natgillin/translations-raw huggingface dataset:
In the first study symptoms improved substantially in 50 and 52% respectively of patients taking Xeljanz and adalimumab for 3 months, compared with 33% of those receiving placebo; patients given Xeljanz or adalimumab also showed a greater improvement in their ability to perform everyday activities. 
V prvi študiji so se simptomi pri 50 % oziroma 52 % bolnikov, ki so tri mesece jemali zdravilo Xeljanz oziroma adalimumab, znatno izboljšali, medtem ko je ta delež pri bolnikih, ki so prejemali placebo, znašal 33 %; pri bolnikih, ki so prejemali zdravilo Xeljanz ali adalimumab, se je tudi bolj izboljšala njihova sposobnost opravljanja vsakodnevnih dejavnosti.
The first study compared Xeljanz with adalimumab (an injected medicine for psoriatic arthritis) and placebo in 422 patients. 
V prvi študiji se je pri 422 bolnikih zdravilo Xeljanz primerjalo z adalimumabom (vbrizganim zdravilom za psoriatični artritis) in placebom.
Xeljanz is available as tablet (5 and 10 mg) to be taken by mouth. 
Zdravilo Xeljanz je na voljo v obliki 5- in 10-miligramskih tablet, ki se jemljejo peroralno.
In patients with rheumatoid arthritis, Xeljanz can also be taken alone by patients who cannot take or are intolerant to methotrexate. 
Bolniki z revmatoidnim artritisom, ki metotreksata ne smejo jemati ali ga ne prenašajo, lahko zdravilo Xeljanz jemljejo tudi kot samostojno zdravilo.
The most important side effect seen with the medicine is infection and there are specific recommendations to help healthcare professionals reduce this risk. 
Obstajajo posebna priporočila za zdravstvene delavce, kako zmanjšati to tveganje.
In the first study in 614 patients with ulcerative colitis, 18% of patients treated with Xeljanz 10 mg twice a day had mild or no symptoms after 8 weeks of treatment compared with 8% of patients who received placebo. 
V prvi študiji, ki je bila opravljena na 614 bolnikih z ulceroznim kolitisom, je imelo po osmih tednih zdravljenja 18 % bolnikov, ki so dvakrat dnevno prejeli 10 mg zdravila Xeljanz, blage simptome ali pa jih niso imeli v primerjavi z 8 % bolnikov, ki so prejemali placebo.
Similarly, in a second study with 547 patients, after 8 weeks of treatment 17% of patients treated with Xeljanz had mild or no symptoms compared with 4% of placebo-treated patients. 
Podobno je v drugi študiji, v kateri je sodelovalo 547 bolnikov, po osmih tednih zdravljenja imelo 17 % bolnikov, zdravljenih z zdravilom Xeljanz, blage simptome ali pa jih niso imeli, v primerjavi s 4 % bolnikov, ki so prejemali placebo.
How does Xeljanz work? 
Kako zdravilo Xeljanz deluje?
The second study compared Xeljanz with placebo in 395 patients. 
V drugi študiji se je pri 395 bolnikih zdravilo Xeljanz primerjalo s placebom.
How is Xeljanz used? 
Kako se zdravilo Xeljanz uporablja?
In one of the studies, where Xeljanz was taken alone, Xeljanz was more effective than methotrexate at slowing down joint damage and reducing symptoms. 
V eni od študij, v kateri so bolniki zdravilo Xeljanz jemali kot samostojno zdravilo, je bilo zdravilo Xeljanz pri upočasnitvi poškodb sklepov in zmanjševanju simptomov učinkovitejše od metotreksata.
Xeljanz, in combination with methotrexate, was shown to be effective at improving symptoms of psoriatic arthritis in 3 main studies. 
V treh glavnih študijah se je zdravilo Xeljanz v kombinaciji z metotreksatom izkazalo kot učinkovito pri izboljšanju simptomov psoriatičnega artritisa.
Xeljanz was more effective than placebo at reducing the symptoms of ulcerative colitis in three main studies. 
V treh glavnih študijah je bilo zdravilo Xeljanz učinkovitejše od placeba pri zmanjšanju simptomov ulceroznega kolitisa.
In a third study with 593 patients, 34% of patients treated with Xeljanz 5 mg twice a day had mild or no symptoms after a year of treatment compared with 11% of patients receiving placebo. 
V tretji študiji, v kateri je sodelovalo 593 bolnikov, je imelo po enem letu zdravljenja 34 % bolnikov, ki so dvakrat dnevno prejeli 5 mg zdravila Xeljanz, blage simptome ali pa jih niso imeli, kar je veljalo za
In another study, Xeljanz taken alone was more effective than placebo (a dummy treatment) at reducing symptoms, such as pain and swelling. 
V drugi študiji je bilo jemanje zdravila Xeljanz kot samostojnega zdravila pri zmanjševanju simptomov, kot sta bolečina in otekanje, učinkovitejše od placeba (zdravilo brez zdravilne učinkovine).
Date of first authorisation: 11 May 2016 
Datum prve odobritve: 11. maj 2016
(initial level) 
(začetna raven)
Please contact your doctor immediately: 
Prosimo, da nemudoma obvestite zdravnika:
The required dose is determined using the following formulae: 
Potrebni odmerek določimo z uporabo naslednje formule:
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. 
Če se pojavijo taki inhibitorji, se bo stanje pokazalo kot nezadosten klinični odziv.
Of note, ABR is not comparable between different factor concentrates and between different clinical studies. 
Pomembno je omeniti, da ABR ni primerljiv med različnimi koncetrati faktorjev in med različnimi kliničnimi študijami.
Immune tolerance induction 
Indukcija imunske tolerance
Frequency of doses (hours) / Duration of therapy (days) 
Pogostnost odmerkov (ure) /trajanje zdravljenja (dnevi)
• if you notice symptoms of allergic reactions (see below) 
• če opazite simptome alergijskih reakcij (glejte spodaj),
The amount of IDELVION you need to take and the duration of treatment depend on: 
Količina zdravila IDELVION, ki ga morate vzeti in trajanje zdravljenja sta odvisna od:
• Inhibitors: the medicine stops working properly (continuous bleeding). 
• Inhibitorji: zdravilo preneha delovati pravilno (vztrajna krvavitev).
Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated. 
Zato se lahko faktor IX uporablja med nosečnostjo in dojenjem le, če je jasno indicirano.
Your doctor should inform you of the early signs of hypersensitivity reactions. 
Vaš zdravnik vas bo poučil o zgodnjih znakih preobčutljivostnih reakcij.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. 
Zato je treba bolnike, pri katerih se pojavi alergijska reakcija, pregledati za prisotnost inhibitorja.
After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at 2-25 °C). 
Po rekonstituciji so kemijsko in fizikalno obstojnost med uporabo dokazali za 8 ur pri temperaturi 2-25 °C.
- Reconstitution and withdrawal must be carried out under aseptic conditions. 
- Rekonstitucijo in izsesanje izvajajte pod aseptičnimi pogoji.
All 85 bleeding episodes were successfully treated with 1 or 2 doses of IDELVION. 
Vseh 85 epizod krvavitev je bilo uspešno zdravljenih z 1 ali 2 odmerkoma zdravila IDELVION.
Single dose should be sufficient for majority of bleeds. 
Enkratni odmerek bi moral zadoščati za večino krvavitev.
The safety and efficacy in the perioperative setting was evaluated in two pivotal Phase 3 studies (Study 3001 and 3002) and the on-going Phase 3 safety extension study (Study 3003). 
Varnost in učinkovitost v perioperativnem okolju so ovrednotili v dveh osrednjih študijah faze III (študiji 3001 in 3002) in v podaljšku študije varnosti faze III, ki še poteka (študija 3003).
Frequencies have been evaluated according to the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). 
Pogostnost je bila ocenjena z naslednjimi dogovorjenimi izrazi: zelo pogosti (≥1/10), pogosti (≥1/100 do < 1/10), občasni (≥1/1000 do <1/100), redki (≥1/10.000 do < 1/1000), zelo redki (< 1/10.000), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
Your doctor will calculate the dose of IDELVION you need. 
Zdravnik bo izračunal odmerek zdravila IDELVION, ki ga potrebujete.
• If you suffer from liver or cardiac disease or if you have recently had major surgery, please inform your doctor, as there is an increased risk for blood clotting (coagulation) complications. 
• Če imate obolenje jeter ali srca ali ste nedavno imeli večji kirurški poseg, obvestite svojega zdravnika, saj obstaja povečano tveganje za zaplete pri strjevanju krvi.
Currently available information support extension of treatment intervals for some patients though potentially associated with an increased risk for bleeding compared to a once weekly regimen. 
Trenutno dostopni podatki podpirajo podaljšanje intervala zdravljenja pri nekaterih bolnikih, čeprav so potencialno povezani s povečanim tveganjem za krvavitve v primerjavi s shemo odmerjanja enkrat na teden.
Without opening the vials, warm the IDELVION powder and the liquid to room or body temperature. 
Brez da bi odprli viali, segrejte prašek IDELVION in tekočino na sobno ali telesno temperaturo.
IDELVION can be used for all age groups. 
Zdravilo IDELVION se lahko uporablja za vse starostne skupine.
Elimination t1/2 (h) 
t1/2 izločanja (h)
Repeat PK assessment for up to 30 weeks demonstrated a stable pharmacokinetic profile and incremental recovery was consistent over time. 
Ponovitve ocene farmakokinetike v obdobju do 30 tednov so pokazale stabilen farmakokinetičen profil, postopna povrnitev aktivnosti je bila ves čas konsistentna.
Clinical studies investigating safety and efficacy of longer treatment intervals than once weekly are ongoing. 
Klinične študije za preučevanje varnosti in učinkovitosti intervalov odmerjanja, daljših od enega tedna, še potekajo.
General Instructions 
Splošna navodila
Of the 106 bleeding episodes, the majority (94; 88.7%) was treated with single injection, 103; 97.2% were treated with 1-2 injections. 
Od skupno 106 epizod krvavitev je bila večina (94; 88,7 %) zdravljena z enkratno injekcijo, 103; 97,2 % pa z 1-2 injekcijama.
Albumin is a natural, inert carrier protein in plasma with a half-life of approximately 20 days. 
Albumin je naravni, inertni nosilec proteinov v plazmi z razpolovno dobo približno 20 dni.
• IDELVION must not be mixed with other medicines or solvents except those mentioned in section 6. 
• Zdravila IDELVION ne smemo mešati z drugimi zdravili ali vehikli, razen s tistimi, ki so navedeni v poglavju 6.
If you have any side effects that might be related to the administration of IDELVION, the injection should be stopped (see also sections 2 and 4). 
Če se pojavijo neželeni učinki, ki bi lahko bili povezani z dajanjem zdravila IDELVION, je treba injiciranje ustaviti (glejte tudi poglavji 2 in 4).
From a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega vidika je treba zdravilo uporabiti takoj po rekonstituciji.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available. 
Na podlagi redke pojavnosti hemofilije B pri ženskah, podatki o izkušnjah glede uporabe faktorja IX med nosečnostjo in dojenjem niso na voljo.
The product contains traces of hamster proteins (see also “Do not use IDELVION”). 
Zdravilo vsebuje sledi proteinov hrčka (glejte tudi podpoglavje "Ne uporabljajte zdravila IDELVION").
Patients with haemophilia B have a lack of this factor which means that their blood does not clot as quickly as it should so there is an increased tendency to bleed. 
Bolniki s hemofilijo B imajo pomanjkanje tega faktorja kar pomeni, da se njihova kri ne strjuje tako hitro kot bi se morala in je zato povečana verjetnost za krvavitve.
Haemostatic efficacy at resolution of a bleed was rated excellent or good in 96% of all treated bleeding episodes. 
Hemostatska učinkovitost ob prenehanju krvavitve je bila ocenjena kot odlična ali dobra pri 96 % vseh zdravljenih epizod krvavitev.
