FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to launch of Obizur in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: Pred prihodom zdravila OBIZUR na trg v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom dogovoriti s pristojnim nacionalnim organom glede vsebine in oblike izobraževalnega programa, vključno s komunikacijskimi mediji, načini distribucije in z vsemi ostalimi vidiki programa.
English: • An on-line video to further elaborate on the required calculation and administration of the drug
Slovenian: • Spletni videoposnetek za nadaljnje pojasnilo glede predpisanega izračuna in dajanja zdravila.
English: It is recommended that treatment should be based on clinical judgement and not based on detection of inhibitory antibodies by the Bethesda assay.
Slovenian: Priporočljivo je, da zdravljenje temelji na klinični presoji in ne na detektiranju inhibitornih protiteles s testom Bethesda.
English: Development of inhibitory antibodies
Slovenian: Pojav inhibitornih protiteles
English: The European Medicines Agency has waived the obligation to submit the results of studies with OBIZUR in all subsets of the paediatric population in treatment of acquired haemophilia (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom OBIZUR za vse podskupine pediatrične populacije za zdravljenje pridobljene hemofilije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: What you need to know before you use OBIZUR
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo OBIZUR
English: One pack of OBIZUR contains 1, 5 or 10 each of the following
Slovenian: Eno pakiranje zdravila OBIZUR vsebuje 1, 5 ali 10 kosov naslednjega:
English: The dose, frequency, and duration of the therapy with OBIZUR depend on the location, extent and severity of the bleeding episode, target Factor VIII activity, and on the patient´s clinical condition.
Slovenian: Odmerek, pogostnost in trajanje zdravljenja z zdravilom OBIZUR so odvisni od mesta, obsega in resnosti krvavitve, ciljne aktivnosti faktorja VIII in kliničnega stanja bolnika.
English: It requires clinical supervision of the bleeding status of the patient.
Slovenian: Zahteva klinični nadzor nad stanjem hemostaze bolnika.
English: What OBIZUR is and what it is used for
Slovenian: Kaj je zdravilo OBIZUR in za kaj ga uporabljamo
English: The BHK cells are cultured in media that contains fetal bovine serum.
Slovenian: Celice BHK se gojijo v gojišču, ki vsebuje fetusni serum goveda.
English: High and sustained Factor VIII activity in blood may predispose to thromboembolic events.
Slovenian: Visoke in ohranjene ravni aktivnosti faktorja VIII v krvi lahko morda vplivajo na pojav trombembolitičnih zapletov.
English: One Unit (U) of Factor VIII activity is equivalent to that quantity of Factor VIII in one ml of normal human plasma.
Slovenian: Ena enota (e.) aktivnosti faktorja VIII ustreza količini faktorja VIII v enem ml normalne humane plazme.
English: Therefore, OBIZUR must only be administered when considered clinically necessary.
Slovenian: Zato je treba zdravilo OBIZUR uporabljati le, ko se presodi, da je to klinično nujno.
English: OBIZUR is not currently approved for treatment of patients under 18 years of age, in whom acquired haemophilia is rare.
Slovenian: Zdravilo OBIZUR trenutno ni dovoljeno za zdravljenje bolnikov, mlajših od 18 let starosti, pri katerih je pridobljena hemofilija redka.
English: OTHER Baxalta Logo
Slovenian: Logotip Baxalta
English: Known anaphylactic reactions to the active substance, hamster protein, or to any of the excipients listed in section 6.1.
Slovenian: Znana anafilaktična reakcija na učinkovino, beljakovine hrčka ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Do not use OBIZUR: - if you are allergic to susoctocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hamster proteins (trace amounts may be present in Obizur arising from the manufacturing process)
Slovenian: Ne uporabljajte zdravila OBIZUR: - če ste alergični na susoktokog alfa ali katero koli sestavino tega zdravila (navedeno v poglavju 6), - če ste alergični na beljakovine hrčka (v zdravilu OBIZUR so lahko prisotne v sledovih zaradi postopka izdelave).
