natgillin/translations-raw huggingface dataset:
If such inhibitors occur, the condition will manifest itself as an insufficient clinical response. 
Če se taki inhibitorji pojavijo, se lahko stanje pokaže kot nezadosten klinični odziv.
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), not known (cannot be estimated from the available data). 
Pogostnost je ocenjena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), neznana (ni mogoče oceniti iz razpoložljivih podatkov).
BeneFIX can be used for all age groups. 
Zdravilo BeneFIX se lahko uporablja pri vseh starostnih skupinah.
Administration (Intravenous Injection): 
Aplikacija (intravensko injiciranje):
Common to < 1/10 
Pogosti do < 1/10
Thrombin then converts fibrinogen into fibrin and a clot can be formed. 
Trombin nato pretvori fibrinogen v fibrin in nastane strdek.
Repeat infusion every 8 to 24 hours until threat is resolved. 
Ponovite infuzijo vsakih 8 do 24 ur, dokler nevarnost ne mine.
The terminal phase has not been covered unambiguously due to lack of data beyond 24 hours in paediatric subjects < 6 years of age. 
Končna faza ni nedvoumno raziskana zaradi pomanjkanja podatkov po 24 urah pri pediatričnih osebah, starih < 6 let.
- If you are allergic to nonacog alfa or any of the other ingredients of this medicine (listed in section 6). 
če ste alergični na nonakog alfa ali katerokoli sestavino tega zdravila (navedeno v poglavju 6).
X 1.3 IU/kg 
X 1,3 i.e./kg
This is of importance particularly when changing the laboratory and/or reagents used in the assay. 
To je še posebej pomembno ob zamenjavi laboratorija in/ali reagentov za testiranje.
• two alcohol swabs 
•dva alkoholna zloženca,
• Development of neutralising antibodies (inhibitors) 
• razvoj nevtralizirajočih protiteles (inhibitorjev)
• Lack of response to treatment (failure to stop or prevent bleeding episodes) 
• nezadosten odziv na zdravljenje (neuspešno zaustavljanje ali preprečevanje krvavitev)
In the case of shock, the current medical standards for treatment of shock should be observed. 
V primeru šoka se ravnajte po trenutno veljavnih medicinskih standardih za zdravljenje šoka.
The contents of the pack are: 
Pakiranje vsebuje:
Mean  SD Pharmacokinetic Parameters Based on Individual Bayes Estimates from Population Pharmacokinetic Analysis 
Povprečni  SD farmakokinetični parametri na osnovi posameznih Bayesovih ocen iz populacijske farmakokinetične analize
Do not use this medicine after the expiry date which is stated on the outer box and vial label. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. 
Zdravljenje je treba izvajati pod nadzorom zdravnika, ki je izkušen v zdravljenju hemofilije.
Do not stop taking BeneFIX without consulting your doctor. 
Ne prenehajte jemati zdravila BeneFIX, ne da bi se posvetovali z zdravnikom.
Therefore, if you experience allergic reactions such as those described above, you should be tested for the presence of an inhibitor. 
Če boste doživeli alergijske reakcije, kot so opisane zgoraj, vas bo zato treba testirati na prisotnost inhibitorja.
Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated. 
Zato naj se faktor IX uporablja med nosečnostjo in dojenjem le, če je to nujno potrebno.
METHOD OF ADMINISTRATION Use the entire contents. 
Porabite vso vsebino.
- If you suffer from liver or heart disease or if you have recently had surgery, there is an increased risk for blood clotting (coagulation) complications. 
Če imate bolezen jeter ali srca ali če ste bili pred nedavnim operirani, je tveganje za zaplete s strjevanjem krvi (koagulacijo) zvečano.
Pharmacotherapeutic group: Antihaemorrhagics, blood coagulation factor IX; ATC code: B02BD04 
Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktor IX; oznaka ATC: B02BD04
At least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved. 
Vsaj 1 dan, dokler sodeč po bolečini krvavitev ne izzveni ali je dosežena ozdravitev.
This dose and duration will depend upon your individual needs for replacement factor IX therapy and how quickly your body uses up factor IX, which will be checked regularly. 
Odmerek in trajanje bosta odvisna od vaših individualnih potreb po nadomestnem zdravljenju s faktorjem IX in od tega, kako hitro vaše telo porabi faktor IX, kar bo treba redno nadzirati.
In each of these situations, the benefit of treatment with BeneFIX should be weighed against the risk of these complications. 
Pri teh stanjih je treba pretehtati korist zdravljenja z zdravilom BeneFIX v primerjavi s tveganjem za omenjene zaplete.
