FrancophonIA/ELRC3.0 huggingface dataset:
English: Elevation of FVIII levels following administration, in particular in those with existing cardiovascular risk factors, might cause a patient to have the same risk for vessel closure or myocardial infarction as for the non-haemophilic population.
Slovenian: Povečanje vrednosti faktorja VIII po aplikaciji, zlasti pri tistih s prisotnimi srčnožilnimi dejavniki tveganja, predstavlja pri bolniku najmanj enako tveganje za zaporo žil ali miokardni infarkt kakor pri populaciji, ki nima hemofilije.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Slovenian: obsežnejše krvavitve v sklepe, mišice ali hematomi
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of Iblias in previously untreated patients the MAH will submit the results of the ongoing study “13400 - Leopold Kids Part B”
Slovenian: Poavtorizacijska študija učinkovitosti: Z namenom raziskati varnost in učinkovitost zdravila Iblias pri predhodno nezdravljenih bolnikih, mora imetnik dovoljenja za promet predložiti izsledke študije, ki je v teku “13400 - Leopold Kids Part B”
English: Minor surgery including tooth extraction
Slovenian: Kirurški posegi manjši kirurški posegi tudi izdrtje zob
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Slovenian: Jakost zdravila (i.e.) se določa s pomočjo kromogenega preizkusa po Evropski farmakopeji.
English: Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay.
Slovenian: Preglednica 4: Farmakokinetični parametri (geometrična sredina (% CV)) na podlagi kromogenega preizkusa*
English: Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII.
Slovenian: Določanje APTČ je običajna in vitro metoda za ugotavljanje biološke aktivnosti faktorja VIII.
English: ABR annualized bleed rate
Slovenian: LSK - letna stopnja krvavitve
English: While keeping the syringe plunger pressed, turn the system upside down and draw the solution into the syringe by pulling the plunger back slowly.
Slovenian: Medtem ko pritiskate na bat brizge, sistem obrnite navzdol, raztopino pa potegnite v injekcijsko brizgo s počasnim vlečenjem bata brizge nazaj.
English: Iblias is a medicine that contains the active substance human recombinant coagulation factor VIII, also called octocog alfa.
Slovenian: Zdravilo Iblias vsebuje zdravilno učinkovino humani rekombinantni koagulacijski faktor VIII, imenovan tudi oktokog alfa.
English: Although this became non-significant when UK patients (also included in the
Slovenian: Vendar je to postalo statistično nepomembno, ko so iz študije izključili bolnike iz Združenega kraljestva (vključeni tudi v študijo RODIN/Pednet).
English: Draw air into an empty, sterile syringe.
Slovenian: V prazno, sterilno injekcijsko brizgo potegnite zrak.
English: This medicine contains less than 1 mmol (23 mg) sodium per dose, and is therefore considered essentially ‘sodium- free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Slovenian: Previdno odstranite pretisni omot s kompleta Mix2Vial tako, da ga držite na robu, nato pa ga potegnite navpično navzgor.
English: Ensure product and solvent vial flip caps are removed and the stoppers are treated with an antiseptic solution and allowed to dry prior to opening the Mix2Vial package.
Slovenian: Preverite, ali sta pokrovčka na viali z zdravilom in viali z vehiklom odstranjena in zamaška obrišite z antiseptično raztopino in pustite, da se posuši, preden odprete pakiranje z Mix2Vial.
English: Skin and subcutaneous tissue disorders Pruritus, rash***, dermatitis allergic common
Slovenian: Bolezni kože in podkožja pruritus, izpuščaj***, alergijski dermatitis pogosti urtikarija občasni
English: Filtering is achieved by using the vial adapter.
Slovenian: Za filtriranje uporabite adapter za vialo.
English: 0-<6 years N=24
Slovenian: 0-< 6 let N = 24
English: The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at room temperature.
Slovenian: Po rekonstituciji je bilo zdravilo, shranjeno pri sobni temperaturi, kemijsko in fizikalno stabilno 3 ure.
English: • local reactions where you injected the medication (e.g. bleeding under the skin, intense itching, swelling, burning sensation, temporary redness)
Slovenian: • lokalne reakcije na mestu injiciranja (npr. krvavitev pod kožo, močno srbenje, oteklina, pekoča bolečina, prehodna rdečina)
English: The rate of administration should be determined by the patient's comfort level (maximal rate of infusion: 2 mL/min).
