natgillin/translations-raw huggingface dataset:
Almene symptomer og reaktioner på administrationsstedet Feber (38,5 °C eller derover), erytem på injektionsstedet, smerter på injektionsstedet og hævelser på injektionsstedet 
General disorders and administration site conditions Fever (38.5°C or higher), Injection site erythema,
1 Jeryl Lynn™ stamme [niveau B]) (levende, svækket) ikke under 12,5x10 3 CCID50* 
1 Jeryl Lynn™ [Level B] strain (live, attenuated)………not less than 12.5x10 3 CCID50*
† , febrile konvulsioner (hos børn), Guillain-Barres syndrom, hovedpine, mæslingeencefalitis (MIBE) (se pkt. 
†, Febrile convulsion (in children), Guillain-Barre syndrome, Headache, Measles inclusion body encephalitis (MIBE) (see section 4.3), Ocular palsies, Optic neuritis, Paraesthesia, Polyneuritis, Polyneuropathy, Retrobulbar neuritis, Syncope
M-M-RVAXPRO anvendes på følgende måde: Én dosis gives på en bestemt dato, som regel fra 12-måneders alderen. 
One dose is given at an elected date usually from 12 months of age.
M-M-RVAXPRO pulver til injektionsvæske, suspension. 
M-M-RVAXPRO powder for suspension for injection
Sådan får De/Deres barn M-M-RVAXPRO 4. 
How to use M-M-RVAXPRO 4.
Overførsel af rubellavaccinevirus til spædbørn via modermælken uden holdepunkter for klinisk sygdom er dog dokumenteret (se pkt. 
Consequently, transmission through close personal contact, while accepted as a theoretical possibility, is not regarded as a significant risk; however, transmission of the rubella vaccine virus to infants via breast milk has been documented without any evidence of clinical disease (see section 4.6).
FYLDT SPRØJTE MED SOLVENS 
PRE-FILLED SYRINGE OF SOLVENT
Dosis 1 ved 9 md. / dosis 2 ved 12 md. N= 527 
Dose 1 at 9 months / Dose 2 at 12 months
M-M-RVAXPRO kan under særlige omstændigheder gives til spædbørn fra 9-måneders alderen (se pkt. 
M-M-RVAXPRO can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1).
1 - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50* 
1 Jeryl Lynn™ [Level B] strain (live, attenuated)……...…not less than 12.5x10 3 CCID50*
Bronkospasme, hoste, pneumoni, pneumonit (se pkt. 
Bronchial spasm, Cough, Pneumonia, Pneumonitis (see section 4.3), Sore throat
ikke under 1 x 10 3 CCID50* Parotitisvirus - Jeryl Lynn™-stamme [niveau B](levende, svækket) ikke under 12,5 x 10 3 CCID50* 
3 CCID50* Mumps virus Jeryl Lynn™ [Level B] strain (live attenuated) not less than 12,5 x10
10 enkeltdosishætteglas (pulver) + 10 hætteglas (solvens). 
10 single dose vials (powder) + 10 vials (solvent).
Advarsler og forsigtighedsregler Kontakt lægen eller apoteket, før De/Deres barn får M-M-RVAXPRO: - Hvis De eller Deres barn har haft en allergisk reaktion på æg eller noget der indeholder æg. 
Warnings and precautions Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following: - If you or your child have an allergic reaction to eggs or anything that contained egg - If you or your child have a history or family history of allergies or of convulsions (fits) - If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual - If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease.
Pulver og solvens til injektionsvæske, suspension i fyldt sprøjte. 
Powder and solvent for suspension for injection in pre-filled syringe.
EU/1/06/337/011 - pakning a 1 stk. EU/1/06/337/012 - pakning a 10 stk. EU/1/06/337/013 - pakning a 20 stk. 
EU/1/06/337/011 - pack of 1 EU/1/06/337/012 - pack of 10 EU/1/06/337/013 - pack of 20
Opløsningsmiddel: Vand til injektionsvæsker. 
