FrancophonIA/ELRC3.0 huggingface dataset:
English: The product is for single use only.
Slovenian: Zdravilo je samo za enkratno uporabo.
English: Allergic type hypersensitivity reactions are possible with ADYNOVI.
Slovenian: Pri uporabi zdravila ADYNOVI so možne preobčutljivostne reakcije alergijskega tipa.
English: The median total dose for major surgeries was 553 IU/kg (range: 248-1394 IU/kg) and the median total dose of minor surgeries was 106 IU/kg (range: 76132 IU/kg).
Slovenian: Mediana skupnega odmerka pri večjih kirurških posegih je bila 553 i.e./kg (razpon: 248-1394 i.e./kg), mediana skupnega odmerka pri manjših kirurških posegih pa 106 i.e./kg (razpon: 76-132 i.e./kg).
English: The frequency of administration will depend on how well ADYNOVI is working for you.
Slovenian: Pogostnost uporabe bo odvisna od vašega odziva na zdravilo ADYNOVI.
English: Sterilised water for injections
Slovenian: sterilizirana voda za injekcije
English: Other medicines and ADYNOVI Tell your doctor if you are using, have recently used or might use any other medicines.
Slovenian: Obvestite zdravnika, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: Twenty four out of 65 subjects (37%) experienced no bleeding episodes, 47 out of 65 subjects (72%) experienced no joint bleeding episodes, and 43 out of 65 subjects (66%) experienced no spontaneous bleeding episodes on prophylaxis.
Slovenian: V skupini s profilaktičnim zdravljenjem se krvavitev ni pojavila pri 24 preiskovancih od 65 (37 %), pri 47 preiskovancih od 65 (72 %) ni prišlo do krvavitve v sklep in pri 43 preiskovancih od 65 (66 %) ni prišlo do spontane krvavitve.
English: - ADYNOVI in BAXJECT III system: Each pack contains a ready to use BAXJECT III system in a sealed blister, withthe powder vial and the solvent vial preassembled for reconstitution.
Slovenian: - Zdravilo ADYNOVI v sistemu BAXJECT III: Eno pakiranje vsebuje sistem BAXJECT III, pripravljen za uporabo, v zapečatenem pretisnem omotu, z vialo s praškom in vialo z vehiklom, sestavljenima za rekonstitucijo.
English: The following table can be used to guide dosing in bleeding episodes and surgery.
Slovenian: Naslednjo preglednico lahko uporabite kot vodilo za odmerjanje pri krvavitvah in kirurških posegih.
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A (congenital factor VIII deficiency).
Slovenian: Zdravljenje in profilaksa krvavitev pri bolnikih, starih 12 let in več, s hemofilijo A (prirojenim pomanjkanjem faktorja VIII).
English: Do not use ADYNOVI: - if you are allergic to rurioctocog alfa pegol, octocog alfa or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to mouse or hamster proteins
Slovenian: Ne uporabljajte zdravila ADYNOVI: - če ste alergični na rurioktokog alfa pegol, oktokog alfa ali katero koli sestavino tega zdravila
English: Haemorrhage Early haemarthrosis, muscle bleeding or oral bleeding.
Slovenian: Zgodnja hemartroza, krvavitev v mišico ali krvavitev v ustno votlino
English: In the repeat dose toxicity study in Cynomologous monkey, two animals showed vacuolation in the kidney in the mid dose group (350IU/kg).
Slovenian: V študiji toksičnosti pri ponavljajočih odmerkih pri opicah rodu Cynomolgus je pri dveh živalih iz skupine, ki je prejemala srednje velik odmerek (350 i.e./kg), prišlo do vakuolizacije v ledvicah.
English: Each powder vial contains nominally 250, 500, 1000, or 2000 IU rurioctocog alfa pegol.
Slovenian: Ena viala s praškom vsebuje nominalno 250, 500, 1000 ali 2000 i.e. rurioktokoga alfa pegola.
English: Rurioctocog alfa pegol is a covalent conjugate of octocog alfa consisting of 2,332 amino acids with polyethylene glycol (PEG) reagent (MW 20 kDa).