Slovenian: Hitrost injiciranja naj bo prilagojena bolnikovemu počutju (največja dovoljena hitrost injiciranja je 2 ml/min).
English: Sodium chloride Calcium chloride Polysorbate 80
Slovenian: Prašek saharoza histidin glicin natrijev klorid kalcijev klorid polisorbat 80
English: You are filtering by using the Mix2Vial adapter.
Slovenian: Za filtriranje uporabite adapter Mix2Vial.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Kot vodilo za odmerjanje pri krvavitvah in kirurških posegih se lahko uporablja naslednja preglednica:
English: Hold the syringe upright and push the plunger until no air is left in the syringe.
Slovenian: Injekcijsko brizgo držite navpično in potiskajte bat injekcijske brizge toliko časa, da v injekcijski brizgi ni več zraka.
English: For major surgery in particular, close monitoring of the replacement therapy by means of coagulation analysis must be carried out.
Slovenian: Predvsem pri večjih kirurških posegih je treba potek nadomestnega zdravljenja nujno skrbno spremljati s testom strjevanja krvi.
English: NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF ADMINISTRATION
Slovenian: IME ZDRAVILA IN, ČE JE POTREBNO, POT(I) UPORABE Voda za injekcije
English: Note the new expiry date on the carton.
Slovenian: Označite novi datum izteka roka uporabnosti zdravila na škatli.
English: Pyrexia, chest discomfort, injection site reactions **
Slovenian: Splošne težave in spremembe na mestu aplikacije pireksija, neprijeten občutek v prsnem košu, reakcije na mestu injiciranja**
English: 6-<12 years N=27
Slovenian: 6-< 12 let N = 27
English: Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of long-term treatment with Iblias, the MAH will submit the results of the ongoing study “13400 - Leopold Kids extension”
Slovenian: Poavtorizacijska študija učinkovitosti: Z namenom raziskati varnost in učinkovitost zdravila Iblias pri predhodno nezdravljenih bolnikih, mora imetnik dovoljenja za promet predložiti izsledke študije, ki je v teku “13400 - Leopold Kids extension”
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: S tem se začasno nadomesti pomanjkanje faktorja VIII in zmanjša nagnjenost h krvavitvam.
English: • an additional package with: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Slovenian: • dodatno vsebuje še: - 1 pripomoček s filtrom za prenos 20/20 [Mix2Vial] - 1 pribor za vensko punkcijo
English: Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counter clockwise.
Slovenian: Sedaj ko ste raztopino prenesli v injekcijsko brizgo, močno držite valjasti del injekcijske brizge (bat injekcijske brizge naj gleda navzdol) in ločite prozorni adapter Mix2Vial od injekcijske brizge z obračanjem v nasprotni smeri urinega kazalca.
English: 12-<18 years N=23
Slovenian: 12-< 18 let N = 23
English: With one hand grasp the product-side of the Mix2Vial set and with the other hand grasp the solvent-side and unscrew counter clockwise the set carefully into two pieces.
Slovenian: Z eno roko primite Mix2Vial na strani, kjer je zdravilo, z drugo pa stran z vehiklom, in z obračanjem v nasprotni smeri urinega kazalca razstavite set previdno na dva dela.
English: Take the Mix2Vial together with the blister package and push the spike of the blue adapter end straight down through the solvent vial stopper.
Slovenian: Vzemite Mix2Vial skupaj s pretisnim omotom in potisnite konico modrega dela adapterja naravnost navzdol skozi zamašek viale z vehiklom.
English: May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the label.
Slovenian: Zdravilo lahko shranjujete pri temperaturi do 25 °C do 12 mesecev, vendar samo do datuma izteka roka uporabnosti navedenega na nalepki.
English: The reconstituted solution must be used within 3 hours.
Slovenian: Pripravljeno raztopino morate uporabiti v 3 urah.
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII:C. Posledice so obsežne krvavitve v sklepe, mišice ali notranje organe.
English: LIST OF EXCIPIENTS Sucrose, histidine, glycine, sodium chloride, calcium chloride, polysorbate 80.
Slovenian: SEZNAM POMOŽNIH SNOVI Pomožne snovi: saharoza, histidin, glicin, natrijev klorid, kalcijev klorid, polisorbat 80.
English: FVIII inhibition uncommon (PTPs)*
Slovenian: občasni (PZB)*
English: • one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend stopper and aluminium seal)
Slovenian: • eno vialo s praškom (10-mililitrska viala je iz prozornega stekla tipa 1 s sivim halogenobutilnim gumijastim zamaškom in aluminijastim tesnilom)
English: Do not use solutions containing visible particles or that are cloudy.
Slovenian: Ne uporabite raztopine, če vsebuje vidne delce ali je motna.
English: • one vial with solvent (6 mL clear glass type 1 vial with grey chlorobutyl rubber blend stopper and aluminium seal)
Slovenian: • eno vialo z vehiklom (6-mililitrska viala je iz prozornega stekla tipa 1 s sivim klorbutilnim gumijastim zamaškom in aluminijastim tesnilom)
English: Study 2 3 x/week dosing
Slovenian: 3 x/teden
English: Blood and lymphatic system disorders Lymphadenopathy common
Slovenian: Bolezni krvi in limfatičnega sistema limfadenopatija pogosti zaviranje faktorja VIII
English: • urticaria (itchy rash)
Slovenian: • urtikarija (srbeč izpuščaj)
English: Allergic type hypersensitivity reactions are possible with Iblias.
Slovenian: Po uporabi zdravila Iblias se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: Do not use Iblias if you notice visible particulate matter or turbidity.
Slovenian: Ne uporabite zdravila Iblias, če v raztopini opazite vidne delce ali je raztopina motna.
English: How to use Iblias
Slovenian: Kako uporabljati zdravilo Iblias
English: Older children years)
Slovenian: Mlajši otroci (0 < 6 let)
English: Do not use Iblias if either of the above applies to you.
Slovenian: Če kar koli od zgoraj navedenega velja za vas, ne uporabljajte zdravila Iblias.
English: When infused into a haemophiliac patient, factor VIII binds to vWF in the patient's circulation.
Slovenian: Po injiciranju faktorja VIII bolniku s hemofilijo, se faktor VIII v krvnem obtoku veže na vWF.
English: 4.9 Overdose No symptoms of overdose with recombinant human coagulation factor VIII have been reported.
Slovenian: Ni poročil o simptomih zaradi prevelikega odmerjanja rekombinantnega humanega koagulacijskega faktorja VIII.
English: Palpitation, sinus tachycardia common
Slovenian: Srčne bolezni palpitacije, sinusna tahikardija pogosti
English: This medicine is intended for injection into a vein over 2 to 5 minutes depending on the total volume and your comfort level and should be used within 3 hours after preparing the solution.
Slovenian: To zdravilo se injicira v veno 2 do 5 minut, odvisno od skupne količine in vašega počutja.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea,
Slovenian: Opažene so bile preobčutljivost ali alergijske reakcije (ki lahko vključujejo angioedem, pekoč občutek in občutek zbadanje na mestu infundiranja, 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: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free'.
Slovenian: Zdravilo Iblias vsebuje natrij To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: What Iblias contains
Slovenian: Kaj vsebuje zdravilo Iblias
English: Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Slovenian: Vialo z zdravilom s pritrjenim prozornim adapterjem nežno obračajte, dokler se prašek povsem ne raztopi.
English: • flushing (redness of the face)
Slovenian: • pordelost (rdečica obraza)
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Slovenian: Vialo vehikla s pritrjenim modrim adapterjem Mix2Vial zavrzite.
English: How Iblias is given
Slovenian: Kako se daje zdravilo Iblias
English: Apply a tourniquet to your arm. 14.
Slovenian: Namestite prevezo na roko.
English: Non-clinical data reveal no special risk for humans based on safety pharmacology, in vitro genotoxicity, and short term repeat-dose toxicity studies.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, in vitro genotoksičnosti in kratkotrajnih študij toksičnosti s ponavljajočimi odmerki ne kažejo posebnega tveganja za človeka.
English: Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored up to 25 °C for a limited period of 12 months.
Slovenian: V 30-mesečnem roku uporabnosti lahko zdravilo shranjujete v zunanji ovojnini pri sobni temperaturi (do 25 °C) največ 12 mesecev.
English: If you switch factor VIII products, you may be at risk of your inhibitor coming back.
Slovenian: Pri menjavah zdravil s faktorjem VIII, obstaja tveganje za ponovni nastanek zaviralcev.
English: It is strongly recommended that appropriate laboratory tests be performed on your plasma at suitable intervals to ensure that adequate factor VIII levels have been reached and are maintained.
Slovenian: Za doseganje in vzdrževanje ustreznih vrednosti faktorja VIII je zelo priporočljivo, da se v rednih presledkih naredijo ustrezne laboratorijske preiskave plazme.
