FrancophonIA/ELRC3.0 huggingface dataset:
English: Because of the risk of allergic reactions with factor IX products, the initial administration of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Slovenian: Zaradi tveganja za nastanek alergijskih reakcij pri uporabi zdravil s faktorjem IX je treba začetno dajanje faktorja IX po presoji lečečega zdravnika izvajati pod zdravniškim nadzorom, kjer lahko zagotovimo ustrezno medicinsko oskrbo v primeru nastopa alergijskih reakcij.
English: IDELVION 250 IU powder and solvent for solution for injection 175 - 215 mOsm/kg.
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje 175 - 215 mOsm/kg
English: It is suggested that the initial administrations of factor IX should, according to the treating physician's judgment, be performed under medical observation where proper medical care for allergic reactions could be provided.
Slovenian: Dajanje začetnih odmerkov faktorja IX, po presoji lečečega zdravnika, je treba izvajati pod zdravniškim nadzorom, kjer lahko zagotovimo ustrezno medicinsko oskrbo v primeru nastopa alergijskih reakcij.
English: How to use IDELVION
Slovenian: Kako uporabljati zdravilo IDELVION
English: The mean factor IX activity at day 7 and day 14 was 13.76% and 6.10%, respectively, after a single dose of 50 IU/kg IDELVION.
Slovenian: Povprečna aktivnost faktorja IX je bila po enkratnem odmerku 50 i.e./kg zdravila IDELVION na 7. in 14. dan 13,76 % oziroma 6,10 %.
English: Pale yellow to white powder and clear, colourless solvent for solution for injection.
Slovenian: prašek in vehikel za raztopino za injiciranje Bledo rumen do bel prašek in bister, brezbarven vehikel za raztopino za injiciranje.
English: What is IDELVION used for?
Slovenian: Za kaj uporabljamo zdravilo IDELVION?
English: The active substance is:
Slovenian: Učinkovina je:
English: IDELVION 250 IU
Slovenian: IDELVION 250 i.e.
English: Albutrepenonacog alfa 2000 IU
Slovenian: albutrepenonakog alfa 2000 i.e.
English: Pharmacokinetic Parameters for subjects with severe haemophilia (Median (min, max)) following a single injection of 50 IU/kg IDELVION
Slovenian: Farmakokinetični parametri za preiskovance s hudo hemofilijo (mediana (min, maks)) po enkratni injekciji zdravila IDELVION v odmerku 50 i.e./kg
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 counterclockwise.
Slovenian: Zdaj ko je raztopina prenešena v injekcijsko brizgo, trdno primite tulec injekcijske brizge (bat naj bo še vedno obrnjen navzdol) in snemite set Mix2Vial z injekcijske brizge z odvijanjem v nasprotni smeri urinega kazalca.
English: Trough levels of 5-10% have been targeted in clinical trials for achieving bleeding control while on prophylaxis.
Slovenian: V kliničnih preskušanjih obvladovanja krvavitev med prejemanjem profilaktičnega zdravljenja so bile ciljne najnižje koncentracije med 5 - 10 %.
English: A dose of 1000 IUs of IDELVION, administered to a 25 kg patient, should be expected to result in a peak post-injection factor IX increase of 1000 IUs/25 kg x 1.0 (IU/dl per IU/kg) = 40 IU/dl (40 % of normal).
Slovenian: Za odmerek 1000 i.e. zdravila IDELVION, uporabljen pri bolniku s telesno maso 25 kg, se pričakuje, da po injiciranju povzroči najvišje zvišanje ravni faktorja IX za 1000 i.e./25 kg x 1,0 (i.e./dl na i.e./kg) = 40 i.e./dl (40 % normalne vrednosti).
English: A peak level of 50 % of normal is required in a 20 kg patient with severe haemophilia B. The appropriate dose would be 20 kg x 50 IU/dl x 1 dl/kg = 1000 IUs.