Solvent: water for injections
Hertil kommer, at andre bivirkninger er rapporteret under anvendelse efter markedsføring af M-MRVAXPRO og/eller i kliniske forsøg efter markedsføringen af tidligere formuleringer af monovalente og kombinerede mæslinge-, parotitis- og rubellavacciner fremstillet af Merck & Co., Inc. uden hensyntagen til kausalitet eller hyppighed. 
Additionally, other adverse reactions reported with post-marketing use of M-M-RVAXPRO and/or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck & Co., Inc. without regard to causality or frequency are available and are summarised in section b. The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data.
5.1), og den generelle sikkerhedsprofil var sammenlignelig med den tidligere formulering af mæslinge-, parotitis- og rubellavaccine fremstillet af Merck & Co., Inc. 
In clinical trials, M-M-RVAXPRO was administered to 1965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.
M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, Mæslinge-, parotitis- og rubellavaccine (levende) 
M-M-RVAXPRO Powder and solvent for suspension for injection Measles, mumps and rubella vaccine (live)
M-M-RVAXPRO pulver til injektionsvæske, suspension, i en fyldt sprøjte. 
M-M-RVAXPRO powder for suspension for injection in pre-filled syringe
EU/1/06/337/005 - pakning a 1 stk. EU/1/06/337/006 - pakning a 10 stk. EU/1/06/337/007 - pakning a 20 stk. 
EU/1/06/337/005 - pack of 1 EU/1/06/337/006 - pack of 10 EU/1/06/337/007 - pack of 20
20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) uden kanyle. 
20 single dose vials (powder) + 20 prefilled syringes (solvent) without needle.
Mæslingevirus 
Measles virus
Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med stempelprop (chlorbutylgummi) og hætte (styren butadiengummi), med en eller to separate kanyler i pakningsstørrelser på 1, 10 og 20 stk. 
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), with one or two unattached needles, in pack size 1, 10 and 20.
M-M-RVAXPRO Pulver og solvens til injektionsvæske, suspension, i fyldt sprøjte Mæslinge-, parotitis- og rubellavaccine (levende) 
M-M-RVAXPRO Powder and solvent for suspension for injection in pre-filled syringe Measles, mumps and rubella vaccine (live)
Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med stempelprop (chlorbutylgummi)og hætte (styren butadiengummi), uden kanyle i pakningsstørrelser på 1, 10 og 20 stk. 
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with plunger stopper (chlorobutyl rubber) and tip cap (styrene-butadiene rubber), without needle, in pack size 1, 10, and 20.
20 enkeltdosishætteglas (pulver) + 20 fyldte sprøjter (solvens) + 40 kanyler. 
20 single dose vials (powder) + 20 pre-filled syringes (solvent) + 40 needles.
M-M-RVAXPRO - Pulver i hætteglas og solvens i hætteglas - Pakning a 1, 10 stk. 
M-M-RVAXPRO - Powder in vial and solvent in vial- Pack of 1, 10
Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i hætteglas (glas) med en prop (chlorbutyl) i pakningsstørrelser på 1 og 10 stk. 
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a vial (glass) with stopper (chlorobutyl rubber) in a pack size of 1 and 10.
Pulver i hætteglas (glas) med en prop (butylgummi) og solvens i fyldt sprøjte (glas) med påsat kanyle med stempelprop (chlorbutylgummi) og kanylebeskyttelse (naturgummi) i pakningsstørrelser på 1 og 10 stk. 
Powder in a vial (glass) with a stopper (butyl rubber) and solvent in a pre-filled syringe (glass) with attached needle with plunger stopper (chlorobutyl rubber) and needle-shield (natural rubber) in a pack size of 1 and 10.
Træk hele mængden af solvens op i en sprøjte (unødvendigt, hvis der anvendes fyldt sprøjte). 
Withdraw the entire volume of solvent into a syringe.
ikke under 1 x 10 3 CCID50* 
not less than 1 x10
Mæslingevirus - Enders' Edmonston-stamme (levende, svækket) 
After reconstitution,1 dose (0.5 ml) contains: Measles virus Enders' Edmonston strain (live attenuated)
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) + 20 kanyler. 
10 single dose vials (powder) + 10 pre-filled syringes (solvent) + 20 needles.
Derfor kan nogle af disse patienter få mæslinger, parotitis og rubella i tilfælde af kontakt til trods for passende administration af vaccinen. 
Immunocompromised patients who have no contraindication for this vaccination (see section 4.3) may not respond as well as immunocompetent patients; therefore, some of these patients may acquire measles, mumps, or rubella in case of contact, despite appropriate vaccine administration.
EU/1/06/337/003 - pakning a 1 stk. EU/1/06/337/004 - pakning a 10 stk. 
EU/1/06/337/003 - pack of 1 EU/1/06/337/004 - pack of 10
• Udslæt (herunder mæslingelignende udslæt). 
• Rash (including measles-like rash).
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) uden kanyle. 
10 single dose vials (powder) + 10 prefilled syringes (solvent) without needle.
M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte med 2 separate kanyler - Pakning a 1, 10, 20 stk. 
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with two unattached needlesPack of 1, 10, 20
2 - Wistar RA 27/3 stamme ikke under 1 x 10 3 CCID50* 
2 Wistar RA 27/3 strain (live, attenuated) …………….….not less than 1x10 3 CCID50*
10 enkeltdosishætteglas (pulver) + 10 fyldte sprøjter (solvens) med kanyle. 
10 single dose vials (powder) + 10 prefilled syringes (solvent) with needle.
* Cellekultur infektiøs dosis 50 %. 
*50% cell culture infectious dose produced in chick embryo cells.
/ dosis 2 ved 12 md. N= 527 
N = 527
M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte uden kanyle - Pakning a 1, 10, 20 stk. 
M-M-RVAXPRO - Powder in vial and solvent in pre-filled syringe with one unattached needlePack of 1, 10, 20
Vaskulære sygdomme Vaskulit 
Vascular disorders Vasculitis
EU/1/06/337/009 - pakning a 10 stk. EU/1/06/337/010- pakning a 20 stk. 
EU/1/06/337/008 - pack of 1 EU/1/06/337/009 - pack of 10 EU/1/06/337/010 - pack of 20
EU/1/06/337/001 - pakning a 1 stk. EU/1/06/337/002 - pakning a 10 stk. 
EU/1/06/337/001 - pack of 1 EU/1/06/337/002 - pack of 10
Efter rekonstitution skal vaccinen anvendes straks eller inden for 8 timer, hvis den opbevares i køleskab. 
Keep the vial of powder in the outer carton in order to protect from light After reconstitution, use immediately or within 8 hours if stored in a refrigerator
1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) + 1 kanyle. 
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 1 needle.
ikke under 1x10 3 CCID50* 
not less than 1x10
1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) uden kanyle. 
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) without needle.
Fortæl det til Deres læge, hvis De ammer eller har til hensigt at amme. 
Persons who are breast-feeding or intend to breast-feed should tell the doctor.
• Døvhed. 
• Deafness.
1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) med kanyle. 
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) with needle.
1 enkeltdosishætteglas (pulver) + 1 fyldt sprøjte (solvens) + 2 kanyler. 
Powder and solvent for suspension for injection in pre-filled syringe 1 single dose vial (powder) + 1 prefilled syringe (solvent) + 2 needles.
M-M-RVAXPRO - Pulver i hætteglas og solvens i fyldt sprøjte med påsat kanyle Pakning a 1, 10 stk 
M-M-RVAXPRO - Powder in vial and solvent in prefilled syringe with attached needle - Pack of
Dette forventes og kan vare i et par måneder. 
This is expected and may last for a few months.
Alder ≥ 65 år 
Age ≥ 65 years
Tag dernæst din næste dosis som sædvanligt. 
Then take your next dose as usual.
Det betyder sædvanligvis ikke, at din blodkræft er blevet værre. 
This generally does not mean that your blood cancer is getting worse.
Denne liste er ikke udtømmende, og den er kun beregnet til at være vejledende. 
This list is not exhaustive and is intended to serve as guidance only.
Medianen for varighed af responset (DOR) er ikke nået. 
The median duration of response (DOR) has not been reached.
Dato for første markedsføringstilladelse: 18. september 2014 Dato for seneste fornyelse: 30. april 2019 
Date of first authorisation: 18 September 2014 Date of latest renewal: 30 April 2019
Tal med lægen om, hvad dine testresultater betyder. 
Talk to your doctor about what your test results mean.
Progressionsfri overlevelse (%) 
Progression free survival (%)
Giv ikke dette lægemiddel til børn og unge under 18 år, da det ikke er undersøgt til denne aldersgruppe. 
Do not give this medicine to children and adolescents under 18 years of age because it has not been studied in this age group.
N med risiko (hændelser) 
N at risk (Events)
Dette er for at kontrollere, at du ikke har en infektion, at din lever fungerer korrekt, og at dine blodtal er normale. 
This is to check that you do not have an infection, that your liver is working properly, and that your blood counts are normal.
HOLD OP med at tage Zydelig og søg straks lægehjælp, hvis du oplever noget af følgende: 
STOP taking Zydelig and seek medical help immediately if you experience any of the following:
Det er meget vigtigt, at du også læser indlægssedlerne, der leveres med disse lægemidler. 
It is very important that you read the package leaflets that are provided with these medicines too.
Din læge vil monitorere dig for tegn på infektion. 
Your doctor will monitor you for evidence of infection.
Der er ingen information om sikkerheden af dette lægemiddel til gravide kvinder. 
There is no information about the safety of this medicine in pregnant women.
In vitro interaktionsdata 
In vitro interaction data
Andre lægemidler, som f.eks. olanzapin, kan overvejes. 
Alternative medicinal products, such as olanzapine, may be considered.
• Zydelig må ikke anvendes under graviditet. 
• Zydelig should not be used during pregnancy.
• hvis du har andre medicinske sygdomme (især en infektion eller feber) 
• if you have any other medical conditions or illness (especially an infection or fever)
• ændringer i antallet af hvide blodlegemer 
• changes in the number of white blood cells
Zydelig bør ikke anvendes sammen med andre lægemidler, medmindre lægen har fortalt dig, at det er sikkert at gøre det. 
Zydelig should not be used with any other medicines unless your doctor has told you it is safe to do so.
Fortæl det straks til lægen ved det første tegn på diarré. 
Tell your doctor right away at the first sign of diarrhoea.
Zydelig kan tages med eller uden mad. 
Zydelig can be taken with or without food.
< 1/1.000), meget sjælden (< 1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
< 1/1,000), very rare (< 1/10,000), and not known (cannot be estimated from available data).
Hvis det er nødvendigt, kan din læge beslutte sig for at stoppe behandlingen i et stykke tid, før behandlingen startes igen med den samme eller en lavere dosis. 
If necessary, your doctor may decide to stop treatment for a while, before starting treatment again at the same or a lower dose.
INFORMATION I BRAILLESKRIFT 17. 
INFORMATION IN BRAILLE 17.
Analysen af PFS var baseret på evaluering af en IRC. 
The analysis of PFS was based on evaluation by an IRC.
Zydelig er til oral anvendelse. 
Zydelig is for oral use.
Tag tabletbeholderen og denne indlægsseddel med dig, så du let kan beskrive, hvad du har taget. 
Keep the bottle and this leaflet with you so that you can easily describe what you have taken.
For pulmonal arteriel hypertension: 
For pulmonary arterial hypertension:
→ Kontakt lægen, hvis dette gælder dig. 
→ Talk to your doctor if this applies to you.
DOR var et sekundært endepunkt, og det blev defineret som tiden fra det første dokumenterede respons (CR, PR eller MR) til den første dokumentation af sygdomsprogression eller død af enhver årsag. 
DOR was a secondary endpoint and was defined as the time from the first documented response (CR, PR, or MR) to the first documentation of disease progression or death from any cause.
Din læge kan imidlertid reducere denne dosis til 100 mg to gange dagligt, hvis du oplever særlige bivirkninger. 
However, your doctor may reduce this dose to 100 mg twice a day if you experience particular side effects.
Mediantiden fra diagnosticering var 7,7 år. 
The median time since diagnosis was 7.7 years.
Bivirkningerne er opstillet efter systemorganklasse og hyppighed. 
Adverse reactions are listed by system organ class and frequency.
Mediantiden fra diagnose af CLL til randomisering var 8,5 år. 
The median time from diagnosis of CLL to randomisation was 8.5 years.
Medianen for antal tidligere behandlinger var 3,0. 
The median number of prior therapies was 3.0.
Virkningerne på embryoføtal udvikling blev ikke undersøgt i en anden dyreart. 
Effects on embryo-foetal development were not investigated in a second species.
Alle grader 
Any grade
Fortæl det til lægen: 
Tell your doctor:
Da dette enzym er overaktiveret i visse kræftagtige hvide blodlegemer, vil Zydelig ved at blokere det dræbe og reducere antallet af kræftceller. 
Because this enzyme is overactivated in certain cancerous white blood cells, by blocking it, Zydelig will kill and reduce the number of cancer cells.
Grad ≥ 3 
Grade ≥ 3
Hvis du tager Zydelig sammen med visse lægemidler, kan det stoppe dem fra at virke korrekt, eller det kan gøre bivirkninger værre. 
Taking Zydelig with certain medicines may stop them working properly, or may make side effects worse.
Der blev observeret misdannelser ved eksponeringer fra 12 gange den humane eksponering baseret på AUC. 
Malformations were observed at exposures from 12 times the human exposure based on AUC.
Din læge kan også beslutte sig for at stoppe behandlingen med Zydelig permanent. 
Your doctor may also decide to permanently stop treatment with Zydelig.
Der er forekommet alvorlige og dødelig infektioner hos patienter, som tager Zydelig. 
Serious and fatal infections have occurred in patients taking Zydelig.
Kontakt øjeblikkeligt lægen eller den nærmeste skadestude for rådgivning. 
Contact your doctor or nearest emergency department immediately for advice.
Afskalning af huden kan føre til alvorlig infektion. 
Peeling away of the skin may lead to serious infection.
Generelt var B-lymfocytafhængige områder mere påvirkede end T-lymfocytafhængige områder. 
In general, B-lymphocyte dependent areas were more affected than T-lymphocyte dependent areas.
Undersøgelser Forhøjede triglycerider 
Investigations Increased triglycerides
Behandlingen bør fortsættes indtil sygdomsprogression eller uacceptabel toksicitet. 
Treatment should be continued until disease progression or unacceptable toxicity.
Læger bør overveje PML i differentialdiagnosen hos patienter med nye eller forværrende neurologiske, kognitive eller adfærdsmæssige tegn eller symptomer. 
Physicians should consider PML in the differential diagnosis in patients with new or worsening neurological, cognitive or behavioural signs or symptoms.
Til erektil dysfunktion: 
For erectile dysfunction:
Patienterne skal informeres om straks at rapportere nye respiratoriske symptomer. 
Patients should be advised to report new respiratory symptoms promptly.
Monitorér ANC mindst én gang ugentligt. 
Monitor ANC at least weekly.
Det primære endepunkt var PFS. Virkningsresultaterne er opsummeret i tabel 5 og 6. 
The primary endpoint was PFS. Efficacy results are summarised in Tables 5 and 6.
Idelalisib er 93 - 94 % bundet til humane plasmaproteiner ved koncentrationer der observeres klinisk. 
Idelalisib is 93% to 94% bound to human plasma proteins at concentrations observed clinically.
UNIK IDENTIFIKATOR - MENNESKELIGT LÆSBAR DATA 
UNIQUE IDENTIFIER - HUMAN READABLE DATA
Du vil have behov for at få taget regelmæssige blodprøver før og under behandlingen med Zydelig. 
You will need regular blood tests before and during treatment with Zydelig.
Spørg lægen, hvis du har spørgsmål om nogle af dine lægemidler. 
Ask your doctor if you have any questions about any of your medicines.
Kontakt straks din læge, hvis du bliver syg (især med feber, hoste eller vejrtrækningsbesvær), mens du tager Zydelig. 
Tell your doctor right away if you become ill (especially with a fever, cough or breathing difficulties) while you are taking Zydelig.
SJS eller TEN forekom inden for en måned efter administration af lægemiddelkombinationen, og er resulteret i dødelig udgang. 
SJS or TEN occurred within one month of the medicinal combination and fatal outcomes have resulted.
Vurderingen af bivirkninger er baseret på to fase 3-studier (studie 312-0116 og studie 312-0119) og seks fase 1- og fase 2-studier. 
Assessment of adverse reactions is based on two Phase 3 studies (study 312-0116 and study 312-0119) and six Phase 1 and 2 studies.
Dette er yderst vigtigt, da lægemidlernes virkning kan forstærkes eller svækkes, hvis der bruges mere end ét lægemiddel på samme tid. 
This is extremely important, as using more than one medicine at the same time can strengthen or weaken their effect.
Et hundrede og tolv (89,6 %) patienter var refraktære til deres sidste behandlingsprogram, før de indgik i studiet. 
One hundred and twelve (89.6%) subjects were refractory to their last regimen prior to study entry.
ALFA 1-ADRENORECEPTORANTAGONISTER 
ALPHA-1 ADRENORECEPTOR ANTAGONISTS
Fortæl straks lægen, hvis du eller andre bemærker, at du har: hukommelsestab, problemer med at tænke, gangbesvær eller synstab - dette kan skyldes en meget sjælden men alvorlig hjerneinfektion, der kan være dødelig (progressiv multifocal leukoencephalopati eller PML). 
Tell your doctor immediately if you notice or someone notices in you: memory loss, trouble thinking, difficulty walking or sight loss - these may be due to a very rare but serious brain infection which can be fatal (progressive multifocal leukoencephalopathy or PML).
Laboratorieundersøgelser vil muligvis vise en stigning i antallet af hvide blodlegemer (“kaldet lymfocytter”) i dit blod i de første par uger med behandling. 
Laboratory tests may show an increase in white blood cells (called “lymphocytes”) in your blood in the first few weeks of treatment.
Det tilsyneladende fordelingsvolumen for idelalisib (gennemsnit) var ca. 96 l. 
The apparent volume of distribution for idelalisib (mean) was approximately 96 L.
Det primære endepunkt var progressionsfri overlevelse (PFS, progression free survival). 
The primary endpoint was progression free survival (PFS).
Fortæl det til lægen, hvis du har problemer med at sluge tabletter. 
Tell your doctor if you have problems swallowing tablets.
Patienterne skal monitoreres for respiratoriske tegn og symptomer under hele behandlingsforløbet. 
Patients should be monitored for respiratory signs and symptoms throughout treatment.
Behandling af en overdosis med Zydelig består af generel støttende behandling, herunder overvågning af vitale tegn og observation af patientens kliniske tilstand. 
Treatment of overdose with Zydelig consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Idelalisib inducerede inflammatoriske ændringer hos både rotter og hunde. 
Idelalisib induced inflammatory changes in both rats and dogs.
Du skal tage ekstra medicin, som din læge vil ordinere, mens du tager Zydelig, for at forebygge en type infektion. 
You should take additional medicine provided by your doctor while you are taking Zydelig to prevent one type of infection.
Det gennemsnitlige koncentrationsforhold mellem blod og plasma var ca. 0,5. 
The mean blood-to-plasma concentration ratio was approximately 0.5.
For patienter med CrCl < 60 ml/min bør alternative antibakterielle midler overvejes. 
For patients with CrCl < 60 mL/min, alternative antibacterials should be considered.