English: The safety and efficacy of OBIZUR for the treatment of serious bleeding episodes in subjects with acquired haemophilia with autoimmune inhibitory antibodies to human Factor VIII was investigated in a prospective, non-randomised, open-label trial of 28 subjects (18 Caucasian, 6 Black, and 4 Asian).
Slovenian: Varnost in učinkovitost zdravila OBIZUR za zdravljenje epizod hudih krvavitev pri preiskovancih s pridobljeno hemofilijo z avtoimunskimi inhibitornimi protitelesi proti humanemu faktorju VIII so raziskali v prospektivnem, nerandomiziranem, neslepem preskušanju pri 28 preiskovancih (18 belcih, 6 temnopoltih in 4 Azijcih).
English: These autoantibodies neutralize circulating human Factor VIII thus creating a deficiency of available Factor VIII.
Slovenian: Ta avtoprotitelesa nevtralizirajo krožeči humani faktor VIII in s tem povzročijo pomanjkanje razpoložljivega faktorja VIII.
English: • Large sterile syringe to contain the final volume of reconstituted product
Slovenian: • veliko, sterilno brizgo za prenos končnega volumna rekonstituiranega zdravila.
English: The specific activity of OBIZUR is approximately 10,000 U/mg protein.
Slovenian: Specifična aktivnost zdravila OBIZUR je približno 10.000 e./mg beljakovin.
English: The number of units of Factor VIII administered is expressed in Units (U) that are derived from an in-house standard that has been calibrated with the current WHO standard for Factor VIII products.
Slovenian: Število danih enot faktorja VIII je izraženo v enotah (e.), ki se nanašajo na interni standard, ki je bil kalibriran s trenutnim standardom SZO za zdravila s faktorjem VIII.
English: Remove the plastic package (Figure E).
Slovenian: Odstranite plastično ovojnino (slika E).
English: Type of Bleeding Target Factor VIII Trough Activity (Units per dL or % of normal)
Slovenian: Vrsta krvavitve Najnižja ciljna aktivnost faktorja VIII (enot na dl ali % normalne vrednosti)
English: The median number of daily infusions per subject was 1.76 (range: 0.2 to 5.6).
Slovenian: Mediana števila dnevnih infundiranj na preiskovanca je bila 1,76 (razpon: od 0,2 do 5,6).
English: Measurement of Factor VIII activity must always be carried out using the same assay methodology on any one patient.
Slovenian: Zato je treba meritve aktivnosti faktorja VIII pri vsakem bolniku vedno opravljati z isto testno metodologijo.
English: - The solvent is 1 ml sterilised water for injections.
Slovenian: - Vehikel je 1 ml sterilizirane vode za injekcije.
English: Common side effects (may affect up to 1 in 10 people) - Development of antibodies against the medicine
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): - Pojav protiteles proti zdravilu.
English: A total of 24/28 (86%) had successful control (resolution) of the initial bleeding episode.
Slovenian: Prvotno krvavitev so uspešno obvladali pri skupno 24/28 (86 %) preiskovancih.
English: OBIZUR (antihaemophilic Factor VIII (recombinant), porcine sequence) is a purified protein that has 1448 amino acids with an approximate molecular mass of 175kDa.
Slovenian: Zdravilo OBIZUR (antihemofilni faktor VIII (rekombinantni), iz prašičjega zaporedja) je prečiščena beljakovina iz 1448 aminokislin s približno molekulsko maso 175 kDa.
English: • Do not administer OBIZUR in the same tubing or container with other medicinal products for injection.
Slovenian: • Zdravila OBIZUR ne smete dajati v cevje ali vsebnik, ki vsebuje drugo zdravilo za injiciranje.
English: Your doctor will check your blood Factor VIII to confirm that enough Factor VIII is being given to you.
Slovenian: Zdravnik bo morda določil faktorja VIII v vaši krvi, da preveri, ali prejemate zadostno količino faktorja VIII.
English: If you forget to use OBIZUR
Slovenian: Če ste pozabili uporabiti zdravilo OBIZUR
English: One, five, ten pre-filled syringes with solvent One, five, ten vial adapters
Slovenian: Ena, pet, deset napolnjenih injekcijskih brizg z vehiklom En, pet, deset nastavkov za vialo
English: To collect and analyse immediate and long-term data on clinical efficacy and safety of all patients with acquired haemophilia and who are treated with Obizur, the MAH must conduct a surveillance programme/ registry according to an agreed protocol and for an indefinite time.
