FrancophonIA/ELRC3.0 huggingface dataset:
English: Talk to your doctor, pharmacist or nurse before you receive HBVAXPRO 40 micrograms.
Slovenian: Preden prejmete cepivo HBVAXPRO 40 mikrogramov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: How much and how often to take?
Slovenian: Koliko in kako pogosto vzeti?
English: These infections may be serious and include:
Slovenian: Te okužbe so lahko resne in vključujejo:
English: (See section 4.5).
Slovenian: (glejte poglavje 4.4).
English: 36400 O Porriño Pontevedra, Spain and
Slovenian: 36400 O Porriño Pontevedra, Španija in
English: Wash and dry your hands.
Slovenian: Umijte in posušite si roke.
English: • Do not inject through clothes
Slovenian: • Ne injicirajte skozi oblačila
English: What should I do before I give myself a subcutaneous injection of Humira?
Slovenian: Kaj moram narediti, preden si dam podkožno injekcijo zdravila Humira?
English: This represented an 84% median reduction in injection site pain.
Slovenian: To je predstavljalo 84 % srednjega zmanjšanja bolečine na mestu injiciranja.
English: If the yellow indicator is not shown in the window, the plunger has not advanced adequately and the injection is not complete.
Slovenian: Če se rumeni kazalnik ne prikaže v okencu, se bat ni ustrezno premaknil naprej in injiciranje ni dokončano.
English: Available data suggest that Humira does not worsen or cause strictures.
Slovenian: Razpoložljivi podatki kažejo, da zdravilo Humira ne poslabša in ne povzroči striktur.
English: Date of first authorisation: 8 September 2003 Date of latest renewal: 8 September 2008
Slovenian: Datum prve odobritve: 8 September 2003 Datum zadnjega podaljšanja: 8 September 2008
English: For example, do not warm it in a microwave or in hot water
Slovenian: Na primer, ne smete segrevati v mikrovalovni pečici ali v vroči vodi.
English: DO NOT use the same site that was used for the last injection.
Slovenian: NE UPORABITE istega mesta kot ste ga uporabili za zadnje injiciranje
English: c,d,e
Slovenian: ASDASc,d,e
English: 2D code
Slovenian: 2D koda
English: Overall, among the patients who discontinued the study, 18% discontinued due to adverse events, and 8% due to insufficient response to adalimumab treatment.
Slovenian: Na splošno med bolniki, ki so prekinili študijo, jih je 18 % prekinilo študijo zaradi neželenih učinkov in 8 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
English: Check the inspection window.
Slovenian: Preverite kontrolno okence.
English: Date of first authorisation: 08 September 2003 Date of latest renewal: 08 September 2008
Slovenian: Datum prve odobritve: 08 September 2003 Datum zadnjega podaljšanja: 08 September 2008
English: • A loud “click” will signal the start of the injection
Slovenian: • Glasen “klik” bo znak, da se je injiciranje začelo.
English: Slowly take your thumb off the plunger.
Slovenian: Počasi umaknite palec iz bata.
English: Store in a refrigerator (2C - 8C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: Double-Blind Response at Week 68
Slovenian: Dvojno slepa Odziv v 68. tednu
English: Clinical results were assessed for induction of remission at Week 8 and for maintenance of remission at Week 52.
Slovenian: Klinične rezultate so ocenili glede indukcije remisije 8. teden in glede ohranitve remisije 52. teden.
English: • Do not touch the needle with your fingers or let the needle touch anything
Slovenian: • Ne dotikajte se igle s prsti ali dovolite, da se igla dotakne česar koli.
English: doctor or pharmacist.
Slovenian: medicinska sestra ali farmacevt.
English: Significant response was first observed at Week 2 and maintained through 24 weeks (Table 13).
Slovenian: Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
English: Monoclonal antibodies are proteins that attach to a specific target.
Slovenian: Monoklonska protitelesa so beljakovine, ki se vežejo na specifične tarče.
English: Patients were allowed to continue on study medication beyond Week 78 until they had access to Humira.
Slovenian: Bolnikom je bilo dovoljeno prejemati zdravilo v preskušanju tudi po 78. tednu, dokler niso imeli dostopa do zdravila Humira.
English: • The automatic needle guard will not activate unless all the liquid is injected
Slovenian: • Avtomatski ščitnik za iglo se ne bo aktiviral, razen če se vsa tekočina injicira.
English: The recommended doses for Humira in each of the approved uses are shown in the following table.
Slovenian: Priporočeni odmerki zdravila Humira za vsako odobreno uporabo so prikazani v naslednji tabeli.
English: There are two caps - one is grey and labelled ‘1' and the other is plum and labelled ‘2'.
Slovenian: Nameščena ima dva pokrovčka - eden je siv in označen z '1', drugi pa škrlatne in označen z '2'.
English: First read all the instructions carefully and then follow them step by step.
Slovenian: Navodila najprej natančno preberite in jih upoštevajte korak za korakom.
English: aspergillosis and listeriosis).
Slovenian: aspergiloza in listerioza).
English: Double-Blind Response at Week 12
Slovenian: Dvojno slepa Odziv v 12. tednu
English: Humira may be available in other strengths and/or presentations depending on the individual treatment needs.
Slovenian: Zdravilo Humira je lahko na voljo v drugih jakostih in/ali oblikah, odvisno od individualnih potreb zdravljenja.
English: • infections caused by viruses, fungi, parasites or bacteria
Slovenian: • okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije
English: 1 Pack of 2 boxes each containing:
Slovenian: 1 pakiranje z dvema škatlama vsebuje:
English: What Humira is and what it is used for
Slovenian: Kaj je zdravilo Humira in za kaj ga uporabljamo
English: Humira is intended for the treatment of the inflammatory diseases described below:
Slovenian: Zdravilo Humira je namenjeno za zdravljenje vnetnih bolezni, opisanih spodaj:
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Slovenian: * Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 ** Vključno pri odprtih podaljšanih študijah
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Slovenian: Omejeni podatki iz objavljene literature kažejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 %
English: DO NOT RECAP as you may damage the needle inside.
Slovenian: NE POKRIVAJTE S POKROVČKOM, ker lahko poškodujete iglo v notranjosti.
English: It must be clear and colourless.
Slovenian: Biti mora bistra in brezbarvna.
English: 1) Setting up
Slovenian: 1) Priprava
English: You will set the volume to the prescribed dose in step 4, Dose Preparation.
Slovenian: Količino boste nastavili na predpisani odmerek v 4. koraku, Priprava odmerka.
English: Place hand on the middle of the pen so that neither the grey cap (1) nor the plum cap (2) is covered.
Slovenian: Roko položite na sredino peresnika, tako da ne zakrivate ne sivega pokrovčka (1) in ne škrlatnega pokrovčka (2).
English: Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1 with an IC50 of0.1-0.2 nM).
Slovenian: Adalimumab modulira tudi biološke odzive, ki jih sproži ali uravnava TNF, vključno s spremembami koncentracije adhezijskih molekul, odgovornih za migracijo levkocitov (ELAM-1, VCAM-1 in ICAM-1 z IK50 0,1-0,2 nM).
English: The primary endpoint of the study was clinical remission at Week 26, defined as PCDAI score  10.
Slovenian: Primarni cilj študije je bila klinična remisija v 26. tednu, definirana kot vrednost PCDAI ≤ 10.
English: Data beyond Week 78 were generally consistent with these results but the number of enrolled subjects declined after this time.
Slovenian: Podatki, zbrani po 78. tednu, so bili na splošno v skladu s temi rezultati, vendar se je število vključenih bolnikov zmanjšalo po tem času.
English: Take Humira out of the refrigerator.
Slovenian: Zdravilo Humira vzemite iz hladilnika.
English: • A small amount of liquid on the injection site is normal
Slovenian: • Majhna količina tekočine na mestu injiciranja je normalna.
English: NA NA 9.5% 41.5%
Slovenian: NP 9,5 % 41,5 %
English: ≥30% Reduction in Skin Pain
Slovenian: ≥30 % zmanjšanje bolečine na kožib
English: • Certain vaccines may cause infections and should not be given while receiving Humira.
Slovenian: • Določena cepiva lahko povzročijo okužbe, zato se jih med zdravljenjem z zdravilom Humira ne sme uporabljati.
English: • severe infection in the blood (sepsis)
Slovenian: • hudo okužbo krvi (sepso)
English: Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests.
Slovenian: Nekateri neželeni učinki, ki so bili opaženi pri zdravilu Humira, nimajo simptomov in se jih lahko odkrije le pri krvnih testih.
English: Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Humira se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: Do not use the product after the month and year shown.
Slovenian: Zdravila ne uporabljajte po preteku navedenega meseca in leta.
English: Corticosteroid taper was permitted after Week 8.
Slovenian: Postopno zmanjšanje odmerka kortikosteroidov je bilo dovoljeno po 8. tednu.
English: Leave Humira at room temperature for 15 to 30 minutes before injecting.
Slovenian: Zdravilo Humira pred injiciranjem pustite na sobni temperaturi 15 do 30 minut.
English: Other medicines and Humira
Slovenian: Druga zdravila in zdravilo Humira
English: The Patient Reminder Cards (adult and paediatric) contain the following key elements
Slovenian: Opozorilna kartica za bolnika (za odrasle in otroke) vsebuje naslednje ključne podatke:
English: Humira can also be given alone.
Slovenian: Zdravilo Humira se lahko daje tudi samo.
English: • Release the skin with the first hand
Slovenian: • Spustite kožo s prvo roko.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Slovenian: Rezultati klinične remisije so ostali relativno konstantni ne glede na prejšnjo izpostavljenost TNF
English: A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Veliko število (približno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo živorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.6% of the eyes at week 78.
Slovenian: Najboljša korigirana ostrina vida se je ali izboljšala ali pa ohranila (poslabšanje ostrine vida < 5 črk) pri 88,6 % očeh v 78. tednu.
English: • If you have moderate or severe heart failure.
Slovenian: • če imate zmerno ali hudo srčno popuščanje.
English: N Failure N (%)
Slovenian: N Neuspeh N (%)
English: Pull the plum safety cap (labelled ‘2') straight off to expose the plum coloured activation button.
Slovenian: Snemite škrlatni varnostni pokrovček (označen z '2') naravnost dol, da se bo pokazal škrlatni sprožilni gumb.
English: Germany and
Slovenian: Nemčija in
English: • On the front of your child's thighs or
Slovenian: • na sprednji strani stegen vašega otroka ali
English: • liquid has been frozen or left in direct sunlight
Slovenian: • je bila tekočina zamrznjena ali izpostavljena neposredni sončni svetlobi
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba korist in tveganje zdravljenja z zdravilom Humira zelo natančno pretehtati.
English: Treatment with Humira 40 mg every week significantly reduced the risk of worsening of abscesses and draining fistulas.
Slovenian: Zdravljenje z zdravilom Humira 40 mg vsak teden signifikantno zmanjša tveganje za poslabšanje abscesov in fistul z izcedkom.
English: If retreatment with Humira is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom Humira, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
English: Choose a site on the top of your thigh or stomach (except the area around the navel).
Slovenian: Izberite mesto na zgornjem delu stegna ali trebuha (ne v okolici popka).
English: • The Humira syringe should NEVER be reused.
Slovenian: • Brizge z zdravilom Humira NIKDAR ne smete ponovno uporabiti.
English: • According to a pregnancy study, there was no higher risk of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
Slovenian: • Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala zdravilo Humira med nosečnostjo, v primerjavi z materami z enako boleznijo, ki zdravila Humira niso jemale.
English: TNF-antagonists, such as Humira affect the immune system and their use may affect the body's defence against infection and cancer.
Slovenian: Humira, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
English: Side effects may occur at least up to 4 months after the last Humira injection.
Slovenian: Neželeni učinki se lahko pojavijo vsaj še 4 mesece po zadnji injekciji zdravila Humira.
English: NA NA 24.0% 58.9%
Slovenian: NP 24,0 % 58,9 %
English: Of the 364 remaining patients, 269 evaluable patients (74%) reached 78 weeks of open-label adalimumab treatment.
Slovenian: Od preostalih 364 bolnikov je 269 ovrednotenih bolnikov (74 %) zaključilo 78. tedensko odprto zdravljenje z adalimumabom.
English: • Choose a site on your thigh or stomach.
Slovenian: • Izberite mesto na stegnu ali trebuhu.
English: Yellow Indicator Visible
Slovenian: Rumeni kazalnik viden
English: General handling: DO NOT dispose of any waste items until after the injection is completed.
Slovenian: Splošno ravnanje: NE ZAVRZITE nobenega uporabljenega dela, dokler ne dokončate injiciranja.
English: Rhabdomyolysis, systemic lupus erythematosus
Slovenian: občasni rabdomioliza, sistemski eritematozni lupus
English: Patients in clinical response (decrease in CDAI ≥ 70) at Week 4 were stratified and analysed separately from those not in clinical response at Week 4.
Slovenian: Bolnike s kliničnim odzivom (zmanjšanje CDAI ≥ 70) v 4. tednu so preučili in analizirali ločeno od tistih brez kliničnega odziva v 4. tednu.
English: • anakinra
Slovenian: • anakinro
English: Radiographic response
Slovenian: Radiografski odziv
English: Patients who completed Studies UV I and UV II were eligible to enroll in an uncontrolled long-term extension study with an originally planned duration of 78 weeks.
Slovenian: Bolniki, ki so zaključili študiji UV I in UV II, so bili primerni za vključitev v nenadzorovano, dolgoročno, podaljšano študijo, s prvotno načrtovanim trajanjem 78 tednov.
English: Before initiation of therapy with Humira, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Humira je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
English: Wash your hands thoroughly.
Slovenian: Dobro si umijte roke.
English: Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira'.
Slovenian: Podrobna navodila o tem, kako injicirati zdravilo Humira, so navedena v poglavju 7 ‘Injiciranje zdravila Humira'.
English: Thus additional caution should be exercised in considering Humira treatment of these patients (see section 4.8).
Slovenian: Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z zdravilom Humira pri teh bolnikih (glejte poglavje 4.8).
English: Treatment with Humira should not be initiated in patients with active infections including chronic or localised infections until infections are controlled.
Slovenian: Zdravljenja z zdravilom Humira se ne sme začeti pri bolnikih z aktivnimi okužbami, vključno s kroničnimi ali lokaliziranimi, dokler te niso obvladane.
English: Name and address of the manufacturers of the biological active substance
Slovenian: Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine
English: • It is normal to see 1 or more bubbles in the window
Slovenian: • Normalno je, če skozi okence vidite enega ali več mehurčkov.
English: Tell your doctor immediately if you notice any of the following • severe rash, hives or other signs of allergic reaction;
Slovenian: Svojemu zdravniku takoj povejte, če opazite kaj od naslednjega: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
English: Longer term treatment with Humira 40 mg weekly for 96 weeks identified no new safety findings.
Slovenian: Dolgotrajno zdravljenje z zdravilom Humira 40 mg na teden, ki je trajalo 96 tednov, ni dalo nobenih novih ugotovitev o varnosti.
English: Population pharmacokinetic analyses with data from over 1,300 RA patients revealed a trend toward higher apparent clearance of adalimumab with increasing body weight.
Slovenian: Analize populacijske farmakokinetike s podatki za več kot 1300 bolnikov z revmatoidnim artritisom so pokazale trend k večjemu navideznemu očistku adalimumaba z večanjem telesne teže.
English: By attaching to TNFα, Humira decreases the process of inflammation in these diseases.
Slovenian: Z vezavo na TNF zdravilo Humira zmanjša vnetni proces pri teh boleznih.
English: Humira in combination with methotrexate, is indicated for:
Slovenian: Zdravilo Humira je v kombinaciji z metotreksatom indicirano za:
English: • If you are over 65 years you may be more susceptible to infections while taking Humira.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Humira.
English: Surgery or dental procedure
Slovenian: Kirurški ali dentalni poseg
English: For paediatric use
Slovenian: za pediatrično uporabo
English: Hold the body of the pre-filled syringe in one hand between the thumb and index fingers, like you would a pencil.
Slovenian: Telo napolnjene injekcijske brizge držite v eni roki, med palcem in kazalcem, kot bi držali svinčnik.
English: 15 Seconds
Slovenian: 15 sekund
English: Due to its inhibition of TNF, adalimumab administered during pregnancy could affect normal immune responses in the newborn.
Slovenian: Ker adalimumab zavira TNFα, bi njegova uporaba med nosečnostjo lahko okrnila normalne imunske odzive novorojenčka.
English: • Do not warm Humira in any other way.
Slovenian: • Zdravila Humira ne smete segrevati na kateri koli drug način.
English: In patients with Crohn's disease, a reduction of the number of cells expressing inflammatory markers in the colon including a significant reduction of expression of TNFα was seen.
Slovenian: Pri bolnikih s Crohnovo boleznijo so opazili zmanjšanje števila celic, ki izražajo vnetne označevalce v kolonu, vključno z bistvenim zmanjšanjem ekspresije TNFα.
English: Because immunogenicity analyses are product-specific, comparison of antibody rates with those from other products is not appropriate.
Slovenian: Ker so analize imunogenosti specifične za posamezno zdravilo, primerjava z deleži protiteles pri drugih zdravilih ne pride v poštev.
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through Week 156.
Slovenian: Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih odprtih študijah ohranjalo do 156. tedna.
English: If a few small drops of liquid come out of the needle, that is okay.
Slovenian: Če iz brizge pride nekaj majhnih kapljic tekočine, je to normalno.
English: Patients on Humira may receive concurrent vaccinations, except for live vaccines.
Slovenian: Bolniki, ki prejemajo zdravilo Humira, lahko sočasno dobijo cepiva, razen živih cepiv.
English: With your other hand, pull the grey cap (1) straight off, check that the small black needle cover of the syringe has been removed with the cap, then discard cap.
Slovenian: Z drugo roko snemite sivi pokrovček (1), preverite, da ste s pokrovčkom vred odstranili tudi malo črno pokrivalo igle na brizgi in ga nato zavrzite.
English: 117/276 patients from CD study I and 272/777 patients from CD studies II and III were followed through at least 3 years of open-label adalimumab therapy.
Slovenian: 117/276 bolnikov iz študije Crohnove bolezni I in 272/777 bolnikov iz študij Crohnove bolezni II in III so spremljali vsaj 3 leta odprtega zdravljenja z adalimumabom.
English: • autoantibodies present in the blood
Slovenian: • avtoprotitelesa prisotna v krvi
English: At Week 12 and Week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Slovenian: 12. teden je bil odziv PedACR30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
English: The proportions of subjects with PedACR50/70/90 at Week 12 and Week 24 were 90.3%/61.3%/38.7% and 83.3%/73.3%/36.7%, respectively.
Slovenian: Deleži preiskovancev s PedACR50/70/90 so bili 12. teden 90,3 %/61,3 %/38,7 % in 24. teden 83,3 %/73,3 %/36,7 %.
English: • It is normal to see a drop of liquid at the end of the needle
Slovenian: • Normalno je, da na koncu igle vidite kapljico tekočine.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Humira, who are chronic carriers of this virus (i.e. surface antigen positive).
Slovenian: Reaktivacijo hepatitisa B so opažali pri bolnikih, ki so dobivali antagonist TNF (vključno z zdravilom Humira) in ki so bili kronični nosilci virusa (tj. pozitivni na površinski antigen).
English: This may mean there is an infection.
Slovenian: Te spremembe lahko pomenijo okužbo.
English: Clinical remission Clinical response (CR-100)
Slovenian: Klinični odziv (CR-100)
English: • If your child has moderate or severe heart failure.
Slovenian: • če ima vaš otrok zmerno ali hudo srčno popuščanje.
English: If your doctor determines that methotrexate is inappropriate, Humira can be given alone.
Slovenian: Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Humira dobivate samo.
English: • Your doctor should test you for HBV.
Slovenian: • Zdravnik vas mora testirati na HBV.
English: Efficacy of adalimumab for the treatment of adolescent patients with HS is predicted based on the demonstrated efficacy and exposureresponse relationship in adult HS patients and the likelihood that the disease course, pathophysiology, and drug effects are substantially similar to that of adults at the same exposure levels.
Slovenian: Učinkovitost adalimumaba za zdravljenje mladostnikov s HS je napovedana na podlagi dokazane učinkovitosti in razmerja med izpostavljenostjo in odzivom pri odraslih bolnikih s HS ter verjetnosti, da so potek bolezni, patofiziologija in učinek zdravila bistveno podobni kot pri odraslih bolnikih, pri enaki ravni izpostavljenosti.
English: Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira (see section 4.4).
Slovenian: Oftalmologom se svetuje, da se pred začetkom zdravljenja z zdravilom Humira posvetujejo z ustreznim specialistom (glejte poglavje 4.4).
English: Patients subsequently underwent a mandatory taper schedule, with complete corticosteroid discontinuation by Week 19.
Slovenian: Bolniki so bili kasneje deležni obveznega programa postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 19. tedna.
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Slovenian: Faza Odprta uvajalna faza 16 tednov Odziv »Ped ACR« 30 (n/N)