FrancophonIA/ELRC3.0 huggingface dataset:
English: Volume of distribution (Vss) (ml/kg) Factor IX activity 168 h post dosing (IU/ml)
Slovenian: 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)
English: Factor IX activity 168 h post dosing (IU/ml)
Slovenian: Aktivnost faktorja IX 168 ur po odmerku (i.e./ml)
English: • Immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Slovenian: • Potisni bat takoj pritrdite na injekcijsko brizgo z vrtenjem v smeri urinega kazalca v batni zamašek znotraj napolnjene injekcijske brizge dokler ne začutite upora.
English: Incremental Recovery (IR) (IU/ml per IU/kg)
Slovenian: Inkrementalno izboljšanje (IR) (i.e./ml na i.e./kg)
English: 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.
Slovenian: Očistek = očistek, prilagojen na telesno maso; inkrementalno izboljšanje = inkrementalno izboljšanje 30 min po odmerku,
English: Table 4 Steady state pharmacokinetic parameters of Refixia (40 IU/kg) in adolescents and adults (geometric mean (CV%)) PK Parameter
Slovenian: Preglednica 4: Farmakokinetični parametri zdravila Refixia (40 i.e./kg) v stanju dinamičnega ravnovesja pri mladostnikih in odraslih (geometrijska sredina (KV %))
English: • Refixia is provided as a powder and solvent for solution for injection (500 IU, 1000 IU or
Slovenian: • Zdravilo Refixia je na voljo v obliki praška in vehikla za raztopino za injiciranje (500 i.e.,
English: Non-clinical data reveal no concern for humans based on conventional safety pharmacology and repeated dose toxicity studies in rats and monkeys.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih pri podganah in opicah ne kažejo posebnega tveganja za človeka.
English: Inject the reconstituted solution
Slovenian: Injiciranje rekonstituirane raztopine
English: Refixia is administered by intravenous bolus injection over several minutes after reconstitution of the powder for injection with the histidine solvent.
Slovenian: Zdravilo Refixia se po rekonstituciji praška za injiciranje z vehiklom s histidinom aplicira v obliki intravenske bolus injekcije, ki traja nekaj minut.
English: 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.
Slovenian: 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.
English: For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Slovenian: Za navodila za rekonstitucijo zdravila pred aplikacijo glejte navodilo za uporabo.
English: What you need to know before you use Refixia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Refixia Ne uporabljajte zdravila Refixia:
English: The powder in the vial appears as a white to off-white powder.
Slovenian: Prašek v viali je bele do skoraj barve.
English: Mean residence time (MRT) (hours)
Slovenian: (MRT) (ure)
English: Novo Nordisk A/S Novo Alle DK-2880 Bagsværd Denmark
Slovenian: Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd Danska
English: If you have a central venous access device (CVAD), you may develop infections or blood clots at the site of the catheter.
Slovenian: Pri bolnikih, ki imajo vstavljen osrednji venski kateter, lahko pride do okužb ali nastanka krvnih strdkov na mestu, kjer je vstavljen kateter.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja srbenje*
English: Do not freeze reconstituted Refixia solution or store it in syringes.
Slovenian: Rekonstituirane raztopine zdravila Refixia ne smete zamrzovati ali shranjevati v injekcijskih brizgah.
English: Rubber stopper (under plastic cap)
Slovenian: (pod plastično zaporko)
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, 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).
Slovenian: nemir, tahikardijo, tiščanje v prsnem košu, mravljinčenje, bruhanje, piskajoče dihanje), ki se lahko v nekaterih primerih razvijejo v hudo anafilaksijo (vključno s šokom).
English: No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported.
Slovenian: 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.
English: There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Slovenian: Pri uporabi zdravil s faktorjem IX obstaja tveganje za pojav trombemboličnih dogodkov, ki je večje pri uporabi zdravil majhne čistote.
English: Injecting Refixia via needleless connectors for intravenous (IV) catheters
Slovenian: Injiciranje zdravila Refixia preko brezigelnih nastavkov za intravenske (i.v.)
English: Powder: sodium chloride, histidine, sucrose, polysorbate 80, mannitol, sodium hydroxide, hydrochloric acid
Slovenian: Prašek: natrijev klorid, histidin, saharoza, polisorbat 80, manitol, natrijev hidroksid in klorovodikova kislina.
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Slovenian: Upoštevajte navodila zdravnika ali medicinske sestre za pravilno uporabo konektorja in naprave za centralni venski dostop.
English: Pack contains: 1 powder vial, 4 ml solvent in a pre-filled syringe, 1 plunger rod and 1 vial adapter
Slovenian: Vsebina pakiranja: 1 viala s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, 1 potisni bat in 1 nastavek za vialo.
English: Remove the protective cap from the vial adapter.
Slovenian: Odstranite zaščitno zaporko z nastavka za vialo.
English: 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.
Slovenian: Pri uporabi zdravila Refixia obstaja majhno tveganje za pojav nenadne in hude alergijske reakcije (npr. anafilaktična reakcija).
English: 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
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA
English: These devices are not included in the Refixia package.
Slovenian: Ti pripomočki niso priloženi ovojnini zdravila Refixia.
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Slovenian: Rekonstituirano zdravilo morate pred aplikacijo vizualno pregledati glede prisotnosti delcev in spremembe barve.
English: Prepare the vial and the syringe
Slovenian: Priprava viale in injekcijske brizge
English: 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
Slovenian: 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
English: Overdoses up to 169 IU/kg have been reported in clinical trials.
Slovenian: 4.9 Preveliko odmerjanje V kliničnih preskušanjih so poročali o uporabi prevelikih odmerkov do 169 i.e./kg.
English: Refixia is supplied as a powder.
Slovenian: Zdravilo Refixia je na voljo v obliki praška.
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Slovenian: Preglednica v nadaljevanju temelji na navedbi organskih sistemov in prednostnih izrazov po MedDRA.
English: Refixia contains the active substance nonacog beta pegol and is a long-acting recombinant coagulation factor IX product.
Slovenian: Zdravilo Refixia vsebuje učinkovino nonakog beta pegol, ki je dolgodelujoči rekombinantni koagulacijski faktor IX.
English: Refixia is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Slovenian: Zdravilo Refixia je treba aplicirati intravensko po rekonstituciji praška z vehiklom, ki je na voljo v injekcijski brizgi.
English: Allergic type hypersensitivity reactions are possible with Refixia.
Slovenian: Preobčutljivost Pri uporabi zdravila Refixia se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 2000 i.e.
English: Solvent: Histidine, water for injections, sodium hydroxide, hydrochloric acid
Slovenian: Vehikel: histidin, voda za injekcije, natrijev hidroksid in klorovodikova kislina.
English: 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).
Slovenian: 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).
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Slovenian: • Obrnite zaščitno zaporko in nastavek za vialo namestite na vialo.
English: Instructions on how to use Refixia
Slovenian: Navodila za uporabo zdravila Refixia
English: • Remove the protective paper from the vial adapter.
Slovenian: • Z nastavka za vialo odstranite zaščitni papir.
English: Store the reconstituted product in the vial.
Slovenian: Rekonstituirano zdravilo shranjujte v viali.
English: Must not be returned to refrigerator after storage at room temperature Date removed from refrigerator: ____________ Store in the original package to protect from light
Slovenian: Datum odvzema zdravila iz hladilnika: ____________ Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: 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
Slovenian: 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
English: Please record on the carton the date Refixia is removed from the refrigerator and placed at room temperature.
Slovenian: Datum odvzema zdravila Refixia iz hladilnika in začetek shranjevanja pri sobni temperaturi zabeležite na škatlo.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),
Slovenian: Prašek: 2000 i.e. nonakog beta pegola (približno 500 i.e./ml po rekonstituciji),
English: 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).
Slovenian: 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
English: (2°C - 8°C) and 4 hours stored at room temperature (≤ 30°C).
Slovenian: (2 °C - 8 °C).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 1000 i.e.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 500 IU
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 500 i.e.
English: After reconstitution, 1 ml of Refixia contains approximately 125 IU nonacog beta pegol.
Slovenian: Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 125 i.e. nonakog beta pegola.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Slovenian: Prašek: 500 i.e. nonakog beta pegola (približno 125 i.e./ml po rekonstituciji),
English: • shortness of breath or wheezing
Slovenian: • sopeče ali piskajoče dihanje
English: In a dedicated surgery trial, the efficacy analysis included 13 major surgical procedures performed in 13 previously treated adult and adolescent patients.
Slovenian: V namenskem kirurškem preskušanju so z analizo učinkovitosti zajeli 13 večjih kirurških posegov,
English: Consider two repeated doses of 40 IU/kg (in 1-3 day intervals) within the first week after surgery.
Slovenian: V prvem tednu po kirurškem posegu je treba presoditi o aplikaciji dveh odmerkov po 40 i.e./kg (z 1-3 dnevnim vmesnim presledkom).
English: Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Slovenian: Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. nonakog beta pegola*.
English: 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.
Slovenian: 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.
English: Keep reconstituted Refixia solution out of direct light.
Slovenian: Rekonstituirano raztopino zdravila Refixia shranjujte zaščiteno pred svetlobo.
English: 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.
Slovenian: Če se krvavitev ne ustavi po pričakovanjih ali če ste za zaustavitev krvavitve morali znatno povečati uporabo zdravila Refixia, se nemudoma posvetujte z zdravnikom.
English: Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Slovenian: Če uporaba kromogenega testa ali primernega enostopenjskega testa strjevanja krvi lokalno ni na voljo, priporočamo uporabo referenčnega laboratorija.
English: 18-65 years
Slovenian: 18-65 let N=20
English: How to use Refixia
Slovenian: Način uporabe zdravila Refixia
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Slovenian: • Potisni bat potegnite rahlo navzdol, da boste rekonstituirano raztopino izvlekli v injekcijsko brizgo.
English: 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.
Slovenian: Odmerek in trajanje nadomestnega zdravljenja sta odvisna od mesta in resnosti krvavitve.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Slovenian: Prašek: 1000 i.e. nonakog beta pegola (približno 250 i.e./ml po rekonstituciji),
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 bolnikih s hemofilijo B z zaviralci faktorja IX in predhodno alergijsko reakcijo so po poskusu indukcije imunske tolerance poročali o nefrotskem sindromu.
English: not use the pre-filled syringe.
Slovenian: raztopine ne uporabljajte.
English: After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Slovenian: Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 250 i.e. nonakog beta pegola.
English: • feeling sick (nausea)
Slovenian: • slabost (navzea)
English: • allergic reactions (hypersensitivity).
Slovenian: • alergijske reakcije (preobčutljivost); te lahko postanejo hude in so lahko smrtno nevarne
English: Table 6 Mean of trough levels* of Refixia (40 IU/kg) at steady state
Slovenian: Preglednica 6: Srednje najmanjše koncentracije* zdravila Refixia (40 i.e./kg) v stanju dinamičnega ravnovesja
English: Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Slovenian: Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 500 i.e. nonakog beta pegola*.
English: If you touch the spike on the vial adapter, germs from your fingers can be transferred.
Slovenian: Če se konice nastavka za vialo dotaknete s prsti, jo lahko kontaminirate z mikrobi.
English: Bleeding episodes were treated with Refixia at 40 IU/kg for mild or moderate bleeds.
Slovenian: Blage in zmerne krvavitve so zdravili z zdravilom Refixia v odmerku 40 i.e./kg.
English: Your doctor may need to treat you promptly for these reactions.
Slovenian: V primeru pojava takih reakcij bo zdravnik morda moral nemudoma uvesti ustrezno zdravljenje.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Refixia nima vpliva na sposobnost vožnje in upravljanja strojev.
English: Mean steady state factor IX trough levels above 15% were observed for all age groups, see section 5.2 for details.
Slovenian: Pri vseh starostnih skupinah je povprečna najmanjša koncentracija faktorja IX v stanju dinamičnega ravnovesja znašala nad 15 %.
English: After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Slovenian: Po rekonstituciji 1 ml zdravila Refixia vsebuje približno 500 i.e. nonakog beta pegola.
English: If you notice particles or discolouration, do not use it. Use a new package instead.
