FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 1: Individual pharmacokinetic data for factor VIII activity after administration of the final dose of OBIZUR to 5 subjects with acquired haemophilia.
Slovenian: Preglednica 1: Individualni farmakokinetični podatki o aktivnosti faktorja VIII po dajanju enega odmerka zdravila OBIZUR pri 5 preiskovancih s pridobljeno hemofilijo.
English: Treatment with OBIZUR should be under the supervision of a physician experienced in the treatment of haemophilia.
Slovenian: Zdravljenje z zdravilom OBIZUR mora nadzorovati zdravnik, ki ima izkušnje z zdravljenjem hemofilije.
English: It is strongly recommended that every time OBIZUR is used, the name and batch number of the medicine are recorded by the medical professional to maintain a link between your treatment and the batch of the medicine.
Slovenian: Močno priporočamo, da zdravstveno osebje ob vsaki uporabi zdravila OBIZUR zabeleži ime in številko serije zdravila, da se ohrani povezava med vašim zdravljenjem in serijo zdravila.
English: Patients developing inhibitory antibodies to OBIZUR Your doctor may check if you have inhibitory antibodies to porcine Factor VIII.
Slovenian: Bolniki, pri katerih se pojavijo inhibitorna protitelesa proti zdravilu OBIZUR Zdravnik bo morda preveril, če imate inhibitorna protitelesa proti prašičjemu faktorju VIII.
English: Do not stop using OBIZUR without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo OBIZUR Ne prenehajte uporabljati zdravila OBIZUR brez posvetovanja z zdravnikom.
English: Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Slovenian: Ena viala vsebuje 4,4 mg (198 mM) natrija na ml rekonstituirane raztopine.
English: Other medicines and OBIZUR
Slovenian: Druga zdravila in zdravilo OBIZUR
English: Name and batch number
Slovenian: Ime in številka serije zdravila
English: Inhibitory antibodies against porcine Factor VIII (measured using a modification of the Nijmegen variation of the Bethesda assay) were detected before and after exposure to OBIZUR.
Slovenian: Inhibitorna protitelesa proti prašičjemu faktorju VIII (izmerjena z modifikacijo različice Nijmegen, testa Bethesda) so dokazali pred in po izpostavitvi zdravilu OBIZUR.
English: • pre-filled (type I glass) syringes with a stopper (butyl rubber), a rubber tip cap and a Luer Lock adapter
Slovenian: • napolnjena (steklo vrste I) injekcijska brizga z zamaškom (butilna guma), gumijasto zaporko konice in nastavkom Luer Lock,
English: Acquired haemophilia is a rare bleeding disorder in which patients with normal Factor VIII genes develop inhibitory autoantibodies directed against Factor VIII.
Slovenian: Pridobljena hemofilija je redka motnja strjevanja krvi, pri kateri se pri bolnikih z normalnimi geni za faktor VIII pojavijo inhibitorna avtoprotitelesa, ki so usmerjena proti faktorju VIII.
English: Do not to touch the luer lock (tip) in the centre of the vial adapter.
Slovenian: Pazite, da se ne dotaknete Luer Lock (konice) priključka na sredini nastavka viale.
English: A-1221 Vienna Austria
Slovenian: A-1221 Vienna Avstrija
English: All initial bleeding episodes had a positive response to treatment at 24 hours after initial dosing as assessed by the primary investigator.
Slovenian: Po oceni glavnega raziskovalca so se vse začetne epizode krvavitve v 24 urah po prvem odmerku pozitivno odzvale na zdravljenje.
English: The product contains trace amounts of hamster proteins.
Slovenian: Zdravilo vsebuje beljakovine hrčka v sledovih.
English: Factor VIII activity determined by the chromogenic assay is generally lower than Factor VIII activity determined by the one-stage clotting assay.
Slovenian: Aktivnost faktorja VIII, določena s kromogenim testom, je običajno nižja kot aktivnost faktorja VIII, določena z enostopenjskim koagulacijskim testom.
English: Manufacturer Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Slovenian: Izdelovalec Baxter AG Industriestrasse 67 A-1221 Vienna Avstrija
English: Excipient(s) with known effect Each vial contains 4.4 mg (198 mM) sodium per ml of reconstituted solution.
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Ena viala vsebuje 4,4 mg (198 mM) natrija na ml rekonstituirane raztopine.
English: Use the reconstituted solution immediately but no longer than 3 hours once the powder is completely dissolved.
Slovenian: Rekonstituirano raztopino morate uporabiti takoj, vendar najkasneje v 3 urah po popolni raztopitvi praška.
English: Unscrew the large syringe counterclockwise from the vial adapter, and repeat this process for all reconstituted vials of OBIZUR until the total volume to be administered is reached.
Slovenian: Veliko brizgo odvijte z nastavka viale z vrtenjem v nasprotni smeri urinih kazalcev in ponovite postopek za vse rekonstituirane viale zdravila OBIZUR, dokler ne zberete celotnega volumna, potrebnega za dajanje.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu <, and on the website of {name of MS Agency (link)}>.
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu < in na spletni strani {ime agencije v državi članici (povezava)}>, kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
English: The required initial dose of Obizur for a patient is calculated using the following formula: Initial dose (U/kg)  Product strength (U/vial) × Body weight (kg) = Number of vials e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows: 200 U/kg  500 U/vial × 70 kg = 28 vials
Slovenian: Potreben začetni odmerek zdravila OBIZUR za bolnika izračunate z naslednjo enačbo: začetni odmerek (e./kg)  jakost zdravila (e./vialo) × telesna masa (kg) = število vial npr. za osebo, težko 70 kg, se število vial za začetni odmerek izračuna po naslednjem postopku: 200 e./kg  500 e./vialo × 70 kg = 28 vial
English: It is strongly recommended that every time that OBIZUR 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 medicinal product.
Slovenian: Močno priporočamo, da ob vsaki uporabi zdravila OBIZUR pri bolniku zabeležite ime in številko serije zdravila, da ohranite povezavo med bolnikom in serijo zdravila.
English: If you use more OBIZUR than recommended, tell your doctor as soon as possible.
Slovenian: Če ste uporabili večji odmerek zdravila OBIZUR, kot bi smeli, se čimprej posvetujte z zdravnikom.
English: When treatment was required beyond 24 hours, a median total dose of 1050 U/kg were utilized with a median of 10.5 infusions (median dose 100 U/kg) to control a bleeding episode.
Slovenian: V primerih, ko je bilo zdravljenje potrebno več kot 24 ur, je bilo za obvladovanje krvavitve potrebna mediana skupnega odmerka 1050 e./kg in mediana števila infundiranj 10,5 (mediana vrednost odmerka 100 e./kg).
English: Immediately after release in the patient's circulation, Factor VIII binds to von Willebrand factor (vWF).
Slovenian: Faktor VIII se nemudoma po vstopu krvni obtok veže na von Willebrandov faktor (vWF).
English: • fluid transfer device with an integral plastic spike
Slovenian: • pretočni komplet z vgrajeno plastično konico.
English: Do not use this medicine after the expiry date which is stated on the carton, on the vial and on the pre-filled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, viali in napolnjeni injekcijski brizgi poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: In patients with acquired haemophilia, FVIII is not working properly because the patient has developed antibodies to his own Factor VIII which neutralize this blood clotting factor.
Slovenian: Faktor VIII pri bolnikih s pridobljeno hemofilijo ne deluje pravilno, ker imajo ti bolniki protitelesa proti lastnemu faktorju VIII, ki nevtralizirajo omenjeni faktor strjevanja krvi.
English: Administer the reconstituted OBIZUR intravenously at a rate of 1 to 2 mL per minute.
Slovenian: Rekonstituirano zdravilo OBIZUR dajajte intravensko s hitrostjo od 1 do 2 ml na minuto.
English: Invert the vial; push the air in the syringe into the vial and withdraw the reconstituted OBIZUR into the syringe (Figure I).
Slovenian: Vialo obrnite na glavo; iztisnite zrak iz brizge v vialo in povlecite rekonstituirano zdravilo OBIZUR v brizgo (slika I).
English: The one-stage assay is recommended because it has been used in determination of the potency and the mean recovery rate of OBIZUR (see sections 4.2 and 5.2).
Slovenian: Priporoča se uporaba enostopenjskega koagulacijskega testa, saj je že bil uporabljen za določanje jakosti in povprečne hitrosti obnovitve pri zdravilu OBIZUR (glejte poglavji 4.2 in 5.2)
English: In the initial 24 hour period, the median total dose of 493 U/kg were utilized in the clinical study with a median of 3 infusions.
Slovenian: V klinični študiji je bila v prvih 24 urah mediana skupnega odmerka 493 e./kg, mediana števila infundiranj pa 3.
English: Animal reproduction studies have not been conducted with OBIZUR.
Slovenian: Študije zdravila OBIZUR na živalih niso bile opravljene.
English: Push the plunger down to slowly inject all of the diluent from the syringe into the OBIZUR powder vial.
Slovenian: Bat potisnite navzdol in počasi injicirajte ves vehikel iz brizge v vialo s praškom zdravila OBIZUR.
English: Marketing authorisation holder Baxalta Innovations GmbH Industriestrasse 67
Slovenian: Imetnik dovoljenja za promet z zdravilom Baxalta Innovations GmbH Industriestrasse 67
English: • Alcohol swabs
Slovenian: • alkoholne krpice,
English: The product is for in-patient administration only.
Slovenian: To zdravilo je namenjeno samo dajanju hospitaliziranim bolnikom.
English: The one-stage clotting assay for Factor VIII is recommended as it has been used in determination of the potency of OBIZUR and the mean recovery rate (see section 4.4 and 5.2).
Slovenian: Priporočen je enostopenjski koagulacijski test za raven faktorja VIII, ki je bil že uporabljen tudi za določanje jakosti zdravila OBIZUR in povprečne hitrosti obnovitve (glejte poglavje 4.4 in 5.2).
English: Single use injection.
Slovenian: Za enkratno injiciranje.
English: Each powder vial contains 500 U susoctocog alfa.
Slovenian: Ena viala s praškom vsebuje 500 e. susoktokoga alfa.
English: How to use OBIZUR
Slovenian: Kako uporabljati zdravilo OBIZUR
English: OBIZUR is used for the treatment of bleeding episodes in adults with acquired haemophilia (a bleeding disorder caused by lack of Factor VIII activity due to antibody development).
Slovenian: Zdravilo OBIZUR se uporablja za zdravljenje krvavitev pri bolnikih s pridobljeno hemofilijo (motnja strjevanja krvi, ki nastane zaradi pomanjkanja aktivnosti faktorja VIII kot posledica pojava protiteles).
English: The effects of higher than recommended doses of OBIZUR have not been characterised.
Slovenian: Učinki prevelikega odmerjanja zdravila OBIZUR niso znani.
English: What OBIZUR contains - The active substance is susoctocog alfa (antihaemophilic Factor VIII, porcine sequence produced by recombinant DNA technology).
Slovenian: Kaj vsebuje zdravilo OBIZUR - Učinkovina je susoktokog alfa (antihemofilni faktor VIII, prašičje zaporedje, izdelan s tehnologijo rekombinantne DNA).
English: In the clinical trial of OBIZUR for acquired haemophilia, 29 adult subjects were evaluable for safety.
Slovenian: Varnost zdravila OBIZUR so ocenili v kliničnem preskušanju pri 29 odraslih preiskovancih s pridobljeno hemofilijo.
English: Treatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to Factor VIII.
Slovenian: Zdravljenje krvavitev pri bolnikih s pridobljeno hemofilijo, ki jo povzročajo protitelesa proti faktorju VIII.
English: Gently swirl (in a circular motion) the OBIZUR powder vial without removing the syringe until all of the powder is fully dissolved /reconstituted (Figure G).
Slovenian: (S krožnimi gibi) previdno zvrtinčite vialo s praškom zdravila OBIZUR z nameščeno brizgo, da se ves prašek popolnoma raztopi / rekonstituira (slika G).
English: • powder vials (type I glass) with a stopper (butyl rubber) and a flip-off seal
Slovenian: • viala s praškom (steklo vrste I) z zamaškom (butilna guma) in snemno ploščico,
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR PREPARATION AND ADMINISTRATION Preparation
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju:
English: The recommended first dose is 200 U per kilogram bodyweight given by intravenous injection.
Slovenian: Priporočeni začetni odmerek je 200 e. na kilogram telesne mase z intravenskim injiciranjem.
English: Do not remove the vial adapter from the package.
Slovenian: Nastavka viale ne jemljite iz ovojnine.
English: Place the vial adapter package on a clean surface with the luer lock pointing up.
Slovenian: Ovojnino nastavka viale odložite na čisto površino tako, da je Luer Lock priključek obrnjen navzgor.
English: The reconstituted solution should be used immediately, but no longer than 3 hours after reconstitution.
Slovenian: Rekonstituiran raztopino morate uporabiti takoj, vendar najkasneje v 3 urah po rekonstituciji.
English: Baxter AG Industriestrasse 67 A-1221 Vienna AUSTRIA
Slovenian: Baxter AG Industriestrasse 67 1221 Vienna AVSTRIJA
English: OBIZUR is produced by recombinant DNA technology in baby hamster kidney cells.
Slovenian: Zdravilo OBIZUR je izdelano s tehnologijo rekombinantne DNA v ledvičnih celicah mladiča hrčka.
English: The recommended initial dose is 200 U per kilogram bodyweight, given by injection.
Slovenian: Priporočeni začetni odmerek je 200 e. na kilogram telesne mase z injiciranjem.
English: Patients with acquired haemophilia may develop inhibitory antibodies to porcine Factor VIII.
Slovenian: Pri bolnikih s pridobljeno hemofilijo se lahko pojavijo inhibitorna protitelesa proti prašičjemu faktorju VIII.
English: Pharmacokinetic data from 5 subjects with acquired haemophilia whilst in a non-bleeding state are presented in Table 1.
Slovenian: V preglednici 1 so predstavljeni farmakokinetični podatki 5 preiskovancev s pridobljeno hemofilijo, ko niso krvaveli.
English: Do not over tighten (Figure D).
Slovenian: Pazite, da brizge ne privijete premočno (slika D).
English: Place the OBIZUR powder vial on a clean, flat, hard surface.
Slovenian: Vialo s praškomzdravila OBIZUR postavite na čisto, ravno in trdno površino.
English: OBIZUR contains sodium This medicine contains 4.4 mg sodium per milliliter once it is made up.
Slovenian: Zdravilo po pripravi vsebuje 4,4 mg natrija na mililiter.
English: Warnings and precautions Talk to your doctor before using OBIZUR.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila OBIZUR se posvetujte z zdravnikom.
English: There is a lack of clinical information on the development of inhibitory antibodies to OBIZUR following repeated administration.
Slovenian: O pojavu inhibitornih protiteles pri večkratnem jemanju zdravila OBIZUR je malo kliničnih informacij.
English: These antibodies have less neutralizing effect against OBIZUR than against human Factor VIII.
Slovenian: Ta protitelesa v manjši meri nevtralizirajo zdravilo OBIZUR kot humani faktor VIII.
English: Each powder vial contains nominally 500 Units of B domain deleted antihaemophilic Factor VIII (recombinant), porcine sequence, susoctocog alfa.
Slovenian: Ena viala s praškom nominalno vsebuje 500 enot (rekombinantnega) antihemofilnega faktorja VIII brez domene B, iz prašičjega zaporedja, susoktokog alfa.
English: Factor VIII activity was measured by the one-stage clotting assay.
Slovenian: Aktivnost faktorja VIII je bila izmerjena z enostopenjskim koagulacijskim testom.
English: You must contact your doctor immediately if you have any of the following early symptoms:
Slovenian: Če opazite katerega koli izmed naslednjih zgodnjih simptomov, se nemudoma posvetujte z zdravnikom:
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology or repeated dose toxicity.However, in repeated dose toxicity studies, the incidence and severity of glomerulopathy observed in monkeys intravenously administered OBIZUR at doses of 75, 225 and 750 U/kg/day tended to increase over time.
Slovenian: Vendar sta se v študijah toksičnosti pri ponavljajočih odmerkih pri opicah, ki so intravensko prejemale zdravilo OBIZUR v odmerkih 75, 225 in 750 e./kg/dan, pojavnost in resnost glomerulopatije s časom povečevala.
English: Sodium chloride Calcium chloride dihydrate Sucrose
Slovenian: Prašek polisorbat 80 natrijev klorid kalcijev klorid dihidrat saharoza trometamol trometamolijev klorid trinatrijev citrat dihidrat
English: Once all vials have been reconstituted, connect a large syringe to the vial adapter by gently pushing the syringe tip down onto the luer lock in the centre of the vial adapter, and turning clockwise until the syringe is secured.
Slovenian: Ko rekonstuitirate vse viale, na nastavek viale namestite veliko brizgo, tako da konico brizge previdno potisnite na Luer Lock priključek v središču nastavka za vialo in brizgo obrnite v smeri urinih kazalcev, da jo tesno privijete.
English: Repeat following reconstitution instructions for each powder vial to be reconstituted.
Slovenian: Spodnji postopek rekonstitucije ponovite za vsako vialo s praškom, ki jo boste rekonstituirali.
English: What OBIZUR is and what it is used for What you need to know before you use OBIZUR How to use OBIZUR
Slovenian: Kaj je zdravilo OBIZUR in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo OBIZUR Kako uporabljati zdravilo OBIZUR Možni neželeni učinki
English: Tabulated list of adverse reactions:
Slovenian: Preglednica neželenih učinkov:
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Bolnikom svetujte, naj nemudoma prekinejo uporabo zdravila in se posvetujejo z zdravnikom, če se pojavijo simptomi preobčutljivosti.
English: Remove the plastic cap from the OBIZUR powder vial (Figure A).
Slovenian: Snemite plastično zaporko viale s praškom zdravila OBIZUR (slika A).
English: - The other ingredients in the powder are polysorbate 80, sodium chloride (see also section 2),
Slovenian: - Druge sestavine v prašku so polisorbat 80, natrijev klorid (glejte tudi poglavje 2), kalcijev klorid dihidrat, saharoza, trometamol, trometamolijev klorid, trinatrijev citrat dihidrat.
English: Treatment with OBIZUR will be conducted by a doctor who is experienced in the care of patients with haemophilia (bleeding disorders).
Slovenian: Zdravljenje z zdravilom OBIZUR mora uvesti in nadzirati zdravnik z izkušnjami pri zdravljenju hemofilije (motenj strjevanja krvi).
English: Investigations
Slovenian: Preiskovanec
English: Bring the OBIZUR powder vial and pre-filled diluent solvent syringe to room temperature.
Slovenian: Vialo s praškom zdravila OBIZUR in napolnjeno injekcijsko brizgo z vehiklom ogrejte na sobno temperaturo.
English: Subject Dose (U)
Slovenian: Odmerek (e.)
English: No interactions of OBIZUR with other medicines are known.
Slovenian: Medsebojno delovanje zdravila OBIZUR z drugimi zdravili ni znano.
English: Antibodies to baby hamster kidney cell protein were not detected in subjects after exposure to OBIZUR.
Slovenian: Pri preiskovancih po izpostavitvi zdravila OBIZUR niso bila zaznana protitelesa proti beljakovinam ledvičnih celic mladiča hrčka.
English: OBIZUR contains the active substance susoctocog alfa, antihaemophilic Factor VIII, porcine sequence.
Slovenian: Zdravilo OBIZUR vsebuje učinkovino susoktokog alfa, ki je antihemofilni faktor VIII iz prašičjega zaporedja.
English: Peel back the cover of the vial adapter package (Figure B).
Slovenian: Odlepite zaščitno folijo z ovojnine nastavka viale (slika B).
English: Talk to your doctor if you are on a controlled sodium diet.
Slovenian: Če ste na dieti z nadzorovanim vnosom natrija, se posvetujte z zdravnikom.
English: OBIZUR 500 U powder and solvent for solution for injection Susoctocog alfa
Slovenian: OBIZUR 500 e. prašek in vehikel za raztopino za injiciranje susoktokog alfa
English: The frequency and duration of administration will depend on how well OBIZUR is working for you.
Slovenian: Pogostnost in trajanje uporabe bo odvisno od odziva vašega telesa na zdravilo OBIZUR.
English: Place the vial adapter over the OBIZUR powder vial and firmly push the filter spike of the vial adapter through the centre of the OBIZUR powder vial's rubber circle until the clear plastic cap snaps onto the vial (Figure F).
Slovenian: Nastavek viale namestite na vialo zdravila OBIZUR in odločno potisnite filtracijsko konico nastavka skozi središče kroga izpostavljenega gumijastega zamaška viale s praškom zdravila OBIZUR, da se prozoren plastičen pokrovček zaskoči na vialo (slika F).
English: Snap off the tamper resistant cap of the pre-filled solvent syringe (Figure C).
Slovenian: Snemite pečatno zaporko z napolnjene injekcijske brizge z vehiklom (slika C).
English: Monitor Factor VIII activity immediately prior to and 30 minutes after subsequent doses and refer to the table below for recommended target Factor VIII trough levels.
Slovenian: Aktivnost faktorja VIII preverite neposredno pred vsakim naslednjim odmerkom in 30 minut po vsakem naslednjem odmerku.
English: Do not use if particulate matter or discoloration is observed.
Slovenian: Raztopine z delci ali spremenjeno barvo ne smete uporabiti.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One ml of solution contains approximately 500 U of antihaemophilic factor VIII (recombinant), porcine sequence, susoctocog alfa after reconstitution.
Slovenian: En ml vehikla po rekonstituciji vsebuje približno 500 e. (rekombinantnega) antihemofilnega faktorja VIII, iz prašičjega zaporedja, susoktokog alfa.
English: The solution should be clear and colorless in appearance.
Slovenian: Raztopina mora biti bistra in brezbarvna.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA
English: Use OBIZUR immediately and within 3 hours after reconstitution when stored at room temperature.
Slovenian: Zdravilo OBIZUR, shranjeno pri sobni temperaturi, uporabite takoj in v 3 urah po rekonstituciji.
English: rFVIIa, activated prothrombin-complex concentrate, tranexamic acid) prior to first treatment with OBIZUR.
Slovenian: Enajst preiskovancev je pred prvim zdravljenjem z zdravilom OBIZUR prejelo antihemoragike (npr. rFVIIa, koncentrat aktiviranega protrombinskega kompleksa, traneksamsko kislino).
English: Dosing
Slovenian: Odmerjanje
English: With one hand hold the vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled solvent syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H).
Slovenian: Z eno roko primite vialo in nastavek viale, z drugo roko pa čvrsto primite telo napolnjene injekcijske brizge z vehiklom in jo v nasprotni smeri urinih kazalcev odvijte z nastavka viale (slika H).
English: With one hand hold the powder vial and vial adapter, and with the other hand firmly grasp the barrel of the pre-filled solvent syringe and in a counterclockwise motion unscrew the syringe from the vial adapter (Figure H).
Slovenian: Z eno roko primite vialo s praškom in nastavek viale, z drugo roko pa čvrsto primite telo napolnjene injekcijske brizge z vehiklom in jo v nasprotni smeri urinih kazalcev odvijte z nastavka viale (slika H).
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation Factor VIII, porcine sequence.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII, prašičje zaporedje, oznaka ATC: B02BD14
English: Figure E
Slovenian: Slika I
English: Initial dose (U/kg)  Product strength (U/vial) × Body weight (kg) = Number of vials e.g. for a 70 kg subject the number of vials for an initial dose will be calculated as follows: 200 U/kg  500 U/vial × 70 kg = 28 vials
Slovenian: začetni odmerek (e./kg)  jakost zdravila (e./vialo) × telesna masa (kg) = število vial npr. za osebo s telesno maso 70 kg, se število vial za začetni odmerek izračuna po naslednjem postopku: