FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Uncommon (Frequency %)
Danish: Ikke almindelig (Hyppighed %)
English: 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).
Danish: 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.
English: Despite reduction to 0.97 mg/m2
Danish: Trods reduktion til 0,97 mg/m2
English: Ethanol anhydrous,Water for injections, Hydrochloric acid, Sodium hydroxide See leaflet for further information
Danish: Ethanol, vandfrit, vand til injektionsvæsker, saltsyre, natriumhydroxid Se indlægssedlen for yderligere oplysninger
English: What HALAVEN contains
Danish: HALAVEN indeholder alkohol
English: Dose reduction recommendations Adverse reaction after previous HALAVEN administration Recommended dose of eribulin
Danish: Anbefalinger for dosisreduktion Bivirkning efter tidligere HALAVEN-indgivelse
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Dose reduction during therapy
Danish: Dosisreduktioner under behandling
English: Chest pain Influenza like illness
Danish: Kulderystelser Brystsmerter Influenza-lignende sygdom
English: However it has been shown that at clinically relevant concentrations eribulin is not a Pgp inhibitor in vitro.
Danish: Det er imidlertid blevet vist, at eribulin ikke er en Pgp-hæmmer in vitro ved klinisk relevante koncentrationer.
English: 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.
Danish: 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
English: HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml or 3ml of solution.
Danish: HALAVEN er en klar, farveløs, vandig injektionsvæske, opløsning, i hætteglas indeholdende 2 ml eller 3 ml injektionsvæske.
English: Other medicines and HALAVEN Tell your doctor if you are using, have recently used or might use any other medicines.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: 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.
Danish: 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.
English: 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).
Danish: 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).
English: Hazard Ratio (95% CI) p-value (log rank)
Danish: Hazard ratio (95 % CI) p-værdi (log rank)
English: Impaired liver function due to cirrhosis
Danish: Nedsat leverfunktion på grund af cirrose
English: 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.
Danish: Gennemsnitstiden til nadir var 13 dage, og gennemsnitstiden til bedring fra svær neutropeni (< 0,5 x 109/l) var 8 dage.
English: For storage conditions after first opening or dilution of the medicinal product, see section 6.3.
Danish: Opbevaringsforhold efter anbrud og fortynding af lægemidlet, se pkt.
English: 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).
Danish: 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).
English: Capecitabine (n=548)
Danish: Capecitabin (n=548)
English: Gastrooesophageal reflux disease Abdominal distension
Danish: Gastroøsofageal reflukssygdom Udspilet abdomen
English: Dyspnoea (15.2%)a (G3/4: 3.5%)a Cough (15.0%) (G3/4: 0.5%)
Danish: Dyspnø (15,2 %)a (G3/4: 3,5 %)a Hoste (15,0 %) (G3/4: 0,5 %)
English: Sodium hydroxide (for pH-adjustment)
Danish: Vand til injektionsvæsker Saltsyre (til pH-justering) Natriumhydroxid (til pH-justering)
English: Although data are limited, patients with bilirubin >1.5 x ULN also have a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Danish: Selvom data er begrænsede, har patienter med bilirubin > 1,5 x ULN også en højere forekomst af grad 4 neutropeni og febril neutropeni.
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 3 ml of solution.
Danish: 5 ml type I hætteglas med teflonbelagt butylgummiprop og flip-off aluminium forsegling, indeholdende 3 ml opløsning.
English: See section 4.2 for treatment recommendations.
Danish: 4.2 for behandlingsvejledning.
English: 5 ml type I glass vial, with teflon-coated, butyl rubber stopper and flip-off aluminium over seal, containing 2 ml of solution.
Danish: 5 ml type I hætteglas med teflonbelagt butylgummiprop og flip-off aluminium forsegling, indeholdende 2 ml opløsning.
English: Study 309 - Progression Free Survival in the Liposarcoma Subgroup
Danish: Studie 309 - progressionsfri overlevelse i liposarkom-undergruppen
English: Tel.: + 420 242 485 839 Danmark
Danish: Tel.: + 420 242 485 839
English: Study 309 ITT Population
Danish: Studie 309 ITT-population
English: Haematuria Proteinuria Renal failure
Danish: Hæmaturi Proteinuri Nyresvigt
English: 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.
Danish: 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]).
English: 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).
Danish: Eribulins farmakokinetik er karakteriseret ved en hurtig fordelingsfase, efterfulgt af en langvarig elimineringsfase, men med gennemsnitlig terminal halveringstid på ca. 40 timer.
English: Dacarbazine HALAVEN Dacarbazine (n=152)
Danish: Dacarbazin HALAVEN Dacarbazin HALAVEN Dacarbazin (n=72)
English: Haematological:
Danish: Hæmatologisk:
English: 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.
Danish: 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.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: 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.
Danish: 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.
English: 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
Danish: 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
English: The dose may be diluted in up to 100 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: Dosis kan fortyndes i op til 100 ml natriumchlorid 9 mg/ml (0,9 %) injektionsvæske.
English: Study 301 - Overall Survival (ITT Population)
Danish: Studie 301 - Samlet overlevelse (ITT-population)
English: What you need to know before you use HALAVEN
Danish: Det skal du vide, før du begynder at bruge HALAVEN Brug ikke HALAVEN:
English: At relevant clinical concentrations, eribulin did not inhibit BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 and OATP1B3 transporter-mediated activity.
Danish: Eribulin hæmmede ikke den transportmedierende aktivitet af BCRP, OCT1, OCT2, OAT1, OAT3, OATP1B1 og OATP1B3 ved klinisk relevante koncentrationer.
English: Lacrimation increased (5.8%) (G3/4: 0.1%)
Danish: Øget tårestrøm (5,8 %) (G3/4: 0,1 %)
English: 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.
Danish: 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.
English: Neutropenia (53.6%) (G3/4: 46.0%) Leukopenia (27.9%) (G3/4: 17.0%) Anaemia (21.8%) (G3/4: 3.0%)
Danish: Neutropeni (53,6 %) (G3/4: 46,0 %) Leukopeni (27,9 %) (G3/4: 17,0 %) Anæmi (21,8 %) (G3/4: 3,0 %)
English: Patients with ALT or AST > 3 x ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia.
Danish: Patienter med ALT eller AST > 3 x ULN (øvre normalgrænse) oplevede en højere forekomst af grad 4 neutropeni og febril neutropeni.
English: 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).
Danish: 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.
English: Lymphopenia (5.7%) (G3/4: 2.1%) Febrile neutropenia (4.5%) (G3/4: 4.4%)
Danish: Lymfopeni (5,7 %) (G3/4: 2,1 %) Febril neutropeni (4,5 %) (G3/4: 4,4 %)
English: Abdominal pain Stomatitis (11.1%) (G3/4: 1.0%)
Danish: Abdominalsmerter Stomatitis (11,1 %) (G3/4: 1,0 %)
English: 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
Danish: Urinvejsinfektion (8,5 %) (G3/4: 0,7 %) Pneumoni (1,6 %) (G3/4: 1,0 %) Oral candidiasis Oral herpes
English: Study 305 Updated Overall Survival ITT Population
Danish: Studie 305 opdateret samlet overlevelse ITT-population
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - Breast-feeding
Danish: - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Hyperhidrosis Palmar plantar erythrodysaesthesia (1.0%) (G3/4: 0.1%)d
Danish: Hyperhidrose Palmoplantar erytrodysæstesi (1,0 %) (G3/4: 0,1 %)
English: Using aseptic technique HALAVEN can be diluted up to 100 ml with sodium chloride 9 mg/ml (0.9%) solution for injection.
Danish: HALAVEN kan fortyndes med aseptiske teknikker op til 100 ml med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning.
English: Interstitial lung disease (0.2%) (G3/4:
Danish: Interstitiel lungesygdom (0,2 %) (G3/4:
English: 6 vials of 3 ml
Danish: 6 hætteglas med 3 ml
English: - 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
Danish: - Blodpropper - Unormale prøver for leverfunktionen (leverskade) - Nyresvigt, blod eller protein i urinen - Udbredt betændelse i lungerne, hvilket kan medføre ardannelse - Betændelse i bugspytkirtlen - Mundsår
English: Neutropenic sepsis (0.2%) (G3/4: 0.2%)a
Danish: Neutropenisk sepsis (0,2 %) (G3/4: 0,2 %)a
English: 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%)
Danish: 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 %)
English: Study 309 - Overall Survival in the Liposarcoma Subgroup
Danish: Studie 309 - samlet overlevelse i liposarkom-undergruppen
English: Number of Events Median months Hazard Ratio (95% CI) p-value (log rank)
Danish: Antal hændelser Median måneder Hazard ratio (95 % CI) p-værdi (log rank)
English: 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,
Danish: 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,
English: - 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
Danish: - 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
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Danish: En ml indeholder eribulinmesilat svarende til 0,44 mg eribulin.
English: Study 309 Leiomyosarcoma Subgroup
Danish: Studie 309 Leiomyosarkomundergruppe
English: Study 309 Liposarcoma Subgroup
Danish: Studie 309 Liposarkom-undergruppe
English: Hepatic impairment
Danish: Hypæstesi Letargi
English: Mouth ulceration Pancreatitis
Danish: Mundsår Pankreatitis
English: 6 vials of 2 ml
Danish: 6 hætteglas med 2 ml
English: Study 305 - Updated Overall Survival ( ITT Population)
Danish: Studie 305 -opdateret samlet overlevelse (ITT-population)
English: Do not use HALAVEN: - if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for eribulinmesilat eller et af de øvrige indholdsstoffer i HALAVAN
English: Suomi/Finland Eisai AB
Danish: Suomi/Finland
English: Hyperbilirubinaemia (1.4%) (G3/4: 0.4%)
Danish: Hyperbilirubinæmi (1,4 %) (G3/4: 0,4 %)
English: Package leaflet: Information for the user HALAVEN 0.44 mg/ml solution for injection eribulin
Danish: Indlægsseddel: Information til brugeren HALAVEN 0,44 mg/ml injektionsvæske, opløsning eribulin
English: Fatigue/Asthenia (53.2%) (G3/4 : 7.7%) Pyrexia (21.8%) (G3/4: 0.7%)
Danish: Træthed/asteni (53,2 %) (G3/4: 7,7 %) Pyreksi (21,8 %) (G3/4: 0,7 %)
English: Thrombocytopenia (4.2%) (G3/4: 0.7%)
Danish: Trombocytopeni (4,2 %) (G3/4: 0,7 %)
English: Study 301 Overall Survival ITT Population
Danish: Studie 301 samlet overlevelse ITT-population
English: Capecitabine (n = 380)
Danish: HALAVEN Capecitabin (n = 380)
English: The pharmacokinetics of eribulin were evaluated in a Phase 1 study in patients with normal renal function (Creatinine clearance: ≥ 80 ml/min; n=6),
Danish: 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.
English: Oropharyngeal pain Epistaxis
Danish: Orofaryngeal smerte Epistaxis
English: Very common side effects (may affect more than 1 in 10 people) are:
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 personer) er:
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 3 ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton 3 ml hætteglas
English: Ethanol anhydrous
Danish: Ethanol, vandfrit
English: Median (months) Hazard Ratio (95% CI)
Danish: Median (måneder) Hazard ratio (95 % CI)a b
English: Consider discontinuation
Danish: Overvej seponering
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton 2ml vial
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton 2 ml hætteglas
English: HALAVEN contains ethanol (alcohol) This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.
Danish: Denne medicin indeholder en mindre mængde alkohol, mindre end 100 mg i et hætteglas.
English: - Decrease in the number of platelets (which may result in bruising or taking longer to stop bleeding) - Infection with fever, pneumonia, chills - Fast heart rate, flushing - Vertigo, dizziness - Increased production of tears, conjunctivitis (redness and soreness of the surface of the eye),
Danish: - Nedsat antal blodplader (hvilket kan føre til blå mærker eller det kan tage længere at stoppe en blødning) - Infektion med feber, lungebetændelse kulderystelser - Hurtig puls, rødmen - Svimmelhed - Forøget tåreproduktion, konjunktivitis (rødmen og ømhed på øjets overflade), næseblod - Dehydrering, mundtørhed, forkølelsessår, svampeinfektion i munden, fordøjelsesbesvær,
English: ANC < 0.5 x 109/l lasting more than 7 days ANC < 1 x 109/l neutropenia complicated by fever or infection
Danish: Absolut neutrofiltal < 1 x 109/l neutropeni kompliceret af feber eller infektion
English: Dry mouth Dyspepsia (6.5%) (G3/4: 0.3%)d
Danish: Mundtørhed Dyspepsi (6,5 %) (G3/4: 0,3 %)d
English: Development of Grade 3 or 4 peripheral neuropathy occurred in 7.4% of breast cancer patients and 3.5% of sarcoma patients.
Danish: 7,4 % af brystcancerpatienterne og 3,5 % af sarkompatienterne udviklede grad 3 eller 4 perifer neuropati.