Slovenian: Imetnik dovoljenja za promet z zdravilom mora, da bi zbral in analiziral takojšnje in dolgoročne podatke o klinični učinkovitosti in varnosti pri vseh bolnikih s pridobljeno hemofilijo in ki se zdravijo z zdravilom OBIZUR, v skladu s potrjenim protokolom in za nedoločen čas izvajati program za nadzor/register.
English: The mean half-life of OBIZUR in nine evaluable subjects in the bleeding state was (about) 10 hours (range 2.6 to 28.6 hours).
Slovenian: Povprečna razpolovna doba zdravila OBIZUR pri devetih ocenljivih preiskovancih, ki so krvaveli, je bila (približno) 10 ur (v razponu od 2,6 do 28,6 ur).
English: The required initial dose of OBIZUR for a patient is calculated using the following formula:
Slovenian: Potreben začetni odmerek zdravila OBIZUR za bolnika izračunate z naslednjo enačbo:
English: It is produced by recombinant DNA (rDNA) technology in baby hamster kidney (BHK) cells.
Slovenian: Izdelano je s tehnologijo rekombinantne DNA (rDNA) v ledvičnih celicah mladiča hrčka (BHK - baby hamster kidney).
English: OBIZUR has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo OBIZUR nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The procedures below are provided as general guidelines for the preparation and reconstitution of OBIZUR.
Slovenian: Postopki v nadaljevanju so splošne smernice za pripravo in rekonstitucijo zdravila OBIZUR.
English: OBIZUR temporarily replaces the inhibited endogenous Factor VIII that is needed for effective haemostasis.
Slovenian: Zdravilo OBIZUR začasno nadomesti zavrti endogeni faktor VIII, ki je potreben za učinkovito hemostazo.
English: Talk to your doctor if you have had a cardiovascular disease in the past or if you have a known risk of thrombosis (diseases from blood clots in normal vasculature), because the possiblity of developing thromboembolic diseases at high and sustained blood Factor VIII levels cannot be excluded.
Slovenian: Posvetujte se z zdravnikom, če ste kadar koli imeli srčno-žilno bolezen ali če imate dokazano tveganje tromboze (bolezni zaradi krvnih strdkov v normalnem ožilju), ker obstaja možnost pojava trombemboličnih bolezni v prisotnosti visokih in ohranjenih ravni faktorja VIII.
English: After reconstitution the solution should be clear and colourless.
Slovenian: Po rekonstituciji mora biti raztopina bistra in brezbarvna.
English: Of these 11 subjects, eight had eventual successful treatment (73%).
Slovenian: Pri osmih (73 %) od omenjenih 11 preiskovancev je bilo zdravljenje na koncu uspešno.
English: The median dose per injection to successfully treat the primary bleed was 133 U/kg and the median total dose was 1523 U/kg for a median of 6 days.
Slovenian: Mediana vrednost odmerka na injiciranje pri uspešno zdravljenih primarnih krvavitvah je bila 133 e./kg, mediana skupnega odmerka pa 1523 e./kg pri mediani trajanja 6 dni.
English: The bleeding will usually respond within the first 24 hours, your doctor will adjust the dose and duration of OBIZUR until the bleeding stopped.
Slovenian: Krvavitev se običajno odzove v prvih 24 urah, nato bo zdravnik prilagodil odmerek in trajanje uporabe zdravila OBIZUR, dokler krvavitev ne preneha.
English: Usually, the replacement therapy with OBIZUR is a temporary treatment until bleeding is resolved or the antibodies against your own Factor VIII are eradicated.
Slovenian: Običajno je nadomestno zdravljenje z zdravilom OBIZUR začasno, dokler krvavitev ne preneha ali protitelesa proti lastnemu faktorju VIII ne izginejo.
