FrancophonIA/ELRC3.0 huggingface dataset:
English: A separate table (Table 5) shows the adverse reactions for the CSU indication resulting from differences in dosages and treatment populations (with significantly different risk factors, comorbidities, co-medications and ages [e.g. asthma trials included children from 6-12 years of age]).
Croatian: Zasebna tablica (Tablica 5) navodi nuspojave za indikaciju KSU-a koje su bile rezultat razlika u dozama i među liječenim populacijama (sa značajno različitim rizičnim čimbenicima, komorbiditetima, istodobno primjenjivanim lijekovima i dobi [npr. ispitivanja astme uključivala su djecu u dobi od 6-12 godina]).
English: Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Croatian: Simptomi koji upućuju na serumsku bolest uključuju artritis/artralgije, osip (urtikarija ili drugi oblici), vrućicu i limfadenopatiju.
English: Frequency categories are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000).
Croatian: Učestalost je definirana kao: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), rijetko (≥1/10 000 i <1/1000) i vrlo rijetko (<1/10 000).
English: In all five studies a significantly greater proportion of Xolair treated patients were judged to have achieved either a marked improvement or complete control of their asthma compared to placebo patients.
Croatian: U svih pet ispitivanja utvrđeno je da je značajno veći udio bolesnika liječenih Xolairom postigao ili značajno poboljšanje ili potpunu kontrolu astme u usporedbi s bolesnicima na placebu.
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.
Croatian: Prije vađenja igle iz bočice povući klip sasvim natrag do kraja tijela štrcaljke, kako bi se izvukla sva otopina iz preokrenute bočice.
English: No pattern of persistent decrease in platelet counts, as observed in non-human primates (see section 5.3), has been reported in humans (patients above 6 years of age), even though isolated cases of idiopathic thrombocytopenia, including severe cases, have been reported in the post-marketing setting.
Croatian: Nije zabilježen obrazac trajnog sniženja broja trombocita u ljudi (bolesnici stariji od 6 godina) kao što je to opaženo u nečovjekolikih primata (vidjeti dio 5.3), iako su u postmarketinškim uvjetima zabilježeni izolirani slučajevi idiopatske trombocitopenije, uključujući teške slučajeve.
English: Use immediately after reconstitution (may be stored at 2°C - 8°C for up to 8 hours or at 25°C for 2 hours).
Croatian: Primijeniti odmah nakon pripreme otopine (može se čuvati do 8 sati pri 2˚C - 8˚C ili do 2 sata pri 25˚C).
English: In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy.
Croatian: U tih bolesnika liječnici trebaju pripaziti na razvoj izražene eozinofilije, vaskulitičnog osipa, pogoršanja plućnih simptoma, abnormalnosti paranazalnih sinusa, srčanih komplikacija i/ili neuropatije.
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.
Croatian: Sigurnost i podnošljivost omalizumaba ispitivane su s dozama od 75 mg, 150 mg i 300 mg svaka četiri tjedna u 975 oboljelih od KSU-a, od kojih je 242 primalo placebo.
English: However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Croatian: Međutim, ispitivanja na životinjama ne ukazuju na izravan ili neizravan štetan učinak na reprodukciju (vidjeti dio 5.3).
English: The clinical relevance of anti-Xolair antibodies is not well understood.
Croatian: Klinički značaj protutijela na Xolair nije dobro poznat.
English: Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of omalizumab; thus, there is little potential for drug-drug interactions.
Croatian: U klirens omalizumaba nisu uključeni citokrom P450 enzimi, pumpe za izbacivanje i mehanizmi vezanja proteina, stoga ima malo mogućnosti za interakcije tipa lijek-lijek.
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.
Croatian: Tablica 5 navodi nuspojave (događaje koji se javljaju u ≥1% bolesnika u bilo kojoj terapijskoj skupini i ≥2% češće u bilo kojoj terapijskoj skupini koja je primala omalizumab nego uz placebo (nakon medicinske revizije)) zabilježene uz 300 mg u tri objedinjena ispitivanja faze III.
English: Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, even after a long duration of treatment.
Croatian: Lokalne ili sustavne alergijske reakcije tipa I, uključujući anafilaksiju i anafilaktički šok, mogu se javiti pri uzimanju omalizumaba, čak i nakon dugotrajnog liječenja.
English: Remove the plastic tray from the box and peel back the paper cover.
