natgillin/translations-raw huggingface dataset:
• diarré forstoppelse, opkastning, halsbrand eller luft i maven, mavesmerter 
• diarrhoea, constipation, being sick (vomiting), heartburn, breaking wind, stomach pain
DULOXETIN BOEHRINGER INGELHEIM kan gøre dig søvnig og svimmel. 
DULOXETINE BOEHRINGER INGELHEIM may make you feel sleepy of dizzy.
- tidligere har haft krampeanfald - tidligere har haft mani - lider af bipolar sygdom - har øjenproblemer, såsom visse typer af grøn stær (glaukom - forøget tryk i øjet) - tidligere har lidt af blødningsforstyrrelser (tendens til blå mærker) - har risiko for at få lavt indhold af natrium i blodet. 
- are taking other medicines to treat depression(see ‘Taking other medicines') - are taking St. John's Wort, a herbal treatment (Hypericum perforatum) - have kidney disease - have had seizures (fits) - have had mania - suffer from bipolar disorder - have eye problems, such as certain kinds of glaucoma (increased pressure in the eye) - have a history of bleeding disorders (tendency to develop bruises) - are at risk of low sodium levels - are currently being treated with another medicine which may cause liver damage - are taking other medicines containing duloxetine - have intolerance to some sugars (see end of Section 2) - are considering stopping DULOXETINE BOEHRINGER INGELHEIM (see section 3)
Indehaver af markedsføringstilladelsen og fremstiller Indehaver af markedsføringstilladelsen: Boehringer Ingelheim International GmbH, Binger Str. 173 D55216 Ingelheim am Rhein, Tyskland. 
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Boehringer Ingelheim International GmbH, Binger Str. 173 D-55216 Ingelheim am Rhein, Germany.
Edible Green Ink: Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og shellac. 
Edible green ink: black iron oxide-synthetic (E172), yellow iron oxide- synthetic (E172), propylene glycol, shellac.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 60 mg of duloxetine (as hydrochloride).
• muskelsmerter, muskelstivhed eller muskelkramper 
• muscle pain, muscle tightness, muscle spasm
• krampeanfald 
• throat inflammation
Luftveje, thorax og mediastinum Gaben 
Vertigo Ear pain Respiratory, thoracic and mediastinal disorders Yawning
• ændret smagsoplevelse, koncentrationsbesvær, spasmer og ufrivillige bevægelser af musklerne, 
• tasting things differently than usual, disturbance in attention, stiffness, spasms and involuntary movements of the muscles, muscle twitching, abnormal manner of walking
Du bedes henvende dig til din læge, hvis din læge har udskrevet DULOXETIN BOEHRINGER INGELHEIM til en patient under 18 år, og du gerne vil diskutere dette. 
If your doctor has prescribed DULOXETINE BOEHRINGER INGELHEIM for a patient under 18 and you want to discuss this, please go back to your doctor.
Almindelige bivirkninger (det sker hos mellem 1 til 10 ud af 100 patienter) 
Very common side effects (these can affect more than 10 in 100 patients treated)
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS 60 MG HÅRDE ENTEROKAPSLER 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 60 mg hard gastro-resistant capsules
Triethylcitrat. 
Hypromellose.
DULOXETINE BOEHRINGER INGELHEIM 30 mg findes i pakninger med 7, 28 og 98 kapsler. 
DULOXETINE BOEHRINGER INGELHEIM 30 mg is available in packs of 7, 28 and 98 capsules.
StevensJohnsons syndrom 
Angio-neurotic oedema StevensJohnson Syndrome
Svært nedsat nyrefunktion (kreatinin-clearance < 30 ml/min.). 
Severe renal impairment (creatinine clearance <30 ml/min) (see section 4.4).
DULOXETINE BOEHRINGER INGELHEIM 60 mg findes i pakninger med 28 og 98 kapsler. 
DULOXETINE BOEHRINGER INGELHEIM 60 mg is available in packs of 28 and 98 capsules.
