FrancophonIA/ELRC3.0 huggingface dataset:
English: You may see an air bubble, which is normal.
Slovenian: Morda lahko vidite majhen zračni mehurček, kar je normalno.
English: If necessary, the product may be returned to the refrigerator for later use, but this must not be done more than once.
Slovenian: Če je potrebno, je injekcijsko brizgo mogoče ponovno shraniti v hladilnik za kasnejšo uporabo, vendar tega ne smete storiti več kot enkrat.
English: Do not use if solid particles are present.
Slovenian: Ne uporabite ga, če so prisotni trdni delci.
English: Then talk to your doctor to discuss when you should inject the next dose.
Slovenian: Nato se pogovorite z zdravnikom in se posvetujte, kdaj si morate injicirati naslednji odmerek.
English: Note that in some cases it may take longer than 20 minutes for the powder to dissolve completely.
Slovenian: Upoštevajte, da utegne včasih trajati dalj kot 20 minut, da se bo prašek povsem raztopil.
English: Most of the reactions were mild or moderate in severity.
Slovenian: Reakcije so bile večinoma blage ali zmerne.
English: There are not enough data in this group.
Slovenian: V tej starostni skupini ni dovolj podatkov.
English: Training to recognise serious allergic reactions
Slovenian: Učenje prepoznavanja resnih alergijskih reakcij
English: 15 months.
Slovenian: 15 mesecev
English: Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue France
Slovenian: Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue Francija
English: Age, Race/Ethnicity, Gender, Body Mass Index
Slovenian: Starost, rasa/narodnost, spol, indeks telesne mase
English: Whole study 1 population Xolair N=209
Slovenian: Celotna populacija študije 1 Xolair N=209
English: • If you need to give more than one injection for the full dose, choose a different injection site each time you inject.
Slovenian: • Če morate za celotni odmerek dati več kot eno injekcijo, si za to vsakokrat izberite drugo mesto injiciranja.
English: Follow your doctor's instructions.
Slovenian: Upoštevajte navodila svojega zdravnika.
English: The lyophilised medicinal product takes 15-20 minutes to dissolve, although in some cases it may take longer.
Slovenian: Za raztopitev liofiliziranega zdravila je potrebno 15-20 minut, v nekaterih primerih pa lahko tudi več.
English: • Do not inject into areas where the skin is tender, bruised, red, or hard.
Slovenian: • Zdravila ne injicirajte v predele, kjer je koža bolj občutljiva, podpluta, rdeča ali trda.
English: 1 vial and 1 ampoule.
Slovenian: 1 viala in 1 ampula.
English: Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.
Slovenian: Zdravnik se bo z vami pogovoril o koristih in možnih nevarnostih uporabe tega zdravila v nosečnosti.
English: Quality of life scores were measured using the Juniper Asthma-related Quality of Life Questionnaire.
Slovenian: Rezultate kvalitete življenja so vrednotili z uporabo vprašalnika “Juniper Asthma-related Quality of Life Questionnaire”.
English: p-value is derived from ANCOVA t-test.
Slovenian: Vrednost p je pridobljena z ANCOVA t-testom.
English: - It is important to be properly trained on how to inject the medicine before injecting yourself.
Slovenian: - Pomembno je, da ste ustrezno usposobljeni za injiciranje zdravila, preden si ga injicirate sami.
English: No effects on the breast-fed newborns/infants are anticipated.
Slovenian: Učinka na dojene novorojenčke/dojenčke ni pričakovati.
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.
Slovenian: Kemijsko in fizikalno stabilnost rekonstituiranega zdravila so dokazali za 8 ur pri 2 °C do 8 °C in za 4 ure pri 30 °C.
English: Other items you need for your injection:
Slovenian: Dodatni pripomočki, ki jih potrebujete pri injiciranju:
English: Doses should be adjusted for significant changes in body weight (see Tables 2 and 3).
Slovenian: Odmerke je treba prilagajati pomembnim spremembam telesne mase (glejte preglednici 2 in 3).
English: The pathogenesis of SLE is not well understood.
Slovenian: Patogeneza SLE ni dobro pojasnjena.
English: Clinical trial experience of long-term treatment beyond 6 months in this indication is limited.
Slovenian: Kliničnih izkušenj z dolgotrajnim zdravljenjem več kot 6 mesecev za to indikacijo je malo.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji.
English: The shelf life includes potential temperature excursions.
Slovenian: Rok uporabnosti vključuje tudi morebitne temperaturne odklone.