Slovenian: Najvišja raven, ki je 50 % normalne vrednosti, je potrebna pri bolniku s telesno maso 20 kg in hudo hemofilijo B. Ustrezen odmerek bi bil 20 kg x 50 i.e./dl x 1 dl/kg = 1000 i.e.
English: The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism.
Slovenian: Uporaba zdravil faktorja IX majhne čistote je bila povezana s primeri miokardnega infarkta, diseminirane intravaskularne koagulacije, venske tromboze in pljučne embolije, medtem ko je uporaba zdravil faktorja IX velike čistote le redko povezana s takšnimi neželenimi učinki.
English: Do not use the solution if it is cloudy or if it contains flakes or particles.
Slovenian: Motnih raztopin ali raztopin, ki vsebujejo kosmiče ali delce, ne uporabite.
English: Open the Mix2Vial by peeling off the lid. Do not remove the Mix2Vial from the blister package!
Slovenian: Ne odstranite Mix2Vial iz pretisnega omota!
English: For routine prophylaxis the recommended dose regimen for paediatric subjects is 35 to 50 IU/kg once weekly.
Slovenian: Za rutinsko profilakso je priporočena shema odmerjanja pri pediatričnih bolnikih 35 do 50 i.e./kg enkrat na teden.
English: Comparison of Pharmacokinetic Parameters of IDELVION by Age Category (Median (min, max)) Following a Single Injection of 50 IU/kg IDELVION
Slovenian: Primerjava farmakokinetičnih parametrov zdravila IDELVION po starostnih skupinah (mediana (min, maks)) po enkratni injekciji zdravila IDELVION v odmerku 50 i.e./kg Farmakokinetični parametri
English: Albutrepenonacog alfa 250 IU
Slovenian: albutrepenonakog alfa 250 i.e.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using IDELVION.
Slovenian: Pred začetkom uporabe zdravila IDELVION se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: For an incremental recovery of 1 IU/dl per 1 IU/kg, the dose is calculated as follows: Dose (IU) = body weight (kg) x desired factor IX increase (IU/dl) x 1 dl/kg
Slovenian: Za postopno povrnitev aktivnosti 1 i.e./dl na 1 i.e./kg se odmerek izračuna kot sledi: Odmerek (i.e.) = telesna masa (kg) x želeno zvišanje ravni faktorja IX (i.e./dl) x 1 dl/kg
English: • If you have further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: FIX inhibition/Inhibitor development
Slovenian: Inhibicija faktorja IX /razvoj inhibitorjev neznana pogostnost
English: IDELVION 1000 IU
Slovenian: IDELVION 1000 i.e.
English: Posology
Slovenian: Pakiranja
English: Expected factor IX rise (IU/dl or % of normal) = Dose (IU) x Recovery (IU/dl per IU/kg)/body weight (kg)
Slovenian: Pričakovani dvig faktorja IX (i.e./dl ali % normalne vrednosti) = odmerek (i.e.) x povrnitev aktivnosti (i.e./dl na i.e./kg)/telesna masa (kg)
English: IDELVION (INN: albutrepenonacog alfa) is a recombinant coagulation factor IX.
Slovenian: Zdravilo IDELVION (INN: albutrepenonakog alfa) je rekombinantni koagulacijski faktor IX.
English: Single dose may be sufficient for a majority of minor surgeries.
Slovenian: 50 - 80 (začetna raven) Enkratni odmerek lahko zadostuje za večino manjših operacij.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 2.5 ml
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH viala z vehiklom 2,5 ml
English: Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Slovenian: Pri poskusu indukcije imunske tolerance pri bolnikih s hemofilijo B, ki so imeli inhibitorje faktorja IX in alergijske reakcije v anamnezi, so poročali o nefrotskem sindromu.
English: Albutrepenonacog alfa 1000 IU
Slovenian: albutrepenonakog alfa 1000 i.e.
English: Inhibitor development has been observed in previously treated patients in the post-marketing experience with IDELVION.
