natgillin/translations-raw huggingface dataset:
• ciclosporin, sirolimus, tacrolimus, lægemidler, der anvendes til at kontrollere din krops immunrespons efter en transplantation 
• ciclosporin, sirolimus, tacrolimus, medicines used to control your body's immune response after a transplant
Hvis der forekommer en overdosering, skal patienten overvåges for tegn på toksicitet (se pkt. 
If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8).
Behandlingen kan genoptages ved en lavere dosis, når værdierne er vendt tilbage til grad 1 eller derunder (ALAT/ASAT ≤ 3 x ULN). 
Treatment may be resumed at a lower dose once values have returned to Grade 1 or below (ALT/AST ≤ 3 x ULN).
Hvis du har glemt at tage Zydelig 
If you forget to take Zydelig
Zydelig påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner. 
Zydelig has no or negligible influence on the ability to drive and use machines.
Patienterne fik 150 mg idelalisib oralt to gange dagligt, indtil bevis for sygdomsprogression eller uacceptabel toksicitet. 
Subjects received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity.
Klinisk anbefaling ved administration sammen med idelalisib 
Clinical recommendation upon co-administration with idelalisib
Lymofocytose** 
Lymphocytosis**
Idelalisib hæmmede imidlertid ikke det normale værtsrespons mod Staphylococcus aureus, og det forstærkede ikke den myelosuppressive virkning af cyklophosphamid. 
However, idelalisib did not inhibit the normal host response to Staphylococcus aureus and did not exacerbate the myelosuppressive effect of cyclophosphamide.
Almindelig * Omfatter opportunistiske infektioner samt bakterielle og virale infektioner såsom pneumoni, bronkitis og sepsis. 
Common * Comprised of opportunistic infections as well as bacterial and viral infections such as pneumonia, bronchitis, and sepsis.
Det primære endepunkt var ORR defineret som andelen af patienter, der opnåede et CR eller PR (baseret på de reviderede responskriterier for malignt lymfom [Cheson]), og for patienter med Waldenströms makroglobulinæmi, et mindre respons (MR) (baseret på responsvurderingen for Waldenströms makroglobulinæmi [Owen]). 
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]).
Sørg for ikke at springe en dosis med Zydelig over. 
Take care to not miss a dose of Zydelig.
Behandlingsrelateret neutropeni af grad 3 eller 4, herunder febril neutropeni, er forekommet i patienter behandlet med idelalisib. 
Treatment-emergent Grade 3 or 4 neutropenia, including febrile neutropenia, have occurred in patients treated with idelalisib.
Klinisk overvågning anbefales for telithromycin. 
Clinical monitoring is recommended for telithromycin.
Dyreforsøg indikerer mulighed for skadelige virkninger af idelalisib på fertilitet og føtal udvikling (se pkt. 
Animal studies indicate the potential for harmful effects of idelalisib on fertility and foetal development (see section 5.3).
Forhøjede levertransaminaser blev generelt observeret inden for de første 12 ugers behandling og var reversible ved dosisafbrydelse (se pkt. 
Increases in liver transaminases were generally observed within the first 12 weeks of treatment, and were reversible with dose interruption (see section 4.2).
Kvinder i den fertile alder/kontraception 
Women of childbearing potential / contraception
Stevens-Johnsons syndrom/toksisk epidermal nekrolyse 
Stevens-Johnson syndrome/ toxic epidermal necrolysis
• rifabutin, et lægemiddel, der anvendes til at behandle bakterieinfektioner, herunder tuberkulose 
• rifabutin, a medicine used to treat bacterial infections including tuberculosis
Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med idelalisib i en eller flere undergrupper af den pædiatriske population ved behandling af modne B-celle-neoplasmer (se pkt. 
The European Medicines Agency has deferred the obligation to submit the results of studies with idelalisib in one or more subsets of the paediatric population in the treatment of mature B-cell neoplasms (see section 4.2 for information on paediatric use).
Afbryd Zydelig-dosering. 
Interrupt Zydelig dosing.
I forhold til fastende betingelser førte administration af en tidlig kapselformulering af idelalisib sammen med et måltid med højt fedtindhold ikke til nogen ændring i Cmax og til en 36 % forhøjelse i gennemsnitlig AUCinf. 
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.
Medianen for DOR for alle patienter var 12,5 måneder (12,5 måneder for patienter med SLL og 11,8 måneder for patienter med FL, 20,4 måneder for LPL/WM og 18,4 måneder for MZL). 
The median DOR for all subjects was 12.5 months (12.5 months for SLL subjects, and 11.8 months for FL, 20.4 months for LPL/WM and 18.4 months for MZL subjects).
Sammenlignet med behandling med rituximab + placebo førte behandling med idelalisib + rituximab til statistisk signifikante og klinisk meningsfulde forbedringer i det fysiske velbehag, socialt velbehag, funktionelt velbehag samt i de leukæmi-specifikke underskalaer fra Functional Assessment of Cancer Therapy: Leukaemia (FACT-LEU)-instrumenterne, og til statistisk signifikante og klinisk meningsfulde forbedringer i angst, depression og sædvanlige aktiviteter, målt ved hjælp af EuroQoL Five-Dimensions (EQ-5D)-instrumentet. 
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.
Idelalisib både hæmmede og inducerede CYP2C8 in vitro, men det er ukendt, om dette kan overføres til en in vivo-virkning på CYP2C8-substrater. 
In vitro, idelalisib both inhibited and induced CYP2C8, but it is not known whether this translates to an in vivo effect on CYP2C8 substrates.
Der er meget begrænset erfaring med behandling af patienter, hvis anamnese inkluderer inflammatorisk tarmsygdom. 
There is very limited experience from the treatment of patients with a history of inflammatory bowel disease.
• cisaprid, et lægemiddel, der anvendes til at lindre visse maveproblemer 
• cisapride, a medicine used to relieve certain stomach problems
Zydelig bør ikke anvendes under graviditeten og til kvinder i den fertile alder, som ikke anvender sikker kontraception. 
Zydelig is not recommended during pregnancy and in women of childbearing potential not using contraception.
Amning Det er ukendt, om idelalisib/metabolitter udskilles i human mælk. 
Breast-feeding It is not known whether idelalisib and its metabolites are excreted in human milk.
Idelalisib inducerede ikke mutationer i den mikrobielle mutagenese (Ames)-analyse, det var ikke klastogent i in vitro kromosomsaberrationsanalysen med humane perifere blodlymfocytter, og det var ikke genotoksisk i in vivo rotte mikronukleusstudiet. 
Idelalisib did not induce mutations in the microbial mutagenesis (Ames) assay, was not clastogenic in the in vitro chromosome aberration assay using human peripheral blood lymphocytes, and was not genotoxic in the in vivo rat micronucleus study.
Blandt de 122 patienter med målbare lymfeknuder både ved baseline og efter baseline opnåede 71 patienter (58,2 %) en ≥ 50 % reduktion fra baseline i summen af produkterne for diametrene (SPD, sum of the products of the diameters) af indekslæsionerne. 
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.
Hvis fordelene ved genoptagelse af idelalisib-behandling vurderes at opveje risiciene, skal forebyggende CMV-behandling overvejes. 
If the benefits of resuming idelalisib are judged to outweigh the risks, consideration should be given to administering pre-emptive CMV therapy.
Idelalisib i kombination med rituximab 
Idelalisib in combination with rituximab
Der indgik 64 patienter i studie 101-08/99 med tidligere ubehandlet CLL, herunder 5 patienter med småcellet lymfatisk lymfom (SLL). 
Study 101-08/99 enrolled 64 subjects with previously untreated CLL, including 5 subjects with small lymphocytic lymphoma (SLL).
Brug ikke lægemidlet efter den udløbsdato, der står på tabletbeholderen og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the bottle and carton after EXP.
Clarithromycin, telithromycin ↑ serumkoncentrationer Dosisjustering af clarithromycin er ikke nødvendig hos patienter med normal nyrefunktion eller let nedsat nyrefunktion (kreatininclearance [CrCl] 60-90 ml/min). 
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).
↑ serumkoncentrationer ↑ serumkoncentrationer 
↑ serum concentrations ↑ serum concentrations
• Anvend en meget sikker præventionsmetode for at undgå at blive gravid, mens du behandles med Zydelig, og i 1 måned efter din sidste behandling. 
• Use a reliable method of contraception to avoid becoming pregnant while you are being treated with Zydelig, and for 1 month after your last treatment.
Af patienter, som genoptog behandlingen med idelalisib ved en lavere dosis, oplevede 26 % recidiv af forhøjelserne i ALAT og ASAT. 
In patients who resumed idelalisib at a lower dose, 26% had recurrence of ALT/AST elevation.
↑ serumkoncentrationer Nøje overvågning af tolerancen over for disse midler mod cancer anbefales. 
↑ serum concentrations Careful monitoring of the tolerance to these anti-cancer agents is recommended.
Der er ikke identificeret nogen mekanistiske forklaringer på udviklingen af resistens over for behandlingen med idelalisib i kliniske studier. 
No mechanistic explanations for the development of resistance to treatment with idelalisib have been identified from clinical studies.
Der er forekommet alvorlige og dødelige infektioner med idelalisib, herunder opportunistiske infektioner, som f.eks. pneumocystis jirovecii pneumoni (PJP) og cytomegalovirus (CMV). 
Serious and fatal infections have occurred with idelalisib, including opportunistic infections such as Pneumocystis jirovecii pneumonia (PJP) and cytomegalovirus (CMV).
Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/. 
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Hvis patienten glemmer en dosis Zydelig inden for 6 timer fra det tidspunkt den normalt tages, skal patienten tage den glemte dosis snarest muligt og genoptage det normale doseringsskema. 
If the patient misses a dose of Zydelig within 6 hours of the time it is usually taken, the patient should take the missed dose as soon as possible and resume the normal dosing schedule.
Stevens-Johnsons syndrom og toksisk epidermal nekrolyse Tilfælde af Stevens-Johnsons syndrom (SJS) og toksisk epidermal nekrolyse (TEN) med dødelig udgang er blevet rapporteret, når idelalisib blev administreret samtidigt med andre lægemidler forbundet med disse syndromer. 
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.
I et embryoføtalt udviklingsstudie med rotter blev der observeret øget post-implantationstab, misdannelser (ingen kaudal vertebra og i nogle tilfælde også ingen sakral vertebra), variationer i skelettet og lavere legemsvægt af fosteret. 
In an embryo-foetal development study in rats, increased post-implantation loss, malformations (absence of caudal vertebrae and in some cases also of sacral vertebrae), skeletal variations and lower foetal body weights were observed.
Ud af de 125 patienter, der indgik, var 80 (64 %) mænd, og medianalderen var 64 år (interval: 33 til 87 år), og 110 (89 %) var hvide. 
Of the 125 subjects enrolled, 80 (64%) were male, the median age was 64 years (range: 33 to 87), and 110 (89%) were white.
Den primære metabolit, GS-563117, kan øge fototoksicitet, når cellerne samtidigt eksponeres over for UVA-lys. 
The major metabolite, GS-563117, may enhance phototoxicity when cells are simultaneously exposed to UVA light.
Vablerne kan også omfatte slimhinden i munden, kønsdelene og/eller øjnene. 
Blistering can also involve the lining of the mouth, genitals, and/or eyes.
Forventet virkning af idelalisib på lægemiddelniveauer 
Expected effect of idelalisib on drug levels
Varigheden af profylakse efter behandling skal baseres på en klinisk vurdering, eventuelt under hensyntagen til patientens risikofaktorer såsom samtidig kortikosteroidbehandling og forlænget neutropeni (se pkt. 
The duration of post-treatment prophylaxis should be based on clinical judgment and may take into account a patient's risk factors such as concomitant corticosteroid treatment and prolonged neutropenia (see section 4.8).
• som førstevalgsbehandling hos patienter med 17p-deletion eller TP53-mutation, som ikke er egnede til at få andre behandlinger (se pkt. 
• as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies (see section 4.4).
En dosisrelateret forøgelse af pankreatiske øcelletumorer blev observeret med lav hyppighed hos hanrotter ved eksponeringer op til 0,4 gange sammenlignet med den menneskelige eksponering ved den anbefalede dosis; lignende fund blev ikke konstateret hos hunrotter ved 0,62 gange eksponeringsmargin. 
A dose-related increase in pancreatic islet cell tumors was observed at low incidence in male rats at exposures up to 0.4-fold compared to the human exposure at the recommended dose; a similar finding was not observed in female rats at 0.62-fold exposure margin.
Hos patienter, der får alvorlige lungehændelser, bør idelalisib afbrydes, og patienten vurderes for en forklarende ætiologi. 
In patients presenting with serious lung events, idelalisib should be interrupted and the patient assessed for an explanatory aetiology.
Start af isoleret lymfocytose forekommer typisk i de første 2 uger af behandling med idelalisib og er ofte forbundet med reduceret lymfadenopati. 
The onset of isolated lymphocytosis typically occurs during the first 2 weeks of idelalisib therapy and is often associated with reduction of lymphadenopathy.
Potentielle interaktioner mellem idelalisib ved administration sammen med lægemidler, der er CYP3A-substrater er opstillet i tabel 1 (en stigning er indikeret ved ”↑”). 
Potential interactions between idelalisib and co-administered medicinal products that are CYP3A substrates are listed in Table 1 (increase is indicated as “↑”).
Hud og subkutane væv Udslæt*** 
Skin and subcutaneous tissue disorders Rash***
Da en reduktion af plasmakoncentrationen af idelalisib kan føre til nedsat virkning, bør det undgås at administrere Zydelig sammen med moderate eller stærke CYP3A-inducere (se pkt. 
Since a reduction in idelalisib plasma concentrations may result in decreased efficacy, co-administration of Zydelig with moderate or strong CYP3A inducers should be avoided (see section 4.5).
^ Analysen af samlet overlevelse (OS, overall survival) inkluderer data fra patienter, der fik placebo + R i studie 312-0116 og efterfølgende fik idelalisib i et forlængelsesstudie, baseret på intent-to-treat-analyse. 
^ Overall survival (OS) analysis includes data from subjects who received placebo + R on study 312-0116 and subsequently received idelalisib in an extension study, based on intent-to-treat analysis.
Efter start af idelalisib er der blevet observeret en midlertidig stigning i antallet af lymfocytter (dvs. ≥ 50 % stigning fra baseline og over det absolutte lymfocyttal på 5.000/mikroliter). 
Upon initiation of idelalisib, a temporary increase in lymphocyte counts (i.e., ≥ 50% increase from baseline and above absolute lymphocyte count of 5,000/mcL) has been observed.
Ketoconazol, itraconazol, posaconazol, voriconazol 
Ketoconazole, itraconazole, posaconazole, voriconazole
Pakningsstørrelser og yderligere oplysninger Zydelig indeholder: 
Contents of the pack and other information What Zydelig contains
• pimozid, et lægemiddel, der anvendes til at behandle unormale tanker og følelser 
• pimozide, a medicine used to treat abnormal thoughts or feelings
Regelmæssig klinisk og laboratoriemæssig monitorering for CMV-infektion anbefales hos patienter med positiv CMV-serologi ved påbegyndelse af idelalisib eller med anden evidens for CMV-infektion i anamnesen. 
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.
Kronisk hepatitis 
Chronic hepatitis
Analyserne af PFS, samlet responsrate (ORR, overall response rate) og lymfeknude responsrate (LNR, lymph node response rate) var baseret på evaluering af en uafhængig bedømmelseskomité (IRC, independent review committee). 
The analyses of PFS, overall response rate (ORR) and lymph node response rate (LNR) were based on evaluation by an independent review committee (IRC).
Hyppighederne er defineret som: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til 
(≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to
Ved formodning om SJS eller TEN, bør idelalisib straks seponeres, og patienten bør behandles i overensstemmelse hermed. 
If SJS or TEN is suspected, idelalisib should be immediately interrupted and the patient treated accordingly.
Tyrosinkinasehæmmere, såsom dasatinib og nilotinib, også vincristin og vinblastin 
Tyrosine kinase inhibitors such as dasatinib and nilotinib, also vincristine and vinblastine
Behandlingen med Zydelig skal pauseres i tilfælde af en grad 3 eller 4 aminotransferaseforhøjelse (alaninaminotransferase [ALAT]/aspartataminotransferase [ASAT] > 5 x øvre normalgrænse [ULN]). 
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]).
Du skal også anvende en barrieremetode til prævention, såsom kondomer eller spiral, mens du tager Zydelig, og i 1 måned efter din sidste behandling. 
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.
• hvis du er stakåndet eller har vejrtrækningsbesvær 
• if you have shortness of breath or difficulty breathing
Zydelig kan forårsage lungebetændelse. 
Zydelig can cause lung inflammation.
Behandlingen med Zydelig skal pauseres hos patienter, så længe patientens absolutte neutrofiltal (ANC) er under 500 pr. mm3. 
Treatment with Zydelig should be withheld in patients while absolute neutrophil count (ANC) is below 500 per mm3.
Derfor har idelalisib potentialet til at påvirke andre lægemidler, der metaboliseres af CYP3A, som kan føre til øgede serumkoncentrationer af det andet produkt (se pkt. 
Thus, idelalisib has the potential to interact with medicinal products that are metabolised by CYP3A, which may lead to increased serum concentrations of the other product (see section 4.5).
Populationsfarmakokinetiske analyser indikerede, at køn og race ikke havde nogen klinisk relevant virkning på eksponeringerne over for idelalisib eller GS-563117. 
Population pharmacokinetic analyses indicated that gender and race had no clinically relevant effect on the exposures to idelalisib or GS-563117.
Der er utilstrækkelige data til at give dosisanbefalinger for patienter med svært nedsat leverfunktion. 
There is insufficient data to make dose recommendations for patients with severe hepatic impairment.
Idelalisib og GS-563117 er substrater af P-gp og BCRP. 
Idelalisib and GS-563117 are substrates of P-gp and BCRP.
• som har fået mindst en tidligere behandling (se pkt. 
• who have received at least one prior therapy (see section 4.4), or
Reaktion 
Reaction
Der rådes til forsigtighed, hvis Zydelig anvendes sammen med lægemidler med et snævert terapeutisk indeks, der er substrater for disse enzymer (warfarin, phenytoin, S-mephenytoin). 
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of these enzymes (warfarin, phenytoin, S-mephenytoin).
En indledende dosisjustering af idelalisib anses ikke for at være nødvendig ved administration sammen med CYP3A/P-gp-hæmmere, men det anbefales at intensivere overvågning for bivirkninger. 
No initial dose adjustment of idelalisib is considered necessary when administered with CYP3A/P-gp inhibitors, but an intensified monitoring of adverse reactions is recommended.
Makrolid-antibiotika 
Macrolide antibiotics
↑ serumkoncentrationer Nøje overvågning af bivirkninger (f.eks. respirationsdepression, sedation) anbefales. 
↑ serum concentrations Careful monitoring of adverse reactions (e.g., respiratory depression, sedation) is recommended.
Forhøjelser i serumtransaminase korrelerede med levernekrose hos hunde, men blev ikke observeret hos rotter. 
Serum transaminase elevations correlated with hepatic necrosis in dogs, but were not observed in rats.
Der rådes til forsigtighed, hvis Zydelig anvendes sammen med lægemidler med et snævert terapeutisk indeks, der er substrater for CYP2C8 (paclitaxel). 
Caution is advised if Zydelig is used together with narrow therapeutic index drugs that are substrates of CYP2C8 (paclitaxel).
Højdensitets-polyethylen (HDPE)-tabletbeholder med et børnesikret lukke af polypropylen, der indeholder 60 filmovertrukne tabletter og en vatspiral af polyester. 
High density polyethylene (HDPE) bottle, capped with a polypropylene child-resistant closure, containing 60 film-coated tablets and a polyester coil.
• Zydelig kan få p-piller og implanterede hormonelle præventionsmidler til at være mindre effektive. 
• Zydelig may make the contraceptive “pill” and implanted hormonal contraceptives work less well.
Desuden fik 86 patienter fra dette studie, som blev randomiseret til placebo + rituximab, efterfølgende idelalisib som enkeltstof i et forlængelsesstudie (studie 312-0117). 
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).
Behandlingen med Zydelig skal pauseres i tilfælde af grad 3 eller 4 diarré/colitis. 
Treatment with Zydelig must be withheld in the event of Grade 3 or 4 diarrhoea/colitis.
Der er desuden blevet rapporteret hepatocellulær leverskade, herunder leversvigt. 
There have also been reports of hepatocellular injury including hepatic failure.
Blod og lymfesystem Neutropeni 
Blood and lymphatic system disorders Neutropenia
Der er set tilfælde af PJP efter seponering af idelalisib. 
There have been cases of PJP after stopping idelalisib treatment.
Amlodipin, diltiazem, felodipin, nifedipin, nicardipin 
Amlodipine, diltiazem, felodipine, nifedipine, nicardipine
• clarithromycin, telithromycin, lægemidler, der anvendes til at behandle bakterieinfektioner 
• clarithromycin, telithromycin, medicines used to treat bacterial infections
Der er blevet observeret forhøjelser af ALAT og ASAT af grad 3 og 4 (> 5 x ULN) i kliniske studier med idelalisib. 
Elevations in ALT and AST of Grade 3 and 4 (> 5 x ULN) have been observed in clinical studies of idelalisib.