natgillin/translations-raw huggingface dataset:
Loss of efficacy was reported in 1 out of 398 patients. 
O izgubi učinkovitosti so poročali pri 1 od 398 bolnikov.
● Let the skin dry for about 10 seconds. 
● Pustite približno 10 sekund, da se koža posuši.
In some cases, this can cause damage to the kidneys and other organs. 
V nekaterih primerih lahko to poškoduje ledvice in druge organe.
Please see below recommended features: 
Za njihove priporočene lastnosti glejte spodaj:
Children below the age of 1 year 
Otroci, mlajši od 1 leta
<24 hours 24-48 hours 
< 24 ur 24-48 ur
● Wash your hands well with soap and water. 
● Roke si dobro umijte z milom in vodo.
Clinically meaningful difference: Total score: 7 points; Physical Health: 10 points. 
Klinično pomembna razlika: celotna ocena: 7 točk; telesno zdravje: 10 točk.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. 
Ker študij kompatibilnosti ni na voljo, se zdravila ne sme mešati z drugimi zdravili.
● Only use the vial once. 
● Vialo uporabite le enkrat.
No dose adjustment is required for this demographic factor. 
Prilagoditev odmerka glede na ta demografski dejavnik ni potrebna.
Do not use if they appear damaged or if they have been dropped. 
Ne uporabite ga, če je videti poškodovan, ali če je kam padel.
Use of aPCC should be avoided unless no other treatment options/alternatives are available. 
Uporabi aPCC se je treba izogniti, razen če ni na voljo nobenih drugih alternativ/možnosti zdravljenja.
Use aPCC only if no other treatment can be used. 
aPCC uporabljajte le, če ni mogoče uporabiti nobenega drugega zdravljenja.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 February 2018 
Datum prve odobritve: 23. februar 2018
In case of clinical signs of loss of efficacy, a change of treatment should be considered. 
V primeru znakov izgube učinkovitosti je treba razmisliti o spremembi zdravljenja.
● if you are allergic to emicizumab or any of the other ingredients of this medicine (listed in section 6). 
● če ste alergični na emicizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
- upright and stable during use. 
- biti pokončen in stabilen med uporabo.
Injecting into a muscle could cause discomfort. 
Injiciranje v mišico lahko povzroči neugodje.
Includes all instances of aPCC treatment excluding those in the first 7 days and those that occurred 30 days after the discontinuation of Hemlibra. 
Vključuje vse primere zdravljenja z aPCC, razen tistih v prvih 7 dneh in tistih, ki so se zgodili 30 dni po prekinitvi zdravila Hemlibra.
Human IgG is known to be present in human milk. 
Znano je, da je človeški IgG pri človeku prisoten v materinem mleku.
Based on limited data, there is no evidence to suggest a difference in efficacy or safety in patients aged 65 years or above. 
Na podlagi majhnega števila podatkov ni dokazov o različni učinkovitosti in varnosti pri bolnikih, starih 65 let ali več.
The loading dose regimen is the same, irrespective of the maintenance dose regimen. 
Shema polnilnih odmerkov je enaka, ne glede na shemo vzdrževalnega odmerka.
If you stop using Hemlibra, you may no longer be protected against bleeding. 
Če prenehate uporabljati zdravilo Hemlibra, morda ne boste več zaščiteni pred krvavitvami.
If your child is less than one year old, your doctor may prescribe Hemlibra only after carefully weighing the expected benefits and risks of using this product. 
Če je vaš otrok star manj kot eno leto, mu lahko zdravnik zdravilo Hemlibra predpiše le, ko skrbno pretehta pričakovane koristi in tveganja uporabe tega zdravila.
Each time you use Hemlibra, record the name and batch number of the medicine. 
Vsakič, ko uporabite zdravilo Hemlibra, zabeležite ime in številko serije zdravila.
Monoclonal antibodies are a type of protein that recognise and bind to a target in the body. 
