natgillin/translations-raw huggingface dataset:
Virkningen blev hovedsageligt målt på ændringen i blodets indhold af hæmoglobin fra studiets start til vurderingsperioden, dvs. fra uge 25 til 29. 
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Når Epoetin Alfa Hexal anvendes til autolog blodtransfusion, skal de begrænsninger, der normalt gælder for denne form for transfusion, overholdes. 
When Epoetin Alfa Hexal is used for autologous blood transfusion, the restrictions normally associated with this type of transfusion should be observed.
De hyppigste bivirkninger ved Epoetin Alfa Hexal (der kan forekomme hos mere end 1 ud af 10 patienter) er kvalme, diarré, opkastning, feber og hovedpine. 
The most common side effects with Epoetin Alfa Hexal (seen in more than 1 patient in 10) are nausea (feeling sick), diarrhoea, vomiting, pyrexia (fever) and headache.
• patienter, der gennemgår kirurgiske indgreb, og som ikke må få lægemidler til forebyggelse af blodpropper 
• patients undergoing surgery who cannot receive medicines for the prevention of blood clots.
Epoetin Alfa Hexal fik en markedsføringstilladelse med gyldighed i hele EU den 28. august 2007. 
The European Commission granted a marketing authorisation valid throughout the European Union for Epoetin Alfa Hexal on 28 August 2007.
Epoetin Alfa Hexal må ikke anvendes til følgende grupper: 
Epoetin Alfa Hexal must not be used in the following groups:
Hos patienter i kemoterapi eller patienter med nyreproblemer kan der opstå anæmi, fordi de mangler erytropoietin, eller fordi kroppen ikke reagerer tilstrækkeligt på det naturlige erytropoietin. 
In patients receiving chemotherapy or with kidney problems, anaemia can be caused by a lack of erythropoietin, or by the body not responding enough to the erythropoietin it has naturally.
Epoetin Alfa Hexal injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer. 
Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Epoetin Alfa Hexal? 
What measures are being taken to ensure the safe and effective use of Epoetin Alfa Hexal?
Alle patienterne havde fået Eprex/Erypo som injektion i en blodåre i mindst 8 uger, inden de enten skiftede til Epoetin Alfa Hexal eller fortsatte med Eprex/Erypo. 
All of the patients had been receiving Eprex/Erypo injected into a vein for at least eight weeks before they were either switched to Epoetin Alfa Hexal or remained on Eprex/Erypo.
Referencelægemidlet for Epoetin Alfa Hexal er Eprex/Erypo. 
The reference medicine for Epoetin Alfa Hexal is Eprex/Erypo.
• patienter, der skal have foretaget større ortopædkirurgiske indgreb, og som har alvorlige hjerte kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde. 
It must not be used in patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Epoetin Alfa Hexal anvendes til patienter med normalt jernindhold i blodet, hos hvem der vil kunne opstå komplikationer ved blodtransfusion, hvis de ikke inden operationen får tappet blod til eget brug, og som forventes at miste 900-1.800 ml blod. 
It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Der kan indhentes yderligere oplysninger om biosimilære lægemidler her. 
For more information on biosimilar medicines, see the question-and-answer document here.
• patienter, der har fået "pure red cell aplasia" (nedsat eller ophørt dannelse af røde blodlegemer) 
• patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin;
Det aktive stof i Epoetin Alfa Hexal, epoetin alfa, er en kopi af det menneskelige hormon erytropoietin og har nøjagtigt samme stimulerende virkning på dannelsen af røde blodlegemer i rygmarven som det naturlige hormon. 
The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of a hormone called erythropoietin, and works in exactly the same way as the natural hormone to stimulate the production of red blood cells from the bone marrow.
Det betyder, at Epoetin Alfa Hexal i høj grad svarer til et andet biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i EU. 
This means that Epoetin Alfa Hexal is similar to and contains the same active substance as a biological medicine that is already authorised in the European Union (EU), which is known as the ‘reference medicine'.
Andre oplysninger om Epoetin Alfa Hexal 
Other information about Epoetin Alfa Hexal
Epoetin Alfa Hexal fås i fyldte sprøjter med forskellig styrke og indgives som injektion i en blodåre eller som injektion under huden, alt efter hvilken sygdom patienten behandles for. 
Epoetin Alfa Hexal is given as an injection into a vein or as an injection under the skin, depending on the condition for which the patient is being treated.
Epoetin Alfa Hexal udleveres kun efter recept, og behandlingen skal iværksættes under tilsyn af en læge, der har erfaring i behandling af patienter med de sygdomme, som lægemidlet er beregnet til. 
Treatment with Epoetin Alfa Hexal must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
For mere information om brug af Epoetin Alfa Hexal, se indlægssedlen eller kontakt lægen eller apotekspersonalet. 
For more information about treatment with Epoetin Alfa Hexal, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Desuden er det i adskillige studier påvist, at Epoetin Alfa Hexal er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer. 
Epoetin Alfa Hexal was as effective as Eprex/Erypo in increasing and maintaining red blood cell counts.
Hvilke risici er der forbundet med Epoetin Alfa Hexal? 
What is the risk associated with Epoetin Alfa Hexal?
Et yderligere studie 416 patienter med kronisk nyresvigt viste, at Epoetin Alfa Hexal var sikkert og effektivt, når det blev injiceret under huden. 
The study in patients with chronic kidney failure showed that Epoetin Alfa Hexal was safe and effective when given under the skin.
Hvorfor blev Epoetin Alfa Hexal godkendt i EU? 
Why has Epoetin Alfa Hexal been approved?
I disse tilfælde anvendes epoetin alfa til at øge antallet af røde blodlegemer. 
In these cases, epoetin alfa is used to replace the missing hormone or to increase red blood cell counts.
Den fuldstændige liste over bivirkninger ved Epoetin Alfa Hexal fremgår af indlægssedlen. 
For the full list of all side effects reported with Epoetin Alfa Hexal, see the package leaflet.
Injektionen under huden kan indgives af patienterne selv eller deres omsorgspersoner, hvis de har lært at gøre det. Dosen, injektionshyppigheden og behandlingsvarigheden beregnes ud fra, hvad Epoetin Alfa Hexal anvendes til og hvor meget patienten vejer, og skal desuden tilpasses patientens respons. 
The dose, the frequency of injection and how long it is used for also depend on why Epoetin Alfa Hexal is being used and on the patient's bodyweight, and are adjusted according to the patient's response.
Patienter, der skiftede til Epoetin Alfa Hexal, fastholdt niveauet af hæmoglobin i samme omfang som dem, der fortsatte med Eprex/Erypo. 
In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/Erypo.
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Epoetin Alfa Hexal har en struktur, renhed og biologisk aktivitet, der svarer til Eprex/Erypos, og at det fordeles i kroppen på samme måde. 
The CHMP concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/Erypo.
Epoetin Alfa Hexal indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel". 
Epoetin Alfa Hexal is a ‘biosimilar' medicine.
Et andet studie med 114 kræftpatienter, der var i kemoterapi, viste, at Epoetin Alfa Hexal injiceret under huden var lige så effektivt som Eprex/Erypo til at fastholde hæmoglobinniveauet. 
The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/Erypo when it was injected under the skin.
Det var derfor agenturets opfattelse, at fordelene ved Epoetin Alfa Hexal opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes. 
Therefore, the CHMP's view was that, as for Eprex/Erypo, the benefit outweighs the identified risks.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Epoetin Alfa Hexal. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epoetin Alfa Hexal, including the appropriate precautions to be followed by healthcare professionals and patients.
Epoetin Alfa Hexal er et lægemiddel, der anvendes til: 
Epoetin Alfa Hexal is used for the following:
Hvad er Epoetin Alfa Hexal, og hvad anvendes det til? 
What is Epoetin Alfa Hexal used for?
Hvordan anvendes Epoetin Alfa Hexal? 
How is Epoetin Alfa Hexal used?
Hvilke fordele viser studierne, at der er ved Epoetin Alfa Hexal? 
What benefit has Epoetin Alfa Hexal shown during the studies?
Hvordan virker Epoetin Alfa Hexal? 
How does Epoetin Alfa Hexal work?
Laboratoriestudier, der sammenligner Epoetin Alfa Hexal med referencelægemidlet Eprex/Erypo, har påvist, at det aktive stof i Epoetin Alfa Hexal svarer til det aktive stof i Eprex/Erypo, hvad angår struktur, renhed og biologisk aktivitet. 
Epoetin Alfa Hexal was studied to show that it is comparable to the reference medicine, Eprex/Erypo.
Hvad er Protium? 
What is Protium?
Dr. Enzmann (Tyskland) 
Dr Enzmann (Germany)
De ændrede informationer for læger og patienter findes her Europa-Kommissionen traf en afgørelse den 15. april 2010. 
The amended information to doctors and patients is available here The European Commission issued a decision on 15 April 2010.
De vigtigste harmoniserede områder omfatter: 
The main areas harmonised include:
Protium er godkendt i EU efter nationale procedurer. 
Protium is authorised in the EU via national procedures.
Dr. Calvo-Rojas (Spanien) 
Dr Calvo-Rojas (Spain)
1 Artikel 30 i direktiv 2001/83/EF, med senere ændringer, indbringelse på grund af indbyrdes afvigende afgørelser vedtaget af medlemsstaterne 
1 Article 30 of Directive 2001/83/EC as amended, referral on the grounds of divergent decisions adopted by member States
Hvorfor blev Protium vurderet igen? 
Why was Protium reviewed?
6. april 2009, 24. august 2009 og 19. oktober 
6 April 2009, 24 August 2009 and 19 October
Tabletternes dosis kan fordobles, såfremt der ikke har været nogen respons på behandlingen. 
The dose of the tablets may be doubled in cases where there has been no response to treatment.
Ved at blokere for pumperne reducerer pantoprazol syreproduktionen. 
By blocking the pumps, pantoprazole reduces acid production.
Det aktive stof i Protium, pantoprazol, er en protonpumpehæmmer (PPI). 
The active substance in Protium, pantoprazole, is a proton pump inhibitor (PPI).
Udvalget var af den opfattelse, at samtidig brug af atazanavir og andre hivlægemidler ikke bør være kontraindiceret, men at der bør medtages en advarsel i punkt 4.4. 
The Committee was of the opinion that the concomitant use of atazanavir and other anti-HIV medicines should not be contraindicated, but that a warning should be added in section 4.4.
Den 3. september 2008 henviste Europa-Kommissionen sagen til Udvalget for Lægemidler til Mennesker (CHMP) med henblik på harmonisering af markedsføringstilladelserne for Protium og relaterede navne i EU og EØS. 
On 3 September 2008, the European Commission referred the matter to the Committee for Medicinal Products for Human Use (CHMP) in order to harmonise the marketing authorisations for Protium and associated names in the EU and the EEA.
CHMP godkendte en harmoniseret indikation (den sygdom, som lægemidlet kan anvendes til). 
The CHMP agreed on a harmonised indication (the disease for which the medicine may be used).
Protium anvendes til at behandle sygdomme, hvor der produceres for meget mavesyre. 
Protium is used to treat diseases where the stomach produces too much acid.
Det Europæiske Lægemiddelagentur (EMA) har foretaget en revurdering af Protium og relaterede navne. 
The European Medicines Agency has completed a review of Protium and associated names.
Disse lægemidler markedsføres af virksomheden Nycomed. 
The company that markets these medicines is Nycomed.
CHMP harmoniserede produktresuméets punkter om graviditet og amning, virkning på evnen til at føre motorkøretøj eller betjene maskiner, bivirkninger og overdosering. 
The CHMP harmonised the SPC sections on pregnancy and lactation, the ability to drive and use machines, undesirable effects and overdose.
CHMP medtog ligeledes en advarsel om, at behandling med Protium og andre protonpumpehæmmere kan medføre en stigning i antallet af infektioner i tarmene. 
The CHMP also included a warning that treatment with Protium and other PPIs may lead to an increase in infections of the gut.
EMA's Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at der er behov for at harmonisere ordineringsoplysningerne for Protium og relaterede navne i Den Europæiske Union (EU) og Det Europæiske Økonomiske Samarbejdsområde (EØS). 
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Protium and associated names in the European Union (EU) and the European Economic Area (EEA).
Zollinger-Ellisons syndrom og andre patologiske hypersekretionstilstande behandles med en daglig dosis på 80 mg pantoprazol, enten som to 40 mg tabletter eller som injektion. 
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions are treated with a daily dose of 80 mg of pantoprazole, either as two 40 mg tablets or an injection.
• mavesår eller duodenal ulcus (sår på tolvfingertarmen), 
• stomach or duodenal ulcer,
40 mg enterotabletter kan ligeledes anvendes til at fjerne Helicobacter pylori (H. pylori) i kombination med passende antibiotikabehandling hos patienter med H. pylori-associeret ulcus. 
The 40 mg gastroresistant tablets can also be used to eradicate Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Dosis kan øges til 40 mg om dagen, såfremt der optræder tilbagefald af symptomer på refluksøsofagitis. 
This can be increased to 40 mg a day in cases where symptoms of reflux oesophagitis relapse.
Protium markedsføres ligeledes i EU og EØS under andre særnavne: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc, Pantoloc, PantoLomberg, Pantopan, Pantoprazol 20 mg Byk, Pantoprazol NYC, Pantoprazol Nycomed, Pantoprazol-Byk, Pantoprazole ALTANA, Pantoprazole Lomberg, Pantorc, Pantozol, Peptazol, Rifun, Somac, Ulcotenal, Zurcal, Zurcale og Zurcazol. 
Protium is also available in the EU and EEA under other trade names: Anagastra, Apton, Controloc, Eupantol, Inipomp, Pantec, Pantecta, Pantipp, Panto-Byk-20, Panto-Byk-40, Panto-Byk-IV, Pantoc,
Protium kan ligeledes anvendes til forebyggelse af mavesår, der skyldes visse lægemidler, som anvendes til behandling af smerter og betændelse, kaldet non-selektive, non-steroide antiinflammatoriske lægemidler (NSAID'er), når patienten har brug for fortsat NSAID-behandling, og for at hjælpe med at fjerne en bakterie i maven, der kaldes Helicobacter pylori, og som er kendt for at forårsage mavesår. 
Protium can also be used for the prevention of the stomach ulcers that can be caused by some medicines used to treat pain and inflammations called non-selective non-steroidal anti-inflammatory drugs (NSAIDs), when the patient needs continuous NSAID treatment, and to help rid the stomach of a bacterium called Helicobacter pylori, which is known to cause stomach ulcers.
Dosis kan justeres ud fra den mængde mavesyre, der produceres. 
The dose can be adjusted depending on the amount of acid being secreted in the stomach.
Udvalget anbefalede, at 40 mg enterotabletter og 40 mg pulver til injektionsvæske, opløsning, anvendes til behandling af refluksøsofagitis, gastroduodenal ulcus og Zollinger-Ellisons syndrom samt andre patologiske hypersekretionstilstande. 
The Committee recommended that the 40 mg gastro-resistant tablets and the 40 mg powder for solution for injection should be used to treat reflux oesophagitis, gastric and duodenal ulcer, and Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Den anbefalede dosis ved refluksøsofagitis og gastrisk eller duodenal ulcus er én 40 mg tablet eller én 40 mg injektion dagligt. 
The recommended dose for reflux oesophagitis and gastric or duodenal ulcers is one 40 mg tablet or one 40 mg injection daily.
• reflukssygdom, hvor det behandler symptomer såsom halsbrand og sure opstød, 
• reflux disease to treat symptoms such as heartburn and acid regurgitation (acid flowing up in the mouth),
Udvalget anbefalede, at 20 mg enterotabletter anvendes til behandling af symptomatisk gastroøsofageal reflukssygdom, langvarig behandling og forebyggelse af tilbagefald ved refluksøsofagitis samt forebyggelse af gastroduodenal ulcus forårsaget af non-selektive, non-steroide antiinflammatoriske lægemidler (NSAID'er) hos patienter i risikogruppen med behov for fortsat NSAIDbehandling. 
The Committee recommended that the 20 mg gastro-resistant tablets should be used for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management and prevention of relapse in reflux oesophagitis and the prevention of gastroduodenal ulcers induced by non-selective nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at risk with a need for continuous NSAID treatment.
Den anbefalede dosering til behandling af symptomatisk gastroøsofageal reflukssygdom, langvarig behandling af refluksøsofagitis og forebyggelse af gastroduodenal ulcus hos patienter, der tager NSAID'er, er én 20 mg tablet én gang dagligt. 
The recommended dosage for the treatment of symptomatic gastro-oesophageal reflux disease, the long-term management of reflux oesophagitis and the prevention of gastroduodenal ulcers in patients taking NSAIDs, the recommended dose is one 20 mg tablet once daily.
pylori i maven er en 40 mg enterotablet to gange dagligt i kombination med en passende antibiotikabehandling. 
To eradicate H. pylori in the stomach, the recommended dose is one 40 mg gastro-resistant tablet taken twice a day in combination with appropriate antibiotic treatment.
Koordinationsgruppen for gensidig anerkendelse og decentrale procedurer - lægemidler til mennesker (CMD(h)) har bestemt, at Protium bør harmoniseres. 
Protium has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Pantoprazol, 20 eller 40 mg enterotabletter og 40 mg pulver til injektionsvæske, opløsning 
Questions and answers on the referral for Protium and associated names pantoprazole, 20 or 40 mg gastro-resistant tablets and 40 mg powder for solution for injection
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Samtidig indgivelse af atazanavir og protonpumpehæmmere anbefales ikke. 
4.4 Special warnings and precautions for use
Uåbnet hætteglas 12 måneder. 
Unopened vial 12 months.
Andre relevante symptomatiske tiltag bør iværksættes efter behov. 
Other appropriate symptomatic measures should be taken, as needed.
Resultaterne for disse endepunkter understøttede de primære endepunktsresultater. 
Results on these end-points were supportive of the primary end-points results.
• hårtab (i de fleste tilfælde vil normal hårvækst vende tilbage) 
• hair loss (in most cases normal hair growth should return)
Brug af handsker anbefales. 
The use of gloves is recommended.
TTP = tid til progression; “ne” indikerer at den ikke kunne estimeres eller endnu ikke var nået. 
TTP = time to progression; “ne” indicates that it could not be estimated or it was not yet reached.
73% af de kutane reaktioner var reversible inden for 21 dage. 
73% of the cutaneous reactions were reversible within 21 days.
- hvis du har en alvorlig leversygdom. 
- if you have a severe liver disease.
Median tid til progression (uger): 
Median time to progression (weeks):
I nogle tilfælde kan samtidigt tilstedeværende faktorer have bidraget til udviklingen af disse bivirkninger. 
In some cases concomitant factors may have contributed to the development of these effects.
Hvis der forekommer krystaller, må opløsningen ikke længere anvendes og skal kasseres. 
If crystals appear, the solution must no longer be used and shall be discarded.
• ændring eller udeblivelse af menstruationer 
• change or absence of menstrual period
• feber: hvis dette forekommer, skal du straks fortælle det til din læge 
• fever: if this happens you must tell your doctor immediately
I alt 70 Gy anbefales ved accelererede regimer og 74 Gy for hyperfraktionerede systemer. 
A total of 70 Gy was recommended for accelerated regimens and 74 Gy for hyperfractionated schemes.
Total overlevelse (Primært endepunkt): 
Overall survival (Primary end-point):
I begge arme blev livskvaliteten målt ved hjælp af EORTC-spørgeskemaet og var sammenlignelig og stabil under behandling og opfølgning. 
In both arms, quality of life measured by the EORTC questionnaire was comparable and stable during treatment and follow-up.
Der blev udført en endelig analyse med en aktuel median followup på 96 måneder. 
A final analysis was performed with an actual median follow up of 96 months.
• forhøjede leverenzymer (derfor behovet for regelmæssige blodprøver) 
• raised liver enzymes (hence the need for regular blood tests).
Evalueringen af effekten og sikkerheden fokuserede udelukkende på overlevelsesendepunkter, mens succesrig organbevarelse ikke blev undersøgt formelt. 
The efficacy and safety evaluation solely addressed survival endpoints and the success of organ preservation was not formally addressed.
Den totale responsrate var 6,8% hos de evaluerbare patienter, og den mediane responsvarighed var 26,1 uge. 
The overall response rate was 6.8% in the evaluable patients, and the median duration of response was 26.1 weeks.
Dato for første tilladelse: 31. januar 2012 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 31 January 2012
Instruktioner vedrørende sikker håndtering: 
Recommendations for the safe handling:
Hvis patienten fortsætter med at få disse reaktioner ved 60 mg/m² bør behandlingen stoppes. 
If the patient continues to experience these reactions at 60 mg/m², the treatment should be discontinued.
Der blev ikke observeret statistiske forskelle i forhold til global livskvalitet grupperne imellem. 
No statistical differences were observed between treatment groups for Global Quality of Life.
I alt 1.006 patienter med KPS ≥ 60 blev randomiseret til følgende behandlingsgrupper: 
A total of 1006 patients with KPS ≥ 60 were randomized to the following treatment groups:
I tilfælde af overdosering skal patienten indlægges på et specialafsnit og de vitale funktioner monitoreres nøje. 
In case of overdose, the patient should be kept in a specialised unit and vital functions closely monitored.
- hvis antallet af hvide blodlegemer er for lavt. 
Mylan - if the number of white blood cells is too low.
Operation på det primære sygdomssted og/eller hals kunne overvejes på et hvilket som helst tidspunkt efter endt CRT. 
Surgery on the primary site of disease and/or neck could be considered at anytime following completion of CRT.