FrancophonIA/ELRC3.0 huggingface dataset:
English: Subsequent doses: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 10
Danish: Efterfølgende doser: Topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1 x 10
English: The elimination of topotecan has only been partly investigated in man. A major route of clearance of topotecan was by hydrolysis of the lactone ring to form the ring-opened carboxylate.
Danish: Hydrolyse af laktonringen med dannelse af et ringåbnet carboxylat er en vigtig udskillelsesvej for topotecan.
English: • Feeling sick (nausea), being sick (vomiting); diarrhoea; stomach pain; constipation.
Danish: • Kvalme, opkastning, diarre, mavesmerter, forstoppelse.
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion topotecan
Danish: Topotecan Hospira 4 mg/4 ml koncentrat til infusion, opløsning topotecan
English: Mucosal inflammation
Danish: Nedsat nyrefunktion
English: Each 4 ml vial of concentrate contains 4 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas med 4 ml koncentrat indeholder 4 mg topotecan (som hydrochlorid)
English: ≥ 100 x 10 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Danish: trombocyttallet ≥ 100 x 10 9/l og hæmoglobinniveauet ≥ 9 g/dl (om nødvendigt efter transfusion).
English: 9/l and a haemoglobin level of ≥ 9g/dl (after transfusion if necessary).
Danish: 9/l og et hæmoglobinniveau på ≥ 9g/dl (om nødvendigt efter transfusion).
English: • High body temperature (fever).
Danish: • Kløende udslæt (eller nældefeber)
English: 9/l) for seven days or more or severe neutropenia associated with fever or infection, or who have had treatment delayed due to neutropenia, the dose should be reduced by 20% to 0.60 mg/m 2/day for subsequent courses (or subsequently down to 0.45 mg/m 2/day if necessary).
Danish: I de følgende serier bør dosis reduceres med 20 % til 0,60 mg/m 2/dag (eller derefter om nødvendigt ned til 0,45 mg/m2 /dag) hos patienter, som får svær neutropeni (neutrofiltal < 0,5 x 10
English: Plasma clearance in patients with renal impairment (creatinine clearance 41-60 ml/min.)
Danish: Plasmaclearance hos patienter med nedsat nyrefunktion (creatininclearance mellem 41 og 60 ml/min) faldt til ca. 67 %, sammenlignet med kontrolgruppen.
English: When treating cervical cancer, Topotecan Hospira is combined with another medicine, called cisplatin.
Danish: Ved behandling af livmoderhalskræft gives Topotecan Hospira sammen med et andet lægemiddel,
English: Topotecan Hospira 4 mg/4 ml concentrate for solution for infusion
Danish: Topotecan Hospira 4 mg/4 ml koncentrat til infusionsvæske, opløsning
English: 9/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Danish: 9/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
English: 9/l, a platelet count of ≥ 100 x 10 9/l and a haemoglobin level of ≥ 9 g/dl (after transfusion if necessary).
Danish: 9/l, trombocyttallet er ≥ 100 x 9/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
English: Subsequent doses: Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 10
Danish: Efterfølgende doser: Topotecan bør ikke gives igen, medmindre neutrofiltallet er ≥ 1,5 x 10
English: There is insufficient experience with the use of topotecan in patients with severely impaired renal function (creatinine clearance <20 ml/min).
Danish: Monoterapi ((ovariekarcinom og småcellet lungecancer) Der findes ikke tilstrækkeligt med data til at anbefale behandling af patienter med en creatininclearance på < 20 ml/min.
English: A doctor or a nurse will give you the medicine as an infusion into a vein in hospital.
Danish: Topotecan Hospira hjælper med at ødelægge tumorer.Medicinen gives som intravenøs infusion i en vene, på hospitalet af en læge eller en sygeplejerske.
English: Topotecan Hospira helps to destroy tumours.
Danish: Topotecan kan medføre træthed.
English: Initial dose The recommended dose of topotecan is 1.5 mg/m2 body surface area perday administered by intravenous infusion over 30 minutes daily for five consecutive days with a three-week interval between the start of each course.
Danish: Dosis gives som en 30 minutters intravenøs infusion hver dag fem dage i træk med et interval på tre uger mellem begyndelsen af hver behandling.
English: • Itching sensation.
Danish: • En kløende fornemmels.e
English: What is in this leaflet:
Danish: Symptomer inkluderer:
English: Tell your doctor if you are taking, have recently taken, or might take any other medicines, including any herbal products or medicines obtained without a prescription.
Danish: - Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1.5 x 10
Danish: Efterfølgende doser Der bør ikke gives topotecan igen, medmindre neutrofiltallet er ≥ 1,5 x 10
English: When topotecan (0.75 mg/m2/day for 5 consecutive days) and cisplatin (60 mg/m2/day on day 1) were administered in 13 patients with ovarian cancer, a slight increase in AUC (12%, n=9) and Cmax (23%, n=11) was noted on day 5.
Danish: Der blev set en lille stigning i AUC (12 %, n=9) og i Cmax (23 %, n=11) på dag 5.
English: Reports of significant sequelae associated with thrombocytopenia including fatalities due to tumour bleeds, have been infrequent.
Danish: Der blev sjældent rapporteret om signifikante senfølger af trombocytopeni inkl.
English: After 10 years, the marketing authori renewed for a further five years.
Danish: Efter ti år blev markedsføringstilladelsen fornyet for yderligere fem år.
English: This document is a summary of the European Public Assessment Report (EPAR) for Avandia.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Avandia.
English: EMEA/H/C/268
Danish: EMA/230001/2010 EMEA/H/C/268
English: Other information about Avandia:
Danish: Andre oplysninger om Avandia:
English: Avandia is a medicine that contains the active substance rosiglitazone.
Danish: Avandia er et lægemiddel, der indeholder det aktive stof rosiglitazon.
English: For more information about treatment with Avandia, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Avandia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Avandia taken alone was more effective than placebo in reducing HbA1c.
Danish: Avandia taget alene var betydeligt bedre end placebo til at reducere HbA1c.
English: The recommended starting dose of Avandia is 4 mg per day, given as a single do doses.
Danish: Den anbefalede startdosis for Avandia er 4 mg pr. dag, givet som en enkeltdosis eller som to doser a 2 mg.
English: The doses of Avandia may need to be adjusted when given with certain other medicines such as gemfibrozil or rifampicin.
Danish: Det kan være nødvendigt at justere Avandia-doserne, når Avandia gives sammen med visse andre lægemidler såsom gemfibrozil eller rifampicin.
English: The full EPAR for Avandia can be found here
Danish: Den fuldstændige EPAR for Avandia findes her.
English: It explains e 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 able as tablets (pink:
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 Avandia.
English: What is the risk associated with Avandia?
Danish: Hvilken risiko er der forbundet med Avandia?
English: orange: 4 mg; red-brown: 8 mg).
Danish: Det fås som tabletter (lyserøde: 2 mg, orange: 4 mg, rødbrune: 8 mg).
English: For the full list of all side effects reported with Avandia, see the Package Leaflet.
Danish: Den fuldstændige liste over alle de indberettede bivirkninger ved Avandia fremgår af indlægssedlen.
English: The active substance in (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Danish: Det aktive stof i Avandia, rosiglitazon, gør cellerne (fedt, muskel og lever) mere følsomme over for insulin, hvilket betyder, at kroppen bedre udnytter den insulin, den selv producerer.
English: It must not be used in patients who have heart failure, problems with their liver, an ‘acute coronary syndrome' such as unstable angina (a severe type of chest pain that changes in intensity) or certain types of heart attack, or complications of diabetes (diabetic ketoacidosis or diabetic precoma).
Danish: Det må ikke anvendes til patienter med hjerteinsufficiens, leverproblemer, akut koronarsyndrom såsom ustabil angina (en svær form for brystsmerter, der varierer i intensitet), visse typer af hjertetilfælde eller diabeteskomplikationer (diabetisk ketoacidose eller diabetisk prækoma).
English: Avandia should not be used in people who may be hypersensitive (allergic) to rosiglitazone or any of the other ingredients.
Danish: Avandia bør ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for rosiglitazon eller andre af indholdsstofferne.
English: Com antidiabetes medicines led to further decreases in the level of HbA1c, ind levels had been further reduced.
Danish: Kombinationen med andre lægemidler mod diabetes førte til yderligere fald i niveauet af HbA1c, hvilket viste, at blodsukkerniveauerne var blevet yderligere reduceret.
English: Why has Avandia been approved?
Danish: Hvorfor blev Avandia godkendt?
English: The most common side effects with Avandia (low red blood cell counts) and oedema (swelling), as well as hypercholesterolaemi cholesterol levels), hypertriglyceridaemia (high blood levels of triglycerides, a type o hyperlipaemia (high blood fat levels), weight increase, increased appetite, cardia oxygen supply to the heart muscle), constipation, bone fractures (broken bon (low blood glu side effects may occur.
Danish: De hyppigste bivirkninger ved Avandia (som ses hos mellem 1 og 10 patienter ud af 100) er anæmi (lavt antal røde blodlegemer) og ødemer (hævelser) samt hypercholesterolæmi (højt blodkolesterol), hypertriglyceridæmi (forhøjet indhold af triglycerider i blodet, en bestemt type fedtstoffer), hyperlipæmi (øget fedtindhold i blodet), vægtøgning, øget appetit, hjerteiskæmi (nedsat ilttilførsel til hjertemusklen), forstoppelse, knoglefrakturer (knoglebrud) og hypoglykæmi (lavt blodsukkerniveau).
English: The studi a substance in the blood called glycosylated haemoglobin (HbA1c), which gives well the blood glucose is c
Danish: I undersøgelserne måltes niveauet i blodet af et stof kaldet glykosyleret hæmoglobin (HbA1c), som viser, hvor godt blodglukosen er reguleret.
English: Avandia to SmithKline Beecham Ltd. on 11 July 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Avandia til SmithKline Beecham Ltd. den 11. juli 2000.
English: Doctors should monitor patients for fluid retention as failure (an inability of the heart to pump enough blood aro
Danish: Læger bør overvåge patienterne for væskeansamlinger, da sådanne kan føre til hjerteinsufficiens (når hjertet ikke er i stand til at pumpe tilstrækkeligt blod rundt i kroppen).
English: Avandia can also be used with both metformin and a sulphonylurea in patients who are not satisfactorily controlled despite dual therapy by mouth (‘triple therapy').
Danish: Avandia kan desuden anvendes sammen med både metformin og et sulfonylurinstof hos patienter, som ikke er tilfredsstillende kontrolleret på trods af oral ”dobbeltbehandling” (”tredobbelt behandling”).
English: mary for the public
Danish: EPAR - sammendrag for offentligheden
English: Avandia is used in adults who have type 2 diabetes, particularly those wh addition to diet and exercise.
Danish: Avandia anvendes til voksne med type 2-diabetes, navnlig overvægtige patienter.
English: vandia's benefits are greater than its risks and recommended that it be given
Danish: CHMP besluttede, at fordelene ved Avandia er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for Avandia.
English: Avandia can also be used in combination with metformin in patients who are not satisfactorily controlled on metformin alone, or with a sulphonylurea (another type of antidiabetes medicine) when metformin is not suitable (‘dual therapy').
Danish: Avandia kan også anvendes i kombination med metformin til patienter, som ikke er tilfredsstillende kontrolleret på metformin alene, eller sammen med et sulfonylurinstof (en anden type lægemiddel mod diabetes), hvor metformin ikke er egnet (”dobbeltbehandling”).
English: What is Avandia?
Danish: Hvad er Avandia?
English: This dose may need to be increased to 8 mg per day after eight weeks if better bl sulphonylurea, due to the r
Danish: Denne dosis skal muligvis øges til 8 mg pr. dag efter otte uger, hvis der er behov for bedre blodsukkerregulering, men det bør anvendes med forsigtighed hos patienter, der også tager et sulfonylurinstof på grund af risikoen for væskeansamling.
English: It has also been studied in metformin, a sulphonylurea, or both metformin and a sulphonylurea.
Danish: Det er også blevet undersøgt hos patienter, som allerede anvendte metformin, et sulfonylurinstof eller både metformin og et sulfonylurinstof.
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin t glucose in the blood or when the
Danish: Type 2-diabetes er en sygdom, som opstår, når bugspytkirtlen enten ikke danner tilstrækkeligt insulin til at regulere blodsukkeret, eller når kroppen ikke er i stand til at udnytte insulinet effektivt.
English: Avandia, rosiglitazone, makes cells and this helps to control type 2 diabetes.
Danish: Derved reduceres blodsukkeret, og dette hjælper med til at kontrollere type 2-diabetes.
English: If Avandia is used in combination with other antidiabetes medicines, other this can lead to heart und the body).
Danish: Hvis Avandia anvendes i kombination med andre lægemidler mod diabetes, kan der opstå andre bivirkninger.
English: How has Avandia been studied?
Danish: Hvordan blev Avandia undersøgt?
English: What is Avandia used for?
Danish: Hvad anvendes Avandia til?
English: How is Avandia used?
Danish: Hvordan anvendes Avandia?
English: How does Avandia work?
Danish: Hvordan virker Avandia?
English: Avandia
Danish: Avandia rosiglitazon
English: It is used in hom metformin (another antidiabetes medicine) is not suitable.
Danish: Avandia anvendes alene til patienter, hos hvem metformin (et andet lægemiddel mod diabetes) ikke er egnet
English: Avandia, used on its own, has been compared with placebo (a dummy treatment), metformin and patients who were already using es measured the level of an indication of how ontrolled.
Danish: Avandia anvendt alene er blevet sammenlignet med placebo (en uvirksom behandling), metformin og glibenklamid (et sulfonylurinstof).
English: What benefit has Avandia shown
Danish: Hvilken fordel viser undersøgelserne, at der er ved Avandia?
English: It is available as white tablets (75, 150 and 300 mg).
Danish: Det fås som hvide tabletter (75, 150 og 300 mg).
English: Other information about Irbesartan Teva:
Danish: Andre oplysninger om Irbesartan Teva:
English: The usual recommended dose is 150 mg once a day.
Danish: Den normalt anbefalede dosis er 150 mg en gang dagligt.
English: Irbesartan Teva is not recommended for use in patients below 18 years of age, because of a lack of information on safety and effectiveness in this age group.
Danish: Irbesartan Teva anbefales ikke til patienter under 18 år på grund af manglende data om sikkerhed og virkning i denne aldersgruppe.
English: This means that Irbesartan Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Aprovel.
Danish: Det betyder, at Irbesartan Teva er identisk med et ‘referencelægemiddel', som allerede er godkendt i Den Europæiske Union (EU), og som hedder Aprovel.
English: Therefore, the CHMP's view was that, as for Aprovel, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Aprovel.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Irbesartan Teva to Teva Pharma B.V. on 30 October 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Irbesartan Teva til Teva Pharma B.V.
English: The active substance in Irbesartan Teva, irbesartan, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Danish: Det aktive stof i Irbesartan Teva, irbesartan, er en ”angiotensin II-receptorantagonist”, hvilket betyder, at den blokerer virkningen af et hormon i kroppen kaldet angiotensin II.
English: Irbesartan Teva is a medicine that contains the active substance irbesartan.
Danish: Irbesartan Teva er et lægemiddel, der indeholder det aktive stof irbesartan.
English: What are the benefit and risk of Irbesartan Teva?
Danish: Hvilken fordel og risiko er der forbundet med Irbesartan Teva?
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Irbesartan Teva has been shown to have comparable quality and to be bioequivalent to Aprovel.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Irbesartan Teva i overensstemmelse med EU-kravene har vist sig at være af sammenlignelig kvalitet og at være bioækvivalent med Aprovel.
English: The full EPAR for Irbesartan Teva can be found here.
Danish: Den fuldstændige EPAR for Irbesartan Teva findes her.
English: Irbesartan Teva is also used to treat kidney disease in patients with hypertension and type 2 diabetes (non-insulin-dependent diabetes).
Danish: Irbesartan Teva anvendes desuden til behandling af nyresygdom hos patienter med hypertension og type 2-diabetes (ikke-insulinafhængig diabetes).
English: Irbesartan Teva is taken by mouth, with or without food.
Danish: Irbesartan Teva indtages gennem munden enten ved et måltid eller mellem måltiderne.
English: Irbesartan Teva is a ‘generic medicine'.
Danish: Irbesartan Teva er et ‘generisk lægemiddel'.
English: What is Irbesartan Teva?
Danish: Hvad er Irbesartan Teva?
English: Irbesartan Teva is used in patients who have essential hypertension (high blood pressure).
Danish: Irbesartan Teva anvendes til patienter med essentiel hypertension (forhøjet blodtryk).
English: The Committee recommended that Irbesartan Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Irbesartan Teva.
English: Because Irbesartan Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Aprovel.
Danish: Da Irbesartan Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Aprovel.
English: Why has Irbesartan Teva been approved?
Danish: Hvorfor blev Irbesartan Teva godkendt?
English: Because Irbesartan Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Danish: Da Irbesartan Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: In patients with hypertension and type 2 diabetes, Irbesartan Teva is added to other treatments for hypertension.
Danish: Hos patienter med forhøjet blodtryk og type 2-diabetes gives Irbesartan Teva som supplement til andre lægemidler mod forhøjet blodtryk.
English: How has Irbesartan Teva been studied?
Danish: Hvordan blev Irbesartan Teva undersøgt?
English: How is Irbesartan Teva used?
Danish: Hvordan anvendes Irbesartan Teva?
English: What is Irbesartan Teva used for?
Danish: Hvad anvendes Irbesartan Teva til?
English: How does Irbesartan Teva work?
Danish: Hvordan virker Irbesartan Teva?
English: This summary was last updated in 06-2012.
Danish: Dette sammendrag blev sidst ajourført i 06-2012.
English: It can be taken at any time of day.
Danish: Tabletten kan tages på alle tidspunkter af dagen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fablyn on 24 February 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fablyn den 24. februar 2009.
English: The full EPAR for Fablyn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Fablyn findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The recommended dose of Fablyn is one tablet once a day.
Danish: Den anbefalede dosis af Fablyn er en tablet én gang dagligt.
English: This is a summary of the European public assessment report (EPAR) for Fablyn.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fablyn.
English: The effects of Fablyn were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Fablyn blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: Fablyn lasofoxifene
Danish: Fablyn lasofoxifen
English: Over five years, 6% of the women taking Fablyn 500 micrograms had a new spine fracture (155 out of 2,748), compared with 9% of those taking placebo (255 out of 2,744).
Danish: I løbet af fem år fik 6 % af de kvinder, som fik Fablyn 500 mikrogram, et nyt rygsøjlebrud (155 ud af 2 748) sammenlignet med 9 % af dem, der fik placebo (255 ud af 2 744).
English: Fablyn was more effective than placebo at reducing the number of new fractures.
Danish: Fablyn var mere effektivt end placebo til at mindske antallet af nye brud.
English: It must not be used in women with unexplained bleeding from the womb.
Danish: Det må ikke anvendes til kvinder med uforklarlige blødninger fra livmoderen.
English: Also, results with the 250-microgram dose were pointing to 500 micrograms being more effective.
Danish: Desuden pegede resultaterne ved anvendelse af en dosis på 250 mikrogram på, at en dosis på 500 mikrogram var mere effektiv.
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 Fablyn.
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 Fablyn.
English: Fablyn did not reduce the number of hip fractures to a level that would be relevant for patients.
Danish: Fablyn reducerede ikke antallet af hoftebrud til et niveau, som kunne være af relevans for patienterne.
English: Other information about Fablyn
Danish: Andre oplysninger om Fablyn
English: The CHMP decided that Fablyn's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Fablyn opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: For more information about treatment with Fablyn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fablyn, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The study also looked at existing spine fractures that got worse, new fractures in other parts of the body and the density of bones throughout the body.
Danish: I undersøgelsen så man også på eksisterende rygsøjlebrud, som blev værre, nye brud i andre dele af kroppen og knogletætheden i hele kroppen.