FrancophonIA/ELRC3.0 huggingface dataset:
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
Croatian: Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: These events are commonly associated with the reduction of oral corticosteroid therapy.
Croatian: Ovi događaji su često povezani sa smanjenjem doze oralnih kortikosteroida.
English: The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects.
Croatian: Najviša kumulativna doza primijenjena bolesnicima bila je 44 000 mg tijekom 20-tjednog perioda i ova doza nije rezultirala nikakvim akutnim neželjenim učincima.
English: Oral corticosteroid, theophylline and leukotrienemodifier maintenance therapies were allowed (22%, 27%, and 35% of patients, respectively).
Croatian: Terapije održavanja oralnim kortikosteroidima, teofilinom i leukotrienskim modifikatorima bile su dopuštene (22%, 27%, odnosno 35% bolesnika).
English: This is intended to protect against accidental needlestick injuries.
Croatian: Svrha je toga zaštita od slučajnih ozljeda ubodom igle.
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.
Croatian: Ako Vaš liječnik utvrdi da Vi ili njegovatelj možete primjenjvati injekcije Xolaira kod kuće, liječnik, medicinska sestra ili ljekarnik moraju Vas tome podučiti prije nego date injekciju sebi ili drugima.
English: BOCF (Baseline Observation Carried Forward) was used to impute missing data.
Croatian: Baseline Observation Carried Forward - početno opažanje preneseno nadalje) upotrijebljen je za imputiranje podataka koji nedostaju.
English: There was no evidence that the safety of omalizumab was altered when used with these medicinal products relative to its known safety profile in allergic asthma.
Croatian: Nije bilo dokaza da je sigurnost omalizumaba bila promijenjena kada se koristio s tim lijekovima u odnosu na njegov poznati sigurnosni profil kod alergijske astme.
English: Elderly (65 years of age and older)
Croatian: Starije osobe (65 godina starosti i više)
English: BOCF=baseline observation carried forward; mITT=modified intention-to-treat population
Croatian: BOCF=početno opažanje preneseno nadalje; mITT=modificirana populacija s namjerom liječenja
English: Xolair must not be administered by the intravenous or intramuscular route.
Croatian: Xolair se ne smije primjenjivati intravenskim ili intramuskularnim putem.
English: The side effects caused by Xolair are usually mild to moderate but can occasionally be serious.
Croatian: Nuspojave koje uzrokuje Xolair obično su blage do umjereno jake, ali ponekad mogu biti ozbiljne.
English: Precipitating complexes and complexes larger than one million Daltons in molecular weight are not observed in vitro or in vivo.
Croatian: Precipitirajući kompleksi i kompleksi molekulske mase veće od milijun daltona nisu opaženi in vitro niti in vivo.
English: There are not enough data in this group.
Croatian: Ne postoji dovoljno podataka za ovu skupinu bolesnika.
English: Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk.
Croatian: Imunoglobulini G (IgG) su prisutni u majčinom mlijeku i stoga se očekuje da će omalizumab biti prisutan u majčinom mlijeku.
English: The course, severity, and response to treatment of infections were unaltered (see section 4.4).
Croatian: Tijek, težina i odgovor na liječenje infekcije ostali su nepromijenjeni (vidjeti dio 4.4).
English: To aid in dissolution after completing step 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids.
Croatian: Da se olakša otapanje nakon završetka postupka iz točke 3, nježno vrtjeti bočicu 5-10 sekundi približno svakih 5 minuta, da se otope sve preostale krute čestice.
English: Do not stop taking any asthma medicines without talking to your doctor.
Croatian: Nemojte prestati koristiti niti jedan lijek za astmu bez dogovora sa svojim liječnikom.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution (see section 6.3).
Croatian: S mikrobiološkog stajališta, lijek treba primijeniti odmah nakon rekonstitucije (vidjeti dio 6.3).
English: You will need the injections either every two weeks, or every four weeks.
Croatian: Injekcije će Vam biti potrebne svaka dva ili svaka četiri tjedna.
English: The pathogenesis of SLE is not well understood.
Croatian: Patogeneza SLE još nije dobro poznata.
English: Characteristics in patient populations
Croatian: Karakteristike po populacijama bolesnika
English: Milk levels of omalizumab were 0.15% of the maternal serum concentration.
Croatian: Razine omalizumaba u mlijeku su iznosile 0,15% koncentracije u serumu majke.
English: • Remember to take the syringe out of the refrigerator and allow it to reach room temperature (25°C) before preparing it for injection (it will take about 20 minutes).
Croatian: • Sjetite se izvaditi štrcaljku iz hladnjaka i pustiti je da dosegne sobnu temperaturu (25°C) prije nego što je pripremite za injekciju (za to će trebati oko 20 minuta).
English: Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Croatian: Xolair je indiciran u odraslih, adolescenata i djece (6 do <12 godina starosti).
English: Follow carefully all instructions given by your doctor or nurse.
Croatian: Pažljivo se pridržavajte svih uputa svog liječnika ili medicinske sestre.
English: • Do not use this medicine if either the seal on the outer box or the seal of the plastic tray is broken, as it may not be safe for you to use.
Croatian: • Ne upotrebljavajte ovaj lijek ako su originalno zalijepljena mjesta na vanjskoj kutiji ili na plastičnom podlošku oštećena, jer lijek možda nije siguran za uporabu.
English: For detailed instructions on how to inject Xolair, see “Instructions for use of Xolair pre-filled syringe” at the end of this leaflet.
Croatian: Za detaljne upute za ubrizgavanje Xolaira, vidjeti „Upute za uporabu Xolair napunjene štrcaljke” na kraju ove upute.
English: Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
Croatian: Držeći bočicu u uspravnom položaju, snažno ju vrtjeti (ne tresti) približno 1 minutu, da se prašak jednolično navlaži.
English: No natural rubber latex has to date been detected in the removable needle cap.
Croatian: Do danas nije otkriven prirodni gumeni lateks u uklonjivom zatvaraču igle.
English: In addition, covariate effects were evaluated by analysing the relationship between omalizumab concentrations and clinical responses.
Croatian: Osim toga, učinci kovarijata bili su ocijenjeni analizom odnosa između koncentracija omalizumaba i kliničkih odgovora.
English: Studies 3-5 used exacerbation as primary endpoint, whereas study 6 primarily evaluated inhaled corticosteroid sparing.
Croatian: Studije 3-5 su kao primarni ishod ispitivanja imale egzacerbacije, dok je studija 6 primarno ispitivala uštedu inhalacijskih kortikosteroida.
English: Common * Despite not showing a 2% difference to placebo, injection site reactions were included as all cases were assessed causally related to study treatment.
Croatian: Često * Usprkos tome što ne pokazuju razliku od 2% u odnosu na placebo, reakcije na mjestu primjene injekcije bile su uključene budući da se za sve slučajeve procijenilo da su uzročno povezani s ispitivanim lijekom.
English: Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Croatian: Smanjenje doze kortikosteroida treba se obavljati pod izravnim nadzorom liječnika te, po potrebi, postupno provoditi.
English: If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair should be considered.
Croatian: Ukoliko bolesnici ne reagiraju na preporučeno liječenje antihelminticima, potrebno je razmotriti prekid primjene Xolaira.
English: The first 3 doses are always given by or under the supervision of a healthcare professional (see section 2).
Croatian: Prve 3 doze uvijek daje zdravstveni radnik ili se daju pod njegovim nadzorom (vidjeti dio 2).
English: Xolair may pass into breast milk.
Croatian: Xolair može prijeći u majčino mlijeko.
English: The decision to continue Xolair following the 16-week timepoint, or on subsequent occasions, should be based on whether a marked improvement in overall asthma control is seen (see section 5.1, Physician's overall assessment of treatment effectiveness).
Croatian: Odluku o nastavku primjene Xolaira nakon 16. tjedna, ili u sljedećim prilikama, treba temeljiti na tome je li uočeno značajno poboljšanje u ukupnoj kontroli astme (vidjeti dio 5.1, Ukupna liječnička procjena učinkovitosti liječenja).
English: Patients with IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1).
Croatian: Bolesnici s IgE nižim od 76 IU/ml imaju manju vjerojatnost koristi liječenja (vidjeti dio 5.1).
English: Limited data are available on the use of Xolair in combination with specific immunotherapy (hypo-sensitisation therapy).
Croatian: Postoje ograničeni podaci o uporabi Xolaira u kombinaciji sa specifičnom imunoterapijom (terapija hiposenzibilizacije).
English: Clinical trial data on adolescents (12 to 17 years) included a total of 39 patients, of whom 11 received the 300 mg dose.
Croatian: Podaci iz kliničkih ispitivanja na adolescentima (u dobi od 12 do 17 godina) uključivali su ukupno 39 bolesnika, od kojih je 11 primalo dozu od 300 mg.
English: There are limited data available on the use of Xolair in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
Croatian: Postojeći podaci o primjeni Xolaira u bolesnika starijih od 65 godina su ograničeni, ali ne postoje podaci koji bi upućivali da stariji bolesnici zahtijevaju različito doziranje od mlađih odraslih osoba.
English: Children (6 to 11 years of age) are not expected to self-administer Xolair.
Croatian: Od djece (u dobi od 6 do 11 godina) se ne očekuje da sami primjenjuju Xolair.
English: Furthermore, no genotoxic effects were observed in a separate non-clinical genotoxicity study.
Croatian: Nadalje, nisu bili uočeni genotoksični učinci u zasebnom nekliničkom ispitivanju genotoksičnosti.
English: In controlled clinical trials and during interim analyses of an observational study, a numerical imbalance of ATE was observed.
Croatian: U kontroliranim kliničkim ispitivanjima i tijekom privremenih analiza opažajnog ispitivanja, uočila se brojčana neravnoteža u ATE.
English: Instructions on how to use Xolair are given in the section “Information for the healthcare professional”.
Croatian: Upute o primjeni Xolaira navedene su u dijelu „Informacije za zdravstvene radnike“.
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.
Croatian: Ograničeni podaci u trudnica (između 300-1000 trudnoća) na temelju registra trudnoće i spontanih prijava nakon stavljanja lijeka u promet, ne ukazuju na malformacije ili feto/neonatalnu toksičnost.
English: Adults and adolescents ≥12 years of age
Croatian: Odrasli i adolescenti ≥12 godina starosti
English: There may be a small amount of blood at the injection site.
Croatian: Mala količina krvi može se pojaviti na mjestu primjene.
English: Physician's overall assessment was performed in five of the above studies as a broad measure of asthma control performed by the treating physician.
Croatian: Ukupna liječnička procjena je provedena u pet od gore navedenih ispitivanja kao opsežno mjerenje kontrole astme koje je provodio liječnik.
English: AQL improvement % of patients ≥0.5 improvement p-value * marked improvement or complete control ** p-value for overall distribution of assessment
Croatian: AQL poboljšanje % bolesnika s ≥0,5 poboljšanja p-vrijednost * značajno poboljšanje ili potpuna kontrola ** p-vrijednost za ukupnu raspodjelu procjena
English: Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
Croatian: Polako otpustite klip i pustite da štitnik igle automatski pokrije izloženu iglu.
English: If the wings are touched, the syringe guard may be activated too early.
Croatian: Ako ih dodirnete, štitnik igle mogao bi se prerano aktivirati.
English: The effects of demographic characteristics and other factors on omalizumab exposure were evaluated based on population pharmacokinetics.
Croatian: Učinci demografskih karakteristika i drugih čimbenika na izloženost omalizumabu bili su ocijenjeni na temelju populacijske farmakokinetike.
English: Across all three studies, patients reported receiving on average 4 to 6 medications (including H1 antihistamines) for CSU symptoms prior to study enrollment.
Croatian: U sva tri ispitivanja bolesnici su prijavili primanje prosječno 4 do 6 lijekova (uključujući H1 antihistaminike) za simptome KSU-a prije uključivanja u ispitivanje.
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.
Croatian: Ipak, primjena Xolair otopine za injekciju u napunjenoj štrcaljki u pojedinaca osjetljivih na lateks nije bila ispitivana pa stoga postoji potencijalni rizik od reakcija preosjetljivosti koji se ne može u potpunosti isključiti.
English: IgE may be involved in the immunological response to some helminth infections.
Croatian: IgE može biti uključen u imunološki odgovor kod nekih helmintijaza.
English: The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Croatian: Štrcaljku je potrebno izvaditi iz hladnjaka 20 minuta prije ubrizgavanja kako bi mogla dosegnuti sobnu temperaturu.
English: Children (6 to less than 12 years of age) are not expected to inject Xolair themselves, however, if deemed appropriate by their doctor, a caregiver may give them their Xolair injection after proper training.
Croatian: Od djece (u dobi od 6 do ispod 12 godina) se ne očekuje da si sami daju injekciju Xolaira, međutim, ako to liječnik bude smatrao primjerenim, njegovatelj im može davati injekciju Xolaira nakon odgovarajuće poduke.
English: Multipack comprising 10 packs
Croatian: Višestruko pakiranje koje sadrži 10 pakiranja
English: (autoimmune disease).
Croatian: (autoimuna bolest).
English: Seek medical attention immediately if you notice any signs of the following side effects: Rare (may affect up to 1 in 1,000 people) - Severe allergic reactions (including anaphylaxis).
Croatian: Odmah zatražite liječničku pomoć ako primijetite bilo koje znakove sljedećih nuspojava: Rijetko (mogu se javiti u manje od 1 na 1000 ljudi) - Teške alergijske reakcije (uključujući anafilaksiju).
English: The magnitude of the efficacy outcomes observed at week 24 of treatment was comparable to that observed at week 12:
Croatian: Razmjer ishoda djelotvornosti uočenih u 24. tjednu liječenja bio je usporediv s onim uočenim u 12. tjednu:
English: After the medicine has been injected, the syringe guard will be activated to cover the needle.
Croatian: Nako što se lijek ubrizga, aktivirat će se štitnik igle da pokrije iglu.
English: The three studies enrolled 975 patients aged between 12 and 75 years (mean age 42.3 years; 39 patients 12-17 years, 54 patients ≥65 years; 259 males and 716 females).
Croatian: U ta tri ispitivanja bilo je uključeno 975 bolesnika u dobi od 12 do 75 godina (srednja dob 42,3 godine; 39 bolesnika 12-17 godina, 54 bolesnika ≥65 godina; 259 muškaraca i 716 žena).
English: Therefore Xolair should not be used to treat such symptoms.
Croatian: Stoga se Xolair ne smije primjenjivati za liječenje takvih simptoma.
English: If you become pregnant while being treated with Xolair, tell your doctor immediately.
Croatian: Ako zatrudnite tijekom liječenja Xolairom, o tome odmah obavijestite svog liječnika.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX05
Croatian: Farmakoterapijska skupina: Lijekovi za opstruktivne bolesti dišnih puteva, ostali sustavni lijekovi za opstruktivne bolesti dišnih puteva, ATK oznaka: R03DX05
English: Very common (may affect more than 1 in 10 people) - fever (in children)
Croatian: Vrlo često (mogu se javiti u više od 1 na 10 ljudi) - vrućicu (u djece)
English: The EXPECT study, with 154 infants who had been exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects on the breast-fed infant.
Croatian: Ispitivanje EXPECT, sa 154 dojenčadi koja su bila izložena Xolairu tijekom trudnoće i dojenja, nije ukazivalo na štetne učinke na dojeno dijete.
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Croatian: Dan oralno, imunoglobulin G proteini prolaze intestinalnu proteolizu i imaju slabu bioraspoloživost.
English: Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper.
Croatian: Preokrenuti bočicu na najmanje 15 sekundi, kako bi se otopina spustila prema čepu.
English: Number of injections
Croatian: Broj injekcija
English: Latex-sensitive individuals
Croatian: Pojedinci osjetljivi na lateks
English: 24-Week
Croatian: 24-tjedno
English: 1 vial and 1 ampoule.
Croatian: 1 bočica i 1 ampula.
English: Mean values at the end of the follow-up period were similar to the placebo group, but lower than respective mean baseline values.
Croatian: Srednje vrijednosti na kraju razdoblja praćenja bile su slične onima u placebo skupini, ali niže nego odgovarajuće srednje početne vrijednosti.
English: Medical treatment should be sought and instituted appropriately.
Croatian: Potrebno je zatražiti liječničku pomoć i započeti odgovarajuće liječenje.
English: Baseline IgE (IU/ml)
Croatian: Početni IgE (IU/ml)
English: Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Croatian: Nuspojave zabilježene u post-marketinškom okruženju navedeni su s učestalošću nepoznato (ne može se procijeniti iz dostupnih podataka).
English: After subcutaneous administration, omalizumab is absorbed with an average absolute bioavailability of 62%.
Croatian: Nakon supkutane primjene omalizumab je apsorbiran s prosječnom apsolutnom bioraspoloživošću od 62%.
English: For a 75 mg dose, draw up 0.6 ml into the syringe and discard the remaining solution.
Croatian: Za dozu od 75 mg, izvući 0,6 ml u štrcaljku, a preostalu otopinu odbaciti.
English: How Xolair is used Xolair is used as an injection under your skin (known as a subcutaneous injection).
Croatian: Kako se primjenjuje Xolair Xolair se primjenuje kao injekcija pod kožu (to se naziva supkutanom injekcijom).
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.
Croatian: Ovo je posebno važno ako uzimate: - lijekove za liječenje infekcije uzrokovane parazitima, budući da Xolair može smanjiti učinak tih lijekova, - inhalacijske kortikosteroide i druge lijekove za alergijsku astmu.
English: Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.
Croatian: Na temelju ovih rezultata, za svaku primjenu može biti potrebno 75 do 600 mg Xolaira u 1 do 4 injekcije.
English: The chemical and physical stability of the reconstituted medicinal product have been demonstrated for 8 hours at 2°C to 8°C and for 4 hours at 30°C.
Croatian: Kemijska i fizikalna stabilnost rekonstituiranog lijeka dokazana je tijekom 8 sati pri 2°C do 8°C te tijekom 4 sata pri 30°C.
English: Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Croatian: Omalizumab je DNA-rekombinantno humanizirano monoklonsko protutijelo koje se selektivno veže na humani imunoglobulin E (IgE).
English: Liver elimination of IgG includes degradation in the reticuloendothelial system and endothelial cells.
Croatian: Eliminacija IgG u jetri uključuje razgradnju u retikuloendotelnom sustavu i stanicama endotela.
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).
Croatian: U multivarijantnoj analizi uz kontroliranje dostupnih početnih čimbenika kardiovaskularnog rizika, omjer hazarda bio je 1,32 (95%-tni interval pouzdanosti 0,91-1,91).
English: Omalizumab reduced the rate of asthma exacerbations by 19% (p = 0.153).
Croatian: Omalizumab je smanjio stopu egzacerbacija astme za 19% (p = 0,153).
English: - A caregiver (for example a parent) may also give you your Xolair injection after he or she has received proper training.
Croatian: - Njegovatelj (primjerice roditelj) također Vam može dati Vašu injekciju Xolaira nakon što je primio/la odgovarajuću poduku.
English: Xolair has no or negligible influence on the ability to drive and use machines.
Croatian: Xolair ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Discontinuation of Xolair treatment generally results in a return to elevated free IgE levels and associated symptoms.
Croatian: Prekid liječenja Xolairom općenito rezultira povratom povišenih razina slobodnog IgE i povezanih simptoma.
English: Allergic asthma
Croatian: Alergijska astma
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.
Croatian: • Zatvarač igle na štrcaljki može sadržavati suhu gumu (lateks), s kojom ne bi smjele rukovati osobe osjetljive na tu tvar.
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomised design.
Croatian: Na interpretaciju podataka mogu utjecati metodološka ograničenja ispitivanja koja uključuju malu veličinu uzorka i nerandomizirani dizajn.
English: The results were similar in study 3.
Croatian: Rezultati su bili slični u ispitivanju
English: Of those, 412 patients were treated for up to 12 weeks and 333 patients were treated for up to 24 weeks at the 300 mg dose.
Croatian: Od njih, 412 bolesnika bilo je liječeno do 12 tjedana, a 333 bolesnika bilo je liječeno do 24 tjedna dozom od 300 mg.
English: - if you are travelling to region where infections caused by parasites are common - Xolair may weaken your resistance to such infections.
Croatian: - ako putujete u područje gdje su parazitske infekcije česte - Xolair može oslabiti Vašu otpornost prema takvim infekcijama.
English: You may also use the lower abdomen, but not the area 5 centimetres around the navel (belly button).
Croatian: Možete upotrijebiti i donji dio trbuha, ali ne područje 5 centimetara oko pupka.
English: Note: It is possible to rotate the inner part of the syringe assembly so that the label can be read in the viewing window.
Croatian: Napomena: moguće je okrenuti unutarnji dio sklopa štrcaljke kako bi se u kontrolnom prozorčiću mogla očitati naljepnica.
English: However, post-marketing data following a cumulative search in the safety database retrieved a total of 898 anaphylaxis cases.
Croatian: Ipak, nakon kumulativne pretrage sigurnosnih baza podataka, post-marketinški podaci ukazali su na ukupno 898 slučajeva anafilaksije.
English: Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.
Croatian: Stoga se ponovno određivanje razine IgE tijekom liječenja Xolairom ne može koristiti kao pokazatelj za određivanje doze.