FrancophonIA/ELRC3.0 huggingface dataset:
English: The completed clinical trial programme included one phase 1 trial and four phase 3 multicentre, noncontrolled trials.
Slovenian: Klinična učinkovitost Dokončani program kliničnega preskušanja vključuje eno preskušanje 1. faze in štiri multicentrična,
English: Steady state pharmacokinetic parameters for adolescents and adults are shown in Table 4
Slovenian: Farmakokinetični parametri v stanju dinamičnega ravnovesja pri mladostnikih in odraslih so prikazani v preglednici 4.
English: Dosing recommendations
Slovenian: Priporočila za odmerjanje
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Slovenian: Ne zavrzite nobenega pripomočka, dokler ne injicirate rekonstituirane raztopine.
English: Use the injection immediately after reconstitution.
Slovenian: Zdravilo injicirajte takoj po rekonstituciji.
English: • The powder is white to off-white and the solvent is clear and colourless.
Slovenian: • Prašek je bel do skoraj bel, vehikel pa bister in brezbarven.
English: Overall haemostatic efficacy
Slovenian: Celokupna učinkovitost hemostaze
English: • 1 plunger rod (placed under the syringe)
Slovenian: • 1 potisni bat (nameščen je pod injekcijsko brizgo).
English: Single-dose pharmacokinetic parameters of Refixia are listed by age in Table 5.
Slovenian: Farmakokinetični parametri po enkratnem odmerku zdravila so prikazani glede na starost v preglednici 5.
English: The analysis of plasma samples was conducted using the one-stage clotting assay.
Slovenian: Analiza vzorcev plazme je bila izvedena z enostopenjskim testom strjevanja krvi.
English: Record of use
Slovenian: Beleženje uporabe
English: Factor IX is a single chain glycoprotein.
Slovenian: Faktor IX je enoverižni glikoprotein.
English: The use of Refixia in children below 12 years is not indicated.
Slovenian: Uporaba zdravila Refixia pri otrocih, mlajših od 12 let, ni indicirana.
English: Because of the risk of allergic reactions with factor IX, your initial treatment with Refixia should be given in a medical clinic or in the presence of health care professionals where proper medical care for allergic reactions can be provided if needed.
Slovenian: Zaradi tveganja za pojav alergijskih reakcij pri uporabi faktorja IX, je treba zdravljenje z zdravilom Refixia uvesti v zdravstveni ustanovi ali v prisotnosti zdravstvenih delavcev, da je v primeru pojava alergijske reakcije možno nemudoma uvesti ustrezno zdravljenje, če je le-to potrebno.
English: ≥18 years N=6
Slovenian: ≥ 18 let N=6
English: Do not use the powder if the colour has changed.
Slovenian: Če se je barva praška spremenila, ga ne uporabljajte.
English: If the plastic cap is loose or missing, do not use the vial.
Slovenian: Če plastična zaporka ni trdno pritrjena ali manjka, viale ne uporabljajte.
English: If you have to significantly increase your usage of Refixia to stop a bleed, talk to your doctor immediately.
Slovenian: Če ste za zaustavitev krvavitve morali znatno povečati uporabo zdravila Refixia, se nemudoma posvetujte z zdravnikom.
English: • Do not touch the syringe tip.
Slovenian: • Ne dotikajte se konice injekcijske brizge.
English: The dose of Refixia is 40 international units (IU) per kg of body weight.
Slovenian: Odmerek zdravila Refixia je 40 mednarodnih enot (i.e.) na kg telesne mase.
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: Bolnika je treba poučiti o zgodnjih znakih preobčutljivostne reakcije, vključno s koprivnico, generalizirano urtikarijo, stiskanjem v prsnem košu, pojavom piskajočega dihanja, hipotenzijo in anafilaksijo.
English: Treatment with Refixia will be started by a doctor who is experienced in the care of patients with haemophilia B. Always use this medicine exactly as your doctor has told you.
