FrancophonIA/ELRC3.0 huggingface dataset:
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1,500 cells/mm³ and platelets should be ≥ 100,000 cells/mm³.
Danish: Før påbegyndelse af en kemoterapiserie skal patienter opfylde følgende parametre: Det absolutte neutrofiltal (ANC) skal være ≥ 1.500 celler/mm³, og trombocyttallet skal være ≥ 100.000 celler/mm³.
English: Dose of pemetrexed (mg/m²)
Danish: Dosis af pemetrexed (mg/m²)
English: Nadir platelets < 50,000/mm³ regardless of nadir ANC
Danish: Nadir for trombocytter < 50.000/mm³ uanset ANC-nadir
English: a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition of ≥ CTC Grade 2 bleeding
Danish: a Disse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥ CTC grad 2 blødning.
English: Adenocarcinoma (N = 847)
Danish: Adenocarcinom (N = 847)
English: − if you experience sudden breathlessness, intense chest pain or cough with bloody sputum (uncommon) (may indicate a blood clot in the blood vessels of the lungs)
Danish: − Hvis du pludselig får åndenød, stærke smerter i brystet eller hoste med blodigt spyt (ikke almindeligt) (dette kan betyde, at der er en blodprop i en af lungernes blodårer).
English: − bullous conditions (blistering skin diseases) including Stevens-Johnson syndrome and Toxic epidermal necrolysis
Danish: − Bulløse tilstande (hudsygdomme med blæredannelser), inklusive Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
English: Women must use effective contraception during treatment with Pemetrexed medac.
Danish: Kvinder skal anvende effektive svangerskabsforebyggende midler under behandlingen med Pemetrexed medac.
English: − you currently have or have previously had problems with your kidneys, as you may not be able to receive Pemetrexed medac.
Danish: − du har eller tidligere har haft nyreproblemer, da du muligvis ikke må få Pemetrexed medac.
English: Dose of premetrexed (mg/m²) Dose for cisplatin (mg/ m²) 100 % of previous dose
Danish: Dosis af pemetrexed (mg/m²) Dosis af cisplatin (mg/m²) 100 % af tidligere dosis
English: This medicine contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 100 mg hætteglas, dvs. det er i det væsentlige natrium-frit.
English: − if you start feeling chest pain (common) or having a fast heart rate (uncommon)
Danish: − Hvis du begynder at føle brystsmerter (almindelig) eller har hjertebanken (ualmindelig).
English: Pharmacotherapeutic group: antineoplastic agents, folic acid analogues, ATC code: L01BA04 Pemetrexed medac is a multi-targeted anti-cancer antifolate agent that exerts its action by disrupting crucial folate-dependent metabolic processes essential for cell replication.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, folsyreanaloger, ATC-kode L01BA04 Pemetrexed medac er et bredspektret anti-cancer-antifolat, som virker ved at forstyrre de centrale folatafhængige metaboliske processer, der er afgørende for celledannelsen.
English: Dose for cisplatin (mg/m²)
Danish: Dosis af cisplatin (mg/m²)
English: − lower limb swelling with pain and redness
Danish: − Hævelse i de nedre lemmer med smerte og rødme
English: Alkaline phosphatase (AP), aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) should be ≤ 3 times upper limit of normal.
Danish: aspartataminotransferase (ASAT) og alaninaminotransferase (ALAT) skal være ≤ 3 gange den normale øvre grænseværdi.
English: System organ class Frequency Event*
Danish: Systemorganklasse Hyppighed Bivirkning*
English: − if you experience tiredness, feeling faint, becoming easily breathless or if you look pale (since you might have less haemoglobin than normal which is very common)
Danish: − Hvis du føler træthed, svimmelhed, hurtigt mister vejret, eller hvis du er bleg (fordi du muligvis har mindre hæmoglobin end normalt, hvilket er meget almindeligt).
English: This medicine contains 54 mg sodium (main component of cooking/table salt) in each 500 mg vial.
Danish: Dette lægemiddel indeholder 54 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. 500 mg hætteglas.
English: Less toxicity and reduction in Grade 3/4 haematologic and non-haematologic toxicities such as neutropenia, febrile neutropenia and infection with Grade 3/4 neutropenia were reported when pre-treatment with folic acid and vitamin B12 was administered.
Danish: Der blev observeret en mindre toksicitet og en reduktion i antallet af hæmatologiske og ikke-hæmatologiske toksiciteter af grad 3/4 såsom neutropeni, febril neutropeni og infektion med neutropeni af grad 3/4, når patienterne var i forbehandling med folsyre og B12-vitamin.
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1,500 cells/mm³ and platelet count returns to ≥ 100,000 cells/mm³.
Danish: Under behandlingen skal patienten monitoreres for myelosuppression, og pemetrexed må ikke gives til patienter, før det absolutte neutrofiltal (ANC) igen er ≥ 1.500 celler/mm³, og trombocyt-tallet igen er ≥ 100.000 celler/mm³.
English: Patients must take oral folic acid or a multivitamin containing folic acid (350 - 1,000 µg) on a daily basis.
Danish: Patienter skal dagligt tage et oralt folsyretilskud eller en multivitamin indeholdende folsyre (350-1.000 µg).
English: − if you experience bleeding from the gums, nose or mouth or any bleeding that would not stop reddish or pinkish urine, unexpected bruising (since you might have less platelets than normal which is very common)
Danish: − Hvis du bløder fra gummer, næse eller mund eller anden blødning, som ikke vil stoppe, rødlig eller lyserødlig urin, uventede blå mærker (fordi du muligvis har færre blodplader end normalt, hvilket er meget almindeligt).
English: Type I glass vial with rubber (bromobutyl rubber coated with fluoropolymer) stopper containing 100, 500 or 1,000 mg of pemetrexed.
Danish: Hætteglas af type I med fluorpolymer-belagt bromobutylgummiprop, der indeholder 100, 500 eller 1.000 mg pemetrexed.
English: When prepared as directed, chemical and physical in-use stability of reconstituted and infusion solutions of pemetrexed were demonstrated for 24 hours at refrigerated temperature (2 °C - 8 °C).
Danish: Hvis produktet er forberedt som angivet, har genfortyndede opløsninger og infusionsopløsninger af pemetrexed vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved køleskabstemperatur (28 °C).
English: There is no relevant use of Pemetrexed medac in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Danish: Det er ikke relevant at anvende Pemetrexed medac til malignt pleuramesoteliom og ikke-småcellet lungecancer i den pædiatriske population.
English: ** According to National Cancer Institute CTC (v2.0; NCI 1998), alopecia should only be reported as Grade 1 or 2.
Danish: ** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), bør alopeci kun rapporteres som grad 1 eller 2.
English: Children and adolescents There is no relevant use of Pemetrexed medac in the paediatric population.
Danish: Børn og unge Det er ikke relevant at bruge Pemetrexed medac til børn og unge.
English: − fever
Danish: − Feber
English: This medicine contains 108 mg sodium (main component of cooking/table salt) in each 1,000 mg vial.
Danish: Dette lægemiddel indeholder 108 mg natrium (hovedkomponent af madlavnings-/bordsalt) pr. 1.000 mg hætteglas.
English: − Extremity pain, low temperature and discolouration have been reported.
Danish: − Smerter i arme og ben, lav temperatur og misfarvning er indberettet
English: What you need to know before you use Pemetrexed medac
Danish: Det skal du vide, før du begynder at bruge Pemetrexed medac
English: In patients with normal renal function (creatinine clearance ≥ 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1,600 mg/day) and acetylsalicylic acid at higher dose (≥ 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Danish: Hos patienter med en normal nyrefunktion (kreatinin-clearance ≥ 80 ml/min) kan høje doser af nonsteroide anti-inflammatoriske lægemidler (NSAID-præparater såsom ibuprofen > 1.600 mg/dag) og acetylsalicylsyre i høje doser (≥ 1,3 g daglig) nedsætte udskillelsen af pemetrexed, og dermed øge forekomsten af bivirkninger relateret til pemetrexed.
English: − diarrhoea
Danish: − Diarré
English: − fast heart rate
Danish: − Hurtig puls
English: In clinical trials, cases of colitis (including intestinal and rectal bleeding, sometimes fatal, intestinal perforation, intestinal necrosis and typhlitis) have been reported uncommonly in patients treated with pemetrexed.
Danish: Tilfælde af colitis (inklusive intestinal og rektal blødning, sommetider dødelig, tarmperforation, intestinal nekrose og typhlitis) er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske studier.