Slovenian: Po prihodu zdravila IDELVION na trg so pri predhodno zdravljenih bolnikih opazili razvoj inhibitorjev.
English: The active substance in IDELVION is albutrepenonacog alfa (recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP)).
Slovenian: Učinkovina v zdravilu IDELVION je albutrepenonakog alfa (rekombinantni fuzijski protein, sestavljen iz koagulacijskega faktorja IX, povezanega z albuminom (rIX-FP)).
English: Albutrepenonacog alfa 500 IU
Slovenian: albutrepenonakog alfa 500 i.e.
English: IDELVION 500 IU
Slovenian: IDELVION 500 i.e.
English: Clinical studies of IDELVION did not include subjects aged 65 and over.
Slovenian: Osebe, stare 65 let in več, niso bile vključene v klinične študije zdravila IDELVION.
English: 1 vial with 5 ml water for injections 1 filter transfer device 20/20
Slovenian: 1 vialo s 5 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
English: 1 venipuncture set
Slovenian: 1 komplet za punkcijo vene
English: Discard the solvent vial with the blue Mix2Vial adapter attached.
Slovenian: Zavrzite vialo vehikla skupaj z modrim adapterjem, pritrjenim na Mix2Vial.
English: What IDELVION contains
Slovenian: Kaj vsebuje zdravilo IDELVION
English: After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Po filtraciji/izsesanju (glejte spodaj) pred dajanjem preverite videz rekonstituiranega zdravila, da raztopina ne vsebuje delcev in da ni obarvana.
English: 1 vial with 2.5 ml water for injections 1 filter transfer device 20/20
Slovenian: 1 viala z 2,5 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 2000 IU
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH viala s praškom 2000 i.e.
English: • Eczema
Slovenian: • ekcem.
English: While the product vial is upright, connect the syringe to the Mix2Vial's Luer Lock fitting by screwing clockwise.
Slovenian: Medtem ko je viala z zdravilom v pokončnem položaju, priključite injekcijsko brizgo na »Luerjev zaklop« na setu Mix2Vial s privijanjem v smeri urinega kazalca.
English: 2.5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: 2,5 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: 5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: 5 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 250 IU
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH viala s praškom 250 i.e.
English: IDELVION 2000 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje 260 - 300 mOsm/kg
English: IDELVION 2000 IU powder and solvent for solution for injection Powder (2000 IU) in a 10 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje Prašek (2000 i.e) v 10 ml viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Germany
Slovenian: CSL Behring GmbH Emil-von-Behring Strasse 76 35041 Marburg Nemčija
English: powder and solvent for solution for injection 1 vial with powder: 250 IU albutrepenonacog alfa (100 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 250 i.e. albutrepenonakoga alfa (100 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
English: 1 disposable 5 ml syringe
Slovenian: 1 injekcijska brizga (5 ml) za enkratno uporabo
English: IDELVION 1000 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje 260 - 300 mOsm/kg
English: How to store IDELVION
Slovenian: Shranjevanje zdravila IDELVION
English: IDELVION 250 IU powder and solvent for solution for injection Powder (250 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje Prašek (250 i.e) v 6 ml viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Germany
Slovenian: CSL Behring GmbH Emil-von-Behring-Str. 76 35041 Marburg Nemčija
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 500 IU
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH viala s praškom 500 i.e.
English: IDELVION 500 IU powder and solvent for solution for injection 260 - 300 mOsm/kg.
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje 260 - 300 mOsm/kg
English: powder and solvent for solution for injection 1 vial with powder: 500 IU albutrepenonacog alfa (200 IU/ml after reconstitution) 1 vial with 2.5 ml water for injections
Slovenian: prašek in vehikel za raztopino za injiciranje 1 viala s praškom: 500 i.e. albutrepenonakoga alfa (200 i.e./ml po rekonstituciji) 1 viala z 2,5 ml vode za injekcije
English: IDELVION 2000 IU powder and solvent for solution for injection 1 vial with powder
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje 1 viala s praškom
English: IDELVION 250 IU powder and solvent for solution for injection One vial contains nominally 250 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. rekombinantnega fuzijskega proteina, sestavljenega iz koagulacijskega faktorja IX, povezanega z albuminom (rIX-FP), (INN = albutrepenonakog alfa).
