FrancophonIA/ELRC3.0 huggingface dataset:
English: The doses after the initial dose should be adjusted if neutrophil count is below 500 cells/mm3 for more than 5 days.
Danish: Doserne, som følger efterden initiale dosis, skal justeres, hvis neutrofiltallet er under 500 celler/mm3 i mere end 5 dage.
English: A decision must be made whether to discontinue breast-feeding or to discontinue ETOPOPHOS and associated names, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman (see section 4.3).
Danish: Det skal besluttes, om amning skal ophøre eller behandling med ETOPOPHOS og relaterede navne seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen (se pkt.
English: To be completed nationally
Danish: Skal udfyldes nationalt
English: Skin and subcutaneous tissue disorders very common alopecia, pigmentation common pruritus, rash, urticaria rare radiation recall dermatitis, StevensJohnsons syndrome, toxic epidermal necrolysis
Danish: Hud og subkutane væv meget almindelig alopeci, pigmentering almindelig kløe, udslæt, nældefeber sjælden radiation recall dermatitis, StevensJohnsons syndrom, toksisk epidermal nekrolyse
English: See Annex I - To be completed nationally
Danish: Se bilag I - Skal udfyldes nationalt
English: Total body clearance and the terminal elimination half-life are independent of dose over a range 100 to 600 mg/m2.
Danish: Værdier for total clearance fra kroppen og eliminationshalveringstiden for den terminale fase er uafhængige af dosen i et dosisområde på 100 til 600 mg/m2.
English: The products administered by parenteral route must be visually examined to check for any particulates or discoloration prior to administration.
Danish: Produkter, som administreres parenteralt, skal visuelt inspiceres for at undersøge, om der er eventuelle partikler eller misfarvning inden administration.
English: Granulocyte and platelet nadirs tend to occur about 10 to14 days after administration of etoposide phosphate depending on the way of administration and treatment scheme.
Danish: Lavpunkter for granulocytter og trombocytter forekommer som regel omkring 10 til 14 dage efter administration af etoposidfosfat, afhængig af adminstrationsvejen og behandlingsplanen.
English: Hodgkin's lymphoma; non-Hodgkin's lymphoma; acute myeloid leukaemia
Danish: Hodgkins lymfom; non-Hodgkins lymfom; akut myeloid leukæmi
English: • skin problems such as itching or rash
Danish: • hudproblemer såsom kløe eller udslæt
English: For children being treated for cancer of the blood or lymphatic system the dose used is 75 to 150 mg/m2 body surface area daily for 2 to 5 days.
Danish: Til børn som behandles for blodkræft eller kræft i lymfekarsystemet anvendes dosen på 75 til 150 mg/m legemsoverflade dagligt i 2 til 5 dage.
English: Respiratory, thoracic and mediastinal disorders rare interstitial pneumonitis, pulmonary fibrosis not known bronchospasm
Danish: Luftveje, thorax og mediastinum sjælden interstitiel pneumoni, lungefibrose ikke kendt bronkospasme
English: Dosage should be modified to take into account the myelosuppressive effects of other drugs in the combination or the effects of prior radiation therapy or chemotherapy which may have compromised bone marrow reserve.
Danish: Dosering skal modificeres for at tage højde for de myelosuppressive virkninger på andre lægemidler i kombinationen eller virkningerne af tidligere stråleterapi eller kemoterapi, som kan have kompromitteret knoglemarvsreserverne.
English: The following haematological parameters should be measured at the start of therapy and prior to each subsequent dose of ETOPOPHOS and associated names: platelet count, haemoglobin, white blood cell count and differential.
Danish: De følgende hæmatologiske parametre skal måles ved start af behandling og før hver efterfølgende dosis af ETOPOPHOS og associerede navne: trombocyttal, hæmoglobin, leukocyttal og differentialtælling.
English: These reactions have usually responded promptly to the cessation of the infusion and administration of pressor agents, corticosteroids, antihistamines, or volume expanders as appropriate.
Danish: Disse reaktioner har som regel reageret med det samme på ophør af infusion og administration af pressormidler, kortikosteroider, antihistaminer eller volumenekspandere efter lægens skøn.
English: The content of each injection vial of ETOPOPHOS and associated names 1000 mg has to be diluted in 100 ml of:
Danish: Indholdet af hver injektionsflaske med ETOPOPHOS og relaterede navne1000 mg skal fortyndes i 100 ml:
English: Doses subsequent to initial dose should be adjusted if neutrophil count less than 500 cells/mm3 occurs for more than 5 days or is associated with fever or infection, if platelet count less than 25,000 cells/mm3 occurs, if any grade 3 or 4 toxicity develops or if renal clearance is less than 50 ml/min.
Danish: Dosis efter den initiale dosis skal justeres, hvis neutrofiltallet er under 500 celler/mm3 i mere end 5 dage eller er forbundet med feber og infektion, hvis trombocyttallet er under 25.000 celler/mm3, hvis der udvikles toksicitet af grad 3 eller 4, eller hvis renal clearance er under 50 ml/min.
English: Injection site reactions may occur during administration of ETOPOPHOS and associated names.
Danish: Reaktioner på injektionsstedet kan forekomme under administration af ETOPOPHOS og associerede navne.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label (100 mg)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglassets etikette (100 mg)
English: Etoposide has been shown to cause metaphase arrest in chick fibroblasts.
Danish: Etoposid er blevet påvist at forårsage metafasestop i fibroblaster hos kyllinger.
English: This will yield a reconstituted stock solution containing 20 mg/ml or 10 mg/ml etoposide.
Danish: Dette vil give en restitueret stamopløsning, som indeholder 20 mg/ml eller 10 mg/ml etoposid.
English: Hepatobiliary disorders very common alanine aminotransferase increased, alkaline phosphatase increased, aspartate amino transferase increased, bilirubin increased, hepatotoxicity
Danish: Lever og galdeveje meget almindelig forhøjet alaninaminotransferase, forhøjet alkalisk phosphatase, forhøjet aspartataminotransferase, forhøjet bilirubin, levertoksicitet
English: - testicular cancer - small cell lung cancer - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma) - reproductive system cancers (gestational trophoblastic neoplasia and ovarian cancer)
Danish: - testikelkræft - småcellet lungekræft - blodkræft (akut myeloid leukæmi) - tumor i lymfekarsystemet (Hodgkins lymfom, non-Hodgkins lymfom) - kræft i det reproduktive system (trofoblastisk neoplasi under graviditet og kræft i æggestokkene)
English: Do not take ETOPOPHOS and associated names
Danish: Tag ikke ETOPOPHOS og associerede navne
English: The exact reason why you have been prescribed ETOPOPHOS and associated names is best discussed with your doctor.
Danish: Det er bedst at diskutere den specifikke grund til, at du har fået ordineret ETOPOPHOS og associerede navne, med din læge.
English: Nervous system disorders common dizziness uncommon neuropathy peripheral rare cortical blindness transient, neurotoxicities (e.g., somnolence and fatigue), optic neuritis, seizure***
Danish: Nervesystemet almindelig svimmelhed ikke almindelig perifer neuropati sjælden forbigående barkblindhed, neurotoksiciteter (f.eks. somnolens og træthed), opticusneuritis, krampeanfald***
English: Acute fatal reactions associated with bronchospasm have also been reported with etoposide phosphate.
Danish: Akutte dødelige reaktioner forbundet med bronkospasme er blevet rapporteret med etoposidfosfat.
English: ETOPOPHOS and associated names should only be administered and monitored under the supervision of a qualified physician experienced in the use of anti-neoplastic medicinal products.
Danish: ETOPOPHOS og relaterede navne må kun administreres og monitoreres under opsyn af en kvalificeret læge med erfaring i brugen af antineoplastiske lægemidler.
English: - if you are taking any drugs with a similar mechanism of action as ETOPOPHOS and associated names.
Danish: - hvis du tager nogen lægemidler med en virkningsmekaniske svarende til ETOPOPHOS og associerede navne.
English: No dosage adjustment is necessary in elderly patients (age > 65 years old), other than based on renal function (see section 5.2).
Danish: Det er ikke nødvendigt at justere dosen hos ældre patienter (alder > 65 år), undtagen når det gælder nyrefunktionen (se pkt.
English: - cancer of the blood (acute myeloid leukaemia) - tumour in the lymphatic system (Hodgkin's lymphoma, non-Hodgkin's lymphoma)
Danish: - blodkræft (akut myeloid leukæmi) - tumor i lymfekarsystemet (Hodgkins lymfom, non-Hodgkins lymfom)
English: Effects of other drugs on the pharmacokinetics of etoposide phosphate
Danish: Virkningerne af andre lægemidler på farmakokinetikken af etoposidfosfat
English: In the paragraphs below the incidences of adverse events, given as the mean percent, are derived from studies that utilized single agent ETOPOPHOS and associated names therapy.
Danish: I nedenstående afsnit er forekomsten af bivirkninger, angivet ved den gennemsnitlige procent, afledt fra studier, hvori ETOPOPHOS og relaterede navne blev brugt som monoterapi.
English: Ovarian cancer; small cell lung cancer; gestational trophoblastic neoplasia; testicular cancer
Danish: Kræft i æggestokkene; småcellet lungekræft; trofoblastisk neoplasi under graviditet; testikelkræft
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Label (1000 mg)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglassets etikette (1000 mg)
English: As with other potentially toxic compounds, caution should be exercised in handling and preparing ETOPOPHOS and associated names solutions.
Danish: Som med andre potentielt toksiske forbindelser skal der udvises forsigtighed ved håndtering og forberedelse af opløsningen af ETOPOPHOS og associerede navne.
English: Gastrointestinal disorders very common abdominal pain, anorexia, constipation, nausea and vomiting common diarrhoea, mucositis (including stomatitis and esophagitis)
Danish: Mave-tarm-kanalen meget almindelig mavesmerter, anoreksi, forstoppelse, kvalme og opkastning almindelig diarré, mucositis (herunder stomatitis og esophagitis)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER [Skal udfyldes nationalt]
English: You must not breastfeed while you are receiving ETOPOPHOS and associated names.
Danish: Du må ikke amme, mens du tager ETOPOPHOS og associerede navne.
English: Batch No.
Danish: Batchnr.
English: This will yield a reconstituted stock solution containing 10 mg/ml etoposide.
Danish: Dette vil give en restitueret stamopløsning indeholdende 10 mg/ml etoposid.
English: Fatal myelosuppression has been reported following etoposide phosphate administration.
Danish: Letal myelosuppression er blevet indberettet efter administration af etoposidfosfat.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains etoposide 100 mg (as phosphate) Each vial contains etoposide 1000 mg (as phosphate)
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder etoposid 100 mg (som fosfat) Hvert hætteglas indeholder etoposid 1000 mg (som fosfat)
English: ETOPOPHOS and associated names should be terminated immediately, followed by the administration of pressor agents, corticosteroids, antihistamines, or volume expanders at the discretion of the physician.
Danish: Behandling med ETOPOPHOS og relaterede navne skal straks afbrydes efterfulgt af administration af pressormidler, kortikosteroider, antihistaminer eller volumenekspandere efter lægens skøn.
English: Testicular cancer
Danish: Testikelkræft
English: - The active substance is etoposide phophate.
Danish: - Aktivt stof: etoposidfosfat.
English: Dose limiting bone marrow suppression is the most significant toxicity associated with ETOPOPHOS and associated names therapy.
Danish: Dosisbegrænsende knoglemarvssuppression er den vigtigste toksicitet forbundet med behandling med ETOPOPHOS og associerede navne.
English: Administration Precautions: As with other potentially toxic compounds, caution should be exercised in handling and preparing the solution of ETOPOPHOS and associated names.
Danish: Sikkerhedsforanstaltninger, der skal tages før administration: Som med andre toksiske forbindelser skal der udvises forsigtighed ved håndtering og forberedelse af opløsningen af ETOPOPHOS og associerede navne.
English: ETOPOPHOS and associated names is used in the treatment of certain types of cancers in children:
Danish: ETOPOPHOS og relaterede navnebruges i behandlingen af visse typer kræft hos børn:
English: ETOPOPHOS and associated names is used in the treatment of certain types of cancers in adults:
Danish: ETOPOPHOS og relaterede navnebruges i behandlingen af visse typer kræft hos voksne:
English: ETOPOPHOS and associated names in paediatric patients has been used in the range of 75 to 150 mg/m2/day (etoposide equivalent) for 2 to 5 days in combination with other antineoplastic agents.
Danish: ETOPOPHOS og relaterede navne hos pædiatriske patienter er blevet anvendt i værdiområdet 75 til 150 mg/m2/d (etoposid ækvivalent) i 2 til 5 dage i kombination med andre antineoplastiske midler.
English: The following information is intended for healthcare professionals only:
Danish: Nedenstående oplysninger er til læger og sundhedspersonale: Forberedelse af intravenøs opløsning
English: The recommended dose of ETOPOPHOS and associated names is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4 weeks in combination with other drugs indicated in the disease to be treated.
Danish: Den anbefalede dosis af ETOPOPHOS og relaterede navne er 50 til 100 mg/m2/dag (etoposid ækvivalent) på dag 1 til 5 eller 100 til 120 mg/m2 på dag 1, 3, og 5 hver 3. til 4. uge i kombination med andre lægemidler indiceret til sygdommen, som behandles.
English: Preparation of ETOPOPHOS and associated names 1000 mg powder for solution for infusion
Danish: Forberedelse af ETOPOPHOS og relaterede navne 1000 mg pulver til infusionsvæske, opløsning
English: Each vial contains etoposide phosphate equivalent to etoposide 100 mg or 1000 mg as the active ingredient.
Danish: Hvert hætteglas indeholder etoposidfosfat svarende til 100 mg eller 1000 mg etoposid som det aktive indholdsstof.
English: 6.4 Special precautions for storage [To be completed nationally]
Danish: 6.4 Særlige opbevaringsforhold [Skal udfyldes nationalt]
English: infections, or at a thrombocyte count below 25,000 cells/mm3, which is not caused by the disease.
Danish: Endvidere skal dosis justeres i tilfælde af feber, infektioner eller et trombocyttal på under 25.000 celler/mm3, som ikke er forårsaget af sygdommen.
English: Tumour lysis syndrome (sometimes fatal) has been reported following the use of etoposide phosphate in association with other chemotherapeutic drugs (see section 4.4).
Danish: Tumorlysesyndrom (undertidenletalt) er blevet rapporteret efter brug af etoposidfosfat sammen med andre kemoterapimidler (se pkt.
English: ETOPOPHOS and associated names should not be administered to patients with neutrophil counts less than 1,500 cells/mm3
Danish: ETOPOPHOS og relaterede navne må ikke administreres til patienter med neutrofiltal på under 1.500 celler/mm eller trombocyttal på under 100.000 celler/mm3, medmindre det er forårsaget af malign sygdom.
English: The usual dose, based on etoposide, is 50 to100mg/m2 body surface area, daily for 5 days in a row or 100 to 120 mg/ m2 body surface area on days 1, 3 and 5.
Danish: Den almindelige dosis baseret på etoposid er 50 til 100 mg/m legemsoverflade, dagligt i 5 dage i træk, eller 100 til 120 mg/m legemsoverflade på dag 1, 3 og 5.
English: • bleeding Rare side effects (affecting between 1 in 1,000 and 1 in 10,000 people)
Danish: • infektion Ikke almindelige bivirkninger (påvirker mellem 1 ud af 100 og 1 ud af 1.000 personer)
English: What you need to know before you are given ETOPOPHOS and associated names
Danish: Det skal du vide, før du begynder at få ETOPOPHOS og associerede navne
English: Each vial contains 1136 mg etoposide phosphate equivalent to 1000 mg etoposide.
Danish: Hvert hætteglas indeholder 1136 mg etoposidfosfat svarende til 1000 mg etoposid.
English: Possible side effects experienced with ETOPOPHOS and associated names that are;
Danish: Bivirkninger erfaret med ETOPOPHOS og associerede navne, som er:
English: 56% (45% of the dose was excreted as etoposide) and faecal recovery of radioactivity was 44% of the adminitered dose at 120 hours.
Danish: Efter intravenøs administration af 14C etoposid (100 til 124 mg/m2) var den gennemsnitlige genvinding af radioaktivitet i urinen 56 % (45 % af dosen blev udskilt som etoposid), mens genvinding af radioaktivitet i afføringen var 44 % af den administrerede dosis efter 120 timer.
English: The recommended dose of ETOPOPHOS and associated names in adult patients is 50 to 100 mg/m2/day (etoposide equivalent) on days 1 to 5 or 100 to 120 mg/m2 on days 1, 3, and 5 every 3 to 4
Danish: Den anbefalede dosis af ETOPOPHOS og relaterede navne til voksne patienter er 50 til 100 mg/m2/dag (etoposid ækvivalent) på dag 1 til 5 eller 100 til 120 mg/m2 på dag 1, 3 og 5 hver 3. til 4.
English: ETOPOPHOS and associated names is indicated for the treatment of platinum-resistant/refractory epithelial ovarian cancer in adults.
Danish: ETOPOPHOS og relaterede navneer indiceret til behandling af platinresistent/refraktær epitelial kræft i æggestokkene hos voksne.
English: Dose of Etoposide Phosphate
Danish: Dosis af etoposidfosfat
English: If ETOPOPHOS and associated names solution contacts the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water.
Danish: Hvis opløsningen af ETOPOPHOS og relaterede navnefår kontakt med hud eller slimhinder, skal huden straks vaskes med vand og sæbe, og slimhinderne skylles med vand.
English: Given the mutagenic potential of etoposide, an effective contraceptive is required for both male and female patients during treatment and up to 6 months after ending treatment (see section 4.4).
Danish: På baggrund af mutageniciteten af etoposid skal både mandlige og kvindelige patienter bruge sikker kontraception under behandlingen og i op til 6 måneder efter behandlingsophør (se pkt.
English: Immune system disorders common anaphylactic reactions** not known angioedema, bronchospasm Metabolism and nutrition disorders not known tumour lysis syndrome
Danish: Immunsystemet almindelig anafylaktiske reaktioner** ikke kendt angioødem, bronkospasme
English: Skin reactions associated with accidental exposure to ETOPOPHOS and associated names may occur.
Danish: Der kan forekomme hudreaktioner ved utilsigtet eksponering for ETOPOPHOS og associerede navne.
English: If etoposide phosphate should contact the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water.
Danish: Hvis etoposidfosfat kommer i kontakt med hud, eller slimhinder, skal huden straks vaskes med sæbe og vand, og slimhinderne skylles med vand.
English: Concomitant phenytoin therapy is associated with increased etoposide clearance and reduced efficacy, and other enzyme-inducing antiepileptic therapy may be associated with increased ETOPOPHOS and associated names clearance and reduced efficacy.
Danish: Anden enzyminduceret antiepileptisk behandling kan være forbundet med øget clearance af ETOPOPHOS og relaterede navneog reduceret effekt.
English: The mean renal clearance of etoposide is 7 to 10 mL/min/m2 or about 35% of the total body clearance over a dose range of 80 to 600 mg/m2.
Danish: Gennemsnitlig renal clearance af etoposid er 7 til 10 ml/min/m eller cirka 35 % af kroppens totale clearance i et
English: After reconstitution, the solution can be administered without further dilution or it can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to obtain concentrations as low as 0.1 mg/ml etoposide.
Danish: Efter restitution kan opløsningen administreres uden yderligere fortynding, eller den kan fortyndes yderligere med 5 % glukoseopløsning eller 0,9 % natriumchloridopløsning for at opnå koncentrationer på helt ned til 0,1 mg/ml etoposid.
English: If ETOPOPHOS and associated names solution contacts the skin or mucosa, immediately wash the skin with soap and water and flush the mucosa with water (see section 6.6).
Danish: Hvis opløsningen af ETOPOPHOS og relaterede navne får kontakt med hud eller slimhinder, skal huden straks vaskes med vand og sæbe, og slimhinderne skylles med vand (se pkt.
English: The resulting stock solution may be administered without further dilution or can be further diluted with 5% glucose solution or 0.9% sodium chloride solution to a final concentration of 0.1 mg/ml etoposide.
Danish: Den resulterende stamopløsning kan administreres uden yderligere fortynding, eller den kan fortyndes yderligere med 5 % glukoseopløsning eller 0,9 % natriumchloridopløsning for at opnå en endelig koncentration på 0,1 mg/ml etoposid.
English: ETOPOPHOS and associated names is indicated in combination with other approved chemotherapeutic agents for the treatment of first line, recurrent or refractory testicular cancer in adults.
Danish: ETOPOPHOS og relaterede navne er indiceret i kombination med andre godkendte kemoterapimidler til behandling af førstelinje-, recidiverende eller refraktær testikelkræft hos voksne.
English: Cardiac disorders common arrythmia, myocardial infarction
Danish: Hjerte almindelig arytmi, hjerteinfarkt
English: • inflammation of a vein • infection
Danish: • betændelse i en vene
English: Myelosuppression (see section 4.4) with fatal outcome has been reported following administration of etoposide phosphate.
Danish: 4.4) med dødlig udgang er blevet indberettet efter administration af etoposidfosfat.
English: ETOPOPHOS and associated names contains
Danish: ETOPOPHOS og relaterede navneindeholder
English: What ETOPOPHOS and associated names is and what it is used for What you need to know before you are given ETOPOPHOS and associated names How you will be given ETOPOPHOS and associated names Possible side effects
Danish: Det skal du vide, før du begynder at tage ETOPOPHOS og associerede navne Sådan får du ETOPOPHOS og associerede navne Bivirkninger
English: Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people) • tingling or numbness in hands and feet
Danish: Sjældne bivirkninger (påvirker mellem 1 ud af 1.000 og 1 ud af 10.000 personer) • gastroøsofageal reflux
English: Other medicines and ETOPOPHOS and associated names
Danish: Brug af anden medicin sammen med ETOPOPHOS og associerede navne
English: ETOPOPHOS and associated names (see Annex I) 100 mg powder for solution for infusion ETOPOPHOS and associated names (see Annex I) 1000 mg powder for solution for infusion
Danish: ETOPOPHOS og relaterede navne(se bilag I) 100 mg pulver til infusionsvæske, opløsning ETOPOPHOS og relaterede navne(se bilag I) 1000 mg pulver til infusionsvæske, opløsning
English: There is the potential for serious adverse reactions in nursing infants from ETOPOPHOS and associated names.
Danish: Der er risiko for alvorlige bivirkninger fra ETOPOPHOS og relaterede navne hos spædbørn, som ammes.
English: doses) for these findings at the no-observed adverse-effect-level in the preclinical studies were ≥ approximately
Danish: Dosismultiplikatoren (baseret på mg/m2 doser) for disse fund ved niveauet uden observerede bivirkninger var i de prækliniske studier ≥ cirka 0,05 gange sammenlignet med den højeste kliniske dosis.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 113.6 mg etoposide phosphate equivalent to 100 mg etoposide.
Danish: Hvert hætteglas indeholder 113,6 mg etoposidfosfat svarende til 100 mg etoposid.
English: • damage to the liver (hepatotoxicity)
Danish: • leverbeskadigelse (levertoksicitet)