FrancophonIA/ELRC3.0 huggingface dataset:
English: This is a special type of vaccine that can be developed to help with the management of a future pandemic.
Danish: En mockup-vaccine er en særlig vaccinetype, der kan udvikles for at kontrollere en fremtidig pandemi.
English: The resulting ‘emulsion' will then be injected.
Danish: Emulsionen kan derefter injiceres.
English: A further study looked at the immunogenicity of single or double doses in 437 people aged over 60 years, and two studies looked at the effect of giving a single injection of the vaccine to adults who had previously been vaccinated with a prepandemic vaccine containing a related virus strain.
Danish: I en yderligere undersøgelse så man på den immunogene aktivitet ved en enkelt eller en dobbeltdosis hos 437 personer i alderen over 60 år, og i to undersøgelser så man nærmere på effekten af at give en enkelt injektion af vaccinen til voksne, som tidligere var blevet vaccineret med en præpandemisk vaccine indeholdende en beslægtet virusstamme.
English: Adjupanrix is a ‘mock-up' vaccine.
Danish: Adjupanrix er en ‘mockup'-vaccine.
English: A study in 405 children three to nine years of age looked at the immunogenicity triggered by a vaccine containing half the amount of haemagglutinins compared with the vaccine containing the full amount.
Danish: I en undersøgelse af 405 børn i alderen tre til ni år vurderede man den immunogene aktivitet, som blev udløst af en vaccine indeholdende den halve mængde hæmagglutininer sammenlignet med en vaccine, som indeholdt den fulde mængde.
English: What benefit has this vaccine shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, der er ved denne vaccine?
English: In children aged three to nine years, the half-dose vaccine was shown bring about levels of antibodies that were comparable with the full-dose vaccine.
Danish: Hos børn i alderen tre til ni år viste det sig, at en vaccine med halv dosis udløste antistofmængder, som var sammenlignelige med en vaccine med fuld dosis.
English: When a person is given the vaccine, the immune system recognises the virus as ‘foreign' and makes antibodies against it.
Danish: Når en person vaccineres, opfatter immunsystemet virusset som ‘fremmed' og producerer antistoffer mod det. Immunsystemet kan således hurtigere danne antistoffer, når det udsættes for samme virus igen.
English: What is this vaccine used for?
Danish: Hvad anvendes denne vaccine til?
English: How has this vaccine been studied?
Danish: Hvordan blev denne vaccine undersøgt?
English: This means that, because the vaccine is a mock up and does not yet contain the strain of flu virus that is causing a pandemic, it has not been possible to obtain full information about the final pandemic vaccine.
Danish: Det betyder, at det ikke har været muligt at opnå fyldestgørende oplysninger om den endelige pandemiske vaccine, da det er en mockupvaccine, som endnu ikke indeholder den influenzavirusstamme, der forårsager en pandemi.
English: How is this vaccine used?
Danish: Hvordan anvendes denne vaccine?
English: How does this vaccine work?
Danish: Hvordan virker denne vaccine?
English: • a severe headache that does not go away.
Danish: • kraftig hovedpine, som ikke går væk.
English: • if you have ever had or might now have a hepatitis B infection.
Danish: • hvis du nogensinde har fået konstateret eller på nuværende tidspunkt har en hepatitis B-infektion.
English: If you are a newly-diagnosed patient, treatment will occur in two phases:
Danish: Hvis du er nydiagnosticeret patient, vil behandlingen ske i to faser:
English: In this case, your doctor will also prescribe medicine to help you prevent this type of pneumonia (PCP).
Danish: I så fald vil din læge også udskrive medicin, der kan hjælpe med at forebygge denne form for lungebetændelse (PCP).
English: Paediatric population Interaction studies have only been performed in adults.
Danish: Pædriatrisk population Interaktionsstudier er kun udført hos voksne.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Hexal should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør Temozolomide HEXAL indgives uden føde.
English: You will take this dose every day for 42 days (up to 49 days) in combination with radiotherapy.
Danish: Du skal tage denne dosis hver dag i 42 dage (i op til 49 dage) i kombination med strålebehandling.
English: This is because you must not be treated with Temozolomide Hexal during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at du ikke må tage Temozolomide HEXAL under graviditet, medmindre det er klart angivet af din læge.
English: There is limited information in patients over 3 years of age who have taken Temozolomide Hexal.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temozolomide HEXAL.
English: However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance.
Danish: Da de pågældende doser for retinal degeneration imidlertid lå i området for de dødelige doser, og ingen sammenlignelig effekt er set i kliniske forsøg, blev dette fund ikke betragtet som værende klinisk relevant.
English: Temozolomide Hexal should not be administered to pregnant women.
Danish: Temozolomide HEXAL bør ikke anvendes til gravide kvinder.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines webportal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Temozolomide Hexal may make you feel tired or sleepy.
Danish: Når du tager Temozolomide HEXAL, kan du føle dig træt eller søvnig.
English: Temozolomide Hexal is used in these tumours if they return or get worse after standard treatment.
Danish: Temozolomide HEXAL bruges til behandling af disse svulster, hvis de vender tilbage eller bliver værre efter standardbehandlingen.
English: If Temozolomid Hexal comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temozolomide HEXAL kommer i kontakt med hud eller slimhinder bør området straks vaskes grundigt med sæbe og vand.
English: • treatment together with radiotherapy (concomitant phase) first
Danish: • behandling sammen med strålebehandling (konkomitant-fasen) først
English: Temozolomide Hexal treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temozolomide HEXAL kan give et fald i antallet af visse typer blodceller.
English: Take your prescribed dose of Temozolomide Hexal once a day, preferably at the same time each day.
Danish: Tag den ordinerede dosis af Temozolomide HEXAL én gang dagligt, helst på samme tidspunkt hver dag.
English: This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and reduced resistance to infections.
Danish: Det kan betyde, at du lettere får blå mærker eller blødning, anæmi (mangel på røde blodlegemer), feber og nedsat modstandskraft over for infektioner.
English: If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving Temozolomide Hexal for 42 days in combination with radiotherapy.
Danish: Hvis du er en nydiagnosticeret patient (glioblastoma multiforme,) får du muligvis Temozolomide HEXAL i 42 dage i kombination med strålebehandling.
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43 %) and vomiting (36 %).
Danish: I kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger mave-tarmlidelser, særligt kvalme (43 %) og opkastninger (36 %).
English: Hexal AG Industriestraße 25 83607 Holzkirchen Germany
Danish: HEXAL AG Industriestrasse 25 D-83607 Holzkirchen Tyskland
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, Før du tager dette lægemiddel.
English: During the monotherapy phase, the dose and way you take Temozolomide Hexal will be different.
Danish: Under monoterapi-fasen vil dosis og måden, du tager Temozolomide HEXAL på, være anderledes.
English: 5 hard capsules.
Danish: 5 hårde kapsler.
English: In some cases, it may be necessary to stop treatment with Temozolomide Hexal.
Danish: I nogle tilfælde vil det være nødvendigt at stoppe behandlingen med Temozolomide HEXAL.
English: • followed by treatment with only Temozolomide Hexal (monotherapy phase).
Danish: • efterfulgt af behandling kun med Temozolomide HEXAL (monoterapi-fasen).
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Hexal (see also “Male fertility” below).
Danish: Både mandlige og kvindelige patienter skal anvende sikre pæventionsmidler, mens de tager Temozolomide HEXAL (se også ”Frugtbarhed hos mænd” nedenfor).
English: Multipack (Bottles)
Danish: Multipakning (flasker)
English: Each bottle contains either 5 or 20 capsules.
Danish: Hver flaske indeholder 5 eller 20 kapsler.
English: Opportunistic infections and reactivation of infections Opportunistic infections (such as Pneumocystis jirovecii pneumonia) and reactivation of infections (such as HBV, CMV) have been observed during the treatment with TMZ (see section 4.8).
Danish: Opportunistiske infektioner og reaktivering af infektioner Opportunistiske infektioner (såsom Pneumocystis jirovecii-pneumonia) og reaktivering af infektioner (såsom HBV, CMV) er blevet observeret under behandling med TMZ (se afsnit 4.8).
English: In a multicentre, prospective phase II trial evaluating the safety and efficacy of oral TMZ in the treatment of patients with anaplastic astrocytoma at first relapse, the 6 month PFS was 46 %.
Danish: I et prospektivt multicenterforsøg i fase II til vurdering af sikkerheden ved og effekten af oral TMZ i behandlingen af patienter med anaplastisk astrocytom ved første relaps, var PFS efter 6 måneder 46 %.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Hexal on your blood cells.
Danish: Du vil regelmæssigt få undersøgt dit blod under behandlingen for at følge bivirkningerne af Temozolomide HEXAL på dine blodceller.
English: Temozolomide Hexal should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temozolomide HEXAL bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Danish: Patienter, der modtager temozolomid i kombination med strålebehandling, kan opleve andre bivirkninger end patienter, der kun får temozolomid.
English: Always take Temozolomide Hexal exactly as your doctor has told you.
Danish: Tag altid Temozolomide HEXAL nøjagtigt efter lægens anvisning.
English: Temozolomide Hexal is used for the treatment of specific forms of brain tumours:
Danish: Temozolomide HEXAL anvendes til behandling af specifikke former for hjernesvulster:
English: In some cases, your Temozolomide Hexal dose will be reduced or treatment stopped.
Danish: I visse tilfælde vil din dosis af Temozolomide HEXAL blive nedsat, eller din behandling vil blive stoppet.
English: Very rare cases of severe rash with skin swelling, including on the palms of the hands and soles of the feet, or painful reddening of the skin and/or blisters on the body or in the mouth have been observed.
Danish: Der er set meget sjældne tilfælde af alvorligt udslæt med hævelser i huden, som omfatter håndfladerne og fodsålerne, eller smertefuld rødmen af huden og/eller blærer på kroppen eller i munden er set.
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Hexal until the vomiting is under control.
Danish: Hvis du ofte kaster op før eller under behandlingen, så spørg din læge om, hvornår du helst skal tage Temozolomide HEXAL, indtil opkastningerne er under kontrol.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and
Danish: I forhold til AUC for TMZ er eksponeringen for MTIC og AIC henholdsvis ~ 2,4 % og 23 %.
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Hexal to prevent or control nausea and vomiting.
Danish: Du vil eventuelt få ordineret anden medicin (kvalmestillende), der skal tages før og/eller efter, at du har taget Temozolomide HEXAL, for at undgå eller regulere kvalme og opkastning.
English: • absent or heavy menstrual periods
Danish: • udeblivende eller kraftige menstruationer
English: The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Danish: Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA hovedsageligt ved O6- og N7-positionen i guanin.
English: Before each new treatment cycle, your blood will be tested to see if the Temozolomide dose needs to be adjusted.
Danish: Før hver ny behandlingscyklus vil dit blod blive undersøgt for, om dosen af Temozolomide HEXAL skal justeres.
English: In very rare cases, patients taking temozolomide and medicines like it may have a small risk of developing secondary cancers, including leukaemia.
Danish: Meget sjældent kan patienter, som tager Temozolomide HEXAL eller lignende medicin, have en lille risiko for at udvikle en sekundær kræftform, herunder leukæmi.
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Danish: Nye eller reaktiverede (recidiverende) cytomegalovirusinfektioner og reaktiverede hepatitis Bvirusinfektioner er blevet rapporteret som værende ualmindelige.
English: • a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty),
Danish: • en kraftig allergisk (overfølsomheds)reaktion (kløende udslæt, hvæsende vejrtrækning eller anden form for åndedrætsbesvær)
English: Package leaflet: information for the user Temozolomide Hexal 5 mg hard capsules Temozolomide Hexal 20 mg hard capsules Temozolomide Hexal 100 mg hard capsules Temozolomide Hexal 140 mg hard capsules Temozolomide Hexal 180 mg hard capsules Temozolomide Hexal 250 mg hard capsules temozolomide
Danish: Indlægssedel: Information til brugeren Temozolomide HEXAL 5 mg hårde kapsler Temozolomide HEXAL 20 mg hårde kapsler Temozolomide HEXAL 100 mg hårde kapsler Temozolomide HEXAL 140 mg hårde kapsler Temozolomide HEXAL 180 mg hårde kapsler Temozolomide HEXAL 250 mg hårde kapsler temozolomid
English: • increased skin sensitivity to sunlight
Danish: • øget lysfølsomhed af huden
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Danish: Brev Brev af polyester/aluminium/polyethylen (PET/alu/PE).
English: The Temozolomide Hexal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Danish: Dosen af Temozolomide HEXAL kan blive justeret, udskudt eller afbrudt afhængig af dit blodtal, og hvordan du tåler din medicin under hver behandlingscyklus.
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic.
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk.
English: If you accidentally take more Temozolomide Hexal capsules than you were told to, contact your doctor or pharmacist or nurse immediately .
Danish: Hvis du ved en fejl tager flere kapsler med Temozolomide HEXAL end foreskrevet, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet.
English: Type III amber glass bottle with polypropylene child-resistant closure containing 5 or 20 hard capsules.
Danish: Type III-flaske af brunt glas med børnesikret polypropylen-låg indeholdende 5 eller 20 hårde kapsler.
English: You will take Temozolomide Hexal alone once daily for the first 5 days.
Danish: Du vil tage Temozolomide HEXAL alene én gang dagligt i de første 5 dage.
English: Temozolomide Hexal contains a medicine called temozolomide.
Danish: Temozolomide HEXAL indeholder en medicin, som kaldes temozolomid.
English: Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The Temozolomide Hexal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Danish: Dosen af Temozolomide HEXAL kan udskydes eller afbrydes, afhængig af dine blodtal og af, hvordan du tåler medicinen under den konkomitante fase.
English: Multipack: 20 (4 packs of 5) hard capsules
Danish: Multipakning: 20 (4 pakninger med 5) hårde kapsler
English: Then you will have 23 days without Temozolomide Hexal.
Danish: Derefter vil du have 23 dage uden Temozolomide HEXAL.
English: Temozolomide Hexal may cause permanent infertility.
Danish: Temozolomide HEXAL giver muligvis permanent ufrugtbarhed.
English: The results from the trial were not consistent in the subgroup of patients with a poor performance status (WHO PS=2, n=70), where overall survival and time to progression were similar in both arms.
Danish: Figur 1 Kaplan-Meier-kurver for total overlevelse (intent-to-treat population) Resultaterne fra undersøgelsen var ikke konsistente i undergruppen af patienter med dårlig performance status (WHO PS=2, n=70), hvor total overlevelse og tid til progression var ens for de to grupper.
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Hexal
Danish: Kontakt lægen, apotekspersonaletet eller sundhedspersonalet, før du tager Temozolomide HEXAL.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01AX03 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Andre alkyleringsmidler, ATC-kode: L01AX03.
English: • if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er overfølsom (allergisk) over for temozolamid eller et af de øvrige indholdsstoffer i Temozolomide HEXAL (angivet i pkt.
English: When laboratory abnormalities and adverse events were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic events were observed in 8 % of the patients.
Danish: Ved sammenlægning af unormale laboratorieværdier og bivirkninger på tværs af behandlingsfaserne med konkomitant behandling og monoterapi blev der observeret neutrofile abnormiteter af Grad 3 eller Grad 4, herunder neutropenibivirkninger, hos 8 % af patienterne.
English: What you need to know before you take Temozolomide Hexal Do not take Temozolomide Hexal
Danish: Det skal du vide, før du begynder at tage Temozolomide HEXAL Tag ikke Temozolomide HEXAL
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Danish: Efter peroral administration af 14C-mærket TMZ var den gennemsnitlige fækale udskillelse af 14C over 7 dage post dosis 0,8 %, hvilket tyder på fuldstændig absorption.
English: You should stop breast-feeding while receiving treatment with Temozolomide Hexal.
Danish: Du skal stoppe med at amme, mens du behandles med Temozolomide HEXAL.
English: Table 5 includes adverse reactions reported during clinical trials for recurrent or progressive malignant glioma and following the marketing of TMZ.
Danish: Tabel 5 omfatter bivirkninger rapporteret under kliniske forsøg ved tilbagevendende eller progressivt malignt gliom samt efter markedsføring af Temozolomide HEXAL.
English: You will take your new dose of Temozolomide Hexal alone once daily for the first 5 days (“dosing days”) of each cycle.
Danish: Du vil tage din nye dosis én gang dagligt i de første 5 dage ("doseringsdage") i hver cyklus.
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia,
Danish: a: Samtidig behandling med TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut neutrofiltal ≥ 1,5 x 109/l; trombocyttal ≥ 100 x 109/l; CTC ikke-hæmatologisk toksicitet ≤ Grad 1 (undtagen alopeci, kvalme, opkastning).
English: If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: The cap is imprinted with “TMZ”.
Danish: Hætten er præget med ”TMZ”.
English: Temozolomide Hexal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Danish: Temozolomide HEXAL bruges først sammen med strålebehandling (behandlingsfase med samtidig behandling med strålebehandling og lægemiddel) og efterfølgende alene (behandlingsfase med kun ét lægemiddel).
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk
English: The body is imprinted with “5”.
Danish: Kroppen er præget ”5”.
English: If you forget to take Temozolomide Hexal
Danish: Hvis du har glemt at tage Temozolomide HEXAL
English: Temozolomide Hexal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Danish: Temozolomide HEXAL administreres samtidig med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier med monoterapi med temozolomid (TMZ) (monoterapi-fase).
English: In patients previously treated with chemotherapy, the initial dose is 150 mg/m2 once daily, to be increased in the second cycle to 200 mg/m2 once daily, for 5 days if there is no haematological toxicity (see section 4.4).
Danish: Til patienter, som tidligere er behandlet med kemoterapi, er den initiale dosis 150 mg/m2 én gang dagligt, og denne dosis skal i den anden serie øges til 200 mg/m2 én gang dagligt i 5 dage, såfremt der ikke er hæmatologisk toksicitet (se pkt.
English: During the concomitant phase, your doctor will start Temozolomide Hexal at a dose of 75 mg/m2
Danish: Under konkomitant-fasen vil din læge starte behandlingen med en dosis Temozolomide HEXAL på 75 mg/m2 (sædvanlig dosis).
English: Temozolomide Hexal contains lactose
Danish: Temozolomide HEXAL indeholder lactose
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Hexal only: A treatment cycle with Temozolomide Hexal lasts 28 days.
Danish: Patienter med tilbagevendende eller forværrede svulster (malignt gliom såsom glioblastoma multiform eller anaplastisk astrocytoma) som kun tager Temozolomide HEXAL:
English: If you have been previously treated with chemotherapy, your first dose of Temozolomide Hexal will be 150 mg/m2 once daily for the first 5 days.
Danish: Hvis de tidligere er blevet behandlet med kemoterapi, vil din første dosis af Temozolomide HEXAL være på 150 mg/m2 én gang dagligt i de første 5 dage.
English: You will again receive Temozolomide Hexal once daily for 5 days, followed by 23 days without Temozolomide Hexal.
Danish: Du vil igen tage Temozolomide HEXAL én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temozolomide HEXAL.