FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore based on the results of the submitted bioequivalence studies, the CHMP members agreed that Myoson 50 and 150 mg tablets are bioequivalent to the reference medicinal product Mydeton 50 and 150-mg tablets (Gedeon Richter Plc) under fasting conditions.
Croatian: Stoga su na temelju dostavljenih rezultata ispitivanja bioekvivalencije članovi CHMP-a bili suglasni da su tablete Myoson od 50 i 150 mg bioekvivalenti referentnog lijeka Mydeton u tabletama od 50 i 150 mg (Gedeon Richter Plc) u uvjetima natašte.
English: Your healthcare professional will throw away any medicines that are no longer being used.
Croatian: Vaš zdravstveni radnik bacit će sve lijekove koji se više ne koriste.
English: You may need medical treatment.
Croatian: Možda će Vam biti potrebno liječenje.
English: Clearly label each infusion bag.
Croatian: Jasno označite svaku infuzijsku vrećicu.
English: The diluted solution should not be shaken or frozen.
Croatian: Razrijeđena otopina se ne smije tresti niti zamrzavati.
English: 82377 Penzberg GERMANY
Croatian: 82377 Penzberg
English: Stage 1a
Croatian: Stadij 1a
English: However, no notable differences in quality of life during follow up have been identified to date.
Croatian: Međutim, do sada nisu identificirane primjetne razlike u kvaliteti života tijekom praćenja.
English: Often these are colds, but there have been cases of more severe infections.
Croatian: Često se radi o prehladama, ali bilo je i slučajeva težih infekcija.
English: Any additional guidelines according to standard practice should be followed.
Croatian: Potrebno je pridržavati se svih dodatnih smjernica u skladu s uobičajenom praksom.
English: Do not give Gazyvaro to children or young people under 18 years of age.
Croatian: Nemojte dati Gazyvaro djeci ni osobama mlađima od 18 godina.
English: Gazyvaro should not be administered to pregnant women unless the possible benefit outweighs the potential risk.
Croatian: Gazyvaro se ne smije primjenjivati u trudnica, osim ako moguća korist ne nadmašuje mogući rizik.
English: Results of subgroup analyses
Croatian: Rezultati analiza podskupina
English: · Keep this leaflet.
Croatian: · Sačuvajte ovu uputu.
English: Bendamustine N=166
Croatian: Bendamustin N=166
English: The affected “B-lymphocytes” multiply too quickly and live too long.
Croatian: B-limfociti prebrzo se množe i predugo žive.
English: Based on your disease status after the initial treatment cycles your doctor will decide whether you will receive treatment in the maintenance phase.
Croatian: Ovisno o statusu Vaše bolesti nakon početnih ciklusa liječenja, liječnik će odlučiti hoćete li primati liječenje u razdoblju održavanja.
English: Each cycle lasts 28 days.
Croatian: Svaki ciklus traje 28 dana.
English: In such instances, all subsequent visits and the start of Cycle 2 will be shifted to accommodate for the delay in Cycle 1.
Croatian: U takvim će se slučajevima svi sljedeći posjeti i početak 2. ciklusa pomaknuti kako bi se uračunala odgoda u 1. ciklusu.
English: This is because for this medicine to be as effective as possible, it is important to follow the dosing schedule.
Croatian: Naime, da bi ovaj lijek bio što učinkovitiji, važno je pridržavati se rasporeda primjene.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 July 2014
Croatian: Datum prvog odobrenja: 23. srpnja 2014.
English: Worsening of pre-existing cardiac conditions
Croatian: Pogoršanje postojećih srčanih bolesti
English: Gazyvaro is available in a pack containing 1 glass vial.
Croatian: Gazyvaro je dostupan u pakiranju koje sadrži 1 staklenu bočicu.
English: · you are allergic to obinutuzumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: · ako ste alergični na obinutuzumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: Stage 2
Croatian: Stadij 2
English: Hypersensitivity symptoms can occur after previous exposure and very rarely with the first infusion.
Croatian: Simptomi preosjetljivosti mogu nastupiti nakon prethodnog izlaganja, a vrlo se rijetko javljaju kod prve infuzije.
English: Gazyvaro will be stored by the healthcare professionals at the hospital or clinic.
Croatian: Gazyvaro će čuvati zdravstveni radnici u bolnici ili klinici.
English: A post hoc analysis was performed 8 months after the primary analysis data cut.
Croatian: Provedena je post-hoc analiza 8 mjeseci nakon završetka prikupljanja podataka za primarnu analizu.
English: Gazyvaro can be used in adults to treat two different types of cancer
Croatian: Gazyvaro se može koristiti u odraslih osoba za liječenje dviju različitih vrsta raka:
English: These reactions are more likely to happen with the first infusion.
Croatian: Pojava tih reakcija vjerojatnija je tijekom prve infuzije.
English: Fatal infections have been reported.
Croatian: Prijavljene su infekcije sa smrtnim ishodom.
English: Tell your doctor or nurse if you are taking, have recently taken or might start taking any other medicines.
Croatian: Obavijestite svog liječnika ili medicinsku sestru ako uzimate, nedavno ste uzeli ili biste mogli početi uzimati bilo koje druge lijekove.
English: to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000).
Croatian: i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i vrlo rijetko (< 1/10 000).
English: Gazyvaro can cause some serious side effects that you need to tell your doctor or nurse about straight away.
Croatian: Gazyvaro može uzrokovati neke ozbiljne nuspojave o kojima odmah morate obavijestiti svog liječnika ili medicinsku sestru.
English: This is because small amounts of the medicine may pass into your breast milk.
Croatian: Naime, male količine lijeka mogu se izlučiti u majčino mlijeko.
English: While the clinical significance of HAHA is not known, a potential correlation between HAHA and clinical course cannot be ruled out.
Croatian: Iako klinički značaj HAHA nije poznat, ne može se isključiti moguća korelacija između HAHA i kliničkog tijeka bolesti.
English: Antibodies work by attaching themselves to specific targets in your body.
Croatian: Protutijela djeluju tako da se spoje na posebna ciljna mjesta u tijelu.
English: The majority of the patients in study GAO4753g had FL (81.1%).
Croatian: Većina bolesnika u ispitivanju GAO4753g imala je FL (81,1%).
English: Therefore, no pharmacokinetic interaction is expected with medicinal products known to be metabolised by these enzyme systems.
Croatian: Stoga se ne očekuje farmakokinetička interakcija s lijekovima za koje se zna da ih metaboliziraju spomenuti enzimski sustavi.
English: No specific dose recommendations can be made.
Croatian: Nije moguće dati posebne preporuke za doziranje.
English: The safety and efficacy of Gazyvaro in children and adolescents aged below 18 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka Gazyvaro u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
English: · On Day 1 of your first cycle, you will be given part of your first Gazyvaro dose of 100 milligrams (mg) very slowly.
Croatian: · Prvoga dana prvog ciklusa primit ćete dio prve doze lijeka Gazyvaro od 100 miligrama (mg) vrlo polako.
English: The incidence and intensity of adverse reactions reported in these studies did not appear to be dose dependent.
Croatian: Incidencija i intenzitet nuspojava prijavljenih u tim ispitivanjima nisu bili ovisni o dozi.
English: · CLL and FL are types of cancer that affect white blood cells called “B-lymphocytes”.
Croatian: · KLL i FL su vrste raka koje zahvaćaju bijele krvne stanice koje se zovu B-limfociti.
English: Standard dosing of CHOP and CVP was given.
Croatian: Primjenjivalo se standardno doziranje za protokole CHOP i CVP.
English: Due to the open label design the patient reported outcomes should be interpreted with caution.
Croatian: Zbog otvorenog dizajna ispitivanja ishode koje su prijavili bolesnici potrebno je tumačiti uz oprez.
English: The patient should be referred to a neurologist for the evaluation and treatment of PML.
Croatian: Bolesnika je potrebno uputiti neurologu radi procjene i liječenja PML-a.
English: Patients should continue to receive repeated prophylaxis prior to each subsequent infusion, if deemed appropriate.
Croatian: Bolesnici bi trebali nastaviti primati profilaksu i prije svake sljedeće infuzije, ako se to smatra prikladnim.
English: The majority of patients were Caucasian (95%) and male (61%).
Croatian: Većina bolesnika bili su bijelci (95%) i muškarci (61%).
English: The PFS results in the post hoc analysis are consistent with the primary analysis and its significance is unchanged and the safety profile is consistent with the primary analysis.
Croatian: Rezultati za PFS iz post-hoc analize u skladu su s primarnom analizom i njihova se značajnost nije promijenila, a sigurnosni profil u skladu je s primarnom analizom.
English: Antibodies are mostly cleared by catabolism.
Croatian: Protutijela se uglavnom uklanjaju katabolizmom.
English: This decreasing trend continued during maintenance therapy with Gazyvaro alone.
Croatian: Taj trend smanjenja nastavio se i tijekom terapije održavanja samo lijekom Gazyvaro.
English: No studies have been performed to establish the carcinogenic potential of obinutuzumab.
Croatian: Nisu provedena istraživanja kojima bi se utvrdio kancerogeni potencijal obinutuzumaba.
English: Dose modifications during treatment (all indications) No dose reductions of Gazyvaro are recommended.
Croatian: Prilagodbe doze tijekom liječenja (sve indikacije) Ne preporučuje se smanjivati dozu lijeka Gazyvaro.
English: Pay attention to the following side effects
Croatian: Pripazite na sljedeće nuspojave
English: In order to improve the traceability of biological medicinal products, the trade name and batch number of the administered product should be clearly recorded (or stated) in the patient file.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati (ili navesti) u zdravstvenom kartonu bolesnika.
English: The storage details are as follows: · Keep this medicine out of the sight and reach of children.
Croatian: Uvjeti čuvanja su sljedeći: · Lijek čuvajte izvan pogleda i dohvata djece.
English: Patients with positive hepatitis B serology should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation.
Croatian: Bolesnici s pozitivnim serološkim testovima na hepatitis B moraju se prije početka liječenja konzultirati sa stručnjacima za jetrene bolesti te ih je potrebno nadzirati i liječiti sukladno lokalnim medicinskim standardima kako bi se spriječila reaktivacija hepatitisa.
English: · Store in a refrigerator (2 °C-8 °C).
Croatian: · Čuvati u hladnjaku (2°C-8°C).
English: However, if you get an infusion related reaction, (see section 4), do not drive, cycle or use any tools or machines until the reaction stops.
Croatian: Međutim, ako se pojavi reakcija na infuziju (pogledajte dio 4.), nemojte upravljati vozilom, voziti bicikl niti raditi s alatima i strojevima dok se reakcija ne povuče.
English: NR (22.5,-)
Croatian: ND (22,5;-)
English: For subgroups, reduction of the risk of disease progression or death ranged from 92% to 58% for GClb versus Clb and 72% to 29% for GClb versus RClb.
Croatian: U podskupinama se smanjenje rizika od progresije bolesti ili smrti kretalo u rasponu od 92% do 58% za GClb naspram Clb te od 72% do 29% za GClb naspram RClb.
English: In the follicular lymphoma studies, a high incidence of infections was observed in all phases of the studies, including follow-up, with the highest incidence seen in the maintenance phase.
Croatian: U ispitivanjima primjene kod folikularnog limfoma primijećena je visoka incidencija infekcija u svim fazama ispitivanja, uključujući praćenje, s najvišom incidencijom zabilježenom tijekom faze održavanja.
English: Patients with active hepatitis B disease should not be treated with Gazyvaro.
Croatian: Bolesnici s aktivnim hepatitisom B ne smiju se liječiti lijekom Gazyvaro.
English: Instructions on the rate of infusion are shown in Tables 4 and 5.
Croatian: Smjernice za brzinu infuzije prikazane su u Tablicama 4 i 5.
English: What Gazyvaro looks like and contents of the pack
Croatian: Kako Gazyvaro izgleda i sadržaj pakiranja
English: From a microbiological point of view, the prepared infusion solution should be used immediately.
Croatian: S mikrobiološkog stajališta, pripremljena otopina za infuziju mora odmah biti primijenjena.
English: Your doctor/nurse will monitor you carefully for infusion related reactions.
Croatian: Liječnik/medicinska sestra će Vas pažljivo nadzirati zbog moguće pojave reakcija na infuziju.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC15
Croatian: Farmakoterapijska skupina: Antineoplastici, monoklonska protutijela, ATK oznaka: L01XC15
English: A risk for interactions with other concomitantly used medicinal products cannot be excluded.
Croatian: Ne može se isključiti rizik od interakcija s drugim lijekovima u istodobnoj primjeni.
English: Gazyvaro should be administered under the close supervision of an experienced physician and in an environment where full resuscitation facilities are immediately available.
Croatian: Gazyvaro se mora primjenjivati pod strogim nadzorom iskusnog liječnika i to u okruženju u kojem je odmah dostupna potpuna oprema za oživljavanje.
English: A type of liver disease called “hepatitis B” has also been reported to reoccur in patients who have had hepatitis B in the past.
Croatian: Prijavljena je i ponovna pojava jedne vrste jetrene bolesti, koja se zove hepatitis B, u onih bolesnika koji su imali hepatitis B u prošlosti
English: The safety and timing of vaccination should be discussed with the infant's physician (see section 4.6).
Croatian: sigurnosti i vremenu cijepljenja treba razgovarati s djetetovim liječnikom (vidjeti dio 4.6).
English: Elderly No dose adjustment is required in elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: The symptoms of PML are nonspecific and can vary depending on the affected region of the brain.
Croatian: Simptomi PML-e nisu specifični i razlikuju se ovisno o tome koji je dio mozga zahvaćen.
English: No definitive conclusions could be drawn on efficacy in the MZL and SLL sub-populations.
Croatian: Nije bilo moguće donijeti definitivne zaključke o djelotvornosti u podskupinama bolesnika s MZL-om i SLL-om.
English: · If you become pregnant during treatment with Gazyvaro, tell your doctor or nurse as soon as possible.
Croatian: · Ako zatrudnite tijekom liječenja lijekom Gazyvaro, obavijestite o tome svog liječnika ili medicinsku sestru što je prije moguće.
English: #with a higher incidence (difference of ≥ 2% between the treatment arms).
Croatian: #s većom incidencijom (razlika > 2% između liječenih skupina).
English: Patients with FL Grade 3b were excluded from the study.
Croatian: Bolesnici s FL-om gradusa 3b nisu bili uključeni u ispitivanje.
English: What you need to know before you are given Gazyvaro
Croatian: Što morate znati prije nego počnete primati Gazyvaro
English: The median time from initial diagnosis was 3 years and the median number of prior therapies was 2 (range 1 to 10); 44% of patients had received 1 prior therapy and 34% of patients had received 2 prior therapies.
Croatian: Medijan vremena od početne dijagnoze bio je 3 godine, a medijan broja prethodnih terapija iznosio je 2 (raspon: 1 - 10); 44% bolesnika prethodno je primilo 1 terapiju, a njih 34% prethodno je primilo 2 terapije.
English: During maintenance, maintain the original dosing schedule for subsequent doses.
Croatian: Tijekom terapije održavanja treba se pridržavati prvobitnog rasporeda doziranja za sljedeće doze.
English: · changes in blood tests: anaemia (low levels of red blood cells) low levels of all types of white blood cell (combined) low levels of neutrophils (a type of white blood cell) low level of platelets (a type of blood cell that helps your blood to clot)
Croatian: · promjene u krvnoj slici: - anemija (niske razine crvenih krvnih stanica) - niske razine svih vrsta bijelih krvnih stanica (zajedno) - niske razine neutrofila (jedne vrste bijelih krvnih stanica) - niske razine trombocita (vrste krvnih stanica koje sudjeluju u zgrušavanju krvi)
English: It is given into a vein as a drip (intravenous infusion) over several hours.
Croatian: Daje se ukapavanjem u venu (intravenskom infuzijom) tijekom nekoliko sati.
English: At the start of treatment for FL, Gazyvaro is used together with other medicines for cancer.
Croatian: - Na početku liječenja za FL, Gazyvaro se koristi zajedno s drugim lijekovima za liječenje raka.
English: Since human immunoglobulin G (IgG) is secreted in human milk and the potential for absorption and harm to the infant is unknown, women should be advised to discontinue breast-feeding during Gazyvaro therapy and for 18 months after the last dose of Gazyvaro.
Croatian: Budući da se humani imunoglobulin G (IgG) izlučuje u majčino mlijeko, a vjerojatnost apsorpcije i štetnih učinaka za dojenče nije poznata, ženama je potrebno savjetovati da prekinu dojenje tijekom terapije lijekom Gazyvaro i 18 mjeseci nakon posljednje doze lijeka Gazyvaro.
English: This is because treatment with Gazyvaro may affect yours or the baby's health.
Croatian: Naime, liječenje lijekom Gazyvaro može utjecati na Vaše zdravlje ili zdravlje Vašeg djeteta.
English: CLL only - Cycle 1
Croatian: Samo KLL - 1. ciklus
English: There are no data from the use of obinutuzumab in pregnant women.
Croatian: Nema podataka o primjeni obinutuzumaba u trudnica.
English: The median age was 73 years, with 44% being 75 years or older.
Croatian: Medijan dobi iznosio je 73 godine, a 44% bolesnika bilo je u dobi od 75 ili više godina.
English: In the pivotal studies in iNHL up to 1% of patients experienced gastrointestinal perforation.
Croatian: U ključnim ispitivanjima kod iNHL-a, do 1% bolesnika doživjelo je gastrointestinalnu perforaciju.
English: Any signs of concomitant infection should be treated as appropriate.
Croatian: Bilo koje simptome prateće infekcije potrebno je adekvatno liječiti.
English: Hydrocortisone should not be used as it has not been effective in reducing rates of IRR.
Croatian: Ne smije se koristiti hidrokortizon jer se nije pokazao djelotvornim u smanjivanju stopa reakcija na infuziju.
English: Gazyvaro can then be used on its own for up to 2 years as a “maintenance treatment”.
Croatian: - Gazyvaro se nakon toga može primjenjivati sam kao 'terapija održavanja' do najviše 2 godine.
English: Health-related quality of life assessments, specific to fatigue through treatment period, show no statistically significant difference suggesting that the addition of Gazyvaro to a chlorambucil regimen does not increase the experience of fatigue for patients.
Croatian: Ocjene kvalitete života vezane uz zdravlje, koje se posebno odnose na umor tijekom razdoblja liječenja, ne pokazuju statistički značajne razlike, što ukazuje na to da dodatak lijeka Gazyvaro liječenju klorambucilom ne povećava umor u bolesnika.
English: Gazyvaro is given under the supervision of a doctor experienced in such treatment.
Croatian: Gazyvaro se daje pod nadzorom liječnika koji ima iskustva s takvim liječenjem.
English: Obinutuzumab is administered intravenously, therefore absorption is not applicable.
Croatian: Obinutuzumab se primjenjuje intravenski pa apsorpcija nije primjenjiva.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/937/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/937/001
English: · Six 28-day cycles in combination with bendamustine2 or
Croatian: · šest 28-dnevnih ciklusa u kombinaciji s bendamustinom2 ili
English: This is indicative of target mediated drug disposition (TMDD), where the initial abundance of CD20 cells causes a rapid removal of obinutuzumab from the circulation.
Croatian: To ukazuje na raspoloživost lijeka ovisnu o vezanju za ciljno mjesto (engl. target mediated drug disposition, TMDD), kod koje početna velika količina CD20 stanica uzrokuje brzo uklanjanje obinutuzumaba iz cirkulacije.
English: If a hypersensitivity reaction is suspected during or after an infusion, the infusion must be stopped and treatment permanently discontinued.
Croatian: Ako se tijekom ili nakon infuzije posumnja na reakciju preosjetljivosti, infuzija se mora prekinuti, a liječenje trajno obustaviti.
English: Gazyvaro was administered prior to chemotherapy.
Croatian: Gazyvaro se primjenjivao prije kemoterapije.
English: Patients at acute risk of hypertensive crisis should be evaluated for the benefits and risks of withholding their anti-hypertensive medicine.
Croatian: U bolesnika u kojih postoji akutni rizik od hipertenzivne krize potrebno je procijeniti koristi i rizike suzdržavanja od antihipertenziva.
English: Tumour lysis syndrome is a potentially life-threatening complication, caused by chemical changes in the blood due to the breakdown of dying cancer cells (see section 3).
Croatian: Sindrom lize tumora je komplikacija koja može biti opasna po života, a uzrokuju je kemijske promjene u krvi uslijed raspadanja umirućih stanica raka (pogledajte dio 3.).
English: This is because there is no information about its use in these age groups.
Croatian: Naime, nema informacija o njegovoj primjeni u tim dobnim skupinama.
English: Antiviral and antifungal prophylaxis should also be considered (see section 4.2).
Croatian: Također se trebaju razmotriti antivirusna i antifungalna profilaksa (vidjeti dio 4.2).
English: Cycle 1: Day 1 for CLL and FL
Croatian: 1. ciklus: 1. dan, kod KLL-a i FL-a
English: 2See section 5.1 for information on bendamustine dose
Croatian: Vidjeti dio 5.1 za informacije o dozi bendamustina
English: · If you do not have an infusion related reaction following the small part of your first dose, you may be given the rest of your first dose (900 mg) on the same day.
Croatian: · Ako se nakon primjene malog dijela prve doze ne pojavi reakcija na infuziju, istoga dana možete primiti i ostatak prve doze (900 mg).
English: Gastro-Intestinal Perforation
Croatian: Gastrointestinalna perforacija
English: Day 2 (or Day 1 continued)
Croatian: 2. dan (ili nastavak 1. dana)
English: Chlorambucil N=118
Croatian: klorambucil N=118
English: Gazyvaro has no or negligible influence on the ability to drive and use machines.
Croatian: Gazyvaro ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: An updated RMP should be submitted: · At the request of the European Medicines Agency; · Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: Ažurirani RMP treba dostaviti: · na zahtjev Europske agencije za lijekove; · prilikom svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik,
English: Patients with no IRR during the previous infusion
Croatian: Bolesnici bez reakcije na infuziju tijekom prethodne infuzije
English: · When Gazyvaro is given to patients with CLL or FL together with other medicines for cancer - this slows down the time it takes for their disease to get worse.
Croatian: · Kada se Gazyvaro daje bolesnicima s KLL-om ili FL-om zajedno s drugim lijekovima za liječenje raka, to usporava pogoršanje njihove bolesti.
English: If toxicity occurs before Cycle 1 Day 8 or Cycle 1 Day 15, requiring delay of treatment, these doses should be given after resolution of toxicity.
Croatian: Ako prije 8. dana 1. ciklusa ili 15. dana 1. ciklusa nastupi toksičnost koja zahtijeva odgodu liječenja, odgođene doze treba primijeniti nakon što se toksičnost povuče.