natgillin/translations-raw huggingface dataset:
TMZ er et embryotoksisk, teratogent og genotoksisk alkylerende stof.
TMZ is an embryotoxic, teratogenic and genotoxic alkylating agent.
Dosisreduktioner og seponeringer under monoterapi-fasen bør ske i henhold til tabel 2 og 3.
Dose reductions and discontinuations during the monotherapy phase should be applied according to Tables 2 and 3.
I den ikke-randomiserede undersøgelse var PFS efter 6 måneder 19 %, den mediane progressionsfri overlevelse 2,1 måneder, og den mediane samlede overlevelse 5,4 måneder.
In the non-comparative trial, the PFS at 6 months was 19%, the median progression-free survival was 2.1 months, and the median overall survival 5.4 months.
- da De skal overvåges nøje for udvikling af en alvorlig form for infektion i brystet, som kaldes Pneumocystis jirovecii pneumoni (PCP).
- as you should be observed closely for the development of a serious form of chest infectioncalled Pneumocystis jirovecii pneumonia (PCP).
Data for tiden til forværring af neurologisk status var bedre for TMZ end for procarbazin, ligesom data for tiden til forværring af performance status (reduktion til en KPS på < 70 eller en reduktion på mindst 30 points).
Data on time to worsening of neurological status favoured TMZ over procarbazine as did data on time to worsening of performance status (decrease to a KPS of < 70 or a decrease by at least 30 points).
Hos patienter med tidligere kemoterapi, blev der registreret forbedring hos patienter med en KPS ≥ 80.
In patients with prior chemotherapy a benefit was indicated in those with a KPS ≥ 80.
En behandlingsserie med Temozolomide Accord varer 28 dage.
A treatment cycle with Temozolomide Accord comprises 28 days.
Hvis De tager Temozolomide Accord i kombination med strålebehandling (nydiagnosticerede patienter):
If you are taking Temozolomide Accord in combination with radiotherapy (newly diagnosed patients):
Efter oral administration genfindes cirka 5 % til 10 % af dosis uomdannet i urinen efter 24 timer, og resten udskilles som temozolomidsyre, 5-aminoimidazol-4-carboxamid (AIC) eller uidentificerede polære metabolitter.
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-4carboxamide (AIC) or unidentified polar metabolites.
Afhængig af resultaterne af blodprøverne ændrer lægen måske dosis i den næste serie.
Depending on your blood test results, your doctor may adjust your dose for the next cycle.
Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager Temozolomide Accord
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temozolomide Accord,
Erfaring efter markedsføringen
Post-marketing experience
Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de bruger Temozolomide Accord (se også ”Frugtbarhed hos mænd” nedenfor).
Effective contraceptive precautions must be taken by both male and female patients who are taking Temozolomide Accord (see also “Male fertility” below).
Indehaver af markedsføringstilladelsen Accord Healthcare S.L.U.
Marketing Authorisation Holder Accord Healthcare S.L.U.
Da TMZ imidlertid ikke metaboliseres i leveren og har en lav proteinbinding, er det usandsynligt, at det vil påvirke andre lægemidlers farmakokinetik (se pkt.
However, since TMZ does not undergo hepatic metabolism and exhibits low protein binding, it is unlikely that it would affect the pharmacokinetics of other medicinal products (see section 5.2).
SÆRLIGE OPBEVARINGSBETINGELSER Må ikke opbevares ved temperaturer over 25 °C.
SPECIAL STORAGE CONDITIONS Do not store above 25ºC.
Systemorganklasse TMZ + konkomitant RT n=288*
System organ class TMZ + concomitant RT n=288*
Der er set meget sjældne tilfælde af lungebivirkninger med temozolomid.
Very rare cases of lung side effects have been observed with temozolomide.
Recidiverende anaplastisk astrocytom
Recurrent anaplastic astrocytoma
Derefter skal De have op til 6 serier, og hver serie varer i 28 dage.
Then there may be up to 6 treatment cycles, and each one lasts 28 days.
Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge eller apotekspersonalet til råds, før De tager dette lægemiddel.
If you are pregnant or, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- De kan have en lille risiko for andre forandringer i Deres blodceller, for eksempel leukæmi.
- you may have a small risk of other changes in blood cells, including leukaemia.
Afhængig af hvilken dosis lægen har ordineret, skal De måske tage flere kapsler på hver behandlingsdag i en serie.
Depending on the dose of temozolomide that your doctor prescribes, you may have to take several capsules on each dosing day of the treatment cycle.
Cytomegalovirusinfektion, reaktivering af infektion såsom cytomegalovirus, hepatitis B-virus†, Meningoencephalitis herpetica†, sepsis†
cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, Meningoencephalitis herpetic†, sepsis†
Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESS)
Drug reaction with eosinophilia and systemic symptoms (DRESS)
Patienter, der er blevet behandlet med TMZ, kan opleve myelosuppression, inklusive vedvarende pancytopeni, hvilket kan resultere i aplastisk anæmi, som i visse tilfælde har haft dødeligt udfald.
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.
Én patient tog en overdosis på 10.000 mg (totaldosis i en enkelt serie over 5 dage), og de rapporterede bivirkninger var pancytopeni, pyreksi, multiorgansvigt og død.
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.
Cytotoksiciteten af MTIC menes primært at skyldes alkyleringen af DNA, hovedsageligt ved O6 og N7 positionerne i guanin.
The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA mainly at the O6 and N7 positions of guanine.
Erythema multiforme, erythroderma, urticaria, exantem Almene symptomer og reaktioner på administrationsstedet Meget almindelig:
Erythema multiforme, erythroderma, urticaria, exanthema General disorders and administration site conditions Very common:
I sjældne tilfælde kan patienter, som tager temozolomid eller lignende medicin, have en lille risiko for at udvikle andre ændringer i blodets celler, herunder leukæmi.
Very rarely, patients taking temozolomide and medicines like it may have a small risk of other changes in blood cells, including leukaemia.
- hvis De har problemer med lever eller nyrer, da der så kan være brug for at ændre dosis af temozolomid.
- if you have liver or kidney problems as your dose of temozolomide may need to be adjusted.
Hvis dosis ikke blev øget i serie 2, bør den ikke øges i de følgende serier.
If the dose was not escalated at Cycle 2, escalation should not be done in subsequent cycles.
Samtidig indtagelse af valproat var forbundet med et lille, men statistisk signifikant fald i TMZs clearance.
Co-administration with valproic acid was associated with a small but statistically significant decrease in clearance of TMZ.
Hver gang De påbegynder en ny behandlingsserie, skal De være sikker på, at De er klar over, hvor mange kapsler af hver styrke, De skal tage og i hvor mange dage.
Each time you start a new treatment cycle, be sure you understand exactly how many capsules of each strength you need to take each day and how many days you will receive this dose.
I en populationsfarmakokinetisk analyse af resultaterne fra kliniske undersøgelser var der 101 kvindelige og 169 mandlige forsøgspersoner, for hvem nadir for neutrofiltallet forelå, og 110 kvindelige og 174 mandlige forsøgspersoner, for hvem nadir for trombocyttallet forelå.
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.
Ældre patienter er mere modtagelige for infektioner og har øget tendens til blå mærker eller blødninger.
Older patients are more prone to infections, increased bruising or bleeding.
Temozolomidee Accord giver muligvis permanent ufrugtbarhed.
Temozolomide Accord may cause permanent infertility.
Figur 1 Kaplan-Meier kurver for samlet overlevelse (intent-to-treat population) Resultaterne fra undersøgelsen var ikke konsistente i den patientundergruppe, som havde en dårlig performance status (WHO PS = 2, n = 70), hvor samlet overlevelse og tid til progression var ens for de to grupper.
Figure 1 Kaplan-Meier curves for overall survival (intent-to-treat population) 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.
Sådan åbnes brevet Åbn brevet ved at folde og rive langs foldelinjen med hakket i hjørnet af brevet.
How to open sachet Open the sachet by folding and tearing along the fold line with the notch in the corner of the sachet.
Der er rapporter om patienter, som har taget den anbefalede dosis i mere end 5 dage (op til 64 dage), med bivirkninger, som inkluderede knoglemarvssuppression, med eller uden infektion, i nogle tilfælde alvorlige og langvarige og resulterende i død.
There are reports of patients who have taken the recommended dose for more than 5 days of treatment (up to 64 days) with adverse reactions reported including bone marrow suppression, with or without infection, in some cases severe and prolonged and resulting in death.
Der er blevet rapporteret om hepatitis forårsaget af hepatitis B-virus (HBV)-reaktivering, som i nogle tilfælde medførte døden.
Hepatitis due to hepatitis B virus (HBV) reactivation, in some cases resulting in death, has been reported.
TMZ blev givet som ”salvage” behandling i opfølgningsfasen til 161 patienter af de 282 (57 %) i armen, som kun fik RT, og til 62 patienter af de 277 (22 %) i armen, som fik TMZ + RT.
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.
Populationsfarmakokinetisk analyse af TMZ viste, at TMZs clearance i plasma var uafhængig af alder, nyrefunktion og tobaksforbrug.
Analysis of population-based pharmacokinetics of TMZ revealed that plasma TMZ clearance was independent of age, renal function or tobacco use.
Disse bivirkninger var oftest af grad 1 eller 2 (0-5 opkastninger inden for 24 timer), og de ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standardbehandling.
These reactions were usually Grade 1 or 2 (0 - 5 episodes of vomiting in 24 hours) and were either self-limiting or readily controlled with standard anti-emetic therapy.
Der kan anvendes antiemetisk behandling (se pkt.
Anti-emetic therapy may be administered (see section 4.4).
Pakningsstørrelser med 5 eller 20 hårde kapsler forseglet individuelt i breve.
Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Kapselskal Gelatine
Capsule shell Gelatine
Hvis De kaster op efter at have taget en dosis, må De ikke tage en ny dosis den samme dag.
If you vomit after your dose, do not take a second dose on the same day.
Tilfælde af fatal respirationssvigt er rapporteret hos patienter, der fik TMZ, især i kombination med dexamethason eller andre steroider.
Cases of fatal respiratory failure have been reported in patients using TMZ, in particular in combination with dexamethasone or other steroids.
Det kan betyde, at De kan få flere blå mærker eller blødning, blodmangel (anæmi), feber og/eller nedsat modstandskraft over for infektioner.
This may cause you to have increased bruising or bleeding, anaemia (a shortage of red blood cells), fever, and/or a reduced resistance to infections.
Hazard ratio (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.
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.
Hvis De får feber eller symptomer på en infektion, skal De omgående kontakte Deres læge.
If you develop fever or symptoms of an infection contact your doctor immediately.
In vivo var t1/2 for MTIC den samme som for TMZ, 1,8 timer.
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Hvis De kun tager Temozolomide Accord (uden strålebehandling):
If you are taking Temozolomide Accord capsules alone (without radiotherapy):
Forsigtighed bør imidlertid udvises, når TMZ gives til disse patienter.
However, caution should be exercised when TMZ is administered in these patients.
Behandlingen med TMZ bør afbrydes midlertidigt eller permanent under den konkomitante fase i henhold til de hæmatologiske og ikke-hæmatologiske toksicitetskriterier som angivet i Tabel 1.
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.
Data om klinisk effekt hos patienter med glioblastoma multiforme (Karnofsky performance status [KPS] ≥70), progressiv eller recidiverende efter kirurgi eller RT, var baseret på to kliniske forsøg med oral TMZ.
Data on clinical efficacy in patients with glioblastoma multiforme (Karnofsky performance status [KPS] ≥70), progressive or recurrent after surgery and RT, were based on two clinical trials with oral TMZ.
Farmakoterapeutisk klassifikation: Antineoplastiske midler - Andre alkylerende midler, ATC-kode: L01A X03.
Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03
Bivirkningerne kan kræve lægebehandling.
Medical attention may be required.
I prækliniske undersøgelser på rotter og kaniner, som fik doser på 150 mg/m2, blev der påvist teratogenicitet og/eller føtal toksicitet (se pkt.
In preclinical studies in rats and rabbits receiving 150 mg/m2, teratogenicity and/or foetal toxicity were demonstrated (see section 5.3).
Forebyggende behandling mod PCP er derfor påkrævet for alle patienter, der får konkomitant TMZ og RT i 42 dages regimet (højst 49 dage), uanset lymfocyttallet.
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.
Der er ingen klinisk erfaring med brug af TMZ til børn under 3 år.
There is no clinical experience with use of TMZ in children under the age of 3 years.
Patienter, som tager temozolomid i kombination med strålebehandling kan få andre bivirkninger end patienter, som kun tager temozolomid.
Patients taking temozolomide in combination with radiation therapy may experience different side effects than patients taking temozolomide alone.
Bed lægen eller apoteket om at skrive ned, hvor mange kapsler (og af hvilken farve), De skal tage af hver styrke på hver behandlingsdag.
Ask your doctor or pharmacist to write down the number of each strength (including colour) that you need to take each dosing day.
MTIC hydrolyseres spontant til 5-amino-imidazol-4-carboxamid (AIC), et kendt mellemprodukt i purin- og nukleinsyrebiosyntesen, og til methylhydrazin, som menes at være det aktive alkylerende stof.
MTIC is spontaneously hydrolyzed to 5-amino-imidazole-4carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Der blev set myelosuppression (neutropeni og trombocytopeni), som er en kendt dosisbegrænsende toksicitet for de fleste cytotoksiske stoffer, inklusive TMZ.
Myelosuppression (neutropenia and thrombocytopenia), which is known dose-limiting toxicity for most cytotoxic agents, including TMZ, was observed.
Det medførte hospitalisering og/eller seponering af TMZ hos henholdsvis 8 % and 4 % af patienterne.
This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Temozolomide Accord indeholder lactose
Temozolomide Accord contains lactose
De følgende bivirkninger kan forekomme, hvis De kun tager temozolomid (patienter, som behandles for tilbagevendende hjernesvulster eller hjernesvulster, som har spredt sig).
The following side effects may occur if you are taking only temozolomide (patients treated for brain tumours that have come back or that have spread)
Otitis media, tinnitus, hyperacusis, øresmerter
Otitis media, tinnitus, hyperacusis, earache
Symptomer på diabetes insipidus inkluderer øget vandladning og tørst.
Symptoms of diabetes insipidus include passing a lot of urine and feeling thirsty.
• angst, depression, ændringer i emotionelle følelser, manglende evne til at falde i søvn eller sove igennem,
• anxiety, depression, changing emotions, inability to fall asleep or stay asleep,
Der er set meget sjældne tilfælde af alvorlig udslæt med hævelser i huden, som inkluderer håndfladerne og fodsålerne, eller smertefuld rødme af huden og/eller blærer på kroppen eller i munden.
Very rare cases of 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.
Det anbefales at søge råd med hensyn til nedfrysningaf sædvæske før behandling
It is recommended to seek advice on conservation of sperm prior to treatment.
Deres læge vil tjekke Dem for tegn på denne infektion, før behandlingen startes.
Patients will be carefully checked by their doctor for signs of this infection before treatment.
Hvis der er gået en hel dag, skal De kontakte Deres læge straks.
If a full day has gone by, check with your doctor.
• hyppig vandladning, vanskeligheder med at holde på vandet eller urinlækage
• frequent urination, difficulty with holding your urine or urine leakage
Allergiske reaktioner, inklusive anafylaksi, angioødem
Allergic reactions, including anaphylaxis, angioedema
Hvis De tit kaster op før og under behandlingen, skal De bede Deres læge om medicin til at forebygge eller behandle opkastningerne og spørge om, hvornår De helst skal tage temozolomid for at bringe opkastningerne under kontrol.
If you vomit frequently before or during treatment, ask your doctor about medicines to help prevent vomiting or control the vomiting and the best time to take temozolomide until the vomiting is under control.
Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anørt i pkt 6.1.
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
I visse tilfælde vil dosis af temozolomid blive sat ned, eller behandlingen vil blive stoppet.
In some cases, your temozolomide dose will be reduced or discontinued.
Baseret på TMZs farmakokinetiske egenskaber er det usandsynligt, at dosisreduktion er påkrævet hos patienter med svær lever- eller nyreinsufficiens.
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.
Når de abnorme laboratorieværdier og bivirkningerne blev slået sammen på tværs af konkomitante og monoterapi-behandlingsfaser, blev der set neutrofilabnormaliteter af grad 3 eller 4, inklusive neutropeniske bivirkninger, hos 8 % af patienterne.
When laboratory abnormalities and adverse reactions were combined across concomitant and monotherapy treatment phases, Grade 3 or Grade 4 neutrophil abnormalities including neutropenic reactions were observed in 8% of the patients.
Det ene var et non-komparativt forsøg med 138 patienter (29 % havde fået kemoterapi tidligere), og det andet var et aktivt kontrolleret forsøg, som sammenlignede TMZ med procarbazin hos 225 patienter (67 % havde tidligere fået kemoterapi baseret på nitrosourea).
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).
Neutropeni eller lymfopeni (grad 3-4), trombocytopeni (grad 3-4),
Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Temozolomid fås i kapsler med forskellig styrke (styrken i milligram fremgår af den ydre etiket).
Temozolomide comes in different strength capsules (shown on the outer label in mg).
I en separat fase I-undersøgelse medførte administration af TMZ og ranitidin ingen ændringer i absorptionen af TMZ eller i eksponeringen over for dets aktive metabolit monomethyltriazenoimidazolcarboxamid (MTIC).
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).
Pneumocystis jirovecii lungebetændelse
Pneumocystis jirovecii pneumonia
Temozolomid må kun ordineres af specialister med erfaring i hjernesvulster.
Temozolomide should only be prescribed by specialists experienced in brain tumours.
PET-undersøgelser hos mennesker og prækliniske data tyder på, at TMZ passerer blodhjernebarrieren hurtigt og er til stede i CSF.
PET studies in humans and preclinical data suggest that TMZ crosses rapidly the blood-brain barrier and is present in the CSF.
• ændringer i blodets celler
• changes in blood cells,
Hold flasken tæt tillukket for at beskytte mod fugtighed.
Keep the bottle tightly closed in order to protect from moisture.
• unormalt eller sløret syn, dobbeltsyn
• abnormal or blurred vision, double-vision
De hårde kapsler udleveres i brune glas, som indeholder 5 eller 20 kapsler.
The hard capsules are dispensed in amber glass bottles containing 5 or 20 capsules.
De hårde kapsler udleveres i breve indeholdende 1 kapsel.
The hard capsules are dispensed in sachet containing 1 capsule.
I en prospektiv multicenterundersøgelse i fase II, der vurderede sikkerhed og effekt af oral TMZ i behandlingen af patienter med anaplastisk astrocytom efter første relaps, var 6 måneders PFS 46 %.
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%.
Temozolomide Accord 5 mg hårde kapsler Temozolomide Accord 20 mg hårde kapsler Temozolomide Accord 100 mg hårde kapsler Temozolomide Accord 140 mg hårde kapsler Temozolomide Accord 180 mg hårde kapsler Temozolomide Accord 250 mg hårde kapsler temozolomid
Temozolomide Accord 5 mg hard capsules Temozolomide Accord 20 mg hard capsules Temozolomide Accord 100 mg hard capsules Temozolomide Accord 140 mg hard capsules Temozolomide Accord 180 mg hard capsules Temozolomide Accord 250 mg hard capsules temozolomide
Brug af anden medicin sammen med Temozolomide Accord Fortæl lægen eller apotekspersonalet, hvis De bruger anden medicin, gjort det for nylig eller måske skal gøre det.
Other medicines and Temozolomide Accord Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Kvalme og opkastning forekommer meget almindeligt i forbindelse med TMZ.
Nausea and vomiting are very commonly associated with TMZ.
- hvis De har et nedsat antal blodceller, for eksempel hvide blodceller og blodplader.
- if you have a reduced number of blood cells, such as your white blood cell count and platelet count.
De må ikke åbne, knuse eller tygge kapslerne.
Do not open, crush or chew the capsules.
Hvis De er diagnosticeret for nylig (glioblastoma multiforme), skal De muligvis have temozolomid i 42 dage i kombination med strålebehandling.
If you are a newly-diagnosed patient (glioblastoma multiforme) you may be receiving temozolomide for 42 days in combination with radiotherapy.
Tilfælde af forhøjede leverenzymer er almindelig rapporteret.
Cases of elevations of liver enzymes have been commonly reported.