Hver DULOXETIN BOEHRINGER INGELHEIM-kapsel indeholder pellets af det aktive stof med en belægning, som beskytter dem mod mavesyre. 
What DULOXETINE BOEHRINGER INGELHEIM looks like and contents of the pack DULOXETINE BOEHRINGER INGELHEIM is a hard gastro-resistant capsule Each capsule of DULOXETINE BOEHRINGER INGELHEIM contains pellets of duloxetine hydrochloride with a covering to protect them from stomach acid.
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN Boehringer Ingelheim UDLØBSDATO EXP {MM/ÅÅÅÅ} 
NAME OF THE MARKETING AUTHORISATION HOLDER Boehringer Ingelheim
DULOXETINE BOEHRINGER INGELHEIM må ikke anvendes sammen med ikke-selektive, irreversible monoaminoxidase-hæmmere - MAO-hæmmere (se pkt. 
Concomitant use of DULOXETINE BOEHRINGER INGELHEIM with nonselective, irreversible Monoamine Oxidase Inhibitors (MAOIs) is contraindicated (see section 4.5).
• svimmelhed og ørepine 
Mania and seizures
30 mg kapslerne har mat hvid bund med påskriften "30 mg" og mat blå top med påskriften "9543". 
The 30 mg capsules has an opaque white body, imprinted with ‘30 mg' and an opaque blue cap, imprinted with ‘9543'.
Nedsat nyrefunktion: Patienter med terminal nyresygdom i dialysebehandling havde et dobbelt så højt duloxetin-Cmaks. 
Renal impairment: end stage renal disease (ESRD) patients receiving dialysis had 2-fold higher duloxetine Cmax and AUC values compared with healthy subjects.
60 mg kapslerne har mat grøn bund med påskriften "60 mg" og mat blå top med påskriften "9542". 
The 60 mg capsules has an opaque green body, imprinted with ‘60 mg' and an opaque blue cap, imprinted with ‘9542'.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/003-005 
MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/003-005
DULOXETINE BOEHRINGER INGELHEIM bør ikke gives til patienter med nedsat leverfunktion på grund af leversygdom (se pkt. 
DULOXETINE BOEHRINGER INGELHEIM should not be used in patients with liver disease resulting in hepatic impairment (see sections 4.3 and 5.2).
Den anbefalede dosis af DULOXETIN BOEHRINGER INGELHEIM er 1 kapsel (60 mg) én gang daglig. 
The usual dose of DULOXETINE BOEHRINGER INGELHEIM is 1 capsule (60 mg) once a day, but your doctor will prescribe the dose that is right for you.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE DULOXETIN BOEHRINGER INGELHEIM 
BEFORE YOU TAKE DULOXETINE BOEHRINGER INGELHEIM
Letargi Smags 
Hepatic impairment
• svimmelhed, prikkende følelse som når noget sover, søvnforstyrrelse (livagtige drømme, mareridt, søvnløshed), rastløshed eller uro, angst, kvalme eller opkastning, rystelser, hovedpine, irritation, diaré, forøget tendens til at svede eller svimmelhed. 
inability to sleep), feeling restless or agitated, feeling anxious, feeling sick (nausea) or being sick (vomiting), tremor (shakiness), headaches, feeling irritable, diarrhoea, excessive sweating or vertigo.
• nedsat aktivitet af skjoldbruskkirtlen 
• decreased thyroid gland activity
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 hårde enterokapsler 
PHARMACEUTICAL FORM AND CONTENTS 7 hard gastro-resistant capsules, 28 hard gastro-resistant capsules 98 hard gastro-resistant capsules
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/011-012 
MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/011-012
Besværet vandladning Natlig vandladning Nedsat urinmængde 
Urinary Retention Dysuria Urinary hesitation Nocturia Polyuria Urine flow decreased
Palpitationer 
Agitation
Du må ikke tage mere DULOXETIN BOEHRINGER INGELHEIM pr. dag, end lægen har ordineret. 
Do not take more than the daily amount of DULOXETINE BOEHRINGER INGELHEIM that has been prescribed for you in one day.
