FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition 4 weeks toxicity studies with the PEG moiety of Jivi were conducted in two species.
Slovenian: Poleg tega so pri dveh živalskih vrstah izvedli tudi 4-tedenske študije toksičnosti z delom PEG, ki je del zdravilne učinkovine v zdravilu Jivi.
English: • tightness in the chest, fall in blood pressure (often shown by feeling dizzy when getting up quickly), itchy nettle-rash, wheezing, feeling sick or faint.
Slovenian: • imate občutek tiščanja v prsnem košu, znižan krvni tlak (pogosto se kaže kot občutek vrtoglavice ob hitrem vstajanju), srbeč izpuščaj (koprivnica), ste zasopli, imate občutek siljenja na bruhanje ali ste omotični.
English: Stop injecting the product immediately and get medical help at once if this occurs.
Slovenian: V tem primeru takoj prenehajte injicirati zdravilo in takoj poiščite medicinsko pomoč.
English: It is not for use in children younger than 12 years of age.
Slovenian: Zdravilo ni primerno za uporabo pri otrocih, mlajših od 12 let.
English: There is limited experience in patients ≥ 65 years.
Slovenian: Izkušnje o uporabi zdravila pri bolnikih, starih 65 let in več, so omejene.
English: One 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: • 60 IU per kg body weight every 7 days or
Slovenian: • 60 i.e. na kg telesne mase vsakih 7 dni ali
English: A total of 73 previously treated pediatric patients (44 subjects < 6 years and 29 subjects 6 to <12 years) received prophylaxis treatment twice weekly, every 5 days or every 7 days in the phase III study.
Slovenian: Skupaj 73 predhodno zdravljenih pediatričnih bolnikov (44 bolnikov, starih < 6 let in 29 bolnikov, starih od 6 do < 12 let) je v študiji faze III profilaktično zdravljenje prejelo dvakrat na teden, vsakih 5 dni ali vsakih 7 dni.
English: Each single package of Jivi contains:
Slovenian: Vsako posamezno pakiranje zdravila Jivi vsebuje:
English: During the course of treatment, appropriate determination of factor VIII levels is advised to confirm that adequate FVIII levels have been achieved.
Slovenian: Med zdravljenjem je priporočljivo določiti aktivnost faktorja VIII za potrditev, da so bile dosežene ustrezne aktivnosti faktorja VIII.
English: AUCnorm (kg.h/dL) t1/2 (h) Vss (dL/kg) CL (dL/h/kg)
Slovenian: AUCnorm (h*kg/dl) t1/2 (h) Vss (dl/kg) Cl (dl/h/kg)
English: For reconstitution using the vial adapter read package leaflet before use.
Slovenian: Glede rekonstitucije zdravila z uporabo adapterja za vialo pred uporabo preberite priloženo navodilo.
English: The total number of exposure days (ED) was 18432 with a median of 131 ED (range: 1 to 309) per subject; median time in study for paediatric patients < 12 years was 237 days with a total of 3219 ED and median of 53 ED (range 1-68) per subject.
Slovenian: Skupno število dni izpostavitve zdravilu (ED - exposure days) je bilo 18.432, pri preiskovancih je bila mediana dni izpostavitve zdravilu 131 (razpon: 1 do 309 dni izpostavitve); pediatrični bolniki, mlajši od 12 let, so bili v študiji z mediano trajanja zdravljenja 237 dni, skupno število dni izpostavitve zdravilu je bilo 3219, pri preiskovancih je bila mediana dni izpostavitve 53 (razpon 1-68).
English: After reconstitution the solution is clear and colourless and then drawn back into the syringe.
Slovenian: Po rekonstituciji je raztopina bistra in brezbarvna.
English: Table 2: Frequency of adverse drug reactions in clinical trials
Slovenian: Preglednica 2: Pogostnost neželenih učinkov zdravila v kliničnih preskušanjih Standardni sistem organskih sistemov po MedDRA
English: Driving and using machines Jivi has no influence on your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Jivi nima vpliva na sposobnost vožnje in upravljanja strojev.
English: PHARMACEUTICAL FORM AND CONTENTS powder and solvent for solution for injection.
