FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with mild to moderate renal insufficiency (creatinine clearance from 45 to 79 ml/min) should avoid taking non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, and acetylsalicylic acid (> 1.3 g daily) for 2 days before, on the day of, and 2 days following pemetrexed administration (see section 4.5).
Danish: Patienter med let til moderat nyreinsufficiens (kreatinin-clearance på 45-79 ml/min) skal undgå at tage non-steroide anti-inflammatoriske lægemidler (NSAID-præparater) såsom ibuprofen og acetylsalicylsyre (> 1,3 g daglig) i mindst 2 dage før, på dagen for og i mindst 2 dage efter indgift af pemetrexed (se pkt.
English: What Pemetrexed medac is and what is it used for Pemetrexed medac is a medicine used in the treatment of cancer.
Danish: Pemetrexed medac er et lægemiddel, der anvendes til behandling af kræft.
English: Table 2 - Dose modification table for pemetrexed (as single agent or in combination) and cisplatin - Non-haematologic toxicitiesa,b
Danish: Tabel 2 - Dosisjustering for pemetrexed (som enkeltstof eller i kombination) og cisplatinikke-hæmatologisk toksiciteta,b
English: − nausea
Danish: − Kvalme
English: − oedema (excess fluid in body tissue, causing swelling)
Danish: − Ødemer (væskeophobning i væv, som medfører hævelse)
English: − hair loss
Danish: − Hårtab
English: Pemetrexed medac is indicated as monotherapy for the maintenance treatment of locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology in patients whose disease has not progressed immediately following platinum-based chemotherapy (see section 5.1).
Danish: Pemetrexed medac er indiceret som monoterapi til vedligeholdelsesbehandling af lokalt fremskreden eller metastatisk ikke-småcellet lungecancer, bortset fra cancer hovedsageligt bestående af pladeepitelceller, hos patienter, hvis sygdom ikke har vist progression umiddelbart efter platinbaseret kemoterapi (se pkt.
English: Clinically relevant CTC toxicity that was reported in < 1 % of the patients that were randomly assigned to pemetrexed include: allergic reaction/hypersensitivity, erythema multiforme, supraventricular arrhythmia and pulmonary embolism.
Danish: De klinisk relevante CTC-toksiciteter, som blev rapporteret hos < 1 % af de patienter, som blev randomiseret til pemetrexed, omfatter: allergisk reaktion/overfølsomhed, erythema multiforme, supraventrikulær arytmi og lungeemboli.
English: The recommended dose of Pemetrexed medac is 500 mg/m² of body surface area (BSA) administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: Den anbefalede dosis af Pemetrexed medac er 500 mg/m² legemsoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
English: Frequency Event**
Danish: Hyppighed Bivirkning*
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed medac and should therefore use effective contraception during treatment with Pemetrexed medac 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 medac.
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 %-CI = 0,47-0,74) målt fra start af pemetrexed og cisplatin førstelinje-induktionsbehandling.
English: − hypernatraemia - increased sodium in blood
Danish: − Øget koncentration af natrium i blodet (hypernatriæmi)
English: Pemetrexed medac is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Danish: Pemetrexed medac er også en behandling, som gives i kombination med cisplatin, som 1. linjebehandling af patienter med fremskreden lungecancer.
English: Following pemetrexed plus cisplatin induction (4 cycles), treatment with pemetrexed was statistically superior to placebo for OS (median 13.9 months versus 11.0 months, hazard ratio = 0.78, 95 % CI = 0.64 - 0.96, p = 0.0195).
Danish: Efter induktionsbehandling med pemetrexed plus cisplatin (4 serier) var behandling med pemetrexed statistisk superior i forhold til placebo med hensyn til total overlevelse (median 13,9 måneder versus 11,0 måneder, hazard ratio = 0,78; 95 %-CI = 0,64-0,96; p = 0,0195).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Pemetrexed medac 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Pemetrexed medac 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: The appropriate volume of reconstituted pemetrexed solution must be further diluted to 100 ml with 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, and administered as an intravenous infusion over 10 minutes.
Danish: Den passende mængde rekonstitueret pemetrexedopløsning skal fortyndes yderligere til 100 ml med 0,9 % natriumchloridinjektionsvæske, uden konserveringsmiddel, og indgives som langsom intravenøs infusion over 10 minutter.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Pemetrexed medac 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Pemetrexed medac 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
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 pemetrexeddelen 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: The study met its primary endpoint and showed a statistically significant improvement in PFS in the pemetrexed arm over the placebo arm (n = 472, independently reviewed population; median of 3.9 months and 2.6 months, respectively) (hazard ratio = 0.64, 95 % CI = 0.51 - 0.81, p = 0.0002).
Danish: Studiets primære endepunkt blev mødt og viste en statistisk signifikant forbedring i PFS i pemetrexedarmen over for placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis 3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95 %-CI = 0,51-0,81; p = 0,0002).
English: The median OS for the overall population (n = 663) was 13.4 months for the pemetrexed arm and 10.6 months for the placebo arm, hazard ratio = 0.79 (95 % CI = 0.65 - 0.95, p = 0.01192).
Danish: Den gennemsnitlige overlevelse (OS, overall survival) for den totale population (n = 663) var 13,4 måneder for pemetrexed-delen og 10,6 måneder for placebodelen, hazard ratio = 0,79 (95 %-CI = 0,65-0,95; p = 0,01192).
English: What Pemetrexed medac is and what it is used for What you need to know before you use Pemetrexed medac How to use Pemetrexed medac Possible side effects
Danish: Det skal du vide, før du begynder at bruge Pemetrexed medac Sådan skal du bruge Pemetrexed medac Bivirkninger
English: From the start of pemetrexed plus cisplatin first line induction treatment, the median OS of patients was 16.9 months for the pemetrexed arm and 14.0 months for the placebo arm (hazard ratio = 0.78, 95 % CI = 0.64 - 0.96).
Danish: Målt fra starttidspunktet for pemetrexed plus cisplatin førstelinje-induktionsbehandling var den mediane overlevelse 16,9 måneder for pemetrexed-armen og 14,0 måneder for placebo-armen (hazard ratio = 0,78, 95 %-CI = 0,64-0,96).
English: Common Constipation 5.7
Danish: Almindelig Forstoppelse 5,7 Lever og galdeveje Almindelig ALATøgning
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: Contraception in males and females Women of childbearing potential must use effective contraception during treatment with pemetrexed.
Danish: Kvinder i den fertile alder skal anvende effektiv kontraception under behandling med pemetrexed.
English: may occur in patients who are also treated with radiation either before, during or after their
Danish: kan opstå hos patienter, som også behandles med stråling enten før, under eller efter deres behandling med Pemetrexed medac
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1038/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1038/001
English: Pemetrexed as single agent
Danish: Pemetrexed givet alene
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1038/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1038/003
English: Pemetrexed medac in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Danish: Pemetrexed medac er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: − loss of sensation
Danish: − Hudirritation og -kløe
English: Table 3 - Dose modification table for premetrexed (as single agent or in combination) and cisplatin - Neurotoxicity
Danish: Tabel 3 - Dosisjustering for pemetrexed (som enkeltstof eller i kombination) og cisplatinneurotoksicitet
English: − Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Danish: − Strålingspneumonitis (arvæv i de fineste bronkier samt alveolerne på grund af strålebehandling)
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 = 0.00001).
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: Extravasation should be managed by local standard practice as with other non-vesicants.
Danish: Som med andre ikke blæretrækkende stoffer skal eventuel ekstravasation håndteres i henhold til lokal standardpraksis.
English: Common Conjunctivitis
Danish: Almindelig Opkastning
English: How to use Pemetrexed medac
Danish: Sådan skal du bruge Pemetrexed medac
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: Stomatitis/
Danish: − Udslæt
English: Fatigue Common Pain Oedema Renal Disorders Common Renal disorders**** 7.6
Danish: Almindelig Smerte Ødemer Nyrer og urinveje Almindelig Nyresygdomme****
English: − conjunctivitis (inflamed eye)
Danish: − Bindehindebetændelse (øjenbetændelse)
English: − hepatitis (inflammation of the liver)
Danish: − Leverbetændelse (hepatitis)
English: CTC
Danish: CTCa-grad
English: What Pemetrexed medac looks like and contents of the pack Pemetrexed medac is a powder for concentrate for solution for infusion in a glass vial with rubber stopper.
Danish: Pemetrexed medac er et pulver til koncentrat til infusionsvæske, opløsning, i hætteglas med gummiprop.
English: Creatinine elevation 10.1* 0.8 6.9* 0.5
Danish: ASAT-øgning 6,8
English: Preparation and administration precautions
Danish: Forsigtighedsregler i forbindelse med forberedelse og indgivelse:
English: Uncommon (may affect up to 1 in 100 people)
Danish: Ikke almindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede)
English: Please tell your doctor or hospital pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Danish: − Kontakt lægen eller apotekspersonalet, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige bivirkninger (forekommer hos op til 1 ud af 10 patienter)
English: − interstitial pneumonitis (scarring of the air sacs of the lung)
Danish: − Interstitiel lungebetændelse (lungebetændelse med talrige små udbredte infektionsområder mellem alveolerne)
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-delen og 13,6 måneder for placebodelen (hazard ratio = 0,71, 95 %-CI = 0,56-0,88, p = 0,002).
English: − vomiting
Danish: − Mavegener
English: Pemetrexed medac 100 mg: Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed medac 100 mg: Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Pemetrexed medac 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 medac 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 medac 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 medac 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: 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, p = 0,002).
English: − watery eyes
Danish: − Rindende øjne
English: The other ingredients are mannitol, hydrochloric acid and sodium hydroxide, please see section 2 “Pemetrexed medac contains sodium”.
Danish: - Øvrige indholdsstoffer: Mannitol, saltsyre og natriumhydroxid, se pkt.
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: n = 63) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: n = 539).
English: Pemetrexed medac 500 mg: Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed medac 500 mg: Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Pemetrexed medac 1,000 mg: Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed medac 1.000 mg: Hvert hætteglas indeholder 1.000 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Neutrophils/ Granulocytes decreased
Danish: Nedsat neutrofiler/ granulocytter Nedsat leukocytter Nedsat hæmoglobin Nedsat trombocytter
English: Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed medac 1.000 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 1.000 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Efficacy of pemetrexed plus cisplatin vs. cisplatin in malignant pleural mesothelioma Randomized and treated patients
Danish: Effekt af pemetrexed sammen med cisplatin versus cisplatin alene til patienter med malignt pleuramesoteliom
English: Pemetrexed medac 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed medac 500 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: − inflammation of the lining of the oesophagus (gullet) has been experienced with Pemetrexed medac / radiation therapy
Danish: − Betændelse i spiserørets overflade er forekommet med Pemetrexed medac i kombination med strålebehandling
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE HÆTTEGLAS
English: Common Leukocytes decreased
Danish: Nedsat hæmoglobin Almindelig Nedsat leukocyttal Nedsat neutrofilocyttal
English: C/ Castello, nº1, Pol. Las Salinas,
Danish: C/ Castello, nº1, Pol. Las Salinas, Sant Boi de Llobregat 08830 Barcelona, Spanien
English: − upset stomach
Danish: − Mavesmerter
English: − if you are breast-feeding; you must discontinue breast-feeding during treatment with
Danish: − hvis du ammer, skal du afbryde amningen under behandlingen med Pemetrexed medac.
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 1,000 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed medac 1.000 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Nadir platelets < 50,000/mm³ with bleedinga, regardless of nadir ANC 50 % of previous dose (both pemetrexed and cisplatin)
Danish: Nadir for trombocytter < 50.000/mm³ med blødninga uanset ANCnadir
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 100 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed medac 100 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: − constipation
Danish: − Træthed
English: Pemetrexed*** (N = 800)
Danish: Systemorganklasse Hyppighed Bivirkning** Pemetrexed*** (n = 800)
English: NAME OF THE MEDICINAL PRODUCT Pemetrexed medac 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed medac 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: What Pemetrexed medac contains
Danish: Pemetrexed medac indeholder:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1,000 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 1.000 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Breast-feeding
Danish: Adenocarcinom
English: Excipients
Danish: Cisplatin
English: Reconstitute 1,000 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 1.000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %), uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Reconstitute each 1,000 mg vial with 40 ml of 9 mg/ml (0.9 %) sodium chloride solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.
Danish: Hvert hætteglas med 1.000 mg rekonstitueres med 40 ml natriumchloridinjektionsvæske 9 mg/ml (0,9 %) til injektion, uden konserveringsmiddel, til en opløsning indeholdende 25 mg/ml pemetrexed.
English: Name and address of the manufacturers responsible for batch release Synthon Hispania, S.L.
Danish: Synthon Hispania, S.L.
English: Common Neuropathy-sensory 8.5* 0.0* 12.4* 0.6* Taste disturbance
Danish: Lever og galdeveje Almindelig ALAT-forhøjelse 6,5
English: − If you have further questions, ask your doctor or pharmacist.
Danish: − Spørg lægen eller sundhedspersonalet, hvis der er mere, du vil vide.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 100 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 500 mg of pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatrium-hemipentahydrat).
English: Skin and sub-cutaneous tissue disorders
Danish: ITT-population og histologiske undergruppe
English: − taste change
Danish: − Smagsforstyrrelser
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 medac versus placebo hos patienter med NSCLC bortset fra cancer hovedsagelig bestående af pladeepitelceller:
English: OTHER sun as symbol moon as symbol
Danish: ANDET sol som symbol måne som symbol
English: • age ≥ 75 years
Danish: • alder ≥ 75 år
English: Therefore, it is not recommended in these patients.
Danish: Derfor anbefales det ikke til disse patienter.
English: Try to take the tablets at the same times every day to have the best treatment effect.
Danish: Forsøg at tage tabletterne på samme tidspunkt hver dag for at få den bedste virkning af behandlingen.
English: Take the card
Danish: Tag kortet
English: Date of latest renewal: 14 January 2016
Danish: Dato for seneste fornyelse: 14. januar 2016
English: Your doctor will decide how long you must continue treatment for.
Danish: Deres læge vil afgøre, hvor længe De skal fortsætte behandlingen.