FrancophonIA/ELRC3.0 huggingface dataset:
English: For overweight patients, the maximum dose per injection for prophylaxis should not be higher than approximately 6000 IU.
Slovenian: Za bolnike s preveliko telesno maso največji profilaktični odmerek ne sme preseči 6000 i.e na injiciranje.
English: Dose proportional increases were observed between the doses of 25 and 60 IU/kg indicating dose linearity between 25 IU/kg and 60 IU/kg.
Slovenian: Opaženo je bilo naraščanje sorazmerno z odmerki med 25 in 60 i.e./kg, kar kaže na linearnost pri odmerkih med 25 i.e./kg in 60 i.e./kg.
English: The PEG-linker moiety was also tested in a standard set of in vivo and in vitro genotoxicity studies and they did not indicate a potential for genotoxicity.
Slovenian: PEG-linker so testirali v standardnih in vivo in in vitro genotoksičnih študijah, ki niso pokazale genotoksičnosti.
English: The dose of factor VIII units is measured in International Units (IU).
Slovenian: Odmerek enot faktorja VIII je izražen v mednarodnih enotah (i.e.).
English: In such cases, it is recommended that a specialized haemophilia centre be contacted.
Slovenian: V takih primerih se priporoča, da se obrnete na specialistični center za zdravljenje hemofilije.
English: • bacteria in the blood
Slovenian: • prisotnostjo bakterij v krvi,
English: • 30-40 IU per kg body weight two times per week.
Slovenian: • 30 - 40 i.e. na kg telesne mase dvakrat na teden.
English: • allergic to mouse or hamster proteins.
Slovenian: • alergični na beljakovine miši ali hrčkov.
English: Treatment with Jivi will be started by a doctor who is experienced in the care of patients with haemophilia A. After suitable training patients or carers may be able to give Jivi at home.
Slovenian: Zdravljenje z zdravilom Jivi lahko začne zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo A. Po ustrezni poučitvi si lahko bolniki zdravilo Jivi dajejo doma sami ali jim ga dajo njihovi skrbniki.
English: • a vial adapter
Slovenian: • adapter za vialo
English: No adverse events were reported.
Slovenian: O neželenih učinkih niso poročali.
English: In 3 of 44 patients (7%), loss of drug effect was combined with hypersensitivity reactions (see section 4.4).
Slovenian: Pri 3 od 44 bolnikov (7 %) zdravilo ni bilo učinkovito, pojavile so se tudi preobčutljivostne reakcije (glejte poglavje 4.4).
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal) in the corresponding period.
Slovenian: V primeru spodaj navedenih krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno raven aktivnosti (% normalne aktivnosti) v ustreznem obdobju.
English: Perioperative haemostatic efficacy was rated as good or excellent during all major surgeries.
Slovenian: Perioperativna hemostatična učinkovitost je bila v vseh velikih kirurških posegih ocenjena kot dobra ali odlična.
English: The median total dose for major surgeries was 219 IU/kg (range: 50-1500 IU/kg, including postoperative period up to 3 weeks).
Slovenian: Mediana skupnega odmerka pri velikih kirurških posegih je bila 219 i.e./kg (razpon: 50-1500 i.e./kg, vključno z obdobjem po operaciji do 3 tedne).
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalized urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: Opažene so bile preobčutljivost ali alergijske reakcije (le-te lahko vključujejo angioedem, pekoč občutek in občutek zbadanja na mestu injiciranja, mrzlico, pordelost, generalizirano urtikarijo, glavobol, koprivnico, hipotenzijo, letargijo, navzeo, nemir, tahikardijo, tiščanje v prsnem košu, ščemenje, bruhanje, zasoplost), ki lahko v nekaterih primerih napredujejo do hude anafilakse (tudi do šoka).
English: • bleeding that is not being controlled with your usual dose of this medicine.
Slovenian: • se krvavitev po uporabi za vas predpisanega običajnega odmerka tega zdravila ne ustavi.
