natgillin/translations-raw huggingface dataset:
LÆGEMIDLETS NAVN Saroten og relaterede navne 10 mg filmovertrukne tabletter Saroten og relaterede navne 25 mg filmovertrukne tabletter Saroten og relaterede navne 50 mg filmovertrukne tabletter KVALITATIV OG KVANTITATIV SAMMENSÆTNING [Skal udfyldes nationalt] 
Saroten and associated names 10 mg film-coated tablets Saroten and associated names 25 mg film-coated tablets Saroten and associated names 50 mg film-coated tablets
Ældre patienter (> på 65 år) og patienter med kardiovaskulær sygdom Initialt 10-25 mg dagligt. 
Elderly patients over 65 years of age and patients with cardiovascular disease Initially 10 mg - 25 mg daily.
Søvnighed, tremor, svimmelhed, hovedpine, døsighed, taleforstyrrelse (dysartri) Almindelig Opmærksomhedsforstyrrelse, smagsforstyrrelser, paræstesi, ataksi Ikke almindelig Kramper Meget sjælden Akatisi, polyneuropati Ikke kendt 
excitement, anxiety, difficulties sleeping, nightmares convulsions tinnitus increased blood pressure diarrhoea, vomiting skin rash, nettle rash (urticarial), swelling of the face and tongue difficulties passing urine increased production of breast milk or breast milk outflow without breast feeding increased pressure in the eye ball collapse conditions worsening of cardiac failure liver function impairment (e.g. cholestatic liver disease)
Initialdosis er 10-25 mg om aftenen. 
The initial dose should be 10 mg - 25 mg in the evening.
Voksne Den anbefalede dosis er 25-75 mg dagligt om aftenen. 
Recommended doses are 25 mg - 75 mg daily in the evening.
• -unormal hjerterytme eller hjertefrekvens 
• abnormality in the heart's rhythm, or heartbeat pattern
<[Saroten og relaterede navne 50 mg filmovertrukne tabletter] Tabletten kan deles i fire lige store doser.> 
PHARMACEUTICAL FORM [To be completed nationally] <[Saroten and associated names 50 mg film-coated tablets] The tablet can be divided into 4 equal doses.>
Leversvækkelse kan reducere hepatisk ekstraktion og resultere i højere plasmaniveauer. 
Hepatic impairment may reduce hepatic extraction resulting in higher plasma levels and caution should be exercised when dosing these patients (see section 4.2).
Ekstrapyramidale forstyrrelser 
Vascular disorders
CYP2D6-hæmmere 
Cytochrome P450 inhibitors of CYP2D6
Akkommodationsforstyrrelser Almindelig Mydriasis 
Very common Palpitations, tachycardia Common
Ældre patienter (over 65 år) og patienter med kardiovaskulær sygdom Den anbefalede startdosis er 10 mg - 25 mg dagligt. 
Elderly (above 65 years of age) and patients with cardiovascular disease The recommended initial dose is 10 mg - 25 mg in the evening.
INFORMATION I BRAILLESKRIFT [Skal udfyldes nationalt] 
6.3 Shelf life [To be completed nationally]
systemorganklasse 
Method of administration
Antikolinergika: Tricykliske antidepressiva kan potensere antikolinerge lægemidlers virkning på øjne, centralnervesystem, tarme og blære. 
Anticholinergic agents: Tricyclic antidepressants may potentiate the effects of these drugs on the eye, central nervous system, bowel and bladder; concomitant use of these should be avoided due to an increased risk of paralytic ileus, hyperpyrexia, etc.
• vandladningsbesvær 
• difficulties passing water
• forstyrrelse i øjnenes koordination 
• disturbed coordination
Vaskulære sygdomme Meget almindelig 
Hepatobiliary disorders Rare
Gulsot 
Excipients
• Profylaktisk ved kronisk spændingshovedpine 
• Chronic tension type headache prophylaxis
Mundtørhed, obstipation, kvalme Ikke almindelig Diarré, opkastning, tungeødem. 
