FrancophonIA/ELRC3.0 huggingface dataset:
English: Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Austria
Danish: Sandoz GmbH Biochemiestraße 10 A-6250 Kundl Østrig
English: Very rare cases of lung side effects have been observed with temozolomide.
Danish: Der er set meget sjældne tilfælde af lungebivirkninger med temozolomide.
English: The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred.
Danish: De primære målorganer for toksicitet omfattede knoglemarven, det lymforetikulære system, testes, mave-tarmkanalen og ved højere doser, der var dødelige hos 60 % til 100 % af de undersøgte rotter og hunde, forekom degeneration af retina.
English: Tell your doctor immediately if this occurs
Danish: Kontakt straks din læge, hvis dette forekommer.
English: Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Danish: Samtidig indtagelse af valproat var forbundet med et lille, men statistisk signifikant fald i TMZ-clearance.
English: Do not open, crush or chew the capsules.
Danish: Lad være med at åbne, knuse eller tygge kapslerne.
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: 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: In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
Danish: Hos patienter, der tidligere havde fået kemoterapi, blev der registreret en forbedring hos patienter med en KPS ≥ 80.
English: Relative to the AUC of TMZ, the exposure to MTIC and AIC is ~ 2.4 % and 23 %, respectively.
Danish: I forhold til AUC for TMZ er eksponeringen for MTIC og AIC henholdsvis ~ 2,4 % og 23 %.
English: Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
Danish: Dosisreduktioner og seponeringer under monoterapi-fasen bør ske i henhold til Tabel 2 og 3.
English: Following oral administration, approximately 5 % to 10 % of the dose is recovered unchanged in the urine over 24 hours, and the remainder excreted as temozolomide acid, 5-aminoimidazole-4-carboxamide (AIC) or unidentified polar metabolites.
Danish: Efter peroral administration genfindes cirka 5 % til 10 % af dosis uomdannet i urinen over 24 timer, og resten udskilles som temozolomidsyre, 5-aminoimidazol-4-carboxamid (AIC) eller uidentificerede polære metabolitter.
English: CTC Grade 3 or 4
Danish: CTC Grad 3 eller 4
English: If a full day has gone by, check with your doctor.
Danish: Hvis der er gået en hel dag, skal du kontakte din læge straks.
English: Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Sandoz (see also “Male fertility” below).
Danish: Både mandlige og kvindelige patienter skal anvende sikre pæventionsmidler, mens de tager Temozolomide Sandoz (se også ”Frugtbarhed hos mænd” nedenfor).
English: Take your prescribed dose of Temozolomide Sandoz once a day, preferably at the same time each day.
Danish: Tag den ordinerede dosis af Temozolomide Sandoz én gang dagligt, helst på samme tidspunkt hver dag.
English: Accidental ingestion can be lethal for children.
Danish: Utilsigtet indtagelse kan være dødbringende for børn.
English: An overdose of 10,000 mg (total dose in a single cycle, over 5 days) was taken by one patient and the adverse reactions reported were pancytopenia, pyrexia, multi-organ failure and death.
Danish: Én patient har taget en overdosis på 10.000 mg (total dosis i en enkelt serie over 5 dage), og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og dødsfald.
English: • hallucination and memory impairment
Danish: • hallucinationer og forringet hukommelse
English: Results of the Ames/salmonella and Human Peripheral Blood Lymphocyte (HPBL) chromosome aberration tests showed a positive mutagenicity response.
Danish: Resultaterne af Ames/Salmonellas test og kromosomaberrationstest i humane perifere blodlymfocytter (HPBL) viste en positiv mutagenicitetsrespons.
English: Dose levels include 100 mg/m2, 150 mg/m2, and 200 mg/m2.
Danish: Dosistrinerne omfatter 100 mg/m2, 150 mg/m2 og 200 mg/m2.
English: Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Danish: Myelosuppression (neutropeni og trombocytopeni), som er en kendt dosisbegrænsende toksicitet for de fleste cytotoksiske stoffer, herunder TMZ, blev observeret.
English: TMZ administration should be temporarily interrupted or permanently discontinued during the concomitant phase according to the haematological and non-haematological toxicity criteria as noted in Table 1.
Danish: Indgift af TMZ bør afbrydes midlertidigt eller seponeres permanent under den konkomitante fase i henhold til de hæmatologiske og ikke-hæmatologiske toksicitetskriterier som angivet i Tabel 1.
English: Patients treated with TMZ may experience myelosuppression, including prolonged pancytopenia, which may result in aplastic anaemia, which in some cases has resulted in a fatal outcome.
Danish: Patienter, der er blevet behandlet med TMZ, kan opleve myelosuppression, herunder vedvarende pancytopeni, hvilket kan resultere i aplastisk anæmi, som i visse tilfælde har haft dødeligt udfald.
English: Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
Danish: Hepatitisreaktivering på grund af hepatitis B-virus (HBV), der i visse tilfælde er resulteret i dødsfald, er blevet rapporteret.
English: Temozolomide Sandoz may make you feel tired or sleepy.
Danish: Når du tager Temozolomide Sandoz, kan du føle dig træt eller søvnig.
English: Severe myelosuppression (see section 4.4).
Danish: Svær myelosuppression (se pkt.
English: There is no clinical experience with use of TMZ in children under the age of 3 years.
Danish: Der er ingen klinisk erfaring med anvendelse af TMZ til børn under 3 år.
English: In a population pharmacokinetics analysis of clinical trial experience there were 101 female and 169 male subjects for whom nadir neutrophil counts were available and 110 female and 174 male subjects for whom nadir platelet counts were available.
Danish: I et observationsmateriale fra farmakokinetisk analyse af kliniske forsøg var erfaringen, at der var 101 kvindelige og 169 mandlige forsøgspersoner, for hvem nadir neutrofiltallet forelå, og 110 kvindelige og 174 mandlige forsøgspersoner, for hvem nadir blodpladetallet forelå.
English: TMZ Dose (mg/m2/day)
Danish: monoterapi Dosisniveau TMZ Dosis (mg/m2/dag)
English: Male fertility
Danish: Mandlig fertilitet
English: • change in skin colour
Danish: • ændring i hudfarve
English: Patients receiving temozolomide in combination with radiotherapy may experience different side effects than patients taking temozolomide alone.
Danish: Patienter, der får temozolomid i kombination med strålebehandling, kan opleve andre bivirkninger end patienter, der kun får temozolomid.
English: The hazard ratio (HR) for overall survival was 1.59 (95 % CI for HR=1.33-1.91) with a log-rank p < 0.0001 in favour of the TMZ arm.
Danish: Hazard rate (HR) for den totale overlevelse var 1,59 (95 % CI for HR=1,33-1,91) med en log-rank p < 0,0001 til fordel for TMZ-gruppen.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: TMZ was administered as salvage therapy in the follow-up phase in 161 patients of the 282 (57 %) in the RT alone arm, and 62 patients of the 277 (22 %) in the TMZ + RT arm.
Danish: TMZ blev administreret som salvage-behandling i opfølgningsfasen hos 161 patienter af 282 (57 %) i armen med kun strålebehandling, og 62 patienter af 277 (22 %) i armen med TMZ + strålebehandling.
English: Temozolomide Sandoz treatment can cause a reduction in certain kinds of blood cells.
Danish: Behandling med Temozolomide Sandoz kan give et fald i antallet af visse typer blodceller.
English: • low potassium level in the blood
Danish: • lavt kaliumindhold i blodet
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.
English: Herpes simplex, herpes zoster, influenza-like symptoms
Danish: Herpes simplex, herpes zoster, influenzalignende symptomer
English: Endocrine disorders*
Danish: Endokrine lidelser*
English: New or reactivated (recurring) cytomegalovirus infections and reactivated hepatitis B virus infections have been uncommonly reported.
Danish: Nye eller reaktiverede (recidiverende) cytomegalovirus-infektioner og reaktiverede hepatitis Bvirusinfektioner er blevet rapporteret som værende ualmindelige.
English: No dose reductions are recommended, but delay or discontinuation of TMZ administration should be decided weekly according to haematological and non-haematological toxicity criteria.
Danish: Det anbefales ikke at foretage dosisreduktioner, men udskydelse eller seponering af TMZ-indgift bør overvejes hver uge i henhold til hæmatologiske og ikkehæmatologiske toksicitetskriterier.
English: Patients who received concomitant TMZ and RT in a pilot trial for the prolonged 42-day schedule were shown to be at particular risk for developing Pneumocystis jirovecii pneumonia (PCP).
Danish: Patienter, som fik konkomitant TMZ og strålebehandling i et pilotforsøg af det længerevarende 42 dages-program, viste sig at have særlig risiko for at udvikle Pneumocystis jirovecii pneumonia (PCP).
English: The dose should be reduced or administration discontinued according to Table 3.
Danish: Dosis bør reduceres eller indgiften seponeres i henhold til Tabel 3.
English: Erythema multiforme, erythroderma, urticaria, exanthema
Danish: Erythema multiforme, erythroderma, urticaria, exantem
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 + strålebehandling (n=287) eller kun strålebehandling (n=286).
English: Each carton contains 5 or 20 hard capsules.
Danish: Hver karton indeholder 5 eller 20 hårde kapsler.
English: Based on the pharmacokinetic properties of TMZ, it is unlikely that dose reductions are required in patients with severe hepatic impairment or any degree of renal impairment.
Danish: Baseret på TMZ's farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær leverinsufficiens eller en hvilken som helst grad af nyreinsufficiens.
English: Each hard capsule (capsule) is individually packed in a sachet.
Danish: Alle hårde kapsler (kapslerne) er pakket enkeltvist i breve.
English: During the monotherapy phase, the dose and way you take Temozolomide Sandoz will be different.
Danish: Under monoterapi-fasen vil dosis og måden, du tager Temozolomide Sandoz på, være anderledes.
English: Therefore, special care should be taken when TMZ is administered in elderly patients.
Danish: Derfor bør der udvises særlig forsigtighed, når TMZ gives til ældre patienter.
English: The first dose will be 150 mg/m2.
Danish: Den første dosis vil være på 150 mg/m2.
English: However, caution should be exercised when TMZ is administered in these patients.
Danish: Der bør imidlertid udvises forsigtighed, når TMZ gives til disse patienter.
English: The hard capsules are dispensed in amber glass bottles (Type 3 glass) with polypropylene childresistant closures.
Danish: De hårde kapsler leveres i brune glasflasker (Type III-glas) med børnesikret polypropylen-låg.
English: Patients should be advised to keep capsules out of the sight and reach of children, preferably in a locked cupboard.
Danish: Patienter bør rådes til at opbevare kapslerne utilgængeligt og ude af syne for børn, helst i et aflåst skab.
English: - This medicine has been prescribed for you only.
Danish: Lægen har ordineret dette lægemiddel dig personligt.
English: Temozolomide Sandoz should only be prescribed by physicians experienced in the oncological treatment of brain tumours.
Danish: Temozolomide Sandoz bør kun ordineres af læger, der har erfaring med onkologisk behandling af hjernetumorer.
English: • uncontrolled bleeding,
Danish: • ukontrolleret blødning
English: Always take Temozolomide Sandoz exactly as your doctor has told you.
Danish: Tag altid Temozolomide Sandoz nøjagtigt efter lægens anvisning.
English: One was a non-comparative trial in 138 patients (29 % received prior chemotherapy), and the other was a randomised active-controlled trial of TMZ vs procarbazine in a total of 225 patients (67 % received prior treatment with nitrosourea based chemotherapy).
Danish: Den ene var et non-komparativt forsøg hos 138 patienter (29 % fik tidligere kemoterapi), og den anden var et randomiseret aktiv-kontrolleret forsøg med TMZ versus procarbazin hos i alt 225 patienter (67 % fik tidligere behandling med nitrosurea baseret kemoterapi).
English: In some cases, your Temozolomide Sandoz dose will be reduced or treatment stopped.
Danish: I visse tilfælde vil din dosis af Temozolomide Sandoz blive nedsat, eller din behandling vil blive stoppet.
English: If you vomit frequently before or during treatment, ask your doctor about the best time to take Temozolomide Sandoz 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 Sandoz, indtil opkastningen er under kontrol.
English: If you accidentally take more Temozolomide Sandoz capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du ved en fejl tager flere kapsler med Temozolomide Sandoz end foreskrevet, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet.
English: A complete blood count should be obtained on Day 22 (21 days after the first dose) or within 48 hours of that day, and weekly until ANC > 1.5 x 109/l and platelet count > 100 x 109/l.
Danish: En fuldstændig blodtælling skal foretages på dag 22 (21 dage efter den første dosis) eller inden for 48 timer herefter, og ugentligt indtil ANC > 1,5 x 109/l og trombocyttallet > 100 x 109/l.
English: Cases of sepsis (when bacteria and their toxins circulate in the blood and start to damage the organs) have been uncommonly reported.
Danish: Der er rapporteret tilfælde af sepsis (blodforgiftning - når bakterier og deres toksiner (giftstoffer) er kommet ind i blodet og begynder at skade kroppens organer) med hyppigheden ”ikke almindelig”.
English: • confusion
Danish: • forvirring
English: Laboratory results
Danish: Laboratorieresultater
English: CTC Grade 3
Danish: CTC Grad 3
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 (såsom Pneumocystis jirovecii-pneumonia) og reaktivering af infektioner (såsom HBV, CMV) er blevet observeret under behandling med TMZ (se afsnit 4.8).
English: You may be given other medicines (anti-emetics) to take before and/or after taking Temozolomide Sandoz 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 Sandoz for at undgå eller regulere kvalme og opkastning.
English: In a separate phase I study, administration of TMZ with ranitidine did not result in alterations in the extent of absorption of temozolomide or the exposure to its active metabolite monomethyl triazenoimidazole carboxamide (MTIC).
Danish: I et separat fase I-studie resulterede indtagelse af TMZ sammen med ranitidin ikke i ændringer i absorptionsgraden af temozolomid eller eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
English: • partial paralysis
Danish: • delvis lammelse
English: Each sachet contains 1 hard capsule.
Danish: Hvert brev indeholder 1 hård kapsel.
English: Nausea and vomiting are very commonly associated with TMZ.
Danish: Kvalme og opkastning er meget almindeligt i forbindelse med TMZ.
English: OTHER SPECIAL WARNING, IF NECESSARY Cytotoxic
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk .
English: MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Danish: MTIC hydrolyseres spontant til 5-amino-imidazol-4-carboxamid (AIC), et kendt mellemprodukt i purin- og nucleinsyrebiosyntesen, og til methylhydrazin, som menes at være det aktive alkyleringsmiddel.
English: Temozolomide Sandoz contains lactose (a kind of sugar).
Danish: Temozolomide Sandoz indeholder lactose (en form for sukker).
English: The median survival was 7.34 and 5.66 months for TMZ and procarbazine, respectively (log rank p = 0.33).
Danish: Den mediane overlevelse var 7,34 og 5,66 måneder for henholdsvis TMZ og procarbazin (log rank p = 0,33).
English: Allergic reactions, including anaphylaxis, angioedema
Danish: Allergiske reaktioner, herunder anafylaksi, angioødem
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V*.
English: myelodysplastic syndrome (MDS), secondary malignancies, including myeloid leukaemia
Danish: Myelodysplastisk syndrom (MDS), sekundære maligne lidelser, inklusive myeloid leukæmi
English: • allergic reaction
Danish: • allergiske reaktioner
English: Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Danish: Ved analyse af populationsbaseret farmakokinetik for TMZ blev det fundet, at plasmaclearance af TMZ var uafhængig af alder, nyrefunktion og tobaksforbrug.
English: Male patients
Danish: Mandlige patienter
English: Thus, prophylaxis against PCP is required for all patients receiving concomitant TMZ and RT for the 42-day regimen (with a maximum of 49 days) regardless of lymphocyte count.
Danish: Forebyggende behandling mod PCP er derfor påkrævet for alle patienter, der får konkomitant TMZ og strålebehandling i 42 dages regimen (med højst 49 dage) uafhængigt af lymfocyttal.
English: • a cold or the flu
Danish: • forkølelse eller influenza
English: • absent or heavy menstrual periods,
Danish: • udeblivende eller kraftige menstruationer
English: If abnormal, physicians should assess the benefit/risk prior to initiating temozolomide including the potential for fatal hepatic failure.
Danish: Hvis disse er unormale, bør lægen vurdere fordel/risiko-forholdet før initiering af temozolid-behandling herunder risikoen for letalt leversvigt.
English: Women of childbearing potential should be advised to use effective contraception to avoid pregnancy while they are receiving TMZ.
Danish: Kvinder i den fertile alder skal anbefales at anvende sikker kontraception for at undgå graviditet under behandling med TMZ.
English: TMZ + concomitant RT n=288*
Danish: TMZ + konkomitant strålebehandling n=288*
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 Sandoz eller lignende medicin, have en lille risiko for at udvikle en sekundær kræftform, herunder leukæmi.
English: Reduction for prior toxicity Dose during Cycle 1
Danish: Reduktion på grund af tidligere toksicitet Dosis under serie 1
English: Based on an analysis of population pharmacokinetics in phase II trials, co-administration of dexamethasone, prochlorperazine, phenytoin, carbamazepine, ondansetron, H2 receptor antagonists, or phenobarbital did not alter the clearance of TMZ.
Danish: På basis af en analyse af populationsfarmakokinetik i fase II-forsøg, ændrede samtidig administration af dexamethason, prochlorperazin, phenytoin, carbamazepin, ondansetron, H2-receptorantagonister eller phenobarbital ikke clearance af TMZ.
English: Temozolomide Sandoz is used for the treatment of specific forms of brain tumours:
Danish: Temozolomide Sandoz anvendes til behandling af specifikke former for hjernesvulster:
English: Your blood will be tested frequently during treatment to monitor the side effects of Temozolomide Sandoz on your blood cells.
Danish: Du vil regelmæssigt få undersøgt dit blod under behandlingen for at følge bivirkningerne af Temozolomide Sandoz på dine blodceller.
English: Toxicity
Danish: Toksicitet
English: In preclinical studies in rats and rabbits receiving 150 mg/m2 TMZ, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Danish: I prækliniske forsøg udført på rotter og kaniner med doser på 150 mg/m2 TMZ blev teratogenicitet og/eller føtal toksicitet påvist (se pkt.
English: No data are available on the administration of TMZ in patients with severe hepatic impairment (Child's Class C) or with renal impairment.
Danish: Der er ingen tilgængelige data vedrørende indgift af TMZ til patienter med svær leverinsufficiens (Child's Class C) eller med nedsat nyrefunktion.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Danish: I nogle tilfælde vanskeliggøres vurderingen af samtidig eksponering for lægemidler, der er associeret med aplastisk anæmi, herunder carbamazepin, phenytoin og sulfamethoxazol/trimethoprim.
English: Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Danish: Tilfælde af dødeligt åndedrætssvigt er set hos patienter, som fik TMZ, især i kombination med dexamethason eller andre steroider.
English: • vaginal irriation
Danish: • vaginal irritation
English: • increased skin sensitivity to sunlight
Danish: • øget lysfølsomhed i huden
English: It is recommended to seek advice on conservation of sperm prior to treatment.
Danish: Det anbefales at søge råd med hensyn til nedfrysning af sædvæske før behandling.
English: Package leaflet: information for the user Temozolomide Sandoz 5 mg hard capsules Temozolomide Sandoz 20 mg hard capsules Temozolomide Sandoz 100 mg hard capsules Temozolomide Sandoz 140 mg hard capsules Temozolomide Sandoz 180 mg hard capsules Temozolomide Sandoz 250 mg hard capsules temozolomide
Danish: Indlægsseddel: Information til brugeren Temozolomide Sandoz 5 mg hårde kapsler Temozolomide Sandoz 20 mg hårde kapsler Temozolomide Sandoz 100 mg hårde kapsler Temozolomide Sandoz 140 mg hårde kapsler Temozolomide Sandoz 180 mg hårde kapsler Temozolomide Sandoz 250 mg hårde kapsler temozolomid
English: Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
Danish: Symptomer på diabetes insipidus omfatter hyppige vandladninger og tørstighed.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 % indicating complete absorption.
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: Pancytopenia, anaemia (grade 3-4), leukopenia
Danish: Pancytopeni, anæmi (grad 3-4), leukopeni
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekpersonalet, hvis du bruger anden medicin eller har gjort det for nylig.