natgillin/translations-raw huggingface dataset:
The active substance in Veyvondi, vonicog alfa, works in the body in the same way as natural von Willebrand factor. 
Učinkovina v zdravilu Veyvondi, vonikog alfa, deluje v telesu enako kot naravni von Willebrandov faktor.
An overview of Veyvondi and why it is authorised in the EU 
Pregled zdravila Veyvondi in zakaj je odobreno v EU
Veyvondi must not be used in patients who have had allergic reactions to mouse or hamster proteins. 
Zdravilo Veyvondi se ne sme uporabljati pri bolnikih, pri katerih se je pojavila alergijska reakcija na beljakovine miši ali hrčka.
What are the risks associated with Veyvondi? 
Kakšna tveganja so povezana z zdravilom Veyvondi?
The first study involved 37 patients who were given Veyvondi for the treatment of bleeding episodes. 
Prva študija je vključevala 37 bolnikov, ki so zdravilo Veyvondi prejemali za zdravljenje epizod krvavenja.
The benefits of Veyvondi in controlling bleeding have been shown in two main studies involving 52 patients with von Willebrand disease. 
Koristi zdravila Veyvondi pri nadzoru krvavenja so bile dokazane v dveh glavnih študijah z 52 bolniki z von Willebrandovo boleznijo.
The second study involved 15 patients who were given Veyvondi to prevent bleeding during surgery, including major surgery such as knee replacement. 
V drugo študijo je bilo vključenih 15 bolnikov, ki so prejemali zdravilo Veyvondi za preprečevanje krvavitev med kirurškim posegom, vključno z obsežnimi poškodbami, na primer zamenjavo kolena.
What is Veyvondi and what is it used for? 
Kaj je zdravilo Veyvondi in za kaj se uporablja?
The side effects with Veyvondi were considered typical for this type of medicine. 
Neželeni učinki zdravila Veyvondi so bili ocenjeni kot značilni za to vrsto zdravila.
Veyvondi is a medicine used to control bleeding in patients with von Willebrand disease (an inherited bleeding disorder), who cannot be treated with another medicine called desmopressin or when desmopressin is ineffective. 
Veyvondi je zdravilo, ki se uporablja za nadzor krvavenja pri bolnikih z von Willebrandovo boleznijo (dedno motnjo krvavenja), ki jih ni mogoče zdraviti z drugim zdravilom, imenovanim dezmopresin, ali kadar je dezmopresin neučinkovit.
In the 15 major and minor surgeries that occurred during the study, Veyvondi was rated as excellent or good at preventing bleeding episodes for all 15 surgeries. 
Pri 15 velikih in malih kirurških posegih, ki so bili opravljeni med študijo, je bilo zdravilo Veyvondi pri vseh 15 kirurških posegih ocenjeno kot odlično ali dobro pri preprečevanju epizod krvavitve.
It is used ‘on demand' to treat bleeding episodes and is also used to prevent and treat bleeding during surgery. 
Uporablja se na zahtevo za zdravljenje epizod krvavenja ter za preprečevanje in zdravljenje krvavenja med kirurškimi posegi.
Veyvondi is available as a powder and solvent that are mixed together to make a solution for injection into a vein. 
Zdravilo Veyvondi je na voljo v obliki praška in vehikla, ki se zmešata v raztopino za injiciranje v veno.
Veyvondi was shown to be effective in treating bleeding episodes in patients with von Willebrand disease. 
Zdravilo Veyvondi se je pokazalo kot učinkovito za zdravljenje epizod krvavenja pri bolnikih z von Willebrandovo boleznijo.
Veyvondi contains the active substance vonicog alfa. 
Zdravilo Veyvondi vsebuje učinkovino vonikog alfa.
The following side effects may occur during treatment with Veyvondi: hypersensitivity (allergic) reactions, thromboembolic events (problems due to the formation of blood clots in the blood vessels), development of inhibitors (antibodies) against von Willebrand factor, causing the medicine to stop working and resulting in a loss of bleeding control. 
Pri zdravljenju z zdravilom Veyvondi se lahko pojavijo naslednji neželeni učinki: preobčutljivostne (alergijske) reakcije, tromembolični dogodki (težave zaradi nastajanja krvnih strdkov v krvnih žilah), nastanek zaviralcev (protiteles) proti von Willebrandovi bolezni, ki povzročijo prenehanje delovanja zdravila in izgubo nadzora nad krvavenjem.
For the full list of side effects of Veyvondi, see the package leaflet. 
Za celoten seznam neželenih učinkov zdravila Veyvondi glejte navodilo za uporabo.
Veyvondi was also effective for preventing and treating bleeding related to surgery. 
Prav tako je bilo učinkovito pri preprečevanju in zdravljenju krvavitev, povezanih s kirurškimi posegi.
Veyvondi can only be obtained with a prescription and treatment should be supervised by a doctor experienced in treating patients with bleeding disorders. 
Predpisovanje in izdaja zdravila Veyvondi je le na recept, zdravljenje pa mora uvesti zdravnik z izkušnjami z zdravljenjem motenj strjevanja krvi.
How is Veyvondi used? 
Kako se zdravilo Veyvondi uporablja?
How does Veyvondi work? 
Kako zdravilo Veyvondi deluje?
Date of first authorisation: 21 May 2007 Date of latest renewal: 21 May 2012 
Datum prve odobritve: 21. maj 2007 Datum zadnjega podaljšanja: 21. maj 2012
Slight bleeding is normal. 
Rahla krvavitev je normalna.
Some of these infections have been fatal. 
Nekatere od teh okužb so bile usodne.
Long-term extension period 
Dolgoročno podaljšano obdobje
Health-related outcomes and quality of life 
Z zdravstvenim stanjem povezani izidi in kvaliteta življenja
Improve your physical function and your ability to do normal daily activities. 
izboljšanje telesne zmogljivosti in zmožnosti za opravljanje vsakdanjih aktivnosti.
The relevance of these results to humans is unknown. 
Pomen teh rezultatov za ljudi ni znan.
OTHER SPECIAL WARNING(S), IF NECESSARY 8. 
DRUGA POSEBNA OPOZORILA, ČE SO POTREBNA 8.
• Show this card to any doctor involved in your treatment. 
• To kartico pokažite vsakemu zdravniku, ki sodeluje pri vašem zdravljenju.
After that you will receive a dose every 4 weeks. 
Odmerek zdravila boste nato prejemali vsake 4 tedne.
Safety and structural damage assessments were conducted at one and two years. 
Varnost in strukturne poškodbe so ovrednotili po enem in dveh letih.
Important instructions for use. 
Pomembna navodila za uporabo.
Period Cb (day 1765) 
obdobje Cb (1765. dan)
E. Wash your hands thoroughly with soap and warm water. 
E. Temeljito si umijte roke z milom in toplo vodo.
RA is usually a chronic (long-term), progressive disease. 
RA je običajno kronična (dolgotrajna) in napredujoča bolezen.
It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB. 
Zelo pomembno je, da zdravnika obvestite, če ste kdaj imeli tuberkulozo ali če ste bili v tesnem stiku z osebo, ki je imela tuberkulozo.
This is normal and will not affect your dose. 
To je običajen pojav in ne vpliva na odmerek.
Important instructions for use Please read these instructions carefully and follow them step by step. 
Pomembna navodila za uporabo Navodila natančno preberite in jim sledite korak za korakom.
Rheumatoid arthritis (RA) affects everyone differently. 
Revmatoidni artritis (RA) prizadene vsakega bolnika drugače.
BEFORE YOU BEGIN: 
PREDEN ZAČNETE:
End of Period Ba (day 169) 
konec obdobja Ba (169. dan)
If you have active psoriatic arthritis you will first be given other medicines. 
Če imate aktivni psoriazni artritis, se boste najprej zdravili z drugimi zdravili.
PsA-IIb,c 
Študija PsA-IIb,c
There are no adequate data from use of abatacept in pregnant women. 
Ni zadostnih podatkov o uporabi abatacepta pri nosečnicah.
Proportion of patients with a clinically meaningful improvementd 
Odstotek bolnikov s klinično pomembnim izboljšanjemd
Reductions in serum TNFα were also observed. 
Opaženo je bilo tudi zmanjšanje serumskega TNFα.
Disease activity was also assessed using the Disease Activity Score 28. 
Aktivnost bolezni so vrednotili tudi na osnovi ocene aktivnosti bolezni 28 (Disease Activity Score 28).
Study SC-I 
Študija SC-I
c Health Assessment Questionnaire; 0 = best, 3 = worst; 20 questions; 8 categories: dressing and grooming, arising, eating, 
c Vprašalnik za oceno zdravstvenega stanja; 0 = boljše, 3 = slabše; 20 vprašanj; 8 kategorij: oblačenje in nega, vstajanje,
Read carefully. 
Natančno preberite.
The final concentration of abatacept in the bag or bottle will depend upon the amount of active substance added, but will be no more than 10 mg/mL. 
Končna koncentracija abatacepta v vrečki ali steklenici je odvisna od količine dodane učinkovine, vendar pa ne sme biti večja od 10 mg/ml.
Combination with other medicinal products that affect the immune system and with vaccinations 
Kombinacija z drugimi zdravili, ki vplivajo na imunski sistem in s cepljenji
The clinical significance of this observation is unknown (see section 5.3). 
Klinični pomen teh ugotovitev ni znan (glejte poglavje 5.3).
The type of pre-filled syringe you receive depends on the dose prescribed by your doctor. 
Vrsta napolnjene injekcijske brizge, ki jo boste prejeli, je odvisna od odmerka, ki vam ga je predpisal zdravnik.
No systemic hypersensitivity reactions were reported. 
O sistemskih preobčutljivostnih reakcijah niso poročali.
30 Minutes 
30 minut
D. Gather your additional supplies and keep them within easy reach. 
D. Pripravite dodatne potrebščine in jih imejte na dosegu roke.
After 1 year of treatment, the maintenance of remission was assessed by the relapse of the disease. 
Po 1 letu zdravljenja je bilo vzdrževanje remisije ovrednoteno glede na povrnitev bolezni.
In most people, joint symptoms develop gradually over several years. 
Pri večini bolnikov se simptomi prizadetosti sklepov razvijajo postopoma več let.
This is equivalent to 1.7% of the recommended maximum daily dietary intake of sodium for an adult. 
To je enako 1,7 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
Of the 219 patients treated, 205 completed the short-term period and 200 entered the ongoing longterm extension period. 
Od 219 zdravljenih bolnikov je 205 zaključilo kratkoročno obdobje, 200 pa jih je nato bilo vključenih v dolgoročno podaljšano obdobje, ki še poteka.
BEFORE YOU BEGIN 
PREDEN ZAČNETE
Remission rates at end of drug treatment and drug withdrawal phases in study SC-III 
Deleži remisije na koncu zdravljenja z zdravilom in faze odtegnitve zdravila v študiji SC-III
Most of these reactions were mild to moderate. 
Večina teh neželenih učinkov je bila blagih do zmernih.
The occurrence of anaphylaxis remained rare during the double blind and the cumulative period. 
Pojavnost anafilaksije je med dvojno slepim in kumulativnim obdobjem ostala redka.
Studies in adult mice and monkeys have not demonstrated similar findings. 
Pri študijah pri odraslih miših in opicah o takih ugotovitvah ne poročajo.
DAS28 response 
DAS28 odziv
* No active joints, physician's global assessment of disease severity ≤10 mm and CRP ≤0.6 mg/dL. 
* Brez aktivnih sklepov, zdravnikova globalna ocena resnosti bolezni ≤ 10 mm in CRP ≤ 0,6 mg/dl.
Similar efficacy was observed in these patients and in younger patients. 
Pri teh bolnikih je bila učinkovitost podobna kot pri mlajših bolnikih.
The exposure adjusted incidence rate (expressed per 100 person-years) remained stable over the treatment duration. 
Na izpostavljenost prilagojeni delež pojavnosti (izražen na 100 oseblet) je s trajanjem zdravljenja ostal stabilen.
The ACRP responses and inactive disease results were maintained through 2 years. 
Rezultati v obliki ACRP odziva in neaktivnosti bolezni so se v 2-letnem obdobju ohranili.
Study IV did not require any specific number of tender or swollen joints. 
Študija IV ni zahtevala specifičnega števila občutljivih ali oteklih sklepov.
Avoid prolonged or vigorous agitation. 
Izogibajte se dolgotrajnemu ali močnemu tresenju.
Consequently, these infants may be at increased risk of infection. 
Pri teh dojenčkih se posledično lahko poveča tveganje za okužbo.
The significance of the higher incidence in the 2 to 5 year age cohort is unknown, taking into account the difference in sample size. 
Pomen večje pojavnosti v kohorti bolnikov, starih od 2 do 5 let, ni znan, upoštevajoč razliko v velikosti vzorca.
Abatacept Abatacept Placebo Abatacept group in Period B 
abatacept abatacept placebo skupina z abataceptom v obdobju B
Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 USA 
Lonza Biologics Inc. 101 International Drive Portsmouth, NH 03801-2815 ZDA
The relevance of these findings to the clinical use of abatacept is unknown. 
Pomen teh ugotovitev za klinično uporabo abatacepta ni znan.
Reduce the signs and symptoms of your disease. 
zmanjšanje znakov in simptomov bolezni,
HOW TO USE 
KAKO UPORABLJATI
Formal studies of the potential effect of abatacept on human fertility have not been conducted. 
Formalne študije o možnih učinkih abatacepta na plodnost pri človeku niso bile izvedene.
Inadequate response to MTX 
Nezadosten odziv na MTX
c Major clinical response is defined as achieving an ACR 70 response for a continuous 6-month period. 
c Večji klinični odziv je definiran kot dosežen odziv ACR 70, ki je trajal neprekinjeno 6 mesecev.
WAIT until blue indicator stops moving 
POČAKAJTE dokler se moder kazalec
Long-term safety data in 2 to 5 year age cohort with pJIA was limited, but the existing evidence did not reveal any new safety concern in this younger paediatric population. 
Podatkov o dolgoročni varnosti v kohorti bolnikov s pJIA, starih od 2 do 5 let, je malo, vendar pa obstoječi dokazi ne kažejo na nobene nove varnostne zadržke pri tej mlajši pediatrični populaciji.
Non-responder in Period A 
bolniki brez odziva v obdobju A
Immunogenicity and safety of abatacept upon withdrawal and restart of treatment 
Imunogenost in varnost abatacepta po prekinitvi in ponovni uvedbi zdravljenja
How to use ORENCIA 4. 
Kako uporabljati zdravilo ORENCIA 4.
Confirm: after a complete injection, the needle guard will cover the needle and you may hear a click. 
Potrditev: po popolnem injiciranju bo varovalo za iglo prekrilo iglo, pri tem pa lahko zaslišite klik.
N/A Proportion of randomised patients in remission at 12 months and at 18 months (6 months of complete drug withdrawal) 
N/A Delež randomiziranih bolnikov v remisiji v 12. mesecu in v 18. mesecu (6 mesecev popolne odtegnitve zdravila)
The types of infections were consistent with those commonly seen in outpatient paediatric populations. 
Vrste okužb so bile konsistentne s tistimi, pogosto opaženimi pri ambulantno zdravljenih pediatričnih populacijah.
Samples with confirmed binding activity to CTLA-4 were assessed for the presence of neutralizing antibodies. 
Vzorci s potrjenim vezalnim delovanjem za CTLA-4 so bili ovrednoteni na prisotnost nevtralizirajočih protiteles.
The respective values for ACR 50 and ACR 70 at 12 months and 24 months were consistent and similar for abatacept and adalimumab. 
Ustrezne vrednosti ACR 50 in ACR 70 so bile po 12 mesecih in 24 mesecih konsistentne in podobne za abatacept in adalimumab.
The systemic clearance was approximately 0.22 mL/h/kg. 
Sistemski očistek je bil približno 0,22 ml/h/kg.
Complete ALL steps to deliver your full dose of the medicine 
Dokončajte VSE korake, da aplicirate celoten odmerek zdravila.
Patients continued abatacept treatment in an ongoing open-label extension, which assessed long-term safety and efficacy for an additional 20 months. 
Bolniki nadaljujejo zdravljenje z abataceptom v odprtem podaljšku študije, ki še poteka, z njim pa bodo ovrednotili dolgoročno varnost in učinkovitost za še dodatnih 20 mesecev.
- Any unused portion in the vials must be immediately discarded in accordance with local requirements. 
- Neporabljeno vsebino vial morate nemudoma zavreči v skladu z lokalnimi predpisi.
Studies in rats exposed to abatacept have shown immune system abnormalities including a low incidence of infections leading to death (juvenile rats). 
Študije pri podganah, ki so bile izpostavljene abataceptu, so pokazale nepravilnosti imunskega sistema, vključno z manjšo incidenco okužb, ki so povzročile pogine (mladiči podgan).
Mean radiographic changes over 12 months in study II 
Srednje vrednosti radiografskih sprememb med 12 meseci v študiji II
Treatment with immunosuppressive therapy, such as ORENCIA, may be associated with progressive multifocal leukoencephalopathy (PML). 
Zdravljenje z imunosupresivnimi zdravili, kot je zdravilo ORENCIA, je lahko povezano s progresivno multifokalno levkoencefalopatijo (PML).
Non-clinical studies relevant for use in the paediatric population 
Predklinične študije, relevantne za uporabo zdravila pri pediatrični populaciji
Determine the dose and the number of ORENCIA vials needed (see section 4.2). 
Določite odmerek in potrebno število vial zdravila ORENCIA (glejte poglavje 4.2).
Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. 
Za vse bolnike, še posebej tiste z dejavniki tveganja za kožnega raka, so priporočljivi redni pregledi kože.
Full activation of T lymphocytes requires two signals provided by antigen presenting cells: recognition of a specific antigen by a T cell receptor (signal 1) and a second, costimulatory signal. 
Za polno aktivacijo limfocitov T sta potrebna dva signala antigen predstavljajočih celic: spoznava specifičnega antigena s T receptorsko celico (signal 1) in drugi, kostimulacijski signal.
This alert card contains important safety information that you need to be aware of before you are given ORENCIA and during treatment with ORENCIA. 
Opozorilna kartica za bolnika vsebuje pomembne informacije o varnosti, s katerimi morate biti seznanjeni pred začetkom zdravljenja in med zdravljenjem z zdravilom ORENCIA.
Other medicines and ORENCIA 
Druga zdravila in zdravilo ORENCIA
In addition, serum levels of matrix metalloproteinase-3, which produces cartilage destruction and tissue remodelling, were decreased. 
Zmanjšale so se tudi serumske vrednosti matriks metaloproteinaze-3, ki povzroča poškodbe hrustanca in preoblikovanje tkiva.
if you have cancer, your doctor will decide if you can still be given ORENCIA. 
če imate raka bo vaš zdravnik presodil, ali se lahko kljub temu zdravite z zdravilom ORENCIA.
Response rates at the end of the short-term exposure are summarised in Table 9: 
Deleži odziva na koncu kratkoročne izpostavljenosti so povzeti v preglednici 9:
The medicinal product is for single use only. 
Zdravilo je namenjeno le za enkratno uporabo.
ORENCIA will be given to you under the supervision of an experienced doctor. 
Zdravilo ORENCIA boste prejeli pod nadzorom izkušenega zdravnika.
The safety of ORENCIA in individuals with latent tuberculosis is unknown. 
Varnost uporabe zdravila ORENCIA pri bolnikih z latentno tuberkulozo ni znana.
Safety information related to the pharmacological class 
Informacije o varnosti, povezane s farmakološko skupino
However, you and your doctor may decide that you can inject ORENCIA yourself. 
Vendar pa se lahko skupaj z zdravnikom odločite, da si boste zdravilo injicirali sami.
What ORENCIA is and what it is used for 2. 
Kaj je zdravilo ORENCIA in za kaj ga uporabljamo 2.
Further improvement was observed at 12 months with abatacept. 
Po 12-ih mesecih so pri abataceptu opazili nadaljnje izboljšanje.
ORENCIA, in combination with methotrexate, is indicated for: 
Zdravilo ORENCIA je v kombinaciji z metotreksatom indicirano za:
PUSH DOWN on skin 
PRITISNITE NAVZDOL na kožo
Structural response 
Strukturni odziv
ACR response 
ACR odziv
Adverse reactions in patients with chronic obstructive pulmonary disease (COPD) 
Neželeni učinki pri bolnikih s kronično obstrukcijsko pljučno boleznijo (KOPB)
Recommended dose in adults 
Priporočeni odmerek pri odraslih
ORENCIA is intended for use under the guidance of a healthcare professional. 
Zdravilo ORENCIA je namenjeno za uporabo pod vodstvom zdravstvenega delavca.
Press button, HOLD for 15 seconds AND watch window. 
Pritisnite na gumb za injiciranje in ga ZADRŽITE 15 sekund TER opazujte okence.
No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving abatacept. 
Podatkov o sekundarnem prenosu okužbe z oseb, ki so bile cepljene z živimi cepivi na bolnike, ki prejemajo abatacept, ni na voljo.
d After 6 months, patients were given the opportunity to enter an open-label study. 
d Po 6 mesecih so imeli bolniki možnost vključitve v odprto študijo.
Do not use if your pre-filled syringe does not have the correct amount of liquid. 
Ne uporabljajte, če napolnjena injekcijska brizga ne vsebuje ustrezne količine tekočine.
Pharmacotherapeutic group: Immunosuppressants, selective immunosuppressants, ATC code: L04AA24 
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zdravila za selektivno zaviranje imunske odzivnosti, oznaka ATC: L04AA24
Overall antibodies against abatacept were generally transient and of low titer. 
V celoti so bila protitelesa proti abataceptu na splošno prehodna in nizkega titra.
Severe and uncontrolled infections such as sepsis and opportunistic infections (see section 4.4). 
Hude in nenadzorovane okužbe, kot je sepsa, in oportunistične okužbe (glejte poglavje 4.4).
It is used in combination with a medicine called methotrexate. 
Uporablja se skupaj z zdravilom, ki vsebuje metotreksat.
Start: 
Začetek:
The ACR responses in study V were consistent with the DAS28 score. 
V študiji V so bili odzivi ACR konsistentni z rezultatom DAS28.
In these studies, clinically and statistically significant improvement was observed in the abatacept group as compared with the placebo group in all 8 domains of the SF-36 (4 physical domains: physical function, role physical, bodily pain, general health; and 4 mental domains: vitality, social function, role emotional, mental health), as well as the Physical Component Summary (PCS) and the Mental Component Summary (MCS). 
V teh študijah so v primerjavi s skupino, ki je prejemala placebo, v skupini, ki je prejemala abatacept, opazili klinično in statistično pomembno izboljšanje v vseh 8 domenah SF-36 (4 fizične domene: fizična funkcija, fizična vloga, telesna bolečina, splošno zdravstveno stanje in 4 duševne domene: vitalnost, socialna funkcija, čustvena vloga, duševno zdravje), kot tudi pri povzetku telesnih komponent in povzetku duševnih komponent.
Patients who develop a new infection while undergoing treatment with ORENCIA should be monitored closely. 
Bolnike, pri katerih se med zdravljenjem z zdravilom ORENCIA pojavi nova okužba, je treba skrbno nadzirati.
The response at year 1 in the abatacept group was maintained through year 2. 
V skupini, ki je prejemala abatacept, se je odziv po prvem letu ohranil tudi v drugem letu.
If a response to abatacept is not present within 6 months of treatment, the continuation of the treatment should be reconsidered (see section 5.1). 
Če v 6 mesecih po začetku zdravljenja z abataceptom ni odziva, je treba presoditi o nadaljevanju zdravljenja (glejte poglavje 5.1).
The powder is a white to off-white whole or fragmented cake. 
Prašek je v obliki belega do sivobelega celega ali razdrobljenega skupka.
From a microbiological point of view, the product should be used immediately. 
Z mikrobiološkega stališča je bolje zdravilo uporabiti takoj.
Check the liquid 
Preverite tekočino
The safety and efficacy of intravenous abatacept were assessed in a three-part study. 
Varnost in učinkovitost intravenske uporabe abatacepta so vrednotili v tridelni študiji.
ORENCIA is available in the following presentations: 
Zdravilo ORENCIA je na voljo v naslednjih pakiranjih:
The mean distribution volume (Vss) was 0.07 L/kg and ranged from 0.02 to 0.13 L/kg. 
Srednji volumen porazdelitve (Vss) je bil 0,07 l/kg, gibal pa se je od 0,02 do 0,13 l/kg.
No dose adjustment is required (see section 4.4). 
Prilagajanje odmerka ni potrebno (glejte poglavje 4.4).
Estimate of difference (95% CI) 
Ocenjena razlika (95% IZ)
A major costimulatory pathway involves the binding of CD80 and CD86 molecules on the surface of antigen presenting cells to the CD28 receptor on T lymphocytes (signal 2). 
Glavna kostimulacijska pot vključuje vezavo CD80 in CD86 molekul na površino antigen predstavljajočih celic za CD28 receptor na limfocitih T (signal 2).
Comparison of incidence rates across different assays is not appropriate, as the ECL assay was developed to be more sensitive and drug tolerant than the previous ELISA assay. 
Primerjava deležev pojavnosti med različnimi testi ni možna, saj je ECL test bolj občutljiv in toleranten do zdravila kot prejšnji ELISA test.