FrancophonIA/ELRC3.0 huggingface dataset:
English: Seek medical help immediately if you notice any signs indicating a severe allergic reaction or other serious side effects.
Croatian: Odmah potražite liječničku pomoć ako primijetite bilo kakve znakove koji ukazuju na tešku alergijsku reakciju ili druge ozbiljne nuspojave.
English: In vitro, omalizumab forms complexes of limited size with IgE.
Croatian: In vitro omalizumab stvara komplekse s IgE ograničene veličine.
English: *Omalizumab is a humanised monoclonal antibody manufactured by recombinant DNA technology in a Chinese hamster ovary (CHO) mammalian cell line.
Croatian: * Omalizumab je humanizirano monoklonsko protutijelo proizvedeno tehnologijom rekombinantne DNK iz stanične linije jajnika sisavca kineskog hrčka (CHO).
English: You will be given 1 to 4 injections at a time, either every two weeks, or every four weeks.
Croatian: Dobiti ćete jednu do četiri injekcije, svaka dva ili svaka četiri tjedna.
English: Antibodies to omalizumab have been detected in a low number of patients in clinical trials (see section 4.8).
Croatian: Protutijela na omalizumab otkrivena su u malom broju bolesnika u kliničkim ispitivanjima (vidjeti dio 4.8).
English: Seek medical help immediately if you notice any signs indicating a possible serious side effect.
Croatian: Odmah potražite liječničku pomoć ako primijetite bilo kakve znakove koji ukazuju na moguću ozbiljnu nuspojavu.
English: Results for the 300 mg are available for 9 patients at week 12 and 6 patients at week 24, and show a similar magnitude of response to omalizumab treatment compared to the adult population.
Croatian: Rezultati za 300 mg dostupni su za 9 bolesnika nakon 12 tjedana i za 6 bolesnika nakon 24 tjedna te pokazuju sličan razmjer odgovora na liječenje omalizumabom u usporedbi s odraslom populacijom.
English: The adverse reactions presented are divided into two groups: those identified in the 12-week and the 24-week treatment periods.
Croatian: Navedene nuspojave podijeljene su u dvije skupine: one uočene u 12-tjednom i one uočene u 24-tjednom razdoblju liječenja.
English: Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue France
Croatian: Novartis Pharma S.A.S. Centre de Biotechnologie 8, rue de l'Industrie F-68330 Huningue Francuska
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.
Croatian: Stope osoba s odgovorom bile su: 33% nakon 12 tjedana i 67% nakon 24 tjedna za UAS7=0, te 56% nakon 12 tjedana i 67% nakon 24 tjedna za UAS7≤6.
English: A thin layer of small bubbles may remain at the top of the solution in the syringe.
Croatian: Tanki sloj malih mjehurića smije zaostati na vrhu otopine u štrcaljki.
English: CARTON CONTAINING 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX)
Croatian: KARTONSKA KUTIJA KOJA SADRŽI 1 BOČICU I 1 AMPULU KAO JEDINIČNO PAKIRANJE (UKLJUČUJUĆI PLAVI OKVIR)
English: Omalizumab or placebo administered
Croatian: Primijenjeni omalizumab ili placebo
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”).
Croatian: Važno je da vas Vaš liječnik nauči kako prepoznati rane simptome teških alergijskih reakcija te kako ih zbrinuti ako se pojave, prije nego što sami ubrizgate Xolair ili prije nego što Vam netko tko nije zdravstveni radnik da injekciju Xolaira (vidjeti dio 3., „Kako primjenjivati Xolair”).
English: Read ALL the way through these instructions before injecting.
Croatian: Pročitajte DO KRAJA ove upute prije primjene injekcije.
English: If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
Croatian: U tom slučaju ponavljajte postupak iz točke 4 sve dok u otopini više ne bude vidljivih, gelu sličnih čestica.
English: There was no evidence of an anaphylactic response due to mast-cell degranulation in cynomolgus monkeys.
Croatian: Nije bilo dokaza o anafilaktičkom odgovoru zbog degranulacije mastocita u cynomolgus majmuna.
English: Week 12 Primary Endpoint
Croatian: 12. tjedan Primarna mjera ishoda
English: 12-Week
Croatian: 12-tjedno
English: In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range.
Croatian: U kliničkim ispitivanjima nekoliko bolesnika imalo je broj trombocita ispod donje granice normalnog laboratorijskog raspona.