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA prašek in vehikel za raztopino za injiciranje
English: One-hundred and fifty nine (159) subjects were ≥ 12 years of age,
Slovenian: 159 preiskovancev je bilo starih ≥ 12 let.
English: How to use Jivi
Slovenian: Kako uporabljati zdravilo Jivi
English: Children Jivi is not for use in children younger than 12 years of age.
Slovenian: Otroci Zdravilo Jivi ni namenjeno za uporabo pri otrocih, mlajših od 12 let.
English: When infused into a patient with haemophilia, factor VIII binds to patient's von Willebrand factor.
Slovenian: Po infundiranju bolniku s hemofilijo, se faktor VIII veže na bolnikov von Willebrandov faktor.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels or absence of factor VIII:C that results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja ali odsotnosti faktorja VIII:C, ki se kaže kot krvavitve v sklepe, mišice ali notranje organe.
English: These items are not included in the Jivi package.
Slovenian: Ti pripomočki niso priloženi v pakiranju zdravila Jivi.
English: Phase III (Paediatric): Pharmacokinetics, safety, and efficacy of Jivi for three prophylaxis regimens (twice weekly, every 5 and every 7 days) and treatment of breakthrough bleeds were evaluated in a multi-national, uncontrolled, open-label trial in 73 paediatric patients (<12 years of age) during a period of 50 EDs and at least 6 months.
Slovenian: Faza III (pediatrična populacija): Farmakokinetiko, varnost in učinkovitost zdravila Jivi za profilaktično uporabo s tremi režimi (dvakrat na teden, vsakih 5 in vsakih 7 dni) in za zdravljenje vmesnih krvavitev so ocenili v multinacionalnem, nenadzorovanem, odprtem preskušanju pri 73 pediatričnih bolnikih (starih < 12 let), v obdobju 50 dni izpostavitve zdravilu in najmanj 6 mesecev.
English: What is in this leaflet What Jivi is and what it is used for What you need to know before you use Jivi How to use Jivi
Slovenian: Kaj je zdravilo Jivi in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Jivi Kako uporabljati zdravilo Jivi Možni neželeni učinki
English: The median dose for prophylaxis was 47.7 IU/kg.
Slovenian: Mediana profilaktičnega odmerka je bil 47,7 i.e./kg.
English: • feeling sick (nausea)
Slovenian: • občutek siljenja na bruhanje (navzea).
English: Jivi is not known to influence or be influenced by other medicines.
Slovenian: Ni znano, ali zdravilo Jivi vpliva na druga zdravila oziroma ali druga zdravila vplivajo nanj.
English: Jivi is not indicated in patients < 12 years of age and in previously untreated patients.
Slovenian: Zdravilo Jivi ni indicirano pri bolnikih, mlajših od 12 let, in pri predhodno nezdravljenih bolnikih.
English: The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
Slovenian: Po rekonstituciji je zdravilo, shranjeno pri sobni temperaturi, kemijsko in fizikalno stabilno 3 ure.
English: If the calculated dose fails to attain the expected factor VIII levels or if bleeding is not controlled after administration of the calculated dosage, the presence of a circulating factor VIII-inhibitor or anti-PEG antibodies in the patient should be suspected (see section 4.4).
Slovenian: Če z izračunanim odmerkom ni mogoče dobiti pričakovane aktivnosti faktorja VIII ali če krvavitev po aplikaciji izračunanega odmerka ni ustrezno obvladana, je treba pri tem bolniku pomisliti na prisotnost protiteles proti faktorju VIII ali na protitelesa proti PEG v krvnem obtoku (glejte poglavje 4.4).
English: Within its overall shelf life of 2 years, the product (when kept in its outer carton) may be stored at up to 25 °C for a limited period of 6 months.
Slovenian: V celotnem 2-letnem roku uporabnosti lahko zdravilo (kadar je v zunanji ovojnini) shranjujete pri sobni temperaturi (do 25 °C) največ 6 mesecev.
English: Degree of haemorrhage/Type of surgical procedure
Slovenian: Stopnja krvavitve/ vrsta kirurškega posega
English: Anti¬PEG antibodies
Slovenian: Protitelesa proti PEG
English: If you use more Jivi than you should Tell your doctor if this occurs.
