FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: Mannitol (E 421), hydrochloric acid , sodium hydroxide (see package leaflet for further information).
Danish: Hjælpestoffer: Mannitol (E 421), saltsyre, natriumhydroxid (se indlægssedlen for yderligere information).
English: Pemetrexed at a dose of 500 mg/m 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 enkeltstofbehandling til 64 patienter med malignt pleuramesoteliom, som ikke tidligere havde modtaget kemoterapi.
English: Efficacy of pemetrexed + cisplatin vs. gemcitabine + cisplatin in first-line non-small cell lung cancer - ITT population and histology subgroups.
Danish: Effekt af pemetrexed + cisplatin versus gemcitabin + cisplatin ved 1. linje-behandling af ikkesmåcellet lungecancer - ITT-population og histologiske undergrupper
English: CIAMBRA 100 mg contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Danish: CIAMBRA 100 milligram indeholder mindre end 1 mmol (23 mg) natrium pr. hætteglas, dvs. den er i det væsentlige natrium-fri.
English: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
Danish: Indehaver af markedsføringstilladelsen MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare
English: There is no relevant use of CIAMBRA in the paediatric population in malignant pleural mesothelioma and non-small cell lung cancer.
Danish: Det er ikke relevant at bruge CIAMBRA til malignt pleuramesoteliom og ikke-småcellet lungecancer hos den pædiatriske population.
English: Vitamin supplementation: your doctor will prescribe you oral folic acid (vitamin) or a multivitamin containing folic acid (350 to 1000 micrograms) that you must take once a day while you are taking CIAMBRA.
Danish: Vitamintilskud: De skal tage en folsyretablet (vitamin) eller en multivitamin indeholdende folsyre (350-1.000 mikrogram) 1 gang dagligt, mens De tager CIAMBRA.
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: Fortæl altid lægen eller hospitalsapoteket, hvis De tager anden medicin eller har gjort det for nylig.
English: An insufficient number of patients has been studied with creatinine clearance of below 45 ml/min.
Danish: Der er ikke foretaget studier med tilstrækkeligt mange patienter med en kreatininclearance på under 45 ml/min.
English: The dose of CIAMBRA is 500 milligrams for every square metre of your body's surface area.
Danish: Dosis CIAMBRA er 500 milligram pr. m² legemsoverflade.
English: Unopened vial This medicinal product does not require any special storage conditions.
Danish: Ubrudt hætteglas Der er ingen særlige opbevaringsbetingelser for dette lægemiddel.
English: CIAMBRA is also a treatment for patients with advanced stage of lung cancer whose disease has progressed after other initial chemotherapy has been used.
Danish: CIAMBRA er også en behandling til patienter med fremskreden lungekræft, hvor sygdommen har udviklet sig, efter anden indledende behandling med kemoterapi har været forsøgt.
English: Dose for cisplatin (mg/m
Danish: Dosis cisplatin (mg/m²)
English: If pemetrexed solutions contact the mucous membranes, flush thoroughly with water.
Danish: Hvis pemetrexedopløsningen kommer i kontakt med slimhinderne, skal de skylles grundigt med vand.
English: There were no clinically relevant differences observed for the safety profile of pemetrexed plus cisplatin within the histology subgroups.
Danish: Der blev ikke set nogen klinisk relevante forskelle i sikkerhedsprofilen af pemetrexed inden for de histologiske undergrupper.
English: Each vial contains an excess of pemetrexed to facilitate delivery of the label amount.
Danish: Hvert hætteglas indeholder tilstrækkeligt med pemetrexed til at levere den angivne mængde.
English: The pH of the reconstituted solution is between 6.6 and 7.8 The osmolality of the reconstituted solution is 230-270 mOsmol/kg.
Danish: Den rekonstituerede opløsning har en osmolalitet 230-270 mosmol/kg.
English: CIAMBRA should be administered as an intravenous infusion over 10 minutes on the first day of each 21-day cycle.
Danish: CIAMBRA skal infunderes intravenøst infusion over 10 minutter på den første dag i hver 21-dagesserie.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER HÆTTEGLASETIKET
English: How to use CIAMBRA
Danish: Sådan skal De bruge CIAMBRA
English: Other medicines and CIAMBRA
Danish: Brug af anden medicin sammen med CIAMBRA
English: The most commonly reported undesirable effects related to pemetrexed, whether used as monotherapy or in combination, are bone marrow suppression manifested as anaemia, neutropenia, leukopenia, thrombocytopenia; and gastrointestinal toxicities, manifested as anorexia, nausea, vomiting, diarrhoea, constipation, pharyngitis, mucositis, and stomatitis.
Danish: De hyppigst indberettede bivirkninger relateret til pemetrexed ved både monoterapi og kombinationsbehandling, er knoglemarvssuppression med anæmi, neutropeni, leukopeni, trombocytopeni samt gastrointestinal toksicitet i form af anoreksi, kvalme, opkastning, diaré, forstoppelse, pharyngitis, mucositis og stomatitis.
English: Common Taste disturbance
Danish: Almindelig Smagsforstyrrel ser
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should notbe longer than 24 hours at 2°C to 8°C or at 15°C to 25°C.
Danish: Hvis den ikke anvendes med det samme, er det brugerens ansvar at vurdere holdbarheden og opbevaringsforholdene, inden produktet anvendes, og holdbarheden vil højst være 24 timer ved 2-8 °C eller 15-25 °C.
English: - The other ingredients are mannitol (E 421), hydrochloric acid (pH adjustment) and sodium hydroxide (pH adjustment) (see section 2, “Ciambra contains sodium”).
Danish: Øvrige indholdsstoffer: Mannitol (E421), saltsyre (pH-justering) og natriumhydroxid (pH-justering) (se punkt 2, ”CIAMBRA indeholder natrium”).
English: Oesophagitis / radiation oesophagitis has been uncommonly reported during clinical trials with pemetrexed.
Danish: Øsophagitis/strålingsøsophagitis er ikke almindeligt rapporteret under kliniske studier med pemetrexed.
English: Gemcitabine/ cisplatin (N = 830)
Danish: Gemcitabin/ cisplatin (n=830)
English: Table 2 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin- Non-haematologic toxicities a, b
Danish: Tabel 2 - Dosisjustering for CIAMBRA (som enkeltstof eller i kombination) og cisplatin - ikke-hæmatologisk toksicitet a, b
English: Intravenous use after reconstitution and dilution
Danish: Intravenøs brug efter rekonstitution of opløsning
English: Before the start of any cycle of chemotherapy, patients are required to have the following: absolute neutrophil count (ANC) should be ≥ 1500 cells/mm and platelets should be ≥ 100,000 cells/mm
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: Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding)
Danish: Tyktarmsbetændelse (betændelse i tyktarmen, som kan ledsages af blødning fra tarm eller endetarm)
English: CTC
Danish: Grad CTC
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/darbopoietin (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: Patients must take oral folic acid or a multivitamin containing folic acid (350 to 1000 micrograms) on a daily basis.
Danish: Patienter skal dagligt tage et oralt folsyretilskud eller en multivitamin indeholdende folsyre (350-1.000 mg).
English: Breast-feeding must be discontinued during pemetrexed therapy (see section
Danish: Amning skal ophøre under behandling med pemetrexed (se pkt.
English: *** According to National Cancer Institute CTC (v2.0; NCI 1998), taste disturbance and alopecia should only be reported as Grade 1 or 2.
Danish: *** I henhold til National Cancer Institute CTC (v2.0; NCI 1998), bør smagsforstyrrelser og alopeci kun rapporteres som grad 1 eller 2.
English: Gemcitabine + cisplatin
Danish: Gemcitabin + cisplatin
English: Chemical and physical in-use stability of the infusion solution of pemetrexed was demonstrated for 24 hours at 2°C-8°C or 15-25°C.
Danish: Infusionsopløsningen af pemetrexed har vist sig at have en kemisk og fysisk holdbarhed på 24 timer ved 2-8 °C eller 15-25 °C.
English: Method of administration For precautions to be taken before handling or administering CIAMBRA, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af CIAMBRA, 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 839 patients with NSCLC who were randomized to receive cisplatin and pemetrexed and 830 patients with NSCLC who were randomized to receive cisplatin and gemcitabine.
Danish: Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev vurderet som muligt relateret til studielægemidlet, og som blev rapporteret hos > 5 % af de 839 patienter med NSCLC, der blev randomiseret til at få cisplatin og pemetrexed, samt de 830 patienter med NSCLC, som blev randomiseret til at få cisplatin og gemcitabin.
English: NSCLC, second-line treatment:
Danish: NSCLC, 2. linje-behandling
English: Each pack of CIAMBRA consists of one glass vial with rubber stopper and an aluminium seal with flip off cap, and it is covered with a shrink-wrapped plastic sleeve.
Danish: Hver pakke CIAMBRA indeholder et hætteglas med gummiprop samt aluminiumlåg med hætte til at vippe af.
English: The percentage of patients that received post study treatment was 64.3% for pemetrexed and 71.7% for placebo.
Danish: 64,3 % af pemetrexed-patienterne og 71,7 % af placebo-patienterne fik behandling efter studiet.
English: In patients with normal renal function (creatinine clearance > 80 ml/min), high doses of non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen > 1600 mg/day) and aspirin at higher dose (> 1.3 g daily) may decrease pemetrexed elimination and, consequently, increase the occurrence of pemetrexed adverse events.
Danish: 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: A multicentre, randomised, open label phase 3 study of pemetrexed versus docetaxel in patients with locally advanced or metastatic NSCLC after prior chemotherapy has shown median survival times of 8.3 months for patients treated with pemetrexed (Intent To Treat population n = 283) and 7.9 months for patients treated with docetaxel (ITT n = 288).
Danish: Et åbent, randomiseret fase 3-multicenterstudie med pemetrexed versus docetaxel til patienter med lokalt fremskreden eller metastatisk NSCLC (ikke-småcellet lungekræft), der tidligere var behandlet med kemoterapi, har vist en median overlevelsestid på 8,3 måneder for patienter, som blev behandlet med pemetrexed (Intent-To-Treat-population n=283), og 7,9 måneder for patienter, som blev behandlet med docetaxel (ITT n=288).
English: Efficacy parameter pemetrexed / cisplatin (N = 226)
Danish: Effektparameter pemetrexed / cisplatin (n=226)
English: Patients received a median of 4 cycles of maintenance treatment with pemetrexed and 4 cycles of placebo.
Danish: Median var 4 serier vedligeholdelsesbehandling med pemetrexed og 4 serier med placebo.
English: CIAMBRA is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Danish: CIAMBRA er også en behandling, som gives i kombination med cisplatin, som 1. linje-behandling af patienter med fremskreden lungecancer.
English: Adenocarcinoma (N=847)
Danish: Adenokarcinom (n=847)
English: Type I glass vial with chlorobutyl rubber stopper and an aluminium seal with flip off cap.
Danish: Hætteglas af type I med klorbutylgummiprop samt aluminiumlåg med hætte til at vippe af.
English: Table 3 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin - Neurotoxicity
Danish: Tabel 3 - Dosisjustering for CIAMBRA (som enkeltstof eller i kombination) og cisplatin - neurotoksicitet
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 versus gemcitabin plus cisplatin til patienter, der ikke tidligere har fået kemoterapi, med lokalt fremskreden eller metastatisk (stadie IIIb eller IV) ikke-småcellet lungecancer (NSCLC) viste, at pemetrexed plus cisplatin (IntentTo-Treat (ITT) population n=865) mødte dets primære endepunkt og viste tilsvarende klinisk virkning som gemcitabin plus cisplatin (ITT n=863) på total overlevelse (justeret hazard ratio 0,94; 95 % CI = 0,84-1,05).
English: Median time to tumour progression (months) (95 % CI)
Danish: Median tid til tumorprogression (måneder) (95 % CI)
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 opstillet efter, hvor alvorlige bivirkningerne er.
English: In the absence of data regarding potential interaction with NSAIDs having longer half-lives such as piroxicam or rofecoxib, the concomitant administration with pemetrexed in patients with mild to moderate renal insufficiency should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.4).
Danish: Da der ikke foreligger data om potentielle interaktioner mellem pemetrexed og NSAID-præparater med længere halveringstid, såsom piroxicam og rofecoxib, skal samtidig behandling med pemetrexed afbrydes hos patienter med let til moderat nyreinsufficiens mindst 5 dage før, på behandlingsdagen og i mindst 2 dage efter administration af pemetrexed (se pkt.
English: Other (N=252)
Danish: Andre (n=252)
English: Patients received a median of 5 cycles of maintenance treatment with pemetrexed and 3.5 cycles of placebo.
Danish: Median var 5 serier af vedligeholdelsesbehandling med pemetrexed og 3,5 serier med placebo.
English: Median overall survival (months) (95 % CI)
Danish: Median overlevelse (måneder) (95 % CI)
English: Abbreviations: CI = confidence interval; ITT = intent-to-treat; N = total population size.
Danish: n=229 Forkortelser: CI = konfidensinterval; ITT = Intent-To-Treat; n = samlet populationsstørrelse.
English: The table below provides the frequency and severity of undesirable effects that have been reported in > 5 % of 265 patients randomly assigned to receive single agent pemetrexed with folic acid and vitamin B12 supplementation and 276 patients randomly assigned to receive single agent docetaxel.
Danish: Nedenstående tabel viser hyppigheden og sværhedsgraden af bivirkninger, der blev rapporteret hos > 5 % af 265 patienter, som var randomiseret til enkeltstofbehandling med pemetrexed og tilskud af folsyre og B12-vitamin, og 276 patienter, som var randomiseret til enkeltstofbehandling med docetaxel.
English: Breast-feeding must be discontinued during CIAMBRA treatment.
Danish: Amningen skal afbrydes under behandling med CIAMBRA.
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: In a study conducted in beagle dog by intravenous bolus injection for 9 months, testicular findings (degeneration/necrosis of the seminiferous epithelium) have been observed.
Danish: Der blev set en påvirkning af testiklerne (degenerering/nekrose af seminiferus epitel) i et studie udført med beaglehunde, der fik intravenøse bolusinjektioner i 9 måneder.
English: CIAMBRA 500 mgcontains 54 mg sodium (main component of cooking salt) in each vial.
Danish: CIAMBRA 500 milligram indeholder 54 mg natrium (hoved komponent af madlavnings-/bordsalt) pr. hætteglas.
English: Rare side effects (may affect up to 1 in 1,000 people) Radiation recall (a skin rash like severe sunburn) which can occur on skin that has previously been exposed to radiotherapy, from days to years after the radiation.
Danish: Meget ualmindelige bivirkninger (som kan berøre op til 1 ud af 1.000) Radiation recall (et hududslæt, der ligner en alvorlig solskoldning), som kan opstå på hud, der tidligere har været udsat for strålebehandling dage eller op til år efter strålebehandlingen Bulløse tilstande (hudsygdomme med blæredannelser), inklusive Stevens-Johnsons syndrom og toksisk epidermal nekrolyse
English: CIAMBRA 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
Danish: CIAMBRA 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: NSCLC, first-line treatment:
Danish: NSCLC, 1. linje-behandling
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, intestinal nekrose og tyflitis) er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske studier.
English: DE Berlin-Chemie AG Tel: +49 (0) 30 67070
Danish: Tel: +420 267 199 333 DE Berlin-Chemie AG Tel: +49 (0) 30 67070
English: CIAMBRA is a powder for concentrate for solution for infusion in a vial.
Danish: CIAMBRA er et pulver til koncentrat til infusionsvæskeopløsning i hætteglas.
English: Nadir platelets <50,000/mm with bleeding a,
Danish: Nadir for trombocytter < 50.000 /mm med blødning a uanset ANC-nadir
English: Patients should be monitored for myelosuppression during therapy and pemetrexed should not be given to patients until absolute neutrophil count (ANC) returns to ≥ 1500 cells/mm and platelet count returns to ≥ 100,000 cells/mm
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 trombocyttallet igen er ≥ 100.000 celler/mm
English: The median time from the start of pemetrexed plus cisplatin induction therapy to the start of maintenance treatment was 2.96 months on both the pemetrexed arm and the placebo arm. Randomised patients received maintenance treatment until disease progression.
Danish: Median tiden fra start af induktionsbehandling med pemetrexed og cisplatin til start af vedligeholdelsesbehandling var 2,96 måneder i både pemetrexed- og placeboarmen.
English: In patients with mild to moderate renal insufficiency eligible for pemetrexed therapy NSAIDs with long elimination half-lives should be interrupted for at least 5 days prior to, on the day of, and at least 2 days following pemetrexed administration (see section 4.5).
Danish: Hos patienter med let til moderat nyreinsufficiens, som er egnet til behandling med pemetrexed, skal behandling med NSAID-præparater med en lang halveringstid afbrydes mindst 5 dage før, på dagen for og i mindst 2 dage efter administration af pemetrexed (se pkt.
English: Table 1 - Dose modification table for CIAMBRA (as single agent or in combination) and cisplatin - Haematologic toxicities
Danish: Tabel 1 - Dosisjustering for CIAMBRA (som enkeltstof eller i kombination) og cisplatin - hæmatologisk toksicitet
English: Interactions common to all cytotoxics
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Cytotoksisk
English: In clinical trials, cases of interstitial pneumonitis with respiratory insufficiency, sometimes fatal, have been reported uncommonly in patients treated with pemetrexed.
Danish: Tilfælde af interstiel pneumoni med respiratorisk insufficiens, sommetider dødeligt, er ikke almindeligt rapporteret hos patienter behandlet med pemetrexed i kliniske studier.
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 og størrelsen af det totale respons var ens for de to behandlingsarme: Median progressionsfri overlevelse var 4,8 måneder for pemetrexed plus cisplatin versus 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 versus 28,2 % (95 % CI = 25,0-31,4) for gemcitabin plus cisplatin.
English: Men are advised not to father a child during and up to 6 months following treatment with CIAMBRA and should therefore use effective contraception during treatment with CIAMBRA 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 CIAMBRA.
English: Efficacy of pemetrexed plus cisplatin vs.cisplatin in malignant pleural mesothelioma Randomized and treated patients
Danish: Effekt af pemetrexed plus cisplatin versus cisplatin alene til patienter med malignt mesoteliom Randomiserede og behandlede patienter
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, der var randomiseret til pemetrexed, omfatter: allergisk reaktion/overfølsomhed, erythema multiforme, supraventrikulær arytmi og lungeemboli.
English: EU/1/15/1055/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/15/1055/001
English: Rarely, immune-mediated haemolytic anaemia has been reported in patients treated with pemetrexed.
Danish: Der er rapporteret sjældne, immunmedierede tilfælde af hæmolytisk anæmi hos patienter behandlet med pemetrexed.
English: Common Constipation
Danish: Almindelig Konjunktivitis
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en særlig recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.