natgillin/translations-raw huggingface dataset:
Ud af de 404 sarkompatienter seponerede 2 patienter eribulin på grund af perifer neuropati. 
Out of the 404 sarcoma patients, 2 patients discontinued treatment with eribulin due to peripheral neuropathy.
Kontakt lægen eller sundhedspersonalet, før du bruger HALAVEN - hvis du har leverproblemer - hvis du har feber eller en infektion - hvis du oplever følelsesløshed, prikkende, stikkende fornemmelser, følsomhed over for berøring eller muskelsvaghed - hvis du har hjerteproblemer 
Talk to your doctor or nurse before using HALAVEN: - if you have liver problems - if you have a fever or an infection - if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness - if you have heart problems
Uomdannet eribulin var det hovedsagelige cirkulerende stof i plasma efter indgivelse af 14C-eribulin til patienter. 
Unchanged eribulin was the major circulating species in plasma following administration of 14C
De hyppigst rapporterede bivirkninger i forbindelse med HALAVEN er knoglemarvssuppression i form af neutropeni, leukopeni, anæmi og trombocytopeni med tilhørende infektioner. 
The most commonly reported adverse reactions related to HALAVEN, are bone marrow suppression manifested as neutropenia, leucopenia, anaemia, thrombocytopenia with associated infections.
Et studie evaluerede eribulins farmakokinetik hos patienter med let (Child-Pugh A, n=7) og moderat (Child-Pugh B, n=4) nedsat leverfunktion på grund af levermetastaser. 
A study evaluated the pharmacokinetics of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=4) hepatic impairment due to liver metastases.
Intravenøs anvendelse Læs indlægssedlen inden brug. 
Read the package leaflet before use.
Det anvendes også hos voksne med fremskreden eller metastatisk liposarkom (en type cancer, der opstår fra fedtvævet), når tidligere behandling er prøvet, men ikke længere virker. 
It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.
Patienter med alaninaminotransferase (ALAT) eller aspartataminotransferase (ASAT) >3 x den øvre normalgrænse (ULN) oplevede en højere forekomst af grad 4 neutropeni og febril neutropeni. 
Patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Eribulin var positiv i en mutagenese-assay af muselymfom, og det var klastogent i en in vivo micronukleus-assay hos rotter. 
Eribulin was positive in the mouse lymphoma mutagenesis assay and was clastogenic in the in vivo rat micronucleus assay.
De kombinerede hyppigheder for TEAE og unormale neutrofiltal var hhv. 307/404 (76,0 %) og 1.314/1.559 (84,3 %). 
The combined grouped TEAE and neutrophil laboratory abnormality frequencies were 307/404 (76.0%) and 1314/1559 (84.3%), respectively.
Sammenlignet med patienter med normal leverfunktion (n=6), var eribulins eksponering forhøjet 1,8 gange og tre gange hos patienter med hhv. let og moderat nedsat leverfunktion. 
Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 3-fold in patients with mild and moderate hepatic impairment, respectively.
Eribulin er ikke substrat for brystcancer-resistensprotein(BCRP), organisk anion- (OAT1, OAT3, OATP1B1, OATP1B3), multidrug-resistensprotein- (MRP2, MRP4) og galdesalt-eksportpumpe- (BSEP) transportørerne . 
Eribulin is not a substrate of breast cancer resistance protein (BCRP), organic anion (OAT1, OAT3, OATP1B1, OATP1B3), multi-drug resistance-associated protein (MRP2, MRP4) and bile salt export pump (BSEP) transporters.
Nominel P-værdi (log rank) 
Nominal P value (log rank)
Behandling med eribulin skal kun påbegyndes hos patienter med absolut antal neutrofile ≥ 1,5 x 109/l og trombocytter > 100 x 109/l. 
Treatment with eribulin should only be initiated in patients with ANC values ≥ 1.5 x 109/l and platelets > 100 x 109/l.
Trombocytter < 25 x 109/l trombocytopeni Trombocytter < 50 x 109/l trombocytopeni kompliceret af blødning eller som kræver blod- eller trombocyttransfusion 
Platelets < 25 x 109/l thrombocytopenia Platelets < 50 x 109/l thrombocytopenia complicated by haemorrhage or requiring blood or platelet transfusion Non-haematological:
Hvis der er kontakt med slimhinder, skal slimhinderne skylles grundigt med vand. 
