FrancophonIA/ELRC3.0 huggingface dataset:
English: The primary endpoint was the percent reduction in daily OCS dose (weeks 20-24), whilst maintaining asthma control by defined dose reduction categories (see Table 4).
Slovenian: Primarni opazovani dogodek je bilo odstotno zmanjšanje dnevnega odmerka PKS (20. do 24. teden) ob vzdrževanju urejenosti astme glede na opredeljene kategorije zmanjšanja odmerka (glejte preglednico 4).
English: The solution for injection can be stored between 2°C to 30°C for no more than 8 hours.
Slovenian: Raztopina za injiciranje je lahko shranjena pri temperaturi od 2 °C do 30 °C največ 8 ur.
English: In monkeys, mepolizumab had no effect on pregnancy or on embryonic/fetal and postnatal development (including immune function) of the offspring.
Slovenian: Pri opicah mepolizumab ni vplival na brejost, razvoj zarodkov/plodov ali postnatalni razvoj (vključno z imunskim delovanjem) mladičev.
English: Dispose 9.
Slovenian: Zavrzite 9.
English: • Gauze pad or cotton wool ball (not included) Do not perform the injection if you do not have all these.
Slovenian: • zloženec gaze ali kosem vate (nista priložena) Ne injicirajte zdravila, če nimate vsega tega.
English: The baseline mean prednisone equivalent dose was approximately 13 mg per day.
Slovenian: Izhodiščni povprečni prednizonu enakovredni odmerek je bil približno 13 mg na dan.
English: Nucala should not be used to treat acute asthma exacerbations.
Slovenian: Zdravila Nucala se ne sme uporabljati za zdravljenje akutnih poslabšanj astme.
English: The most common manifestations reported with these events included pain, erythema, swelling, itching, and burning sensation.
Slovenian: Med najpogostejšimi manifestacijami teh dogodkov so bile bolečine, eritem, oteklost, srbenje in pekoč občutek.
English: If appropriate, they will then provide training to show you or your caregiver the correct way to use Nucala.
Slovenian: Če je primerno, vam bosta zagotovila usposabljanje, na katerem se boste vi ali vaš negovalec naučili pravilno uporabiti zdravilo Nucala.
English: Any unused concentrate or solution remaining after 8 hours must be discarded.
Slovenian: Ves neporabljeni koncentrat oz. vso neporabljeno raztopino, ki ostane po 8 urah, je treba zavreči.
English: Pre-bronchodilator FEV1 (mL) at week 32
Slovenian: FEV1 pred bronhodilatatorjem (ml) 32. teden
English: • upper abdominal pain (stomach pain or discomfort in the upper area of the stomach)
Slovenian: • bolečine v zgornjem delu trebuha (bolečine v trebuhu ali nelagodje v zgornjem delu trebuha),
English: Mepolizumab inhibits the bioactivity of IL-5 with nanomolar potency by blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival of eosinophils.
Slovenian: Mepolizumab zavira bioaktivnost IL-5 z nanomolarno potenco tako, da blokira vezavo IL-5 na alfa-verigo IL-5 receptorskega kompleksa, izraženega na površini eozinofilnih celic; s tem zavre signalizacijo z IL-5 in zmanjša nastajanje in preživetje eozinofilcev.
English: Hold the pen in place to complete your injection
Slovenian: Držite peresnik na mestu, da boste dokončali injiciranje
English: Contents of the pack and other information What Nucala contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Nucala
English: • Remove the needle cap from the syringe by firmly pulling it straight off, extending your hand away from the needle end (as shown).
Slovenian: • Odstranite pokrovček igle z brizge tako, da ga odločno potegnete naravnost dol in iztegnete roko proč od konca igle (kot je prikazano).
English: Do not touch the needle.
Slovenian: Ne dotikajte se igle.
English: Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
Slovenian: Če je treba odmerke kortikosteroidov zmanjšati, mora biti zmanjšanje postopno in mora potekati pod nadzorstvom zdravnika.
English: These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days).
Slovenian: Po navadi se te reakcije pojavijo v nekaj urah po uporabi, v nekaterih primerih pa se lahko pojavijo pozno (tj.
English: As a precautionary measure, it is preferable to avoid the use of Nucala during pregnancy.
Slovenian: Iz previdnosti se je med nosečnostjo bolje izogniti uporabi zdravila Nucala.
English: Table 2 provides the results of the primary and secondary endpoints for patients treated with subcutaneous mepolizumab or placebo.
Slovenian: Preglednica 2 prikazuje rezultate primarnih in sekundarnih opazovanih dogodkov za bolnike, ki so dobivali mepolizumab subkutano ali placebo.
English: If patients become infected whilst receiving treatment with Nucala and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
Slovenian: Če se bolnik okuži med zdravljenjem z zdravilom Nucala in se ne odzove na zdravljenje z antihelmintiki, pride v poštev začasno prenehanje zdravljenja.
English: Open-label extension studies in severe refractory eosinophilic asthma MEA115666 (COLUMBA), MEA115661 (COSMOS) and 201312 (COSMEX)
Slovenian: Odprte podaljšane študije pri težki trdovratni eozinofilni astmi MEA115666 (COLUMBA), MEA115661 (COSMOS) in 201312 (COSMEX)
English: Keep the skin pinched throughout your injection.
Slovenian: Kožo držite stisnjeno med celotnim injiciranjem.
English: Frequency of exacerbations requiring hospitalisation
Slovenian: Pogostnost poslabšanj, ki so zahtevala sprejem v bolnišnico
English: What Nucala is and what it is used for 2.
Slovenian: Kaj je zdravilo Nucala in za kaj ga uporabljamo 2.
English: • To start your injection, push the pen down all the way and keep it held down against your skin.
Slovenian: • Da boste začeli injiciranje, potisnite peresnik do konca dol in ga držite pritisnjenega na kožo.
English: Parasitic infections
Slovenian: Okužbe s paraziti
English: • Take the carton out of the refrigerator.
Slovenian: • Vzemite škatlo iz hladilnika.
English: There are limited pharmacokinetic data available in elderly patients (≥65 years old) across all clinical studies (N=90).
Slovenian: Farmakokinetičnih podatkov za starejše bolnike (≥ 65 let), je v vseh kliničnih študijah skupaj malo (N = 90).
English: For instructions on the reconstitution of the medicinal product before administration, see section 6.6.
Slovenian: Za navodila glede rekonstitucije zdravila pred dajanjem glejte poglavje 6.6.
English: If you may have had a similar reaction to any injection or medicine,
Slovenian: Če ste morda kdaj imeli podobno reakcijo na kakšno injekcijo ali zdravilo,
English: Ask your doctor or pharmacist for advice if necessary.
Slovenian: Če je treba, za nasvet prosite zdravnika ali farmacevta.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj, razen če postopek rekonstitucije preprečuje tveganje za mikrobno kontaminacijo.
English: These may affect up to 1 in 1,000 people: • severe allergic reactions (anaphylaxis)
Slovenian: Pojavijo se lahko pri največ 1 od 1.000 oseb: • hude alergijske reakcije (anafilaksija).
English: • Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
Slovenian: • Poskrbite, da je bat potisnjen do konca dol, dokler zamašek ne doseže dna brizge in je vsa raztopina injicirana.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab.
Slovenian: Encimi citokroma P450, iztočne črpalke in mehanizmi vezave na proteine ne sodelujejo pri očistku mepolizumaba.
English: The trade name (Nucala) and batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Zaščiteno ime (Nucala) in serijska številka uporabljenega zdravila morata biti jasno zabeležena v bolnikovi dokumentaciji.
English: Inspection window (medicine inside)
Slovenian: Okence za ogled (zdravilo znotraj)
English: Nucala may be self-administered by the patient or administered by a caregiver if their healthcare professional determines that it is appropriate, and the patient or caregiver are trained in injection techniques.
Slovenian: Zdravilo Nucala si lahko injicira bolnik sam, ali mu ga injicira negovalec, če zdravnik presodi, da je to primerno, ter če bolnik oziroma negovalec opravita usposabljanje o tehniki injiciranja.
English: Do not inject within 5 cm of your navel (belly button).
Slovenian: Ne injicirajte v predel 5 cm okrog popka.
English: These may affect more than 1 in 10 people: • headache
Slovenian: Pojavijo se lahko pri več kot 1 od 10 oseb: • glavobol.
English: Following repeat subcutaneous administration every 4 weeks, there is approximately a two-fold accumulation at steady state.
Slovenian: Po ponavljajoči se subkutani uporabi na 4 tedne je kopičenje v stanju dinamičnega ravnovesja približno dvakratno.
English: • Clean your injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Slovenian: • Očistite mesto injiciranja tako, da ga obrišete z alkoholnim robčkom in pustite, da se na zraku posuši.
English: For storage conditions after reconstitution of the medicinal product, see section 6.3.
Slovenian: Za pogoje shranjevanja zdravila po rekonstituciji glejte poglavje 6.3.
English: Make sure the white plunger is fully down
Slovenian: Poskrbite, da je bel bat potisnjen do konca dol
English: If a mechanical reconstitution device (swirler) is used to reconstitute Nucala, reconstitution can be accomplished by swirling at 450 rpm for no longer than 10 minutes.
Slovenian: Če za rekonstitucijo zdravila Nucala uporabljate mehanično napravo, je rekonstitucijo mogoče opraviti z vrtenjem s 450 obrati na minuto, a ne več kot 10 minut.
English: This medicine is not intended for use in children below 6 years of age.
Slovenian: To zdravilo ni namenjeno za uporabo pri otrocih, mlajših od 6 let.
English: • Do not remove the needle cap until just before your injection.
Slovenian: • Pokrovček igle odstranite šele tik pred injiciranjem.
English: Talk to your doctor before using this medicine.
Slovenian: Pred uporabo tega zdravila se posvetujte z zdravnikom.
English: If you already have a parasitic infection; it should be treated before you start treatment with Nucala.
Slovenian: Če že imate kakšno okužbo s paraziti, jo je treba zdraviti, preden začnete zdravljenje z zdravilom Nucala.
English: However, in the population pharmacokinetic analysis, there were no indications of an effect of age on the pharmacokinetics of mepolizumab over the age range of 12 to 82 years.
Slovenian: Toda populacijska farmakokinetična analiza ni pokazala, da bi starost vplivala na farmakokinetiko mepolizumaba v starostnem razponu od 12 do 82 let.
English: By blocking the action of this protein, it limits the production of more eosinophils from the bone marrow and lowers the number of eosinophils in the bloodstream and the lungs.
Slovenian: Zavrtje delovanja te beljakovine zmanjša nastajanje eozinofilcev v kostnem mozgu in njihovo število v krvnem obtoku in pljučih.
English: After use, the automatic needle guard is activated and pulls up (retracts) the needle.
Slovenian: Po uporabi se avtomatski ščitnik igle aktivira in potegne
English: Common Rare
Slovenian: pogosti redki
English: Patients were required to have a history of two or more severe asthma exacerbations requiring oral or systemic corticosteroid treatment in the past 12 months and reduced lung function at baseline (pre-bronchodilator FEV1<80% in adults and <90% in adolescents).
Slovenian: Bolniki so morali imeti anamnezo vsaj dveh hudih poslabšanj astme, ki so zahtevala peroralno ali sistemsko zdravljenje s kortikosteroidi, v preteklih 12 mesecih in izhodiščno zmanjšano delovanje pljuč (FEV1 pred bronhodilatatorjem < 80 % pri odraslih in < 90 % pri mladostnikih).
English: The primary endpoint was the frequency of clinically significant exacerbations of asthma and the reductions for both mepolizumab treatment arms compared to placebo were statistically significant (p<0.001).
Slovenian: Primarni opazovani dogodek je bila pogostnost klinično pomembnih poslabšanj astme; zmanjšanje v obeh skupinah z mepolizumabom je bilo v primerjavi s placebom statistično značilno (p < 0,001).
English: You or your caregiver should inject the next dose of Nucala as soon as you remember.
Slovenian: Vi (ali vaš negovalec) morate naslednji odmerek zdravila Nucala injicirati, čim se spomnite.
English: Exacerbation reduction MEA115588 (MENSA) study
Slovenian: Študija zmanjšanja poslabšanj MEA115588 (MENSA)
English: Consistent with the potentially immunogenic properties of protein and peptide therapeutics, patients may develop antibodies to mepolizumab following treatment.
Slovenian: Glede na možno imunogenost beljakovinskih in peptidnih zdravil se lahko bolnikom po zdravljenju pojavijo protitelesa proti mepolizumabu.
English: The two exacerbations studies MEA112997 and MEA115588 enrolled a total of 1192 patients, 60% females, with a mean age of 49 years (range 12- 82).
Slovenian: Dve študiji poslabšanj (MEA112997 in MEA115588) sta skupaj zajeli 1192 bolnikov, 60 % žensk, s povprečno starostjo 49 let (razpon: od 12 do 82).
English: For children aged 6-11 years, contact your doctor who will prescribe the recommended dose of Nucala which will be administered by a nurse or doctor.
Slovenian: Za otroke v starosti od 6 do 11 let se obrnite na zdravnika; predpisal bo priporočen odmerek zdravila Nucala,
English: • Hold the pen with its inspection window facing towards you, so you can see it, and with the yellow needle guard facing down.
Slovenian: • Držite peresnik tako, da je okence za ogled obrnjeno k vam in ga lahko vidite, in da rumeni ščitnik igle gleda dol.
English: Table 4: Results of the primary and secondary endpoints in MEA115575
Slovenian: Preglednica 4: Rezultati primarnih in sekundarnih opazovanih dogodkov v študiji MEA115575
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the patient file.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba ime in številko serije uporabljenega zdravila jasno zabeležiti v bolnikovi dokumentaciji.
English: There are limited pharmacokinetic data available in the paediatric population (59 subjects with eosinophilic esophagitis, 55 subjects with severe refractory eosinophilic asthma).
Slovenian: Farmakokinetičnih podatkov za pediatrično populacijo je malo (59 preiskovancev z eozinofilnim ezofagitisom, 55 preiskovancev s težko trdovratno eozinofilno astmo).
English: Hypersensitivity reactions (systemic allergic)*
Slovenian: Bolezni imunskega sistema preobčutljivostne reakcije (sistemske alergijske)* anafilaksija**
English: There are limited data available in patients with creatinine clearance values <50 mL/min.
Slovenian: Podatkov o bolnikih z očistkom kreatinina < 50 ml/min je malo.
English: No decrease in OCS/lack of asthma control/ withdrawal from treatment Odds ratio (95% CI) p-value
Slovenian: Brez zmanjšanja PKS/odsotnost urejenosti astme/umik iz zdravljenja Razmerje obetov (95 % IZ) Vrednost p
English: Mepolizumab 100 mg (subcutaneous) N= 194
Slovenian: mepolizumab 100 mg (subkutano) N = 194
English: Patients continued to receive their existing asthma medicine during the studies.
Slovenian: V obeh študijah so bolniki nadaljevali z uporabo svojega dotedanjega zdravila za astmo.
English: Paediatric pharmacokinetics was largely predictable from adults, after taking into account bodyweight.
Slovenian: Pediatrična farmakokinetika je bila v veliki meri predvidljiva na podlagi farmakokinetike pri odraslih, upoštevaje telesno maso.
English: Reconstitution is typically complete within 5 minutes after the sterile water has been added, but it may take additional time.
Slovenian: Rekonstitucija je praviloma dokončana v 5 minutah po dodatku sterilne vode,
English: Eosinophils are thought to be associated with immune system responses to some parasitic infections.
Slovenian: Eozinofilci so domnevno povezani z odzivom imunskega sistema na nekatere okužbe s paraziti.
English: This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
Slovenian: To bo omogočilo, da se bat dvigne in da se igla umakne (dvigne)
English: • chest tightness, cough, difficulty breathing
Slovenian: • tiščanje v prsnem košu, kašelj, težko dihanje,
English: The potential for interactions with mepolizumab is therefore considered low.
Slovenian: Možnost za medsebojno delovanje zdravil z mepolizumabom je zato majhna.
English: In the population pharmacokinetic analysis estimated mepolizumab systemic clearance was 3.1 mL/day/kg.
Slovenian: Sistemski očistek mepolizumaba, ocenjen v populacijski farmakokinetični analizi, je bil 3,1 ml/dan/kg.
English: • Place the pen straight onto your injection site with the yellow needle guard flat against the surface of your skin, as shown.
Slovenian: • Položite peresnik naravnost na mesto injiciranja, z rumenim ščitnikom igle plosko na površini kože, kot je prikazano.
English: Data in cynomolgus monkeys demonstrate that mepolizumab crossed the placenta.
Slovenian: Podatki pri opicah cynomolgus kažejo, da mepolizumab prehaja skozi placento.
English: ≥500 cells/µL
Slovenian: ≥500 celic/µl n
English: Other medicines and Nucala
Slovenian: Druga zdravila in zdravilo Nucala
English: Note: The reconstituted solution must not be shaken during the procedure as this may lead to product foaming or precipitation.
Slovenian: Opomba: Rekonstituirane raztopine med postopkom ne smete pretresati, ker to lahko povzroči penjenje ali precipitacijo zdravila.
English: Store in a refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2-8 °C).
English: The proportion of patients on maintenance OCS was 31% and 24%, respectively.
Slovenian: V prvi študiji je vzdrževalne PKS uporabljalo 31 % bolnikov in v drugi 24 %.
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg dose, i.e., it is essentially “sodiumfree”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 100-mg odmerek, kar v bistvu pomeni "brez natrija".
English: In a combined analysis of these studies, a 40% reduction in clinically significant exacerbations was observed in adolescents following mepolizumab treatment compared to placebo (rate ratio 0.60; 95% CI: 0.17, 2.10).
Slovenian: V kombinirani analizi teh študij so pri mladostnikih po uporabi mepolizumaba opažali 40 % manj klinično pomembnih poslabšanj kot s placebom (razmerje deležev 0,60, 95 % IZ: 0,17, 2,10).
English: 1st “Click”
Slovenian: “klik”
English: Do not lift the pen from your skin at this stage, as that may mean you don't get your full dose of medicine.
Slovenian: V tej fazi peresnika ne dvigajte s kože, saj se sicer lahko zgodi, da ne boste dobili celotnega odmerka zdravila.
English: MEA115575 evaluated the effect of mepolizumab 100 mg administered subcutaneously on reducing the requirement for maintenance oral corticosteroids (OCS) while maintaining asthma control in subjects with severe refractory eosinophilic asthma.
Slovenian: Študija MEA115575 je ocenila učinek 100 mg mepolizumaba, uporabljenega subkutano, na zmanjšanje potrebe po vzdrževalnih peroralnih kortikosteroidih (PKS) med vzdrževanjem urejenosti astme pri bolnikih s težko trdovratno eozinofilno astmo.
English: Worsening asthma
Slovenian: Poslabšanje astme
English: Based on population pharmacokinetic analyses, no dose adjustment is required in patients with creatinine clearance values between 50-80 mL/min.
Slovenian: Na podlagi populacijske farmakokinetične analize bolnikom z očistkom kreatinina med 50 in 80 ml/min odmerka ni treba prilagoditi.
English: Intravenous and subcutaneous administration to monkeys was associated with reductions in peripheral and lung eosinophil counts, with no toxicological findings.
Slovenian: Intravenska in subkutana uporaba pri opicah sta bili povezani z zmanjšanjem perifernega števila eozinofilcev in števila eozinofilcev v pljučih, brez toksikoloških ugotovitev.
English: Animal studies showed no adverse effects of anti-IL5 treatment on fertility (see section 5.3).
Slovenian: Študije na živalih niso pokazale neželenih učinkov zdravil proti IL5 na plodnost (glejte poglavje 5.3).
English: This condition is called eosinophilic asthma - the type of asthma Nucala can treat.
Slovenian: To bolezen imenujemo eozinofilna astma - to je vrsta astme, ki jo lahko zdravi zdravilo Nucala.
English: Lyophilised white powder.
Slovenian: Liofiliziran bel prašek.
English: Secondary endpoints (weeks 20-24)
Slovenian: Sekundarni opazovani dogodki (20.
English: The reduction rate with mepolizumab was greater in patients with higher blood eosinophil counts.
Slovenian: Delež zmanjšanj je bil z mepolizumabom večji pri bolnikih z večjim številom eozinofilcev v krvi.
English: • fainting, dizziness, feeling lightheaded (due to a drop in blood pressure)
Slovenian: • omedlevica, omotica, vrtoglavica (zaradi znižanja krvnega tlaka),
English: Studies conducted in mice treated with anti-IL-5 antibodies or genetically deficient in IL-5 or eosinophils have not shown impaired ability to clear parasitic infections.
Slovenian: Študije pri miših, ki so dobivale protitelesa proti IL-5, ali jim je genetsko primanjkovalo IL-5 ali eozinofilcev, niso odkrile slabše sposobnosti za odpravo okužb s paraziti.
English: In patients with asthma the absolute bioavailability of mepolizumab administered subcutaneously in the arm ranged from 74-80%.
Slovenian: Pri bolnikih z astmo je bila absolutna biološka uporabnost mepolizumaba, injiciranega subkutano v roko, od 74 do 80 %.
English: Mepolizumab is a humanized IgG1 monoclonal antibody degraded by proteolytic enzymes which are widely distributed in the body and not restricted to hepatic tissue.
Slovenian: Mepolizumab je humanizirano monoklonsko protitelo IgG1, ki ga razgradijo proteolitični encimi, ki so v telesu široko porazdeljeni in niso omejeni na jetrno tkivo.
English: Following administration of a single 100 mg subcutaneous dose in healthy subjects, mepolizumab systemic exposure was comparable between formulations.
Slovenian: Po subkutani uporabi enkratnega 100-mg odmerka pri zdravih preiskovancih je bila sistemska izpostavljenost mepolizumabu med oblikami primerljiva.
English: Nucala should be prescribed by physicians experienced in the diagnosis and treatment of severe refractory eosinophilic asthma.
Slovenian: Zdravilo Nucala mora predpisati zdravnik, ki ima izkušnje z diagnosticiranjem in zdravljenjem težke trdovratne eozinofilne astme.
English: Nucala is given to you by a doctor, nurse or healthcare professional, as an injection just under the skin (subcutaneously).
Slovenian: Zdravilo Nucala vam bo dal zdravnik, medicinska sestra ali zdravstveni delavec v obliki injekcije tik pod kožo (subkutano).
English: Animal studies do not indicate reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo reproduktivnih toksičnih učinkov (glejte poglavje 5.3).
English: Alternatively, swirling at 1000 rpm for no longer than 5 minutes is acceptable.
Slovenian: Druga možnost je vrtenje s 1000 obrati na minuto, a ne več kot 5 minut.
English: If particulate matter remains in the solution or if the solution appears cloudy or milky, the solution must not be used.
Slovenian: Če v raztopini ostanejo delci, ali če je raztopina motna ali mlečna, je ne smete uporabiti.
English: Eosinophils may be involved in the immunological response to some helminth infections.
Slovenian: Okužbe s paraziti Eozinofilci so lahko vpleteni v imunski odziv na nekatere okužbe s helminti.
English: Primary endpoint Frequency of clinically significant exacerbations
Slovenian: Primarni opazovani dogodek Pogostnost klinično pomembnih poslabšanj