natgillin/translations-raw huggingface dataset:
Udvalget fandt, at fordelene ved DepoCyte opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse. 
The Committee decided that DepoCyte's benefits are greater than its risks and recommended that it be given marketing authorisation.
I undersøgelsen så man endvidere på, hvor lang tid patienterne levede uden en forværring af deres nervesygdom. 
The study also looked at how long the patients lived without their nerve disease getting worse.
DepoCyte må ikke gives til patienter, der kan være overfølsomme (allergiske) over for cytarabin eller andre af indholdsstofferne. 
DepoCyte should not be given to people who may be hypersensitive (allergic) to cytarabine or any of the other ingredients.
DepoCyte anvendes til behandling af lymfomatøs meningitis. 
DepoCyte is used to treat lymphomatous meningitis.
Patienterne skal desuden gives dexamethason (et steroid) som hjælp til at regulere nogle af lægemidlets bivirkninger. 
The patient should also receive dexamethasone (a steroid) to help control some of the medicine's side effects.
CHMP bemærkede, at DepoCyte havde vist sig effektiv til behandling af lymfomatøs meningitis ved sammenligning med standardformuleringen af cytarabin, og at det kunne forbedre patienternes livskvalitet, eftersom færre intratekale injektioner er påkrævet. 
The CHMP noted that DepoCyte had shown effectiveness in lymphomatous meningitis when compared with the standard formulation of cytarabine, and that it could improve patients' quality of life because fewer intrathecal injections are needed.
Denne dosis kan nedsættes til 25 mg, hvis patienten viser tegn på nervebeskadigelse (såsom hovedpine, unormalt syn, muskelsvaghed eller smerter). 
The dose can be decreased to 25 mg if the patient shows signs of damage to the nerves (such as headache, abnormal vision, muscle weakness or pain).
Disse symptomer påvirker hovedsageligt nerverne og forårsager smerter, anfald, hovedpine, gangbesvær, hukommelsesproblemer, inkontinens og unormale fornemmelser. 
These symptoms mainly affect the nerves, and include pain, fits, headache, problems walking, memory problems, incontinence and unusual sensations.
Hvilken risiko er der forbundet med DepoCyte? 
What is the risk associated with DepoCyte?
I DepoCyte findes cytarabin i liposomer (små fedtpartikler), hvorfra lægemidlet langsomt frigives. 
In DepoCyte, cytarabine is contained in liposomes (small fatty particles), from which the medicine is released slowly.
DepoCyte er en injektionsvæske, suspension, der indeholder 50 mg af det aktive stof cytarabin. 
DepoCyte is a suspension for injection that contains 50 mg of the active substance, cytarabine.
Dette følges af yderligere fire vedligeholdelsesdoser på 50 mg hver fjerde uge. 
This is then followed by maintenance doses of 50 mg every four weeks for a further four doses.
DepoCyte gives som en ”depotinjektion” (en form for injektion, hvor lægemidlet er fremstillet på en sådan måde, at det optages meget langsomt i kroppen). 
DepoCyte is a ‘depot' injection (a type of injection where the medicine is prepared so that it is absorbed by the body very slowly).
Dette er en tilstand, hvor celler fra et lymfom (en svulst i lymfesystemet) har spredt sig til rygmarvsvæsken og meninges (de membraner, der omgiver hjernen og rygmarven). 
This is a condition in which cells from a lymphoma (a tumour in the lymphatic system) have spread to the spinal fluid and the meninges (the membranes that surround the brain and spinal cord).
Den fuldstændige liste over alle de indberettede bivirkninger ved DepoCyte fremgår af indlægssedlen. 
For the full list of all side effects reported with DepoCyte, see the Package Leaflet.
DepoCyte blev sammenlignet med en standardformulering af cytarabin i en hovedundersøgelse af 35 patienter med lymfomatøs meningitis. 
DepoCyte has been compared with a standard formulation of cytarabine in one main study involving 35 patients with lymphomatous meningitis.
I kroppen indtager cytarabin pyrimidinets plads og forstyrrer virkningen af de enzymer, der medvirker ved dannelse af dna. 
In the body, cytarabine takes the place of pyrimidine and interferes with the enzymes involved in the production of new DNA.
Hvorfor blev DepoCyte godkendt? 
Why has DepoCyte been approved?
Lægemidlet skal indgives ved ”intratekal” injektion (direkte i rygmarvsvæsken i det rum, der omgiver rygmarven og hjernen). 
The medicine must be injected ‘intrathecally' (directly into the spinal fluid in the space that surrounds the spinal cord and the brain).
Det er vævsgiftigt (dvs. det ødelægger celler, der deler sig, f.eks. kræftceller), og tilhører gruppen af antimetabolitter (stofskiftehæmmere). 
It is a cytotoxic (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the ‘anti-metabolite' group.
Derved hæmmer cytarabin væksten af kræftceller, der til sidst dør. 
As a result, cytarabine slows down the growth of tumour cells and eventually kills them.
Hvad er DepoCyte? 
What is DepoCyte?
De oftest forekommende bivirkninger (som observeres hos mellem 1 ud af 10) er hovedpine, araknoiditis (betændelse af en af de membraner, der beskytter rygsøjlen og hjernen), konfusion, kvalme, opkast, diarré, pyrexi (feber), kraftesløshed, trombocytopeni (lavt antal blodplader). 
The most common side effects with DepoCyte (seen in more than 1 treatment cycle in 10) are headache, arachnoiditis (inflammation of one of the membranes protecting the spine and the brain), confusion, nausea (feeling sick), vomiting, diarrhoea, pyrexia (fever), weakness and thrombocytopenia (low blood platelet counts).To minimise the symptoms of arachnoiditis, patients should receive dexamethasone by mouth or by injection at the same time as DepoCyte and must be closely monitored.
Hvilken fordel viser undersøgelserne, at der er ved DepoCyte? 
What benefit has DepoCyte shown during the studies?
De første fem doser af DepoCyte gives først i en dosis på 50 mg til injektion hver anden uge. 
DepoCyte is first given as a 50-mg injection every two weeks for the first five doses, followed by a further 50 mg four weeks later.
Hvad anvendes DepoCyte til? 
What is DepoCyte used for?
Hvordan blev DepoCyte undersøgt? 
How has DepoCyte been studied?
Hvordan anvendes DepoCyte? 
How is DepoCyte used?
28 x 1 tabletter 
28 x 1 tablets
Dosisjustering kan være nødvendig hos sådanne patienter. 
Dose adjustments might be necessary in these patients.
Ny tekst, der skal tilføjes produktinformationen, er understreget. 
New text to be added to the product information is underlined.
Kontakt straks lægen, hvis du bemærker nogen af følgende symptomer efter at have fået dette lægemiddel, da de kan være alvorlige: 
Contact your doctor immediately if you experience any of the following symptoms after taking this medicine as they can be serious:
Vedtaget på PRAC's møde 6.-9. juni 2017 
Adopted at the 6-9 June 2017 PRAC
Gabapentin har været forbundet med svær respirationsdepression. 
Gabapentin has been associated with severe respiratory depression.
Særlige advarsler og forsigtighedsregler vedrørende brugen Samtidigt brug med opioider 
Special warnings and precautions for use Concomitant use with opioids
Gabapentin - respirationsdepression uden ledsagende brug af opioider (EPITT nr. 18814) 
Gabapentin - Respiratory depression without concomitant opioid use (EPITT no 18814)
Det skal du vide, før du begynder at tage <særnavn> Advarsler og forsigtighedsregler 
What you need to know before you take <brand name> Warnings and precautions
− vejrtrækningsproblemer, som - hvis de er alvorlige - kan kræve hurtig intensiv behandling, for at du stadig kan trække vejret normalt 
- breathing problems, which if severe you may need emergency and intensive care to continue breathing normally
Patienter med kompromitteret respirationsfunktion, luftvejssygdom eller neurologisk sygdom, nedsat nyrefunktion, sideløbende brug af CNS-depressiva samt ældre kan have forhøjet risiko for denne alvorlige bivirkning. 
Patients with compromised respiratory function, respiratory or neurological disease, renal impairment, concomitant use of CNS depressants and the elderly might be at higher risk of experiencing this severe adverse reaction.
Kontakt lægen eller apotekspersonalet, før du tager <særnavn> 
Talk to your doctor or pharmacist before taking <brand name>
− hvis du har nerve- eller luftvejssygdomme eller er over 65 år, vil lægen muligvis foreskrive en anden doseringsplan til dig 
- if you have nervous system disorders, respiratory disorders, or you are more than 65 years old, your doctor may prescribe you a different dosing regimen
Luftveje, thorax og mediastinum Hyppighed "sjælden": Respirationsdepression 
Undesirable effects Respiratory, thoracic and mediastinal disorders Frequency ‘rare': Respiratory depression
Fortæl din læge eller på apoteket, hvis du for nylig har taget andre lægemidler eller påtænker at gøre det. Fortæl især din læge (eller på apoteket), hvis du tager eller for nylig har taget medicin mod kramper, søvnforstyrrelser, depression, angst eller andre problemer med nervesystemet eller psykiske problemer. 
In particular, tell your doctor (or pharmacist) if you are taking or have been recently taking any medicines for convulsions, sleeping disorders, depression, anxiety, or any other neurological or psychiatric problems.
Ny ordlyd af produktinformation - uddrag af PRAC's anbefalinger vedrørende signaler EMA/PRAC/388998/2017 
New product information wording - Extracts from PRAC recommendations on signals EMA/PRAC/337624/2017
Sjælden (forekommer hos indtil 1 ud af 1 000 behandlede): − Vejrtrækningsbesvær, overfladisk vejrtrækning (respirationsdepression) 
Rare (may affect up to 1 in 1,000 people):
5 mg Pulver til koncentrat til infusionsvæske, opløsning 
Powder for concentrate for solution for infusion
Mylotarg 
Pack size
Behandlingen bør fortsætte, så længe det er til fordel for patienten. 
Treatment should be continued for as long as the patient benefits from it.
Plasteret kan beholdes på under badning og i varmt vejr. 
The patches can be worn during bathing and hot weather.
Plasteret må ikke klippes i stykker. 
The patches should not be cut into pieces.
Patienten kan skifte fra rivastigmin i form af kapsler eller oral opløsning til plastre. 
Patients can be switched from rivastigmine capsules or oral solution to the patches.
Plasteret sættes på tør, ren, ubehåret, intakt hud på ryggen, overarmen eller brystkassen og skal skiftes hver 24 timer. 
The patches are applied to clean, dry, hairless, intact skin on the back, upper arm or chest, and are replaced every 24 hours.
Den fuldstændige EPAR og en sammenfatning af risikohåndteringsplanen for Rivastigmine 3M Health Care Ltd findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR and risk management plan summary for Rivastigmine 3M Health Care Ltd can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Plasteret må ikke anbringes på irriteret eller rød hud, på låret eller maven eller på steder, hvor det vil gnide mod tætsiddende tøj. 
They should not be placed on irritated or red skin, on the thigh or abdomen (tummy), or in places where they will be rubbed by tight clothing.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rivastigmine 3M Health Care Ltd den 03. april 2014. 
The European Commission granted a marketing authorisation valid throughout the European Union for Rivastigmine 3M Health Care Ltd on 3 April 2014.
Behandlingen med Rivastigmine 3M Health Care Ltd bør indledes og overvåges af en læge med erfaring i diagnosticering og behandling af Alzheimers sygdom. 
Treatment with Rivastigmine 3M Health Care Ltd should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's dementia.
