natgillin/translations-raw huggingface dataset:
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. 
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.
13-17 years N=3 
13-17 let N=3
• Hold the pre-filled syringe slightly tilted with the vial pointing downwards. 
• Napolnjeno injekcijsko brizgo držite rahlo nagnjeno, tako da je viala usmerjena navzdol.
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. 
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.
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. 
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 .
INFORMATION IN BRAILLE Refixia 500 IU 
PODATKI V BRAILLOVI PISAVI Refixia 500 i.e.
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. 
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.
Please record the beginning of storage at room temperature on the product carton. 
Začetek shranjevanja pri sobni temperaturi je treba zabeležiti na škatlo z zdravilom.
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. 
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.
Water for injections Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) 
Vehikel histidin voda za injekcije natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
Refixia is a purified recombinant human factor IX (rFIX) with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein. 
Zdravilo Refixia je prečiščen rekombinantni humani faktor IX (rFIX) s 40 kDa polietilen glikola (PEG), konjugiranega na beljakovino.
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. 
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
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. 
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).
The dose will depend on your weight and what the medicine is being used for. 
Odmerek je odvisen od telesne mase in namena uporabe zdravila.
When you bleed, Refixia is activated in the blood to form factor IX. 
Po pojavu krvavitve se zdravilo Refixia v krvi aktivira, pri čemer nastane faktor IX.
• The ingredients in the sterilised solvent are histidine, water for injections, sodium hydroxide and hydrochloric acid. 
• Sestavine v sterilnem vehiklu so histidin, voda za injekcije, natrijev hidroksid in klorovodikova kislina.
Excipient with known effect Less than 1 mmol sodium (23 mg) per vial. 
Manj kot 1 mmol natrija (23 mg) na vialo.
• Do not touch the syringe tip under the syringe cap. 
• Ne dotikajte se konice brizge pod zaporko brizge.
• The other ingredients in the powder are sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide and hydrochloric acid. 
• Druge sestavine v prašku so natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid in klorovodikova kislina.
This is because if left, the medicine may no longer be sterile and could cause infections. 
Če zdravila ne uporabite takoj, lahko postane nesterilno, kar lahko povzroči okužbe.
Refixia is used to treat and prevent bleeding in patients 12 years and above with haemophilia B (inborn factor IX deficiency). 
Zdravilo Refixia uporabljamo za zdravljenje in preprečevanje krvavitev pri bolnikih, starih 12 let in več, s hemofilijo B (prirojeno pomanjkanje faktorja IX).
Type of surgical procedure 
Vrsta kirurškega posega
• 1 vial with Refixia powder 
• 1 vialo s praškom zdravila Refixia,
7-12 years N=13 
7-12 let N=13
EU/1/17/1193/002 
EU/1/17/1193/001 EU/1/17/1193/002 EU/1/17/1193/003
Volume of distribution (Vss) (ml/kg) Factor IX activity 168 h post dosing (IU/ml) 
Očistek (CL) (ml/ura/kg) Srednji čas zadrževanja (MRT) (ure) Volumen porazdelitve (Vss) (ml/kg) Aktivnost faktorja IX 168 ur po odmerku (i.e./ml)
Factor IX activity 168 h post dosing (IU/ml) 
Aktivnost faktorja IX 168 ur po odmerku (i.e./ml)
• Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt. 
• Potisni bat takoj pritrdite na injekcijsko brizgo z vrtenjem v smeri urinega kazalca v batni zamašek znotraj napolnjene injekcijske brizge dokler ne začutite upora.
Incremental Recovery (IR) (IU/ml per IU/kg) 
Inkrementalno izboljšanje (IR) (i.e./ml na i.e./kg)
Clearance = body weight adjusted clearance; Incremental recovery = incremental recovery 30 min post dosing, Volume of distribution = body weight adjusted volume of distribution at steady state. 