In some cases, these reactions have progressed to severe anaphylaxis. 
V nekaterih primerih so te reakcije napredovale do hude anafilaksije.
This should be considered during the preparation and administration of BeneFIX. 
To je treba upoštevati pri pripravi in dajanju zdravila BeneFIX.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, you should only take BeneFIX upon specific instructions from your doctor. 
Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, smete uporabiti zdravilo BeneFIX le po posebnem navodilu zdravnika.
White/almost white powder and clear and colourless solvent. 
Bel/skoraj bel prašek in bister in brezbarven vehikel.
Administration by continuous infusion has not been approved and is not recommended (see also sections 4.4 and 6.6). 
Kontinuirana infuzija Dajanje s kontinuirano infuzijo ni odobreno in ni priporočljivo (glejte tudi poglavji 4.4 in 6.6).
Clinical studies of BeneFIX did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. 
V kliničnih študijah z zdravilom BeneFIX ni sodelovalo dovolj oseb, starih 65 let ali več, da bi določili, ali se odzivajo drugače kot mlajše osebe.
The safety and efficacy of using BeneFIX for immune tolerance induction has not been established. 
Varnost in učinkovitost uporabe zdravila BeneFIX za indukcijo imunske tolerance nista bili dokazani.
In such cases, it is recommended that a specialised haemophilia centre be contacted. 
V teh primerih je priporočljivo, da se obrnete na specializiran center za hemofilijo.
Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL) 
Ponovite infuzijo vsakih 8-24 ur, dokler se rana ustrezno ne zaceli, nato zdravljenje nadaljujte še vsaj 7 dodatnih dni, da aktivnost faktorja IX vzdržujete na 30 % do 60 % (i.e./dl).
Month 6 n = 23 Mean ± SD 
6. mesec n = 23 povprečje ± SD
The specific activity of BeneFIX is not less than 200 IU/mg protein. 
Specifična aktivnost zdravila BeneFIX je najmanj 200 i.e./mg beljakovin.
The reconstituted product does not contain a preservative and should be used immediately, but no longer than 3 hours after reconstitution. 
Rekonstituirano zdravilo ne vsebuje konzervansa in ga je treba uporabiti takoj, najpozneje pa 3 ure po rekonstituciji.
There are insufficient data to provide information on inhibitor incidence in PUPs (see also section 5.1). 
Na voljo ni dovolj podatkov, da bi lahko posredovali informacije o incidenci pojavljanja inhibitorjev pri PUP (glejte tudi poglavje 5.1).
Nonacog alfa is a purified protein that has 415 amino acids in a single chain. 
Nonakog alfa je prečiščena beljakovina, ki ima 415 aminokislin v eni sami verigi.
Two patients underwent surgical procedures (circumcision and port-a-catheter insertion). 
Pri dveh bolnikih so izvedli kirurški poseg (cirkumcizija in vstavitev katetra s portom).
In the case of the following haemorrhagic events, the factor IX activity should not fall below the given plasma activity levels (in % of normal or in IU/dL) in the corresponding period. 
V primeru naslednjih hemoragičnih dogodkov aktivnost faktorja IX ne sme pasti pod dano raven plazemske aktivnosti (v % normalne vrednosti ali v i.e./dl) v ustreznem obdobju.
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor IX activity) is indispensable. 
Posebno v primeru večjih kirurških posegov je nujno treba natančno spremljanje nadomestnega zdravljenja s pomočjo analize koagulacije (plazemska aktivnost faktorja IX).
Infants and children had higher clearance, larger volume of distribution, shorter half-life and lower recovery than adolescents and adults. 
Dojenčki in otroci imajo večji očistek, večji volumen porazdelitve, krajši razpolovni čas in manjši porast koncentracije faktorja IX v primerjavi z mladostniki in odraslimi.
X reciprocal of observed recovery 
X recipročna vrednost ugotovljenega porasta koncentracije
Note: If you use more than one vial of BeneFIX per infusion, each vial should be reconstituted as per the previous instructions. 
Opomba: Če uporabite na infuzijo več kot eno vialo zdravila BeneFIX, morate vsako vialo rekonstituirati po zgornjih navodilih.
The procedures below are provided as guidelines for the reconstitution and administration of BeneFIX. 
Spodaj opisani postopki naj služijo kot smernice za rekonstitucijo in uporabo zdravila BeneFIX.
deep vein thrombosis*; thrombosis*; thrombophlebitis* 
globoka venska tromboza*, tromboza*, tromboflebitis*
- Allergic reactions are possible. 
Možne so alergijske reakcije.
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 tej količini faktorja IX v enem ml normalne človeške plazme.
Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breastfeeding is not available. 
Ker se hemofilija B pri ženskah pojavlja redko, izkušenj z uporabo faktorja IX med nosečnostjo in dojenjem ni na voljo.
The cap may need to be replaced (if not administering reconstituted BeneFIX immediately), so set it aside by placing it on its top. 
Morda boste morali pokrovček namestiti nazaj (če rekonstituiranega zdravila BeneFIX ne boste uporabili takoj), zato ga začasno odložite, tako da ga postavite na njegov zgornji del.
The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case. 
Količino in pogostost uporabe zdravila je treba prilagoditi glede na klinično učinkovitost v posameznem primeru.
The following table can be used to guide dosing in bleeding episodes and surgery: 
Naslednja preglednica nas lahko vodi pri odmerjanju v primerih krvavitev in operacije:
Side effects with unknown frequency (frequency cannot be estimated from the available data) 
Neželeni učinki z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
The solution should appear clear and colourless. 
Raztopina mora biti bistra in brezbarvna.
Abbreviations: AUC∞ = area under the plasma concentration-time curve from time zero to infinity; Cmax = peak concentration; t1/2 = plasma elimination half-life; CL = clearance; SD = standard deviation. 
Kratice: AUC∞ = površina pod plazemsko koncentracijsko krivuljo v odvisnosti od časa, od časa nič do neskončnosti; Cmax = največja plazemska koncentracija; t1/2 = razpolovni čas izločanja v plazmi; CL = očistek; SD = standardna deviacija.
In addition, pharmacokinetic parameters were followed up in 23 of the same patients after repeated administration of BeneFIX for six months and found to be unchanged compared with those obtained at the initial evaluation. 
Poleg tega so pri 23 od teh bolnikov šest mesecev spremljali farmakokinetične parametre po večkratnem odmerjanju zdravila BeneFIX in ugotovili, da so v primerjavi s parametri, pridobljenimi pri prvotni oceni, nespremenjeni.
- If you are allergic to hamster proteins. 
če ste alergični na beljakovine hrčka.
Do not take BeneFIX: 
Ne uporabljajte zdravila BeneFIX:
However, the half-life of the product (see section 5.2) and the limited pharmacokinetic study data for the once-weekly regimen do not allow recommending this regimen in general for long-term prophylaxis in severe haemophilia B patients. 
Vendar zaradi razpolovnega časa zdravila (glejte poglavje 5.2) in omejenih podatkov iz farmakokinetičnih študij za režim enkrat na teden na splošno tega režima ni mogoče priporočiti za dolgotrajno profilakso pri bolnikih s hudo hemofilijo B.
No interactions of human coagulation factor IX (rDNA) products with other medicinal products have been reported. 
O medsebojnem delovanju zdravil s humanim koagulacijskim faktorjem IX (rDNA) z drugimi zdravili niso poročali.
If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician. 
Če se pojavijo simptomi preobčutljivosti, je treba bolnikom svetovati, naj nemudoma prekinejo uporabo zdravila in se posvetujejo z zdravnikom.
If such inhibitors occur, a sign may be an increase in the amount of BeneFIX typically required to treat a bleed and or continued bleeding after treatment. 
Če se taki inhibitorji pojavijo, se lahko to pokaže kot zvečanje količine zdravila BeneFIX, ki je običajno potrebna za zdravljenje krvavitev, in/ali kot nadaljnje krvavitve po zdravljenju.
No investigations on carcinogenicity, fertility impairment and foetal development have been conducted. 
Študije kancerogenosti in vpliva na plodnost in na razvoj ploda niso bile izvedene.
Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved. 
Ponovite infuzijo vsakih 24 ur 3-4 dni ali dlje, dokler ne izzvenita bolečina in akutna nezmožnost.
This patient was able to continue treatment with BeneFIX with no anamnestic rise in inhibitor or anaphylaxis (see section 4.4). 
Ta bolnik je lahko nadaljeval zdravljenje z zdravilom BeneFIX brez anamnestičnega porasta inhibitorja ali anafilaksije (glejte poglavje 4.4).
Slowly draw back all the solution into the syringe. 
Počasi izvlecite vso raztopino v brizgo.
The table lists adverse reactions reported in the clinical trials of previously treated patients and identified in postmarketing use. 
V preglednici so navedeni neželeni učinki, o katerih so poročali v kliničnih preskušanjih predhodno zdravljenih bolnikov in ki so jih odkrili v obdobju trženja.
Please dispose of all unused solution, empty vials and used needles and syringes in an appropriate container for throwing away waste as it may hurt others if not handled properly. 
Vso neporabljeno raztopino, prazne viale in uporabljene injekcijske igle ter brizge odvrzite v ustrezen vsebnik za odpadke, saj lahko pri neustreznem ravnanju z odpadki ti predmeti ranijo ali poškodujejo druge osebe.
BeneFIX must be stored below 30°C and must be used by the expiry date on the label. 
Zdravilo BeneFIX morate hraniti pri temperaturi do 30 °C in ga morate porabiti do datuma izteka roka uporabnosti, ki je naveden na oznaki.
The treatment required depends on the nature and severity of side-effects (see also “Warnings and precautions”). 
Zahtevano zdravljenje je odvisno od narave in stopnje neželenih učinkov (glejte tudi “Opozorila in previdnostni ukrepi”).
It has a primary amino acid sequence that is comparable to the Ala allelic form of plasma-derived factor IX, and some post-translational modifications of the recombinant molecule are different from those of the plasma-derived molecule. 
Ima primarno aminokislinsko sekvenco, ki je primerljiva z alelno obliko Ala148 iz plazme pridobljenega faktorja IX, in nekatere posttranslacijske modifikacije rekombinantne molekule se razlikujejo od tistih v molekuli, pridobljeni iz plazme.
Wipe the top of the vial with an alcohol swab provided, or use another antiseptic solution and allow to dry. 
Obrišite vrh viale s priloženim alkoholnim zložencem ali s kakšno drugo antiseptično raztopino in pustite, da se posuši.
Age Group (years) 
Starostna skupina (leta)
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 se te reakcije razvile v hudo anafilaksijo in so se pojavile v tesni časovni povezavi z razvojem inhibitorjev faktorja IX (glejte tudi poglavje 4.4).
This is done by bending the cap up and down until the perforation is broken. 
To naredite tako, da upogibate pokrovček navzgor in navzdol, dokler se ne prelomi po perforaciji.
Efficacy analysis in study 3090A1-301-WW was based on 22 evaluable paediatric subjects on prophylaxis regimen including 4 on-demand patients who shortly changed to prophylaxis. 
Analiza učinkovitosti v študiji 3090A1-301-WW je temeljila na 22 ovrednotenih pediatričnih osebah, ki so se zdravile profilaktično, vključno s 4 bolniki, ki so se zdravili po potrebi in so kmalu prešli na profilaktično zdravljenje.
- The production of factor IX in the body is controlled by the factor IX gene. 
Nastajanje faktorja IX v telesu nadzira gen za faktor IX.
It is strongly recommended that every time BeneFIX 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. 
Močno priporočamo, da ob vsaki uporabi zdravila BeneFIX pri bolniku zabeležite ime in številko serije zdravila za ohranjanje povezave med bolnikom in serijo zdravila.
BeneFIX has no influence on the ability to drive or use machines. 
Zdravilo BeneFIX nima vpliva na sposobnost vožnje in upravljanja strojev.
In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary. 
V nekaterih primerih, predvsem pri mlajših bolnikih, bodo morda potrebni krajši presledki med odmerjanjem ali večji odmerki.
• Thrombotic events (abnormal blood clots) 
• trombotični dogodki (nenormalni krvni strdki)
Patients should follow the specific venipuncture procedures provided by their doctor. 
Bolniki naj se ravnajo po specifičnih postopkih venepunkcije, ki jih bodo dobili od zdravnika.
FIX consumption for routine prophylaxis in 22 evaluable patients was 4607 ( 1849) IU/kg per year and 378 ( 152) IU/kg per month. 
Poraba faktorja IX za rutinsko profilakso pri 22 ovrednotenih bolnikih je bila 4.607 ( 1.849) i.e./kg na leto in 378 ( 152) i.e./kg na mesec.
Haemophilia B is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor IX and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma. 
Hemofilija B je spolno vezana dedna bolezen motnje koagulacije krvi zaradi zmanjšane ravni faktorja IX in povzroča obilne krvavitve v sklepe, mišice ali notranje organe, bodisi spontano, bodisi zaradi nezgodne ali kirurške travme.
The only documented serious adverse event related with BeneFIX was reported from the only included PUP, who experienced hypersensitivity and inhibitor development. 
O edinemu zabeleženemu resnemu neželenemu učinku v povezavi z zdravilom BeneFIX so poročali pri edinemu vključenemu PUP, ki se mu je pojavila preobčutljivost in razvoj inhibitorja.
In case of severe allergic reactions, alternative haemostatic measures should be considered. 
V primeru hudih alergijskih reakcij je treba razmisliti o drugih hemostatičnih ukrepih.
BeneFIX may increase the risk of thrombosis (abnormal blood clots) in your body if you have risk factors for developing blood clots, including an indwelling venous catheter. 
Zdravilo BeneFIX lahko zveča tveganje tromboze (nenormalnih krvnih strdkov) v telesu, če imate dejavnike tveganja za nastajanje krvnih strdkov, vključno s stalnim venskim katetrom.
The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 224 subjects. 
Pogostnost temelji na neželenih učinkih iz vseh vzrokov, ki so se pojavili med zdravljenjem v združenih kliničnih preskušanjih z 224 preskušanci.
Your doctor will decide the dose of BeneFIX you will receive. 
Zdravnik bo določil odmerek zdravila BeneFIX, ki ga boste prejemali.
Mean dosage ( standard deviation) for prophylaxis was 63.7 ( 19.1) IU/kg at intervals of 3 to 7 days. 
Povprečni odmerek ( standardna deviacija) za profilakso je 63,7 ( 19,1) i.e./kg v presledkih od 3 do 7 dni.
BeneFIX should be injected intravenously over several minutes. 
Zdravilo BeneFIX morate vbrizgavati v veno več minut.
Always wash your hands prior to performing the following procedures. 
Preden začnete s spodaj opisanimi postopki, si vedno najprej umijte roke.
The calculation of the required dose of BeneFIX can be based on the finding that one unit of factor IX activity per kg body weight is expected to increase the circulating level of factor IX, an average of 0.8 IU/dL (range from 0.4 to 1.4 IU/dL) in patients  12 years (further information in section 5.2). 
Potrebni odmerek zdravila BeneFIX lahko izračunamo na podlagi ugotovitve, da ena enota aktivnosti faktorja IX na kilogram telesne mase pričakovano zviša raven faktorja IX v krvi za povprečno 0,8 i.e./dl (razpon od 0,4 do 1,4 i.e./dl) pri bolnikih  12 let (dodatne informacije so v poglavju 5.2).
Dose and duration of the substitution therapy depend on the severity of the factor IX deficiency, on the location and extent of bleeding, and on the patient's clinical condition. 
Odmerek in trajanje nadomestnega zdravljenja sta odvisna od stopnje pomanjkanja faktorja IX, mesta in obsega krvavitve ter bolnikovega kliničnega stanja.
Your doctor may want to monitor you for inhibitor development (see “Warnings and precautions”). 
Zdravnik vas bo morda želel spremljati glede razvoja inhibitorja (glejte tudi “Opozorila in previdnostni ukrepi”).
Recombinant coagulation factor IX is a recombinant DNA-based protein therapeutic which has structural and functional characteristics comparable to endogenous factor IX. 
Rekombinantni koagulacijski faktor IX je rekombinantno beljakovinsko zdravilo na podlagi DNA, katerega strukturne in funkcijske značilnosti so primerljive z endogenim faktorjem IX.
The safety and efficacy of BeneFIX administration by continuous infusion have not been established (see also sections 4.2 and 4.8). 
Varnost in učinkovitost dajanja zdravila BeneFIX s kontinuirano infuzijo nista bili dokazani (glejte tudi poglavji 4.2 in 4.8).
• Chest discomfort (including chest pain) 
• nelagodje v prsnem košu (vključno z bolečino v prsnem košu)
- Even in the absence of factor IX inhibitor, higher doses of BeneFIX may be needed than required for other plasma-derived factor IX products that you may have taken previously. 
Celo v odsotnosti inhibitorja faktorja IX utegnejo biti potrebni večji odmerki zdravila BeneFIX, kot so potrebni za druga zdravila, ki vsebujejo faktor IX, pridobljen iz plazme, in ki ste jih morda jemali pred tem.
Factor IX activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an international standard for factor IX in plasma). 
Aktivnost faktorja IX v plazmi se izraža bodisi v odstotkih (glede na normalno človeško plazmo) ali v mednarodnih enotah (glede na mednarodni standard za faktor IX v plazmi).
Patients known to have major deletion mutations of the factor IX gene should be observed closely for signs and symptoms of acute hypersensitivity reactions, particularly during the early phases of initial exposure to product. 
Bolnike z znanimi pomembnejšimi delecijskimi mutacijami na genu za faktor IX moramo skrbno opazovati glede znakov in simptomov akutnih preobčutljivostnih reakcij, še posebej v zgodnjih fazah začetne izpostavljenosti zdravilu.
The effect of BeneFIX on fertility has not been established. 
Vpliv zdravila BeneFIX na plodnost ni bil dokazan.
Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed. 
Razvoj protiteles proti beljakovinam hrčka s povezanimi preobčutljivostnimi reakcijami so opazili zelo redko.