natgillin/translations-raw huggingface dataset:
-if you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Coagadex. 
- če imate večjo ali daljšo krvavitev kot običajno in se krvavitev po injekciji zdravila Coagadex ne ustavi.
Although the dose can be estimated using the calculations above, whenever possible appropriate laboratory tests, such as serial factor X assays, should be performed to guide dose adjustments. 
Čeprav je odmerek mogoče oceniti s pomočjo zgornjih izračunov, je treba opraviti ustrezne laboratorijske preiskave, kadar je to mogoče, npr. serijske preskuse faktorja X, ki naj usmerjajo prilagoditve odmerkov.
Four bleeding episodes in two subjects were considered treatment failures. 
Štiri epizode krvavitev pri dveh bolnikih so veljale za neuspešno zdravljenje.
After reconstitution, the product should be administered by the intravenous route at a suggested rate of 10 mL/min, but no more than 20 mL/min. 
Po rekonstituciji je treba zdravilo dati intravensko s predlagano hitrostjo 10 ml/min, vendar ne hitreje od 20 ml/min.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
Nosečnost, dojenje in plodnost Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
• Each individual bleed should be judged on its own severity 
• Vsako posamezno krvavitev je treba oceniti glede stopnje resnosti.
Three children (33.3%), one in the 0-5 years age group and two in the 6-11 years age group had a total of 10 bleeds due to epistaxes, trauma or menorrhagia. 
Trije otroci (33,3 %), in sicer eden v starostni skupini 0-5 let in dva v starostni skupini 6-11 let, so imeli skupno 10 krvavitev zaradi epistaks, poškodb ali menoragije.
For safety information with respect to transmissible agents, see section 4.4. 
Za varnostne informacije v zvezi s prenosljivimi povzročitelji bolezni glejte poglavje 4.4.
During the dose-adjustment phase, two trough levels were <5 IU/dL but thereafter none were below this threshold. 
V obdobju prilagajanja odmerka sta bili dve najnižji ravni <5 i.e./dl, od takrat dalje pa nobena ni zdrsnila pod ta prag.
The third study evaluated the use of Coagadex in routine prophylaxis of bleeding episodes in nine children aged less than 12 years of age. 
V tretji študiji so ocenili uporabo zdravila Coagadex pri rutinski profilaksi epizod krvavitev pri devetih otrocih, starih manj kot 12 let.
This should be taken into consideration by patients on a controlled sodium diet. 
To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija.
Neither subject had any bleeds during these periods. 
V teh obdobjih noben bolnik ni imel krvavitev.
• The injection should be repeated as necessary to stop the bleeding 
• Injiciranje je treba po potrebi ponavljati, dokler se krvavitev ne ustavi.
There is a potential for thromboembolism with overdose. 
Pri prevelikem odmerjanju obstaja potencial za trombembolijo.
• pain or redness at site of injection 
• bolečina ali pordelost na mestu injiciranja
Factor Xa associates with factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions. 
Faktor Xa se poveže s faktorjem Va na fosfolipidni površini, kjer tvorita protrombinazni kompleks, ki v prisotnosti kalcijevih ionov aktivira protrombin v trombin.
70 kg x 90 IU/dL/{[2 IU/dL]/[IU/kg]} = 3150 IU. 
70 kg x 90 i.e./dl/{[2 i.e./dl]/[i.e./kg]} = 3150 i.e.
Once made up, Coagadex must be used within one hour. 
Ko je zdravilo Coagadex pripravljeno, ga morate uporabiti v eni uri.
It is recommended that your blood factor X level is kept above 50 units/dL. 
Priporočljivo je, da se vaša raven faktorja X v krvi ohrani nad 50 enot/dl.
Before injection, look at the solution. 
Pred injiciranjem si raztopino oglejte.
Eight subjects had severe FX deficiency, the other had moderate deficiency. 
Osem bolnikov je imelo resno pomanjkanje FX, eden pa zmerno pomanjkanje FX.
Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot. 
Trombin nato deluje na topni fibrinogen in faktor XIII, da ustvarita premrežen fibrinski strdek.
The careful control of dose and duration of treatment is especially important in cases of major surgery. 
Natančen nadzor nad odmerkom in trajanjem zdravljenja je še posebej pomemben v primerih večjih operativnih posegov.
Adult How much Coagadex is given to treat a bleed or prevent further bleeding? 
Koliko zdravila Coagadex je treba dati za zdravljenje krvavitve ali za preprečevanje nadaljnje krvavitve?
This also applies to any unknown or emerging viruses or other types of infections. 
To se nanaša tudi na morebitne neznane ali nove viruse in druge tipe okužb.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. 
Standardni ukrepi za preprečevanje okužb zaradi uporabe zdravil, pripravljenih iz človeške krvi ali plazme, vključujejo selekcijo darovalcev, presejalno testiranje posameznih darovanih enot in zbrane plazme na specifične markerje okužbe ter uporabo učinkovitih proizvodnih postopkov za inaktivacijo oz. odstranjevanje virusov.
One subject, aged 58 years, used 28 IU/kg once weekly for 8 weeks and, later, 25 IU/kg every 2 weeks for more than 5 months. 
En bolnik, star 58 let, je uporabljal odmerek 28 i.e./kg enkrat na teden 8 tednov, nato pa 25 i.e./kg vsaka 2 tedna več kot 5 mesecev.
Before injecting this medicine at home, you should have received training by your healthcare professional on how to do so. 
Pred injiciranjem tega zdravila doma vas mora zdravstveni delavec usposobiti za samostojno uporabo zdravila.
Routine prophylaxis was used by two subjects. 
Rutinsko profilakso so uporabili pri dveh bolnikih.
The other subject, aged 22 years, used 24.6 IU/kg once weekly for 8.5 months. 
Drugi bolnik, star 22 let, je uporabljal odmerek 24,6 i.e./kg enkrat na teden 8,5 mesecev.
If your blood factor X concentration is too low (this will be tested by your doctor), or if it decreases faster than expected, an inhibitor to factor X may be present which stops Coagadex from working properly. 
Če je koncentracija faktorja X v vaši krvi prenizka (to bo preveril zdravnik), ali če pada hitreje, kot je pričakovano, je morda prisoten zaviralec faktorja X, ki preprečuje, da bi zdravilo Coagadex ustrezno delovalo.
Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived factor X products. 
Zdravnik vam bo morda priporočil, da se odločite za cepljenje proti hepatitisu A in B, če redno ali večkrat prejemate zdravila s humanim faktorjem X, izdelanim iz plazme.
There were no adverse drug reactions in this study in children less than 12 years of age. 
V tej študiji ni bilo neželenih učinkov zdravila pri otrocih, mlajših od 12 let.
The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19. 
Ti ukrepi se smatrajo za učinkovite v primeru virusov z ovojnicami, kakršni so HIV, HBV in HCV, ter virusov brez ovojnic, kakršna sta HAV in parvovirus B19.
There are no data available on routine prophylaxis in paediatric patients aged >12 to <18 years. 
Podatki o rutinski profilaksi pri pediatričnih bolnikih, starih >12 let do <18 let, niso na voljo.
For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly. 
Za rutinsko profilakso epizod krvavitev pri otrocih, starih manj kot 12 let: 40 i.e./kg dvakrat tedensko.
For home therapy, the patient should be given appropriate training and reviewed at intervals. 
Za zdravljenje na domu mora bolnik prejeti ustrezno usposabljanje, zdravljenje pa je treba periodično spremljati.
The powder should only be reconstituted with the water for injections provided in the pack. 
Prašek se lahko rekonstituira samo z vodo za injekcije, ki je priložena v pakiranju.
Some patients may achieve desired FX trough levels on once weekly prophylactic therapy (see section 5.1). 
Nekateri bolniki lahko dosežejo želene najnižje ravni faktorja X ob profilaktičnem zdravljenju enkrat na teden (glejte poglavje 5.1).
Your doctor will advise if this use is suitable for you and, if so, of the appropriate dose. 
Zdravnik vam bo povedal, ali je taka uporaba primerna za vas in kakšen bi bil primeren odmerek.
Factor X is an inactive zymogen, which can be activated by factor IXa (via the intrinsic pathway) or by factor VIIa (via the extrinsic pathway). 
Faktor X je neaktivni zimogen, ki ga lahko aktivira faktor IXa (po intrinzični poti) ali faktor VIIa (po ekstrinzični poti).
Human coagulation factor X is largely retained within the vascular compartment: mean apparent volume of distribution (Vss) was 56.3 (24.0) mL/kg. 
Humani koagulacijski faktor X se večinoma zadrži v žilnem prostoru: srednji navidezni volumen porazdelitve (Vss) je znašal 56,3 (24,0) ml/kg.
Coagadex has no or negligible influence on the ability to drive and use machines. 
Zdravilo Coagadex nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
After reconstitution, from a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega stališča morate zdravilo uporabiti takoj po rekonstituciji.
Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes. 