Slovenian: Kako uporabljati zdravilo Refixia Zdravljenje z zdravilom Refixia bo uvedel zdravnik, ki ima izkušnje z zdravljenjem bolnikov s hemofilijo B. Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: In children aged 0-12 years, the median (IQR) annualised bleeding rate was 1.0 (0.00; 2.06) and the spontaneous bleeding rate was 0.00 (0.00; 0.00).
Slovenian: Pri otrocih, starih 0-12 let, je mediana (IQR, kvartilni razmik) deleža krvavitev v enem letu znašala 1,0 (0,00; 2,06), delež spontanih krvavitev pa 0,00 (0,00; 0,00).
English: If it cannot be used immediately, use within 24 hours if stored in a refrigerator at 2°C - 8°C or within 4 hours if stored out of the refrigerator at a maximum temperature of 30°C.
Slovenian: Če zdravila ne morete uporabiti takoj, ga porabite v 24 urah, če ga shranjujete v hladilniku pri temperaturi 2 °C - 8 °C, ali v 4 urah, če ga shranjujete izven hladilnika pri temperaturi do 30 °C.
English: Adjustments of doses and administration intervals may be considered based on achieved FIX levels and individual bleeding tendency.
Slovenian: Odmerke in časovne intervale aplikacij se lahko prilagodi na osnovi doseženih vrednosti FIX in nagnjenosti posameznega bolnika h krvavitvam.
English: Method of administration Intravenous use.
Slovenian: Način uporabe intravenska uporaba
English: • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na učinkovino ali katero koli sestavino tega zdravila (navedeno v poglavju 6), • če ste alergični na hrčkove beljakovine.
English: In 29 adult and adolescent patients treated, 13 patients with 20 target joints were treated for one year with a weekly prophylactic dose of 40 IU/kg.
Slovenian: Od 29 zdravljenih odraslih in mladostnikov se je 13 bolnikov z 20 sklepi s pogostimi krvavitvami (target joints) eno leto zdravilo s tedenskim profilaktičnim odmerkom 40 i.e./kg.
English: There were no apparent differences in the pharmacokinetic profiles between normal weight and overweight patients.
Slovenian: Med bolniki z normalno telesno maso in bolniki s prekomerno telesno maso niso opazili očitnih razlik v farmakokinetičnem profilu.
English: 2 years.
Slovenian: Pred odprtjem2 leti.
English: Refixia is recommended to be used immediately after it has been reconstituted.
Slovenian: Priporočljivo je, da zdravilo Refixia uporabite takoj po rekonstituciji.
English: Each pack contains: - 1 glass vial (type I) with powder and chlorobutyl rubber stopper - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 ml histidine solvent with backstop (polypropylene), a rubber plunger
Slovenian: Eno pakiranje vsebuje: - 1 stekleno vialo (steklo tipa I) s praškom in zamaškom iz klorobutilne gume, - 1 sterilni nastavek za vialo za rekonstitucijo, - 1 napolnjeno injekcijsko brizgo s 4 ml vehikla s histidinom z držalom (polipropilen),
English: Do not use Refixia after the expiry date which is stated after “EXP” on the carton and on the vial and the pre-filled syringe labels.
Slovenian: Zdravila Refixia ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki na viali ter napolnjeni injekcijski brizgi poleg oznake “EXP”.
English: Novo Nordisk A/S Hagedornsvej 1 DK-2820 Gentofte Denmark
Slovenian: Novo Nordisk A/S Hagedornsvej 1 DK-2820 Gentofte Danska
English: The solvent is a histidine solution.
Slovenian: Vehikel je raztopina histidina.
English: Pre-operative dose.
Slovenian: Odmerek pred kirurškim posegom.
English: If you use more Refixia than you should If you use more Refixia than you should, contact your doctor.
Slovenian: Če ste uporabili večji odmerek zdravila Refixia, kot bi smeli, se posvetujte z zdravnikom.
English: No symptoms associated with overdoses have been reported.
Slovenian: povezanih s prevelikim odmerjanjem, niso poročali.
English: By replacement therapy the plasma levels of factor IX are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: Z nadomestnim zdravljenjem se povečajo koncentracije faktorja IX v plazmi in tako začasno odpravi pomanjkanje tega faktorja ter zmanjša nagnjenost bolnika h krvavitvam.
English: Each vial of Refixia contains nominally 500 IU, 1000 IU or 2000 IU nonacog beta pegol corresponding to approximately 125 IU/ml, 250 IU/ml or 500 IU/ml respectively after reconstitution with histidine solvent.
Slovenian: Ena viala zdravila Refixia vsebuje nominalno 500 i.e., 1000 i.e. ali 2000 i.e. nonakog beta pegola, kar po rekonstituciji z vehiklom s histidinom ustreza približno 125 i.e./ml, 250 i.e./ml ali 500 i.e./ml.
English: Refixia can be used only in adolescents (12 years and above).
Slovenian: Uporaba pri otrocih in mladostnikih Zdravilo Refixia se lahko uporablja le pri mladostnikih (starih 12 let in več).
English: The mean trough levels at steady state are presented in Table 6; based on all pre-dose measurements taken every 8 weeks at steady state for all patients on once weekly dosing of 40 IU/kg.
Slovenian: Srednje najmanjše koncentracije v stanju dinamičnega ravnovesja so prikazane v preglednici 6 na osnovi vseh meritev pred odmerkom, izvedenih vsakih 8 tednov v stanju dinamičnega ravnovesja pri vseh bolnikih, ki so se zdravili z odmerkom 40 i.e./kg enkrat na teden.
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Slovenian: Zdravilo lahko shranjujete pri sobni temperaturi (do 30 °C), največ enkrat za obdobje do 6 mesecev.
English: Table 5 Single-dose pharmacokinetic parameters of Refixia (40 IU/kg) by age (geometric mean (CV%))
Slovenian: Preglednica 5: Farmakokinetični parametri po enkratnem odmerku zdravila Refixia (40 i.e./kg) glede na starost (geometrijska sredina (KV %))
English: What Refixia looks like and contents of the pack
Slovenian: Izgled zdravila Refixia in vsebina pakiranja
English: Refixia is given as an injection into a vein.
Slovenian: Zdravilo Refixia se daje v obliki injekcije v veno.
English: The median (IQR) overall annual bleeding rate (ABR) in patients (13-65 years) treated with a prophylactic dose of 40 IU/kg once weekly was 1.04 (0.00; 4.01) whereas the traumatic ABR was 0.00 (0.00; 2.05), joint ABR was 0.97 (0.00; 2.07) and spontaneous ABR was 0.00 (0.00; 0.99).
Slovenian: Mediana (IQR, kvartilni razmik) celokupnega deleža krvavitev v enem letu (ABR - Annual Bleeding Rate) pri bolnikih (starih od 13 do 65 let), ki so se zdravili s profilaktičnim odmerkom 40 i.e./kg enkrat na teden, je znašala 1,04 (0,00; 4,01), medtem ko je delež travmatskih krvavitev v enem letu znašal 0,00 (0,00; 2,05), delež krvavitev v sklepe v enem letu 0,97 (0,00; 2,07), delež spontanih krvavitev v enem letu pa 0,00 (0,00; 0,99).
English: No additives of human or animal origin are used in the cell culture, purification, conjugation, or formulation of Refixia.
Slovenian: postopkih na celični kulturi, pri čiščenju, konjugaciji ali končni izdelavi zdravila Refixia se ne uporabljajo snovi humanega ali živalskega izvora.
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Slovenian: • Pri injiciranju zdravila v napravo za centralni venski dostop boste za odvzem rekonstituirane (pripravljene) raztopine morda morali uporabiti sterilno 10-ml plastično injekcijsko brizgo.
English: Early haemarthrosis, muscle bleeding or oral bleeding.
Slovenian: Zgodnja hemartroza, krvavitev v mišico ali krvavitev v ustni votlini
English: *recombinant human factor IX, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology, covalently conjugated to a 40 kDa polyethylene-glycol (PEG).
