natgillin/translations-raw huggingface dataset:
Therefore, factor IX should be used during pregnancy and lactation only if clearly indicated. 
Faktor IX se lahko med nosečnostjo in dojenjem uporablja le, če je to nujno potrebno.
The dose in adolescents is also calculated according to body weight and is the same dose as for adults. 
Tudi pri mladostnikih se odmerek izračuna na osnovi telesne mase in je enak kot pri odraslih.
An overall assessment of haemostatic efficacy was performed by the patient or caretaker (for home treatment) or study site investigator (for treatment under health care professional supervision) using a 4-point scale of excellent, good, moderate, or poor. 
Vrednotenje celokupne učinkovitosti hemostaze je izvedel bolnik oziroma skrbnik (pri zdravljenju na domu) ali raziskovalec v študiji (pri zdravljenju pod nadzorom zdravstvenega osebja) s pomočjo 4-točkovne lestvice kot odličen, dober, zmeren ali slab.
Allergic reactions are possible with this medicine. 
Pri uporabi tega zdravila se lahko pojavijo alergijske reakcije.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. 
Zdravljenje mora potekati pod nadzorom zdravnika z izkušnjami pri zdravljenju hemofilije.
If you forget a dose, inject the missed dose as soon as you remember. 
Če ste pozabili uporabiti odmerek, pozabljeni odmerek injicirajte takoj, ko se spomnite.
The listed warnings and precautions apply both to adults and adolescents (12-18 years). 
Navedena opozorila in previdnostni ukrepi veljajo tako za odrasle kot mladostnike (12-18 let).
For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja pri sobni temperaturi in pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
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).
Factor IX is a protein naturally found in the blood that helps to stop bleeding. 
Faktor IX je beljakovina, ki je naravno prisotna v krvi in sodeluje pri zaustavljanju krvavitve.
Non-interventional post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a noninterventional post-authorisation safety study deriving from a registry of Haemophilia patients according to an agreed protocol. 
Neintervencijska študija o varnosti zdravila po pridobitvi dovoljenja za promet z zdravilom (PASS): Da bi raziskali morebitne učinke kopičenja PEG v horoidnem pletežu možganov in drugih tkivih/organih, mora imetnik dovoljenja za promet z zdravilom izvesti in predložiti rezultate neintervencijske študije o varnosti zdravila po pridobitvi dovoljenja za promet iz registra bolnikov s hemofilijo v skladu z dogovorjenim protokolom.
In patients with haemophilia B, factor IX is missing or does not work properly. 
Pri bolnikih s hemofilijo B faktor IX manjka ali pa ne deluje pravilno.
• you suffer from other serious illness e.g. liver disease, heart disease, or cancer 
• imate kakšno drugo resno bolezen, npr. bolezen jeter, bolezen srca ali raka,
If you are not sure if either of the above applies to you, talk to your doctor before using this medicine. 
Če ste negotovi, ali katera koli od zgornjih navedb velja za vas, se pred začetkom uporabe tega zdravila posvetujte z zdravnikom.
Cardiovascular event 
Kardiovaskularni dogodki
A single dose is recommended. 
Priporočamo uporabo enkratnega odmerka.
Three trials of which one trial was a dedicated surgery trial included in total 15 major and 26 minor surgery procedures (patients aged 13 to 56 years). 
Tri preskušanja, od katerih je bilo eno preskušanje namenjeno kirurškemu poskušanju, so vključevala skupno 15 večjih in 26 manjših kirurških posegov (pri bolnikih, starih od 13 do 56 let).
Frequencies have been evaluated according to the following convention: very common (≥ 1/10); 
Pogostnost je navedena v skladu z naslednjim dogovorom: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do
Routine monitoring of factor IX activity levels for the purpose of dose adjustment is not necessary. 
Spremljanje zdravljenja Rutinsko spremljanje ravni aktivnosti faktorja IX zaradi prilagajanja odmerka ni potrebno.
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 v hudo anafilaksijo, pojavile pa so se v tesni časovni povezavi z razvojem zaviralcev faktorja IX (glejte tudi poglavje 4.4).
The number of units of factor IX administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products. 
Število uporabljenih enot faktorja IX se izraža v mednarodnih enotah (i.e.), ki so prilagojene trenutnim standardom SZO za proizvode faktorja IX.
• pale and cold skin, fast heartbeat, and/or dizziness (low blood pressure). 
• bleda in hladna koža, hiter srčni utrip in/ali omotica (nizek krvni tlak)
• In case you only need part of the entire vial, use the scale on the syringe to see how much reconstituted solution you withdraw, as instructed by your doctor or nurse. 
• Če potrebujete le del celotne vsebine viale, s pomočjo skale na injekcijski brizgi preverite koliko rekonstituirane raztopine ste izvlekli, kot vam je to pokazal zdravnik ali medicinska sestra.
If you forget to use Refixia 
Če ste pozabili uporabiti zdravilo Refixia
For Refixia some reagents will cause underestimation (30-50%), while most silica containing reagents will cause severe overestimation of the factor IX activity (more than 400%). 
Pri zdravilu Refixia nekateri reagenti podcenijo (30-50 %), večina reagentov s silicijevim dioksidom pa močno preceni aktivnost faktorja IX (več kot 400 %).
In case of residual FIX activity levels, there is a risk of interference when performing the Nijmegen modified Bethesda assay for inhibitor testing. 
V primeru rezidualne aktivnosti FIX obstaja tveganje interference pri izvedbi po Nijmegenu modificiranega Bethesda testa za testiranje zaviralca.
• Use a clean and germ free (aseptic) technique. 
• Uporabite čisto in aseptično (brezkužno) tehniko.
The European Medicines Agency has deferred the completion of the study with Refixia in previously untreated patients (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila dokončanje študije z zdravilom Refixia pri predhodno nezdravljenih bolnikih (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Known allergic reaction to hamster protein. 
Znana alergijska reakcija na hrčkove beljakovine.
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port: 
Injiciranje raztopine preko naprave za centralni venski dostop (CVAD - Central Venous Access Device), kot sta centralni venski kateter ali podkožni port:
• Inject the reconstituted solution as instructed by your doctor or nurse. 
• Rekonstituirano raztopino injicirajte v skladu z navodili zdravnika ali medicinske sestre.
• redness and/or swelling of the lips, tongue, face or hands 
• stiskanje v prsnem košu • rdečina in/ali otekanje ustnic, jezika, obraza ali rok
The long-term safety of Refixia in children below 12 years has not yet been established. 
Dolgoročna varnost zdravila Refixia pri otrocih, mlajših od 12 let, še ni bila dokazana.
There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions. 
V literaturi obstajajo poročila, ki kažejo soodvisnost med pojavom zaviralca faktorja IX in alergijskimi reakcijami.
You must contact your doctor or an emergency unit immediately if you have early signs of an allergic reaction such as: 
Nemudoma se posvetujte z zdravnikom ali poiščite zdravniško pomoč v najbližjem urgentnem centru, če opazite zgodnje znake alergijske reakcije, kot so:
The dose level and dosing intervals for surgery depend on the procedure and local practice. 
Odmerek in odmerni intervali pri kirurških posegih so odvisni od vrste posega in lokalne prakse.
In the absence of compatibility studies, this medicine must not be mixed with other medicinal products or reconstituted with infusion solutions other than the provided histidine solvent. 
Zaradi pomanjkanja študij kompatibilnosti, zdravila ne smemo mešati z drugimi zdravili ali rekonstituirati z drugimi raztopinami za infundiranje razen s priloženim vehiklom s histidinom.
Volume of distribution (Vss) (ml/kg) 
Volumen porazdelitve (Vss) (ml/kg)
In distribution and excretion studies in mice and rats, the 40 kDa polyethylene-glycol (PEG) moiety of Refixia was shown to be widely distributed to and eliminated from organs, and excreted via plasma in urine (44-56%) and faeces (28-50%). 
Študije porazdelitve in izločanja pri miših in podganah so pokazale, da se 40 kDa polietilen glikola (PEG) zdravila Refixia obsežno porazdeli in odstranjuje iz organov ter preko plazme izloči v urin (4456 %) in blato (28-50 %).
The success rate for treatment of bleeding episodes was also independent of whether the bleed was traumatic or spontaneous of nature. 
Delež uspešnosti zdravljenja epizod krvavitve tudi ni bil odvisen od travmatske ali spontane narave krvavitve.
Do not throw it out with the ordinary household waste. 
Nič od navedenega ne smete zavreči med običajne gospodinjske odpadke.
It is strongly recommended that every time that Refixia 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 po vsaki aplikaciji zdravila Refixia zabeleži ime in številka serije uporabljenega zdravila, da se zagotovi povezava med bolnikom in serijo uporabljenega zdravila.
If the medicine has not been used before the new expiry date, it should be disposed of. 
Če zdravila ne uporabite pred novim iztekom roka uporabnosti, ga morate zavreči.
It is a vitamin-K dependent coagulation factor and it is synthesised in the liver. 
Je od vitamina K odvisen koagulacijski faktor, ki se sintetizira v jetrih.
The primary amino acid sequence of the rFIX in Refixia is identical to the Ala148 allelic form of human plasma-derived factor IX. 
Primarno aminokislinsko zaporedje rFIX v zdravilu Refixia je identično alelni obliki Ala148 iz humane plazme pridobljenega faktorja IX.
The overall success rate for treatment of breakthrough bleeds was 97.1% (67 out of 69 evaluated bleeds). 
Delež celokupne uspešnosti zdravljenja krvavitev med uporabo zdravila je znašal 97,1 % (67 od 69 ovrednotenih krvavitev).
A total of 69 (98.6%) of the 70 bleeding episodes were treated with one injection. 
Skupno 69 (98,6 %) od 70 krvavitev so zdravili z eno injekcijo.
Additional doses of 40 IU/kg can be given. 
Aplicira se lahko dodatne odmerke po 40 i.e./kg
What Refixia is and what it is used for What you need to know before you use Refixia How to use Refixia 
Kaj je zdravilo Refixia in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Refixia Kako uporabljati zdravilo Refixia
Other medicines and Refixia Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
All pharmacokinetic studies with Refixia were conducted in previously treated patients with haemophilia B (factor IX ≤2%). 
Vse farmakokinetične študije zdravila Refixia so bile izvedene pri predhodno zdravljenih bolnikih s hemofilijo B (faktor IX ≤ 2 %).
Half-life (t1/2) (hours) 
Razpolovni čas (t1/2) (ure)
In a repeat dose toxicity study in monkeys, mild and transient body tremors were seen 3 hours post dosing and abated within 1 hour. 
V študiji toksičnosti pri ponavljajočih se odmerkih so pri opicah 3 ure po odmerjanju opazili blag in prehoden tremor telesa, ki je popustil v 1 uri.
Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor. 
Zato je treba pri bolnikih, pri katerih se pojavi alergijska reakcija, določiti prisotnost zaviralca.
Of the 597 treated bleeds observed in 79 (75%) of the 105 patients, 521 (87%) of the bleeds were resolved with 1 injection and 60 (10%) of the bleeds were resolved with 2 injections of Refixia. 
Od 597 zdravljenih krvavitev, opaženih pri 79 od 105 bolnikov (75 %), se je 521 krvavitev (87 %) ustavilo z 1 injekcijo, 60 krvavitev (10 %) pa z 2 injekcijama zdravila Refixia.
• Do not touch the rubber stopper with your fingers as this can transfer germs. 
• Gumijastega zamaška se ne dotikajte s prsti, saj ga lahko tako kontaminirate z mikrobi.
• you have risk factors for heart disease e.g high blood pressure, obesity, or smoking. 
• imate dejavnike tveganja za razvoj bolezni srca, npr. visok krvni tlak, debelost ali ste kadilec.
The use of Refixia in children below 12 years is not indicated (see section 4.2 for information on paediatric use). 
Uporaba zdravila Refixia pri otrocih, mlajših od 12 let, ni indicirana (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
For modified long-acting factor products it is known that the one-stage clotting assay results are highly dependent on the aPTT reagent and reference standard used. 
Znano je, da so rezultati enostopenjskega testa strjevanja krvi pri modificiranih dolgodelujočih proizvodih faktorja močno odvisni od uporabljenega aPTT reagenta in referenčnega standarda.
Haemostatic effect of Refixia during surgery was confirmed with a success rate of 100% in the 15 major surgeries in the trials. 
Hemostatski učinek zdravila Refixia med kirurškim posegom potrjuje delež uspešnosti, ki je pri 15 večjih posegih v preskušanjih znašal 100 %.
There are insufficient data to provide information on inhibitor incidence in previously untreated patients. 
Za navedbo informacij o pojavnosti zaviralcev pri predhodno nezdravljenih bolnikih ni dovolj podatkov.
The trough levels achieved with the weekly 40 IU/kg dosing regimen are summarised in section 5.2. 
Najmanjše koncentracije, dosežene pri režimu odmerjanja 40 i.e./kg enkrat na teden, so povzete v poglavju 5.2.
The potency (International Units) is determined using the European Pharmacopeia one-stage clotting test. 
Jakost (mednarodne enote) je določena z enostopenjskim testom strjevanja krvi po Evropski farmakopeji.
• Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible. 
• Gumijasti zamašek viale obrišite s sterilno alkoholno blazinico in pred uporabo počakajte nekaj sekund, da se posuši na zraku, da zagotovite čim večjo sterilnost.
The average molecular weight of Refixia is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa. 
