FrancophonIA/ELRC3.0 huggingface dataset:
English: Canagliflozin; dapagliflozin; empagliflozin; ertugliflozinFournier's gangrene (EPITT no 19308)
Danish: Canagliflozin; dapagliflozin; empagliflozin; ertugliflozinFourniers gangræn (EPITT nr. 19308)
English: If thiamazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4).
Danish: Hvis thiamazol anvendes under graviditet, anbefales nøje overvågning af moderen, fostret og det nyfødte barn (se pkt.
English: Women of childbearing potential have to use effective contraceptive measures during treatment (see section 4.4).
Danish: Fertile kvinder skal bruge sikker prævention under behandlingen (se pkt.
English: When initiating Saxenda, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycaemia.
Danish: Når behandling med Saxenda initieres, skal det overvejes at reducere dosis af insulin eller βcellestimulerende midler (f.eks. sulfonylurinstoffer), der administreres samtidigt, for at mindske risikoen for hypoglykæmi.
English: Women of childbearing potential have to use effective contraceptive measures during treatment.
Danish: Fertile kvinder skal bruge sikker prævention under behandlingen.
English: What you need to know before you take <medicinal product> Do not take <medicinal product> …if you had inflammation of the pancreas (acute pancreatitis) after administration of thiamazole or carbimazole in the past…
Danish: Det skal du vide, før du begynder at tage <lægemiddel> Tag ikke <lægemiddel> ... hvis du tidligere har haft betændelse i bugspytkirtlen (akut pancreatitis) efter administration af thiamazol eller carbimazol…
English: What you need to know before you take <medicinal product> Do not take <medicinal product> …if you had inflammation of the pancreas (acute pancreatitis) after administration of carbimazole or thiamazole in the past.
Danish: Det skal du vide, før du begynder at tage <lægemiddel> Tag ikke <lægemiddel> ... hvis du tidligere har haft betændelse i bugspytkirtlen (akut pancreatitis) efter administration af carbimazol eller thiamazol.
English: If carbimazole is used during pregnancy, close maternal, foetal and neonatal monitoring is recommended (see section 4.4).
Danish: Hvis carbimazol anvendes under graviditet, anbefales nøje overvågning af moderen, fostret og det nyfødte barn (se pkt.
English: Frequency ‘not known': Raynaud's phenomenon
Danish: Oversigt over bivirkninger Vaskulære sygdomme Hyppighed "ikke kendt": Raynauds syndrom
English: Blood glucose selfmonitoring may be necessary to adjust the dose of sulphonylurea.
Danish: Selvmonitorering af blodglucose kan være nødvendigt for at justere dosis af sulfonylurea.
English: Self-monitoring of blood glucose is not needed in order to adjust the dose of Victoza.
Danish: Selv-monitorering af blodglucose er ikke nødvendig for at justere patientens dosis af Victoza.
English: In patients with diabetes mellitus Saxenda must not be used as a substitute for insulin.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Saxenda må ikke anvendes som erstatning for insulin til patienter med diabetes mellitus.
English: Self-monitoring may be necessary to adjust the dose of sulphonylurea or insulin.
Danish: Det kan være nødvendigt med egenkontrol for at justere dosen af sulfonylurinstoffet eller insulinet.
English: Thiamazole must only be administered during pregnancy after a strict individual benefit/risk assessment and only at the lowest effective dose without additional administration of thyroid hormones.
Danish: Thiamazol må kun administreres under graviditet efter en kritisk vurdering af benefit/risk-forholdet hos den enkelte patient og kun ved den laveste virksomme dosis uden yderligere administration af thyroideahormoner.
English: If thiamazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered.
Danish: Hvis thiamazol anvendes under graviditet, bør det ske under anvendelse af den laveste virksomme dosis uden yderligere administration af thyroideahormoner.
English: Trulicity is not an insulin and should therefore not be used as a substitute for insulin.
Danish: Trulicity er ikke et insulinpræparat og bør derfor ikke anvendes som erstatning for insulin.
English: Carbimazole must only be administered during pregnancy after a strict individual benefit/risk assessment and only at the lowest effective dose without additional administration of thyroid hormones.
Danish: Carbimazol må kun administreres under graviditet efter en kritisk vurdering af benefit/risk-forholdet hos den enkelte patient og kun ved den laveste virksomme dosis uden yderligere administration af thyroideahormoner.
English: However, when initiating treatment with Victoza in combination with a sulfonylurea or insulin, blood glucose selfmonitoring may become necessary to adjust the dose of the sulfonylurea or the insulin.
Danish: Dog kan selv-monitorering af glucose i blodet ved behandlingsstart med Victoza i kombination med sulfonylurinstof eller insulin være nødvendig for at justere dosis af sulfonylurinstof eller insulin.
English: What you need to know before you use Trulicity Warnings and precautions
Danish: Det skal du vide, før du begynder at bruge Trulicity
English: There have been post-marketing reports of acute pancreatitis in patients receiving carbimazole or its active metabolite thiamazole.
Danish: Der er efter markedsføring indberettet tilfælde af akut pancreatitis hos patienter, der fik carbimazol eller dets aktive metabolit thiamazol.
English: Exenatide is not a substitute for insulin.
Danish: Depotformuleringen af exenatid er ikke en erstatning for insulin.
English: If carbimazole is used during pregnancy, the lowest effective dose without additional administration of thyroid hormones should be administered.
Danish: Hvis carbimazol anvendes under graviditet, bør det ske under anvendelse af den laveste virksomme dosis uden yderligere administration af thyroideahormoner.
English: Bydureon is not an insulin and should therefore not be used as a substitute for insulin.
Danish: Bydureon er ikke et insulinpræparat og bør derfor ikke anvendes som erstatning for insulin.
English: Patients with a history of acute pancreatitis after administration of carbimazole or its active metabolite thiamazole.
Danish: Patienter med tidligere akut pancreatitis efter administration af carbimazol eller dets aktive metabolit thiamazol.
English: Women of childbearing potential and pregnancy
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Fertile kvinder og graviditet
English: Blood glucose selfmonitoring is necessary to adjust the dose of insulin or insulin-secretagogues.
Danish: Selvmonitorering af blodglucose er nødvendig for at justere dosen af insulin eller β-cellestimulerende midler.
English: There have been post-marketing reports of acute pancreatitis in patients receiving thiamazole or its prodrug carbimazole.
Danish: Der er efter markedsføring indberettet tilfælde af akut pancreatitis hos patienter, der fik thiamazol eller dets prodrug (carbimazol).
English: However, blood glucose self-monitoring may become necessary to adjust the dose of sulphonylureas or the dose of basal insulin.
Danish: Det kan dog være nødvendigt, at patienterne selv skal overvåge deres blodglucose for at justere dosis af sulfonylurinstof eller dosis af basal insulin.
English: Patients with a history of acute pancreatitis after administration of thiamazole or its prodrug carbimazole.
Danish: Patienter med tidligere akut pancreatitis efter administration af thiamazol eller dets prodrug (carbimazol).
English: Posology and method of administration Add-on therapy
Danish: Dosering og administration Tillægsbehandling
English: Close maternal, foetal and neonatal monitoring is warranted (see section 4.6).
Danish: Nøje overvågning af moderen, fostret og det nyfødte barn er påkrævet (se pkt.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Trulicity therapy is started and insulin is reduced.
Danish: Egenkontrol af blodglucose er nødvendig for at tilpasse dosen af sulfonylurinstof eller insulin, især når behandlingen med Trulicity påbegyndes, og dosen af insulin reduceres.
English: Prolonged-release exenatide is not a substitute for insulin.
Danish: Særlige advarsler og forsigtighedsregler vedrørende brugen Exenatid er ikke en erstatning for insulin.
English: Blood glucose selfmonitoring is necessary to adjust the dose of sulphonylurea or insulin, particularly when Byetta therapy is started and insulin is reduced.
Danish: Selv-monitorering af glucoseniveauet i blodet er nødvendigt for at tilpasse dosen af sulfonylurinstof eller insulin, især når behandlingen med Byetta påbegyndes, og dosen af insulin reduceres.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin particularly when prolonged-release exenatide therapy is started and insulin is reduced.
Danish: Selvmonitorering af blodglucose er nødvendig for at tilpasse dosen af sulfonylurinstof og insulin, især når behandling med depotformuleringen af exenatid påbegyndes, og insulindosen reduceres.
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and insulin, particularly when Victoza therapy is started and insulin is reduced.
Danish: Selvmonitorering af glucoseniveauet i blodet er nødvendig for at tilpasse dosen af sulfonylurinstof og insulin, især når behandlingen med Victoza påbegyndes, og insulindosen reduceres.
English: Carbimazole
Danish: Produktresumé
English: Strength Pharmaceutical Form Route of Administration Packaging
Danish: Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse
English: MA (EU) number (Invented) name Strength Pharmaceutical Form
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration
English: ANNEX A
Danish: BILAG A
English: The European Commission granted a marketing authorisation valid throughout the European Union for Celsentri on 18 September 2007.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Celsentri den 18. september 2007.
English: The safety profile of Celsentri is considered acceptable and no major concerns have been identified.
Danish: Celsentris sikkerhedsprofil anses for at være acceptabel, og der er ikke identificeret nogen væsentlige betænkeligheder.
English: Other information about Celsentri
Danish: Andre oplysninger om Celsentri
English: The full EPAR for Celsentri can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Celsentri findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The patients had previously taken other treatments for HIV for at least six months, but these had stopped working.
Danish: Patienterne havde tidligere fået andre hivbehandlinger i mindst seks måneder, men disse virkede ikke længere.
English: This is a summary of the European public assessment report (EPAR) for Celsentri.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Celsentri.
English: In the studies Celsentri was compared with placebo (a dummy treatment).
Danish: I undersøgelserne blev Celsentri sammenlignet med placebo (en virkningsløs behandling).
English: Patients who have reduced kidney function may need to take Celsentri less frequently.
Danish: Patienter med nedsat nyrefunktion skal muligvis tage Celsentri mindre hyppigt.
English: Celsentri is available as tablets (25, 75, 150 and 300 mg) and as a liquid (20 mg/ml) to be taken by mouth.
Danish: Celsentri fås som tabletter (25 mg, 75 mg, 150 mg og 300 mg) og som væske (20 mg/ml) til indtagelse gennem munden.
English: What measures are being taken to ensure the safe and effective use of Celsentri?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Celsentri?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) therefore decided that Celsentri's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede derfor, at fordelene ved Celsentri opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Celsentri.
English: Celsentri contains the active substance maraviroc.
Danish: Celsentri indeholder det aktive stof maraviroc.
English: What is Celsentri and what is it used for?
Danish: Hvad er Celsentri, og hvad anvendes det til?
English: In adults, the recommended dose is 150, 300 or 600 mg twice a day, depending on the other medicines that the patient is taking.
Danish: Den anbefalede dosis er 150 mg, 300 mg eller 600 mg to gange dagligt, afhængigt af hvilke andre lægemidler patienten tager.
English: All of the patients also took ‘optimised background therapy' (a combination of other HIV medicines chosen for each patient to increase the chances of reducing the levels of HIV in the blood).
Danish: Alle patienterne modtog desuden "optimeret baggrundsbehandling" (en kombination af andre hivlægemidler udvalgt til hver patient med henblik på at øge chancen for at mindske indholdet af hiv i blodet).
English: Celsentri tablets must not be used in patients who are hypersensitive (allergic) to peanut and soya.
Danish: Celsentritabletter må ikke anvendes hos patienter, som er overfølsomme (allergiske) over for jordnødder og soja.
English: In children, the dose is based on body weight.
Danish: Hos børn afhænger dosis af legemsvægten.
English: Celsentri does not cure HIV infection or AIDS, but it may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Danish: Celsentri helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
English: The active substance in Celsentri, maraviroc, is a ‘CCR5 antagonist'.
Danish: Det aktive stof i Celsentri, maraviroc, er en "CCR5-antagonist".
English: It is not intended to provide practical advice on how to use Celsentri.
Danish: Det er ikke en praktisk vejledning i, hvordan Celsentri bør anvendes.
English: Why is Celsentri approved?
Danish: Hvorfor blev Celsentri godkendt?
English: Before treatment, the doctor must check that the patient's blood only shows infection with CCR5-tropic virus.
Danish: Før behandlingen indledes, skal lægen kontrollere, at patientens blod kun viser infektion med CCR5-tropisk virus.
English: Additional data indicate that Celsentri given at a suitable dose to children is handled by their body in the same way as in adults.
Danish: Yderligere data viser, at Celsentri, når det gives i passende dosis til børn, håndteres på samme måde i kroppen som hos voksne.
English: What are the risks associated with Celsentri?
Danish: Hvilke risici er der forbundet med Celsentri?
English: Celsentri cannot work against viruses that attach to another protein called CXCR4, or when it can attach to both CCR5 and CXCR4.
Danish: Celsentri virker ikke mod virus, som bindes til et andet protein kaldet CXCR4, eller når det kan bindes til både CCR5 og CXCR4.
English: The most common side effects with Celsentri (which may affect up to 1 in 10 people) are nausea (feeling sick), diarrhoea, fatigue (tiredness) and headache.
Danish: De hyppigste bivirkninger ved Celsentri (som optræder hos op til 1 ud af 10 patienter) er kvalme, diarré, træthed og hovedpine.
English: For more information about treatment with Celsentri, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Celsentri, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that the virus, when infecting a cell, attaches to a specific protein called CCR5 on the surface of the cell.
Danish: Dette betyder, at virus, når det inficerer en celle, bindes til et bestemt protein kaldet CCR5 på cellens overflade.
English: CCR5-tropic HIV uses this protein to enter the cells.
Danish: CCR5-tropisk hiv bruger dette protein til at trænge ind i cellerne.
English: Celsentri can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Danish: Celsentri udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i behandling af hivinfektion.
English: Similar results were also seen when looking at the patients who continued treatment with Celsentri 300 mg twice a day for 48 weeks.
Danish: Tilsvarende resultater sås hos de patienter, der fortsatte i 48 uger med Celsentri 300 mg to gange dagligt.
English: Celsentri is an HIV medicine used to treat patients from 2 years of age and weighing at least 10 kg who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Danish: Celsentri er et hivlægemiddel, der anvendes til behandling af patienter på to år og derover med en vægt på mindst 10 kg, og som er smittet med humant immundefektvirus type 1 (hiv-1), et virus der forårsager erhvervet immundefektsyndrom (aids).
English: The proportion of patients who had undetectable levels of HIV in their blood after 24 weeks was about 45% with Celsentri compared to 23% with placebo.
Danish: Andelen af patienter, hos hvem der efter 24 uger ikke kunne påvises hiv i blodet, var ca. 45 % ved Celsentri sammenlignet med 23 % ved placebo.
English: Celsentri used in combination with other HIV medicines has been shown to be effective at reducing the levels of HIV in the blood in adults, and similar effects are expected in children.
Danish: Det er blevet påvist, at Celsentri anvendt i kombination med andre hivlægemidler er effektivt til at reducere indholdet af hiv i blodet hos voksne, og der forventes en tilsvarende virkning hos børn.
English: Based on these data, effectiveness is expected to be similar in children and adults.
Danish: På baggrund af disse data forventes virkningen hos børn at svare til virkningen hos voksne.
English: By attaching itself to the protein, Celsentri prevents the virus from entering the cells.
Danish: Celsentri bindes til proteinet og forhindrer derved virusset i at trænge ind i cellerne.
English: For practical information about using Celsentri, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Celsentri, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Looking at the results of the two studies taken together, the levels of HIV in the blood had fallen by an average of 99% after 24 weeks in the patients adding Celsentri to optimised background therapy, compared with 90% in those adding placebo.
Danish: Sammenlagt viste resultaterne af de to undersøgelser, at indholdet af hiv i blodet efter 24 uger i gennemsnit var faldet med 99 % hos de patienter, der fik Celsentri som tillægsbehandling til optimeret baggrundsbehandling, sammenlignet med 90 % hos dem, der fik placebo som tillægsbehandling.
English: Celsentri is used in combination with other HIV medicines, and only in patients who have been treated for HIV infection before and only when the HIV-1 they are infected with is ‘CCR5-tropic', which is determined by a blood test.
Danish: Celsentri anvendes i kombination med andre hivlægemidler og kun hos patienter, der tidligere er blevet behandlet for deres hivinfektion, og kun, når det hiv-1, de er inficeret med, er "CCR5-tropisk".
English: For the full list of all side effects reported with Celsentri, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Celsentri fremgår af indlægssedlen.
English: It blocks the CCR5 protein on the surface of the cells in the body that HIV infects.
Danish: Det blokerer proteinet CCR5 på overfladen af cellerne i den hivinficerede patients krop.
English: What benefits of Celsentri have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Celsentri?
English: How does Celsentri work?
Danish: Hvordan virker Celsentri?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Celsentri have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Celsentri.
English: How is Celsentri used?
Danish: Hvordan anvendes Celsentri?
English: As HIV can only reproduce itself within cells, Celsentri, taken in combination with other HIV medicines, reduces the level of CCR5-tropic HIV, and keeps it at a low level.
Danish: Kombineret med andre hivlægemidler nedsætter Celsentri derfor indholdet af CCR5-tropisk hiv og holder det nede.
English: Celsentri has been shown to be effective at reducing the levels of HIV in the blood in two main studies involving a total of 1,076 mostly adult patients with CCR5-tropic HIV infection.
Danish: Det er i to hovedundersøgelser, der omfattede i alt 1 076 hovedsagelig voksne patienter med CCR5tropisk hivinfektion, blevet påvist, at Celsentri er effektivt til at reducere indholdet af hiv i blodet.
English: Aprovel was used for two years or more.
Danish: Aprovel blev anvendt i to år eller mere.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aprovel on 27 August 1997.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Aprovel den 27. august 1997.
English: This is a summary of the European public assessment report (EPAR) for Aprovel.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Aprovel.
English: The full EPAR for Aprovel can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Aprovel findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: ‘Essential' means that the hypertension has no obvious cause.
Danish: ”Essentiel” betyder, at hypertensionen ikke har nogen umiddelbar årsag.
English: Aprovel is a medicine that contains the active substance irbesartan.
Danish: Aprovel er et lægemiddel, der indeholder det aktive stof irbesartan.
English: Other information about Aprovel
Danish: Andre oplysninger om Aprovel:
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 Aprovel.
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 Aprovel.
English: The usual recommended dose of Aprovel is 150 mg once a day.
Danish: Den normalt anbefalede dosis af Aprovel er 150 mg en gang dagligt.
English: For more information about treatment with Aprovel, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Aprovel, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Aprovel was originally studied in 11 trials for its effects on blood pressure.
Danish: Aprovel var oprindelig genstand for 11 undersøgelser vedrørende dets virkning på blodtrykket.
English: What is the risk associated with Aprovel?
Danish: Hvilken risiko er der forbundet med Aprovel?
English: In this study, Aprovel was compared with placebo and with amlodipine.
Danish: I denne undersøgelse blev Aprovel sammenlignet med placebo og med amlodipin