FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect up to 1 in 10 people) - Allergic reaction: skin rash / burning or prickling sensation - Infection including sepsis - Fever - Dehydration - Kidney failure - Irritation of the skin and itching - Chest pain - Muscle weakness - Conjunctivitis (inflamed eye) - Upset stomach - Pain in the abdomen - Taste change - Liver: abnormal blood tests - Watery eyes - Increased skin pigmentation
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 patienter) - Allergisk reaktion: udslæt/en brændende eller prikkende fornemmelse - Infektion, inklusive sepsis (blodforgiftning) - Feber - Dehydrering (væskemangel) - Nyresvigt - Hudirritation og -kløe - Brystsmerter - Muskelsvaghed - Bindehindebetændelse (øjenbetændelse) - Mavegener - Mavesmerter - Smagsforstyrrelser - Lever: abnorme blodprøveresultater - Rindende øjne - Øget hudpigmentering
English: Pemetrexed Krka in combination with cisplatin The recommended dose of Pemetrexed Krka 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: Pemetrexed Krka i kombination med cisplatin Den anbefalede dosis af Pemetrexed Krka er 500 mg/m2 legemesoverflade indgivet som intravenøs infusion over 10 minutter på den første dag i hver 21-dages-serie.
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 pemetrexed-opløsning skal fortyndes yderligere til 100 ml med 9 mg/ml (0,9 %) natriumchlorid-injektionsvæske, uden konserveringsmiddel, og indgives som langsom intravenøs infusion over 10 minutter.
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: A multi-centre, randomised, double-blind, placebo-controlled Phase 3 study (JMEN), compared the efficacy and safety of maintenance treatment with pemetrexed plus best supportive care (BSC) (N=441) with that of placebo plus BSC (N=222) in patients with locally advanced (Stage IIIB) or metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC) who did not progress after 4 cycles of first-line doublet therapy containing Cisplatin or Carboplatin in combination with Gemcitabine, Paclitaxel, or Docetaxel.
Danish: Et randomiseret, dobbeltblindt, placebokontrolleret fase 3-multicenterstudie (JMEN) sammenlignede virkning og sikkerhed af vedligeholdelsesbehandling med pemetrexed plus bedste understøttende pleje (BSC) (n = 441) med placebo plus BSC (n = 222) hos patienter med lokalt fremskreden (trin IIIB) eller metastatisk (trin IV) ikke-småcellet lungecancer (NSCLC), som ikke fik bedring efter 4 serier med 1. linje-dubletbehandling bestående af cisplatin eller carboplatin sammen med gemcitabin, paclitaxel eller docetaxel.
English: Pemetrexed Krka 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: Pemetrexed Krka 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: Table 3 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Neurotoxicity
Danish: Tabel 3 - Dosisjustering for Pemetrexed Krka (som enkeltstof eller i kombination) og cisplatin - neurotoksicitet
English: Pemetrexed Krka is also given in combination with cisplatin for the initial treatment of patients with advanced stage of lung cancer.
Danish: Pemetrexed Krka er også en behandling, som gives i kombination med cisplatin, som 1. linjebehandling af patienter med fremskreden lungecancer.
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 pemetrexed armen over for placebo-armen (n = 472, uafhængigt evalueret population; median på henholdsvis3,9 måneder og 2,6 måneder) (hazard ratio = 0,64; 95% CI = 0,51-0,81; p = 0,0002).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion 10 ml vial (transparent type I glass) with bromobutyl rubber stopper and aluminium cap with tear off part made of polypropylene (embossed with sign “FLIP OFF”): containing 100 mg pemetrexed.
Danish: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning 10 ml hætteglas (gennemsigtigt type 1 glas) med bromobutyl gummiprop og aluminiumlåg med en afrivningsdel lavet af polypropylen (påtrykt med ”FLIP OFF”): indeholder 100 mg pemetrexed.
English: For precautions to be taken before handling or administering Pemetrexed Krka, see section 6.6.
Danish: For information om sikkerhedsforanstaltninger, der skal tages før håndtering og administration af Pemetrexed Krka, se pkt.
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: Table 1 - Dose modification table for Pemetrexed Krka (as single agent or in combination) and cisplatin - Haematologic toxicities
Danish: Tabel 1 - Dosisjustering for Pemetrexed Krka (som enkeltstof eller i kombination) og cisplatin - hæmatologisk toksicitet
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 placebo-delen, hazard ratio = 0,79 (95 % CI = 0,65-0,95; p = 0,01192).
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion 50 ml vial (transparent type I glass) with bromobutyl rubber stopper and aluminium cap with tear off part made of polypropylene (embossed with sign “FLIP OFF”): containing 500 mg pemetrexed.
Danish: Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning 50 ml hætteglas (gennemsigtigt type 1 glas) med bromobutyl gummiprop og aluminiumlåg med en afrivningsdel lavet af polypropylen (påtrykt med ”FLIP OFF”): indeholder 500 mg pemetrexed.
English: 3 and platelets should be ≥ 100,000 cells/mm Creatinine clearance should be ≥ 45 ml/min.
Danish: Kreatinin-clearance skal være  45 ml/min.
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 placebo-delen (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: After reconstitution, each vial contains 25 mg/ml pemetrexed.
Danish: Efter rekonstitution indeholder hvert hætteglas 25 mg/ml pemetrexed.
English: *p-values < 0.05 comparing pemetrexed/cisplatin to gemcitabine/cisplatin, using Fisher Exact test.
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: AC GC
Danish: CTC a-grad
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) (n = 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. linje-dubletbehandling bestående af pemetrexed i kombination med cisplatin.
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 Neuropathy-sensory Taste disturbance
Danish: Nervesystemet Almindelig Sensorisk neuropati Smagsforstyrrelser
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: Median time to tumour progression (months) (95% CI)
Danish: Log-rank-p-værdi* Median-tid til tumorprogression (måneder) (95 % CI)
English: As with other potentially toxic anti-cancer agents, care should be exercised in the handling and preparation of pemetrexed infusion solutions.
Danish: Forsigtighedsregler i forbindelse med forberedelse og indgivelse Som med et hvilket som helst andet potentielt toksisk lægemiddel til behandling af kræft skal der udvises forsigtighed ved håndtering og forberedelse af infusions-opløsninger af pemetrexed.
English: N=106
Danish: Andre n = 106
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), smagsforstyrrelser og alopeci bør kun rapporteres som grad 1 eller 2.
English: Cytotoxic
Danish: Cytotoksisk stof
English: Consistent with other pemetrexed studies, a difference in efficacy according to NSCLC histology was observed in JMEN.
Danish: I lighed med andre studier med pemetrexed blev der i JMEN set en forskel i virkning i
English: Pemetrexed/Cisplati n (N=839)
Danish: Pemetrexed/ cisplatin (n = 839)
English: Pemetrexed Krka in combination with cisplatin is indicated for the treatment of chemotherapy naïve patients with unresectable malignant pleural mesothelioma.
Danish: Pemetrexed Krka er indiceret til behandling af kemoterapinaive patienter med inoperabelt malignt pleuramesoteliom i kombination med cisplatin.
English: What Pemetrexed Krka is and what it is used for What you need to know before you use Pemetrexed Krka How to use Pemetrexed Krka Possible side effects
Danish: Det skal du vide, før du begynder at bruge Pemetrexed Krka Sådan skal du bruge Pemetrexed Krka Bivirkninger
English: Pemetrexed Krka as single agent
Danish: Pemetrexed Krka givet alene
English: Pemetrexed Krka 100 mg: Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Krka 100 mg: Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
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: powder for concentrate for solution for infusion
Danish: Pulver til koncentrat til infusionsvæske, opløsning
English: Patients in both study arms were fully supplemented with folic acid and vitamin B12.
Danish: Patienterne i begge behandlingsgrupper fik fuldstændigt dækkende tilskud af folsyre og cyanocobalamin (B12-vitamin).
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 placebo-delen (hazard ratio = 0,70, 95 % CI = 0,56-0,88, p = 0,002).
English: Pemetrexed Krka 500 mg: Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Krka 500 mg: Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Men are advised not to father a child during and up to 6 months following treatment with Pemetrexed Krka and should therefore use effective contraception during treatment with Pemetrexed Krka 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 Krka.
English: Overall response rate** (95% CI)
Danish: Log-rank-p-værdi* Samlet responsrate** (95 % CI)
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 Krka.
English: 9 l/m2.
Danish:  100.000 celler/mm 3.
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 placebo-delen (hazard ratio = 0,71, 95 % CI = 0,56-0,88, p = 0,002).
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 singleagent 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 = 663) og studiet med pemetrexed induktionsbehandling efterfulgt af pemetrexed vedligeholdelsesbehandling (PARAMOUNT: n = 539).
English: Leukocytes decreased Haemoglobin decreased 19.2 Common Platelets decreased
Danish: Nedsat leukocytter Nedsat hæmoglobin Almindelig Nedsat trombocytter
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 Krka 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 Krka 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 Krka 500 mg powder for concentrate for solution for infusion 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: Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning 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: 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
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: Pemetrexed Krka 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 Krka 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: Common Leukocytes decreased
Danish: Almindelig Nedsat leukocytter Nedsat neutrofiler
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion 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: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning 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: Uncommon (may affect up to 1 in 100 people) - Acute renal failure - Fast heart rate - Inflammation of the lining of the oesophagus (gullet) has been experienced with pemetrexed/radiation therapy - Colitis (inflammation of the lining of the large bowel, which may be accompanied by intestinal or rectal bleeding) - Interstitial pneumonitis (scarring of the air sacs of the lung) - Oedema (excess fluid in body tissue, causing swelling) - Some patients have experienced a heart attack, stroke or “mini-stroke” while receiving pemetrexed usually in combination with another anticancer therapy - Pancytopenia- combined low counts of white cells, red cells and platelets - Radiation pneumonitis (scarring of the air sacs of the lung associated with radiation therapy)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 patienter) - Akut nyresvigt - Hurtig puls - Betændelse i spiserørets overflade er forekommet med pemetrexed i kombination med strålebehandling - Tyktarmsbetændelse (betændelse i tyktarmen, som kan ledsages af blødning fra tarm eller endetarm) - Interstitiel lungebetændelse (lungebetændelse med talrige små udbredte infektionsområder mellem alveolerne) - Ødemer (væskeophobning i væv, som medfører hævelse).
English: Time to treatment failure (months) (95% CI)
Danish: Log-rank-p-værdi* Tid til behandlingssvigt (måneder) (95 % CI)
English: Common Neuropathy-sensory 7.4
Danish: Nervesystemet Almindelig Sensorisk neuropati Mave-tarmkanalen
English: What Pemetrexed Krka looks like and contents of the pack Pemetrexed Krka is a powder for concentrate for solution for infusion (powder for concentrate).
Danish: Pemetrexed Krka er et pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat).
English: Pemetrexed Krka 500 mg powder for concentrate pemetrexed
Danish: Pemetrexed Krka 500 mg pulver til koncentrat pemetrexed i.v.
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Each vial contains 100 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 100 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Pemetrexed Krka 100 mg powder for concentrate for solution for infusion Pemetrexed Krka 500 mg powder for concentrate for solution for infusion pemetrexed
Danish: Pemetrexed Krka 100 mg pulver til koncentrat til infusionsvæske, opløsning Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning pemetrexed
English: Pemetrexed Krka 100 mg powder for concentrate pemetrexed
Danish: Pemetrexed Krka 100 mg pulver til koncentrat pemetrexed i.v.
English: Pemetrexed Krka 500 mg powder for concentrate for solution for infusion Each vial contains 500 mg pemetrexed (as pemetrexed disodium hemipentahydrate).
Danish: Pemetrexed Krka 500 mg pulver til koncentrat til infusionsvæske, opløsning Hvert hætteglas indeholder 500 mg pemetrexed (som pemetrexeddinatriumhemipentahydrat).
English: Other (N=252)
Danish: (n = 222)
English: Reconstitute each 100 mg vial with 4.2 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 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: Reported symptoms of overdose include neutropenia, anaemia, thrombocytopenia, mucositis, sensory polyneuropathy, and rash.
Danish: De rapporterede symptomer ved overdosering omfattede neutropeni, anæmi, trombocytopeni,