FrancophonIA/ELRC3.0 huggingface dataset:
English: Type I colourless glass vial with a butyl rubber stopper covered with an aluminium flip-off seal containing 0.25 mg of trabectedin.
Danish: Type I farveløst glashætteglas med butylgummiprop, dækket af en aluminium flip-off-forsegling, indeholdende 0,25 mg trabectedin.
English: • decreased (examples are medicines containing rifampicin (for bacterial infections), phenobarbital (for epilepsy) or St. John's Wort (Hypericum perforatum, an herbal medicine for depression)) or
Danish: • nedsætter virkningen af Yondelis (eksempler på lægemidler, der kan nedsætte virkningen af Yondelis, er lægemidler, der indeholder rifampicin (mod bakterieinfektioner), phenobarbital (til behandling af epilepsi) eller perikon (Hypericum perforatum, et naturlægemiddel mod depression) eller
English: No sufficient clinical data on exposed pregnancies are available.
Danish: Der er utilstrækkelige data for anvendelse af trabectedin til gravide kvinder.
English: Based on independent oncology review, patients with platinum-free interval (PFI) < 6 months (35% in Yondelis+PLD and 37% in PLD arm) had similar PFS in the two arms with both showing median PFS of 3.7 months (HR=0.89, CI: 0.67-1.20).
Danish: Baseret på den uafhængige onkologiske evaluering havde patienter med et platinfrit interval (platinum-free interval - PFI) < 6 måneder (35 % i Yondelis+PLD- og 37 % i PLD-armen) sammenlignelige PFS i de to arme, hvor begge viste en median PFS på 3,7 måneder (HR=0,89; CI: 0,67-1,20).
English: Very common: may affect more than 1 in 10 people
Danish: Meget almindelig: forekommer hos flere end 1 ud af 10 patienter
English: Adequate contraceptive precautions must be used by men in fertile age when receiving Yondelis and for 5 months following the end of treatment.
Danish: Fertile mænd skal anvende sikker prævention, mens de får Yondelis og i 5 måneder efter behandlingens afslutning.
English: - Increase of aminotransferases (AST or ALT) > 2.5 x ULN (monotherapy) or > 5 x ULN
Danish: - Forhøjelse af aminotransferaser (ASAT eller ALAT) > 2,5 x ULN (monoterapi) eller >
English: Other medicines and Yondelis
Danish: Brug af anden medicin sammen med Yondelis
English: The recommended dose in Japanese patients is lower than the usual dose for all other races, and is 1.2 mg/m2 of body surface area.
Danish: Den anbefalede dosis for japanske patienter er lavere end den sædvanlige dosis for alle andre racer.
English: Yondelis must not be mixed or diluted with other medicinal products except those mentioned in section 6.6.
Danish: Yondelis må ikke blandes eller fortyndes med andre lægemidler end dem, der er anført under pkt.
English: The solution obtained has a concentration of 0.05 mg/ml and is for single-use only.
Danish: Den opløsning, der hermed opnås, har en koncentration på 0,05 mg/ml.
English: For storage conditions after reconstitution and dilution of the medicinal product, see the package leaflet.
Danish: Opbevaringsforhold efter rekonstitution og fortynding af lægemidlet, se pkt.
English: These findings were secondary to severe local reaction at the administration site, and therefore uncertainly attributable to trabectedin; however, caution must be guaranteed in the interpretation of these renal findings, and treatment-related toxicity cannot be excluded.
Danish: Disse fund var sekundære til svære lokale reaktioner ved administrationsstedet og kunne derfor ikke nødvendigvis tilskrives trabectedin.
English: The PR corresponded to a patient with an alveolar rhabdomyosarcoma.
Danish: Den partielle respons svarede til en patient med alveolært rabdomyosarkom.
English: A population pharmacokinetic analysis showed that when administered in combination with PLD, the plasma clearance of trabectedin was decreased by 31%; the plasma pharmacokinetics of PLD were not influenced by the concomitant administration of trabectedin.
Danish: En populationsfarmakokinetisk analyse viste, at ved administration i kombination med PLD faldt plasmaclearance af trabectedin med 31 %.
English: How to use Yondelis
Danish: Sådan skal De bruge Yondelis
English: For the treatment of soft tissue sarcoma, the usual dose is 1.5 mg/m2 of body surface area.
Danish: Til behandling af bløddelssarkom er den sædvanlige dosis 1,5 mg/m2 legemsoverflade.
English: Breast-feeding is contraindicated during treatment and 3 months thereafter (see section 4.3).
Danish: Amning er kontraindiceret under behandlingen og tre måneder derefter (se pkt.
English: Yondelis 0.25 mg: Each vial of powder contains 0.25 mg of trabectedin.
Danish: Yondelis 0,25 mg: Hvert hætteglas med pulver indeholder 0,25 mg trabectedin.
English: Yondelis contains potassium
Danish: Yondelis indeholder kalium
English: Each vial containing 1 mg of trabectedin is reconstituted with 20 ml of water for injections.
Danish: Hvert hætteglas med 1 mg trabectedin rekonstitueres med 20 ml vand til injektionsvæsker.
English: When Yondelis is used in combination with PLD, the intravenous line should be flushed well with 50 mg/ml (5%) glucose solution for infusion after administration of PLD and before administration of Yondelis.
Danish: Når Yondelis anvendes i kombination med PLD, skal den intravenøse slange gennemskylles grundigt med 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning, efter administration af PLD og inden administration af Yondelis.
English: The analysis per cycle performed in these patients showed thrombocytopenia of grade 3 and 4 in approximately 3% and < 1% of cycles respectively.
Danish: Analysen per cyklus udført hos disse patienter viste trombocytopeni grad 3 og 4 i henholdsvis cirka 3 % og < 1 % af cyklusserne.
English: Yondelis 1 mg: Each vial of powder contains 1 mg of trabectedin.
Danish: Yondelis 1 mg: Hvert hætteglas med pulver indeholder 1 mg trabectedin.
English: Starting dose
Danish: Startdosisdosis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 0.25 mg vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton - 0,25 mg hætteglas
English: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Danish: de los Reyes 1, Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spanien
English: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) Spain
Danish: Polígono Industrial La Mina 28770 Colmenar Viejo (Madrid) SPANIEN
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 September 2007
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
English: Efficacy results from Study ET743-SAR-3007 Endpoints / Study population Trabectedin Dacarbazine Hazard Ratio / Odds Ratio p value Primary endpoint n=384
Danish: Endepunkter / Studiepopulation Trabectedin Dacarbazin Hazard / odds ratio p-værdi
English: Each vial containing 0.25 mg of trabectedin is reconstituted with 5 ml of water for injections.
Danish: Hvert hætteglas med 0,25 mg trabectedin rekonstitueres med 5 ml vand til injektionsvæsker.
English: Cardiac Dysfunction
Danish: Hjerteinsufficiens
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - 1 mg vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton - 1 mg hætteglas
English: • You may present some digestive symptoms such as loss of appetite, sick (nausea) or vomit, pain in the abdomen, diarrhoea or constipation.
Danish: • De kan også opleve nogle fordøjelsessymptomer såsom ingen appetit, kvalme eller opkastning, mavesmerter, diaré ellerforstoppelse.
English: Its use should be confined to qualified oncologists or other health professionals specialised in the administration of cytotoxic medicines.
Danish: Yondelis bør kun indgives af onkologer eller andet sundhedspersonale, der er specialiseret i indgivelse af cytotoksiske lægemidler.
English: Yondelis 0.25 mg: Inject 5 ml of sterile water for injections into the vial.
Danish: Yondelis 0,25 mg: Injicer 5 ml vand til injektionsvæsker i hætteglasset.
English: For the treatment of ovarian cancer, the usual dose is 1.1 mg/m2 body surface area after the administration of 30 mg/m2 body surface area of PLD.
Danish: Til behandling af ovariekræft er den sædvanlige dosis 1,1 mg/m2 legemsoverflade efter indgivelse af PLD 30 mg/m2 legemsoverflade.
English: Yondelis 1 mg: Inject 20 ml of sterile water for injections into the vial.
Danish: Yondelis 1 mg: Injicer 20 ml vand til injektionsvæsker i hætteglasset.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 mg trabectedin
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 mg trabectedin
English: - Platelet count ≥ 100,000/mm - Bilirubin ≤ upper limit of normal (ULN) - Alkaline phosphatase ≤ 2.5 x ULN (consider hepatic isoenzymes 5-nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin).
Danish: - Alkalisk fosfatase ≤ 2,5 x ULN (overvej hepatiske isoenzymer 5-nukleotidase eller gammaglutamyltranspeptidase (GGT), hvis forhøjelsen kunne have ossøse årsager).
English: If you get any of these symptoms or signs, tell your nurse or doctor immediately.
Danish: Hvis De får nogen af disse symptomer eller tegn, skal De omgående fortælle det til sundhedspersonalet eller lægen.
English: In this case you may experience fever, difficulty in breathing, redness or flushing of the skin or a rash, feeling sick (nausea) or being sick (vomiting).
Danish: I så fald kan De opleve feber, åndedrætsbesvær, hudrødme eller hududslæt, kvalme eller opkastning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label - 0.25 mg vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas - 0,25 mg hætteglas
English: Each vial of powder contains 1 mg of trabectedin.
Danish: Hvert hætteglas med pulver indeholder 1 mg trabectedin.
English: Yondelis is a powder for concentrate for solution for infusion.
Danish: Yondelis er et pulver til koncentrat til infusionsvæske, opløsning.
English: The median survival by histology tumour type was 16.2 months [95% CI: 14.1, 19.5] for subjects with leiomyosarcomas and liposarcomas and 8.4 months [95% CI: 7.1, 10.7] for subjects with other types of sarcomas.
Danish: Den genemsnitlige overlevelse efter histologisk tumortype var 16,2 måneder [95 % CI: 14,1-19,5] for patienter med leimyosarkom og liposarkom og 8,4 måneder for patienter med andre sarkomer.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial label - 1 mg vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Etiket til hætteglas - 1 mg hætteglas
English: Most frequent adverse reactions
Danish: De hyppigste bivirkninger
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 0.25 mg trabectedin
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 0,25 mg trabectedin
English: Instructions for reconstitution
Danish: Anvisninger for rekonstitution
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelig: kan forekomme hos op til 1 ud af 100 behandlede
English: If you develop any of these symptoms you should seek medical attention immediately.
Danish: Hvis De udvikler et eller flere af disse symptomer, skal De omgående søge lægehjælp.
English: Using the RECIST criteria the ORR among patients treated with trabectedin was 3 (8.1%; 95% CI: 1.7.21.9%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 24 (64.9%, 95% CI: 47.5-79.9%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Danish: Ved anvendelse af RECIST-kriterierne var den samlede responsrate (ORR) 3 (8,1 %; 95 % CI: 1,7-21,9 %) for trabectedin-gruppen og 0 (0 %; 95 % CI: 0,0-9,7 %) for BSC-gruppen, mens den kliniske gevinstrate (CBR) var henholdsvis 24 (64,9 %; 95 % CI: 47,5-79,9 %) og 0 (0 %; 95 % CI: 0,0-9,7 %).
English: (combination therapy), which has not recovered by day 21 - Any other grade 3 or 4 adverse reactions (such as nausea, vomiting, fatigue)
Danish: - En hvilken som helst anden grad 3- eller 4-bivirkning (såsom kvalme, opkastning, træthed).
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed grade 3 elevations of AST and ALT in 12% and 20% of cycles respectively.
Danish: Analysen per cyklus udført hos patienter behandlet med monoterapiregimet viste grad 3-forhøjelser af ASAT og ALAT i henholdsvis 12 % og 20 % af cyklusserne.
English: The vial must be shaken until complete dissolution.
Danish: Hætteglasset skal rystes, indtil pulveret er helt opløst.
English: This reconstituted solution contains 0.05 mg/ml of trabectedin.
Danish: Den rekonstituerede opløsning indeholder 0,05 mg/ml trabectedin.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 1 mg trabectedin
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 1 mg trabectedin
English: Blood creatine phosphokinase increased
Danish: Rygsmerter Forhøjet kreatinfosfokinase i blodet
English: Using the Choi criteria the ORR among patients treated with trabectedin was 4 (10.8%; 95% CI: 3.0-25.4%) and 0 (0%, 95% CI: 0.0-9.7%) among patients treated with best supportive care, while the CBR was 7 (18.9%, 95% CI: 8.0-35.2%) versus 0 (0%, 95% CI: 0.0-9.7%), respectively.
Danish: Ved anvendelse af Choi-kriterierne var ORR 4 (10,8 %; 95 % CI: 3,0-25,4 %) for trabectedingruppen og 0 (0 %; 95 % CI: 0,0-9,7 %) for BSC-gruppen, mens CBR var henholdsvis 7 (18,9 %; 95 % CI: 8,0-35,2 %) og 0 (0 %; 95 % CI: 0,0-9,7 %).
English: Any unused medicine or waste material should be disposed of in accordance with local requirements for cytotoxic medicines.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer for cytotoksiske lægemidler.
English: - Albumin ≥ 25 g/l - Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x ULN - Creatinine clearance ≥ 30 ml/min (monotherapy), serum creatinine ≤ 1.5 mg/dl (≤ 132.6 μmol/l)
Danish: - Kreatininclearance ≥ 30 ml/min (monoterapi), serumkreatinin ≤ 1,5 mg/dl (≤ 132,6 μmol/l)
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed neutropenia of grade 3 and 4 in approximately 19% and 8% of cycles respectively.
Danish: Analysen per cyklus udført hos patienter, der blev behandlet med monoterapiregimet, viste neutropeni grad 3 og 4 i henholdsvis cirka 19 % og 8 % af cyklusserne.
English: Considering the pharmacokinetic characteristics of trabectedin (see section 5.2), no dose adjustments are warranted in patients with mild or moderate renal impairment.
Danish: 5.2) er dosisjusteringer ikke påkrævet hos patienter med mild eller moderat nyreinsufficiens.
English: It could lead to damage and death of your tissue cells around the injection site (tissue necrosis, see also section 4) which may require surgery.
Danish: Dette kan medføre, at vævscellerne omkring injektionsstedet bliver beskadigede eller dør (vævsnekrose), hvilket kan kræve kirurgisk indgriben (se også pkt.
English: PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 0.25 mg trabectedin
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 0,25 mg trabectedin
English: The median survival for subjects with liposarcoma was 18.1 months [95% CI: 15.0, 26.4] and for subjects with leiomyosarcoma 16.2 months [95% CI: 11.7, 24.3].
Danish: Den gennemsnitlige overlevelsestid var 18,1 måneder [95 % CI: 15,0-26,4] for patienter med liposarkom og 16,2 måneder [95 % CI: 11,7-24,3] for patienter med leiomyosarkom.
English: 1 ml of reconstituted solution contains 0.05 mg of trabectedin.
Danish: 1 ml af den rekonstituerede opløsning indeholder 0,05 mg trabectedin.
English: - if you are breast-feeding.
Danish: - hvis De ammer.
English: Instructions for dilution
Danish: Anvisninger for fortynding
English: Each vial of powder contains 0.25 mg of trabectedin.
Danish: Hvert hætteglas med pulver indeholder 0,25 mg trabectedin.
English: The analysis per cycle performed in patients treated with the monotherapy regimen showed anaemia of grade 3 and 4 in approximately 3% and 1% of cycles respectively.
Danish: Analysen per cyklus udført hos patienter behandlet med monoterapiregimet viste anæmi grad 3 og 4 i henholdsvis cirka 3 % og 1 % af cyklusserne.
English: Hypotension Flushing
Danish: Hypotension Rødmen
English: Trabectedin crossed the placenta when administered to pregnant rats.
Danish: Efter administration til drægtige rotter passerer trabectedin placenta.
English: It seems that plasma clearance and distribution volume of trabectedin are not influenced by age.
Danish: Det tyder på, at trabectedins plasmaclearance og distributionsvolumen ikke påvirkes af alder. Der bør derfor ikke som rutine foretages dosisjusteringer, der udelukkende er baseret på alderskriterier.
English: Yondelis 0.25 mg powder for concentrate for solution for infusion Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Danish: Yondelis 0,25 mg pulver til koncentrat til infusionsvæske, opløsning Yondelis 1 mg pulver til koncentrat til infusionsvæske, opløsning (Trabectedin)
English: Men in fertile age must use effective contraception during treatment and 5 months after treatment (see section 4.4).
Danish: Fertile mænd skal anvende sikker kontraception under behandlingen og i 5 måneder efter behandlingen (se pkt.
English: A syringe is used to inject the correct amount of sterile water for injections into the vial.
Danish: Med en sprøjte injiceres den krævede mængde vand til injektionsvæsker i hætteglasset.
English: It could lead to damage and death of your tissue cells around the injection site (tissue necrosis) which may require surgery.
Danish: Det kan medføre skader på huden omkring injektionsstedet, eller at vævet dør (vævsnekose), hvilket kan kræve operation.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 1 mg of trabectedin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 1 mg trabectedin.
English: • You may experience, loss of water from the body, weight loss, digestive discomfort and a change in your sense of taste.
Danish: • De kan få væskemangel, , vægttab, fordøjelsesubehag samt ændring af smagssansen.
English: Placental transfer of trabectedin and fetal exposure to trabectedin were observed in a study in pregnant rats that received a single i.v.
Danish: Overførsel af trabectedin via placenta og fostereksponering blev observeret i et studie med drægtige rotter, der fik en enkelt intravenøs dosis 14C-trabectedin på 0,061 mg/kg.
English: A syringe is used to inject 20 ml of sterile water for injections into the vial.
Danish: Med en sprøjte injiceres 20 ml vand til injektionsvæsker i hætteglasset.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 1 mg powder for concentrate for solution for infusion Trabectedin
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Yondelis 1 mg pulver til koncentrat til infusionsvæske, opløsning Trabectedin
English: One ml of reconstituted solution contains 0.05 mg of trabectedin.
Danish: En ml af den rekonstituerede opløsning indeholder 0,05 mg trabectedin.
English: Yondelis 1 mg powder for concentrate for solution for infusion.
Danish: Yondelis 1 mg pulver til koncentrat til infusionsvæske, opløsning.
English: Each vial of powder contains 8 mg of potassium and 0.4 g of sucrose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas med pulver indeholder 8 mg kalium og 0,4 g saccharose.
English: Dyspnoea Cough
Danish: Dyspnø Hoste
English: A syringe is used to inject 5 ml of sterile water for injections into the vial.
Danish: Med en sprøjte injiceres 5 ml vand til injektionsvæsker i hætteglasset.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Yondelis 0,25 mg pulver til koncentrat til infusionsvæske, opløsning Trabectedin
English: Abdominal pain Nausea
Danish: Mave-tarm-kanalen Abdominalsmerter Kvalme
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 0.25 mg of trabectedin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 0,25 mg trabectedin.
English: Extravasation Soft tissue necrosis
Danish: Ekstravasation Bløddelsnekrose
English: Each vial of powder contains 2 mg of potassium and 0.1 g of sucrose.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hvert hætteglas med pulver indeholder 2 mg kalium og 0,1 g saccharose.
English: Discard any unused product or waste material in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Blood alkaline phosphatase increased
Danish: Forhøjet ALAT Forhøjet ASAT Forhøjet Alkalisk fosfatase i blodet
English: Dilute the reconstituted solution with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Danish: Fortynd den rekonstituerede opløsning med 9 mg/ml (0,9 %) natriumchloridinfusionsvæske, opløsning eller med 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning.
English: If you get any of the previous described symptoms or signs, seek medical care immediately.
Danish: Hvis De får nogen af ovennævnte symptomer eller tegn, skal De omgående søge lægehjælp.
English: What Yondelis is and what it is used for What you need to know before you are given Yondelis How to use Yondelis
Danish: Det skal De vide, før De begynder at få Yondelis Sådan skal De bruge Yondelis Bivirkninger
English: The reconstituted solution should be diluted with sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion.
Danish: Den rekonstituerede opløsning fortyndes med 9 mg/ml (0,9 %) natriumchloridinfusionsvæske, opløsning eller med 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning.
English: Skin and Subcutaneous Tissue Disorders
Danish: Hud og subkutane væv Palmoplantar erytrodysæstesi-syndrom*
English: If central venous access is not feasible and a peripheral venous line has to be used, the reconstituted solution should be added to an infusion bag containing ≥ 1,000 ml of diluent (sodium chloride 9 mg/ml (0.9%) solution for infusion or glucose 50 mg/ml (5%) solution for infusion).
Danish: Hvis centralvenøs adgang ikke er mulig, og der må anvendes en perifer venøs adgang, skal den rekonstituerede opløsning overføres til en infusionspose indeholdende ≥ 1 000 ml fortyndingsmiddel (9 mg/ml (0,9 %) natriumchloridinfusionsvæske, opløsning eller 50 mg/ml (5 %) glucoseinfusionsvæske, opløsning).
English: • You may notice that Yondelis infusion leaks out of your vein (extravasation) while you are being given it. Then you will notice some redness, swelling, itchiness and discomfort at the injection site.
Danish: • De kan bemærke, at Yondelis infusionsvæske lækker ud af Deres blodåre (ekstravasation), mens De får den.
English: Mucosal inflammation
Danish: Slimhindeinflammation*
English: Soft tissue sarcoma is a malignant disease that starts somewhere in the soft tissues, such as the muscles, fat or other tissues (for example cartilages or vessels).
Danish: Yondelis anvendes til behandling af patienter med fremskredet bløddelssarkom, når forudgående lægemidler har været uden succes, eller patienterne har været uegnede til at få dem. Bløddelssarkom er en ondartet sygdom, der begynder et eller andet sted i bløddelene som f.eks. muskler, fedt eller andre væv (f.eks. brusk eller blodkar).
English: NAME OF THE MEDICINAL PRODUCT Yondelis 0.25 mg powder for concentrate for solution for infusion Trabectedin
Danish: Yondelis 0,25 mg pulver til koncentrat til infusionsvæske, opløsning Trabectedin
English: or creatinine clearance ≥ 60 ml/min (combination therapy) - Creatine phosphokinase (CPK) ≤ 2.5 x ULN - Haemoglobin ≥ 9 g/dl
Danish: - Kreatinfosfokinase (CPK) ≤ 2,5 x ULN.
English: - Neutropenia < 500/mm3 lasting for more than 5 days or associated with fever or infection - Thrombocytopenia < 25,000/mm3 - Increase of bilirubin > ULN and/or alkaline phosphatase > 2.5 x ULN
Danish: - Neutropeni < 500/mm3 varende i mere end 5 dage eller associeret med feber eller infektion.