natgillin/translations-raw huggingface dataset:
Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10 personer): - appetitløshed, talebesvær, hovedpine - opkastning, kvalme, diarré, forstoppelse - udslæt, hårtab - træthed. 
Very Common side effects (may affect more than 1 in 10 people) are: - loss of appetite, difficulty speaking, headache - vomiting, nausea, diarrhoea, constipation - rash, hair loss - tiredness
Hvis Temodal 2,5 mg/ml kommer i kontakt med hud eller slimhinder bør området straks vaskes omhyggeligt med sæbe og vand. 
If Temodal 2.5 mg/ml comes into contact with skin or mucosa, it should be washed immediately and thoroughly with soap and water.
†, herpes simplex, reaktivering af infektion, sårinfektion, gastroenteritis Benigne, maligne og uspecificerede tumorer Ikke almindelig: 
†, herpes simplex, infection reactivation, wound infection, gastroenteritis Neoplasm benign, malignant, and unspecified Uncommon:
Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de bruger Temodal (se også ”Frugtbarhed hos mænd” nedenfor). 
Effective contraceptive precautions must be taken by both male and female patients who are using Temodal (see also “Male fertility” below).
In vivo var t1/2 for MTIC 1,8 timer som for TMZ. 
In vivo, the t1/2 of MTIC was similar to that of TMZ, 1.8 hr.
Brug ikke lægemidlet efter den udløbsdato, der står på etiketten og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the label and carton.
Hos patienter fra 3 år bør TMZ kun bruges ved recidiverende eller progressivt malignt gliom. 
In patients 3 years of age or older, TMZ is only to be used in recurrent or progressive malignant glioma.
I en separat farmakokinetikundersøgelse var plasmafarmakokinetikprofilen hos patienter med let til moderat leverinsufficiens sammenlignelig med profilen for patienter med normal leverfunktion. 
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.
Se indlægssedlen for mere information. 
See package leaflet for further information.
 0,5 og < 1,5 x 10 
 0.5 and < 1.5 x 10
Pneumocystis jirovecii-lungebetændelse 
Pneumocystis jirovecii pneumonia
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. 
In a study of 288 subjects with newlydiagnosed 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.
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.
Pulver til infusionsvæske, opløsning er et hvidt pulver. 
The powder for solution for infusion is a white powder.
Pneumocystis jirovecii pneumoni (PCP) forebyggende behandling var påkrævet under strålebehandling og konkomitant TMZ behandling. 
Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data). 
Frequency groupings are defined according to the following convention: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000); Not known (cannot be estimated from the available data).
Lungebetændelse, dyspnø, sinusitis, bronchitis, hoste, øvre luftvejsinfektion 
Pneumonia, dyspnoea, sinusitis, bronchitis, coughing, upper respiratory infection
Hos patienter behandlet med TMZ i kliniske studier var de hyppigste bivirkninger: kvalme, opkastning, obstipation, anoreksi, hovedpine, træthed, kramper og udslæt. 
In patients treated with TMZ in clinical trials, the most common adverse reactions were nausea, vomiting, constipation, anorexia, headache, fatigue, convulsions, and rash.
Forebyggende behandling mod PCP er derfor påkrævet for alle patienter, der får konkomitant TMZ og strålebehandling i 42 dages regime (med højst 49 dage) uafhængigt af lymfocyttal. 
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.
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 bruger dette lægemiddel. 
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, angioødem, erythema multiforme, erythroderma, hudeksfoliering, lysoverfølsomhedsreaktion, urticaria, eksantem, dermatitis, øget svedtendens, unormal pigmentering 
Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, erythema multiforme, erythroderma, skin exfoliation, photosensitivity reaction, urticaria, exanthema, dermatitis, sweating increased, pigmentation abnormal
Når unormale laboratorieværdier og bivirkninger blev slået sammen på tværs af konkomitante og monoterapi behandlingsfaser, blev Grad 3- eller Grad 4-neutrofilabnormaliteter inklusive neutropeni-bivirkninger set hos 8 % af patienterne. 
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.
†, leverskade, hepatitis, kolestase, hyperbilirubinæmi 
†, hepatic injury, hepatitis, cholestasis, hyperbilirubinemia
Dosisniveauerne omfatter 100 mg/m 2, 150 mg/m 2 og 200 mg/m 2. 
Dose levels include 100 mg/m 2, 150 mg/m 2, and
Hætten bærer et tryk med ”Temodal”. 
The cap is imprinted with “Temodal”.
Klart hætteglas (type I glas) forseglet med bromobutyl gummiprop og aluminium oversegl med ferskenfarvet flipp-off hætte. 
Clear type I glass vial sealed with bromobutyl rubber stopper and aluminium overseal with peach-coloured flip-off bonnet.
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, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Stråleskader 
Radiation injury
Dette lægemiddel indeholder 2,4 mmol natrium pr. hætteglas. 
This medicine contains 2.4 mmol sodium per vial.
Både mandlige og kvindelige patienter skal anvende sikre præventionsmidler, mens de tager Temodal (se også ”Frugtbarhed hos mænd” nedenfor). 
Effective contraceptive precautions must be taken by both male and female patients who are taking Temodal (see also “Male fertility” below).
Nedenstående oplysninger er til læger og sundhedspersonale 
The following information is intended for medical or health care professional use only:
Deres læge vil fastsætte den rigtige dosis Temodal for Dem. 
Your doctor will work out your dose of Temodal.
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 alkylerende stof. 
MTIC is spontaneously hydrolyzed to 5-aminoimidazole-4-carboxamide (AIC), a known intermediate in purine and nucleic acid biosynthesis, and to methylhydrazine, which is believed to be the active alkylating species.
Foruden de ovenstående bivirkninger kan følgende også forekomme ved brug af Temodal pulver til infusionsvæske, opløsning: smerter, irritation, kløe, varme, hævelse eller rødme på injektionsstedet; også blå mærker (hæmatoma). 
In addition to the side effects listed above, the following may also occur with the use of Temodal powder for solution for infusion: pain, irritation, itching, warmth, swelling or redness at the injection site; also bruising (haematoma).
†, interstitiel pneumonitis/pneumonitis, lungefibrose, næsetæthed 
†, interstitial pneumonitis/pneumonitis, pulmonary fibrosis, nasal congestion
Temodal indeholder 
What Temodal contains
Hvis opkastning forekommer, efter dosis er indtaget, skal en anden dosis ikke indtages samme dag. 
If vomiting occurs after the dose is administered, a second dose should not be administered that day.
Hvis De er nydiagnosticeret patient, vil behandlingen ske i to faser: - behandling sammen med strålebehandling (konkomitant-fasen) først - efterfulgt af behandling kun med Temodal (monoterapi-fasen) 
If you are a newly-diagnosed patient, treatment will occur in two phases: - treatment together with radiotherapy (concomitant phase) first - followed by treatment with only Temodal (monotherapy phase).
Temodal 2,5 mg/ml pulver til infusionsvæske, opløsning, leverer TMZ doser samt udsættelse for både TMZ og den aktive metabolit MTIC ækvivalent med den tilsvarende Temodal hårde kapsel (se pkt. 
Temodal 2.5 mg/ml powder for solution for infusion delivers equivalent TMZ dose and exposure to both TMZ and its active metabolite MTIC as the corresponding Temodal hard capsules (see section 5.2).
De hårde kapsler til oral brug udleveres i ravgule glasflasker, der indeholder 5 eller 20 kapsler. 
The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
Læs denne indlægsseddel grundigt, inden De begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger - Gem indlægssedlen. 
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Temodal er indiceret til behandling af: - voksne patienter med nydiagnosticeret glioblastoma multiforme konkomitant med strålebehandling og herefter som monoterapi-behandling. 
Temodal is indicated for the treatment of: - adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment.
Hvis De ved en fejl tager flere Temodal-kapsler end foreskrevet, skal De straks kontakte Deres læge, apotekspersonalet eller sygeplejersken. 
If you take more Temodal than you should If you accidentally take more Temodal capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Ataksi, nedsat balanceevne, nedsat kognitiv funktionsevne, nedsat koncentrationsevne, bevidsthedssvækkelse, svimmelhed, hypoæstesi, nedsat hukommelse, neurologisk lidelse, neuropati d, paræstesi, søvnighed, taleforstyrrelse, smagsforstyrrelse, tremor 
Ataxia, balance impaired, cognition impaired, concentration impaired, consciousness decreased, dizziness, hypoesthesia, memory impaired, neurologic disorder, neuropathy d, paraesthesia, somnolence, speech disorder, taste perversion, tremor
TMZ hydrolyseres spontant ved fysiologisk pH primært til det aktive stof, 3-methyl-(triazen-1yl)imidazol-4-carboxamid (MTIC). 
TMZ is spontaneously hydrolyzed at physiologic pH primarily to the active species, 3-methyl(triazen-1-yl)imidazole-4-carboxamide (MTIC).
I den ikke-randomiserede undersøgelse var PFS efter 6 måneder 19 %, median progressiv overlevelse var 2,1 måneder, og median samlet 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.
Brug af anden medicin sammen med Temodal 
Other medicines and Temodal
MTIC's cytotoksiske effekt formodes primært at skyldes alkyleringen ved O 
The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O
9/l, eller trombocyttallet er < 50 x 10 
9/l or the platelet count is < 50 x 10
Dette fald i antallet af blodceller er oftest forbigående, men i nogle tilfælde kan det være længerevarende og medføre en meget alvorlig form for anæmi (aplastisk anæmi). 
In some cases, it may be prolonged and may lead to a very severe form of anaemia (aplastic anaemia).
kapselskal: 
capsule shell:
Temodal indeholder lactose 
Temodal contains lactose
9/l; trombocyttal  100 x 10 
9/l; thrombocyte count  100 x 10
Figur 1 Kaplan-Meier kurver for total overlevelse (ITT population) 
Figure 1 Kaplan-Meier curves for overall survival (Intent to treat population)
Dette blev efterfulgt af monoterapi med TMZ (150 - 200 mg/m2) på dag 1 - 5 i hver 28-dags-serie i op til 6 serier, startende 4 uger efter afsluttet strålebehandling. 
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.
TMZ dosisreduktion eller seponering under monoterapi-behandling Toksicitet 
TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Temodal bruges først sammen med strålebehandling (konkomitant fase af behandlingen) og efterfølgende alene (monoterapibehandling). 
Temodal is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Se indlægssedlen for mere information omkring natrium. 
For sodium, see leaflet for further information.
TMZ-doseringsafbrydelse eller seponering under konkomitant strålebehandling og TMZ 
TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
I et åbent-label, two-way crossover bioækvivalensstudie af farmakokinetikken for oral og intravenøs TMZ hos patienter med primært CNS maligniciteter, blev Temodal 2,5 mg/ml pulver til infusionsvæske, opløsning, indgivet over 90 min fundet til at være bioækvivalent mht. Cmax og AUC for TMZ og MTIC sammenlignet med Temodal hårde kapsler efterfulgt af en indgift på 150 mg/m Gennemsnits Cmax-værdier for TMZ og MTIC var henholdsvis 7,4 µg/ml og 320 ng/ml efter 90 min intravenøs infusion. 
In an open-label, two-way crossover bioequivalence study of the pharmacokinetics of oral and intravenous TMZ in patients with primary CNS malignancies, Temodal 2.5 mg/ml powder for solution for infusion administered over 90 minutes was found to be bioequivalent for Cmax and AUC
Temodal indgives af Deres læge dråbevis i en vene (intravenøs infusion) i løbet af kun ca. 90 min. Andre infusionssteder end en vene er ikke acceptable. 
Temodal will be given to you by your doctor in a drip into a vein (intravenous infusion), only over approximately 90 minutes.
Temodal 2,5 mg/ml pulver til infusionsvæske, opløsning, givet som en intravenøs infusion over 90 min er bioækvivalent med den hårde kapselformulering (se pkt. 
Temodal 2.5 mg/ml powder for solution for infusion, given as an intravenous infusion over 90 minutes, is bioequivalent to the hard capsule formulation (see section 5.2).
Kontakt øjeblikkeligt Deres læge, hvis De oplever noget af følgende: - en kraftig allergisk (overfølsomheds) reaktion (kløende udslæt, hvæsende vejrtrækning eller anden form for åndedrætsbesvær), - ukontrolleret blødning, - anfald (kramper), - feber, - kulderystelser, - kraftig hovedpine, som ikke går væk. 
Contact your doctor immediately if you have any of the following: - a severe allergic (hypersensitive) reaction (hives, wheezing or other breathing difficulty), - uncontrolled bleeding, - seizures (convulsions), - fever, - chills, - severe headache that does not go away.
Bivirkninger hos patienter behandlet med temozolomid Det reproduktive system og mammae Ikke almindelig: 
Adverse reactions in patients treated with temozolomide Reproductive system and breast disorders Uncommon:
Status epilepticus, hemiplegi, ekstrapyramidal lidelse, parosmi, unormal gang, hyperæstesi, føleforstyrrelse, abnorm koordinationsevne 
Status epilepticus, hemiplegia, extrapyramidal disorder, parosmia, gait abnormality, hyperaesthesia, sensory disturbance, coordination abnormal
Kartonen indeholder 5 eller 20 hårde kapsler, som individuelt er forseglet i breve. 
The carton contains 5 or 20 hard capsules, individually sealed in sachets.
Prækliniske studier viste ikke permanent vævsskade (se pkt. 
Preclinical studies did not show permanent tissue damage (see sections 4.8 and 5.3).
Immunsystemet Almindelig: 
Immune system disorders Common:
Grad- 3 eller Grad 4-trombocytabnormaliteter, inklusive trombocytopeni-bivirkninger blev set hos 14 % af patienterne, der fik TMZ. 
Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Efter rekonstitution er den kemiske og fysiske stabilitet ved anvendelse demonstreret i 14 timer ved oC, inklusive infusionstiden. 
Reconstituted solution: after reconstitution the chemical and physical in-use stability has been demonstrated for 14 hours at 25C, including infusion time.
De vil tage Deres nye dosis én gang dagligt i de første 5 dage (”doseringsdage”) i hver cyklus. 
You will take your new dose of Temodal alone once daily for the first 5 days (“dosing days”) of each cycle.
Cytotoksisk Undgå kontakt med hud, øjne og næse. 
Cytotoxic Avoid contact with skin, eyes, nose.
- hos børn i alderen 3 år og ældre og voksne patienter med malignt (ondartet) gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma. 
- in children 3 years and older and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma.
Febril neutropeni, neutropeni, trombocytopeni, lymfopeni, leukopeni, anæmi 
Febrile neutropenia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, anaemia
Temodal dosen kan blive justeret, udskudt eller afbrudt afhængig af Deres blodtal, og hvordan De tåler Deres medicin under hver behandlingscyklus. 
The Temodal dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Vaginal blødning, menoragi, amenorré, vaginitis, brystsmerter, impotens Almene symptomer og reaktioner på administrationsstedet Meget almindelig: 
Vaginal haemorrhage, menorrhagia, amenorrhoea, vaginitis, breast pain, impotence General disorders and administration site conditions Very common:
Der skal udvises forsigtighed ved håndteringen af Temodal 2,5 mg/ml pulver til infusionsvæske, opløsning. 
Caution must be exercised in handling Temodal 2.5 mg/ml powder for solution for infusion.
- børn fra 3 år, unge og voksne med malignt gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma, der får recidiv eller progression efter standardbehandling. 
- children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
België/Belgique/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32 (0)2 776 62 11 dpoc_belux@merck.com 
Belgique/België/Belgien MSD Belgium BVBA/SPRL Tél/Tel: +32(0)27766211 dpoc_belux@merck.com
De øvrige indholdsstoffer er mannitol (E421), threonin, polysorbat 80, natriumcitrat (til pH justering)og saltsyre koncentreret (til pH justering) (se pkt. 
The other ingredients are mannitol (E421), threonine, polysorbate 80, sodium citrate (for pH-adjustment) and hydrochloric acid concentrated (for pH-adjustment) (see section 2).
CTC ikke-hæmatologisk toksicitet (undtagen for alopeci, kvalme, opkastning) 
CTC non-haematological toxicity (except for alopecia, nausea, vomiting)
Til patienter, som tidligere er behandlet med kemoterapeutika, er den initiale dosis 150 mg/m 2 én gang dagligt stigende i den anden serie til 200 mg/m 2 én gang dagligt i 5 dage, såfremt der ikke er hæmatologisk toksicitet (se pkt. 
In patients previously treated with chemotherapy, the initial dose is 150 mg/m 2 once daily, to be increased in the second cycle to 200 mg/m 2 once daily, for 5 days if there is no haematological toxicity (see section 4.4)
Inkluderer faryngitis, faryngitis i næsesvælget, streptokok faryngitis Inkluderer gastroenteritis, viral gastroenteritis Inkluderer Cushingoide symptomer, Cushings syndrom Inkluderer neuropati, perifer neuropati, polyneuropati, perifer sensorisk neuropati, perifer motorisk neuropati Inkluderer synsnedsættelse, øjensygdom Inkluderer døvhed, bilateral døvhed, neurosensorisk døvhed, unilateral døvhed Inkluderer øresmerter, ubehag i øret Inkluderer abdominalsmerter, nedre abdominalsmerter, øvre abdominalsmerter, abdominalt ubehag Inkluderer perifert ødem, perifer hævelse Inkluderer forhøjet leverfunktionstest, forhøjet alaninaminotransferase, forhøjet aspartataminotransferase, forhøjede leverenzymer Inkluderer stråleskader, stråleskader på huden Inkluderer tilfælde med dødelig udgang 
Includes pharyngitis, nasopharyngeal pharyngitis, pharyngitis Streptococcal Includes gastroenteritis, gastroenteritis viral Includes cushingoid, Cushing syndrome Includes neuropathy, peripheral neuropathy, polyneuropathy, peripheral sensory neuropathy, peripheral motor neuropathy Includes visual impairment, eye disorder Includes deafness, deafness bilateral, deafness neurosensory, deafness unilateral Includes earache, ear discomfort Includes abdominal pain, abdominal pain lower, abdominal pain upper, abdominal discomfort Includes oedema peripheral, peripheral swelling Includes liver function test increased, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased Includes radiation injury, radiation skin injury Including cases with fatal outcome
I meget sjældne tilfælde har der også været observeret myelodysplastisk syndrom og sekundær malignitet, inklusive myeloid leukæmi (se pkt. 
Cases of myelodysplastic syndrome and secondary malignancies, including myeloid leukaemia, have also been reported very rarely (see section 4.8).
Pulver til infusionsvæske, opløsning 100 mg 
Powder for solution for infusion 100 mg
Temodal anvendes konkomitant med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier af temozolomid (TMZ) monoterapi (monoterapi-fase). 
Temodal is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Det skal De vide, før De begynder at bruge Temodal 
What you need to know before you use Temodal
9/l, eller trombocyttallet er 
9/l, and the thrombocyte count is
Adominal distension, fækal inkontinens, gastrointestinal lidelse, hæmorroider, mundtørhed 
Abdominal distension, faecal incontinence, gastrointestinal disorder, haemorrhoids, mouth dry
Patienter med nydiagnosticeret glioblastoma multiform: 
Patients with newly-diagnosed glioblastoma multiforme:
Diarré, obstipation, kvalme, opkastning 
Diarrhoea, constipation, nausea, vomiting
Temodal-dosen kan udskydes eller afbrydes afhængig af Deres blodtal og hvordan De tåler Deres medicin under den konkomitante fase. 
The Temodal dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
TMZ dosistrin for monoterapi-behandling 
TMZ dose levels for monotherapy treatment
Pulver til infusionsvæske, opløsning 1 hætteglas 100 mg 
Powder for solution for infusion 1 vial 100 mg
Kontakt lægen, apotekspersonalet eller sygeplejersken, før De bruger Temodal, - da De skal opbserveres tæt for udviklingen af en alvorlig form for lungebetændelse kaldet 
Warnings and precautions Talk to your doctor, pharmacist or nurse before using Temodal, - as you should be observed closely for the development of a serious form of chest infection called Pneumocystis jirovecii pneumonia (PCP).
ETIKET HÆTTEGLAS 
VIAL LABEL
Forhøjede leverenzymer j, vægttab, vægtøgning 
Liver enzymes elevation j, weight decreased, weight increased
Eventuelt ikke anvendt lægemiddel eller affald skal kasseres i henhold til lokale krav. 
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Den maksimalt tolererede dosis (MTD) var 1.000 mg/m2 pr. serie for både børn og voksne. 
Paediatric patients had a higher AUC than adult patients; however, the maximum tolerated dose (MTD) was 1,000 mg/m2 per cycle both in children and in adults.