Očistek = očistek, prilagojen na telesno maso; inkrementalno izboljšanje = inkrementalno izboljšanje 30 min po odmerku,
Table 4 Steady state pharmacokinetic parameters of Refixia (40 IU/kg) in adolescents and adults (geometric mean (CV%)) PK Parameter 
Preglednica 4: Farmakokinetični parametri zdravila Refixia (40 i.e./kg) v stanju dinamičnega ravnovesja pri mladostnikih in odraslih (geometrijska sredina (KV %))
• Refixia is provided as a powder and solvent for solution for injection (500 IU, 1000 IU or 
• Zdravilo Refixia je na voljo v obliki praška in vehikla za raztopino za injiciranje (500 i.e.,
Non-clinical data reveal no concern for humans based on conventional safety pharmacology and repeated dose toxicity studies in rats and monkeys. 
Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih pri podganah in opicah ne kažejo posebnega tveganja za človeka.
Inject the reconstituted solution 
Injiciranje rekonstituirane raztopine
Refixia is administered by intravenous bolus injection over several minutes after reconstitution of the powder for injection with the histidine solvent. 
Zdravilo Refixia se po rekonstituciji praška za injiciranje z vehiklom s histidinom aplicira v obliki intravenske bolus injekcije, ki traja nekaj minut.
In this pivotal trial in adolescent and adult patients, there were 70 breakthrough bleeding episodes for 16 out of 29 patients in the 40 IU/kg prophylaxis arm. 
V tem ključnem preskušanju pri mladostnikih in odraslih bolnikih so v skupini s profilaktičnim zdravljenjem z odmerkom 40 i.e./kg pri 16 od 29 bolnikov poročali o pojavu 70 krvavitev med uporabo zdravila.
For instructions on reconstitution of the medicinal product before administration, see the package leaflet. 
Za navodila za rekonstitucijo zdravila pred aplikacijo glejte navodilo za uporabo.
What you need to know before you use Refixia 
Kaj morate vedeti, preden boste uporabili zdravilo Refixia Ne uporabljajte zdravila Refixia:
The powder in the vial appears as a white to off-white powder. 
Prašek v viali je bele do skoraj barve.
Mean residence time (MRT) (hours) 
(MRT) (ure)
Novo Nordisk A/S Novo Alle DK-2880 Bagsværd Denmark 
Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Danska
If you have a central venous access device (CVAD), you may develop infections or blood clots at the site of the catheter. 
Pri bolnikih, ki imajo vstavljen osrednji venski kateter, lahko pride do okužb ali nastanka krvnih strdkov na mestu, kjer je vstavljen kateter.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja srbenje*
Do not freeze reconstituted Refixia solution or store it in syringes. 
Rekonstituirane raztopine zdravila Refixia ne smete zamrzovati ali shranjevati v injekcijskih brizgah.
Rubber stopper (under plastic cap) 
(pod plastično zaporko)
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with recombinant factor IX products and may in some cases progress to severe anaphylaxis (including shock). 
nemir, tahikardijo, tiščanje v prsnem košu, mravljinčenje, bruhanje, piskajoče dihanje), ki se lahko v nekaterih primerih razvijejo v hudo anafilaksijo (vključno s šokom).
No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported. 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij O medsebojnem delovanju med zdravili s humanim koagulacijskim faktorjem IX (rDNA) in drugimi zdravili niso poročali.
There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations. 
Pri uporabi zdravil s faktorjem IX obstaja tveganje za pojav trombemboličnih dogodkov, ki je večje pri uporabi zdravil majhne čistote.
Injecting Refixia via needleless connectors for intravenous (IV) catheters 
Injiciranje zdravila Refixia preko brezigelnih nastavkov za intravenske (i.v.)
Powder: sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid 
Prašek: natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid in klorovodikova kislina.
Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse. 
Upoštevajte navodila zdravnika ali medicinske sestre za pravilno uporabo konektorja in naprave za centralni venski dostop.
Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter 
Vsebina pakiranja: 1 viala s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, 1 potisni bat in 1 nastavek za vialo.
Remove the protective cap from the vial adapter. 
Odstranite zaščitno zaporko z nastavka za vialo.
Allergic reactions and development of inhibitors There is a rare risk that you may experience a sudden and severe allergic reaction (e.g. anaphylactic reaction) to Refixia. 
Pri uporabi zdravila Refixia obstaja majhno tveganje za pojav nenadne in hude alergijske reakcije (npr. anafilaktična reakcija).
ANNEX II A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
These devices are not included in the Refixia package. 
Ti pripomočki niso priloženi ovojnini zdravila Refixia.
Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration. 
Rekonstituirano zdravilo morate pred aplikacijo vizualno pregledati glede prisotnosti delcev in spremembe barve.
Prepare the vial and the syringe 
Priprava viale in injekcijske brizge
Refixia 500 IU powder and solvent for solution for injection Refixia 1000 IU powder and solvent for solution for injection Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol 
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol
Overdoses up to 169 IU/kg have been reported in clinical trials. 
4.9 Preveliko odmerjanje V kliničnih preskušanjih so poročali o uporabi prevelikih odmerkov do 169 i.e./kg.
Refixia is supplied as a powder. 
Zdravilo Refixia je na voljo v obliki praška.
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). 
Preglednica v nadaljevanju temelji na navedbi organskih sistemov in prednostnih izrazov po MedDRA.
Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product. 
Zdravilo Refixia vsebuje učinkovino nonakog beta pegol, ki je dolgodelujoči rekombinantni koagulacijski faktor IX.
Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe. 
Zdravilo Refixia je treba aplicirati intravensko po rekonstituciji praška z vehiklom, ki je na voljo v injekcijski brizgi.
Allergic type hypersensitivity reactions are possible with Refixia. 
Preobčutljivost Pri uporabi zdravila Refixia se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2000 i.e.
Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid 
Vehikel: histidin, voda za injekcije, natrijev hidroksid in klorovodikova kislina.
2000 IU powder in a vial and 4 ml solvent in a pre-filled syringe, a plunger rod with a vial adapter - pack size of 1). 
1000 i.e. ali 2000 i.e. praška v viali, 4 ml vehikla v napolnjeni injekcijski brizgi, potisni bat in nastavek za vialo - velikost pakiranja je 1 pakiranje).
• Turn over the protective cap, and snap the vial adapter onto the vial. 
• Obrnite zaščitno zaporko in nastavek za vialo namestite na vialo.
Instructions on how to use Refixia 
Navodila za uporabo zdravila Refixia
• Remove the protective paper from the vial adapter. 
• Z nastavka za vialo odstranite zaščitni papir.
Store the reconstituted product in the vial. 
Rekonstituirano zdravilo shranjujte v viali.
Must not be returned to refrigerator after storage at room temperature Date removed from refrigerator: ____________ Store in the original package to protect from light 
Datum odvzema zdravila iz hladilnika: ____________ Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection Refixia 1000 IU powder and solvent for solution for injection Refixia 2000 IU powder and solvent for solution for injection 
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje
Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature. 
Datum odvzema zdravila Refixia iz hladilnika in začetek shranjevanja pri sobni temperaturi zabeležite na škatlo.
STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution), 
Prašek: 2000 i.e. nonakog beta pegola (približno 500 i.e./ml po rekonstituciji),
If you cannot use the reconstituted Refixia solution immediately, it should be used within 4 hours when stored at room temperature (up to 30°C) and within 24 hours when stored in a refrigerator (2°C - 8°C). 
Če raztopine zdravila Refixia ne morete uporabiti takoj po rekonstituciji, jo morate porabiti v 4 urah, če jo shranjujete pri sobni temperaturi (do 30 °C), in v 24 urah, če jo shranjujete v hladilniku
(2°C - 8°C) and 4 hours stored at room temperature (≤ 30°C). 
(2 °C - 8 °C).
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e.
After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol. 
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 125 i.e. nonakog beta pegola.
STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution), 
Prašek: 500 i.e. nonakog beta pegola (približno 125 i.e./ml po rekonstituciji),
• shortness of breath or wheezing 
• sopeče ali piskajoče dihanje
In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients. 
V namenskem kirurškem preskušanju so z analizo učinkovitosti zajeli 13 večjih kirurških posegov,
Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery. 
V prvem tednu po kirurškem posegu je treba presoditi o aplikaciji dveh odmerkov po 40 i.e./kg (z 1-3 dnevnim vmesnim presledkom).
Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*. 
Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. nonakog beta pegola*.
All patients assessed in the steady state pharmacokinetic session had factor IX activity levels above 0.24 IU/ml at 168 hours post dosing with a weekly dose of 40 IU/kg. 