English: Clean the injection site with an alcohol swab.
Croatian: Očistite mjesto injiciranja alkoholnim tupferom.
English: Overall, 733 patients were treated with omalizumab for up to 12 weeks and 490 patients for up to 24 weeks.
Croatian: Ukupno je 733 bolesnika bilo liječeno omalizumabom tijekom do 12 tjedana, a 490 bolesnika do 24 tjedna.
English: Single intravenous doses up to 4,000 mg have been administered to patients without evidence of dose-limiting toxicities.
Croatian: Pojedinačne intravenske doze do 4000 mg primjenjivane su bolesnicima bez znakova toksičnosti koje bi ograničavale doziranje.
English: Doses of more than 150 mg (Table 1) should be divided across two or more injection sites.
Croatian: Doze veće od 150 mg (Tablica 1) potrebno je podijeliti na dva ili više mjesta primjene injekcije.
English: If a caregiver is giving the injection, the outer upper arms may also be used.
Croatian: Ako njegovatelj daje injekciju, može se upotrijebiti i vanjski dio nadlaktice.
English: The box contains Xolair pre-filled syringe(s) individually sealed in a plastic tray.
Croatian: Kutija sadrži Xolair napunjenu štrcaljku (štrcaljke) pojedinačno zapakirane u plastičnom podlošku.
English: Allergic reactions type I
Croatian: Alergijske reakcije tipa
English: Clinical efficacy and safety in allergic asthma
Croatian: Klinička djelotvornost i sigurnost u alergijskoj astmi
English: While no particular dose adjustment is recommended for these patients, Xolair should be administered with caution (see section 4.4).
Croatian: Iako se kod ovih bolesnika ne preporučuje posebno prilagođavanje doze, Xolair se treba davati s oprezom (vidjeti dio 4.4).
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.
Croatian: Injekcije se primjenjuju supkutano u deltoidno područje nadlaktice, donji dio trbuha (ali ne područje 5 centimetara oko pupka) ili bedro.
English: Xolair is used for the treatment of: - allergic asthma - chronic spontaneous urticaria (CSU)
Croatian: Xolair se koristi za liječenje: - alergijske astme - kronične spontane urtikarije (KSU)
English: The in vitro histamine release from basophils isolated from Xolair-treated subjects was reduced by approximately 90% following stimulation with an allergen compared to pre-treatment values.
Croatian: In vitro oslobađanje histamina iz bazofila izoliranih iz osoba liječenih Xolairom bilo je smanjeno za približno 90% nakon stimulacije alergenom u usporedbi s vrijednostima prije liječenja.
English: Antibodies to omalizumab were detected in some monkeys following repeated subcutaneous or intravenous administration.
Croatian: Protutijela na omalizumab otkrivena su u nekih majmuna nakon ponavljane supkutane ili intravenske primjene.
English: However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic.
Croatian: Međutim, potreban je oprez kod bolesnika s visokim rizikom od helmintijaza, posebno u slučaju putovanja u područja s endemskim helmintijazama.
English: The shelf life includes potential temperature excursions.
Croatian: Rok valjanosti uključuje moguća odstupanja temperature.
English: The safety of omalizumab has been studied in the cynomolgus monkey, since omalizumab binds to cynomolgus and human IgE with similar affinity.
Croatian: Sigurnost omalizumaba ispitivana je u cynomolgus majmuna, budući da se omalizumab veže na IgE cynomolgusa i ljudi sa sličnim afinitetom.
English: P-value vs. placebo *Modified intent-to-treat (mITT) population: included all patients who were randomised and received at least one dose of study medication.
Croatian: P-vrijednost naspram placeba *Modificirana populacija s namjerom liječenja (engl. modified intent-to-treat -mITT): uključivala je sve bolesnike koji su bili randomizirani i primili najmanje jednu dozu ispitivanog lijeka.
English: Multipack comprising 4 packs
Croatian: Višestruko pakiranje koje sadrži 4 pakiranja
English: When the medicinal product is fully dissolved, there should be no visible gel-like particles in the solution.
Croatian: Kada je lijek potpuno otopljen, u otopini ne smije biti vidljivih gelu sličnih čestica.
English: Table 5 Adverse reactions from the pooled CSU safety database (day 1 to week 24) at 300 mg omalizumab
Croatian: Tablica 5 Nuspojave iz objedinjene baze sigurnosnih podataka o KSU-u (od 1. dana do 24. tjedna) uz omalizumab 300 mg
English: - if you have had a previous severe allergic reaction (anaphylaxis) for example resulting from a medicine, an insect bite or food.
