FrancophonIA/ELRC3.0 huggingface dataset:
English: Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue LIFMIOR therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Ker se imunoglobulini, tako kot mnoga druga zdravila, lahko izločajo v mleko pri človeku, se je treba odločiti, ali bo med zdravljenjem z zdravilom LIFMIOR bolnica prenehala dojiti ali pa bo med dojenjem prekinila zdravljenje s tem zdravilom, pri čemer je treba upoštevati tako korist dojenja za otroka kot korist zdravljenja za mater.
English: Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
Slovenian: Predklinični podatki o perinatalni in postnatalni toksičnosti etanercepta ter učinkih etanercepta na plodnost in splošno sposobnost za razmnoževanje niso na voljo.
English: Treatment with LIFMIOR should continue until remission is achieved, for up to 24 weeks.
Slovenian: Zdravljenje z zdravilom LIFMIOR je treba nadaljevati, dokler ne dosežemo remisije, vendar največ 24 tednov.
English: • Once the seal has been broken, remove the short, wide end of the plastic container.
Slovenian: Po prelomu plombe odstranite krajši, širši del plastične embalaže.
English: At baseline, patients had a moderate degree of disability, with mean HAQ scores of 1.4 to 1.5.
Slovenian: V izhodišču so imeli bolniki zmerno stopnjo invalidnosti, s povprečno oceno po HAQ od 1,4 do 1,5.
English: The absolute bioavailability is 76%.
Slovenian: Absolutna biološka uporabnost etanercepta je 76 %.
English: The known side effects of LIFMIOR include the following in groups of decreasing frequency:
Slovenian: Znani neželeni učinki zdravila LIFMIOR so v nadaljevanju navedeni v skupinah po padajoči pogostnosti:
English: LIFMIOR treatment may increase mortality in patients with established sepsis.
Slovenian: Zdravljenje z zdravilom LIFMIOR lahko zveča smrtnost pri bolnikih z dokazano sepso.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE UČINKOVINE IN IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed.
Slovenian: V deležih spontanega splava, mrtvorojenosti ali manjših malformacij niso opazili sprememb.
English: Responses observed during the open-label period were similar to those observed in the double-blind period.
Slovenian: Odzivi, ki so jih opažali med obdobjem odprtega zdravljenja, so bili podobni tistim v dvojno slepem obdobju.
English: • Psoriatic arthritis in patients from the age of 12 years
Slovenian: • psoriatičnega artritisa pri bolnikih, starejših od 12 let.
English: Two large clinical trials evaluating the use of LIFMIOR in the treatment of CHF were terminated early due to lack of efficacy.
Slovenian: Dve veliki klinični preskušanji za ovrednotenje uporabe zdravila LIFMIOR pri zdravljenju KSP sta bili predčasno prekinjeni zaradi slabe učinkovitosti zdravila.
English: Make sure that the tip does not touch anything.
Slovenian: Pazite, da se konica ničesar ne dotika.
English: If you prefer, you may alternatively use the stomach area, but make sure you choose a site at least 5 cm away from the belly button (navel).
Slovenian: Če vam je ljubše, lahko uporabite tudi predel trebuha, vendar izberite mesto, ki je vsaj 5 cm oddaljeno od popka.
English: • Very rare (may affect up to 1 in 10,000 people): failure of the bone marrow to produce crucial blood cells.
Slovenian: Zelo redki (pojavijo se lahko pri največ 1 od 10.000 bolnikov): prenehanje tvorbe nujnih krvnih celic v kostnem mozgu.
English: The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations.
Slovenian: Učinek višje starosti na farmakokinetiko zdravila so proučevali s populacijsko farmakokinetično analizo serumskih koncentracij etanercepta.
English: If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of LIFMIOR, and in accordance with local recommendations.
Slovenian: Če se ugotovi neaktivna ('latentna') tuberkuloza, je treba pred uvedbo zdravila LIFMIOR in v skladu z nacionalnimi priporočili začeti zdravljenje latentne tuberkuloze s tuberkulostatiki.
English: This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1.
Slovenian: Domena Fc humanega IgG1 vsebuje "gibljivo mesto" (hinge) in področji CH2 in CH3, ne pa tudi področja CH1 IgG1.
English: • Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2 years
Slovenian: • poliartritisa (pozitivnega ali negativnega za revmatoidni faktor) in razširjenega oligoartritisa pri bolnikih, starejših od 2 let.
English: If you have used more LIFMIOR than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately.
Slovenian: Če ste uporabili večji odmerek zdravila LIFMIOR, kot bi smeli (bodisi ste ga naenkrat injicirali preveč bodisi prepogosto), se nemudoma posvetujte z zdravnikom ali farmacevtom.
English: To help you remember, it may be helpful to write in a diary which day(s) of the week LIFMIOR should be used.
Slovenian: Da si boste lažje zapomnili, vam bo morda pomagalo, če si v koledarju zabeležite dan (dneve) v tednu, ko morate uporabiti zdravilo LIFMIOR.
English: Time
Slovenian: Čas
English: There have been reports of worsening of hepatitis C in patients receiving LIFMIOR.
Slovenian: Poročali so o poslabšanju hepatitisa C pri bolnikih, ki so prejemali zdravilo LIFMIOR.
English: Physicians should use caution when considering combination therapy with sulfasalazine.
Slovenian: Zdravniki morajo biti previdni, kadar razmišljajo o kombiniranem zdravljenju s sulfasalazinom.
English: Step 4: Disposing of supplies
Slovenian: Korak 4: Odstranjevanje odpadkov
English: If needed, you may cover the injection site with a bandage.
Slovenian: Če je treba, lahko mesto injiciranja prekrijete z obližem.
English: Linearity
Slovenian: Linearnost
English: The proportion of subjects who developed antibodies to etanercept in longer-term trials (of up to 3.5 years) increases over time, as expected.
Slovenian: Delež bolnikov, pri katerih so se pojavila protitelesa proti etanerceptu v dolgoročnejših preskušanjih (do 3,5 let), se po pričakovanjih sčasoma povečuje.
English: Discontinuation of treatment should be considered in patients who show no response after 4 months.
Slovenian: O prekinitvi zdravljenja je treba razmisliti pri bolnikih, ki ne kažejo odziva po 4 mesecih zdravljenja.
English: Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of LIFMIOR (10 mg, 25 mg or 50 mg).
Slovenian: Natančen odmerek za otroka bo določil zdravnik in predpisal ustrezno jakost zdravila LIFMIOR (10 mg, 25 mg ali 50 mg).
English: The solvent is a clear, colourless liquid.
Slovenian: Vehikel je bistra, brezbarvna tekočina.
English: The pen's inspection window should now be completely purple, confirming that the dose has been injected correctly (see Diagram 8).
Slovenian: Okence za pregledovanje sedaj postane povsem vijolično, kar potrjuje, da je bil odmerek injiciran pravilno (glejte sliko 8).
English: ACR Responsesa ACR 20
Slovenian: Odzivi ACR ACR 20 ACR 50 ACR 70
English: The modified TSS at 12 months is presented in the table below.
Slovenian: Modificirani TSS po 12 mesecih je prikazan v spodnji preglednici.
English: There may be a little bleeding at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavi manjša krvavitev.
English: Inspect the solution in the syringe.
Slovenian: Preglejte raztopino v brizgi.
English: For patients with multiple symmetrical painful or swollen joints (e.g., hands, wrists and feet), LIFMIOR can slow down the structural damage to those joints caused by the disease.
Slovenian: Pri bolnikih z več simetrično prizadetimi bolečimi ali oteklimi sklepi (npr. dlanmi, zapestji ali stopali) lahko zdravilo LIFMIOR upočasni razvoj strukturnih okvar teh sklepov, ki jih povzroča bolezen.
English: After discontinuation of LIFMIOR, symptoms of arthritis generally returned within a month.
Slovenian: Po prekinitvi zdravljenja z zdravilom LIFMIOR so se simptomi artritisa največkrat ponovno pojavili že v enem mesecu.
English: In addition, one study found more birth defects when the mother had received LIFMIOR in pregnancy, compared with mothers who had not received LIFMIOR or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported.
Slovenian: Poleg tega so v eni študiji ugotovili več prirojenih napak, kadar je mati med nosečnostjo prejemala zdravilo LIFMIOR, v primerjavi z materami, ki niso prejemale zdravila LIFMIOR ali drugih podobnih zdravil (antagonistov TNF), vendar niso poročali o nobeni določeni vrsti prirojene okvare.
English: For storage conditions of the reconstituted medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja po rekonstituciji zdravila glejte poglavje 6.3.
English: Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present.
Slovenian: Raztopine ne uporabljajte, če je drugačne barve, motna, ali če so prisotni delci, ki ne ustrezajo opisu zgoraj.
English: If not used immediately, storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at temperatures of up to 25°C, unless reconstitution has taken place in controlled and validated aseptic conditions.
Slovenian: Če zdravila ne uporabite takoj, je za čas shranjevanja, ki normalno ne sme presegati 6 ur pri temperaturi do 25 C, in razmere pred uporabo odgovoren uporabnik, razen če je bila rekonstitucija zdravila izvedena v kontroliranih in validiranih aseptičnih pogojih.
English: In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection (pneumonia).
Slovenian: V dvojno slepih in odprtih preskušanjih psoriatičnega artritisa je 1 bolnik poročal o 1 resni okužbi (pljučnici).
English: However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.
Slovenian: Pojavnost je bila sicer redka, obdobje spremljanja bolnikov, ki so prejemali placebo, pa krajše kot pri bolnikih, ki so prejemali antagonist TNF.
English: It is very important that you tell your doctor if the child has ever had tuberculosis, or has been in close contact with someone who has had tuberculosis.
Slovenian: Zelo pomembno je, da poveste zdravniku, če je vaš otrok kdaj imel tuberkulozo ali bil v tesnem stiku s kom, ki je imel tuberkulozo.
English: Alcoholic hepatitis
Slovenian: Alkoholni hepatitis
English: • The needle has been placed in a plastic container to keep it sterile.
Slovenian: Igla se nahaja v plastični embalaži, da ostane sterilna.
English: Adult population
Slovenian: Odrasla populacija
English: The needle will remain protected inside the pen until the pen is activated.
Slovenian: Igla bo ostala zaščitena v peresniku, dokler ne boste peresnika aktivirali.
English: A total of 401 patients were enrolled, from which 203 were treated with LIFMIOR.
Slovenian: Sodeloval je 401 bolnik in od tega so bili 203 zdravljeni z zdravilom LIFMIOR.
English: If the window is not completely purple, contact your nurse or pharmacist for assistance, since the pen may not have injected the LIFMIOR solution completely.
Slovenian: Če okence ni povsem vijolično, za pomoč prosite medicinsko sestro ali farmacevta, saj peresnik raztopine zdravila LIFMIOR morda ni injiciral v celoti.
English: No rebound flare of disease and no psoriasis-related serious adverse events were observed.
Slovenian: Opazili niso nobenega preobratnega ponovnega izbruha bolezni in nobenih s psoriazo povezanih resnih neželenih učinkov.
English: Within the organ system classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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); very rare (<1/10,000); not known (cannot be estimated from the available data).
Slovenian: Znotraj organskih sistemov so neželeni učinki navedeni po pogostnosti (število bolnikov, pri katerih se pričakuje pojav učinka), z uporabo naslednjih kategorij: 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), zelo redki (< 1/10.000); neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with LIFMIOR for up to 48 months.
Slovenian: Resne okužbe so se pojavile pri 6,3 % bolnikov z revmatoidnim artritisom, ki so prejemali zdravilo LIFMIOR do 48 mesecev.
English: This section is divided into the following subsections:
Slovenian: To poglavje je razdeljeno na naslednja podpoglavja:
English: The safety and efficacy profiles of the two LIFMIOR treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Slovenian: Profil varnosti in učinkovitosti obeh shem zdravljenja z zdravilom LIFMIOR je bil po 8 tednih primerljiv glede učinka na znake in simptome revmatoidnega artritisa; podatki po 16 tednih niso pokazali primerljivosti (neinferiornosti) med obema shemama.
English: The conduct of these tests should be recorded on the Patient Alert Card.
Slovenian: Rezultati teh testov morajo biti vpisani na opozorilni kartici za bolnika.
English: In this situation, the benefit/risk balance of LIFMIOR therapy should be very carefully considered.
Slovenian: V takem primeru je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom LIFMIOR.
English: If you notice any of the following, you or the child may need urgent medical attention.
Slovenian: Če opazite karkoli od naslednjega, boste vi ali vaš otrok morda potrebovali nujno zdravniško pomoč:
English: Prior to launch in each Member State, the MAH shall agree the final educational material with the competent authority in that Member State comprising of information provided to all healthcare professionals expected to prescribe the product on the correct and safe use of the pre-filled pen and a Patient Alert Card which is to be given to patients using LIFMIOR.
Slovenian: Imetnik dovoljenja za promet z zdravilom se mora pred pričetkom trženja napolnjenega peresnika v vsaki državi članici s pristojnim organom v tej državi dogovoriti glede končnega izobraževalnega gradiva, sestavljenega iz informacij za predpisovalce glede pravilne in varne uporabe napolnjenega peresnika, ter opozorilne kartice za bolnika, ki jo morajo izročiti bolnikom, ki se zdravijo z zdravilom LIFMIOR.
English: Children and adults taking LIFMIOR may have an increased risk of developing lymphoma or another cancer.
Slovenian: Pri otrocih in odraslih, ki prejemajo zdravilo LIFMIOR, je morda tveganje za nastanek limfoma ali druge oblike raka večje.
English: Hold the pen at a right angle (90º) to the injection site.
Slovenian: Peresnik držite pod pravim kotom (90°) na mesto injiciranja.
English: The recommended injection site is the middle of the front of the thighs.
Slovenian: Priporočeno mesto injiciranja je sredina sprednjega dela stegen.
English: They should not be used after the month and year shown.
Slovenian: Po preteku označenega meseca in leta ju ne smete uporabiti.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Slovenian: Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu
English: The specific activity of etanercept is 1.7 x 106 units/mg.
Slovenian: Specifična aktivnost etanercepta je 1,7 x 10
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: If you feel that the effect of LIFMIOR is too strong or too weak, talk to your doctor or pharmacist.
Slovenian: Če menite, da je učinek zdravila LIFMIOR premočan ali prešibak, se posvetujte z zdravnikom ali farmacevtom.
English: Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma.
Slovenian: Pri bolnikih s hudim revmatoidnim artritisom, ki že dlje časa trpijo za to boleznijo, je lahko tveganje za nastanek limfoma večje od povprečnega.
English: If you use more LIFMIOR than you should
Slovenian: Če ste uporabili večji odmerek zdravila LIFMIOR, kot bi smeli
English: It is recommended that you record the date that LIFMIOR is removed from the refrigerator and the date after which LIFMIOR should be discarded (no more than 4 weeks following the removal from the refrigerator).
Slovenian: Priporočljivo si je zabeležiti datum odvzema zdravila LIFMIOR iz hladilnika in datum, po katerem je treba zdravilo LIFMIOR zavreči (do 4 tedne po odvzemu iz hladilnika).
English: LIFMIOR did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2000 mg/kg or a single intravenous dose of 1000 mg/kg.
Slovenian: Zdravilo LIFMIOR ni povzročilo smrtnosti ali pomembne toksičnosti pri miših ali podganah po enkratnem subkutanem odmerku 2.000 mg/kg ali enkratnem intravenskem odmerku 1.000 mg/kg.
English: The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.
Slovenian: Med drugimi primeri so bile raznolike vrste malignosti, ki so vključevale redke vrste malignosti, običajno povezane z imunosupresijo.
English: Radiographic changes were assessed in the psoriatic arthritis study.
Slovenian: V študiji psoriatičnega artritisa so ocenjevali radiografske spremembe.
English: Patients who develop a new infection while undergoing treatment with LIFMIOR should be monitored closely.
Slovenian: Bolnike, pri katerih se med zdravljenjem z zdravilom LIFMIOR pojavi nova okužba, je treba skrbno spremljati.
English: There is no known antidote to LIFMIOR.
Slovenian: Znanega antidota za zdravilo LIFMIOR ni.
English: When you remove the needle cover, there may be a drop of liquid at the end of the needle; this is normal.
Slovenian: Ko odstranite pokrovček igle, lahko na konici igle opazite kapljico tekočine, kar je normalno.
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors, ATC code: L04AB01
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, Antagonisti tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB01
English: Waiting until the solution reaches room temperature may make the injection more comfortable for you.
Slovenian: Če počakate, da bo raztopina dosegla sobno temperaturo, bo injekcija za vas manj neprijetna.
English: LIFMIOR works by reducing the inflammation associated with certain diseases.
Slovenian: Deluje tako, da zmanjšuje vnetje, ki spremlja določene bolezni.
English: Sepsis or risk of sepsis.
Slovenian: Sepsa ali tveganje za nastanek sepse.
English: The impact of long-term treatment with LIFMIOR on the development of autoimmune diseases is unknown.
Slovenian: Vpliv dolgotrajnega zdravljenja z zdravilom LIFMIOR na razvoj avtoimunskih bolezni ni znan.
English: If you notice any of the following, the child may need urgent medical attention.
Slovenian: Če opazite karkoli od naslednjega, bo otrok morda potreboval nujno zdravniško pomoč:
English: Each injection should be given at least 3 cm from where you last injected.
Slovenian: Vsako naslednjo injekcijo morate dati vsaj 3 cm stran od mesta prejšnje injekcije.
English: The needle cover contains dry natural rubber (latex) (see section 4.4).
Slovenian: Pokrovček igle vsebuje posušen naravni kavčuk (lateks) (glejte poglavje 4.4).
English: After you have withdrawn the LIFMIOR from the vial, you may have some air in the syringe.
Slovenian: Po tem, ko ste potegnili zdravilo LIFMIOR iz viale, je možno, da je v brizgo prišlo tudi nekaj zraka.
English: Patients should be evaluated for infections before, during, and after treatment with LIFMIOR, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
Slovenian: Pred zdravljenjem z zdravilom LIFMIOR, med njim in po njem je treba bolnike pregledati glede okužb in pri tem upoštevati, da je povprečni razpolovni čas izločanja etanercepta iz telesa približno 70 ur (razpon 7 do 300 ur).
English: What you need to know before you use LIFMIOR
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo LIFMIOR
English: A slight depression in the skin will be seen (see Diagram 4).
Slovenian: Vidna bo rahla vdrtina v koži (glejte sliko 4).
English: Tell the doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including anakinra, abatacept or sulfasalazine), even those not prescribed by the doctor.
Slovenian: Obvestite zdravnika ali farmacevta, če vi ali otrok jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo (vključno z anakinro, abataceptom ali sulfasalazinom), tudi če ste ga dobili brez recepta.
English: Use only the items listed.
Slovenian: Vedno uporabljajte le naštete pripomočke.
English: It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis.
Slovenian: Zelo pomembno je, da poveste zdravniku, če ste vi ali vaš otrok kdaj imeli tuberkulozo ali bili v tesnem stiku s kom, ki je imel tuberkulozo.
English: In patients who develop HBV infection, LIFMIOR should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Slovenian: Pri bolnikih, pri katerih se razvije okužba s HBV, je treba zdravljenje z zdravilom LIFMIOR prekiniti in uvesti učinkovito protivirusno ter ustrezno podporno zdravljenje.
English: This may include a thorough medical history, a chest X-ray and a tuberculin test.
Slovenian: To bo storil s temeljito medicinsko anamnezo, rentgenskim slikanjem prsnega koša in tuberkulinskim testom.
English: The 10 mg LIFMIOR dose had consistently less effect on structural damage than the 25 mg dose.
Slovenian: 10 mg odmerek zdravila LIFMIOR je imel ves čas manjši učinek na strukturno poškodbo sklepov kot 25 mg odmerek.
English: You may now lift the pen from your skin (see Diagram 7).
Slovenian: Sedaj lahko peresnik umaknete s kože (glejte sliko 7).
English: Whilst pushing the pen firmly against the skin to ensure that the needle safety shield is fully depressed inside the pen, press the centre of the green button on top of the pen with your thumb to start the injection (see Diagram 5).
Slovenian: Medtem ko peresnik čvrsto pritiskate ob kožo in s tem zagotovite, da je varnostni ščit v celoti skrit v peresniku, s palcem pritisnite sredino zelenega gumba na vrhu peresnika, da se prične injiciranje (glejte sliko 5).
English: During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three LIFMIOR doses.
Slovenian: V prvih 12 tednih dvojno slepega obdobja zdravljenja so bolniki dobivali placebo ali enega od navedenih odmerkov zdravila LIFMIOR.
English: There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Slovenian: Poročali so tudi o redkih primerih lupusa, lupusu podobnih stanj in vaskulitisa.
English: The exposure-adjusted rate was 0.06 events per 100 patient-years.
Slovenian: Za stopnjo izpostavljenosti popravljena pogostnost je bila 0,06 dogodka na 100 bolnikov-let.