Nervous system disorders Very common Somnolence, tremor, dizziness, headache, drowsiness, speech disorder (dysarthria).
Profylaktisk behandling af kronisk spændingshovedpine og profylaktisk behandling af migræne hos voksne 
Prophylactic treatment of chronic tension type headache and prophylactic treatment of migraine in adults Treatment must be continued for an appropriate length of time.
• hedeture. 
Gynaecomastia.
Du eller dine pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V*. 
You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.
Seponering 
Arrhythmia.
• døsighed 
• convulsions
Startdosis er 10-25 mg om aftenen. 
A starting dose of 10 mg - 25 mg in the evening is recommended.
Det er vigtigt, at du læser dette kort omhyggeligt. 
It is important that you read this card carefully.
1 PRAC's anbefalinger udstedt den 11. februar 2016 
1 PRAC recommendations issued on 11 February 2016
Tysabri blev godkendt i Den Europæiske Union i juni 2006. 
Tysabri was authorised in the European Union in June 2006.
Hav kortet på dig, og sørg for, at din partner eller omsorgsgiver kender dets indhold. 
Keep this card with you and make sure your partner or carer is aware of its content.
Gennemgangen af Tysabri blev indledt den 7. maj 2015 på anmodning af Europa-Kommissionen i medfør af artikel 20 i forordning (EF) nr. 726/2004. 
The review of Tysabri was initiated on 7 May 2015 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Ingen indeksværdi 
No index value
For sundhedspersoner gælder følgende anbefalinger: 
Healthcare professionals should follow these recommendations:
• har været i behandling med Tysabri i over 2 år, og 
• have been treated with Tysabri for more than 2 years, and
• er testet positive for JC-virus, og 
• have tested positive for JC virus, and
Patienterne bør instrueres om at søge læge, hvis de mener, at sygdommen er ved at blive værre, eller hvis de bemærker nye eller usædvanlige symptomer. 
Patients should be instructed to seek medical advice if they think their disease is getting worse, or if they notice any new or unusual symptoms.
Hos sådanne patienter bør behandlingen med Tysabri kun fortsættes, hvis fordelene er større end risiciene. 
In these patients, treatment with Tysabri should only be continued if benefits outweigh the risks.
Indeks 0,9 til 
Index 0.9 to
Disse test vil muligvis blive foretaget oftere, hvis du vurderes til at have højere risiko for PML. 
These tests may be done more often if you are considered at higher risk for PML.
Dette protein findes på overfladen af de fleste hvide blodlegemer (leukocytter), som deltager i inflammationsprocessen. 
This protein is found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Hvis du mener, at sygdommen er ved at blive værre, eller hvis du bemærker nye eller usædvanlige symptomer, mens du bruger Tysabri og i indtil 6 måneder efter at være holdt op med Tysabri, skal du snarest tale med lægen. 
If you believe your disease is getting worse or if you notice any new or unusual symptoms while using Tysabri and for up to 6 months after stopping Tysabri, speak to your doctor as soon as possible.
PML er en sjælden hjerneinfektion, der forårsages af John Cunningham-virus (JC-virus). 
PML is a rare brain infection caused by John Cunningham (JC) virus.
På baggrund af de nye resultater anses patienterne for at have højere risiko for at udvikle PML, hvis de: 
In light of the new evidence, patients are considered at higher risk of developing PML if they:
Ved at bindes til integrinet forhindrer natalizumab leukocytterne i at vandre fra blodet ind i hjernen, hvorved det nedsætter den inflammation og nervebeskadigelse, der forårsages af MS. 
By attaching to the integrin, natalizumab stops the leucocytes from going from the blood into the brain, thereby reducing the inflammation and nerve damage caused by MS.
EMA's anbefalinger bygger på en indledende gennemgang foretaget af agenturets Udvalg for Risikovurdering inden for Lægemiddelovervågning (PRAC). 
EMA's recommendations are based on an initial review by its Pharmacovigilance Risk Assessment Committee (PRAC).
Lægen vil desuden kontrollere dig for tegn og symptomer, der tyder på PML. 
Your doctor will also check for signs and symptoms suggestive of PML.
• Der bør testes for anti-JC-virus-antistoffer hver 6. måned hos antistofnegative patienter. 
• Anti-JC virus antibody testing should be done every 6 months in antibody-negative patients.
Indeks 0,9 eller derunder 
Index 0.9 or less
CHMP's udtalelse blev derefter overgivet til Europa-Kommissionen, som vedtog en retligt bindende beslutning med gyldighed i hele EU. 
The CHMP's opinion was then sent to the European Commission, which issued a legally-binding decision valid throughout the EU.
Den 25. februar 2016 afsluttede EMA sin gennemgang af den kendte risiko for progressiv multifokal leukoencefalopati (PML) med lægemidlet mod multipel sklerose Tysabri (natalizumab), og bekræftede sine oprindelige anbefalinger1 for minimering af denne risiko. 
On 25 February 2016, EMA completed its review of the known risk of progressive multifocal leukoencephalopathy (PML) with the multiple sclerosis medicine Tysabri (natalizumab), and confirmed initial recommendations1 aimed at minimising this risk.
Der er udstedt nye anbefalinger, som kan være medvirkende til tidlig opdagelse af PML og bedre udfald for patienternes. 
New recommendations have been issued which may help early detection of PML and improve patients' outcomes.
Ingen tidligere anvendelse af immunosuppressiva 
No prior use of immunosuppressants
Mere detaljerede oplysninger om risikostratificering, diagnose og behandling af PML vil indgå i de ajourførte retningslinjer "Physician Information and Management Guidelines" for Tysabri. 
More detailed information on the risk stratification, diagnosis and treatment of PML will be included in the updated Physician Information and Management Guidelines for Tysabri.
Indeks over måneder * fra retningslinjerne "Physician Information and Management Guidelines" for Tysabri 
months *from Tysabri Physician Information and Management Guidelines
CHMP's udtalelse blev overgivet til Europa-Kommissionen, som 25/04/2016 vedtog en endelig retligt bindende beslutning med gyldighed i alle EU-medlemsstater. 
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 25/04/2016.
Ud fra disse faktorer vil din læge kunne fortælle dig om din risiko for at få PML. 
Considering these factors, your doctor will be able to advise you about your risk of developing PML.
De hyppigste symptomer på PML er tiltagende svaghed, tale- og kommunikationsbesvær, synsændringer og undertiden ændringer i humør eller adfærd. 
The most common symptoms of PML are progressive weakness, speech and communication difficulties, vision changes, and sometimes changes in mood or behaviour.
Tidligere anvendelse af immunosuppressiva 
Prior use of immunosuppressants
Det anvendes, når behandling med visse andre lægemidler, der anvendes mod MS (beta-interferon eller glatirameracetat) ikke har virket, eller sygdommen er svær og hurtigt forværres. 
It is used when the disease has failed to respond to treatment with a beta-interferon or glatiramer acetate (other types of medicines used in MS), or is severe and getting worse rapidly.
• Flere oplysninger om risikoen for PML med Tysabri findes på det patientkort, du har fået udleveret af din læge. 
• More information about the risk of PML with Tysabri is included in the Patient Alert Card you have been given by your doctor.
• PML bør overvejes ved differentialdiagnose af alle patienter med neurologiske symptomer og/eller nye hjerneforandringer på MRI. 
• PML should be considered in the differential diagnosis of any patient presenting with neurological symptoms and/or new brain lesions on MRI.
Hos patienter, der er testet negative for JC-virusantistoffer, er den beregnede risiko for PML uændret 0,1 pr. 1 000 patienter. 
In patients who tested negative for JC virus antibodies, the PML risk estimate remains unchanged at 0.1 per 1,000 patients.
Beregningen af risikoen for PML blev foretaget med livstabelmetoden på grundlag af den poolede kohorte på 21 696 patienter, som deltog i de kliniske undersøgelser STRATIFY-2, TOP, TYGRIS, og STRATA. 
2 PML risk estimates were derived using the life table method based on the pooled cohort of 21,696 patients who participated in the STRATIFY-2, TOP, TYGRIS, and STRATA clinical studies.
FLAIR, T2-vægtet og DW-billeddannelse), da tidligere opdagelse af PML hos asymptomatiske patienter er forbundet med bedre udfald af PML. 
FLAIR, T2-weighted and DW imaging) should be considered, as earlier detection of PML in asymptomatic patients is associated with improved PML outcomes.
• Under behandlingen med Tysabri bør patienterne overvåges regelmæssigt for tegn og symptomer på ny neurologisk dysfunktion, og der bør foretages en fuldstændig hjerne-MRI mindst én gang årligt i hele behandlingens varighed. 
• During treatment with Tysabri, patients should be monitored at regular intervals for signs and symptoms of new neurological dysfunction, and a full brain MRI should be performed at least once a year for the duration of treatment.
Tysabri er et lægemiddel til behandling af voksne med højaktiv multipel sklerose (MS), som er en nervesygdom, hvor den beskyttende skede omkring nervecellerne ødelægges ved inflammation. 
Tysabri is a medicine used to treat adults with highly active multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Patienter med lavt indeks og uden tidligere behandling med immunosuppressiva bør desuden på ny testes hver 6. måned, når de har været behandlet i 2 år. 
Patients who have low index values and no history of prior immunosuppressant use should also be retested every 6 months once they reach the 2-year treatment point.
Alle patienter, der får Tysabri, bør have foretaget fuldstændig MRI-skanning mindst én gang årligt, men på grundlag af de nye data anbefalede EMA, at det bør overvejes at MRI-skanne patienter med større risiko for PML hyppigere (f.eks. hver 3. til 6. måned) efter de forenklede protokoller. 
All patients taking Tysabri should undergo full MRI scans at least once a year, but on the basis of the new data EMA recommended that for patients at higher risk of PML more frequent MRI scans (e.g. every 3 to 6 months) performed using simplified protocols should be considered.
• Før påbegyndelse af behandling med Tysabri bør patienter og omsorgsgivere adviseres om risikoen for PML. 
• Before starting treatment with Tysabri, patients and carers should be advised about the risk of PML.
• Patienter og omsorgsgivere bør adviseres om fortsat at være opmærksomme på risikoen for PML i op til 6 måneder efter seponering af Tysabri. 
• Patients and carers should be advised to continue to be vigilant about the risk of PML for up to 6 months following discontinuation of Tysabri.
• Før påbegyndelse af behandlingen med Tysabri, og derefter regelmæssigt under behandlingen, vil din læge tage blodprøver til bestemmelse af indholdet af antistoffer mod JC-virus og lade foretage MRI-skanning for at overvåge din tilstand. 
• Before starting treatment with Tysabri, and then regularly during treatment, your doctor will do blood tests to measure the level of antibodies for JC virus and MRI scans to monitor your condition.
Asymptomatiske tilfælde af PML kan påvises ved MRI-skanning, og eksperter inden for MRI og multipel sklerose er enige om, at PML-forandringerne kan identificeres med forenklede MRI-protokoller (som giver mulighed for kortere procedurer og desuden er mindre belastende for de patienter, der skannes). 
Asymptomatic cases of PML can be detected on MRI scans, and experts in the field of MRI and multiple sclerosis agree that simplified MRI protocols (which allow for shorter procedures, and also limit the burden for patients undergoing the scans) permit the identification of PML lesions.
• Efter 2 års behandling bør patienterne på ny informeres om risikoen for PML med Tysabri. 
• After 2 years of treatment, patients should be informed again about the risk of PML with Tysabri.
• Den alvorlige hjerneinfektion PML (progressiv multifokal leukoencefalopati) er kendt som en ikke almindelig risiko ved lægemidlet Tysabri, der anvendes mod multipel sklerose. 
• Progressive multifocal leukoencephalopathy (PML, a serious brain infection) is known to be an uncommon risk with the multiple sclerosis medicine Tysabri.
• Før påbegyndelse af behandlingen bør der foreligge en baseline-MRI (sædvanligvis inden for 3 måneder) som reference, og der bør foretages en baseline-anti-JCV antistoftest for at underbygge risikostratificeringen for PML. 
• Before starting treatment, a baseline MRI should be available (usually within 3 months) as a reference, and a baseline anti-JCV antibody test should be performed to support PML risk stratification.
• Din risiko for PML afhænger af en række faktorer, såsom om du har haft antistoffer mod JC-virus i blodet (som tegn på, at du har været udsat for det virus, der forårsager PML) og i hvilken koncentration, hvor længe du har fået Tysabri, og om du har fået lægemidler, der undertrykker immunsystemet, før du begyndte behandlingen med Tysabri. 
• Your risk of PML depends on several factors, such as whether you have antibodies against JC virus in your blood (a sign that you have been exposed to the virus that causes PML) and what their level is, how long you have been treated with Tysabri, and whether or not you were treated with medicines that suppress your immune system before starting Tysabri.
• Symptomerne på PML kan svare til symptomerne på et anfald af multipel sklerose og kan bestå i tiltagende svaghed, tale- og kommunikationsbesvær, synsvanskeligheder og undertiden ændringer i humør og adfærd. 
• Symptoms of PML may be similar to those of a multiple sclerosis attack, and include progressive weakness, speech and communication difficulties, vision problems, and sometimes changes in mood or behaviour.
Der er beskrevet tilfælde af asymptomatisk PML baseret på MRI og positiv JC-virus-DNA-test i cerebrospinalvæske. 
Cases of asymptomatic PML based on MRI and positive JC virus DNA in the CSF have been reported.
For patienter med højere risiko bør hyppigere MRI-skanning overvejes 
More frequent MRI scans should be considered for patients at higher risk
• For patienter med højere risiko for PML bør der overvejes hyppigere MRI-skanning (f.eks. hver 3.6. måned) med brug af en forkortet protokol (f.eks. 
• For patients at higher risk of PML, more frequent MRIs (e.g. every 3-6 months) using an abbreviated protocol (e.g.
De ajourførte risikoberegninger viser, at ved antistof-indeksværdier på 0,9 eller derunder er risikoen for at udvikle PML lille og lavere end tidligere beregnet, og at risikoen øges væsentligt ved indeks over 1,5 og behandling med Tysabri længere end 2 år. 
The updated risk estimates above show that the risk of developing PML is small, and lower than previously estimated, at antibody index values of 0.9 or less, and increases substantially in patients with index values above 1.5 who have been treated with Tysabri for longer than 2 years.
Kendte risikofaktorer for at udvikle PML ved behandling med Tysabri er tilstedeværelse af antistoffer mod JC-virus, behandling med Tysabri længere end to år, samt forudgående brug af immunosuppressiva. 
Known risk factors for the development of PML in patients treated with Tysabri are the presence of antibodies against JC virus, treatment with Tysabri for more than two years, and previous use of immunosuppressants.
PRAC's anbefalinger blev overgivet til Udvalget for Lægemidler til Mennesker (CHMP), som vedtog udvalgets endelige udtalelse. 
The PRAC recommendations were sent to the Committee for Medicinal Products for Human Use (CHMP), which confirmed them and adopted its final opinion.
Yderligere stratificering af PMLrisikoen efter anti-JC virus-antistofindeks for patienter, der ikke tidligere havde brugt immunosuppressiva, blev foretaget ved kombination af den samlede årlige risiko med fordelingen af antistofindeks. 
Further stratification of PML risk by anti-JC virus antibody index interval for patients with no prior use of immunosuppressants were derived from combining the overall yearly risk with the antibody index distribution.
• Spørg lægen, sygeplejersken eller apotekspersonalet, hvis der er mere, du vil vide. 
• If you have any questions or concerns, speak to your doctor, nurse or pharmacist.
• enten har fået et immundæmpende middel før de begyndte at få Tysabri eller har højt JC-virusantistofindeks uden at have fået immundæmpende midler. 
• either have used an immunosuppressant before starting Tysabri, or have not used immunosuppressants and have a high JC virus antibody index.
Hvis der konstateres forandringer tydende på PML, bør MRI-protokollen udvides til at omfatte "kontrastforstærket T1-vægtet MRI", og det bør overvejes at undersøge spinalvæsken for JC-virus. 
If lesions suggestive of PML are discovered, the MRI protocol should be extended to include ‘contrast-enhanced T1-weighted MRI', and testing the spinal fluid for the presence of JC virus should be considered.
Nyere undersøgelser viser, at udfaldet for patienterne kan forbedres ved tidlig opdagelse og behandling af PML, mens sygdommen endnu er i de indledende stadier og er uden symptomer (asymptomatisk). 
Recent studies suggest that early detection and treatment of PML when the disease is asymptomatic (is still in the initial stages and shows no symptoms) may improve patients' outcomes.
Dette virus er meget udbredt hos den almindelige befolkning og er normalt harmløst. 
This virus is very common in the general population and is normally harmless; however, it can lead to PML in persons whose immune system is weakened.
Det aktive stof i Tysabri, natalizumab, er et protein af typen monoklonalt antistof. 
The active substance in Tysabri, natalizumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a specific part of a protein called ‘α4β1 integrin'.
• Ved mistanke om PML bør MRI-protokollen udvides til at omfatte kontrastforstærket T1-vægtet billeddannelse, og det bør overvejes at undersøge cerebrospinalvæsken for JC-virus-DNA ved hjælp af ultrafølsom PCR. 
• If PML is suspected, the MRI protocol should be extended to include contrast-enhanced T1weighted imaging and testing of CSF for the presence of JC virus DNA using ultrasensitive PCR should be considered.
Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket. 
If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
Poolede data fra store kliniske undersøgelser tyder på, at der for patienter, der ikke tidligere har fået immunosuppressiva, er sammenhæng mellem niveauet af anti-JC-virus antistofrespons (-indeks) og risikoen for PML. 
Pooled data from large clinical studies suggest that, in patients with no prior immunosuppressant use, the level of anti-JC virus antibody response (index) relates to the level of risk for PML.
Mennesker (CHMP), som har ansvar for alle spørgsmål vedrørende lægemidler til mennesker, og som vedtog agenturets endelige udtalelse. 
The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
• Ved mistanke om PML vil lægen standse behandlingen med Tysabri, indtil PML kan udelukkes. 
• If PML is suspected, your doctor will stop treatment with Tysabri until PML can be ruled out.
• Hvis der på noget tidspunkt er mistanke om PML, skal behandlingen med Tysabri standses, indtil PML er udelukket. 
• If PML is suspected at any time, treatment with Tysabri must be stopped until PML has been excluded.
På grundlag af disse data foreligger der ajourførte beregninger af risikoen for PML2 ved behandling af JC-virus-antistof-positive patienter med Tysabri, som vist i tabel 1 nedenfor: Tabel 1: Risiko for PML (pr. 1 000 patienter) for anti-JC-virus-antistofpositive patienter* Varighed af anvendelse af Tysabri 
Table 1: PML risk estimates per 1,000 patients in anti-JC virus antibody positive patients* Duration of Tysabri use