Croatian: - ako ste prethodno imali tešku alergijsku reakciju (anafilaksiju), primjerice zbog lijeka, uboda insekta ili hrane.
English: Study 2 assessed the efficacy and safety of Xolair in a population of 312 severe allergic asthmatics which matched the population in study 1.
Croatian: Ispitivanje 2 procjenjivalo je djelotvornost i sigurnost Xolaira u populaciji od 312 bolesnika s teškom alergijskom astmom koji su bili podudarni s populacijom iz studije 1.
English: Patients or caregivers should be instructed to inject the full amount of Xolair according to the instructions provided in the package leaflet.
Croatian: Bolesnike ili njegovatelje potrebno je uputiti da ubrizgaju cjelokupnu količinu Xolaira prema uputama navedenima u uputi o lijeku.
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.
Croatian: Bolesnik ili njegovatelj moraju prethodno biti educirani o pravilnoj tehnici primjene injekcije te prepoznavanja ranih znakova i simptoma ozbiljnih alergijskih reakcija.
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.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja su odgovornost osobe koja primjenjuje lijek, a ne bi smjeli biti dulji od 8 sati pri 2°C do 8°C ili 2 sata pri 25°C.
English: Not known (frequency cannot be estimated from the available data) - Churg-Strauss syndrome or hypereosinophilic syndrome.
Croatian: Nepoznato (učestalost se ne može procijeniti iz dostupnih podatatka) - Churg-Straussov sindrom ili hipereozinofilni sindrom.
English: Available data in non-human primates have shown excretion of omalizumab into milk (see section 5.3).
Croatian: Dostupni podaci u nečovjekolikih primata pokazuju da se omalizumab izlučuje u mlijeko (vidjeti dio 5.3).
English: The maximum recommended dose is 600 mg omalizumab every two weeks.
Croatian: Najveća preporučena doza iznosi 600 mg omalizumaba svaka dva tjedna.
English: The serum concentration required to attain a 50% drop in platelets from baseline in adult cynomolgus monkeys was roughly 4- to 20-fold higher than anticipated maximum clinical serum concentrations.
Croatian: Koncentracija u serumu potrebna za postizanje 50%-tnog pada trombocita prema početnoj vrijednosti u odraslih cynomolgus majmuna bila je otprilike 4 do 20 puta viša od očekivanih najviših kliničkih koncentracija u serumu.
English: Use 1.4 ml and discard the rest.
Croatian: Iskoristiti 1,4 ml, a ostatak baciti.
English: There are no human fertility data for omalizumab.
Croatian: Ne postoje podaci o plodnosti kod ljudi za omalizumab.
English: The corresponding frequency category for each adverse reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1000); very rare (<1/10,000) and not known (cannot be estimated from the available data).
Croatian: Odgovarajuće kategorije učestalosti za svaku nuspojavu temelje se na sljedećem načelu: vrlo često (≥1/10); često (≥1/100 i <1/10); manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i <1/1000); vrlo rijetko (<1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
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).
Croatian: Definicija kompozitnih mjera ishoda ATE obuhvaćaju moždani udar, tranzitornu ishemijsku ataku, infarkt miokarda, nestabilnu anginu te kardiovaskularnu smrt (uključujući smrt nepoznatog uzroka).
English: Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature (leave the syringe in the box to protect it from light).
Croatian: Izvadite kutiju sa štrcaljkom iz hladnjaka i ostavite je neotvorenu oko 20 minuta kako bi dosegnula sobnu temperaturu (ostavite štrcaljku u kutiji radi zaštite od svjetlosti).
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).
Croatian: Primarni podaci koji podupiru sigurnost i djelotvornost Xolaira u skupini od 6 do <12 godina starosti dolaze iz jednog randomiziranog, dvostruko slijepog, placebom kontroliranog multicentričnog ispitivanja (studija 7).
English: In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis.
Croatian: U rijetkim slučajevima bolesnici na terapiji antiastmaticima, uključujući omalizumab, mogu dobiti ili razviti sistemsku eozinofiliju i vaskulitis.
English: The rate of asthma exacerbations requiring treatment with bursts of systemic corticosteroids was the primary endpoint.
Croatian: Stopa egzacerbacija astme koje su zahtijevale liječenje visokim dozama sistemskih kortikosteroida bila je primarni cilj ispitivanja.
English: Adults and adolescents (12 years of age and older)
Croatian: Odrasli i adolescenti (12 godina starosti i više)
English: Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab.
Croatian: Serumska bolest i reakcije poput serumske bolesti, koje su odgođene alergijske reakcije tipa III, uočene su kod bolesnika liječenih humaniziranim monoklonskim protutijelima uključujući i omalizumab.
English: However, if considered appropriate by their doctor, a caregiver may give them their Xolair injection after proper training.
Croatian: Međutim, ako to liječnik smatra primjerenim, njegovatelj im može dati injekciju Xolaira nakon odgovarajuće poduke.
English: Use 0.9 ml and discard the rest.
Croatian: Iskoristiti 0,9 ml, a ostatak baciti.
English: Caution: Keep the syringe out of the sight and reach of children.
Croatian: Upozorenje: Štrcaljku čuvajte izvan pogleda i dohvata djece.
English: The pharmacokinetics of omalizumab are linear at doses greater than 0.5 mg/kg.
Croatian: Farmakokinetika omalizumaba je linearna u dozama većim od 0,5 mg/kg.
English: The physician was able to take into account PEF (peak expiratory flow), day and night time symptoms, rescue medication use, spirometry and exacerbations.
Croatian: Liječnik je mogao uzeti u obzir PEF (engl. peak expiratory flow; vršni ekspiracijski protok), simptome tijekom dana i noći, primjenu lijekova za hitne slučajeve, spirometriju i egzacerbacije.
English: Physician's overall assessment % responders* p-value**
Croatian: Ukupna liječnička procjena % bolesnika s odgovorom * p-vrijednost **
English: The following table gives examples of how many injections of each dose strength you need for a given dose:
Croatian: U tablici u nastavku navedeni su primjeri koliko Vam je injekcija od svake jačine doze (plave i ljubičaste) potrebno za postizanje određene doze:
English: Rare (may affect up to 1 in 1,000 people) - parasitic infection
Croatian: Rijetko (mogu se javiti u manje od 1 na 1000 ljudi) - parazitske infekcije
English: Doubling of body weight approximately doubled apparent clearance.
Croatian: Udvostručenje tjelesne težine približno je udvostručilo prividni klirens.
English: Small bubbles or foam around the edge of the vial are common.
Croatian: Manji mjehurići ili pjena oko rubova bočice su česti.
English: See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts in adults, adolescents and children (6 to <12 years of age).
Croatian: Pogledati Tablicu 1 za shemu konverzije te Tablice 2 i 3 za sheme određivanja doze u odraslih, adolescenata i djece (6 do <12 godina starosti).
English: In addition, a population pharmacokinetic analysis showed no relevant effect of H2 antihistamines and LTRAs on omalizumab pharmacokinetics (see section 5.2).
Croatian: Nadalje, populacijska farmakokinetička analiza nije pokazala nikakav relevantan učinak H2 antihistaminika i antagonista leukotrijenskih receptora na farmakokinetiku omalizumaba (vidjeti dio 5.2).
English: IgE plays a key role in causing allergic asthma.
Croatian: IgE igra ključnu ulogu u pojavi alergijske astme.
English: No studies have been performed in children under 12 years.
Croatian: Nisu provedena ispitivanja u djece mlađe od 12 godina.
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.
Croatian: U sva tri ispitivanja srednji tjedni rezultat za težinu svrbeža povećao se postupno tijekom 16-tjednog razdoblja naknadnog praćenja bez terapije, što je u skladu s ponovnom pojavom simptoma.
English: Xolair does not treat acute asthma symptoms, such as a sudden asthma attack.
Croatian: Xolair ne liječi simptome akutne astme, poput iznenadnog napadaja astme.
English: The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab.
Croatian: Predloženi patofiziološki mehanizam uključuje stvaranje imunokompleksa i njihovo taloženje uslijed razvoja protutijela na omalizumab.
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.
Croatian: Churg-Straussov sindrom i hipereozinofilni sindrom Bolesnici s teškom astmom mogu rijetko oboljeti od sistemskog hipereozinofilnog sindroma ili alergijskog eozinofilnog granulomatoznog vaskulitisa (Churg-Straussov sindrom), a oba se uglavnom liječe sistemskim kortikosteroidima.
English: Look out for signs of allergic reactions and other serious side effects Xolair can potentially cause serious side effects.
Croatian: Pripazite na znakove alergijskih reakcija i drugih ozbiljnih nuspojava Xolair bi mogao uzrokovati ozbiljne nuspojave.
English: In clinical studies in CSU patients, maximum suppression of free IgE was observed 3 days after the first subcutaneous dose.
Croatian: U kliničkim ispitivanjima u bolesnika s KSU-om najveća supresija slobodnog IgE-a bila je uočena 3 dana nakon prve supkutane doze.
English: • Do not remove the needle cap until just before you give the injection.
Croatian: • Ne uklanjajte zatvarač igle do trenutka neposredno prije same primjene injekcije.
English: Since IgE may be involved in the immunological response to some helminth infections, Xolair may indirectly reduce the efficacy of medicinal products for the treatment of helminthic or other parasitic infections (see section 4.4).
Croatian: Budući da IgE mogu biti uključeni u imunološki odgovor na neke infekcije helmintima, Xolair može posredno smanjiti djelotvornost lijekova koji se koriste za liječenje helmintijaza ili drugih infekcija parazitima (vidjeti dio 4.4).
English: Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of Xolair therapy is not recommended.
Croatian: Ne preporučuje se nagli prekid primjene sistemskih ili inhalacijskih kortikosteroida nakon uvođenja terapije Xolairom.
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.
Croatian: Supkutani Xolair ili placebo primjenjivani su kao dodatna terapija uz >1000 mikrograma beklometazon-dipropionata (ili ekvivalenta) s dugodjelujućim beta2-agonistom.
English: Patients with asthma
Croatian: Bolesnici s astmom
English: • Do not use the syringe after the expiry date which is stated on the outer box and syringe label.
Croatian: • Ne upotrebljavajte štrcaljku nakon isteka roka valjanosti koji je naveden na vanjskoj kutiji i naljepnici štrcaljke.
English: Formal carcinogenicity studies have not been conducted with omalizumab.
Croatian: S omalizumabom nisu provedena formalna ispitivanja karcinogenosti.
English: No relevant data was obtained in clinical studies in CSU that would require a modification of the sections below.
Croatian: Nisu dobiveni relevantni podaci iz kliničkih ispitivanja KSU-a koji bi zahtijevali preinaku dijelova u nastavku.
English: What Xolair contains - The active substance is omalizumab.
Croatian: Što Xolair sadrži - Djelatna tvar je omalizumab.
English: Xolair is not indicated for the treatment of these conditions.
Croatian: Xolair nije indiciran za liječenje ovih stanja.
English: Administration of Xolair manufactured as a lyophilised or liquid formulation resulted in similar serum concentration-time profiles of omalizumab.
Croatian: Primjena Xolaira proizvedenog u liofiliziranoj ili tekućoj formulaciji rezultirala je sličnim profilima koncentracije u serumu u ovisnosti o vremenu za omalizumab.
English: The omalizumab group showed greater decreases in beta-agonist rescue medication use than the placebo group at the end of the 52-week treatment period, although the difference between treatment groups was not statistically significant.
Croatian: Skupina liječena omalizumabom pokazala je veća smanjenja u uporabi beta-agonista za hitne slučajeve u odnosu na placebo skupinu na kraju 52-tjednog razdoblja liječenja, iako razlika između terapijskih skupina nije bila statistički značajna.
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.
Croatian: Ako ste ranije imali tešku alergijsku reakciju (anafilaksija) koja nije bila povezana sa Xolairom, u Vas može postojati veći rizik od razvoja teške alergijske reakcije nakon primjene Xolaira.
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.
Croatian: Studija 7 bila je placebom kontrolirano ispitivanje koje je uključivalo specifičnu podskupinu bolesnika (n=235), kao što je definirano u trenutnoj indikaciji, koji su bili liječeni visokim dozama inhalacijskih kortikosteroida (što odgovara ≥500 µg/dan flutikazona) i dugodjelujućim beta-agonistom.
English: Influenza-like illness, swelling arms, weight increase, fatigue *: Very common in children 6 to <12 years of age **: In children 6 to <12 years of age
Croatian: Manje često bolest nalik gripi, oticanje ruku, povećanje tjelesne težine, umor *: vrlo često u djece od 6 do <12 godina starosti **: u djece od 6 do <12 godina starosti