: Single-dose pharmacokinetic parameters of Esperoct are listed in table 4.
Slovenian: Farmakokinetični parametri po enkratnem odmerku zdravila Esperoct so prikazani v preglednici 4.
English: Esperoct replaces this faulty or missing factor VIII and helps blood to form clots at the site of bleeding.
Slovenian: Zdravilo Esperoct nadomesti okvarjen ali manjkajoč faktor VIII in pomaga pri nastanku krvnega strdka na mestu krvavitve.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: Zdravljenje takšnih bolnikov morajo voditi zdravniki z izkušnjami zdravljenja hemofilije in z zaviralci faktorja VIII.
English: Adults and adolescents (12 years of age and above): The recommended starting dose is 50 IU of Esperoct per kg body weight every 4 days.
Slovenian: Odrasli in mladostniki (stari 12 let in več): priporočeni začetni odmerek je 50 i.e. zdravila Esperoct na kilogram telesne mase na 4 dni.
English: Catheter-related problems
Slovenian: Težave, povezane s katetrom
English: The dose of Esperoct is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek zdravila Esperoct se izračuna glede na telesno maso in koncentracijo faktorja VIII, ki jo je treba doseči.
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: L-metionin kalcijev klorid dihidrat natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: An incorrect technique can introduce germs that can infect your blood.
Slovenian: Zaradi nepravilne tehnike lahko pride do vnosa mikrobov in posledične okužbe krvi.
English: • skin reactions where the injection is given
Slovenian: • kožne reakcije na mestu injiciranja
English: Do not use this medicine after the expiry date which is stated after ‘EXP' on the carton, on the vial, and on the pre-filled syringe labels.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti zdravila, ki je naveden na škatli, viali in nalepki napolnjene injekcijske brizge poleg oznake »EXP«.
English: • gauze pads and plasters.
Slovenian: • zložence in obliže.
English: An infusion set (butterfly needle with tubing), sterile alcohol swabs, gauze pads and plasters will also be needed.
Slovenian: Potrebovali boste tudi infuzijski komplet (cevka in injekcijska igla z metuljčkom), sterilne alkoholne blazinice, zložence in obliže.
English: Esperoct is recommended to be used immediately after it has been reconstituted.
Slovenian: Priporočljivo je, da zdravilo Esperoct uporabite takoj po pripravi.
English: If symptoms of hypersensitivity occur, patients should be advised to immediately discontinue the use of the medicinal product and contact their physician.
Slovenian: Bolnikom je treba naročiti, da morajo v primeru pojava simptomov preobčutljivosti takoj prenehati uporabljati zdravilo in se posvetovati s svojim zdravnikom.
English: The activity of factor VIII in plasma is expressed either as percentage (relative to normal human plasma level) or in International Units per dL (relative to the current International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je lahko izražena v odstotkih (glede na koncentracijo v normalni človeški plazmi) ali v mednarodnih enotah na deciliter (glede na trenutni mednarodni standard za faktor VIII v plazmi).
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila o pripravi zdravila pred uporabo glejte poglavje 6.6.
English: See “Development of ‘FVIII inhibitors' (antibodies)” in section 2.
Slovenian: Glejte »Nastanek »zaviralcev FVIII« (protiteles)« v poglavju 2.
English: • Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution.
Slovenian: • Pri injiciranju zdravila v napravo za centralni venski dostop boste za odvzem pripravljene raztopine morda morali uporabiti sterilno 10-ml plastično injekcijsko brizgo.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Slovenian: Potrebno količino zdravila in pogostnost uporabe je treba vedno določiti glede na klinično učinkovitost pri posameznem bolniku.
English: The use of Esperoct in children below 12 years is not indicated.
Slovenian: Uporaba zdravila Esperoct pri otrocih, mlajših od 12 let, ni indicirana.
English: The clinical efficacy of Esperoct for prophylaxis and treatment of bleeds was investigated in five prospective, multi-centre clinical studies in 270 previously treated patients (PTPs) with severe haemophilia A.
