FrancophonIA/ELRC3.0 huggingface dataset:
English: Study 2 assessed the efficacy and safety of Xolair in a population of 312 severe allergic asthmatics which matched the population in study 1.
Slovenian: V študiji 2 so ocenili učinkovitost in varnost zdravila Xolair v skupini 312 težkih alergičnih astmatikov, ki se je ujemala s skupino v študiji 1.
English: Furthermore, no genotoxic effects were observed in a separate non-clinical genotoxicity study.
Slovenian: Poleg tega v ločeni ne-klinični študiji genotoksičnosti niso opažali genotoksičnega delovanja.
English: Formal carcinogenicity studies have not been conducted with omalizumab.
Slovenian: Formalnih študij kancerogenosti z omalizumabom niso opravili.
English: Immune system disorders For further information, see section 4.4.
Slovenian: Bolezni imunskega sistema Za več podatkov glejte poglavje 4.4.
English: The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Slovenian: Injekcijsko brizgo je treba vzeti iz hladilnika 20 minut pred injiciranjem, da se ogreje na sobno temperaturo.
English: What Xolair is and what it is used for
Slovenian: Kaj je zdravilo Xolair in za kaj ga uporabljamo
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity.
Slovenian: Zmerno velik obseg podatkov o nosečnicah (med 300 in 1.000 izidov nosečnosti), pridobljenih iz registra nosečnosti in spontanih poročil iz obdobja trženja zdravila, ne kaže na malformativno toksičnost ali toksično delovanje na plod oziroma novorojenca.
English: c or use 0.6 ml from a 150 mg vial.
Slovenian: c ali uporabite 0,6 ml iz 150-miligramske viale.
English: The injection site is the place on the body where you are going to use the syringe.
Slovenian: Mesto injiciranja je predel telesa, na katerem boste uporabili injekcijsko brizgo.
English: Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment.
Slovenian: Koncentracije celotnega IgE so med zdravljenjem zvišane in ostanejo po prekinitvi zdravljenja zvišane do enega leta.
English: Use 1.4 ml and discard the rest.
Slovenian: Uporabite 1,4 ml, ostalo zavrzite.
English: Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more.
Slovenian: Vrednosti celotnega serumskega IgE lahko ponovno uporabimo za določanje odmerka, če je bilo zdravljenje z zdravilom Xolair prekinjeno za najmanj eno leto.
English: The effects of demographic characteristics and other factors on omalizumab exposure were evaluated based on population pharmacokinetics.
Slovenian: Vpliv demografskih značilnosti in drugih dejavnikov na izpostavljenost omalizumabu so ocenjevali s pomočjo populacijske farmakokinetike.
English: Table 4 Adverse reactions in allergic asthma
Slovenian: Preglednica 4 Neželene reakcije pri alergijski astmi
English: The first 3 doses are always given by or under the supervision of a healthcare professional (see section 2).
Slovenian: Prve 3 odmerke mora vedno injicirati ali injiciranje nadzorovati zdravstveni delavec (glejte poglavje 2).
English: For detailed instructions on how to inject Xolair, see “Instructions for use of Xolair pre-filled syringe” at the end of this leaflet.
Slovenian: Za podrobna navodila, kako injicirati zdravilo Xolair, glejte pod naslovom “Navodila za uporabo zdravila Xolair v napolnjeni injekcijski brizgi” na koncu tega Navodila za uporabo.
English: Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions listed first.
Slovenian: V posameznem organskem sistemu so neželeni učinki navedeni po pogostnosti, pri čemer so najpogostejši navedeni najprej.
English: Multipack comprising 4 packs
Slovenian: skupno pakiranje, ki vsebuje 4 pakiranja
English: The onset has typically been 1-5 days after administration of the first or subsequent injections, also after long duration of treatment.
Slovenian: Reakcije praviloma nastopijo 1 do 5 dni po uporabi prve ali katere od naslednjih injekcij, lahko tudi po dolgotrajnem zdravljenju.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and also information for the healthcare professional section of the package leaflet.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6 in tudi poglavje z informacijami za zdravstveno osebje na koncu Navodila za uporabo.
English: Treatment with Xolair in this open label study led to a 61% reduction in clinically significant asthma exacerbation rate compared to current asthma therapy alone.
Slovenian: Zdravljenje z zdravilom Xolair v tej odprti študiji je povzročilo 61-odstotno zmanjšanje pogostnosti klinično pomembnih eksacerbacij astme v primerjavi z zdravljenjem samo s trenutnimi zdravili za astmo.
English: Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet.
Slovenian: Bolnikom oziroma njihovim negovalcem je treba naročiti, naj injicirajo celotno količino zdravila Xolair po navodilih v Navodilu za uporabo.
English: Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination.
Slovenian: Določanje odmerka po prekinitvah zdravljenja, krajših od enega leta, naj temelji na serumskih koncentracijah IgE, izmerjenih pri začetnem določanju odmerka.
English: Allergic reactions type I
Slovenian: Alergijske reakcije tipa I
English: Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms.
Slovenian: Prekinitev zdravljenja z zdravilom Xolair v glavnem povzroči vrnitev prostega IgE na zvišane vrednosti in z njimi povezane simptome.
English: - Do not use any pack that is damaged or shows signs of tampering.
Slovenian: - Ne uporabite pakiranja, če je poškodovano ali kaže znake, da je bilo že odprto.
English: Precipitating complexes and complexes larger than one million Daltons in molecular weight are not observed in vitro or in vivo.
Slovenian: Precipitirajočih kompleksov in kompleksov z večjo molekulsko maso od enega milijona daltonov niso našli niti in vitro niti in vivo.
English: In controlled clinical trials and during interim analyses of an observational study, a numerical imbalance of ATE was observed.
Slovenian: V kontroliranih kliničnih preskušanjih in pri vmesni analizi podatkov iz observacijske študije, so opažali številčno neravnovesje arterijskih trombemboličnih dogodkov.
English: - Do not use this medicine after the expiry date which is stated on the label.
Slovenian: - Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki.
English: - A caregiver (for example a parent) may also give you your Xolair injection after he or she has received proper training.
Slovenian: - Tudi negovalec (na primer eden od staršev) vam lahko injicira zdravilo Xolair šele po tem, ko se je za to ustrezno usposobil.
English: In all these cases, return the entire pack to the pharmacy.
Slovenian: V vseh navedenih primerih vrnite celotno pakiranje zdravila v lekarno.
English: If your doctor decides that you or a caregiver may be able to give your injections of Xolair at home, you need to be trained by your doctor, nurse or pharmacist before you inject yourself or others.
Slovenian: Če zdravnik presodi, da si lahko zdravilo Xolair doma injicirate sami oziroma da vam ga lahko injicira oseba, ki skrbi za vas (negovalec), vas mora zdravnik, medicinska sestra ali farmacevt ustrezno usposobiti, preden zdravilo injicirate sebi ali drugim.
English: All studies had a 16-week treatment-free follow-up period.
Slovenian: Vse tri študije so vključevale 16-tedensko obdobje spremljanja brez zdravljenja.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions.
Slovenian: Encimi s citokromom P450, iztočne črpalke in mehanizmi vezave beljakovin nimajo vpliva na očistek omalizumaba, zato obstajajo za interakcije med zdravili le manjše možnosti.
English: In a multivariate analysis controlling for available baseline cardiovascular risk factors, the hazard ratio was 1.32 (95% confidence interval 0.91-1.91).
Slovenian: Po rezultatih multivariatne analize z upoštevanjem izhodiščnih kardiovaskularnih dejavnikov tveganja je bilo razmerje ogroženosti 1,32 (95-odstotni interval zaupanja 0,91-1,91).
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Slovenian: Kategorije pogostnosti so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in zelo redki (<1/10.000).
English: Baseline IgE (IU/ml)
Slovenian: Izhodiščni IgE (i.e./ml)
English: If an anaphylactic or other serious allergic reaction occurs, administration of Xolair must be discontinued immediately and appropriate therapy initiated.
Slovenian: Če pride do anafilaktične ali druge resne alergijske reakcije, je treba odmerjanje zdravila Xolair takoj prekiniti in uvesti ustrezno zdravljenje.
English: However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic.
Slovenian: Vendar utegne biti pri bolnikih z velikim tveganjem infestacije s helminti upravičena previdnost, posebno pri potovanjih v predele, kjer je infestacija s helminti endemična.
English: Use 0.9 ml and discard the rest.
Slovenian: Uporabite 0,9 ml, ostalo zavrzite.
English: You can press a cotton ball or gauze over the injection site and hold it for 30 seconds.
Slovenian: Na to mesto lahko pritisnete kosem vate ali zloženec iz gaze in ga držite 30 sekund.
English: The serum concentration required to attain a 50% drop in platelets from baseline in adult cynomolgus monkeys was roughly 4- to 20-fold higher than anticipated maximum clinical serum concentrations.
Slovenian: Serumska koncentracija, ki je bila potrebna za dosego 50-odstotnega zmanjšanja koncentracije trombocitov od izhodišča pri odraslih opicah cinomolgus, je bila približno 4 do 20-krat višja od predvidenih najvišjih kliničnih serumskih koncentracij.
English: Antibodies to omalizumab were detected in some monkeys following repeated subcutaneous or intravenous administration.
Slovenian: Protitelesa proti omalizumabu so odkrili pri nekaterih opicah po ponavljajoči subkutani ali intravenski aplikaciji.
English: Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy).
Slovenian: Razpoložljivi podatki o uporabi zdravila Xolair v kombinaciji s specifično imunoterapijo (zdravljenje s hiposenzitizacijo) so omejeni.
English: Results for the 300 mg are available for 9 patients at week 12 and 6 patients at week 24, and show a similar magnitude of response to omalizumab treatment compared to the adult population.
Slovenian: Rezultati po 12 tednih zdravljenja z odmerkom 300 mg so na voljo za 9 bolnikov, po 24 tednih zdravljenja pa za 6 bolnikov in kažejo podobno velik odziv na zdravljenje z omalizumabom kot pri populaciji odraslih.
English: Use immediately after reconstitution (may be stored at 2°C - 8°C for up to 8 hours or at 25°C for 2 hours).
Slovenian: Uporabite takoj po rekonstituciji (zdravilo smete hraniti do 8 ur dolgo pri 2 °C - 8 °C ali 2 uri dolgo pri 25 °C).
English: Four additional large placebo-controlled supportive studies of 28 to 52 weeks duration in 1,722 adults and adolescents (studies 3, 4, 5, 6) assessed the efficacy and safety of Xolair in patients with severe persistent asthma.
Slovenian: V štirih dodatnih velikih, s placebom kontroliranih, 28 do 52 tednov trajajočih, podpornih študijah na 1.722 odraslih in mladostnikih (študije 3, 4, 5, 6) so ocenjevali učinkovitost in varnost zdravila Xolair pri bolnikih s težko trdovratno astmo.
English: In a clinical trial where Xolair was co-administered with immunotherapy, the safety and efficacy of Xolair in combination with specific immunotherapy were found to be no different to that of Xolair alone.
Slovenian: V kliničnem preskušanju, v katerem so zdravilo Xolair dajali sočasno z imunoterapijo, so ugotovili, da se varnost in učinkovitost zdravila Xolair v kombinaciji s specifično imunoterapijo ne razlikujeta od varnosti in učinkovitosti pri samostojni uporabi zdravila Xolair.
English: It is also important that you do not inject Xolair yourself until you have been trained by your doctor or nurse on: - how to recognise the early signs and symptoms of serious allergic reactions - what to do if the symptoms occur.
Slovenian: Prav tako je pomembno, da si zdravila Xolair ne injicirate sami, dokler vas zdravnik ali medicinska sestra ne naučita: - kako prepoznati zgodnje znake in simptome resne alergijske reakcije, - kako ukrepati, če se simptomi pojavijo.
English: Overall, 733 patients were treated with omalizumab for up to 12 weeks and 490 patients for up to 24 weeks.
Slovenian: Skupaj je 733 bolnikov prejemalo omalizumab do 12 tednov in 490 bolnikov do 24 tednov.
English: With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.
Slovenian: Postavite vialo pokonci na vodoravno površino, zapičite iglo in vbrizgajte vodo za injekcije v vialo z liofiliziranim praškom, pri tem uporabljajte standardne aseptične tehnike, vodo za injekcije pa usmerite naravnost v prašek.
English: • The needle cap of the syringe may contain dry rubber (latex), which should not be handled by anyone who is sensitive to this substance.
Slovenian: • Pokrovček igle pri tej brizgi lahko vsebuje suho gumo (lateks), zato osebe, ki so preobčutljive na to snov, ne smejo rokovati z njim.
English: Clean the injection site with an alcohol swab.
Slovenian: Mesto injiciranja očistite z alkoholnim zložencem.
English: - Low blood platelet count with symptoms such as bleeding or bruising more easily than normal.
Slovenian: - nizko število trombocitov z znaki, kot so krvavitev ali pojavljanje modric v večji meri kot normalno.
English: Available data in non-human primates have shown excretion of omalizumab into milk (see section 5.3).
Slovenian: Razpoložljivi podatki pri primatih, razen pri človeku, kažejo na izločanje omalizumaba v mleko (glejte poglavje 5.3).
English: Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended.
Slovenian: Nenadne ukinitve sistemskih kortikosteroidov ali kortikosteroidov za inhalacijo po uvedbi zdravljenja z zdravilom Xolair ne priporočajo.
English: Do not use Xolair: - if you are allergic to omalizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila Xolair: - če ste alergični na omalizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The maximum recommended dose is 600 mg omalizumab every two weeks.
Slovenian: Največji priporočeni odmerek je 600 mg omalizumaba enkrat na dva tedna.
English: Very common (may affect more than 1 in 10 people) - fever (in children)
Slovenian: Zelo pogosti (lahko se pojavijo pri več kot 1 od 10 bolnikov) - zvišana telesna temperatura (pri otrocih)
English: Clearance of omalizumab involves IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.
Slovenian: Očistek omalizumaba vključuje tako procese očistka IgG kot tudi očistek preko specifične vezave in sestavljanja kompleksov z njegovim ciljnim ligandom, IgE.
English: Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by MedDRA system organ class and frequency.
Slovenian: Preglednica 4 navaja neželene reakcije, zabeležene v kliničnih študijah pri celotni populaciji za oceno varnosti, zdravljeni z zdravilom Xolair, razvrščene po organskih sistemih po sistemu MedDRA in po pogostnosti.
English: This is especially important if you are taking: - medicines to treat an infection caused by a parasite, as Xolair may reduce the effect of your medicines, - inhaled corticosteroids and other medicines for allergic asthma.
Slovenian: To je posebno pomembno, če jemljete: - zdravila za zdravljenje okužb, ki jih povzročajo paraziti (zajedavci), saj zdravilo Xolair lahko oslabi delovanje vaših zdravil, - kortikosteroide za inhaliranje in druga zdravila proti alergijski astmi.
English: The physician was able to take into account PEF (peak expiratory flow), day and night time symptoms, rescue medication use, spirometry and exacerbations.
Slovenian: Zdravnik je lahko upošteval PEF (največji pretok zraka med izdihom), dnevne in nočne simptome, uporabo ustreznejših zdravil, spirometrijo in eksacerbacije.
English: Xolair is given to you by a doctor or nurse as an injection just under the skin (subcutaneously).
Slovenian: Zdravilo Xolair vam dajeta zdravnik ali medicinska sestra v obliki injekcije tik pod kožo (subkutano).
English: The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Slovenian: Razporeditev neželenega učinka v kategorijo pogostnosti temelji na naslednjem dogovoru: zelo pogosti (≥1/10); pogosti (≥1/100 do <1/10); občasni (≥1/1.000 do <1/100); redki (≥1/10.000 do <1/1000); zelo redki (<1/10.000) in neznana pogostnost (je ni mogoče oceniti iz razpoložljivih podatkov).
English: • Do not use the syringe after the expiry date which is stated on the outer box and syringe label.
Slovenian: • Injekcijske brizge ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in na nalepki injekcijske brizge.
English: Characteristics in patient populations
Slovenian: Značilnosti v posameznih skupinah bolnikov
English: AQL improvement % of patients ≥0.5 improvement p-value * marked improvement or complete control ** p-value for overall distribution of assessment
Slovenian: Vrednost p * izrazito izboljšanje ali popolno obvladanje bolezni ** vrednost p za celotno porazdelitev ocen
English: In these patients in study 1 Xolair reduced the rate of asthma exacerbations by 40% (p = 0.002).
Slovenian: Pri teh bolnikih v študiji 1 je zdravilo Xolair zmanjšalo pogostnost eksacerbacij astme za 40 % (p = 0,002).
English: Adults and adolescents (12 years of age and older)
Slovenian: Odrasli in mladostniki (stari 12 let ali več)
English: You will be given 1 to 4 injections at a time, either every two weeks, or every four weeks.
Slovenian: Potrebovali boste po 1 do 4 injekcije hkrati, in sicer vsaka dva tedna ali vsake štiri tedne.
English: Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature (leave the syringe in the box to protect it from light).
Slovenian: Škatlo z injekcijsko brizgo vzemite iz hladilnika in jo pustite zaprto približno 20 minut, da doseže sobno temperaturo (injekcijsko brizgo pustite v škatli, da ostane zaščitena pred svetlobo).
English: Allergic asthma
Slovenian: Alergijska astma
English: Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities.
Slovenian: Bolnikom so intravensko vbrizgali posamezne odmerke do 4.000 mg brez znakov toksičnosti, ki bi omejevala odmerjanje.
English: Disposal instructions
Slovenian: Navodila za odstranjevanje
English: Injecting Xolair - You and your doctor will decide if you should inject Xolair yourself.
Slovenian: Injiciranje zdravila Xolair - Skupaj z vašim zdravnikom se bosta odločila, ali si lahko sami injicirate zdravilo Xolair.
English: Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.
Slovenian: Zato ponovnega določanja koncentracije IgE med zdravljenjem z zdravilom Xolair ne moremo uporabljati kot smernice za določanje odmerka.
English: See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).
Slovenian: Glejte preglednico 1 za pretvorbeno shemo in preglednici 2 in 3 za shemi za določanje odmerkov pri odraslih, mladostnikih in otrocih (starih 6 do <12 let).
English: Parasitic (helminth) infections
Slovenian: Infestacije s paraziti (helminti)
English: Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24.
Slovenian: Povprečna sprememba izraženosti srbenja v enem tednu od izhodišča kaže na zmanjšanje ocene za 8,25 po 12 tednih in za 8,95 po 24 tednih.
English: This will depend on your child's weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in his/her blood.
Slovenian: To je odvisno od otrokove telesne mase in rezultatov krvne preiskave, ki jo bo otrok opravil pred začetkom zdravljenja, da bi izmerili količino protiteles IgE v njegovi krvi.
English: The in vitro histamine release from basophils isolated from Xolair-treated subjects was reduced by approximately 90% following stimulation with an allergen compared to pre-treatment values.
Slovenian: In vitro se je sproščanje histamina iz bazofilcev, izoliranih pri bolnikih, zdravljenih z zdravilom Xolair, po stimulaciji z alergenom zmanjšalo za približno 90 % v primerjavi z vrednostmi pred zdravljenjem.
English: For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.
Slovenian: Za 75 mg odmerek potegnite v brizgo 0,6 ml raztopine, preostanek pa zavrzite.
English: In asthma patients the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4  1.1 ml/kg/day.
Slovenian: Pri bolnikih z astmo je bil razpolovni čas odstranjevanja omalizumaba iz seruma povprečno 26 dni, navidezni očistek pa je bil povprečno 2,4  1,1 ml/kg/dan.
English: Nevertheless, the use of Xolair solution for injection in pre-filled syringe in latex-sensitive individuals has not been studied and thus there is a potential risk for hypersensitivity reactions which cannot be completely ruled out.
Slovenian: Čeprav uporabe zdravila Xolair raztopina za injiciranje v napolnjeni injekcijski brizgi niso proučevali pri osebah, ki so preobčutljive na lateks, obstaja določeno tveganje za preobčutljivostne reakcije, ki ga ni mogoče povsem izključiti.
English: General disorder and administration site conditions Injection site reaction*
Slovenian: Splošne težave in spremembe na mestu aplikacije reakcije na mestu injiciranja*
English: Xolair is used for the treatment of: - allergic asthma - chronic spontaneous urticaria (CSU)
Slovenian: Zdravilo Xolair uporabljamo za zdravljenje: - alergijske astme - kronične spontane urtikarije (KSU)
English: Syncope, paraesthesia, somnolence, dizziness
Slovenian: občasni sinkopa, parestezije, zaspanost, vrtoglavost
English: This medicinal product must not be mixed with other medicinal products.
Slovenian: Zaradi pomanjkanja študij kompatibilnosti zdravila ne smemo mešati z drugimi zdravili.
English: The majority of severe allergic reactions occur within the first 3 doses of Xolair.
Slovenian: Hude alergijske reakcije se večinoma pojavijo v okviru prvih treh odmerjanj zdravila Xolair.
English: There was no indication that the safety of Xolair was altered with these other commonly used anti-asthma medicinal products.
Slovenian: Ni bilo znakov, da bi se varnost zdravila Xolair zaradi uporabe teh pogosto uporabljanih zdravil proti astmi spremenila.
English: At 16 weeks after commencing Xolair therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered.
Slovenian: 16 tednov po začetku zdravljenja z zdravilom Xolair mora zdravnik pri bolniku oceniti učinkovitost zdravljenja, preden nadaljuje zdravljenje.