If it contacts mucous membranes, the membranes should be flushed thoroughly with water.
Johnsons syndrom/ Toksisk epidermal nekrolyse b 
Stevens-Johnson syndrome/ Toxic epidermal necrolysisb
Muskuloskeletale smerter Muskuloskeletale brystsmerter 
Musculoskeletal pain Musculoskeletal chest pain
Hos de 1.559 brystcancerpatienter var den bivirkning, som hyppigst resulterede i seponering af eribulin, perifer neuropati (3,4 %). 
In the 1559 breast cancer patients the most common adverse reaction resulting in discontinuation of treatment with eribulin was peripheral neuropathy (3.4%).
Patienter med allerede eksisterende neuropati grad 1 eller 2 var imidlertid ikke mere tilbøjelige til at udvikle nye eller forværrede neuropati symptomer end patienter, der indgik i studiet uden neuropati. 
However, patients with pre-existing neuropathy Grade 1 or 2 were no more likely to develop new or worsening symptoms than those who entered the study without the condition.
Svær neutropeni kan behandles med granulocyt-kolonistimulerende faktor (G-CSF) eller lignende efter lægens skøn i henhold til relevante retningslinjer (se pkt. 
Severe neutropenia may be managed by the use of granulocyte colony-stimulating factor (G-CSF) or equivalent at the physician's discretion in accordance with relevant guidelines (see section 5.1).
b aCox proportional hazard bStratificeret af geografisk region, HER2/neu-status og tidligere capecitabinbehandling. 
aCox proportional hazard bStratified by geographic region, HER2/neu status, and prior capecitabine therapy.
Den positive virkning på den samlede overlevelse blev set både hos capecitabin-naive og capecitabinforbehandlede patientgrupper. 
The positive effect on OS was seen both in capecitabine-naïve and in capecitabine pre-treated patient groups.
HALAVEN er indiceret til behandling af voksne patienter med lokalt fremskreden eller metastatisk brystcancer med sygdomsprogression efter mindst ét kemoterapiregime for fremskreden sygdom (se pkt. 
HALAVEN is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease (see section 5.1).
Trods reduktion til 0,62 mg/m2 
Despite reduction to 0.62 mg/m2
Ud af de 404 sarkompatienter, der blev behandlet med eribulin, var 90 patienter (22,3 %) ≥ 65 år. 
In the 404 sarcoma patient population, 90 patients (22.3%) treated with eribulin were ≥ 65 years of age.
Eribulin er embryotoksisk, føtotoksisk og teratogent hos rotter. 
Eribulin is embryotoxic, foetotoxic, and teratogenic in rats.
I de kliniske studier var det lige så sandsynligt, at patienter med allerede eksisterende neuropati udviklede nye eller forværrede symptomer end patienter, der indgik i studiet uden neuropati. 
In clinical trials, patients with pre-existing neuropathy were as likely to develop new or worsening symptoms as those who entered the study without the condition.
Objektiv responsrate, bedømt ved en uafhængig vurdering, var også sammenlignelig for eribulin og capecitabin; 11,0 % (95 % CI: 8,5; 13,9) i eribulingruppen og 11,5 % (95 % CI: 8,9; 14,5) i capecitabingruppen. 
Objective response rate as assessed by independent review was also similar between eribulin and capecitabine; 11.0% (95% CI: 8.5, 13.9) in the eribulin group and 11.5% (95% CI: 8.9, 14.5) in the capecitabine group.
Ikke almindelig (Hyppighed %) 
Uncommon (Frequency %)
HALAVEN er indiceret til behandling af voksne patienter med ikke-resekterbart liposarkom, som tidligere har fået antracyklinholdig behandling (medmindre de ikke var egnede hertil) af fremskreden eller metastatisk sygdom (se pkt. 
HALAVEN is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease (see section 5.1).