Slovenian: Rurioktokog alfa pegol je kovalentni konjugat oktokoga alfa, sestavljen iz 2.332 aminokislin s polietilenglikolnim (PEG) reagentom (z molekulsko maso 20 kDa).
English: The median number of exposure days to ADYNOVI per subject was 103.5 (min-max: 1-278).
Slovenian: Mediana števila dni izpostavljenosti zdravilu ADYNOVI na preiskovanca je bila 103,5 (razpon: 1-278).
English: This should be taken into consideration by patients on a controlled sodium diet.
Slovenian: To je treba upoštevati pri bolnikih na dieti z nadzorovanim vnosom natrija.
English: How to use ADYNOVI
Slovenian: Kako uporabljati zdravilo ADYNOVI
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the injection site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: V redkih primerih so opazili preobčutljivostne ali alergijske reakcije (vključno z angioedemom, pekočim občutkom in zbadanjem na mestu injiciranja, mrzlico, pordelostjo, generalizirano urtikarijo, glavobolom, koprivnico, hipotenzijo, letargijo, navzeo, nemirnostjo, tahikardijo, tiščanjem v prsih, ščemenjem, bruhanjem in piskanjem v pljučih), ki so v nekaterih primerih napredovale do hude anafilaksije (vključno s šokom).
English: Instructions for reconstitution
Slovenian: Navodilo za rekonstitucijo
English: You or someone else might also administer ADYNOVI as an injection, but only after receiving adequate training.
Slovenian: Po ustreznem usposabljanju si lahko zdravilo ADYNOVI kot injekcijo dajete tudi sami ali vam jo da druga oseba.
English: During the shelf life the powder vial may be kept at room temperature (up to 30 °C) for a single period not exceeding 3 months.
Slovenian: V času roka uporabnosti lahko vialo s praškom hranite pri sobni temperaturi (do 30 °C) za čas enkratnega obdobja največ 3 mesecev.
English: Store refrigerated (2°to 8° C).
Slovenian: Shranjujte na hladnem (2 °C - 8 °C).
English: Instructions for preparation and administration
Slovenian: Navodilo za pripravo in uporabo
English: Peel-off labels are provided on the powder vial.
Slovenian: Nalepke so nalepljene na viali s praškom.
English: ADYNOVI in BAXJECT III system: Keep the sealed blister in the outer carton in order to protect from light.
Slovenian: Zdravilo ADYNOVI v sistemu BAXJECT III: Zapečaten pretisni omot shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Before opening the product may be stored at room temperature (up to 30 °C) for a period of up to 3 months.
Slovenian: Preden zdravilo odprete, ga lahko hranite pri sobni temperaturi (do 30 °C) največ 3 mesece.
English: - rash, hives, wheals, generalised itching, - swelling of lips and tongue, - difficulty in breathing, wheezing, tightness in the chest, - general feeling of being unwell, - dizziness and loss of consciousness.
Slovenian: - izpuščaj, koprivnica, gnojni mehurčki, generalizirano srbenje, - otekanje ustnic in jezika, - težave z dihanjem, piskanje v pljučih, tiščanje v prsih, - splošno slabo počutje, - omotica in izguba zavesti.
English: The median overall ABR was 2.0 (IQR: 3.9) for the 65 subjects in the per-protocol population and the median ABRs for spontaneous and joint bleeding episodes were both 0 (IQR: 1.9).
Slovenian: Mediana celokupne vrednosti ABR pri 65 preiskovancih v populaciji po protokolu je bila 2,0 (IQR: 3,9), mediani vrednosti ABR za spontane krvavitve in krvavitve v sklep pa obe 0 (IQR: 1,9).
English: The observed event of hypersensitivity was a mild transient non-serious rash, occurring in one 2-year-old patient who had developed a previous rash while on ADYNOVI.
Slovenian: Opažena preobčutljivost se je izrazila v obliki blagega, prehodnega izpuščaja, ki ni bil resen in se je pojavil pri 2-letnem bolniku, pri katerem se je izpuščaj pojavil že pri predhodnem zdravljenju z zdravilom ADYNOVI.
English: Do not use if the solution is not fully clear or not completely dissolved.
Slovenian: Zdravila ne uporabite, če raztopina ni popolnoma bistra ali zdravilo ni popolnoma raztopljeno.
