natgillin/translations-raw huggingface dataset:
Indehaveren af markedsføringstilladelsen skal løbende sikre, at alle læger, som forventes at ordinere Erivedge, modtager følgende: 
• Measures to ensure that all appropriate actions have been performed prior to Erivedge being prescribed and dispensed The MAH shall continuously ensure that all physicians who are expected to prescribe Erivedge are provided with the following: Product information Healthcare professional educational material Healthcare professional reminder card Patient educational material Patient reminder card The healthcare professional educational material for Erivedge should contain the following key elements:
• kløe 
Myalgia
• Knogler stopper med at vokse 
• Bones stop growing (epiphyses premature fusion)
• Huskekort til patienter 
• Patient Reminder Card
• mavesmerter 
Contraceptive steroids
• Leverskade 
Asthenia
Hvordan virker Erivedge? 
How Erivedge works
Låget er beklædt med voksbehandlet træpap, som er foret med aluminiumfolie. 
The cap liner is aluminum foil-lined waxed pulp board.
Kutant planocellulært karcinom 
Cutaneous squamous cell carcinoma (cuSCC)
Muskelspasmer Artralgi 
Muscle spasms Arthralgia Pain in extremity
Hvis du tager Erivedge, kan det skade fostret eller slå fostret ihjel 
This is because Erivedge may harm or cause the death of your unborn baby.
Lever og galdeveje 
Flank pain
Actrapid indgives 30 minutter inden et måltid. 
Actrapid is given 30 minutes before a meal.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Actrapid den 7. oktober 2002. 
The European Commission granted a marketing authorisation valid throughout the European Union for Actrapid on 7 October 2002.
Den fuldstændige EPAR for Actrapid findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
The full EPAR for Actrapid can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Actrapid. 
This is a summary of the European public assessment report (EPAR) for Actrapid.
Actrapid anvendes til behandling af diabetes. 
Actrapid is used to treat diabetes.
EPAR - sammendrag for offentligheden human insulin 
EPAR summary for the public human insulin
HbA1c-niveauerne holdt sig forholdsvis stabilt i løbet af den seks måneder lange behandlingsperiode med Actrapid. 
HbA1c levels remained fairly steady over the six months of treatment with Actrapid.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Actrapid. 
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Actrapid.
Actrapid kan også indgives intravenøst (i en vene), men kun af en læge eller sygeplejerske. 
Actrapid may also be given intravenously (into a vein) but only by a doctor or a nurse.
HbA1c viser, hvor godt blodsukkeret reguleres. 
HbA1c gives an indication of how well the blood glucose is controlled.
Andre oplysninger om Actrapid: 
Other information about Actrapid
Hvis du ønsker yderligere oplysninger om behandling med Actrapid, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Actrapid, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Actrapid blev undersøgt hos patienter med type 1-diabetes, hvor bugspytkirtlen ikke kan producere insulin (to undersøgelser, som omfattede 1954 patienter), eller type 2-diabetes, hvor kroppen ikke er i stand til at udnytte insulin effektivt (en undersøgelse, som omfattede 182 patienter). 
Actrapid has been studied in patients with type 1 diabetes, when the pancreas cannot produce insulin (two studies involving 1,954 patients), and type 2 diabetes, when the body is unable to use insulin effectively (one study involving 182 patients).
CHMP besluttede, at fordelene ved Actrapid opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Actrapid. 
The CHMP decided that Actrapid's benefits are greater than its risks and recommended that it be given marketing authorisation.
Erstatningsinsulinen fungerer på samme måde som naturligt produceret insulin og hjælper glukosen til at trænge ind i cellerne fra blodet. 
The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
I undersøgelserne sammenlignede man over en periode på seks måneder Actrapid med en anden erstatningsinsulin kaldet insulin aspart ved at måle niveauet af glykosyleret hæmoglobin (HbA1c), som er den procentdel af hæmoglobin i blodet, der binder glukose til sig. 
The studies compared Actrapid with another replacement insulin called insulin aspart over six months by measuring the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
De hyppigste bivirkninger ved Actrapid (som optræder hos flere end 1 ud af 10 patienter) er hypoglykæmi (lave blodsukkerniveauer). 
The most common side effect with Actrapid (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Det fås som hætteglas, cylinderampuller (Penfill) eller fyldte penne (NovoLet, InnoLet eller FlexPen). 
It is available as vials, cartridges (Penfill) or prefilled pens (NovoLet, InnoLet or FlexPen).
Actrapid er hurtigtvirkende insulin og kan anvendes sammen med mellemvirkende eller langtidsvirkende insulinpræparater. 
Actrapid is a fast-acting insulin and may be used with intermediate or long-acting insulins.
Hvilken risiko er der forbundet med Actrapid? 
What is the risk associated with Actrapid?
Actrapid gives som injektion under huden i låret, bugvæggen (maveskindet), deltamuskelregionen (skulderen) ellr sædemuskelregionen (ballerne). 
Actrapid is given by injection under the skin in the thigh, the abdominal wall (at the front of the waist), the deltoid region (shoulder) or the gluteal region (buttocks).
Actrapid må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for human insulin eller andre af indholdsstofferne. 
Actrapid must not be used in people who are hypersensitive to human insulin or any of the other ingredients.
Hvorfor blev Actrapid godkendt? 
Why has Actrapid been approved?
Actrapid er en injektionsvæske, opløsning, som indeholder det aktive stof human insulin. 
Actrapid is a solution for injection that contains the active substance human insulin.
Actrapid er et erstatningsinsulin, der er næsten identisk med det insulin, der produceres af bugspytkirtlen. 
Actrapid is a replacement insulin that is very similar to the insulin made by the pancreas.
Den fuldstændige liste over indberettede bivirkninger ved Actrapid fremgår af indlægssedlen. 
For the full description of all side effects reported with Actrapid, see the package leaflet.
Hvordan blev Actrapid undersøgt? 
How has Actrapid been studied?
Hvilken fordel viser undersøgelserne, at der er ved Actrapid? 
What benefit has Actrapid shown during the studies?
Hvad er Actrapid? 
What is Actrapid?
Hvad anvendes Actrapid til? 
What is Actrapid used for?
Hvordan anvendes Actrapid? 
How is Actrapid used?
Insulinen er fremstillet af gær, der har modtaget et gen (DNA), som sætter den i stand til at producere insulin. 
The active substance in Actrapid, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast that has received a gene (DNA), which makes it able to produce insulin.
Hvordan virker Actrapid? 
How does Actrapid work?
Æske med 6 flasker 24 timer 
1 bottle 24 hours
Hunde: Ikke relevant 
Cattle: 46 days Dogs: not applicable injection
EU/2/97/003/003 Dicural 100 mg Oral opløsning Kyllinger og kalkuner I drikkevand HDPE-flaske 1000 ml 
Bottle (HDPE) 1,000 ml Pack of 6 bottles
Kvæg: 46 dage 
24 hours
Dette kan tage op til 20 minutter. 
This may take up to 20 minutes.
- hvis du nogensinde har haft problemer med din lever. 
if you have ever had problems with your liver.
Kina, Hong Kong, Indonesien, Japan, Malaysia, Filippinerne, Singapore, Taiwan og Thailand 
China, Hong Kong, Indonesia, Japan, Malaysia, Philippines, Singapore, Taiwan and Thailand.
Den potentielle risiko hos mennesker er ikke kendt. 
The potential risk for humans is unknown.
En opdateret RMP skal fremsendes: 
An updated RMP shall be submitted:
Dato for første markedsføringstilladelse: 24/06/2009 Dato for seneste fornyelse: 23/04/2014 
Date of first authorisation: 24/06/2009 Date of latest renewal: 23/04/2014
* fra følgende studier: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE 
*from the following studies: INTEREST, ISEL, INTACT 1&2, IDEAL 1&2, INVITE
Drik væsken med det samme. 
Drink the liquid straight away.
IRESSA forlængede ikke overlevelsen hos den totale population. 
IRESSA did not prolong survival in the overall population.
ORR var i henhold til investigators gennemgang 70 % og median-PFS var 9,7 måneder. 
The ORR according to investigator review was 70% and the median PFS was 9.7 months.
LCS symptomforbedringsrate 
LCS symptom improvement rate
Disse data er i overensstemmelse med den planlagte eksploratoriske japanske subgruppeanalyse i IPASS (Goto 2012). 
These data are consistent with the pre-planned exploratory Japanese subgroup analysis in IPASS (Goto 2012).
Dette kan ramme cirka 1 ud af 100 patienter, som tager IRESSA, og kan være livstruende. 
This may affect about 1 in 100 patients taking IRESSA and can be life-threatening.
Dette protein er involveret i vækst og spredning af kræftceller. 
This protein is involved in the growth and spread of cancer cells.
IRESSA må derfor ikke anvendes under graviditet, medmindre det er strengt nødvendigt. 
IRESSA should not be used during pregnancy unless clearly necessary.
Allergiske reaktioner (1,1 %), inklusive angioødem og urticaria 
Allergic reactions (1.1%), including angioedema and urticaria
HR Hazard ratio (hazard ratio <1 favoriserer IRESSA) 
HR Hazard ratio (hazard ratios <1 favour IRESSA)
Disse data svarer til dem, der blev rapporteret i IPASS-studiet. 
These data are similar to those reported in the IPASS study.
Ingen af patienterne led af cancer, alle led af cirrose, og nogle havde hepatitis. 
None of the patients had cancer, all had cirrhosis and some had hepatitis.
Læberne, næsen, øjnene og kønsorganerne kan også være påvirkede. 
The lips, nose, eyes and genitals may also be affected.
Denne bivirkning er ikke almindelig, men nogle patienter er døde af den. 
This side effect is uncommon; however, some patients have died from this.
Plasma-proteinbindingen er ca. 90 %. 
Plasma protein binding is approximately 90%.
Derfor anbefales periodisk kontrol af leverfunktionen. 
Therefore, periodic liver function testing is recommended.
Der er ingen data for anvendelse af gefitinib hos gravide kvinder. 
There are no data from the use of gefitinib in pregnant women.
Dette lægemiddel kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines this medicine can cause side effects, although not everybody gets them.
b ”m” er medianer i måneder. 
b “m” is medians in months.
Fortæl hurtigst muligt din læge, hvis du lægger mærke til en af følgende bivirkninger: 
Tell your doctor as soon as possible if you notice any of the following side effects:
• Tag ikke antacida (for at mindske syre i din mave) 2 timer før og 1 time efter du tager IRESSA. 
Do not take antacids (to reduce the acid level of your stomach) 2 hours before or 1 hour after taking IRESSA.
Hvis en dosis glemmes, skal den tages, så snart patienten husker det. 
If a dose is missed, it should be taken as soon as the patient remembers.
Samlet resumé af sikkerhedsprofilen 
Summary of the safety profile
Andre potentielle interaktioner 
Other potential interactions
I dette studie var sensibiliteten 43,1 % og specificiteten 100 %. 
In that study, sensitivity was 43.1%, specificity was
Gefitinib udviste ikke genotoksisk potentiale. 
Gefitinib showed no genotoxic potential.
Frekvenser for forekomsten af bivirkninger er defineret som: Meget almindelige (≥ 1/10); almindelige (≥ 1/100 til < 1/10); ikke almindelige (≥ 1/1.000 til < 1/100); sjældne (≥ 1/10.000 til < 1/1.000); meget sjældne (< 1/10.000), ikke kendte (kan ikke estimeres ud fra forhåndenværende data). 
Frequencies of occurrence of undesirable effects are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 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).
Hvis du tager et lægemiddel, der indeholder dette aktive stof, kan det være, at din læge vil tage blodprøver oftere end normalt. 
If you are taking a medicine containing this active substance, your doctor may need to do blood tests more often.
Glasset skal svinges forsigtigt rundt af og til, indtil tabletten er opslæmmet (det kan tage op til 20 minutter). 
The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes).
Det bør overvejes at afbryde behandlingen, hvis ændringerne er alvorlige. 
Discontinuation should be considered if changes are severe.
Bivirkningerne forekommer normalt inden for den første måned af behandlingen og er generelt reversible. 
ADRs usually occur within the first month of therapy and are generally reversible.
Ikke-justeretanalyse PP population for kliniske faktorer ITT population for biomarkøre faktorer 
Unadjusted analysis PP population for clinical factors ITT population for biomarker factors
Tabletten tages oralt sammen med eller uden mad på cirka det samme tidspunkt hver dag. 
The tablet may be taken orally with or without food, at about the same time each day.
Ikke-justeretanalyse EFR population 
Unadjusted analysis EFR population
Blisterfolien kan være perforeret eller ikkeperforeret. 
The blister foil may be perforated or non-perforated.
9.8 v. 13.1 Kvinder 
9.8 v. 13.1 Female
Patienter, der oplever dette symptom, bør derfor være forsigtige, når de fører motorkøretøj eller betjener maskiner. 
Therefore, patients who experience this symptom should be cautious when driving or using machines.
• Tag tabletten på ca. samme tidspunkt hver dag. 
Take the tablet at about the same time each day.
Trial outcome index-resultater understøttede FACT-L- og LCS-resultaterne. 
Trial outcome index results were supportive of FACT-L and LCS results
Opslæmningen skal drikkes umiddelbart herefter (dvs. inden for 60 minutter). 
The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes).
Der er ingen specifik behandling i tilfælde af overdosering af gefitinib. 
There is no specific treatment in the event of overdose of gefitinib.
• Du kan tage tabletten sammen med mad eller uden mad. 
You can take the tablet with or without food.
Behandling med IRESSA skal initieres og superviseres af en læge med erfaring inden for cancerbehandling. 
Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anti-cancer therapies.
- Warfarin (et såkaldt oralt antikoagulationsmiddel, til forebyggelse af blodpropper). 
Warfarin (a so-called oral anticoagulant, to prevent blood clots).
Positiv indikator (9,5 % af den totale population har positiv EGFR-mutation (M+)) 
Positive predictive value (9.5% of the overall population are EGFR mutation-positive (M+))
Tag ikke IRESSA hvis du ammer af hensyn til dit barns sikkerhed. 
Do not take IRESSA if you are breast-feeding for the safety of your baby.
Brug ikke andre væsker. 
Do not use any other liquids.
Figur 1 og 2 Data for virkning i undergrupper af ikke-asiatiske patienter i INTEREST-studiet (N patienter = antal randomiserede patienter) 
Figures 1 and 2 Efficacy outcomes in subgroups of non-Asian patients in the INTEREST study (N patients = Number of patients randomised)
Disse patienter skal monitoreres tæt for bivirkninger. 
These patients should be closely monitored for adverse events.
FACT-L QoLforbedringshyppighed 
N FACT-L QoL improvement rate
Knus ikke tabletten. 
Do not crush the tablet.
Sikkerhedsprofilen, som fremgår af Tabel 1, er baseret på det kliniske udviklingsprogram med gefitinib og postmarketing-erfaringer. 
The safety profile presented in Table 1 is based on the gefitinib clinical development programme and postmarketed experience.
Fortæl det straks til din læge, hvis du oplever en af følgende bivirkninger - det kan være, du behøver akut medicinsk behandling: 
Tell your doctor immediately if you notice any of the following side effects - you may need urgent medical treatment:
Kvinder i den fertile alder skal tilrådes ikke at blive gravide under behandlingen. 
Women of childbearing potential must be advised not to get pregnant during therapy.
N Antal randomiserede patienter. 
N Number of patients randomised.
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA Storbritannien 
AstraZeneca UK Limited Macclesfield Cheshire SK10 2NA United Kingdom
Tilfælde med fatale udfald har været rapporteret. 
Cases with fatal outcomes have been reported.
Indeholder lactose og natrium, se indlægsseddel for yderligere information. 
Contains lactose and sodium, see package leaflet for further information.
Der er identificeret 5 metabolitter i ekskret og 8 metabolitter i plasma. 
Five metabolites have been fully identified in excreta and 8 metabolites in plasma.
Fænotypisk skift til småcellet lungecancer er rapporteret i 5-10 % af tilfældene. 
Phenotypic switch to small cell lung cancer has also been reported in 5-10% of cases.
4.4 v. 4.6 Mænd 
4.4 v. 4.6 Male
Kun robuste, pålidelige, sensitive test(s) med påvist anvendelighed til bestemmelse af EGFR-mutationsstatus af tumorer eller ctDNA bør anvendes for at undgå falsk negative eller falsk positive bestemmelser (se pkt 5.1). 
Only robust, reliable and sensitive test(s) with demonstrated utility for the determination of EGFR mutation status of tumours or ctDNA should be used to avoid false negative or false positive determinations (see section 5.1).
Resultater vedrørende livskvalitet varierede afhængig af status for EGFR-mutationen. 
Quality of life outcomes differed according to EGFR mutation status.
Dosisjustering på grund af toksicitet 
Dose adjustment due to toxicity
Nogle lungeproblemer kan blive værre under behandling med IRESSA. 
Some lung problems may get worse during treatment with IRESSA.
0,0397 1,7 gange højere hos kvinder end hos mænd 
0.0397 1.7 times higher in females than males
Gastrointestinal perforation er blevet rapporteret hos patienter, der tager gefitinib. 
Gastrointestinal perforation has been reported in patients taking gefitinib.
• Heftige hudreaktioner (sjælden) på store dele af kroppen. 
Severe skin reactions (rare) affecting large areas of your body.
N patienter 
N patients
Efter oral administration af C-14-mærket gefitinib til diende rotter 14 dage post partum var koncentrationen af radioaktivitet i mælken 11 til 19 gange højere end i blodet. 
Following oral administration of C-14 labelled gefitinib to lactating rats 14 days post-partum, concentrations of radioactivity in milk were 11-19 fold higher than in blood.
Det anbefales, at du undgår at blive gravid og/eller at du ammer, mens du er i behandling med IRESSA, fordi IRESSA kan skade dit barn. 
It is recommended that you avoid becoming pregnant during treatment with IRESSA because IRESSA could harm your baby.
Hazard Ratio (Gefitinib versus Docetaxel) og 95% CI 
Hazard Ratio (Gefitinib versus Docetaxel) and 95% CI
I ca. 60 % af tilfældene er resistens associeret med en sekundær T790M-mutation, for hvilke T790M-målrettede EGFR TKI'er kan overvejes som næste behandlingsmulighed. 
In about 60% of cases, resistance is associated with a secondary T790M mutation for which T790M targeted EGFR TKIs may be considered as a next line treatment option.
Patienter, der tager warfarin og gefitinib samtidig, bør monitoreres regelmæssigt for ændringer i protrombintiden (PT) eller INR. 
Patients taking warfarin and gefitinib concomitantly should be monitored regularly for changes in prothrombin time (PT) or INR.
IRESSAs sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt. 
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
IRESSA bruges til at behandle voksne med ikke-småcellet lungekræft. 
IRESSA is used to treat adults with non-small cell lung cancer.
Der må ikke anvendes andre væsker. 
No other liquids should be used.
Perforeret PVC/Aluminiumsfolieblistre indeholdende 10 tabletter eller PVC/Aluminiumsfolieblistre indeholdende 10 tabletter. 
PVC/Aluminium perforated blister containing 10 tablets or PVC/Aluminium non-perforated blister containing 10 tablets.
Den epidermale vækstfaktor (EGF) og dens receptor (EGFR [HER1; ErbB1]) er blevet identificeret som de vigtigste faktorer under cellevækst og proliferation for normale celler og cancerceller. 
The epidermal growth factor (EGF) and its receptor (EGFR [HER1; ErbB1]) have been identified as key drivers in the process of cell growth and proliferation for normal and cancer cells.
Børn og unge IRESSA er ikke beregnet til børn og teenagere under 18 år. 
Children and adolescents IRESSA is not indicated in children and adolescents under 18 years.
** Inkluderer isolerede rapporter om leversvigt, som i nogle tilfælde havde letalt udfald. 
**This includes isolated reports of hepatic failure which in some cases led to fatal outcomes.
Gefitinibs totale plasmaclearance er omkring 500 ml/min og den gennemsnitlige terminale halveringstid er 41 timer hos cancerpatienter. 
Gefitinib total plasma clearance is approximately 500 ml/min and the mean terminal half-life is 41 hours in cancer patients.
Tabletfilmovertræk: Hypromellose (E464) Macrogol 300 
Tablet coating Hypromellose (E464) Macrogol 300
Den gennemsnitlige absolutte biotilgængelighed hos cancerpatienter er 59 %. 
Mean absolute bioavailability is 59% in cancer patients.
Gefitinib plus den bedste understøttende behandling blev sammenlignet med placebo plus den bedste understøttende behandling. 
Gefitinib plus best supportive care was compared to placebo plus best supportive care.
Hvis der er mindre end 12 timer til den næste dosis, skal patienten ikke tage den glemte dosis. 
If it is less than 12 hours to the next dose, the patient should not take the missed dose.
Glasset skal renses med et halvt glas vand, som også skal drikkes. 
The glass should be rinsed with half a glass of water, which should also be drunk.
Tid til behandlingsstandsning ab 
Time to treatment failure ab
Disse lægemidler kan påvirke virkningen af IRESSA. 
These medicines may affect the way IRESSA works.
Har aldrig røget 
Never smoker
40/235 (17 %) af kvinderne er M+ 35/551 (6 %) af mændene er M+ 
40/235 (17%) of females are M+ 35/551 (6%) of males are M+
Gefitinib har et gennemsnitligt steady-state-volumen på 1400 l, hvilket tyder på, at der sker en omfattende distribution til væv. 
Gefitinib has a mean steady-state volume of distribution of 1400 l indicating extensive distribution into tissue.
Bivirkninger, der ikke er observeret i kliniske forsøg, men i dyr, når de eksponeres for niveauer magen til de kliniske eksponeringsniveauer og med mulig relevans for klinisk brug, var som følger: 
Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to the clinical exposure levels and with possible relevance to clinical use were as follows:
Asymptomatisk stigning i kreatinin i blodprøver Proteinuri 
Asymptomatic laboratory elevations in blood creatinine Proteinuria
Yderligere forholdsregler ved brug 
Further precautions for use
Symptomer herpå kan blandt andet være generel utilpashed med eller uden mulig gulsot (gullig hud og øjne). 
Symptoms may include a general feeling of being unwell, with or without possible jaundice (yellowing of the skin and eyes).
Resultaterne for overlevelse varierede efter rygningsprofil og etnisk oprindelse (se tabel 6). 
Survival outcomes differed by smoking status and ethnicity (see Table 6).