FrancophonIA/ELRC3.0 huggingface dataset:
English: Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue.
Croatian: Idelalisib uzrokuje limfocitnu depleciju u slezeni, timusu, limfnim čvorovima i limfnom tkivu povezanom s crijevima.
English: Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Croatian: Ispitivanje 312-0119 bilo je randomizirano, kontrolirano, otvoreno ispitivanje u kojem su 173 ispitanika prethodno liječena zbog KLL primala idelalisib + ofatumumab.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Croatian: Liječenje Zydeligom mora se prekinuti u slučaju osipa 3. ili 4. stupnja.
English: • colchicine, a medicine used to treat gout
Croatian: • kolhicin, lijek koji se primjenjuje za liječenje gihta
English: ANTI-HYPERTENSIVES
Croatian: ANTIHIPERTENZIVI
English: Idelalisib in combination with rituximab
Croatian: Idelalisib u kombinaciji s rituksimabom
English: Study 312-0116 was a Phase 3, randomised, double-blind, placebo-controlled study in 220 subjects with previously treated CLL who required treatment but were not considered suitable for cytotoxic chemotherapy.
Croatian: Ispitivanje 312-0116 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje faze 3 na 220 ispitanika prethodno liječenih zbog KLL kojima je bilo potrebno liječenje, ali nisu bili pogodni za citotoksičnu kemoterapiju.
English: In general, the SmPC for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors (see section 4.4).
Croatian: Općenito, za preporuke o istovremenoj primjeni s CYP3A4 inhibitorima mora se pročitati SPC drugog lijeka (vidjeti dio 4.4).
English: Bepridil, disopyramide, lidocaine
Croatian: Bepridil, dizopiramid, lidokain
English: Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
Croatian: Ispitanici su primali idelalisib 150 mg dva puta dnevno i rituksimab 375 mg/m
English: Film-coated tablets 60 film-coated tablets
Croatian: OBLIK I SADRŽAJ Filmom obložene tablete 60 filmom obloženih tableta
English: Orange, oval-shaped, film-coated tablet of dimensions 9.7 mm by 6.0 mm, debossed on one side with “GSI” and “100” on the other side.
Croatian: Narančasta, ovalna filmom obložena tableta, dimenzija 9,7 x 6,0 mm, s utisnutom oznakom "GSI" s jedne i "100" s druge strane.
English: Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
Croatian: Pratite ABN najmanje jedanput tjedno sve dok ne bude ≥ 500/mm3, a zatim možete nastaviti s primjenom Zydeliga u dozi od 100 mg dvaput na dan.
English: If a patient misses a dose by more than 6 hours, the patient should not take the missed dose and simply resume the usual dosing schedule.
Croatian: Ako je od propuštene doze prošlo više od 6 sati, ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati lijek prema uobičajenom rasporedu doziranja.
English: Pink, oval-shaped, film-coated tablet of dimensions 10.0 mm by 6.8 mm, debossed on one side with “GSI” and “150” on the other side.
Croatian: Ružičasta, ovalna filmom obložena tableta, dimenzija 10,0 x 6,8 mm, s utisnutom oznakom "GSI" s jedne i "150" s druge strane.
English: • carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
Croatian: • karbamazepin, S-mefenitoin, fenitoin, lijekovi koji se primjenjuju za sprječavanje napadaja
English: There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
Croatian: Iskustva u liječenju bolesnika s ranijim upalnim bolestima crijeva vrlo su ograničena.
English: DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
Croatian: DOR (mjeseci) medijan (95% CI) PFS (mjeseci) medijan (95% CI) OS (mjeseci) medijan (95% CI)
English: Diarrhoea/colitis
Croatian: Proljev/kolitis
English: Elevated liver transaminases
Croatian: Prilagodba doze Povišena razina jetrenih transaminaza
English: Clarithromycin, telithromycin ↑ serum concentrations No dose adjustment of clarithromycin is required for patients with normal renal function or mild renal impairment (creatinine clearance [CrCl] 60-90 mL/min).
Croatian: ↑ koncentracije u serumu Nije potrebna prilagodba doze klaritromicina kod bolesnika s normalnom funkcijom bubrega ili blagim oštećenjem funkcije bubrega (klirens kreatinina [CrCl]
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
Croatian: Primarni metabolit idelalisiba, GS-563117, jaki je CYP3A4 inhibitor.
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Croatian: Idelalisib se primarno metabolizira putem aldehid-oksidaze, a u manjoj mjeri putem CYP3A i UGT1A4.
English: The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Croatian: Primarni metabolit idelalisiba, GS-563117, jaki je CYP3A inhibitor.
English: • budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
Croatian: • budezonid, flutikazon, lijekovi koji se primjenjuju za liječenje peludne groznice i astme te salmeterol, koji se primjenjuje za liječenje astme
English: Blood and lymphatic system disorders Neutropenia
Croatian: Poremećaji krvi i limfnog sustava Neutropenija vrlo često vrlo često
English: Clinical efficacy in chronic lymphocytic leukaemia
Croatian: Klinička djelotvornost u kroničnoj limfocitnoj leukemiji
English: Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Croatian: Vaši laboratorijski testovi krvi mogu pokazati povećanje broja bijelih krvnih stanica (nazivaju se „limfociti“).
English: The primary endpoint was the ORR defined as the proportion of subjects who achieved a CR or PR (based on the Revised Response Criteria for Malignant Lymphoma [Cheson]), and, for subjects with Waldenström macroglobulinaemia, a minor response (MR) (based on the Response Assessment for Waldenström macroglobulinaemia [Owen]).
Croatian: Revised Response Criteria for Malignant Lymphoma [Cheson]) i, za ispitanike s Waldenströmovom makroglobulinemijom, koji su dosegli slab odgovor (MR, minor response) (temeljeno na Procjeni odgovora na liječenje za Waldenströmovu makroglobulinemiju, engl.
English: Boceprevir, telaprevir
Croatian: Inhibitori HCV proteaze Boceprevir, telaprevir
English: • redness and blistering of the skin • swelling and blistering of the lining of the mouth, genitals, and/or eyes
Croatian: • oticanje i mjehure na sluznici usta, spolnih organa i/ili očiju.
English: Chronic lymphocytic leukaemia
Croatian: Kronične limfocitne leukemije
English: Adverse reactions are listed by system organ class and frequency.
Croatian: Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
English: Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Croatian: Pomoćne tvari Zydelig sadrži azo boju sunset yellow FCF (E110) koja može uzrokovati alergijske reakcije.
English: Investigations Increased triglycerides
Croatian: Povišene vrijednosti triglicerida vrlo često često
English: Hepatocellular injury
Croatian: Hepatocelularno oštećenje često često
English: Clinical efficacy in follicular lymphoma
Croatian: Klinička djelotvornost u folikularnom limfomu
English: ANTI-PSYCHOTICS/NEUROLEPTICS
Croatian: ANTIPSIHOTICI/NEUROLEPTICI Kvetiapin, pimozid
English: Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Croatian: Ispitivanje 312-0116 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem je 110 ispitanika prethodno liječenih zbog KLL primalo idelalisib + rituksimab.
English: Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily.
Croatian: Kada se vrijednosti vrate na 1. stupanj ili niže (ALT/AST ≤ 3 x GGN), može se nastaviti liječenje dozom od 100 mg dva puta dnevno.
English: Contains sunset yellow FCF (E110), see leaflet for further information.
Croatian: POPIS POMOĆNIH TVARI Sadrži boju sunset yellow FCF (E110), za daljnje informacije vidjeti uputu o lijeku.
English: Ketoconazole, itraconazole, posaconazole, voriconazole
Croatian: ANTIINFEKTIVI Antimikotici Ketokonazol, itrakonazol, posakonazol, vorikonazol
English: In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Croatian: U bolesnika u kojih se jave ozbiljni plućni događaji liječenje idelalisibom treba prekinuti te je bolesnika potrebno pregledati kako bi se razjasnila etiologija.
English: ↑ serum concentrations Idelalisib should not be co-administered with quetiapine or pimozide.
Croatian: ↑ koncentracije u serumu Idelalisib se ne smije istovremeno primjenjivati s kvetiapinom ili pimozidom.
English: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Croatian: • amiodaron, bepridil, dizopiramid, lidokain, kinidin, lijekovi koji se primjenjuju za liječenje srčanih tegoba
English: Follicular lymphoma
Croatian: Folikularnog limfoma
English: Idelalisib should not be co-administered with colchicine to patients with renal or hepatic impairment.
Croatian: Idelalisib se ne smije istovremeno primjenjivati s kolhicinom u bolesnika s oštećenjem funkcije bubrega ili jetre.
English: ANTICOAGULANTS
Croatian: ANTIKOAGULANSI
English: • diarrhoea/inflammation of the large intestine
Croatian: • proljev/upala debelog crijeva
English: The film-coated tablets are orange, oval-shaped tablets, debossed on one side with “GSI” and “100” on the other side.
Croatian: Filmom obložene tablete su narančaste, ovalne tablete s utisnutom oznakom “GSI” s jedne i “100” s druge strane.
English: • itraconazole, ketoconazole, posaconazole, voriconazole, medicines used to treat fungal infections • boceprevir, telaprevir, medicines used to treat hepatitis C
Croatian: • itrakonazol, ketokonazol, posakonazol, vorikonazol, lijekovi koji se primjenjuju za liječenje gljivičnih infekcija
English: ↑ serum concentrations ↑ serum concentrations
Croatian: ↑ koncentracije u serumu ↑ koncentracije u serumu
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), sunset yellow FCF (E110) (see Section 2, What you need to know before you take Zydelig).
Croatian: Poli(vinilni alkohol) (E1203), makrogol 3350 (E1521), titanijev dioksid (E171), talk (E553B), sunset yellow FCF (E110) (pogledajte dio 2, Što morate znati prije nego počnete uzimati
English: Each film-coated tablet contains 100 mg of idelalisib.
Croatian: Jedna filmom obložena tableta sadrži 100 mg idelalisiba.
English: ↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Croatian: ↑ koncentracije u serumu Preporučuje se kliničko praćenje terapijskog učinka i nuspojava.
English: • alfentanil, fentanyl, methadone, buprenorphine/naloxone, medicines used for pain relief
Croatian: • alfentanil, fentanil, metadon, buprenorfin/nalokson, lijekovi protiv bolova
English: PFS median (months) (95% CI) Hazard ratio (95% CI) ORR (95% CI)
Croatian: PFS medijan (mjeseci) (95% CI) Omjer hazarda (95% CI) ORR (95% CI)
English: If rash does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Croatian: Ako se osip ne javi ponovo, doza se može povećati na 150 mg dva puta dnevno, prema procjeni nadležnog liječnika (vidjeti dio 4.8).
English: Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.
Croatian: U kliničkim ispitivanjima idelalisiba uočena su povišenja vrijednosti ALT i AST 3. i 4. stupnja (> 5 x GGN).
English: If diarrhoea/colitis does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician (see section 4.8).
Croatian: Ako se proljev/kolitis ne javi ponovo, doza se može povećati na 150 mg dva puta dnevno, prema procjeni nadležnog liječnika (vidjeti dio 4.8).
English: Idelalisib should not be co-administered with sildenafil.
Croatian: Idelalisib se ne smije istovremeno primjenjivati sa sildenafilom.
English: ↑ serum concentrations Idelalisib should not be co-administered with alfuzosin.
Croatian: ↑ koncentracije u serumu Idelalisib se ne smije istovremeno primjenjivati s alfuzosinom.
English: Respiratory, thoracic and mediastinal disorders Pneumonitis
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja Pneumonitis često često
English: Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS^ Median (months) (95% CI)
Croatian: Omjer hazarda (95% CI) P-vrijednost ORR* n (%) (95% CI) Omjer izgleda (95% CI) P-vrijednost LNR** n/N (%) (95% CI) Omjer izgleda (95% CI) P-vrijednost OS^ Medijan (mjeseci) (95% CI)
English: Microcrystalline cellulose, hydroxypropyl cellulose (E463), croscarmellose sodium, sodium starch glycolate, magnesium stearate.
Croatian: Mikrokristalična celuloza, hidroksipropilceluloza (E463), umrežena karmelozanatrij, natrijev škroboglikolat, magnezijev stearat.
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis.
Croatian: Liječenje Zydeligom mora se prekinuti u slučaju proljeva/kolitisa 3. ili 4. stupnja.
English: Substrates of inducible enzymes (e.g., CYP2C9, CYP2C19, CYP2B6 and UGT) In vitro, idelalisib was an inducer of several enzymes, and a risk for decreased exposure and thereby decreased efficacy of substrates of inducible enzymes such as CYP2C9, CYP2C19, CYP2B6 and UGT cannot be excluded.
Croatian: In vitro, idelalisib je inducirao nekoliko enzima pa se ne može isključiti rizik od smanjene izloženosti supstratima inducibilnih enzima kao što su CYP2C9, CYP2C19, CYP2B6 i UGT te posljedično tome njihove smanjene djelotvornosti.
English: ANTICONVULSANTS
Croatian: ANTIKONVULZIVI
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 ALT/AST elevation and liver function monitored.
Croatian: U slučaju povišenja vrijednosti ALT/AST na 3. ili 4. stupanj, liječenje Zydeligom mora se prekinuti, a funkciju jetre treba pratiti.
English: The median age was 68 years (range: 61 to 74) with 64.0% of subjects over 65 years; 71.3% were male, and 84.3% were white; 63.6% had a Rai stage of III or IV, and 58.2% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 39.5% had a 17p chromosomal deletion and/or TP53 mutation, and 78.5% had unmutated genes for IGHV.
Croatian: Medijan dobi iznosio je 68 godina (raspon: 61-74), sa 64,0% ispitanika starijih od 65 godina; 71,3% muškaraca i 84,3% bijelaca; 63,6% imalo je Rai stadij III ili IV, a 58,2% imalo je Binet stadij C.
English: PFS median (months) (95% CI)
Croatian: PFS medijan (mjeseci) (95% CI)
English: Each film-coated tablet contains 150 mg of idelalisib.
Croatian: Jedna filmom obložena tableta sadrži 150 mg idelalisiba.
English: ↑ serum concentrations Idelalisib should not be co-administered with cisapride.
Croatian: ↑ koncentracije u serumu Idelalisib se ne smije istovremeno primjenjivati s cisapridom.
English: • sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
Croatian: • sildenafil, tadalafil, lijekovi koji se primjenjuju za liječenje impotencije i plućne hipertenzije,
English: CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Croatian: CI: interval pouzdanosti; O: ofatumumab; n: broj ispitanika s odgovorom; N: broj ispitanika u skupini; NR: nije dostignuto (od engl. not reached).
English: If you get any side effects, talk to your doctor.
Croatian: Ako imate problema s gutanjem tableta, obratite se svom liječniku.
English: Package leaflet: Information for the patient Zydelig 150 mg film-coated tablets idelalisib
Croatian: Uputa o lijeku: Informacije za bolesnika Zydelig 150 mg filmom obložene tablete idelalisib
English: Zydelig 150 mg film-coated tablets idelalisib
Croatian: Zydelig 150 mg filmom obložene tablete idelalisib
English: Zydelig 100 mg film-coated tablets idelalisib
Croatian: Zydelig 100 mg filmom obložene tablete idelalisib
English: PFS Median (months) (95% CI) Hazard ratio (95% CI) P-value ORR* n (%) (95% CI) Odds ratio (95% CI) P-value LNR** n/N (%) (95% CI) Odds ratio (95% CI) P-value OS Median (months) (95% CI)
Croatian: PFS Medijan (mjeseci) (95% CI) Omjer hazarda (95% CI) P-vrijednost ORR* n (%) (95% CI) Omjer izgleda (95% CI) P-vrijednost LNR** n/N (%) (95% CI) Omjer izgleda (95% CI) P-vrijednost OS Medijan (mjeseci) (95% CI)
English: Idelalisib should not be co-administered with lovastatin or simvastatin.
Croatian: Idelalisib se ne smije istovremeno primjenjivati s lovastatinom ili simvastatinom.
English: Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Croatian: U bolesnika liječenih idelalisibom pojavila se neutropenija 3. ili 4. stupnja nakon početka liječenja, uključujući febrilnu neutropeniju.
English: Package leaflet: Information for the patient Zydelig 100 mg film-coated tablets idelalisib
Croatian: Uputa o lijeku: Informacije za bolesnika Zydelig 100 mg filmom obložene tablete idelalisib
English: You will need regular blood tests before and during treatment with Zydelig.
Croatian: Prije i tijekom liječenja Zydeligom, trebate obavljati uobičajene pretrage krvi.
English: CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Croatian: CI: interval pouzdanosti; R: rituksimab; n: broj ispitanika s odgovorom; N: broj ispitanika u skupini; NR: nije dostignuto (engl. not reached).
English: Medicinal product
Croatian: FARMACEUTSKI PODACI
English: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
Croatian: Jezgra tablete celuloza, mikrokristalična hidroksipropilceluloza (E463) karmelozanatrij, umrežena natrijev škroboglikolat magnezijev stearat
English: Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Croatian: Kada se proljev/kolitis povuče na 1. stupanj ili niže, može se nastaviti liječenje dozom od 100 mg dva puta dnevno.
English: Inhaled/nasal corticosteroids: Budesonide, fluticasone
Croatian: Inhalacijski/nazalni kortikosteroidi:
English: • liver damage
Croatian: Oštećenje funkcije jetre
English: ANTI-INFECTIVES Antifungals
Croatian: ANTITUMORSKI LIJEKOVI
English: • dasatinib, nilotinib, paclitaxel, vinblastine, vincristine, medicines used to treat cancer • oral or implanted hormonal contraceptives, used to prevent pregnancy
Croatian: • dasatinib, nilotinib, paklitaksel, vinblastin, vinkristin, lijekovi koji se primjenjuju za liječenje raka
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Iron oxide red (E172)
Croatian: Film ovojnica poli(vinilni alkohol) (E1203) makrogol 3350 (E1521) titanijev dioksid (E171) talk (E553B) crveni željezov oksid (E172)
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
Croatian: Film ovojnica: Poli(vinilni alkohol) (E1203), makrogol 3350 (E1521), titanijev dioksid (E171), talk (E553B), crveni željezov oksid (E172).
English: Bosentan
Croatian: Nuspojava
English: Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Croatian: Kada se osip povuče na 1. stupanj ili niže, može se nastaviti liječenje dozom od 100 mg dva puta dnevno.
English: ↑ serum concentrations Anticonvulsant drug levels should be monitored.
Croatian: ↑ koncentracije u serumu Potrebno je pratiti razine antikonvulzivnog lijeka.
English: The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Croatian: Kako Zydelig izgleda i sadržaj pakiranja Filmom obložene tablete su ružičaste, ovalne tablete s utisnutom oznakom “GSI” s jedne i “150” s druge strane.
English: You must also use a barrier method of contraception such as condoms or the “coil” while taking Zydelig and for 1 month after your last treatment.
Croatian: Dok uzimate Zydelig i još mjesec dana nakon završetka liječenja morate koristiti i barijernu metodu kontracepcije, kao što su kondomi ili „spirala“.
English: Zydelig 150 mg film-coated tablets
Croatian: NAZIV LIJEKA Zydelig 150 mg filmom obložene tablete
English: CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Croatian: CI: interval pouzdanosti; R: rituksimab; N: broj ispitanika u skupini, NR: nije dostignuto
English: The median age was 71 years (range: 47 to 92) with 78.2% of subjects over 65 years; 65.5% were male, and 90.0% were white; 64.1% had a Rai stage of III or IV, and 55.9% had Binet Stage C. Most subjects had adverse cytogenetic prognostic factors: 43.2% had a 17p chromosomal deletion and/or tumour protein 53 (TP53) mutation, and 83.6% had unmutated genes for the immunoglobulin heavy chain variable region (IGHV).
Croatian: Medijan dobi ispitanika iznosio je 71 godinu (raspon: 47-92) sa 78,2% ispitanika starijih od 65 godina; 65,5% muškaraca i 90,0% bijelaca; 64,1% imalo je Rai stadij III ili IV, a 55,9% Binet stadij C.
English: Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
Croatian: Tablica 4: Kratak pregled PFS-a i stopa odgovora u unaprijed određenim podskupinama iz ispitivanja 312-0116
English: Hazard ratio (95% CI) ORR (95% CI)
Croatian: Omjer hazarda (95% CI) ORR (95% CI) Dob ≥ 65 godina
English: EU/1/14/938/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/938/001
English: • inflammation of the lungs
Croatian: • upala pluća • oštećenja jetre
English: Zydelig 100 mg film-coated tablets
Croatian: NAZIV LIJEKA Zydelig 100 mg filmom obložene tablete
English: Subjects were randomised 1:1 to receive 8 cycles of rituximab (first cycle at 375 mg/m2 body surface area [BSA], subsequent cycles at 500 mg/m2 BSA) in combination with either an oral placebo twice daily or with idelalisib 150 mg taken twice daily until disease progression or unacceptable toxicity.
Croatian: BSA) u kombinaciji s placebom uzimanim peroralno dva puta dnevno ili s idelalisibom 150 mg dva puta dnevno do progresije bolesti ili neprihvatljive toksičnosti.
English: ↑ serum concentrations
Croatian: ↑ koncentracije u serumu
English: Ofatumumab N = 87
Croatian: N = 87
English: EU/1/14/938/002
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/14/938/002
English: ↑ serum concentrations Therapeutic monitoring is recommended.
Croatian: ↑ koncentracije u serumu Preporučuje se terapijsko praćenje.
English: Subjects had a median CIRS score of 4.
Croatian: Medijan bodova na ljestvici CIRS u ispitanika bio je 4. Medijan broja prethodnih terapija bio je 3,0.
English: ↑ serum concentrations Clinical monitoring is recommended.
Croatian: ↑ koncentracije u serumu Preporučuje se kliničko praćenje.
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Croatian: Film ovojnica poli(vinilni alkohol) (E1203) makrogol 3350 (E1521) titanijev dioksid (E171) talk (E553B)
English: [ULN]).
Croatian: Zydelig).
English: Table 6: Summary of PFS and response rates in pre-specified subgroups from study 312-0119 Idelalisib + O Ofatumumab
Croatian: Tablica 6: Kratak pregled PFS-a i stopa odgovora u unaprijed određenim podskupinama iz ispitivanja 312-0119
English: Oral budesonide
Croatian: RECEPTORA Bosentan
English: • rifampicin, a medicine used to prevent and treat tuberculosis and other infections • St. John's wort (Hypericum perforatum), a herbal remedy used for depression and anxiety
Croatian: • gospinu travu (Hypericum perforatum), biljni pripravak za liječenje depresije i tjeskobe
English: Reaction
Croatian: Doziranje
English: Frequencies are defined as follows: very common
Croatian: vrlo često vrlo često