natgillin/translations-raw huggingface dataset:
Læger bør læse nab-paclitaxels produktresumé for specifikke forholdsregler og kontraindikationer for dette lægemiddel. 
Physicians should consult the nab-paclitaxel summary of product characteristics (SmPC) for specific precautions and contraindications of this medicine.
Behandling med Tecentriq skal påbegyndes og superviseres af læge med erfaring i behandling af cancer. 
Tecentriq must be initiated and supervised by physicians experienced in the treatment of cancer.
Etoposid administreres også som intravenøs infusion på dag 2 og 3. 
Etoposide is also administered by intravenous infusion on days 2 and 3.
Indehaveren af markedsføringstilladelsen skal fremsende den første PSUR for dette præparat inden for 6 måneder efter godkendelsen. 
The Marketing Authorisation Holder shall submit the first periodic safety update report for this product within 6 months following authorisation.
Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V. 
Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.
** Baseret på Kaplan-Meier estimat. 
** Based on Kaplan-Meier estimate
På grund af øget hæmatologisk toksicitet observeret i asiatiske patienter i studiet IMpower150, anbefales det, at startdosis for paclitaxel er 175 mg/m2 hver tredje uge for denne population. 
Due to increased haematologic toxicities observed in Asian patients in IMpower150, it is recommended that the starting dose of paclitaxel should be 175 mg/m2 every three weeks.
Tecentriq er kræftmedicin, der indeholder det aktive stof atezolizumab. 
Tecentriq is an anti-cancer medicine that contains the active substance atezolizumab.
Bedste understøttende behandling eller pemetrexed a 
Best supportive care or pemetrexed a
Thyroideafunktionen bør monitoreres inden og periodisk under behandling med atezolizumab. 
Thyroid function should be monitored prior to and periodically during treatment with atezolizumab.
Klargøringen skal: · udføres under aseptiske betingelser af uddannet personale i overensstemmelse med reglerne for god praksis, især hvad angår aseptisk fortynding af parenterale produkter. 
• performed under aseptic conditions by trained personnel in accordance with good practice rules especially with respect to the aseptic preparation of parenteral products.
· foregå i et aftræksskab med laminar strømning eller et biologisk sikkerhedsskab med anvendelse af standardforholdsreglerne for sikker håndtering af intravenøse midler. 
• prepared in a laminar flow hood or biological safety cabinet using standard precautions for the safe handling of intravenous agents.
Atezolizumabs metabolisme er ikke direkte undersøgt. 
The metabolism of atezolizumab has not been directly studied.
· Hvis du ikke oplever reaktioner på den første infusion, vil de næste infusioner tage 30 minutter. 
• If you do not have an infusion reaction during the first infusion, the next infusions will be given to you over a period of 30 minutes.
Grad 4 diarré eller colitis (livstruende; akut intervention indiceret) 
Grade 4 Diarrhoea or Colitis (life threatening; urgent intervention indicated)
Hvis der er formodning om immunrelaterede bivirkninger, skal der udføres grundig evaluering for at bekræfte ætiologi og udelukke andre årsager. 
For suspected immune-related adverse reactions, thorough evaluation to confirm aetiology or exclude other causes should be performed.
Disse resultater indikerer en potentiel risiko for, at administration af atezolizumab under graviditet, på grund af virkningsmekanismen, kan forårsage fosterskader, inklusive øget frekvens af abort og dødfødsel. 
These results indicate a potential risk, based on its mechanism of action, that administration of atezolizumab during pregnancy could cause foetal harm, including increased rates of abortion or stillbirth.
Bivirkninger angives, inden for hver frekvensgruppe, efter alvorlighedsgrad, i faldende rækkefølge. 
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
75% af patienterne havde kun haft ét tidligere platinholdig regime. 
Seventy-five percent of patients received only one prior platinum-based therapeutic regimen.
Der blev i alt inkluderet 1225 patienter, hvoraf de første 850 randomiserede patienter blev inkluderet i den primære effektanalyse jævnfør analyseplanen. 
A total of 1,225 patients were enrolled and per the analysis plan the first 850 randomised patients were included in the primary efficacy analysis.
Opbevares i køleskab (2°C-8°C). 
Store in a refrigerator (2 °C - 8 °C).
Nedsat appetit 
• loss of appetite
· Opbevares i køleskab (2°C til 8°C). 
• Store in a refrigerator (2 °C - 8 °C).
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
Af de 107 patienter i behandlingsarm B, som havde en responsstatus for stabil sygdom, patiel respons eller komplet respons efter induktionsbehandlingen, skiftede 40 patienter over til vedligeholdelsesbehandling med pemetrexed. 
Among 107 Arm B patients who had a response status of stable disease, partial response, or complete response after induction therapy, 40 received pemetrexed switch maintenance therapy.
24,2% af patienterne fik kun forudgående platinholdig adjuverende eller neoadjuverende behandling og oplevede progression inden for 12 måneder. 
There were 24.2% of patients who received only prior platinum-containing adjuvant or neoadjuvant therapy and progressed within 12 months.
Patienter, der ikke kunne inkluderes i kliniske studier 
Patients excluded from clinical trials
* Analyse af samlet overlevelse hos ITT-population blev udført på basis af den stratificerede log-rank-test; og resultaterne medtages udelukkende med et deskriptivt formål (p=0,0378); i overensstemmelse med det præspecificerede analysehierarki, kan p-værdien for samlet overlevelsesanalysen i ITT-populationen ikke betragtes som statistisk signifikant. 
* An analysis of OS in the all comer population was performed based on the stratified log-rank test and the result is provided for descriptive purposes only (p = 0.0378); according to the pre-specified analysis hierarchy, the p-value for the OS analysis in the all comer population cannot be considered statistically significant.
· Forpligtelse til at gennemføre foranstaltninger efter udstedelse af markedsføringstilladelse 
• Obligation to conduct post-authorisation measures
Syv (0,2%) patienter havde behov for kortikosteroidbehandling. 
Seven (0.2%) patients required the use of corticosteroids.
Startdosis af Tecentriq skal administreres over 60 minutter. 
The initial dose of Tecentriq must be administered over 60 minutes.
Inkluderer indberetninger om nefritis, Henoch-Schonlein Purpura nefritis. 
Includes report of nephritis, Henoch-Schonlein Purpura nephritis.
Ved at binde sig til proteinet, hjælper Tecentriq immunforsvaret med at bekæmpe kræften. 
By attaching to the protein, Tecentriq helps your immune system to fight your cancer.
Patienter, der tidligere havde fået anti-CTLA4 behandling, kunne imidlertid inkluderes, hvis den sidste dosis var administreret mindst 6 uger inden randomisering, og såfremt der ikke var alvorlige immunrelaterede bivirkninger fra behandling med anti-CTLA-4 (NCI CTCAE grad 3 og 4) i anamnesen. 
However, patients who had prior anti-CTLA-4 treatment could be enrolled, as long as the last dose was received at least 6 weeks prior to randomization, and there was no history of severe immunerelated adverse effects from anti-CTLA-4 (NCI CTCAE Grades 3 and 4).
Uddannelsesmaterialet for sundhedspersonalet skal indeholde: 
The physician educational material should contain:
Medianen af antal behandlingsserier var 7 for atezolizumab og 6 for nab-paclitaxel for hver behandlingsarm. 
The median number of treatment cycles was 7 for atezolizumab and 6 for nab-paclitaxel in each treatment arm.
17 ENTYDIG IDENTIFIKATOR - 2D-STREGKODE Der er anført en 2D-stregkode, som indeholder en entydig identifikator 
UNIQUE IDENTIFIER - 2D BARCODE 2D barcode carrying unique identifier included.
Udledningen af Tecentriq til miljøet bør minimeres. 
The release of Tecentriq in the environment should be minimised.
eller symptomatisk colitis 
Symptomatic Colitis
Patienter bør monitoreres for ændringer i nyrefunktionen. 
Patients should be monitored for changes in renal function.
Diabetes melitus 
Diabetes mellitus
Atezolizumab administreres som intravenøs infusion. 
Atezolizumab is administered as an intravenous infusion.
Da der ikke foreligger studier af eventuelle uforligeligheder, må dette lægemiddel må ikke blandes med andre lægemidler end dem, der er anført under pkt. 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Ikke almindelig: Kan påvirke op til 1 ud af 100 patienter 
Uncommon: may affect up to 1 in 100 people
Omkring halvdelen af patienterne havde modtaget taxan (51%) eller anthracyklin (54%) som (neo)adjuverende behandling. 
Approximately half the patients had received a taxane (51%) or anthracycline (54%) in the (neo)adjuvant setting.
Primære effekt-endepunkter n=185 
Primary efficacy endpoints n=185
Advarsel til patienter om vigtigheden af at kontakte lægen omgående, hvis de udvikler de ovennævnte symptomer og vigtigheden af ikke at prøve at behandle dem selv. 
• Warning message for patients on the importance of consulting their doctor immediately in case they develop any of the listed signs and symptoms and on the important not attempting to treat themselves.
Størstedelen af patienterne var kvinder (99,6%), 67,5% var hvide og 17,8% var asiater. 
Most patients were women (99.6%), 67.5% were white and 17.8% Asian.
Nøgleresultaterne i dette studie med en median overlevelsesopfølgning på 21 måneder vises i tabel 5. 
The key results of this study with a median survival follow-up of 21 months are summarised in Table 5.
Behandling med Tecentriq seponeres permanent (bortset fra endokrinopati, der kan kontrolleres med hormonsubstitution). 
Permanently discontinue Tecentriq (except endocrinopathies controlled with replacement hormones)
En farmakokinetisk populationsanalyse har vist, at clearance af atezolizumab er 0,200 l/dag og, at den typiske halveringstid er 27 dage. 
A population pharmacokinetic analysis indicates that the clearance of atezolizumab is 0.200 L/day and the typical terminal elimination half-life is 27 days.
Aspartataminotransferase (ASAT), alaninaminotransferase (ALAT) og bilirubin bør monitoreres inden behandlingen startes, periodisk under behandling med atezolizumab samt efter behov baseret på klinisk evaluering. 
Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin should be monitored prior to initiation of treatment, periodically during treatment with atezolizumab and as indicated based on clinical evaluation.
I IMpassion130 studiet havde 89 patienter (15%) ud af de 614 testede patienter, patogene BRCA1/2mutationer. 
In the IMpassion130 study, of the 614 patients tested, 89 (15%) carried pathogenic BRCA1/2 mutations.
Overordnet havde 41% af patienterne PD-L1-ekspression ≥1%, 27% havde levermetastaser og 7% havde asymptomatiske hjernemetastaser ved baseline. 
Overall, 41% of enrolled patients had PD-L1 expression ≥1%, 27% had liver metastases and 7% asymptomatic brain metastases at baseline.
Tid til forværring af andre lungekræftsymptomer (dvs. hoste, dyspnø og arm-/skuldersmerter) målt ved EORTC QLQ-LC13 var ens for atezolizumab og docetaxel. 
The time to deterioration in other lung cancer symptoms (i.e. cough, dyspnoea, and arm/shoulder pain) as measured by the EORTC QLQ-LC13 was similar between atezolizumab and docetaxel.
Demografiske og baseline sygdomskarakteristika i studiepopulationen, defineret som ITT-WT, (n=679) var velafbalancerede behandlingsarmene imellem. 
The demographics and baseline disease characteristics of the study population defined as ITT-WT (n=679) were well balanced between the treatment arms.
Samlet overlevelse sammenlignet mellem behandlingsarmene hos patienter med PD-L1-ekspression ≥1% blev ikke formelt testet, i overensstemmelse med det præ-specificerede analysehierarki. 
OS comparisons between treatment arms in patients with PD-L1 expression ≥1% were not formally tested, as per the pre-specified analysis hierarchy.
Størstedelen af patienterne havde en baseline ECOG-performancestatus på 1 (59%) og PD-L1-ekspression <1% (ca. 52%). 
The majority of patients had a baseline ECOG performance status of 1 (59%) and PDL1 expression <1% (approximately 52%).
Behandling efter sygdomsprogression var tilladt efter lægens vurdering. 
Treatment beyond disease progression was permitted at the discretion of the physician.
‡ Stratificeret efter tilstedeværelsen af levermetastaser, samt tidligere taxanbehandling. 
‡ Stratified by presence of liver metastases, and by prior taxane treatment.
Der sås klinisk relevant objektivt respons vurderet af et uafhængigt bedømmelsespanel ved hjælp af RECISTv1.1; men når det blev sammenlignet med en præspecificeret historisk kontrolresponsfrekvens på 10% var der dog ikke statistisk signifikans for det primære endepunkt. 
Clinically relevant IRF-assessed ORRs per RECIST v1.1 were shown; however, when compared to a pre-specified historical control response rate of 10%, statistical significance was not reached for the primary endpoint.
Da atezolizumab udskilles fra kredsløbet via katabolisme, forventes ingen metaboliske interaktioner med andre lægemidler. 
Since atezolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected.
Interimanalyse af samlet overlevelse* 
OS interim analysis*
*Atezolizumab er et Fc-designet, humaniseret IgG1 anti-programmeret døds-ligand 1 (PD-L1) monoklonalt antistof fremstillet i ovarieceller fra kinesisk hamster ved hjælp af rekombinant DNAteknologi. 
*Atezolizumab is an Fc-engineered, humanised IgG1 anti-programmed death-ligand 1 (PD-L1) monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Tecentriq fås i pakker med 1 hætteglas. 
Tecentriq is available in a pack containing 1 glass vial.
Alderens betydning for atezolizumabs farmakokinetik er vurderet i en farmakokinetisk populationsanalyse. 
The effect of age on the pharmacokinetics of atezolizumab was assessed in a population pharmacokinetic analysis.
Hypothyroidisme eller hyperthyroidisme 
Hypothyroidism or hyperthyroidism
Resultaterne for samlet overlevelse var lignende for henholdsvis subgrupper med patienter < 65 år og ³ 65 år. 
OS results were similar for patients aged < 65 and ≥ 65 subgroups, respectively.
Brug af systemiske kortikosteroider eller immunsupprimerende midler, inden behandlingen med atezolizumab påbegyndes, bør undgås på grund af potentiel påvirkning af farmakodynamisk aktivitet og virkning af atezolizumab. 
The use of systemic corticosteroids or immunosuppressants before starting atezolizumab should be avoided because of their potential interference with the pharmacodynamic activity and efficacy of atezolizumab.
Binding af PD-L1 til PD-1- og B7.1-receptorer på T-celler og antigenpræsenterende celler hæmmer cytotoksisk T-celleaktivitet, T-celleproliferation og cytokinproduktion. 
Binding of PD-L1 to the PD-1 and B7.1 receptors found on T-cells and antigen presenting cells suppresses cytotoxic T-cell activity, T-cell proliferation and cytokine production.
En farmakokinetisk populationsanalyse har vist, at det centrale, kompartmentale fordelingsvolumen hos den typiske patient er 3,28 l, og at volumen ved steady-state er 6,91. 
A population pharmacokinetic analysis indicates that central compartment volume of distribution is 3.28 L and volume at steady-state is 6.91 L in the typical patient.
· Hvis du er gravid, har en formodning om, at du er gravid, eller planlægger at blive gravid, skal du kontakte lægen. 
• Tell your doctor if you are pregnant, think you might be pregnant or are planning to become pregnant.
Baseret på en anbefaling fra en uafhængig dataovervågningskomité (iDMC), som følge af en tidlig gennemgang af overlevelsesdata, blev rekruttering af patienter i atezolizumabmonoterapibehandlingsarmen, hvis tumorer har en lav PD-L1-ekspression (mindre end 5% af immunceller var farvet positive for PD-L1 ved immunhistokemi), stoppet efter observeret nedsat samlet overlevelse for denne subgruppe. 
Based on an independent Data Monitoring Committee (iDMC) recommendation following an early review of survival data, accrual of patients on the atezolizumab monotherapy treatment arm whose tumours have a low PD-L1 expression (less than 5% of immune cells staining positive for PD-L1 by immunohistochemistry) was stopped after observing decreased overall survival for this subgroup.
Dosisreduktion af atezolizumab var ikke tilladt. 
No dose reduction of atezolizumab was allowed.
Nøgleresultaterne i helepopulationen opsummeres i tabel 4. 
The key results in the all comer population are summarised in Table 3.
Relevant behandling af patienter med unormale thyroideaværdier ved baseline bør overvejes. 
Appropriate management of patients with abnormal thyroid function tests at baseline should be considered.
Patienter med EGFR mutationer eller ALK-rearrangementer skulle også tidligere have fået behandling med tyrosinkinasehæmmere. 
Patients with EGFR mutations or ALK rearrangements should have been previously treated with tyrosine kinase inhibitors.
51% af patienternes tumorer havde PD-L1-ekspression på ≥ 1% TC eller ≥ 1% IC, og 49% af patienternes tumorer havde PD-L1-ekspression på < 1% TC og < 1% IC. 
51% of patients' tumours had PD-L1 expression of ≥ 1% TC or ≥ 1% IC and 49% of patients' tumours had PD-L1 expression of < 1% TC and < 1% IC.
Administration af atezolizumab kan skade fostret og forårsage embryoletalitet. 
Administration of atezolizumab could cause foetal harm, including embryo-foetal lethality.
Behandling med atezolizumab skal seponeres permanent ved enhver grad af myastenisk syndrom/myasthenia gravis eller Guillain-Barré syndrom. 
Treatment with atezolizumab must be permanently discontinued for any grade of myasthenic syndrome / myasthenia gravis or Guillain-Barré syndrome.
6.6 Regler for bortskaffelse og anden håndtering Tecentriq indeholder ikke antimikrobiologisk konserveringsmiddel eller bakteriostatiske midler og bør fortyndes af sundhedspersonale ved hjælp af aseptisk teknik for at sikre steriliteten af den fortyndede opløsning. 
6.6 Special precautions for disposal and other handling Tecentriq does not contain any antimicrobial preservative or bacteriostatic agents and should be prepared by a healthcare professional using aseptic technique to ensure the sterility of prepared solutions.
Hvis du ikke er sikker, skal du kontakte lægen eller sygeplejersken inden du får Tecentriq. 
If you are not sure, talk to your doctor or nurse before you are given Tecentriq.
Hvis du ikke tidligere har fået kemoterapi for fremskreden lungekræft, vil du få Tecentriq sammen med eller uden bevacizumab og kemoterapi (kaldet carboplatin og paclitaxel eller nab-paclitaxel). 
If you have not received anticancer medicines before for advanced lung cancer, Tecentriq will be given to you in combination with or without bevacizumab and anticancer medicines (chemotherapies called carboplatin and paclitaxel or nab paclitaxel).
Det co-primære effekt-endepunkt inkluderede investigator-vurderet progressionsfri overlevelse (PFS) hos ITT populationen og patienter med PD-L1-ekspression ≥ 1% per RECIST v1.1, samt samlet overlevelse (OS) hos ITT populationen og patienter med PD-L1-ekspression ≥ 1%. 
The co-primary efficacy endpoints included investigator-assessed progression free survival (PFS) in the ITT population and in patients with PD-L1 expression ≥ 1% per RECIST v1.1 as well as overall survival (OS) in the ITT population and in patients with PD-L1 expression ≥ 1%.
Patienterne, inklusive dem med EGFR mutationer eller ALK-rearrangementer, blev inkluderet og randomiseret (2:1) til at få et af behandlingsregimerne beskrevet i tabel 8. 
Patients, including those with EGFR mutations or ALK rearrangements, were enrolled and were randomised in a 2:1 ratio to receive one of the treatment regimens described in Table 8.
Infusion-relaterede reaktioner 
Infusion-related reactions
Ugentlig administration af atezolizumab til hun-aber, til et AUC ca. 6 gange højere end det hos mennesker behandlet med anbefalet dosis, forårsagede uregelmæssig menstruationscyklus og manglende nydannelse af corpora lutea i ovarierne, som var reversible. 
Weekly administration of atezolizumab to female monkeys at an estimated AUC approximately 6 times the AUC in patients receiving the recommended dose caused an irregular menstrual cycle pattern and a lack of newly formed corpora lutea in the ovaries which were reversible.
Urotelialt carcinom 
Urothelial carcinoma
Derudover er der ikke set uforligelighed med in-line filtermembraner bestående af polyethersulfon eller polysulfon samt infusionssæt og andre infusionshjælpemidler bestående af PVC, PE, polybutadien eller polyetherurethan. 
In addition, no incompatibilities have been observed with in-line filter membranes composed of polyethersulfone or polysulfone, and infusion sets and other infusion aids composed of PVC, PE, polybutadiene, or polyetherurethane.
Atezolizumabs sikkerhed som enkeltstofbehandling er vurderet på baggrund af poolede data fra 3.178 patienter med flere tumortyper. 
The safety of atezolizumab as monotherapy is based on pooled data in 3,178 patients across multiple tumour types.
Der foreligger ingen data vedrørende patienter med moderat svær eller svær nedsat leverfunktion. 
No data are available in patients with either moderate or severe hepatic impairment.
Tecentriq påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner. 
Tecentriq has minor influence on your ability to drive and use machines.
Patienter, der tidligere var behandlet med CD137-agonister eller immun checkpoint hæmmere (anti-PD-1 og anti-PD-L1 terapeutiske antistoffer) kunne ikke inkluderes i studiet. 
Patients who had prior treatment with CD137 agonists or immune checkpoint blockade therapies (anti-PD-1, and anti-PD-L1 therapeutic antibodies) were not eligible.
· svære reaktioner på infusionen (kan opstå under infusionen eller inden for 1 dag efter infusionen): symptomer kan omfatte feber, kulderystelser, åndenød og hedeture. 
• severe reactions associated with infusion (events occurring during the infusion or within one day of the infusion): may include fever, chills, shortness of breath and flushing.
Der er observeret myastenisk syndrom/myasthenia gravis og Guillain-Barré syndrom, som kan være livstruende, hos patienter behandlet med atezolizumab. 
Myasthenic syndrome/myasthenia gravis or Guillain-Barré syndrome, which may be life threatening, were observed in patients receiving atezolizumab.
Det primære effekt-endepunkt for IMvigor211 er samlet overlevelse. 
The primary efficacy endpoint for IMvigor211 is overall survival (OS).
Opdaterede resultater for progressionsfri overlevelse vises også i figur 4 og 5. 
Updated PFS results are also presented in Figures 4 and 5.
Inkluderer indberetninger om diabetes mellitus, type 1 diabetes mellitus, diabetisk ketoacidose, ketoacidose. 
Includes reports of diabetes mellitus, type 1 diabetes mellitus, diabetic ketoacidosis, ketoacidosis.
Symptomatisk 
Symptomatic
Til intravenøst brug 
Intravenous use
Sammenligning af samlet overlevelse mellem behandlingsarmen og med kontrolarmen inden for IC2/3-, IC1/2/3- og ITT-populationen (intention-to-treat, dvs. alle grupper) blev testet ved hjælp af en hierarkisk procedure i en fastsat rækkefølge, baseret på en stratificeret log-rank-test ved et 2-sidet niveau på 5%: trin 1) IC2/3-population; trin 2) IC1/2/3-population; trin 3) alle grupper. 
Comparisons with respect to OS between the treatment arm and control arm within the IC2/3, IC1/2/3, and ITT (Intention-to-treat, i.e. all comers) populations were tested using a hierarchical fixed-sequence procedure based on a stratified log-rank test at two-sided level of 5% as follows: step 1) IC2/3 population; step 2) IC1/2/3 population; step 3) all comers population.