natgillin/translations-raw huggingface dataset:
• 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)
Abseamed indeholder det aktive stof epoetin alfa og er et "biosimilært lægemiddel". 
Abseamed contains the active substance epoetin alfa and is a ‘biosimilar medicine'.
Abseamed anvendes, når patienterne har lav eller mellemstor risiko for at udvikle akut myeloid leukæmi og har et lavt niveau af det naturlige hormon erytropoietin. 
Abseamed is used when patients are at low or intermediate risk of developing acute myeloid leukaemia and have low levels of the natural hormone erythropoietin.
• patienter med forhøjet blodtryk, der ikke er velreguleret 
• patients with high blood pressure that is not controlled;
Virkningen blev hovedsagelig 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.
Abseamed injiceret i en blodåre blev sammenlignet med referencelægemidlet i et hovedstudie, som omfattede 479 patienter med anæmi forårsaget af nyreproblemer. 
Abseamed, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
• 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;
Hvordan anvendes Abseamed? 
How is Abseamed used?
I disse tilfælde anvendes epoetin alfa til at øge antallet af røde blodlegemer. 
In these cases, epoetin alfa is used to increase red blood cell counts.
Abseamed 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. 
Abseamed is available in pre-filled syringes of various strengths and 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.
Referencelægemidlet for Abseamed er Eprex/Erypo. 
The reference medicine for Abseamed is Eprex/Erypo.
• behandling af anæmi hos voksne, som får kemoterapi for visse former for kræft, og til nedsættelse af behovet for blodtransfusioner 
• to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions;
Alle patienterne havde fået Eprex/Erypo som injektion i en blodåre i mindst 8 uger, inden de enten skiftede til Abseamed eller fortsatte med Eprex/Erypo. 
All of the patients had been receiving Eprex/Erypo injected into a vein for at least 8 weeks before they were either switched to Abseamed or remained on Eprex/Erypo.
Abseamed udleveres kun efter recept, og behandlingen skal iværksættes under tilsyn af en læge, der har erfaring i behandling af patienter med de sygdomme, som Abseamed er beregnet til. 
Abseamed can only be obtained with a prescription and treatment must be started under the supervision of a doctor who has experience in the management of patients with the conditions that Abseamed is used for.
• patienter, der skal have foretaget større ortopædkirurgiske indgreb, og som har alvorlige hjerte kar-problemer, herunder nyligt hjerteanfald eller slagtilfælde. 
• patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Da Abseamed er et biosimilært lægemiddel, behøver de studier af epoetin alfas virkning og sikkerhed, der er udført for Eprex/Erypo, ikke at blive gentaget for Abseamed. 
Because Abseamed is a biosimilar medicine, the studies on effectiveness and safety of epoetin alfa carried out with Eprex/Erypo do not all need to be repeated for Abseamed.
Abseamed 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 9001.800 ml blod. 
It is used in patients with normal blood iron levels who could experience complications from a blood transfusion, if they do not donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood;
• at øge mængden af blod, som kan tappes hos voksne patienter med moderat anæmi og normalt jernindhold i blodet, der skal opereres, og som skal donere deres eget blod inden det kirurgiske indgreb (autolog blodtransfusion) 
• to increase the amount of blood that can be taken in adult patients with moderate anaemia and normal blood iron levels who are going to have an operation and donate their own blood before surgery (autologous blood transfusion);
• behandling af anæmi hos voksne med myelodysplastisk syndrom (tilstand, hvor dannelsen af raske blodlegemer er nedsat). 
• to treat anaemia in adults with myelodysplastic syndromes (conditions in which the production of healthy blood cells is defective).
Epoetin alfa anvendes også forud for et kirurgisk indgreb til at øge antallet af røde blodlegemer og afbøde virkningerne af blodtab. 
Epoetin alfa is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
• behandling af anæmi (lavt antal røde blodlegemer), som giver symptomer hos patienter med kronisk nyresvigt (langvarig, fremadskridende nedsættelse af nyrefunktionen) eller andre nyreproblemer 
• to treat anaemia (low red blood cell counts) that is causing symptoms in patients with chronic kidney failure (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems;
Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Abseamed har en struktur, renhed og biologisk aktivitet, der svarer til Eprex/Erypos, og at det fordeles i kroppen på samme måde. 
The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Abseamed has a highly similar structure, purity and biological activity to Eprex/Erypo and is distributed in the body in the same way.
Det aktive stof i Abseamed, 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 Abseamed, 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 in the bone marrow.
Patienter, der skiftede til Abseamed, fastholdt niveauet af hæmoglobin i samme omfang som dem, der fortsatte med Eprex/Erypo. 
Patients switching to Abseamed maintained haemoglobin levels to the same extent as those continuing with Eprex/Erypo.
Den fuldstændige liste over bivirkninger ved Abseamed fremgår af indlægssedlen. 
For the full list of side effects of Abseamed, see the package leaflet.
Hvilke fordele viser studierne, at der er ved Abseamed? 
What benefits of Abseamed have been shown in studies?
• at mindske behovet for blodtransfusioner hos voksne med moderat anæmi, som skal gennemgå større ortopædkirurgiske indgreb, f.eks. hofteoperation. 
• to reduce the need for blood transfusions in adults with moderate anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Laboratoriestudier, der sammenligner Abseamed med referencelægemidlet Eprex/Erypo, har vist, at det aktive stof i Abseamed svarer til det aktive stof i Eprex/Erypo, hvad angår struktur, renhed og biologisk aktivitet. 
Laboratory studies comparing Abseamed with the reference medicine Eprex/Erypo have shown that the active substance in Abseamed is highly similar to that in Eprex/Erypo in terms of structure, purity and biological activity.
Det var derfor agenturets opfattelse, at fordelene ved Abseamed opvejer de identificerede risici, som for Eprex/Erypo, og at det kan godkendes. 
Therefore the Agency's view was that, as for Eprex/Erypo, the benefit of Abseamed outweighs the identified risk and it can be authorised.
Studier har også vist, at indgivelse af Abseamed giver samme niveau af det aktive stof i kroppen som indgivelse af Eprex/Erypo. 
Studies have also shown that giving Abseamed produces similar levels of the active substance in the body to giving Eprex/Erypo.
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Abseamed. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Abseamed have been included in the summary of product characteristics and the package leaflet.
Desuden er det i adskillige studier påvist, at Abseamed er lige så effektivt som Eprex/Erypo til at øge og fastholde antallet af røde blodlegemer. 
In addition, Abseamed was shown to be as effective as Eprex/Erypo at increasing and maintaining red blood cell counts in several studies.
Et yderligere studie hos 416 patienter med kronisk nyresvigt viste, at Abseamed var sikkert og effektivt, når det blev injiceret under huden. 
A further study showed that Abseamed was safe and effective when given under the skin in 416 patients with chronic kidney failure.
Et andet studie hos 114 kræftpatienter, som var i kemoterapi, viste, at Abseamed injiceret under huden var lige så effektivt som Eprex/Erypo til at fastholde hæmoglobinniveauet. 
Another study showed that Abseamed injected under the skin was as effective in maintaining haemoglobin levels as Eprex/Erypo in 114 cancer patients who were receiving chemotherapy.
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 Abseamed 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 Abseamed is being used and on the patient's bodyweight, and are adjusted according to how well the medicine is working.
Hvordan virker Abseamed? 
How does Abseamed work?
--1 Equin influenzavirus stammer: A/equine-2/Sydafrika/4/03 stamme 
--1 Equine influenza virus strains: A/equine-2/South Africa/4/03 strain
Intramuskulær Hætteglas (Type I glas) lukket med en halogenobutyl gummiprop og aluminiumshætte. 