English: This medicine may be stored at ambient room temperature (up to 25 °C) for a limited period of 12 months when you keep it in its outer carton.
Slovenian: To zdravilo lahko shranjujete v zunanji ovojnini pri sobni temperaturi (do 25 °C) največ 12 mesecev.
English: Life threatening haemorrhages
Slovenian: življenjsko ogrožajoče krvavitve
English: The SIPPET study was an open-label, randomized, multi-centre, multi-national trial investigating the incidence of neutralising allo-antibodies in patients with severe congenital haemophilia A
Slovenian: Študija SIPPET je bila neslepo, randomizirano, multicentrično, večnacionalno preskušanje, v kateri so preučili pojavnost nevtralizirajočih aloprotiteles pri bolnikih s hudo prirojeno hemofilijo A (plazemska koncentracija FVIII < 1 %) s koncentrati pdFVIII ali rFVIII.
English: Common (may affect up to 1 in 10 users):
Slovenian: Pogosti: pojavijo se lahko pri več kot 1 od 10 bolnikov
English: • stomach pain or discomfort
Slovenian: • bolečina ali neprijeten občutek v trebuhu
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: Krvavitev zgodnje krvavitve v sklepe, mišice ali ustno votlino
English: Iblias is provided as a powder and solvent for solution for injection and is a dry, white to slightly yellow powder or cake.
Slovenian: Zdravilo Iblias je na voljo kot prašek (suh, bel do rahlo rumen prašek ali pogača) in vehikel za raztopino za injiciranje.
English: Solvent Water for injections.
Slovenian: VIALA Z VODO ZA INJEKCIJE
English: On Demand Treatment
Slovenian: Zdravljenje po potrebi
English: 39 IU/kg (21;72 IU /kg)
Slovenian: 31 i.e./kg (13; 72 i.e./kg)
English: However the PRAC is of the view that there are uncertainties with regards to the findings of the SIPPET study which preclude the conclusion that there is a higher risk of inhibitor development in PUPs treated with rFVIII products than pdFVIII products studied in this clinical trial, as detailed below:
Slovenian: večje tveganje za pojav zaviralcev pri predhodno zdravljenih bolnikih z rFVIII kot s pdFVIII v zdravilih, preučenih v tem kliničnem preskušanju, kot je podrobno opisano v nadaljevanju:
English: Open the Mix2Vial package by peeling away the lid. Do not remove the Mix2Vial from the blister package!
Slovenian: Ne vzemite Mix2Vial iz pretisnega omota!
English: One device pack containing: - 1 filter transfer device 20/20 [Mix2Vial] - 1 venipuncture set - 1 disposable 5 mL syringe - 2 alcohol swabs for single use
Slovenian: 1 viala s praškom 1 viala z 2,5 ml vode za injekcije 1 viala s 5 ml vode za injekcije Ena škatla s pripomočkom vsebuje: - 1 pripomoček s filtrom za prenos 20/20 [Mix2Vial] - 1 pribor za vensko punkcijo - 1 injekcijsko brizgo po 5 ml za enkratno uporabo - 2 alkoholna zloženca za enkratno uporabo
English: How Iblias is prepared for administration
Slovenian: Kako se pripravi zdravilo Iblias za uporabo
English: Abdominal pain, abdominal discomfort, dyspepsia common
Slovenian: Bolezni prebavil bolečina v trebuhu, neprijeten občutek v trebuhu, dispepsija pogosti
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with IbliasIf such inhibitors occur, the condition will manifest itself as an insufficient clinical response.
Slovenian: Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom Iblias, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: While the product vial is upright, connect the syringe to the Mix2Vial´s Luer Lock fitting by screwing clockwise.
Slovenian: Viala z zdravilom naj stoji navpično, medtem pa injekcijsko brizgo pritrdite na Luer Lock na Mix2Vial z obračanjem v smeri urinega kazalca.
English: Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Slovenian: Obrnite vialo z vehiklom in pritrjenim Mix2Vial in potisnite konico prozornega dela adapterja naravnost navzdol skozi zamašek viale z zdravilom.
English: Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Pred uporabo zdravila raztopino vizualno preglejte, če so v njej prisotni delci in ali je obarvana.
English: Uncommon (may affect up to 1 in 100 users):
Slovenian: Občasni: pojavijo se lahko pri največ 1 od 100 bolnikov
English: • chest pain or discomfort
Slovenian: • bolečine ali neprijeten občutek v prsnem košu
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: • preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1 • znane alergijske reakcije na beljakovine miši ali hrčkov
English: Iblias 250 IU powder for solution for injection Iblias 500 IU powder for solution for injection Iblias 1000 IU powder for solution for injection Iblias 2000 IU powder for solution for injection Iblias 3000 IU powder for solution for injection recombinant human coagulation factor VIII (octocog alfa) Intravenous use.
Slovenian: Iblias 250 i.e. prašek za raztopino za injiciranje Iblias 500 i.e. prašek za raztopino za injiciranje Iblias 1000 i.e. prašek za raztopino za injiciranje Iblias 2000 i.e. prašek za raztopino za injiciranje Iblias 3000 i.e. prašek za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa) Intravenska uporaba.
English: * PK parameter
Slovenian: Farmakokinetični parameter
English: Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection
Slovenian: Iblias 250 i.e. prašek in vehikel za raztopino za injiciranje Iblias 500 i.e. prašek in vehikel za raztopino za injiciranje Iblias 1000 i.e. prašek in vehikel za raztopino za injiciranje Iblias 2000 i.e. prašek in vehikel za raztopino za injiciranje Iblias 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: CSL Behring S.p.A. Tel: +39-02-34964200
Slovenian: Tel: +39-02-34964200
English: Vascular disorders
Slovenian: • prebavne motnje
English: 29 IU/kg 54 IU/kg)
Slovenian: 29 i.e./kg 54 i.e./kg)
English: Hypersensitivity uncommon
Slovenian: Psihiatrične motnje nespečnost pogosti
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not available.
Slovenian: Izkušenj o uporabi faktorja VIII med nosečnostjo ni.
English: Hold a pad firmly over the injection site on your outstretched arm for about 2 minutes.
Slovenian: Držite roko iztegnjeno in na mestu vboda še približno 2 minuti pritiskajte blazinico.
English: How to store Iblias
Slovenian: Shranjevanje zdravila Iblias
English: If this dose does not control your bleeding your doctor may consider giving you another product.
Slovenian: Če tudi večji odmerek ne bo zadostoval, se lahko zdravnik odloči za drugo zdravilo.
English: 32 IU/kg 50 IU/kg)
Slovenian: 32 i.e./kg 50 i.e./kg)
English: Iblias 250 IU powder and solvent for solution for injection Iblias 500 IU powder and solvent for solution for injection Iblias 1000 IU powder and solvent for solution for injection Iblias 2000 IU powder and solvent for solution for injection Iblias 3000 IU powder and solvent for solution for injection recombinant human coagulation factor VIII (octocog alfa)
Slovenian: Iblias 250 i.e. prašek in vehikel za raztopino za injiciranje Iblias 500 i.e. prašek in vehikel za raztopino za injiciranje Iblias 1000 i.e. prašek in vehikel za raztopino za injiciranje Iblias 2000 i.e. prašek in vehikel za raztopino za injiciranje Iblias 3000 i.e. prašek in vehikel za raztopino za injiciranje rekombinantni humani koagulacijski faktor VIII (oktokog alfa)
English: 37 IU/kg 42 IU/kg)
Slovenian: 37 i.e./kg 42 i.e./kg)
English: 36 IU/kg 58 IU/kg)
Slovenian: 36 i.e./kg 58 i.e./kg)
English: • One mL Iblias 250 IU contains approximately 100 IU (250 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Slovenian: • 1 ml zdravila Iblias 250 i.e. vsebuje približno 100 i.e. (250 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
English: Detailed instructions for reconstitution and administration of Iblias using the Mix2Vial adapter:
Slovenian: Podrobnejša navodila za rekonstitucijo in dajanje zdravila Iblias s pomočjo adapterja za vialo Roke si temeljito umijte z milom in toplo vodo.
English: • the severity of your haemophilia
Slovenian: • stopnja hemofilije
English: • One mL Iblias 500 IU contains approximately 200 IU (500 IU / 2.5 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution with water for injections.
Slovenian: • 1 ml zdravila Iblias 500 i.e. vsebuje približno 200 i.e. (500 i.e./2,5 ml) rekombinantnega humanega koagulacijskega faktorja VIII (INN: oktokog alfa) po rekonstituciji z vodo za injekcije.
English: PHARMACEUTICAL FORM Powder and solvent for solution for injection.
Slovenian: VIALA S PRAŠKOM ZA RAZTOPINO ZA INJICIRANJE