Natančen nadzor nad nadomestnim zdravljenjem je še posebej pomemben v primerih večjih operativnih posegov ali življenjsko nevarnih epizod krvavitev.
Post-surgery: dose as necessary to maintain plasma factor X levels at a minimum of 50 IU/dL until the subject is no longer at risk of bleeding due to surgery. 
Po posegu: odmerjajte po potrebi, tako da vzdržujete ravni faktorja X v plazmi na vsaj 50 i.e./dl, dokler bolnik ni več izpostavljen tveganju za krvavitev zaradi kirurškega posega.
Of the 187 bleeding episodes in the efficacy analysis, 155 bleeds (83%) were treated with one infusion, 28 bleeds (15%) with two infusions, 3 bleeds (2%) with three infusions and 1 bleed (0.5%) with four infusions. 
155 krvavitev (83 %) zdravljenih z eno infuzijo, 28 krvavitev (15 %) z dvema infuzijama, 3 krvavitve (2 %) s tremi infuzijami in 1 krvavitev (0,5 %) s štirimi infuzijami.
Judge each individual bleed on its own severity. 
Ocenite vsako posamezno krvavitev glede resnosti.
Pharmacotherapeutic group: Anti-haemorrhagics, vitamin K and other haemostatics, coagulation factor X, ATC code: B02BD13. 
Farmakoterapevtska skupina: antihemoragiki, vitamin K in drugi hemostatiki, koagulacijski faktor X, oznaka ATC: B02BD13
When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to recipients. 
Kadar so zdravila izdelana iz človeške krvi ali plazme, se uporabljajo določeni ukrepi za preprečevanje prenosa okužb na prejemnike.
Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to 
Pogostnosti občasnih (≥1/1.000 do <1/100), redkih
This also applies to unknown or emerging viruses and other pathogens. 
To velja tudi za neznane ali nove viruse in druge povzročitelje bolezni.
Treatment should be initiated under the supervision of a physician experienced in the treatment of rare bleeding disorders. 
Zdravljenje je treba uvesti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem redkih motenj strjevanja krvi.
For intravenous use after reconstitution Read the package leaflet before use. 
za intravensko uporabo po rekonstituciji Pred uporabo preberite priloženo navodilo!
It is used to treat and prevent bleeding in patients with hereditary factor X deficiency, including during surgery. 
Uporablja se za zdravljenje in preprečevanje krvavitev pri bolnikih z dednim pomanjkanjem faktorja X, tudi med kirurškimi posegi.
A transfer device called Mix2Vial is also provided. 
Priložen je tudi pribor za prenos vehikla, imenovan Mix2Vial.
Do not use the water for injections if signs of particulate matter are visible. 
Vode za injekcije ne uporabljajte, če so v njej vidni delci.
Your doctor will arrange for the appropriate laboratory tests to see if this is the case. 
Zdravnik bo poskrbel za ustrezne laboratorijske preiskave, s katerimi bodo preverili, ali je prišlo do nastanka teh zaviralcev.
This medicinal product contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. 
To zdravilo vsebuje do 0,4 mmol/ml (9,2 mg/ml) natrija.
The safety and efficacy of Coagadex for perioperative management was evaluated in five subjects aged 14 to 59 years with mild (n=2), moderate (n=1), and severe (n=2) disease, who underwent a total of seven surgical procedures. 
Varnost in učinkovitost zdravila Coagadex v perioperativni obravnavi sta bili ocenjeni pri petih bolnikih, starih od 14 do 59 let z blago (n=2), zmerno (n=1) in hudo (n=2) boleznijo, ki so skupno prestali sedem kirurških postopkov.
In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests. 
Na splošno je treba pri vseh bolnikih, ki se zdravijo z zdravilom Coagadex, z ustreznim kliničnim opazovanjem in z laboratorijskimi preiskavami skrbno spremljati, ali je prišlo do nastanka zaviralcev.
The dose and duration of the treatment depend on the severity of the factor X deficiency (i.e. the patient's baseline factor X level), on the location and extent of the bleeding and on the patient's clinical condition. 
Odmerjanje Odmerjanje in trajanje zdravljenja sta odvisna od resnosti pomanjkanja faktorja X (npr. od bolnikove izhodiščne ravni faktorja X), od mesta in obsega krvavitve in od kliničnega stanja bolnika.
The mean (CV%) for incremental recovery was 2.08 (18.1). 
Srednja vrednost (CV %) za prirastno zvečanje aktivnosti je znašala 2,08 (18,1).
Of the 208 bleeding episodes treated with Coagadex, 187 bleeding episodes in 15 subjects were evaluated for efficacy. 