English: IDELVION 1000 IU powder and solvent for solution for injection Powder (1000 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje Prašek (1000 i.e) v 6 ml viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj občasni ekcem občasni
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, na katero je pritrjen set Mix2Vial, in porinite konico prozornega adapterja naravnost navzdol skozi zamašek viale z zdravilom.
English: IDELVION 500 IU powder and solvent for solution for injection Powder (500 IU) in a 6 ml vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje Prašek (500 i.e) v 6 ml viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
English: IDELVION 2000 IU powder and solvent for solution for injection One vial contains nominally 2000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. rekombinantnega fuzijskega proteina, sestavljenega iz koagulacijskega faktorja IX, povezanega z albuminom (rIX-FP), (INN = albutrepenonakog alfa).
English: IDELVION 500 IU powder and solvent for solution for injection 1 vial with powder
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje 1 viala s praškom
English: Dizziness
Slovenian: Odmerek
English: IDELVION 250 IU powder and solvent for solution for injection
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje
English: IDELVION 500 IU powder and solvent for solution for injection One vial contains nominally 500 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. rekombinantnega fuzijskega proteina, sestavljenega iz koagulacijskega faktorja IX, povezanega z albuminom (rIX-FP), (INN = albutrepenonakog alfa).
English: IDELVION 1000 IU powder and solvent for solution for injection One vial contains nominally 1000 IU of recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP), (INN = albutrepenonacog alfa).
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. rekombinantnega fuzijskega proteina, sestavljenega iz koagulacijskega faktorja IX, povezanega z albuminom (rIX-FP), (INN = albutrepenonakog alfa).
English: IDELVION 2000 IU powder and solvent for solution for injection
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje
English: 2000 IU per vial; after reconstitution with 5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Slovenian: 2000 i.e. na vialo; po pripravi s 5 ml vode za injekcije raztopina vsebuje približno 400 i.e./ml albutrepenonakoga alfa.
English: IDELVION 1000 IU powder and solvent for solution for injection
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje
English: IDELVION 500 IU powder and solvent for solution for injection
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje
English: IDELVION 1000 IU powder and solvent for solution for injection 1 vial with powder
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje 1 viala s praškom
English: 500 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.
Slovenian: 500 i.e. na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 200 i.e./ml albutrepenonakoga alfa.
English: IDELVION 2000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 2000 i.e. prašek in vehikel za raztopino za injiciranje albutrepenonakog alfa
English: After reconstitution with 5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Slovenian: Po rekonstituciji s 5 ml vode za injekcije raztopina vsebuje 400 i.e./ml albutrepenonakoga alfa.
English: IDELVION 500 IU powder and solvent for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 500 i.e. prašek in vehikel za raztopino za injiciranje albutrepenonakog alfa
English: 250 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.
Slovenian: 250 i.e na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 100 i.e./ml albutrepenonakoga alfa.
English: 1000 IU per vial; after reconstitution with 2.5 ml of water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Slovenian: 1000 i.e na vialo; po pripravi z 2,5 ml vode za injekcije raztopina vsebuje približno 400 i.e./ml albutrepenonakoga alfa.
English: IDELVION 250 IU powder and solvent for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje albutrepenonakog alfa
English: After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of albutrepenonacog alfa.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 200 i.e./ml albutrepenonakoga alfa.
English: IDELVION 250 IU powder and solvent for solution for injection: 1 vial with powder
Slovenian: IDELVION 250 i.e. prašek in vehikel za raztopino za injiciranje 1 viala s praškom
English: After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of albutrepenonacog alfa.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 100 i.e./ml albutrepenonakoga alfa.