Croatian: Izvadite plastični podložak iz kutije i odlijepite papirnati pokrov.
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.
Croatian: Prospektivno ispitivanje registra trudnoće (EXPECT) u 250 trudnica s astmom izloženih Xolairu pokazalo je da je prevalencija velikih urođenih anomalija bila slična (8,1% u odnosu na 8,9%) između bolesnica u ispitivanju EXPECT i usporednih bolesnica s istom bolešću (umjerenom i teškom astmom).
English: Treatment with Xolair in this open label study led to a 61% reduction in clinically significant asthma exacerbation rate compared to current asthma therapy alone.
Croatian: U ovom otvorenom ispitivanju liječenje Xolairom dovelo je do 61% smanjenja stope klinički značajne egzacerbacije astme u usporedbi sa samo uobičajenom postojećom terapijom astme.
English: However, if you are being treated for CSU, your doctor may stop Xolair treatment from time to time so that your symptoms can be assessed.
Croatian: Međutim, ako se liječite zbog kronične spontane urtikarije, liječnik Vam može povremeno prekinuti liječenje Xolairom kako bi se mogli procijeniti Vaši simptomi.
English: In addition, doubling of body weight approximately doubled apparent clearance.
Croatian: Osim toga, udvostručenje tjelesne težine približno je udvostručilo prividni klirens.
English: Serum sickness, may include fever and lymphadenopathy
Croatian: Nepoznato serumska bolest, može uključivati vrućicu i limfadenopatiju
English: The removable needle cap of this pre-filled syringe contains a derivative of natural rubber latex.
Croatian: Uklonjivi zatvarač igle na ovoj napunjenoj štrcaljki sadrži derivat prirodnog gumenog lateksa.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Sav neiskorišteni lijek ili otpadni material potrebno je zbrinuti sukladno nacionalnim propisima.
English: In clinical studies Xolair was commonly used in conjunction with inhaled and oral corticosteroids, inhaled short-acting and long-acting beta agonists, leukotriene modifiers, theophyllines and oral antihistamines.
Croatian: U kliničkim ispitivanjima Xolair se obično primjenjivao zajedno s inhalacijskim i oralnim kortikosteroidima, inhalacijskim kratkodjelujućim i dugodjelujućim beta-agonistima, leukotrienskim modifikatorima, teofilinima i oralnim antihistaminicima.
English: Leave the syringe in the box to protect it from light.
Croatian: Ostavite štrcaljku u kutiji radi zaštite od svjetlosti.
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).
Croatian: Bolesnici bez anafilaksije u anamnezi mogu si sami ubrizgati Xolair ili im injekciju može davati njegovatelj od četvrte doze nadalje ako liječnik utvrdi da je to primjereno (vidjeti dio 4.4.).
English: In asthma patients the omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4  1.1 ml/kg/day.
Croatian: U bolesnika s astmom poluvrijeme eliminacije omalizumaba iz seruma prosječno je iznosilo 26 dana, s prividnim klirensom od prosječno 2,4  1,1 ml/kg/dan.
English: After repeated dosing once every 4 weeks, pre-dose serum free IgE levels remained stable between 12 and 24 weeks of treatment.
Croatian: Nakon opetovanog doziranja jednom svaka 4 tjedna razine slobodnog IgE-a u serumu prije doze ostale su stabilne između 12 i 24 tjedana liječenja.
English: • Store this medicine sealed in its outer box to protect it from light.
Croatian: • Čuvajte ovaj lijek originalno zatvorenim u njegovoj vanjskoj kutiji radi zaštite od svjetlosti.
English: Four additional large placebo-controlled supportive studies of 28 to 52 weeks duration in 1,722 adults and adolescents (studies 3, 4, 5, 6) assessed the efficacy and safety of Xolair in patients with severe persistent asthma.
Croatian: Četiri dodatna, velika, placebom kontrolirana, suportivna ispitivanja, s trajanjem od 28 do 52 tjedna na 1722 odrasle osobe i adolescenta (studije 3, 4, 5, 6) procjenjivala su djelotvornost i sigurnost Xolaira u bolesnika s teškom perzistentnom astmom.
English: • Alcohol swab.
Croatian: • Alkoholni tupfer.
English: There is limited clinical experience in re-treatment of patients with omalizumab.
Croatian: Klinička iskustva s ponovnim liječenjem bolesnika omalizumabom su ograničena.
English: Children 6 to <12 years of age
Croatian: Djeca od 6 do <12 godina starosti
English: Powder: white to off-white lyophilisate Solvent: clear and colourless solution
Croatian: Prašak: bijeli do bjelkasti liofilizat Otapalo: bistra i bezbojna otopina
English: Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment.
Croatian: Budući da u klirensu omalizumaba pri kliničkim dozama dominira retikuloendotelni sustav (RES), nije vjerojatno da će se klirens promijeniti zbog oštećenja funkcije bubrega ili jetre.
English: Xolair is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Croatian: Xolair nije indiciran za liječenje akutnih egzacerbacija astme, akutnog bronhospazma ili astmatskog statusa.
English: Based on population pharmacokinetics, distribution of omalizumab was similar in patients with allergic asthma and patients with CSU.
Croatian: Na temelju populacijske farmakokinetike, distribucija omalizumaba bila je slična u bolesnika s alergijskom astmom i bolesnika s KSU-om.
English: Carefully remove the needle cap from the syringe.
Croatian: Pažljivo uklonite zatvarač igle sa štrcaljke.
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.
Croatian: 1. Srednji tjedni rezultati za težinu svrbeža značajno su se smanjili s najvećim učinkom oko 12. tjedna koji se održao tijekom 24-tjednog razdoblja liječenja.
English: Push the needle all the way in to ensure that the medicine can be fully administered.
Croatian: Gurnite iglu do kraja kako biste bili sigurni da se cjelokupna količina lijeka može primijeniti.
English: If clinically needed, the use of Xolair may be considered during pregnancy.
Croatian: Ako je klinički potrebno, može se razmotriti primjena Xolaira tijekom trudnoće.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6 and also information for the healthcare professional section of the package leaflet.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6 te također dio s informacijama za zdravstvenog radnika u Uputi o lijeku.
English: Clinical efficacy and safety in chronic spontaneous urticaria (CSU)
Croatian: Klinička djelotvornost i sigurnost u kroničnoj spontanoj urtikariji (KSU)
English: There is limited experience with self-administration of Xolair powder and solvent for solution for injection.
Croatian: Postoji ograničeno iskustvo u samoprimjeni Xolair praška i otapala za otopinu za injekciju.
English: Table 6 Results of study 1
Croatian: Tablica 6 Rezultati studije 1
English: Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination.
Croatian: Određivanje doze nakon prekida liječenja koje traje manje od godinu dana treba se temeljiti na razinama IgE u serumu koje su dobivene prilikom određivanja početne doze.
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).
Croatian: Odgovarajuća doza i učestalost doziranja Xolaira uvjetovana je početnom IgE vrijednošću (IU/ml) izmjerenom prije početka liječenja, kao i tjelesnom težinom (kg).
English: Following doses of 75 mg, 150 mg or 300 mg every 4 weeks in patients with CSU, trough serum concentrations of omalizumab increased proportionally with the dose level.
Croatian: Nakon doza od 75 mg, 150 mg ili 300 mg svaka 4 tjedna u bolesnika s KSU-om najniže koncentracije omalizumaba u serumu povećale su se proporcionalno razini doze.
English: Subsequently, IgE receptors (FcεRI) on cells down-regulate.
Croatian: Posljedično tome, dolazi do „regulacije prema dolje“ (down-regulation) IgE receptora (FcεRI) na stanicama.
English: If you have missed an appointment, contact your doctor or hospital as soon as possible to re-schedule it.
Croatian: Ako ste propustili planirani termin, čim prije obavijestite svog liječnika ili bolnicu kako biste dogovorili novi termin.
English: Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Croatian: Polako gurajte klip do kraja sve dok glava klipa cijela ne bude između kvačica štitnika igle.
English: Solvent for Xolair Water for injections
Croatian: Otapalo za Xolair voda za injekcije
English: If an anaphylactic or other serious allergic reaction occurs, administration of Xolair must be discontinued immediately and appropriate therapy initiated.
Croatian: Ako dođe do anafilaktičke ili neke druge ozbiljne alergijske reakcije, mora se odmah obustaviti primjena Xolaira i započeti odgovarajuća terapija.
English: Table 4 lists the adverse reactions recorded in clinical studies in the total safety population treated with Xolair by MedDRA system organ class and frequency.
Croatian: Tablica 4 navodi nuspojave zabilježene u kliničkim ispitivanjima u ukupnoj populaciji liječenoj Xolairom u kojoj je ispitivana sigurnost, prema MedDRA klasifikaciji organskih sustava i učestalosti.
English: Keep the plunger fully depressed while you carefully lift the needle straight out from the injection site.
Croatian: Držite klip potisnut do kraja dok pažljivo ravno izvlačite iglu iz mjesta primjene.
English: Because the solution is slightly viscous, it may take 5-10 seconds to administer the solution by subcutaneous injection.
Croatian: Budući da je otopina slabo viskozna, za primjenu otopine putem supkutane injekcije može biti potrebno 5-10 sekundi.
English: These analyses suggest that no dose adjustments are necessary in patients with CSU for age (12-75 years), race/ethnicity, gender, body weight, body mass index, baseline IgE, anti-FcRI autoantibodies or concomitant use of H2 antihistamines or LTRAs.
Croatian: Te analize upućuju na to da nije potrebno prilagođavanje doze u bolesnika s KSU-om glede životne dobi (12-75 godina), rase/etničke pripadnosti, spola, tjelesne težine, indeksa tjelesne mase, početnog IgE-a, anti-FcRI autoantitijela ili istodobne primjene H2 antihistaminika ili antagonista leukotrijenskih receptora.
English: Children (6 to <12 years of age)
Croatian: Djeca (6 do <12 godina starosti)
English: With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.
Croatian: U uspravno postavljenu bočicu na ravnoj površini uvesti iglu i standardnim aseptičkim postupkom prenijeti vodu za injekcije u bočicu koja sadrži liofilizirani prašak, usmjeravajući vodu za injekcije izravno na prašak.
English: Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2).
Croatian: Liječenje Xolairom treba razmotriti samo kod bolesnika s dokazanom IgE (imunoglobulin E) posredovanom astmom (vidjeti dio 4.2).
English: Holding the syringe horizontally, look into the viewing window to check the expiry date printed on the label.
Croatian: Držeći štrcaljku vodoravno, pogledajte kontrolni prozorčić kako biste provjerili rok valjanosti otisnut na naljepnici.
English: Xolair is not recommended for children under 6 years of age.
Croatian: Xolair se ne preporučuje za djecu mlađu od 6 godina.
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.
Croatian: To će ovisiti o Vašoj tjelesnoj težini i o rezultatima krvne pretrage kojom se mjeri količina IgE-a u Vašoj krvi, a koja se provodi prije početka liječenja.
English: Chronic spontaneous urticaria (CSU) You will need two 150 mg injections at a time every four weeks.
Croatian: Kronična spontana urtikarija (KSU) Bit će Vam potrebne dvije injekcije od 150 mg svaka četiri tjedna.
English: Patients with CSU
Croatian: Bolesnici s KSU-om
English: • Cotton ball or gauze.
Croatian: • Pamučna vata ili gaza.
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%).
Croatian: Bolesnici u terapijskoj skupini koja je primala 300 mg postigli su najviši srednji udio dana bez angioedema od 4. do 12. tjedna, (91,0-96,1%; p<0,001) u usporedbi s placebo skupinama (88,1-89,2%).
English: Table 5 Results of study 1
Croatian: Tablica 5 Rezultati studije 1
English: Its use in children under 12 has not been studied.
Croatian: Njegova primjena u djece mlađe od 12 godina nije bila ispitivana.
English: Omalizumab is a man-made protein that is similar to natural proteins produced by the body.
Croatian: Omalizumab je sintetska bjelančevina koja je slična prirodnim bjelančevinama koje proizvodi ljudski organizam.
English: Figure 1 Mean weekly itch severity score over time, study 1 (mITT population)
Croatian: Slika 1 Srednji tjedni rezultat za težinu svrbeža tijekom vremena, ispitivanje 1 (mITT populacija)
English: - Low blood platelet count with symptoms such as bleeding or bruising more easily than normal.
Croatian: - Snižen broj trombocita u krvi sa znakovima poput krvarenja ili lakšeg nastanka modrica nego uobičajeno.
English: All patients were required to have inadequate symptom control, as assessed by a weekly urticaria activity score (UAS7, range 0-42) of ≥16, and a weekly itch severity score (which is a component of the UAS7; range 0-21) of ≥8 for the 7 days prior to randomisation, despite having used an antihistamine for at least 2 weeks beforehand.
Croatian: Svi su bolesnici trebali imati neodgovarajuću kontrolu simptoma, ocijenjenu tjednim rezultatom za aktivnost urtikarije (UAS7, engl. weekly urticaria activity score, raspon 0-42) od ≥16, te tjednim rezultatom za težinu svrbeža (koji je komponenta UAS7; raspon 0-21) od ≥8 tijekom 7 dana prije randomizacije, unatoč tome što su uzimali antihistaminik najmanje 2 tjedna prije toga.
English: In a subgroup analysis, patients with pre-treatment total IgE ≥76 IU/ml were more likely to experience clinically meaningful benefit to Xolair.
Croatian: U analizi podskupine bolesnici s ukupnim IgE ≥76 IU/ml prije liječenja imali su veću vjerojatnost klinički značajne koristi od Xolaira.
English: For all six studies there was a statistically significant improvement from baseline in quality of life scores for Xolair patients versus the placebo or control group.
Croatian: U svih šest ispitivanja primijećeno je statistički značajno povećanje bodova kvalitete života od početnih vrijednosti kod bolesnika liječenih Xolairom u odnosu na placebo ili kontrolnu skupinu.
English: Gently pinch the skin at the injection site and insert the needle as shown.
Croatian: Nježno prstima uhvatite kožu na mjestu primjene u nabor i uvedite iglu kako je prikazano.
English: Table 7 Change from baseline to week 12 in weekly itch severity score, studies 1, 2 and 3 (mITT population*)
Croatian: Tablica 7 Promjena od početne vrijednosti do 12. tjedna u tjednom rezultatu za težinu svrbeža, ispitivanja 1, 2 i 3 (populacija mITT*)
English: Xolair is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, eczema or hay fever because Xolair has not been studied in these conditions.
Croatian: Xolair nije namijenjen za sprječavanje ili liječenje drugih alergijskih stanja, poput iznenadnih alergijskih reakcija, sindroma hiperimunoglobulinemije E (nasljedni imunološki poremećaj), aspergiloze (gljivična bolest pluća), alergije na hranu, alergijskog kožnog osipa ili peludne hunjavice jer Xolair nije bio ispitivan u ovim uvjetima.
English: Mean change from baseline in weekly itch severity score showed a reduction of 8.25 at week 12 and of 8.95 at week 24.
Croatian: Srednja promjena u odnosu na početnu vrijednost u tjednom rezultatu za težinu svrbeža pokazala je smanjenje od 8,25 nakon 12 tjedana te od 8,95 nakon 24 tjedna.
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.
Croatian: Potpuno rekonstituirani lijek je bistar do lagano opalescentan, bezbojan do blijedo smeđkasto-žute boje i može imati malo mjehurića ili pjene oko rubova bočice.
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).
Croatian: U ispitivanju 6 značajno više bolesnika s teškom alergijskom astmom liječenih Xolairom bilo je u mogućnosti smanjiti dozu flutikazona na ≤500 mikrograma/dan bez pogoršanja kontrole astme (60,3%) u usporedbi s placebo skupinom (45,8%, p<0,05).
English: Table 1 Conversion from dose to number of syringes, number of injections and total injection volume for each administration
Croatian: Tablica 1 Konverzija doze u broj štrcaljki, broj injekcija i ukupni injekcijski volumen za svaku primjenu
English: In the final analysis of the observational study, the rate of ATE per 1,000 patient years was 7.52 (115/15,286 patient years) for Xolair-treated patients and 5.12 (51/9,963 patient years) for control patients.
Croatian: U završnoj analizi opažajnog ispitivanja, stopa ATE-a na 1000 bolesnik-godina bila je 7,52 (115/15 286 bolesnik-godina) za bolesnike liječene Xolairom te 5,12 (51/9963 bolesnik-godina) za kontrolne bolesnike.
English: Description of selected adverse reactions pertinent to allergic asthma and CSU indications
Croatian: Opis odabranih nuspojava koji su važni za indikacije alergijske astme i KSU-a
English: One year after discontinuation of Xolair dosing, the IgE levels had returned to pre-treatment levels with no observed rebound in IgE levels after washout of the medicinal product.
Croatian: Jednu godinu nakon prekida primjene Xolaira IgE razine su se vratile na razine prije liječenja, bez uočenog odskoka u IgE razinama nakon uklanjanja lijeka iz organizma.