FrancophonIA/ELRC3.0 huggingface dataset:
English: Temomedac contains a medicine called temozolomide.
Danish: Temomedac indeholder en medicin, som kaldes temozolomid.
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 en ikke-sammenlignende undersøgelse hos 138 patienter (29 % fik tidligere kemoterapi), og den anden var en randomiseret aktiv-kontrolleret undersøgelse med TMZ versus procarbazin hos i alt 225 patienter (67 % fik tidligere behandling med nitrosurea-baseret kemoterapi).
English: Pharmacotherapeutic group: Antineoplastic agents - Other alkylating agents, ATC code: L01A X03 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler - Andre alkylerende midler, ATC-kode: L01A X 03
English: The Temomedac dose may be adjusted, delayed or stopped depending on your blood counts and how you tolerate your medicine during each treatment cycle.
Danish: Temomedac-dosen kan blive justeret, udskudt eller afbrudt afhængig af dit blodtal, og hvordan du tåler din medicin under hver behandlingscyklus.
English: A total of 573 patients were randomised to receive either TMZ + RT (n = 287) or RT alone (n = 286).
Danish: Et samlet antal patienter på 573 blev randomiseret til at få enten TMZ + strålebehandling (n = 287) eller strålebehandling alene (n = 286).
English: Pancytopenia, anaemia (Grade 3 - 4), leukopenia
Danish: Pancytopeni, anæmi (grad 3 - 4), leukopeni
English: Very rare cases of lung side effects have been observed with Temomedac.
Danish: Der er set meget sjældne tilfælde af lungebivirkninger med Temomedac.
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 givet som salvage-behandling i opfølgningsfasen hos 161 patienter af 282 (57 %) i gruppen med strålebehandling alene, og 62 patienter af 277 (22 %) i gruppen med TMZ + strålebehandling.
English: Then you will have 23 days without Temomedac.
Danish: Derefter vil du have 23 dage uden Temomedac.
English: Amber glass bottle with white polypropylene child-resistant closure equipped with an induction seal of polyethylene containing 5 or 20 capsules.
Danish: Ravfarvet glasflaske med hvidt børnesikret polypropylenlåg med en induktionsforsegling af polyethylen, indeholdende 5 eller 20 kapsler.
English: The hard capsules for oral use are dispensed in amber glass bottles containing 5 or 20 capsules.
Danish: De hårde kapsler til peroral brug udleveres i ravfarvede glasflasker indeholdende 5 eller 20 kapsler.
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 en pilotundersøgelse af det længerevarende 42 dages-program, viste sig at have særlig risiko for at udvikle Pneumocystis jiroveciilungebetændelse (PCP).
English: During the concomitant phase, your doctor will start Temomedac at a dose of 75 mg/m² (usual dose).
Danish: Under konkomitant-fasen vil din læge starte behandlingen med en dosis Temomedac på 75 mg/m2 (sædvanlig dosis).
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 de hvide blodlegemer og antallet af blodplader.
English: Neutropenia or lymphopenia (Grade 3 - 4), thrombocytopenia (Grade 3 - 4)
Danish: Neutropeni eller lymfopeni (grad 3 - 4), trombocytopeni (grad 3 - 4)
English: MTIC is spontaneously hydrolysed 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.
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 alkylerende stof.
English: Temomedac may cause permanent infertility.
Danish: Temomedac giver muligvis permanent ufrugtbarhed.
English: Detailed information on this medicine is available on the European Medicines Agency website: 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: Additional information for Temomedac 20 mg hard capsules The excipient sunset yellow FCF (E110) included in the capsules shell may cause allergic reactions.
Danish: Yderligere oplysninger for Temomedac 20 mg hårde kapsler Hjælpestoffet Sunset Yellow FCF (E 110), der findes i kapselskallen, kan fremkalde allergiske reaktioner.
English: You will take your new dose of Temomedac alone once daily for the first 5 days (“dosing days”) of each cycle.
Danish: Du vil tage din nye dosis Temomedac alene én gang dagligt i de første 5 dage (”doseringsdage”) i hver cyklus.
English: Temomedac hard capsules should be administered in the fasting state.
Danish: Temomedac hårde kapsler bør indtages fastende.
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 undersøgelser udført på rotter og kaniner med doser på 150 mg/m2 TMZ blev teratogenicitet og/eller føtal toksicitet påvist (se pkt.
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: 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: Risikoforholdene (HR) for den totale overlevelse var 1,59 (95 % CI for HR = 1,33 - 1,91) med en logrank p < 0,0001 til fordel for TMZ-gruppen.
English: Your blood will be tested frequently during treatment to monitor the side effects of Temomedac on your blood cells.
Danish: • da du vil regelmæssigt få undersøgt dit blod under behandlingen for at følge Temomedacs bivirkninger på dine blodceller.
English: TMZ + concomitant RT n = 288*
Danish: TMZ + samtidig strålebehandling n = 288*
English: Rare (may affect up to 1 in 1,000 people): cough, infections including pneumonia.
Danish: Sjælden (kan påvirke op til 1 ud af 1.000): Hoste, infektioner inklusive lungebetændelse.
English: If you forget to take Temomedac
Danish: Hvis du har glemt at tage Temomedac
English: You will take Temomedac alone once daily for the first 5 days.
Danish: Du vil tage Temomedac alene én gang dagligt i de første 5 dage.
English: Patients will be carefully checked by their doctor for signs of this infection before treatment is started.
Danish: Din læge vil tjekke du for tegn på denne infektion, før behandlingen startes.
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 den randomiserede aktive kontrollerede undersøgelse var 6 måneders PFS 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 = 0,0063).
English: There were higher rates of Grade 4 neutropenia (ANC < 0.5 x 109/l), 12 % vs 5 %, and thrombocytopenia (< 20 x 109/l), 9 % vs 3 %, in women vs men in the first cycle of therapy.
Danish: Der var større hyppighed af Grad 4-neutropeni (ANC < 0,5 x 109/l), 12 % vs. 5 %, og trombocytopeni (< 20 x 109/l), 9 % vs. 3 %, hos kvinder vs. mænd i det første terapiforløb.
English: The Temomedac dose may be delayed or stopped, depending on your blood counts and how you tolerate your medicine during the concomitant phase.
Danish: Temomedac-dosen kan udskydes eller afbrydes afhængig af dit blodtal og hvordan du tåler din medicin under den konkomitante fase.
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 strålebehandling alene (Figur 1).
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Temomedac,
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Temomedac,
English: Temomedac contains lactose
Danish: Temomedac indeholder lactose
English: TMZ is spontaneously hydrolysed at physiologic pH primarily to the active species, 3-methyl-(triazen1-yl)imidazole-4-carboxamide (MTIC).
Danish: TMZ hydrolyseres spontant ved fysiologisk pH primært til det aktive stof, 3-methyl-(triazen1-yl)imidazol-4-carboxamid (MTIC).
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 hjernestamme-gliom eller recidiverende astrocytom af høj grad i et regime, der administreres dagligt i 5 dage hver 28. dag.
English: In some cases, exposure to concomitant medicinal products associated with aplastic anaemia, including carbamazepine, phenytoin, and sulfamethoxazole/trimethoprim, complicates assessment.
Danish: nogle tilfælde vanskeliggøres vurderingen af samtidig eksponering for lægemidler, der er associeret med aplastisk anæmi, herunder carbamazepin, phenytoin, og sulfamethoxazole/trimethoprim.
English: Uncommon (may affect up to 1 in 100 people): reduced blood cell counts (pancytopenia, anaemia, leukopenia).
Danish: Ikke almindelig (kan påvirke op til 1 ud af 100): Reduceret antal blodceller (pancytopeni, anæmi, leukopeni).
English: Temomedac in combination treatment with radiotherapy in newly-diagnosed glioblastoma
Danish: Temomedac i kombination med strålebehandling i nydiagnosticeret glioblastoma
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Temomedac findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: CTC non-haematological toxicity (except for alopecia, nausea, vomiting)
Danish: CTC ikke-hæmatologisk toksicitet (undtaget alopeci, kvalme, opkastning)
English: Temomedac is first used together with radiotherapy (concomitant phase of treatment) and after that alone (monotherapy phase of treatment).
Danish: Temomedac bruges først sammen med strålebehandling (konkomitant fase af behandlingen) og efterfølgende alene (monoterapibehandling).
English: Do not take Temomedac - if you are allergic to temozolomide or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for temozolomid eller et af de øvrige indholdsstoffer i Temomedac (angivet i punkt 6).
English: Pneumocystis jirovecii pneumonia (PCP) prophylaxis was required during RT and combined TMZ therapy.
Danish: Pneumocystis jirovecii-pneumoni (PCP) forebyggende behandling var påkrævet under strålebehandling og konkomitant TMZ-behandling.
English: Summary of events reported with temozolomide in the post-marketing setting Uncommon:
Danish: Opsummering af bivirkninger, der er indberettet med temozolomid efter markedsføring Ikke almindelig:
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 28-dags-serie i op til 6 serier, startende 4 uger efter afsluttet strålebehandling.
English: Temomedac monotherapy in recurrent or progressive glioma
Danish: Temomedac-monoterapi i tilbagevendende eller progressiv glioma
English: You will again receive Temomedac once daily for 5 days, followed by 23 days without Temomedac.
Danish: Du vil igen modtage Temomedac én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temomedac.
English: After oral administration of 14C-labelled TMZ, mean faecal excretion of 14C over 7 days post-dose was 0.8 %
Danish: Efter peroral administration af 14C-mærket TMZ var den gennemsnitlige fækale udskillelse af 14C over 7 dage 0,8 %, hvilket tyder på fuldstændig absorption.
English: Dose in Cycle 1 (monotherapy) is 150 mg/m² once daily for 5 days followed by 23 days without treatment.
Danish: Dosis i serie 1 (monoterapi) er 150 mg/m2 én gang dagligt i 5 dage efterfulgt af 23 dage uden behandling.
English: Your doctor will work out your dose of Temomedac.
Danish: Din læge vil fastsætte den rigtige dosis Temomedac for dig.
English: Infection, herpes simplex, wound infection, pharyngitis, candidiasis oral
Danish: Infektion, herpes simplex, sårinfektion, faryngitis, oral candidiasis
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: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen Opportunistiske infektioner og reaktivering af infektioner Der er set opportunistiske infektioner (såsom Pneumocystis jirovecii lungebetændelse) og reaktivering af infektioner (såsom HBV, CMV) under behandling med TMZ (se pkt.
English: What you need to know before you take Temomedac
Danish: Det skal du vide, før du begynder at tage Temomedac
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-trombocytopeni hos 1 % af de kvindelige vs. 0 % af de mandlige forsøgspersoner i det første terapiforløb.
English: Hypokalaemia, alkaline phosphatase increased, weight increased
Danish: Hypokalæmi, forhøjet alkalisk fosfatase, vægtøgning
English: Patients with tumours that have returned or worsened (malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma) taking Temomedac only
Danish: Patienter med tilbagevendende eller forværrede svulster (malignt gliom såsom glioblastoma multiforme eller anaplastisk astrocytoma), som kun tager Temomedac
English: Grade 3 or Grade 4 thrombocyte abnormalities, including thrombocytopenic events were observed in 14 % of the patients who received TMZ.
Danish: Grad 3- eller Grad 4-trombocytabnormaliteter, inklusive trombocytopeni-bivirkninger blev set hos 14 % af patienterne, der fik TMZ.
English: If you take more Temomedac than you should If you accidentally take more Temomedac capsules than you were told to, contact your doctor, pharmacist or nurse immediately.
Danish: Hvis du ved en fejl tager flere Temomedac-kapsler end foreskrevet, skal du straks kontakte din læge, apotekspersonalet eller sundhedspersonalet.
English: At the start of Cycle 2, the dose is escalated to 200 mg/m² if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/l, and the thrombocyte count is ≥ 100 x 109/l.
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikkehæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen alopeci, kvalme og opkastning), absolut antal neutrofile (ANC) er ≥ 1,5 x 109/l og trombocyttal er ≥ 100 x 109/l.
English: You will again take Temomedac once daily for 5 days followed by 23 days without Temomedac.
Danish: Du vil igen tage Temomedac én gang dagligt i 5 dage, efterfulgt af 23 dage uden Temomedac.
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 kemoterapeutika, er den initiale dosis 150 mg/m2 én gang dagligt stigende i den anden serie til 200 mg/m2 én gang dagligt i 5 dage, såfremt der ikke er hæmatologisk toksicitet (se pkt.
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: QUALITATIVE AND QUANTITATIVE COMPOSITION Temomedac 5 mg hard capsules
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Temomedac 5 mg hårde kapsler
English: - The active substance is temozolomide.
Danish: • Aktivt stof: Temozolomid.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 5 hard capsules
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 5 hårde kapsler
English: TMZ is administered orally at a dose of 75 mg/m² daily for 42 days concomitant with focal radiotherapy (60 Gy administered in 30 fractions).
Danish: TMZ indgives oralt i en dosis på 75 mg/m2 dagligt i 42 dage konkomitant med fokal strålebehandling (60 Gy indgivet i 30 fraktioner).
English: In a 400 subject recurrent glioma data set, Grade 4 neutropenia occurred in 8 % of female vs 4 % of male subjects and Grade 4 thrombocytopenia in 8 % of female vs 3 % of male subjects in the first cycle of therapy.
Danish: I et gentaget glioma-datasæt med 400 forsøgspersoner forekom Grad 4-neutropeni hos 8 % af de kvindelige vs. 4 % af de mandlige forsøgspersoner og Grad 4-trombocytopeni hos 8 % af de kvindelige vs. 3 % af de mandlige forsøgspersoner i det første terapiforløb.
English: TMZ dose reduction or discontinuation during monotherapy treatment Toxicity
Danish: TMZ-dosisreduktion eller -seponering under monoterapi-behandling
English: If you have been previously treated with chemotherapy, your first dose of Temomedac will be 150 mg/m² once daily for the first 5 days.
Danish: Hvis du tidligere er blevet behandlet med kemoterapi, vil din første dosis af Temomedac være på 150 mg/m2 én gang dagligt i de første 5 dage.
English: If you have not been previously treated with chemotherapy, your first dose of Temomedac 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 Temomedac være på 200 mg/m2 én gang dagligt i de første 5 dage.
English: You should make sure you fully understand and remember the following: - how many capsules you need to take every dosing day.
Danish: • hvor mange kapsler, du skal tage hver doseringsdag.
English: Each hard capsule contains 72 mg of anhydrous lactose and sunset yellow FCF (E110).
Danish: Hver hård kapsel indeholder 72 mg vandfri lactose og Sunset Yellow FCF (E 110).
English: LIST OF EXCIPIENTS Contains lactose, sunset yellow FCF (E110).
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose, Sunset Yellow FCF (E 110).
English: a: Treatment with concomitant TMZ can be continued when all of the following conditions are met: absolute neutrophil count ≥ 1.5 x 109/l; thrombocyte count ≥ 100 x 109/l; CTC non-haematological toxicity ≤ Grade 1 (except for alopecia, nausea, vomiting).
Danish: Behandling med konkomitant TMZ kan fortsættes, når alle de følgende betingelser er opfyldt: Absolut antal neutrofile ≥ 1,5 x 109/l; trombocyttal ≥ 100 x 109/l; CTC ikke-hæmatologisk toksicitet ≤ Grad 1 (undtaget alopeci, kvalme, opkastning).
English: interstitial pneumonitis/pneumonitis, pulmonary fibrosis, respiratory failure†
Danish: Interstitiel pneumonitis/pneumonitis, lungefibrose, respirationsinsufficiens
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 astrocytoma.
English: TMZ dose levels for monotherapy treatment
Danish: TMZ-dosistrin for monoterapi-behandling
English: - 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.
Danish: • børn fra 3 år, unge og voksne med malignt gliom, såsom glioblastoma multiforme eller anaplastisk astrocytoma, der får recidiv eller progression efter standardbehandling.
English: Temomedac is administered in combination with focal radiotherapy (concomitant phase) followed by up to 6 cycles of temozolomide (TMZ) monotherapy (monotherapy phase).
Danish: Temomedac hårde kapsler anvendes konkomitant med fokal strålebehandling (konkomitant fase) efterfulgt af op til 6 serier af temozolomid (TMZ)-monoterapi (monoterapi fase).
English: What Temomedac contains
Danish: Temomedac indeholder:
English: Temomedac 5 mg hard capsules Temomedac 20 mg hard capsules Temomedac 100 mg hard capsules Temomedac 140 mg hard capsules Temomedac 180 mg hard capsules Temomedac 250 mg hard capsules temozolomide
Danish: Temomedac 5 mg hårde kapsler Temomedac 20 mg hårde kapsler Temomedac 100 mg hårde kapsler Temomedac 140 mg hårde kapsler Temomedac 180 mg hårde kapsler Temomedac 250 mg hårde kapsler
English: TMZ dosing interruption or discontinuation during concomitant radiotherapy and TMZ
Danish: TMZ-doseringsafbrydelse eller -seponering under konkomitant strålebehandling og TMZ Toksicitet
English: ≥ 0.5 and < 1.5 x 109/l < 0.5 x 109/l
Danish: ≥ 0,5 og < 1,5 x 109/l
English: - The other ingredients are: capsule content: anhydrous lactose, colloidal anhydrous silica, sodium starch glycolate type A, tartaric acid, stearic acid (see section 2 “Temomedac contains lactose”).
Danish: • Øvrige indholdsstoffer: kapselindhold: vandfri lactose, vandfri silica kolloid, natriumstivelsesglycolat (type A), vinsyre, stearinsyre (se pkt.
English: Very rare (may affect up to 1 in 10,000 people): skin redness, urticaria (hives), skin eruption, allergic reactions.
Danish: Meget sjælden (kan påvirke op til 1 ud af 10.000): Rødmen af huden, nældefeber (kløende udslæt), hududslæt, allergiske reaktioner.
English: Very common (may affect more than 1 in 10 people): reduced number of blood cells (neutropenia or lymphopenia, thrombocytopenia), loss of appetite, headache, vomiting, nausea (feeling sick in your stomach), constipation (difficulty passing stools), tiredness.
Danish: Meget almindelig (kan påvirke flere end 1 ud af 10): Reduceret antal blodceller (neutropeni eller lymfopeni, trombocytopeni), tab af appetit, hovedpine, opkastning, kvalme (følelse af ubehag i maven), forstoppelse (besvær med afføring), træthed.
English: - if you have nausea (feeling sick in your stomach) and/or vomiting which are very common side effects of Temomedac (see section 4), your doctor may prescribe you a medicine (an antiemetic) to help prevent vomiting.
Danish: • hvis du har kvalme og/eller kaster op, hvilket er meget almindelige bivirkninger ved Temomedac (se pkt.