FrancophonIA/ELRC3.0 huggingface dataset:
English: The concentration of topotecan is higher (3 mg/ml) than with other topotecan products.
Danish: Koncentrationen af topotecan er højere (3 mg/ml) end med andre topotecan-midler.
English: - abnormally low white blood cell count (neutropenia) which may be accompanied with fever and signs of infection (febrile neutropenia) - weight loss and loss of appetite, feeling tired or weak - feeling or being sick, diarrhoea, stomach pain, constipation - inflammation and ulcers of the mouth, throat, tongue or gums (mucositis) - high body temperature (fever) - infections - hair loss.
Danish: - vægttab og tab af appetit, følelse af slaphed eller træthed - kvalme eller opkastning, diarré, mavesmerter, forstoppelse - betændelse og sår i mund, hals, på tunge eller gummer (mucositis)
English: If dose reduction is chosen for patients who experience severe neutropenia (neutrophil count less than 0.5 x 109/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/m2/day for subsequent courses (or subsequently down to 0.45 mg/m2/day if necessary).
Danish: Ved dosisreduktion hos patienter, som oplever alvorlig neutropeni (neutrofiltal < 0,5 x 109/l) i syv dage eller mere, eller alvorlig neutropeni forbundet med feber eller infektion, eller hvis behandling er blevet udskudt på grund af neutropeni, bør dosis reduceres med 20 % til 0,60 mg/m2 /dag i de efterfølgende behandlinger (eller derefter om nødvendigt ned til 0,45 mg/m2 /dag).
English: Topotecan has been shown to cause embryo-foetal lethality and malformations in preclinical studies (see section 5.3).
Danish: Prækliniske forsøg har vist, at topotecan medfører embryo/fosterdødelighed og misdannelser (se pkt.
English: Oral and intravenous topotecan were associated with similar symptom palliation in patients with relapsed sensitive SCLC in patient selfreports on an unblinded symptom scale assessment in each of these two studies.
Danish: I patienternes egne rapporteringer vha. en ublindet vurdering på en symptomskala i begge forsøg var oral og intravenøs topotecan forbundet med samme symptomlindring hos patienter med recidiverende, sensitiv SCLC.
English: − already have severe bone marrow depression prior to starting first course, as evidenced by baseline neutrophils < 1.5 x 109/l and/or a platelet count of < 100 x 109/l.
Danish: Topotecan er kontraindiceret til patienter, som har haft alvorlige overfølsomhedsreaktioner over for det aktive indholdsstof eller over for et lider af alvorlig knoglemarvssuppression allerede inden første serie indledes, defineret som et neutrofiltal på < 1,5 x 109/l og/eller et trombocyttal på < 100 x 109/l ved baseline.
English: Very rare: extravasation3
Danish: Almindelig: sepsis2
English: For reduced dose '1.0 mg/m2'
Danish: For reduceret dosis '1,0 mg/m2'
English: The recommended monotherapy dose of topotecan in patients with small cell lung carcinoma and a creatinine clearance between 20 and 39 ml/min is 0.75 mg/m2/day for five consecutive days.
Danish: Den rekommanderede topotecandosis ved monoterapi hos patienter med ovariekarcinom eller småcellet lungecancer og en kreatinin-clearance mellem 20 og 39 ml/min er
English: The concentration of topotecan in the 5 ml vial is higher (3 mg/ml) than with other topotecan products.
Danish: Koncentrationen af topotecan i 5 ml hætteglasset er højere (3 mg/ml) end med andre topotecan-midler.
English: Fatalities due to neutropenic colitis have been reported in clinical trials with topotecan.
Danish: I kliniske forsøg med topotecan er der set dødsfald på grund af neutropenisk colitis.
English: Instructions for Preparation for Intravenous Administration for Cervical Cancer For recommended dose '0.75 mg/m
Danish: Instruktioner for forberedelse til intravenøs administration for cervixcancer For anbefalet dosis '0,75 mg/m2'
English: - All items for administration or cleaning, including gloves, should be placed in high-risk, waste disposal bags for high-temperature incineration.
Danish: - Alt udstyr brugt til administration eller rengøring, herunder handsker, bør anbringes i en højrisiko
English: Reactions have been mild and have not generally required specific therapy.
Danish: Reaktionerne har været milde og har
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: • Tal med lægen, hvis en bivirkning bliver værre, eller du får bivirkninger, som ikke er nævnt her.
English: Difference in response rate (95 % CI) Median time to progression (weeks)
Danish: Medianoverlevelse (uger) (95 % CI)
English: Instructions for Preparation for Intravenous Administration for Small Cell Lung Cancer For reduced dose '1.25 mg/m
Danish: Instruktioner for forberedelse til intravenøs administration for småcellet lungecancer For reduceret dosis '1,25 mg/m
English: IV
Danish: De
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: Not known: severe bleeding (associated with thrombocytopenia) Respiratory, thoracic and mediastinal disorders Rare: interstitial lung disease (some cases have been fatal)
Danish: Sjælden: interstitiel lungesygdom (nogle tilfælde har været letale)
English: For reduced dose '0.45 mg/m
Danish: For reduceret dosis '0,45 mg/m2'
English: One ml of concentrate for solution for infusion contains 3 mg topotecan (as hydrochloride).
Danish: En ml koncentrat til infusionsvæske, opløsning indeholder 3 mg topotecan (som hydrochlorid).
English: Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion topotecan
Danish: Topotecan Eagle 3 mg/1 ml koncentrat til infusionsvæske, opløsning topotecan
English: Topotecan should not be re-administered unless the neutrophil count is ≥ 1 x 109/l, the platelet count is ≥ 100 x 109/l, and the haemoglobin level is ≥ 9 g/dl (after transfusion if necessary).
Danish: Efterfølgende doser af topotecan bør ikke gives, medmindre neutrofiltallet er  1 x 109/l, trombocyttallet er  100 x 109/l og hæmoglobinniveauet er  9g/dl (om nødvendigt efter transfusion).
English: Small cell lung cancer - The usual dose is 1.5 mg of the medicine for each square meter of your body.
Danish: - Den sædvanlige dosis er 1,5 mg af kroppens overfladeareal pr. dag.
English: The concentration of topotecan in the 1 ml vial is higher (3 mg/ml) than with other topotecan products.
Danish: Koncentrationen af topotecan i 1 ml hætteglas er højere (3 mg/ml) end ved andre topotecan-midler.
English: Hazard ratio (95 % C.I.)
Danish: Risikoforhold (95 % C.I.)
English: For reduced dose '0.60 mg/m
Danish: For reduceret dosis '0,60 mg/m2'
English: Marketing Authorisation Holder Eagle Laboratories Limited The Clock House Station Approach Marlow, Bucks, SL7 1NT United Kingdom
Danish: Indehaver af markedsføringstilladelsen: Eagle Laboratories Limited The Clock House
English: Topotecan should not be re-administered unless the neutrophil count is more than or equal to 1.5 x 109/l, the platelet count is more than or equal to 100 x 109/l, and the haemoglobin level is more than or equal to 9 g/dl (after transfusion if necessary).
Danish: Efterfølgende doser af topotecan bør ikke gives, medmindre neutrofiltallet er  1,5 x 109/l, trombocyttallet er  100 x 109/l og hæmoglobinniveauet er  9 g/dl (om nødvendigt efter transfusion).
English: Instructions for Preparation for Intravenous Administration for Small Cell Lung Cancer For recommended dose '1.5 mg/m2'
Danish: Instruktioner for forberedelse til intravenøs administration for småcellet lungecancer For anbefalet dosis '1,5 mg/m2'
English: This increase is considered unlikely to be of clinical relevance.
Danish: Det er vurderet usandsynligt, at
English: In reproductive toxicity studies with topotecan in rats there was no effect on male or female fertility; however, in females super-ovulation and slightly increased pre-implantation loss were observed.
Danish: I reproduktionstoksiske forsøg af topotecan til rotter sås ingen virkning på fertilitet hos hverken hanner eller hunner.
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion
Danish: Navnet på dette lægemiddel er Topotecan Eagle 15 mg/5 ml koncentrat til infusion, opløsning
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Topotecan Eagle 3 mg/1 ml koncentrat til infusionsvæske, opløsning
English: NAME OF THE MEDICINAL PRODUCT Topotecan Eagle 15 mg/5 ml concentrate for solution for infusion topotecan
Danish: LÆGEMIDLETS NAVN Topotecan Eagle 15 mg/5 ml koncentrat til infusionsvæske, opløsning
English: Haematological toxicity is dose-related and full blood count including platelets should be monitored regularly (see section 4.2).
Danish: Den hæmatologiske toksicitet er dosisafhængig, og det samlede blodbillede - herunder trombocyttal
English: The name of your medicine is Topotecan Eagle 3 mg/1 ml concentrate for solution for infusion (called Topotecan Eagle in this leaflet).
Danish: Navnet på dette lægemiddel er Topotecan Eagle 3 mg/1 ml koncentrat til infusion, opløsning (herefter
English: Initial dose
Danish: For reduceret dosis
English: GENERAL CLASSIFICATION FOR SUPPLY Medicinal product subject to medical prescription.
Danish: Personale skal oplæres i rekonstitution af medikamentet.
English: For reduced dose '1.0 mg/m surface area
Danish: For reduceret dosis '1,0 mg/m
English: The experience in children is limited, therefore no recommendation for treatment of paediatric patients with topotecan can be given (see sections 5.1 and 5.2).
Danish: Topotecan bør ikke anvendes til pædiatriske patienter, da erfaringen med børn er begrænset (se pkt.
English: Combination therapy (Cervical carcinoma)
Danish: Ikke kendt: alvorlig blødning (associeret med trombocytopeni)
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Danish: Der er rapporteret om myelosuppression, der har ført til sepsis, som igen har ført til dødsfald, efter behandling med topotecan
English: For a full list of excipients, see section 6.1.
Danish: Læs om opbevaringsforhold for det fortyndede lægemiddel efter åbning i pkt 6.3.
English: 5 ml 3 mg/ml
Danish: '1,25 mg/m2'
English: Monotherapy (Small cell lung carcinoma)
Danish: Sjælden: interstitiel lungesygdom (nogle tilfælde har været letale) Mave-tarm-kanalen
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma level laboratory testing
Danish: Læger og patienter skal gøres opmærksomme på, at at der findes en ad hocinformationsservice, som rådgiver i forbindelse med laboratorietests af leflunomid i plasma.
English: The Member States shall ensure that the Marketing Authorisation Holder (MAH) provides physicians who are expected to prescribe/use Repso with a physician educational pack containing the following:
Danish: Indehaveren af markedsføringstilladelsen (MAH) skal sikre, at alle læger, som forventes at ordinere/anvende Repso forsynes med informationsmateriale til lægerne, indeholdende følgende:
English: The information provided in the Physician Leaflet should provide information on dose reduction, discontinuation and wash out procedures in the event of raised ALT.
Danish: Informationen i folderen bør oplyse om reduktion af dosis, afbrydelse af behandling samt udvaskningsprocedure.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate)
Danish: • Information om den identificerede risiko for synergistisk hepato- eller hæmatotoksicitet forbundet med kombinationsbehandling med andre DMARDs (Disease-Modifying Antirheumatic Drugs) (f.eks. methotrexat).
English: Subsequent injections should be given in different areas.
Danish: Efterfølgende injektioner bør gives i andre områder.
English: • inactivated polioviruses;
Danish: • inaktiverede poliovirusser
English: The choice of booster vaccine depends on official recommendations.
Danish: Valget af boostervaccine afhænger af de officielle anbefalinger.
English: This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Danish: Det betyder, at de aktive stoffer er bundet til aluminiumholdige forbindelser for at fremkalde et bedre respons.
English: This helps to protect against the diseases that these bacteria and viruses cause.
Danish: Dette medvirker til at beskytte mod de sygdomme, som bakterierne og virusserne forårsager.
English: The full EPAR for Infanrix hexa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Infanrix hexa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • parts of the hepatitis B virus;
Danish: • dele af hepatitis B-virus
English: The European Commission granted a marketing authorisation valid throughout the EU for Infanrix hexa on 23 October 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Infanrix hexa den 23. oktober 2000.
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) to defend the body against the infections.
Danish: Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod infektionerne.
English: The main measure of effectiveness was the production of protective antibodies.
Danish: Det primære mål for virkning var dannelsen af beskyttende antistoffer.
English: This is a summary of the European public assessment report (EPAR) for Infanrix hexa.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Infanrix hexa.
English: Infanrix hexa has been studied in nine studies, involving a total of almost 5,000 children aged between 6 weeks and 2 years.
Danish: Infanrix hexa blev undersøgt i ni undersøgelser af næsten 5 000 børn i alderen seks uger til to år.
English: Infanrix hexa contains the following active substances:
Danish: Infanrix hexa indeholder følgende aktive stoffer:
English: The immune system will then be able to produce antibodies more quickly when the person comes into contact with the bacteria or viruses.
Danish: Derefter vil immunsystemet fremover langt hurtigere kunne danne antistoffer, når personen næste gang kommer i kontakt med disse bakterier eller virusser.
English: • polysaccharides (sugars) from Haemophilus influenzae type b.
Danish: • polysakkarider (sukkerstoffer) fra Haemophilus influenzae type b.
English: Over 3,000 of the children received a course of vaccination with Infanrix hexa.
Danish: Over 3 000 af børnene fik et vaccinationsforløb med Infanrix hexa.
English: When a child is given the vaccine, the immune system recognises the parts of the bacteria and viruses in the vaccine as ‘foreign' and makes antibodies against them.
Danish: Når et barn bliver vaccineret, opfatter immunsystemet bakteriedelene og virusserne i vaccinen som "fremmede" og danner antistoffer mod dem.
English: What measures are being taken to ensure the safe and effective use of Infanrix hexa?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Infanrix hexa?
English: The European Medicines Agency therefore decided that Infanrix hexa's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Infanrix hexa opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Infanrix hexa.
English: • parts of Bordetella pertussis (B. pertussis, a bacterium that causes whooping cough);
Danish: • dele af Bordetella pertussis (B. pertussis, en bakterie, der forårsager kighoste)
English: • toxoids (chemically weakened toxins) from diphtheria and tetanus;
Danish: • toxoider (kemisk svækkede toksiner) fra difteri og stivkrampe
English: The most common side effects with Infanrix hexa (seen in more than 1 in 10 doses of the vaccine) are swelling, pain and redness at the injection site, loss of appetite, fever of 38ºC or more, tiredness, abnormal crying, irritability and restlessness.
Danish: De hyppigste bivirkninger ved Infanrix hexa (set ved flere end én ud af 10 doser vaccine) er hævelse, ømhed og rødme omkring injektionsstedet, appetitløshed, feber på 38 ºC eller derover, træthed, unormal gråd, irritabilitet og rastløshed.
English: An additional five studies looked at the effects of a booster vaccination with Infanrix hexa.
Danish: Yderligere fem undersøgelser så på virkningen af en boostervaccination med Infanrix hexa.
English: A booster dose of Infanrix hexa or a similar vaccine must be given at least 6 months after the last dose of the initial course.
Danish: En boosterdosis af Infanrix hexa eller en tilsvarende vaccine skal gives mindst seks måneder efter den sidste dosis i det første vaccinationsforløb.
English: Infanrix hexa must not be used in infants who have had encephalopathy (brain disease) of unknown cause within 7 days of receiving a pertussis vaccine.
Danish: Infanrix hexa må ikke gives til børn, som tidligere har haft encephalopati (en hjernesygdom) af ukendt årsag inden for syv dage efter at have modtaget en vaccine mod kighoste.
English: Infanrix hexa is a vaccine that protects against a range of infections.
Danish: Infanrix hexa er en vaccine, der beskytter mod en række infektioner.
English: For more information about treatment with Infanrix hexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Infanrix hexa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Infanrix hexa is given by deep injection into a muscle.
Danish: Infanrix hexa gives som en dyb injektion i en muskel.
English: The vaccination schedule for Infanrix hexa is a course of 2 or 3 doses, given at least 1 month apart, according to official recommendations, usually in the first 6 months of life.
Danish: Vaccinationsprogrammet for Infanrix hexa er et forløb på to til tre doser, der gives med mindst én måneds mellemrum i henhold til officielle anbefalinger (typisk i løbet af de første seks måneder efter fødslen).
English: What is Infanrix hexa and what is it used for?
Danish: Hvad er Infanrix hexa, og hvad anvendes det til?
English: Why is Infanrix hexa approved?
Danish: Hvorfor blev Infanrix hexa godkendt?
English: The safety of Infanrix hexa is similar to other vaccines used to prevent these conditions.
Danish: Sikkerheden ved Infanrix hexa er den samme som ved andre vacciner, der anvendes til at forebygge disse sygdomme.
English: Infanrix hexa must not be used in infants who are hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics) and formaldehyde.
Danish: Infanrix hexa må ikke gives til børn, der er overfølsomme (allergiske) over for nogle af de aktive stoffer, over for nogle af de øvrige indholdsstoffer i vaccinen eller over for neomycin, polymyxin (antibiotika) og formaldehyd.
English: These studies showed that booster vaccinations with Infanrix hexa were as effective as giving separate vaccines containing the same active substances 1 month after the booster vaccination.
Danish: Disse undersøgelser viste, at boostervaccinationer med Infanrix hexa var lige så effektive som separate vacciner, der indeholdt de samme aktive stoffer, en måned efter boostervaccinationen.
English: Infanrix hexa should be postponed in infants with a severe sudden fever.
Danish: Vaccination med Infanrix hexa bør udskydes hos børn, der får pludselig høj feber.
English: It is not intended to provide practical advice on how to use Infanrix hexa.
Danish: Det er ikke en praktisk vejledning i, hvordan Infanrix hexa bør anvendes.
English: Overall, between 95 and 100% of the children had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, 1 month after the vaccination course.
Danish: I alt havde mellem 95 og 100 % af børnene antistoffer mod difteri, stivkrampe, kighoste, hepatitis B-virus, poliovirusser og Hib én måned efter vaccinationsforløbet.
English: Infanrix hexa diphtheria (D), tetanus (T), pertussis (acellular, component) (PA), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)
Danish: Infanrix hexa difteri (D)-, stivkrampe (T)-, kighoste (acellulær, komponent) (PA)-, hepatitis B (rDNA) (HBV)-, poliomyelitis (inaktiveret) (IPV)- og Haemophilus influenzae type b (Hib)-vaccine, konjugeret (adsorberet)
English: The effects of Infanrix hexa were compared with those of separate vaccines containing the same active substances.
Danish: Virkningen af Infanrix hexa blev sammenlignet med separate vacciner, der indeholdt de samme aktive stoffer.
English: For practical information about using Infanrix hexa, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Infanrix hexa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: What is the risk associated with Infanrix hexa?
Danish: Hvilken risiko er der forbundet med Infanrix hexa?
English: For the full list of side effects reported with Infanrix hexa, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Infanrix hexa fremgår af indlægssedlen.
English: It must not be used in infants who have had an allergic reaction to a vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib.
Danish: Det må ikke gives til børn, som tidligere har haft en allergisk reaktion på en vaccine indeholdende difteri, stivkrampe, kighoste, hepatitis B, polio eller Hib.
English: Results of the studies taken together showed that a course of injections with Infanrix hexa was as effective at producing protective levels of antibodies as giving separate vaccines containing the same active substances.
Danish: Resultaterne af undersøgelserne viste, at det første injektionsforløb med Infanrix hexa var lige så effektivt til at danne beskyttende antistoffer som separate vacciner, der indeholdt de samme aktive stoffer.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Infanrix hexa 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 Infanrix hexa.
English: Infanrix hexa is a vaccine used to protect babies and toddlers against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases such as bacterial meningitis caused by the bacterium Haemophilus influenzae type b (Hib).
Danish: Infanrix hexa er en vaccine, der anvendes til at beskytte babyer og spædbørn mod difteri, stivkrampe, kighoste, hepatitis B, polio og sygdomme som f.eks. bakteriel meningitis forårsaget af bakterien Haemophilus influenzae type b (Hib).
English: Other information about Infanrix hexa:
Danish: Andre oplysninger om Infanrix hexa
English: Infanrix hexa has been shown to be effective at producing protective levels of antibodies against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib.
Danish: Det er påvist, at Infanrix hexa er effektivt til at danne beskyttende antistoffer mod difteri, stivkrampe, kighoste, hepatitis B-virus, poliovirusser og Hib.
English: How is Infanrix hexa used?
Danish: Hvordan anvendes Infanrix hexa?
English: Infanrix hexa is available as a powder and suspension that are made up into a suspension for injection.
Danish: Infanrix hexa fås som et pulver og en suspension, der blandes til en væske, som injiceres.