FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity to the active substance (recombinant human coagulation factor IX, and/or Fc domain) or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino (rekombinantni humani koagulacijski faktor IX in/ali domeno Fc) ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dL) x {reciprocal of observed recovery (IU/kg per IU/dL)}
Slovenian: Potrebno število enot = telesna masa (kg) x želeni dvig faktorja IX (%) (i.e./dl) x {recipročna vrednost opaženemu porastu (i.e./kg na i.e./dl)}
English: • 50 IU/kg once weekly, adjust dose based on individual response or
Slovenian: • 50 i.e./kg enkrat na teden, odmerek se prilagodi glede na bolnikov odziv ali
English: Hold the vial adapter in its protective cap and place it squarely over the top of the vial.
Slovenian: Nastavek za vialo držite v zaščitnem ovoju in ga položite pravokotno na vrh viale.
English: The procedure below describes the preparation and administration of ALPROLIX.
Slovenian: Spodnji postopek opisuje pripravo in injiciranje zdravila ALPROLIX.
English: Excipient with known effect: 0.3 mmol (6.4 mg) sodium per vial.
Slovenian: 0,3 mmol (6,4 mg) natrija na vialo.
English: Because of the potential risk of thrombotic complications with factor IX products, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to newborn infants, or to patients at risk of thrombotic phenomena or disseminated intravascular coagulation (DIC).
Slovenian: Zaradi morebitnega tveganja trombotičnih zapletov z zdravili, ki vsebujejo faktor IX, je potreben klinični nadzor zgodnjih znakov trombotične in porabnostne koagulopatije z ustreznim biološkim testiranjem, če to zdravilo dajemo bolnikom z boleznijo jeter, bolnikom po kirurškem posegu, novorojenčkom ali bolnikom s tveganjem trombotičnih pojavov ali diseminirane intravaskularne koagulacije (DIK).
English: Cmax (IU/dL)
Slovenian: Cmax (i.e./dl)
English: The median time on Study II+III was 2.88 years and median number of exposure days was 166.
Slovenian: 2,88 leta, mediana števila dni izpostavljenosti pa 166.
English: Other medicines and ALPROLIX
Slovenian: Druga zdravila in zdravilo ALPROLIX
English: For children below the age of 12 years, higher or more frequent doses may be required and the recommended starting dose is 50-60 IU/kg every 7 days.
Slovenian: Za otroke, stare manj kot 12 let, bodo morda potrebni večji ali pogostejši odmerki, priporočeni začetni odmerek pa je 50-60 i.e./kg vsakih 7 dni.
English: With the exception of one patient whose last prescribed dose was 100 IU/kg every 5 days, the other 29 patients last prescribed doses were up to 70 IU/kg every 7 days.
Slovenian: Z izjemo enega bolnika z zadnjim predpisanim odmerkom 100 i.e./kg vsakih 5 dni so bili zadnji predpisani odmerki pri ostalih 29 bolnikih do 70 i.e./kg vsakih 7 dni.
English: Pharmacokinetic parameters1
Slovenian: FK parametri1
English: The total dose on the day of surgery ranged from 49 to 341 IU/kg and the total dose in the 14 day perioperative period ranged from 60 to 1947 IU/kg.
Slovenian: Razpon skupnega odmerka na dan kirurškega posega je bil od 49 do 341 i.e./kg, razpon skupnega odmerka v 14-dnevnem perioperativnem obdobju pa od 60 do 1947 i.e./kg.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodiumfree”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na vialo, kar v bistvu pomeni ‘brez natrija'.
English: Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor IX in plasma).
Slovenian: Aktivnost faktorja IX v plazmi izražamo bodisi v odstotkih (glede na normalno humano plazmo) bodisi v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor IX activity in patients' blood samples, plasma factor IX activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Slovenian: Pri uporabi enostopenjskega testa strjevanja in vitro na osnovi tromboplastinskega časa (aPTČ) za določanje aktivnosti faktorja IX v krvnih vzorcih bolnikov lahko na rezultate aktivnosti faktorja IX v plazmi bistveno vplivata vrsta uporabljenega reagenta aPTČ in referenčni standard.
English: Median annualised bleeding rates in subjects <12 years of age evaluable for efficacy were 1.97 (interquartile range 0.00-3.13) in Study II and remained similar throughout Study III (extension study).
Slovenian: Mediana letnega deleža krvavitev pri preizkušancih < 12 let, pri katerih je bilo mogoče oceniti učinkovitost, je bila 1,97 (interkvartilni razpon 0,00-3,13) v študiji II in je ostala podobna v študiji III (podaljšana študija).
English: The effects of higher than recommended doses of ALPROLIX have not been characterised.
Slovenian: Učinki odmerkov zdravila ALPROLIX, ki bi presegali priporočene odmerke, niso bili ugotovljeni.
English: ALPROLIX increases factor IX level in the blood and temporarily corrects the bleeding tendency.
Slovenian: Zdravilo ALPROLIX zvišuje ravni faktorja IX v krvi in začasno popravi nagnjenost h krvavitvam.
English: Pharmacokinetic parameters of the non-compartmental analysis after 50 IU/kg dose of ALPROLIX are presented in Table 3.
Slovenian: Farmakokinetični parametri neprostorske analize po odmerku 50 i.e./kg zdravila ALPROLIX so predstavljeni v preglednici 3.
English: One International Unit (IU) of recombinant factor IX Fc activity is equivalent to that quantity of factor IX in one mL of normal human plasma.
Slovenian: Ena mednarodna enota (i.e.) aktivnosti rekombinantnega faktorja IX Fc ustreza količini faktorja IX v enem mililitru normalne humane plazme.
English: • Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive, as there can be several reasons for this.
Slovenian: • Če menite, da vaša krvavitev z odmerkom, ki ga prejemate, ni pod nadzorom, se posvetujte z zdravnikom, saj je razlogov za to lahko več.
English: Study II enrolled a total of 30 previously treated male paediatric patients with severe hemophilia B (≤2% endogenous FIX activity).
Slovenian: V študijo II je bilo skupaj vključenih 30 predhodno zdravljenih pediatričnih bolnikov moškega spola s hudo hemofilijo B (≤ 2 % endogene aktivnosti FIX).
English: Name and address of the manufacturer(s) of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine
English: The study enrolled a total of 123 previously treated male patients (12 to 71 years of age) with severe haemophilia B (≤2% endogenous FIX activity).
Slovenian: V študijo je bilo skupaj vključenih 123 predhodno zdravljenih bolnikov moškega spola (starih 12 do 71 let) s hudo hemofilijo B (≤ 2 % endogene aktivnosti FIX).
English: The number of units of recombinant factor IX Fc administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Slovenian: Število danih enot rekombinantnega faktorja IX Fc je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard WHO za zdravila s faktorjem IX.
English: Table 1: Guide to ALPROLIX dosing for treatment of bleeding episodes and surgery
Slovenian: Preglednica 1: Vodilo za odmerjanje zdravila ALPROLIX za zdravljenje krvavitev in pri kirurških posegih
English: The potency (International Units) is determined using the European Pharmacopoeia one stage clotting test against an in-house standard that is referenced to the WHO factor IX standard.
Slovenian: Jakost (mednarodne enote) je določena s pomočjo enostopenjskega testa strjevanja krvi po Evropski farmakopeji v primerjavi z internim standardom, ki temelji na standardu WHO za faktor IX.
English: The powder for injection in each vial must be reconstituted with the supplied solvent (sodium chloride solution) from the pre-filled syringe using the sterile vial adapter for reconstitution.
Slovenian: Prašek za injiciranje v vsaki viali je treba rekonstituirati s priloženim vehiklom (raztopina natrijevega klorida) iz napolnjene injekcijske brizge s pomočjo sterilnega nastavka viale za rekonstitucijo.
English: ALPROLIX should be administered using the infusion set (E) provided in this pack.
Slovenian: Zdravilo ALPROLIX se daje z uporabo infuzijskega kompleta (E), priloženega v pakiranju.
English: • 100 IU/kg once every 10 days, adjust interval based on individual response.
Slovenian: • 100 i.e./kg enkrat vsakih 10 dni, presledek prilagodite glede na bolnikov odziv.
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter -site blood clots should be considered.
Slovenian: Če potrebujete centralni venski kateter (CVK), morate upoštevati možnost zapletov, povezanih s CVK, vključno z lokalnimi okužbami, prisotnostjo bakterij v krvi in krvnih strdkov na mestu katetrizacije.
English: All of the 30 patients were treated with ALPROLIX on a prophylactic dosing regimen starting with 50-60 IU/kg every 7 days, with adjustment of dose to a maximum of 100 IU/kg and dosing interval to a minimum of once weekly and a maximum of twice weekly.
Slovenian: Vseh 30 bolnikov so zdravili z zdravilom ALPROLIX z režimom profilaktičnega odmerjanja z začetnim odmerkom 50-60 i.e./kg vsakih 7 dni, pri čemer so odmerek prilagodili na največ 100 i.e./kg, interval odmerjanja pa na vsaj enkrat na teden in največkrat dvakrat na teden.
English: 144h 168h 192h 240 h 288 h
Slovenian: minut 1 ura 3 ure 6 ur 24 ur 48 ur 96 ur 144 ur 168 ur 192 ur 240 ur 288 ur n/v n/v 77,1
English: The median average weekly dose of ALPROLIX was 59.40 IU/kg (interquartile range, 52.95 to 64.78 IU/kg) for subjects <6 years of age and 57.78 IU/kg (interquartile range, 51.67 to 65.01 IU/kg) for subjects 6 to <12 years of age.
Slovenian: Mediana povprečnega tedenskega odmerka zdravila ALPROLIX je bila 59,40 i.e./kg in (interkvartilni razpon 52,95 do 64,78 i.e./kg) za bolnike < 6 let starosti in 57,78 i.e./kg (interkvartilni razpon 51,67 do 65,01 i.e./kg) za bolnike od 6 do < 12 let starosti.
English: ALPROLIX should be injected intravenously over several minutes.
Slovenian: Zdravilo ALPROLIX se injicira intravensko nekaj minut.
English: • The active substance is eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion protein).
Slovenian: • Učinkovina je eftrenonakog alfa (rekombinantni koagulacijski faktor IX, fuzijska beljakovina Fc).
English: Non-clinical data reveal no special hazard for humans based on thrombogenicity test in rabbits (Wessler stasis model) and repeated dose toxicity studies (which included assessment of local toxicity, male reproductive organs and electrocardiographic parameters) in rats and monkeys.
Slovenian: Predklinični podatki na osnovi testa trombogenosti pri kuncih (Wesslerjev model staze) in toksičnosti pri ponavljajočih odmerkih pri podganah in opicah (to vključuje oceno lokalne toksičnosti, moških reprodukcijskih organov in elektrokardiografskih parametrov) ne kažejo posebnega tveganja za človeka.
English: The median average dose per injection to maintain hemostasis during surgery was 94.7 IU/kg (range: 49 to 152 IU/kg).
Slovenian: Mediana povprečnega odmerka na injekcijo za ohranitev hemostaze med kirurškim posegom je bila 94,7 i.e./kg (razpon: 49 do 152 i.e./kg).
English: Subjects had a median of 0.38 (IQR: 0.00-1.43) spontaneous joint bleeds in Study III.
Slovenian: Osebe so imele v študiji III mediano 0,38 (IQR: 0,00-1,43) spontanih krvavitev v sklepih.
English: ALPROLIX is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia B (inherited bleeding disorder caused by factor IX deficiency).
Slovenian: Zdravilo ALPROLIX se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih vseh starostnih skupin s hemofilijo B (dedna motnja strjevanja krvi zaradi pomanjkanja faktorja IX).
English: Common side effects (may affect up to 1 in 10 people): headache, mouth numbness or tingling, pain in your side with blood in your urine (obstructive uropathy).
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov): glavobol, otrplost ali mravljinčenje ust, bočna bolečina s krvjo v urinu (obstruktivna uropatija).
English: • The other ingredients are sucrose, L-Histidine, mannitol, polysorbate 20, sodium hydroxide and hydrochloric acid.
Slovenian: • Druge sestavine zdravila so saharoza, L-histidin, manitol, polisorbat 20, natrijev hidroksid in klorovodikova kislina.
English: A total of 35 major surgical procedures were performed and assessed in 22 subjects (21 adults and adolescents, and 1 paediatric patient <12 years of age) in Study I and Study III.
Slovenian: Perioperativno obvladovanje (kirurška profilaksa): Pri 22 osebah (21 odraslih in mladostnikov in 1 pediatrični bolnik < 12 let starosti) v študiji I in v študiji III
English: Powder: sucrose, L-histidine, mannitol, polysorbate 20, sodium hydroxide, hydrochloric acid
Slovenian: Prašek: saharoza, L-histidin, manitol polisorbat 20, natrijev hidroksid, klorovodikova kislina
English: Open the infusion set package and remove the cap at the end of the tubing.
Slovenian: Odprite pakiranje z infuzijskim kompletom in odstranite pokrovček na koncu cevke.
English: You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, general feeling of being unwell, nausea, restlessness, fast heartbeat, and low blood pressure.
Slovenian: Takoj se posvetujte z zdravnikom, če se pojavijo kateri od naslednjih simptomov alergijskih reakcij: oteklost obraza, izpuščaj, generalizirano srbenje, koprivnica, stiskanje v prsnem košu, težave z dihanjem, pekoč občutek in zbadanje na mestu injiciranja, mrzlica, vročinski oblivi, glavobol, splošno slabo počutje, siljenje na bruhanje, nemir, hiter srčni utrip in nizek krvni tlak.
English: Swedish Orphan Biovitrum AB (publ) Strandbergsgatan 49
Slovenian: Swedish Orphan Biovitrum AB (publ) Strandbergsgatan 49 11276 Stockholm Švedska
English: A population pharmacokinetic model was developed based on FIX activity data from 161 subjects of all ages (2-76 years of age) weighing between 12.5 kg to 186.7 kg in three clinical studies (12 subjects in a phase 1/2a study, 123 subjects in study I and 26 subjects in study II).
Slovenian: 161 preizkušancev vseh starosti (2-76 let) s telesno maso od 12,5 kg do 186,7 kg v treh kliničnih študijah (12 preizkušancev v študiji faze 1/2a, 123 preizkušancev v študiji I in 26 preizkušancev v študiji II).
English: If you stop using ALPROLIX
Slovenian: Če ste prenehali uporabljati zdravilo ALPROLIX
English: Table 4: The Observed Mean (SD) FIX activity [IU/dL] following a single dose of ALPROLIX1 for patients
Slovenian: Preglednica 4: Opažena povprečna (SD) aktivnost FIX [i.e./dl] po enem odmerku zdravila ALPROLIX1 pri bolnikih starosti ≥ 12 let
English: If you forget to use ALPROLIX
Slovenian: Če ste pozabili uporabiti zdravilo ALPROLIX
English: Degree of haemorrhage / Type of surgical procedure
Slovenian: Stopnja krvavitve/vrsta kirurškega posega
English: The observed mean (SD) activity time profile following a single dose of ALPROLIX in patients with severe haemophilia B is shown below (see Table 4).
Slovenian: aktivnosti po enem odmerku zdravila ALPROLIX pri bolnikih s hudo hemofilijo B je prikazan spodaj (glejte preglednico 4).
English: No interactions of ALPROLIX with other medicinal products have been reported.
Slovenian: Študij medsebojnega delovanja zdravila ALPROLIX z drugimi zdravili niso izvedli.
English: The median average dose per injection to treat a bleeding episode was 46.07 (IQR: 32.86-57.03) IU/kg.
Slovenian: Mediana povprečnega odmerka na injekcijo za zdravljenje epizode krvavitve je bila 46,07 (IQR: 32,86-57,03) i.e./kg.
English: Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid has reached the infusion set needle.
Slovenian: Ves zrak iz cevke infuzijskega kompleta odstranite s počasnim pritiskanjem na nosilec za bat brizge, da tekočina doseže iglo infuzijskega kompleta.
English: By replacement therapy the plasma level of factor IX is increased thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem se zveča plazemska raven faktorja IX in s tem omogoči začasna poprava pomanjkanja faktorja in nagnjenosti h krvavitvam.
English: For example, the formation of antibodies (also known as inhibitors) to factor IX is a known complication that can occur during the treatment of haemophilia B.
Slovenian: Nastajanje protiteles (znanih tudi kot zaviralci) proti faktorju IX je na primer znan zaplet, ki se lahko pojavi med zdravljenjem hemofilije B. Protitelesa preprečujejo pravilno delovanje zdravljenja.
English: In post-marketing experience, FIX inhibitor development and hypersensitivity (including anaphylaxis) have been observed.
Slovenian: V obdobju po prihodu zdravila na trg so opazili razvoj zaviralca faktorja IX in preobčutljivost (vključno z anafilakso).
English: Table 5: Comparison of PK Parameters of ALPROLIX (rFIXFc) by Age Category PK Parameters1
Slovenian: Preglednica 5: Primerjava FK parametrov zdravila ALPROLIX (rFIXFc) po kategoriji starosti
English: After preparation, ALPROLIX can be stored at room temperature for up to 6 hours before administration.
Slovenian: Po pripravi lahko zdravilo ALPROLIX do 6 ur pred dajanjem shranjujete pri sobni temperaturi.
English: Incremental Recovery (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg)
Slovenian: Postopno okrevanje (i.e./dl na i.e./kg) AUC/odmerek (i.e.*h/dl na i.e./kg)
English: Remove the clear plastic protective cover from the needle.
Slovenian: igle odstranite brezbarven zaščitni plastični pokrovček.
English: Table 3: Pharmacokinetic parameters of ALPROLIX (50 IU/kg dose)
Slovenian: Preglednica 3: Farmakokinetični parametri zdravila ALPROLIX (50 i.e./kg odmerek) Farmakokinetični parametri1
English: Patients with a factor IX inhibitor may be at an increased risk of anaphylaxis during future treatment with factor IX.
Slovenian: Pri bolnikih z zaviralcem faktorja IX je lahko tveganje za anafilaksijo med prihodnjim zdravljenjem s faktorjem IX povečano.
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 je treba poučiti o zgodnjih znakih preobčutljivostnih reakcij, ki vključujejo koprivnico, generalizirano urtikarijo, stiskanje v prsnem košu, sopenje, hipotenzijo in anafilakso.
English: After this time, the prepared ALPROLIX should be discarded.
Slovenian: Po poteku tega časa morate pripravljeno zdravilo ALPROLIX zavreči.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Slovenian: Po ponavljajočem zdravljenju z zdravili, ki vsebujejo humani koagulacijski faktor IX, je treba pri bolniku spremljati razvoj nevtralizirajočih protiteles (zaviralcev), ki jih je treba količinsko opredeliti v enotah
English: The usual dose of ALPROLIX is 50 IU per kg of body weight, given once a week or 100 IU per kg of body weight, given once every 10 days.
Slovenian: Običajni odmerek zdravila ALPROLIX je 50 i.e. na kg telesne mase, ki se daje enkrat na teden, ali 100 i.e. na kg telesne mase vsakih 10 dni.
English: Haemophilia B is an X-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija B je na kromosom X vezana dedna motnja strjevanja krvi zaradi znižanih ravni faktorja IX in povzroči krvavitev v sklepe, mišice ali notranje organe,
English: The safety, efficacy, and pharmacokinetics of ALPROLIX were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study in adults and adolescents, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Slovenian: osrednjih študijah; v študiji faze 3 pri odraslih in mladostnikih, imenovani študija I, in pediatrični študiji faze 3, imenovani študija II (glejte Pediatrična populacija).
English: If ALPROLIX has been stored in a refrigerator, allow the vial of ALPROLIX (A) and the syringe with solvent (B) to reach room temperature before use.
Slovenian: ALPROLIX (A) in injekcijska brizga z vehiklom (B) pred uporabo ogrejeta na sobno temperaturo.
English: It is strongly recommended that every time ALPROLIX is given, the name and batch number of the product are recorded.
Slovenian: Močno se priporoča, da se ob vsaki uporabi zdravila ALPROLIX zabeleži ime in številka serije zdravila,
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Slovenian: Po dajanju zdravil s faktorjem IX je prisotno morebitno tveganje za trombembolične epizode, z večjim tveganjem pri zdravilih z manjšo čistoto.
English: MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
English: In case of self-administration or administration by a caregiver appropriate training is needed.
Slovenian: Način uporabe intravenska uporaba Za samoinjiciranje ali injiciranje, ki ga opravi negovalec, je potrebno ustrezno usposabljanje.
English: No fertility studies have been conducted in animals with ALPROLIX.
Slovenian: Študij plodnosti pri živalih z zdravilom ALPROLIX niso izvedli.
English: Each pack contains: - powder in a type 1 glass vial with a chlorobutyl rubber stopper - 5 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper - a plunger rod - a sterile vial adapter for reconstitution - a sterile infusion set - alcohol swab(s) - plaster(s) - gauze pad(s).
Slovenian: Eno pakiranje vsebuje: - prašek v viali iz stekla tipa 1 s klorobutilnim gumijastim zamaškom - 5 ml vehikla v napolnjeni injekcijski brizgi iz stekla tipa 1 z zamaškom z batom iz brombutilne gume - nosilec za bat brizge - sterilni nastavek za vialo za rekonstitucijo - sterilni infuzijski komplet - alkoholni zloženec(ci) - obliž(i) - gazo(e)
English: The median average dose per injection to treat a bleeding episode was 63.51 (interquartile range, 48.9299.44) IU/kg.
Slovenian: Mediana povprečnega odmerka na injiciranje za zdravljenje epizode krvavitve je bila 63,51 (interkvartilni razpon 48,92-99,44) i.e./kg.
English: What ALPROLIX looks like and contents of the pack
Slovenian: Izgled zdravila ALPROLIX in vsebina pakiranja
English: Allergic type hypersensitivity reactions have been reported with ALPROLIX.
Slovenian: Pri uporabi zdravila ALPROLIX so poročali o preobčutljivostnih reakcijah alergijskega tipa.
English: Contents of the pack and other information Instructions for preparation and administration
Slovenian: Shranjevanje zdravila ALPROLIX Vsebina pakiranja in dodatne informacije Navodila za pripravo in dajanje
English: Solvent: 5 mL sodium chloride and water for injections.
Slovenian: Vehikel: 5 ml natrijevega klorida in vode za injekcije
English: A) 1 Powder vial
Slovenian: H) 1 gazo