natgillin/translations-raw huggingface dataset:
14. oktober 2016 EMA/659373/2016 EMEA/H/C/004306 
14 October 2016 EMA/659373/2016 EMEA/H/C/004306
Derved forhindres kræftcellerne i at vokse og dele sig, mens de normale celler kun påvirkes i begrænset omfang. 
This prevents the cancer cells from growing and dividing, while normal cells are only slightly affected.
Omdannelsen til den aktive form sker hurtigere i kræftceller end i normale celler. 
active form happens more readily in cancer cells than in normal cells.
I sit brev til agenturet om tilbagetrækningen af ansøgningen anførte virksomheden, at tilbagetrækningen er sket på grund af en ændring i deres handelsstrategi. 
In its letter notifying the Agency of the withdrawal of the application, the company stated that it was withdrawing its application because of a change in commercial strategy.
Ansøgningen blev trukket tilbage, efter at CHMP havde vurderet den dokumentation, virksomheden oprindeligt havde fremlagt, og udarbejdet en liste med spørgsmål. 
The application was withdrawn after the CHMP had evaluated the initial documentation provided by the company and formulated a list of questions.
På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen bad CHMP virksomheden om at gøre nærmere rede for nogle aspekter med hensyn til fremstilling og opbevaring samt planer for overvågning af lægemidlets sikkerhed og virkning efter godkendelse. 
Based on the review of the data at the time of the withdrawal, the CHMP had asked the company to provide clarification on some aspects of manufacturing, storage and plans to monitor safety and effectiveness of the medicine after authorisation.
Det aktive stof i de to lægemidler, pemetrexed, omsættes i kroppen til en aktiv form, der blokerer de enzymer, som skal bruges til at danne genetisk materiale (dna og rna). 
The active substance in both medicines, pemetrexed, is changed in the body into an active form that blocks enzymes needed to make genetic material (DNA and RNA).
Den 22. september 2016 meddelte Hospira UK Limited officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at tilbagetrække sin ansøgning om markedsføringstilladelse for Pemetrexed Hospira (som ditromethamin) til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft. 
On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.
Det betyder, at det var hensigten, at Pemetrexed Hospira (som ditromethamin) skulle være identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union, og som hedder Alimta. 
This means that it was intended to be similar to a ‘reference medicine' already authorised in the European Union called Alimta.
Da Pemetrexed Hospira (som ditromethamin) blev udviklet som et generisk lægemiddel, fremlagde virksomheden resultaterne af undersøgelser for at påvise lægemidlets kvalitet. 
Because Pemetrexed (as ditromethamine) Hospira was developed as a generic medicine, the company presented the results of studies to show the quality of the medicine.
Der er ikke gennemført yderligere undersøgelser, da Pemetrexed Hospira (som ditromethamin), der gives ved infusion i en blodåre, er et generisk lægemiddel, som indeholder det samme aktive stof som referencelægemidlet Alimta. 
No further studies were carried out because Pemetrexed (as ditromethamine) Hospira is a generic medicine that is given by infusion into a vein and contains the same active substance as the reference medicine, Alimta.
CHMP mente, at virksomheden kunne have afhjulpet disse betænkeligheder, og var af den foreløbige opfattelse, at Pemetrexed Hospira (som ditromethamin) kunne være blevet godkendt til behandling af kræft i lungehinderne (malignt pleuramesoteliom) og ikke-småcellet lungekræft. 
The CHMP thought that the company could have addressed these questions and was of the provisional opinion that Pemetrexed (as ditromethamine) Hospira could have been approved for the treatment of malignant pleural mesothelioma and nonsmall-cell lung cancer.
Pemetrexed Hospira (som ditromethamin) skulle anvendes til behandling af to typer lungekræft: kræft i lungehinderne (malignt pleuramesoteliom), som typisk skyldes eksponering for asbest, og fremskreden ikke-småcellet lungekræft af typen ikke-pladecellekræft. 
Pemetrexed (as ditromethamine) Hospira was expected to be used to treat two types of lung cancer: malignant pleural mesothelioma (a cancer of the lining of the lungs usually caused by exposure to asbestos) and advanced non-small-cell lung cancer of the kind known as ‘non-squamous'.
Pemetrexed Hospira (som ditromethamin) er et kræftlægemiddel, der indeholder det aktive stof pemetrexed. 
Pemetrexed (as ditromethamine) Hospira is a cancer medicine that contains the active substance pemetrexed.
Det skulle markedsføres som et pulver, der fortyndes til en opløsning, som gives som infusion (drop) i en blodåre. 
It was to be available as a powder to be made up into a solution for infusion (drip) into a vein.
Pemetrexed Hospira (som ditromethamin) blev udviklet som et "generisk lægemiddel". 
Pemetrexed (as ditromethamine) Hospira was developed as a ‘generic medicine'.
Pemetrexed Hospira (som ditromethamin) forventes at virke på samme måde som referencelægemidlet Alimta. 
Pemetrexed (as ditromethamine) Hospira is expected to work in the same way as the reference medicine, Alimta.
Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Pemetrexed Hospira (som ditromethamin) med særlig udleveringstilladelse. 
The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for this product.
Hvad er Pemetrexed Hospira (som ditromethamin)? 
What is Pemetrexed (as ditromethamine) Hospira?
Hvad forventedes Pemetrexed Hospira (som ditromethamin) anvendt til? 
What was Pemetrexed (as ditromethamine) Hospira expected to be used for?
Hvordan virker Pemetrexed Hospira (som ditromethamin)? 
How does Pemetrexed (as ditromethamine) Hospira work?
Yderligere information vedrørende Enurev Breezhaler findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Further information on Enurev Breezhaler can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Agenturet bemærkede endvidere, at det, at lægemidlet tages en gang dagligt, kan gøre det lettere for patienterne at overholde behandlingen. 
The Agency also noted that the fact that the medicine is used once a day may help patients to adhere to their treatment.
Enurev Breezhaler fik markedsføringstilladelse med gyldighed i hele EU den 28. september 2012. 
Enurev Breezhaler received a marketing authorisation valid throughout the EU on 28 September 2012.
undersøgelser blev virkningen hovedsageligt målt på forbedringen af patienternes forcerede ekspirationsvolumen (FEV1, den maksimale luftmængde, en person kan udånde på et sekund). 
the main measure of effectiveness was improvement in patients' forced expiratory volumes (FEV1, the maximum volume of air a person can breathe out in one second).
Efter 12 måneders behandling havde Enurev Breezhaler øget FEV1 med 97 ml mere end placebo i den første undersøgelse, og med 108 ml mere i den anden undersøgelse. 
After 12 weeks of treatment, Enurev Breezhaler increased FEV1 by 97 ml more than with placebo in the first study, and by 108 ml more in the second study.
Patienterne bør højst anvende en kapsel dagligt. 
Patients should not use more than one capsule in a day.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler? 
What measures are being taken to ensure the safe and effective use of Enurev Breezhaler?
Enurev Breezhaler (glycopyrroniumbromid) EMA/326865/2018 
Enurev Breezhaler (glycopyrronium bromide) EMA/326865/2018
De hyppigste bivirkninger ved Enurev Breezhaler (som optræder hos mere end 1 ud af 100 patienter) er tørhed i munden, nasopharyngitis (betændelse i næse og hals), søvnløshed, muskel- og knoglesmerter og gastroenteritis (diarré og opkast). 
The most common side effects with Enurev Breezhaler (seen in more than 1 patient in 100) are dry mouth, nasopharyngitis (inflammation of the nose and throat), insomnia (difficulty sleeping), muscle and bone pain and gastroenteritis (diarrhoea and vomiting).
Hvis du ønsker mere information om brugen af Enurev Breezhaler, kan du læse indlægssedlen eller kontakte lægen eller apoteket. 
For more information about using Enurev Breezhaler, see the package leaflet or contact your doctor or pharmacist.
Som for alle lægemidler bliver data vedrørende brugen af Enurev Breezhaler løbende overvåget. 
As for all medicines, data on the use of Enurev Breezhaler are continuously monitored.
Det betyder, at det udvider luftvejene ved at blokere de muskarine receptorer (mål) i muskelceller og lungerne. 
This means that it widens the airways by blocking muscarinic receptors (targets) in muscle cells in the lungs.
Desuden var der ingen væsentlige sikkerhedsproblemer forbundet med Enurev Breezhaler, hvis bivirkninger svarer til dem, der er forbundet med andre muskarine receptorantagonistlægemidler. 
In addition, there were no major safety concerns with Enurev Breezhaler, with side effects similar to other muscarinic receptor antagonist medicines.
Enurev Breezhaler-kapsler, som indeholder et pulver til inhalation, anvendes udelukkende med Enurev Breezhaler-inhalatoren og må ikke sluges. 
Enurev Breezhaler capsules, which contain a powder for inhalation, are only used with the Enurev Breezhaler inhaler and must not be swallowed.
Agenturet afgjorde, at fordelene ved Enurev Breezhaler opvejer risiciene, og at det kan godkendes til anvendelse i EU. 
Therefore, the Agency decided that Enurev Breezhaler's benefits are greater than its risks and it can be authorised for use in the EU.
De bivirkninger, der er indberettet for Enurev Breezhaler, vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne. 
Side effects reported with Enurev Breezhaler are carefully evaluated and any necessary action taken to protect patients.
Dosis tages ved, at patienten anbringer en kapsel i inhalatoren og indånder pulveret fra kapslen gennem munden. 
To take a dose, the patient places a capsule into the inhaler and breathes in through the mouth the powder from the capsule.
Agenturet bemærkede, at Enurev Breezhaler havde en beskeden, men relevant gavnlig virkning hos patienterne med hensyn til forbedring af lungefunktionen og også viste sig at forbedre symptomerne på KOL. 
The European Medicines Agency noted that Enurev Breezhaler had a modest but relevant benefit for patients in terms of improving lung function, and also improved the symptoms of COPD.
Hvad er Enurev Breezhaler, og hvad anvendes det til? 
What is Enurev Breezhaler and what is it used for?
Enurev Breezhaler anvendes til (regelmæssig) vedligeholdelsesbehandling. 
Enurev Breezhaler is used for maintenance (regular) treatment.
Enurev Breezhaler er et lægemiddel, der anvendes til at lindre symptomerne på kronisk obstruktiv lungesygdom (KOL) hos voksne. 
Enurev Breezhaler is a medicine that is used to relieve the symptoms of chronic obstructive pulmonary disease (COPD) in adults.
Hvorfor er Enurev Breezhaler godkendt i EU? 
Why is Enurev Breezhaler authorised in the EU?
Oversigt over Enurev Breezhaler, og hvorfor det er godkendt i EU 
An overview of Enurev Breezhaler and why it is authorised in the EU
Enurev Breezhaler (glycopyrroniumbromid) 
Enurev Breezhaler (glycopyrronium bromide)
Hvilke risici er der forbundet med Enurev Breezhaler? 
What are the risks associated with Enurev Breezhaler?
Det aktive stof i Enurev Breezhaler, glycopyrroniumbromid, er en muskarin receptorantagonist. 
The active substance in Enurev Breezhaler, glycopyrronium bromide, is a muscarinic receptor antagonist.
Enurev Breezhaler udleveres kun på recept. 
Enurev Breezhaler can only be obtained with a prescription.
Den fuldstændige liste over bivirkninger og begrænsninger ved Enurev Breezhaler fremgår af indlægssedlen. 
For the full list of side effects and restrictions with Enurev Breezhaler, see the package leaflet.
Andre oplysninger om Enurev Breezhaler 
Other information about Enurev Breezhaler
Enurev Breezhaler indeholder det aktive stof glycopyrroniumbromid. 
Enurev Breezhaler contains the active substance glycopyrronium bromide.
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Enurev Breezhaler. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Enurev Breezhaler have been included in the summary of product characteristics and the package leaflet.
Hvordan anvendes Enurev Breezhaler? 
How is Enurev Breezhaler used?
Hvilke fordele viser studierne, at der er ved Enurev Breezhaler? 
What benefits of Enurev Breezhaler have been shown in studies?
Det blev i to hovedundersøgelser med i alt 1 888 patienter med KOL påvist, at Enurev Breezhaler er mere effektivt end placebo (en uvirksom behandling) til at lindre symptomerne på KOL. 
Enurev Breezhaler was found to be more effective than placebo (a dummy treatment) at relieving symptoms of COPD in two main studies involving a total of 1,888 patients with COPD.
Hvordan virker Enurev Breezhaler? 
How does Enurev Breezhaler work?
Indhold (Koncentrati on) 
Content (concentration)
1 cylinderampul 
Cartridge (glass) 3 ml (3.5 mg/ml) 1 cartridge
For alle indikationer 
For all indications
Det er ingen grund til, at du skynder dig med injektionen - 5 minutter giver dig rigeligt tid. 
There is no need to rush your injection - 5 minutes gives you enough time.
• Vask dine hænder grundigt. 
• Wash your hands thoroughly.
Den tilbageværende tid vises på skærmen. 
The time left is shown on screen.
Lægen kan rådgive dig. 
Your doctor can provide advice.
Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data): 
Not known (frequency cannot be estimated from the available data):
Disse data er i rimelig overensstemmelse med observerede data. 
These data are reasonably in agreement with observed data.
Del af multipakning, kan ikke sælges separat 
Component of a multipack, cannot be sold separately
- Visse vaccinationer kan medføre infektion. 
- Certain vaccinations may cause infections.
Værdien af denne dokumentation for evalueringen af risikoen for mennesker kan være begrænset. 
The value of these data to the evaluation of human risk may be limited.
• spontan abort. 
• spontaneous abortion.
Til hver injektion skal du bruge: 
For each injection you will need:
Indikator for medicinniveau 3. 
Medication level indicator 3.
CH-1630 Bulle Schweiz 
CH-1630 Bulle Switzerland
Mikro-USB-port 
Micro-USB Port
- Du kan ændre denne hastighed ved at anvende ”rullehjulet” på siden af ava. 
- You can change this speed using the “scroll wheel” on the side of your ava.
• generel svækkelse af den fysiske helbredstilstand. 
• general physical health deterioration.
• efter 16 uger, hvis du har plaque psoriasis. 
• after 16 weeks if you have plaque psoriasis.
• AutoClicks fyldte pen er lavet til at fungere præcist og sikkert. 
• AutoClicks pre-filled pen is designed to work accurately and safely.
Anordningen udleveres separat. 
The device is provided separately.
Dette kan tage op til 15 sekunder. 
This can take up to 15 seconds.
Antistoffer er proteiner, der genkender og binder sig til visse andre proteiner. 
Antibodies are proteins that specifically recognise and bind to other proteins.
Da du får denne medicin af din læge eller sygeplejerske, er det usandsynligt, at du vil få for meget. 
As this medecine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Alle patienter havde en fortid med massiv rygning. 
All patients had a history of heavy smoking.
- Prøv at slappe af, det vil gøre injektionen mere behagelig. 
- Try to relax as this will make the injection more comfortable.
Injektionsanordning: ava 
Injection device: ava
* Hodges-Lehmann punktestimat af skift og 95% asymptotisk (Moses) konfidensinterval. 
* Hodges-Lehmann point estimate of shift and 95% asymptotic (Moses) confidence interval.
Regelmæssig undersøgelse af huden anbefales, især hos patienter med risikofaktorer for hudcancer. 
Periodic skin examination is recommended, particularly for patients with risk factors for skin cancer.
C-EARLY-studiet mødte dets primære og vigtigste sekundære endepunkter. 
The C-EARLY trial met its primary and key secondary endpoints.
Det kan tage op til 10 sekunder at tømme sprøjten. 
It can take up to 10 seconds to empty the syringe.
• multipel sclerose* 
• multiple sclerosis*
Dette sikrer, at du indgiver injektionen korrekt. 
This will make sure you are giving the injection correctly.
• Nålens sikkerhedsanordning aktiveres ikke, medmindre hele dosen er injiceret. 
•The needle safety device will not activate unless the entire dose is given.
Dette tager 30 minutter. 
This will take 30 minutes.
De øvrige tilfælde repræsenterede en række forskellige maligniteter, herunder sjældne maligniteter, der som regel er forbundet med immunsuppression. 
The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression.
PASI 90 i uge 16 var et vigtigt sekundært effektmål i alle 3 studier. 
PASI 90 at Week 16 was a key secondary endpoint in all 3 studies.
ASAS 40 var et sekundært endepunkt. 
ASAS 40 was a secondary endpoint.
(Stevens-Johnsons syndrom) 
(Stevens-Johnson syndrome)
Procentrespons er baseret på antallet af deltagere, der bidrager (n) til dette effektmål og tidspunkt, hvilket kan være forskelligt fra N 
Percentage response based upon number of subjects contributing data (n) to that endpoint and time point which may differ from N
CIMPACT-studiet evaluerede 559 patienter. 
The CIMPACT study evaluated 559 patients.
Nonrespondent imputation blev brugt til manglende data. 
Non-responder imputation was used for missing data.
Dette lægemiddel er kun til engangsanvendelse. 
This medicinal product is for single use only.
• antistof rettet mod normalt væv 
• antibody directed against normal tissue
Forsøg ikke at berøre nålen, da det kan aktivere den fyldte pen. 
Do not try to touch the needle as it could activate the pre-filled pen.
Det er meget vigtigt, at du fortæller det til lægen, hvis du nogensinde har haft tuberkulose, eller hvis du har været i tæt kontakt med en person, som har haft tuberkulose. 
It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis.
- Hos nogle patienter producerer kroppen ikke tilstrækkeligt af de blodlegemer, som hjælper kroppen med at bekæmpe infektioner eller stoppe blødninger. 
- In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding.
Cimzia er ikke blevet undersøgt hos disse patientpopulationer. 
Cimzia has not been studied in these patient populations.
- Du kan vælge ”langsomst”, ”langsom”, ”hurtig” eller ”hurtigst” - dette angiver hvor hurtigt medicinen bliver injiceret og bør vælges (og justeres) i forhold den hastighed, du personligt foretrækker. 
- You can choose “slowest”, “slow”, “fast” or “fastest” - this controls how fast the medicine will be injected and should be selected (and adjusted) as per your personal comfort preference.
Radiografisk sæt med lineær ekstrapolation. 
Radiographic set with linear extrapolation.
Vær omhyggelig med ikke at berøre nålen eller lade nålen røre nogen overflade. 
Take care not to touch the needle or let the needle touch any surface.
Hold den fyldte pen lodret (i en 90 graders vinkel) mod huden, som tidligere er blevet renset (”injektionsstedet”). 
Hold the pre-filled pen straight (at a 90° degree angle) against the skin, that previously has been cleaned (the “injection site”).
• Du skal også læse hele vejledningen i ava brugermanualen nøje. 
• You must also carefully read the full instructions in the ava User Manual.
Injektionen vil nu være afsluttet. 
At this time, the injection will be complete.
Dette tager 30 til 45 minutter. 
This will take 30 to 45 minutes.
Resultaterne ved uge 34 er vist i tabel 7. 
The results at week 34 are shown in Table 7.
Baseline PGA-scoren gik fra moderat (70 %) til svær (30 %). 
The baseline PGA score ranged from moderate (70%) to severe (30%).
Reaktivering af Hepatitis B-virus (HBV) 
Hepatitis B virus (HBV) reactivation
• Slip huden med den første hånd. 
• Release the skin with the first hand.
- Medicinen indeholder 1 ml Cimzia og er ikke helt fuld - dette er normalt. 
- The medication contains 1ml of Cimzia and is not completely full - this is normal.
Frekvensgrupperne er defineret som følger: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1000 to < 1/100); Rare (≥ 1/10,000 to < 1/1000); Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Derfor er tidlig påvisning af enhver infektion, især kliniske atypiske tegn på en alvorlig infektion, afgørende for at mindske forsinkelser af diagnosticering og initiering af behandling. 
Therefore, early detection of any infection, particularly atypical clinical presentations of a serious infection, is critical to minimise delays in diagnosis and initiation of treatment.
In vitrofunktionsstudier af humane vakuoliserede makrofager indikerede, at alle testede funktioner blev bevaret. 
In vitro functional studies of human vacuolated macrophages indicated all functions tested were retained.
- Hvis du har moderat til alvorligt HJERTESVIGT. 
- If you have moderate to severe HEART FAILURE.
• Tag ikke nålehætten af, før ava instruerer dig i at gøre det. 
• Do not remove the needle cap until ava instructs you to do so.
Denne sjældne type af T-celle-lymfom har et meget aggressivt sygdomsforløb og er sædvanligvis dødelig. 
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Opløsningens pH er ca. 4,7. 
The pH of the solution is approximately 4.7.
Patient antal 
Patient numbers
Dette antal falder med stigende doser af samtidig behandling med MTX. 
This number decreases with increasing doses of concomitant MTX treatment.
Kontroller at den røde ”medicinniveau-indikator” er i toppen af kassetten. 
Check that the red “medication level indicator” is at the top of the cartridge.
• Nålen vil automatisk trækkes tilbage i den tømte pen. 
• The needle will automatically move back into the empty pen.
Den primære effektvariabel var Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) respons ved uge 52. 
The primary efficacy variable was the Ankylosing Spondylitis Disease Activity Score major improvement (ASDAS-MI) response at Week 52.
Den terminale eliminationsfasehalveringstid (t1/2) var tilnærmelsesvis 14 dage for alle doser, som blev undersøgt. 
The terminal elimination phase half-life (t1/2) was approximately 14 days for all doses tested.
• Merkelcellekarcinom (en type hudkræft)* 
• Merkel cell carcinoma (a type of skin cancer)*
Der er ingen evidens for en øget risiko for infektioner med fortsat eksponering over tid. 
There is no evidence of an increased risk of infections with continued exposure over time.
**Disse hændelser er relateret til gruppen af TNF-antagonister. 
**These events have been related to the class of TNF-antagonists.
Forsøg ikke at selv-injicere før du er sikker på, at du er klar over, hvordan du skal forberede og give injektionen. 
Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
ASDAS-MI Uge 52 
ASDAS-MI Week 52
- Injicér ikke, før huden er tør. 
Do not inject until the skin is dry.