Slovenian: *rekombinantni humani faktor IX, pridobljen s tehnologijo rekombinantne DNA v ovarijskih celicah kitajskega hrčka (CHO - Chinese Hamster Ovary), kovalentno konjugiran na 40 kDa polietilen glikola (PEG).
English: Animal reproduction studies have not been conducted with factor IX.
Slovenian: Študij o vplivu faktorja IX na sposobnost razmnoževanja pri živalih niso izvedli.
English: OTHER Novo Nordisk A/S
Slovenian: DRUGI PODATKI Novo Nordisk A/S
English: It should be noted that patients with factor IX inhibitors may be at an increased risk of anaphylaxis with subsequent challenge with factor IX.
Slovenian: Poudariti je treba, da je pri bolnikih z zaviralci faktorja IX tveganje za pojav anafilaksije pri naslednjem zdravljenju s faktorjem IX lahko večje.
English: The reconstituted solution will be clear and colourless.
Slovenian: Rekonstituirana raztopina je bistra in brezbarvna.
English: INFORMATION IN BRAILLE Refixia 2000 IU
Slovenian: PODATKI V BRAILLOVI PISAVI Refixia 2000 i.e.
English: Pack size of 1.
Slovenian: Velikost pakiranja: 1 pakiranje.
English: Recommended dose IU/kg body weight
Slovenian: Priporočeni odmerek v i.e./kg telesne mase
English: Refixia has a prolonged half-life compared to unmodified factor IX.
Slovenian: Zdravilo Refixia ima podaljšan razpolovni čas v primerjavi z nemodificiranim faktorjem IX.
English: Refixia is now ready to inject into your vein.
Slovenian: Zdravilo Refixia je sedaj pripravljeno za injiciranje v veno.
English: In an ongoing trial in previously untreated patients, anaphylaxis has occurred in close temporal association with development of factor IX inhibitors following treatment with Refixia.
Slovenian: V preskušanju pri predhodno nezdravljenih bolnikih, ki še poteka, so poročali o pojavu anafilaksije v tesni časovni povezavi z razvojem zaviralcev faktorja IX po zdravljenju z zdravilom Refixia.
English: After storage at room temperature the medicine must not be put back in the refrigerator.
Slovenian: Po začetku shranjevanja pri sobni temperaturi zdravila ne smete dajati nazaj v hladilnik.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Bolniku je treba pojasniti, da mora v primeru pojava simptomov preobčutljivostne reakcije takoj prenehati uporabljati zdravilo in se nemudoma posvetovati z zdravnikom.
English: INFORMATION IN BRAILLE Refixia 1000 IU
Slovenian: PODATKI V BRAILLOVI PISAVI Refixia 1000 i.e.
English: Estimated mean factor IX trough levels IU/ml (95% CI)
Slovenian: Ocenjena srednja najmanjša koncentracija faktorja IX v i.e./ml (95 % IZ)
English: Treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency).
Slovenian: Zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let in več, s hemofilijo B (prirojeno pomanjkanje faktorja IX).
English: Because of the risk of allergic reactions with factor IX products, the initial administrations 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: Ker je uporaba zdravil s faktorjem IX povezana s tveganjem za pojav alergijske reakcije, je treba začetno aplikacijo faktorja IX, v skladu s presojo lečečega zdravnika, izvesti pod zdravniškim nadzorom v okolju, kjer je možno nemudoma uvesti ustrezno zdravljenje v primeru pojava alergijske reakcije.
English: No dose adjustment was required for paediatric or adolescent patients in clinical trials.
Slovenian: V kliničnih preskušanjih pri otrocih ali mladostnikih odmerka ni bilo treba prilagajati.
English: Once the product has been taken out of the refrigerator the product must not be returned to the refrigerator.
Slovenian: Ko se zdravilo enkrat vzame iz hladilnika, se ga ne sme več dati nazaj v hladilnik.