Rivastigmine 3M Health Care Ltd udleveres kun på recept og leveres som depotplastre, der afgiver 4,6 eller 9,5 mg rivastigmin gennem huden i løbet af 24 timer. 
Rivastigmine 3M Health Care Ltd can only be obtained with a prescription and is available as transdermal patches, which release either 4.6 or 9.5 mg rivastigmine across the skin over 24 hours.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Rivastigmine 3M Health Care Ltd. 
This is a summary of the European public assessment report (EPAR) for Rivastigmine 3M Health Care Ltd.
Det aktive stof i Rivastigmine 3M Health Care Ltd, rivastigmin, blokerer de enzymer, der nedbryder acetylcholin: acetylcholinesterase og butyrylcholinesterase. 
The active substance in Rivastigmine 3M Health Care Ltd, rivastigmine works by blocking the enzymes that break down acetylcholine: acetylcholinesterase and butyrylcholinesterase.
CHMP fandt derfor, at fordelene er større end risiciene, ligesom for Exelon. 
Therefore, the CHMP's view was that, as for Exelon, the benefit outweighs the identified risk.
Der er udarbejdet en risikostyringsplan for at sikre, at Rivastigmine 3M Health Care Ltd anvendes så risikofrit som muligt. 
A risk management plan has been developed to ensure that Rivastigmine 3M Health Care Ltd is used as safely as possible.
Det betyder, at Rivastigmine 3M Health Care Ltd svarer til et “referencelægemiddel”, som allerede er godkendt i Den Europæiske Union (EU). 
This means that Rivastigmine 3M Health Care Ltd is similar to a ‘reference medicine' already authorised in the European Union (EU) called Exelon.
Hvis du ønsker yderligere oplysninger om behandling med Rivastigmine 3M Health Care Ltd, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Rivastigmine 3M Health Care Ltd, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Da Rivastigmine 3M Health Care Ltd er et generisk lægemiddel og er bioækvivalent med referencelægemidlet, antages det at have de samme fordele og risici som referencelægemidlet. 
Because Rivastigmine 3M Health Care Ltd is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Udvalget for Lægemidler til Mennesker (CHMP) fandt, at Rivastigmine 3M Health Care Ltd i overensstemmelse med EU-kravene er påvist at have en kvalitet svarende til Exelon og at være bioækvivalent med dette. 
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Rivastigmine 3M Health Care Ltd has been shown to have comparable quality and to be bioequivalent to Exelon.
Rivastigmine 3M Health Care Ltd er et lægemiddel, der indeholder det aktive stof rivastigmin. 
Rivastigmine 3M Health Care Ltd is a medicine that contains the active substance rivastigmine.
Tåles denne dosis godt, kan der efter mindst fire uger skiftes til den højere styrke 9,5 mg pr. 24 timer. 
Treatment should be started with the 4.6-mg-per-24-hours patch, with the dose increased to the higher strength 9.5 mg/24-h patch after at least four weeks if the lower dose is well tolerated.
Behandlingen bør kun iværksættes, hvis patienten har en omsorgsgiver, der regelmæssigt giver Rivastigmine 3M Health Care Ltd og overvåger patientens anvendelse af lægemidlet. 
Treatment should only be started if a caregiver is available who will regularly give and monitor the use of Rivastigmine 3M Health Care Ltd by the patient.
Rivastigmine 3M Health Care Ltd er et “generisk lægemiddel”. 
Rivastigmine 3M Health Care Ltd is a ‘generic medicine'.
Det anvendes til behandling af let til moderat svær Alzheimers sygdom, som er en fremadskridende hjernesygdom, der gradvis angriber hukommelse, intellektuelle evner og adfærd. 
Rivastigmine 3M Health Care Ltd is used to treat patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Da Rivastigmine 3M Health Care Ltd er et generisk lægemiddel, er der udelukkende udført undersøgelser til at fastslå, at det er bioækvivalent med referencelægemidlet, Exelon. 
Because Rivastigmine 3M Health Care Ltd is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Exelon.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Rivastigmine 3M Health Care Ltd? 
What measures are being taken to ensure the safe and effective use of Rivastigmine 3M Health Care Ltd?
Hvis du ønsker praktisk vejledning om anvendelsen af Rivastigmine 3M Health Care Ltd, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Rivastigmine 3M Health Care Ltd, patients should read the package leaflet or contact their doctor or pharmacist.
I produktresuméet og indlægssedlen for Rivastigmine 3M Health Care Ltd er der indsat sikkerhedsoplysninger baseret på denne plan, herunder passende forholdsregler, der skal følges af sundhedspersonale og patienter. 
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rivastigmine 3M Health Care Ltd, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvad er Rivastigmine 3M Health Care Ltd, og hvad anvendes det til? 
What is Rivastigmine 3M Health Care Ltd and what is it used for?
Andre oplysninger om Rivastigmine 3M Health Care Ltd 
Other information about Rivastigmine 3M Health Care Ltd
Hvilke fordele og risici er der forbundet med Rivastigmine 3M Health Care Ltd? 
What are the benefits and risks of Rivastigmine 3M Health Care Ltd?
Det medfører for lavt indhold af neurotransmitteren acetylcholin, som er et signalstof, nervecellerne anvender til deres indbyrdes kommunikation. 
In patients with Alzheimer's dementia, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a substance that allows nerve cells to communicate with each other).
Det er ikke en praktisk vejledning i, hvordan Rivastigmine 3M Health Care Ltd bør anvendes. 
It is not intended to provide practical advice on how to use Rivastigmine 3M Health Care Ltd.
Rivastigmine 3M Health Care Ltd rivastigmin 
Rivastigmine 3M Health Care Ltd rivastigmine
Ved at blokere disse enzymer øger Rivastigmine 3M Health Care Ltd hjernens indhold af acetylcholin. 
By blocking these enzymes, Rivastigmine 3M Health Care Ltd allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia.
Flere oplysninger herom findes i produktresuméet, der ligeledes er en del af EPAR. 
See the summary of product characteristics (also part of the EPAR) for detailed information.
Udvalget anbefalede udstedelse af markedsføringstilladelse i EU for Rivastigmine 3M Health Care Ltd. 
The Committee recommended that Rivastigmine 3M Health Care Ltd be approved for use in the EU.
Hvorfor er Rivastigmine 3M Health Care Ltd blevet godkendt? 
Why is Rivastigmine 3M Health Care Ltd approved?
Hvordan blev Rivastigmine 3M Health Care Ltd undersøgt? 
How has Rivastigmine 3M Health Care Ltd been studied?
Hvordan anvendes Rivastigmine 3M Health Care Ltd? 
How does Rivastigmine 3M Health Care Ltd work?
CVMP blev anmodet om at afgive en udtalelse om sagen. 
The CVMP was requested to give its opinion on the matter.
1. oktober 2009 Dok. 
1 October 2009 Doc.
Artikel 35 i direktiv 2001/82/EF, med senere ændringer. 
Article 35 of Directive 2001/82/EC, as amended.
Internationalt fællesnavn (INN): Ivermectin 
International Non-Proprietary Name (INN): Ivermectin
Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 1. oktober 2009. 
The final opinion was converted into a Decision by the European Commission on 1 October 2009.
Der blev afgivet mundtlige redegørelser den 12. maj 2009. 
Oral explanations were given on 12 May 2009.
De nærmere begrundelser for revurderingen blev fremlagt af Norbrook Laboratories Ltd den 14. april 2009. 
The detailed grounds for the re-examination were submitted by Norbrook Laboratories Ltd on 14 April 2009.
De indsendte oplysninger vedrørte 173 af de 293 markedsføringstilladelser, som denne indbringelsesprocedure omfatter. 
The submitted information concerned 173 of the 293 Marketing Authorisations involved in this referral procedure.
Den 21. maj 2008 modtog EMEA i alt 19 skriftlige redegørelser fra indehaverne af markedsføringstilladelserne (enten som en gruppe af eller som enkeltstående indehavere af markedsføringstilladelser). 
On 21 May 2008 the EMEA received a total of 19 written explanations from the Marketing Authorisation Holders (either as a group of or individual Marketing Authorisation Holders).
Revurderingsproceduren indledtes den 15. april 2009. 
The re-examination procedure started on 15 April 2009.
Der er udstedt markedsføringstilladelser for injicerbare lægemidler indeholdende ivermectin til anvendelse i kvæg i alle Den Europæiske Unions medlemsstater via forskellige godkendelsesprocedurer (gensidige anerkendelsesprocedurer eller nationale procedurer) og i henhold til forskellige retsgrundlag. 
National Marketing Authorisations for injectable products containing ivermectin for use in cattle have been granted in all the Member States of the European Union via different authorisation procedures (mutual recognition procedures or national procedures) and under various legal bases.
Den 9. december 2008 og den 14. januar 2009 afgav to indehavere af markedsføringstilladelse mundtlige redegørelser efter egen anmodning. 
On 9 December 2008 and 14 January 2009 two Marketing Authorisation Holders provided oral explanations at their request.
Udvalget udpegede dr. G. J. Schefferlie som rapportør og dr. J. G. Beechinor, prof. C. Friis, prof. R. Kroker og dr. B. Urbain som medrapportører. 
The Committee appointed Dr G. J. Schefferlie as rapporteur and Dr J. G. Beechinor, Prof C. Friis, Prof R. Kroker and Dr B. Urbain as co-rapporteurs.
Den 17. september 2008 konstaterede CVMP, at der stadig var spørgsmål med hensyn til visse af lægemidlerne, for hvilke der manglede yderligere oplysninger, og udvalget anmodede derfor de relevante indehavere af markedsføringstilladelser om at besvare de udestående spørgsmål skriftligt. 
On 17 September 2008 the CVMP considered that there were still issues with regard to some products which needed further clarification and therefore the Committee requested the relevant Marketing Authorisation Holders to address the outstanding issues in writing.
Indbringelsesproceduren indledtes den 16. januar 2008. 
The referral procedure started on 16 January 2008.
Som følge af betænkeligheder ved, at forskellen i tilbageholdelsestider, som er fastsat i Den Europæiske Union for injicerbare veterinærlægemidler indeholdende ivermectin, der er indiceret til anvendelse i kvæg ved en dosis a 200 µg ivermectin/kg kropsvægt, kan udgøre en potentiel alvorlig risiko for menneskers sundhed, indbragte Det Forenede Kongerige sagen for EMEA den 14. december 2007 i henhold til artikel 35 i direktiv 2001/82//EF. 
Due to concerns that the difference in withdrawal periods established across the European Union for injectable veterinary medicinal products containing ivermectin which are indicated for use in cattle and with a dose of 200µg ivermectin/kg bodyweight may present a potential serious risk to human health, the United Kingdom referred the matter to the EMEA on 14 December 2007, under Article 35 of Directive 2001/82/EC.
Den 4. juni 2008 blev de nationale kompetente myndigheder anmodet om at indsende de manglende oplysninger for de resterende 120 markedsføringstilladelser. 
On 4 June 2008 the National Competent Authorities of the Member States were requested to provide the missing information for the outstanding 120 Marketing Authorisations.
CVMP udpegede på sit møde den 10.-12. marts 2009 dr. A. Holm som rapportør og dr. M. Holzhauser-Alberti som medrapportør for revurderingen af ovennævnte udtalelse. 
During its 10-12 March 2009 meeting, the CVMP, appointed Dr A. Holm as rapporteur and Dr M. Holzhauser-Alberti as co-rapporteur for the re-examination of the above mentioned opinion.