English: See 4.2 for information on paediatric use.
Slovenian: Za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: This medicine contains 0.45 mmol sodium (10 mg) per vial.
Slovenian: To zdravilo vsebuje 0,45 mmol natrija (10 mg) na vialo.
English: The prophylactic regimen was 40 to 60 IU/kg of ADYNOVI twice a week.
Slovenian: Profilaktična shema odmerjanja je bila od 40 do 60 i.e. zdravila ADYNOVI/kg dvakrat tedensko.
English: Prevention of bleeding The usual dose of ADYNOVI is 40 to 50 IU per kg body weight, administered 2 times per week.
Slovenian: Preprečevanje krvavitev Običajni odmerek zdravila ADYNOVI je od 40 do 50 i.e. na kilogram telesne mase dvakrat na teden.
English: Allow the vials of powder and solvent to reach room temperature (between 15 °C and 25 °C) before use.
Slovenian: Pred uporabo počakajte, da se viali s praškom in vehiklom segrejeta na sobno temperaturo (med 15 °C in 25 °C).
English: Open the ADYNOVI blister by peeling away the lid.
Slovenian: Odprite pretisni omot zdravila ADYNOVI tako, da odlepite pokrov.
English: ADYNOVI with BAXJECT II Hi-Flow device: Keep the vial in the outer carton in order to protect from light.
Slovenian: Zdravilo ADYNOVI s pripomočkom BAXJECT II Hi-Flow: Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: You must contact your doctor immediately if you have any of the following early symptoms of allergic reactions:
Slovenian: Če opazite katerega koli izmed naslednjih zgodnjih simptomov alergijskih reakcij, se nemudoma posvetujte z zdravnikom:
English: For long term prophylaxis, the recommended dose is 40 to 50 IU of ADYNOVI per kg bodyweight twice weekly in 3 to 4 day intervals.
Slovenian: Za dolgotrajno profilakso je priporočeni odmerek od 40 do 50 i.e. zdravila ADYNOVI na kg telesne mase dvakrat tedensko v intervalih na 3 do 4 dni.
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 preobčutljivosti, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, piskanjem v pljučih, hipotenzijo in anafilakso.
English: Forty out of 101 subjects (40%) experienced no bleeding episodes, 58 out of 101 subjects (57%) experienced no joint bleeding episodes, and 58 out of 101 subjects (57%) experienced no spontaneous bleeding episodes in the prophylaxis arm. All subjects in the on-demand arm experienced a bleeding episode, including a joint or spontaneous bleeding episode.
Slovenian: V skupini s profilaktičnim zdravljenjem pri 40 preiskovancih od 101 (40 %) ni prišlo do epizode s krvavitvijo, pri 58 preiskovancih od 101 (57 %) ni prišlo do krvavitve v sklep in pri 58 preiskovancih od 101 (57 %) ni prišlo do spontane krvavitve.
English: Place the powder vial on a flat surface with the solvent vial on top (Figure 1).
Slovenian: Vialo s praškom položite na ravno površino tako, da je viala z vehiklom zgoraj (slika 1).
English: Rurioctocog alfa pegol, is a pegylated recombinant human factor VIII with an extended half-life.
Slovenian: Rurioktokog alfa pegol je pegilirani rekombinantni humani faktor VIII s podaljšano razpolovno dobo.
English: - ADYNOVI with BAXJECT II Hi-Flow device: Each pack contains a powder vial, a solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Slovenian: - Zdravilo ADYNOVI s pripomočkom BAXJECT II Hi-Flow: Eno pakiranje vsebuje vialo s praškom, vialo z vehiklom in pripomoček za rekonstitucijo (BAXJECT II Hi-Flow).
English: o The appearance of the reconstituted solution is clear and colourless.
Slovenian: o Rekonstituirana raztopina je bistra in brezbarvna.
English: Do not use this medicine after the expiry date, which is stated on the label and carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Marketing Authorisation Holder Baxalta Innovations GmbH Industriestrasse 67
Slovenian: Imetnik dovoljenja za promet z zdravilom Baxalta Innovations GmbH Industriestrasse 67
English: Please record the end of the 3-month storage at room temperature on the product carton.
Slovenian: Konec 3-mesečnega obdobja hranjenja pri sobni temperaturi zabeležite na škatlo zdravila.
English: ADYNOVI has an extended half-life of 1.4 to 1.5-fold compared to recombinant human coagulation factor VIII (octocog alfa) in the adolescent and adult population, as determined based on one stage clotting and chromogenic assays, respectively.
Slovenian: Zdravilo ADYNOVI ima pri mladostnikih in odraslih podaljšano razpolovno dobo, ki je od 1,4do 1,5-krat daljša od razpolovne dobe rekombinantnega humanega koagulacijskega faktorja VIII (oktokog alfa), kot so jo določili na podlagi enostopenjskega testa strjevanja oziroma kromogenega testa.
English: An increase in AUC and a decrease in clearance as compared to the parent molecule, octocog alfa, were also observed.
Slovenian: V primerjavi z izhodno molekulo, oktokogom alfa, so opazili tudi povečanje AUC in zmanjšanje očistka.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly (Figure F).
Slovenian: Rekonstituirano raztopino povlecite v brizgo tako, da počasi povlečete bat (slika F).
English: Each pack contains one powder vial, one solvent vial and a device for reconstitution (BAXJECT II Hi-Flow).
Slovenian: Eno pakiranje vsebuje eno vialo s praškom, eno vialo z vehiklom in pripomoček za rekonstitucijo (BAXJECT II Hi-Flow).
English: The powder is a white to off-white crumbly powder.
Slovenian: Prašek je bel do sivobel in drobljiv.
English: Quickly insert the purple plastic spike fully into the powder vial stopper by pushing straight down (Figure D).
Slovenian: Hitro v celoti uvedite vijolično plastično konico v zamašek viale s praškom tako, da jo potisnete naravnost navzdol (slika D).
English: A total of 66 PTPs with severe haemophilia A were dosed (32 subjects aged < 6 years and 34 subjects aged 6 to < 12 years) in the paediatric study.
Slovenian: V pediatrični študiji je zdravilo prejemalo 66 predhodno zdravljenih bolnikov s hudo hemofilijo A (32 preiskovancev, starih < 6 let, in 34 preiskovancev, starih od 6 do < 12 let).
English: Uncommon side effects (may affect up to 1 in 100 people) Flushing, allergic reaction (hypersensitivity)
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri 1 od 100 bolnikov) rdečica na obrazu z vročinskimi oblivi, alergijske reakcije (preobčutljivost).
English: Medicinal product subject to restricted medical prescription.
Slovenian: Predpisovanje in izdaja zdravila je le na recept z omejitvami.
English: Do not remove the blue cap from the BAXJECT II Hi-Flow device.
Slovenian: Modrega pokrovčka ne snemite s pripomočka BAXJECT II Hi-Flow.
English: Solvent: Clear and colourless solution.
Slovenian: Vehikel: bistra in brezbarvna raztopina.
English: After reconstitution this medicinal product contains 0.45 mmol sodium (10 mg) per vial.
Slovenian: To zdravilo po rekonstituciji vsebuje 0,45 mmol (10 mg) natrija na vialo.
English: Draw the reconstituted solution into the syringe by pulling the plunger back slowly.
Slovenian: Rekonstituirano raztopino povlecite v brizgo tako, da počasi povlečete bat.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, 1000 IU or 2000 IU of powder.
Slovenian: Viala iz stekla tipa I, zaprta z zamaškom iz klorobutilne gume, ki vsebuje 250 i.e., 500 i.e., 1000 i.e. ali 2000 i.e. praška.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 2 ml of sterilised water for injections.
Slovenian: Viala iz stekla tipa I, zaprta z zamaškom iz klorobutilne gume, ki vsebuje 2 ml sterilizirane vode za injekcije.
English: - The solvent vial contains 5 ml of sterilised water for injections.
Slovenian: - Viala z vehiklom vsebuje 5 ml sterilizirane vode za injekcije.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 5 ml of sterilised water for injections.
Slovenian: Viala iz stekla tipa I, zaprta z zamaškom iz klorobutilne gume, ki vsebuje 5 ml sterilizirane vode za injekcije.
