FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the oral retinoids acitretin, alitretinoin and isotretinoin, which are used to treat conditions mainly affecting the skin, must be used in accordance with the conditions of a new pregnancy prevention programme by women able to have children.
Danish: Desuden skal de orale retinoider acitretin, alitretinoin og isotretinoin, der anvendes til behandling af sygdomme, der hovedsagelig rammer huden, anvendes i overensstemmelse med betingelserne i et nyt graviditetsforebyggelsesprogram til kvinder, der kan blive gravide.
English: Retinoids include the active substances acitretin, adapalene, alitretinoin, bexarotene, isotretinoin, tazarotene and tretinoin.
Danish: Retinoider omfatter de aktive stoffer acitretin, adapalen, alitretinoin, bexaroten, isotretinoin, tazaroten og tretinoin.
English: However, as a precaution, they must not be used during pregnancy and by women planning to have a baby.
Danish: Som forholdsregel må de dog ikke anvendes under graviditet, og kvinder, der planlægger at blive gravide, må heller ikke anvende dem.
English: • For bexarotene and oral tretinoin it is considered that, in the light of the target population and an oncological indication subject to specialist care in the hospital setting, the implementation of a PPP is not necessary.
Danish: • Hvad angår bexaroten og oral tretinoin, vurderes det, at gennemførelse af et graviditetsforebyggelsesprogram ikke er nødvendigt i betragtning af målpopulationen og den onkologiske indikation med speciallægebehandling på hospital.
English: Topical retinoids (those applied to the skin) must also not be used during pregnancy, and by women planning to have a baby.
Danish: Topiske retinoider (der smøres på huden) må heller ikke anvendes under graviditet, ligesom kvinder, der planlægger at blive gravide, heller ikke må anvende dem.
English: • In addition, the oral retinoids acitretin, alitretinoin and isotretinoin must not be taken by women able to have children unless the conditions of a special pregnancy prevention programme are met.
Danish: • Desuden må de orale retinoider acitretin, alitretinoin og isotretinoin ikke tages af kvinder, der kan blive gravide, medmindre de opfylder betingelserne i et særligt graviditetsforebyggelsesprogram.
English: More about the medicine
Danish: Yderligere oplysninger om lægemidlet
English: • Oral retinoids (acitretin, alitretinoin, bexarotene, isotretinoin and tretinoin) are highly teratogenic and must not be used during pregnancy.
Danish: • Orale retinoider (acitretin, alitretinoin, bexaroten, isotretinoin og tretinoin) er stærkt teratogene og må ikke anvendes under graviditet.
English: • For topical retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin), the available data show that systemic absorption is negligible following topical application and that these products are unlikely to cause fetal harm.
Danish: • Hvad angår topiske retinoider (adapalen, alitretinoin, isotretinoin, tazaroten og tretinoin), viser de tilgængelige oplysninger, at den systemiske absorption er ubetydelig efter topisk anvendelse, og at disse produkter sandsynligvis ikke skader det ufødte barn.
English: − pregnancy tests before starting treatment, during treatment and after treatment;
Danish: − graviditetstest før, under og efter behandlingen
English: • For topically applied retinoids (adapalene, alitretinoin, isotretinoin, tazarotene and tretinoin), systemic absorption is negligible, and unlikely to result in psychiatric disorders.
Danish: • For topiske retinoider (adapalen, alitretinoin, isotretinoin, tazaroten og tretinoin) er den systemiske absorption ubetydelig og vil sandsynligvis ikke medføre psykiatriske forstyrrelser.
English: − a ‘risk acknowledgement form' for patients and prescribers to go through and confirm that appropriate advice has been given and understood.
Danish: − en erklæringsblanket, der angiver, at patienten og den ordinerende læge har gennemgået de relevante oplysninger, og at patienten har forstået rådgivningen.
English: • With oral retinoids, there may be a possible risk of disorders such as depression and anxiety.
Danish: • Der er risiko for forstyrrelser som f.eks. depression og angst ved behandling med orale retinoider.
English: Member State EU/EEA
Danish: Medlemslan EU/EAA
English: List of the names, pharmaceutical form, strengths of the medicinal product, route of administration, applicants in the Member States
Danish: Navneliste, lægemiddelform, medicinske produkters styrke, indgivelsesvej og ansøgere i medlemslande
English: Strength Pharmaceutical form Route of administration
Danish: Lægemiddelform Indgivelsesvej
English: - if you are older than 70 years of age.
