natgillin/translations-raw huggingface dataset:
• sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult 
• sildenafil, tadalafil, zdravili, ki se uporabljata za zdravljenje impotence in pljučne hipertenzije - bolezni pljuč, ki otežuje dihanje
Following a single 150 mg oral dose of [14C]-labelled idelalisib, approximately 78% and 15% was excreted in faeces and urine, respectively. 
Po peroralnem dajanju enega 150 mg odmerka s [14C] označenega idelaliziba se ga je približno 78 % izločilo v blatu in približno 15 % v urinu.
• ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant 
• ciklosporin, sirolimus, takrolimus, zdravila za nadzor imunskega odziva telesa po presaditvi
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). 
Pri vseh bolnikih je treba prvih 6 mesecev zdravljenja z idelalizibom najmanj vsaka 2 tedna spremljati krvno sliko, pri bolnikih z ANC pod 1.000 na mm3 pa najmanj enkrat tedensko (glejte poglavje 4.2).
For patients with evidence of CMV viraemia and clinical signs of CMV infection, consideration should be given to interrupting idelalisib until the infection has resolved. 
Pri bolnikih z znaki viremije CMV in kliničnimi znaki okužbe s CMV je treba razmisliti o prekinitvi zdravljenja z idelalizibom, dokler okužba ne izgine.
Its primary metabolite is GS-563117, which is not pharmacologically active. 
Njegov primarni presnovek je GS-563117, ki ni farmakološko aktiven.
Serum transaminase elevations correlated with hepatic necrosis in dogs, but were not observed in rats. 
Povečanje transaminaze v serumu je bilo pri psih soodvisno od jetrne nekroze, pri podganah pa tega niso opazili.
Stevens-Johnson syndrome and toxic epidermal necrolysis Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) with fatal outcomes have been reported when idelalisib was administered concomitantly with other medicinal products associated with these syndromes. 
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza Poročali so o Stevens-Johnsonovem sindromu (SJS) in toksični epidermalni nekrolizi (TEN) s smrtnimi izidi, ko so idelalizib dajali sočasno z drugimi zdravili, povezanimi s tema sindromoma.
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. 
Med 122 osebami z merljivimi bezgavkami ob izhodišču in po izhodišču je 71 oseb (58,2 %) doseglo ≥ 50-odstotno zmanjšanje od izhodišča glede na vsoto zmnožkov premerov (SPD) indikacijskih lezij.
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin). 
Previdnost se svetuje pri uporabi zdravila Zydelig skupaj z zdravili z ozkim terapevtskim indeksom, ki so substrati teh encimov (varfarin, fenitoin, S-mefenitoin).
GS-563117 is not an inhibitor of the metabolising enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or UGT1A1, or of the transporters P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3, or OCT2. 
GS-563117 ni zaviralec presnovnih encimov CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali UGT1A1 ali prenašalcev P-gp, BCRP, OATP1B1, OATP1B3, OAT1, OAT3 ali OCT2.
Monitor ANC at least weekly until ANC ≥ 500/mm3, then may resume Zydelig dosing at 100 mg twice daily. 
ANC spremljajte najmanj enkrat tedensko, dokler ni ANC ≥ 500/mm3, nato lahko nadaljujete z odmerjanjem zdravila Zydelig 100 mg dvakrat dnevno.
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. 
Po odmerjanju idelaliziba 150 mg dvakrat na dan sta bila povprečna (razpon) Cmax in AUC v stanju dinamičnega ravnovesja 1.953 (272; 3.905) ng/ml in 10.439 (2.349; 29.315) ng•h/ml za idelalizib oz. 4.039 (669; 10.897) ng/ml in 39.744 (6.002; 119.770) ng•h/ml za GS-563117.
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. 
Prvo infundiranje ofatumumaba je vključevalo odmerek 300 mg in se je nadaljevalo s 7 tedenskimi odmerki 1.000 mg v skupini z idelalizibom + ofatumumabom ali 2.000 mg v skupini, ki je prejemala samo ofatumumab, nato pa s 4 odmerki vsake 4 tedne.
Caution should be exercised when administering Zydelig in patients with active hepatitis. 
Pri dajanju zdravila Zydelig bolnikom z aktivnim hepatitisom je potrebna previdnost.
In addition, 86 subjects from this study who were randomised to receive placebo + rituximab went on to receive idelalisib as a single agent in an extension study (study 312-0117). 
Poleg tega je 86 oseb iz te študije, ki so bili randomizirani za prejemanje placeba + rituksimaba, v podaljšani študiji (študija 312-0117) nadaljevalo s prejemanjem samostojnega idelaliziba.
Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) Rarely, cases of SJS and TEN have occurred when idelalisib was administered concomitantly with other medicinal products associated with these syndromes (bendamustine, rituximab, allopurinol, and amoxicillin). 
Stevens-Johnsonov sindrom in toksična epidermalna nekroliza (glejte poglavje 4.4) Redko so poročali o primerih SJS in TEN, ko so idelalizib dajali sočasno z drugimi zdravili, povezanimi s tema sindromoma (bendamustin, rituksimab, alopurinol in amoksicilin).
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. 
Če bolnik izpusti odmerek za več kot 6 ur, naj bolnik ne nadomesti izpuščenega odmerka in nadaljuje z jemanjem po običajnem režimu odmerjanja.
Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses. 
Osebe so prejemale idelalizib 150 mg dvakrat na dan in 8 tedenskih odmerkov rituksimaba 375 mg/m2 BSA.
ENDOTHELIN RECEPTOR ANTAGONISTS 
ANTAGONISTI RECEPTORJEV ENDOTELINA bosentan
How to take Zydelig 
Kako jemati zdravilo Zydelig
Idelalisib should not be co-administered with midazolam (oral) or triazolam. 
Idelaliziba se ne sme dati sočasno z midazolamom (peroralnim) ali triazolamom.
The Kaplan-Meier curve for PFS is provided in Figure 1. 
KaplanMeierjeva krivulja za PFS je na sliki 1.
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. 
V primerjavi s pogoji na tešče dajanje zgodnje oblike kapsule idelaliziba z obrokom z visoko vsebnostjo maščob ni povzročilo spremembe vrednosti Cmax, povprečna vrednost AUCinf pa se je povečala za 36 %.
Therefore, women of childbearing potential must use highly effective contraception while taking Zydelig and for 1 month after stopping treatment. 
Zato morajo ženske v rodni dobi med jemanjem zdravila Zydelig in še 1 mesec po prenehanju zdravljenja uporabljati zelo učinkovito kontracepcijo.
Idelalisib in combination with ofatumumab 
Idelalizib v kombinaciji z ofatumumabom
Based on findings in animals, idelalisib may cause foetal harm. 
Na podlagi izsledkov pri živalih lahko idelalizib škoduje plodu.
In general, B-lymphocyte dependent areas were more affected than T-lymphocyte dependent areas. 
Na splošno so bili predeli, odvisni od limfocitov B, bolj prizadeti, kot predeli,
The primary and only circulating metabolite, GS-563117, is inactive against PI3Kδ. 
Njegov primarni in edini cirkulirajoči presnovek, GS-563117, je proti PI3Kδ neaktiven.
There are no or limited amount of data from the use of idelalisib in pregnant women. 
Podatkov o uporabi idelaliziba pri nosečnicah ni oziroma so omejeni.
Effect of idelalisib on the pharmacokinetics of other medicinal products 
Učinek idelaliziba na farmakokinetiko drugih zdravil
Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib 
Preglednica 2: Neželeni učinki zdravila, o katerih so poročali v kliničnih študijah pri osebah s hematološkimi malignostmi, ki so dobivali idelalizib Neželeni učinek
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). 
ANC je treba spremljati najmanj enkrat tedensko, dokler ni ANC ≥ 500 na mm3, nato se zdravljenje lahko nadaljuje s 100 mg dvakrat dnevno (glejte poglavje 4.4).
Fentanyl, alfentanil, methadone, buprenorphine/naloxone 
fentanil, alfentanil, metadon, buprenorfin/nalokson
Effect of other medicinal products on idelalisib pharmacokinetics 
Učinek drugih zdravil na farmakokinetiko idelaliziba
Following a single 150 mg dose, idelalisib AUC (total, i.e., bound plus unbound) was ~60% higher in moderate and severe impairment compared to matched controls. 
Po enem 150 mg odmerku je bila vrednost AUC za idelalizib (skupni, tj. vezan in nevezan) ~60 % višja pri zmerni in hudi okvari v primerjavi z ustrezno kontrolno skupino.
Co-administration of Zydelig with moderate or strong CYP3A inducers such as rifampicin, phenytoin, St. John's wort, or carbamazepine should be avoided as this may result in decreased efficacy (see section 4.4). 
Sočasnemu dajanju zdravila Zydelig z zmernimi ali močnimi induktorji CYP3A, kot so rifampicin, fenitoin, šentjanževka ali karbamazepin, se je treba izogniti, saj lahko to zmanjša učinkovitost (glejte poglavje 4.4).
Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data). 
Pogostnosti so opredeljene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do
Zydelig can cause severe diarrhoea. 
Zdravilo Zydelig lahko povzroči hudo drisko.
Boceprevir, telaprevir 
Zaviralci proteaze HCV boceprevir, telaprevir
Idelalisib and GS-563117 are substrates of P-gp and BCRP. 
Idelalizib in GS-563117 sta substrata P-gp in BCRP.
Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine. 
ERGOT ALKALOIDI ergotamin, dihidroergotamin ↑ koncentracij v serumu Idelaliziba se ne sme dati sočasno z ergotaminom ali dihidroergotaminom.
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 ALT/AST elevation and liver function monitored. 
Zdravljenje z zdravilom Zydelig je treba prekiniti v primeru povečanja ravni ALT/AST 3. in 4. stopnje ter opazovati funkcijo jeter.
Zydelig can cause lung inflammation. 
Zdravilo Zydelig lahko povzroči vnetje pljuč.
You should take additional medicine provided by your doctor while you are taking Zydelig to prevent one type of infection. 
Medtem ko jemljete zdravilo Zydelig, morate jemati tudi dodatno zdravilo, ki vam ga predpiše zdravnik, da preprečite okužbo.
Table 1: Interactions between idelalisib and other medicinal products that are CYP3A substrates 
Preglednica 1: Medsebojna delovanja med idelalizibom in drugimi zdravili, ki so substrati
If the event recurs, treatment with Zydelig must be withheld until the values return to Grade 1 or less, after which re-initiation at 100 mg twice daily may be considered at the discretion of the physician (see sections 4.4 and 4.8). 
Če se dogodek ponovi, je treba zdravljenje z zdravilom Zydelig začasno ustaviti, dokler se vrednosti ne vrnejo na 1. ali nižjo stopnjo, nato naj se po presoji zdravnika nadaljuje z jemanjem 100 mg dvakrat na dan (glejte poglavji 4.4 in 4.8).
↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended. 
↑ koncentracij v serumu Priporoča se skrbno spremljanje prenašanja teh zdravil proti raku.
Serious and fatal infections have occurred in patients taking Zydelig. 
Pri bolnikih, ki so jemali zdravilo Zydelig, so se pojavile resne in smrtne okužbe.
Clinical monitoring is recommended for patients with CrCl < 90 mL/min. 
Pri bolnikih s CrCl < 90 ml/min se priporoča klinično spremljanje.
↑ serum concentrations Dose reductions of colchicine may be required. 
↑ koncentracij v serumu Morda bo treba odmerek kolhicina zmanjšati.
• if you have redness and blistering of the skin 
• če imate pordelo ali mehurjasto kožo,
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. 
V klinični študiji medsebojnega delovanja zdravil so ugotovili, da je sočasno dajanje idelaliziba z midazolamom (občutljiv substrat CYP3A) povzročilo ~140-odstotno povečanje Cmax in ~440-odstotno povečanje AUCinf midazolama, ker GS-563117 zavira CYP3A.
Medicinal product 
FARMACEVTSKI PODATKI
CYP3A/P-gp inhibitors 
Zaviralci CYP3A/P-gp
Once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN), treatment can be resumed at 100 mg twice daily. 
Ko se vrednosti vrnejo na 1. ali nižjo stopnjo (ALT/AST ≤ 3 x ULN), se lahko zdravljenje nadaljuje z odmerkom 100 mg dvakrat na dan.
*** 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. 
*** Vključuje prednostne izraze generalizirani eksfoliativni dermatitis, medikamentni izpuščaj, izpuščaj, eritematozni izpuščaj, generalizirani izpuščaj, makularni izpuščaj, makulopapularni izpuščaj, papularni izpuščaj, pruritični izpuščaj, pustularni izpuščaj, vezikularni izpuščaj, papule, kožni plak in eksfoliativni izpuščaj.
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. 
V klinični študiji medsebojnega delovanja zdravil so ugotovili, da je sočasno dajanje enega odmerka 400 mg idelaliziba s ketokonazolom 400 mg enkrat na dan (močan zaviralec CYP3A, P-gp in BCRP) povzročilo 26-odstotno zmanjšanje Cmax in 79-odstotno povečanje AUCinf idelaliziba.
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. 
Študija 312-0119 je bila randomizirana, odprta, multicentrična študija 3. faze z vzporednimi skupinami, v kateri je bilo 261 oseb s predhodno zdravljeno KLL, ki so imeli izmerljivo limfadenopatijo, ki je zahtevala zdravljenje in pri katerih je KLL napredovala < 24 mesecev od končanja predhodnega zdravljenja.
Idelalisib can be administered without regard to food. 
Idelalizib se lahko uporablja ne glede na hrano.
When idelalisib is co-administered with other medicinal products, the Summary of Product Characteristics (SmPC) for the other product must be consulted for the recommendations regarding co-administration with CYP3A4 inhibitors. 
Pri sočasni uporabi idelaliziba z drugimi zdravili je treba upoštevati povzetek glavnih značilnosti zdravila za druga zdravila glede priporočil o sočasni uporabi z zaviralci CYP3A4.
Particular caution must be used and dose reduction may be considered when prescribing sildenafil or tadalafil with idelalisib with increased monitoring for adverse events. 
Pri predpisovanju sildenafila ali tadalafila z idelalizibom je potrebna posebna previdnost in razmisli se lahko o zmanjšanju odmerka s povečanim spremljanjem neželenih učinkov.
ANTI-CANCER AGENTS 
ZDRAVILA PROTI RAKU
• alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood 
• alfuzosin; zdravilo, ki se uporablja za zdravljenje povečanja prostate • dabigatran in varfarin; zdravila, ki se uporabljajo za redčenje krvi
Elderly No specific dose adjustment is required for elderly patients (aged ≥ 65 years) (see section 5.2). 
Starejši bolniki Pri starejših bolnikih (starost ≥ 65 let) odmerka ni treba posebej prilagajati (glejte poglavje 5.2).
• if you have a new or worsening cough 
• če se pojavi kašelj ali če se obstoječi kašelj poslabša,
ALT, AST, and total bilirubin must be monitored in all patients every 2 weeks for the first 3 months of treatment, then as clinically indicated. 
Pri vseh bolnikih je treba prve 3 mesece zdravljenja vsaka 2 tedna spremljati vrednosti ALT, AST in skupnega bilirubina, nato pa kot je klinično indicirano.
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. 
Podatki in vitro kažejo, da idelalizib ni zaviralec presnovnih encimov CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A ali UGT1A1 ali prenašalcev OAT1, OAT3 ali OCT2.
Carbamazepine 
karbamazepin
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. 
Vrednost ORR je bila 96,9 %, z 12 CR (18,8 %) in 50 PR (78,1 %), vključno s 3 CR in 6 PR pri osebah z delecijo 17p in/ali mutacijo TP53, ter 2 CR in 34 PR pri osebah z nemutiranim IGHV.
Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis. 
Preiskave povečanje trigliceridov zelo pogosti pogosti * Obsega oportunistične okužbe ter bakterijske in virusne okužbe, kot so pljučnica, bronhitis in sepsa.
• if you have swelling and blistering of the lining of the mouth, genitals, and/or eyes 
• če imate oteklo in mehurjasto ustno sluznico, spolovila in/ali oči.
• buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders 
• buspiron, klorazepat, diazepam, estazolam, flurazepam, zolpidem, zdravila, ki se uporabljajo za zdravljenje motenj živčnega sistema
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. 
V klinični študiji medsebojnega delovanja zdravil so ugotovili, da je sočasno dajanje enega odmerka 150 mg idelaliziba z rifampicinom (močan induktor CYP3A) povzročilo ~75-odstotno zmanjšanje AUCinf idelaliziba.
INHALED BETA AGONIST 
INHALIRANI AGONISTI BETA salmeterol
DOR (months) median (95% CI) PFS (months) median (95% CI) OS (months) median (95% CI) 
DOR (meseci) mediana (95-odstotni IZ) PFS (meseci) mediana (95-odstotni IZ) OS (meseci) median (95-odstotni IZ)
In patients who resumed idelalisib at a lower dose, 
bolnikov, ki so ponovno začeli jemati idelalizib z nižjim odmerkom.
Do not chew or crush the tablet. 
Tablete ne žvečite ali drobite.
Table 3: Efficacy results from study 312-0116 Idelalisib + R N = 110 
Preglednica 3: Rezultati učinkovitosti iz študije 312-0116 Idelalizib + R
Caution is recommended when administering Zydelig in this population. 
Pri dajanju zdravila Zydelig tej populaciji se priporoča previdnost.
Subjects were randomised 2:1 to receive idelalisib 150 mg twice daily and 12 infusions of ofatumumab over 24 weeks, or 12 infusions of ofatumumab only over 24 weeks. 
Osebe so bile randomizirane v razmerju 2 : 1 v skupino, ki je prejemala idelalizib 150 mg dvakrat na dan in 12 infundiranj ofatumumaba v 24-tedenskem obdobju, ali skupino, ki je prejela samo 12 infundiranj ofatumumaba v 24-tedenskem obdobju.
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). 
↑ koncentracij v serumu Pri bolnikih z normalnim delovanjem ledvic ali blago ledvično okvaro (očistek kreatinina [CrCl-creatinine clearance] 60-90 ml/min) prilagoditev odmerka klaritromicina ni potrebna.
ORR (95% CI) 
ORR (95-odstotni IZ)
• budesonide, fluticasone, medicines used to treat hayfever and asthma, and salmeterol, used to treat asthma 
• budezonid, flutikazon, zdravili, ki se uporabljata za zdravljenje senenega nahoda in astme, in salmeterol, ki se uporablja za zdravljenje astme
19.4 (13.9, NR) 
19,4 (13,9, ND)
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). 
Pri uvedbi zdravljenja z zdravilom Zydelig pri bolnikih z blago ali zmerno jetrno okvaro odmerka ni treba prilagajati, vendar se priporoča intenzivnejše spremljanje neželenih učinkov (glejte poglavji 4.4 in 5.2).
Maintain Zydelig dosing. 
Vzdržujte odmerjanje zdravila Zydelig.
The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2. 
Seznam neželenih učinkov v obliki preglednice Neželeni učinki zdravila, o katerih so poročali z idelalizibom samim ali v kombinaciji z monoklonskimi protitelesi proti CD20 (rituksimabom ali ofatumumabom), so navedeni v preglednici 2.
• dihydroergotamine, ergotamine, medicines used to treat migraine headache 
• dihidroergotamin, ergotamin; zdravili, ki se uporabljata za zdravljenje glavobola zaradi migrene
Contains sunset yellow FCF (E110), see leaflet for further information. 
SEZNAM POMOŽNIH SNOVI Vsebuje sončno rumeno FCF (E110), za nadaljnje informacije glejte navodilo za uporabo.
• amlodipine, diltiazem, felodipine, nicardipine, nifedipine, medicines used to treat high blood pressure and heart problems 
• amlodipin, diltiazem, felodipin, nikardipin, nifedipin, zdravila, ki se uporabljajo za zdravljenje visokega krvnega tlaka ali težav s srcem
Interrupt Zydelig dosing. 
Prekinite odmerjanje zdravila Zydelig.
Breast-feeding should be discontinued during treatment with Zydelig. 
Med zdravljenjem z zdravilom Zydelig je treba prenehati z dojenjem.
Response category*† CR 
95-odstotni IZ Kategorija odziva*† CR
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4. 
Idelalizib se primarno presnavlja s pomočjo aldehidne oksidaze in v manjšem obsegu s pomočjo CYP3A in UGT1A4.
• inflammation of the lungs 
• vnetje pljuč
NR (12.3, NR) 
ND (12,3; ND)
Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and glucuronidation (UGT1A4). 
Idelalizib se primarno presnavlja s pomočjo aldehidne oksidaze in v manjšem obsegu s pomočjo CYP3A in glukuronidacije (UGT1A4).
Treatment with Zydelig must be withheld in the event of suspected pneumonitis. 
Zdravljenje z zdravilom Zydelig je treba pri sumu na pnevmonitis začasno ustaviti.
Diarrhoea/colitis 
Driska/kolitis
No dose adjustment is required for patients with mild, moderate, or severe renal impairment (see section 5.2). 
Pri bolnikih z blago, zmerno ali hudo ledvično okvaro odmerka ni treba prilagajati (glejte poglavje 5.2).
The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6. 
Rezultati učinkovitosti so povzeti v preglednicah 5 in 6.
Prophylaxis for PJP should therefore be administered to all patients throughout idelalisib treatment, and for a period of 2 to 6 months after discontinuation. 
Ves čas zdravljenja z idelalizibom in v obdobju 2 do 6 mesecev po prekinitvi zdravljenja je treba vsem bolnikom dajati profilakso za PJP.
↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended. 
↑ koncentracij v serumu Priporoča se klinično spremljanje terapevtskega učinka in neželenih učinkov.
Women should avoid becoming pregnant while taking Zydelig, and for up to 1 month after ending treatment. 
Ženske med jemanjem zdravila Zydelig in še 1 mesec po prenehanju zdravljenja ne smejo zanositi.