FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were given either EnCyzix, or placebo (a dummy treatment) with and without application of a testosterone gel.
Danish: Patienterne fik enten EnCyzix eller placebo (ikke-aktivt stof) med og uden påføring af testosteron-gel.
English: EnCyzix blocks the excess oestrogen enabling release of gonadotrophins and normal testicular function.
Danish: EnCyzix blokerer for det overskydende østrogen, så der kan frigives gonadotropiner og opnås normal testikelfunktion.
English: How does EnCyzix work?
Danish: Hvordan virker EnCyzix?
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with EnCyzix.
Danish: Virksomheden har oplyst til CHMP, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse med særlig udleveringstilladelse for EnCyzix.
English: In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine.
Danish: Derudover indebærer lægemidlet en risiko for venøs tromboemboli (blodpropper i venerne).
English: This summary was last updated in 11-2012.
Danish: Dette sammendrag blev sidst ajourført 11-2012.
English: The results of the two measurements were compared to see if they were in agreement.
Danish: Resultaterne af de to målinger blev sammenlignet for at se, om de stemte overens.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thyrogen on 9 March 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Thyrogen den 9. marts 2000.
English: The full EPAR for Thyrogen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Thyrogen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Thyrogen.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Thyrogen.
English: Thyrogen must not be used during pregnancy.
Danish: Thyrogen må ikke anvendes under graviditet.
English: Following this, 51 of the patients went on to be followed up for an average of three and a half more years.
Danish: Herefter fortsatte 51 af patienterne med en opfølgning i gennemsnitligt tre et halvt år mere.
English: This finding was confirmed in the follow-up study: all 43 patients whose results could be evaluated after a further three and a half years had successful treatment.
Danish: Dette blev bekræftet i opfølgningsundersøgelsen: Hos alle 43 patienter, hvis resultater kunne evalueres efter yderligere tre et halvt år, var behandlingen effektiv.
English: Other information about Thyrogen
Danish: Andre oplysninger om Thyrogen
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Thyrogen.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Thyrogen.
English: For more information about treatment with Thyrogen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Thyrogen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The most common side effect with Thyrogen (seen in more than 1 patient in 10) is nausea (feeling sick).
Danish: Den hyppigste bivirkning ved Thyrogen (som ses hos flere end 1 ud af 10 patienter) er kvalme.
English: In these cases, a scan will be carried out a few days later to see if there is any more thyroid tissue left.
Danish: I så fald udføres der en scanning nogle dage senere for at se, om der er mere skjoldbruskkirtelvæv tilbage.
English: Thyrotropin alfa is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes the cell able to produce the hormone.
Danish: Thyrotropin-alfa fremstilles ved en metode, der kaldes "rekombinant dna-teknologi": Det produceres af en celle, der har fået indsat et gen (dna), som gør den i stand til at producere hormonet.
English: The company also presented the results of 13 studies from the published literature, including one key study that compared the effect of Thyrogen and the effect of stopping replacement therapy in 394 patients who were followed up for around two and a half years.
Danish: Virksomheden fremlagde ligeledes resultaterne af 13 undersøgelser fra den offentliggjorte litteratur, herunder en nøgleundersøgelse, hvor man sammenlignede virkningen af Thyrogen og virkningen af at stoppe erstatningsbehandlingen hos 394 patienter, som man fulgte op på i ca. to et halvt år.
English: This included 25 patients using Thyrogen and 18 whose replacement therapy was stopped.
Danish: Ud af disse var der 25 patienter, som anvendte Thyrogen, og 18 patienter, hvis erstatningsbehandling blev stoppet.
English: It contains the active substance thyrotropin alfa.
Danish: Det indeholder det aktive stof thyrotropin-alfa.
English: Thyrogen should not be used in people who may be hypersensitive (allergic) to bovine (cow) or human TSH or to any of the other ingredients.
Danish: Thyrogen bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for bovint TSH (fra køer) eller menneskeligt TSH eller over for andre af indholdsstofferne.
English: It is given as two injections into the buttock muscle, 24 hours apart.
Danish: Det gives som to indsprøjtninger i baldemusklen med 24 timers mellemrum.
English: The iodine is given 24 hours after the last Thyrogen injection and scan is performed 48 to 72 hours later.
Danish: Det radioaktive jod gives 24 timer efter den sidste injektion af Thyrogen, og scanningen udføres 48-72 timer senere.
