FrancophonIA/ELRC3.0 huggingface dataset:
English: Lartruvo is used together with doxorubicin (another cancer medicine) in patients who cannot undergo surgery or radiotherapy (treatment with radiation) and who have not been previously treated with doxorubicin.
Danish: Lartruvo anvendes sammen med doxorubicin (et andet kræftlægemiddel) hos patienter, der ikke kan gennemgå operation eller strålebehandling, og som ikke tidligere er blevet behandlet med doxorubicin.
English: Data from the main study show that Lartruvo in combination with doxorubicin improves progressionfree and overall survival of patients with advanced soft tissue sarcoma.
Danish: Data fra hovedundersøgelsen viser, at Lartruvo + doxorubicin forbedrer den progressionsfrie overlevelse og samlede overlevelse hos patienter med fremskredent bløddelskarcinom.
English: Lartruvo has been investigated in one main study involving 133 adults with advanced soft tissue sarcoma who couldn't undergo surgery or radiotherapy and who had not been previously treated with anthracyclines (a group of cancer medicines that includes doxorubicin).
Danish: Lartruvo er undersøgt i én hovedundersøgelse med 133 voksne med fremskredent bløddelskarcinom, som ikke kunne gennemgå operation eller strålebehandling, og som ikke tidligere var blevet behandlet med antracykliner (en gruppe lægemidler, der omfatter doxorubicin).
English: For practical information about using Lartruvo, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Lartruvo, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Lartruvo is a cancer medicine used to treat adults with advanced soft tissue sarcoma, a type of cancer that affects the soft, supportive tissues of the body such as muscles, blood vessels and fat tissue.
Danish: Lartruvo er et kræftlægemiddel til behandling af voksne med fremskredent bløddelskarcinom, der er en type kræft, som starter i bløddelene, f.eks. musklerne, blodkarrene og fedtvævet.
English: For the full list of all side effects and restrictions with Lartruvo, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved og begrænsninger for Lartruvo fremgår af indlægssedlen.
English: With regards to the safety profile of the medicine, it was observed that patients treated with Lartruvo plus doxorubicin experienced an increase in the frequency of side effects; however, in view of the benefits of treatment, side effects were considered tolerable and manageable.
Danish: For så vidt angår lægemidlets sikkerhedsprofil, blev det observeret, at de patienter, der blev behandlet med Lartruvo + doxorubicin, oplevede en stigning i hyppigheden af bivirkninger.
English: How is Lartruvo used?
Danish: Hvordan anvendes Lartruvo?
English: The active substance in Lartruvo, olaratumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to a protein called ‘platelet-derived growth factor receptor alpha' (PDGFRα).
Danish: Det er fremstillet, så det genkender og binder til et specifikt protein, der kaldes trombocytafledt vækstfaktorreceptor-alfa (PDGFR-α).
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lartruvo have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Lartruvo.
English: How does Lartruvo work?
Danish: Hvordan virker Lartruvo?
English: What benefits of Lartruvo have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Lartruvo?
English: Patients who tolerate the first 90-minute infusion can receive subsequent infusions over 30 minutes.
Danish: Patienter, der tåler at få den første infusion i løbet af 90 minutter, kan få de efterfølgende infusioner i løbet af 30 minutter.
English: This is a summary of the European public assessment report (EPAR) for Herzuma.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Herzuma.
English: The infusion may be associated with allergic reactions, so the patient should be monitored during and after the infusion.
Danish: Infusionen kan være forbundet med allergiske reaktioner, og patienten bør overvåges under og efter infusionen.
English: Other information about Herzuma
Danish: Andre oplysninger om Herzuma
English: This means that Herzuma is similar to another biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Danish: Det betyder, at Herzuma svarer til et biologisk lægemiddel ("referencelægemidlet"), der allerede er godkendt i Den Europæiske Union (EU).
English: The full EPAR for Herzuma can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Herzuma findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reportsema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is used on its own in patients in whom previous treatments have failed.
Danish: Det anvendes som enkeltstofbehandling til patienter, hos hvem tidligere behandlinger ikke har virket.
English: • metastatic breast cancer (cancer that has spread to other parts of the body).
Danish: • Metastatisk brystkræft (brystkræft, der har spredt sig til andre dele af kroppen).
English: Herzuma is a cancer medicine used to treat the following conditions:
Danish: Herzuma er et lægemiddel mod kræft, der anvendes til behandling af følgende tilstande:
English: There were no relevant differences in the main measure of effectiveness (absence of invasive cancer cells in the breast or in linked tissues called lymph nodes) between the two products: this was seen in nearly 44% of those given Herzuma (118 of 271) and 47% of those given Herceptin (131 of 278).
Danish: Der var ingen relevante forskelle i det primære mål for virkning (fravær af invasive kræftceller i brystet eller lymfeknuderne) mellem de to produkter: Denne virkning sås hos omkring 44 % af dem, der fik Herzuma (118 ud af 271), og 47 % af dem, der fik Herceptin (131 ud af 278).
English: What measures are being taken to ensure the safe and effective use of Herzuma?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Herzuma?
English: In addition, one main study involving 549 patients with early breast cancer that overexpressed HER2 showed that Herzuma was as effective as Herceptin.
Danish: Desuden viste 1 hovedundersøgelse, der omfattede 549 patienter med tidlige stadier af brystkræft med overudtryk af HER2, at Herzuma var lige så effektivt som Herceptin.
English: Herzuma is a ‘biosimilar medicine'.
Danish: Herzuma er et "biosimilært" lægemiddel.
English: Herzuma can only be obtained with a prescription and treatment should be started by a doctor who has experience in the use of cancer medicines.
Danish: Herzuma udleveres kun efter recept, og behandlingen bør iværksættes af en læge med erfaring i brug af kræftmedicin.
English: Why is Herzuma approved?
Danish: Hvorfor blev Herzuma godkendt?
English: The reference medicine for Herzuma is Herceptin.
Danish: Referencelægemidlet for Herzuma er Herceptin.
English: It is not intended to provide practical advice on how to use Herzuma.
Danish: Det er ikke en praktisk vejledning i, hvordan Herzuma bør anvendes.
English: Because Herzuma is a biosimilar medicine, the studies on effectiveness and safety of trastuzumab carried out with Herceptin do not all need to be repeated for Herzuma.
Danish: Da Herzuma er et biosimilært lægemiddel, behøver de undersøgelser af trastuzumabs virkning og sikkerhed, der er udført for Herceptin, ikke at blive gentaget for Herzuma.
English: What is Herzuma and what is it used for?
Danish: Hvad er Herzuma, og hvad anvendes det til?
English: Patients were given either Herzuma or Herceptin with other cancer medicines before surgery to remove the cancer, and then the same medicine on its own every three weeks for 1 year.
Danish: Patienterne fik enten Herzuma eller Herceptin sammen med anden kræftmedicin inden operativ fjernelse af kræftvævet og derefter samme lægemiddel alene hver tredje uge i 1 år.
English: Herzuma must not be used in people who are hypersensitive (allergic) to trastuzumab, mouse proteins or to any of the other ingredients.
Danish: Herzuma må ikke anvendes hos personer, der er overfølsomme (allergiske) over for trastuzumab, museproteiner eller et af de øvrige indholdsstoffer.
English: The most common or serious side effects with Herzuma are heart problems, reactions related to the Herzuma infusion, reduced levels of blood cells (especially white blood cells), infections and lung problems.
Danish: De hyppigste bivirkninger ved Herzuma er hjerteproblemer, reaktioner i forbindelse med Herzumainfusionen, nedsat antal blodlegemer (navnlig hvide blodlegemer), infektioner og lungeproblemer.
English: The infusion is given over 90 minutes every week or every three weeks for breast cancer, and every three weeks for gastric cancer.
Danish: Lægemidlet gives som en 90-minutters infusion hver eller hver tredje uge til behandling af brystkræft og hver tredje uge til behandling af mavekræft.
English: It must not be used in patients who have serious breathing problems because of advanced cancer, even when resting, or who need oxygen therapy.
Danish: Det må ikke anvendes hos patienter, der selv i hviletilstand har alvorlige vejrtrækningsproblemer på grund af fremskreden kræft, eller som har brug for iltbehandling.
English: The active substance in Herzuma, trastuzumab, is a monoclonal antibody (a type of protein) that has been designed to recognise and attach to the HER2 protein.
Danish: Det aktive stof i Herzuma, trastuzumab, er et monoklonalt antistof (en type protein), der er designet til at genkende og binde til HER2-proteinet.
English: What are the risks associated with Herzuma?
Danish: Hvilke risici er der forbundet med Herzuma?
English: For tumours that are locally advanced (including those that are inflammatory) or more than 2 cm wide, Herzuma is used before surgery in combination with chemotherapy and then again after surgery on its own;
Danish: Ved tumorer, som er lokalt fremskredne (herunder inflammatoriske tumorer), eller som er mere end 2 cm brede, anvendes Herzuma før operation i kombination med kemoterapi og igen efter operation som enkeltstofbehandling.
English: The recommended dose depends on the patient's body weight, on the condition being treated and on whether Herzuma is given weekly or three-weekly.
Danish: Den anbefalede Herzuma-dosis afhænger af patientens kropsvægt, den tilstand, der skal behandles, og om lægemidlet gives hver uge eller hver tredje uge.
English: For more information about treatment with Herzuma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Herzuma, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Herzuma can only be used when the cancer has been shown to ‘overexpress HER2': this means that the cancer produces a protein called HER2 in large quantities on the surface of the tumour cells.
Danish: Herzuma må kun anvendes, hvis kræften har såkaldt overudtryk af proteinet HER2, dvs. hvis der på overfladen af tumorcellerne produceres store mængder HER2.
English: It is also used in combination with other cancer medicines: with paclitaxel or docetaxel, or with another class of medicines called aromatase inhibitors;
Danish: Det anvendes også i kombination med andre kræftlægemidler (paclitaxel eller docetaxel) eller sammen med såkaldte aromatase-hæmmere (en anden lægemiddelklasse).
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Herzuma has been shown to have a comparable quality, safety and effectiveness to Herceptin.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Herzuma og Herceptins kvalitet, sikkerhed og virkning svarer til hinanden.
English: Herzuma contains the active substance trastuzumab.
Danish: Herzuma indeholder det aktive stof trastuzumab.
English: Studies have also shown that giving Herzuma produces similar levels of the active substance in the body to giving Herceptin.
Danish: Undersøgelser har også vist, at indgivelse af Herzuma giver samme niveau af det aktive stof i kroppen som indgivelse af Herceptin.
English: Laboratory studies comparing Herzuma with Herceptin have shown that the active substance in Herzuma is highly similar to that in Herceptin in terms of structure, purity and biological activity.
Danish: Laboratorieundersøgelser, der sammenligner Herzuma med Herceptin, har vist, at det aktive stof i Herzuma svarer til Herceptin, hvad angår struktur, renhed og biologisk aktivitet.
English: • early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy (medicines to treat cancer), and radiotherapy (treatment with radiation) if applicable.
Danish: • Tidlige stadier af brystkræft (når kræften har spredt sig inde i brystet eller til kirtlerne under armen, men ikke til andre dele af kroppen) efter operation, kemoterapi eller strålebehandling.
English: Herzuma can cause cardiotoxicity (harm to the heart), including heart failure (when the heart does not work as well as it should).
Danish: Herzuma kan forårsage hjerteskade (kardiotoksicitet), herunder hjertesvigt (nedsat hjertefunktion).
English: • metastatic gastric (stomach) cancer, in combination with cisplatin and either capecitabine or fluorouracil (other cancer medicines).
Danish: • Metastatisk mavekræft, hvor det anvendes i kombination med cisplatin og enten capecitabin eller 5-fluorouracil (andre kræftlægemidler).
English: For practical information about using Herzuma, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Herzuma, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: For the full list of all side effects and restrictions with trastuzumab, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Herzuma fremgår af indlægssedlen.
English: How is Herzuma used?
Danish: Hvordan anvendes Herzuma?
English: Therefore, the Agency's view was that, as for Herceptin, the benefit outweighs the identified risk and Herzuma should be given marketing authorisation.
Danish: Agenturet var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for Herceptin, og anbefalede, at Herzuma godkendes til anvendelse i EU.
English: What benefits of Herzuma have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Herzuma?
English: It is available as a powder used to make up a solution for adding to an infusion (drip) into a vein.
Danish: Det fås som et pulver, der blandes til en infusionsvæske, dvs. en opløsning til indgivelse via et drop i en blodåre.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Herzuma have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Herzuma.
English: How does Herzuma work?
Danish: Hvordan virker Herzuma?
English: 56 ampoules x 1 administration device
Danish: 56 ampuller x 1 administrationsanordning
English: 170 mg Nebuliser solution Inhalation use ampoule (PE)
Danish: Til inhalation ampul (PE)
English: Strength Pharmaceutical
Danish: Styrke Lægemiddelform Administration Emballage
English: Further information about the EU-wide safety review:
Danish: Yderligere oplysninger om det EU-dækkende sikkerhedseftersyn:
English: 20 September 2013 EMA/564255/2013
Danish: Den 20. september 2013 EMA/564255/2013
English: • Parents who have any questions or concerns should speak to the treating doctor or other healthcare professional.
Danish: • Forældre, der har spørgsmål eller betænkeligheder, skal tale med den behandlende læge eller en anden sundhedsperson.
English: Information to parents and carers
Danish: Oplysninger til forældre og omsorgsgivere
English: This should be done in accordance with routine clinical practice and the clinical needs of the individual patient.
Danish: Dette bør ske efter sædvanlig klinisk praksis og den individuelle patients behov.
English: The review was conducted by the Pharmacovigilance Risk Assessment Committee (PRAC).
Danish: Gennemgangen blev foretaget af Udvalget for Risikovurdering inden for Lægemiddelvurdering (PRAC).
English: Stakeholders were also invited to submit any relevant information to support the assessment, and the Agency's Paediatric Committee (PDCO) was consulted for advice.
Danish: Involverede parter blev desuden opfordrede til at indsende alle relevante oplysninger til støtte for vurderingen, og der blev søgt rådgivning hos agenturets pædiatriske udvalg (PDCO).
English: Numeta G13%E and Numeta G16%E have been authorised since 2011 via national procedures in the following Member States: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Spain, Sweden, United Kingdom.
Danish: Numeta G13%E og Numeta G16%E har været godkendt siden 2011 via nationale procedurer i følgende medlemsstater: Østrig, Belgien, Tjekkiet, Danmark, Finland, Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Malta, Nederlandene, Norge, Polen, Portugal, Spanien, Sverige og Det Forenede Kongerige
English: However, healthcare professionals should be aware of the potential risk for hypermagnesaemia.
Danish: Sundhedspersoner bør dog være opmærksomme på den potentielle risiko for hypermagnesiæmi.
English: This report was confounded by the fact that additional magnesium may have been given.
Danish: Denne indberetning var konfunderet, idet der kan være givet ekstra magnesiumtilskud.
English: As the review only covers nationally authorised medicines, the PRAC recommendation was forwarded to the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Danish: Da gennemgangen kun omfatter nationalt godkendte lægemidler, blev anbefalingerne fra PRAC overgivet til koordinationsgruppen vedrørende gensidig anerkendelse og decentraliserede godkendelsesprocedurer - human (CMDh), som vedtog et endeligt standpunkt.
English: They contain nutrients such as glucose (sugar), lipids (fats), aminoacids and other important substances including magnesium.
Danish: De indeholder næringsstoffer såsom sukker (glukose), fedtstoffer (lipider), aminosyrer og andre vigtige stoffer, herunder magnesium.
English: As the PRAC recommendations were endorsed by consensus by the CMDh, they will now be implemented directly in all Member States, according to an agreed timetable.
Danish: Da PRAC's anbefalinger blev vedtaget enstemmigt af CMDh, vil de nu blive gennemført direkte af alle medlemsstater i henhold til den aftalte tidsplan.
English: References:
Danish: Litteraturhenvisninger:
English: The review of Numeta G13%E and Numeta G16%E was initiated on 13 June 2013 at the request of Sweden, under Article 107i of Directive 2001/83/EC, also known as the urgent Union procedure.
Danish: Eftersynet af Numeta G13%E og Numeta G16%E blev indledt den 13. juni 2013 på anmodning fra Sverige i medfør af artikel 107i i direktiv 2001/83/EF, også kaldet EU-hasteproceduren.
English: Magnesium levels mainly ranged from 1.025 mmol/L to > 1.5 mmol/L and no clinical signs or symptoms were reported for any of the cases.
Danish: Magnesiumværdierne lå hovedsagelig i området mellem 1,025 mmol/l og > 1,5 mmol/l, og der blev ikke indberettet kliniske tegn eller symptomer i nogen af tilfældene.
English: • The appropriate parenteral magnesium intake in preterm infants is uncertain.
Danish: • Det er usikkert, hvad der er en passende parenteral tilførsel af magnesium hos præmature spædbørn.
English: Safe Practices for Parenteral Nutrition JPEN 2004; 28: S 39 - S 70
Danish: Mirtallo et al. Safe Practices for Parenteral Nutrition JPEN 2004; 28: S 39 - S 70
English: Although this is within the recommendations reported in the literature as a whole, it is slightly more than suggested by some recognised guidelines1,2,3 (0.15-0.25 mmol/kg/day and 0.2 mmol/kg/day for term infant to one year of age, 0.15-0.25 mmol/kg/day and 0.1 mmol/kg/day for children from one year to two years of age).
Danish: Skønt dette er inden for de værdier, der anbefales i litteraturen som helhed, at det lidt højere end det, der foreslås i visse anerkendte retningslinjer1,2,3 (0,15-0,25 mmol/kg/dag og 0,2 mmol/kg/dag til fuldbårne spædbørn op til et år, 0,15-0,25 mmol/kg/dag og 0,1 mmol/kg/dag til børn fra et år til to år).
English: Because the CMDh position was agreed by consensus, the agreement will be directly implemented by the Member States where the medicines are authorised.
Danish: Da CMDh's standpunkt blev vedtaget enstemmigt, vil det blive direkte gennemført i de medlemsstater, hvor lægemidlerne er godkendt.
English: • Severe hypermagnesaemia is rare but can have adverse clinical consequences.
Danish: • Svær hypermagnesiæmi er sjælden, men kan have negative følger for patienten.
English: Clinical signs may not be identifiable unless hypermagnesaemia is severe.
Danish: Der vil ikke nødvendigvis være kliniske tegn, medmindre hypermagnesiæmien er alvorlig.
English: Parenteral nutrition is necessary in premature neonates and in some full-term babies in order to prevent complications such as growth retardation and breathing complications and to promote the normal development of the brain.
Danish: Parenteral ernæring er nødvendig hos for tidligt fødte nyfødte og hos visse fuldbårne spædbørn for at undgå komplikationer i form af nedsat vækst og åndedrætsbesvær og for at fremme den normale udvikling af hjernen.
English: This risk is increased in patients with reduced renal function, and in newborn infants of mothers who were receiving supplemental magnesium prior to delivery.
Danish: Denne risiko er forhøjet hos patienter med nedsat nyrefunktion og hos nyfødte børn af mødre, som fik magnesiumtilskud før fødslen.
English: In addition, the PRAC noted that this risk is further increased in premature newborns because their kidneys are immature and less able to clear the body of magnesium.
Danish: Desuden konstaterede PRAC, at denne risiko er yderligere forhøjet hos for tidligt fødte nyfødte, fordi deres nyrer er umodne og dårligere i stand til at udskille magnesium af kroppen.
English: However, widelyrecognised guidelines 1,2 recommend a parenteral magnesium intake of 0.15 - 0.25 mmol/kg/day.
Danish: Almindeligt anerkendte retningslinjer1,2 anbefaler dog et parenteralt magnesiumindtag på 0,15-0,25 mmol/kg/dag.
English: While Numeta G13%E is suspended, healthcare professionals should use alternative nutrition solutions which may include authorised standardised or individually prepared solutions.
Danish: Mens Numeta G13%E er suspenderet, skal sundhedspersoner anvende andre næringsopløsninger, der kan omfattegodkendte standardiserede eller individuelt fremstillede opløsninger.
English: As a precautionary measure, the manufacturer decided to voluntarily recall Numeta G13%E in the EU.
Danish: Som sikkerhedsforanstaltning besluttede lægemidlets fremstiller frivilligt at trække G13%E tilbage i EU.
English: The PRAC also noted the difficulty in identifying symptoms of hypermagnesaemia in premature newborns, which means that hypermagnesaemia may not be detected until it causes serious complications.
Danish: PRAC tog desuden hensyn til, at det er vanskeligt at fastslå symptomer på hypermagnesiæmi hos for tidligt fødte nyfødte, hvilket indebærer, at hypermagnesiæmi kan forblive uopdaget, indtil der opstår alvorlige komplikationer.