English: Turn the system over so that the solvent vial is on top.
Slovenian: Sistem obrnite tako, da je viala z vehiklom zgoraj.
English: or 1000 IU rurioctocog alfa pegol.
Slovenian: 1000 i.e. rurioktokoga alfa pegola.
English: - The solvent vial contains 2 ml of sterilised water for injections.
Slovenian: - Viala z vehiklom vsebuje 2 ml sterilizirane vode za injekcije.
English: Press straight down to fully insert the clear plastic spike through the solvent vial stopper (Figure B).
Slovenian: Pritisnite naravnost navzdol in v celoti uvedite prozorno plastično konico skozi zamašek viale z vehiklom (slika B).
English: Instructions for injection Antiseptic technique (clean and low-germ conditions) is required during administration.
Slovenian: Med pripravo raztopine in uporabo je potrebna aseptična tehnika (čisto stanje, z nizko ravnijo mikroorganizmov).
English: Grip the BAXJECT II Hi-Flow package at its edge and pull the package off the device (Figure C).
Slovenian: Ovojnino pripomočka BAXJECT II Hi-Flow primite na robu in jo snemite s pripomočka (slika C).
English: Solvent Sterilised water for injections
Slovenian: Sterilizirana voda za injekcije
English: The half-life extension in the paediatric population was 1.3 to 1.5 fold using both the one stage clotting and chromogenic assays.
Slovenian: Podaljšanje razpolovne dobe v pediatrični populaciji, ugotovljeno z enostopenjskih testom strjevanja in s kromogenim testom, je bilo od 1,3 do 1,5-kratno.
English: Type I glass vial, closed with a chlorobutyl rubber stopper, containing 250 IU, 500 IU, or 1000 IU of powder.
Slovenian: Viala iz stekla tipa I, zaprta z zamaškom iz klorobutilne gume, ki vsebuje 250 i.e., 500 i.e. ali 1000 i.e. praška.
English: Remove plastic caps from the powder and solvent vials.
Slovenian: Z vial s praškom in vehiklom snemite plastični zaporki.
English: Plasma factor VIII activity was measured by the one stage clotting assay and chromogenic assay.
Slovenian: Aktivnost faktorja VIII v plazmi so izmerili z enostopenjskim testom strjevanja in s kromogenim testom.
English: After reconstitution the solution should be clear, colourless and free from particles.
Slovenian: Po rekonstituciji mora biti raztopina bistra, brezbarvna in brez delcev.
English: Use antiseptic technique (clean and low-germ conditions) and a flat work surface during the reconstitution procedure.
Slovenian: Med rekonstitucijo uporabljajte aseptično tehniko (čisto stanje, z nizko ravnijo mikroorganizmov) in ravno delovno površino.
English: Common side effects (may affect up to 1 in 10 people) Headache, nausea, diarrhoea, rash
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) Glavobol, siljenje na bruhanje, driska, izpuščaj
English: Remove the blue cap from BAXJECT III.
Slovenian: Snemite modri pokrovček s pripomočka BAXJECT III.
English: Peel-off labels are provided on the blister.
Slovenian: Nalepke so nalepljene na pretisnem omotu.
English: ADYNOVI contains the active substance rurioctocog alfa pegol, pegylated human coagulation factor VIII.
Slovenian: Zdravilo ADYNOVI vsebuje učinkovino rurioktokog alfa pegol, pegilirani humani koagulacijski faktor VIII.
English: The active substance rurioctocog alfa pegol is a covalent conjugate of the protein octocog alfa* with a 20 kDa polyethylene glycol (PEG).
Slovenian: Učinkovina rurioktokog alfa pegol je kovalentni konjugat beljakovine oktokog alfa* s polietilenglikolom (PEG) z molekulsko maso 20 kDa.
English: The mean clearance (based on body weight) of ADYNOVI was higher and the mean half-life was lower in children less than 12 years of age than adults.
Slovenian: mlajših od 12 let, je bil večji, povprečna razpolovna doba pa krajša, kot pri odraslih.
English: Table 2: Adverse reactions reported for ADYNOVI
Slovenian: Preglednica 2: Neželeni učinki, o katerih so poročali pri zdravilu ADYNOVI Organski sistem po klasifikaciji MedDRA
English: - The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80 and sterilised water for injections.
Slovenian: - Druge sestavine zdravila so manitol, trehaloza dihidrat, histidin, glutation, natrijev klorid, kalcijev klorid dihidrat, tris(hidroksimetil)aminometan, polisorbat 80 in sterilizirana voda za injekcije.
English: ADYNOVI contains sodium
Slovenian: Zdravilo ADYNOVI vsebuje natrij
English: The reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirano zdravilo pred uporabo s prostim očesom preglejte glede vsebnosti delcev in spremembe barve.
English: How to store ADYNOVI
Slovenian: Kako dajati zdravilo ADYNOVI
English: • Visually inspect the reconstituted solution for particulate matter and discoloration prior to administration.
Slovenian: • Rekonstituirano raztopino pred uporabo s prostim očesom preglejte glede vsebnosti delcev in spremembe barve.
English: The solvent is a clear, colourless solution.
Slovenian: Vehikel je bistra, brezbarvna raztopina.
English: After reconstitution, the solution is clear, colourless and free from foreign particles.
Slovenian: Po rekonstituciji je raztopina bistra, brezbarvna in brez tujkov.
English: Paediatric Pharmacokinetics
Slovenian: Farmakokinetika v pediatrični populaciji
English: After reconstitution the solution should be clear, colourless and free from foreign particles.
Slovenian: Po rekonstituciji mora biti raztopina bistra, brezbarvna in brez tujkov.
English: Use the product within 3 hours once the powder is completely dissolved.
Slovenian: Ko se prašek popolnoma raztopi, zdravilo uporabite v 3 urah.
English: Excipients: mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80
Slovenian: Pomožne snovi: manitol, trehaloza dihidrat, histidin, glutation, natrijev klorid, kalcijev klorid dihidrat, tris(hidroksimetil)aminometan, polisorbat 80
English: 1 powder vial, 1 vial with 5 ml solvent, 1 BAXJECT II Hi-Flow device.
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom, 1 viala s 5 ml vehikla, 1 pripomoček BAXJECT II Hi-Flow.
English: • Do not refrigerate the solution after preparation.
Slovenian: • Raztopine po pripravi ne shranjujte v hladilniku.
English: Remove the blue cap from the BAXJECT II Hi-Flow device (Figure E).
Slovenian: S pripomočka BAXJECT II Hi-Flow snemite modri pokrovček (slika E).
English: 250 IU
Slovenian: 250 i.e.
English: 1 powder vial, 1 vial with 2 ml solvent, 1 BAXJECT II Hi-Flow device.
Slovenian: Prašek in vehikel za raztopino za injiciranje 1 viala s praškom, 1 viala z 2 ml vehikla, 1 pripomoček BAXJECT II Hi-Flow.
English: o Do not use if particulate matter or discoloration is observed.
Slovenian: o Ne uporabljajte raztopine, če opazite, da vsebuje delce ali ima spremenjeno barvo.
English: ADYNOVI 250 IU / 5 ml powder and solvent for solution for injection ADYNOVI 500 IU / 5 ml powder and solvent for solution for injection ADYNOVI 1000 IU / 5 ml powder and solvent for solution for injection ADYNOVI 2000 IU / 5 ml powder and solvent for solution for injection
Slovenian: ADYNOVI 250 i.e./5 ml prašek in vehikel za raztopino za injiciranje ADYNOVI 500 i.e./5 ml prašek in vehikel za raztopino za injiciranje ADYNOVI 1000 i.e./5 ml prašek in vehikel za raztopino za injiciranje ADYNOVI 2000 i.e./5 ml prašek in vehikel za raztopino za injiciranje
English: - The other ingredients are mannitol, trehalose dihydrate, histidine, glutathion, sodium chloride, calcium chloride dihydrate, tris(hydroxymethyl)aminomethane, polysorbate 80.
Slovenian: - Druge sestavine zdravila so manitol, trehaloza dihidrat, histidin, glutation, natrijev klorid, kalcijev klorid dihidrat, tris(hidroksimetil)aminometan, polisorbat 80.