Trods reduktion til 0,97 mg/m2 
Despite reduction to 0.97 mg/m2
Ethanol, vandfrit, vand til injektionsvæsker, saltsyre, natriumhydroxid Se indlægssedlen for yderligere oplysninger 
Ethanol anhydrous,Water for injections, Hydrochloric acid, Sodium hydroxide See leaflet for further information
HALAVEN indeholder alkohol 
What HALAVEN contains
Anbefalinger for dosisreduktion Bivirkning efter tidligere HALAVEN-indgivelse 
Dose reduction recommendations Adverse reaction after previous HALAVEN administration Recommended dose of eribulin
Blandt patienter med evaluerbart respons var den objektive responsrate efter RECISTkriterierne 12,2 % (95 % CI: 9,4 %; 15,5 %), baseret på en uafhængig vurdering, for eribulin-armen sammenlignet med 4,7 % (95 % CI: 2,3 %; 8,4 %) for TPC-armen. 
In response evaluable patients, the objective response rate by the RECIST criteria was 12.2% (95% CI: 9.4%, 15.5%) by independent review for the eribulin arm compared to 4.7% (95% CI: 2.3%, 8.4%) for the TPC arm.
Efter administration anbefales det, at den intravenøse slange skylles med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning, for at sikre administration af hele dosen. 
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.
Dosisreduktioner under behandling 
Dose reduction during therapy
Kulderystelser Brystsmerter Influenza-lignende sygdom 
Chest pain Influenza like illness
Det er imidlertid blevet vist, at eribulin ikke er en Pgp-hæmmer in vitro ved klinisk relevante koncentrationer. 
However it has been shown that at clinically relevant concentrations eribulin is not a Pgp inhibitor in vitro.
Fortyndede opløsninger af HALAVEN (eribulin 0,018 mg/ml til 0,18 mg/ml i natriumchlorid 9 mg/ml (0,9 %)) injektionsvæske, opløsning, må ikke opbevares i over 24 timer ved temperaturer på 2 °C 
Diluted solutions of HALAVEN (0.018 mg/ml to 0.18 mg/ml eribulin in sodium chloride 9 mg/ml (0.9%)) solution for injection should not be stored longer than 24 hours at 2°C - 8°C, unless dilution has taken place in controlled and validated aseptic conditions.
HALAVEN er en klar, farveløs, vandig injektionsvæske, opløsning, i hætteglas indeholdende 2 ml eller 3 ml injektionsvæske. 
HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml or 3ml of solution.
Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig. 
Other medicines and HALAVEN Tell your doctor if you are using, have recently used or might use any other medicines.
HALAVEN anvendes hos voksne med lokalt fremskreden eller metastatisk brystkræft (brystkræft, som har spredt sig udover den oprindelige kræftknude), når mindst en anden behandling er prøvet, men ikke længere virker. 
It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.
Den opdaterede overlevelsesanalyse viste en overlevelsesfordel for eribulin-gruppen sammenlignet med TPC både hos capecitabin-forbehandlede patienter med en HR på 0,787 (95 % CI 0,645; 0,961), og for capecitabin-naive patienter med en tilsvarende HR på 0,865 (95 % CI 0,606; 1,233). 
The updated OS analysis showed a survival benefit for the eribulin group compared to TPC both in capecitabine pre-treated patients with a HR of 0.787 (95% CI: 0.645, 0.961), and for the capecitabine-naïve patients with a corresponding HR of 0.865 (95% CI: 0.606, 1.233).
Hazard ratio (95 % CI) p-værdi (log rank) 
Hazard Ratio (95% CI) p-value (log rank)
Nedsat leverfunktion på grund af cirrose 
Impaired liver function due to cirrhosis
Gennemsnitstiden til nadir var 13 dage, og gennemsnitstiden til bedring fra svær neutropeni (< 0,5 x 109/l) var 8 dage. 
The neutropenia observed was reversible and not cumulative; the mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (< 0.5 x 109/l) was 8 days.
Opbevaringsforhold efter anbrud og fortynding af lægemidlet, se pkt. 
For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Ved en uafhængig vurdering var den mediane progressionsfrie overlevelse (PFS) 3,7 måneder for eribulin-armen sammenlignet med 2,2 måneder for TPC-armen (HR 0,865, 95 % CI: 0,714; 1,048, p=0,137). 
