FrancophonIA/ELRC3.0 huggingface dataset:
English: • Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Icelandic: Zydelig getur valdið því að getnaðarvarnarpillan og ígræddar hormónagetnaðarvarnir virki ekki eins vel.
English: Figure 1: Kaplan-Meier curve of PFS from study 312-0116 (intent-to-treat population)
Icelandic: Kaplan-Meier ferill varðandi PFS úr rannsókn 312-0116 (meðferðarþýði)
English: 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.
Icelandic: Hjá sjúklingum með vísbendingar um veirublóðsýkingu af völdum stórfrumuveiru og klínísk merki um sýkingu af völdum stórfrumuveiru, skal íhuga að stöðva tímabundið meðferð með idelalisibi þar til sýkingin hefur gengið til baka.
English: Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Icelandic: 64 einstaklingar þátt sem höfðu áður ómeðhöndlað CLL, þ.m.t. 5 einstaklingar með lítið eitilfrumuæxli (SLL).
English: Study 312-0119 was a randomised, controlled, open-label study in which 173 subjects with previously treated CLL received idelalisib + ofatumumab.
Icelandic: Rannsókn 312-0119 var slembuð, opin samanburðarrannsókn þar sem 173 einstaklingar sem höfðu áður fengið meðferð við CLL fengu idelalisib + ofatumumab.
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)
Icelandic: Áhættuhlutfall (95% CI) P-gildi ORR* n (%) (95% CI) Hlutfallslíkur (95% CI) P-gildi LNR** n/N (%) (95% CI) Hlutfallslíkur (95% CI) P-gildi OS^ Miðgildi (mánuðir) (95% CI)
English: Respiratory, thoracic and mediastinal disorders Pneumonitis
Icelandic: Öndunarfæri, brjósthol og miðmæti Lungnabólga
English: Ergotamine, dihydroergotamine ↑ serum concentrations Idelalisib should not be co-administered with ergotamine or dihydroergotamine.
Icelandic: Idelalisib má ekki gefa samhliða ergotamíni eða dihýdróergotamíni.
English: Each film-coated tablet contains 150 mg of idelalisib.
Icelandic: Hver filmuhúðuð tafla inniheldur 150 mg af idelalisibi.
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).
Icelandic: Komi útbrot ekki fram aftur, má hækka skammtinn í 150 mg tvisvar á dag samkvæmt ákvörðun meðferðarlæknisins (sjá kafla 4.8).
English: • clarithromycin, telithromycin, medicines used to treat bacterial infections
Icelandic: • klaritrómýsín, telitrómýsín, notuð gegn bakteríusýkingum
English: Compared with rituximab + placebo, treatment with idelalisib + rituximab resulted in statistically significant and clinically meaningful improvements in physical well-being, social well-being, functional well-being, as well as in the leukaemia-specific subscales of the Functional Assessment of Cancer Therapy: Leukaemia (FACT-LEU) instruments, and in statistically significant and clinically meaningful improvements in anxiety, depression and usual activities as measured by the EuroQoL Five-Dimensions (EQ-5D) instrument.
Icelandic: Samanborið við rituximab + lyfleysu, leiddi meðferð með idelalisibi + rituximab til tölfræðilega mikilvægra og klínískt marktækra framfara í líkamlegri vellíðan, félagslegri vellíðan, atferlislegri vellíðan og einnig hvað varðar sérstaka skala fyrir hvítblæði sem falla undir Functional Assessment of Cancer Therapy:
English: CI: confidence interval; R: rituximab; N: number of subjects per group; NR: not reached
Icelandic: öryggismörk; R: rituximab; N: fjöldi einstaklinga í hverjum hópi; NR: ekki náð (not reached)
English: 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.
Icelandic: Eftir stakan 150 mg skammt var AUC (samtals, þ.e. bundið og óbundið) fyrir idelalisibi ~60% hærra við í meðallagi og alvarlega skerta lifrarstarfsemi miðað við samsvarandi viðmið.
English: Ciclosporin, sirolimus, tacrolimus
Icelandic: Ciklósporín, sírólímus, takrólímus
English: Clinical monitoring is recommended for telithromycin.
Icelandic: Mælt er með klínísku eftirliti með telitrómýsíni.
English: ↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
Icelandic: Mælt er með nánu eftirliti með þoli gagnvart þessum krabbameinslyfjum.
English: Clinical monitoring is recommended.
Icelandic: Mælt er með klínísku eftirliti.
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).
Icelandic: Komi niðurgangur/ristilbólga ekki fram aftur, má hækka skammtinn í 150 mg tvisvar á dag samkvæmt ákvörðun meðferðarlæknisins (sjá kafla 4.8).
English: ANTI-CANCER AGENTS
Icelandic: Krabbameinsvaldandi áhrif
English: The recommended dose is 150 mg idelalisib twice daily.
Icelandic: Ráðlagður skammtur er 150 mg idelalisib tvisvar á dag.
English: Zydelig contains the azo colouring agent sunset yellow FCF (E110), which may cause allergic reactions.
Icelandic: Hjálparefni Zydelig inniheldur azo-litarefnið sunset yellow FCF (E110), sem getur valdið ofnæmisviðbrögðum.
English: Idelalisib in combination with ofatumumab
Icelandic: Idelalisib + O Ofatumumab
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)
Icelandic: PFS Miðgildi (mánuðir) (95% CI) Áhættuhlutfall (95% CI) P-gildi ORR* n (%) (95% CI) Hlutfallslíkur (95% CI) P-gildi LNR** n/N (%) (95% CI) Hlutfallslíkur (95% CI) P-gildi OS Miðgildi (mánuðir) (95% CI)
English: The adverse drug reactions reported with idelalisib alone or in combination with anti-CD20 monoclonal antibodies (rituximab or ofatumumab) are provided in Table 2.
Icelandic: Í töflu 2 er að finna tilkynntar aukaverkanir með idelalisibi sem einlyfjameðferð eða ásamt einstofna mótefni gegn CD20 (rituximabi eða ofatumumabi).
English: Regular clinical and laboratory monitoring for CMV infection is recommended in patients with positive CMV serology at the start of treatment with idelalisib or with other evidence of a history of CMV infection.
Icelandic: Mælt er með reglulegu klínísku eftirliti og að fylgjast með rannsóknarniðurstöðum hvað varðar sýkingu af völdum stórfrumuveiru hjá sjúklingum með jákvæða mótefnagreiningu fyrir stórfrumuveiru við upphaf meðferðar með idelalisibi eða þegar til staðar eru aðrar vísbendingar um sögu um sýkingu af völdum stórfrumuveiru.
English: Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x upper limit of normal [ULN]).
Icelandic: aspartat amínótransferasa [ASAT] > 5 x efri eðlileg mörk [upper limit of normal, ULN]).
English: Alfuzosin
Icelandic: Alfúsózín
English: Lovastatin, simvastatin
Icelandic: Lovastatín, simvastatín
English: Idelalisib is metabolised primarily via aldehyde oxidase, and to a lesser extent via CYP3A and UGT1A4.
Icelandic: Idelalisib umbrotnar fyrst og fremst fyrir tilstilli aldehýð oxídasa og í minna mæli fyrir tilstilli CYP3A og UGT1A4.
English: CI: confidence interval; O: ofatumumab; N: number of subjects per group
Icelandic: öryggismörk; O: ofatumumab; N: fjöldi einstaklinga í hverjum hópi
English: • amiodarone, bepridil, disopyramide, lidocaine, quinidine, medicines used to treat heart problems
Icelandic: • amíódarón, bepridíl, disópýramíð, lidókaín, kínidín, notuð til að meðhöndla hjartasjúkdóma
English: Do not stop taking Zydelig
Icelandic: Ekki má nota Zydelig
English: Caution is recommended when administering Zydelig in this population.
Icelandic: Mælt með því að varúðar sé gætt þegar Zydelig er gefið þessum sjúklingahópi.
English: For subjects in the placebo + R group, the summary includes data up to the first dosing of idelalisib in an extension study.
Icelandic: + R nær samantektin yfir gögn fram að fyrsta skammti af idelalisib í framhaldsrannsókn.
English: • atorvastatin, lovastatin, simvastatin, medicines used to lower cholesterol
Icelandic: • atorvastatín, lovastatín, simvastatín, notuð til að lækka kólesteról
English: Diarrhoea/colitis
Icelandic: RÓANDI LYF/SVEFNLYF
English: Caution should be exercised, including consideration of dose reduction, when co-administering tadalafil with idelalisib.
Icelandic: Gæta skal varúðar, m.a. íhuga að minnka skammta, þegar tadalafíl og idelalisib eru gefin samhliða.
English: In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Icelandic: Hjá sjúklingum með alvarlega lungnasjúkdóma skal stöðva meðferð með idelalisibi tímabundið og meta sjúklinginn m.t.t. sjúkdómsorsaka.
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).
Icelandic: Pólývínyl alkóhól (E1203), makrógól 3350 (E1521), títantvíoxíð (E171), talkúm (E553B), sunset yellow FCF (E110) (sjá kafla 2, Áður en byrjað er að nota Zydelig).
English: Reproductive and developmental toxicity
Icelandic: Eiturverkun á æxlun og þroska
English: Patients should be monitored for respiratory signs and symptoms throughout treatment.
Icelandic: Fylgjast skal með sjúklingum hvað varðar einkenni í öndunarfærum meðan á meðferð stendur.
English: The film-coated tablets are pink, oval-shaped tablets, debossed on one side with “GSI” and “150” on the other side.
Icelandic: 150 mg filmuhúðuðu töflurnar eru bleikar, sporöskjulaga töflur, ígreyptar á annarri hliðinni með „GSI “ og „150“ á hinni hliðinni.
English: Neutropenia Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Icelandic: Daufkyrningafæð Stöðva skal meðferð með Zydelig hjá sjúklingum þegar heildarfjöldi daufkyrninga (ANC) er minni en
English: The film-coated tablets are orange, oval-shaped tablets, debossed on one side with “GSI” and “100” on the other side.
Icelandic: 100 mg filmuhúðuðu töflurnar eru appelsínugular, sporöskjulaga töflur, ígreyptar á annarri hliðinni með „GSI “ og „100“ á hinni hliðinni.
English: PFS median (months) (95% CI)
Icelandic: PFS Miðgildi (mánuðir) (95% CI)
English: PFS Median (months) (95% CI)
Icelandic: PFS miðgildi (mánuðir) (95% CI)
English: Grade ≥ 3
Icelandic: 3. stig
English: • colchicine, a medicine used to treat gout
Icelandic: • kolkisín, notað til að meðhöndla þvagsýrugigt
English: If you take more Zydelig than you should
Icelandic: Ef tekinn er stærri skammtur en mælt er fyrir um
English: HMG CO-A REDUCTASE INHIBITORS
Icelandic: HMG CoA REDÚKTASAHEMLAR
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.
Icelandic: Miðgildi aldurs var 68 ár (á bilinu 61 til 74) þar sem 64,0% einstaklinga voru eldri en 65 ára; 71,3% voru karlar og 84,3% voru af hvítum kynþætti; 63,6% voru með Rai-stig III eða IV og 58,2% voru með Binet-stig C. Flestir voru með neikvæða frumuerfðafræðilega forspárþætti um batahorfur:
English: Clinical recommendation upon co-administration with idelalisib
Icelandic: Klínískar ráðleggingar varðandi samhliða gjöf með idelalisibi
English: • carbamazepine, S-mephenytoin, phenytoin, medicines used to prevent seizures
Icelandic: • karbamazepín, S-mefenýtóín, fenýtóín, notuð til að koma í veg fyrir flog
English: Dose modification
Icelandic: Breyting skammta
English: Microcrystalline cellulose Hydroxypropyl cellulose (E463) Croscarmellose sodium Sodium starch glycolate Magnesium stearate
Icelandic: Örkristallaður sellulósi Hýdroxýprópýl sellulósi (E463) Kroskarmellósi natríum Natríumsterkju glýkólat
English: Idelalisib is not considered to have broad immunosuppressive activity.
Icelandic: Idelalisib er ekki talið hafa breiða ónæmisbælandi verkun.
English: Zydelig 150 mg film-coated tablets
Icelandic: Zydelig 150 mg filmuhúðaðar töflur
English: Ketoconazole, itraconazole, posaconazole, voriconazole
Icelandic: Ketókónazól, itrakónazól, posakónazól, vorikónazól
English: 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.
Icelandic: Hærri heildartíðni sýkinga, þar á meðal 3. og 4. stigs sýkinga, kom fram hjá hópunum sem fengu idelalisib miðað við samanburðarhópana í klínískum rannsóknum með idelalisibi.
English: Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.
Icelandic: Í klínískum rannsóknum með idelalisibi hefur komið fram 3. og 4. stigs hækkun ALAT og ASAT (> 5 x ULN).
English: Subjects received idelalisib 150 mg twice daily and rituximab 375 mg/m2 BSA weekly for 8 doses.
Icelandic: 375 mg/m2 af líkamsyfirborði (BSA) vikulega í 8 skömmtum.
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Sunset yellow FCF (E110)
Icelandic: Pólývínyl alkóhól (E1203) Makrógól 3350 (E1521) Títantvíoxíð (E171) Talkúm (E553B) Sunset yellow FCF (E110)
English: Idelalisib should not be co-administered with lovastatin or simvastatin.
Icelandic: Idelalisib má ekki gefa samhliða lovastatíni eða simvastatíni.
English: Maintain Zydelig dosing.
Icelandic: Viðhaldið skömmtun Zydelig.
English: • quetiapine, a medicine used to treat schizophrenia, bipolar disorder and major depressive disorder
Icelandic: quetiapín, notað til að meðhöndla geðklofa, geðhvarfasýki og alvarlegt þunglyndi
English: • if you have shortness of breath or difficulty breathing
Icelandic: ef þú ert með mæði eða öndunarerfiðleika
English: Cases of pneumonitis and organising pneumonia (some with fatal outcome) have been reported with idelalisib.
Icelandic: Lungnabólga og trefjavefslungnabólga (organising pneumonia) Tilkynnt hefur verið um tilvik lungnabólgu og trefjavefslungnabólgu (sum banvæn) með idelalisibi.
English: Cisapride
Icelandic: Cisapríð
English: Zydelig 100 mg film-coated tablets
Icelandic: Zydelig 100 mg filmuhúðaðar töflur
English: 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.
Icelandic: Tilkynnt hefur verið um banvæn tilvik Stevens-Johnson heilkennis og eitrunardreploss í húðþekju við samhliða gjöf idelalisibs og annarra lyfja sem tengjast þessum heilkennum.
English: Amiodarone, quinidine
Icelandic: Amíódarón, kínidín
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Icelandic: Tíðnin er skilgreind á eftirfarandi hátt: mjög algengar (≥ 1/10); algengar (≥ 1/100 til < 1/10);
English: Zydelig 100 mg film-coated tablets idelalisib
Icelandic: Zydelig 100 mg filmuhúðaðar töflur idelalisib
English: Zydelig 150 mg film-coated tablets idelalisib
Icelandic: Zydelig 150 mg filmuhúðaðar töflur idelalisib
English: Treatment with Zydelig must be withheld in the event of a Grade 3 or 4 aminotransferase elevation (alanine aminotransferase [ALT]/aspartate aminotransferase [AST] > 5 x upper limit of normal
Icelandic: Stöðva verður meðferð með Zydelig ef fram kemur 3. eða 4. stigs hækkun amínótransferasa (alanín amínótransferasa [ALAT]/
English: Overall iNHL cohort (N=125) n (%)
Icelandic: Samantekt á verkun í rannsókn 101-09 (mat IRC-nefndarinnar) Eiginleiki iNHL heildarþýði (N=125) n (%)
English: Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019
Icelandic: 30. apríl 2019
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 rash.
Icelandic: Stöðva verður meðferð með Zydelig við 3. eða 4. stigs útbrot.
English: CI: confidence interval; R: rituximab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Icelandic: öryggismörk; R: rituximab; n: fjöldi einstaklinga sem sýndu svörun; N: fjöldi einstaklinga í hverjum hópi; NR: ekki náð (not reached).
English: Based on findings in animals, idelalisib may cause foetal harm.
Icelandic: Byggt á niðurstöðum rannsókna hjá dýrum getur idelalisib valdið fósturskaða.
English: In vitro interaction data
Icelandic: Gögn um milliverkanir in vitro
English: ↑ serum concentrations Clinical monitoring of therapeutic effect and adverse reactions is recommended.
Icelandic: Mælt er með klínísku eftirliti með meðferðaráhrifum og aukaverkunum.
English: You should take additional medicine provided by your doctor while you are taking Zydelig to prevent one type of infection.
Icelandic: Þú átt að taka viðbótarlyf sem læknirinn útvegar þér meðan á töku
English: If SJS or TEN is suspected, idelalisib should be immediately interrupted and the patient treated accordingly.
Icelandic: á StevensJohnson heilkenni eða eitrunardreplosi í húðþekju, skal stöðva gjöf idelalisibs tafarlaust og veita sjúklingnum viðeigandi meðferð.
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).
Icelandic: Miðgildi aldurs var 71 ár (á bilinu 47 til 92) þar sem 78,2% einstaklinga voru eldri en 65 ára; 65,5% voru karlar og 90,0% voru af hvítum kynþætti; 64,1% voru með Rai-stig III eða IV og 55,9% voru með Binet-stig C. Flestir voru með neikvæða frumuerfðafræðilega forspárþætti um batahorfur:
English: Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Icelandic: Vart varð við meðferðartengda daufkyrningafæð af stigi 3 eða 4, hjá sjúklingum sem fengu idelalisib, þ.m.t. daufkyrningafæð ásamt hita.
English: Polyvinyl alcohol (E1203), macrogol 3350 (E1521), titanium dioxide (E171), talc (E553B), iron oxide red (E172).
Icelandic: Pólývínyl alkóhól (E1203), makrógól 3350 (E1521), títantvíoxíð (E171), talkúm (E553B), járnoxíð rautt (E172).
English: Antimycobacterials
Icelandic: Lyf gegn Mycobacteriaceae tegundum
English: Treatment with Zydelig must be withheld in the event of suspected pneumonitis.
Icelandic: Stöðva verður meðferð með Zydelig við grun um lungnabólgu (pneumonitis).
English: • buspirone, clorazepate, diazepam, estazolam, flurazepam, zolpidem, medicines used to treat nervous system disorders
Icelandic: • búspírón, klórasepat, díasepam, estasólam, flúrasepam, zólpídem, notuð við meðferð sjúkdóma í taugakerfi
English: • sildenafil, tadalafil, medicines used to treat impotence and pulmonary hypertension, a lung disease that makes breathing difficult
Icelandic: sildenafíl, tadalafíl, notuð til að meðhöndla getuleysi og háþrýsting í slagæðum lungna,
English: CI: confidence interval; O: ofatumumab; n: number of responding subjects; N: number of subjects per group; NR: not reached.
Icelandic: öryggismörk; O: ofatumumab; n: fjöldi einstaklinga sem sýndu svörun; N: fjöldi einstaklinga í hverjum hópi; NR: ekki náð (not reached).
English: Polyvinyl alcohol (E1203) Macrogol 3350 (E1521) Titanium dioxide (E171) Talc (E553B) Iron oxide red (E172)
Icelandic: Pólývínyl alkóhól (E1203) Makrógól 3350 (E1521) Títantvíoxíð (E171) Talkúm (E553B) Járnoxíð rautt (E172)
English: • alfuzosin, a medicine used to treat an enlarged prostate • dabigatran, warfarin, medicines used to thin the blood
Icelandic: • dabigatran, warfarín, notuð til að þynna blóðið
English: HCV protease inhibitors
Icelandic: HCV-próteasahemlar
English: 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.
Icelandic: Eftir inntöku staks skammts af idelalisibi, kom hámarksþéttni í plasma fram 2 til 4 klst.
English: ANTIARRHYTHMICS
Icelandic: LYFJAFRÆÐILEGAR
English: • bosentan, a medicine used to treat pulmonary arterial hypertension
Icelandic: • bósentan, notað við lungnaháþrýstingi
English: ↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Icelandic: Mælt er með nánu eftirliti með aukaverkunum (t.d. öndunarbæling, slæving).
English: Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Icelandic: Fylgjast skal vel með sjúklingum með veirublóðsýkingu af völdum stórfrumuveiru án tilheyrandi klínískra einkenna.
English: Idelalisib induces apoptosis and inhibits proliferation in cell lines derived from malignant B-cells and in primary tumour cells.
Icelandic: Idelalisib virkjar stýrðan frumudauða og hamlar fjölgun frumna upprunnum úr illkynja B-eitilfrumum og frumæxlisfrumna.
English: ENDOTHELIN RECEPTOR ANTAGONISTS
Icelandic: ENDÓTELÍN VIÐTAKAHEMLAR
English: ANALGESICS
Icelandic: Zydelig
English: Pneumonitis
Icelandic: LYFJAFORM
English: Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis.
Icelandic: Stöðva verður meðferð með Zydelig við 3. eða 4. stigs niðurgang/ristilbólgu.
English: For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.
Icelandic: Hafa skal í huga önnur sýklalyf hjá sjúklingum með CrCl < 60 ml/mín að öðrum kosti.
English: Monitor ANC at least weekly.
Icelandic: Fylgjast skal með ANC a.m.k.
English: Table 4: Summary of PFS and response rates in pre-specified subgroups from study 312-0116 Idelalisib + R
Icelandic: Samantekt á PFS og svörunarhlutfalli hjá fyrirfram skilgreindum undirhópum í rannsókn 312-0116
English: Once diarrhoea/colitis has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Icelandic: Þegar niðurgangur/ristilbólga er aftur kominn á 1. stig eða lægra má hefja að nýju meðferð með 100 mg tvisvar á dag.
English: Carbamazepine
Icelandic: Karbamazepín
English: Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Icelandic: Brjóstagjöf Ekki er þekkt hvort idelalisib og umbrotsefni skiljast út í brjóstamjólk.
English: ANTI-INFECTIVES Antifungals
Icelandic: Eiturverkun á erfðaefni
English: Once rash has returned to Grade 1 or below, treatment can be resumed at 100 mg twice daily.
Icelandic: Þegar útbrot eru aftur komin á 1. stig eða lægra má hefja að nýju meðferð með 100 mg tvisvar á dag.
English: ↑ serum concentrations ↑ serum concentrations
Icelandic: ↑ þéttni í sermi ↑ þéttni í sermi
English: Table 2: Adverse drug reactions reported in clinical studies in subjects with haematologic malignancies receiving idelalisib
Icelandic: Tilkynntar aukaverkanir í klínískum rannsóknum hjá einstaklingum með illkynja blóðsjúkdóma sem fengu idelalisib
English: Reporting of suspected adverse reactions
Icelandic: Tilkynnt hefur verið um tilvik ágengrar fjölhreiðra innlyksuheilabólgu
English: Interrupt Zydelig dosing.
Icelandic: Gerið hlé á skömmtun Zydelig.
English: In many instances the pathogen was not identified; however, both conventional and opportunistic pathogens, including PJP and CMV, were among those identified.
Icelandic: Hins vegar, meðal þeirra sem greindust, fundust bæði hefðbundnir sýklar og sýklar sem valda tækifærissýkingum, þ.m.t. Pneumocystis jiroveci pneumonia (PJP) og stórfrumuveira.
English: Idelalisib should not be co-administered with sildenafil.
Icelandic: Idelalisib má ekki gefa samhliða alfúsózíni.
English: 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.
Icelandic: 1,9; 37,2) klst. og sýnilegt brotthvarf idelalisibs var 14,9 (á bilinu: