FrancophonIA/ELRC3.0 huggingface dataset:
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Sandoz and should therefore use effective contraception during treatment with Pemetrexed Sandoz and for up to 6 months afterwards.
Danish: Mænd rådes til ikke at gøre en kvinde gravid hverken under eller i op til 6 måneder efter behandlingen med Pemetrexed Sandoz.
English: In patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min), the concomitant administration of pemetrexed with NSAIDs (e.g., ibuprofen) or acetylsalicylic acid at higher dose should be avoided for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.4).
Danish: Hos patienter med let til moderat nyreinsufficiens (kreatinin-clearance 45-79 ml/min) bør samtidig administration af pemetrexed og NSAID-præparater (for eksempel ibuprofen) eller acetylsalicylsyre i højere doser undgås 2 dage inden, på behandlingsdagen og i mindst 2 dage efter indgift af pemetrexed (se pkt.
English: See package leaflet for further information.
Danish: Se indlægssedlen for yderligerer information.
English: After reconstitution each vial contains 25 mg/ml of pemetrexed.
Danish: Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CTCAE = Common Terminology Criteria for Adverse Event; NCI = National Cancer Institute; SGOT = serum glutamic oxaloacetic aminotransferase; SGPT = serum glutamic pyruvic aminotransferase.
Danish: Forkortelser: ALAT = alanin-aminotransferase; ASAT = aspartat-aminotransferase;
English: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (N = 581, independently reviewed population; median of 4.0 months and 2.0 months, respectively) (hazard ratio = 0.60,95% CI = 0.49-0.73, p < 0.00001).
Danish: Studiet mødte dets primære endepunkt og viste statistisk signifikant forbedring i PFS i pemetrexed- delen i forhold til placebodelen (n = 581, en uafhængig overvåget population, gennemsnit på henholdsvis 4 måneder og 2 måneder) (hazard ratio = 0,60, 95% CI = 0,49-0,73; p < 0,00001).
English: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (PARAMOUNT), compared the efficacy and safety of continuation maintenance treatment with pemetrexed plus BSC (N = 359) with that of placebo plus BSC (N = 180) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) NSCLC other than predominantly squamous cell histology who did not progress after 4 cycles of first-line doublet therapy of pemetrexed in combination with cisplatin.
Danish: Et multi-center, randomiseret, dobbeltblindet, placebokontrolleret fase 3-studie (PARAMOUNT) sammenlignede virkningen og sikkerheden af fortsat vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC, Best Supportive Care) (Nn=359) med placebo plus BSC (n=180) hos patienter med lokalt fremskreden (stadium IIIB) eller metastaserende (stadium IV) ikke-småcellet lungecancer (NSCLC) bortset fra cancer hovedsageligt bestående af pladeepitelceller, som ikke progredierede efter 4 serier med 1. linjedubletbehandling bestående af pemetrexed i kombination med cisplatin.
English: Domaniewska 50C 02-672 Warszawa
Danish: Domaniewska 50C
English: The independent review of patient scans confirmed the findings of the investigator assessment of PFS. For randomised patients, as measured from the start of pemetrexed plus cisplatin first-line induction treatment, the median investigator-assessed PFS was 6.9 months for the pemetrexed arm and 5.6 months for the placebo arm (hazard ratio = 0.59, 95% CI = 0.47-0.74).
Danish: Den uafhængige evaluering af patienternes skanninger bekræftede investigatorernes vurdering af PFS. Investigatorernes mediane PFS-vurdering for de randomiserede patienter var 6,9 måneder for pemetrexed-armen og 5,6 måneder for placebo-armen (hazard ratio = 0,59; 95%
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: infection without neutropenia, febrile neutropenia, allergic reaction/hypersensitivity, increased creatinine, motor neuropathy, sensory neuropathy, erythema multiforme, and abdominal pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og < 5 % af de patienter, der var randomiseret til pemetrexed, omfattede: infektion uden neutropeni, febril neutropeni, allergisk reaktion/overfølsomhed, forhøjet kreatinin, motorisk neuropati, sensorisk neuropati, erythema multiforme og mavesmerter.
English: Serious cardiovascular events, including myocardial infarction and cerebrovascular events, have been uncommonly reported during clinical studies with pemetrexed, usually when given in combination with another cytotoxic agent.
Danish: Under kliniske studier med pemetrexed er der ikke almindeligt rapporteret om svære kardiovaskulære hændelser herunder myokardieinfarkt og cerebrovaskulære hændelser sædvanligvis når pemetrexed gives i kombination med et andet cytotoksisk lægemiddelstof.
English: Dose modification table for Pemetrexed Sandoz (as single agent or in combination) and cisplatin - Haematologic toxicities
Danish: Tabel 1 - Dosisjustering for Pemetrexed Sandoz (som enkeltstof eller i kombination) og cisplatin - hæmatologisk toksicitet
English: Haemoglobin decreased Leucocytes decreased
Danish: Nedsat hæmoglobin Nedsat leukocytter
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelige (kan forekomme hos flere end l ud af 10 behandlede) Lavt antal hvide blodlegemer
English: Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
Danish: 02-672 Warszawa Tel.: + 48 22 209 70 00 biuro.pl@sandoz.com
English: Fatigue Pain
Danish: Træthed Smerte
English: • Response rate (%) (95% CI)
Danish: Respons (n: kvalificeret til respons) Responsrate (%) (95 %-CI) Stabilsygdom(%)
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 (HR) 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
English: How to use Pemetrexed Sandoz
Danish: Sådan skal du bruge Pemetrexed Sandoz
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the treatment of chemotherapy naive patients with unresectable malignant pleural mesothelioma.
Danish: Pemetrexed Sandoz er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: For patients with NSCLC other than predominantly squamous cell histology (N = 430, independently reviewed population) median PFS was 4.4 months for the pemetrexed arm and 1.8 months for the placebo arm, hazard ratio = 0.47 (95% CI = 0.37-0.60, p =
Danish: For patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 430), uafhængig overvåget population) var middel PFS 4,4 måneder for pemetrexed-delen og 1,8 måneder for placebodelen, hazard ratio = 0,47, 95% CI = 0,37-0,60; p=0,00001.
English: Very common Alopecia
Danish: Meget almindelig Alopeci Forhøjet kreatininniveau
English: Clinically relevant CTC toxicity of any grade that was reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to pemetrexed include: febrile neutropenia, infection, decreased platelets, diarrhoea, constipation, alopecia, pruritus/itching, fever (in the absence of neutropenia), ocular surface disease (including conjunctivitis), increased lacrimation, dizziness and motor neuropathy.
Danish: De klinisk relevante CTC-toksiciteter af enhver grad, der blev rapporteret hos ≥1% og ≤5% af de patienter, som var randomiseret til pemetrexed, omfatter: febril neutropeni, infektion, nedsat antal blodplader, diarré, forstoppelse, alopeci, kløe, feber (uden neutropeni), sygdom i øjets overflade (inklusive konjunktivitis), øget tåreflåd, svimmelhed og motorisk neuropati.
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion This medicinal product contains 54 mg sodium per vial.
Danish: Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Lægemiddelet indeholder 54 mg natirum pr. hætteglas.
English: • Hypernatraemia - increased sodium in blood
Danish: Øget koncentration af natrium i blodet (hypernatriæmi)
English: Patients must receive adequate antiemetic treatment and appropriate hydration prior to and/or after receiving cisplatin (see also cisplatin Summary of Product Characteristics for specific dosing advice).
Danish: Patienten skal have modtaget passende antiemetisk behandling og relevant hydrering inden og/eller efter indgift af cisplatin.
English: • If you have pain, redness, swelling or sores in your mouth (very common).
Danish: ● Hvis du har smerter, rødmen, hævelse eller sår i munden (meget almindelig).
English: Granulocytes decreased
Danish: Nedsat hæmoglobin
English: Time to treatment failure (months)
Danish: Tid til behandlingssvigt (måneder) (95 %-CI)
English: Excipient with known effect Each vial contains approximately 108 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 108 mg natrium.
English: Renal Disorders Common Renal disorders****
Danish: Almindelig Nyresygdomme****
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning
English: Excipient with known effect Each vial contains approximately 11 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 11 mg natrium.
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion This medicinal product contains 108 mg sodium per vial.
Danish: Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning Lægemiddelet indeholder 108 mg natirum pr. hætteglas.
English: Therefore, the use of pemetrexed in patients with creatinine clearance of < 45ml/min is not recommended (see section 4.2).
Danish: Pemetrexed anbefales derfor ikke til patienter med en kreatinin-clearance på < 45 ml/min
English: Survival time (months)
Danish: Overlevelsestid (måneder) Median (m)
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma
Danish: Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom
English: Including the induction phase, the median OS for patients with NSCLC other than predominantly squamous cell histology was 18.6 months for the pemetrexed arm and 13.6 months for the placebo arm, hazard ratio = 0.71 (95% CI = 0.56-0.88, p = 0.002).
Danish: Ved at inkludere induktionsfasen blev middel OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller 18,6 måneder for Pemetrexed Sandozdelen og 13,6 måneder for placebodelen (hazard ratio=0,71, 95% CI = 0,56 - 0,88, p=0,002).
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Clear, colorless 50 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 500 mg of pemetrexed.
Danish: Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Klart, farveløst 50 ml hætteglas af type I med chlorobutyl-gummiprop og aluminiumshætte med afrivningskapsel, indeholdende 500 mg pemetrexed.
English: Excipient with known effect Each vial contains approximately 54 mg sodium.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder ca. 54 mg natrium.
English: Clinically relevant CTC toxicities that were reported in ≥ 1 % and ≤ 5 % of the patients that were randomly assigned to receive cisplatin and pemetrexed include: renal failure, infection, pyrexia, febrile neutropenia, increased AST, ALT, and GGT, urticaria and chest pain.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos ≥ 1 % og < 5 % af de patienter, der var randomiseret til cisplatin og pemetrexed, omfattede: nyresvigt, infektion, pyreksi, febril neutropeni, forhøjet ASAT, ALAT og GGT, nældefeber og brystsmerter.
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Clear, colorless 10 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 100 mg of pemetrexed.
Danish: Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning Klart, farveløst 10 ml hætteglas af type I med chlorobutyl-gummiprop og aluminiumshætte med afrivningskapsel, indeholdende 100 mg pemetrexed.
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: legemsoverflade infunderet over 2 timer cirka 30 minutter efter afsluttet infusion af pemetrexed på den første dag i hver 21-dages-serie.
English: Pemetrexed Sandoz in combination with cisplatin is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Sandoz er indiceret til behandling sammen med cisplatin, som 1. linje-behandling til patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Danish: Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddinatrium).
English: Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion Clear, colorless 100 ml type I glass vial with chlorobutyl rubber stopper and aluminium crimp cap with a flip-off cap, containing 1000 mg of pemetrexed.
Danish: Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning Klart, farveløst 100 ml hætteglas af type I med chlorobutyl-gummiprop og aluminiumshætte med afrivningskapsel, indeholdende 1000 mg pemetrexed.
English: Squamous cell (N = 473)
Danish: Pladeepitelceller (n=473)
English: Pemetrexed Sandoz 500 mg: Each vial contains 500 milligrams of pemetrexed (as pemetrexed disodium).
Danish: Pemetrexed Sandoz 500 mg: Hvert hætteglas indeholder 500 milligram pemetrexed (som pemetrexeddinatrium)
English: Pemetrexed Sandoz is indicated as monotherapy for the second-line treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology (see section 5.1).
Danish: Pemetrexed Sandoz er indiceret som 2. linjes monoterapi til behandling af patienter med lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller (se pkt.
English: Pemetrexed Sandoz 100 mg: Each vial contains 100 milligrams of pemetrexed (as pemetrexed disodium).
Danish: Pemetrexed Sandoz 100 mg: Hvert hætteglas indeholder 100 milligram pemetrexed (som pemetrexeddinatrium)
English: Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium).
Danish: Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatrium).
English: Pemetrexed Sandoz 1000 mg: Each vial contains 1000 milligrams of pemetrexed (as pemetrexed disodium).
Danish: Pemetrexed Sandoz 1000 mg: Hvert hætteglas indeholder 1000 milligram pemetrexed (som pemetrexeddinatrium)
English: Taste disturbance Nausea
Danish: Almindelig Smagsforstyrrelser
English: The median OS for patients with NSCLC other than predominantly squamous cell histology (N = 481) was 15.5 months for the pemetrexed arm and 10.3 months for the placebo arm, hazard ratio = 0.70 (95% CI = 0.56-0.88, p = 0.002).
Danish: Den gennemsnitlige OS for patienter med NSCLC bortset fra cancer hovedsageligt bestående af pladeepitelceller (n = 481) var 15,5 måneder for pemetrexed-delen og 10,3 måneder for placeboarmen (hazard ratio = 0,70, 95% CI = 0,56 - 0,88,
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1000 mg of pemetrexed (as pemetrexed disodium).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 1000 mg pemetrexed (som pemetrexeddinatrium).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: • Fever
Danish: Almindelig Feber
English: • Interstitial pneumonitis (scarring of the air sacs of the lung)
Danish: Interstitiel lungebetændelse (lungebetændelse med talrige små udbredte infektionsområder mellem alveolerne).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1037/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1037/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1037/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1037/003
English: a These criteria meet the National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI
Danish: aDisse kriterier opfylder National Cancer Institute Common Toxicity Criteria (CTC v2.0; NCI 1998) definition på ≥CTC grad 2 blødning.
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER cytostaticum
English: • Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving
Danish: Ødemer (væskeophobning i væv, som medfører hævelse) Nogle patienter har oplevet et hjertetilfælde, et slagtilfælde eller et ”mini-slagtilfælde”, mens de har fået Pemetrexed Sandoz, sædvanligvis i kombination med anden kræftbehandling.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 1000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Sandoz 1000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: If you have heart disease or a history of heart disease, please tell your doctor.
Danish: Informér din læge, hvis du har en hjertesygdom eller tidligere har haft en hjertesygdom.
English: Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 500 mg rekonstitueres med 20 ml natriumchlorid-injektionsvæske 9 mg/ml (0,9%), (uden konserveringsmiddel), til en opløsning indeholdende 25 mg/ml pemetrexed.
English: • Kidney failure
Danish: Hudirritation og -kløe
English: Reconstitute 1000-mg vials with 40 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 1000 mg rekonstitueres med 40 ml natriumchlorid-injektionsvæske 9 mg/ml (0,9%), (uden konserveringsmiddel), til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9%) solution for injection (without preservative), resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hætteglas med 100 mg rekonstitueres med 4,2 ml natriumchlorid-injektionsvæske 9 mg/ml (0,9%), (uden konserveringsmiddel), til en opløsning indeholdende 25 mg/ml pemetrexed.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Sandoz 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning
English: The table below provides the frequency and severity of undesirable effects considered possibly related to study drug that have been reported in > 5 % of 800 patients randomly assigned to receive single-agent pemetrexed and 402 patients randomly assigned to receive placebo in the single-agent pemetrexed maintenance (JMEN: N= 663) and continuation pemetrexed maintenance (PARAMOUNT: N=539) studies.
Danish: Bivirkningerne blev rapporteret hos > 5 % af de 800 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed, og de 402 patienter, som var randomiseret til placebo i studiet med pemetrexed vedligeholdelsesbehandling (JMEN:
English: Stomatitis ALT (SGPT) elevation
Danish: Mucositis/ stomatitis ALAT-forhøjelse
English: Pemetrexed Sandoz 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pemetrexed Sandoz 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium).
English: • Conjunctivitis (inflamed eye)
Danish: Bindehindebetændelse (øjenbetændelse) Mavegener
English: • Dehydration
Danish: Dehydrering (væskemangel)
English: Special precautions for disposal and other handling
Danish: Instruktioner vedrørende anvendelse, håndtering samt bortskaffelse.
English: Pemetrexed Sandoz.
Danish: Pemetrexed Sandoz givet alene
English: JMEN: Kaplan-Meier plots of progression-free survival (PFS) and overall survival pemetrexed versus placebo in patients with NSCLC other than predominantly squamous cell histology:
Danish: Pemetrexed versus placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller:
English: Common Dyspepsia/ heartburn 5.2 Very common
Danish: Almindelig Dyspepsi/ halsbrand
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Novem on 2 March 2004.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Novem den 2. marts 2004.
English: The full EPAR for Novem can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary Medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Novem findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: What is Novem and what is it used for?
Danish: Hvad er Novem, og hvad anvendes det til?
English: What are the risks associated with Novem?
Danish: Hvilke risici er der forbundet med Novem?
English: Why is Novem approved?
Danish: Hvorfor er Novem blevet godkendt?
English: Other information about Novem:
Danish: Andre oplysninger om Novem