FrancophonIA/ELRC3.0 huggingface dataset:
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defense against infection and cancer.
Slovenian: TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okužbi in raku.
English: • You will set the volume to the prescribed dose in a later step.
Slovenian: • Količino boste nastavili na predpisani odmerek v poznejšem koraku.
English: • When you push down, the injection starts.
Slovenian: • Ko potisnete navzdol, se injiciranje začne.
English: 5000 Davis Drive Research Triangle Park North Carolina
Slovenian: Research Triangle Park North Carolina
English: Patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Slovenian: Bolniki z redko, dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
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: It is normal to see a few drops of liquid come out of the needle.
Slovenian: Povsem normalno je, če iz konice igle izstopi nekaj kapljic tekočine.
English: Not sure if you received your dose?
Slovenian:  Niste prepričani, ali ste prejeli svoj odmerek?
English: Never reuse a vial and other components.
Slovenian: Viale in drugih komponent nikoli ne smete ponovno uporabiti.
English: Efficacy Outcomes Double Blind 32 weeks Adalimumab /MTX (N=38)
Slovenian: Rezultati učinkovitosti Dvojno slepa 32 tednov Adalimumab/MTX (N = 38)
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80 % of patients continued to receive at least one of these medications.
Slovenian: Dovoljena je bila sočasna uporaba stabilnih odmerkov aminosalicilatov, kortikosteroidov in/ali imunomodulacijskih zdravil; 80 % bolnikov je še naprej prejemalo vsaj eno od takšnih zdravil.
English: • Certain vaccines contain weakened but live forms of disease-causing bacteria or viruses, and these vaccines should not be given while receiving Imraldi.
Slovenian: • Določena cepiva vsebujejo oslabljene, vendar žive oblike bakterij ali virusov, ki povzročajo bolezni, in teh cepiv se med zdravljenjem z zdravilom Imraldi ne sme uporabljati.
English: Fatty areas, like your stomach, are generally the best injection sites.
Slovenian: Območja z več podkožne maščobe, na primer trebuh, so na splošno najprimernejša mesta za injiciranje.
English: You will see the liquid medication from the vial go into the syringe.
Slovenian: Videli boste, kako tekoče zdravilo iz viale prehaja v brizgo.
English: Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin disease.
Slovenian: Hidradenitis suppurativa (včasih imenovan tudi acne inversa) je kronična in pogosto boleča vnetna bolezen kože.
English: • The new injection site should be given at least 3 cm from the last injection site.
Slovenian: • Novo mesto injiciranja mora biti najmanj 3 cm stran od mesta zadnjega injiciranja.
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: If there is a second box in the carton for a future injection, place it back in the refrigerator immediately.
Slovenian: Če pakiranje vsebuje še eno škatlo za naslednje injiciranje, le-to nemudoma shranite v hladilnik.
English: Mean exposure in all adalimumab population was 762 days.
Slovenian: Povprečen čas izpostavljenosti v vsej populaciji za zdravljenje z adalimumabom je bil 762 dni.
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: • If you are over 65 years you may be more susceptible to infections while taking Imraldi.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okužbe, če jemljete zdravilo Imraldi.
English: • Recheck the prescribed medication amount.
Slovenian: • Ponovno preverite predpisano količino zdravila.
English: 73% of patients enrolled in Psoriasis studies I and II had received prior systemic therapy or phototherapy.
Slovenian: 73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
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 % glede na materin serum.
English: For paediatric use.
Slovenian: Za pediatrično uporabo.
English: The needle is now attached to the syringe.
Slovenian: Igla je zdaj nameščena na brizgo.
English: Concurrent administration of biologic DMARDS or TNF-antagonists
Slovenian: Sočasna uporaba bioloških DMARDS ali antagonistov TNF
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Slovenian: V koloni organski sistem se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
English: Longer term treatment with adalimumab 40 mg weekly for 96 weeks identified no new safety findings.
Slovenian: Pri daljšem zdravljenju s 40 mg adalimumaba na teden 96 tednov ni bilo novih varnostnih ugotovitev.
English: • The syringe, needle, vial and vial adapter MUST NEVER be reused.
Slovenian: • Brizge, igle, viale in adapterja za vialo NE SMETE nikoli ponovno uporabiti.
English: Without MTX
Slovenian: Brez MTX
English: Imraldi can also be given alone.
Slovenian: Zdravilo Imraldi se lahko daje tudi samo.
English: There is no reason to remove it.
Slovenian: To ne predstavlja težave in ni ga treba odstraniti.
English: • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);
Slovenian: • oportunistične okužbe (vključujejo tuberkulozo in druge okužbe, ki se pojavijo ob slabši telesni odpornosti na bolezen);
English: • a bump or open sore that doesn't heal;
Slovenian: • bulo ali odprto rano, ki se ne zaceli;
English: Therefore, the combination of adalimumab and anakinra is not recommended.
Slovenian: Zato kombinacija adalimumaba in anakinre ni priporočljiva.
English: Percent Change in Total Fingernail NAPSI (%)
Slovenian: Odstotek spremembe v celotnem indeksu NAPSI (%)
English: After proper training, the injection can be self-administered or given by another person, for example a family member or friend.
Slovenian: Po ustreznem urjenju lahko injekcije vašemu otroku dajete sami ali mu jih daje kdo drug, npr. svojec ali prijatelj.
English: Consequently, adalimumab can be used during breastfeeding.
Slovenian: Posledično se adalimumab lahko uporablja med dojenjem.
English: A large number (approximately 2,100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1,500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Veliko število (približno 2.100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo živorojenih otrok z znanim izidom, vključno s 1.500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
English: After injecting Imraldi, confirm that the entire medication window is yellow.
Slovenian: Po injiciranju zdravila Imraldi se prepričajte, da je celotno okence za zdravilo rumeno.
English: Travel/recurrent infection
Slovenian: Potovanja/ponavljajoča se okužba
English: • With the other hand, hold syringe at 45-degree angle to skin.
Slovenian: • Z drugo roko držite brizgo pod kotom 45 stopinj na kožo.
English: During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
Slovenian: Med vzdrževalnim zdravljenjem je mogoče kortikosteroide postopoma zmanjšati v skladu s smernicami za klinično prakso.
English: Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski kožni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
English: • feeling weak or tired;
Slovenian: • občutek šibkosti ali utrujenosti;
English: - If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - če ste alergični na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (black dots or wispy lines that move across the field of vision).
Slovenian: To vnetje lahko povzroči poslabšanje vida in/ali prisotnost delcev v očesu (črnih pik ali koprenastih črt, ki se premikajo po vidnem polju).
English: This could bend or damage the needle.
Slovenian: To bi namreč lahko zlomilo ali ukrivilo iglo.
English: The primary nonresponders were excluded from the studies and therefore these patients were not further evaluated.
Slovenian: Študija ni vključila primarno neodzivnih bolnikov in ti tako niso bili dodatno ocenjeni.
English: • Choose a site on your thigh or abdomen (except the area around the navel).
Slovenian: • Izberite mesto na stegnu ali trebuhu (razen območja okoli popka).
English: Imraldi contains sodium and sorbitol
Slovenian: Zdravilo Imraldi vsebuje natrij in sorbitol
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 tudi zmanjšanje števila celic, ki izražajo vnetne označevalce v kolonu, vključno z bistvenim zmanjšanjem ekspresije TNFα.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Slovenian: Danska Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom:
English: When you push the pre-filled pen firmly onto your skin, the injection will start automatically.
Slovenian: Ko napolnjen injekcijski peresnik trdno pritisnete ob kožo, se bo injiciranje samodejno začelo.
English: Continue with injection site and dose preparation immediately.
Slovenian: Takoj nadaljujte s pripravo mesta za injiciranje in pripravo odmerka.
English: • Use a different injection site every time:
Slovenian: • Uporabite vsakič drugo mesto za injiciranje:
English: Clinical response (CR-100)
Slovenian: Klinični odziv (CR-100)
English: • With the free hand, gently grasp the cleaned area of skin and hold firmly.
Slovenian: • S prosto roko obzirno primite očiščeni predel kože in ga trdno držite.
English: The educational program consists of a Patient Reminder Card.
Slovenian: Izobraževalni program zajema Opozorilno kartico za bolnika.
English: Place the greenbase straight (90 degrees) on your skin, and push the entire pre-filled pen down firmly to start the injection.
Slovenian: Položite zeleno osnovo navpično (pod kotom 90 stopinj) na kožo in trdno potisnite ves napolnjen injekcijski peresnik navzdol, da sprožite injiciranje.
English: • If you see remaining air bubbles or air gaps in the liquid medication in the syringe, you may repeat this process up to 3 times.
Slovenian: • Če v tekočem zdravilu v brizgi opazite preostale zračne mehurčke ali zračne presledke, lahko ta postopek do 3-krat ponovite.
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Slovenian: Pri približno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
English: 3) Choosing and preparing an injection site
Slovenian: 3) Izbira in priprava mesta injiciranja zdravila
English: • Check to see that the fluid remaining in the syringe is at least the prescribed dose volume.
Slovenian: • Preverite, ali je preostala količina tekočine v brizgi vsaj tolikšna, kot je količina predpisanega odmerka.
English: When choosing an injection site, select an area that has not recently been used to avoid soreness and bruises.
Slovenian: Ko izbirate mesto za injiciranje, izberite območje, kjer niste pred kratkim injicirali, saj boste tako laže preprečili bolečine in modrice.
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 (znižanje CDAI ≥ 70) 4. teden so stratificirali in analizirali ločeno od bolnikov brez kliničnega odziva 4. teden.
English: NOTE:
Slovenian: OPOMBA:
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Slovenian: Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je približno 15-kraten priporočen odmerek.
English: If retreatment with Imraldi is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom Imraldi, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljenja.
English: - If you have moderate or severe heart failure.
Slovenian: - če imate zmerno ali hudo srčno popuščanje.
English: Thus additional caution should be exercised in considering adalimumab treatment of these patients (see section 4.8).
Slovenian: Torej je potrebna dodatna previdnost, kadar razmišljamo o zdravljenju z adalimumabom pri teh bolnikih (glejte poglavje 4.8).
English: Tuberculosis can develop during therapy even if your child has received preventative treatment for tuberculosis.
Slovenian: Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok prejel preventivno zdravljenje za tuberkulozo.
English: • difficulty sleeping;
Slovenian: • otežkočeno spanje;
English: By attaching to TNFα, Imraldi decreases the process of inflammation in these diseases.
Slovenian: S tem, ko se pritrdi na TNFα, zdravilo Imraldi zmanjšuje vnetni proces pri teh boleznih.
English: Treatment with Imraldi can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Imraldi se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.
English: If you receive Imraldi while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Slovenian: Če prejemate zdravilo Imraldi med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: • severe rash, hives or other signs of allergic reaction;
Slovenian: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije;
English: Patients may first be given other medicines.
Slovenian: Bolniki bodo morda najprej dobili druga zdravila.
English: Contact your doctor, nurse or pharmacist.
Slovenian: Obrnite se na zdravnika, medicinsko sestro ali farmacevta.
English: In study UC-II, treatment with adalimumab resulted in improvements in the Inflammatory Bowel Disease Questionnaire (IBDQ) score.
Slovenian: V študiji UC-II je zdravljenje z adalimumabom pripeljalo do izboljšanja rezultatov Vprašalnika o vnetni bolezni črevesa (IBDQ - Inflammatory Bowel Disease Questionnaire).
English: • To reduce the chance of infection, wipe the injection site with the other alcohol pad.
Slovenian: • Za zmanjšanje možnosti okužbe obrišite mesto injiciranja s priloženim alkoholnim zložencem.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Slovenian: Adalimumab je rekombinantno humano monoklonsko protitelo, ki nastaja v celicah jajčnika kitajskega hrčka.
English: Phase
Slovenian: Faza
English: • Using a piece of gauze, apply pressure over the injection site for 10 seconds.
Slovenian: • S koščkom gaze 10 sekund pritiskajte na mesto injiciranja.
English: Prior to launch of Imraldi in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Slovenian: • Dodatni ukrepi za zmanjševanje tveganj Pred začetkom trženja zdravila Imraldi v vsaki državi članici se mora imetnik dovoljenja za promet z zdravilom (MAH) s pristojnim nacionalnim organom dogovoriti o vsebini in obliki izobraževalnega programa, vključno z modalitetami distribucije in vsemi drugimi vidiki programa.
English: Side effects may occur up to 4 months or more after the last Imraldi injection.
Slovenian: Neželeni učinki se lahko pojavijo do 4 mesece po zadnji injekciji zdravila Imraldi ali pozneje.
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with the reference medicinal product containing adalimumab in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje adalimumab, za eno ali več podskupin pediatrične populacije pri ulceroznem kolitisu (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Tuberculosis can develop during therapy even if you have received preventative treatment for tuberculosis.
Slovenian: Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste prejeli preventivno zdravljenje za tuberkulozo.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5 % due to insufficient response to adalimumab treatment.
Slovenian: Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neželenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
English: What Imraldi is and what it is used for 2.
Slovenian: Kaj je zdravilo Imraldi in za kaj ga uporabljamo 2.
English: • Hold the syringe at eye-level with the needle pointing up to see the amount clearly.
Slovenian: • Držite brizgo na ravni oči in z iglo obrnjeno navzgor, da boste jasno videli količino.
English: Fistula remission3
Slovenian: Remisija fistule3
English: For instructions for use, refer to section 7.
Slovenian: Za navodila za uporabo glejte poglavje 7.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Slovenian: • Če ste noseči, menite, da bi lahko bili noseči, ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: • Look at the expiry date on the box to be used.
Slovenian: • Preverite rok uporabnosti na škatli.
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, other opportunistic infections (unusual infections associated with a weakened immune system) and sepsis (blood poisoning).
Slovenian: Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije, druge oportunistične okužbe (neobičajne okužbe, povezane z oslabljenim imunskim sistemom) in sepso (zastrupitev krvi).
English: • reactivation of hepatitis B;
Slovenian: • reaktivacija hepatitisa B;
English: Adalimumab significantly decreased the risk of treatment failure by 75 % relative to placebo, as shown by the hazard ratio (HR = 0.25 [95 % CI: 0.12, 0.49]).
Slovenian: Adalimumab je značilno zmanjšal tveganje za neuspeh zdravljenja za 75 % glede na placebo, kot prikazuje razmerje ogroženosti (HR = 0,25 [95 % IZ: 0,12, 0,49]).
English: • If you received Imraldi during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: • Če prejemate zdravilo Imraldi med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okužbo.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class and frequency in Table 6 below: 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 not known (cannot be estimated from the available data).
Slovenian: Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6, spodaj: 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 neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) (< 1/10.000).
English: You and your doctor should pay special attention to signs of infection while you are being treated with Imraldi.
Slovenian: Vi sami in zdravnik morata biti posebej pozorna na znake okužbe, medtem ko ste zdravljeni z zdravilom Imraldi.
English: Before initiation of therapy with Imraldi, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection.
Slovenian: Pred začetkom zdravljenja z zdravilom Imraldi je vse bolnike treba pregledati glede aktivne ali neaktivne (latentne) tuberkulozne okužbe.
English: The following instructions explain how to inject Imraldi.
Slovenian: Spodnja navodila pojasnjujejo, kako injicirati zdravilo Imraldi.
English: DO NOT touch the vial adapter.
Slovenian: NE DOTIKAJTE se adapterja za vialo.
English: These infections have not consistently been recognised in patients taking TNF-antagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Slovenian: Takšnih okužb pri uporabnikih antagonistov TNF niso konsistentno prepoznavali, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
English: - If your child has moderate or severe heart failure.
Slovenian: - če ima vaš otrok zmerno ali hudo srčno popuščanje.
English: • On rare occasions, treatment with Imraldi could result in lupus-like syndrome.
Slovenian: • V redkih primerih lahko zdravljenje z zdravilom Imraldi povzroči lupusu podoben sindrom.
English: Clinical remission (defined as Mayo score ≤2 with no subscore >1) was assessed at week 8.
Slovenian: Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
English: Patients on adalimumab may receive concurrent vaccinations, except for live vaccines.
Slovenian: Bolniki, ki prejemajo adalimumab, lahko sočasno dobijo cepiva, razen živih cepiv.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje kot stanje, ki mu pravimo sarkoidoza);
English: Caring for your vial
Slovenian: Skrb za vašo vialo
English: P value*
Slovenian: Vrednost p*
English: Hold the pen against your skin until the yellow indicator fills the medication window and stops moving.
Slovenian: Peresnik držite pritisnjen ob kožo, dokler rumeni indikator na zapolni okenca za zdravilo in se neha premikati.
English: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Slovenian: Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediani čas do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA "zmerno" ali slabše) je bil približno 5 mesecev.