FrancophonIA/ELRC3.0 huggingface dataset:
English: No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Slovenian: 4.9 Preveliko odmerjanje O simptomih prevelikega odmerjanja rekombinantnega koagulacijskega faktorja VIII niso poročali.
English: Thirty-two patients had pre-existing anti-PEG antibodies before administration of Esperoct.
Slovenian: Dvaintrideset bolnikov je imelo protitelesa proti PEG že pred uporabo zdravila Esperoct.
English: • If the CVAD line needs to be flushed before or after the injection of Esperoct, use sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: • Če je linijo naprave za centralni venski dostop pred injiciranjem zdravila Esperoct ali po njem treba sprati, uporabite 9 mg/ml (0,9 %) raztopino natrijevega klorida za injekcije.
English: During the course of treatment, appropriate determination of factor VIII activity levels is advised to guide adjustments of the dosing regimen of Esperoct, if needed.
Slovenian: Med zdravljenjem je priporočljivo določanje aktivnosti faktorja VIII, v skladu s katero se lahko po potrebi prilagodi odmerjanje zdravila Esperoct.
English: The PEG is attached to the O-linked glycan in the truncated B-domain of rFVIII (turoctocog alfa).
Slovenian: PEG je pritrjen na O-vezan glikan v ciljno skrajšani domeni B rFVIII (turoktokog alfa).
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Slovenian: Če zaščitni papir ni popolnoma pritrjen ali je kakor koli poškodovan, nastavka za vialo ne uporabite.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja je sestavljen iz dveh molekul (faktorja VIII
English: Allergic-type hypersensitivity reactions are possible with Esperoct.
Slovenian: Pri uporabi zdravila Esperoct se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: If you have to significantly increase your usage of Esperoct to stop a bleed, talk to your doctor immediately.
Slovenian: Če ste za zaustavitev krvavitve morali znatno povečati uporabo zdravila Esperoct, se nemudoma posvetujte z zdravnikom.
English: • Keep the plunger rod pushed completely in.
Slovenian: • Potisni bat naj ostane popolnoma potisnjen noter.
English: • Remove the plastic cap from the vial.
Slovenian: • Z viale odstranite plastično zaporko.
English: • Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Slovenian: • Prenehajte pritiskati na potisni bat in pustite, da se pomakne nazaj sam od sebe, medtem ko pripravljena raztopina polni injekcijsko brizgo.
English: Turoctocog alfa pegol is a purified recombinant human factor VIII (rFVIII) product with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Slovenian: Turoktokog alfa pegol je prečiščen rekombinantni humani faktor VIII (rFVIII) s 40 kDa polietilen glikola (PEG), konjugiranega na beljakovino.
English: Rubber stopper (under plastic cap)
Slovenian: Pregled plastična zaporka gumijasti zamašek (pod plastično zaporko)
English: • While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Slovenian: • Medtem ko držite vialo obrnjeno na glavo, nežno potrkajte po injekcijski brizgi, da se bodo morebiti prisotni zračni mehurčki dvignili na vrh.
English: The vast majority of bleeds treated with Esperoct were of mild/moderate severity.
Slovenian: Večinoma so bile krvavitve, zdravljene z zdravilom Esperoct, blage ali zmerne.
English: The median annualised bleeding rate (ABR) in adults and adolescents receiving Esperoct was 1.18 (Interquartile range IQR: 0.00;4.25), whereas the spontaneous ABR was 0.00 (IQR: 0.00;1.82), traumatic ABR was 0.00 (IQR: 0.00;1.74) and joint ABR was 0.85 (IQR: 0.00;2.84).
Slovenian: Mediani letni delež krvavitev (ABR - Annualised Bleeding Rate) pri odraslih in mladostnikih, ki so prejemali zdravilo Esperoct, je bil 1,18 (kvartilni razmik [KvR]: 0,00, 4,25); ABR spontanih krvavitev je bil 0,00 (KvR: 0,00, 1,82), ABR travmatskih krvavitev 0,00 (KvR: 0,00, 1,74) in ABR krvavitev v sklepe
English: What Esperoct looks like and contents of the pack
Slovenian: Izgled zdravila Esperoct in vsebina pakiranja
English: The powder in the vial appears as a white to off-white powder.
Slovenian: Prašek v viali je bele do skoraj bele barve.
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let ali več, s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: 1500 IU
Slovenian: 1500 i.e.
English: Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Slovenian: Ko je zdravilo enkrat vzeto iz hladilnika, se ga ne sme več vrniti vanj.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing is achieved
Slovenian: Ponovitev injekcije na 8 do 24 ur,
English: Injecting Esperoct via needleless connectors for intravenous (IV) catheters
Slovenian: Injiciranje zdravila Esperoct preko brezigelnih nastavkov za intravenske (i.v.)
English: If the plastic cap is loose or missing, do not use the vial.
Slovenian: Če plastična zaporka ni trdno pritrjena ali manjka, viale ne uporabite.
English: After the injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Slovenian: Po injiciranju injekcijsko brizgo z infuzijskim kompletom in vialo z nastavkom za vialo varno odstranite.
English: A total of 108 single dose pharmacokinetic profiles at 50 IU/kg Esperoct were evaluated in 69 patients.
Slovenian: Pri 69 bolnikih je bilo ocenjenih skupno108 farmakokinetičnih profilov po enkratnem odmerku 50 i.e./kg zdravila Esperoct.
English: Esperoct is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Slovenian: Zdravilo Esperoct je treba aplicirati intravensko po pripravi praška z vehiklom, ki je na voljo v injekcijski brizgi.
English: On demand treatment and treatment of bleeding episodes
Slovenian: Zdravljenje po potrebi in zdravljenje krvavitev
English: The rate of administration should be determined by the patient's comfort level over approximately 2 minutes.
Slovenian: Hitrost apliciranja v okvirnem razponu dveh minut morate določiti glede na bolnikovo počutje.
English: These devices are not included in the Esperoct package.
Slovenian: Pakiranje zdravila Esperoct teh pripomočkov ne vsebuje.
English: The factor VIII activity of Esperoct can be measured using the conventional factor VIII assays, the chromogenic assay and the one-stage assay.
Slovenian: Aktivnost faktorja VIII je mogoče za zdravilo Esperoct meriti z običajnimi preizkusi za faktor VIII, s kromogenim preizkusom ali z enostopenjskim preizkusom.
English: There is a risk that you may experience a severe and sudden allergic reaction (e.g. anaphylactic reaction) to Esperoct.
Slovenian: Pri uporabi zdravila Esperoct obstaja tveganje za pojav hude in nenadne alergijske reakcije (npr. anafilaktične reakcije).
English: • Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
Slovenian: • Odstranite zaporko brizge z napolnjene injekcijske brizge, tako da jo upognete, dokler se perforacija ne prelomi.
English: Esperoct is supplied as a powder.
Slovenian: Zdravilo Esperoct je na voljo v obliki praška.
English: The active substance turoctocog alfa pegol is a covalent conjugate of the protein turoctocog alfa* with a 40 kDa polyethylene-glycol (PEG).
Slovenian: Učinkovina turoktokog alfa pegol je kovalentni konjugat proteina turoktokog alfa* s 40 kDa polietilen glikolom (PEG).
English: Name and address of the manufacturer responsible for batch release
Slovenian: Združene države Amerike Ime in naslov izdelovalca, odgovornega za sproščanje serij
English: • The ingredients in the solvent are sodium chloride 9 mg/mL (0.9%) solution for injection and water for injections.
Slovenian: • Sestavini v vehiklu sta 9 mg/ml (0,9 %) raztopina natrijevega klorida za injekcije in voda za injekcije.
English: Table 2 Guidance for dosing of Esperoct for perioperative management Type of surgical procedure
Slovenian: Preglednica 2: Smernice za odmerjanje zdravila Esperoct pri perioperativni uporabi
English: What you need to know before you use Esperoct Do not use Esperoct:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Esperoct
English: The efficacy of Esperoct in the treatment of bleeding episodes was demonstrated in all age groups.
Slovenian: Klinična učinkovitost zdravila Esperoct pri zdravljenju krvavitev in zdravljenju po potrebi Učinkovitost zdravila Esperoct pri zdravljenju krvavitev je bila dokazana v vseh starostnih skupinah.
English: Before injection, it must be reconstituted with the solvent supplied in the syringe.
Slovenian: Pred injiciranjem ga je treba pripraviti z vehiklom, ki se nahaja v injekcijski brizgi.
English: Esperoct 500 IU powder and solvent for solution for injection Esperoct 1000 IU powder and solvent for solution for injection Esperoct 1500 IU powder and solvent for solution for injection Esperoct 2000 IU powder and solvent for solution for injection Esperoct 3000 IU powder and solvent for solution for injection.
Slovenian: Esperoct 500 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 1000 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 1500 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 2000 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: Vial with Esperoct powder
Slovenian: Viala s praškom zdravila Esperoct
English: The median and estimated mean annualised bleeding rate in children below 12 years receiving Esperoct twice weekly was 1.95 and 2.13 (95% CI: 1.48;3.06), whereas the spontaneous ABR was 0.00 and 0.58 (95% CI: 0.24;1.40), traumatic ABR was 0.00 and 1.52 (95% CI: 1.07;2.17) and joint ABR was 0.00 and 1.03 (95% CI: 0.59;1.81), respectively.
Slovenian: 1,48; 3,06), pri čemer je bil spontan ABR 0,00 oz. 0,58 (95 % IZ: 0,24; 1,40), travmatski ABR 0,00 oz. 1,52 (95 % IZ: 1,07; 2,17) in ABR krvavitev v sklepe 0,00 oz. 1,03 (95 % IZ: 0,59; 1,81).
English: Non-clinical data reveal no special concern for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: Factor VIII level required (%) (IU/dL)a
Slovenian: (%) (i.e./dl)a
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Slovenian: Ne zavrzite nobenega pripomočka, dokler ne injicirate pripravljene raztopine.
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem VIII (rDNA) z drugimi zdravili niso poročali.
English: • Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Slovenian: • Potisni bat takoj pritrdite na injekcijsko brizgo z vrtenjem v smeri urinega kazalca v batni zamašek znotraj napolnjene injekcijske brizge, dokler ne začutite upora.
English: This leaflet was last revised in Other sources of information
Slovenian: Navodilo je bilo nazadnje revidirano:
English: Each pack of Esperoct contains a vial with white to off-white powder, a 4 mL pre-filled syringe with a clear colourless solvent, a plunger rod and a vial adapter.
Slovenian: Eno pakiranje zdravila Esperoct vsebuje vialo z belim do skoraj belim praškom, 4-ml napolnjeno injekcijsko brizgo z bistrim, brezbarvnim vehiklom, potisni bat in nastavek za vialo.
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema zaviranje faktorja VIII
English: Do not touch the syringe tip under the syringe cap.
Slovenian: Ne dotikajte se konice brizge pod zaporko brizge.
English: • If your bleeding is not being controlled with Esperoct, tell your doctor immediately
Slovenian: • Če z zdravilom Esperoct ne morete več uspešno obvladati svojih krvavitev, o tem nemudoma obvestite zdravnika.
English: Frequency of doses (hours) Duration of therapy
Slovenian: Pogostnost odmerkov (ure) Trajanje zdravljenja manjši kirurški posegi,
English: Factor VIII inhibition Uncommon (PTPs)**
Slovenian: občasni (PZB)**
English: • Check the reconstituted solution.
Slovenian: • Preverite pripravljeno raztopino.
English: • an infusion set (butterfly needle with tubing)
Slovenian: • infuzijski komplet (cevka in injekcijska igla z metuljčkom),
English: More extensive haemarthrosis, muscle bleeding, haematoma
Slovenian: zmerna obsežnejša hemartroza, krvavitev v mišico ali hematom
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII:C. Povzroči obsežne krvavitve v sklepe, mišice ali notranje organe.
English: (IU*hour/dL) CL (mL/hour/kg) Vss (mL/kg) MRT (hours)
Slovenian: AUCinf (i.e.*ura/dl) CL (ml/ura/kg)
English: The required dose is determined using the following formula: Required units (IU) = body weight (kg) x desired factor VIII rise (%) (IU/dL) x 0.5 (IU/kg per IU/dL).
Slovenian: Potrebno število enot (i.e.) = telesna masa (kg) x želeno zvišanje faktorja VIII (%) (i.e./dl) x 0,5 (i.e./kg na i.e./dl)
English: The reconstituted solution must be clear and colourless.
Slovenian: Pripravljena raztopina mora biti bistra in brezbarvna.
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Slovenian: Če zaporka brizge ni trdno pritrjena ali manjka, napolnjene injekcijske brizge ne uporabite.
English: For further information, see “Development of ‘FVIII inhibitors' (antibodies)” in section
Slovenian: Za nadaljnje informacije glejte »Nastanek »zaviralcev FVIII« (protiteles)« v poglavju 2.
English: The overall success rate for the treatment of bleeds was 87.7% and 94.4% of all bleeds treated with 1-2 injections.
Slovenian: Splošna uspešnost zdravljenja krvavitev je bila 87,7 %.
English: • 1 vial with Esperoct powder
Slovenian: • 1 vialo s praškom zdravila Esperoct,
English: Disposal • After injection, safely dispose of all unused Esperoct solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Slovenian: injekcijsko brizgo z infuzijskim kompletom, vialo z nastavkom za vialo in drug odpadni material v skladu z navodili farmacevta.
English: IR (IU/dL) per (IU/kg)a
Slovenian: Število profilov IR (i.e./dl) na i.e./kg)a
English: The reconstituted medicinal product should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Rekonstituirano zdravilo morate pred aplikacijo vizualno pregledati glede prisotnosti delcev in spremembe barve.
English: Once attached, do not remove the vial adapter from the vial.
Slovenian: Ko je nastavek za vialo nameščen, ga ne odstranjujte več z viale.
English: A maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Slovenian: Največji enkratni odmerek zdravila Esperoct, ki se lahko uporabi, je 75 i.e./kg, največji skupni odmerek pa 200 i.e./kg/24 ur.
English: The solvent is a sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Vehikel je 9 mg/ml (0,9 %) raztopina natrijevega klorida za injekcije.
English: To treat bleeding
Slovenian: Zdravljenje krvavitev
English: By factor VIII 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: Tako se začasno nadomesti pomanjkanje faktorja VIII in zmanjša nagnjenost h krvavitvam.
English: What Esperoct is and what it is used for What Esperoct is
Slovenian: Kaj je zdravilo Esperoct in za kaj ga uporabljamo
English: 3000 IU
Slovenian: 3000 i.e.
English: • 1 vial adapter
Slovenian: • 1 nastavek za vialo,
English: Do not freeze the reconstituted solution or store it in syringes.
Slovenian: Pripravljene raztopine ne smete zamrzovati ali shranjevati v injekcijskih brizgah.
English: Early haemarthrosis, mild muscle bleeding or mild oral bleeding
Slovenian: Trajanje zdravljenja blaga zgodnja hemartroza, blaga krvavitev v mišico ali ustno votlino
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Slovenian: • Obrnite zaščitni pokrovček in nastavek za vialo namestite na vialo.
English: Do not shake the vial as this will cause foaming.
Slovenian: Viale ne stresajte, ker to povzroči penjenje.
English: Esperoct contains the active substance turoctocog alfa pegol and is a long-acting recombinant coagulation factor VIII product.
Slovenian: Zdravilo Esperoct vsebuje učinkovino turoktokog alfa pegol, ki je dolgodelujoči rekombinantni koagulacijski faktor VIII.
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII.
English: Esperoct 500 IU powder and solvent for solution for injection Esperoct 1000 IU powder and solvent for solution for injection Esperoct 1500 IU powder and solvent for solution for injection Esperoct 2000 IU powder and solvent for solution for injection Esperoct 3000 IU powder and solvent for solution for injection turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)) This medicine is subject to additional monitoring.
Slovenian: Esperoct 500 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 1000 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 1500 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 2000 i.e. prašek in vehikel za raztopino za injiciranje Esperoct 3000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa pegol (pegilirani humani koagulacijski faktor VIII (rDNA))
English: • Remove the protective cap from the vial adapter.
Slovenian: • Odstranite zaščitni pokrovček z nastavka za vialo.
English: • Push the plunger rod to inject all the solvent into the vial.
Slovenian: • Potisnite potisni bat, da v vialo iztisnete celotno količino vehikla.
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje se mora začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
English: Adjustments of doses and administration intervals may be considered based on achieved factor VIII levels and individual bleeding tendency.
Slovenian: Odmerke in časovne intervale odmerjanja je mogoče prilagoditi na osnovi doseženih ravni faktorja
English: 30 months at 2°C - 8°C, during which the product may be stored for up to 30°C for a single period not exceeding 12 months, but not beyond the expiry date written on the package.
Slovenian: 30 °C največ enkrat za obdobje do 12 mesecev, a ne po datumu izteka roka uporabnosti zdravila, ki je označen na embalaži.
English: The expiry date is printed on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Slovenian: Datum izteka roka uporabnosti je naveden na škatli, viali, nastavku za vialo in napolnjeni injekcijski brizgi.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Esperoct Vsebina pakiranja in dodatne informacije
English: Each pack of Esperoct contains: - 1 glass vial (type I) with powder closed with a chlorobutyl rubber stopper, an aluminium seal with a plastic snap-off cap - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 mL solvent with backstop (polypropylene), a rubber plunger
Slovenian: Eno pakiranje zdravila Esperoct vsebuje: - 1 stekleno vialo (steklo tipa I) s praškom, z zamaškom iz klorobutilne gume in aluminijsko zaporo s plastično snemno zaporko,
English: If you use more Esperoct than you should, contact your doctor straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Esperoct, kot bi smeli Če ste uporabili večji odmerek zdravila Esperoct, kot bi smeli, se takoj posvetujte z zdravnikom.
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Slovenian: Upoštevajte navodila zdravnika ali medicinske sestre za pravilno uporabo nastavka in naprave za centralni venski dostop.
English: 2000 IU
Slovenian: 2000 i.e.
English: The efficacy of Esperoct for prophylaxis and treatment of bleeds was evaluated in an open-label, non-controlled trial in adolescents and adult patients with severe haemophilia A ages 12 years and above.
Slovenian: Učinkovitost in varnost zdravila Esperoct za profilaktično zdravljenje krvavitev so ocenili v odprtem, nekontroliranem preskušanju z eno samo skupino pri 68 otrocih, mlajših od 12 let, ki so imeli hudo hemofilijo A.
English: Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines
Slovenian: Med zdravljenjem z vsemi zdravili s faktorjem VIII lahko nastanejo zaviralci (protitelesa).
English: If you cannot use the reconstituted solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C).
Slovenian: Če raztopine zdravila Esperoct ne morete uporabiti takoj po pripravi, jo morate porabiti v 4 urah, če jo shranjujete pri sobni temperaturi (do 30 °C), in v 24 urah, če jo shranjujete v hladilniku
English: Posology
Slovenian: Vsebina
English: The solvent is clear and colourless.
Slovenian: Vehikel je bister in brezbarven.
English: If you touch the syringe tip, germs from your fingers can be transferred.
Slovenian: Če se konice injekcijske brizge dotaknete s prsti, jo lahko kontaminirate z mikrobi.
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 mL solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Slovenian: Vsebina pakiranja: 1 viala s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, 1 potisni bat in 1 nastavek za vialo.
English: Do not put Esperoct in the refrigerator again after it has been stored at room temperature.
Slovenian: Esperoct pri sobni temperaturi zdravila ne smete več dajati nazaj v hladilnik.
English: 18 years and above N=42
Slovenian: N = 42
English: 500 IU
Slovenian: 500 i.e.
English: Including tooth extraction
Slovenian: PODATKI NA ZUNANJI OVOJNINI
English: Attach the vial adapter • Remove the protective paper from the vial adapter.
Slovenian: • Z nastavka za vialo odstranite zaščitni papir.
English: The solution should be clear and colourless.
Slovenian: Raztopina mora biti bistra in brezbarvna.
English: If you notice particles or discolouration, do not use it. Use a new package instead.
Slovenian: Če opazite delce ali kakršno koli drugačno barvo, raztopine ne uporabite.
English: Record the date when you store Esperoct at room temperature on the carton.
Slovenian: Datum začetka shranjevanja zdravila pri sobni temperaturi zabeležite na škatlo.
English: For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Slovenian: Za navodila za pripravo zdravila pred aplikacijo glejte navodilo za uporabo.
English: Esperoct is used to treat and prevent bleeding in people 12 years and above with haemophilia A (inborn factor VIII deficiency).
Slovenian: Za kaj uporabljamo zdravilo Esperoct Zdravilo Esperoct uporabljamo za zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let in več, s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Esperoct nima vpliva na sposobnost vožnje in upravljanja strojev.