English: • Calculated number of powder vials
Slovenian: • izračun števila vial s praškom,
English: Although factor VIII activity determined by the chromogenic assay is generally lower than the Factor VIII activity determined by the one-stage clotting assay, post-infusion Factor VIII activities in patients with acquired haemophilia in clinical study OBI-1-301 tended to be higher when determined with the chromogenic assay than with the one-stage clotting assay (see section 4.4).
Slovenian: Čeprav je aktivnost faktorja VIII, ki je določena s kromogenim testom običajno nižja kot aktivnost faktorja VIII, ki je določena z enostopenjskim koagulacijskim testom, je bila aktivnost faktorja VIII pri bolnikih s pridobljeno hemofilijo v klinični študiji OBI-1-301 takoj po infuziji običajno višja pri merjenju s kromogenim testom kot pa pri enostopenjskem koagulacijskem testu (glejte poglavje 4.4)
English: You should be aware of the early signs of allergic reactions (see section 4 for signs and symptoms).
Slovenian: Obstaja majhna verjetnost, da bi lahko pri vas nastopila alergijska reakcija na zdravilo OBIZUR, zato morate poznati zgodnje znake alergijskih reakcij, (glede znakov in simptomov glejte poglavje 4).
English: Three of the five subjects had no detectable anti-porcine Factor VIII titres post-treatment (< 0.6 BU/mL based on the last reported result), two subjects had a detectable anti-porcine Factor VIII titre (≥ 0.6 BU/mL).
Slovenian: Trije od petih preiskovancev niso imeli zaznavnih titrov inhibitorjev proti prašičjemu faktorju VIII po zdravljenju (<0,6 BU/ml na osnovi zadnjega opravljenega testa), dva preiskovanca sta imela zaznaven titer inhibitorjev proti prašičjemu faktorju VIII (≥0,6 BU/ml).
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Slovenian: Bolnike morate poučiti o zgodnjih znakih preobčutljivostnih reakcij, med katere sodijo koprivnica, generalizirana urtikarija, tiščanje v prsnem košu, piskanje v pljučih, hipotenzija in anafilaksija.
English: Titrate subsequent doses based on clinical response and to maintain target Factor VIII trough activity
Slovenian: Titracija naslednjih odmerkov na osnovi kliničnega odziva in za ohranjanje najmanjše ciljne aktivnosti faktorja VIII
English: Of those subjects treated with OBIZUR as first-line therapy, defined as no immediate previous use of anti-haemorrhagic agents prior to the first OBIZUR treatment, 16/17 (94%) had eventual treatment success reported.
Slovenian: Od preiskovancev, zdravljenih z zdravilom OBIZUR kot prvo izbiro, kar je bilo opredeljeno kot odsotnost neposredne predhodne uporabe antihemoragikov pred prvim zdravljenjem z zdravilom OBIZUR, je bilo uspešno zdravljenih 16/17 (94 %) preiskovancev.
English: The potency (U) is determined using the one-stage coagulation assay (OSCA).
Slovenian: Jakost (e.) se določa z enostopenjskim koagulacijskim testom (OSCA - one-stage coagulation assay).
English: The total volume of reconstituted OBIZUR should be administered at a rate of 1 to 2 mL per minute.
Slovenian: Skupni volumen uporabljenega rekonstituiranega zdravila OBIZUR se daje s hitrostjo od 1 do 2 ml na minuto.
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) are possible and may progress to severe anaphylaxis (including shock) (see section 4.4).
Slovenian: Možne so preobčutljivostne ali alergijske reakcije (med katere sodijo angioedem, pekoč občutek in zbadanje na mestu vboda, mrzlica, vročinski oblivi, generalizirana urtikarija, glavobol, koprivnica, hipotenzija, letargija, siljenje na bruhanje, nemirnost, tahikardija, tiščanje v prsih, mravljinčenje, bruhanje, piskajoče dihanje), ki lahko napredujejo do hude anafilakse (vključno s šokom) (glejte poglavje 4.4).
English: Once bleeding has responded, usually within the first 24 hours, continue OBIZUR with a dose that maintains the trough FVIII activity at 30-40% until bleeding is controlled.
Slovenian: Ko se krvavitev odzove, ponavadi v prvih 24 urah, nadaljujte z odmerkom zdravila OBIZUR, ki ohranja najmanjšo aktivnost faktorja VIII pri 30-40 %, dokler krvavitve ne obvladate.
English: The trial included subjects presenting with life and / or limb threatening bleeding requiring hospitalisation.
Slovenian: Med preskušanjem so preiskovanci imeli krvavitve, ki so ogrožale življenje in/ali okončine in so zahtevale hospitalizacijo.
English: Therefore, OBIZUR should be used during pregnancy and lactation only if clearly indicated.
Slovenian: Zdravilo OBIZUR lahko med nosečnostjo in v obdobju dojenja uporabljate le, če je jasno indicirano.
English: Dose (U/kg)
Slovenian: Odmerek (e./kg)
English: Monitor Factor VIII activity and clinical condition 30 minutes after the first injection and 3 hours after administering OBIZUR.
Slovenian: Aktivnost faktorja VIII in klinično stanje preverite 30 minut po prvem injiciranju in 3 ure po dajanju zdravila OBIZUR.
English: The MAH shall ensure that in each Member State where Obizur is marketed, all healthcare professionals who are expected to prescribe and dispense Obizur have access to/are provided with the following educational package:
Slovenian: Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da imajo v vsaki državi članici, kjer se trži zdravilo OBIZUR, zdravstveni delavci, ki bodo predpisovali in izdajali zdravilo OBIZUR, dostop do izobraževalnega paketa oziroma jim je na voljo:
English: Subjects were in a non-bleeding state.
Slovenian: Preiskovanci niso krvaveli.
English: Inhibitor titres of up to 29 Bethesda units were recorded at baseline yet subjects responded positively to OBIZUR.
Slovenian: Čeprav so imeli preiskovanci v izhodišču titre inhibitorjev do 29 enot Bethesda, so se na zdravilo OBIZUR odzvali pozitivno.
English: Wipe the rubber stopper with an alcohol swab (not supplied) and allow it to dry prior to use.
Slovenian: Gumijasti zamašek prebrišite z alkoholno krpico (ni priložena) in počakajte, da se osuši.
English: The mean recovery rate after the initial dose of 200 U/kg was 1.06 ± 0.75 U/ml per U/kg (range 0.10-2.61) measured with the one stage coagulation assay.
Slovenian: Povprečna hitrost obnovitve po začetnem odmerku 200 e./kg je bila 1,06 ± 0,75 e./ml na e./kg (razpon 0,10-2,61), izmerjena z enostopenjskim koagulacijskim testom.
English: 6.6 Special precautions for disposal and other handling After reconstitution, the solution is clear, colourless, free from particles and has a pH of 6.8 to 7.2.
Slovenian: Raztopina je po rekonstituciji bistra, brezbarvna, brez delcev z vrednostjo pH med 6,8 in 7,2.
English: Your doctor will measure your Factor VIII activity regularly to decide the subsequent dose and frequency of OBIZUR.
Slovenian: Zdravnik bo redno meril aktivnost faktorja VIII pri vas, da bo določil naslednji odmerek in pogostnost uporabe zdravila OBIZUR.
English: • Same number of 1 mL solvent syringes and sterile vial adapters
Slovenian: • enako število 1 ml injekcijskih brizg z vehiklom in sterilnih nastavkov za viale,
English: Experience regarding the use of OBIZUR during pregnancy and breast-feeding is not available.
Slovenian: Izkušenj z uporabo zdravila OBIZUR med nosečnostjo in v obdobju dojenja ni.
English: Mild and moderate superficial muscle/no neurovascular compromise and joint bleeding
Slovenian: Blaga do zmerna krvavitev iz površinske mišice / brez nevromuskularne kompromitiranosti in krvavitev iz sklepov
English: The recommended initial dose is 200 U per kilogram bodyweight, given by intravenous injection (see section 6.6).
Slovenian: Priporočeni začetni odmerek je 200 e. na kilogram telesne mase z intravenskim injiciranjem (glejte poglavje 6.6).
English: Using aseptic technique, administer using the following procedure:
Slovenian: Med naslednjim postopkom dajanja uporabljajte aseptično tehniko:
English: - Swelling of lips and tongue - Burning and stinging at the injection site - Chills, flushing - Hives, generalised itching - Headache, low blood pressure - Lethargy, sickness, restlessness - Rapid beating of the heart, tightness of the chest - Tingling, vomiting - Wheezing
Slovenian: - otekanje ustnic in jezika, - pekoč občutek in zbadanje na mestu injiciranja, - mrzlica, vročinski oblivi, - koprivnica, generalizirano srbenje, - glavobol, nizek krvni tlak, - zaspanost (letargija), slabost, nemirnost, - hiter srčni utrip, tiščanje v prsih, - mravljinčenje, bruhanje, - piskanje v pljučih.
English: Circulating antibodies (inhibitors) targeted against human Factor VIII have minimal or no cross reactivity against OBIZUR.
Slovenian: Krožeča protitelesa (inhibitorji), usmerjena proti humanemu faktorju VIII, imajo minimalno navzkrižno reaktivnost za zdravilo OBIZUR ali pa sploh nobene.
English: Three subjects included in pharmacokinetic analysis had a detectable anti-porcine factor VIII inhibitor titre at baseline (≥ 0.6 Bethesda Units (BU)/mL).
Slovenian: Trije preiskovanci, vključeni v farmakokinetično analizo, so imeli zaznavne titre inhibitorjev proti prašičjemu faktorju VIII v izhodišču (≥0,6 enot Bethesda (BU - Bethesda Units)/ml).
English: What OBIZUR looks like and contents of the pack One pack contains 1, 5 or 10 of the following: - glass vial of OBIZUR 500 U white, friable powder with a rubber stopper and a flip-off seal - pre-filled glass syringe of 1 ml sterilised water for injections with a rubber tip cap and a Luer
Slovenian: Eno pakiranje vsebuje 1, 5 ali 10 kosov naslednjega: - steklena viala z zdravilom OBIZUR 500 e, belim, drobljivim praškom, in gumijastim zamaškom ter snemno ploščico, - napolnjena steklena injekcijska brizga z 1 ml sterilizirane vode za injekcije z gumijasto zaporko konice in Luer Lock nastavkom, - pretočni komplet z vgrajeno plastično konico.
English: 10000 133.3 N/A 4.2 0.75 178 1583 1686 Amax = maximum observed % activity; AUC0-t = area under the concentration-time curve from time 0 to the last measurable concentration; AUC0-∞ = area under the concentration-time curve from time 0 extrapolated to infinity; t½ = terminal half-life; Tmax = time of maximum observed % activity, N/A = not available.
Slovenian: Amax = največja ugotovljena aktivnost v %; AUC0-t = površina pod krivuljo koncentracija-čas od časa 0 do zadnje merljive koncentracije; AUC0-∞ = površina pod krivuljo koncentracija-čas od časa 0 do neskončnosti; t½ = končna razpolovna doba; Tmax = čas do največje zabeležene aktivnosti v %, n/v = ni na voljo.
English: Driving and using machines OBIZUR has no influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo OBIZUR nima vpliva na sposobnost vožnje in upravljanja strojev.
English: If you are not sure, talk to your doctor before using this medicine.
Slovenian: Če ste negotovi, se pred začetkom uporabe posvetujte z zdravnikom.
English: Inhibitory antibodies against OBIZUR were measured using a modification of the Nijmegen variation of the Bethesda assay method.
Slovenian: Inhibitorna protitelesa proti zdravilu OBIZUR so bila izmerjena z modifikacijo različice Nijmegen, testa Bethesda.
English: OBIZUR restores this missing Factor VIII activity and helps blood to form clots at the site of bleeding.
Slovenian: Zdravilo OBIZUR obnovi odsotno aktivnost faktorja VIII in pripomore k strjevanju krvi na mestu krvavitve.
English: The physician educational material should contain:
Slovenian: • Izobraževalno gradivo za zdravnike Izobraževalno gradivo za zdravnike mora vsebovati:
English: To be taken into consideration by patients on a controlled sodium diet.
Slovenian: To morajo upoštevati bolniki, ki imajo dieto z nizkim vnosom natrija.