English: *Pruritus includes the terms pruritus and ear pruritus **Injection site reactions include injection site pain, infusion site pain, injection site swelling, injection site erythema and injection site rash.
Slovenian: **Reakcije na mestu injiciranja vključujejo bolečino na mestu injiciranja, bolečino na mestu infundiranja, oteklino na mestu injiciranja, rdečino na mestu injiciranja in izpuščaj na mestu injiciranja.
English: Vial adapter Protective cap
Slovenian: Nastavek za vialo zaščitna zaporka konica
English: What Refixia is and what it is used for
Slovenian: Kaj je zdravilo Refixia in za kaj ga uporabljamo Kaj je zdravilo Refixia
English: Before injection it must be reconstituted with the solvent supplied in the syringe.
Slovenian: Pred injiciranjem ga je treba rekonstituirati z vehiklom, ki je na voljo v injekcijski brizgi.
English: (bromobutyl) and a tip cap with a stopper (bromobutyl) - 1 plunger rod (polypropylene).
Slovenian: gumijastim batnim zamaškom (bromobutil) in zaporko konice z zamaškom (bromobutil), - 1 potisni bat (polipropilen).
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds or 80 IU/kg for severe bleeds, where one bleed was evaluated as severe.
Slovenian: Blage ali zmerne krvavitve so zdravili z zdravilom Refixia v odmerku 40 i.e./kg, hude krvavitve, kjer je bila ena krvavitev ocenjena kot huda, pa v odmerku 80 i.e./kg.
English: Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Slovenian: Pri bolnikih s hemofilijo B se lahko razvijejo nevtralizirajoča protitelesa (zaviralci) proti faktorju IX.
English: After injection, safely dispose of the syringe with the infusion set and the vial with the vial adapter.
Slovenian: Po injiciranju injekcijsko brizgo z infuzijskim kompletom in vialo z nastavkom za vialo varno odstranite.
English: In the post-surgery period Day 1 to 6 and Day 7 to 13, the median number of additional 40 IU/kg doses administered was 2.0 and 1.5, respectively.
Slovenian: V obdobju po operaciji je mediana števila dodatno apliciranih odmerkov od 1. do 6. dne po operaciji znašala 2,0, od 7. do 13. dne po operaciji pa 1,5.
English: Stop the injection and contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, shortness of breath, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, and/or dizziness.
Slovenian: srbenje na velikem predelu kože, rdečina in/ali otekanje ustnic, jezika, obraza ali rok, težave pri požiranju ali dihanju, sopeče ali piskajoče dihanje, stiskanje v prsnem košu, bleda in hladna koža, hiter srčni utrip in/ali omotica, takoj prenehajte z injiciranjem zdravila in se nemudoma posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru.
English: 13-17 years N=3
Slovenian: 13-17 let N=3
English: • Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Slovenian: • Napolnjeno injekcijsko brizgo držite rahlo nagnjeno, tako da je viala usmerjena navzdol.
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) selectively attached to specific N-linked glycans in the rFIX activation peptide.
Slovenian: Zdravilo Refixia je prečiščen rekombinantni humani faktor IX (rFIX) s 40 kDa polietilen glikola (PEG), ki je selektivno pritrjen na specifično N-vezane glikane na aktivacijskem peptidu rFIX.
English: A total of 115 previously treated male patients with moderate or severe haemophilia B have been exposed to Refixia for a total of 170 patient years in the completed clinical trials.
Slovenian: V dokončanih kliničnih preskušanjih je bilo od 115 predhodno zdravljenih moških bolnikov z zmerno do hudo hemofilijo B izpostavljenih zdravilu Refixia skupno 170 bolnikov-let .
English: INFORMATION IN BRAILLE Refixia 500 IU
Slovenian: PODATKI V BRAILLOVI PISAVI Refixia 500 i.e.
English: In the pivotal trial there was a non-randomised arm where 15 patients were treated in an on-demand regimen with 40 IU/kg for mild or moderate bleeds and 80 IU/kg for severe bleeds.