English: Hemostasis was assessed as good or excellent in all available cases.
Slovenian: V vseh primerih, ki so na voljo, je bila hemostaza ocenjena kot dobra ali odlična.
English: If you store it at room temperature it expires after 6 months, or the expiry date if this is earlier.
Slovenian: Če ga shranjujete pri sobni temperaturi, se rok uporabnosti izteče ob koncu 6-mesečnega obdobja ali z datumom izteka roka uporabnosti, odvisno kaj nastopi prej.
English: On demand and prophylactic treatment dosing in adolescent patients is the same as for adult patients.
Slovenian: Za mladostnike je odmerek zdravljenja po potrebi in za profilakso enak kot pri odraslih bolnikih.
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 1.5-2.5 % of normal activity.
Slovenian: Izračun potrebnega odmerka faktorja VIII temelji na empirični ugotovitvi, da 1 mednarodna enota (i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 1,5 - 2,5 % normalne aktivnosti.
English: A significant decrease in the risk of an immune response to PEG was observed with an increase in age.
Slovenian: Opazili so, da se je tveganje za imunski odziv na PEG s starostjo bistveno zmanjšalo.
English: Jivi is for intravenous use.
Slovenian: Zdravilo Jivi je namenjeno za intravensko uporabo.
English: The dose and duration of substitution therapy depends on the severity of the factor VIII deficiency, the location and extent of the bleeding and on the patient's clinical condition.
Slovenian: Odmerjanje zdravila in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja aktivnosti faktorja VIII, mesta in obsega krvavitve in od kliničnega stanja bolnika.
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Slovenian: Če pričakovane aktivnost faktorja VIII v plazmi niso dosežene ali če krvavitve z ustreznim odmerkom ni mogoče obvladati, je treba opraviti preiskave glede prisotnosti inhibitorjev faktorja VIII.
English: Median time on study was 713 days with a median of 131 exposure days (range: 1 to 309 days).
Slovenian: V študiji je bila mediana trajanja zdravljenja 713 dni, pri preiskovancih je bila mediana dni izpostavitve zdravilu 131 (razpon: 1 do 309 dni).
English: In a long-term, 6-months chronic toxicity study no indication of PEG accumulation or other effects related to administration of Jivi were seen.
Slovenian: V dolgotrajnih, 6-mesečnih študijah kronične toksičnosti niso opazili znakov kopičenja PEG ali drugih učinkov, povezanih z uporabo zdravila Jivi.
English: No long-term studies in animals to evaluate the carcinogenic potential of Jivi, or studies to determine the effects of Jivi on reproduction have been conducted.
Slovenian: Dolgotrajnih študij pri živalih za oceno kancerogenega potenciala zdravila Jivi ali študij za določitev učinka zdravila Jivi na sposobnost razmnoževanje niso izvedli.
English: Hypersensitivity reactions could also be related to antibodies against PEG (see paragraph Immune response to polyethylene glycol (PEG)).
Slovenian: Preobčutljivostne reakcije so lahko povezane tudi s protitelesi proti PEG (glejte poglavje Imunski odziv na polietilenglikol (PEG)).
English: • a glass vial of powder
Slovenian: • stekleno vialo s praškom
English: It is recommended that every time you use Jivi, you note down the name and batch number of the product.
Slovenian: Priporočljivo je, da ob vsaki uporabi zdravila Jivi zabeležite ime zdravila in številko serije.
English: Immunogenicity was evaluated during clinical trials with Jivi in 159 (including surgery patients) previously treated adolescents (≥ 12 years of age) and adults diagnosed with severe haemophilia A (FVIII:C < 1%), and ≥ 150 previous exposure days.
Slovenian: Imunogenost so ocenili v kliničnih preskušanjih z zdravilom Jivi pri 159 (vključno z bolniki s kirurškim posegom) predhodno zdravljenih mladostnikih (≥ 12 let starosti) in odraslih z diagnozo težke stopnje hemofilije A (FVIII:C < 1 %), pri katerih je bilo predhodno število dni izpostavitve ≥ 150.
English: Jivi should be injected intravenously over a period of 2 to 5 minutes depending on the total volume.
Slovenian: Zdravilo Jivi je treba injicirati intravensko 2 do 5 minut, odvisno od skupnega volumna zdravila.
English: Known allergic reactions to mouse or hamster proteins.
Slovenian: Znane alergijske reakcije na beljakovine miši ali hrčkov.
English: Total (≥ 12 years) N=145
Slovenian: Skupaj (≥ 12 let) n = 145
English: Only the components provided in the package should be used for reconstitution and injection because treatment failure can occur as a consequence of factor VIII adsorption to the internal surfaces of some injection equipment.
Slovenian: Za rekonstitucijo in injiciranje zdravila se sme uporabiti samo v pakiranju priloženi pribor, ker je lahko zdravljenje zaradi adsorpcije faktorja VIII na notranje površine nekaterih drugih pripomočkov za injiciranje neuspešno.
English: Table 3 summarizes the PK parameters after single dose of 60 IU/kg from the Phase II/III study where PK was evaluated in 22 subjects.
Slovenian: V preglednici 3 so povzeti farmakokinetični parametri po enkratnem odmerku 60 i.e./kg iz študije faze II/III, kjer so farmakokinetiko ocenili pri 22 preiskovancih.
English: • nausea, vomiting
Slovenian: • navzea, bruhanje
English: Phase II/III: The pharmacokinetics, safety and efficacy of Jivi for on demand treatment, prophylaxis with three regimens (two times per week 30-40 IU/kg, every 5-days 45-60 IU/kg and every 7-days 60 IU/kg) and haemostasis during major surgeries were evaluated in a multinational, open-label, uncontrolled, partially randomized study which was performed in compliance with the agreed Paediatric Investigation Plan.
Slovenian: Faza II/III: Farmakokinetiko, varnost in učinkovitost zdravila Jivi v zdravljenju po potrebi, profilaktični uporabi s tremi režimi (dvakrat na teden 30 - 40 i.e./kg, vsakih 5 dni 45 - 60 i.e./kg in vsakih 7 dni 60 i.e./kg) in hemostazi med velikimi kirurškimi posegi so ocenili v multinacionalni, odprti, nenadzorovani, delno randomizirani študiji, ki je bila izvedena v skladu z dogovorjenim načrtom pediatričnih raziskav (PIP - paediatric investigation plan).
English: PK was also evaluated in 22 subjects (≥12 yrs) and in 16 of these subjects after 6 months of prophylaxis treatment in the Phase II/III study.
Slovenian: Farmakokinetiko so ocenili tudi pri 22 preiskovancih (≥ 12 let) in pri 16 izmed teh preiskovancev po 6 mesecih profilaktičnega zdravljenja v študiji faze II/III.
English: For treatment of bleeds, 84.4 % of the bleeds were resolved with 1 injection, and 91.9% of the bleeds were resolved with 1 or 2 injections.
Slovenian: Pri zdravljenju krvavitev je 84,4 % krvavitev izzvenelo po 1 injekciji, 91,9 % krvavitev je izzvenelo po 1 ali 2 injekcijah.
English: Symptomatic treatment for hypersensitivity should be instituted as appropriate.
Slovenian: Kadar je potrebno, je treba začeti simptomatsko zdravljenje preobčutljivosti.
English: This medicine is for single use only.
Slovenian: Zdravilo je samo za enkratno uporabo.
English: The median (range) dose per injection was 31.7 IU/kg (14; 62).
Slovenian: Mediana odmerka (razpon) na injekcijo je bila 31,7 i.e./kg (14; 62).
English: It should be noted that there can be significant discrepancies between assay results obtained by specific reagents used in the aPTTbased one stage clotting assay and the chromogenic assay.
