FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Esperoct
Slovenian: Druga zdravila in zdravilo Esperoct
English: The safety and efficacy of Esperoct in previously untreated patients have not yet been established.
Slovenian: Predhodno nezdravljeni bolniki Varnost in učinkovitost zdravila Esperoct pri predhodno nezdravljenih bolnikih še nista bili dokazani.
English: Overall, including all extensions parts, 31 of 61 patients on every 7 days prophylaxis switched back to every 4 days treatment.
Slovenian: Skupno (in vključujoč vsa podaljšanja) je 31 od 61 bolnikov s profilakse na 7 dni prešlo nazaj na zdravljenje na 4 dni.
English: Of the total 1,126 bleeds, 86.9% were effectively treated with 1 injection and 96.8% were effectively treated with 1-2 injections of Esperoct.
Slovenian: Med skupno 1126 krvavitvami je bilo 86,9 % krvavitev učinkovito zdravljenih z 1 injekcijo, 96,8 % pa učinkovito zdravljenih z 1 do 2 injekcijama zdravila Esperoct.
English: • redness of skin (erythema)
Slovenian: • pordelost kože (eritem)
English: If you forget a dose, inject the missed dose as soon as you remember.
Slovenian: Če ste pozabili uporabiti odmerek, izpuščeni odmerek injicirajte takoj, ko se spomnite.
English: Within one hour before surgery to achieve factor VIII activity within the target range
Slovenian: Znotraj ene ure pred posegom za doseganje aktivnosti faktorja VIII v okviru ciljne vrednosti.
English: This incompatibility may prevent administration of the medicine and result in damage to the needleless connector.
Slovenian: Ta nezdružljivost lahko onemogoči aplikacijo zdravila in povzroči poškodbo brezigelnega nastavka.
English: (pre- and post-operative)
Slovenian: (pred posegom in po njem)
English: The reconstituted product should not be administered in the same tubing or container with other medicinal products.
Slovenian: Rekonstituirano zdravilo se ne sme aplicirati v isti cevki ali v istem vsebniku z drugimi zdravili.
English: If a central venous access device (CVAD) is required, the risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Slovenian: Če je potreben pripomoček za centralni venski dostop (CVAD - Central Venous Access Device), je treba upoštevati tveganja za zaplete, povezane s tem pripomočkom, kot npr. lokalne okužbe, bakteriemija in tromboza na mestu katetra.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestno zdravljenje s faktorjem VIII poveča tveganje za srčno-žilne dogodke.
English: Nine of these patients reverted back to prophylaxis every 4 days during the randomised study phase.
Slovenian: Devet od teh bolnikov je med randomizirano fazo študije prešlo nazaj na profilakso na 4 dni.
English: The equipment in this package is designed to reconstitute and inject Esperoct.
Slovenian: Sestavni deli tega pakiranja so namenjeni pripravi in injiciranju zdravila Esperoct.
English: Within one hour before surgery
Slovenian: Znotraj ene ure pred posegom.
English: Each reconstituted vial contains 30.5 mg of sodium (see section 4.4).
Slovenian: Ena pripravljena viala vsebuje 30,5 mg natrija (glejte poglavje 4.4).
English: If, at any point, there is air in the syringe, inject the air back into the vial.
Slovenian: Če v injekcijski brizgi kadar koli opazite zrak, zrak iztisnite nazaj v vialo.
English: • itching (pruritus)
Slovenian: • srbenje (pruritus)
English: The use of Esperoct in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Slovenian: Uporaba zdravila Esperoct pri otrocih do 12. leta ni indicirana (za informacije o pediatrični uporabi glejte poglavje 4.2).
English: If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people).
Slovenian: Če ste se predhodno več kot 150 dni zdravili s faktorjem VIII, lahko pri vas nastanejo zaviralci (pojavijo se lahko pri največ 1 od 100 bolnikov).
English: Do not disassemble the equipment before disposal.
Slovenian: Pripomočkov pred odstranjevanjem ne razstavljajte.
English: As expected incremental recovery appeared to be lower while body weight adjusted clearance appeared to be higher in children compared to adults and adolescents.
Slovenian: Po pričakovanjih je bilo postopno izboljšanje nižje, očistek glede na telesno maso pa višji pri otrocih kot pri odraslih in mladostnikih.
English: Frequencies have been evaluated according to the following convention: very common (≥ 1/10),
Slovenian: Pogostnosti so ocenjene po naslednjem dogovoru: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10),
English: The single dose pharmacokinetic parameters are comparable between young children (0 to below 6 years) and older children (6 to below 12 years), and between adolescents (12 to17 years) and adults (18 years and above).
Slovenian: Farmakokinetični parametri po enkratnem odmerku so primerljivi med majhnimi otroki (od 0 do 6 let) in starejšimi otroki (od 6 do 12 let) ter med mladostniki (od 12 do 17 let) in odraslimi (18 let in več).
English: *Human factor VIII, produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cells line, and no additives of human or animal origin are used in the cell culture, purification, conjugation or formulation of Esperoct.
Slovenian: *Humani faktor VIII, pridobljen s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka (CHO - Chinese Hamster Ovary) in pripravljen brez dodajanja snovi človeškega ali živalskega izvora v celično kulturo, v procesu prečiščevanja, konjugacije ali v končno pripravljeno zdravilo Esperoct.
English: Maximum factor VIII activity (IU/dL)a t1/2 (hours)
Slovenian: Največja aktivnost faktorja VIII (i.e./dl)a t1/2 (ure)
English: Talk to your doctor or pharmacist if you have heart disease or you are at risk of heart disease.
Slovenian: Srčna bolezen Posvetujte se z zdravnikom ali farmacevtom, če imate srčno bolezen ali tveganje zanjo.
English: Known allergic reaction to hamster protein.
Slovenian: Znana alergijska reakcija na beljakovine hrčkov.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: Ta količina predstavlja 1,5 % priporočenega največjega dnevnega vnosa natrija za odraslega človeka.
English: These may become severe and could be life-threatening, see
Slovenian: Te reakcije lahko postanejo hude in so lahko smrtno nevarne;
English: The half-life of Esperoct was 1.6 fold longer compared to unmodified factor VIII products in adults.
Slovenian: Razpolovni čas zdravila Esperoct je bil 1,6-krat daljši kot pri zdravilih z nemodificiranim faktorjem VIII pri odraslih.
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Slovenian: Tveganje za nastanek zaviralcev je odvisno od resnosti bolezni in izpostavljenosti faktorju VIII, pri čemer je tveganje največje v prvih 50 dneh izpostavljenosti, občasno tveganje pa obstaja vse življenje.
English: Severe or life-threatening haemorrhages
Slovenian: hude ali življenje ogrožajoče krvavitve
English: Anti-PEG antibodies
Slovenian: Protitelesa proti PEG
English: Contents of the pack and other information What Esperoct contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Esperoct
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Slovenian: Ker je hemofilija A pri ženskah redka, izkušenj z uporabo faktorja VIII med nosečnostjo in dojenjem ni na voljo.
English: The maximum single dose is 75 IU/kg.
Slovenian: Največji enkratni odmerek je 75 i.e./kg.
English: The patient had a factor VIII gene intron 22 inversion and was at a high risk of developing factor VIII inhibitors.
Slovenian: Bolnik je imel inverzijo introna 22 gena za faktor VIII in je imel veliko tveganje za pojav zaviralcev faktorja VIII.
English: • difficulty in swallowing or breathing
Slovenian: • težave pri požiranju ali dihanju
English: • if you are allergic to the active substance or to any of the other ingredients of this medicine
Slovenian: • če ste alergični na učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
English: The categories of adverse reactions presented in table 3 is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Kategorije neželenih učinkov, ki so predstavljene v preglednici 3, so podane v skladu z razvrstitvijo organskih sistemov po MedDRA (organski sistem in prednostni izraz).
English: Adolescents (12 years of age and above) can use the same dose as adults.
Slovenian: Mladostniki (stari 12 let in več) lahko uporabijo enak odmerek kot odrasli.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or reconstituted with injection solutions other than the provided sodium chloride solvent.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti se zdravila ne sme mešati z drugimi zdravili ali rekonstituirati z drugimi raztopinami za injiciranje, razen s priloženim vehiklom z natrijevim kloridom.
English: Consideration should be given to maintain a factor VIII activity at or above the target range.
Slovenian: Paziti je treba na ohranitev aktivnosti faktorja VIII pri ciljni vrednosti ali nad njo.