Vial (type I glass) closed with a halogenobutyl rubber stopper and aluminium cap
≥ 30 IE/ml 
40 Lf/ml
A/equine-2/Newmarket/2/93 stamme 50 AE/ml Tetanus toksoid 
A/equine-2/Newmarket/2/93 strain
Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, indgivelsesvej, ansøger/indehaver af markedsføringstilladelse i Medlemsstaterne 
List of the names, pharmaceutical form, strength of the medicinal product, route of administration, applicant / marketing authorisation holder in the Member States
Ansøgningen blev indgivet i Irland, som var referencemedlemsstat, og de berørte medlemsstater var Østrig, Bulgarien, Danmark, Spanien, Finland, Frankrig, Ungarn, Nederlandene, Polen, Portugal, Rumænien, Sverige og Slovenien samt Island og Norge. 
The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Denmark, Spain, Finland, France, Hungary, the Netherlands, Poland, Portugal, Romania, Sweden, Slovenia as concerned Member States, as well as Iceland and Norway.
Ansøgeren, Pfizer Limited, har indgivet en ansøgning efter den decentrale procedure for ovennævnte veterinærlægemiddel i henhold til artikel 32 i direktiv 2001/82/EØF, som ændret. 
The applicant, Pfizer Limited, has submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Under den decentrale procedure påpegede to berørte medlemsstater (Nederlandene og Frankrig) potentielle alvorlige risici vedrørende miljørisikovurderingen. 
Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France).
Prontax, pour-on opløsning, 5 mg/ml, til kvæg (og relaterede navne) indeholder doramectin. 
Prontax 5 mg/ml pour-on solution for cattle (and associated names) contains doramectin.
På grundlag af de foreliggende data anså CVMP benefit/risk-forholdet for at være positivt for Prontax, pour-on opløsning, 5 mg/ml, forudsat at der i produktoplysningerne tilføjes de anbefalede foranstalt 
Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 5 mg/ml pour-on solution for cattle and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna.
1, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne 
referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Udtalelse efter en indbringelse i henhold til artikel 33, stk. 4F F, for Prontax, pour-on opløsning til kvæg, 5 mg/ml, og relaterede navne EMA/421633/2012 
Opinion following an Article 33(4)F F referral for Prontax 5 mg/ml pour-on solution for cattle and associated names
Den 8. februar 2012 vedtog CVMP derfor en positiv udtalelse og anbefalede udstedelse af markedsføringstilladelse for Prontax, pour-on opløsning, 5 mg/ml, til kvæg, og relaterede navne. 
recommending the granting of a Marketing Authorisation for Prontax 5 mg/ml pour-on solution for cattle and associated names.
Det aktive stof i Pioglitazone Teva Generics, pioglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv danner. 
The active substance in Pioglitazone Teva Generics, pioglitazone, makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Det betyder, at Pioglitazone Teva Generics er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), kaldet Actos. 
This means that Pioglitazone Teva Generics is similar to a ‘reference medicine' already authorised in the European Union (EU) called Actos.
CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Pioglitazone ratio er af sammenlignelig kvalitet og er bioækvivalent med Actos. 
The CHMP concluded that, in accordance with EU requirements, Pioglitazone Teva Generics had been shown to have comparable quality and to be bioequivalent to Actos.
Pioglitazone Teva Generics skulle have været anvendt til behandling af type 2-diabetes hos voksne, især overvægtige. 
Pioglitazone Teva Generics was to be used to treat type 2 diabetes in adults, particularly those who are overweight.
Pioglitazone Teva Generics blev udviklet som et ‘generisk lægemiddel'. 
Pioglitazone Teva Generics was developed as a ‘generic medicine'.
På tidspunktet for tilbagetrækningen havde CHMP derfor afgivet en positiv udtalelse, hvori der anbefaledes udstedelse af markedsføringstilladelse for Pioglitazone Teva Generics til behandling af type 2-diabetes. 
Therefore, at the time of the withdrawal, the CHMP had given a positive opinion, recommending that a marketing authorisation be granted for Pioglitazone Teva Generics for the treatment of type 2 diabetes.
Pioglitazone Teva Generics er et lægemiddel, der indeholder det aktive stof pioglitazon. 
Pioglitazone Teva Generics is a medicine that contains the active substance pioglitazone.
Da Pioglitazone Teva Generics er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Actos. 
Because Pioglitazone Teva Generics is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Actos.
Hvad er Pioglitazone Teva Generics? 
What is Pioglitazone Teva Generics?
Pioglitazone Teva Generics skulle også have været anvendt sammen med insulin til patienter, som ikke er tilfredsstillende reguleret med insulin alene, og som ikke kan tage metformin. 
Pioglitazone Teva Generics was also to be used together with insulin in patients who are not satisfactorily controlled with insulin alone and cannot take metformin.
officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse for Pioglitazone Teva Generics til behandling af type 2-diabetes tilbage. 
On 26 January 2012, TEVA Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type 2 diabetes.
Pioglitazone Teva Generics skulle have været anvendt alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet. 
Pioglitazone Teva Generics was to used on its own in patients for whom metformin (another antidiabetes medicine) is not suitable.
Pioglitazone Teva Generics skulle også have været anvendt i kombination med metformin til patienter, som ikke er tilfredsstillende reguleret med metformin alene (‘tostofsbehandling'). 
Pioglitazone Teva Generics was also to be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone.
Hvad forventedes Pioglitazone Teva Generics anvendt til? 
What was Pioglitazone Teva Generics expected to be used for?
Hvordan forventedes Pioglitazone Teva Generics at virke? 
How is Pioglitazone Teva Generics expected to work?
FØR DU STARTER 
BEFORE YOU START
En observatør er en person, der: 
An observer is someone who:
Det er normalt at se en luftboble. 
It is normal to see an air bubble.
Der er også observeret relativt lave titre af IgE. 
Relatively low titres of IgE has also been observed.
De fleste mennesker reagerer inden for 18 måneder, men det kan sommetider tage op til 30 måneder. 
Most people respond within 18 months, but it can sometimes take up to 30 months.
o Lægen vil fortælle dig, om du har brug for en observatør i mere end 6 måneder. 
o Your doctor will tell you if you need an observer for longer than 6 months.
Symptomer på uopmærksomhed og humør blev også evalueret i denne periode. 
Symptoms of inattention and mood were also evaluated during this period.
Linearitet/non-linearitet 
Linearity/nonlinearity
Alvorlige bivirkninger omfatter: 
Serious side effects include:
Den tid, det tog at opnå respons, lå mellem 0,5 og 30 måneder. 
The time to reach a response ranged from 0.5 to 30 months.
Den absolutte biotilgængelighed hos mennesker er ukendt. 
The absolute bioavailability in humans is unknown.
Varighed indtil næste øgning af dosis 
Duration prior to next dose increase
Generel behandlingserfaring fra studie 301 og studie 302 
Overall treatment experience from Study 301 and Study 302
Nogle af disse allergiske reaktioner kan være mere alvorlige, som beskrevet nedenfor, og vil kræve øjeblikkelig behandling. 
Some of these allergic reactions can be more serious, as described below, and will require immediate attention.
Immunrespons påvirker clearance og tid til opnåelse af steady state. 
Immune response affects clearance and time to reach steady state.
Studie 302: Effektvurdering 
Study 302: Efficacy assessment
De anbefalede injektionssteder er: 
The recommended injection sites are:
Immunresponset stabiliserer sig over 6 til 9 måneders samlet behandling. 
The immune response stabilises over 6 to 9 months of total treatment.
Lægen fortæller dig, hvor længe du skal fortsætte med hver dosis. 
Your doctor will tell you how long to stay at each dose.
Fortæl din læge, at du har haft en svær allergisk reaktion. 
Tell your doctor that you had a severe allergic reaction.
Der blev ikke observeret vakuolation i hjernen. 
No vacuolation was observed in the brain.
Brug ikke en mikroovn, og anbring ikke produktet i varmt vand. 
Do not use a microwave and do not place in hot water.
Den kliniske betydning af disse resultater og de funktionsmæssige konsekvenser er ukendte. 
The clinical significance of these findings and functional consequences are unknown.
Det kan være samme del af kroppen eller en anden del af kroppen (se figur E og F). 
It can be on the same part of the body or a different part of the body (see Figures E and F).
Disse lægemidler er med til at reducere symptomerne på en allergisk reaktion. 
These medicines help to reduce the symptoms of an allergic reaction.
Langsigtet forlængelsesperiode 
Long-term extension period
Se produktinformationen for adrenalin for at få fuldstændige oplysninger. 
Refer to the adrenaline product information for complete information.
Efter 6 måneders behandling med Palynziq kan behovet for en observatør genovervejes. 
After 6 months of Palynziq treatment, the need for an observer may be reconsidered.
Disse patienter fik det samme induktions-/titrerings-/vedligeholdelsesregime som patienter i alderen 18 år og derover i dette studie. 
These patients received the same induction/titration/maintenance regimen as patients aged 18 years and older in this study.
Hvis dit fenylalaninniveau er for højt eller for lavt under graviditet, kan det skade dig eller barnet. 
If your phenylalanine levels are too high or too low during pregnancy, this may harm you or your baby.
Tal desuden med sundhedspersonalet om din medicinske tilstand eller din behandling. 
Also, talk to your healthcare provider about your medical condition or your treatment.
Dosistitrering og tid til at opnå respons 
Dose titration and time to achieve response
4 Ændring fra baseline var baseret på forsøgspersoner med tilgængelige målinger på begge tidspunkter. 
4 Change from baseline was based on subjects with available measurements at both time points.
Størstedelen af patienterne (66 %) opnåede respons efter 18 måneders samlet behandling. 
The majority of patients (66%) reached a response by 18 months of total treatment.
Tabel 1: Anbefalet doseringsregime 
Table 1: Recommended dosing regimen
• uddanne patienten og vurdere patientens kompetence til korrekt selvadministration af dette lægemiddel 
• train the patient and assess patient competency on proper self-administration of this medicinal product.
• Du må ikke ændre dit proteinindtag, medmindre lægen beder dig om det. 
• Do not change your protein intake unless your doctor tells you to.
Individuelle værdier for halveringstid ligger i intervallet 14 til 132 timer. 
Individual values for half-life range from 14 to 132 hours.
Derfor havde disse patienter større sandsynlighed for at udvikle hypofenylalaninæmi. 
As a consequence, these patients were more likely to develop hypophenylalaninaemia.
Anbefalet maksimal dosis 
Maximum recommended dose
• er til stede sammen med patienten under og efter administration af Palynziq 
• would be present with the patient during and after Palynziq administration,
Se punkt 4 for at få oplysninger om, hvad du skal gøre på basis af dine symptomer. 
See section 4 for details on what to do based on your symptoms.
Hyppigheder defineres som: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Frequencies are defined as: 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) and not known (cannot be estimated from the available data).
Kontrollér udløbsdatoen på pakningen. 
Check the expiry date on the carton.
Trin 15: Behandl injektionsstedet (hvis det er nødvendigt). 
Step 15: Treat injection site (if needed).
Mennesker, der har PKU, har et højt niveau af fenylalanin, og det kan føre til alvorlige helbredsproblemer. 
People who have PKU have high levels of phenylalanine and this can lead to serious health problems.
Den gennemsnitlige molekylmasse er ca. 1.000 kDa, hvoraf proteinmolekyledelen udgør ca. 248 kDa. 
The average molecular mass is approximately 1,000 kDa of which the protein moiety constitutes approximately 248 kDa.