Od 208 epizod krvavitev, zdravljenih z zdravilom Coagadex, je bilo glede učinkovitosti ocenjenih 187 epizod krvavitev pri 15 bolnikih.
Repeat this step with the solvent vial. 
Ponovite ta korak z vialo vehikla.
The recommended dose of 25 IU/kg Coagadex to treat a bleed was maintained during the study for 14 of the 16 subjects. 
Priporočeni odmerek 25 i.e./kg zdravila Coagadex za zdravljenje krvavitve so v času študije vzdrževali pri 14 od 16 bolnikov.
Example: to raise plasma factor X level from 15 IU/dL to 90 IU/dL in a 70 kg patient, the appropriate dose is: 
Primer: za dvig ravni faktorja X v plazmi s 15 i.e./dl na 90 i.e./dl pri bolniku s telesno maso 70 kg je ustrezni odmerek:
Your treatment centre will provide a special container to dispose of any solution that remains, any used syringes, needles and empty containers. 
V zdravstvenem centru boste prejeli posebno posodo za morebitne ostanke raztopine, uporabljene injekcijske brizge, igle in prazne vsebnike.
Therefore, Coagadex should be used during pregnancy only if clearly indicated. 
Zato se lahko zdravilo Coagadex v času nosečnosti in dojenja uporablja le, če je to jasno indicirano.
The efficacy of Coagadex in treating bleeding episodes was assessed by the subject and/or investigator for each new bleeding episode, using a pre-determined bleed-specific ordinal rating scale of excellent, good, poor and unassessable. 
Učinkovitost zdravila Coagadex pri zdravljenju epizod krvavitev je ocenjeval bolnik in/ali raziskovalec za vsako novo epizodo krvavitve, z uporabo vnaprej določene vrstilne ocenjevalne lestvice za krvavitve, ki je vsebovala ocene »odlično«, »dobro«, »slabo« in »ni mogoče oceniti«.
Not more than 60 IU/kg daily should be administered in any age group. 
Pri nobeni starostni skupini se ne sme dati več kot 60 i.e./kg na dan.
Solvent vial containing clear colourless liquid. 
Viala z vehiklom vsebuje prozorno, brezbarvno tekočino.
Due to inter-and intra-patient variability, it is recommended that trough blood levels of Factor X should be monitored at intervals, especially in the first weeks of therapy or after dosage changes. 
Zaradi variacij pri posameznih bolnikih in med njimi se priporoča redno spremljanje najnižjih vrednosti faktorja X v krvi, še posebej v prvih tednih zdravljenja ali po spremembah odmerka.
Coagadex is indicated in all age groups 
Zdravilo Coagadex je indicirano za vse starostne skupine.
Make sure you use the product within an hour after it has been made up. 
Zdravilo morate uporabiti v eni uri po pripravi.
No investigations on genotoxicity, carcinogenicity and reproductive or developmental toxitcity have been conducted since human plasma coagulation factor X (as contained in Coagadex) is an endogenous protein. 
Preiskav genotoksičnosti, kancerogenega potenciala, toksičnosti za razmnoževanje in razvoj niso izvedli, saj je koagulacijski faktor X, pridobljen iz človeške plazme (ki ga vsebuje zdravilo Coagadex), endogena beljakovina.
Patients may vary in their pharmacokinetic (e.g. half-life, in vivo recovery) and clinical responses to Coagadex. 
Bolniki imajo lahko različne farmakokinetične (npr. razpolovna doba, in vivo zvečanje aktivnosti) in klinične odzive na zdravilo Coagadex.
Your treatment should be initiated by a doctor who is experienced in the treatment of bleeding disorders. 
Zdravljenje mora uvesti zdravnik, ki ima izkušnje z zdravljenjem motenj strjevanja krvi.
The following examples assume the patient's baseline factor X level is <1 IU/dL: 
V naslednjih primerih smo predpostavili, da je bolnikova izhodiščna raven faktorja X < 1 i.e./dl:
If any of these symptoms occur, they should be advised to discontinue use of the product immediately and contact their physician. 
Bolnikom je treba svetovati, naj v primeru, da se pojavi kateri koli od teh simptomov, takoj prenehajo uporabljati zdravilo in se posvetujejo z zdravnikom.
Before: The dose of Coagadex used should be sufficient to raise your blood factor X level to between 70 and 90 units/dL. 
Pred: Uporabljeni odmerek zdravila Coagadex mora zadoščati za dvig vaše ravni krvnega faktorja X na 70 enot/dl do 90 enot/dl.
Coagadex should be injected directly into a vein. 
Zdravilo Coagadex je treba injicirati neposredno v veno.
Patients with factor X deficiency do not have sufficient factor X for their blood to clot properly, leading to excessive bleeding. 
Bolniki s pomanjkanjem faktorja X v svoji krvi nimajo dovolj faktorja X, da bi se njihova kri ustrezno strjevala, kar povzroča močne krvavitve.
Depending on individual clinical response, longer intervals, e.g. once weekly, might be adequate (see section 5.1). 
Lahko so primerni daljši intervali odmerjanja, npr. enkrat tedensko, odvisno od kliničnega odziva posameznika (glejte poglavje 5.1).
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. 
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.
powder and solvent for solution for injection human coagulation factor X This medicine is subject to additional monitoring. 
prašek in vehikel za raztopino za injiciranje humani koagulacijski faktor X Za to zdravilo se izvaja dodatno spremljanje varnosti.
Side effects in children are expected to be the same as in adults. 
Neželeni učinki pri otrocih in mladostnikih Pričakujemo, da so neželeni učinki pri otrocih enaki kot pri odraslih.
A total of 537 (mean 59.7 per subject) prophylactic infusions were administered. 
537 profilaktičnih infuzij (v povprečju 59,7 infuzij na bolnika).
Four subjects were aged 0 to 5 years and five were aged 6 to 11 years inclusive. 
let do vključno 5 let in pet bolnikov je bilo starih od vključno 6 let do vključno 11 let.
The mean (CV%) maximum plasma concentration (Cmax) was 0.504 (17.2) IU/mL. 
Srednja (CV %) največja koncentracija v plazmi (Cmax) je znašala 0,504 (17,2) i.e./ml.
When the reconstitution process is complete, the used transfer device should be disposed of it in the ‘sharps box'. 
Ko je postopek rekonstitucije končan, odvrzite pribor za prenos vehikla v "škatlo za ostre predmete".
There are no known effects of this medicine on the ability to drive or operate machinery. 
Zdravilo nima znanih učinkov na sposobnost upravljanja vozil in strojev.
The factor X in Coagadex is extracted from human plasma (the liquid part of blood). 
Faktor X v zdravilu Coagadex je pridobljen iz človeške plazme (tekočega dela krvi).
What you need to know before you use Coagadex Do not use Coagadex: 
Kaj morate vedeti, preden boste uporabili zdravilo Coagadex Ne uporabljajte zdravila Coagadex:
The other two subjects used doses up to 30 IU/kg and 33 IU/kg. 
Druga dva bolnika sta uporabljala odmerke do 30 i.e./kg in 33 i.e./kg.
You can dissolve Coagadex using the needle-free Mix2Vial transfer device included within each pack. 
Zdravilo Coagadex lahko raztopite s pomočjo pribora za prenos vehikla brez igel Mix2Vial, ki je priložen vsakemu pakiranju.
Due to the rarity of hereditary factor X deficiency, experience regarding the use of Coagadex during pregnancy and breast-feeding is not available. 
Zaradi redkosti dednega pomanjkanja faktorja X izkušenj v zvezi z uporabo zdravila Coagadex med nosečnostjo in dojenjem ni.
There are limited data on the use of Coagadex for long periods of prophylaxis in adults. 
Podatki o uporabi zdravila Coagadex za dolga obdobja profilakse pri odraslih so omejeni.
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. 
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.
After being made up, the solution is colourless, clear or pearl-like (opalescent). 
Po pripravi je raztopina brezbarvna, prozorna ali bisernata (opalescentna).
The adverse reactions that occurred in the highest frequency were infusion site erythema, infusion site pain, fatigue, and back pain. 
Neželeni učinki, ki so se pojavljali z največjo pogostnostjo, so bili: eritem na mestu infundiranja, bolečina na mestu infundiranja, utrujenost in bolečine v hrbtu.
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. 
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.
Allergic type hypersensitivity reactions, including anaphylaxis, are possible. 
Pri tem zdravilu so mogoče preobčutljivostne reakcije alergijskega tipa, vključno z anafilaksijo.
What Coagadex is and what it is used for 
Kaj je zdravilo Coagadex in za kaj ga uporabljamo
Contents of the pack and other information What Coagadex contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Coagadex
Do not use this medicine if you notice small bits in the dissolved product. 
Ne uporabljajte tega zdravila, če v raztopini opazite vidne delce.
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. 
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.
Transfer Device (Mix2Vial). 
Pribor za prenos vehikla (Mix2Vial).