FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, the solution has a pH of 6.7 to 7.3.
Slovenian: Po rekonstituciji je vrednost pH raztopine od 6,7 do 7,3.
English: Be sure that the powder is completely dissolved, otherwise not all reconstituted solution will pass through the device filter.
Slovenian: Prepričajte se, da se je prašek popolnoma raztopil, sicer ne bo vsa rekonstituirana raztopina prešla skozi filter v pripomočku.
English: The safety and efficacy of ADYNOVI in previously untreated patients have not yet been established.
Slovenian: Varnost in učinkovitost zdravila ADYNOVI pri predhodno nezdravljenih bolnikih še nista bili dokazani.
English: Do not use if packaging is opened or damaged.
Slovenian: Ne uporabljajte, če je ovojnina odprta ali poškodovana.
English: The medicinal product is provided in one of the following configurations:
Slovenian: Zdravilo je na voljo v eni izmed naslednjih oblik:
English: Every 24 hours at least 1 day, until healing is achieved.
Slovenian: Na 24 ur vsaj 1 dan, dokler ne dosežemo celjenja.
English: The listed warnings and precautions also apply to adolescents.
Slovenian: Navedena opozorila in previdnostni ukrepi veljajo tudi za mladostnike.
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Slovenian: V primeru anafilaktičnega šoka je treba začeti s standardnimi medicinskimi postopki za zdravljenje šoka.
English: Do not touch the exposed purple plastic spike.
Slovenian: Ne dotikajte se izpostavljene vijolične plastične konice.
English: The specific activity of ADYNOVI is approximately 4000-6500 IU/mg protein.
Slovenian: Specifična aktivnost zdravila ADYNOVI je približno 4000-6500 i.e./mg beljakovin.
English: Cardiovascular events
Slovenian: Kardiovaskularni dogodki
English: Required international units (IU) = body weight (kg) x desired factor VIII rise (%) x 0.5
Slovenian: Potrebno število mednarodnih enot (i.e.) = telesna masa (kg) x želeno zvišanje faktorja VIII (%) x 0,5
English: The clearance value of 12.18 ml/(kg·h) for subject 122001 in age group 12 to < 18 years was not included in the analysis of clearance.
Slovenian: Vrednost očistka 12,18 ml/(kg·h) na preiskovanca 122001 v starostni skupini od 12 do < 18 let ni bila vključena v analizo očistka.
English: Twenty-five of the 137 subjects were adolescents (12 to less than 18 years of age).
Slovenian: Petindvajset od 137 preiskovancev je bilo mladostnikov (starih od 12 do manj kot 18 let).
English: Chemical and physical in-use stability has been demonstrated for 3 hours at a temperature not above 30 °C.
Slovenian: Kemijska in fizikalna stabilnost med uporabo sta bili dokazani za obdobje 3 ur pri temperaturi do 30 °C.
English: The dose in adolescents is also calculated to body weight and is the same dose as for adults.
Slovenian: Odmerek pri mladostnikih se prav tako izračuna na podlagi telesne mase in je enak kot odmerek pri odraslih.
English: If a patient is to receive more than one vial of ADYNOVI, the contents of multiple vials may be drawn into the same syringe.
Slovenian: Če mora bolnik prejeti več kot eno vialo zdravila ADYNOVI, lahko v isto brizgo potegnete vsebino več vial.
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor VIII levels.
Slovenian: Zdravnik bo opravil primerne laboratorijske preiskave, s katerimi bo preveril, ali je raven faktorja VIII ustrezna.
English: Repeat injections every 8 to 24 hours until adequate wound healing, then continue therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl).
Slovenian: Injekcije ponavljajte na vsakih 8 do 24 ur, dokler se rana ustrezno ne zaceli, nato nadaljujte s terapijo še najmanj 7 dni za vzdrževanje aktivnosti faktorja VIII med 30 % in 60 % (i.e./dl).
English: Individual PK with 12 post-infusion samples.
Slovenian: Individualna PK z 12 vzorci po infuziji.
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Slovenian: Aktivirani faktor VIII deluje kot kofaktor za aktivirani faktor IX in pospeši pretvorbo faktorja X v aktivirani faktor X. Aktivirani faktor X pretvarja protrombin v trombin.
English: The table presented below is according to the MedDRA system organ classification (System Organ Class and Preferred Term Level).
Slovenian: Spodnja preglednica je pripravljena v skladu z razvrstitvijo organskih sistemov po klasifikaciji MedDRA (raven organskih sistemov in prednostnih izrazov).
English: • Do not use if the BAXJECT II Hi-Flow device, its sterile barrier system or its packaging is damaged or shows any sign of deterioration.
Slovenian: • Pripomočka BAXJECT II Hi-Flow ne uporabite, če sta njegov sistem sterilne bariere ali njegova ovojnina poškodovana ali če ima pripomoček znake okvare.
English: ADYNOVI is usually injected into a vein (intravenously) by your doctor or nurse.
Slovenian: Zdravilo ADYNOVI vam običajno v veno (intravensko) injicira zdravnik ali medicinska sestra.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Slovenian: Trombin potem pretvori fibrinogen v fibrin in omogoči nastanek krvnega strdka.
English: UNITED STATES
Slovenian: Združene države Amerike
English: (pre- and postoperative)
Slovenian: (pred posegom in po posegu)
English: The European Medicines Agency has deferred the obligation to submit results of studies with ADYNOVI in one or more subsets of the paediatric population in the treatment of congenital factor VIII deficiency.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom ADYNOVI za eno ali več podskupin pediatrične populacije za zdravljenje prirojenega pomanjkanja faktorja VIII.
English: These could be early symptoms of anaphylactic shock; additional symptoms may include extreme dizziness, loss of consciousness, and extreme difficulty in breathing.
Slovenian: Ti simptomi so lahko zgodnji simptom anafilaktičnega šoka; dodatni simptomi lahko vključujejo hudo omotico, izgubo zavesti in hude težave z dihanjem.
English: If this happens your medicine may stop working properly and you may experience persistent bleeding.
Slovenian: Če pride do tega, vaše zdravilo morda ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: If you suffer from cardiac disease, please inform your doctor, as there is an increased risk of blood clotting (coagulation) complications.
Slovenian: Obvestite zdravnika, če imate bolezen srca, saj pri vas obstaja povečano tveganje za zaplete s strjevanjem krvi (koagulacijo).
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Slovenian: Pri bolnikih z obstoječimi dejavniki tveganja za kardiovaskularne dogodke nadomestno zdravljenje s faktorjem VIII lahko poveča kardiovaskularno tveganje.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Slovenian: Pediatrična populacija Navedena opozorila in previdnostni ukrepi veljajo za odrasle bolnike in otroke.
English: Abbreviations: Cmax: maximum observed activity; AUC: area under the curve; MRT: mean residence time; CL: clearance; Vss: body weight adjusted volume of distribution at steady-state,
Slovenian: Okrajšave: Cmax: največja ugotovljena aktivnost; AUC: površina pod krivuljo; MRT: povprečni čas zadrževanja (mean residence time); CL: očistek; Vss: porazdelitveni volumen, prilagojen telesni masi, v ravnovesnem stanju,
English: In this case, this medicine expires at the end of this 3-month period or the expiration date printed on the product vial, whichever is earlier.
Slovenian: V tem primeru je datum izteka roka uporabnosti zdravila bodisi konec tega 3-mesečnega obdobja bodisi datum izteka roka uporabnosti, natisnjen na viali z zdravilom, kar je prej.
English: Administer over a period of up to 5 minutes (maximum infusion rate 10 ml per min).
Slovenian: Čas injiciranja naj bo do 5 minut (največja hitrost infuzije 10 ml na min).
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Slovenian: Študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Da bi preučili morebitne učinke kopičenja PEG v horoidnem pletežu možganov in drugih tkivih/organih, mora imetnik dovoljenja za promet z zdravilom opraviti študijo varnosti zdravila po pridobitvi dovoljenja za promet po dogovorjenem protokolu in predložiti njene rezultate.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Slovenian: Odmerek, ki temelji na telesni masi, bo pri bolnikih s premajhno ali preveliko telesno maso morda treba prilagoditi.
English: Paediatric population < 12 years of age
Slovenian: Pediatrična populacija, mlajša od 12 let
English: Thus it was not possible to conclude on the potential risks of PEG accumulation in various tissues/organs relevant for chronic use of ADYNOVI in the paediatric population.
Slovenian: Zato ni bilo mogoče sklepati o morebitnih tveganjih kopičenja PEG v različnih tkivih/organih, ki bi bila pomembna pri kronični uporabi zdravila ADYNOVI v pediatrični populaciji.
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Slovenian: Medsebojna delovanja zdravil s humanim koagulacijskim faktorjem VIII (rDNA) z drugimi zdravili niso znana.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: Kompleks faktorja VIII in von Willebrandovega faktorja je sestavljen iz dveh molekul (faktorja VIII in von Willebrandovega faktorja), ki imata različne fiziološke lastnosti.
English: Prophylactic treatment for patients from 12 to <18 years is the same as for adult patients.
Slovenian: Profilaktično zdravljenje pri bolnikih, starih od 12 do < 18 let, je enako kot pri odraslih bolnikih.
English: AUC0-Inf [IU·h/dL] Vss [dL/kg] Cmax [IU/dL]
Slovenian: AUC0-Inf [i.e.·h/dl] Vss [dl/kg] Cmax [i.e./dl]
English: Population PK model with 3 post-infusion samples based on randomized drawing schedule.
Slovenian: Populacijski PK-model s 3 vzorci po infuziji na osnovi randomiziranega urnika vzorčenja.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila: http://www.ema.europa.eu/
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/
English: The powder must not be mixed with other medicinal products or solvents or used with other reconstitution devices.
Slovenian: Praška ne smete mešati z drugimi zdravili ali vehikli ali uporabljati z drugimi pripomočki za rekonstitucijo.
English: Proceed with the next injection as scheduled and continue as advised by your doctor.
Slovenian: Naslednjo injekcijo injicirajte po razporedu in nadaljujte po navodilu zdravnika.
English: Of the 70 bleeding episodes observed during the paediatric study, 82.9% were controlled with 1 infusion and 91.4% were controlled with 1 or 2 infusions.
Slovenian: Od 70 epizod krvavitev, ki so jih opazili med pediatrično študijo, jih je bilo 82,9 % nadzorovanih z 1 infuzijo, 91,4 % pa z 1 ali 2 infuzijama.
English: Treatment monitoring:
Slovenian: Spremljanje zdravljenja:
English: The required dose is determined using the following formula:
Slovenian: Potrebni odmerek določimo s pomočjo naslednje enačbe:
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Slovenian: Posamezni bolniki se lahko različno odzivajo na faktor VIII, kar se kaže z različnimi razpolovnimi časih in z razlikami v okrevanju.
English: Perioperative haemostatic efficacy was rated as excellent (blood loss less than or equal to that expected for the same type of procedure performed in a non-haemophilic patient, and required blood components for transfusions less than or similar to that expected in non-haemophilic population) for all 26 (21 major, 5 minor) procedures.
Slovenian: Perioperativna hemostatska učinkovitost je bila ocenjena kot izvrstna (izguba krvi manjša od pričakovane ali enaka kot pričakovana za tovrstni poseg pri bolniku brez hemofilije in potreba po krvnih komponentah za transfuzijo je bila manjša od pričakovane ali podobna pričakovani v populaciji brez hemofilije) pri vseh 26 (21 večjih in 5 manjših) kirurških posegih.
English: If severe, sudden allergic reactions (anaphylactic) occur, the injection must be stopped immediately.
Slovenian: Če se pojavi huda, nenadna alergijska (anafilaktična) reakcija, nemudoma prekinite injiciranje zdravila.
English: The vacuum will draw the solvent into the powder vial.
Slovenian: Vakuum bo posesal vehikel v vialo s praškom.
English: • Do not use after the expiry date stated on the labels and carton.
Slovenian: • Zdravila ne uporabljajte po datumu izteka roka uporabnosti, ki je naveden na nalepkah in škatli.
English: A total of 518 bleeding episodes were treated with ADYNOVI in the per-protocol population.
Slovenian: Z zdravilom ADYNOVI so v populaciji po protokolu skupaj zdravili 518 krvavitev.
English: No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Slovenian: O simptomih prevelikega odmerjanja rekombinantnega koagulacijskega faktorja VIII niso poročali.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Slovenian: Še zlasti pri večjih kirurških posegih je nujno natančno spremljanje nadomestnega zdravljenja z analizo strjevanja krvi (aktivnosti faktorja VIII v plazmi).
English: A field study has indicated that plasma factor VIII levels can be monitored using either a chromogenic substrate assay or a one stage clotting assay routinely used in clinical laboratories.
Slovenian: Terenska študija je pokazala, da se raven faktorja VIII v plazmi lahko spremlja s testom s kromogenim substratom ali z enostopenjskim testom strjevanja, ki se rutinsko uporabljata v kliničnih laboratorijih.
English: Population PK with sparse sampling b
Slovenian: Populacijska PK z razpršenim vzorčenjem b
English: What ADYNOVI is and what it is used for
Slovenian: Kaj je zdravilo ADYNOVI in za kaj ga uporabljamo
English: What you need to know before you use ADYNOVI
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo ADYNOVI
English: Overall, 95.9% of bleeding episodes were controlled with 1 to 2 infusions and 85.5% were controlled with only 1 infusion.
Slovenian: Skupaj je bilo 95,9 % krvavitev nadzorovanih z 1 do 2 infuzijama, 85,5 % pa z 1 samo infuzijo.
English: Administration Steps:
Slovenian: Uporaba po korakih:
English: Solutions that are cloudy or have deposits should not be used.
Slovenian: Raztopin, ki so motne ali vsebujejo usedlino, ne smete uporabljati.
English: It is strongly recommended that every time that ADYNOVI 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: Zelo priporočljivo je, da se vsakič, ko bolnik prejme zdravilo ADYNOVI, zabeležita ime in serijska številka zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
English: At least 1 day, until the bleeding episode, as indicated by pain, is resolved or healing is achieved.
Slovenian: Najmanj 1 dan, dokler se krvavitev, ki se kaže z bolečino, ne ustavi oziroma ne dosežemo celjenja.
English: Common * Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs = previously-treated patients.
Slovenian: Pogosti * Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A. PZB = predhodno zdravljeni bolniki.
English: Use of a Luer-lock syringe is recommended.
Slovenian: Priporočamo uporabo luer-lock brizge.
English: Repeat injections every 8 to 24 hours until threat is resolved.
Slovenian: Injekcije ponavljajte na vsakih 8 do 24 ur, dokler ne mine ogroženost.
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 IU factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dl.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da 1 i.e. faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 2 i.e./dl.
English: Repeat injections every 12 to 24 hours for 3 - 4 days or more until pain and acute disability are resolved.
Slovenian: Injekcije ponavljajte na vsakih 12 do 24 ur 3 do 4 dni ali več, dokler ne izgine bolečina in preneha akutna onesposobljenost.
English: Usually, the replacement therapy with ADYNOVI is a life-long treatment.
Slovenian: Nadomestno zdravljenje z zdravilom ADYNOVI običajno traja vse življenje.
English: Factor VIII is necessary for the blood to form clots and stop bleedings.
Slovenian: Faktor VIII je potreben za strjevanje krvi in zaustavitev krvavitev.
English: Known allergic reaction to mouse or hamster protein.
Slovenian: Dokazana alergijska reakcija na beljakovine miši ali hrčka.
English: The mean (SD) age was 3.3 (1.55) and 8.1 (1.92) years respectively.
Slovenian: Povprečna (SD) starost je bila 3,3 (1,55) oziroma 8,1 (1,92) leta.
English: If you forget to use ADYNOVI
Slovenian: Če ste pozabili uporabiti zdravilo ADYNOVI
English: The median (IQR) observed intraoperative blood loss (n = 14) was 10.0 (20.0) ml compared to the predicted average blood loss (n = 14) of 150.0 (140.0) ml for major orthopaedic surgeries.
Slovenian: Mediana (IQR) opažene izgube krvi med posegom (n = 14) je bila 10,0 (20,0) ml v primerjavi z napovedano povprečno izgubo krvi (n = 14) 150,0 (140,0) ml pri večjih ortopedskih kirurških posegih.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Slovenian: Farmakoterapevtska skupina: antihemoragiki, koagulacijski faktor VIII, oznaka ATC: B02BD02.
English: The medicinal product contains traces of mouse and hamster proteins.
Slovenian: Zdravilo vsebuje beljakovine miši in hrčka v sledovih.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Pričakuje se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enake kot pri odraslih.
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem ml normalne humane plazme.
English: Haemophilia A is a X-chromosomal linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Slovenian: Hemofilija A je dedna motnja strjevanja krvi, vezana na kromosom X, ki nastane zaradi zmanjšane ravni faktorja VIII:C in povzroči obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontane ali kot posledica nezgode ali kirurške travme.
English: The safety of ADYNOVI was evaluated in 243 previously treated patients with severe haemophilia A (factor VIII less than 1% of normal), who received at least one dose of ADYNOVI in 3 completed multi-center, prospective, open label clinical studies and 2 ongoing clinical studies.
Slovenian: Varnost zdravila ADYNOVI so vrednotili pri 243 predhodno zdravljenih bolnikih s hudo hemofilijo A (raven faktorja VIII je manj kot 1 % normalne vrednosti), ki so prejeli vsaj en odmerek zdravila ADYNOVI, v 3 zaključenih multicentričnih, prospektivnih, odprtih kliničnih študijah in 2 potekajočih kliničnih študijah.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in International Units (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi se izraža v obliki odstotka (glede na normalno humano plazmo) ali raje v mednarodnih enotah (glede na mednarodni standard za faktor VIII v plazmi).
English: Instructions for injection
Slovenian: Navodilo za injiciranje
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerek in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja VIII, mesta in obsega krvavitve ter kliničnega stanja bolnika.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Slovenian: Faktor VIII lahko med nosečnostjo in v obdobju dojenja uporabljate le, če je nujno potrebno.
English: Hypersensitivity to the active substance, to the parent molecule octocog alfa or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino, na izhodno molekulo oktokog alfa ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Nonclinical data are limited to 1 month exposure and no studies in juvenile animals were conducted with ADYNOVI.
Slovenian: Predklinični podatki so omejeni na enomesečno izpostavljenost in študij pri mladih živalih z zdravilom ADYNOVI niso izvedli.
English: If you or your child´s bleeding is not being controlled with ADYNOVI, tell your doctor immediately.
Slovenian: Če krvavitev pri vas ali vašem otroku z zdravilom ADYNOVI ni obvladana, morate to nemudoma povedati zdravniku.
English: Additional side effects in children Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Slovenian: Dodatni neželeni učinki pri otrocih Pričakuje se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enake kot pri odraslih.
English: Your doctor will calculate your dose of ADYNOVI depending on your condition and body weight, and on whether it is used for prevention or treatment of bleeding.
Slovenian: Zdravnik bo izračunal vaš odmerek zdravila ADYNOVI, pri čemer bo upošteval vaše stanje in telesno maso ter glede na to, ali se uporablja za preprečevanje ali zdravljenje krvavitev.
English: The solution should be administered slowly, at a rate as determined by the patient's comfort level, not to exceed 10 ml per minute.
Slovenian: Raztopina se mora dajati počasi, s hitrostjo, ki zagotavlja ugodje bolnika, in ne presega 10 ml na minuto.
English: The rate of administration should be determined to ensure the comfort of the patient up to a maximum of 10 ml/min.
Slovenian: Hitrost dajanja se mora določiti tako, da zagotavlja ugodje bolnika, znašati pa sme do največ 10 ml/min.
English: Blood and lymphatic system disorders Factor VIII inhibition
Slovenian: Bolezni krvi in limfatičnega sistema zaviranje faktorja VIII
English: ADYNOVI contains sodium, see section 2.
Slovenian: Zdravilo ADYNOVI vsebuje natrij, glejte poglavje 2.
English: ADYNOVI has no influence on the ability to drive and use machines.
Slovenian: Zdravilo ADYNOVI nima vpliva na sposobnost vožnje in upravljanja strojev.
English: The change in PK parameters was similar in both the adult and adolescent populations and between one-stage clotting and chromogenic substrate assays.
Slovenian: Sprememba farmakokinetičnih parametrov je bila podobna pri odraslih in mladostnikih ter pri enostopenjskem testu strjevanja in testu s kromogenim substratom.
English: Animal reproduction studies have not been conducted with factor VIII.
Slovenian: Študije vpliva faktorja VIII na razmnoževanje pri živalih niso bile opravljene.