English: Median overall survival in months (95% CI)
Danish: Middel overlevelse i måneder (95%-CI)
English: − acute renal failure
Danish: − Akut nyresvigt
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups ITT population and histology subgroups
Danish: Effekt af pemetrexed + cisplatin mod gemcitabin + cisplatin ved 1. linje-behandling af ikke-småcellet lungecancer - ITT-population og histologiske undergrupper.
English: Log Rank p-value* Overall response rate** (95 % CI)
Danish: Log-rank-p-værdi* Samlet responsrate** (95 %-CI)
English: Pemetrexed medac 100 mg powder for concentrate for solution for infusion This medicinal product contains less than 1 mmol sodium (23 mg) per 100 mg vial, that is to say essentially ‘sodium-free'.
Danish: Pemetrexed medac 100 mg pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 100 mg hætteglas, dvs. det er i det væsentlige natrium-frit.
English: Oesophagitis/ radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Danish: Øsophagitis/strålings-øsophagitis er ikke almindeligt rapporteret under kliniske studier med pemetrexed.
English: In patients treated for non-small cell lung cancer after prior chemotherapy, the recommended dose of Pemetrexed medac is 500 mg/m² BSA administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Til patienter, der behandles for ikke-småcellet lungecancer efter tidligere behandling med kemoterapi, er den anbefalede dosis af Pemetrexed medac 500 mg/m² legemsoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: Pemetrexed medac 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per 500 mg vial, equivalent to 2.70% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Pemetrexed medac 500 mg pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel indeholder 54 mg natrium pr. 500 mg hætteglas, svarende til 2,70 % af den WHOanbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: The recommended dose of cisplatin is 75 mg/m² BSA infused over two hours approximately 30 minutes after completion of the pemetrexed infusion on the first day of each 21-day cycle.
Danish: Den anbefalede dosis cisplatin er 75 mg/m² legemsoverflade infunderet over 2 timer cirka 30 minutter efter afsluttet infusion af pemetrexed på den første dag i hver 21-dages-serie.
English: Pemetrexed at a dose of 500 mg/m² was studied as a single-agent in 64 chemonaive patients with malignant pleural mesothelioma.
Danish: Pemetrexed i en dosis på 500 mg/m² blev undersøgt som enkeltstof behandling til 64 patienter med malignt pleuramesoteliom, som ikke tidligere havde modtaget kemoterapi.
English: Patients also required lower administration of erythropoietin/darbopoietin (10.4 % versus 18.1 %, p < 0.001), G-CSF/GM-CSF (3.1 % versus 6.1 %, p = 0.004), and iron preparations (4.3 % versus 7.0 %, p = 0.021).
Danish: Patienterne behøvede ligeledes mindre erythropoietin/darbepoetin (10,4 % mod 18,1 %, p < 0,001), G-CSF/GM-CSF (3,1 % mod 6,1 %; p = 0,004) og midler med jern (4,3 mod 7,0 %; p = 0,021).
English: − inflammation of the skin, mainly of the lower limb with swelling, pain and redness
Danish: − Betændelse i huden, hovedsagligt i underbenet med hævelse, smerte og rødme.
English: Patients treated with pemetrexed and cisplatin required fewer transfusions (16.4 % versus 28.9 %, p < 0.001), red blood cell transfusions (16.1 % versus 27.3 %, p < 0.001) and platelet transfusions (1.8 % versus 4.5 %, p = 0.002).
Danish: Patienter, der blev behandlet med pemetrexed og cisplatin, havde brug for færre transfusioner (16,4 % mod 28,9 %; p < 0,001), transfusioner af røde blodlegemer (16,1 % mod 27,3 %; p < 0,001) og blodpladetransfusioner (1,8 % mod 4,5 %; p = 0,002).
English: Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per 1,000 mg vial, equivalent to 5.40% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Pemetrexed medac 1.000 mg pulver til koncentrat til infusionsvæske, opløsning Dette lægemiddel indeholder 108 mg natrium pr. 1.000 mg hætteglas, svarende til 5,40 % af den WHO-anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacectic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase * Definition of frequency terms: Very common - ≥ 10 %; Common - > 5 % and < 10 %.
Danish: Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute.
English: Pemetrexed medac contains sodium
Danish: Pemetrexed medac indeholder natrium
English: * P-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test ** Refer to National Cancer Institute CTC (v2.0; NCI 1998) for each Grade of Toxicity *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2
Danish: *P-værdier < 0,05 sammenligning af pemetrexed/cisplatin med gemcitabin/cisplatin, ved brug af Fisher Exact test. ** Se National Cancer Institute CTC (v2.0; NCI 1998) for hver toksicitetsgrad.
English: Progression free survival (PFS) and overall response rate were similar between treatment arms: median PFS was 4.8 months for pemetrexed plus cisplatin versus 5.1 months for gemcitabine plus cisplatin (adjusted hazard ratio 1.04; 95 % CI = 0.94 - 1.15), and overall response rate was 30.6 % (95 % CI = 27.3 - 33.9) for pemetrexed plus cisplatin versus 28.2 % (95 % CI = 25.0 - 31.4) for gemcitabine plus cisplatin.
Danish: Progressionsfri overlevelse (PFS) og størrelsen af det totale respons var ens mellem de to behandlingsarme: Middel PFS var 4,8 måneder for pemetrexed plus cisplatin mod 5,1 måneder for gemcitabin plus cisplatin (justeret hazard ratio 1,04; 95 %-CI = 0,94-1,15) og det totale respons var 30,6 % (95 %-CI = 27,3-33,9) for pemetrexed plus cisplatin mod 28,2 % (95 %-CI = 25,0-31,4) for gemcitabin plus cisplatin.
English: Log Rank p-value* Median time to tumour progression (months) (95 % CI)
Danish: Log-rank-p-værdi* Median-tid til tumorprogression (måneder) (95 %-CI)
English: PARAMOUNT: Kaplan Meier plot of progression-free survival (PFS) and Overall Survival (OS) for continuation pemetrexed maintenance versus placebo in patients with NSCLC other than predominantly squamous cell histology (measured from randomisation)
Danish: PARAMOUNT: Kaplan Meier-kurver for progressionsfri overlevelse (PFS) og total overlevelse (OS, overall survival) for pemetrexed-vedligeholdelsesbehandling vs. placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller (målt fra randomiseringen)
English: Pemetrexed medac is given in combination with cisplatin, another anti-cancer medicine, as treatment for malignant pleural mesothelioma, a form of cancer that affects the lining of the lung, to patients who have not received prior chemotherapy.
Danish: Pemetrexed medac anvendes sammen med cisplatin, en anden medicin mod kræft, til behandling af malignt pleuramesoteliom, en kræftform som påvirker lungehinderne, til patienter, som ikke tidligere har fået kemoterapi.
English: Do not use Pemetrexed medac
Danish: Brug ikke Pemetrexed medac:
English: Gemcitabine/ cisplatin (N = 830)
Danish: Gemcitabin/ cisplatin (n = 830)
English: Each 500 mg vial contains approximately 54 mg sodium.
Danish: Hvert hætteglas med 500 mg indeholder ca. 54 mg natrium.
English: Log Rank p-value* Time to treatment failure (months) (95 % CI)
Danish: Log-rank-p-værdi* Tid til behandlingssvigt (måneder) (95 %-CI)
English: Each 1,000 mg vial contains approximately 108 mg sodium.
Danish: Hvert hætteglas med 1.000 mg indeholder ca. 108 mg natrium.
English: − Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving
Danish: − Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået Pemetrexed medac, sædvanligvis i kombination med anden kræftbehandling
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter)
English: For precautions to be taken before handling or administering Pemetrexed medac, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af Pemetrexed medac, se pkt.
English: A multicentre, randomised, open-label, Phase 3 study of pemetrexed plus cisplatin versus gemcitabine plus cisplatin in chemonaive patients with locally advanced or metastatic (Stage IIIb or IV) non-small cell lung cancer (NSCLC) showed that pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) met its primary endpoint and showed similar clinical efficacy as gemcitabine plus cisplatin (ITT n = 863) in overall survival (adjusted hazard ratio 0.94; 95 % CI = 0.84 - 1.05).
Danish: Et randomiseret, åbent, fase 3-multicenterstudie af pemetrexed plus cisplatin mod gemcitabin plus cisplatin med patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (fase IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (Intent-To-Treat [ITT] population n = 862) mødte dets primære endepunkt og viste lignende klinisk virkning som gemcitabin plus cisplatin (ITT n = 863) på total overlevelse (justeret hazard ratio 0,94; 95 %-CI = 0,84-1,05).
English: Creatinine elevation 10.7 Creatinine clearance decreased**
Danish: Forhøjet kreatininniveau Nedsat kreatininclearance**
English: Platelets decreased 23.2
Danish: Opkastning 16,2
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness
Danish: Inden for hver gruppe af bivirkninger med samme frekvens er bivirkningerne opstilles efter, hvor alvorlige bivirkningerne er.
English: You should not breast-feed while using Pemetrexed medac.
Danish: Du må ikke amme, mens du er i behandling med Pemetrexed medac.
English: Granulocytes decreased
Danish: − Nedsat føleevne
English: Pemetrexed medac is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Danish: Pemetrexed medac er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
English: Mannitol (E421)
Danish: FARMACEUTISKE OPLYSNINGER 6.1 Hjælpestoffer Mannitol (E421)
English: Package leaflet: Information for the user Pemetrexed medac 100 mg powder for concentrate for solution for infusion Pemetrexed medac 500 mg powder for concentrate for solution for infusion Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Indlægsseddel: Information til brugeren Pemetrexed medac 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed medac 500 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed medac 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Of the 939 patients treated with pemetrexed plus cisplatin induction, 539 patients were randomised to maintenance treatment with pemetrexed or placebo.
Danish: Samlet overlevelse blev 539 patienter randomiseret til vedligeholdelsesbehandling med pemetrexed eller placebo.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjældne bivirkninger (forekommer hos op til 1 ud af 1.000 patienter)
English: Fax: +34 936401146
Danish: Spanien tlf.: +34 936401516 fax: +34 936401146
English: Fax: +49 4103 8006-100
Danish: Tyskland tlf.: +49 4103 8006-0 fax: +49 4103 8006-100
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size a Statistically significant for noninferiority, with the entire confidence interval for HR well below the 1.17645 noninferiority margin (p < 0.001)
Danish: a Statistisk signifikans for non-inferioritet med hele konfidensintervallet for HR pænt under 1,17645 for non-inferioritetmargin (p < 0,001).
English: − loss of appetite
Danish: − Appetitløshed
English: An analysis of the impact of NSCLC histology on the treatment effect on overall survival was in favour of pemetrexed versus docetaxel for other than predominantly squamous histologies (n = 399, 9.3 versus 8.0 months, adjusted HR = 0.78; 95 % CI = 0.61 - 1.00, p = 0.047) and was in favour of docetaxel for squamous cell carcinoma histology (n = 172, 6.2 versus 7.4 months, adjusted HR = 1.56; 95 % CI = 1.08 - 2.26, p = 0.018).
Danish: En analyse af virkningen på NSCLCs histologi for behandlingens virkning på overlevelse var til fordel for pemetrexed versus docetaxel bortset fra cancerformer hovedsageligt bestående af pladeepitelceller (n = 399; 9,3 versus 8,0 måneder, justeret HR = 0,78; 95 %-CI = 0,61-1,00; p = 0,047) og til fordel for docetaxel for carcinom af pladeepitelceller (n = 172; 6,2 versus 7,4 måneder, justeret HR = 1,56; 95 %-CI = 1,08-2,26; p = 0,0018).
English: Czech Republic medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
Danish: Den Tjekkiske republik medac Gesellschaft für klinische Spezialpräparate mbH Theaterstr.
English: Pemetrexed was not mutagenic in either the in vitro chromosome aberration test in Chinese hamster ovary cells, or the Ames test. Pemetrexed has been shown to be clastogenic in the in vivo micronucleus test in the mouse.
Danish: Pemetrexed var hverken mutagent i in vitro-testen for kromosomafvigelse hos kinesiske hamstere eller i Ames testen.
English: Your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (3501,000 µg) that you must take once a day while you are taking Pemetrexed medac.
Danish: Du skal tage en folsyretablet eller en multivitamin indeholdende folsyre (350-1.000 µg) 1 gang dagligt, mens du tager Pemetrexed medac.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ} Du kan finde yderligere oplysninger om Pemetrexed medac på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: When using Pemetrexed medac in combination with cisplatin The doctor or hospital pharmacist will work out the dose you need based on your height and weight.
Danish: Lægen eller hospitalsfarmaceuten beregner den nødvendige dosis ud fra dine højde og vægt.
English: Each 100 mg vial contains approximately 11 mg sodium.
Danish: Hvert hætteglas med 100 mg indeholder ca. 11 mg natrium.