Danish: - hvis De er over 70 år.
English: However, no unacceptable risks appear to be present in this patient group.
Danish: Der syntes imidlertid ikke at være nogen uacceptabel risiko i denne patientgruppe.
English: Although the data is limited, tolerance in children is expected to be the same as in adults.
Danish: Selv om data er begrænsede, forventes tolerancen hos børn at være den samme som hos voksne.
English: The median PFS was 5.4 months.
Danish: Den mediane PFS var 5,4 måneder.
English: In 43 patients stable disease was reported.
Danish: Der blev rapporteret om stabil sygdom hos 43 patienter.
English: During treatment a complete blood count should be obtained weekly.
Danish: Under behandlingen bør der foretages en komplet blodtælling ugentligt.
English: Achieving a radiological objective response or maintaining progression-free status was strongly associated with maintained or improved quality of life.
Danish: Opnåelse af radiologisk objektivt respons eller opretholdelse af progressionsfri status var kraftigt forbundet med bevaret eller forbedret livskvalitet.
English: feeling that one's surroundings are spinning
Danish: følelse af, at omgivelserne drejer rundt
English: Lutomierska 50,95-200 Pabianice, Poland
Danish: Lutomierska 50,95-200 Pabianice, Polen
English: The major route of 14C elimination is renal.
Danish: Den vigtigste eliminationsvej for udskillelsen af 14C er renal.
English: No evidence of cumulative myelosuppression was observed.
Danish: Der blev ikke set tegn på kumulativ myelosuppression.
English: This is because you must not be treated with Temozolomide Accord during pregnancy unless clearly indicated by your doctor.
Danish: Det skyldes, at De ikke må blive behandlet med Temozolomide Accord under graviditet, medmindre Deres læge klart har angivet det.
English: - if you have ever had or might now have a hepatitis B infection.
Danish: - hvis De nogensinde har haft eller ved, at De kan have hepatitis B-infektion.
English: Once the radiotherapy is completed, you will interrupt treatment for 4 weeks to give your body a chance to recover.
Danish: Når strålebehandlingen er afsluttet, skal De afbryde behandlingen i 4 uger for at give kroppen mulighed for at komme sig.
English: * Frequencies estimated based on relevant clinical trials.
Danish: *De estimerede hyppigheder er baseret på relevante kliniske forsøg.
English: This latency period is very short even for an alkylating agent.
Danish: Denne latensperiode er meget kort, selv for et alkylerende stof.
English: Take the dose on an empty stomach; for example, at least one hour before you plan to eat breakfast.
Danish: Tag dosen på tom mave, fx mindst en time før De skal have morgenmad.
English: During treatment patients should be monitored and managed appropriately.
Danish: Under behandlingen skal patienterne monitoreres og behandles hensigtsmæssigt.
English: In the event of an overdose, haematological evaluation is needed.
Danish: I tilfælde af en overdosis, er hæmatologisk vurdering nødvendig.
English: Tell your doctor if you notice any of these symptoms.
Danish: Fortæl det til Deres læge, hvis De bemærker nogle af disse symptomer.
English: Ask your doctor for advice before taking any medicine.
Danish: Spørg Deres læge til råds, før De tager nogen form for medicin.
English: • dose level -1 (100 mg/m2 ) still results in unacceptable toxicity
Danish: • dosisniveau -1 (100 mg/m2) fortsat resulterer i uacceptabel toksicitet
English: In some cases, it may be necessary to stop treatment with temozolomide.
Danish: I nogle tilfælde, kan det blive nødvendigt at stoppe behandlingen med temozolomid.
English: Dosage and duration of treatment
Danish: Dosering og behandlingens varighed
English: - if you have had an allergic reaction to another anti-cancer medicine called dacarbazine.
Danish: - hvis De har haft en allergisk reaktion over for en anden medicin mod kræft, som kaldes dacarbazin.
English: TMZ demonstrates low protein binding (10% to 20%), and thus it is not expected to interact with highly protein-bound substances.
Danish: TMZ har en lav proteinbinding (10 % til 20 %) og forventes derfor ikke at interagere med stærkt proteinbundne stoffer.
English: Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel, da den kan indeholde vigtige oplysninger.
English: † Including cases with fatal outcome
Danish: †Inklusive tilfælde med dødelig udgang
English: Do not double the next dose to make up for a forgotten dose, unless your doctor tells you to do so.
Danish: De må ikke tage en dobbeltdosis som erstatning for den glemte dosis, medmindre Deres læge beder Dem gøre dette.
English: In the tables, undesirable effects are classified according to System Organ Class and frequency.
Danish: I tabellerne er bivirkningerne klassificeret i henhold til systemorganklasse og frekvens.
English: In this case, your doctor will also prescribe medicine to help you prevent this typeof pneumonia (PCP).
Danish: Deres læge vil i det tilfælde også ordinere medicin, der skal forebygge denne type lungebetændelse (PCP).
English: Median overall survival was 14.6 months.
Danish: Den mediane samlede overlevelse var 14,6 måneder.
English: Avoid inhaling the powder.
Danish: Undgå at indånde pulveret.
English: Take your prescribed dose of Temozolomide Accord once a day.
Danish: Tag Deres ordinerede dosis Temozolomide Accord én gang om dagen.
English: Reduction for prior toxicity
Danish: Reduktion for tidligere toksicitet
English: Your doctor may need to reduce the dose of your medicine or interrupt your treatment, or you may need other treatment.
Danish: Deres læge vil måske være nødt til at sætte dosis af Deres medicin ned eller afbryde behandlingen, eller De kan få brug for anden behandling.
English: Opportunistic infections, including PCP
Danish: Opportunistiske infektioner, inklusive PCP
English: - Be sure you understand exactly how many capsules you need to take of each strength.
Danish: - Vær sikker på, at De er klar over nøjagtigt, hvor mange kapsler De skal tage af hver styrke.
English: Tell your doctor immediately if this occurs.
Danish: Kontakt straks Deres læge, hvis dette forekommer.
English: Administration of TMZ with food resulted in a 33 % decrease in Cmax and a 9 % decrease in area under the curve (AUC).
Danish: Administration af TMZ med føde medførte et fald i Cmax på 33 % og et fald i arealet under kurven (AUC) på 9 %.
English: The capsules contain lactose (a kind of sugar).
Danish: Kapslerne indeholder lactose (en form for sukker).
English: The reduction of blood cells is usually temporary, but in some cases may be for longer and may lead to a very severe form of anaemia (aplastic anaemia).
Danish: Faldet i antallet af blodceller er som regel forbigående, men i nogle tilfælde kan det vare længere og medføre en meget alvorlig form for anæmi (aplastisk anæmi).
English: There is limited information in patients over 3 years of age who have taken Temozolomide Accord.
Danish: Der foreligger begrænset information om børn over 3 år, der har fået Temozolomide Accord.
English: In both trials, the primary endpoint was progression-free survival (PFS) defined by MRI scans or neurological worsening.
Danish: I begge undersøgelser var det primære endepunkt progressionsfri overlevelse (PFS) defineret ved MR-scanning eller neurologisk forværring.
English: This is because Temozolomide Accord could cause hepatitis B to become active again, which can be fatal in some cases.
Danish: Dette skyldes, at Temozolomide Accord kan forårsage, at hepatitis B bliver aktiv igen, hvilket kan være dødeligt i nogle tilfælde.
English: The incidence of severe nausea and vomiting was 4%.
Danish: Hyppigheden af alvorlig kvalme og opkastning var 4 %.
English: Swallow the capsule(s) whole with a glass of water.
Danish: Slug kapslen (kapslerne) hel med et glas vand.
English: TMZ is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs.
Danish: TMZ er mere toksisk overfor rotter og hunde end overfor mennesker, og den kliniske dosis nærmer sig den mindste letale dosis hos rotter og hunde.
English: Supportive measures should be provided as necessary.
Danish: Der bør gives understøttende behandling efter behov.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De eller Deres pårørende kan også indberette bivirkninger direkte tilLægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Opportunistic infections and reactivation of infections
Danish: Opportunistiske infektioner og reaktivering af infektioner
English: If Temozolomide Accord comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
Danish: Hvis Temozolomide Accord kommer i kontakt med hud eller slimhinder, bør området straks vaskes grundigt med sæbe og vand.
English: Experts in liver disease should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease).
Danish: Eksperter i leversygdomme skal konsulteres før behandling initieres hos patienter med positiv hepatitis B-serologi (inklusive patienter med aktiv sygdom).
English: CTC Grade 4b a : TMZ dose levels are listed in Table 2. b : TMZ is to be discontinued if:
Danish: CTC grad 4b a : Dosisniveauerne for TMZ fremgår af tabel 2. b : TMZ skal seponeres, hvis:
English: No studies have been conducted to determine the effect of TMZ on the metabolism or elimination of other medicinal products.
Danish: Der er ikke udført undersøgelser for at bestemme TMZs effekt på metabolisering eller elimination af andre lægemidler.
English: Sometimes the dose or the mix of capsules you need to take will be different from the last cycle.
Danish: Det kan ske, at dosis eller blandingen af kapsler, som De skal tage, er forskellig fra sidste serie.
English: Middlesex, HA1 4HF, United Kingdom
Danish: Middlesex, HA1 4HF, Storbritannien
English: • loss of hearing, ringing noise in the ear
Danish: • høretab, ringende støj i øret
English: Tell your pharmacist if you notice any change in the appearance of the capsules.
Danish: Underret apoteket, hvis De bemærker et ændret udseende af kapslerne.
English: Myelosuppression was predictable (usually within the first few cycles, with the nadir between Day 21 and Day 28), and recovery was rapid, usually within 1-2 weeks.
Danish: Myelosuppression var forudsigelig (normalt inden for de første serier med nadir mellem dag 21 og dag 28), og bedring indtraf hurtigt, sædvanligvis i løbet af for 1-2 uger.
English: Temozolomide treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med temozolomid kan forårsage et fald i antallet af visse blodceller.
English: In this case, do not drive or use any tools or machines or cycle until you see how this medicine affects you (see section 4).
Danish: I det tilfælde må De ikke køre bil/motorcykel eller cykle eller arbejde med værktøj eller maskiner, før De ved, hvordan dette lægemiddel påvirker Dem (se pkt.
English: The presence of thrombocytopenia may increase the risk of bleeding, and the presence of neutropenia or leukopenia may increase the risk of infection.
Danish: Tilstedeværelsen af trombocytopeni kan øge risikoen for blødning, og tilstedeværelsen af neutropeni eller leukopeni kan øge risikoen for infektion.
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Danish: Dosisniveauerne omfatter 100 mg/m2, 150 mg/m2 og 200 mg/m2.
English: Your doctor will check your blood to make sure you have enough of these cells before you begin treatment.
Danish: Deres læge vil kontrollere Deres blod for at sikre, at De har tilstrækkelige antal af disse blodceller, inden Deres behandling starter.
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 web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette produkt 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: These blood cells are important for fighting infection and for proper blood clotting.
Danish: Disse blodceller er vigtige i bekæmpelsen af infektioner og for, at blodet kan størkne.
English: Each carton contains 5 or 20 sachets.
Danish: Hver karton indeholder 5 eller 20 breve.
English: Changes in blood cells
Danish: Ændringer i blodets celler
English: Most of the toxicity showed evidence of reversibility, except for adverse reactions on the male reproductive system and retinal degeneration.
Danish: Størstedelen af toksiciteten viste tegn på at være reversibel med undtagelse af bivirkningerne på det mandlige reproduktionssystem og degenerationen af retina.
English: Rats appear to be particularly sensitive to oncogenic effects of TMZ, with the occurrence of first tumours within 3 months of initiating dosing.
Danish: Rotter synes at være særligt følsomme over for de onkogene virkninger af TMZ med forekomst af de første tumorer inden for 3 måneder efter første dosis.
English: Patients who have experienced severe (Grade 3 or 4) vomiting in previous treatment cycles may require anti-emetic therapy.
Danish: Patienter, som har haft svære opkastninger (grad 3 eller 4) i tidligere behandlingsserier kan have behov for antiemetisk behandling.
English: As it cannot be excluded that the change in Cmax is clinically significant, Temozolomide Accord should be administered without food.
Danish: Da det ikke kan udelukkes, at ændringen i Cmax er klinisk signifikant, bør TMZ indgives uden føde.
English: 20 hard capsules
Danish: 20 hårde kapsler
English: Your blood will be tested regularly to monitor your condition.
Danish: Deres blod vil blive tjekket regelmæssigt for at kontrollere Deres helbredstilstand.
English: If you accidentally get some in your eyes or nose, flush the area with water.
Danish: Hvis De alligevel ved et uheld får noget i øjnene eller næsen, skal De skylle det berørte område med vand.