Slovenian: V ključnem preskušanju je bila nerandomizirana skupina v kateri se je 15 bolnikov zdravilo po potrebi, in sicer v primeru blagih ali zmernih krvavitev z odmerkom 40 i.e./kg, v primeru hudih krvavitev pa z odmerkom 80 i.e./kg.
English: Please record the beginning of storage at room temperature on the product carton.
Slovenian: Začetek shranjevanja pri sobni temperaturi je treba zabeležiti na škatlo z zdravilom.
English: Because of the potential risk of thrombotic complications, clinical surveillance for early signs of thrombotic and consumptive coagulopathy should be initiated with appropriate biological testing when administering this product to patients with liver disease, to patients post-operatively, to new-born infants, or to patients at risk of thrombotic phenomena or DIC.
Slovenian: Trombembolija Zaradi možnega tveganja za trombotične zaplete je pri uporabi tega zdravila pri bolnikih z boleznijo jeter, bolnikih po kirurškem posegu, novorojencih ali bolnikih s tveganjem za trombotični fenomen ali diseminirano intravaskularno koagulacijo (DIC) treba uvesti klinični nadzor zgodnjih znakov trombotične in porabnostne koagulopatije z ustreznim biološkim testiranjem.
English: Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: Vehikel histidin voda za injekcije natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Slovenian: Zdravilo Refixia je prečiščen rekombinantni humani faktor IX (rFIX) s 40 kDa polietilen glikola (PEG), konjugiranega na beljakovino.
English: After repeated treatment with human coagulation factor IX (rDNA) 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: Pri ponavljajočem se zdravljenju z zdravili s humanim koagulacijskim faktorjem IX (rDNA) je bolnike treba spremljati glede pojava nevtralizirajočih protiteles (zaviralcev), ki jih je treba kvantificirati v
English: In repeat dose toxicity studies in rats and monkeys, 40 kDa polyethylene-glycol (PEG) was detected by immunohistochemical staining in epithelial cells of choroid plexus in the brain.
Slovenian: V študiji toksičnosti pri ponavljajočih se odmerkih so pri podganah in opicah pri imunohistokemičnem barvanju epitelnih celic horoidnega pleteža v možganih odkrili 40 kDa polietilen glikola (PEG).
English: The dose will depend on your weight and what the medicine is being used for.
Slovenian: Odmerek je odvisen od telesne mase in namena uporabe zdravila.
English: When you bleed, Refixia is activated in the blood to form factor IX.
Slovenian: Po pojavu krvavitve se zdravilo Refixia v krvi aktivira, pri čemer nastane faktor IX.
English: • The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid.
Slovenian: • Sestavine v sterilnem vehiklu so histidin, voda za injekcije, natrijev hidroksid in klorovodikova kislina.
English: Excipient with known effect Less than 1 mmol sodium (23 mg) per vial.
Slovenian: Manj kot 1 mmol natrija (23 mg) na vialo.
English: • Do not touch the syringe tip under the syringe cap.
Slovenian: • Ne dotikajte se konice brizge pod zaporko brizge.
English: • The other ingredients in the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide and hydrochloric acid.
Slovenian: • Druge sestavine v prašku so natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid in klorovodikova kislina.
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Slovenian: Če zdravila ne uporabite takoj, lahko postane nesterilno, kar lahko povzroči okužbe.
English: Refixia is used to treat and prevent bleeding in patients 12 years and above with haemophilia B (inborn factor IX deficiency).
Slovenian: Zdravilo Refixia uporabljamo za zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let in več, s hemofilijo B (prirojeno pomanjkanje faktorja IX).
English: Type of surgical procedure
Slovenian: Vrsta kirurškega posega
English: • 1 vial with Refixia powder
Slovenian: • 1 vialo s praškom zdravila Refixia,
English: 7-12 years N=13
Slovenian: 7-12 let N=13
English: EU/1/17/1193/002
Slovenian: EU/1/17/1193/001 EU/1/17/1193/002 EU/1/17/1193/003