FrancophonIA/ELRC3.0 huggingface dataset:
English: Efgratin was to be used to reduce the duration of neutropenia and the occurrence of febrile neutropenia (neutropenia with fever).
Danish: Efgratin anvendes til at nedsætte varigheden af neutropeni og forekomsten af neutropeni med feber.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate-use programmes for Efgratin.
Danish: Virksomheden har til CHMP oplyst, at der aktuelt ikke gennemføres kliniske undersøgelser eller programmer for anvendelse af Efgratin med særlig udleveringstilladelse.
English: Efgratin was to be used in cancer patients to reduce neutropenia (low levels of neutrophils).
Danish: Efgratin skulles anvendes til behandling af neutropeni (lavt antal neutrofiler) hos kræftpatienter.
English: Withdrawal of the marketing authorisation application for Efgratin (pegfilgrastim) EMA/822770/2016
Danish: EMA/822770/2016
English: The European Commission granted a marketing authorisation valid throughout the European Union for Abraxane on 11 January 2008.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abraxane den 11. januar 2008.
English: By keeping this structure intact the cells cannot divide and they eventually die.
Danish: Når denne struktur holdes intakt, kan cellerne ikke dele sig, og de vil til sidst dø.
English: This document is a summary of the European Public Assessment Report (EPAR) for Abraxane.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Abraxane.
English: ‘Metastatic' means that the cancer has spread to other parts of the body.
Danish: ”Metastatisk" betyder, at canceren har bredt sig til andre dele af kroppen
English: The full EPAR for Abraxane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Nemdatine findes på agenturets websted underema.europa.eu/Find medicine/Human medicines/European public assessment reports..
English: Paclitaxel has been available as a cancer medicine since 1993.
Danish: Paclitaxel er blevet anvendt som kræftlægemiddel siden 1993.
English: A risk management plan has been developed to ensure that Abraxane is used as safely and effectively as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Abraxane anvendes så sikkert og effektivt som muligt.
English: Other information about Abraxane
Danish: Andre oplysninger om Abraxane
English: Around half of the patients in the study had already received treatments for their cancer after it had become metastatic.
Danish: Cirka halvdelen af patienterne i undersøgelsen var allerede blevet behandlet for deres kræftsygdom, efter at den var begyndt at brede sig.
English: Therefore, the company withdrew its application for the use of Abraxane as firstline treatment during the assessment of the medicine.
Danish: Virksomheden trak derfor sin ansøgning om brug af Abraxane som førstevalgsbehandling tilbage under vurderingen af lægemidlet.
English: Abraxane is used to treat the following cancers in adults:
Danish: Abraxane anvendes til behandling af følgende kræfttyper hos voksne:
English: A response was defined as the patient's main tumours disappearing or shrinking in size by at least 30%.
Danish: Det blev betragtet som en reaktion, hvis patientens største kræftknuder forsvandt eller blev reduceret med mindst 30 %.
English: Abraxane is given into a vein over a period of 30 minutes.
Danish: Abraxane indgives i en vene i en periode på 30 minutter.
English: For more information about treatment with Abraxane, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Abraxane, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It should not be interchanged with other medicines containing paclitaxel.
Danish: Det bør ikke skiftes ud med andre lægemidler indeholdende paclitaxel.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Abraxane.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Abraxane skal anvendes.
English: When looking only at the patients who were receiving their first treatment for metastatic breast cancer, there was no difference between the medicines in terms of measures of effectiveness such as the time until the disease got worse and survival.
Danish: Når der kun tages højde for de patienter, der fik deres første behandling for metastatisk brystkræft, sås der ingen forskel mellem lægemidlerne for så vidt angår den målte virkning, f.eks. tiden inden sygdomsprogression og overlevelsestiden.
English: This makes it easy to prepare a suspension of paclitaxel, which can be infused into a vein.
Danish: Dette gør det nemt at lave en paclitaxelopløsning, som kan indgives i en vene.
English: The recommended dose is 260 mg per square metre of body surface area (calculated using the patient's height and weight).
Danish: Den anbefalede dosis er 260 mg pr. kvadratmeter kropsoverflade (beregnet ud fra patientens højde og vægt).
English: The main measure of effectiveness was how long patients lived.
Danish: Virkningen blev hovedsagelig målt på, hvor længe patienterne levede.
English: What measures are being taken to ensure the safe and effective use of Abraxane?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abraxane?
English: Paclitaxel blocks a stage of cell division in which the cell's internal ‘skeleton' is dismantled to allow the cell to divide.
Danish: Paclitaxel blokerer den fase af celledelingen, hvor cellernes indre skelet nedbrydes, så cellerne kan dele sig.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abraxane, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abraxane, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The recommended dose is 125 mg per square metre of body surface area once a day on days 1, 8 and 15 of each cycle.
Danish: Den anbefalede dosis er 125 mg pr. kvadratmeter kropsoverflade én gang dagligt på dag 1, 8 og 15 i hvert forløb.
English: • non-small cell lung cancer, as a first treatment in combination with the cancer medicine carboplatin when the patient cannot have surgery or radiotherapy.
Danish: • ikke-småcellet lungekræft som førstebehandling i kombination med kræftlægemidlet carboplatin, når patienten ikke kan behandles med kirurgisk indgreb eller radioterapi.
English: The most common important side effects with Abraxane (seen in more than 1 patient in 10) are neutropenia (low levels of neutrophils, a type of white blood cells), gastrointestinal disorders (disorders of the digestive system), peripheral neuropathy (nerve damage including damage to the nerves in the hand and feet), arthralgia (joint pain) and myalgia (muscle pain).
Danish: De hyppigste bivirkninger ved Abraxane (som optræder hos flere end 1 ud af 10 patienter) er neutropeni (for få neutrofiler, som er en type hvide blodlegemer), gastrointestinale gener (lidelser i fordøjelsessystemet), perifer neuropati (beskadigelse af nerver, herunder nerverne i hænder og fødder), ledsmerter og muskelsmerter.
English: Abraxane must not be used in patients who are breast-feeding or who have low levels of neutrophils in the blood before starting treatment.
Danish: Abraxane må ikke anvendes hos patienter, som ammer, eller som har et lavt neutrofiltal i blodet inden behandlingens start.
English: Abraxane also affects non-cancer cells such as blood and nerve cells, which can cause side effects.
Danish: Abraxane påvirker også andre celler end kræftcellerne, såsom blod- og nerveceller, hvilket kan medføre bivirkninger.
English: It contains the active substance paclitaxel attached to a human protein called albumin.
Danish: Det indeholder det aktive stof paclitaxel, som er bundet til et menneskeligt protein kaldet albumin.
English: For additional information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Overall, in the main study, 31% of the women receiving Abraxane responded to treatment (72 out of 229), compared with 16% of the women receiving conventional paclitaxel-containing medicines (37 out of 225).
Danish: Samlet set reagerede 31 % (72 ud af 229) af de kvinder i hovedundersøgelsen, som blev behandlet med Abraxane, på behandlingen, sammenlignet med 16 % (37 ud af 225) af de kvinder, der blev behandlet med konventionelle lægemidler indeholdende paclitaxel.
English: • metastatic breast cancer, when the first treatment has stopped working and standard treatment including an ‘anthracycline' (another type of cancer medicine) is not suitable.
Danish: • Metastatisk brystkræft, når førstebehandlingen er holdt op med at virke, og standardbehandling med et antracyklin (en anden type kræftlægemiddel) ikke er velegnet.
English: For metastatic breast cancer, Abraxane has been studied in one main study involving 460 women, around three-quarters of whom had received an anthracycline in the past.
Danish: For metastatisk brystkræft blev Abraxane undersøgt i en hovedundersøgelse, der omfattede 460 kvinder, hvoraf cirka tre fjerdedele tidligere var blevet behandlet med et antracyklin.
English: What is the risk associated with Abraxane?
Danish: Hvilken risiko er der forbundet med Abraxane?
English: The main measure of effectiveness was the percentage of patients who responded to treatment.
Danish: Behandlingens virkning blev hovedsagelig bedømt på, hvor stor en procentdel af patienterne, der reagerede på behandlingen.
English: The main measure of effectiveness was the number of patients who ‘responded' after at least five weeks of treatment.
Danish: Virkningen blev hovedsageligt målt på antallet af patienter, der reagerede på behandlingen efter mindst fem uger.
English: Abraxane should only be given under the supervision of a specialist cancer doctor in units that are specialised in giving ‘cytotoxic' (cell-killing) medicines.
Danish: Abraxane bør kun indgives under nøje overvågning af en speciallæge i kræft på afdelinger, der er specialiserede i at indgive celledræbende (cytotoksiske) lægemidler.
English: In metastatic breast cancer Abraxane is given on its own every three weeks.
Danish: Ved metastatisk brystkræft gives Abraxane alene hver tredje uge.
English: In non-small cell lung cancer, 33% of patients receiving Abraxane and carboplatin responded to treatment compared with 25% of those receiving conventional paclitaxel and carboplatin.
Danish: Ved små-cellet lungekræft responderede 33 % af patienterne, der modtog Abraxane og carboplatin på behandling, sammenlignet med 25 % af dem, der modtog konventionel paclitaxel og carboplatin.
English: Abraxane is a powder that is made up into a suspension for infusion (drip) into a vein.
Danish: Abraxane er et pulver, som anvendes til fremstilling af en infusionsvæske, suspension, (drop i en vene).
English: The active substance in Abraxane, paclitaxel, belongs to the group of cancer medicines known as the ‘taxanes'.
Danish: Det aktive stof i Abraxane, paclitaxel, tilhører en gruppe af kræftlægemidler, som kaldes taxaner.
English: Why has Abraxane been approved?
Danish: Hvorfor blev Abraxane godkendt?
English: Immediately after giving Abraxane gemcitabine should be given at a dose of 1000 mg per square metre of body surface area.
Danish: Umiddelbart efter indgivelsen af Abraxane skal der gives en dosis gemcitabin på 1000 mg pr. kvadratmeter kropsoverflade.
English: The Committee decided that Abraxane's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Abraxane opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Abraxane.
English: In addition, Abraxane given in combination with gemcitabine was shown to improve survival in patients with metastatic adenocarcinoma of the pancreas compared with treatment with gemcitabine alone and was effective in combination with carboplatin in the treatment non-small cell lung cancer.
Danish: Abraxane i kombination med gemcitabin viste sig desuden at forbedre overlevelsen hos patienter med metastatisk adenokarcinom i bugspytkirtlen sammenlignet med behandling med gemcitabine alene og var effektivt i kombination med carboplatin til behandling af ikke-småcellet lungekræft.
English: The CHMP noted that Abraxane was more effective than conventional paclitaxel-containing medicines in patients with metastatic breast cancer whose first treatment had stopped working, and that, unlike other paclitaxel-containing medicines, patients to be treated with Abraxane do not need pre-treatment with other medicines to prevent hypersensitivity reactions.
Danish: CHMP bemærkede, at Abraxane var mere effektivt end konventionelle lægemidler indeholdende paclitaxel hos patienter med metastatisk brystkræft, hvis førstebehandling var holdt op med at virke, og at der hos patienter, der skulle behandles med Abraxane, i modsætning til andre lægemidler indeholdende paclitaxel, ikke var behov for forudgående behandling med andre lægemidler for at forebygge overfølsomhedsreaktioner.
English: The recommended dose of Abraxane is 100 mg per square metre of body surface area.
Danish: Den anbefalede dosis Abraxane er 100 mg pr. kvadratmeter kropsoverflade.
English: In Abraxane, unlike conventional paclitaxel-containing medicines, the paclitaxel is attached to a human protein called albumin in tiny particles known as ‘nanoparticles'.
Danish: I Abraxan er paclitaxel i modsætning til konventionelle lægemidler, der indeholder paclitaxel, bundet til det humane protein albumin i bittesmå partikler, der kaldes for nanopartikler.
English: For non-small cell lung cancer, the Abraxane-carboplatin combination was compared with a combination of a conventional paclitaxel-containing medicine and carboplatin in 1,052 patients.
Danish: Ved små-cellet lungekræft blev kombinationen Abraxane og carboplatin sammenlignet med en kombination af et konventionelt lægemiddel og carboplatin hos 1 052 patienter.
English: Patients survived for around 8.5 months on treatment with the combination of Abraxane and gemcitabine, compared with 6.7 months on gemcitabine alone.
Danish: Patienter, der modtog behandling med kombinationen af Abraxane og gemcitabin, overlevede i gennemsnit 8,5 måned, sammenlignet med 6,7 måneder ved behandling med gemcitabin alene.
English: In metastatic breast cancer, Abraxane was more effective than conventional paclitaxel-containing medicines.
Danish: Til behandling af metastatisk brystkræft var Abraxane mere effektivt end konventionelle lægemidler indeholdende paclitaxel.
English: For metastatic adenocarcinoma of the pancreas, Abraxane was studied in one main study involving 861 patients who received either Abraxane in combination with gemcitabine or gemcitabine alone.
Danish: Metastatisk adenokarcinom i bugspytkirtlen blev undersøgt i en hovedundersøgelse, der omfattede 861 patienter, som enten fik Abraxane i kombination med gemcitabin eller gemcitabin alene.
English: In metastatic adenocarcinoma of the pancreas, Abraxane was shown to improve overall survival.
Danish: Ved metastatisk adenokarcinom i bugspytkirtlen viste Abraxane sig at forbedre den samlede overlevelsestid.
English: What is Abraxane?
Danish: Hvad er Abraxane?
English: Abraxane given on its own was compared with a conventional paclitaxel-containing medicine given together with other medicines to reduce side effects.
Danish: Abraxane som enebehandling blev sammenlignet med et konventionelt paclitaxelholdigt lægemiddel i kombination med andre lægemidler for at minimere bivirkningerne.
English: In contrast, Abraxane was more effective than conventional paclitaxel-containing medicines in patients who had taken other treatments for metastatic breast cancer before.
Danish: Abraxane var mere effektivt end konventionelle lægemidler indeholdende paclitaxel hos gruppen af patienter, der tidligere var blevet behandlet med andre lægemidler for metastatisk brystkræft.
English: In metastatic adenocarcinoma of the pancreas Abraxane is given in 4-week treatment cycles.
Danish: Ved metastatisk adenokarcinom i bugspytkirtlen gives Abraxane i behandlingsforløb på fire uger.
English: In non-small cell lung cancer, treatment is carried out in 3-week cycles with Abraxane given on days 1, 8 and 15 of each cycle and carboplatin given on day 1 immediately after Abraxane.
Danish: hvor Abraxane gives på dag 1, 8 og 15 i hver periode og carboplatin på dag 1 umiddelbart efter .
English: For the full list of restrictions with Abraxane, see the package leaflet.
Danish: Den fuldstændige liste over begrænsninger ved Abraxane fremgår af indlægssedlen.
English: What is Abraxane used for?
Danish: Hvad anvendes Abraxane til?
English: How has Abraxane been studied?
Danish: Hvordan blev Abraxane undersøgt?
English: For the full list of all side effects reported with Abraxane, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Abraxane fremgår af indlægssedlen.
English: How is Abraxane used?
Danish: Hvordan anvendes Abraxane?
English: What benefit has Abraxane shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Abraxane?
English: • metastatic adenocarcinoma of the pancreas, as a first treatment in combination with another cancer medicine, gemcitabine.
Danish: Abraxane anvendes som førstebehandling i kombination med et andet kræftlægemiddel kaldet gemcitabin,
English: How does Abraxane work?
Danish: Hvordan virker Abraxane?
English: Treatment may be repeated for up to five consecutive days.
Danish: Behandlingen kan gentages i op til fem på hinanden følgende dage.
English: No data have been presented on overdoses in adult cats.
Danish: Der er ikke forelagt data om overdosering hos voksne katte.
English: Vomiting is a complex process coordinated centrally by the emetic centre.
Danish: Opkastning er en kompleks proces, der koordineres centralt af det emetiske center.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/17/211/001-004 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2017
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/17/211/001-004 DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19/06/2017
English: Comment: Given the small vial size(s), would it not be preferable to replace these by “SC, IV"
Danish: Kommentar: Pga. den lille hætteglasstørrelse må det vel foretrækkes at erstatte disse med "SC, IV"
English: ATCvet code: QA04AD90
Danish: ATCvet-kode: QA04AD90
English: In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats).
Danish: Hos katte ses moderat til svær reaktion på injektionen meget hyppigt (hos ca. en tredjedel af kattene).