Slovenian: Če ste uporabili večji odmerek zdravila Jivi, kot bi smeli Če ste uporabili večji odmerek, kot bi smeli, o tem obvestite zdravnika.
English: In completed clinical studies with 73 paediatric PTPs < 12 years (44 PTPs < 6 years, 29 PTPs 6¬<12 years), adverse reactions due to immune response to PEG were observed in children less than
Slovenian: V zaključenih kliničnih študijah s 73 pediatričnimi predhodno zdravljenimi bolniki, mlajšimi od 12 let (44 predhodno zdravljenih bolnikov, starih < 6 let, 29 predhodno zdravljenih bolnikov, starih od 6 do < 12 let), so neželene učinke zaradi imunskega odziva na PEG opazili pri otrocih, starih manj kot 6 let.
English: Immunogenicity against PEG with development of specific IgM anti-PEG antibodies was observed in one patient.
Slovenian: razvoj specifičnih IgM protiteles proti PEG, so opazili pri enem bolniku.
English: Jivi is not indicated in previously untreated patients and in patients less than 12 years of age.
Slovenian: Zdravilo Jivi ni namenjeno za predhodno nezdravljene bolnike in bolnike, mlajše od 12 let.
English: 1 vial with powder, 1 pre-filled syringe with 2.5 mL water for injections, 1 vial adapter and 1 venipuncture set.
Slovenian: 1 viala s praškom, 1 napolnjena injekcijska brizga z 2,5 ml vode za injekcije, 1 adapter za vialo in 1 pribor za vensko punkcijo.
English: • 45-60 IU per kg body weight every 5 days or
Slovenian: • 45 - 60 i.e. na kg telesne mase vsakih 5 dni ali
English: One hundred and thirty four male PTPs received at least one injection of Jivi (including 13 subjects aged 12 to 17 years of age) for prophylaxis (n=114) or on-demand treatment (n=20) for a period of 36 weeks.
Slovenian: 134 moških, ki so bili predhodno zdravljeni, je v obdobju 36. tednov prejelo vsaj eno injekcijo zdravila Jivi (vključno s 13 preiskovanci, starimi od 12 do 17 let) profilaktično (n = 114) ali so bili zdravljeni po potrebi (n = 20).
English: Table 4: PK parameters (geometric mean [%CV]) based on population PK model, using chromogenic assay.
Slovenian: Preglednica 4: Farmakokinetični parametri (geometrična sredina [% CV] na podlagi populacijskega farmakokinetičnega modela z uporabo kromogene metode
English: • previously developed factor VIII inhibitors to a different product.
Slovenian: • so pri vas že kdaj nastali inhibitorji faktorja VIII pri uporabi drugih zdravil.
English: AUC: area under the curve; AUC, norm: dose normalized AUC Cmax: maximum drug concentration; , t½: terminal half¬life; MRT IV : mean residence time after an intravenous administration; VSS: apparent volume distribution at steady¬state; CL: clearance
Slovenian: : AUC, normaliziran na odmerek; Cmax: največja koncentracija zdravila; t½: končni razpolovni čas; MRTIV: povprečni čas prisotnosti v krvnem obtoku po i.v.
English: At least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved
Slovenian: Zdravljenje naj traja vsaj 1 dan, dokler se krvavitev (glede na bolečino) ne ustavi oz. se rana ne zaceli.
English: Jivi is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort level.
Slovenian: To zdravilo se injicira v veno 2 do 5 minut, odvisno od skupne količine in vašega počutja.
English: • one vial with powder (10 mL clear type 1 glass vial with grey bromobutyl rubber blend stopper and aluminium seal)
Slovenian: • 1 vialo s praškom (10-mililitrska viala iz prozornega stekla tipa 1 s sivim brombutilnim gumijastim zamaškom in aluminijastim tesnilom)
English: Manufacturer Bayer AG
Slovenian: Proizvajalec Bayer AG
English: During the main study period subjects were assigned to prophylaxis 2x/week (n=24), or randomized to every 5 days (n=43) or every 7 days (n=43) or received on-demand treatment (n=20) with Jivi.
Slovenian: V obdobju glavne študije so bili preiskovanci dodeljeni v skupino, ki je prejemala profilaktično zdravljenje z zdravilom Jivi dvakrat na teden (n = 24) ali so bili randomizirani v skupino, ki je prejemala zdravilo Jivi profilaktično vsakih 5 dni (n = 43) ali skupino, ki je prejemala zdravilo Jivi profilaktično vsakih 7 dni (n = 43) ali skupino, ke je prejemala zdravilo Jivi po potrebi (n = 20).
English: Perioperative Management
Slovenian: Perioperativna obravnava
English: The overall median (Q1; Q3) total ABR was 1.17 (0.0; 4.3) and 0.6 (0.0: 3.2) for spontaneous bleeds in the combined prophylaxis groups and total ABR was 33.0 in the on-demand group.
Slovenian: Celokupna mediana (Q1; Q3) vrednost ABR je bila 1,17 (0,0; 4,3) oz. 0,6 (0,0; 3,2) za spontane krvavitve v skupinah s profilakso skupaj in skupna vrednost ABR je bila 33,0 v skupini po potrebi.
English: Jivi powder should only be reconstituted with the supplied solvent (2.5 mL water for injections) in the prefilled-syringe and the vial adapter.
Slovenian: Prašek zdravila Jivi se lahko rekonstituira le s priloženim vehiklom (2,5 ml vode za injekcije) v napolnjeni injekcijski brizgi in z adapterjem za vialo.
English: The median dose for all prophylaxis regimens was 46.9 IU/kg/injection.
Slovenian: Mediana profilaktičnega odmerka je bila 46,9 i.e./kg/injekcijo.
English: • the severity of your haemophilia A
Slovenian: • stopnja hemofilije A,
English: Each single pack of Jivi contains
Slovenian: Vsako posamezno pakiranje zdravila Jivi vsebuje
English: The reconstituted product must be filtered by using the vial adapter before injection to remove any possible particles in the solution.
Slovenian: Rekonstituirano zdravilo morate pred uporabo filtrirati s pomočjo adapterja za vialo, da odstranite morebitne delce v raztopini.
English: Table 3: Pharmacokinetic parameters (geometric mean (%CV) and arithmetic mean (SD)) for Jivi following a single 60 IU/kg dose based on chromogenic assay.
Slovenian: Preglednica 3: Farmakokinetični parametri (geometrično povprečje (% CV) in aritmetično povprečje (SD)) za zdravilo Jivi po enkratnem odmerku 60 i.e./kg na podlagi kromogene metode
English: • Keep the vial and the pre-filled syringe in the outer carton in order to protect from light.
Slovenian: • Vialo in napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: • taste disturbance
Slovenian: • motnje okušanja
English: Place the powder vial on a firm, non-slip surface.
Slovenian: Vialo s praškom postavite na trdno, nedrsečo površino.
English: The potency International Unit (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost zdravila (i.e.) se določa s pomočjo kromogene metode po Evropski farmakopeji.
English: Speak with your doctor immediately if this occurs.
Slovenian: V tem primeru se takoj pogovorite z zdravnikom.
English: How Jivi is given
Slovenian: Kako se daje zdravilo Jivi
English: Pack sizes 1 single pack.
Slovenian: − 1 posamezno pakiranje
English: The active substance, damoctocog alfa pegol, is a site specifically PEGylated B-domain deleted recombinant human coagulation factor VIII, produced in baby hamster kidney cells (BHK), with a 60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety.
Slovenian: Učinkovina, damoktokog alfa pegol, je rekombinantni humani koagulacijski faktor VIII brez domene B, PEGiliran na specifičnem mestu, pridobljen v ledvičnih celicah mladih hrčkov (BHKbaby hamster kidney cells), s 60 kDa razvejanim polietilenglikolnim delom (dva 30 kDa PEG).
English: The immune response was accompanied by a clinical hypersensitivity reaction after 4 injections of Jivi.
Slovenian: Po 4 injekcijah zdravila Jivi je imunski odziv spremljala tudi klinična preobčutljivostna reakcija.
English: • local reactions at the injection site such as bleeding under the skin, intense itching, swelling,
Slovenian: • lokalne reakcije na mestu injiciranja, kot so podkožna krvavitev, močno srbenje, oteklina, pekoč občutek, prehodna rdečica
English: For Jivi some silica-based one-stage assays (e.g., APTT-SP, STA-PTT) may underestimate the factor VIII activity of Jivi in plasma samples; some reagents, e.g. with kaolin-based activators, have the potential for overestimation.
Slovenian: Pri nekaterih enostopenjskih metodah s silika aktivatorjem (npr. APTT-SP, STA-PTT) se lahko pri zdravilu Jivi oceni prenizka aktivnost faktorja VIII zdravila Jivi v vzorcih plazme; pri nekaterih reagentih, npr. aktivatorjih na osnovi kaolina, pa so lahko ocene aktivnosti previsoke.
English: A single unconfirmed positive result of a low titre of factor VIII inhibitor (1.7 BU/mL) was reported in one adult patient following a surgery.
Slovenian: Pri enem odraslem bolniku po kirurškem posegu so poročali o enem nepotrjenem pozitivnem izvidu nizkega titra inhibitorjev faktorja VIII (1,7 B.e./ml).
English: If this happens, you should contact your doctor immediately.
Slovenian: V tem primeru se takoj posvetujte z zdravnikom.
English: • chest tightness/general feeling of being unwell
Slovenian: • tiščanje v prsnem košu/splošno slabo počutje,
English: MRTIV (h) Vss (dL/kg) CL (dL/h/kg)
Slovenian: MRTIV (h) Vss (dl/kg)
English: Jivi is used to treat and prevent bleeding in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency).
Slovenian: Zdravilo Jivi se uporablja za zdravljenje in preprečevanje krvavitev pri predhodno zdravljenih odraslih in mladostnikih, starih 12 let ali več, s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: Jivi is provided as a powder and solvent for solution for injection.
Slovenian: Zdravilo Jivi je na voljo kot prašek in vehikel za raztopino za injiciranje.
English: The median (Q1; Q3) ABR during prophylaxis was 2.09 (0.0; 6.1) for all bleeds and 0.0 (0;0 4.2) for spontaneous bleeds as compared to 23.4 (18; 37) total bleeds in the on-demand group.
Slovenian: Mediana (Q1; Q3) vrednost ABR je bila 2,09 (0,0; 6,1) za vse krvavitve in 0,0 (0,0; 4,2) za spontane krvavitve za vse skupine s profilakso skupaj v primerjavi s 23,4 (18; 37) vseh krvavitev za skupino, ki je zdravilo prejemala po potrebi.
English: What Jivi looks like and contents of the pack
Slovenian: Izgled zdravila Jivi in vsebina pakiranja
English: Damoctocog alfa pegol is a PEGylated form of rFVIII.
Slovenian: Damoktokog alfa pegol je PEGilirana oblika rekombinantnega faktorja VIII.
English: • allergic reactions (may present as hives, generalized urticaria, tightness of the chest, wheezing,
Slovenian: • alergijske reakcije (lahko se pojavijo kot koprivnica, generalizirana urtikarija, stiskanje v prsnem košu, zasoplost, kratka sapa, nizek krvni tlak.
English: INFORMATION IN BRAILLE Jivi 2000
Slovenian: PODATKI V BRAILLOVI PISAVI Jivi 2000
English: OTHER Bayer-Logo
Slovenian: DRUGI PODATKI znak Bayer
English: Median time on study for the 148 patients ≥12 years of age was 713 days.
Slovenian: 148 bolnikov, starih 12 let in več, je bilo v študiji z mediano trajanja zdravljenja 713 dni.
English: Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravljenje in preprečevanje krvavitev pri predhodno zdravljenih bolnikih, starih 12 let in več, s hemofilijo A (prirojeno pomanjkanje faktorja VIII).
English: Note the new expiry date on the carton.
Slovenian: Na škatli označite novi datum izteka roka uporabnosti zdravila.
English: • one pre-filled syringe with 2.5 mL solvent (clear type 1 glass cylinder syringe with grey bromobutyl rubber blend stopper)
Slovenian: • 1 napolnjeno injekcijsko brizgo z 2,5 ml vehikla (valjasti del iz prozornega stekla tipa 1 s sivim bromobutilnim gumijastim zamaškom)
English: May be stored at temperatures up to 25 °C for up to 6 months within the expiry date indicated on the label.
Slovenian: Zdravilo lahko shranjujete pri temperaturi do 25 °C do 6 mesecev, vendar samo do datuma izteka roka uporabnosti, navedenega na ovojnini.
English: Abdominal pain, Nausea, Vomiting common Skin and subcutaneous tissue disorders Erythema***, Rash**** common Pruritus uncommon
Slovenian: Bolezni kože in podkožja eritem***, izpuščaj****
English: It may be necessary to adjust the individual dosing at patient level in order to attain satisfactory clinical results.
Slovenian: Za dosego zadovoljivih kliničnih rezultatov bo morda treba odmerek prilagoditi posameznemu bolniku.
English: Jivi is available in pack sizes of: 1 single pack 1 multipack with 30 single packs Not all pack sizes may be marketed.
Slovenian: − 1 skupno pakiranje s 30 posameznimi pakiranji Na trgu morda ni vseh navedenih pakiranj.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Jivi (see section 5.1).
Slovenian: Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom Jivi, lahko pride do nastanka nevtralizirajočih protiteles (inhibitorjev) (glejte poglavje 5.1).
English: Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Slovenian: Jivi 250 i.e. prašek in vehikel za raztopino za injiciranje Jivi 500 i.e. prašek in vehikel za raztopino za injiciranje Jivi 1000 i.e. prašek in vehikel za raztopino za injiciranje Jivi 2000 i.e. prašek in vehikel za raztopino za injiciranje Jivi 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: Low post-injection factor VIII levels in the absence of detectable factor VIII inhibitors indicate that loss of drug effect is likely due to anti-PEG antibodies; in such cases Jivi should be discontinued and patients switched to a previously effective factor VIII product.
Slovenian: Nizka aktivnost faktorja VIII po injiciranju brez zaznanih inhibitorjev faktorja VIII kaže, da je izguba učinkovitosti zdravila verjetno posledica protiteles proti PEG.
English: What Jivi contains
Slovenian: Kaj vsebuje zdravilo Jivi
English: Talk to your doctor or pharmacist if you have
Slovenian: Opozorila in previdnostni ukrepi Posvetujte se z zdravnikom ali farmacevtom, če
English: INFORMATION IN BRAILLE Jivi 250
Slovenian: PODATKI V BRAILLOVI PISAVI Jivi 250
English: Life-threatening Haemorrhages
Slovenian: Življenje ogrožajoče krvavitve
English: Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection
Slovenian: Jivi 500 i.e. prašek in vehikel za raztopino za injiciranje Jivi 1000 i.e. prašek in vehikel za raztopino za injiciranje Jivi 2000 i.e. prašek in vehikel za raztopino za injiciranje Jivi 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: Antibodies to PEG disappeared after discontinuation of Jivi.
Slovenian: Po prenehanju uporabe zdravila Jivi so protitelesa proti PEG izginila.
English: AUC (IU*h/dL) AUC, norm (h*kg/dL) Cmax (IU/dL) t½ (h)
Slovenian: (h*kg/dl) Cmax (i.e./dl) t½ (h)
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the exposure to factor VIII, this risk being highest within the first 50 exposure days (ED) but continues throughout life although the risk is uncommon.
Slovenian: Tveganje je največje v prvih 50 dneh izpostavitve; občasno tveganje obstaja vse življenje.
English: Allergic type hypersensitivity reactions are possible with Jivi.
Slovenian: Pri uporabi zdravila Jivi se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: How Jivi is prepared for injection
Slovenian: Kako se pripravi zdravilo Jivi za injiciranje
English: INFORMATION IN BRAILLE Jivi 1000
Slovenian: PODATKI V BRAILLOVI PISAVI Jivi 1000
English: Detailed instructions for reconstitution and administration of Jivi You will need alcohol swabs, gauze pads, plasters and tourniquet.
Slovenian: Potrebovali boste alkoholne zložence, gaze, obliže in prevezo.