natgillin/translations-raw huggingface dataset:
Therefore, women of childbearing potential must use highly effective contraception while taking Zydelig and for 1 month after stopping treatment.
Stoga žene reproduktivne dobi moraju koristiti visoko učinkovitu kontracepciju dok uzimaju Zydelig i još mjesec dana nakon prestanka liječenja.
Each tablet contains 0.1 mg sunset yellow FCF (E110) (see section 4.4).
Jedna tableta sadrži 0,1 mg boje sunset yellow FCF (E110) (vidjeti dio 4.4).
Higher frequencies of infections overall, including Grade 3 and 4 infections, were observed in the idelalisib arms compared to the control arms of idelalisib clinical studies.
U skupinama liječenim idelalisibom uočene su veće učestalosti svih infekcija, uključujući infekcije 3. i 4. stupnja, u usporedbi s kontrolnim skupinama u kliničkim ispitivanjima idelalisiba.
Idelalisib should not be co-administered with midazolam (oral) or triazolam.
Idelalisib se ne smije istovremeno primjenjivati s midazolamom (uzimanim peroralno) ili triazolamom.
There are no or limited amount of data from the use of idelalisib in pregnant women.
Nema podataka ili su podaci o primjeni idelalisiba u trudnica ograničeni.
Following oral administration of a single dose of idelalisib, peak plasma concentrations were observed 2 to 4 hours post-dose under fed conditions and after 0.5 to 1.5 hours under fasted conditions.
Nakon primjene jedne doze idelalisiba peroralno vršna koncentracija u plazmi postiže se za 2 - 4 sata ako je doza uzeta s hranom i za 0,5 - 1,5 sati ako je uzeta natašte.
Skin and subcutaneous tissue disorders Rash***
Poremećaji kože i potkožnog tkiva Osip***
The ORR was 96.9%, with 12 CRs (18.8%) and 50 PRs (78.1%), including 3 CRs and 6 PRs in subjects with a 17p deletion and/or TP53 mutation and 2 CRs and 34 PRs in subjects with unmutated IGHV.
ORR je iznosio 96,9% s 12 CR-ova (18,8%) i 50 PR-ova (78,1%), uključujući 3 CR-a i 6 PR-ova u ispitanika s delecijom 17p i/ili mutacijom TP53 te 2 CR-a i 34 PR-a u ispitanika s nemutiranim IGHV.
No human data on the effect of idelalisib on fertility are available.
Nema podataka o utjecaju idelalisiba na plodnost ljudi.
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Savjetuje se oprez ako se Zydelig primjenjuje zajedno s lijekovima uske terapijske širine koji su supstrati CYP2C8 (paklitaksel).
• cisapride, a medicine used to relieve certain stomach problems
• cisaprid, lijek koji se primjenjuje za ublažavanje određenih želučanih tegoba
Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Zabilježeni su slučajevi pneumonitisa i organizirajuće pneumonije (neki sa smrtnim ishodom) s idelalisibom.
Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Idelalisib inducira apoptozu i inhibira proliferaciju staničnih linija dobivenih iz zloćudnih B-stanica te primarnih tumorskih stanica.
Its primary metabolite is GS-563117, which is not pharmacologically active.
Njegov primarni metabolit je GS-563117 koji nije farmakološki aktivan.
Blood counts should be monitored in all patients at least every 2 weeks for the first 6 months of treatment with idelalisib, and at least weekly in patients while ANC is less than 1,000 per mm3 (see section 4.2).
Potrebno je pratiti krvnu sliku u svih bolesnika najmanje svaka 2 tjedna tijekom prvih 6 mjeseci liječenja idelalisibom, a najmanje jednaput tjedno dok je u bolesnika ABN manji od 1000 po mm
Following 150 mg twice daily administration of idelalisib, average (range) Cmax and AUC at steady-state were 1,953 (272; 3,905) ng/mL and 10,439 (2,349; 29,315) ng•h/mL for idelalisib and 4,039 (669; 10,897) ng/mL and 39,744 (6,002; 119,770) ng•h/mL for GS-563117, respectively.
Nakon primjene 150 mg idelalisiba dva puta dnevno prosječna (raspon) Cmax i AUC u stanju dinamičke ravnoteže iznosile su 1953 (272; 3905) ng/ml i 10 439 (2349; 29 315) ng•h/ml za idelalisib te 4039 (669; 10 897) ng/ml i 39 744 (6002; 119 770) ng•h/ml za GS-563117.
The Kaplan-Meier curve for PFS is provided in Figure 2.
Kaplan-Meierova krivulja PFS-a prikazana je na slici 2.
Follicular lymphoma (FL) is a cancer of a type of white blood cell called B-lymphocytes.
Folikularni limfom (FL) je rak vrste bijelih krvnih stanica koje se zovu B limfociti.
ANC should be monitored at least weekly until ANC is ≥ 500 per mm3 when treatment can be resumed at 100 mg twice daily (see section 4.4).
ABN treba pratiti najmanje jedanput tjedno sve dok ne bude ≥ 500 po mm3, kada se liječenje može nastaviti u dozi od 100 mg dvaput na dan (vidjeti dio 4.4).
Study 312-0119 was a Phase 3, randomised, open-label, multicentre, parallel-group study in 261 subjects with previously treated CLL who had measurable lymphadenopathy, required treatment, and experienced CLL progression < 24 months since the completion of the last prior therapy.
Ispitivanje 312-0119 bilo je randomizirano, otvoreno, multicentrično ispitivanje faze 3 na usporednim skupinama provedeno u 261 ispitanika prethodno liječenih zbog KLL koji su imali mjerljivu limfadenopatiju, zahtijevali liječenje i u kojih je progresija KLL nastupila za < 24 mjeseca od završetka zadnje prethodne terapije.
In vitro data indicated that idelalisib is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A, or UGT1A1, or of the transporters OAT1, OAT3, or OCT2.
In vitro podaci pokazali su da idelalisib nije inhibitor metaboličkih enzima CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A ili UGT1A1 ili prijenosnika OAT1, OAT3 ili OCT2.
The first infusion of ofatumumab was administered at a dose of 300 mg and was continued at a dose of either 1,000 mg in the idelalisib + ofatumumab group or a dose of 2,000 mg in the ofatumumab only group, weekly for 7 doses, and then every 4 weeks for 4 doses.
Ofatumumab se u prvoj infuziji primijenio u dozi od 300 mg te se nastavio primjenjivati u dozi od 1000 mg u skupini koja je primala idelalisib + ofatumumab ili u dozi od 2000 mg u skupini koja je primala samo ofatumumab svakog tjedna dok se nije primijenilo 7 doza, a potom svaka 4 tjedna dok se nije primijenilo 4 doze.
ANC 500 to < 1,000/mm3
ABN 500 do < 1000/mm3
No dose adjustment is required when initiating treatment with Zydelig in patients with mild or moderate hepatic impairment, but an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Nije potrebna prilagodba doze za početak liječenja Zydeligom u bolesnika s blagim ili umjerenim oštećenjem funkcije jetre, ali se preporučuje pojačani nadzor zbog nuspojava (vidjeti dijelove 4.4 i 5.2).
Effect of idelalisib on the pharmacokinetics of other medicinal products
Učinak idelalisiba na farmakokinetiku drugih lijekova
The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ.
Njegov primarni i jedini cirkulirajući metabolit, GS-563117, je inaktivan prema PI3Kδ.
• dihydroergotamine, ergotamine, medicines used to treat migraine headache
• dihidroergotamin, ergotamin, lijekovi koji se primjenjuju za liječenje migrene
Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
ERGOT ALKALOIDI Ergotamin, dihidroergotamin ↑ koncentracije u serumu Idelalisib se ne smije istovremeno primjenjivati s ergotaminom ili dihidroergotaminom.
Interrupt Zydelig dosing.
Prekinite doziranje Zydeliga.
• if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes
• ako imate oticanje i mjehure na sluznici usta, spolnih organa i/ili očiju.
Therefore, caution is recommended when administering Zydelig in this population and an intensified monitoring of adverse reactions is recommended (see sections 4.4 and 5.2).
Zbog toga se preporučuje oprez i pojačani nadzor zbog nuspojava pri primjeni Zydeliga u ovoj populaciji (vidjeti dijelove 4.4 i 5.2).
Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Slika 1: Kaplan-Meierova krivulja PFS-a u ispitivanju 312-0116 (populacija s namjerom liječenja)
The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6.
Rezultati djelotvornosti sažeti su u tablicama 5 i 6.
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2).
Nije potrebna prilagodba doze za bolesnike s blagim, umjerenim ili teškim oštećenjem funkcije bubrega (vidjeti dio 5.2).
Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively.
Nakon jednokratne peroralne doze od 150 mg idelalisiba označenog ugljikom [14C] približno 78% izlučeno je stolicom, a 15% mokraćom.
* ORR defined as the proportion of subjects who achieved a complete response (CR) or partial response (PR) based on the 2013 National Comprehensive Cancer Network (NCCN) response criteria and Cheson (2012).
* ORR je definiran kao udio ispitanika koji su postigli potpuni odgovor (CR, complete response) ili parcijalni odgovor (PR, partial response) prema kriterijima odgovora National Comprehensive Cancer Network (NCCN)
Among the 122 subjects with measurable lymph nodes at both baseline and post-baseline, 71 subjects (58.2%) achieved a ≥ 50% decrease from baseline in the sum of the products of the diameters (SPD) of index lesions.
Od 122 ispitanika s mjerljivim limfnim čvorovima na prvom i kasnijim pregledima, 71 ispitanik (58,2%) dosegao je smanjenje zbroja umnožaka promjera (SPD) praćenih lezija ≥ 50% u odnosu na početak.
In rats, idelalisib has the potential to inhibit T-dependent antibody responses.
Idelalisib je u štakora pokazao mogućnost inhibicije imunološkog odgovora protutijelima ovisnog o T limfocitima.
↑ serum concentrations It is recommended that the international normalised ratio (INR) be monitored upon co-administration and following ceasing treatment with idelalisib.
↑ koncentracije u serumu Preporučuje se pratiti međunarodni normalizirani omjer (INR) pri istovremenoj primjeni i nakon prestanka liječenja idelalisibom.
No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
U kliničkim ispitivanjima nisu utvrđena objašnjenja mehanizma za razvoj rezistencije na liječenje idelalisibom.
CYP3A substrates
CYP3A supstrati
Evaluation of the potential for phototoxicity in the embryonic murine fibroblast cell line BALB/c 3T3 was inconclusive for idelalisib due to cytotoxicity in the in vitro assay.
Procjena moguće fototoksičnosti idelalisiba na staničnoj liniji BALB/c 3T3 embrionalnih fibroblasta miša nije dovela do konačnog zaključka zbog citotoksičnosti na in vitro testu.
Relative to fasting conditions, administration of an early capsule formulation of idelalisib with a highfat meal resulted in no change in Cmax and a 36% increase in mean AUCinf.
U usporedbi s primjenom natašte, primjena idelalisiba u kapsuli formuliranoj u ranoj fazi razvoja lijeka s obrokom bogatim mastima nije uzrokovala promjene u Cmax, a srednja vrijednost AUCinf porasla je za 36%.
↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
↑ koncentracije u serumu Preporučuje se pažljivi nadzor tolerancije na ove antitumorske lijekove.
How to store Zydelig
Kako čuvati Zydelig
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4).
Idelalisib se primarno metabolizira putem aldehid-oksidaze, a u manjoj mjeri putem CYP3A i glukuronidacije (UGT1A4).
Zydelig contains sunset yellow FCF (E110)
Zydelig sadrži boju sunset yellow FCF (E110)
A clinical drug interaction study found that co-administration of a single dose of 400 mg idelalisib with 400 mg once daily ketoconazole (a strong CYP3A, P-gp and BCRP inhibitor) resulted in a 26% increase in Cmax and a 79% increase in AUCinf of idelalisib.
Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena jedne doze od 400 mg idelalisiba s 400 mg ketokonazola jednom dnevno (jakim CYP3A, P-gp i BCRP inhibitorom) izaziva porast Cmax idelalisiba za 26% te porast AUCinf za 79%.
A clinical drug interaction study found that co-administration of idelalisib with midazolam (a sensitive CYP3A substrate) resulted in a ~140% increase in Cmax and a ~440% increase in AUCinf of midazolam due to the CYP3A inhibition by GS-563117.
Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena idelalisiba s midazolamom (osjetljivim supstratom za CYP3A) izaziva porast Cmax midazolama za ~140% i AUCinf za ~440% zbog inhibicije CYP3A metabolitom GS-563117.
Midazolam (oral), triazolam
SEDATIVI/HIPNOTICI Midazolam (uziman peroralno), triazolam
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems
• amlodipin, diltiazem, felodipin, nikardipin, nifedipin, lijekovi koji se primjenjuju za liječenje povišenog krvnog tlaka i srčanih tegoba
Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110
Tablica 3: Rezultati djelotvornosti iz ispitivanja 312-0116 Idelalisib + R
Zydelig can cause severe diarrhoea.
Zydelig može uzrokovati teški proljev.
Zydelig is for oral use.
Zydelig se uzima peroralno.
Idelalisib should not be co-administered with amiodarone or quinidine.
Idelalisib se ne smije istovremeno primjenjivati s amiodaronom ili kinidinom.
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
• buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem, lijekovi koji se primjenjuju za liječenje poremećaja živčanog sustava
Fentanyl, alfentanil, methadone, buprenorphine/naloxone
ANALGETICI Fentanil, alfentanil, metadon, buprenorfin/nalokson
Figure 2: Kaplan-Meier curve of PFS from study 312-0119 (intent-to-treat population)
Slika 2: Kaplan Meierova krivulja PFS-a u ispitivanju 312-0119 (populacija s namjerom liječenja)
*** Includes the preferred terms dermatitis exfoliative generalised, drug eruption, rash, rash erythematous, rash generalised, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, rash vesicular, papule, skin plaque, and exfoliative rash.
*** Uključuje preporučene izraze: generalizirani eksfolijativni dermatitis, izbijanje kožnih promjena uzrokovano lijekom, osip, eritematozni osip, generalizirani osip, makularni osip, makulopapularni osip, papularni osip, pruritični osip, pustularni osip, vezikularni osip, papula, plak na koži i eksfolijativni osip.
Serious and fatal infections have occurred in patients taking Zydelig.
U bolesnika koji uzimaju Zydelig pojavile su se ozbiljne i smrtonosne infekcije.
The terminal elimination half-life of idelalisib was 8.2 (range: 1.9; 37.2) hours and the apparent clearance of idelalisib was 14.9 (range: 5.1; 63.8) L/h following idelalisib 150 mg twice daily oral administration.
Poluvrijeme terminalne eliminacije idelalisiba bilo je 8,2 (raspon: 1,9 - 37,2) sata, a prividni klirens 14,9 (raspon: 5,1 - 63,8) l/h nakon peroralne primjene 150 mg dva puta dnevno.
CI: confidence interval; O: ofatumumab; N: number of subjects per group
CI: interval pouzdanosti; O: ofatumumab; N: broj ispitanika u skupini
If the event does not recur, the dose can be re-escalated to 150 mg twice daily at the discretion of the treating physician.
Ako se povišenje ne ponovi, doza se može ponovno povećati na 150 mg dva puta dnevno, prema procjeni nadležnog liječnika.
↑ serum concentrations Increased monitoring for rifabutinassociated adverse reactions including neutropenia and uveitis is recommended.
↑ koncentracije u serumu Preporučuje se pojačan nadzor zbog nuspojava povezanih s rifabutinom uključujući neutropeniju i uveitis.
HMG CO-A REDUCTASE INHIBITORS
INHIBITORI HMG-CoA REDUKTAZE Lovastatin, simvastatin
A clinical drug interaction study found that co-administration of a single dose of 150 mg idelalisib with rifampicin (a strong CYP3A inducer) resulted in a ~75% reduction in idelalisib AUCinf.
Kliničko ispitivanje interakcija lijekova pokazalo je da istovremena primjena jedne doze od 150 mg idelalisiba s rifampicinom (jakim CYP3A induktorom) izaziva smanjenje AUCinf idelalisiba za ~75%.
Clinical recommendation upon co-administration with idelalisib
Klinička preporuka za istovremenu primjenu s idelalisibom
It is not known whether the active substance in Zydelig passes into human milk.
Nije poznato izlučuje li se djelatna tvar iz Zydeliga u majčino mlijeko.
Idelalisib induced lymphoid depletion in spleen, thymus, lymph nodes and gut-associated lymphoid tissue.
Idelalisib uzrokuje limfocitnu depleciju u slezeni, timusu, limfnim čvorovima i limfnom tkivu povezanom s crijevima.
Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Ispitivanje 312-0119 bilo je randomizirano, kontrolirano, otvoreno ispitivanje u kojem su 173 ispitanika prethodno liječena zbog KLL primala idelalisib + ofatumumab.
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Liječenje Zydeligom mora se prekinuti u slučaju osipa 3. ili 4. stupnja.
• colchicine, a medicine used to treat gout
• kolhicin, lijek koji se primjenjuje za liječenje gihta
ANTI-HYPERTENSIVES
ANTIHIPERTENZIVI
Idelalisib in combination with rituximab
Idelalisib u kombinaciji s rituksimabom
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.
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.
In general, the SmPC for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors (see section 4.4).
Općenito, za preporuke o istovremenoj primjeni s CYP3A4 inhibitorima mora se pročitati SPC drugog lijeka (vidjeti dio 4.4).
Bepridil, disopyramide, lidocaine
Bepridil, dizopiramid, lidokain
Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
Ispitanici su primali idelalisib 150 mg dva puta dnevno i rituksimab 375 mg/m
Film-coated tablets 60 film-coated tablets
OBLIK I SADRŽAJ Filmom obložene tablete 60 filmom obloženih tableta
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.
Narančasta, ovalna filmom obložena tableta, dimenzija 9,7 x 6,0 mm, s utisnutom oznakom "GSI" s jedne i "100" s druge strane.
Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily.
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.
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.
Ako je od propuštene doze prošlo više od 6 sati, ne treba uzeti propuštenu dozu nego jednostavno nastaviti uzimati lijek prema uobičajenom rasporedu doziranja.
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.
Ružičasta, ovalna filmom obložena tableta, dimenzija 10,0 x 6,8 mm, s utisnutom oznakom "GSI" s jedne i "150" s druge strane.
• carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
• karbamazepin, S-mefenitoin, fenitoin, lijekovi koji se primjenjuju za sprječavanje napadaja
There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
Iskustva u liječenju bolesnika s ranijim upalnim bolestima crijeva vrlo su ograničena.
DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI)
DOR (mjeseci) medijan (95% CI) PFS (mjeseci) medijan (95% CI) OS (mjeseci) medijan (95% CI)
Diarrhoea/colitis
Proljev/kolitis
Elevated liver transaminases
Prilagodba doze Povišena razina jetrenih transaminaza
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).
↑ koncentracije u serumu Nije potrebna prilagodba doze klaritromicina kod bolesnika s normalnom funkcijom bubrega ili blagim oštećenjem funkcije bubrega (klirens kreatinina [CrCl]
The primary metabolite of idelalisib, GS-563117, is a strong CYP3A4 inhibitor.
Primarni metabolit idelalisiba, GS-563117, jaki je CYP3A4 inhibitor.
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Idelalisib se primarno metabolizira putem aldehid-oksidaze, a u manjoj mjeri putem CYP3A i UGT1A4.
The primary metabolite of idelalisib, GS-563117, is a strong CYP3A inhibitor.
Primarni metabolit idelalisiba, GS-563117, jaki je CYP3A inhibitor.
• budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma
• budezonid, flutikazon, lijekovi koji se primjenjuju za liječenje peludne groznice i astme te salmeterol, koji se primjenjuje za liječenje astme
Blood and lymphatic system disorders Neutropenia
Poremećaji krvi i limfnog sustava Neutropenija vrlo često vrlo često
Clinical efficacy in chronic lymphocytic leukaemia
Klinička djelotvornost u kroničnoj limfocitnoj leukemiji
Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Vaši laboratorijski testovi krvi mogu pokazati povećanje broja bijelih krvnih stanica (nazivaju se „limfociti“).
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]).
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.
Boceprevir, telaprevir
Inhibitori HCV proteaze Boceprevir, telaprevir
• redness and blistering of the skin • swelling and blistering of the lining of the mouth, genitals, and/or eyes
• oticanje i mjehure na sluznici usta, spolnih organa i/ili očiju.
Chronic lymphocytic leukaemia
Kronične limfocitne leukemije
Adverse reactions are listed by system organ class and frequency.
Nuspojave su navedene prema klasifikaciji organskih sustava i učestalosti.
Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Pomoćne tvari Zydelig sadrži azo boju sunset yellow FCF (E110) koja može uzrokovati alergijske reakcije.
Investigations Increased triglycerides
Povišene vrijednosti triglicerida vrlo često često
Hepatocellular injury
Hepatocelularno oštećenje često često
Clinical efficacy in follicular lymphoma
Klinička djelotvornost u folikularnom limfomu
ANTI-PSYCHOTICS/NEUROLEPTICS
ANTIPSIHOTICI/NEUROLEPTICI Kvetiapin, pimozid
Study 312-0116 was a randomised, double-blind, placebo-controlled study in which 110 subjects with previously treated CLL received idelalisib + rituximab.
Ispitivanje 312-0116 bilo je randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u kojem je 110 ispitanika prethodno liječenih zbog KLL primalo idelalisib + rituksimab.
Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily.
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.
Contains sunset yellow FCF (E110), see leaflet for further information.
POPIS POMOĆNIH TVARI Sadrži boju sunset yellow FCF (E110), za daljnje informacije vidjeti uputu o lijeku.
Ketoconazole, itraconazole, posaconazole, voriconazole
ANTIINFEKTIVI Antimikotici Ketokonazol, itrakonazol, posakonazol, vorikonazol