English: When including imputations, (replacing missing data for withdrawn patients with a substituted value) the estimated mean ABR for all bleeds was 3.70 (95% CI: 2.94;4.66).
Slovenian: Če je bilo uporabljeno imputiranje (vstavitev nadomestnih vrednosti namesto manjkajočih podatkov za bolnike, ki so odstopili iz preskušanja), je bil ocenjeni povprečni ABR za vse krvavitve 3,70 (95 % IZ: 2,94, 4,66).
English: Do not throw it out with the ordinary household waste.
Slovenian: Ničesar od navedenega ne smete zavreči med običajne gospodinjske odpadke.
English: All pharmacokinetic studies with Esperoct were conducted in previously treated patients with severe haemophilia A (factor VIII <1%).
Slovenian: Vse farmakokinetične študije z zdravilom Esperoct so izvedli pri predhodno zdravljenih bolnikih s hudo hemofilijo A (faktor VIII <1 %).
English: • allergic reactions (hypersensitivity).
Slovenian: • alergijske reakcije (preobčutljivost).
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Slovenian: Zdravilo vsebuje 30,5 mg natrija (glavna sestavina kuhinjske soli) na pripravljeno vialo.
English: A total of 55 of the 120 eligible patients chose to be randomised (17 to the every 4 days dosing and 38 to the 75 IU every 7 days).
Slovenian: Skupno 55 od 120 primernih bolnikov se je odločilo za randomizacijo (17 jih je izbralo odmerjanje na 4 dni, 38 pa odmerek 75 i.e. na 7 dni).
English: Solvent for Esperoct Sodium chloride 9 mg/mL
Slovenian: vehikel za zdravilo Esperoct natrijev klorid 9 mg/ml
English: Of the 68 children below 12 years on prophylaxis, 29 (42.6%) did not have any bleeds.
Slovenian: otroki, mlajšimi od 12 let, na profilaksi jih 29 (42,6 %) ni imelo nobenih krvavitev.
English: How much to use
Slovenian: Koliko zdravila morate uporabiti
English: The dose level and dosing intervals for surgery depend on the procedure and local practice.
Slovenian: Odmerjanje in intervali odmerjanja pri kirurških posegih so odvisni od samih posegov in lokalne prakse.
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ-free as possible.
Slovenian: • Gumijasti zamašek viale obrišite s sterilno alkoholno blazinico in pred uporabo počakajte nekaj sekund, da se posuši na zraku, da zagotovite čim večjo sterilnost.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Pri odmerku, ki temelji na telesni masi, je lahko potrebna prilagoditev pri podhranjenih bolnikih ali pri bolnikih s prekomerno telesno maso.
English: Esperoct is for intravenous use.
Slovenian: Zdravilo Esperoct je namenjeno za intravensko uporabo.
English: No difference in the safety profile was observed between previously treated adolescents (12-18 years) and adult patients.
Slovenian: Pri varnostnem profilu zdravila med predhodno zdravljenimi mladostniki (12-18 let) in odraslimi bolniki niso opazili razlik.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Slovenian: Če pričakovana stopnja aktivnosti faktorja VIII v plazmi ni dosežena ali če z ustreznim odmerkom ne obvladate krvavitve, je treba opraviti preiskave glede prisotnosti zaviralcev faktorja
English: The frequency of doses and duration of therapy should always be individually adjusted based on individual clinical response.
Slovenian: Pogostnost odmerjanja in trajanje zdravljenja je treba vedno prilagoditi posamezniku glede na njegov klinični odziv.
English: Esperoct was effective in maintaining haemostasis during major surgery with a success rate of 95.6% in all major surgeries performed (43 out of 45 had the effect rated as ‘excellent‘ or ‘good‘).
Slovenian: Klinična učinkovitost zdravila Esperoct med večjimi kirurškimi posegi Zdravilo Esperoct je bilo učinkovito pri vzdrževanju hemostaze med večjimi kirurškimi posegi, in sicer pri 95,6 % vseh opravljenih večjih kirurških posegov (pri 43 od 45 posegov je bil učinek ocenjen kot »izvrsten« ali »dober«).
English: Do not use any other way to warm the vial and pre-filled syringe.
Slovenian: Za segrevanje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
English: Table 4 Single-dose pharmacokinetic parameters of Esperoct 50 IU/kg in children, adolescents and adults by age using the chromogenic assay (geometric mean [CV%])
Slovenian: Preglednica 4 Farmakokinetični parametri po enkratnem odmerku 50 i.e./kg zdravila Esperoct pri otrocih, mladostnikih in odraslih glede na starost, ugotovljeni z uporabo kromogenega preizkusa (geometrijska sredina [KV %])
English: Also there can be significant discrepancies between assay results obtained by aPTTbased one stage clotting assay and the chromogenic assay according to Ph. Eur.
Slovenian: Obstajajo lahko tudi bistvena odstopanja med rezultati preizkusov, pridobljenimi z enostopenjskim preizkusom strjevanja na podlagi aPTČ, in rezultati, pridobljenimi s kromogenim preizkusom po Ph. Eur.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem mililitru človeške plazme.
English: In total, 129 single-dose pharmacokinetic (PK) profiles of Esperoct were evaluated in 86 patients (including 24 paediatric patients of 0 to below 12 years).
Slovenian: Skupno je bilo ocenjenih 129 farmakokinetičnih (FK) profilov po enkratnem odmerku zdravila Esperoct pri 86 bolnikih (vključno s 24 pediatričnimi bolniki, starimi od 0 do 12 let).
English: Do not use the equipment if you suspect it is contaminated.
Slovenian: Pripomočkov ne uporabljajte, če menite, da so onesnaženi (kontaminirani).
English: If you are in doubt, contact your doctor.
Slovenian: Če ste v dvomih, se posvetujte z zdravnikom.
English: When using a one-stage clotting assay some silica based reagents should be avoided as they cause underestimation.
Slovenian: V primeru uporabe enostopenjskega preizkusa strjevanja se je treba izogniti nekaterim reagentom na podlagi silicijevega dioksida, ker povzročijo prenizke ocene.
English: Novo Nordisk US Bio Production Inc. 9 Technology Drive West Lebanon
Slovenian: Novo Nordisk US Bio Production Inc.
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Slovenian: Nekateri brezigelni nastavki z notranjo konico niso združljivi z napolnjeno injekcijsko brizgo.
English: If you have a catheter where medicines can be injected into your blood (central venous access device), you may develop infections or blood clots at the site of the catheter.
Slovenian: Če imate vstavljen osrednji venski kateter, po katerem vam lahko zdravila injicirajo v kri (pripomoček za centralni venski dostop), lahko na mestu katetra pride do okužb ali nastanka krvnih strdkov.
English: Do not touch the rubber stopper with your fingers as this can transfer germs.
Slovenian: Gumijastega zamaška se ne dotikajte s prsti, saj ga lahko tako kontaminirate z mikrobi.
English: Repeat every 8 to 24 hours to maintain factor VIII activity within the target range
Slovenian: Ponovitev na 8 do 24 ur za ohranjanje aktivnosti faktorja
English: You must contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as:
Slovenian: Nemudoma se posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru, če opazite znake alergijske reakcije, kot so:
English: Esperoct can not be used in children below 12 years of age.
Slovenian: Otroci Zdravila Esperoct se ne uporablja pri otrocih, mlajših od 12 let.
English: Your doctor may choose another dose or how often the injections should be given, based on your need.
Slovenian: Zdravnik vam lahko na osnovi vaših potreb predpiše drugačen odmerek ali pogostnost injiciranja zdravila.
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Slovenian: Zelo redko so opažali pojav protiteles proti beljakovinam hrčkov in s tem povezane preobčutljivostne reakcije.
English: Table 3 Frequency of adverse reactions in clinical trials for PTPs* MedDRA System Organ Class
Slovenian: Preglednica 3: Pogostnost neželenih učinkov v kliničnih preskušanjih za PZB* Organski sistemi po MedDRA
English: The specific activity of turoctocog alfa pegol is approximately 9500 IU/mg protein.
Slovenian: Specifična aktivnost turoktokog alfa pegola je približno 9500 i.e./mg proteina.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo tako za odrasle kot za mladostnike (12 - 18 let).
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection), the prepared solution for injection contains 125, 250, 375, 500 or 750 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1000, 1500, 2000 or 3000 IU).
Slovenian: Po pripravi s priloženim vehiklom (9 mg/ml (0,9 %) raztopina natrijevega klorida za injekcije) vsebuje pripravljena raztopina za injiciranje 125, 250, 375, 500 ali 750 i.e. turoktokog alfa pegola na ml (glede na jakost učinkovine turoktokog alfa pegol, tj. 500, 1000, 1500, 2000 ali 3000 i.e.).
English: It must be clear and colourless and no particles should be visible.
Slovenian: Biti mora bistra in brezbarvna ter ne sme vsebovati vidnih delcev.
English: The dose, dosing interval and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, on the targeted factor VIII activity level and the patient's clinical condition.
Slovenian: Odmerjanje zdravila, interval odmerjanja in trajanje nadomestnega zdravljenja so odvisni od stopnje pomanjkanja faktorja VIII, mesta in obsega krvavitve, ciljne ravni aktivnosti faktorja VIII ter od bolnikovega kliničnega stanja.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and incremental recoveries.
Slovenian: Posamezni bolniki se lahko različno odzivajo na faktor VIII, kar se kaže v različnih razpolovnih časih in različnih časih okrevanja.
English: • pale and cold skin, fast heartbeat, or dizziness (low blood pressure)
Slovenian: • bleda in hladna koža, hiter srčni utrip ali omotica (nizek krvni tlak) • glavobol, slabost ali bruhanje
English: Abbreviations: AUC = area under the factor VIII activity time profile; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state; IR = Incremental recovery.
Slovenian: Okrajšave: KV = koeficient variacije; AUC = območje pod krivuljo časovnega profila aktivnosti faktorja VIII (area under the factor VIII activity time profile); t1/2 = končni razpolovni čas (terminal half-life); MRT = srednji čas zadrževanja (mean residence time); CL = očistek (clearance); Vss = volumen porazdelitve (volume of distribution) v stanju dinamičnega ravnovesja; IR = inkrementalno izboljšanje
English: • Lightly squeeze the protective cap with your thumb and index finger as shown.
Slovenian: • Zaščitni pokrovček rahlo stisnite s palcem in kazalcem, kot prikazuje slika.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost (i.e.) je določena z uporabo kromogenega preizkusa po Evropski farmakopeji.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Slovenian: Po urniku nadaljujte z naslednjo injekcijo, nato pa ravnajte po navodilih svojega zdravnika.
English: 12 to below18 years N=3
Slovenian: od 12 do 18 let N = 3
English: • sterile alcohol swabs
Slovenian: • sterilne alkoholne blazinice
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da 1 mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja v plazmi za 2 i.e./dl.
English: Three patients had transiently positive test results for anti-drug antibodies after administration of Esperoct but no correlation with adverse events could be established.
Slovenian: Trije bolniki so imeli po uporabi zdravila Esperoct prehodno pozitivne rezultate testa za protitelesa proti zdravilu, a povezanosti z neželenimi učinki niso ugotovili.
English: In people with haemophilia A, factor VIII is missing or does not work properly.
Slovenian: Osebe s hemofilijo A nimajo faktorja VIII ali pa ta ne deluje pravilno.
English: If you are not sure, talk to your doctor before using this medicine.
Slovenian: Če ste negotovi, se pred uporabo tega zdravila posvetujte z zdravnikom.
English: These early signs may include rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, or dizziness, headache, nausea and vomiting.
Slovenian: Med te znake spadajo kožni izpuščaj, koprivnica, podplutbe, srbenje na velikem predelu kože, rdečina in/ali otekanje ustnic, jezika, obraza ali rok, težave pri požiranju ali dihanju, piskajoče dihanje, stiskanje v prsnem košu, bleda in hladna koža, hiter srčni utrip, omotica, glavobol, slabost in bruhanje.
English: Chemical and physical in-use stability have been demonstrated for 24 hours when stored in a refrigerator (2°C - 8°C) and 4 hours when stored at room temperature (up to 30°C).
Slovenian: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur v primeru shranjevanja v hladilniku (2 °C do 8 °C) in 4 ure v primeru shranjevanja pri sobni temperaturi (do 30 °C).
English: Do not take the vial adapter out of the protective cap with your fingers.
Slovenian: Nastavka za vialo ne jemljite iz zaščitne zaporke s prsti.
English: What Esperoct is and what it is used for What you need to know before you use Esperoct How to use Esperoct
Slovenian: Kaj je zdravilo Esperoct in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Esperoct Kako uporabljati zdravilo Esperoct Možni neželeni učinki