Povprečna molekulska masa zdravila Refixia je približno 98 kDa, molekulska masa same beljakovine pa 56 kDa.
• If the CVAD line needs to be flushed before or after Refixia injection, use sodium chloride 9 mg/ml solution for injection. 
• Če je linijo naprave za centralni venski dostop pred injiciranjem zdravila Refixia ali po njem treba sprati, uporabite raztopino natrijevega klorida (9 mg/ml) za injiciranje.
• Check the name, strength and colour of the package, to make sure it contains the correct product. 
• Preverite ime, jakost in barvo pakiranja,
Severe or life threatening haemorrhages. 
Hude ali življenjsko nevarne krvavitve
The pivotal trial included 74 adolescent (13-17 years) and adult (18-65 years) previously treated patients. 
V ključno preskušanje je bilo vključenih 74 predhodno zdravljenih mladostnikov (13-17 let) in odraslih (18-65 let) bolnikov.
Do not use the equipment if it has been dropped, or if it is damaged. 
Pripomočkov ne uporabljajte, če so vam padli ali so kakor koli poškodovani.
Do not stop using Refixia without talking to your doctor. 
Ne prenehajte uporabljati zdravila Refixia, ne da bi se o tem prej posvetovali z zdravnikom.
Of note, ABR is not comparable between different factor concentrates and between different clinical studies. 
Opozoriti moramo, da deleža krvavitev v enem letu med različnimi koncentracijami faktorja in med različnimi kliničnimi študijami ni mogoče primerjati.
• The active substance is nonacog beta pegol (pegylated human coagulation factor IX (rDNA)). 
• Učinkovina je nonakog beta pegol (pegilirani humani koagulacijski faktor IX (rDNA)).
Based on modelled data using observed terminal half-lives (1549 days) in rat tissue distribution studies, the 40 kDa polyethylene-glycol (PEG) moiety will reach steady state levels in all human tissues within 1-2 years of treatment. 
Na osnovi modeliranih podatkov z uporabo opaženih končnih razpolovnih časov (15-49 dni) v študijah porazdelitve v tkivu podgane bi 40 kDa polietilen glikola (PEG) pri človeku doseglo vrednosti v stanju dinamičnega ravnovesja v vseh tkivih v 1-2 letih zdravljenja.
The rate of administration should be determined by the patient's comfort level up to a maximum injection rate of 4 ml/min. 
Hitrost aplikacije je treba določiti na osnovi stopnje ugodja pri bolniku, hitrost injiciranja pa ne sme biti večja od 4 ml/min.
If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered. 
Če je potrebna uporaba naprave za centralni venski dostop (CVAD - Central Venous Access Device), je treba upoštevati možno tveganje za pojav zapletov, povezanih z uporabo CVAD, vključno z lokalnimi okužbami, bakteriemijo in trombozo na mestu vstavljenega katetra.
The use of high purity factor IX products like Refixia is rarely associated with such adverse reactions. 
Uporaba zdravil s faktorjem IX velike čistote, kot je zdravilo Refixia, je bila le redko povezana s takšnimi neželenimi učinki.
* Factor IX trough levels = factor IX activity measured prior to next weekly dose (5 to 10 days post dosing) at steady state. 
* Najmanjše koncentracije faktorja IX = aktivnost faktorja IX, izmerjena pred naslednjim tedenskim odmerkom (5 do 10 dni po odmerku) v stanju dinamičnega ravnovesja.
If you are in doubt contact your doctor. 
Če ste v dvomih, se posvetujte z zdravnikom.
Due to the interference of polyethylene glycol (PEG) in the one-stage clotting assay with various aPTT reagents, it is recommended to use a chromogenic assay (e.g. Rox Factor IX or Biophen) when monitoring is needed. 
Zaradi vpliva polietilen glikola (PEG) na enostopenjski test strjevanja krvi z različnimi aPTT reagenti priporočamo uporabo kromogenega testa (npr. Rox Factor IX ali Biophen), če je potrebno spremljanje.
As expected, body weight adjusted clearance in paediatric and adolescent patients was higher compared to adults. 
Po pričakovanjih je bil očistek, prilagojen na telesno maso, pri otrocih in mladostnikih večji kot pri odraslih.
Pharmacokinetics were investigated in 16 adult and adolescent patients of which 6 were normal weight (BMI 18.5-24.9 kg/m2) and 10 were overweight (BMI 25-29.9 kg/m2). 
Farmakokinetiko so raziskovali pri 16 odraslih in mladostnikih, od katerih je 6 bolnikov imelo normalno telesno maso (ITM 18,5-24,9 kg/m2), 10 bolnikov pa prekomerno telesno maso (ITM 2529,9 kg/m2).
Discuss with your doctor the dose and number of injections you need. 
O potrebnem odmerku in številu injekcij se posvetujte z zdravnikom.
The reconstituted product must be injected into your vein (intravenous (IV) injection). 
Rekonstituirano zdravilo je treba injicirati v veno (intravenska (i.v.)
You will also need an infusion set (tubing and butterfly needle), sterile alcohol swabs, gauze pads and plasters. 
Potrebovali boste tudi infuzijski komplet (cevka in injekcijska igla z metuljčkom), sterilne alkoholne blazinice, zložence in obliže.
• After injection, safely dispose of all unused Refixia solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist. 
• Po injiciranju varno zavrzite vso neporabljeno raztopino zdravila Refixia, injekcijsko brizgo z infuzijskim kompletom, vialo z nastavkom za vialo in drug odpadni material v skladu z navodili zdravnika ali farmacevta.
If sudden and severe allergic reactions (e.g. anaphylactic reactions) occur, the injection must be stopped immediately. 
Če pride do pojava nenadne in hude alergijske reakcije (npr. anafilaktična reakcija), morate takoj prekiniti z injiciranjem zdravila.
No difference in the safety profile of Refixia was observed between previously treated adolescent (12-18 years) and adult patients. 
Pri varnostnem profilu zdravila Refixia pri predhodno zdravljenih mladostnikih (12-18 let) in odraslih bolnikih niso opazili razlik.
Driving and using machines Refixia has no influence on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Refixia nima vpliva na sposobnost vožnje in upravljanja strojev.
Refixia is not indicated for use in children (below 12 years). 
Zdravilo Refixia ni indicirano za uporabo pri otrocih (mlajših od 12 let).
If you have such antibodies, you may be at an increased risk of sudden and severe allergic reactions (e.g. anaphylactic reaction) during future treatment with factor IX. 
Če imate ta protitelesa, lahko pri vas obstaja večje tveganje za pojav nenadnih in hudih alergijskih reakcij (npr. anafilaktične reakcije) pri nadaljnjem zdravljenju s faktorjem IX.
Your doctor may also do a blood test to check if you have developed factor IX inhibitors (neutralising antibodies) against your medicine, as inhibitors may develop together with allergic reactions. 
Zdravnik bo morda opravil tudi krvno preiskavo, s katero bo preveril, ali je pri vas prišlo do razvoja zaviralcev faktorja IX (nevtralizirajoča protitelesa proti zdravilu), saj se zaviralci lahko razvijejo skupaj z alergijskimi reakcijami.
In the clinical trial programme, dose adjustment was not performed. 
programu kliničnega preskušanja prilagajanja odmerka niso izvedli.
The risk for developing inhibitors is highest if you have not been treated with factor IX medicines before i.e. for small children. 
Tveganje za razvoj zaviralcev je največje pri bolnikih, ki se predhodno še niso zdravili z zdravili s faktorjem IX, npr. pri majhnih otrocih.
The MAH shall complete, within the stated timeframe, the below measures: Description 
Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okviru izvesti naslednje ukrepe: Opis
These body tremors were seen at doses of Refixia (3,750 IU/kg), which were more than 90 times higher than the recommended dose for humans (40 IU/kg). 
Refixia (3.750 i.e./kg), ki so bili več kot 90-krat večji od priporočenega odmerka za človeka (40 i.e./kg).
Tremors have not been reported in the clinical trials. 
V kliničnih preskušanjih o pojavu tremorja niso poročali.
• Do not use any other way to warm the vial and pre-filled syringe. 
• Za segrevanje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
The mean total consumption of Refixia during and after surgery was 241 IU/kg (range: 81-460 IU/kg). 
Povprečna skupna poraba zdravila Refixia med in po operaciji je znašala 241 i.e./kg (razpon: 81-460 i.e./kg).
Your doctor will calculate your dose for you. 
Odmerek bo izračunal zdravnik.
The product contains traces of hamster proteins. 
Zdravilo vsebuje hrčkove beljakovine v sledeh.
• Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe. 
• Nehajte pritiskati na potisni bat in pustite, da se pomakne nazaj sam od sebe, medtem ko rekonstituirana raztopina polni injekcijsko brizgo.
The use of low purity factor IX products has been associated with instances of myocardial infarction, disseminated intravascular coagulation, venous thrombosis and pulmonary embolism. 
Uporaba zdravil s faktorjem IX majhne čistote je bila povezana s primeri miokardnega infarkta, diseminirane intravaskularne koagulacije, venske tromboze in pljučne embolije.