FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Xolair, including the appropriate precautions to be followed by healthcare professionals and patients.
Croatian: Na temelju tog plana u sažetak opisa svojstava lijeka kao i u uputu o lijeku, za lijek Xolair uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju primjenjivati.
English: Patients with low IgE levels are less likely to benefit from the medicine.
Croatian: Manje je izgledno da će bolesnici s niskim razinama IgE imati koristi od lijeka.
English: The dose of Xolair and how often it is given depend on the level of IgE in the blood and body weight.
Croatian: Doza lijeka Xolair i učestalost primjene ovise o razini IgE u krvi i tjelesnoj težini.
English: Xolair is used to improve the control of severe persistent asthma that is caused by an allergy.
Croatian: Xolair se koristi za poboljšavanje kontrole ozbiljne perzistentne astme uzrokovane alergijom.
English: It is used as an add-on to existing asthma treatment in patients aged six years or over.
Croatian: Primjenjuje se kao dodatak postojećem liječenju protiv astme u bolesnika u dobi od šest godina i starijih.
English: Xolair is a medicine that contains the active substance omalizumab.
Croatian: Xolair je lijek koji sadrži djelatnu tvar omalizumab.
English: What is Xolair?
Croatian: Što je Xolair?
English: The active substance in Xolair, omalizumab, is a monoclonal antibody.
Croatian: Djelatna tvar u lijeku Xolair, omalizumab, je monoklonalno protutijelo.
English: Among the 235 children who were being treated with high doses of inhaled corticosteroids plus a long-acting inhaled beta2 agonist before the start of the study, there was an average of 0.4 exacerbations over the first 24 weeks of treatment in those receiving Xolair, compared with 0.6 in those receiving placebo.
Croatian: Između 235 djece koja su bila liječena velikim dozama inhaliranih kortikosteroida i dugodjelujućim inhaliranim beta2 agonistom prije početka ispitivanja, zabilježeno je prosječno 0,4 eksacerbacija tijekom prvih 24 tjedan liječenja u bolesnika koji su primali Xolair, u usporedbi s 0,6 u onih koji su primili placebo.
English: Xolair treatment should be started by a doctor who has experience in the treatment of severe persistent asthma or chronic spontaneous urticaria.
Croatian: Liječenje lijekom Xolair treba započeti liječnik koji je iskusan u liječenju ozbiljne perzistentne astme ili kronične spontane urtikarije.
English: In the study of patients with severe allergic asthma, there was no difference in the number of asthma exacerbations between Xolair and placebo, but Xolair led to a similar reduction in the number of exacerbations as in previous studies.
Croatian: U ispitivanju bolesnika s ozbiljnom alergijskom astmom, nije bilo razlike u broju astmatičnih eksacerbacija između lijeka Xolair i placeba, no Xolair rezultirao je sličnim smanjenjem u broju eksacerbacija u odnosu na prethodna ispitivanja.
English: The effects of Xolair were greater in patients with severe asthma.
Croatian: Djelovanje lijeka Xolair bilo je veće u bolesnika s ozbiljnijom astmom.
English: For the treatment of asthma, Xolair is given by a healthcare professional as an injection under the skin of the shoulder or the thigh every two or four weeks.
Croatian: Za liječenje astme, zdravstveni djelatnik primjenjuje Xolair kao supkutanu injekciju u rame ili bedro svaka dva ili četiri tjedna.
English: The CHMP decided that Xolair's benefits are greater than its risks and recommended that it be given marketing authorisation.
Croatian: CHMP je odlučio da koristi od lijeka Xolair nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
English: Xolair is also used to treat chronic (long-term) spontaneous urticaria (itchy rash).
Croatian: Xolair se također koristi u liječenju kronične (dugoročne) spontane urtikarije (osipa koji svrbi).
English: In all of the studies, Xolair was compared with placebo (a dummy treatment), when they were added to the patients' existing treatment.
Croatian: U svim ispitivanjima, Xolair je uspoređen s placebom (lažnim liječenjem), u slučaju kada su dodani postojećem liječenju bolesnika.
English: Over the first 28 or 52 weeks of treatment in the first three studies, there were around 0.5 exacerbations per year in the Xolair group and around one per year in the placebo group.
Croatian: Tijekom prvih 28 ili 52 tjedana liječenja u prva tri ispitivanja, u grupi koja je primala lijek Xolair zabilježeno je 0,5 eksacerbacija po godini te otprilike jedna po godini u grupi koja je primala placebo.
English: In patients with chronic spontaneous urticaria, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are sinusitis (inflammation of the sinuses), headache, arthralgia (joint pain), injection site reactions and upper respiratory tract infection (colds).
Croatian: U bolesnika s kroničnom spontanom urtikarijom, najčešće nuspojave od lijeka Xolair (kod između 1 i 10 bolesnika na 100) su sinuzitis (upala sinusa), glavobolja, artralgija (bol u zglobovima), reakcije u mjestu injekcija i infekcija gornjeg respiratornog trakta (prehlade).
English: What benefit has Xolair shown during the studies?
Croatian: Koje su koristi lijeka Xolair dokazane u ispitivanjima?
English: In all of the studies, Xolair was compared with placebo, when they were added to the patients' existing treatment.
Croatian: U svim ispitivanjima, Xolair je uspoređen s placebom u slučaju kada su dodani postojećem liječenju bolesnika.
English: For the treatment of chronic spontaneous urticaria, Xolair is given by a healthcare professional by injection under the skin of the shoulder or the thigh, in a dose of 300 mg every four weeks.
Croatian: Za liječenje kronične spontane urtikarije, zdravstveni djelatnik primjenjuje Xolair kao supkutanu injekciju u rame ili bedro, u dozi od 300 mg svaka četiri tjedna.
English: In the study in children with allergic asthma aged between six and 12 years, the number of exacerbations was lower in those receiving Xolair.
Croatian: U ispitivanju provedenom u djece s alergijskom astmom u dobi između šest i 12 godina, broj eksacerbacija bio je manji u bolesnika koji su primali Xolair.
English: In children aged between six and 12 years, the most common side effects (seen in more than 1 patient in 10) are headache and pyrexia (fever).
Croatian: U djece u dobi između šest godina i 12 godina, najčešće nuspojave (kod između 1 i 10 bolesnika na 100) su glavobolja i pireksija (groznica).
English: What is Xolair used for?
Croatian: Za što se Xolair koristi?
English: Why has Xolair been approved?
Croatian: Zašto je lijek Xolair odobren?
English: In patients with allergic asthma aged 12 years and over, the most common side effects with Xolair (seen in between 1 and 10 patients in 100) are headache and injection site reactions, including swelling, redness, pain and itching.
Croatian: U bolesnika s alergijskom astmom u dobi od 12 godina i onih starijih, najčešće nuspojave od lijeka Xolair (kod između 1 i 10 bolesnika na 100) su glavobolja i reakcije u mjestu injekcije, uključujući i oticanje, crvenilo, bol i svrbež.
English: In the studies in patients with chronic spontaneous urticaria, following 12 weeks of treatment, Xolair 300 mg improved the symptoms of itching by 4.5 to 5.8 points more than placebo.
Croatian: U ispitivanjima bolesnika s kroničnom spontanom urtikarijom, lijek Xolair 300 mg poboljšao je simptome svrbeža za 4,5 do 5,8 poena više u odnosu na placebo nakon 12 tjedana liječenja.
English: In the studies in patients with allergic asthma aged 12 years or over, Xolair reduced the number of exacerbations by around half.
Croatian: U ispitivanjima provedenima na bolesnicima oboljelima od alergijske astme u dobi od 12 godina ili starijih, Xolair je smanjio broj eksacerbacija za otprilike upola.
English: How is Xolair used?
Croatian: Kako se Xolair koristi?
English: By attaching to IgE, omalizumab ‘mops up' the free IgE circulating in the blood.
Croatian: Vezanjem na IgE, omalizumab „čisti“
English: It usually takes 12 to 16 weeks for Xolair to show a benefit.
Croatian: Koristi od lijeka Xolair obično su vidljive nakon 12 do 16 tjedana.
English: How has Xolair been studied?
Croatian: Kako se Xolair ispitivao?
English: How does Xolair work?
Croatian: Kako djeluje Xolair?
English: For the full list of all side effects and restrictions with Xolair, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Xolair, potražite u uputi o lijeku.
English: Sonata will help you to sleep.
Croatian: Sonata će Vam pomoći spavati.
English: They are packed in blisters.
Croatian: Pakirane su u blisterima.
English: As with sleep-driving, patients usually do not remember these events.
Croatian: Kao i kod vožnje u snu, bolesnici se obično ne sjećaju tih događaja.
English: This leaflet was last approved in
Croatian: Ova uputa je zadnji put odobrena u
English: Further, stabilization of circulatory function and intensive monitoring may be required.
Croatian: Nadalje, može biti potrebna stabilizacija cirkulatorne funkcije i intenzivno praćenje.
English: The duration of treatment should usually vary from a few days to two weeks.
Croatian: Trajanje liječenja obično varira od nekoliko dana do dva tjedna.
English: Sonata with food, drink and alcohol
Croatian: Sonata s hranom,pićem i alkoholom
English: Date of latest renewal: 12 March 2009
Croatian: Datum posljednje obnove: 12. ožujka 2009.
English: Ask your pharmacist how to throw away medicines you no longer use.
Croatian: Pitajte svoga ljekarnika kako baciti lijekove koje više ne koristite.
English: This medicine has been prescribed for you.
Croatian: Ovaj je lijek propisan Vama.
English: Sleeping problems do not usually last long, and most people only need a short course of treatment.
Croatian: Problemi sa spavanjem obično ne traju dugo, a većina ljudi treba samo kratkotrajno liječenje.
English: Swallow the capsule(s) with a small glass of water.
Croatian: Kapsulu(e) progutajte uz čašu s malo vode.
English: This includes medicines that can be bought without a prescription.
Croatian: Ovo uključuje lijekove koji se mogu kupiti bez recepta.
English: Just take your next capsule at the usual time, then go on as before.
Croatian: Svoju sljedeću kapsulu uzmite u uobičajeno vrijeme, a zatim nastavite lijek uzimati kao prije.
English: • Rare cases of severe allergic reactions have been reported.
Croatian: • Zabilježeni su rijetki slučajevi teških alergijskih reakcija.
English: Frequencies are defined as
Croatian: Učestalosti su definirane kao
English: The CHMP agrees with the scientific conclusions made by the PRAC.
Croatian: CHMP se slaže sa znanstvenim zaključcima PRAC-a.
English: Use of Sonata is not recommended during pregnancy.
Croatian: Upotreba Sonate nije preporučena tijekom trudnoće.
English: For adults, the recommended dose is 10 mg.
Croatian: Za odrasle, preporučena doza je 10 mg.
English: Psychiatric and “paradoxical” reactions
Croatian: Psihijatrijske i “paradoksalne” reakcije
English: Al. Jana Pawła II nr 15
Croatian: Jana Pawła II nr 15
English: Contact a doctor immediately and say how many capsules you have taken.
Croatian: Odmah se obratite svom liječniku i obavijestite ga koliko ste kapsula uzeli.
English: Any new behavioural sign or symptom requires careful and immediate evaluation.
Croatian: Pojava bilo kojeg novog znaka ili simptoma ponašanja zahtijeva pažljivu i neposrednu evaluaciju.
English: Psychic dependence may occur.
Croatian: Može doći do psihičke ovisnosti.
English: Be aware that such combinations may cause you to feel drowsy the next day.
Croatian: Uzmite u obzir da takve kombinacije mogu uzrokovati osjećaj omamljenosti sljedeći dan.
English: hepatotoxicity (mostly described as transaminase increased)
Croatian: hepatotoksičnost (većinom opisana kao povišene transaminaze)
English: The extent of exposure to zaleplon was similar among all groups.
Croatian: Opseg izloženosti zaleplonu bio je sličan u svim skupinama.
English: • if you are allergic to zaleplon or any of the other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na zaleplon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6)
English: See also below under Depression and Psychiatric and “paradoxical” reactions
Croatian: Također vidjeti u nastavku pod Depresija i Psihijatrijske i “paradoksalne” reakcije
English: It is not recommended that you take Sonata with or immediately after eating a large meal as it may work more slowly.
Croatian: Ne preporučuje se uzimati Sonatu uz ili neposredno nakon konzumiranja velikog obroka jer može sporije djelovati.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave, iako se one neće javiti kod svakoga.
English: Organ/System (Frequency)
Croatian: Organ/Sustav
English: Do not try and catch up on the doses you have missed.
Croatian: Ne pokušavajte nadoknaditi propuštene doze.
English: In these studies, patients were diagnosed with primary (psychophysiological) insomnia.
Croatian: U ovim ispitivanjima bolesnicima je dijagnosticirana primarna (psihofiziološka) nesanica.
English: At least 71% of the orally-administered dose is absorbed.
Croatian: Najmanje 71% peroralno primijenjene doze se apsorbira.
English: The duration of treatment should be as short as possible (see section 4.2), and should not exceed two weeks.
Croatian: Trajanje liječenja mora biti što je moguće kraće (vidjeti dio 4.2) te ne smije premašiti 2 tjedna.
English: Other medicines and Sonata
Croatian: Drugi lijekovi i Sonata
English: Alcohol can increase the undesirable effects of any medicine taken to help you sleep.
Croatian: Alkohol može povećati nuspojave svih lijekova koje ste uzeli da Vam pomognu zaspati.
English: The usual dose for adults is 10 mg just before going to bed, or after you have gone to bed and you are having difficulty falling asleep.
Croatian: Uobičajena doza za odrasle je 10 mg neposredno prije odlaska na spavanje ili nakon što ste već legli u krevet te imate poteškoća s usnivanjem.
English: Concomitant intake with alcohol is not recommended.
Croatian: Ne preporučuje se istodobna primjena s alkoholom.
English: When Sonata is taken with other medicines that act on the brain, the combination may make you more drowsy than it should.
Croatian: Kada se Sonata uzima s drugim lijekovima koji djeluju na mozak, kombinacija Vas može omamiti i više nego bi trebala.
English: Sonata contains lactose.
Croatian: Sonata sadrži laktozu.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Periodička izvješća o neškodljivosti Nositelj odobrenja će periodička izvješća o neškodljivosti za ovaj lijek podnositi u skladu sa zahtjevima navedenim u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Extension beyond these periods should not take place without clinical re-evaluation of the patient.
Croatian: Ovo razdoblje ne smije se produljiti bez ponovne kliničke evaluacije bolesnika.
English: This medicinal product does not require any special temperature storage conditions.
Croatian: Ovaj lijek ne zahtijeva nikakve posebne temperaturne uvjete čuvanja.
English: To reduce the risk, patients should not undertake activities requiring psychomotor co-ordination until 4 hours or more after taking Sonata (see section 4.7).
Croatian: Kako bi se smanjio rizik, bolesnici se ne bi smjeli baviti aktivnostima koje zahtijevaju psihomotornu koordinaciju 4 sata ili duže nakon uzimanja Sonate (vidjeti dio 4.7).
English: Patients should be advised not to take a second dose within a single night.
Croatian: Bolesnike treba savjetovati da ne uzimaju drugu dozu u istoj noći.
English: Children and adolescents (under 18 years of age)
Croatian: Djeca i adolescenti (mlađa od 18 godina)
English: Children and adolescents under 18 years of age must not take Sonata.
Croatian: Djeca i adolescenti mlađi od 18 godina ne smiju uzimati Sonatu.
English: Patients should be advised not to drive or operate machinery until it is established that their performance is not impaired.
Croatian: Bolesnicima se mora savjetovati da ne voze i ne upravljaju strojevima sve dok se ne ustanovi da njihove sposobnosti nisu umanjene.
English: Each pack contains 7, 10 or 14 hard capsules.
Croatian: Svako pakiranje sadrži 7, 10 ili 14 tvrdih kapsula.
English: Some patients have required medical therapy in the emergency department.
Croatian: U nekih bolesnika bila je potrebna terapija lijekovima u odjelu hitne pomoći.
English: These reactions are more likely to occur in the elderly.
Croatian: Vjerojatnost pojave ovih reakcija veća je u starijih osoba.
English: The total daily dose of Sonata should not exceed 10 mg in any patient.
Croatian: Ukupna dnevna doza Sonate ne smije premašiti 10 mg u bilo kojeg bolesnika.
English: If you take more Sonata than you should
Croatian: Ako uzmete više Sonate nego što ste trebali
English: Meda AB Pipers väg 2A S-170 09 Solna Sweden
Croatian: Meda AB Pipers väg 2A S-170 09 Solna Švedska
English: Respiratory insufficiency
Croatian: Respiratorna insuficijencija
English: This can usually be avoided if you remain inactive for at least 4 hours after taking Sonata.
Croatian: Ovo se obično može izbjeći ako 4 sata nakon uzimanja Sonate ostanete neaktivni.
English: Drinking alcohol while being treated with Sonata may also cause you to feel drowsy the next day.
Croatian: Pijenje alkohola tijekom liječenja Sonatom također može uzrokovati osjećaj omamljenosti sljedeći dan.
English: This feeling may be even worse when you sleep for less than 7 to 8 hours after taking your medication or if you are already taking another central nervous system depressant or if you are drinking alcohol (see ‘other medicines and Sonata').
Croatian: Taj osjećaj može bit čak i gori ako spavate manje od 7 do 8 sati nakon uzimanja lijeka ili ako već uzimate neki drugi depresor središnjeg živčanog sustava ili ako pijete alkohol (vidjeti „Drugi lijekovi i Sonata).
English: • Use with extreme caution if you have ever been addicted to medicines or alcohol.
Croatian: • Primjenjivati uz izraziti oprez ako ste ikad bili ovisni o lijekovima ili alkoholu.
English: Increases in transaminases (a group of liver enzymes occurring naturally in the blood) have been reported, which may be a sign of liver problems.
Croatian: Zabilježene su povišene transaminaze (skupina jetrenih enzima koji se prirodno nalaze u krvi), što može biti znak problema s jetrom.
English: If insufficient sleep duration occurs, the likelihood of impaired alertness may be increased.
Croatian: Ako dođe do nedovoljnog trajanja sna vjerojatnost poremećaja budnosti može biti povećana.
English: • if you have myasthenia gravis (very weak or tired muscles).
Croatian: • ako imate mijasteniju gravis (vrlo slabe ili umorne mišiće)
English: Results from the 2- and 4week studies showed that no pharmacological tolerance developed with any dose of Sonata.
Croatian: Rezultati iz 2tjednih i 4-tjednih ispitivanja pokazali su da se nije razvila farmakološka tolerancija kod primjene bilo koje doze Sonate.
English: What Sonata looks like and contents of the pack
Croatian: Kako Sonata izgleda i sadržaj pakiranja
English: These occur most often up to several hours after ingesting the product.
Croatian: Ovo se najčešće javlja nekoliko sati nakon uzimanja lijeka.
English: In very rare cases, allergic reactions, some severe, sometimes with difficulty in breathing, have been reported and may require immediate medical care.
Croatian: U vrlo rijetkim slučajevima zabilježene su alergijske reakcije, neke teške, ponekad s otežanim disanjem, koje mogu zahtijevati hitnu medicinsku skrb.
English: • There is a chance that you may experience somnambulism (sleepwalking), including eating or driving while not fully awake with no memory of the event.
Croatian: • Postoji mogućnost somnambulizma (mjesečarenja), uključujući konzumiranje hrane ili upravljanje vozilima dok niste u potpunosti budni te bez sjećanja na događaje.
English: Zaleplon is excreted in the form of inactive metabolites, mainly in the urine (71%) and faeces (17%).
Croatian: Izlučivanje Zaleplon se izlučuje u obliku inaktivnih metabolita, uglavnom mokraćom (71%) i stolicom (17%).
English: Very common (1/10)
Croatian: Vrlo česte (≥1/10)
English: Anterograde amnesia may occur using recommended therapeutic dosages, the risk increasing at higher dosages.
Croatian: Anterogradna amnezija može nastati primjenom preporučenih terapijskih doza, a rizik se povećava pri većim dozama.
English: A routine dosage adjustment of Sonata is not considered necessary, but patients should be advised that the sedative effects might be enhanced.
Croatian: Rutinska prilagodba doze Sonate ne smatra se nužnom, no bolesnike treba savjetovati o mogućem pojačanju sedativnog učinka.
English: s r.o.. Trnavská cesta 50
Croatian: Trnavská cesta 50
English: Taking into account the PRAC Assessment Report on the PSUR for zaleplon, the scientific conclusions of CHMP are as follows:
Croatian: Uzimajući u obzir PRAC-ovo Izvješće o ocjeni periodičkog izvješća o neškodljivosti (PSUR) za zaleplon, znanstveni zaključci CHMP-a su sljedeći:
English: Sonata may make you feel drowsy, cause loss of concentration or memory or muscle weakness.
Croatian: Zbog Sonate se možete osjećati omamljeno, može uzrokovati gubitak koncentracije ili pamćenja, ili mišićnu slabost.
English: In the case of narcotic analgesics enhancement of the euphoria may occur leading to an increase in physiological dependence.
Croatian: U slučaju narkotičkih analgetika može doći do povećanja euforije što može dovesti do povećanja fiziološke ovisnosti.
English: Driving and using machines
Croatian: Upravljanje vozilima i rad sa strojevima
English: If you notice any of the following, or any other changes in your health, do tell your doctor as soon as possible.
Croatian: Ako primijetite bilo što od sljedećeg, ili bilo kakve promjene u svom zdravlju, čim prije se obratite svom liječniku.
English: • If you are taking any medicines belonging to the sleep inducing group, including Sonata, there is a possibility that you may become dependent on them.
Croatian: • Ako uzimate bilo koji lijek koji pripada skupini lijekova koji izazivaju san, uključujući Sonatu, postoji mogućnost da ćete postati ovisni o njima.
English: Zaleplon's pharmacokinetic profile shows rapid absorption and elimination (see section 5.2).
Croatian: Farmakokinetički profil zaleplona pokazuje brzu apsorpciju i eliminaciju (vidjeti dio 5.2).
English: Alcohol and medicinal product abuse
Croatian: Alkohol i zloupotreba lijekova
English: It may be useful to inform the patient when treatment is started that it will be of limited duration.
Croatian: Pri započinjanju liječenja, korisno je obavijestiti bolesnika da će ono biti ograničenog trajanja.
English: It is important that patients be aware of the possibility of rebound phenomena, thereby minimising anxiety should such symptoms develop when the medicinal product is discontinued.
Croatian: Važno je da su bolesnici svjesni mogućnosti “rebound” fenomena (povrata), kako bi se smanjila tjeskoba ako se takvi simptomi razviju nakon prekida primjene lijeka.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Croatian: Detaljnije informacije o ovom lijeku dostupne su na web stranici Europske agencije za lijekove: http://www.ema.europa.eu/.
English: Pharmacotherapeutic Group: Benzodiazepine related drugs, ATC Code N05CF03
Croatian: Farmakoterapijska skupina: lijekovi srodni benzodiazepinima, ATK oznaka N05CF03
English: The increased incidence of benign liver tumors in mice was likely an adaptive event.
Croatian: Povećana incidencija benignih tumora jetre kod miševa vjerojatno je adaptivni događaj.
English: Capsule, hard.
Croatian: Kapsula, tvrda.