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 DuoResp Spiromax, 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 DuoResp Spiromax uključene su sigurnosne informacije, uključujući odgovarajuće mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati.
English: A risk management plan has been developed to ensure that DuoResp Spiromax is used as safely as possible.
Croatian: Pripremljen je plan upravljanja rizikom kako bi se osigurala što sigurnija primjena lijeka DuoResp Spiromax.
English: What measures are being taken to ensure the safe and effective use of DuoResp Spiromax?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka DuoResp Spiromax?
English: The company initially also applied for a lower strength of DuoResp Spiromax, however bioequivalence to the reference product was not demonstrated and the application for this strength was withdrawn.
Croatian: Tvrtka je prvo primijenila i slabije jačine lijeka DuoResp Spiromax, no bioekvivaletnost s referentnim lijekom nije utvrđena, te je primjena ove jačine povučena.
English: Studies in patients have been limited to tests to determine that DuoResp Spiromax is bioequivalent to the reference medicine, Symbicort Turbohaler.
Croatian: Ispitivanja provedena na bolesnicima ograničena su na testiranja kako bi se utvrdilo je li DuoResp Spiromax bioekvivalent referentnog lijeka, Symbicort Turbohaler.
English: For more information about treatment with DuoResp Spiromax, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o terapiji lijekom DuoResp Spiromax pročitajte u uputi lijeka (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: DuoResp Spiromax is a medicine that contains the active substances budesonide and formoterol.
Croatian: DuoResp Spiromax je lijek koji sadrži djelatne tvari budezonid i formoterol.
English: What is DuoResp Spiromax and what is it used for?
Croatian: Što je DuoResp Spiromax i za što se koristi?
English: Other information about DuoResp Spiromax
Croatian: Ostale informacije o lijeku DuoResp Spiromax
English: The reference medicine for DuoResp Spiromax is Symbicort Turbohaler.
Croatian: Referentni lijek za DuoResp Spiromax je Symbicort Turbohaler.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that DuoResp Spiromax 160/4.5 microgram and 320/9 microgram have been shown to have comparable quality and to be bioequivalent to the corresponding strengths of Symbicort Turbohaler.
Croatian: Povjerenstvo za lijekove za primjenu kod ljudi (CHMP) pri Agenciji zaključilo je kako je, u skladu s preduvjetima EU-a, potvrđeno da DuoResp Spiromax od 160/4.5 mikrograma i 320/9 mikrograma posjeduje usporedivu kvalitetu te je bioekvivalent lijeka Symbicort Turbohaler odgovarajuće jačine.
English: Why is DuoResp Spiromax approved?
Croatian: Zašto je DuoResp Spiromax odobren?
English: What are the benefits and risks of DuoResp Spiromax?
Croatian: Koje su koristi i rizici lijeka DuoResp Spiromax?
English: For practical information about using DuoResp Spiromax, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o korištenju lijeka DuoResp Spiromax pročitajte u uputi o lijeku, odnosno obratite se svom liječniku ili ljekarniku.
English: 160/4.5 microgram (160 micrograms of budesonide and 4.5 micrograms of formoterol) can be used for the regular treatment of asthma and when needed as a reliever.
Croatian: DuoResp Spiromax od 160/4.5 mikrograma (160 mikrograma budezonida i 4,5 mikrograma formoterola) može se primjenjivati u redovnom liječenju astme i ukoliko je u terapiji ublažavanja simptoma astme.
English: The Committee recommended that DuoResp Spiromax be given marketing authorisation.
Croatian: Povjerenstvo je preporučilo izdavanje odobrenja za stavljanje u promet lijeka DuoResp Spiromax u EUu.
English: How is DuoResp Spiromax used?
Croatian: Kako se DuoResp Spiromax koristi?
English: How does DuoResp Spiromax work?
Croatian: Kako djeluje DuoResp Spiromax?
English: How has DuoResp Spiromax been studied?
Croatian: Kako se DuoResp Spiromax ispitivao?
English: This usually takes less than 1 hour.
Croatian: To obično traje manje od sat vremena.
English: 9 months.
Croatian: 9 mjeseci.
English: It will not be given to you again.
Croatian: Nećete ga ponovno dobiti.
English: Date of birth: {DD MMM YYYY} SEC:
Croatian: Datum rođenja: {DD MMM GGGG} SEC:
English: Do not drive, use machines, or take part in activities that need you to be alert for.
Croatian: Nemojte voziti, upravljati strojevima ili sudjelovati u aktivnostima koje zahtijevaju Vašu pozornost.
English: Key elements:
Croatian: Ključni elementi:
English: These other medicines may include:
Croatian: Ti drugi lijekovi mogu uključivati:
English: No alternative adequate animal models are available.
Croatian: Nisu dostupni prikladni alternativni životinjski modeli.
English: * Frequency is based on laboratory values.
Croatian: * Učestalost se temelji na laboratorijskim vrijednostima.
English: • There may be an effect on the results of some types of HIV test - ask your doctor about this.
Croatian: • Lijek bi mogao utjecati na rezultate nekih vrsta testova na HIV - upitajte svog liječnika o tome.
English: June 2022
Croatian: Lipanj 2022.
English: • You have an infection.
Croatian: • imate infekciju.
English: Reasons to delay treatment
Croatian: Razlozi za odgodu liječenja
English: Response at month 6
Croatian: Odgovor u 6. mjesecu
English: Included as part of the annual reports of the non-interventional PASS
Croatian: Uključena u sklopu godišnjih izvješća neintervencijskog PASS-a
English: Annual safety reports and 5-yearly interim reports
Croatian: Godišnja ažurirana izvješća o sigurnosti i 5-godišnje privremeno izvješće
English: The following information is intended for doctors only.
Croatian: Sljedeće informacije namijenjene su samo liječnicima.
English: Test and checks
Croatian: Pretrage i provjere
English: This can take 3 to 6 hours and may need to be repeated.
Croatian: Postupak prikupljanja može trajati 3 do 6 sati i možda će se trebati ponoviti.
English: • Difficulty sleeping
Croatian: • Poteškoće sa spavanjem
English: • after treatment while the immune system is recovering.
Croatian: • nakon liječenja dok se imunološki sustav oporavlja.
English: - Active uncontrolled infection.
Croatian: - Aktivna nekontrolirana infekcija.
English: Some of your white blood cells are separated from your blood and the rest of your blood is returned to your vein.
Croatian: Dio Vaših bijelih krvnih stanica se odvaja od Vaše krvi, a ostatak Vaše krvi se vraća u Vašu venu.
English: • Check your lungs, heart and blood pressure.
Croatian: • provjeriti Vaša pluća, srce i krvni tlak.
English: Name:
Croatian: Ime i prezime:
English: T½ (day)
Croatian: T½ (dan)
English: You may be given medicines to help prevent the condition.
Croatian: Moguće je da ćete dobiti lijekove koji će Vam pomoći spriječiti to stanje.
English: In particular, you must not be given certain vaccines called live vaccines:
Croatian: Ne smijete primiti određena cjepiva koja se nazivaju živa cjepiva:
English: Summary statistics
Croatian: Sumarna statistika
English: • Reduced levels of one or more blood cell types
Croatian: • Snižene razine jedne ili više vrsta krvnih stanica
English: Studies B2202 (N=75) + C2201 (N=111)
Croatian: Ispitivanja B2202 (N=75) + C2201 (N=111)
English: • if you are allergic to any of the ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na neki sastojak ovog lijeka (naveden u dijelu 6.).
English: Kymriah should only be given if the result shows you are not pregnant.
Croatian: Kymriah Vam se može dati samo ako test pokaže da niste trudni.
English: - The information in this leaflet is for you or your child - but in the leaflet it will just say “you”.
Croatian: - Informacije u ovoj uputi namijenjene su Vama ili Vašemu djetetu - ali uputa će se obraćati samo „Vama“.
English: Requires remission status to be maintained for at least 28 days without clinical evidence of relapse.
Croatian: Zahtijeva da se status remisije održava najmanje 28 dana bez kliničkih dokaza relapsa.
English: Read all of this leaflet carefully before you (or your child) are given this medicine because it contains important information.
Croatian: Pažljivo pročitajte cijelu uputu prije nego Vi (ili Vaše dijete) primite ovaj lijek jer sadrži važne podatke.
English: • Very severe inflammation around the body (due to syndrome of immune activation)
Croatian: • Vrlo teška upala po tijelu (zbog sindroma imunološke aktivacije)
English: See Table 4 for efficacy results from this study.
Croatian: Vidjeti Tablicu 4 za rezultate djelotvornosti iz ovog ispitivanja.
English: Special populations No differences in efficacy or safety were observed between different age subgroups.
Croatian: Posebne populacije Nisu bile uočene razlike u djelotvornosti ili sigurnosti između različitih dobnih podskupina.
English: If you think you may be allergic, ask your doctor for advice.
Croatian: Ako mislite da biste mogli biti alergični, upitajte svog liječnika za savjet.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Croatian: Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući lijekove koje ste uzeli bez recepta.
English: Juvenile toxicity studies were not conducted.
Croatian: Ispitivanja juvenilne toksičnosti nisu provedena.
English: • Excessive sweating, night sweats
Croatian: • Prekomjerno znojenje, noćno znojenje
English: No non-clinical reproductive safety studies were conducted as no adequate animal model is available.
Croatian: Nisu provedena neklinička ispitivanja reproduktivne sigurnosti zato što nije dostupan prikladan životinjski model.
English: • You will be given a pregnancy test before treatment starts.
Croatian: • Dobit ćete test za trudnoću prije početka liječenja.
English: These symptoms almost always occur within the first 10 days after infusion.
Croatian: Ovi simptomi se gotovo uvijek pojave u prvih 10 dana nakon infuzije.
English: • Fever, which may be a symptom of an infection.
Croatian: • Vrućicu, koja može biti simptom infekcije.
English: Your doctor will recommend that you return to the hospital daily for at least 10 days and will consider whether you need to stay at the hospital as an in-patient for the first 10 days after infusion.
Croatian: Vaš liječnik će preporučiti da svakodnevno dolazite u bolnicu barem 10 dana i razmotrit će trebate li ostati u bolnici prvih 10 dana nakon infuzije.
English: It usually takes about 3 to 4 weeks to make Kymriah but the time may vary.
Croatian: Obično je potrebno otprilike 3 do 4 tjedna da se pripravi Kymriah, ali to razdoblje može varirati.
English: Bag x of y
Croatian: Vrećica x od y
English: Other medicines and Kymriah
Croatian: Drugi lijekovi i Kymriah
English: They usually happen in the first 8 weeks after the infusion, but can also develop later:
Croatian: One se obično javljaju u prvih 8 tjedana nakon infuzije, ali mogu se razviti i kasnije:
English: • Red or purple spots under the skin
Croatian: • Crvene ili ljubičaste mrlje ispod kože
English: If you miss an appointment, call your doctor or the hospital as soon as possible to reschedule.
Croatian: Ako propustite termin, čim prije nazovite liječnika ili bolnicu da dogovorite novi termin.
English: • You notice the symptoms of your cancer are getting worse.
Croatian: • primijetite da se simptomi Vašeg raka pogoršavaju.
English: What Kymriah is and what it is used for
Croatian: Što je Kymriah i za što se koristi
English: • Your white blood cells are frozen and sent away to make Kymriah.
Croatian: • Vaše bijele krvne stanice se smrzavaju i šalju za pripravljanje lijeka Kymriah.
English: There is no apparent relationship between dose and AUC0-28d or Cmax.
Croatian: Nema očitog odnosa između doze i AUC0-28d ili Cmax.
English: ORR included CR and CRi.
Croatian: ORR je uključivao CR i CRi.
English: Repeat tocilizumab as needed at a minimum interval of 8 hours if there is no clinical improvement.
Croatian: Ponoviti tocilizumab prema potrebi u razmaku od najmanje 8 sati ako ne dođe do kliničkog poboljšanja.
English: Talk to your doctor if you need to have any vaccinations.
Croatian: Obratite se svom liječniku ako trebate dobiti bilo kakvo cjepivo.
English: One individual treatment dose comprises 1 to 3 infusion bags.
Croatian: Jedna pojedinačna doza liječenja sastoji se od 1 do 3 vrećice za infuziju.
English: • Check if your cancer is getting worse.
Croatian: • provjeriti pogoršava li se Vaš rak.
English: HBV reactivation
Croatian: Reaktivacija HBV-a
English: No such risks were identified based on these studies.
Croatian: Takvi rizici nisu utvrđeni u ovim ispitivanjima.
English: • You had a vaccination in the previous 6 weeks or are planning to have one in the next few months.
Croatian: • ste se cijepili u proteklih 6 tjedana ili se planirate cijepiti u sljedećih nekoliko mjeseci.
English: Your doctor will regularly check your blood counts as the number of blood cells and other blood components may decrease.
Croatian: Vaš liječnik redovito će Vam provjeravati krvnu sliku jer bi se mogao smanjiti broj krvnih stanica i drugih sastojaka krvi.
English: Kymriah will always be given to you by a doctor.
Croatian: Lijek Kymriah će Vam uvijek dati liječnik.
English: What you need to know before you are given Kymriah
Croatian: Što morate znati prije nego primite Kymriah
English: Prolonged neutropenia has been associated with increased risk of infection.
Croatian: Produljena neutropenija povezana je s povećanim rizikom od infekcije.
English: - After the first 10 days following the infusion, the patient should be monitored at the physician's discretion.
Croatian: - Poslije prvih 10 dana nakon infuzije, bolesnika je potrebno pratiti prema odluci liječnika.
English: Median (months) (95% CI)
Croatian: Medijan (mjeseci) (95% CI)
English: Do not use this medicine if the infusion bag is damaged or leaking.
Croatian: Ovaj lijek se ne smije upotrijebiti ako je vrećica za infuziju oštećena ili curi.
English: These patient are likely to be more vulnerable to the consequences of the adverse reactions described below and require special attention.
Croatian: Ti su bolesnici vjerojatno osjetljiviji na posljedice nuspojava opisanih u nastavku i zahtijevaju posebnu pozornost.
English: Clinical assessment prior to infusion
Croatian: Klinička procjena prije infuzije
English: Effects of Kymriah on male and female fertility have not been evaluated in animal studies.
Croatian: Učinci lijeka Kymriah na mušku i žensku plodnost nisu bili ocjenjivani u ispitivanjima na životinjama.
English: Cmax (copies/μg)
Croatian: Cmax (kopije/μg)
English: ORR was consistent across all subgroups.
Croatian: ORR je bio dosljedan u svim podskupinama.
English: Please refer to section 6.6 for details on inspection and thawing of the infusion bag.
Croatian: Pogledajte dio 6.6 za pojedinosti o pregledu i odmrzavanju vrećice za infuziju.
English: Before you are given Kymriah tell your doctor or nurse if you are taking any medicines that weaken your immune system such as corticosteroids, since these medicines may interfere with the effect of Kymriah.
Croatian: Prije nego što dobijete Kymriah obavijestite svog liječnika ili medicinsku sestru ako uzimate lijekove koji oslabljuju imunološki sustav kao što su kortikosteroidi, budući da bi ti lijekovi mogli ometati učinak lijeka Kymriah.
English: A genomic insertion site analysis of the lentiviral vector was performed on Kymriah products from 14 individual donors (12 patients and 2 healthy volunteers).
Croatian: Analiza mjesta genomske insercije lentivirusnog vektora provedena je na proizvodima Kymriah od 14 pojedinačnih davatelja (12 bolesnika i 2 zdrava dobrovoljca).
English: This is to help prevent infusion reactions and fever.
Croatian: To će pomoći spriječiti reakcije na infuziju i vrućice.
English: In all indications, appropriate prophylactic and therapeutic treatment for infections should be provided, and complete resolution of any existing infections should be ensured.
Croatian: U svim indikacijama potrebno je osigurati odgovarajuće profilaktičko i terapijsko liječenje infekcija te potpuno rješavanje bilo koje postojeće infekcije.
English: • Kymriah is a one-time treatment.
Croatian: • Kymriah je jednokratno liječenje.
English: Contraception for women and men Discuss pregnancy with your doctor if you have received Kymriah.
Croatian: Kontracepcija za žene i muškarce Razgovarajte o trudnoći sa svojim liječnikom ako ste primili lijek Kymriah.
English: Manufacture and release of Kymriah usually takes about 3-4 weeks.
Croatian: Za proizvodnju i puštanje lijeka Kymriah u promet obično je potrebno 3-4 tjedna.
English: Disease status (%) Refractory to last line of therapy Relapse to last line of therapy
Croatian: Status bolesti (%) Refraktorna na zadnju liniju terapije Relaps na zadnju liniju terapije
English: If these side effects become severe or serious, tell your doctor immediately.
Croatian: Ako ove nuspojave postanu teške ili ozbiljne, odmah se obratite svom liječniku.
English: DLBCL: The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established.
Croatian: DLBCL: Sigurnost i djelotvornost lijeka Kymriah u djece i adolescenata u dobi ispod 18 godina nisu još ustanovljene.
English: Race/ethnicity
Croatian: Rasa/etničko podrijetlo
English: The medicine can be used in children and young adults up to 25 years of age with this cancer.
Croatian: Lijek se može koristiti u djece i mladih odraslih osoba u dobi do 25 godina s ovim oblikom raka.
English: The medicine can be used in adults (18 years of age or older) with this cancer.
Croatian: Lijek se može koristiti u odraslih (u dobi od 18 ili više godina) s ovim oblikom raka.
English: For example, Kymriah should not be washed (spun down and resuspended in new media) prior to infusion.
Croatian: Primjerice, Kymriah se ne smije ispirati (centrifugirati i ponovno suspendirati u novom mediju) prije infuzije.
English: Limit to a maximum total of 4 tocilizumab doses.
Croatian: Ograničiti na ukupno najviše 4 doze tocilizumaba.
English: Headache includes headache and migraine.
Croatian: Glavobolja uključuje glavobolju i migrenu.
English: One patient died due to disease progression and the remaining three patients achieved a CR or CRi and remain alive 1.5-2 years after infusion.
Croatian: Jedan je bolesnik umro zbog progresije bolesti, a preostala tri bolesnika postigla su CR ili CRi i ostala živa 1,5-2 godine nakon infuzije.
English: Screening for HBV, HCV and HIV must be performed in accordance with clinical guidelines before collection of cells for manufacturing.
Croatian: Probir za HBV, HCV i HIV mora se obaviti u skladu s kliničkim smjernicama prije prikupljanja stanica za proizvodnju.
English: Early Tmax may not be representative of the true maximal expansion, rather the amount of transgene present in the catheter from which sample was collected.
Croatian: Rani Tmax možda nije reprezentativan za stvarnu maksimalnu ekspanziju, već za količinu transgena prisutnu u kateteru iz kojeg je uzet uzorak.
English: There was no evidence for preferential integration near genes of concern or preferential outgrowth of cells harbouring integration sites of concern.
Croatian: Nije bilo dokaza preferencijalne integracije blizu relevantnih gena ili preferencijalnog prerastanja stanica koje nose relevantna mjesta integracije.
English: Pharmacotherapeutic group: other antineoplastic agents, ATC code: not yet assigned
Croatian: Farmakoterapijska skupina: ostali antineoplastici, ATK oznaka: nije još dodijeljena Mehanizam djelovanja
English: • Take your temperature twice a day for 3-4 weeks after treatment with Kymriah.
Croatian: • Mjerite si temperaturu dvaput dnevno tijekom 3-4 tjedna nakon primjene lijeka Kymriah.
English: • Low or raised blood pressure
Croatian: • Niski ili povišeni krvni tlak
English: Store and transport below -120°C.
Croatian: Čuvati i transportirati na temperaturi ispod -120°C.
English: See leaflet for further information.
Croatian: Vidjeti uputu za više informacija.
English: Juvenile animal studies
Croatian: Ispitivanja na juvenilnim životinjama
English: Prior transplantation
Croatian: Prethodna transplantacija
English: Infections and infestations presented reflect high-level group terms.
Croatian: Prikazane infekcije i infestacije odražavaju grupne pojmove visoke razine.
English: • Rapid breakdown of tumour cells causing release of their contents into the bloodstream.
Croatian: • brzo raspadanje tumorskih stanica koje uzrokuje otpuštanje njihovog sadržaja u krvotok.
English: This can interfere with the workings of various body organs, especially the kidneys, heart and nervous system (tumour lysis syndrome).
Croatian: To može ometati funkciju raznih tjelesnih organa, osobito bubrega, srca i živčanog sustava (sindrom lize tumora).
English: Sleep disorder includes sleep disorder, insomnia and nightmare.
Croatian: Poremećaj spavanja uključuje poremećaj spavanja, nesanicu i noćne more.
English: DLBCL: No dose adjustment is required in patients over 65 years of age.
Croatian: DLBCL: Nije potrebna prilagodba doze za bolesnike starije od 65 godina.
English: Patients with active, uncontrolled infection should not start Kymriah treatment until the infection is resolved.
Croatian: Bolesnici s aktivnom, nekontroliranom infekcijom ne smiju započinjati terapiju lijekom Kymriah dok se infekcija ne povuče.
English: There is no evidence that the presence of pre-existing and treatment-induced anti-mCAR19 antibodies impacts the safety or effectiveness of Kymriah.
Croatian: Nema dokaza da prisutnost već postojećih i liječenjem induciranih anti-mCAR19 protutijela utječe na sigurnost ili učinkovitost lijeka Kymriah.
English: There are not enough data to determine whether there are any differences in efficacy or safety between different age subgroups, although the clinical benefit and safety experience in elderly patients with DLBCL above the age of 65 years (23% of the study population) were comparable to the overall population.
Croatian: Nema dovoljno podataka da bi se utvrdilo ima li kakvih razlika u djelotvornosti ili sigurnosti između različitih dobnih podskupina, iako su klinička korist i iskustvo vezano uz sigurnost primjene u starijih bolesnika s DLBCL-om iznad dobi od 65 godina (23% ispitivane populacije) bili usporedivi s cjelokupnom populacijom.
English: The infection will be treated before the Kymriah infusion.
Croatian: Infekcija će se liječiti prije infuzije lijeka Kymriah.
English: • Loss of appetite, weight loss
Croatian: • Gubitak apetita, gubitak tjelesne težine
English: B-cell ALL: The safety and efficacy of Kymriah in this population have not been established.
Croatian: ALL B-stanica: Sigurnost i djelotvornost lijeka Kymriah u ovoj populaciji nisu ustanovljene.
English: Very common (≥1/10)
Croatian: Vrlo često (≥1/10)
English: MRD (minimal residual disease) negative was defined as MRD by flow cytometry <0.01%.
Croatian: MRD (minimalna rezidualna bolest) negativan bilo je definirano kao MRD pomoću protočne citometrije <0,01%.
English: In vivo studies in immunocompromised mice did not show signs of abnormal cell growth or signs of clonal cell expansion for up to 7 months, which represents the longest meaningful observation period for immunocompromised mouse models.
Croatian: In vivo ispitivanja kod imunokompromitiranih miševa nisu pokazala znakove poremećenog staničnog rasta ili znakove ekspanzije klonalnih stanica u razdoblju do 7 mjeseci, što predstavlja najduže značajno razdoblje promatranja za imunokompromitirane mišje modele.
English: Update reports:
Croatian: Ažurirana izvješća:
English: Dispersion for infusion 10 mL - 50 mL per bag.
Croatian: Disperzija za infuziju 10 mL - 50 mL po vrećici.
English: Responding patients (CR/CRi)
Croatian: Bolesnici s odgovorom (CR/CRi)