English: This is because Thyrogen will stimulate the cells in the tissue to take up the radioactive iodine, which then eliminates them.
Danish: Dette skyldes, at Thyrogen stimulerer cellerne i vævet til at optage det radioaktive jod, hvilket derefter dræber cellerne.
English: The CHMP decided that Thyrogen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP konkluderede, at fordelene ved Thyrogen opvejer risiciene og anbefalede udstedelse af markedsføringstilladelse for Thyrogen.
English: This study also compared Thyrogen with the patients' own TSH.
Danish: I undersøgelsen blev Thyrogen desuden sammenlignet med patienternes eget TSH.
English: The larger published studies confirmed that Thyrogen had a similar effect to stopping replacement therapy in patients whose cancer had not spread to other parts of the body.
Danish: De mere omfattende offentliggjorte undersøgelser bekræftede, at Thyrogen havde stort set samme virkning som at stoppe erstatningsbehandlingen hos patienter, hvor kræften ikke havde spredt sig til andre dele af kroppen.
English: For eliminating remaining thyroid tissue following thyroid cancer surgery, both treatments were 100% successful after eight months.
Danish: Til fjernelse af tilbageværende skjoldbruskkirtelvæv var begge behandlinger 100 % effektive efter otte måneder.
English: The main measure of effectiveness was based on a test to see if the patient had any thyroid tissue remaining at eight months after treatment.
Danish: Det primære effektmål var baseret på en test, hvor man undersøgte, om patienten havde mere skjoldbruskkirtelvæv tilbage otte måneder efter behandlingen.
English: The use of Thyrogen should be supervised by a doctor with expertise in thyroid cancer.
Danish: Behandlingen med Thyrogen bør overvåges af en læge med erfaring i behandling af skjoldbruskkirtelkræft.
English: The active substance in Thyrogen, thyrotropin alfa, is a copy of TSH and is used to stimulate any remaining thyroid tissue in the body, including cancerous tissue.
Danish: Det aktive stof i Thyrogen, thyrotropin-alfa, er en kopi af TSH og anvendes til at stimulere eventuelt tilbageværende skjoldbruskkirtelvæv i kroppen, herunder kræftvæv.
English: The company also presented the results of studies from the published literature looking at Thyrogen's effect when it was used with a thyroglobulin test, but without a radioactive iodine scan.
Danish: Virksomheden fremlagde ligeledes resultaterne af undersøgelser fra den offentliggjorte litteratur, hvor man undersøgte Thyrogens virkning, når det blev anvendt med en tyreoglobulintest, men uden en scanning med radioaktivt jod.
English: To do this, measurements of thyroid stimulation (production of thyroglobulin and uptake of radioactive iodine) were taken twice: once after treatment with Thyrogen and once after the patients had stopped taking the replacement therapy that inhibits their natural TSH production.
Danish: Derfor fik patienterne to gange målt thyroideastimulationen (produktionen af tyreoglobulin og optagelsen af radioaktivt jod): Én gang efter behandling med Thyrogen, og én gang efter at patienterne var holdt op med at få erstatningsbehandling, der hæmmer den naturlige TSH-produktion.
English: What is the risk associated with Thyrogen?
Danish: Hvilken risiko er der forbundet med Thyrogen?
English: Two further published studies involving 1,190 patients were carried out with Thyrogen using lower doses of radioactive iodine.
Danish: Der blev gennemført og offentliggjort yderligere to undersøgelser, som omfattede 1 190 patienter, der fik Thyrogen med lave doser af radioaktivt jod.
English: Thyrogen can also be used in combination with radioactive iodine to ablate (eliminate) any remaining thyroid tissue in patients who have had all or almost all of their thyroid gland removed and whose cancer has not spread to other parts of the body.
Danish: Thyrogen kan desuden anvendes i kombination med radioaktivt jod til at udrydde eventuelt tilbageværende skjoldbruskkirtelvæv hos patienter, som har fået hele eller næsten hele skjoldbruskkirtlen fjernet, og hvor kræften ikke har spredt sig til andre dele af kroppen.
English: Thyrogen is a powder that is made up into a solution for injection.
Danish: Thyrogen er et pulver, der anvendes til fremstilling af en injektionsvæske, opløsning.
English: Why has Thyrogen been approved?