Slovenian: Klinično učinkovitost zdravila Esperoct za profilakso in zdravljenje krvavitev so raziskali v petih prospektivnih, multicentričnih kliničnih študijah, v katere je bilo vključenih 270 predhodno zdravljenih bolnikov (PZB) s hudo hemofilijo A.
English: If this happens, your medicine may stop working properly and you may experience persistent bleeding.
Slovenian: Če se to zgodi, vaše zdravilo morda ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: a Incremental recovery and factor VIII were assessed 30 min post-dosing for patients 12 years and above and 60 min post-dosing (first sample) for children below12 years.
Slovenian: a Inkrementalno izboljšanje in faktor VIII sta bila ocenjena 30 minut po odmerjanju pri bolnikih, starih 12 let ali več, in 60 minut po odmerjanju (prvi vzorec) pri otrocih, mlajših od 12 let.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Slovenian: Ciljna koncentracija faktorja VIII bo odvisna od tega, kako huda je krvavitev in na katerem mestu je.
English: • Do not increase the total dose of Esperoct to control your bleed without talking to your doctor.
Slovenian: • Ne povečajte odmerka zdravila Esperoct, da bi obvladali krvavitev, ne da bi se o tem prej posvetovali z zdravnikom.
English: In children below 12 years long-term safety has not been established.
Slovenian: Dolgoročna varnost zdravila pri otrocih, mlajših od 12 let, še ni bila dokazana.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C do 8 °C).
English: • Grasp the plunger rod by the wide top end and take it out of the carton.
Slovenian: • Potisni bat primite za razširjen zgornji del in ga vzemite iz škatle.
English: Twenty of the 32 patients were negative for anti-PEG antibodies post administration of Esperoct.
Slovenian: Dvajset od teh 32 bolnikov je bilo po uporabi zdravila Esperoct negativnih za protitelesa proti PEG.
English: The mean annual consumption for prophylaxis was 6475 IU/kg.
Slovenian: Povprečna letna poraba za profilakso je bila 6.475 i.e./kg.
English: No correlation with adverse events could be established.
Slovenian: Povezanosti z neželenimi učinki niso ugotovili.
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2.0 g sodium for an adult.
Slovenian: Opomba o pomožnih snoveh Zdravilo po pripravi vsebuje 30,5 mg natrija na vialo, kar ustreza 1,5 % priporočenega dnevnega vnosa po smernicah WHO, ki za odraslo osebo znaša 2,0 g natrija.
English: Plasma factor VIII activity levels should be maintained at or above the described plasma levels (in IU per dL or % of normal).
Slovenian: Paziti je treba na ohranjanje stopnje aktivnosti faktorja VIII v plazmi pri opisanih koncentracijah v plazmi ali nad njimi (v i.e. na dl ali % normalnega stanja).
English: Prophylaxis The recommended starting dose is 50 IU of Esperoct per kg body weight every 4 days.
Slovenian: Profilaksa Priporočen začetni odmerek je 50 i.e. zdravila Esperoct na kg telesne mase vsake 4 dni.
English: Warnings and precautions Previous use of factor VIII medicine
Slovenian: Predhodna uporaba zdravil s faktorjem VIII
English: Table 2 includes general recommendation for dosing of Esperoct for perioperative management.
Slovenian: V preglednici 2 so splošna priporočila za odmerjanje zdravila Esperoct pri perioperativni uporabi.
English: One confirmed case of factor VIII inhibitor occurred in an 18 year-old previously treated patient on prophylactic treatment with Esperoct.
Slovenian: En potrjen primer zaviralca faktorja VIII se je pojavil pri 18-letnem, predhodno zdravljenem bolniku,
English: • The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
Slovenian: • Druge sestavine v prašku so L-histidin, saharoza, polisorbat 80, natrijev klorid, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid in klorovodikova kislina.
English: After reconstitution the solution appears as a clear and colourless liquid free of visible particles.
Slovenian: Po pripravi je raztopina bistra in brezbarvna tekočina brez vidnih delcev.
English: Anti-drug antibodies
Slovenian: Protitelesa proti zdravilu
English: • The active substance is turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)).
Slovenian: • Učinkovina je turoktokog alfa pegol (pegilirani humani koagulacijski faktor VIII (rDNA)).
English: Spike (under protective paper)
Slovenian: (pod zaščitnim papirjem)
English: • Bring the vial and the pre-filled syringe to room temperature.
Slovenian: • Vialo in napolnjeno injekcijsko brizgo ogrejte na sobno temperaturo.
English: Do not stop using Esperoct without talking to your doctor.
Slovenian: Ne prenehajte uporabljati zdravila Esperoct, ne da bi se o tem prej posvetovali z zdravnikom.
English: Esperoct should be administered by intravenous injection (over approximately 2 minutes) after reconstitution of the powder with 4 mL supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection).
Slovenian: Zdravilo Esperoct je treba injicirati intravensko (v približno 2 minutah) po pripravi praška s 4 ml priloženega vehikla (9 mg/ml (0,9 %) raztopina natrijevega klorida za injekcije).
English: Guidance for the dosing of Esperoct for the on-demand treatment and treatment of bleeding episodes is provided in table 1.
Slovenian: Smernice za odmerjanje zdravila Esperoct pri zdravljenju po potrebi in zdravljenju krvavitev se nahajajo v preglednici 1.
English: The mean trough plasma factor VIII activity levels at steady-state during prophylactic treatment with Esperoct dosed with 50 IU/kg every 4 days is 3.0 IU/dL (95% CI: 2.6;3.4) in patients 12 years and above.
Slovenian: Povprečna najnižja raven aktivnosti faktorja VIII v plazmi v stanju dinamičnega ravnovesja med profilaktičnim zdravljenjem z zdravilom Esperoct v odmerku 50 i.e./kg na 4 dni je pri bolnikih, starih 12 let in več, 3,0 i.e./dl (95 % IZ: 2,6; 3,4).
English: Treatment with Esperoct will be started by a doctor who is experienced in the care of people with haemophilia A.
Slovenian: Zdravljenje z zdravilom Esperoct vam bo uvedel zdravnik, ki je izkušen v zdravljenju bolnikov s hemofilijo A.
English: If you stop using Esperoct
Slovenian: Če ste prenehali uporabljati zdravilo Esperoct
English: Can be stored at room temperature (up to 30°C) for a single period up to 12 months.
Slovenian: Zdravilo lahko shranjujete pri sobni temperaturi (do 30 °C) največ enkrat za obdobje do 12 mesecev.
English: Esperoct is available in packs containing 500 IU, 1000 IU, 1500 IU, 2000 IU, or 3000 IU.
Slovenian: Zdravilo Esperoct je na voljo v pakiranju s 500 i.e., 1000 i.e., 1500 i.e., 2000 i.e. ali 3000 i.e.
English: The ABR for randomised patients was 1.77 (0.59; 5.32) for treatment every 4 days and 3.57 (2.13; 6.00) for once weekly prophylaxis.
Slovenian: ABR za randomizirane bolnike je bil 1,77 (0,59, 5,32) za zdravljenje na 4 dni in 3,57 (2,13,
English: Allergic reactions (hypersensitivity)
Slovenian: Alergijske reakcije (preobčutljivost)
English: Development of ‘FVIII inhibitors' (antibodies)
Slovenian: Nastanek »zaviralcev FVIII« (protiteles)
English: Esperoct is now ready to be injected into your vein.
Slovenian: Zdravilo Esperoct je sedaj pripravljeno za injiciranje v veno.
English: Do not touch the syringe tip.
Slovenian: Ne dotikajte se konice injekcijske brizge.
English: Instructions on how to use Esperoct Read these instructions carefully before using Esperoct.
Slovenian: Navodila za uporabo zdravila Esperoct Pred začetkom uporabe zdravila Esperoct natančno preberite ta navodila.
English: When injected into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Slovenian: Po injiciranju bolniku s hemofilijo se faktor VIII veže na von Willebrandov faktor v bolnikovem krvnem obtoku.
English: After reconstitution
Slovenian: Po pripravi
English: Vial adapter Protective cap
Slovenian: Nastavek za vialo zaščitni pokrovček konica
English: The reconstituted solution should be stored in the vial.
Slovenian: Pripravljena raztopina mora biti shranjena v viali.
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 pro-coagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Slovenian: Pojav nevtralizirajočih protiteles (zaviralcev) faktorja VIII je znan zaplet zdravljenja bolnikov s hemofilijo A. Ti zaviralci so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
English: Catheter-related complications
Slovenian: S katetrom povezani zapleti
English: • Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Slovenian: • Potisni bat držite pritisnjen navzdol in vialo nežno vrtite, dokler se ves prašek ne raztopi.
English: How to use Esperoct
Slovenian: Kako uporabljati zdravilo Esperoct
English: Record the beginning of storage at room temperature on the product carton.
Slovenian: Začetek shranjevanja pri sobni temperaturi je treba zabeležiti na škatlo zdravila.
English: Eleven patients developed transient low titre anti-PEG antibodies.
Slovenian: Pri 11 bolnikih so se prehodno pojavili nizki titri protiteles proti PEG.
English: Animal reproduction studies have not been conducted with factor VIII.
Slovenian: Študij o vplivu faktorja VIII na sposobnost razmnoževanja pri živalih niso izvedli.
English: The frequencies of adverse reactions as observed in 270 unique subjects across five prospective, multi-centre clinical studies in previously treated patients (PTPs) with severe haemophilia A (<1% endogenous factor VIII activity) and no history of inhibitors are listed in table 3.
Slovenian: Pogostnost neželenih učinkov, opaženih pri 270 preiskovancih v petih prospektivnih, multicentričnih kliničnih študijah predhodno zdravljenih bolnikov (PZB) s hudo hemofilijo A (manj kot 1 % aktivnosti endogenega faktorja VIII) in brez anamneze zaviralcev, je navedena v preglednici 3.
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 titri zaviralcev zdravljenje s faktorjem VIII morda ne bo uspešno in v poštev pridejo druge možnosti zdravljenja.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba seznaniti z zgodnjimi znaki preobčutljivosti, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, piskajočim dihanjem, hipotenzijo in anafilaksijo.
English: Do not use the powder if the colour has changed.
Slovenian: Če se je barva praška spremenila, ga ne uporabite.
English: Until the bleeding is resolved
Slovenian: Dokler se krvavitev ne ustavi.
English: Solvent: sodium chloride, water for injections
Slovenian: Vehikel: natrijev klorid, voda za injekcije.
English: • 1 plunger rod (placed under the syringe)
Slovenian: • 1 potisni bat (nameščen je pod brizgo).
English: Single dose or repeat injection every 24 hours for at least 1 day until healing is achieved
Slovenian: 24 ur, vsaj 1 dan, dokler ni doseženo celjenje.
English: Clinical efficacy during prophylaxis and treatment of bleeding episodes
Slovenian: Klinična učinkovitost med profilakso in zdravljenjem krvavitev
English: If you experience that the effect of Esperoct is insufficient, talk to your doctor.
Slovenian: Če se vam zdi, da zdravilo Esperoct ne učinkuje dovolj, se posvetujte z zdravnikom.
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 aPTT reagent and the reference standard used in the assay.
Slovenian: V primeru, da je za določanje aktivnosti faktorja VIII v vzorcih krvi bolnikov uporabljen enostopenjski preizkus strjevanja na podlagi in vitro tromboplastinskega časa (aPTČ - aktivirani parcialni tromboplastinski čas), lahko na rezultate aktivnosti faktorja VIII v plazmi bistveno vplivata tako vrsta reagenta za aPTČ kot tudi referenčni standard, uporabljen v preizkusu.
English: Each vial of Esperoct contains nominally 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa pegol.
Slovenian: Ena viala zdravila Esperoct vsebuje nominalno 500, 1000, 1500, 2000 ali 3000 i.e. turoktokog alfa pegola.
English: Powder: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid
Slovenian: Prašek: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid in klorovodikova kislina.
English: Esperoct has no influence on the ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Esperoct nima vpliva na sposobnost vožnje in upravljanja strojev.