English: IDELVION 1000 IU powder and solvent for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 1000 i.e. prašek in vehikel za raztopino za injiciranje albutrepenonakog alfa
English: Formation of inhibitor to factor IX has been reported during factor replacement therapy with IDELVION in the treatment of haemophilia B. 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 nadomestnem zdravljenju z zdravilom IDELVION pri zdravljenju hemofilije B so poročali o nastanku inhibitorjev proti faktorju IX.
English: IDELVION 250 IU powder for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 250 i.e. prašek za raztopino za injiciranje albutrepenonakog alfa za intravensko uporabo
English: After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of albutrepenonacog alfa.
Slovenian: Po rekonstituciji z 2,5 ml vode za injekcije raztopina vsebuje 400 i.e./ml albutrepenonakoga alfa.
English: IDELVION 2000 IU powder for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 2000 i.e. prašek za raztopino za injiciranje albutrepenonakog alfa za intravensko uporabo
English: 1 disposable 5 ml syringe 1 venipuncture set
Slovenian: 1 injekcijska brizga (5 ml) za enkratno uporabo 1 komplet za punkcijo vene
English: IDELVION 500 IU powder for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 500 i.e. prašek za raztopino za injiciranje albutrepenonakog alfa za intravensko uporabo
English: IDELVION 1000 IU powder for solution for injection Albutrepenonacog alfa
Slovenian: IDELVION 1000 i.e. prašek za raztopino za injiciranje albutrepenonakog alfa za intravensko uporabo
English: Attach the syringe to the threaded, locking end of the venipuncture kit.
Slovenian: Pritrdite injekcijsko brizgo na navojni, zaporni del kompleta za punkcijo vene.
English: 1 disposable 10 ml syringe
Slovenian: 1 viala s 5 ml vode za injekcije
English: Headache
Slovenian: Krvavitev
English: Pharmaceutical Form Route of administrationPackaging
Slovenian: Farmacevtska oblika Pot uporabe
English: This may be painful and can occur at any time.
Slovenian: Lahko so boleče in se pojavijo kadar koli.
English: Frequency: common
Slovenian: Pogostnost: pogosti
English: 2 - What you need to know before you take <product name> Warnings and precautions
Slovenian: 2 - Kaj morate vedeti, preden boste vzeli zdravilo <ime zdravila> Opozorila in previdnostni ukrepi
English: Priapism.
Slovenian: Priapizem.
English: It is important to contact your doctor straight away if your erection lasts for longer than 2 hours, particularly if this is painful.
Slovenian: Pomembno je, da se takoj posvetujete z zdravnikom, če erekcija traja dlje kot 2 uri, zlasti če je boleča.
English: Benign polyps in the stomach
Slovenian: Benigni polipi v želodcu
English: Adopted at the 28 November-1 December 2016 PRAC
Slovenian: Sprejeto na seji odbora PRAC med 28. novembrom in 1. decembrom 2016
English: Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Slovenian: Bolniki, pri katerih se pojavijo nenormalno dolge ali pogoste in boleče erekcije, morajo takoj poiskati zdravniško pomoč.
English: During treatment, boys and adolescents may unexpectedly experience prolonged erections.
Slovenian: Med zdravljenjem se pri dečkih in mladostnikih lahko nepričakovano pojavijo dolgotrajne erekcije.
English: In case calciphylaxis is diagnosed, appropriate treatment should be started and consideration should be given to stopping treatment with <product name>.
Slovenian: Če se ugotovi kalcifilaksija, je treba začeti s primernim zdravljenjem in razmisliti o prekinitvi zdravljenja z zdravilom <ime zdravila>.
English: This adverse reaction occurs more frequently in patients with chronic kidney disease.
Slovenian: Ti neželeni učinki se pogosteje pojavijo pri bolnikih s kronično ledvično boleznijo.