By independent review, the median progression free survival (PFS) was 3.7 months for eribulin compared to 2.2 months for the TPC arm (HR 0.865, 95% CI: 0.714, 1.048, p=0.137).
Capecitabin (n=548) 
Capecitabine (n=548)
Gastroøsofageal reflukssygdom Udspilet abdomen 
Gastrooesophageal reflux disease Abdominal distension
Dyspnø (15,2 %)a (G3/4: 3,5 %)a Hoste (15,0 %) (G3/4: 0,5 %) 
Dyspnoea (15.2%)a (G3/4: 3.5%)a Cough (15.0%) (G3/4: 0.5%)
Vand til injektionsvæsker Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering) 
Sodium hydroxide (for pH-adjustment)
Selvom data er begrænsede, har patienter med bilirubin > 1,5 x ULN også en højere forekomst af grad 4 neutropeni og febril neutropeni. 
Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
5 ml type I hætteglas med teflonbelagt butylgummiprop og flip-off aluminium forsegling, indeholdende 3 ml opløsning. 
5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.
4.2 for behandlingsvejledning. 
See section 4.2 for treatment recommendations.
5 ml type I hætteglas med teflonbelagt butylgummiprop og flip-off aluminium forsegling, indeholdende 2 ml opløsning. 
5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.
Studie 309 - progressionsfri overlevelse i liposarkom-undergruppen 
Study 309 - Progression Free Survival in the Liposarcoma Subgroup
Tel.: + 420 242 485 839 
Tel.: + 420 242 485 839 Danmark
Studie 309 ITT-population 
Study 309 ITT Population
Hæmaturi Proteinuri Nyresvigt 
Haematuria Proteinuria Renal failure
Progressionsfri overlevelse, bedømt ved en uafhængig vurdering, var sammenlignelig for eribulin og capecitabin med medianer på hhv. 4,1 måneder versus 4,2 måneder (HR 1,08, [95 % CI: 0,932; 1,250]). 
Progression free survival assessed by independent review was similar between eribulin and capecitabine with medians of 4.1 months vs 4.2 months (HR 1.08; [95% CI: 0.932, 1.250]) respectively.
Eribulins farmakokinetik er karakteriseret ved en hurtig fordelingsfase, efterfulgt af en langvarig elimineringsfase, men med gennemsnitlig terminal halveringstid på ca. 40 timer. 
The pharmacokinetics of eribulin are characterized by a rapid distribution phase followed by a prolonged elimination phase, with a mean terminal half-life of approximately 40 h. It has a large volume of distribution (range of means 43 to 114 l/m2).
Dacarbazin HALAVEN Dacarbazin HALAVEN Dacarbazin (n=72) 
Dacarbazine HALAVEN Dacarbazine (n=152)
Hæmatologisk: 
Haematological:
I den opdaterede overlevelsesanalyse var HR for eribulin versus TPC 0,90 (95 % CI 0,71; 1,14) i eribulins favør for taxan-refraktære patienter og 0,73 (95 % CI 0,56; 0;96) for patienter, der ikke var taxan-refraktære. 
In the OS update, the HR for eribulin versus TPC was 0.90 (95% CI: 0.71, 1.14) in favour of eribulin for taxane-refractory patients and 0.73 (95% CI: 0.56, 0.96) for patients not taxane-refractory.
ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) 
METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Den anbefalede dosis af eribulin som færdig injektionsvæske er 1,23 mg/m2, som skal indgives intravenøst i løbet af 2 til 5 minutter på Dag 1 og 8 af hver 21 dages cyklus. 
The recommended dose of eribulin as the ready to use solution is 1.23 mg/m2 which should be administered intravenously over 2 to 5 minutes on Days 1 and 8 of every 21-day cycle.
magnesium eller calcium i blodet - Søvnløshed, depression, ændret smagssans - Udslæt, kløe, negleproblemer, tør eller rød hud - Overdreven svedtendens (herunder nattesved) - Ringen for ørerne - Blodpropper i lungerne - Helvedesild - Hævelse af hud og følelsesløshed i hænder og fødder 
magnesium or calcium in the blood - Inability to sleep, depression, changed sense of taste - Rash, itching, nail problems, dry or red skin - Excessive sweating (including night sweats) - Ringing in the ears - Blood clots in the lungs - Shingles - Swelling of the skin and numbness of the hands and feet
Dosis kan fortyndes i op til 100 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske. 
The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Studie 301 - Samlet overlevelse (ITT-population) 
Study 301 - Overall Survival (ITT Population)
Det skal du vide, før du begynder at bruge HALAVEN Brug ikke HALAVEN: 
What you need to know before you use HALAVEN
Eribulin hæmmede ikke den transportmedierende aktivitet af BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 og OATP1B3 ved klinisk relevante koncentrationer. 
At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
Øget tårestrøm (5,8 %) (G3/4: 0,1 %) 
Lacrimation increased (5.8%) (G3/4: 0.1%)
Den anbefalede dosis eribulin til patienter med moderat nedsat leverfunktion (Child-Pugh B) er 0,62 mg/m2 indgivet intravenøst i løbet af 2 til 5 minutter på Dag 1 og 8 i en 21 dages cyklus. 
The recommended dose of eribulin in patients with moderate hepatic impairment (Child-Pugh B) is 0.62 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
Neutropeni (53,6 %) (G3/4: 46,0 %) Leukopeni (27,9 %) (G3/4: 17,0 %) Anæmi (21,8 %) (G3/4: 3,0 %) 
Neutropenia (53.6%) (G3/4: 46.0%) Leukopenia (27.9%) (G3/4: 17.0%) Anaemia (21.8%) (G3/4: 3.0%)
Patienter med ALT eller AST > 3 x ULN (øvre normalgrænse) oplevede en højere forekomst af grad 4 neutropeni og febril neutropeni. 
Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Selvom data er begrænsede, har patienter med bilirubin > 1,5 x ULN også en højere forekomst af grad 4 neutropeni og febril neutropeni (se også pkt. 
Although data are limited, patients with bilirubin > 1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia (see also sections 4.2 and 5.2).
Lymfopeni (5,7 %) (G3/4: 2,1 %) Febril neutropeni (4,5 %) (G3/4: 4,4 %) 
Lymphopenia (5.7%) (G3/4: 2.1%) Febrile neutropenia (4.5%) (G3/4: 4.4%)
Abdominalsmerter Stomatitis (11,1 %) (G3/4: 1,0 %) 
Abdominal pain Stomatitis (11.1%) (G3/4: 1.0%)
Urinvejsinfektion (8,5 %) (G3/4: 0,7 %) Pneumoni (1,6 %) (G3/4: 1,0 %) Oral candidiasis Oral herpes 
Urinary tract infection (8.5%) (G3/4: 0.7%) Pneumonia (1.6%) (G3/4: 1.0%) Oral candidiasis Oral herpes Upper respiratory tract infection Nasopharyngitis Rhinitis
Studie 305 opdateret samlet overlevelse ITT-population 
Study 305 Updated Overall Survival ITT Population
- Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt. 
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Hyperhidrose Palmoplantar erytrodysæstesi (1,0 %) (G3/4: 0,1 %) 
Hyperhidrosis Palmar plantar erythrodysaesthesia (1.0%) (G3/4: 0.1%)d
HALAVEN kan fortyndes med aseptiske teknikker op til 100 ml med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning. 
Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
Interstitiel lungesygdom (0,2 %) (G3/4: 
Interstitial lung disease (0.2%) (G3/4:
6 hætteglas med 3 ml 
6 vials of 3 ml
- Blodpropper - Unormale prøver for leverfunktionen (leverskade) - Nyresvigt, blod eller protein i urinen - Udbredt betændelse i lungerne, hvilket kan medføre ardannelse - Betændelse i bugspytkirtlen - Mundsår 
- Blood clots - Abnormal liver function tests (hepatoxicity) Kidney failure, blood or protein in the urine Widespread inflammation of the lungs which may lead to scarring Inflammation of the pancreas
Neutropenisk sepsis (0,2 %) (G3/4: 0,2 %)a 
Neutropenic sepsis (0.2%) (G3/4: 0.2%)a
Artralgi og myalgi (20,4 %) (G3/4: 1,0 %) Rygsmerter (12,8 %) (G3/4:1,5 %) Smerter i ekstremiteter (10,0 %) (G3/4: 0,7 %) 
Arthralgia and myalgia (20.4%) (G3/4: 1.0%) Back pain (12.8%) (G3/4: 1.5%) Pain in extremity (10.0%) (G3/4: 0.7%)
Studie 309 - samlet overlevelse i liposarkom-undergruppen 
Study 309 - Overall Survival in the Liposarcoma Subgroup
Antal hændelser Median måneder Hazard ratio (95 % CI) p-værdi (log rank) 
Number of Events Median months Hazard Ratio (95% CI) p-value (log rank)
halsbrand, mavesmerter eller hævelse - Hævelse af bløddele, smerter (især i brystet, ryggen og knoglesmerter), muskelspasmer eller svaghed - Mund-, luftvejs- og urinvejsinfektioner, smertefuld vandladning - Ondt i halsen, øm eller løbende næse, influenzalignende symptomer, halssmerter - Unormale leverfunktionsundersøgelser, ændret niveau af sukker, bilirubin, fosfat, kalium, 
nosebleed - Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling - Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness - Mouth, respiratory and urinary tract infections, painful urination - Sore throat, sore or runny nose, flu-like symptoms, throat pain - Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium,
- Nedsat antal hvide blodlegemer eller røde blodlegemer - Træthed eller svaghed - Kvalme, opkastning, forstoppelse, diarré - Følelsesløshed, prikkende eller stikkende fornemmelse - Feber - Appetitløshed, vægttab - Vejrtrækningsbesvær, hoste - Smerter fra led, muskler og ryg - Hovedpine - Hårtab 
- Decrease in the number of white blood cells or red blood cells - Tiredness or weakness - Nausea, vomiting, constipation, diarrhoea - Numbness, tingling or prickling sensations - Fever - Loss of appetite, weight loss - Difficulty breathing, cough - Pain in the joints, muscles and back - Headache - Hair loss
En ml indeholder eribulinmesilat svarende til 0,44 mg eribulin. 
QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Studie 309 Leiomyosarkomundergruppe 
Study 309 Leiomyosarcoma Subgroup
Studie 309 Liposarkom-undergruppe 
Study 309 Liposarcoma Subgroup
Hypæstesi Letargi 
Hepatic impairment
Mundsår Pankreatitis 
Mouth ulceration Pancreatitis
6 hætteglas med 2 ml 
6 vials of 2 ml
Studie 305 -opdateret samlet overlevelse (ITT-population) 
Study 305 - Updated Overall Survival ( ITT Population)
- hvis du er allergisk over for eribulinmesilat eller et af de øvrige indholdsstoffer i HALAVAN 
Do not use HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
Suomi/Finland 
Suomi/Finland Eisai AB
Hyperbilirubinæmi (1,4 %) (G3/4: 0,4 %) 
Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)
Indlægsseddel: Information til brugeren HALAVEN 0,44 mg/ml injektionsvæske, opløsning eribulin 
Package leaflet: Information for the user HALAVEN 0.44 mg/ml solution for injection eribulin
Træthed/asteni (53,2 %) (G3/4: 7,7 %) Pyreksi (21,8 %) (G3/4: 0,7 %) 
Fatigue/Asthenia (53.2%) (G3/4 : 7.7%) Pyrexia (21.8%) (G3/4: 0.7%)
Trombocytopeni (4,2 %) (G3/4: 0,7 %) 
Thrombocytopenia (4.2%) (G3/4: 0.7%)
Studie 301 samlet overlevelse ITT-population 
Study 301 Overall Survival ITT Population
HALAVEN Capecitabin (n = 380) 
Capecitabine (n = 380)
Eribulins farmakokinetik blev evalueret i et fase I-studie hos patienter med normal nyrefunktion (kreatininclearance: ≥ 80 ml/min, n=6), moderat (30-50 ml/min; n=7) eller svært (15-< 30 ml/min; n=6) nedsat nyrefunktion. 
The pharmacokinetics of eribulin were evaluated in a Phase 1 study in patients with normal renal function (Creatinine clearance: ≥ 80 ml/min; n=6),
Orofaryngeal smerte Epistaxis 
Oropharyngeal pain Epistaxis