Monoklonska protitelesa so vrsta beljakovin, ki v telesu prepoznajo določen cilj in se vežejo nanj.
* An instance of aPCC treatment is defined as all doses of aPCC received by a patient, for any reason, until there was a 36-hour treatment-free break. 
* Primer zdravljenja z aPCC je opredeljen kot vsi odmerki aPCC, ki jih je bolnik prejel iz kakršnega koli razloga, do 36-urnega obdobja brez zdravljenja.
The vials should never be exposed to temperatures above 30 °C. 
Viale ne smejo biti nikoli izpostavljene temperaturam nad 30 °C.
Delayed or missed doses 
Zapozneli ali izpuščeni odmerki
Pharmacotherapeutic group: antihemorrhagics, other systemic hemostatics; ATC code: B02BX06 
Farmakoterapevtska skupina: antihemoragiki, drugi hemostatiki za sistemsko zdravljenje; oznaka ATC: B02BX06
● Do not throw away any used sharps disposal container in your household waste unless your local guidelines permit this. 
● Ne zavrzite odrabljenega vsebnika za ostre odpadke med gospodinjske odpadke, razen če vaše lokalne smernice to dovoljujejo.
● If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. 
● Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden uporabite to zdravilo.
In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 
Za izboljšanje sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
If aPCC is required, talk to your doctor in case you feel you need a total of more than 50 units/kg of aPCC. 
Če je aPCC potreben, se posvetujte z zdravnikom, če menite, da potrebujete skupaj več kot 50 enot aPCC na kilogram.
Calculated ABR 
Izračunani ABR
Analyses are based on data from individuals who provided responses at both baseline and Week 25 assessments. 
Analize temeljijo na podatkih posameznikov z odzivi na podlagi ocen v izhodišču in v 25. tednu.
For more information, see in section 6 “What is needed for Hemlibra administration and is not contained in this pack”. 
Za več informacij glejte poglavje 6, "Kaj je potrebno za dajanje zdravila Hemlibra in ni priloženo v tem pakiranju".
● Remove syringe cap (if required). 
● Odstranite pokrovček brizge (če je potrebno).
Of all instances of aPCC treatment, 68 % consisted of only one infusion < 100 U/kg. 
Med vsemi zdravljenji z aPCC jih je 68 % obsegalo le eno infuzijo < 100 e./kg.
Store in a refrigerator (2°C to 8°C). 
Shranjujte v hladilniku (od 2 do 8 °C).
Evidence of improvement was seen within one week following discontinuation of aPCC and interruption of Hemlibra. 
Dokaze o izboljšanju so opazili v enem tednu po prenehanju uporabe aPCC in prekinitvi zdravljenja z zdravilom
Pinching the skin is important to ensure that you inject under the skin (into fatty tissue) but not any deeper (into muscle). 
Stisk kože v gubo je pomemben, da zagotovite injiciranje pod kožo (v maščobno tkivo), ne pa globlje (v mišico).
Do not save unused medicine in the vial for later use. 
Neporabljenega zdravila v viali ne shranjujte za poznejšo uporabo.
Hemlibra is intended for long-term prophylactic treatment. 
Zdravilo Hemlibra je namenjeno za dolgotrajno profilaktično zdravljenje.
The dose and duration of treatment with bypassing agents will depend on the location and extent of bleeding, and the patient's clinical condition. 
Odmerek in trajanje zdravljenja z obvodnimi zdravili sta odvisna od mesta in obsežnosti krvavitve ter bolnikovega kliničnega stanja.
No patients with such characteristics were enrolled in clinical trials. 
Bolniki s takšnimi značilnostmi niso bili vključeni v klinična preskušanja.
Chromogenic factor VIII activity tests may be manufactured with either human or bovine coagulation proteins. 
Kromogeni testi aktivnosti faktorja VIII so lahko izdelani s človeškimi ali govejimi koagulacijskimi beljakovinami.
Factor VIII (FVIII) prophylaxis may be continued for the first 7 days of Hemlibra treatment. 
Profilaksa s faktorjem VIII (FVIII) se lahko nadaljuje še prvih 7 dni zdravljenja z zdravilom Hemlibra.
This is because Hemlibra in the blood may interfere with some laboratory tests, leading to inaccurate results. 
Zdravilo Hemlibra v krvi namreč lahko zmoti nekatere laboratorijske preiskave in povzroči netočne rezultate.
● Once the syringe has been filled with the medicine, the injection must be given immediately. 
● Ko je brizga napolnjena z zdravilom, je treba injekcijo dati takoj.
No fertility data are available in humans. 
Podatkov o plodnosti pri človeku ni na voljo.
Be cautious if you are at high risk for this condition (have had this condition in the past, or a member of your family have suffered from it), or if you are taking medicines that can increase the risk of developing this condition, such as ciclosporin, quinine or tacrolimus. 
Bodite previdni, če imate za to stanje veliko tveganje (če ste ga v preteklosti že imeli ali ga je imel/ima vaš družinski član) ali če uporabljate zdravila, ki lahko povečajo tveganje za razvoj tega stanja, kot so ciklosporin, kinin ali takrolimus.
If you inject Hemlibra yourself or if your caregiver injects it, you or your caregiver must carefully read and follow the instructions in section 7, “Instructions for use”. 
Če si zdravilo Hemlibra injicirate sami ali vam ga injicira skrbnik, morate vi ali vaš skrbnik skrbno prebrati in upoštevati navodila v poglavju 7, "Navodila za uporabo".
● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
● ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
● Once you have been trained, you should be able to inject this medicine at home, by yourself or with the help of a caregiver. 
● Ko boste usposobljeni, boste lahko zdravilo injicirali doma, bodisi sami bodisi s pomočjo skrbnika.
Haem-A-QoL at week 25 
Ocene Haem-A-QoL v 25. tednu
There are no data in patients over 77 years old. 
Za bolnike, starejše od 77 let, ni podatkov.
● Thigh (front and middle). 
● stegno (sprednji in srednji del),
IgG antibodies are mainly catabolised by lysosomal proteolysis and then eliminated from or reused by the body. 
Protitelesa IgG se v glavnem katabolizirajo z lizosomsko proteolizo in jih telo nato izloči ali ponovno uporabi.
The patient dose (in mg) and volume (in mL) should be calculated as follows: 
Bolnikov odmerek (v mg) in volumen (v ml) zdravila je treba izračunati takole:
● Hold plunger firmly to ensure it does not pull back in. 
● Močno primite bat, da zagotovite, da ga ne povleče nazaj noter.
In healthy subjects, the absolute bioavailability following subcutaneous administration of 1 mg/kg was between 80.4% and 93.1% depending on the injection site. 
Pri zdravih preiskovancih je bila absolutna biološka uporabnost po subkutani uporabi 1 mg/kg med 80,4 % in 93,1 %, odvisno od mesta injiciranja.
Clinical experience indicates a drug interaction exists with emicizumab and aPCC (see sections 4.4 and 4.8). 
Klinične izkušnje kažejo, da obstaja medsebojno delovanje med emicizumabom in aPCC (glejte poglavji 4.4 in 4.8).
● If you do not hear a click, look to see that the needle is fully covered by the safety shield. 
● Če ne zaslišite klika, preverite, ali varnostni ščitnik povsem pokriva iglo.
Important information after the injection: 
Pomembne informacije po injiciranju zdravila:
● Do not inject yourself or someone else unless you have been shown how to by your healthcare provider. 
● Ne injicirajte zdravila sebi ali komu drugemu, dokler vam zdravnik ne pokaže, kako to naredite.
● Do not inject air into the medicine as this could create air bubbles in the medicine. 
● Ne injicirajte zraka v zdravilo, ker to lahko povzroči nastanek zračnih mehurčkov v zdravilu.
EQ-5D-5L scores after 24 weeks 
Ocene EQ-5D-5L po 24 tednih
● Vial adapter (To be added on top of vial). 
● Adapterja za vialo (za pritrditev na vrh viale).
Alternating the site of injection may help prevent or reduce injection site reactions (see section 4.8). 
Menjavanje mest injiciranja lahko pomaga preprečiti ali zmanjšati reakcije na mestu injiciranja (glejte poglavje 4.8).
a Lower scores (negative change scores) are reflective of better functioning. 
(n = 43) a nižje ocene (negativne ocene sprememb) pomenijo boljše funkcioniranje.
Hemlibra increases the patient's coagulation potential. 
Zdravilo Hemlibra poveča bolnikov koagulacijski potencial.
The safety profile of Hemlibra was overall consistent between infants, children, adolescents, and adults. 
Varnostne značilnosti zdravila Hemlibra pri dojenčkih, otrocih, mladostnikih in odraslih so se na splošno skladale.
● Decision about dose modifications should take into account the half-life of medications; 
● Pri odločitvi o spremembah odmerka je treba upoštevati razpolovni čas zdravil.
If you cannot remove all medicine, turn the vial upright to reach the remaining amount 
Če iz viale ne morete potegniti vsega zdravila, obrnite vialo pokonci, da boste dosegli preostalo količino.
Arm D patients could uptitrate after the second qualifying bleed. 
Bolnikom v skupini D so odmerek lahko povečali po drugi kvalificirani krvavitvi.
Pharmacokinetic parameters derived from the population PK model. 
Farmakokinetični parametri, pridobljeni iz populacijskega farmakokinetičnega modela.
● Move the safety shield forward 90°, away from the syringe barrel. 
● Pomaknite varnostni ščitnik naprej za 90°, proč od telesa brizge.
Thus, the effect of emicizumab on male and female fertility is unknown. 
Vpliv emicizumaba na plodnost moških in žensk ni znan.
If FVIII is required in the perioperative period, please refer to section 4.5. 
Če je v perioperativnem obdobju potrebna uporaba FVIII, glejte poglavje 4.5.
It is not known whether emicizumab can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. 
Ni znano, ali lahko emicizumab škoduje plodu, če je uporabljen pri nosečnici, in ali lahko vpliva na reprodukcijsko sposobnost.
Average cumulative amount of aPCC over 24 hours (U/kg/24 hours) 
Povprečna kumulativna količina aPCC v 24 urah (e./kg/24 ur)
Each pack of Hemlibra contains 1 glass vial. 
Eno pakiranje zdravila Hemlibra vsebuje 1 stekleno vialo.
Haem-A_QoL scales range from 0 to 100; lower scores are reflective of better HRQoL. 
Razpon lestvice Haem-A_QoL je od 0 do 100; nižje ocene pomenijo boljšo zdravstveno kakovost življenja.
Caution should be taken if intrinsic pathway clotting based laboratory tests are used, as misinterpretation of their results may lead to under-treatment of patients experiencing bleeding episodes, which can potentially result in severe or life-threatening bleeds. 
Previdnost je potrebna, če se uporabijo laboratorijske preiskave, ki temeljijo na intrinzični poti strjevanja, saj lahko napačna razlaga njihovih rezultatov povzroči nazadostno zdravljenje bolnikov s krvavitvami, kar lahko povzroči hude ali življenjsko ogrožajoče krvavitve.
The European Medicines Agency has deferred the obligation to submit the results of studies with Hemlibra in one or more subsets of the paediatric population in the treatment of hereditary factor VIII deficiency (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Hemlibra za eno ali več podskupin pediatrične populacije za zdravljenje prirojenega pomanjkanja faktorja VIII (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Following discontinuation of aPCC and interruption of Hemlibra, evidence of improvement or resolution was seen within one month (see section 4.8). 
Po prenehanju uporabe aPCC in prekinitvi zdravljenja z zdravilom Hemlibra so dokaze o izboljšanju ali izginotju opazili v enem mesecu (glejte poglavje 4.8).
Accidental overdose may result in hypercoagulability. 
Naključno preveliko odmerjanje lahko povzroči hiperkoagulabilnost.
Due to its long half-life, these effects on coagulation assays may persist for up to 6 months after the last dose (see section 5.2). 
Zaradi dolgega razpolovnega časa lahko ti učinki na teste koagulacije trajajo do 6 mesecev po zadnjem odmerku (glejte poglavje 5.2).
Reminder to report any adverse events to their treating doctor. 
Opomnik, da vse neželene dogodke poročajo lečečemu zdravniku.
Large air bubbles can reduce the dose you receive. 
Veliki zračni mehurčki lahko zmanjšajo odmerek, ki ga dobite.
The median observation time for these patients was 29.6 weeks (range: 18.4 to 63.0 weeks). 
Mediani čas opazovanja teh bolnikov je bil 29,6 tedna (razpon: od 18,4 do 63,0 tednov).
● a reaction in the area where the injection is given (redness, itching, pain) 
● reakcija v predelu, kamor je injicirano zdravilo (pordelost, srbenje, bolečina)
Visual Analogue Scale Adjusted mean 
Vizualna analogna skala
● You should use a different injection site for each injection, at least 2.5 cm away from the area you used for your previous injection. 
● Za vsako injiciranje zdravila uporabite drugo mesto, ki naj bo vsaj 2,5 cm proč od predela, kamor ste dali prejšnjo injekcijo.
Inject the medicine 
Injicirajte zdravilo
Hemlibra can be used in adolescents and children of all ages. 
Zdravilo Hemlibra se lahko uporablja pri mladostnikih in otrocih vseh starosti.
● Choose appropriate dosage and volume from vial strengths available. 
● Izberite ustrezen odmerek in volumen med vialami različnih jakosti, ki so na voljo.
Hemlibra is for subcutaneous use only, and it should be administered using appropriate aseptic technique (see section 6.6). 
Zdravilo Hemlibra je namenjeno le za subkutano uporabo in ga je treba injicirati z upoštevanjem ustreznega aseptičnega postopka (glejte poglavje 6.6).
Other medicines and Hemlibra 
Druga zdravila in zdravilo Hemlibra
No cases required anticoagulation therapy. 
V nobenem primeru ni bilo potrebno antikoagulantno zdravljenje.
Emicizumab did not cause any changes in the reproductive organs of male or female cynomolgus monkeys up to the highest tested dose of 30 mg/kg/week (equivalent to 11 times the human exposure at the highest dose of 3 mg/kg/week, based on AUC). 
Emicizumab ni povzročil sprememb reproduktivnih organov samcev ali samic opic cynomolgus vse do največjega testiranega odmerka 30 mg/kg/teden (to na podlagi AUC ustreza 11-kratniku izpostavljenosti med uporabo največjega odmerka 3 mg/kg/teden pri človeku).
Clinical study in paediatric patients 
Klinična študija pri pediatričnih bolnikih
Do not use this medicine after the expiry date which is stated on the carton and the vial label after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznak "Uporabno do" in "EXP".
● Repeat the steps above until you have removed the larger air bubbles. 
● Ponavljajte zgornje korake, dokler ne odstranite večjih zračnih mehurčkov.
Immune tolerance induction (ITI) 
Indukcija imunske tolerance (ITI - immune tolerance induction)
● A child can self-inject the medicine provided the child's healthcare provider and the parent or caregiver agree. 
● Otrok si lahko zdravilo injicira sam, če se otrokov zdravnik in starši ali skrbniki o tem strinjajo.
● Your doctor or nurse will show you how to inject Hemlibra. 
● Zdravnik ali medicinska sestra vam bosta pokazala, kako injicirati zdravilo Hemlibra.
These instructions are for use with the Vial Adapter only. 
Ta navodila se nanašajo le na uporabo adapterja za vialo.
For comprehensive instructions on the administration of Hemlibra, see section 6.6 and package leaflet. 
Za izčrpna navodila o uporabi zdravila Hemlibra glejte poglavje 6.6 in navodilo za uporabo.
● If you do not have a sharps disposal container, you may use a household container that is: - made of heavy-duty plastic. 
● Če nimate vsebnika za ostre odpadke, lahko uporabite kakšen vsebnik za gospodinjsko uporabo, ki pa mora: - biti izdelan iz odporne plastike.
Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator. 
O uporabi obvodnega zdravila ali FVIII med operacijami in posegi se je odločal raziskovalec.
Patient treatment preference was also assessed using a preference survey. 
Na podlagi ankete o preferenci je bila ocenjena tudi preferenca bolnikov glede zdravljenja.
Selecting and preparing an injection site: 
Izbira in priprava mesta za injiciranje:
Important: If your prescribed dose is more than the amount of medicine in the vial, withdraw all of the medicine and go to the “Combining Vials” section now. 
Pomembno: Če je vaš predpisani odmerek večji od količine zdravila v viali, izvlecite vse zdravilo in zdaj nadaljujte pri poglavju "Združevanje vial".
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hemlibra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. 
Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Hemlibra, z upoštevanjem koristi dojenja za otroka in koristi zdravljenja za bolnico.
Hemlibra can be used in all age groups. 
Zdravilo Hemlibra se lahko uporablja v vseh starostnih skupinah.
To measure change in health status, the Index Utility Score (IUS) and the Visual Analog Scale (VAS) from the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) was examined. 
Za merjenje spremembe zdravstvenega stanja sta bila uporabljena IUS (Index Utility Score) in VAS (vizualna analogna skala) vprašalnika EQ-5D5L (EuroQoL Five-Dimension-Five Levels).
For more information on using aPCC while receiving Hemlibra, see in section 2: “Potentially serious side effects of using aPCC while receiving Hemlibra”. 
Za več informacij o uporabi aPCC med prejemanjem zdravila Hemlibra glejte poglavje 2: "Možni resni neželeni učinki uporabe aPCC med zdravljenjem z zdravilom Hemlibra".
Less than 5 % of patients tested positive for anti-emicizumab antibodies and < 1 % of patients had anti-emicizumab antibodies with neutralizing potential (based on declining pharmacokinetics). 
Manj kot 5 % bolnikov je imelo pozitiven izvid protiteles proti emicizumabu in < 1 % bolnikov je imel nevtralizacijska protitelesa proti emicizumabu (na podlagi padajoče farmakokinetike).
The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia A. 
Farmakokinetiko emicizumaba so ugotavljali z nerazdelčno analizo pri zdravih preiskovancih in z uporabo populacijske farmakokinetične analize baze podatkov o 389 bolnikih s hemofilijo A.
No studies have been conducted to assess the impact of emicizumab on milk production or its presence in breast milk. 
Študij za oceno vpliva emicizumaba na nastajanje materinega mleka ali za oceno njegove prisotnosti v materinem mleku niso izvedli.
If you stop using Hemlibra 
Če ste prenehali uporabljati zdravilo Hemlibra
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP. 
● Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
The median duration of exposure across the studies was 33 weeks (range: 0.1 to 94.3 weeks). 
Mediana izpostavljenosti v študijah je bila 33 tednov (razpon: od 0,1 do 94,3 tedna).
PREPARATION 
PRIPRAVA
The mean exposure time (+SD) for all patients on study was 21.38 weeks (12.01). 
(+ std. odklon) vseh bolnikov v študiji je bil 21,38 tedna (12,01).