FrancophonIA/ELRC3.0 huggingface dataset:
English: Relapsed ovarian cancer
Danish: Relapserende ovariecancer
English: There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Danish: Der er ikke tilstrækkelig erfaring i brugen af topotecan til patienter med svært nedsat nyrefunktion (kreatininclearance < 20 ml/min) eller svært nedsat leverfunktion (serumbilirubin ≥ 10 mg/dl) på grund af cirrose.
English: hypersensitivity reaction including rash
Danish: overfølsomhedsreaktion herunder udslæt
English: Difference in response rate (95 % CI)
Danish: Forskel i responserate (95 % CI)
English: Potactasol is supplied in type I colourless glass vials with grey bromobutylic stopper and aluminium seals with plastic flip-off caps.
Danish: Potactasol leveres i type I farveløst hætteglas, type I, med grå brombutylprop og aluminiumsforsegling med plastik flip-off låg.
English: - The other ingredients are: mannitol (E421), tartaric acid (E334), hydrochloric acid (E507) and sodium hydroxide (see section 2).
Danish: Øvrige indholdsstoffer: mannitol (E421), vinsyre (E334), saltsyre (E507) og natriumhydroxid (se punkt 2).
English: Further dilution of the appropriate volume of the reconstituted solution with either sodium chloride 9 mg/ml (0.9 %) or 5 % w/v glucose is required to give a final concentration of between 25 and 50 microgram/ml.
Danish: Yderligere fortynding af den rekonstituerede opløsning med enten natriumchlorid 9 mg/ml (0,9 %) eller 5 % w/v glucose, er påkrævet for at opnå en endelig koncentration på mellem 25 og 50 mikrogram/ml.
English: Each vial contains 0.52 mg (0.0225 mmol) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 0,52 mg natrium (0,0225 mmol).
English: Each vial contains 2.07 mg (0.09 mmol) sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 2,07 mg natrium (0,09 mmol).
English: The clear concentrate is pale yellow in colour and provides 1 mg per ml of topotecan.
Danish: Det klare koncentrat, hvis farve er lys gul, giver 1 mg topotecan pr. ml.
English: Potactasol is not recommended in case of severe liver impairment; - if you suffer from lung inflammation with signs such as cough, fever and difficulties in breathing, see also section 4 “Possible side effects”.
Danish: hvis du har en lungebetændelse med tegn som hoste, feber og vejrtrækningsproblemer, se også punkt 4 ”Bivirkninger”.
English: Myelosuppression leading to sepsis and fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.8).
Danish: 1 Dødsfald på grund af sepsis er rapporteret for patienter i behandling med topotecan (se pkt.
English: nausea, vomiting and diarrhoea (all of which may be severe) constipation abdominal pain2
Danish: Meget almindelig: kvalme, opkastning og diarré (alle muligvis alvorlige) forstoppelse mavesmerter2 mucositis
English: Patients with prior cisplatin chemoradiotherapy Cisplatin
Danish: Patienter med forudgående cisplatin kemo/stråleterapi cisplatin topotecan/cisplatin
English: n = 18), adolescents (aged 12 up to 16 years, n = 9) and young adults (aged 16 to 21 years, n = 9) with refractory solid tumours.
Danish: Et studie med et doseringsinterval på 1,4 til 2,4 mg/m2/dag til børn (fra 2 år og op til 12 år; n = 18), til unge (fra 12 år op til 16 år; n = 9) og yngre voksne (fra 16 år op til 21 år; n = 9) med refraktære solide tumorer.
English: Potactasol 4 mg powder for concentrate for solution for infusion Type I colourless glass vial (8 ml), with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 4 mg topotecan.
Danish: Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning Type I farveløst hætteglas (8 ml) med grå brombutylprop og aluminiumsforsegling med plastik flip-off låg indeholdende 4 mg topotecan.
English: Very rare side effects (may affect up to 1 in 10,000 people)
Danish: Meget sjældne bivirkninger (kan ske hos 1 ud af 10.000personer):
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C in normal light conditions, and for 24 hours at 2°C to 8°C when protected from light.
Danish: Den fysiske og kemiske stabilitet af koncentratet er påvist i 24 timer ved 25 ± 2° C, under normale lysforhold, og i 24 timer ved 2 til 8° C når det er beskyttet mod lys.
English: Potactasol 1 mg powder for concentrate for solution for infusion Type I colourless glass vial (5 ml) with grey bromobutylic stopper and aluminium seal with plastic flip-off cap containing 1 mg topotecan.
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Type I farveløst hætteglas (5 ml) med grå brombutylprop og aluminiumsforsegling med plastik flip-off låg indeholdende 1 mg topotecan.
English: Potactasol 1 mg powder for concentrate for solution for infusion Each vial contains 1 mg topotecan (as hydrochloride).
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid).
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 1 mg vials must be reconstituted with 1.1 ml water for injections.
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Indholdet af Potactasol 1 mg hætteglas skal rekonstitueres med 1,1 ml vand til injektionsvæsker.
English: Rare side effects (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (kan ske hos 1 ud af 1.000personer):
English: Potactasol 4 mg powder for concentrate for solution for infusion Each vial contains 4 mg topotecan (as hydrochloride).
Danish: Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 4 mg topotecan (som hydrochlorid).
English: Potactasol is not recommended in case of severe kidney impairment; - if you have liver problems.
Danish: Potactasol frarådes i tilfælde af alvorlig nedsat leverfunktion.
English: Fatalities due to neutropenic colitis have been reported in clinical studies with topotecan.
Danish: I kliniske studier med topotecan har man set dødsfald på grund af neutropenisk colitis.
English: - Severe hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding (see section 4.6) - 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: − Før den første behandling indledes, alvorlig knoglemarvssuppression, defineret som et baseline neutrofiltal på < 1,5 x 109/l og/eller et trombocyttal på ≤ 100 x 109/l.
English: Potactasol is available in cartons containing 1 vial.
Danish: Potactasol fås i pakninger med 1 hætteglas
English: Chemical and physical stability of the concentrate has been demonstrated for 24 hours at 25 ± 2°C, in normal light conditions and 24 hours at 2°C to 8°C, protected from light.
Danish: Koncentratets fysiske og kemiske stabilitet er påvist i 24 timer ved 25 ± 2° C under normale lysforhold og 24 timer ved 2 til 8° C beskyttet mod lys.
English: Potactasol 4 mg powder for concentrate for solution for infusion Potactasol 4 mg vials must be reconstituted with 4 ml water for injections.
Danish: Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning Indholdet af Potactasol 4 mg hætteglas skal rekonstitueres med 4 ml vand til injektionsvæsker.
English: interstitial lung disease (some cases have been fatal) Gastrointestinal disorders Very common:
Danish: interstitiel lungesygdom (nogle tilfælde har været letale)
English: Vials contain either 1 mg or 4 mg of topotecan.
Danish: Hvert hætteglas indeholder 1 mg eller 4 mg topotecan.
English: - Lung inflammation (rare; may affect up to 1 in 1,000 people), with signs such as: - difficulty breathing - cough - fever The risk of developing this severe condition (interstitial lung disease) is higher if you currently have lung problems, or if you have received previous radiation treatment or medicines that affected your lungs, see also section 2 “Warnings and precautions”.
Danish: Risikoen for at udvikle denne forværrede tilstand (interstitiel lungesygdom) er højere, hvis du har en eksisterende lungesygdom, eller hvis du tidligere har fået strålebehandling eller medicin, der påvirkede dine lunger.
English: Common side effects (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (kan ske hos 1 ud af 10 personer):
English: Each vial contains 4 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 4 mg topotecan (som hydrochlorid).
English: Each vial contains 1 mg topotecan (as hydrochloride).
Danish: Hvert hætteglas indeholder 1 mg topotecan (som hydrochlorid).
English: gastrointestinal perforation Hepatobiliary disorders Common:
Danish: Gastrointestinal perforation
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Potactasol, skal du henvende dig til den lokale repræsentant:
English: 1 ml of 1 mg/ml topotecan solution Add 39 ml to give 40 ml
Danish: Tilsat 39 ml giver 40 ml
English: How to use Potactasol
Danish: Sådan bruges Potactasol
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning
English: 1 Fatalities due to sepsis have been reported in patients treated with topotecan (see section 4.4) 2 Neutropenic colitis, including fatal neutropenic colitis, has been reported to occur as a complication of topotecan-induced neutropenia (see section 4.4).
Danish: Neutropenisk colitis, herunder letal neutropenisk colitis, er set som en komplikation til topotecaninduceret neutropeni (se pkt.
English: anorexia (which may be severe) Respiratory, thoracic and mediastinal disorders Rare:
Danish: Luftveje, thorax og mediastinum Sjælden:
English: hyperbilirubinaemia Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig: alopeci Almindelig:
English: Potactasol 1 mg powder for concentrate for solution for infusion Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning Potactasol 4 mg pulver til 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: trombocyttallet er ≥ 100 x 109/l og hæmoglobinniveauet er ≥ 9 g/dl (om nødvendigt efter transfusion).
English: anaphylactic reaction angioedema urticaria
Danish: anafylaktisk reaktion angioødem urticaria
English: Potactasol 4 mg powder for concentrate for solution for infusion topotecan
Danish: Potactasol 4 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: Potactasol 1 mg powder for concentrate for solution for infusion topotecan
Danish: Potactasol 1 mg pulver til koncentrat til infusionsvæske, opløsning topotecan
English: Additional adverse events were seen when topotecan was given in combination with cisplatin, however, these events were seen with cisplatin monotherapy and were not attributable to topotecan.
Danish: Disse bivirkninger er dog tidligere set som følge af behandling med cisplatin-monoterapi og skyldes ikke topotecan.
English: Topotecan monotherapy is indicated for the treatment of: - patients with metastatic carcinoma of the ovary after failure of first-line or subsequent therapy - patients with relapsed small cell lung cancer (SCLC) for whom re-treatment with the first-line regimen is not considered appropriate (see section 5.1).
Danish: • patienter med recidiverende småcellet lungecancer (SCLC) for hvem gentagelse af 1. linje behandling ikke anses for hensigtsmæssig (se pkt.
English: How to store Potactasol
Danish: Sådan får du Potactasol
English: Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig: anoreksi (muligvis alvorlig)
English: Blood and lymphatic system disorders Very common:
Danish: Blod og lymfesystem
English: In patients (n = 39) with recurrence within 180 days after chemoradiotherapy with cisplatin, the median survival in the topotecan plus cisplatin arm was 4.6 months (95 % CI: 2.6, 6.1) versus 4.5 months (95 % CI: 2.9, 9.6) for the cisplatin arm with a hazard ratio of 1.15 (0.59, 2.23).
Danish: For patienter (n = 39) med recidiv inden for 180 dage efter kemo/stråleterapi med cisplatin, var medianoverlevelsen i den gruppe, der fik topotecan + cisplatin 4,6 mdr.
English: General disorders and administration site conditions Very common:
Danish: Almene symptomer og reaktioner på administrationsstedet Meget almindelig: pyreksi asteni træthed
English: 1 x 1 mg vial
Danish: 1 ml af 1 mg/ml topotecan opløsning
English: mucositis
Danish: Dosering
English: infection
Danish: utilpashed
English: At the end of this period the product can be put back in the refrigerator.
Danish: Efter denne periode kan produktet sættes tilbage i køleskabet.
English: 5 Wald confidence interval.
Danish: 5 Wald konfidensinterval.
English: As with all proteins there is a potential for immunogenicity.
Danish: Som for alle proteiner er der et potentiale for immunogenicitet.
English: Practical advice should be included to mitigate the risk.
Danish: Der skal inkluderes praktisk rådgivning for at nedsætte risikoen.
English: The majority (90.9%) of patients were female.
Danish: Hovedparten (90,9 %) af patienterne var kvinder.
English: Your doctor will calculate this.
Danish: Denne vil lægen beregne.
English: See Table 3.
Danish: Se tabel 3.
English: However, due to the lack of wellcontrolled studies, uncertainties remain.
Danish: På grund af de manglende velkontrollerede studier er der imidlertid fortsat usikkerhed.
English: Min, Max
Danish: Min; Maks
English: Adult Patients:
Danish: Voksne patienter:
English: No substantial differences were seen in safety and efficacy related to age.
Danish: Ingen betydelig forskel blev observeret i sikkerhed og virkning i forhold til alderen.
English: Safety Data from Other Clinical Studies
Danish: Sikkerhedsdata fra andre kliniske studier
English: Patients reported improved health-related quality of life (QoL).
Danish: Patienterne rapporterede om forbedret helbredsrelateret livskvalitet (QoL).
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre websteder om sjældne sygdomme og om,hvordan de behandles.
English: All rates of efficacy endpoints improved or were maintained through 2 years of treatment.
Danish: Alle effektendepunkter blev forbedret eller opretholdt gennem 2 års behandling.
English: • Warning to seek immediate medical care if above are present.
Danish: • advarsel om straks at søge lægehjælp hvis ovenstående er tilstede.
English: You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Danish: Vær opmærksom på, at du skal gå til læge hurtigst muligt, selv om du føler dig bedre efter at have taget antibiotika.
English: Vaccination may further activate complement.
Danish: Vaccination kan forårsage yderligere komplementaktivering.
English: The safety profiles in the different paediatric subsets of age appear similar.
Danish: Sikkerhedsprofilerne hos de forskellige pædiatriske aldersundergrupper forekommer at være de samme.
English: Coombs test positive c
Danish: Positiv Coombs test c
English: Following each infusion, you will be monitored for about one hour.
Danish: Efter hver infusion vil du blive overvåget i ca. en time.
English: *See paragraph Description of selected adverse reactions.
Danish: *Se afsnittet Beskrivelse af udvalgte bivirkninger.
English: • Contact details where a health care practitioner can receive further information.
Danish: • kontaktinformationer hvor sundhedspersonale kan modtage yderligere informationer.
English: In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
Danish: Afhængigt af nationale retningslinjer kan lægen finde det nødvendigt med supplerende foranstaltninger til at forebygge infektion.
English: p-value (using repeated measures analysis)
Danish: p-værdi (fra analyse af gentagne målinger)
English: Type of Plasma Intervention
Danish: Type af plasmaintervention
English: Patients with other diseases
Danish: Patienter med andre sygdomme
English: At 26-weeks
Danish: Efter 26 uger
English: It also resulted in a marked decrease or elimination of blood transfusions, and a trend towards an overall improvement in general function.
Danish: Det førte også til en markant reduktion af eller ophør med blodtransfusioner og en tendens til en samlet forbedring i den almene funktion.
English: Therefore, Soliris should be given to a pregnant woman only if clearly needed.
Danish: Soliris bør derfor kun anvendes til gravide, hvis der er klart behov for det.
English: This card is named: “Patient Safety Card”.
Danish: Kortet kaldes: ”Patientsikkerhedskort”.
English: Other Systemic Infections
Danish: Andre systemiske infektioner
English: Should such a treatment be considered necessary during pregnancy, a close maternal and foetal monitoring according to local guidelines is recommended.
Danish: Hvis en sådan behandling anses for at være nødvendig under graviditet, anbefales en nøje overvågning af moder og foster i henhold til lokale retningslinjer.
English: If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed.
Danish: Hvis du kommer ud for nogen af ovenstående symptomer, skal du tage antibiotika som foreskrevet.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der bør tages hensyn til officielle retningslinjer for hensigtsmæssig brug af antibiotika.
English: At data cut off (20 April 2012)
Danish: 1.Ved data-afslutning (20. april 2012)
English: Both patients were negative for neutralizing antibodies.
Danish: Begge patienter var negative med hensyn til neutraliserende antistoffer.
English: In this setting, a decrease of the daily dose of at least 1 immunosuppressant was observed in 47% of patients.
Danish: I dette regi blev der observeret en reduktion af den daglige dosis på mindst 1 immunsuppressivt middel hos 47 % af patienterne.
English: After dilution, the product should be used within 24 hours.
Danish: Efter fortynding skal produktet anvendes inden for 24 timer.
English: • Signs and symptoms of infection and sepsis.
Danish: • tegn og symptomer på infektion og sepsis.
English: 1/100 (1%) aHUS patients had low positive values for neutralizing antibodies.
Danish: 1/100 (1 %) aHUS-patienter havde lave positive værdier for neutraliserende antistoffer.
English: However, chemical and physical stability has been demonstrated for 24 hours at 2°C - 8°C.
Danish: Kemisk og fysisk stabilitet i indtil 24 timer ved 2 °C til 8 °C er dog påvist.
English: There are no well-controlled studies in pregnant women treated with eculizumab.
Danish: Der foreligger ingen velkontrollerede studier af gravide kvinder behandlet med eculizumab.
English: 4 Based on a stratified Cox proportional hazards model.
Danish: 4 Baseret på en stratificeret Cox-proportional hazards-model.
English: Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italy
Danish: Patheon Italia S.p.A Viale G. B. Stucchi, 110 20900 Monza (MB) Italien
English: Therefore, patients should be closely monitored for disease symptoms after recommended vaccination.
Danish: Derfor bør patienterne monitoreres tæt for sygdomssymptomer efter anbefalet vaccination.
English: Instructions for proper use
Danish: Anvisninger for korrekt brug
English: Transfusion Avoidance during treatment (%)
Danish: Undgåelse af transfusion under behandlingen (%)
English: • irritation of eye
Danish: • irritation i øjet
English: Efficacy outcomes for the pre-specified repeated measures analyses of the primary and secondary endpoints are provided in Table 10.
Danish: Effektresultater for analyser af de præspecificerede gentagne målinger af primære og sekundære endepunkter kan ses i tabel 10.
English: Soliris may be administered to patients aged 65 years and over.
Danish: Soliris kan anvendes til patienter på 65 år og derover.
English: Total number of patient-years in study period n
Danish: Antal patientår i alt i studieperioden n
English: However, this finding was shown in non-controlled clinical trials.
Danish: Dette resultat blev imidlertid opnået i ikke-kontrollerede kliniske studier.
English: The median age at first dose of study drug was 45 years.
Danish: Medianalderen for den første dosis studielægemiddel var 45 år.
English: Soliris No transfusion
Danish: Soliris Ingen transfusion
English: Note: Patients who did not experience an adjudicated On-trial Relapse were censored at the end of the Study Period.
Danish: Bemærk: Patienter, som ikke oplevede et adjudikeret recidiv i løbet af studiet, blev censureret ved slutningen af studieperioden.
English: You should also be aware that vaccination may not prevent this type of infection.
Danish: Du skal vide, at vaccination ikke nødvendigvis beskytter mod denne type infektion.
English: These studies included assessment of fertility and early embryonic development, developmental toxicity, and pre and post-natal development.
Danish: Disse studier omfattede en vurdering af fertilitet og tidlig embryonisk udvikling, udviklingstoksicitet og præ- og postnatal udvikling.
English: Historical Annualized Relapse Rate within 24 months prior to Screening
Danish: Historisk annualiseret recidivrate inden for 24 måneder før screening
English: max)
Danish: maks)
English: After dilution, the medicinal product should be used immediately.
Danish: Efter fortynding skal lægemidlet anvendes straks.
English: Berkshire SL1 4DX United Kingdom
Danish: Berkshire SL1 4DX Storbritannien
English: 3 Based on a stratified log-rank test.
Danish: 3 Baseret på en stratificeret log-rank-test.
English: Refractory Generalized Myasthenia Gravis
Danish: Refraktær generaliseret myasthenia gravis
English: Human antibodies are predominately catabolized by lysosomal enzymes to small peptides and amino acids.
Danish: Humane antistoffer nedbrydes hovedsagelig af lysosomale enzymer til små peptider og aminosyrer.
English: Table 11 presents an overview of the patients reporting clinical deterioration and patients requiring rescue therapy over the 26 weeks.
Danish: Tabel 11 viser en oversigt over patienter, der rapporterede klinisk forværring, og patienter, der havde behov for nødbehandling, i løbet af de 26 uger.
English: 2 Based on the complementary log-log transformation.
Danish: 2 Baseret på den komplementære log-log-transformation.
English: • Details of the PNH and aHUS registries and how to enter patients.
Danish: • detaljer omkring PNH og aHUS registrene og hvordan man indskriver patienter.
English: All patients being treated with eculizumab receive a patient safety card.
Danish: Alle patienter, der behandles med eculizumab, modtager et patientsikkerhedskort
English: Your doctor will want to monitor you closely for at least 8 weeks.
Danish: Din læge vil da ønske at holde dig under nøje observation i mindst 8 uger.
English: Paired t-test
Danish: Parret t-test
English: Approximately half were White (49.0%).
Danish: Ca. halvdelen var kaukasere (49,0 %).
English: The educational material should be agreed with the National Competent Authority and should contain the following:
Danish: Uddannelsesmaterialet skal aftales med den ansvarlige nationale myndighed og skal indeholde følgende elementer:
English: 4- Special Handling and Storage
Danish: 4- Særlig håndtering og opbevaring
English: • Signs and symptoms of severe infection and the need to obtain urgent medical care.
Danish: • tegn og symptomer på svær infektion og behovet for at modtage akut lægehjælp.
English: TMA interventions were defined as PE/PI or new dialysis.
Danish: TMAintervention blev defineret som PE/PI-behandling eller ny dialyse.