Slovenian: Če opazite kakršne koli delce ali spremembo barve, rekonstituirane raztopine ne uporabljajte.
English: Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Slovenian: Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 1000 i.e. nonakog beta pegola*.
English: • heart palpitations
Slovenian: • vročinski oblivi
English: What Refixia is used for
Slovenian: Za kaj uporabljamo zdravilo Refixia
English: 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.
Slovenian: Če kromogeni test ni na voljo, priporočamo uporabo enostopenjskega testa strjevanja krvi z aPTT
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: Prašek natrijev klorid histidin saharoza polisorbat 80 manitol natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: Due date
Slovenian: Razpolovni čas
English: How to store Refixia
Slovenian: Shranjevanje zdravila Refixia
English: NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Slovenian: Refixia 2000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use Intravenous use, after reconstitution
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Pred uporabo preberite priloženo navodilo!
English: What Refixia is
Slovenian: Kaj vsebuje zdravilo Refixia
English: • Take the vial, the vial adapter and the prefilled syringe out of the carton.
Slovenian: • Iz škatle vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo.
English: PK Parameter 0-6 years N=12
Slovenian: 0-6 let N=12
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Slovenian: Refixia 500 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Refixia 2000 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
English: There is a rare risk of developing a specific kidney disorder called “nephrotic syndrome” following high doses of factor IX in haemophilia B patients with factor IX inhibitors and a history of allergic reactions.
Slovenian: Pri bolnikih s hemofilijo B, ki imajo zaviralce faktorja IX in so že doživeli pojav alergijske reakcije, pri uporabi velikih odmerkov faktorja IX obstaja majhno tveganje za razvoj posebne bolezni ledvic, imenovane “nefrotski sindrom”.
English: NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Slovenian: Refixia 1000 i.e. prašek in vehikel za raztopino za injiciranje nonakog beta pegol (rekombinantni koagulacijski faktor IX)
English: Reconstitute the powder with the solvent
Slovenian: Rekonstitucija praška z vehiklom
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Refixia 1000 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
English: PHARMACOLOGICAL PROPERTIES
Slovenian: Farmakokinetični parameter
English: Table 1 Treatment of bleeding episodes with Refixia
Slovenian: Preglednica 1: Zdravljenje krvavitev z zdravilom Refixia Stopnja krvavitve Priporočeni odmerek zdravila Refixia v i.e./kg
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Refixia 500 i.e. prašek za raztopino za injiciranje nonakog beta pegol i.v.
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Slovenian: Če se ga dotaknete ob straneh ali na mestu za pritrditev, ga lahko kontaminirate z mikrobi.
English: Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator
Slovenian: Dokazano je bilo, da je zdravilo med uporabo kemijsko in fizikalno stabilno 24 ur, če se ga shranjuje v hladilniku (2 °C - 8 °C), in 4 ure, če se ga shranjuje pri sobni temperaturi (≤ 30 °C).
English: Syringe tip (under syringe cap) Scale
Slovenian: Napolnjena injekcijska brizga z vehiklom konica brizge (pod zaporko brizge) skala batni zamašek zaporka brizge
English: Pivotal trial
Slovenian: Ključno preskušanje
English: Thread
Slovenian: Viala
English: Vial with Refixia powder
Slovenian: OVOJNINAH Napolnjena injekcijska brizga
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1193/001
English: Hypersensitivity Anaphylaxis Inhibitors
Slovenian: Bolezni imunskega sistema preobčutljivost anafilaksija zaviralci občasni neznana neznana
English: Fifty-four of the patients across all age-groups were treated with a weekly prophylactic dose of 40 IU/kg where 23 (43%) of these patients had no bleeding episodes.
Slovenian: S tedenskim profilaktičnim odmerkom 40 i.e./kg se je zdravilo 54 bolnikov iz vseh starostnih skupin.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Solvent for Refixia
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Vehikel za zdravilo Refixia Raztopina histidina
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (≤ 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place under controlled and validated aseptic conditions.
Slovenian: Zdravila se običajno ne sme shranjevati dlje kot 4 ure pri sobni temperaturi (≤ 30 °C) ali 24 ur v hladilniku