Hos de patienter, som responderede på 8-ugers akut behandling med 60 mg ARICLAIM en gang daglig i et open-label, langtids, ukontrolleret forsøg, holdt smertereduktionen i yderligere 6 måneder. 
In an open label long-term uncontrolled study, the pain reduction in patients responding to 8-weeks of acute treatment of DULOXETINE BOEHRINGER INGELHEIM 60 mg once daily was maintained for a further 6-months as measured by change on the Brief Pain Inventory(BPI) 24-hour average pain item.
Man bør ikke reducere dosis ved behandling af ældre patienter udelukkende på grund af alder. Der bør dog udvises forsigtighed ved behandling af ældre (se pkt. 
No dosage adjustment is recommended for elderly patients solely on the basis of age.
• sammentrækning af kæbemusklen 
• contraction of the jaw muscle
Monoaminoxidasehæmmere (MAO-hæmmere): Du må ikke tage DULOXETIN BOEHRINGER INGELHEIM sammen med en MAO-hæmmer eller inden for 14 dage efter afsluttet behandling med en MAO-hæmmer. 
Monoamine Oxidase Inhibitors (MAOIs): You should not take DULOXETINE BOEHRINGER INGELHEIM if you are taking, or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI).
• unormal urinlugt 
• having abnormal urine odour
30 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132) og Edible Green Ink. 
Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Edible Green Ink
(monoaminoxidasehæmmer) (se afsnittet nedenfor: "Brug af anden medicin") - tager fluvoxamin (til behandling af bl.a. depression), ciprofloxacin eller enoxacin (til behandling af infektioner) 
− are taking fluvoxamine which is usually used to treat depression, ciprofloxacin or enoxacine which are used to treat some infections
Psykiske forstyrrelser Søvnløshed Uro 
Psychiatric Disorders Insomnia
• øget tendens til at gabe • nedsat appetit, vægttab 
• lack of appetite, weight loss
Hvis du skal tage DULOXETINE BOEHRINGER INGELHEIM, vil din læge sige det til dig. 
Always take DULOXETINE BOEHRINGER INGELHEIM exactly as your doctor has told you.
DULOXETINE BOEHRINGER INGELHEIM enterokapsler indeholder saccharose. 
DULOXETINE BOEHRINGER INGELHEIM contains sucrose.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 30 mg of duloxetine (as hydrochloride)
DULOXETIN BOEHRINGER INGELHEIM indeholder: - Aktivt stof: 
What DULOXETINE BOEHRINGER INGELHEIM contains The active substance is duloxetine.
- Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her. 
It may harm them, even if their symptoms are the same as yours - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Edible Green Ink indeholder: Syntetisk sort jernoxid (E172), syntetisk gul jernoxid (E172), propylenglycol og Shellac. 
Edible Green Ink contains: Black Iron Oxide-Synthetic (E172) Yellow Iron Oxide- Synthetic (E172) Propylene glycol
Mydriasis Synsforstyrrelser 
Blurred vision Mydriasis Visual disturbance
Kuldegysninger Generel utilpashed Varmefølelse Gangforstyrrelser 
Feeling hot Gait disturbance
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver kapsel indeholder 60 mg duloxetin (som hydrochlorid). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 60 mg of duloxetine (as hydrochloride)
DULOXETINE BOEHRINGER INGELHEIM-enterokapsler indeholder saccharose. 
DULOXETINE BOEHRINGER INGELHEIM gastro-resistant capsules contain sucrose.
LÆGEMIDLETS NAVN DULOXETINE BOEHRINGER INGELHEIM 30 mg hårde enterokapsler. 
NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg, hard gastro-resistant capsules.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/003 
MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/003
Serotoninsyndrom Ekstrapyramidale symptomer Akatisi 
Serotonin syndrome
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/08/471/011 
MARKETING AUTHORISATION NUMBER(S) EU/1/08/471/011
Edible White Ink indeholder: Titandioxid (E171), propylenglycol, Shellac og povidon. 
Edible White Ink contains: Titanium Dioxide (E171) Propylene glycol Shellac
Det skal du vide, før du begynder at tage DULOXETIN BOEHRINGER INGELHEIM Sådan skal du tage DULOXETIN BOEHRINGER INGELHEIM Bivirkninger 
What DULOXETINE BOEHRINGER INGELHEIM is and what it is used for Before you take DULOXETINE BOEHRINGER INGELHEIM How to take DULOXETINE BOEHRINGER INGELHEIM Possible side effects
• brystsmerter. 
• are breast-feeding.
LÆGEMIDLETS NAVN DULOXETINE BOEHRINGER INGELHEIM 60 mg hårde enterokapsler 
NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules
LISTE OVER HJÆLPESTOFFER Indeholder saccharose. 
LIST OF EXCIPIENTS Contains sucrose See leaflet for further information
60 mg: Gelatine, natriumlaurilsulfat, titandioxid (E171), indigotin (E132), gul jernoxid (E172) og Edible White Ink. 
Sodium Lauryl Sulfate Titanium Dioxide (E171) Indigo Carmine (E132) Yellow Iron Oxide (E172) Edible White Ink
Forstoppelse Diaré 
Breast feeding
• hjertebanken, hedeture, svedtendens, nattesved 
• feeling the heart pumping in the chest, flushing, increased sweating, night sweats
Muskelsitren 
Muscle
Du bør ikke bruge DULOXETIN BOEHRINGER INGELHEIM, mens du ammer. 
DO NOT take DULOXETINE BOEHRINGER INGELHEIM if you:
Problemer med udløsning Forsinket udløsning Seksuel dysfunktion Gynækologisk blødning 
Ejaculation disorder Ejaculation delayed Sexual
Der er ikke foretaget nogen kliniske forsøg med duloxetin på børn. 
Use in children and adolescents under 18 years of age No clinical trials have been conducted with duloxetine in paediatric populations.
Somnolens Svimmelhed 
Tremor Paraesthesia
Lægemidlet er receptpligtigt. 
EFFECTIVE USE OF THE MEDICINAL PRODUCT Not applicable.
Epistaxis 
behaviour
• (kløende) udslæt 
• chest pain
Titandioxid (E171) 
Titanium dioxide (E171) Triethyl citrate.
Vertigo Ørepine 
• vertigo, ear pain
Der er ingen erfaring med brug af DULOXETINE BOEHRINGER INGELHEIM hos børn og unge (se pkt. 
HOW TO STORE DULOXETINE BOEHRINGER INGELHEIM Keep out of the reach and sight of children
Rysten Paræstesier 
Sugar spheres
Gastritis 
Apathy
DULOXETIN BOEHRINGER INGELHEIM 30 mg hårde enterokapsler DULOXETIN BOEHRINGER INGELHEIM 60 mg hårde enterokapsler 
PACKAGE LEAFLET: INFORMATION FOR THE USER DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine (as hydrochloride)
DULOXETINE BOEHRINGER INGELHEIM 30 mg hårde enterokapsler Duloxetin 
NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 30 mg hard gastro-resistant capsules Duloxetine
DULOXETINE BOEHRINGER INGELHEIM 60 mg hårde enterokapsler Duloxetin 
NAME OF THE MEDICINAL PRODUCT DULOXETINE BOEHRINGER INGELHEIM 60 mg hard gastro-resistant capsules Duloxetine
Meget sjælden 
Very Rare Frequency not known
- tager anden medicin til behandling af depression (se ”Brug af anden medicin”) - tager et naturlægemiddel eller kosttilskud, der indeholder perikon (Hypericum perforatum) - har en nyresygdom. 
− have severe kidney disease are taking or have recently taken within the last 14 days, another antidepressant medicine called a monoamine oxidase inhibitor (MAOI) (see also below in section: ‘Taking other medicines')
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver kapsel indeholder 30 mg duloxetin (som hydrochlorid). 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg of duloxetine (as hydrochloride) Excipients: sucrose 8.6 mg.
• symptomer på overgangsalder 
• menopausal symptoms
Letargi forstyrrelse Dyskinesi Uro i benene Dårlig søvnkvalitet 
Dizziness attention Lethargy Dysgeusia Dyskinesia Restless legs syndrome sleep symptoms Akathisia Psychomotor restlessness
kolinerge og adrenerge receptorer. 
Renal and Urinary Disorders
Dysuri 
Haemorrhage
Nyreinsufficiens: 
Renal insufficiency
• bøvsen, fordøjelsesbesvær eller mavekatar 
• burping, indigestion, gastroenteritis
Det var hensigten, at det skulle leveres som tabletter (125 mg og 250 mg). 
It was to be available as tablets (125 mg and 250 mg).
Det vigtigste mål for behandlingens virkning er den andel af patienterne, hos hvem behandlingen virker. 
The main measure of effectiveness is the number of patients who respond to treatment.
EGFR kontrollerer cellers vækst og deling. 
EGFR controls growth and division of cells.
Hvad er Xegafri? 
What is Xegafri?
I disse undersøgelser bliver Xegafri ikke sammenlignet med nogen anden behandling. 
In these studies, Xegafri is not compared with any other treatment.
Den 27. maj 2016 EMA/352428/2016 EMEA/H/C/004053 
EMA/352428/2016 EMEA/H/C/004053
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen skyldtes, at forretningsstrategien for produktet var ændret. 
In its letter notifying the Agency of the withdrawal of application, the company stated that it was withdrawing its application because of a revised business strategy for the product.
Virksomheden har til CHMP oplyst, at den vil ophøre med at indrullere patienter i de igangværende kliniske undersøgelser. 
The company informed the CHMP that they will stop enrolling patients in the ongoing clinical trials.
Virksomheden vil fortsat udlevere Xegafri til patienter, hvis læge anbefaler, at de skal fortsætte med at tage lægemidlet. 
The company will continue to provide Xegafri to patients whose doctor recommend they should continue to take this medicine.
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom 
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 May 2016
Xegafri er et lægemiddel, der indeholder det aktive stof rociletinib. 
Xegafri is a medicine that contains the active substance rociletinib.
Desuden var der et sikkerhedsproblem i form af QT-forlængelse (en ændring i hjertets elektriske aktivitet) og beskrevne tilfælde af alvorlige hjerteproblemer. 
In addition, QT prolongation (a change in the heart's electrical activity) and cases of serious heart problems presented a safety concern.
Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Xegafri ikke opvejede risiciene. 
Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Xegafri did not outweigh its risks.
De forelagte data var for begrænsede til at muliggøre vurdering af effektiviteten på dette tidspunkt. 
The data provided were too limited to enable evaluation of the effectiveness of Xegafri at this time.
I lungekræftceller er EGFR ofte overaktiv, så kræftcellerne deler sig ukontrolleret. 
In lung cancer cells, EGFR is often overactive, causing uncontrolled division of cancer cells.
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Xegafri (rociletinib) EMA/352428/2016 
Withdrawal of the marketing authorisation application for Xegafri (rociletinib) EMA/352428/2016
Den 3. maj 2016 meddelte Clovis Oncology UK Ltd officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning tilbage om markedsføringstilladelse for Xegafri til behandling af ikke-småcellet lungekræft. 
On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.
Hvad forventedes Xegafri anvendt til? 
What was Xegafri expected to be used for?
Tilbagetrækning af ansøgningen om markedsføringstilladelse for Xegafri (rociletinib) 
Withdrawal of the marketing authorisation application for Xegafri (rociletinib)
Ved at blokere tyrosinkinase i EGFR forventes rociletinib at hæmme kræftens vækst og spredning. 
By blocking the tyrosine kinase in EGFR, rociletinib is expected to help reduce the growth and spread of the cancer.
Hvordan forventes Xegafri at virke? 
How is Xegafri expected to work?
De patienter, der på nuværende tidspunkt får Xegafri som led i et program med særlig udleveringstilladelse, kan desuden fortsætte med at få lægemidlet. 
In addition, patients currently receiving Xegafri through a compassionate use programme can continue to receive this medicine.
Det aktive stof i Xegafri, rociletinib, er en tyrosinkinasehæmmer. 
The active substance in Xegafri, rociletinib, is a tyrosine kinase inhibitor.
På baggrund af gennemgangen af de data, der forelå på tidspunktet for tilbagetrækningen af ansøgningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Xegafri ikke kunne være blevet godkendt til behandling af NSCLC-patienter, som har T790M-mutationen. 
Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Xegafri could not have been approved for the treatment of NSCLC patients who have the T790M mutation.
Xegafri forventedes anvendt til behandling af en type lungekræft, der kaldes ikke-småcellet lungekræft (NSCLC) hos voksne, som har T790M-mutationen (en særlig ændring i genet for proteinet epidermal vækstfaktorreceptor eller EGFR), og som i forvejen allerede har fået behandling rettet mod EGFR. 
Xegafri was to be used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) in adults who have the T790M mutation (a particular change in the gene for a protein called epidermal growth factor receptor or EGFR) and who had already been treated with EGFR-targeted therapy.
Det vil sige, at stoffet blokerer virkningen af enzymer af typen tyrosinkinaser, herunder de tyrosinkinaser, der findes i EGFR. 
This means that it blocks the activity of enzymes known as tyrosine kinases, particularly tyrosine kinases that are present in EGFRs.
Xegafri er ved at blive undersøgt i to undersøgelser hos 457 patienter, der har NSCLC og har T790M mutationen og i forvejen har fået behandling rettet mod EGFR. 
Xegafri is being investigated in two studies in 457 NSCLC patients who have the T790M mutation and had already been treated with EGFR-targeted therapy.
I modsætning til de fleste andre tyrosinkinasehæmmere er dette aktive stof aktivt mod kræftceller med mutationen T790M i genet for EGFR. 
Unlike most other tyrosine kinase inhibitors, rociletinib targets cancer cells with the T790M mutation in the EGFR gene.
Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Xegafri eller i programmer for anvendelse af Xegafri med særlig udleveringstilladelse? 
What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
1 ml (100 mg/ml) 2 (2 x 1) fyldte penne (multipakning) 
1 ml (100 mg/ml) 2 (2 x 1) pre-filled pens (multipack)
1 ml (100 mg/ml) 
1 ml (100 mg/ml) 1 pre-filled pen
2 (2 x 1) fyldte injektionssprøjter (multipakning) 
1 ml (100 mg/ml) 2 (2 x 1) pre-filled syringes (multipack)
opløsning 
Route of Administration
2 fyldte injektionssprøjter + 2 beskyttede kanyler 
2 pre-filled syringes + 2 safety needles
1 fyldt injektionssprøjte + 1 beskyttet kanyle 
1 pre-filled syringe + 1 safety needle
2 år. 
3 years.
SI-1000 Ljubljana Slovenien 
1000 Ljubljana Slovenia
Ældre Justering af dosis er ikke nødvendig til ældre patienter. 
No dosage adjustment is necessary for elderly patients.
Brug af gastrobeskyttende midler og lavdosis aspirin var tilladt i undersøgelsen. 
Use of gastroprotective agents and low dose aspirin were permitted in the studies.
[Meget almindelig (>1/10), Almindelig (> 1/100, < 1/10), Ikke-almindelig (> 1/1000, < 1/100), Sjælden (> 1/10.000, < 1/1000), Meget sjælden (< 1/10.000) inklusiv enkeltstående rapporter] 
[Very Common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (<1/10,000), not known (cannot be estimated from the available data)]
BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRINGEN AF PRODUKTRESUMEET FREMLAGT AF EMEA 
ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET PRESENTED BY THE EMEA
FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND 
ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Via G. Fabbroni, 6 I-00191 Roma Italien 
Via G. Fabbroni 6 00191 Roma Italy
COX-2 er isoformen af det enzym, som induceres af proinflammatoriske stimuli, og som man mener hovedsagelig har ansvaret for syntesen af prostanoide mediatorer for smerte, inflammation og feber. 
COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever.