natgillin/translations-raw huggingface dataset:
• hvis du har et nedsat antal hvide blodlegemer (neutrofiltal ved baseline<1.500 celler/mm3- din læge kan fortælle dig om dette). 
• if you have a low white blood cell count (baseline neutrophil counts <1500 cells/mm3 - your doctor will advise you on this).
Rekonstitution af 250 mg: 
Reconstitution of 250 mg:
Abraxane bør ikke anvendes under graviditeten eller til fertile kvinder, der ikke anvender sikker kontraception, medmindre moderens kliniske tilstand kræver behandling med paclitaxel. 
Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.
På baggrund af de videnskabelige konklusioner for paclitaxel albumin er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder paclitaxel albumin, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen. 
On the basis of the scientific conclusions for paclitaxel albumin the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing paclitaxel albumin is unchanged subject to the proposed changes to the product information
Gravide kvinder bør ikke håndtere Abraxane. 
Pregnant staff should not handle Abraxane.
Anvendelse Abraxane anvendes til behandling af de følgende kræfttyper: 
What Abraxane is used for Abraxane is used to treat the following types of cancer:
De vigtigste sekundære endepunkter var progressionsfri overlevelse (progression-free survival, PFS) og samlet responsrate (overall response rate, ORR), begge vurderet ved en uafhængig, central, blindet radiologisk gennemgang ved at bruge retningslinjer fra RECIST (version 1.0). 
The key secondary endpoints were progressionfree survival (PFS) and overall response rate (ORR), both assessed by independent, central, blinded radiological review using RECIST guidelines (Version 1.0).
Mediantiden til stigning med mindst 1 grad var 21 dage, og mediantiden til stigning fra grad 3 perifer neuropati til grad 0 eller 1 var 29 dage. 
The median time to improvement by at least 1 grade was 21 days, and the median time to improvement from Grade 3 peripheral neuropathy to Grade 0 or 1 was 29 days.
1På Dag 1 i 21-dages cyklussen reduceres dosis af Abraxane og carboplatin på samme tid. 
1On Day 1 of the 21-day cycle reduce the dose of Abraxane and carboplatin simultaneously.
Abraxane leveres som et sterilt, frysetørret pulver til rekonstitution inden brug. 
Abraxane is supplied as a sterile lyophilised powder for reconstitution before use.
Sjælden: Pancytopeni 
Rare: Pancytopenia
• medicin til behandling af infektioner (dvs. antibiotika som erythromycin, rifampicin osv. Spørg din læge, sundhedspersonalet eller apotekspersonalet, hvis du ikke er sikker på, om den medicin, 
• medicines for treating infections (i.e. antibiotics such erythromycin, rifampicin, etc.; ask your doctor, nurse or pharmacist if you are unsure whether the medicine you are taking is an antibiotic),
Grad 4 neutropeni (<500 celler/mm3) forekom hos 9 % af de patienter, der blev behandlet med Abraxane. 
Grade 4 neutropenia (< 500 cells/mm3) occurred in 9% of patients treated with Abraxane.
Generelt var hyppigheden og sværhedsgraden af neurotoksicitet dosisafhængig hos patienter, der fik Abraxane. 
In general, the frequency and severity of neurotoxicity was dose-dependent in patients receiving Abraxane.
229 patienter, der blev behandlet med Abraxane i det randomiserede, kontrollerede kliniske studier, blev evalueret med hensyn til sikkerhed. 
Two hundred and twenty nine patients treated with Abraxane in the randomized, controlled clinical trial were evaluated for safety.
Meget almindelig: Anoreksi 
Very common: Anorexia
Meget almindelig: Dyspnø 
Very common: Dyspnoea
Udsæt dosis indtil bedring 
Delay doses until recovery
59 % fik studiemedicinen som anden linje behandling eller senere behandling. 
Fifty-nine percent received study medicinal product as second or greater than second-line therapy.
Dyrestudier viste irreversible, toksiske virkninger på de mandlige forplantningsorganer ved klinisk relevante eksponeringsniveauer. 
Animal studies with Abraxane showed non-reversible, toxic effects on the male reproductive organs at clinically relevant exposure levels.
Den mediane tid til sygdomsprogression var 5,3 måneder (175 mg/m2; 95 % CI: 4,6 - 6,2 måneder) og 6,1 måneder (300 mg/m2; 95 % CI: 4,2 - 9,8 måneder). 
The median time to disease progression was 5.3 months (175 mg/m2; 95% CI: 4.6-6.2 months) and 6.1 months (300 mg/m2; 95% CI: 4.2-9.8 months).
Asteni/træthed blev rapporteret af 40 % af patienterne. 
Asthenia/Fatigue was reported in 40% of the patients.
Farmakokinetiske interaktioner mellem Abraxane og gemcitabin er ikke blevet evalueret hos mennesker. 
Pharmacokinetic interactions between Abraxane and gemcitabine have not been evaluated in humans.
1 Perifer neuropati evalueret ved brug af SMQ (bredt defineret). 
1 Peripheral neuropathy evaluated using the SMQ (broad scope).
Hvis patienterne oplever kvalme, opkastning og diarré efter administration af Abraxane, kan de behandles med de almindeligt anvendte antiemetika og obstiperende midler. 
If patients experience nausea, vomiting and diarrhoea following the administration of Abraxane, they may be treated with commonly used anti-emetics and constipating agents.
Til behandling af metastatisk brystkræft gives Abraxane sædvanligvis én gang hver tredje uge (på dag 1 i en 21-dages cyklus). 
For treatment of metastatic breast cancer, Abraxane is usually given once every three weeks (on day 1 of a 21-day cycle).
Responsraterne hos alle patienter var henholdsvis 39,5 % (95 % CI: 24,9 % - 54,2 %) og 47,6 % (95 % Cl: 35,3 % - 60,0 %). 
The response rates in all patients were 39.5% (95% CI: 24.9%-54.2%) and 47.6% (95% CI: 35.3%-60.0%), respectively.
Doseringsjustering under behandlingen af brystkræft 
Dose adjustments during treatment of breast cancer
Uåbnede hætteglas med Abraxane er stabile indtil den dato, der er angivet på emballagen, så længe hætteglasset opbevares i den ydre karton for at beskytte mod lys. 
Unopened vials of Abraxane are stable until the date indicated on the package when the vial is kept in the outer carton in order to protect from light.
Der var ingen klinisk relevante farmakokinetiske interaktioner mellem Abraxane og carboplatin. 
There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.
Hvis infusionstiden af Abraxane følger anvisningerne og begrænses til 30 minutter, reduceres risikoen for infusionsrelaterede reaktioner. 
Limiting the infusion of Abraxane to 30 minutes, as directed, reduces the likelihood of infusion-related reactions.
Den rekonstituerede infusionsvæske har en pH-værdi på 6-7,5 og en osmolalitet på 300-360 mOsm/kg. 
The reconstituted suspension has a pH of 6-7.5 and an osmolality of 300-360 mOsm/kg.
Du må ikke amme, mens du tager Abraxane, da det er ukendt, om det aktive stof paclitaxel udskilles i mælken. 
Do not breast feed when taking Abraxane as it is not known if the active ingredient paclitaxel passes into the mother's milk.
Brug ikke Abraxane: 
Do not use Abraxane
Første Anden 
First Second
Anæmia,b Neutropeni a,b Trombocytopenib,c a 405 patienter vurderet i gruppen behandlet med Abraxane/gemcitabin b 388 patienter vurderet i gruppen behandlet med gemcitabin c 404 patienter vurderet i gruppen behandlet med Abraxane/gemcitabin 
Anaemiaa,b Neutropenia a,b Thrombocytopeniab,c a 405 patients assessed in Abraxane/gemcitabine-treated group b 388 patients assessed in gemcitabine-treated group c 404 patients assessed in Abraxane/gemcitabine-treated group
De hyppigste klinisk signifikante bivirkninger forbundet med anvendelse af Abraxane har været neutropeni, perifer neuropati, artralgi/myalgi og gastrointestinale symptomer. 
The most common clinically significant adverse reactions associated with the use of Abraxane have been neutropenia, peripheral neuropathy, arthralgia/myalgia and gastrointestinal disorders.
64 % af patienterne havde nedsat performance-status (ECOG 1 eller 2) ved indgang i studiet; 79 % havde viscerale metastaser; og 76 % havde >3 metastaselokalisationer. 
Sixty-four percent of patients had impaired performance status (ECOG 1 or 2) at study entry; 79% had visceral metastases; and 76% had > 3 sites of metastases.
BILAG IV Videnskabelige konklusioner og begrundelser for ændring af betingelserne for markedsføringstilladelsen/-tilladelserne 
ANNEX IV Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)
Patienter i Abraxane/carboplatin-armen havde en signifikant højere samlet responsrate sammenlignet med patienter i kontrolarmen: 33 % versus 25 %, p = 0,005 (Tabel 12). 
Patients in the Abraxane/carboplatin arm had a significantly higher overall response rate compared with patients in the control arm: 33% versus 25%, p = 0.005 (Table 12).
Baseret på en non-kompartmental farmakokinetisk analyse var plasmaclearance af paclitaxel med Abraxane større (43 %) end clearance efter en solvensbaseret paclitaxelindsprøjtning, og fordelingsvolumenen var også højere (53 %). 
Based on non-compartmental PK analysis, the plasma clearance of paclitaxel with Abraxane was larger (43%) than that following a solvent-based paclitaxel injection and its volume of distribution was also higher (53%).
Ud fra et mikrobiologisk synspunkt skal produktet dog anvendes straks efter rekonstitution og fyldning af infusionsposerne, medmindre metoden til rekonstitution og fyldning af infusionsposerne udelukker risiko for mikrobiel kontaminering. 
However, from a microbiological point of view, unless the method of reconstituting and filling of the infusion bags precludes the risks of microbial contamination, the product should be used immediately after reconstitution and filling of the infusion bags.
Baseret på den offentliggjorte litteratur viser in vitro-studier med humane levermikrosomer og vævssnit, at paclitaxel primært bliver metaboliseret til 6-hydroxypaclitaxel og til to mindre metabolitter, 3'-p-hydroxypaclitaxel og 6-3'-p-dihydroxypaclitaxel. 
Based on the published literature, in vitro studies with human liver microsomes and tissue slices show that paclitaxel is metabolised primarily to 6-hydroxypaclitaxel; and to two minor metabolites, 3'-p-hydroxypaclitaxel and 6-3'-p-dihydroxypaclitaxel.
I betragtning af hændelsens alvor, samt at sklerodermi er inkluderet i produktresuméet for flere opløsningsmiddelbaserede paclitaxel produkter, bedes MAH tilføje sklerodermi til afsnit 4.8 iproduktresuméet med hyppigheden ikke kendt. 
Taking into account the seriousness of the event, as well as the fact that scleroderma is included in the SmPC of several solvent-based paclitaxel products, the MAH is requested to add scleroderma to section 4.8 of the SmPC with frequency not known.
EVENTUELLE ANDRE SÆRLIGE ADVARSLER Abraxane bør ikke erstatte eller erstattes med andre paclitaxelformuleringer. 
OTHER SPECIAL WARNING(S), IF NECESSARY Abraxane should not be substituted for or with other paclitaxel formulations.
Gastrointestinal toksicitet: Grad 3 mukosit eller diarré 
Gastrointestinal Toxicity: Grade 3 mucositis or diarrhoea
I dette randomiserede, kontrollerede, åbne fase III-studie, blev bivirkninger, der førte til døden i løbet af 30 dage efter den sidste dosis studiemedicin, rapporteret hos 4% af de patienterne, der fik Abraxane i kombination med gemcitabin, og hos 4% af de patienterne, der fik gemcitabin-monoterapi. 
In this phase III randomized, controlled, open-label trial, adverse reactions resulting in death within 30 days of the last dose of study drug were reported for 4% of patients receiving Abraxane in combination with gemcitabine and for 4% of patients receiving gemcitabine monotherapy.