Slovenian: Treba je opozoriti, da lahko pride do znatnih odstopanj med rezultati enostopenjske koagulacijske metode, ki temelji na aPTČ, pridobljenimi s specifičnimi reagenti, in rezultati kromogene metode.
English: The following side effects may occur with this medicine:
Slovenian: Pri tem zdravilu se lahko pojavijo naslednji neželeni učinki:
English: Dose based on bodyweight may require adjustment in overweight patients.
Slovenian: Odmerek, ki temelji na telesni masi, bo pri bolnikih s preveliko telesno maso morda treba prilagoditi.
English: Of the 702 bleeding events treated with Jivi during the main study, 636 (90.6%) were treated with 1 or 2 injections, thereof 81.1% with 1 injection.
Slovenian: Od 702 krvavitev, ki so jih zdravili z zdravilom Jivi v glavni študiji, jih je bilo 636 (90,6 %) zdravljenih z 1 ali 2 injekcijama, od tega 81,1 % z 1 injekcijo.
English: Eleven patients in the every 7 days arm increased frequency.
Slovenian: Pri 11 bolnikih v kraku, ki je zdravilo prejemal vsakih 7 dni, so pogostnost aplikacije zdravila povečali.
English: For 53 patients who completed the main study, the median (Q1; Q3) annualised bleeding rate was 2.87 (1.1; 6.1) and the spontaneous ABR was 0.0 (0.0; 2.6).
Slovenian: Za 53 bolnikov, ki so zaključili glavno študijo, je bila mediana (Q1:Q3) letne stopnje krvavitev 2,87 (1,1; 6,1), stopnja spontanih ABR pa je bila 0,0 (0,0; 2,6).
English: There was one case of overdose in the clinical trials.
Slovenian: V kliničnih preskušanjih so poročali o enem primeru prevelikega odmerjanja.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified Bethesda assay.
Slovenian: Nastanek protiteles, ki nevtralizirajo faktor VIII (inhibitorji), je znan zaplet pri zdravljenju posameznikov s hemofilijo A. Ti inhibitorji so ponavadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v Bethesda enotah (B.e.) na ml plazme z uporabo modificiranega Bethesda testa.
English: Keep the medicine in its original package in order to protect from light.
Slovenian: Zdravilo shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: Single dose studies in rats with the radio-labelled PEG moiety showed that there was no indication of retention or irreversible binding of radioactivity in the animal body.
Slovenian: Študije z enkratnim odmerkom radioaktivno označenega dela PEG pri podganah, so pokazale, da v telesu živali ni znakov kopičenja ali ireverzibilne vezave radioktivno označene PEG.
English: Jivi has no influence on the ability to drive and use machines.
Slovenian: Zdravilo Jivi nima vpliva na sposobnost vožnje in upravljanja strojev.
English: You may have developed antibodies against factor VIII (inhibitors) or antibodies against polyethylene glycol (PEG).
Slovenian: Morda so se pri vas razvila protitelesa proti faktorju VIII (inhibitorji) ali protitelesa proti polietilenglikolu (PEG).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION Water for injections METHOD OF ADMINISTRATION EXPIRY DATE
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NAPOLNJENA INJEKCIJSKA BRIZGA IME ZDRAVILA IN POT(I) UPORABE Voda za injekcije POSTOPEK UPORABE DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
English: Site-specific PEGylation reduces clearance of factor VIII resulting in an extended half-life while maintaining the normal functions of the B-domain deleted rFVIII molecule (see section 5.2).
Slovenian: PEGilacija na specifičnem mestu zmanjša očistek faktorja VIII, kar povzroči podaljšanje razpolovnega časa, a ohrani normalno delovanje molekule rekombinantnega faktorja VIII brez domene B (glejte poglavje 5.2).
English: This effect may be related to a developmental change in immunity, and although it is difficult to define a clear cut-off age for the change in risk, this phenomenon predominantly occurs in young children with haemophilia.
Slovenian: Ta učinek je lahko povezan z razvojem imunosti, vendar je težko jasno opredeliti starost, pri kateri se tveganje spremeni.
English: Your doctor may switch you back to your previous factor VIII treatment, if needed.
Slovenian: Če je treba, lahko vaš zdravnik preide nazaj na zdravljenje z vašim prejšnjim zdravilom s faktorjem VIII.
English: A total of 232 previously treated patients with severe haemophilia A have been exposed in the clinical trial program which included one phase I study and two phase II/III studies.
Slovenian: V programu kliničnega preskušanja je bilo zdravilu izpostavljenih skupno 232 predhodno zdravljenih bolnikov s težko stopnjo hemofilije A. Program je vključeval eno študijo faze I in dve študiji faze II/III.
English: This date should never exceed the expiry date printed on the outer carton.
Slovenian: Ta datum ne sme preseči datuma izteka roka uporabnosti, navedenega na škatli.
English: In the repeat dose systemic toxicity studies in rats and rabbits with Jivi, treatment related effects on male reproductive organs were not seen (see section 5.3).
Slovenian: V študijah sistemske toksičnosti pri ponavljajočih odmerkih zdravila Jivi pri podganah in kuncih niso opazili z zdravljenjem povezanega vpliva na reprodukcijske organe pri samcih (glejte poglavje 5.3).
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Neželeni učinki, navedeni v spodnji preglednici, so razvrščeni po organskih sistemih po klasifikaciji MedDRA (uporabljen je organski sistem in prednostni izraz po klasifikaciji MedDRA).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike je treba poučiti o zgodnjih znakih preobčutljivosti, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsnem košu, zasoplostjo, hipotenzijo in anafilakso.
English: In 10 of 44 patients (23%) in the age group of younger than 6 years of age loss of drug effect due to neutralising anti-PEG antibodies during the first 4 exposure days was observed.
Slovenian: Pri 10 od 44 bolnikov (23 %), mlajših od 6 let, so opazili, da zdravilo ni bilo učinkovito zaradi nastanka nevtralizirajočih protiteles proti PEG v prvih 4 dneh izpostavitve zdravilu.
English: The median (range) dose was 37.3 (18; 66) IU/kg/injection.
Slovenian: Mediana odmerka (razpon) je bila 37,3 (18; 66) i.e./kg/injekcijo.
English: The rate of administration should be determined by the patient's comfort level (maximal rate of injection: 2.5 mL/min).
Slovenian: Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja: 2,5 ml/min).
English: Hemostasis during 20 major surgeries in 17 patients was evaluated in the surgery part.
Slovenian: Hemostaza med kirurškimi posegi je bila ocenjena pri 20 velikih kirurških posegih pri 17 bolnikih.
English: For prophylaxis the dose is 45-60 IU/kg every 5 days.
Slovenian: Odmerek za profilakso je 45 - 60 i.e./kg vsakih 5 dni.
English: Damoctocog alfa pegol does not contain von Willebrand factor.
Slovenian: Damoktokog alfa pegol ne vsebuje von Willebrandovega faktorja.
English: Each vial of Jivi contains nominally 250 or 500 or 1000 or 2000 or 3000 IU damoctocog alfa pegol.
Slovenian: Ena viala zdravila Jivi vsebuje nominalno 250 ali 500 ali 1000 ali 2000 ali 3000 i.e. damoktokog alfa pegola.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or preferably in IU (relative to an International Standard for factor VIII in plasma).
Slovenian: Aktivnost faktorja VIII v plazmi je izražena v odstotkih (glede na aktivnost v normalni humani plazmi) ali v mednarodnih enotah (i.e.) (glede na mednarodni standard za faktor VIII v plazmi).
English: Blood and lymphatic system disorders FVIII inhibition
Slovenian: Bolezni krvi in limfatičnega sistema inhibicija faktorja VIII
English: Data show that in the affected subjects, following discontinuation of Jivi, the anti-PEG IgM antibodies decreased in titre and became undetectable over time .
Slovenian: Podatki kažejo, da so se pri teh bolnikih po prekinitvi uporabe zdravila Jivi titri IgM protiteles proti PEG zmanjšali in sčasoma postali nezaznavni.
English: A field study has indicated that the factor VIII activity of Jivi can be accurately measured in plasma using either a validated chromogenic substrate (CS) assay or a one-stage (OS) clotting assay using specific reagents.
Slovenian: Študija na terenu je pokazala, da je mogoče aktivnost faktorja VIII zdravila Jivi natančno izmeriti v plazmi z metodo z validiranim kromogenim substratom (CS - chromogenic substrate) ali z enostopenjsko (OS - one-stage) metodo strjevanja krvi z uporabo specifičnih reagentov.
English: The PK data (based on chromogenic assay) indicated that Jivi has a reduced clearance (CL), resulting in a terminal half-life that is 1.4-fold longer and a dose normalized AUC which is 1.4-fold higher, as compared to the comparative factor VIII product.
Slovenian: Farmakokinetični podatki (pridobljeni s kromogeno metodo) kažejo, da ima zdravilo Jivi manjši očistek (CL) in posledično 1,4-krat daljši končni razpolovni čas ter 1,4-krat večji AUC normaliziran na odmerek, v primerjavi z drugim primerljivim zdravilom s faktorjem VIII.
English: A total of 20 major surgical procedures were performed and assessed in 17 patients.
Slovenian: Izvedli in ocenili so skupaj 20 velikih kirurških posegov pri 17 bolnikih.
English: No cross-reactivity of anti-PEG IgM antibodies with other unmodified factor VIII products was observed.
Slovenian: Navzkrižne reaktivnosti protiteles IgM proti PEG z drugimi nemodificiranimi zdravili s faktorjem VIII niso opazili.
English: Forty-two out of 110 in the prophylaxis arms (38.2%) experienced no bleeding episode.
Slovenian: Pri 42 od 110 preiskovancev (38,2 %), ki so prejemali profilakso, ni bilo krvavitve.
English: During the extension, 942 bleeds were treated with Jivi and 92.3% were controlled with 1 or 2 injections, thereof 83% with 1 injection.
Slovenian: V podaljšanju študije je bilo 942 krvavitev zdravljenih z zdravilom Jivi in 92,3 % jih je bilo obvladanih z 1 ali 2 injekcijama, od tega 83 % z 1 injekcijo.
English: Detailed instructions for preparation and administration are contained in the package leaflet provided with Jivi.
Slovenian: Podrobnejša navodila za pripravo in uporabo so v navodilu za uporabo, ki je priložen zdravilu Jivi.
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products.
Slovenian: Število danih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard SZO za zdravila s faktorjem VIII.
English: This medicine may be stored at room temperature (up to 25 °C) for up to 6 months when you keep it in its outer carton.
Slovenian: To zdravilo lahko shranjujete pri sobni temperaturi (do 25 °C) največ 6 mesecev, če ga hranite v zunanji ovojnini.
English: When using an in vitro activated partial thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay, which can result in over- or under-estimation of factor VIII activity.
Slovenian: Pri uporabi enostopenjske koagulacijske metode in vitro, ki temelji na aktiviranem parcialnem tromboplastinskem času (aPTČ; aPTT - activated partial thromboplastin time) za določanje aktivnosti faktorja VIII v vzorcih krvi bolnikov lahko na aktivnost plazemskega faktorja VIII bistveno vplivajo tako vrsta reagenta aPTČ kot referenčni standard, uporabljen v metodi, kar ima lahko za posledico previsoko ali prenizko ocenjeno aktivnost faktorja VIII.
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov proizvajalca biološke učinkovine (učinkovin)