• if you notice that the medicine stops working properly 
• če opazite, da zdravilo ne deluje več pravilno.
Factor IX is involved in blood clotting. 
Faktor IX je vključen v proces strjevanja krvi.
Your treatment should be started and monitored by a doctor who is experienced in the treatment of blood clotting disorders. 
Vaše zdravljenje mora uvesti in nadzorovati zdravnik, ki ima izkušnje z zdravljenjem krvnih motenj strjevanja.
Care should be taken that no blood enters the syringe filled with product, as there is a risk that the blood could coagulate in the syringe and fibrin clots could therefore be administered to the patient. 
Paziti je treba, da kri ne vstopi v brizgo, napolnjeno z zdravilom, saj obstaja tveganje, da kri v brizgi koagulira in bi fibrinski strdek lahko aplicirali bolniku.
• If you are allergic to the active ingredient (albutrepenonacog alfa) or any of the other ingredients 
• če ste alergični na učinkovino (albutrepenonakog alfa) ali katero koli sestavino tega zdravila
• If you are allergic to hamster proteins. 
• če ste alergični na proteine hrčka.
After a bleeding episode during prophylaxis, patients should maintain their prophylaxis regimen as closely as possible, with 2 doses of IDELVION being administered at least 24 hours apart but longer as deemed suitable for the patient. 
Po epizodah krvavitev med profilakso se morajo bolniki čimbolj držati svoje sheme profilakse z 2 odmerkoma zdravila IDELVION, ki sta dana vsaj 24 ur narazen, vendar dlje kot se smatra primerno za bolnika.
IDELVION (50 (IU/kg)) (N=22) 
IDELVION (50 (i.e./kg)) (N=22)
In such cases, it is recommended that a specialised haemophilia centre be contacted. 
V takih primerih je priporočljivo, da se obrnete na specializirani center za hemofilijo.
• Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika ali farmacevta, če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
Patients < 12 years of age 
Bolniki, stari < 12 let
You may develop an inhibitor (neutralising antibody) to factor IX, in which case factor IX will not work properly any more. 
Lahko razvijete inhibitorje (nevtralizirajoča protitelesa) proti faktorju IX in v tem primeru faktor IX ne bo več deloval pravilno.
Paediatric Population Frequency, type and severity of adverse reactions in children are expected to be similar as in adults. 
Pediatrična populacija Pričakuje se, da so pogostnost, vrsta in resnost neželenih učinkov pri otrocih enake kot pri odraslih.
Inhibitor development was reported in an ongoing clinical study with previously untreated patients. 
O razvoju inhibitorjev so poročali v potekajoči klinični študiji s predhodno nezdravljenimi bolniki.
Prolongation of the half-life of IDELVION and the enhanced systemic exposure are achieved by fusion with recombinant albumin. 
Podaljšanje razpolovne dobe zdravila IDELVION in večja sistemska izpostavljenost sta dosežena s fuzijo z rekombinantnim albuminom.
• The formation of inhibitors (neutralising antibodies) is a known complication that has been reported during treatment with IDELVION, which stops the treatment from working properly. 
• Nastanek inhibitorjev (nevtralizirajočih protiteles) je znan zaplet o katerem so poročali med zdravljenjem z zdravilom IDELVION ter ustavi ustrezno delovanje zdravljenja.
- Do not use solutions that are cloudy or have deposits. 
- Ne uporabljajte raztopin, ki so motne ali imajo usedline.
The vials must not be heated above body temperature (37 °C). 
Vial ne smete segrevati na temperaturo, ki je višja od telesne (37 ºC).
Maintenance dose after 24 - 72 hours if there is further evidence of bleeding. 
Vzdrževalni odmerek po 24 - 72 urah, če obstajajo znaki nadaljnje krvavitve.
Haemostasis was maintained throughout the study duration. 
Ves čas trajanja študije je bila hemostaza ohranjena.
The safety and efficacy of using IDELVION for immune tolerance induction has not been established. 
Varnost in učinkovitost uporabe zdravila IDELVION za indukcijo imunske tolerance nista bili dokazani.
Inject the reconstituted solution slowly (as comfortable for you, up to a maximum of 5 ml/min) into the vein following the instructions given to you by your doctor. 
Pripravljeno raztopino injicirajte počasi (tako, da vam je udobno, in sicer do največ 5 ml/min) v veno po navodilih, ki vam jih je dal zdravnik.
The following side effects have been reported but it is not known how many people may be affected: • Development of neutralising antibodies (inhibitors) to IDELVION 
Poročali so o naslednjih neželenih učinkih, vendar ni znano pri koliko bolnikov so se pojavili: • razvoj nevtralizirajočih protiteles (inhibitorjev) proti zdravilu IDELVION.
• The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions. 
• Prašek je treba zmešati z vehiklom (tekočino) in raztopino pod aseptičnimi pogoji posesati iz viale.
The perprotocol efficacy analysis includes 15 surgeries performed in 12 patients between 8 and 51 years of age undergoing major or minor surgical, dental or other surgical invasive procedures. 
Analiza učinkovitosti po protokolu je vključevala 15 kirurških posegov pri 12 bolnikih, starih od 8 do 51 let, pri katerih so opravili večje ali manjše kirurške posege, zobozdravstvene ali druge kirurške invazivne posege.
• Allergic reactions (Hypersensitivity) 
• alergijske reakcije (preobčutljivost),
In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also section 4.4). 
V nekaterih primerih so te reakcije napredovale do hude anafilaksije in so nastopile v časovni povezavi s pojavom inhibitorjev faktorja IX (glejte tudi poglavje 4.4).
The following side effects occurred uncommonly (may affect up to 1 in 100 people): 
Naslednji neželeni učinki so se pojavili občasno (pojavijo se lahko pri največ 1 od 100 bolnikov):
21 PTPs remained on the extended 14 day prophylaxis interval for additional treatment duration of 98 to 575 (median 386) days. 
21 predhodno zdravljenih bolnikov je ostalo na podaljšani 14 dnevni profilaksi za dodatno zdravljenje, ki je trajalo 98 do 575 (mediana 386) dni.
If your bleeding is not being controlled with IDELVION, tell your doctor immediately. 
Če vaša krvavitev z zdravilom IDELVION ni pod nadzorom, nemudoma obvestite zdravnika.
It is strongly recommended that every time that IDELVION is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product. 
Zelo priporočljivo je, da se vsakič, ko bolnik dobi zdravilo IDELVION, zabeležita ime in serija zdravila, da se ohrani povezava med bolnikom in serijo zdravila.
Individual patients may vary in their responses to factor IX, demonstrating different half-lives and recoveries. 
Posamezni bolniki se lahko med seboj razlikujejo pri svojem odzivu na faktor IX, kar se kaže z različnimi razpolovnimi dobami in različnimi ravnmi povrnitve aktivnosti.
Activated factor IX, in combination with activated factor VIII, activates factor X. This results ultimately in the conversion of prothrombin to thrombin. 
Aktivirani faktor IX, v kombinaciji z aktiviranim faktorjem VIII, aktivira faktor X. Ta sodeluje pri pretvorbi protrombina v trombin.
One pack with 250, 500 or 1000 IU containing: 1 vial with powder 
Ena škatla z 250, 500 ali 1000 i.e. vsebuje: 1 vialo s praškom
The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level). 
Spodnja preglednica je pripravljena v skladu s klasifikacijo organskih sistemov MedDRA (organski sistem in najustreznejši izraz).
You should be monitored carefully for the development of inhibitors. 
Potreben bo skrben nadzor glede nastanka inhibitorjev.
From those subjects, 8 (38%) experienced at least one bleeding during the 14 day-prophylaxis, while they had no bleeding events during once weekly prophylaxis. 
Od teh preiskovancev se je 8 (38 %) preiskovancem pojavila vsaj ena krvavitev med 14 dnevno profilakso, medtem ko niso imeli nobene krvavitve med profilakso enkrat na teden.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia B. 
Zdravljenje je treba uvesti pod nadzorom zdravnika, izkušenega v zdravljenju hemofilije B.
Animal reproduction studies have not been conducted with factor IX. 
Študije na živalih o vplivu na sposobnost razmnoževanja s faktorjem IX niso bile opravljene.
The reconstituted solution should be administered by slow intravenous injection. 
Rekonstituirano raztopino je treba injicirati počasi intravensko.
IDELVION has no influence on the ability to drive and use machines. 
Zdravilo IDELVION nima vpliva na sposobnost vožnje in upravljanja strojev.
If you stop using IDELVION Do not stop using IDELVION without consulting your doctor. 
Če ste prenehali uporabljati zdravilo IDELVION Ne prenehajte uporabljati zdravilo IDELVION brez posvetovanja z zdravnikom.
One International Unit (IU) of factor IX activity is equivalent to that quantity of factor IX in one ml of normal human plasma. 
Ena mednarodna enota (i.e.) aktivnosti faktorja IX ustreza količini faktorja IX v enem ml normalne humane plazme.
Osmolality: 
Osmolarnost:
The recombinant factor IX portion is identical to the Thr148 allelic form of plasmaderived factor IX. 
Delež rekombinantnega faktorja IX je enak alelni obliki Thr148 iz plazme pridobljenega faktorja IX.
Four open label clinical studies included 107 subjects with at least one exposure to IDELVION reporting 13 adverse reactions in 7 subjects. 
Štiri odprte klinične študije, ki so vključevale 107 preiskovancev z vsaj enim odmerjanjem zdravila IDELVION, so poročale o 13 neželenih učinkih pri 7 preiskovancih.
The European Medicines Agency has deferred the obligation to submit the results of studies with IDELVION in previously untreated patients in the treatment and prophylaxis of bleeding in haemophilia B (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom IDELVION za predhodno nezdravljene bolnike za zdravljenje in preprečevanje krvavitev pri hemofiliji B (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk. 
Pri bolnikih z obstoječimi srčno-žilnimi dejavniki tveganja lahko nadomestna terapija s faktorjem IX poveča srčno-žilno tveganje.
Patients ≥ 12 years of age 
Bolniki, stari ≥ 12 let
• The solution should be clear or slightly opalescent, yellow to colourless, i.e. it might be sparkling when held up to the light but must not contain any obvious particles. 
• Raztopina mora biti bistra ali nekoliko opalescentna, rumena do brezbarvna, kar pomeni, da se lahko svetlika, če jo pogledate proti svetlobi, ne sme pa vsebovati vidnih delcev.
A subgroup of patients switched to extended treatment intervals (every 10 or 14 days) with a recommended dose of 75 IU/kg and individual adjustments. 
Podskupina bolnikov je prešla na daljši interval (vsakih 10 ali 14 dni) odmerjanja s priporočenim odmerkom 75 i.e./kg in individualnimi prilagoditvami.
For injection of IDELVION, only the provided administration sets should be used because treatment failure can occur as a consequence of factor IX adsorption to the internal surface of some injection equipment. 
Za injiciranje zdravila IDELVION je treba uporabiti le priloženi komplet za uporabo, saj je lahko zdravljenje neuspešno zaradi adsorpcije faktorja IX na notranje površine nekaterih vrst opreme za injiciranje.
Minor or moderate Haemarthrosis, muscle bleeding (except iliopsoas) or oral bleeding 
Manjša ali zmerna hemartroza, krvavitev v mišico (razen mišice iliopsoas) ali krvavitev v ustni votlini
• your clinical condition and response • your body weight 
• vašega kliničnega stanja in odziva,
All 27 subjects received weekly prophylaxis treatment with IDELVION for a mean time on study of 13.1 months (9, 18 months). 
Vseh 27 preiskovancev je prejemalo zdravilo IDELVION za profilakso enkrat na teden v povprečju 13,1 meseca (9, 18 mesecev).
The reconstituted preparation should be injected slowly intravenously at a rate comfortable for the patient up to a maximum of 5 ml/min. 
Rekonstituirano zdravilo je treba injicirati počasi intravensko s hitrostjo, udobno za bolnika do največ 5 ml/min.