English: Rare side effects (may affect up to 1 in 1000 people) are:
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 personer) er:
English: Treatment of Physician's Choice
Danish: Behandling efter lægens skøn (TPC)
English: Patients had previously received up to three prior chemotherapy regimens, including both an anthracycline and a taxane and a maximum of two for advanced disease, with the percentage who had received 0, 1 or 2 prior chemotherapy treatments for metastatic breast cancer being 20.0%, 52.0% or 27.2% respectively.
Danish: Henholdsvis 20,0 %, 52,0 % og 27,2 % havde fået 0, 1 eller 2 tidligere kemoterapi-kure for metastatisk brystcancer.
English: Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg eribulin.
Danish: Hvert 3 ml hætteglas indeholder eribulinmesilat svarende til 1,32 mg eribulin.
English: Peripheral neuropathyc (35.9%) (G3/4: 7.3%) Headache (17.5%) (G3/4: 0.7%)
Danish: (35,9 %) (G3/4: 7,3 %) Hovedpine (17,5 %) (G3/4: 0,7 %)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 2 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas 2 ml hætteglas
English: See section 4.2 for dosage recommendation.
Danish: 4.2 for doseringsvejledning.
English: Tel: + 49 (0) 69 66 58 50
Danish: Eisai GmbH Tel: + 49 (0) 69 66 58 50
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 1.32 mg eribulin in 3 ml
Danish: Indeholder 1,32 mg eribulin i 3 ml
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 3 ml vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas 3 ml hætteglas
English: Pulmonary embolism (1.3%) (G3/4: 1.1%)a
Danish: Lungeemboli (1,3 %) (G3/4: 1,1 %)
English: Bone pain (6.7%) (G3/4: 1.2%) Muscle spasms (5.3%) (G3/4: 0.1%)
Danish: Knoglesmerter ( 6,7 %) (G3/4: 1,2 %) Muskelspasmer (5,3 %) (G3/4: 0,1 %)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Contains 0.88 mg eribulin in 2 ml
Danish: Indeholder 0,88 mg eribulin i 2 ml
English: Hepatotoxicity (0.8%) (G3/4: 0.6%)
Danish: Hepatotoksicitet (0,8 %) (G3/4:
English: Gamma glutamyl transferase increased (1.7%) (G3/4: 0.9%)d
Danish: Forhøjet gammaglutamyltransferase (1,7 %) (G3/4: 0,9 %)d
English: Eribulin mesilate is a microtubule dynamics inhibitor belonging to the halichondrin class of antineoplastic agents.
Danish: Det tilhører halichondrinklassen af antineoplastiske stoffer.
English: Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
Danish: Hvert 2 ml hætteglas indeholder eribulinmesilat svarende til 0,88 mg eribulin.
English: Constipation (22.3%) (G3/4: 0.7%)d
Danish: Nedsat appetit (22,5 %) (G3/4: 0,7 %)d
English: Alanine aminotransferase increased (7.6%) (G3/4: 1.9%)d
Danish: Forhøjet ALAT (7,6 %) (G3/4: 1,9 %)d
English: Inflammation (6.4%) (G3/4: 0.9%)d
Danish: Slimhindeinflammation (6,4 %) (G3/4: 0,9 %)
English: Time (months) NUMBER OF PATIENTS AT RISK: HALAVEN 71 63 51 43 39 34 30 20 15 12 Dacarbazine 72 59 42 33 22 17 12 11 6
Danish: Dacarbazin 72 59 42 33 22 17 12 11 6
English: NAME OF THE MEDICINAL PRODUCT HALAVEN 0.44 mg/ml solution for injection Eribulin
Danish: HALAVEN 0,44 mg/ml injektionsvæske eribulin i.v.
English: EU/1/11/678/002 6 vials
Danish: EU/1/11/678/001 1 hætteglas EU/1/11/678/002 6 hætteglas
English: Tel: + 46 (0) 8 501 01 600
Danish: Eisai AB Tel: + 46 (0) 8 501 01 600
English: What HALAVEN is and what it is used for What you need to know before you use HALAVEN How to use HALAVEN
Danish: Det skal du vide, før du begynder at bruge HALAVEN Sådan skal du bruge HALAVEN Bivirkninger
English: EU/1/11/678/004 6 vials
Danish: EU/1/11/678/003 1 hætteglas EU/1/11/678/004 6 hætteglas
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 personer) er: