FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with factor X deficiency do not have sufficient factor X for their blood to clot properly, leading to excessive bleeding.
Slovenian: Bolniki s pomanjkanjem faktorja X v svoji krvi nimajo dovolj faktorja X, da bi se njihova kri ustrezno strjevala, kar povzroča močne krvavitve.
English: Depending on individual clinical response, longer intervals, e.g. once weekly, might be adequate (see section 5.1).
Slovenian: Lahko so primerni daljši intervali odmerjanja, npr. enkrat tedensko, odvisno od kliničnega odziva posameznika (glejte poglavje 5.1).
English: The desired factor X rise is the difference between the patient's plasma factor X level and the desired level, and based on the observed recovery of 2 IU/dL per IU/kg.
Slovenian: Želeni dvig faktorja X je razlika med ravnjo faktorja X v bolnikovi plazmi in želeno ravnjo ter temelji na opaženem povečanju aktivnosti pri 2 i.e./dl na i.e./kg.
English: powder and solvent for solution for injection human coagulation factor X This medicine is subject to additional monitoring.
Slovenian: prašek in vehikel za raztopino za injiciranje humani koagulacijski faktor X Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: Side effects in children are expected to be the same as in adults.
Slovenian: Neželeni učinki pri otrocih in mladostnikih Pričakujemo, da so neželeni učinki pri otrocih enaki kot pri odraslih.
English: A total of 537 (mean 59.7 per subject) prophylactic infusions were administered.
Slovenian: 537 profilaktičnih infuzij (v povprečju 59,7 infuzij na bolnika).
English: Four subjects were aged 0 to 5 years and five were aged 6 to 11 years inclusive.
Slovenian: let do vključno 5 let in pet bolnikov je bilo starih od vključno 6 let do vključno 11 let.
English: The mean (CV%) maximum plasma concentration (Cmax) was 0.504 (17.2) IU/mL.
Slovenian: Srednja (CV %) največja koncentracija v plazmi (Cmax) je znašala 0,504 (17,2) i.e./ml.
English: When the reconstitution process is complete, the used transfer device should be disposed of it in the ‘sharps box'.
Slovenian: Ko je postopek rekonstitucije končan, odvrzite pribor za prenos vehikla v "škatlo za ostre predmete".
English: There are no known effects of this medicine on the ability to drive or operate machinery.
Slovenian: Zdravilo nima znanih učinkov na sposobnost upravljanja vozil in strojev.
English: The factor X in Coagadex is extracted from human plasma (the liquid part of blood).
Slovenian: Faktor X v zdravilu Coagadex je pridobljen iz človeške plazme (tekočega dela krvi).
English: What you need to know before you use Coagadex Do not use Coagadex:
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Coagadex Ne uporabljajte zdravila Coagadex:
English: The other two subjects used doses up to 30 IU/kg and 33 IU/kg.
Slovenian: Druga dva bolnika sta uporabljala odmerke do 30 i.e./kg in 33 i.e./kg.
English: You can dissolve Coagadex using the needle-free Mix2Vial transfer device included within each pack.
Slovenian: Zdravilo Coagadex lahko raztopite s pomočjo pribora za prenos vehikla brez igel Mix2Vial, ki je priložen vsakemu pakiranju.
English: Due to the rarity of hereditary factor X deficiency, experience regarding the use of Coagadex during pregnancy and breast-feeding is not available.
Slovenian: Zaradi redkosti dednega pomanjkanja faktorja X izkušenj v zvezi z uporabo zdravila Coagadex med nosečnostjo in dojenjem ni.
English: There are limited data on the use of Coagadex for long periods of prophylaxis in adults.
Slovenian: Podatki o uporabi zdravila Coagadex za dolga obdobja profilakse pri odraslih so omejeni.
English: One case of accidental overdose was reported in the clinical trials, in which a subject received approximately 80 IU/kg Coagadex to treat a bleed.
Slovenian: V kliničnih preskušanjih so poročali o enem primeru nenamernega predoziranja, v katerem je bolnik prejel približno odmerek 80 i.e./kg zdravila Coagadex za zdravljenje krvavitve.
English: After being made up, the solution is colourless, clear or pearl-like (opalescent).
Slovenian: Po pripravi je raztopina brezbarvna, prozorna ali bisernata (opalescentna).
English: The adverse reactions that occurred in the highest frequency were infusion site erythema, infusion site pain, fatigue, and back pain.
Slovenian: Neželeni učinki, ki so se pojavljali z največjo pogostnostjo, so bili: eritem na mestu infundiranja, bolečina na mestu infundiranja, utrujenost in bolečine v hrbtu.
English: If expected factor X activity levels are not attained, or if bleeding is not controlled with an expected dose, perform an assay that measures factor X inhibitor concentration.
Slovenian: Če pričakovane aktivnosti faktorja X v plazmi niso dosežene ali če krvavitve s pričakovanim odmerkom ni mogoče nadzirati, je treba opraviti preskus, ki meri koncentracijo zaviralcev faktorja X.
English: Allergic type hypersensitivity reactions, including anaphylaxis, are possible.
Slovenian: Pri tem zdravilu so mogoče preobčutljivostne reakcije alergijskega tipa, vključno z anafilaksijo.
English: What Coagadex is and what it is used for
Slovenian: Kaj je zdravilo Coagadex in za kaj ga uporabljamo
English: Contents of the pack and other information What Coagadex contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Coagadex
English: Do not use this medicine if you notice small bits in the dissolved product.
Slovenian: Ne uporabljajte tega zdravila, če v raztopini opazite vidne delce.
English: In a multicentre, open-label, non-randomised clinical trial to evaluate the pharmacokinetics, safety and efficacy of Coagadex, 16 subjects (aged 12 years and above) with moderate to severe hereditary factor X deficiency (FX:C < 5 IU/dL) received a dose of 25 IU/kg Coagadex to treat spontaneous, traumatic and menorrhagic bleeding episodes.
Slovenian: V multicentričnem nerandomiziranem kliničnem preskušanju odprtega tipa za oceno farmakokinetike, varnosti in učinkovitosti zdravila Coagadex je 16 bolnikov (starih 12 let in več) z zmernim do hudim dednim pomanjkanjem faktorja X (FX:C <5 i.e./dl) prejemalo odmerek 25 i.e./kg zdravila Coagadex za zdravljenje spontanih krvavitev, krvavitev zaradi poškodbe in menoragičnih epizod krvavitev.
English: Transfer Device (Mix2Vial).
Slovenian: Pribor za prenos vehikla (Mix2Vial).
English: The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Slovenian: Pričakovano največje zvišanje ravni faktorja X in vivo, izraženo z i.e./dl (ali z odstotkom običajne vrednosti), je mogoče oceniti z naslednjima formulama:
English: Coagadex is a concentrate of human coagulation factor X, a protein that is needed for blood to clot.
Slovenian: Zdravilo Coagadex je koncentrat humanega koagulacijskega faktorja X, beljakovine, ki jo potrebujemo za strjevanje krvi.
English: - if you are allergic to human coagulation factor X or any of the other ingredients of this medicine
Slovenian: - če ste alergični na humani koagulacijski faktor X ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: If you know you have used too much, tell the doctor, pharmacist or nurse as soon as possible.
Slovenian: Če veste, da ste uporabili prevelik odmerek zdravila, obvestite zdravnika, farmacevta ali medicinsko sestro, kolikor hitro je mogoče.
English: Fertility Animal reproduction studies have not been conducted with Coagadex.
Slovenian: Plodnost Reproduktivnih študij pri živalih z zdravilom Coagadex niso opravili.
English: • Repeat this step with the vial of solvent.
Slovenian: • Ponovite ta korak z vialo vehikla.
English: It is strongly recommended that every time you receive a dose of Coagadex, the name and batch number of the product are recorded in order to maintain a record of the batches used.
Slovenian: Močno priporočamo, da se vsakič, ko prejmete odmerek zdravila Coagadex, zabeleži ime in številka serije zdravila za vodenje evidence uporabljenih serij.
English: A dose of 2000 IU Coagadex administered to a 70 kg patient should be expected to result in a peak post-infusion factor X increase of 2000 x {[2 IU/dL]/[IU/kg]}/[70 kg] = 57 IU/dL (i.e. 57% of normal)
Slovenian: Odmerek 2000 i.e. zdravila Coagadex, dan bolniku s telesno maso 70 kg, naj bi povzročil največji dvig ravni faktorja X po infundiranju 2000 x {[2 i.e./dl]/[i.e./kg]}/[70 kg] = 57 i.e./dl (tj. 57 % običajne vrednosti).
English: Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium.
Slovenian: Zdravilo Coagadex vsebuje do 0,4 mmol/ml (9,2 mg/ml) natrija.
English: Always consult your doctor before deciding to stop your treatment.
Slovenian: Pred prekinitvijo zdravljenja se morate vedno posvetovati z zdravnikom.
English: Similarly, combining t½ values at the Baseline Visit and the Repeat PK assessment gave an overall geometric mean t½ of 29.36 hours.
Slovenian: Podobno je združitev vrednosti t½ ob izhodiščnem obisku in ob ponovljeni oceni farmakokinetike dala skupno geometrično sredino t½ 29,36 ur.
English: The mean dose per infusion and total dose of Coagadex were 25.4 IU/kg and 30.4 IU/kg, respectively.
Slovenian: Srednji odmerek na infuzijo in skupni odmerek zdravila Coagadex sta bila 25,4 i.e./kg in 30,4 i.e./kg.
English: Coagadex replaces the missing factor X and allows their blood to clot normally.
Slovenian: Zdravilo Coagadex nadomesti manjkajoči faktor X in omogoča normalno strjevanje krvi.
English: A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum).
Slovenian: Raztopina, ki jo dobite običajno po manj kot eni minuti (ali največ po 5 minutah),
English: Control of Bleeding Episodes
Slovenian: Nadzorovanje epizod krvavitev
English: The formation of neutralising antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency.
Slovenian: Nastanek nevtralizirajočih protiteles (zaviralcev) proti faktorju X je možen zaplet pri zdravljenju posameznikov s pomanjkanjem faktorja X.
English: 1 powder vial
Slovenian: 1 vialo s praškom
English: 1 Transfer Device (Mix2Vial)
Slovenian: 1 pribor za prenos vehikla (Mix2Vial)
English: Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.
Slovenian: Zdravilo Coagadex je indicirano za zdravljenje in profilakso epizod krvavitev in za perioperativno obravnavo bolnikov z dednim pomanjkanjem faktorja X.
English: Bring the containers of Coagadex to room temperature before mixing.
Slovenian: Pred mešanjem ogrejte vsebnika zdravila Coagadex na sobno temperaturo.
English: Coagadex is a white or off-white powder and is packed in quantities of 250 IU and 500 IU.
Slovenian: Zdravilo Coagadex je bel ali umazano bel prašek in je pakirano v količinah po 250 i.e. in 500 i.e.
English: Adjust dosage regimen to clinical response and trough levels of Factor X of at least 5 IU/dL.
Slovenian: Prilagodite režim odmerjanja glede na klinični odziv in za vzdrževanje najnižjih ravni faktorja X vsaj 5 i.e./dl.
English: The 250 IU and 500 IU presentations should be reconstituted using 2.5 mL and 5 mL water for injections, respectively.
Slovenian: Obliki zdravila z 250 i.e. in 500 i.e. je treba rekonstituirati z uporabo 2,5 ml oziroma 5 ml vode za injekcije.
English: It is strongly recommended that every time that Coagadex is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Slovenian: Zelo priporočljivo je, da se pri dajanju zdravila Coagadex bolnikom vedno zabeleži ime in številka serije zdravila, s čimer se ohrani povezava med bolnikom in serijo zdravila.
English: If you think you may be using too much, stop the injection and tell the doctor, pharmacist or nurse.
Slovenian: Če menite, da uporabljate prevelik odmerek zdravila, prenehajte z injiciranjem in obvestite zdravnika, farmacevta ali medicinsko sestro.
English: For the subgroup aged 6-11 years (n=5), the geometric mean IR30min was 1.91 (range 1.6 -2.2) IU/mL per IU/kg and for the youngest subgroup, 0-5 years (n=4) was 1.53range 1.3-1.8) IU/mL per IU/kg.
Slovenian: V starostni podskupini 6-11 let (n = 5) je bila geometrična sredina IR30min 1,91 (razpon 1,6-2,2) i.e./ml na i.e./kg, v najmlajši starostni podskupini 0-5 let (n = 4) pa je bila 1,53 (razpon 1,3-1,8) i.e./ml na i.e./kg.
English: Therefore, Coagadex should be used during breast-feeding only if clearly indicated.
Slovenian: Zato se lahko zdravilo Coagadex v času dojenja uporablja le, če je to jasno indicirano.
English: The median prophylactic dose per infusion per subject was 39.60 IU/kg (mean 38.76 IU/kg), and ranged from 18.0 to 47.3 IU/kg.
Slovenian: Mediani profilaktični odmerek na posamezno infuzijo na bolnika je bil 39,60 i.e./kg (povprečje 38,76 i.e./kg), z razponom od 18,0 i.e./kg do 47,3 i.e./kg.
English: Your doctor will tell you how much Coagadex to administer to treat a bleed and to prevent further bleeding; the dose required will depend on your normal blood level of factor X
Slovenian: Zdravnik vam bo povedal, koliko zdravila Coagadex je treba aplicirati za zdravljenje krvavitve ali za preprečevanje nadaljnje krvavitve; potrebni odmerek bo odvisen od vaše običajne ravni faktorja X. Kakšen odmerek zdravila je treba prejeti pred večjim operativnim posegom, med njim ter po njem?
English: A peak factor X level of 90% of normal is required in a 70 kg patient.
Slovenian: Pri bolniku, ki tehta 70 kg, je potrebna najvišja raven faktorja X, ki znaša 90 % običajne vrednosti.
English: Also contains: Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose.
Slovenian: Vsebuje tudi: Viala s praškom: citronska kislina, natrijev hidroksid, dinatrijev fosfat dihidrat, natrijev klorid, saharoza.
English: Adults and adolescents aged 12 years or more for treatment of bleeding episodes: 25 IU/kg Coagadex should be injected when the first sign of bleeding occurs or just before the expected onset of menstrual bleeding.
Slovenian: Za zdravljenje epizod krvavenja pri odraslih in mladostnikih, starih 12 let ali več: odmerek 25 i.e./kg zdravila Coagadex je treba injicirati ob prvem znaku krvavitve ali tik pred pričakovanim nastopom menstrualne krvavitve.
English: Step 3: Turn the solvent vial upside down with the transfer device still attached.
Slovenian: 3. korak: Obrnite vialo z vehiklom, pri tem mora biti pribor za prenos vehikla še vedno pritrjen.
English: • Gently swirl the vial to make sure the powder is thoroughly mixed.
Slovenian: • Nežno obračajte vialo, da boste temeljito premešali prašek.
English: Pharmacokinetic studies have not been performed in children under the age of 12 years.
Slovenian: Pediatrična uporaba Pri otrocih, mlajših od 12 let, niso opravili farmakokinetičnih študij.
English: Remove the plastic outer packaging from the transfer device and discard it, taking care not to touch the exposed end of the device.
Slovenian: Odstranite plastično zunanjo embalažo s pribora za prenos vehikla in jo zavrzite, pri tem pa pazite, da se ne dotaknete izpostavljenega dela pribora.
English: • Draw air into the syringe by pulling the plunger to the required volume of water added.
Slovenian: • Povlecite zrak v injekcijsko brizgo s potegom bata na potrebni volumen dodane vode.
English: Step 1: Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Slovenian: 1. korak: Odstranite zaporko z viale praška in očistite zgornji del zamaška z alkoholnim zložencem.
English: The mean (CV%) for area under the curve (AUC 0-144h) was 17.1 (21.0) IU.hr/mL.
Slovenian: Srednja vrednost (CV %) za površino pod krivuljo (AUC 0-144h) je znašala 17,1 (21,0) i.e. x h/ml.
English: • Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab.
Slovenian: • Odstranite pokrovček z viale praška in očistite zgornji del zamaška z alkoholnim zložencem.
English: Coagadex is derived from human plasma and used as a replacement for the naturally existing coagulation factor X in patients with hereditary factor X deficiency.
Slovenian: Farmakodinamični učinki Zdravilo Coagadex je izdelano iz človeške plazme in se uporablja kot nadomestek za naravno obstoječi faktor X pri bolnikih z dednim pomanjkanjem faktorja X.
English: If you administer more Coagadex than your doctor prescribed, it is possible you might develop a blood clot.
Slovenian: Če ste uporabili večji odmerek zdravila Coagadex, kot bi smeli Če daste več zdravila Coagadex, kot ga je predpisal zdravnik, se lahko razvije krvni strdek.
English: The measures taken are considered effective for the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19.
Slovenian: (HIV), virus hepatitisa B, virus hepatitisa C, virus hepatitis A in parvovirus B19.
English: List of adverse reactions (ADRs) in 27 treated subjects MedDRA System Organ Class
Slovenian: Seznam neželenih reakcij pri 27 zdravljenih bolnikih Organski sistem po MedDRA
English: Other medicines and Coagadex
Slovenian: Druga zdravila in zdravilo Coagadex
English: Trough levels of FX:C were measured during the first 6 weeks of the study to individualise the dosage regimen and to maintain a trough level of at least 5 IU/dL.
Slovenian: V prvih 6 tednih študije so izmerili najnižje ravni FX:C za individualno prilagoditev režima odmerjanja in vzdrževanje najnižje ravni vsaj 5 i.e./dl.
English: 500 IU human coagulation factor X, approximately 100 IU/mL
Slovenian: 500 i.e. humanega koagulacijskega faktorja X, približno 100 i.e./ml
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat-dose toxicity, thrombogenicity and local tolerability.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnih in ponavljajočih odmerkih, trombogenosti in lokalnega prenašanja ne kažejo posebnega tveganja za človeka.
English: Perioperative Management (Adults and adolescents aged at least 12 years of age) Pre-surgery: calculate dose of Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Slovenian: Za perioperativno obravnavo pri otrocih, starih manj kot 12 let: Pred posegom: izračunajte potrebni odmerek zdravila Coagadex za dvig ravni faktorja X v plazmi na 70-90 i.e./dl.
English: • Remove the plastic outer packaging from the transfer device and discard it, taking care not to touch the exposed end of the device.
Slovenian: • Odstranite plastično zunanjo embalažo s pribora za prenos vehikla in jo zavrzite, pri tem pa pazite, da se ne dotaknete izpostavljenega dela pribora.
English: Transmissible Agents
Slovenian: Prenosljivi povzročitelji
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required.
Slovenian: Za sekundarno profilakso ponovnih krvavitev ali kratkoročno profilakso pred pričakovano telesno aktivnostjo ali zobozdravniškimi posegi: treba je injicirati 30 i.e./kg zdravila Coagadex in postopek po potrebi ponavljati.
English: 25 IU/kg twice weekly is the proposed starting dose for prophylaxis in patients >12 years of age with dose levels and dosing intervals to be adjusted as clinically indicated.
Slovenian: Predlagani začetni odmerek za profilakso pri bolnikih, starih >12 let, je 25 i.e./kg dvakrat tedensko, pri čemer je treba prilagoditi velikost odmerkov in intervale odmerjanja skladno s kliničnimi indikacijami.
English: 250 IU human coagulation factor X, approximately 100 IU/mL
Slovenian: 250 i.e. humanega koagulacijskega faktorja X, približno 100 i.e./ml
English: No adverse events were reported relating to this overdose.
Slovenian: V zvezi s tem prevelikim odmerjanjem niso poročali o neželenih učinkih zdravila.
English: If you stop using Coagadex
Slovenian: Če ste prenehali uporabljati zdravilo Coagadex
English: The solution should be colourless, clear or slightly opalescent when administered.
Slovenian: Raztopina mora biti ob dajanju brezbarvna, bistra ali rahlo opalescentna.
English: Routine prophylaxis of bleeding episodes
Slovenian: Rutinska profilaksa epizod krvavitev
English: Combining IR values for FX:C at the baseline visit (n=16) and the Repeat PK assessment (n=15) gave an overall geometric mean IR of 2.07 IU/dL per IU/kg administered (n=31).
Slovenian: Z združitvijo vrednosti IR za FX:C ob izhodiščnem obisku (n=16) in ob ponovljeni oceni farmakokinetike (n=15) smo dobili skupno geometrično sredino IR 2,07 i.e./dl na dane i.e./kg (n=31).
English: Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration.
Slovenian: Rekonstituirana zdravila je treba pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev in da niso obarvana.
English: Surgical haemostasis
Slovenian: Kirurška hemostaza
English: Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Slovenian: Kljub temu pri uporabi zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče povsem izključiti prenosa povzročiteljev kužnih bolezni.
English: Sodium hydroxide (for pH adjustment) Disodium phosphate dihydrate Sodium chloride
Slovenian: Prašek: citronska kislina natrijev hidroksid (za uravnavanje pH-vrednosti) dinatrijev fosfat dihidrat natrijev klorid saharoza
English: Disconnect the filled syringe from the device.
Slovenian: Odstranite napolnjeno injekcijsko brizgo s pribora.
English: Volume of solvent
Slovenian: Volumen vehikla
English: BPL Bioproducts Laboratory GmbH Dornhofstraße, 63263 Neu-Isenburg Germany
Slovenian: BPL Bioproducts Laboratory GmbH Dornhofstraße,63263 Neu-Isenburg
English: • A clear or slightly pearl-like solution should be obtained, usually in about 1 minute (5 minutes maximum).
Slovenian: • Raztopina, ki jo dobite po eni minuti (ali največ po 5 minutah), mora biti bistra ali rahlo bisernata.
English: Gently swirl the vial to make sure the powder is thoroughly mixed.
Slovenian: Nežno obračajte vialo, da boste temeljito premešali prašek.
English: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg Germany
Slovenian: BPL Bioproducts Laboratory GmbH 63263 Neu-Isenburg
English: Powder vial: 250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.
Slovenian: Viala s praškom: 250 i.e. ali 500 i.e. humanega koagulacijskega faktorja X v viali iz stekla tipa I, zaprti z zamaškom iz halobutilne gume, zapečateno s polipropilensko snemno zaporko in aluminijasto lakirano obrobo.
English: Median and mean doses per infusion in the four children less than 6 years of age were both 40.1 IU/kg (95% CI 30.70, 49.57) and in the five children 6 to 11 years of age inclusive, median dose was 39.6 IU/kg and mean dose was 37.7 IU/kg (95% CI: 23.42, 51.91).
Slovenian: 30,70, 49,57), pri petih otrocih, starih od vključno 6 let do vključno 11 let, pa je bil mediani odmerek 39,6 i.e./kg in povprečni odmerek 37,7 i.e./kg (95-% IZ: 23,42, 51,91).
English: The product should only be reconstituted using the Mix2Vial that is provided in the pack.
Slovenian: Zdravilo lahko rekonstituirate samo s priborom Mix2Vial, ki je priložen v pakiranju.
English: For minor surgery, a median of 2.5 infusions (range 1 to 4 infusions) and a median cumulative dose of 89 IU/kg (range 51 to 127 IU/kg) were used to maintain haemostasis.
Slovenian: Pri manjših operacijah so za vzdrževanje hemostaze uporabili mediano 2,5 infuzij (od 1 do 4 infuzij) in mediani kumulativni odmerek 89 i.e./kg (od 51 do 127 i.e./kg).
English: Coagadex is likely to be counteracted by factor Xa inhibitors, direct or indirect.
Slovenian: Na zdravilo Coagadex najverjetneje vplivajo neposredni ali posredni zaviralci faktorja Xa.
English: • Turn the solvent vial upside down with the device still attached.
Slovenian: • Obrnite vialo z vehiklom, pri tem mora biti pribor še vedno pritrjen.
English: Pregnancy
Slovenian: Zaviralci
English: General disorders and administration site conditions Infusion site erythema Fatigue
Slovenian: Splošne težave in spremembe na mestu aplikacije Eritem na mestu infundiranja