FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical relevance of anti-Xolair antibodies is not well understood.
Slovenian: Klinični pomen protiteles proti zdravilu Xolair ni v celoti pojasnjen.
English: After repeated dosing once every 4 weeks, pre-dose serum free IgE levels remained stable between 12 and 24 weeks of treatment.
Slovenian: Pri večkratnem odmerjanju vsake 4 tedne je raven prostega IgE v serumu pred vsakim odmerjanjem ostajala stabilna od 12 do 24 tednov zdravljenja.
English: • Never leave the syringe where others might tamper with it.
Slovenian: • Injekcijske brizge nikoli ne puščajte ležati naokoli, da ne bi nanjo naleteli drugi ljudje.
English: • Do not open the sealed outer box until you are ready to use this medicine.
Slovenian: • Originalno zaprto zunanjo škatlo odprite šele takrat, ko boste pripravljeni za injiciranje zdravila.
English: In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range.
Slovenian: V kliničnih preskušanjih so imeli le redki bolniki koncentracije trombocitov pod spodnjo mejo okvira normalnih vrednosti laboratorija.
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.
Slovenian: Opomba: notranji del injekcijske brizge je mogoče zavrteti, tako da lahko v preglednem okencu odčitate oznako.
English: Xolair is not indicated for the treatment of these conditions.
Slovenian: Zdravilo Xolair ni indicirano za zdravljenje teh bolezni.
English: How Xolair is used Xolair is used as an injection under your skin (known as a subcutaneous injection).
Slovenian: Kako uporabljati zdravilo Xolair Zdravilo Xolair je treba dati z injekcijo pod kožo (kar imenujemo subkutana injekcija).
English: If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms.
Slovenian: Pri sumu na preveliko odmerjanje je treba bolnika opazovati glede kakršnihkoli patoloških znakov oziroma simptomov.
English: Treatment of atopic subjects with omalizumab resulted in a marked down-regulation of FcRI receptors on basophils.
Slovenian: Zdravljenje atopijskih oseb z omalizumabom je povzročilo znatno zmanjšanje števila receptorjev FcRI na bazofilcih.
English: The population pharmacokinetics of Xolair were analysed to evaluate the effects of demographic characteristics.
Slovenian: Analizirali so populacijsko farmakokinetiko zdravila Xolair, da bi ovrednotili učinke demografskih značilnosti.
English: Use only as directed by a doctor.
Slovenian: Uporabljajte samo po zdravnikovem navodilu.
English: Adults and adolescents ≥12 years of age
Slovenian: Odrasli in mladostniki, stari ≥12 let
English: Medicinal product or vaccine interaction studies have not been performed with Xolair.
Slovenian: Študij interakcij zdravil ali cepiv z zdravilom Xolair niso opravili.
English: Children (6 to <12 years of age)
Slovenian: Otroci (stari 6 do <12 let)
English: Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.
Slovenian: Ker je raztopina nekoliko viskozna, lahko aplikacija raztopine s subkutano injekcijo traja 5-10 sekund.
English: Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively binds to human immunoglobulin E (IgE).
Slovenian: Omalizumab je humanizirano monoklonsko protitelo, pridobljeno iz rekombinantne DNA, ki se selektivno veže na humani imunoglobulin E (IgE).
English: Avoid areas with scars or stretch marks.
Slovenian: Prav tako se izogibajte predelom z brazgotinami ali strijami.
English: Table 5 lists the adverse reactions (events occurring in ≥1% of patients in any treatment group and ≥2% more frequently in any omalizumab treatment group than with placebo (after medical review)) reported with 300 mg in the three pooled phase III studies.
Slovenian: V preglednici 5 so navedeni neželeni učinki (opredeljeni kot dogodki, do katerih je prišlo pri ≥1 % bolnikov v katerikoli od študijskih skupin in najmanj za 2 % bolj pogosto v kateri od skupin z omalizumabom kot pri uporabi placeba (po strokovnem medicinskem pregledu)), o katerih so poročali pri uporabi odmerkov 300 mg v vseh treh študijah faze III.
English: Hold the syringe as shown.
Slovenian: Injekcijsko brizgo primite tako, kot kaže slika.
English: This depends on your body weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in your blood.
Slovenian: To je odvisno od vaše telesne mase in od izvida krvne preiskave, ki jo boste opravili pred začetkom zdravljenja, da bi ugotovili količino IgE v vaši krvi.
English: Caution should be exercised when administering Xolair in these patient populations.
Slovenian: Pri uporabi zdravila Xolair pri teh skupinah bolnikov je potrebna previdnost.
English: The time that the syringe is kept at room temperature (25°C) before use must not exceed 4 hours.
Slovenian: Pred uporabo injekcijske brizge ne puščajte na sobni temperaturi (25 °C) več kot 4 ure.
English: Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Slovenian: Preden izvlečete iglo iz viale, potegnite bat čisto do konca cilindra brizge, da odstranite res vso raztopino iz preobrnjene viale.
English: The antibody is an IgG1 kappa that contains human framework regions with the complementary-determining regions of a murine parent antibody that binds to IgE.
Slovenian: Protitelo je IgG1 kappa, ki vsebuje človeške okvirne predele, med katerimi določeni predeli določajo komplementarnost izhodnega mišjega protitelesa, ki se veže na IgE.
English: Do not stop taking any medicine without talking to your doctor.
Slovenian: Ne prenehajte jemati nobenega zdravila, ne da bi se prej pogovorili s svojim zdravnikom.
English: Xolair is indicated in adults, adolescents and children (6 to <12 years of age).
Slovenian: Zdravilo Xolair je indicirano pri odraslih, mladostnikih in otrocih (starih 6 do <12 let).
English: The definition of the composite endpoint ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause).
Slovenian: Opredelitev sestavljenega cilja opazovanja arterijskih trombemboličnih dogodkov je vključevala možgansko kap, tranzitorno ishemično atako, miokardni infarkt, nestabilno angino pektoris in kardiovaskularno smrt (vključno s smrtjo iz neznanega vzroka).
English: The primary support for safety and efficacy of Xolair in the group aged 6 to <12 years comes from one randomised, double-blind, placebo-controlled, multi-centre trial (study 7).
Slovenian: Najbolj pomembni podatki, ki dokazujejo varnost in učinkovitost zdravila Xolair v skupini bolnikov, starih 6 do <12 let, so rezultati randomiziranega, dvojno slepega, s placebom kontroliranega, multicentričnega preskušanja (študije 7).
English: Driving and using machines It is unlikely that Xolair will affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Malo verjetno je, da bi zdravilo Xolair vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: • Do not remove the needle cap until just before you give the injection.
Slovenian: • Pokrovček igle snemite šele tik pred injiciranjem.
English: Patients with no known history of anaphylaxis may self-inject Xolair or be injected by a caregiver from the 4th dose onwards if a physician determines that this is appropriate (see section 4.4).
Slovenian: Bolniki brez anamneze anfilaksije si lahko od 4. odmerka dalje sami injicirajo zdravilo Xolair oziroma jim ga lahko injicira njihov negovalec, če zdravnik presodi, da je to primerno (glejte poglavje 4.4).
English: Study 7 was a placebo-controlled trial which included a specific subgroup (n=235) of patients as defined in the present indication, who were treated with high-dose inhaled corticosteroids (≥500 µg/day fluticasone equivalent) plus long-acting beta agonist.
Slovenian: Študija 7 je bila s placebom kontrolirano preskušanje, v katerega je bila vključena posebna podskupina bolnikov (N=235) v skladu s sedanjo indikacijo, ki so se zdravili z visokimi odmerki kortikosteroidov za inhaliranje (z odmerkom ≥500 µg flutikazonu enakovrednega zdravila) in sočasno z agonisti adrenergičnih receptorjev beta.
English: Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
Slovenian: Počasi spustite bat in pustite, da zapiralo brizge samodejno pokrije odkrito iglo.
English: Across all three studies, patients reported receiving on average 4 to 6 medications (including H1 antihistamines) for CSU symptoms prior to study enrollment.
Slovenian: Bolniki iz vseh treh študij so poročali, da so pred vključitvijo v študijo prejemali povprečno 4 do 6 zdravil (vključno z zaviralci histaminskih receptorjev H1) za lajšanje simptomov kronične spontane urtikarije.
English: If you have a history of severe allergic reactions (anaphylaxis) unrelated to Xolair you may be more at risk of developing a severe allergic reaction following use of Xolair.
Slovenian: Če ste že kdaj prej imeli hudo alergijsko reakcijo (anafilaksijo), ki ni bila povezana z zdravilom Xolair, lahko pri vas obstaja povečano tveganje za pojav hude alergijske reakcije po uporabi zdravila Xolair.
English: DO NOT USE if the syringe is broken or if the liquid looks distinctly cloudy or distinctly brown, or contains particles.
Slovenian: Injekcijske brizge NE UPORABLJAJTE, če je poškodovana, če je tekočina v njej izrazito motna, izrazito rjave barve ali če vsebuje delce.
English: Read ALL the way through these instructions before injecting.
Slovenian: Pred injiciranjem preberite ta navodila V CELOTI.
English: Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Slovenian: Zdravilo Xolair ni indicirano za zdravljenje akutnih eksacerbacij astme, akutnega bronhospazma ali astmatičnega statusa.
English: Churg-Strauss syndrome and hypereosinophilic syndrome Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
Slovenian: Churg-Straussov sindrom in hipereozinofilni sindrom Pri bolnikih s hudo astmo se v redkih primerih izrazi sistemski hipereozinofilni sindrom ali alergijski eozinofilni granulomatozni vaskulitis (Churg-Straussov sindrom); pri obeh sindromih je običajno zdravljenje s sistemskimi kortikosteroidi.
English: While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).
Slovenian: Čeprav za te bolnike ni priporočeno posebno prilagajanje odmerkov, je treba zdravilo Xolair pri njih uporabljati previdno (glejte poglavje 4.4).
English: If you become pregnant while being treated with Xolair, tell your doctor immediately.
Slovenian: Če zanosite, medtem ko se zdravite z zdravilom Xolair, to nemudoma povejte svojemu zdravniku.
English: It is important that you receive training from your doctor in how to recognise early symptoms of severe allergic reactions, and how to manage these reactions if they occur, before you inject Xolair yourself or before a non-healthcare professional gives you a Xolair injection (see section 3, “How to use Xolair”).
Slovenian: Pomembno je, da vas zdravnik nauči, kako prepoznati zgodnje simptome hude alergijske reakcije in kako je treba ukrepati v primeru, da pride do take reakcije, še preden si zdravilo Xolair injicirate sami oziroma preden vam zdravilo Xolair injicira nekdo, ki ni zdravstveni delavec (glejte poglavje 3, “Kako uporabljati zdravilo Xolair”).
English: If you stop treatment with Xolair
Slovenian: Če ste prenehali uporabljati zdravilo Xolair
English: If you have missed an appointment, contact your doctor or hospital as soon as possible to re-schedule it.
Slovenian: Če ste pozabili priti na obisk k zdravniku, čimprej pokličite svojega zdravnika oziroma v bolnišnico, da vam določijo nov datum obiska.
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).
Slovenian: • Preden začnete pripravljati injekcijsko brizgo za injiciranje, je ne pozabite vzeti iz hladilnika in počakati, da doseže sobno temperaturo (25 °C) (za kar potrebuje približno 20 minut).
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.
Slovenian: • Če zunanja škatla ali plastični ovitek nista originalno zaprta, ne uporabljajte tega zdravila, saj morda ni varno za uporabo.
English: The majority of anaphylactic reactions occurred within the first 3 doses of Xolair.
Slovenian: Do večine anafilaktičnih reakcij je prišlo v okviru prvih treh odmerjanj zdravila Xolair.
English: In studies 3, 4 and 5 patients treated with Xolair had respective reductions in asthma exacerbation rates of 37.5% (p = 0.027), 40.3% (p<0.001) and 57.6% (p<0.001) compared to placebo.
Slovenian: V študijah 3, 4 in 5 se je pri bolnikih, zdravljenih z zdravilom Xolair, pogostnost eksacerbacij astme zmanjšala za 37,5 % (p = 0,027), 40,3 % (p<0,001) in 57,6 % (p<0,001) v primerjavi s placebom.
English: You should not be given Xolair: - if you are allergic to omalizumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Zdravila Xolair ne smete dobiti - če ste alergični na omalizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Patients with asthma
Slovenian: Bolniki z astmo
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.
Slovenian: Ni bilo znakov, da bi se pri sočasni uporabi teh zdravil varnost uporabe omalizumaba razlikovala od znanega varnostnega profila njegove uporabe pri alergijski astmi.
English: Prescribers are advised to periodically reassess the need for continued therapy.
Slovenian: Zdravniki, ki zdravilo predpisujejo, naj občasno ponovno ocenijo ali je nadaljnje zdravljenje še potrebno.
English: Xolair has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis.
Slovenian: Zdravila Xolair niso proučevali pri bolnikih s sindromom hiperimunoglobulina E ali alergijske bronhopulmonalne aspergiloze ali za preprečevanje anafilaktičnih reakcij, vključno s tistimi, ki jih izzove alergija na hrano, atopijski dermatitis ali alergijski rinitis.
English: Patients received Xolair at 75 mg, 150 mg or 300 mg or placebo by subcutaneous injection every 4 weeks for 24 and 12 weeks in studies 1 and 2, respectively, and 300 mg or placebo by subcutaneous injection every 4 weeks for 24 weeks in study 3.
Slovenian: Bolniki so prejemali zdravilo Xolair v odmerku 75 mg, 150 mg oziroma 300 mg ali placebo s subkutanimi injekcijami vsake 4 tedne, in sicer 24 tednov v študiji 1, 12 tednov v študiji 2, v študiji 3 pa so prejemali odmerek 300 mg ali placebo s subkutanimi injekcijami vsake 4 tedne 24 tednov.
English: Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually.
Slovenian: Zmanjšanje odmerjanja kortikosteroidov je treba opraviti pod neposrednim zdravnikovim nadzorom.
English: Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper.
Slovenian: Zasukajte vialo na glavo vsaj za 15 sekund, da se bo lahko tekočina prelila proti zamašku.
English: The mean weekly itch severity scores significantly decreased with a maximum effect around week 12 that was sustained over the 24-week treatment period.
Slovenian: Povprečna ocena izraženosti srbenja v enem tednu se je statistično značilno znižala, pri čemer je bil učinek največji okrog 12. tedna, ohranil pa se je v celotnem 24-tedenskem obdobju zdravljenja.
English: There is no pharmacological reason to expect that commonly prescribed medicinal products used in the treatment of asthma will interact with omalizumab.
Slovenian: Ni farmakološkega razloga za pričakovanje, da bi pogosto predpisovana zdravila, ki se uporabljajo pri zdravljenju astme, medsebojno delovala z omalizumabom.
English: Children 6 to <12 years of age
Slovenian: Otroci, stari 6 do <12 let
English: In a subgroup analysis, patients with pre-treatment total IgE ≥76 IU/ml were more likely to experience clinically meaningful benefit to Xolair.
Slovenian: Pri analizi podskupin je bilo pri bolnikih, ki so imeli pred zdravljenjem celotni IgE ≥76 i.e./ml, verjetneje, da jim bo zdravilo Xolair klinično pomembno koristilo.
English: Table 5 includes results in the study 1 population.
Slovenian: Preglednica 5 vključuje rezultate populacije študije 1.
English: Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Slovenian: Zdravilo Xolair deluje tako, da zavira snov, ki se imenuje imunoglobulin E (IgE), ki ga izdeluje telo.
English: Anaphylactic reactions were rare in clinical trials.
Slovenian: V kliničnih preskušanjih so bile anafilaktične reakcije redke.
English: Table 6 Results of study 1
Slovenian: Preglednica 6 Rezultati študije 1
English: The removable needle cap of this pre-filled syringe contains a derivative of natural rubber latex.
Slovenian: Snemljiv pokrovček igle pri tej napolnjeni injekcijski brizgi vsebuje derivat naravnega lateksa.
English: There is limited clinical experience in re-treatment of patients with omalizumab.
Slovenian: Kliničnih izkušenj s ponovno uvedbo zdravljenja z omalizumabom je malo.
English: Children (under 6 years of age) Xolair should not be given to children under 6 years of age.
Slovenian: Otroci (stari manj kot 6 let) Zdravila Xolair se ne sme dajati otrokom, mlajšim od 6 let.
English: The injections are administered subcutaneously in the deltoid region of the arm, the lower abdomen (but not the area 5 centimetres around the navel) or the thigh.
Slovenian: Injekcije morate aplicirati subkutano v deltoidni predel nadlakta, spodnji del trebuha (vendar ne v oddaljenosti 5 centimetrov ali manj od popka) ali v stegno.
English: In study 6, significantly more severe allergic asthma patients on Xolair were able to reduce their fluticasone dose to 500 micrograms/day without deterioration of asthma control (60.3%) compared to the placebo group (45.8%, p<0.05).
Slovenian: V študiji 6 je značilno več bolnikov s težko alergijsko astmo, ki so se zdravili z zdravilom Xolair, lahko zmanjšalo svoj odmerek flutikazona na 500 mikrogramov/dan, ne da bi se obvladovanje njihove astme poslabšalo (60,3 %), kot v skupini s placebom (45,8 %, p<0,05).
English: Latex-sensitive individuals
Slovenian: Osebe s preobčutljivostjo na lateks
English: The responder rates were: 33% at week 12 and 67% at week 24 for UAS7=0, and 56% at week 12 and 67% at week 24 for UAS7≤6.
Slovenian: Delež odzivnih bolnikov za oceno UAS7=0 je bil po 12 tednih 33 %, po 24 tednih 67 %, za oceno UAS7≤6 pa je bil po 12 tednih 56 %, po 24 tednih pa 67 %.
English: The safety and tolerability of omalizumab were investigated with doses of 75 mg, 150 mg and 300 mg every four weeks in 975 CSU patients, 242 of whom received placebo.
Slovenian: Za oceno varnosti in učinkovitosti omalizumaba so raziskovali uporabo odmerkov 75 mg, 150 mg in 300 mg vsake štiri tedne, in sicer pri 975 bolnikih s kronično spontano urtikarijo, od katerih jih je 242 prejemalo placebo.
English: What Xolair looks like and contents of the pack
Slovenian: Izgled zdravila Xolair in vsebina pakiranja
English: A clinically significant exacerbation was defined as a worsening of asthma symptoms as judged clinically by the investigator, requiring doubling of the baseline inhaled corticosteroid dose for at least 3 days and/or treatment with rescue systemic (oral or intravenous) corticosteroids for at least 3 days.
Slovenian: Klinično pomembna eksacerbacija je bila opredeljena s slabšanjem simptomov astme, zaradi katerih je bilo po presoji raziskovalca vsaj 3 dni treba podvojiti izhodiščni odmerek kortikosteroida za inhaliranje in/ali vsaj 3 dni uporabiti ustreznejše zdravljenje s sistemskimi (peroralnimi ali intravenskimi) kortikosteroidi.
English: Subcutaneous Xolair or placebo were administered as add-on therapy to >1,000 micrograms beclomethasone dipropionate (or equivalent) plus a long-acting beta2-agonist.
Slovenian: Subkutano zdravilo Xolair ali placebo so aplicirali kot dodatno zdravilo k >1.000 mikrogramov beklametazonovega dipropionata (ali ekvivalentu) in agonistu adrenergičnih receptorjev beta2 z dolgotrajnim delovanjem.
English: Patients in the 300 mg treatment groups achieved the highest mean proportion of angioedema-free days from week 4 to week 12, (91.0-96.1%; p<0.001) compared to the placebo groups (88.1-89.2%).
Slovenian: Pri bolnikih v skupinah z odmerkom 300 mg je bil povprečen delež dni brez angioedema od 4. do 12. tedna največji (91,0-96,1 %; p<0,001) za primerjavo s skupinami s placebom (88,1-89,2 %).
English: CARTON CONTAINING 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX)
Slovenian: ŠKATLA ZA POSAMIČNO PAKIRANJE Z 1 VIALO IN 1 AMPULO (VKLJUČNO Z »BLUE BOX« PODATKI)
English: In all three studies the mean weekly itch severity score increased gradually during the 16-week treatment-free follow-up period, consistent with symptom re-occurrence.
Slovenian: V vseh treh študijah se je v 16-tedenskem obdobju spremljanja brez zdravljenja povprečna ocena izraženosti srbenja v enem tednu postopno zviševala, kar se ujema s ponovnim pojavljanjem simptomov.
English: Its use in children under 12 has not been studied.
Slovenian: Uporaba tega zdravila pri otrocih, ki so stari manj kot 12 let, ni bila raziskana.
English: A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to Xolair showed the prevalence of major congenital anomalies was similar (8.1% vs. 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients.
Slovenian: Rezultati prospektivne študije registra nosečnosti (EXPECT) iz podatkov pri 250 nosečnicah z astmo, ki so bile izpostavljene zdravilu Xolair, kažejo, da je prevalenca večjih prirojenih nepravilnosti približno enaka (8,1 % v primerjavi z 8,9 %) pri nosečnicah iz registra EXPECT in pri kontrolnih bolnicah z ujemajočo se diagnozo (zmerna in huda astma).
English: Table 5 Results of study 1
Slovenian: Preglednica 5 Rezultati študije 1
English: However, post-marketing data following a cumulative search in the safety database retrieved a total of 898 anaphylaxis cases.
Slovenian: Pri kumulativnem pregledu baze varnostnih podatkov so med podatki iz obdobja trženja zdravila našli skupaj 898 primerov anafilaksije.
English: Remove the plastic tray from the box and peel back the paper cover.
Slovenian: Plastični ovitek vzemite iz škatle in potegnite z njega papirno krovno plast.
English: Placebo N=163
Slovenian: kategorija pogostnosti placebo N=163
English: The fully reconstituted medicinal product will appear clear to slightly opalescent, colourless to pale brownish-yellow and may have a few small bubbles or foam around the edge of the vial.
Slovenian: Povsem rekonstituirano zdravilo je videti prozorno do rahlo opalescentno, brezbarvno do bledo rjavorumeno obarvano in ima lahko okrog roba viale nekaj majhnih mehurčkov ali pene.
English: Table 6 includes results in the study 1 population.
Slovenian: Preglednica 6 vključuje rezultate populacije študije 1.