Danish: Hvorfor blev Thyrogen godkendt?
English: However, patients who have had their thyroid gland removed receive medication (thyroid hormone replacement therapy) that stops their production of TSH.
Danish: Patienter, der har fået fjernet skjoldbruskkirtlen, skal imidlertid have medicin (thyroideahormonerstatning), der standser produktionen af TSH.
English: The published studies showed that using Thyrogen was also effective in low-risk patients when leftover tissue was detected only by measuring thyroglobulin levels and that it was not always necessary to do a radioactive iodine scan.
Danish: De offentliggjorte undersøgelser viste, at Thyrogen også var effektivt til lavrisikopatienter, når tilbageværende væv udelukkende blev påvist ved kun at måle tyreoglobulinniveauerne, og at det ikke altid var nødvendigt at foretage en scanning med radioaktivt jod.
English: Seventy-two hours after the last injection, a blood test is carried out to check for the presence of a thyroid protein called thyroglobulin, which indicates the presence of thyroid tissue.
Danish: 72 timer efter den sidste injektion tages en blodprøve for at kontrollere, om der er et skjoldbruskkirtelprotein kaldet tyreoglobulin til stede, hvilket i så fald betyder, at der stadig er skjoldbruskkirtelvæv til stede.
English: Thyrogen used with lower doses of radioactive iodine was also shown to be effective.
Danish: Thyrogen blev desuden påvist at være effektivt med lavere doser af radioaktivt jod.
English: Another way to check for left-over tissue is to give the patient a dose of radioactive iodine that will show up in the thyroid tissue on a scan.
Danish: En anden metode til at kontrollere, om der er mere væv tilbage, er at give patienten en dosis radioaktivt jod, som kan ses i skjoldbruskkirtelvævet på en scanning.
English: For thyroid tissue to be detected, it needs to be active, and this requires the presence of a hormone called thyroid stimulating hormone (TSH).
Danish: For at man kan se, om der er skjoldbruskkirtelvæv til stede, skal vævet være aktivt, og dette forudsætter, at der er et hormon kaldet thyroideastimulerende hormon (TSH) til stede.
English: For the full list of all side effects reported with Thyrogen, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger for Thyrogen fremgår af indlægssedlen.
English: The thyroglobulin test is an alternative to the radioactive iodine scan for detecting remaining thyroid tissue which involves measuring thyroglobulin produced by the thyroid tissue in the blood.
Danish: Tyreoglobulin-testen er et alternativ til scanning med radioaktivt jod for at bestemme tilbageværende skjoldbruskkirtelvæv, hvilket gøres ved at måle blodets indhold af tyreoglobulin, der produceres af thyroideavævet.
English: When Thyrogen is used to eliminate left-over thyroid tissue, radioactive iodine is also given 24 hours after the last Thyrogen injection.
Danish: Når Thyrogen anvendes til at fjerne tilbageværende skjoldbruskkirtelvæv, gives der desuden radioaktivt jod 24 timer efter den sidste injektion af Thyrogen.
English: Thyrogen can be used to eliminate remaining thyroid tissue when the patient is given higher doses of radioactive iodine.
Danish: Thyrogen kan anvendes til at udrydde tilbageværende skjoldbruskkirtelvæv, når en patient får høje doser radioaktivt jod.
English: In these studies the ability of Thyrogen to stimulate left-over thyroid tissue was compared with the patients' own TSH.
Danish: I disse undersøgelser blev Thyrogens evne til at stimulere tilbageværende skjoldbruskkirtelvæv sammenlignet med patientens eget TSH.
English: Thyrogen was used to eliminate any left-over thyroid tissue in a study involving 63 patients with thyroid cancer who were given higher doses of radioactive iodine.
Danish: Thyrogen blev anvendt til at fjerne tilbageværende skjoldbruskkirtelvæv i en undersøgelse med 63 patienter med skjoldbruskkirtelkræft, der fik høje doser af radioaktivt jod.
English: What is Thyrogen?
Danish: Hvad er Thyrogen?
English: What benefit has Thyrogen shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved Thyrogen?
English: Thyrogen is used in patients who have had thyroidectomy (thyroid surgery) because of cancer, to detect any thyroid tissue that might have been left over after the surgery.
Danish: Thyrogen anvendes hos patienter, der har fået foretaget tyroidektomi (fjernelse af skjoldbruskkirtlen) på grund af kræft, for at kontrollere, om der er mere skjoldbruskkirtelvæv tilbage efter operationen.
English: How has Thyrogen been studied?
Danish: Hvordan blev Thyrogen undersøgt?
English: However, Thyrogen has the advantage of allowing patients to remain on their replacement therapy before the test is carried out, resulting in a better quality of life, as the temporary withdrawal of the replacement therapy has transient sideeffects which cannot always be tolerated easily.
Danish: Derved opnår de en bedre livskvalitet, da den midlertidige afbrydelse af erstatningsbehandlingen har forbigående bivirkninger, der ikke altid tåles godt.
English: Thyrogen was used in two studies to detect any remaining thyroid tissue in 381 patients who had had thyroidectomy (thyroid surgery).
Danish: Thyrogen blev anvendt i to undersøgelser til at afsløre eventuelt tilbageværende skjoldbruskkirtelvæv hos 381 patienter, der havde fået fjernet skjoldbruskkirtlen.
English: What is Thyrogen used for?
Danish: Hvad anvendes Thyrogen til?
English: Using Thyrogen to detect left over thyroid tissue following surgery was comparable with using the patients' own TSH after their replacement therapy was stopped.
Danish: Til at påvise, om der var mere skjoldbruskkirtelvæv tilbage efter en operation, virkede Thyrogen lige så godt som patientens eget TSH efter, at erstatningsbehandlingen var ophørt.
English: How is Thyrogen used?
Danish: Hvordan anvendes Thyrogen?
English: The presence of thyroid tissue can be checked by a blood test (showing that the thyroid protein thyroglobulin is being produced by any remaining thyroid tissue) or, if the patient has been given radioactive iodine, by a scan (showing that the remaining thyroid tissue is actively taking up the iodine).
Danish: Om der er skjoldbruskkirtelvæv tilstede, kan kontrolleres ved en blodprøve (som viser, at skjoldbruskkirtelproteinet tyreoglobulin produceres af eventuelt tilbageværende skjoldbruskkirtelvæv).
English: How does Thyrogen work?
Danish: Hvordan virker Thyrogen?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 May 2015 EMA/325007/2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
English: Povidone K 29/32
Danish: Povidon K 29/32
English: Elderly (over 65 years of age)
Danish: Ældre (>65 år)
English: The following side effects can be very serious.
Danish: Følgende bivirkninger kan være meget alvorlige.
English: The dose is the same as for adults.
Danish: Doseringen er den samme som til voksne.
English: • Increased urine production during night time
Danish: • Øget urinproduktion om natten
English: In addition, an updated RMP should be submitted
Danish: Desuden skal et opdateret RMP fremsendes
English: Your doctor will decide whether you will be given this dose for one or two weeks.
Danish: Deres læge afgør, om De skal have denne dosis i en eller to uger.
English: Safety margins based on comparative exposure have thus not been established.
Danish: Der er således ikke fastsat sikkerhedsmarginer ud fra sammenlignelig eksponering.
English: If you forget to take a tablet, take it as soon as you remember and carry on as usual.
Danish: Hvis De har glemt at tage en tablet, skal De tage den, så snart De kommer i tanke om det og derefter fortsætte som vanligt.
English: These could be signs of an allergic reaction.
Danish: Det kan være tegn på en allergisk reaktion.
English: Please tell your doctor if:
Danish: Fortæl det til lægen:
English: Linearity / non-linearity
Danish: Linearitet/nonlinearitet
English: • Inability to speak or write or understand spoken or written language
Danish: • Manglende evne til at tale eller skrive eller forstå tale eller skrift
English: However, due to interindividual variability, the effect may be clinically relevant in some individuals.
Danish: På grund af interindividuel variation kan virkningen være klinisk relevant hos nogle individer.
English: Elderly (over 65 years of age) If you are elderly your doctor will decide the suitable dose for you.
Danish: Ældre (>65 år) Hvis De er ældre, fastsætter lægen en passende dosis.
English: Your doctor will decide how long you should take Exalief for.
Danish: Deres læge afgør, hvor længe De skal tage Exalief.
English: • Increased or decreased appetite
Danish: • Øget eller nedsat appetit
English: Dose when you start treatment
Danish: Dosis når behandlingen startes
English: Tell your doctor immediately if you are pregnant or planning to become pregnant.
Danish: Fortæl det straks til lægen, hvis De er gravid eller planlægger graviditet.
English: There is no known specific antidote.
Danish: Der findes intet specifikt antidot.
English: Adults There are two dosing regimes for adults:
Danish: Voksne Der er to former for dosering til voksne:
English: See ‘Taking other medicines' section for advice about contraception.
Danish: Se ‘Brug af anden medicin' for råd om prævention.
English: The need for antiepileptic therapy should be reviewed when a woman is planning to become pregnant.
Danish: Behovet for behandling med antiepileptika bør revurderes, hvis en kvinde planlægger at blive gravid.
English: Apart from this, sodium levels should be determined during routine laboratory examination.
Danish: Ud over dette bør natriumniveauet kontrolleres ved rutinemæssige laboratorieundersøgelser.
English: Therefore, patients should be advised that their physical and/ or mental abilities needed for operating machinery or driving may be impaired and they are recommended not to do so until it has been established that their ability to perform such activities is not affected.
Danish: Patienterne skal derfor orienteres om, at deres fysiske og/eller mentale evne til at betjene maskiner eller færdes i trafikken kan være svækket, og at det bør undgås, indtil det er fastslået, at deres evne til at udføre disse aktiviteter ikke er påvirket.
English: Do not take Exalief if:
Danish: Tag ikke Exalief:
English: FURTHER INFORMATION What Exalief contains
Danish: YDERLIGERE OPLYSNINGER Exalief indeholder
English: When initiating or discontinuing treatment with Exalief or changing the dose, it may take 2 to 3 weeks to reach the new level of enzyme activity.
Danish: Ved indledning eller seponering af behandling med Exalief eller ændring af dosis kan det tage 2-3 uger atter at opnå enzymaktivitet.
English: Symptomatic and supportive treatment should be administered as appropriate.
Danish: Symptomatisk og understøttende behandling gives efter behov.
English: Please talk to your doctor if you are unsure about the dose you should be taking.
Danish: Tal med Deres læge, hvis De er tvivl om, hvilken dosis De skal tage.
English: The binding of eslicarbazepine to plasma proteins is relatively low (<40%) and independent from concentration.
Danish: Eslicarbazepins binding til plasmaproteiner er relativt lav (<40 %) og uafhængig af koncentrationen.
English: • High or low blood pressure or a fall in blood pressure on standing up
Danish: • Højt eller lavt blodtryk eller blodtryksfald, når man rejser sig
English: • Mood changes or hallucinations
Danish: • Humørforandringer eller hallucinationer
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for eslicarbazepine acetate.
Danish: Mekanismen bag denne risiko kendes ikke, og de forhåndenværende data udelukker ikke en mulig øget risiko i forbindelse med eslicarbazepinacetat.
English: This time delay must be taken into account when Exalief is being used just prior to or in combination with other medicines that require dose adjustment when co-administered with Exalief.
Danish: Der skal tages højde for denne forhaling, når Exalief anvendes umiddelbart før eller i kombination med andre lægemidler, der kræver dosisjustering, når de gives sammen med Exalief.
English: Always take Exalief exactly as your doctor has told you.
Danish: Tag altid Exalief nøjagtigt efter lægens anvisning.
English: • you suffer from seizures that begin with a widespread electric discharge that involves both sides of the brain
Danish: • hvis De lider af anfald, der begynder med en udbredt elektrisk impuls, der omfatter begge hjernehalvdele.
English: Caution should be exercised in the treatment of elderly patients as there is limited safety information on the use of Exalief in these patients.
Danish: Der bør udvises forsigtighed ved behandling af ældre patienter, da der er begrænset dokumentation for sikkerhed ved anvendelse af Exalief hos disse patienter.
English: These seizures may or may not be followed by a seizure affecting all of the brain (secondary generalisation).
Danish: Disse anfald kan være efterfulgt af anfald, der påvirker hele hjernen (sekundær generalisering).
English: The allele HLA-B*1502 is not associated to SJS in the Caucasian population.
Danish: Allelen HLA-B*1502 er ikke sat i forbindelse med SJS hos den kaukasiske population.
English: Therefore patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered.
Danish: Patienten skal derfor monitoreres for tegn på selvmordstanker og -adfærd, og passende behandling bør overvejes.