Der var en statistisk signifikant stigning i OS hos patienter, der blev behandlet med Abraxane/gemcitabin versus gemcitabin alene, med 1,8 måneders stigning i median OS, 28% samlet reduktion i risiko for død, 59% forbedring i 1-års overlevelse og 125% forbedring i 2-års overlevelsesrater. 
There was a statistically significant improvement in OS for patients treated with Abraxane/gemcitabine versus gemcitabine alone, with 1.8 months increase in median OS, 28% overall reduction in risk of death, 59% improvement in 1-year survival, and 125% improvement in 2-year survival rates.
Grad 1-4 
Grades 1-4
Brugsanvisning, håndtering og bortskaffelse 
Instructions for use, handling and disposal
Din læge vil sørge for en graviditetstest, inden behandlingen med Abraxane påbegyndes. 
Your doctor will arrange a pregnancy test before starting treatment with Abraxane.
Selvom data er begrænsede, er der ikke påvist nogen tydelig fordel med hensyn til langvarig samlet overlevelse hos patienter med adenokarcinom i pancreas med normale CA-19-9-niveauer før behandling med Abraxane og gemcitabin (se pkt. 
Although limited data is available, no clear benefit in terms of prolonged overall survival has been demonstrated in pancreatic adenocarcinoma patients with normal CA 19-9 levels prior to start of treatment with Abraxane and gemcitabine (see section 5.1).
Et randomiseret, åbent multicenterstudie blev udført hos 1.052 kemoterapi-naïve patienter med Stadie IIIb/IV ikke-småcellet lungecancer. 
A multicenter, randomized, open-label study was conducted in 1052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer.
Perifer neuropati (hovedsagelig grad 1 eller 2 sensorisk neuropati) blev observeret hos 68 % af patienterne, der fik Abraxane; heraf var 10 % grad 3, og ingen var grad 4 (se pkt. 
Peripheral neuropathy (mostly Grade 1 or 2 sensory neuropathy) was observed in 68% of patients on Abraxane with 10% being Grade 3, and no cases of Grade 4.
(PT med risiko) ABX/GEM: 
ABX/GEM : GEM :
Febril neutropeni: Grad 3 eller 4 
Febrile Neutropenia: Grade 3 or 4
For den behandlede population var den mediane relative dosisintensitet for gemcitabin 75% i Abraxane/gemcitabin-armen og 85% i gemcitabin-armen. 
For the treated population, the median relative dose intensity for gemcitabine was 75% in the Abraxane/gemcitabine arm and 85% in the gemcitabine arm.
• Abraxane anvendes til ikke-småcellet lungekræft, hvis operation eller strålebehandling ikke er egnet til at behandle sygdommen. 
• Abraxane is used in non-small cell lung cancer where surgery or radiotherapy would not be suitable to treat the disease.
I begge studiearme blev behandlingen administreret indtil sygdomsprogression eller udvikling af uacceptabel toksicitet. 
Proportion of Survival both study arms treatment was administered until disease progression or development of an unacceptable toxicity.
• Abraxane anvendes sammen med et lægemiddel, der kaldes carboplatin, hvis du har den mest almindelige type lungekræft, der kaldes ”ikke-småcellet lungekræft”. 
• Abraxane is also used together with a medicine called carboplatin if you have the most common type of lung cancer, called “non-small cell lung cancer”.
Abraxane er en albuminbundet nanopartikelformulering af paclitaxel, som kan have væsentligt forskellige farmakologiske egenskaber sammenlignet med andre formuleringer af paclitaxel (se pkt. 
Abraxane is an albumin-bound nanoparticle formulation of paclitaxel, which may have substantially different pharmacological properties compared to other formulations of paclitaxel (see sections 5.1 and 5.2).
I ét studie blev Abraxane indgivet som en 30-minutters infusion i en dosis på 175 mg/m2 til 43 patienter med metastaserende brystkræft. 
In one study, Abraxane was administered as a 30-minute infusion at a dose of 175 mg/m2 to 43 patients with metastatic breast cancer.
Paclitaxel er et cytotoksisk lægemiddel mod cancer, og som ved andre potentielt toksiske forbindelser, skal der udvises forsigtighed ved håndtering af Abraxane. 
Paclitaxel is a cytotoxic anticancer medicinal product and, as with other potentially toxic compounds, caution should be exercised in handling Abraxane.
Abraxane i kombination med carboplatin er indiceret til førstelinjebehandling af ikke-småcellet lungecancer hos voksne patienter, der ikke er kandidater til potentielt kurativ kirurgi og/eller strålebehandling. 
Abraxane in combination with carboplatin is indicated for the first-line treatment of non-small cell lung cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy.
Ved anvendelse af gentagen måleanalyse var 3 ud af de 4 delskalaer (perifer neuropati, smerter i hænder/fødder samt hørelse) bedre for Abraxane og carboplatin (p ≤ 0,002). 
Using repeated measure analysis, 3 of the 4 subscales (peripheral neuropathy, pain hands/feet, and hearing) favored Abraxane and carboplatin (p ≤ 0.002).
Der er fremsat hypotese om, at denne øgede transendoteliale caveolae-transport formidles af gp-60 albuminreceptoren, og at der er øget akkumulering af paclitaxel i tumorområdet på grund af det albuminbindende protein Secreted Protein 
It is hypothesised that this enhanced transendothelial caveolar transport is mediated by the gp-60 albumin receptor, and that there is enhanced accumulation of paclitaxel in the area of tumour due to the albumin-binding protein Secreted Protein Acidic Rich in Cysteine (SPARC).
Det nøjagtige, totale volumen af 5 mg/ml infusionsvæsken, der kræves til patienten, beregnes, og den korrekte mængde rekonstitueret Abraxane injiceres i en tom, steril (PVC- eller ikke-PVC-type) infusionspose. 
The exact total dosing volume of 5 mg/ml suspension required for the patient should be calculated and the appropriate amount of reconstituted Abraxane should be injected into an empty, sterile, PVC or non-PVC type intravenous bag.
En efterfølgende analyse hos 981 patienter, der fik monoterapi med Abraxane for metastatisk brystkræft, hvoraf 15 % var ≥ 65 år, og 2 % var ≥ 75 år, viste en højere forekomst af epistaxis, diarré, dehydrering, træthed og perifert ødem hos patienter ≥ 65 år. 
However, a subsequent analysis in 981 patients receiving Abraxane monotherapy for metastatic breast cancer, of which 15% were ≥ 65 years old and 2% were ≥ 75 years old, showed a higher incidence of epistaxis, diarrhoea, dehydration, fatigue and peripheral oedema in patients ≥ 65 years.
Hyppighederne af bivirkninger forbundet med administration af Abraxane er angivet i tabel 6 (Abraxane som monoterapi), i tabel 7 (Abraxane i kombination med gemcitabin) og i tabel 9 (Abraxane i kombination med carboplatin). 
The frequencies of adverse reactions associated with the administration of Abraxane are listed in Table 6 (Abraxane as monotherapy) and Table 7 (Abraxane in combination with gemcitabine), and Table 9 (Abraxane in combination with carboplatin).
Virkningen af nedsat leverfunktion på populationsfarmakokinetikken af Abraxane blev undersøgt hos patienter med fremskredne solide tumorer. 
The effect of hepatic impairment on population pharmacokinetics of Abraxane was studied in patients with advanced solid tumours.
Den samlede opbevaringstid for det rekonstituerede lægemiddel i hætteglasset og i infusionsposen, når det opbevares i køleskab og er beskyttet mod lys, er 24 timer. 
The total combined storage time of reconstituted medicinal product in the vial and in the infusion bag when refrigerated and protected from light is 24 hours.
Ud af de 17 tilfælde af pneumonitis, som blev rapporteret hos patienter i behandling med Abraxane i kombination med gemcitabin, havde 2 dødelig udgang. 
Of the 17 cases of pneumonitis reported in patients treated with Abraxane in combination with gemcitabine, 2 had a fatal outcome.
Farmakokinetikken af total-paclitaxel efter 30- og 180-minutters infusioner af Abraxane ved doseringsniveauer på 80 til 375 mg/m2 blev bestemt i kliniske studier. 
The pharmacokinetics of total paclitaxel following 30- and 180-minute infusions of Abraxane at dose levels of 80 to 375 mg/m2 were determined in clinical studies.
Alopeci blev observeret hos mere end 80 % af patienterne, som blev behandlet med Abraxane. 
Alopecia was observed in >80% of the patients treated with Abraxane.
Sjælden:Radiation recall-fænomen, pneumonitis ved strålebehandling 
Rare: Radiation recall phenomenon, radiation pneumonitis
Personer med metastatisk kræft i bugspytkirtlen (kræft i bugspytkirtlen, der har spredt sig til andre dele af kroppen), som fik Abraxane sammen med gemcitabin i et klinisk studie, levede længere end personer, der kun fik gemcitabin. 
People with metastatic pancreatic cancer (pancreatic cancer that has spread to other parts of the body) who received Abraxane with gemcitabine in a clinical trial lived longer than people who had only received gemcitabine.
Let til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 til <90 ml/min) har ingen klinisk vigtig virkning på paclitaxels maksimale eliminationshastighed og systemiske eksponering (AUC og Cmax). 
Mild to moderate renal impairment (creatinine clearance ≥30 to <90 ml/min) has no clinically important effect on the maximum elimination rate and systemic exposure (AUC and Cmax) of paclitaxel.
Data fra 106 patienter, der indgik i to enkeltarmede, ublindede studier og fra 454 patienter, der blev behandlet i et randomiseret fase III sammenligningsstudie understøtter brugen af Abraxane ved metastaserende brystkræft. 
Data from 106 patients accrued in two single-arm open-label studies and from 454 patients treated in a randomised Phase III comparative study are available to support the use of Abraxane in metastatic breast cancer.
• Fingerneglssmerte, fingerneglsubehag, tab af fingernegle, udslæt, hudsmerte, rød hud fra sollys, 
• Fingernail pain, fingernail discomfort, loss of fingernails, hives, skin pain, red skin from sunlight,
Tabel 2: Dosismodifikationer for neutropeni og/eller trombocytopeni ved cyklusstart eller i løbet af en cyklus for patienter med adenokarcinom i pancreas 
Table 2: Dose modifications for neutropenia and/or thrombocytopenia at the start of a cycle or within a cycle for patients with pancreatic adenocarcinoma
På grund af potentielle, alvorlige bivirkninger hos ammede spædbørn er Abraxane kontraindiceret under amning. 
Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation.
Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned. 
Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP.
Administrer Abraxane via et infusionssæt med et indsat 15 µm filter for at undgå administration af disse tråde. 
Administer Abraxane using an infusion set incorporating a 15 µm filter to avoid administration of these strands.
De fleste tilfælde af alopeci forekom inden for en måned efter behandlingsstart med Abraxane. 
The majority of alopecia events occurred less than one month after initiation of Abraxane.
Populationsfarmakokinetiske analyser af Abraxane indikerer, at køn, race (asiatisk versus hvid) og typen af solide tumorer ikke har en klinisk vigtig virkning på paclitaxels systemiske eksponering (AUC og Cmax). 
Population pharmacokinetic analyses for Abraxane indicate that gender, race (Asian vs. White), and type of solid tumours do not have a clinically important effect on systemic exposure (AUC and Cmax) of paclitaxel.
1. reduktion af dosisniveau 2. reduktion af dosisniveau Hvis yderligere dosisreduktioner er nødvendige 
1st dose level reduction 2nd dose level reduction If additional dose reduction required
Mandlige patienter behandlet med Abraxane anbefales at anvende sikker kontraception samt at undgå at gøre kvinder gravide under og i seks måneder efter behandlingen. 
Male patients treated with Abraxane are advised to use effective contraception and to avoid fathering a child during and up to six months after treatment.
Efter administration anbefales det, at den intravenøse slange skylles med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske for at sikre administration af hele dosis. 
Following administration, it is recommended that the intravenous line be flushed with sodium chloride 9 mg/ml (0.9%) solution for injection to ensure administration of the complete dose.