English: A total of 573 patients were randomised to receive either TMZ + RT (n=287) or RT alone (n=286).
Danish: I alt 573 patienter blev randomiseret til at få enten TMZ + RT (n=287) eller RT alene (n=286).
English: Store in the original bottle.
Danish: Opbevares i den originale flaske.
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 degenerationen af retina imidlertid lå i området for de dødelige doser, og da der ikke er set lignende effekt i de kliniske undersøgelser, blev dette fund ikke betragtet som klinisk relevant.
English: Dose-limiting toxicity was haematological and was reported with any dose but is expected to be more severe at higher doses.
Danish: Den dosisbegrænsende toksicitet var hæmatologisk, og den blev rapporteret uanset størrelsen af dosis, men forventes at være alvorligere ved højere doser.
English: Temozolomide Accord should not be administered to pregnant women.
Danish: Temozolomide Accord bør ikke anvendes til gravide kvinder.
English: There may be a higher occurrence of PCP when TMZ is administered during a longer dosing regimen.
Danish: Der kan være en højere forekomst af PCP, når TMZ anvendes i et længerevarende dosisregime.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactase deficit eller glucose-galactose malabsorption bør ikke tage dette lægemiddel.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4% and 23%, respectively.
Danish: I forhold til TMZs AUC er eksponeringen overfor MTIC og AIC henholdsvis ~ 2,4 % og 23 %.
English: In clinical trials, the most frequently occurring treatment-related undesirable effects were gastrointestinal disorders, specifically nausea (43%) and vomiting (36%).
Danish: I de kliniske forsøg var de hyppigst forekommende behandlingsrelaterede bivirkninger gastrointestinale sygdomme, særligt kvalme (43 %) og opkastninger (36 %).
English: Each carton contains 1 bottle.
Danish: Hver karton indeholder 1 flaske.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Danish: Brev af polyester/aluminium/polyethylen (PET/alu/PE).
English: The dose should be reduced or administration discontinued according to Table 3.
Danish: Dosis bør reduceres, eller behandlingen bør stoppes i henhold til tabel 3.
English: If lymphopenia occurs, they are to continue the prophylaxis until recovery of lymphopenia to grade ≤1.
Danish: Hvis der forekommer lymfopeni, skal de fortsætte den forebyggende behandling, indtil bedring af lymfopenien til grad ≤ 1.
English: Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct.
Danish: De cytotoksiske læsioner, der udvikles efterfølgende, synes at involvere aberrant reparation af methyladduktet.
English: Anti-emetic prophylaxis is recommended prior to the initial dose of concomitant phase and it is strongly recommended during the monotherapy phase.
Danish: Antiemetisk profylakse anbefales før den initiale dosis i den konkomitante fase og det anbefales kraftigt i monoterapifasen
English: The estimated probability of surviving 2 years or more (26% vs 10%) is higher for the RT + TMZ arm.
Danish: Den estimerede sandsynlighed for at overleve 2 år eller mere (26 % vs. 10 %) er højere for gruppen, som fik RT + TMZ.
English: During treatment a complete blood count should be obtained on Day 22 (21 days after the first dose of TMZ).
Danish: Under behandlingen bør der foretages en komplet blodtælling på dag 22 (21 dage efter den første dosis TMZ).
English: CTC Grade 3
Danish: CTC grad 3
English: Each strength has a different colour cap.
Danish: Hver styrke har en forskellig farve på kapselhætten.
English: - if you feel sick or vomit, which are very common side effects of Temozolomide (see section 4).
Danish: - hvis De får kvalme eller kaster op, hvilket er meget almindelige bivirkninger af temozolomid (se afsnit 4).
English: You must not breast-feed whilst you are being treated with Temozolomide Accord.
Danish: De må ikke amme, mens De behandles med Temozolomide Accord.
English: The objective response rate (ORR) based on MRI scans was 8%.
Danish: Den objektive responsrate (ORR) var 8 % baseret på MR-scanninger.
English: Dose during Cycles 2-6 in absence of toxicity Table 3.
Danish: Dosis i serie 2-6 ved fravær af toksicitet Tabel 3.
English: For all patients, liver function tests should be checked after each treatment cycle.
Danish: Leverfunktionsprøver bør chekkes hos alle patienter efter hver behandlingscyklus.
English: indicating complete absorption.
Danish: 0,8 %, hvilket tyder på fuldstændig absorption.