FrancophonIA/ELRC3.0 huggingface dataset:
English: Anti-emetic therapy may be administered (see section 4.4).
Danish: Antiemetisk behandling kan anvendes (se pkt.
English: This led to hospitalisation and/or discontinuation of TMZ in 8 % and 4 %, respectively.
Danish: Dette medførte hospitalisering og/eller seponering af TMZ hos henholdsvis 8 % and 4 % af patienter med gliom.
English: • if certain kinds of blood cells are severely reduced (myelosuppression), such as your white blood cell count and platelet count.
Danish: • hvis antallet af visse former for blodceller er svært nedsat (myelosuppression), såsom antallet af hvide blodlegemer og antallet af blodplader.
English: In the randomised active-controlled trial, the PFS at 6 months was significantly greater for TMZ than for procarbazine (21 % vs 8 %, respectively - chi-square p = 0.008) with median PFS of 2.89 and 1.88 months respectively (log rank p = 0.0063).
Danish: I det randomiserede, aktiv-kontrollerede forsøg var PFS efter 6 måneder signifikant større for TMZ end for procarbazin (henholdsvis 21 % versus 8 % - chi-square p = 0,008) med median PFS på henholdsvis 2,89 og 1,88 måneder (log rank p = 0,33).
English: cytomegalovirus infection, infection reactivation such as cytomegalovirus, hepatitis B virus†, meningoencephalitis herpetic†, sepsis†
Danish: Cytomegalovirusinfektion, infektionsreaktivering såsom cytomegalovirus, hepatitis B-virus†, meningoencephalitis herpetica†, sepsis†
English: At 6 months, the fraction of surviving patients was significantly higher in the TMZ arm (60 %) compared with the procarbazine arm (44 %) (chi-square p = 0.019).
Danish: Efter 6 måneder var andelen af overlevende patienter signifikant større i TMZ-gruppen (60 %) sammenlignet med procarbazingruppen (44 %) (chi-square p = 0,019).
English: 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.
Danish: Disse bivirkninger var oftest grad 1 eller 2, (0 - 5 opkastninger inden for 24 timer) og ophørte af sig selv eller kunne let kontrolleres med kvalmestillende standard-behandling.
English: Neutropenia or lymphopenia (grade 3-4), thrombocytopenia (grade 3-4)
Danish: Neutropeni eller lymfopeni (grad 3-4), trombocytopeni (grad 3-4)
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: • ringing in the ears
Danish: • ringen for ørerne
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 Sandoz skal justeres.
English: • diarrhoea
Danish: • diarré
English: Cases of brain infections caused by herpes virus (meningoencephalitis herpetic), including fatal cases, have been uncommonly reported.
Danish: Tilfælde af hjerneinfektioner forårsaget af herpesvirus (meningoencephalitis herpetica), herunder tilfælde med dødelig udgang, er indberettet som ikke almindelige.
English: Metabolism and nutrition disorders Very common:
Danish: Metabolisme og ernæring Meget almindelig
English: Grade 3 or 4 thrombocytopenia and neutropenia occurred in 19 % and 17 % respectively, of patients treated for malignant glioma.
Danish: Trombocytopeni og neutropeni af Grad 3 eller 4 forekom hos henholdsvis 19 % og 17 % af de patienter, som blev behandlet for malignt gliom.
English: TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl-(triazen-1-yl)imidazole-4-carboxamide (MTIC).
Danish: TMZ hydrolyseres spontant ved fysiologisk pH primært til det aktive stof, 3-methyl-(triazen-1yl)imidazol-4-carboxamid (MTIC).
English: • difficulty concentrating
Danish: • koncentrationsbesvær
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temozolomide Sandoz only
Danish: Patienter med tilbagevendende eller forværrede svulster (malignt gliom såsom glioblastoma multiform eller anaplastisk astrocytoma) som kun tager Temozolomide Sandoz:
English: The median times to progression in these endpoints ranged from 0.7 to 2.1 months longer for TMZ than for procarbazine (log rank p = < 0.01 to 0.03).
Danish: Medianen for tiden til progression for disse endpoints varierede fra at være 0,7 til 2,1 måneder længere for TMZ end for procarbazin (log rank p = < 0,01 til
English: The addition of concomitant TMZ to RT, followed by TMZ monotherapy in the treatment of patients with newly-diagnosed glioblastoma multiforme demonstrated a statistically significant improvement in overall survival (OS) compared with RT alone (Figure 1).
Danish: Supplement med konkomitant TMZ til strålebehandling, efterfulgt af TMZ monoterapi i behandlingen af patienter med nydiagnosticeret glioblastoma multiforme viste en statistisk signifikant forbedret total overlevelse sammenlignet med kun strålebehandling (Figur 1).
English: The Temozolomide Sandoz 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 Sandoz kan blive justeret, udskudt eller afbrudt afhængig af dit blodtal, og hvordan du tåler din medicin under hver behandlingscyklus.
English: A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the 6-cycle rat study while no tumours or pre-neoplastic changes were evident in dog studies.
Danish: Forskellige neoplasier, herunder brystcancer, keratoacanthom i huden og basalcelleadenom, blev observeret i et rotteforsøg med 6 serier, mens der ikke sås tumorer eller præneoplastiske forandringer i forsøg på hunde.
English: In post marketing cases, meningoencephalitis herpetic (including fatal cases) has been observed in patients receiving TMZ in combination with radiotherapy, including cases of concomitant steroids administration.
Danish: Efter markedsføring er der observeret tilfælde af meningoencephalitis herpetica (herunder dødsfald) hos patienter, der fik TMZ i kombination med radioterapi, herunder tilfælde af samtidig administration af steroider.
English: Temozolomide is a triazene, which undergoes rapid chemical conversion at physiologic pH to the active monomethyl triazenoimidazole carboxamide (MTIC).
Danish: Temozolomid er et triazen, der hurtigt omdannes kemisk ved fysiologisk pH til det aktive monomethyltriazenoimidazolcarboxamid (MTIC).
English: Male patients should use effective contraception and not father a child for up to 6 months after stopping treatment.
Danish: Mænd skal anvende sikker prævention og ikke gøre nogen kvinde gravid i op til 6 måneder efter afsluttet behandling.
English: Patients in the control arm received RT only.
Danish: Patienter i kontrolgruppen fik kun strålebehandling.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Brug altid lægemidlet nøjagtigt efter lægens eller apotekspersonalets anvisning.
English: This was followed by monotherapy TMZ (150-200 mg/m2) on Days 1-5 of every 28-day cycle for up to 6 cycles, starting 4 weeks after the end of RT.
Danish: Dette blev efterfulgt af monoterapi med TMZ (150-200 mg/m2) på dag 1-5 i hver serie af 28 dages varighed i op til 6 serier, startende 4 uger efter afsluttet strålebehandling.
English: Polyester/aluminium/polyethylene (PET/alu/PE) sachet.
Danish: Brev i polyester/aluminium/polyethylen (PET/alu/PE).
English: Monotherapy phase
Danish: Monoterapi-fase
English: Summary of events reported with temozolomide in the post-marketing setting
Danish: Opsummering af bivirkninger, der er indberettet med temozolomid efter markedsføring
English: Four weeks after completing the TMZ + RT concomitant phase, TMZ is administered for up to 6 cycles of monotherapy treatment.
Danish: Fire uger efter fuldført TMZ + strålebehandling indgives TMZ i op til 6 serier af monoterapi.
English: Oral TMZ has been studied in paediatric patients (age 3-18 years) with recurrent brainstem glioma or recurrent high grade astrocytoma, in a regimen administered daily for 5 days every 28 days.
Danish: Oral TMZ er undersøgt hos pædiatriske patienter (i alderen 3-18 år) med recidiverende hjernestammegliom eller recidiverende astrocytom af høj grad i et regime, der administreres dagligt i 5 dage hver 28. dag.
English: • urticaria (hives)
Danish: • urticaria (nældefeber)
English: Absolute neutrophil count
Danish: Absolut neutrofiltal
English: Plasma concentrations increase in a dose-related manner.
Danish: Plasmakoncentrationen er dosisafhængig.
English: Name and address of the manufacturers responsible for batch release
Danish: Navn og adresse på fremstillerne ansvarlige for batchfrigivelse
English: The Temozolomide Sandoz 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 Sandoz kan udskydes eller afbrydes, afhængig af dine blodtal og af, hvordan du tåler medicinen under den konkomitante fase.
English: After oral administration to adult patients, TMZ is absorbed rapidly with peak concentrations reached as early as 20 minutes post-administration (mean time between 0.5 and 1.5 hours).
Danish: Efter peroral administration til voksne absorberes TMZ hurtigt, og maksimalkoncentrationerne opnås allerede efter 20 minutter (den gennemsnitlige tid er mellem 0,5 og 1,5 time).
English: In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Danish: In vivo var t1/2 for MTIC 1,8 timer ligesom for TMZ.
English: However, all patients receiving TMZ, particularly patients receiving steroids, should be observed closely for the development of PCP, regardless of the regimen.
Danish: Uanset regimen bør alle patienter, der får TMZ, især patienter der får steroider, følges nøje for udvikling af PCP.
English: This adds up to a 28-day treatment cycle.
Danish: Dette giver en behandlingscyklus på 28 dage.
English: If ANC falls to < 1.0 x 109/l or the platelet count is < 50 x 109/l during any cycle, the next cycle should be reduced one dose level (see section 4.2).
Danish: Hvis ANC falder til < 1,0 x 109/l, eller trombocyttallet er < 50 x 109/l i en behandlingsserie, skal næste behandlingsserie reduceres med et Dosistrin (se pkt.
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 astrocytoma ved første relaps, var PFS efter 6 måneder 46
English: • discolouration of your tongue
Danish: • misfarvning af tungen
English: • in children 3 years and older and adult patients with malignant glioma , such as glioblastoma multiforme or anaplastic astrocytoma.
Danish: • hos børn i alderen 3 år og ældre og voksne patienter med malignt (ondartet) gliom, såsom glioblastoma multiforme eller anaplastisk astrocytom.
English: The cap is imprinted with “TMZ”.
Danish: Hætten bærer et tryk med ”TMZ”.
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 TMZ.
English: Single-cycle (5-day dosing, 23 days non-treatment), 3- and 6-cycle toxicity studies were conducted in rats and dogs.
Danish: Der blev udført toksicitetsforsøg med en enkelt serie (5-dages dosering, 23 dages behandlingspause) samt 3 og 6 serier på rotter og hunde.
English: prolonged pancytopenia, aplastic anaemia†
Danish: Længerevarende pancytopeni, aplastisk anæmi†
English: Bottle Do not store above 25°C Store in the original package.
Danish: Må ikke opbevares ved temperaturer over 25° C Opbevares i den originale yderpakning.
English: Contains lactose.
Danish: Indeholder lactose.
English: Experience in older children and adolescents is very limited (see sections 4.2 and 5.1).
Danish: Erfaring med ældre børn og unge er meget begrænset (se pkt.
English: Temozolomide Sandoz contains a medicine called temozolomide.
Danish: Temozolomide Sandoz indeholder en medicin, som kaldes temozolomid.
English: You will take Temozolomide Sandoz alone once daily for the first 5 days.
Danish: Du vil tage Temozolomide Sandoz alene én gang dagligt i de første 5 dage.
English: In a separate pharmacokinetic study, plasma pharmacokinetic profiles in patients with mild to moderate hepatic impairment were similar to those observed in patients with normal hepatic function.
Danish: I et separat farmakokinetisk forsøg var den plasma-farmakokinetiske profil hos patienter med let til moderat leverinsufficiens sammenlignelig med profilen for patienter med normal leverfunktion.
English: Temozolomide Sandoz may cause permanent infertility.
Danish: Temozolomide Sandoz giver muligvis permanent ufrugtbarhed.
English: Infection, Herpes simplex, wound infection, pharyngitis, candidiasis oral
Danish: Infektion, herpes simplex, sårinfektion, faryngitis, oral candidiasis
English: Then you will have 23 days without Temozolomide Sandoz.
Danish: Derefter vil du have 23 dage uden Temozolomide Sandoz.
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Danish: Interstitiel pneumonitis/pneumonitis, lungefibrose, respirationsinsufficiens†
English: Depending on the prescribed dose, you may have to take more than one capsule together, eventually with different strengths (content of active substance, in mg).
Danish: Nogle gange vil det også være nødvendigt at tage kapsler af forskellig styrke (indhold af aktivt stof i mg).
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 Sandoz (angivet i pkt.
English: 5 hard capsules 20 hard capsules
Danish: 5 hårde kapsler 20 hårde kapsler
English: Do not swallow it.
Danish: Må ikke synkes.
English: Discontinue TMZ
Danish: Seponer TMZ
English: Detailed information on this medicine is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Forebyggende behandling mod Pneumocystis jirovecii pneumoni (PCP) var påkrævet under strålebehandling og konkomitant TMZ behandling.
English: If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Danish: Hvis opkastning forekommer efter dosis er indtaget, skal en anden dosis ikke indtages samme dag.
English: - absolute neutrophil count (ANC) ≥ 1.5 x 109/l
Danish: − absolut neutrofiltal (ANC) ≥ 1,5 x 109/l
English: Temozolomide in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Danish: Temozolomid i kombination med strålebehandling ved nydiagnosticeret glioblastoma
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: Temozolomide Sandoz is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Danish: Temozolomide Sandoz bruges først sammen med strålebehandling (behandlingsfase med samtidig behandling med strålebehandling og lægemiddel) og efterfølgende alene (behandlingsfase med kun ét lægemiddel).
English: Stearic acid
Danish: Stearinsyre
English: Pack-size of 5 or 20 hard capsules individually sealed in sachets.
Danish: Pakkestørrelse med 5 eller 20 hårde kapsler forseglet individuelt i breve.
English: Cushingoid
Danish: Cushingoide symptomer
English: Errors in how you take this medicine may have serious health consequences.
Danish: Det kan have alvorlige konsekvenser for helbredet, hvis der sker fejl i måden, hvorpå du tager denne medicin.
English: Fatigue
Danish: Træthed
English: Talk to your doctor, pharmacist or nurse before taking Temozolomide Sandoz
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Temozolomide Sandoz.
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01AX03 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Andre alkyleringsmidler, ATC-kode : L01AX03.
English: Ear and labyrinth disorders Common:
Danish: Øre og labyrint Almindelig
English: Temozolomide Sandoz is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Danish: Temozolomide Sandoz administreres samtidig med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier med monoterapi med temozolomid (TMZ) (monoterapi-fase).
English: If you have not been previously treated with chemotherapy, your first dose of Temozolomide Sandoz will be 200 mg/m2 once daily for the first 5 days.
Danish: Hvis du ikke tidligere er blevet behandlet med kemoterapi, vil din første dosis af Temozolomide Sandoz være på 200 mg/m2 én gang dagligt i de første 5 dage.
English: Lymphopenia, petechiae
Danish: Lymfopeni, petekkier
English: Patients usually present with shortness of breath and cough.
Danish: Hos patienter viser det sig sædvanligvis ved kortåndethed og hoste.
English: Signs of allergic reaction include feeling itchy, breathlessness or wheezing, swelling of the face, lips, tongue or throat.
Danish: Tegn på allergisk reaktion omfatter: kløende fornemmelse, åndenød eller hvæsende åndedræt, hævelser i ansigt, læber, tunge eller svælg.
English: Gelatin
Danish: Gelatine
English: Pneumonia, sinusitis, upper respiratory infection, bronchitis
Danish: Lungebetændelse, sinuitis, øvre luftvejsinfektion, bronchitis
English: Patients in the TMZ + RT arm received concomitant TMZ (75 mg/m2) once daily, starting the first day of RT until the last day of RT, for 42 days (with a maximum of 49 days).
Danish: Patienter, der var i den gruppe, der modtog TMZ + strålebehandling, fik konkomitant TMZ (75 mg/m2) én gang dagligt, begyndende den første strålebehandlingsdag indtil den sidste strålebehandlingsdag, i 42 dage (med højst 49 dage).
English: • frequent urination
Danish: • hyppig vandladning
English: Temozolomide monotherapy in recurrent or progressive glioma
Danish: Temozolomide monoterapi i tilbagevendende eller progressivt gliom
English: In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
Danish: Hos patienter fra 3 år bør TMZ kun bruges ved tilbagevendende eller progressivt malignt gliom.
English: The safety of TMZ in children under the age of 3 years has not been established.
Danish: TMZ's sikkerhed hos børn under 3 år er ikke klarlagt.
English: Temozolomide Sandoz contains lactose
Danish: Temozolomide Sandoz indeholder lactose
English: • impaired coordination
Danish: • forringet koordinationsevne
English: 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.
Danish: Dataene vedrørende den kliniske effekt hos patienter med glioblastoma multiforme (Karnofsky performance status [KPS] ≥ 70), der progredierer eller recidiverer efter kirurgi og strålebehandling, var baseret på to kliniske forsøg med oral TMZ.
English: You should stop breast-feeding while receiving treatment with Temozolomide Sandoz.
Danish: Du skal stoppe med at amme, mens du behandles med Temozolomide Sandoz.
English: Most haematologic adverse reactions were reported commonly or very commonly in both indications (Tables 4 and 5); the frequency of grade 3-4 laboratory findings is presented after each table.
Danish: De fleste hæmatologiske bivirkninger blev rapporteret som værende almindelige eller meget almindelige for begge indikationer (Tabel 4 og 5).
English: Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: Bør ikke anvendes til patienter med hereditær galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Keep the desiccant pouch in the bottle.
Danish: Fjern ikke tørremidlet fra flasken.
English: The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Danish: TMZ's sikkerhed og virkning hos børn under 3 år er ikke klarlagt.
English: In patients previously untreated with chemotherapy, TMZ is administered orally at a dose of 200 mg/m2 once daily for the first 5 days followed by a 23 day treatment interruption (total of 28 days).
Danish: Til patienter, som ikke tidligere er behandlet med kemoterapi, indgives TMZ oralt i en dosis på 200 mg/m2 én gang dagligt i de første 5 dage efterfulgt af en 23 dages behandlingspause (i alt 28 dage).
English: In a study of 288 subjects with newly-diagnosed glioblastoma multiforme, Grade 4 neutropenia occurred in 3 % of female vs 0 % of male subjects and Grade 4 thrombocytopenia in 1 % of female vs 0 % of male subjects in the first cycle of therapy.
Danish: I en undersøgelse med 288 forsøgspersoner med nyligt diagnosticeret multiform glioblastom forekom Grad 4-neutropeni hos 3 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner og Grad 4-thrombocytopeni hos 1 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner i det første terapiforløb.
English: • nausea (feeling sick in your stomach)
Danish: • kvalme (følelse af ubehag i maven)
English: Rash, alopecia
Danish: Udslæt, alopeci
English: If a capsule is damaged, avoid contact of the powder with your skin, eyes or nose.
Danish: Hvis en kapsel bliver ødelagt, skal du undgå, at pulveret kommer i kontakt med hud, øjne og næse.
English: Remarks
Danish: Bemærkninger
English: Investigations Common:
Danish: Undersøgelser Almindelig
English: Clinical trial experience
Danish: Erfaringer fra kliniske forsøg
English: Blood and lymphatic system disorders
Danish: Blod og lymfesystem
English: Febrile neutropenia, anaemia
Danish: Febril neutropeni, anæmi
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 blev observeret neutrofile abnormiteter af Grad 3 eller Grad 4, herunder neutropeni-bivirkninger, hos 8 % af patienterne.
English: Visual acuity reduced, eye pain, eyes dry
Danish: Nedsat synsskarphed, øjensmerte, tørre øjne
English: Prior to dosing, the following laboratory parameters must be met: ANC ≥ 1.5 x 109/l and platelet count ≥ 100 x 109/l.
Danish: Forud for dosering skal følgende laboratorieparametre være opfyldt: ANC ≥ 1,5 x 109/l og trombocyttal ≥ 100 x 109/l.
English: What Temozolomide Sandoz is and what it is used for What you need to know before you take Temozolomide Sandoz How to take Temozolomide Sandoz Possible side effects
Danish: Virkning og anvendelse af Temozolomide Sandoz Det skal du vide, før du begynder at tage Temozolomide Sandoz Sådan skal du tage Temozolomide Sandoz Bivirkninger
English: Experience in these children is very limited (see sections 4.4 and 5.1).
Danish: Erfaring hos disse børn er meget begrænset (se pkt.
English: Laboratory parameters
Danish: Laboratorieprøver