Pri uporabi tedenskega odmerka 40 i.e./kg je bila raven aktivnosti faktorja IX 168 ur po odmerku pri vseh bolnikih, ovrednotenih v stanju dinamičnega ravnovesja, večja od 0,24 i.e./ml.
Keep reconstituted Refixia solution out of direct light. 
Rekonstituirano raztopino zdravila Refixia shranjujte zaščiteno pred svetlobo.
Talk to your doctor immediately if your bleeding does not stop as expected or if you have to significantly increase your usage of Refixia in order to stop a bleed. 
Če se krvavitev ne ustavi po pričakovanjih ali če ste za zaustavitev krvavitve morali znatno povečati uporabo zdravila Refixia, se nemudoma posvetujte z zdravnikom.
Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally. 
Če uporaba kromogenega testa ali primernega enostopenjskega testa strjevanja krvi lokalno ni na voljo, priporočamo uporabo referenčnega laboratorija.
18-65 years 
18-65 let N=20
How to use Refixia 
Način uporabe zdravila Refixia
• Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe. 
• Potisni bat potegnite rahlo navzdol, da boste rekonstituirano raztopino izvlekli v injekcijsko brizgo.
Dose and duration of the substitution therapy depend on the location and severity of the bleeding, see Table 1 for dosing guidance in bleeding episodes. 
Odmerek in trajanje nadomestnega zdravljenja sta odvisna od mesta in resnosti krvavitve.
STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution), 
Prašek: 1000 i.e. nonakog beta pegola (približno 250 i.e./ml po rekonstituciji),
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction. 
Pri bolnikih s hemofilijo B z zaviralci faktorja IX in predhodno alergijsko reakcijo so po poskusu indukcije imunske tolerance poročali o nefrotskem sindromu.
not use the pre-filled syringe. 
raztopine ne uporabljajte.
After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol. 
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 250 i.e. nonakog beta pegola.
• feeling sick (nausea) 
• slabost (navzea)
• allergic reactions (hypersensitivity). 
• alergijske reakcije (preobčutljivost); te lahko postanejo hude in so lahko smrtno nevarne
Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state 
Preglednica 6: Srednje najmanjše koncentracije* zdravila Refixia (40 i.e./kg) v stanju dinamičnega ravnovesja
Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*. 
Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. nonakog beta pegola*.
If you touch the spike on the vial adapter, germs from your fingers can be transferred. 
Če se konice nastavka za vialo dotaknete s prsti, jo lahko kontaminirate z mikrobi.
Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds. 
Blage in zmerne krvavitve so zdravili z zdravilom Refixia v odmerku 40 i.e./kg.
Your doctor may need to treat you promptly for these reactions. 
V primeru pojava takih reakcij bo zdravnik morda moral nemudoma uvesti ustrezno zdravljenje.
4.7 Effects on ability to drive and use machines 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Refixia nima vpliva na sposobnost vožnje in upravljanja strojev.
Mean steady state factor IX trough levels above 15% were observed for all age groups, see section 5.2 for details. 
Pri vseh starostnih skupinah je povprečna najmanjša koncentracija faktorja IX v stanju dinamičnega ravnovesja znašala nad 15 %.
After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol. 
Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 500 i.e. nonakog beta pegola.
If you notice particles or discolouration, do not use it. Use a new package instead. 
Če opazite kakršne koli delce ali spremembo barve, rekonstituirane raztopine ne uporabljajte.
Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*. 
Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. nonakog beta pegola*.
• heart palpitations 
• vročinski oblivi
What Refixia is used for 
Za kaj uporabljamo zdravilo Refixia
If a chromogenic assay is not available, it is recommended to use a one-stage clotting assay with an aPTT reagent (e.g. Cephascreen) qualified for use with Refixia. 
Če kromogeni test ni na voljo, priporočamo uporabo enostopenjskega testa strjevanja krvi z aPTT
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment) 
Prašek natrijev klorid histidin saharoza polisorbat 80 manitol natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
Due date 
Razpolovni čas
How to store Refixia 
Shranjevanje zdravila Refixia
NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX) 
Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use, after reconstitution 
POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
What Refixia is 
Kaj vsebuje zdravilo Refixia