English: Injecting the product at refrigerated temperature may reduce pain at injection.
Danish: Injektion af produktet ved nedkølet temperatur kan formindske smerterne ved injektionen.
English: Specific pharmacovigilance requirements: The PSURs for Prevomax shall be submitted at the same frequency as for Cerenia (reference product).
Danish: Krav til lægemiddelovervågning: PSUR'erne for Prevomax skal indsendes med samme hyppighed som for Cerenia (referenceprodukt).
English: PHARMACOLOGICAL PROPERTIES Pharmacotherapeutic group: Antiemetics.
Danish: FARMAKOLOGISKE EGENSKABER Farmakoterapeutisk gruppe: Antiemetika.
English: This centre consists of several brainstem nuclei (area postrema, nucleus tractus solitarius, dorsal motor nucleus of the vagus) that receive and integrate sensory stimuli from central and peripheral sources and chemical stimuli from the circulation and the cerebro-spinal fluid.
Danish: Dette center består af flere kerner i hjernestammen (area postrema, nucleus tractus solitarius, den dorsale motoriske vagusnucleus), som modtager og integrerer sensoriske stimuli fra centrale og perifere kilder og kemiske stimuli fra kredsløbet og cerebrospinalvæsken.
English: Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated.
Danish: Opkastning kan være forbundet med alvorlige, stærkt svækkende tilstande, og årsagen bør undersøges.
English: Excipients: Benzyl alcohol (E1519)
Danish: Hjælpestoffer: Benzylalkohol (E1519)
English: For subcutaneous or intravenous use in dogs and cats.
Danish: Til subkutan eller intravenøs anvendelse hos hunde og katte.
English: For the major metabolite 10.4% of the maropitant dose was recovered in urine and 9.3% in faeces.
Danish: For hovedmetabolitten blev 10,4 % af dosis af maropitant genfundet i urinen, og 9,3 % i fæces.
English: Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied.
Danish: Pga. den hyppige forekomst af forbigående smerter ved subkutan injektion kan det være nødvendigt med passende foranstaltninger til at fastholde dyret.
English: Maropitant is effective against vomiting.
Danish: Maropitant er effektivt mod opkastning.
English: In laboratory studies, maropitant has been shown to be a potential eye irritant.
Danish: I laboratorieundersøgelser er maropitant påvist at være potentielt øjenirriterende.
English: Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively.
Danish: Skønt maropitant er påvist at være effektivt til både behandling og forebyggelse af emesis fremkaldt af kemoterapi, har det vist sig at være mere effektivt, hvis det anvendes forebyggende.
English: In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af selvinjektion ved hændeligt uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten bør vises til lægen.
English: Substance P is found in significant concentrations in the nuclei comprising the emetic centre and is considered the key neurotransmitter involved in vomiting.
Danish: Stof P findes i betydelige koncentrationer i de kerner, der udgør det emetiske center, og anses for den vigtigste neurotransmitter, som er involveret i opkastning.
English: The duration of effect is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis, e.g. chemotherapy.
Danish: Varigheden af virkningen er ca. 24 timer, hvorfor behandlingen kan gives aftenen før indgivelse af et stof, der kan forårsage emesis, f.eks. kemoterapi.
English: Maropitant is a neurokinin 1 (NK1) receptor antagonist, which acts by inhibiting the binding of substance P, a neuropeptide of the tachykinin family.
Danish: Maropitant er en neurokinin 1- (NK1-) receptorantagonist, der virker ved at hæmme bindingen af stof P, som er et neuropeptid i tachykininfamilien.
English: Overdose (symptoms, emergency procedures, antidotes):
Danish: Overdosis (symptomer, nødforanstaltninger, modgift)::
English: Manufacturer responsible for batch release: Produlab Pharma B.V.
Danish: Fremstiller ansvarlig for batchfrigivelse: Produlab Pharma B.V.
English: Good veterinary practice indicates that antiemetics should be used in conjunction with other veterinary and supportive measures such as dietary control and fluid replacement therapy while addressing the underlying causes of the vomiting.
Danish: God veterinær praksis tilsiger, at antiemetika anvendes sammen med andre veterinære og støttende foranstaltninger såsom diæt og væskeerstatningsterapi, mens de underliggende årsager til opkastning behandles.