natgillin/translations-raw huggingface dataset:
The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae: 
Pričakovano največje zvišanje ravni faktorja X in vivo, izraženo z i.e./dl (ali z odstotkom običajne vrednosti), je mogoče oceniti z naslednjima formulama:
Coagadex is a concentrate of human coagulation factor X, a protein that is needed for blood to clot. 
Zdravilo Coagadex je koncentrat humanega koagulacijskega faktorja X, beljakovine, ki jo potrebujemo za strjevanje krvi.
- if you are allergic to human coagulation factor X or any of the other ingredients of this medicine 
- če ste alergični na humani koagulacijski faktor X ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
If you know you have used too much, tell the doctor, pharmacist or nurse as soon as possible. 
Če veste, da ste uporabili prevelik odmerek zdravila, obvestite zdravnika, farmacevta ali medicinsko sestro, kolikor hitro je mogoče.
Fertility Animal reproduction studies have not been conducted with Coagadex. 
Plodnost Reproduktivnih študij pri živalih z zdravilom Coagadex niso opravili.
• Repeat this step with the vial of solvent. 
• Ponovite ta korak z vialo vehikla.
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. 
Močno priporočamo, da se vsakič, ko prejmete odmerek zdravila Coagadex, zabeleži ime in številka serije zdravila za vodenje evidence uporabljenih serij.
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) 
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).
Coagadex contains up to 0.4 mmol/mL (9.2 mg/mL) of sodium. 
Zdravilo Coagadex vsebuje do 0,4 mmol/ml (9,2 mg/ml) natrija.
Always consult your doctor before deciding to stop your treatment. 
Pred prekinitvijo zdravljenja se morate vedno posvetovati z zdravnikom.
Similarly, combining t½ values at the Baseline Visit and the Repeat PK assessment gave an overall geometric mean t½ of 29.36 hours. 
Podobno je združitev vrednosti t½ ob izhodiščnem obisku in ob ponovljeni oceni farmakokinetike dala skupno geometrično sredino t½ 29,36 ur.
The mean dose per infusion and total dose of Coagadex were 25.4 IU/kg and 30.4 IU/kg, respectively. 
Srednji odmerek na infuzijo in skupni odmerek zdravila Coagadex sta bila 25,4 i.e./kg in 30,4 i.e./kg.
Coagadex replaces the missing factor X and allows their blood to clot normally. 
Zdravilo Coagadex nadomesti manjkajoči faktor X in omogoča normalno strjevanje krvi.
A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum). 
Raztopina, ki jo dobite običajno po manj kot eni minuti (ali največ po 5 minutah),
Control of Bleeding Episodes 
Nadzorovanje epizod krvavitev
The formation of neutralising antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency. 
Nastanek nevtralizirajočih protiteles (zaviralcev) proti faktorju X je možen zaplet pri zdravljenju posameznikov s pomanjkanjem faktorja X.
1 powder vial 
1 vialo s praškom
1 Transfer Device (Mix2Vial) 
1 pribor za prenos vehikla (Mix2Vial)
Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency. 
Zdravilo Coagadex je indicirano za zdravljenje in profilakso epizod krvavitev in za perioperativno obravnavo bolnikov z dednim pomanjkanjem faktorja X.
Bring the containers of Coagadex to room temperature before mixing. 
Pred mešanjem ogrejte vsebnika zdravila Coagadex na sobno temperaturo.
Coagadex is a white or off-white powder and is packed in quantities of 250 IU and 500 IU. 
Zdravilo Coagadex je bel ali umazano bel prašek in je pakirano v količinah po 250 i.e. in 500 i.e.
Adjust dosage regimen to clinical response and trough levels of Factor X of at least 5 IU/dL. 
Prilagodite režim odmerjanja glede na klinični odziv in za vzdrževanje najnižjih ravni faktorja X vsaj 5 i.e./dl.
The 250 IU and 500 IU presentations should be reconstituted using 2.5 mL and 5 mL water for injections, respectively. 
Obliki zdravila z 250 i.e. in 500 i.e. je treba rekonstituirati z uporabo 2,5 ml oziroma 5 ml vode za injekcije.
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. 
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.
If you think you may be using too much, stop the injection and tell the doctor, pharmacist or nurse. 
Če menite, da uporabljate prevelik odmerek zdravila, prenehajte z injiciranjem in obvestite zdravnika, farmacevta ali medicinsko sestro.
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. 
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.
Therefore, Coagadex should be used during breast-feeding only if clearly indicated. 
Zato se lahko zdravilo Coagadex v času dojenja uporablja le, če je to jasno indicirano.
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. 
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.
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 
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?
A peak factor X level of 90% of normal is required in a 70 kg patient. 
Pri bolniku, ki tehta 70 kg, je potrebna najvišja raven faktorja X, ki znaša 90 % običajne vrednosti.
Also contains: Powder vial: citric acid, sodium hydroxide, disodium phosphate dihydrate, sodium chloride, sucrose. 
Vsebuje tudi: Viala s praškom: citronska kislina, natrijev hidroksid, dinatrijev fosfat dihidrat, natrijev klorid, saharoza.
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. 
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.
Step 3: Turn the solvent vial upside down with the transfer device still attached. 
3. korak: Obrnite vialo z vehiklom, pri tem mora biti pribor za prenos vehikla še vedno pritrjen.
• Gently swirl the vial to make sure the powder is thoroughly mixed. 
• Nežno obračajte vialo, da boste temeljito premešali prašek.
Pharmacokinetic studies have not been performed in children under the age of 12 years. 
Pediatrična uporaba Pri otrocih, mlajših od 12 let, niso opravili farmakokinetičnih študij.
Remove the plastic outer packaging from the transfer device and discard it, taking care not to touch the exposed end of the device. 
Odstranite plastično zunanjo embalažo s pribora za prenos vehikla in jo zavrzite, pri tem pa pazite, da se ne dotaknete izpostavljenega dela pribora.
• Draw air into the syringe by pulling the plunger to the required volume of water added. 
• Povlecite zrak v injekcijsko brizgo s potegom bata na potrebni volumen dodane vode.
Step 1: Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab. 
1. korak: Odstranite zaporko z viale praška in očistite zgornji del zamaška z alkoholnim zložencem.
The mean (CV%) for area under the curve (AUC 0-144h) was 17.1 (21.0) IU.hr/mL. 
Srednja vrednost (CV %) za površino pod krivuljo (AUC 0-144h) je znašala 17,1 (21,0) i.e. x h/ml.
• Remove the cap from the powder vial and clean the top of the stopper with an alcohol swab. 
• Odstranite pokrovček z viale praška in očistite zgornji del zamaška z alkoholnim zložencem.
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. 
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.
If you administer more Coagadex than your doctor prescribed, it is possible you might develop a blood clot. 
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.
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. 
(HIV), virus hepatitisa B, virus hepatitisa C, virus hepatitis A in parvovirus B19.
List of adverse reactions (ADRs) in 27 treated subjects MedDRA System Organ Class 
Seznam neželenih reakcij pri 27 zdravljenih bolnikih Organski sistem po MedDRA
Other medicines and Coagadex 
Druga zdravila in zdravilo Coagadex
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. 
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.
500 IU human coagulation factor X, approximately 100 IU/mL 
500 i.e. humanega koagulacijskega faktorja X, približno 100 i.e./ml
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. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri enkratnih in ponavljajočih odmerkih, trombogenosti in lokalnega prenašanja ne kažejo posebnega tveganja za človeka.
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. 
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.
• Remove the plastic outer packaging from the transfer device and discard it, taking care not to touch the exposed end of the device. 
• Odstranite plastično zunanjo embalažo s pribora za prenos vehikla in jo zavrzite, pri tem pa pazite, da se ne dotaknete izpostavljenega dela pribora.
Transmissible Agents 
Prenosljivi povzročitelji
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. 
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.
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. 
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.
250 IU human coagulation factor X, approximately 100 IU/mL 
250 i.e. humanega koagulacijskega faktorja X, približno 100 i.e./ml
No adverse events were reported relating to this overdose. 
V zvezi s tem prevelikim odmerjanjem niso poročali o neželenih učinkih zdravila.
If you stop using Coagadex 
Če ste prenehali uporabljati zdravilo Coagadex
The solution should be colourless, clear or slightly opalescent when administered. 
Raztopina mora biti ob dajanju brezbarvna, bistra ali rahlo opalescentna.
Routine prophylaxis of bleeding episodes 
Rutinska profilaksa epizod krvavitev
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). 
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).
Reconstituted products should be inspected visually for particulate matter and discolouration prior to administration. 
Rekonstituirana zdravila je treba pred dajanjem vizualno pregledati, da ne vsebujejo trdnih delcev in da niso obarvana.
Surgical haemostasis 
Kirurška hemostaza
Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
Kljub temu pri uporabi zdravil, izdelanih iz človeške krvi ali plazme, ni mogoče povsem izključiti prenosa povzročiteljev kužnih bolezni.
Sodium hydroxide (for pH adjustment) Disodium phosphate dihydrate Sodium chloride 
Prašek: citronska kislina natrijev hidroksid (za uravnavanje pH-vrednosti) dinatrijev fosfat dihidrat natrijev klorid saharoza
Disconnect the filled syringe from the device. 
Odstranite napolnjeno injekcijsko brizgo s pribora.
Volume of solvent 
Volumen vehikla
• A clear or slightly pearl-like solution should be obtained, usually in about 1 minute (5 minutes maximum). 
• Raztopina, ki jo dobite po eni minuti (ali največ po 5 minutah), mora biti bistra ali rahlo bisernata.
Gently swirl the vial to make sure the powder is thoroughly mixed. 
Nežno obračajte vialo, da boste temeljito premešali prašek.
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. 
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.
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). 
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).
The product should only be reconstituted using the Mix2Vial that is provided in the pack. 
Zdravilo lahko rekonstituirate samo s priborom Mix2Vial, ki je priložen v pakiranju.
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. 
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).
Coagadex is likely to be counteracted by factor Xa inhibitors, direct or indirect. 
Na zdravilo Coagadex najverjetneje vplivajo neposredni ali posredni zaviralci faktorja Xa.
• Turn the solvent vial upside down with the device still attached. 
• Obrnite vialo z vehiklom, pri tem mora biti pribor še vedno pritrjen.
Pregnancy 
Zaviralci
General disorders and administration site conditions Infusion site erythema Fatigue 
Splošne težave in spremembe na mestu aplikacije Eritem na mestu infundiranja
Powder and solvent for solution for injection. 
Prašek in vehikel za raztopino za injiciranje
- The active substance is human coagulation factor X. One vial contains nominally 250 IU or 500 IU 
- Zdravilna učinkovina je humani koagulacijski faktor X. Ena viala vsebuje nazivno količino 250 i.e. ali
Some patients with a shortage of factor X may develop inhibitors (antibodies) to factor X during treatment. 
Pri nekaterih bolnikih s pomanjkanjem faktorja X se lahko med zdravljenjem razvijejo zaviralci (protitelesa) faktorja X. To bi lahko pomenilo, da zdravljenje ne bo ustrezno delovalo.
Back pain 
Bolečine v hrbtu
Required dose (IU) = body weight (kg) x desired factor X rise (IU/dL) x 0.5 
Potrebni odmerek (i.e.) = telesna masa (kg) x želeni dvig faktorja X (i.e./dl) x 0,5
Pharmacokinetic (PK) parameters were calculated from plasma factor X:C (one-stage clotting assay) activity measurements after subtraction of the pre-dose value. 
Farmakokinetične (FK) parametre so izračunali iz meritev aktivnosti faktorja X:C
Step 6: Immediately invert the vial of solution, which will be drawn into the syringe. 
6. korak: Takoj obrnite vialo z raztopino, ki jo bo potegnilo v injekcijsko brizgo.
Step 4: The solvent will be pulled into the powder vial by the vacuum contained within it. 
4. korak: Vehikel bo stekel v vialo s praškom zaradi vakuuma v viali z zdravilom.
- if the dissolved powder and solvent form a gel or a clot (if this happens please tell your healthcare provider, reporting the batch number printed on the vial). 
- če se vehikel ni prenesel v vialo (to pomeni, da v viali ni bilo vakuuma, zato praška ne smete uporabiti); - če raztopljeni prašek in vehikel tvorita gel ali strdek (v tem primeru obvestite svojega zdravstvenega delavca in sporočite številko serije, ki je odtisnjena na viali).
The vials should be brought to room temperature (not above 30oC) prior to the removal of the snap-off cap closure from the powder vial. 
Preden odstranite snemno zaporko z viale praška, morate viale ogreti na sobno temperaturo (ne več kot 30 oC).
Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal. 
Viala z vehiklom: 2,5 ml ali 5 ml raztopine v viali iz stekla tipa I, zaprti z zamaškom iz halobutilne gume in tesnilom.
Keep container in the outer carton in order to protect it from light. 
Vsebnik shranjujte v zunanji škatli za zagotovitev zaščite pred svetlobo.
Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections. 
Ena viala vsebuje nazivno količino 250 i.e. ali 500 i.e. humanega koagulacijskega faktorja X. Zdravilo Coagadex vsebuje približno 100 i.e./ml humanega koagulacijskega faktorja X po rekonstituciji z 2,5 ml (250 i.e.) ali 5 ml (500 i.e.) sterilizirane vode za injekcije.
Solvent vial: water for injections. 
Viala z vehiklom: voda za injekcije.
What Coagadex looks like and contents of the pack 
Izgled zdravila Coagadex in vsebina pakiranja
Quantity of Coagadex 
Količina zdravila Coagadex
All were treated with a single infusion of Coagadex; mean and median doses 31.7 IU/kg (range 24.6 to 38.8 IU/kg) and all recorded efficacy ratings were categorized as excellent. 
Vsi so bili zdravljeni z enkratno infuzijo zdravila Coagadex; povprečni in mediani odmerek sta bila 31,7 i.e./kg (razpon od 24,6 i.e./kg do
Sodium Content 
Vsebnost natrija
Coagadex contains sodium 
Zdravilo Coagadex vsebuje natrij
Draw air into the syringe by pulling the plunger to the volume of water added. 
Povlecite zrak v injekcijsko brizgo s potegom bata na volumen dodane sterilizirane vode.
• Peel back the top of the transfer device package but leave the device in the package. 
• Odlepite zgornji del pakiranja pribora za prenos vehikla, vendar pustite pribor v embalaži.
For on-demand control of bleeding in children aged less than 12 years: 30 IU/kg Coagadex should be injected when the first sign of bleeding occurs. 
Za obvladovanje krvavitev po potrebi pri otrocih, starih manj kot 12 let: Ob pojavu prvega znaka krvavitve je treba injicirati 30 i.e./kg zdravila Coagadex.
Keep the vial in the outer carton to protect from light. 
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Coagadex is supplied with the amount of solvent as shown in the table. 
5 ml Zdravilu Coagadex je priložena količina vehikla, ki je prikazana v tabeli.
No pharmacokinetic studies have been conducted but there is no anticipated effect of age on the pharmacokinetic profile of Coagadex. 
Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka starosti na farmakokinetični profil zdravila Coagadex.
• Disconnect the filled syringe from the device. 
• Odstranite napolnjeno injekcijsko brizgo s pribora.
- Solvent: water for injections. 
- Vehikel: voda za injekcije.
The following adverse reactions have been reported in clinical studies involving 27 patients treated with 
Tabelarični seznam neželenih učinkov V kliničnih študijah, ki so vključevale 27 bolnikov, zdravljenih z zdravilom Coagadex, so poročali o naslednjih neželenih učinkih.
Vaccination against hepatitis A and B in patients who regularly or repeatedly receive human plasma-derived Factor X products may be warranted. 
Pri bolnikih, ki redno ali večkrat prejemajo zdravila s faktorjem X, pridobljenim iz človeške plazme, bo morda potrebno cepljenje proti hepatitisu A in B.
Connect the syringe to the clear part of the transfer device and push the air into the vial. 
Priključite injekcijsko brizgo na prozorni del pribora za prenos vehikla in potisnite zrak v vialo.
Your medicine must only be dissolved in the solvent provided with the product. 
Zdravilo lahko raztopite le v vehiklu, ki je priložen zdravilu.
How to use Coagadex 
Kako uporabljati zdravilo Coagadex
Step 5: Separate the empty solvent vial and blue part from the clear part by unscrewing anti-clockwise. 
5. korak: Odstranite prazno vialo vehikla in modri del s prozornega dela, tako da ju obračate v nasprotni smeri vrtenja urinega kazalca.
When to inject Coagadex 
Kdaj je treba injicirati zdravilo Coagadex
human coagulation factor X. - The other ingredients are: citric acid, disodium phosphate dihydrate, sodium chloride, 
500 i.e. humanega koagulacijskega faktorja X. - Druge sestavine zdravila so: citronska kislina, dinatrijev fosfat dihidrat, natrijev klorid, natrijev hidroksid in saharoza (za dodatne informacije o sestavinah glejte poglavje 2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL 250 IU 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH OZNAKA NA VIALI 250 i.e.
No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or renal function on the pharmacokinetic profile of Coagadex. 
Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka spola ali delovanja ledvic na farmakokinetični profil zdravila Coagadex.
Do not use a double dose to make up for a forgotten dose. 
Če ste pozabili uporabiti zdravilo Coagadex Ne vzemite uporabite dvojnega odmerka, če ste pozabili vzeti prejšnji odmerek.
Coagadex 250 IU Coagadex 500 IU 
Coagadex 250 i.e. Coagadex 500 i.e.
No pharmacokinetic studies have been conducted but there is no anticipated effect of gender or hepatic function on the pharmacokinetic profile of Coagadex. 
Farmakokinetičnih študij niso opravili, vendar ne pričakujemo učinka spola ali delovanja jeter na farmakokinetični profil zdravila Coagadex.
Powder vial containing white or off-white powder. 
prašek in vehikel za raztopino za injiciranje Viala s praškom vsebuje bel ali umazano bel prašek.
1 vial 500 IU human coagulation factor X powder for solution for injection 1 vial 5 mL water for injections 
1 viala s 500 i.e. humanega koagulacijskega faktorja X, prašek za raztopino za injiciranje 1 viala s 5 ml vode za injekcije