English: Therefore treatment with this formulation is intended to be administered by a healthcare provider only.
Slovenian: Zato je pri zdravljenju s to formulacijo predvideno, da zdravilo aplicira samo zdravstveni delavec.
English: How much you will be given
Slovenian: Koliko zdravila boste prejeli
English: It belongs to a class of medicines called monoclonal antibodies.
Slovenian: Sodi v skupino zdravil, ki jih imenujemo monoklonska protitelesa.
English: Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
Slovenian: Učinkom, o katerih so poročali v obdobju trženja, je pripisana neznana navedba pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov).
English: The dose for adolescents aged 12 years and above is the same as for adults.
Slovenian: Odmerki za mladostnike, ki so stari 12 let ali več, so enaki kot pri odraslih.
English: Important safety information
Slovenian: Pomembni varnostni podatki
English: Total injection volume (ml)
Slovenian: Celotni injicirani volumen (ml)
English: Medical treatment should be sought and instituted appropriately.
Slovenian: Poiskati je treba zdravniško pomoč in ustrezno ukrepati.
English: In addition, covariate effects were evaluated by analysing the relationship between omalizumab concentrations and clinical responses.
Slovenian: Poleg tega so ocenjevali tudi vpliv sospremenljivk z analiziranjem razmerja med koncentracijami omalizumaba in kliničnimi odzivi.
English: The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients.
Slovenian: Pogostnost infestacije s helminti je bila v celotnem kliničnem programu, ki ni bil zasnovan za odkrivanje takih infestacij, manj od 1 na 1.000 bolnikov.
English: This is intended to protect against accidental needlestick injuries.
Slovenian: To je namenjeno zaščiti pred poškodbami zaradi nehotenega vboda z iglo.
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.
Slovenian: O uporabi zdravila Xolair pri bolnikih, starejših od 65 let, so na voljo omejeni podatki, ni pa dokazov, da bi bili pri starejših bolnikih potrebni drugačni odmerki kot pri mlajših odraslih bolnikih.
English: It usually takes between 12 and 16 weeks to have the full effect.
Slovenian: Navadno traja od 12 do 16 tednov, preden se pokaže polni učinek zdravila.
English: Clinical trials have demonstrated that it takes at least 12-16 weeks for Xolair treatment to show effectiveness.
Slovenian: V kliničnih preskušanjih se je izkazalo, da traja vsaj 12-16 tednov, da se pokaže učinkovitost zdravljenja z zdravilom Xolair.
English: For more information about the early signs and symptoms of serious allergic reactions, see section 4.
Slovenian: Za več informacij o zgodnjih znakih in simptomih resnih alergijskih reakcij glejte poglavje 4.
English: Such signs are listed under “Serious side effects” in section 4.
Slovenian: Ti znaki so navedeni v poglavju 4 pod naslovom “Resni neželeni učinki”.
English: From a microbiological point of view, the medicinal product should be used immediately after reconstitution (see section 6.3).
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po rekonstituciji (glejte poglavje 6.3).
English: Treatment duration, monitoring and dose adjustments Xolair is intended for long-term treatment.
Slovenian: Trajanje zdravljenja, spremljanje in prilagajanje odmerkov Zdravilo Xolair je namenjeno dolgotrajnemu zdravljenju.
English: If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
Slovenian: V tem primeru ponavljajte korak 4, dokler v raztopini ni več videti želatinastih delcev.
English: When the medicinal product is fully dissolved, there should be no visible gel-like particles in the solution.
Slovenian: Ko je zdravilo popolnoma raztopljeno, v raztopini ne sme biti več vidnih želatinastih delcev.
English: In addition, doubling of body weight approximately doubled apparent clearance.
Slovenian: Poleg tega je podvojitev telesne mase približno podvojila navidezni očistek.
English: Patients should be informed that such reactions are possible and prompt medical attention should be sought if allergic reactions occur.
Slovenian: Bolnikom moramo povedati, da so takšne reakcije možne, ob pojavu alergijskih reakcij pa morajo poiskati takojšnjo zdravniško pomoč.
English: Intact IgG is also excreted in bile.
Slovenian: Intaktni IgG se izloča tudi v žolč.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX05
Slovenian: Farmakoterapevtska skupina: Zdravila za obstruktivne pljučne bolezni, druga sistemska zdravila za obstruktivne pljučne bolezni, oznaka ATC: R03DX05
English: The course, severity, and response to treatment of infections were unaltered (see section 4.4).
Slovenian: Potek, stopnja izraženosti in odziv na zdravljenje infestacij so bili nespremenjeni (glejte poglavje 4.4).
English: Rare (may affect up to 1 in 1,000 people) - parasitic infection
Slovenian: Redki (lahko se pojavijo pri največ 1 od 1.000 bolnikov) - okužbe s paraziti
English: Most patients were inadequately controlled but were receiving less concomitant asthma therapy than patients in studies 1 or 2.
Slovenian: Pri večini bolnikov je bila bolezen nezadostno kontrolirana, a so dobivali manj spremljajočih zdravil proti astmi kot bolniki v študijah 1 in 2.
English: The following table gives examples of how many injections of each dose strength you need for a given dose:
Slovenian: V naslednji preglednici so navedeni primeri, koliko injekcij posamezne jakosti morate dati za posamezen odmerek:
English: None of these changes were associated with bleeding episodes or a decrease in haemoglobin.
Slovenian: Te spremembe niso bile povezane z epizodami krvavitev ali znižanjem hemoglobina.
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.
Slovenian: Zdravnikovo celotno oceno so uporabili v petih od zgoraj omenjenih študij kot široko merilo obvladovanja astme, opravil pa jo je lečeči zdravnik.
English: BOCF=baseline observation carried forward; mITT=modified intention-to-treat population
Slovenian: BOCF = metoda uporabe izhodiščne vrednosti za nadomeščanje manjkajoče vrednosti (angl. baseline observation carried forward ) ; mITT = modificirana populacija z namenom zdravljenja (angl. modified intention-to-treat population)
English: Number of injections
Slovenian: Število injekcij
English: Oral corticosteroid, theophylline and leukotrienemodifier maintenance therapies were allowed (22%, 27%, and 35% of patients, respectively).
Slovenian: Dovoljeno je bilo vzdrževalno zdravljenje s peroralnimi kortikosteroidi, teofilinom in modifikatorjem levkotriena (22 %, 27 % oziroma 35 % bolnikov).
English: Follow carefully all instructions given by your doctor or nurse.
Slovenian: Skrbno se ravnajte po vseh navodilih, ki vam jih da zdravnik ali medicinska sestra.
English: If you have forgotten to give yourself a dose of Xolair, inject the dose as soon as you remember.
Slovenian: Če ste si pozabili odmeriti zdravilo Xolair, si odmerek injicirajte takoj, ko se spomnite.
English: • The syringe cannot be re-used.
Slovenian: • Injekcijske brizge ne smete ponovno uporabiti.
English: Xolair has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Xolair nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Inspect the syringe.
Slovenian: Preglejte injekcijsko brizgo.
English: After subcutaneous administration, omalizumab is absorbed with an average absolute bioavailability of 62%.
Slovenian: Po subkutani aplikaciji se omalizumab absorbira s povprečno absolutno biološko uporabnostjo 62 %.
English: Doubling of body weight approximately doubled apparent clearance.
Slovenian: Podvojitev telesne mase je približno podvojila navidezni očistek.
English: Note: Depending on the dose prescribed to you by your doctor, you may need to prepare one or more pre-filled syringes, and inject the contents of them all.
Slovenian: Opomba: Glede na to, kako velik odmerek vam bo predpisal zdravnik, boste morali pripraviti eno ali več napolnjenih injekcijskih brizg in injicirati vsebino vseh, ki jih boste pripravili.
English: Based on an estimated exposure of 566,923 patient treatment years, this results in a reporting rate of approximately
Slovenian: Na osnovi ocenjene izpostavljenosti 566.923 bolnikov-let zdravljenja to pomeni pogostnost poročanja približno 0,20 %.
English: When you are ready to use the syringe, wash your hands thoroughly with soap and water.
Slovenian: Ko boste pripravljeni na injiciranje z injekcijsko brizgo, si temeljito umijte roke z milom in vodo.
English: Liver elimination of IgG includes degradation in the reticuloendothelial system and endothelial cells.
Slovenian: Odstranjevanje IgG skozi jetra vključuje razgradnjo v retikuloendotelijskem sistemu in endotelijskih celicah.
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).
Slovenian: Odločitev za nadaljevanje zdravljenja z zdravilom Xolair po 16tedenskem obdobju ali pri nadaljnjih presojah mora temeljiti na izrazitem izboljšanju celotnega obvladovanja astme (glejte poglavje 5.1, Zdravnikova celotna ocena učinkovitosti zdravljenja).
English: For the safety and health of you and others, needles and used syringes must never be re-used.
Slovenian: Iz varnostnih razlogov in za lastno zaščito ter zaščito zdravja drugih ljudi nikoli ne smete ponovno uporabiti že uporabljenih igel in brizg.
English: Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
Slovenian: Držite vialo v pokončnem položaju, približno 1 minuto jo živahno sukajte (ne da bi jo stresali), da se bo prašek enakomerno zmočil.
English: Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.
Slovenian: Pri preprečevanju in zdravljenju teh težav so lahko učinkoviti kortikosteroidi, bolnikom pa je treba naročiti, da poročajo o vseh sumljivih simptomih.
English: • The recommended site is the front of the thighs.
Slovenian: • Priporočeno mesto injiciranja je sprednja stran stegen.
English: IgE plays a key role in causing allergic asthma.
Slovenian: IgE ima ključno vlogo pri povzročanju alergijske astme.
English: Other medicines and Xolair
Slovenian: Druga zdravila in zdravilo Xolair
English: Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk.
Slovenian: Imunoglobulini G (IgG) so prisotni v materinem mleku, zato je v materinem mleku mogoče pričakovati tudi prisotnost omalizumaba.
English: Clinical trial data on adolescents (12 to 17 years) included a total of 39 patients, of whom 11 received the 300 mg dose.
Slovenian: Podatki iz kliničnih študij z mladostniki (starimi od 12 do 17 let) obsegajo skupno 39 bolnikov, od katerih jih je 11 prejemalo odmerek 300 mg.
English: Studies 3-5 used exacerbation as primary endpoint, whereas study 6 primarily evaluated inhaled corticosteroid sparing.
Slovenian: V študijah 3-5 so za primarno končno stanje uporabljali eksacerbacijo, medtem ko so v študiji 6 vrednotili predvsem zmanjšano porabo kortikosteridov za inhaliranje.
English: The general pharmacokinetic characteristics of omalizumab are similar in these populations.
Slovenian: Splošne farmakokinetične lastnosti omalizumaba so v obeh navedenih populacijah podobne.
English: Based on these measurements, 75 to 600 mg of Xolair in 1 to 4 injections may be needed for each administration.
Slovenian: Na podlagi teh meritev utegne biti za vsako aplikacijo potrebnih 75 do 600 mg zdravila Xolair v 1 do 4 injekcijah.
English: IgE may be involved in the immunological response to some helminth infections.
Slovenian: IgE utegne biti vpleten v imunski odziv na nekatere infestacije s helminti.
English: Milk levels of omalizumab were 0.15% of the maternal serum concentration.
Slovenian: Koncentracije omalizumaba v mleku so bile 0,15 % koncentracije v materinem serumu.
English: Xolair may pass into breast milk.
Slovenian: Zdravilo Xolair lahko prehaja v materino mleko.
English: Mean values at the end of the follow-up period were similar to the placebo group, but lower than respective mean baseline values.
Slovenian: Po koncu obdobja spremljanja so bile povprečne vrednosti podobne kot v skupini s placebom, vendar nižje od ustreznih povprečnih izhodiščnih vrednosti.
English: *Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Slovenian: *Omalizumab je humanizirano monoklonsko protitelo, ki ga izdelujejo s tehnologijo rekombinantne DNA v liniji sesalskih celic ovarija kitajskega hrčka (CHO- Chinese hamster ovary).
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.
Slovenian: Po končanem koraku 3 boste pomagali raztopiti prašek z nežnim sukanjem viale za 5-10 sekund približno vsakih 5 minut, da se bo preostala trdna snov raztopila.
English: There may be a small amount of blood at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavi nekaj krvi.
English: Small bubbles or foam around the edge of the vial are common.
Slovenian: Majhni mehurčki ali pena okrog roba viale je nekaj običajnega.
English: Omalizumab reduced the rate of asthma exacerbations by 19% (p = 0.153).
Slovenian: Omalizumab je zmanjšal pogostnost eksacerbacij astme za 19 % (p = 0,153).
English: The side effects caused by Xolair are usually mild to moderate but can occasionally be serious.
Slovenian: Neželeni učinki, ki jih povzroča zdravilo Xolair, so navadno blagi do zmerni, v posameznih primerih pa so lahko resni.
English: Multipack comprising 10 packs
Slovenian: skupno pakiranje, ki vsebuje 10 pakiranj
English: Omalizumab is a man-made protein that is similar to natural proteins produced by the body.
Slovenian: Omalizumab je umetno izdelana beljakovina, podobna naravnim beljakovinam, ki nastajajo v telesu.
English: The pharmacokinetics of omalizumab are linear at doses greater than 0.5 mg/kg.
Slovenian: Farmakokinetika omalizumaba je linearna pri odmerkih, večjih od 0,5 mg/kg.
English: Instructions on how to use Xolair are given in the section “Information for the healthcare professional”.
Slovenian: Navodila za uporabo zdravila Xolair so v poglavju "Informacije za zdravstveno osebje".
English: Patients with IgE lower than 76 IU/ml were less likely to experience benefit (see section 5.1).
Slovenian: Pri bolnikih, ki so imeli IgE nižji od 76 i.e./ml, je bilo manj verjetno, da jim bo to zdravilo koristilo (glejte poglavje 5.1).
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Slovenian: Pri peroralnem dajanju so imunoglobulini G podvrženi intestinalni proteolizi in imajo majhno biološko razpoložljivost.
English: The appropriate dose and frequency of Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg).
Slovenian: Ustrezni odmerek in pogostnost zdravila Xolair se določata z izhodiščnim IgE (i.e./ml), izmerjenim pred začetkom zdravljenja, in s telesno maso (kg).
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomised design.
Slovenian: Na interpretacijo teh podatkov lahko vplivajo metodološke omejitve te študije, med drugim majhnost vzorca in nerandomizirana zasnova.
English: How much to use
Slovenian: Koliko zdravila uporabljati
English: If patients do not respond to recommended anti-helminth treatment, discontinuation of Xolair should be considered.
Slovenian: Če se bolniki ne odzovejo na priporočeno zdravljenje infestacije s helminti, je treba pretehtati možnost ukinitve zdravila Xolair.
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).
Slovenian: V te tri študije je bilo vključenih 975 bolnikov, ki so bili stari od 12 do 75 let (povprečna starost je bila 42,3 let; 39 bolnikov je imelo od 12 do 17 let, 54 bolnikov je imelo najmanj 65 let; 259 je bilo moških in 716 žensk).
English: Elderly (65 years of age and older)
Slovenian: Starejši bolniki (stari 65 let ali več)
English: Doses of more than 150 mg (Table 1) should be divided across two or more injection sites.
Slovenian: Odmerke, ki presegajo 150 mg, (preglednica 1) je treba razdeliti in aplicirati na dveh ali več mestih injiciranja.
English: Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given Xolair.
Slovenian: Bolniki, katerih izhodiščna raven IgE ali telesna masa v kilogramih sta zunaj meja sheme za določanje odmerkov, zdravila Xolair ne smejo dobiti.
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.
Slovenian: Rezultati študije EXPECT s 154 dojenčki, ki so bili izpostavljeni zdravilu Xolair med nosečnostjo ali z dojenjem, niso pokazali neželenih učinkov na dojenega otroka.
English: The adverse reactions presented are divided into two groups: those identified in the 12-week and the 24-week treatment periods.
Slovenian: Navedeni neželeni učinki so razdeljeni v dve skupini, in sicer na tiste, ki so jih ugotavljali v 12-tedenskih študijah, in tiste, ki so jih ugotavljali v 24-tedenskih študijah.
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.
Slovenian: Če ste noseči, menite da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: The product may be kept for a total of 4 hours at 25C.
Slovenian: Zdravilo lahko shranjujete največ 4 ure pri 25 °C.
English: In vitro, omalizumab forms complexes of limited size with IgE.
Slovenian: In vitro omalizumab sestavlja komplekse omejene velikosti z IgE.
English: Clinical efficacy and safety in allergic asthma
Slovenian: Klinična učinkovitost in varnost pri alergijski astmi
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 8 hours at 2°C to 8°C or 2 hours at 25°C.
Slovenian: Če zdravilo ne bo uporabljeno takoj, je za čas hranjenja med uporabo in stanje pred uporabo odgovoren uporabnik, ta čas pa normalno ne bi smel biti daljši od 8 ur pri 2 °C do 8 °C ali daljši od 2 ur pri 25 °C.
English: The patient or the caregiver must have been trained in the correct injection technique and the recognition of the early signs and symptoms of serious allergic reactions.
Slovenian: Bolnika oziroma negovalca je treba pred tem naučiti ustrezne tehnike injiciranja in prepoznavanja zgodnjih znakov in simptomov resne alergijske reakcije.