natgillin/translations-raw huggingface dataset:
For at forhindre lægemiddelfejl er det vigtigt at gennemgå produktresuméet og kontrollere den ydre karton og hætteglassets etiket for at sikre, at lægemidlet, som blandes og administreres, er Kadcyla (trastuzumabemtansin) og ikke Herceptin (trastuzumab).
In order to prevent medicinal product errors it is important to review the Summary of Product Characteristics and to check the outer carton and vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not trastuzumab.
Patienter, der oplever infusionsrelaterede reaktioner (rødme, rysteanfald, feber, dyspnø, hypotension, hvæsen, bronkospasme og takykardi), bør informeres om ikke at føre motorkøretøj og betjene maskiner, før symptomerne er aftaget.
(flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia) should be advised not to drive and use machines until symptoms abate.
(>5 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
(> 5 to ≤ 20´ ULN on day of scheduled treatment)
Der er indberettet aminotransferase-stigninger hos 24,2% af patienterne i kliniske studier med mBC-patienter.
Increased transaminases were reported in 24.2% of patients in MBC clinical studies.
· Opbevares i køleskab (2°C - 8°C).
· Store in a refrigerator at (2°C - 8°C).
Serumtransaminaser >3 ´ øvre normalgrænse og samtidigt total-bilirubin >2 ´ øvre normalgrænse
Serum transaminases > 3 x ULN and concomitant total bilirubin > 2´ ULN
Det relevante volumen koncentrat trækkes fra hætteglasset og tilsættes en infusionspose indeholdende 250 ml natriumchlorid 4,5 mg/ml (0,45%) infusionsvæske eller natriumchlorid 9 mg/ml (0,9%) infusionsvæske.
The appropriate amount of solution should be withdrawn from the vial and added to an infusion bag containing 250 mL of sodium chloride 4.5 mg/mL (0.45%) solution for infusion or sodium chloride 9 mg/mL (0.9%) solution for infusion.
Blandt patienter med eBC blev der indberettet blødningshændelser hos 29% af patienterne og forekomsten af svære blødningshændelser (grad ≥3) var 0,4%, inklusive én hændelse af grad 5.
Haemorrhagic events were reported in 29% of patients with EBC and the incidence of severe haemorrhagic events (Grade ≥3) was 0.4%, including one Grade 5 event.
Der er indberettet infusionsrelaterede reaktioner (på grund af cytokinfrigørelse), karakteriseret ved en eller flere af følgende symptomer: ansigtsrødme, kulderystelser, feber, dyspnø, hypotension, hvæsende vejrtrækning, bronkospasme samt takykardi.
Infusion-related reactions (due to cytokine release), characterized by one or more of the following symptoms have been reported: flushing, chills, pyrexia, dyspnoea, hypotension, wheezing, bronchospasm, and tachycardia.
Du må ikke amme, mens du er i behandling med Kadcyla eller i 7 måneder efter din sidste infusion.
Also you should not breast-feed for 7 months after your last infusion of Kadcyla.
Udseende og pakningsstørrelser · Kadcyla er et hvidt/hvidligt frysetørret pulver til koncentrat til infusionsvæske, opløsning, der leveres i hætteglas.
What Kadcyla looks like and contents of the pack · Kadcyla is a white to off-white lyophilised powder for concentrate for solution for infusion supplied in glass vials.
Dosisændringer
Dose modification
Der er observeret alvorlige, anafylaktiske reaktioner i kliniske studier med trastuzumabemtansin.
Serious, anaphylactic reactions have been observed in clinical studies with trastuzumab emtansine.
Startdosis er 3,6 mg/kg
Dose reduction schedule (Starting dose is 3.6 mg/kg)
Denne tilstand gør, at levercellerne ændres, og kan påvirke leverfunktionen.
This abnormality causes the structure of the liver to change and can change how the liver functions.
Rekonstitueret koncentrat skal inden administration inspiceres visuelt for udfældning og misfarvning.
Reconstituted solution should be inspected visually for particulate matter and discolouration prior to administration.
Trastuzumab blev givet intravenøst, 6 mg/kg på dag 1 i en 21-dages serie.
Trastuzumab was given intravenously at 6 mg/kg on Day 1 of a 21-day cycle.
Giv ikke trastuzumabemtansin før
Do not administer trastuzumab emtansine until
Grad 4 (>20 ´ øvre normalgrænse på hvilket som helst tidspunkt)
Grade 4 (> 20 ´ ULN at any time)
Både særnavnet Kadcyla og det generiske navn (trastuzumabemtansin) skal anvendes og bekræftes, når lægemidlet ordineres og fremstilles som infusionsvæske, og når Kadcyla (trastuzumabemtansin) administreres til patienter.
Both the invented name Kadcyla and its full non-proprietary name (trastuzumab emtansine) should be used and confirmed when prescribing, preparing the infusion solution and administering Kadcyla (trastuzumab emtansine) to patients.
Overfølsomhed var indberettet hos 2,7% af patienterne med eBC; 0,4% af patienterne havde hændelser svarende til grad 3 eller 4.
Hypersensitivity was reported in 2.7% of patients with EBC, with Grade 3 or 4 in 0.4% of patients.
(>3,0 til ≤5´ øvre normalgrænse på dag for planlagt behandling)
(> 3.0 to ≤ 5´ ULN on day of scheduled treatment)
LVEF 45% til <50% og fald er <10% point fra baseline*
LVEF 45% to < 50% and decrease is < 10% points from baseline*
I dette tilfælde fik patienten ved en fejl trastuzumabemtansin 6 mg/kg og døde ca. 3 uger efter overdoseringen.
In the fatal case, the patient incorrectly received trastuzumab emtansine 6 mg/kg and died approximately 3 weeks following the overdose; a causal relationship to trastuzumab emtansine was not established.
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Wyhlen Tyskland
Roche Pharma AG Emil-Barell-Strasse 1 D-79639 Grenzach-Whylen Germany
(>3,0 til ≤20 ´ øvre normalgrænse på dag for planlagt behandling)
(> 3.0 to ≤ 20´ ULN on day of scheduled treatment)
Metastatisk brystkræft (mBC) Kadcyla er, som enkeltstof, indiceret til behandling af voksne patienter med HER2-positiv, inoperabel, lokalt fremskreden eller metastatisk brystkræft, som tidligere har været behandlet med trastuzumab og et taxan, separat eller i kombination.
Kadcyla, as a single agent, is indicated for the treatment of adult patients with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
Tabel 7 Oversigt over virkningsresultater i Studie TDM4370g/BO21977 (EMILIA)
Table 7 Summary of efficacy from study TDM4370g/BO21977 (EMILIA)
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Sådan får du Kadcyla
How you are given Kadcyla
Der er indberettet perifer neuropati, primært i grad 1 og mest sensorisk, i kliniske studier med trastuzumabemtansin.
Peripheral neuropathy, mainly Grade 1 and predominantly sensory, has been reported in clinical studies with trastuzumab emtansine.
Beregn, hvor meget rekonstitueret koncentrat der er behov for, til en dosis på 3,6 mg trastuzumabemtansin/kg kropsvægt:
Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight:
Svimmelhed, smagsforstyrrelser, svækket hukommelse
Dizziness, Dysgeusia, Memory impairment
Tabel 4 Laboratorieafvigelser observeret hos patienter behandlet med trastuzumabemtansin i studie TDM4370g/BO21977/EMILIA
Table 4 Laboratory abnormalities observed in patients treated with trastuzumab emtansine in study TDM4370g/BO21977/EMILIA
Lægen vil kontrollere din leverfunktion med en blodprøve, inden du starter behandling og jævnligt under behandlingen.
Your doctor will check your blood to test your liver function before and regularly during treatment.
Populationsfarmakokinetiske analyser tyder på, at alder ikke har klinisk relevant effekt på trastuzumabemtansins farmakokinetik (se pkt.
Population pharmacokinetic analysis indicates that age does not have a clinically meaningful effect on the pharmacokinetics of trastuzumab emtansine (see sections 5.1 and 5.2).
Der sås gavn af behandling i subgruppen af patienter, der havde haft recidiv inden for 6 måneder efter afsluttet adjuverende behandling, og som ikke tidligere havde fået systemisk kræftbehandling efter udvikling af metastaser (n=118); hazard ratio for progressionfri overlevelse og samlet overlevelse var henholdsvis 0,51 (95% konfidensinterval 0,30; 0,85) og 0,61 (95% konfidensinterval 0,32; 1,16).
A treatment benefit was seen in the subgroup of patients who had relapsed within 6 months of completing adjuvant treatment and had not received any prior systemic anti-cancer therapy in the metastatic setting (n=118); hazard ratios for PFS and OS were 0.51 (95% CI: 0.30, 0.85) and 0.61 (95% CI: 0.32, 1.16), respectively.
Der er indberettet overfølsomhed hos 2,6% af patienterne i kliniske mBC-studier med trastuzumabemtansin; der er indberettet en grad 3 og en grad 4-reaktion.
Hypersensitivity was reported in 2.6% of patients in MBC clinical studies with trastuzumab emtansine, with one Grade 3 and one Grade 4 events reported.
Du kan opleve smerter, følelsesløshed, kløe og en snurrende, kriblende eller prikkende og stikkende fornemmelse i hænder og fødder.
You may experience tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Grad 2 (>2,5 til ≤5 ´ øvre normalgrænse)
Grade 2 (> 2.5 to ≤ 5´ the ULN)
For at undgå lægemiddelfejl er det vigtigt at kontrollere hætteglasetiketten for at sikre, at det lægemiddel, der tilberedes og administreres, er Kadcyla (trastuzumabemtansin) og ikke Herceptin (trastuzumab).
In order to prevent medicinal product errors it is important to check the vial labels to ensure that the medicinal product being prepared and administered is Kadcyla (trastuzumab emtansine) and not Herceptin (trastuzumab).
Der er ikke gennemført formelle farmakokinetiske studier med patienter med nedsat nyrefunktion.
No formal PK study has been conducted in patients with renal impairment.
Seponér trastuzumabemtansin permanent
Permanently discontinue trastuzumab emtansine
Hvis der er symptomer, opleves de som hoste/åndenød ved hvile eller ved søvn i liggende position, brystsmerter og hævede ankler og arme, følelse af hurtige eller uregelmæssige hjerteslag.
If symptoms do occur, cough shortness of breath at rest or when sleeping flat, chest pain and swollen ankles or arms, a sensation of rapid or irregular heartbeats may be observed.
Symptomatisk hjertesvigt Seponér trastuzumabemtansin LVEF <40%
Symptomatic CHF Discontinue trastuzumab emtansine LVEF <40%
Hos patienter ≥65 år (n=138 for begge behandlingsgrupper) var hazard ratio for progressionsfri overlevelse og samlet overlevelse henholdsvis 1,06 (95% konfidensinterval 0,68; 1,66) og 1,05 (95% konfidensinterval 0,58; 1,91).
In patients ≥ 65 years old (n=138 across both treatment arms) the hazard ratios for progression-free survival (PFS) and Overall Survival (OS) were 1.06 (95% CI: 0.68, 1.66) and 1.05 (95% CI: 0.58, 1.91), respectively.
Grad 3 (25.000 til <50.000/mm3)
Thrombocytopenia Grade 3 (25,000 to < 50,000/mm3)
I tilfælde af dysfunktion af venstre ventrikel bør dosering udsættes eller behandlingen seponeres, hvis nødvendigt (se pkt.
The dosing should be delayed, or treatment discontinued as necessary in cases of left ventricular dysfunction (see section 4.2).
Trastuzumabemtansin er et antistof-lægemiddel-konjugat, der indeholder trastuzumab, et humaniseret IgG1-monoklonalt antistof fremstillet ud fra en cellekultursuspension fra pattedyr (ovarier fra kinesiske hamstre), der via den stabile thioether-linker MCC (4-[N-maleimidomethyl] cyclohexan-1-carboxylat) er kovalent bundet til DM1, en mikrotubulær hæmmer.
Trastuzumab emtansine is an antibody-drug conjugate that contains trastuzumab, a humanised IgG1 monoclonal antibody produced by mammalian (Chinese hamster ovary) cell suspension culture, covalently linked to DM1, a microtubule inhibitor, via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Kadcyla, trastuzumabemtansin, er et HER-2-antistof-lægemiddel-konjugat, der indeholder det humaniserede anti-HER2-IgG1, trastuzumab, der via den stabile thioether-linker MCC (4-[N-maleimidomethyl]-cyclohexan-1-carboxylat) er kovalent bundet til den mikrotubulære hæmmer DM1 (et maytansinderivat).
Kadcyla, trastuzumab emtansine, is a HER2-targeted antibody-drug conjugate which contains the humanised anti-HER2 IgG1, trastuzumab, covalently linked to the microtubule inhibitor DM1 (a maytansine derivative) via the stable thioether linker MCC (4-[N-maleimidomethyl] cyclohexane-1-carboxylate).
Rekonstitutionsvejledning
DATE OF REVISION OF THE TEXT
Hvis infusionsvæsken fremstilles med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, skal der anvendes et 0,20 eller 0,22 mikron integrereret polyethersulfonfilter.
If sodium chloride 9 mg/mL (0.9%) solution for infusion is used for infusion, a 0.20 or 0.22 micron in-line polyethersulfone (PES) filter is required.
Den farmakokinetiske populationsanalyse har vist, at kreatinin-clearance ikke påvirker trastuzumabemtansins farmakokinetik.
The population PK analysis showed that creatinine clearance does not affect the PK of trastuzumab emtansine.
Patienterne skal observeres for feber, kulderystelser eller andre infusionsrelaterede reaktioner under infusionen og i mindst 90 minutter efter.
Patients should be observed during the infusion and for at least 90 minutes following the initial infusion for fever, chills, or other infusion-related reactions.
Hvis det rekonstituerede koncentrat indeholder synlige partikler eller er uklart eller misfarvet, må det ikke anvendes.
Do not use if the reconstituted solution contains visible particulates, or is cloudy or discoloured.
● Trastuzumabemtansin bindes ligesom trastuzumab til domæne IV i det HER2-ekstracellulære domæne (ECD) såvel som til Fcγ-receptorer og komplement-C1q.
(ECD), as well as to Fcγ receptors and complement C1q.
· Smerter, følelsesløshed, kløe og en snurrende, kriblende eller prikkende og stikkende fornemmelse i hænder og fødder.
· Tingling, pain, numbness, itching, crawling sensation, pins and needles in your hands and feet.
Natriumchlorid 4,5 mg/ml (0,45%) infusionsvæske kan anvendes uden 0,20 eller 0,22 mikron integrereret polyethersulfonfilter.
Sodium chloride 4.5 mg/mL (0.45%) solution for infusion may be used without a polyethersulfone (PES) 0.20 or 0.22-μm in-line filter.
Efter gentagen dosering var trastuzumabemtansin-eksponeringen (AUC) ved tredje behandlingscyklus inden for det samme interval hos patienter med let og moderat nedsat leverfunktion som hos patienter med normal leverfunktion.
Trastuzumab emtansine exposure (AUC) at Cycle 3 after repeated dosing in patients with mild or moderate hepatic dysfunction was within the range observed in patients with normal hepatic function.
Trastuzumabemtansin er et antistof-lægemiddel-konjugat, som indeholder humaniseret antiHER2-IgG1-antistof trastuzumab og DM1, et mikrotubulærhæmmende maytansinoid.
Trastuzumab emtansine is an antibody-drug conjugate containing humanized anti-HER2 IgG1 antibody trastuzumab and DM1, a microtubule-inhibitory maytansinoid.
Median varigheden for samlet overlevelse var 29,9 måneder i trastuzumabemtansin-armen sammenlignet med 25,9 måneder for lapatinib plus capecitabin-armen.
The median duration of overall survival was 29.9 months in the trastuzumab emtansine arm compared with 25.9 months in the lapatinib plus capecitabine arm. At the time of the descriptive follow-up overall survival analysis, a total of 27.4% of the patients had crossed over from the lapatinib plus capecitabine arm to the trastuzumab emtansine arm.
Vedrørende dosisændring i tilfælde af infusionsrelaterede reaktioner, se pkt.
For dose modifications in the event of infusion-related reactions, see sections 4.2 and 4.4.
Der er i kliniske studier med mBC-patienter indberettet blødningshændelser hos 34,8% af patienterne behandlet med trastuzumabemtansin, og forekomsten af svære blødningshændelser (grad ≥3) var 2,2%.
Haemorrhage Haemorrhagic events were reported in 34.8% of patients in MBC clinical trials with trastuzumab emtansine and the incidence of severe haemorrhagic events (Grade ≥3) occurred in 2.2%.
Hvis nodulær regenerativ hyperplasi diagnosticeres, skal trastuzumabemtansin seponeres permanent.
Upon diagnosis of NRH, trastuzumab emtansine treatment must be permanently discontinued.
Trastuzumabemtansin blev givet intravenøst, 3,6 mg/kg på dag 1 i en 21-dages serie.
Trastuzumab emtansine was given intravenously at 3.6 mg/kg on Day 1 of a 21-day cycle.
Grad 3 (>3 til ≤10 ´ øvre normalgrænse)
Grade 3 (> 3 to ≤ 10´ the ULN)
LVEF 40% til ≤45% og fald er <10% point fra baseline
LVEF 40% to ≤ 45% and decrease is < 10% points from baseline
Der er i kliniske studier observeret stigning i serum-aminotransferase (grad 1-4) under behandling med trastuzumabemtansin (se pkt.
Increase in serum transaminases (Grade 1-4) has been observed during treatment with trastuzumab emtansine in clinical studies (see section 4.4).
Behandling af patienter med nedsat leverfunktion skal ske med forsigtighed (se pkt.
Treatment of patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 5.2).
Trastuzumabemtansin er ikke undersøgt hos patienter med svær nedsat leverfunktion.
Trastuzumab emtansine has not been studied in patients with severe hepatic impairment.
Trastuzumabemtansin-metabolitterne MCC-DM1, Lys-MCC-DM1 og DM1 kunne spores i små mængder i humant plasma.
In human plasma, trastuzumab emtansine catabolites MCC-DM1, Lys-MCC-DM1, and DM1 were detected at low levels.
Glucoseinfusionsvæske (5%) må ikke anvendes.
Glucose (5%) solution should not be used (see section 6.2).
● de hyppigste bivirkninger (≥25%) var kvalme, træthed, muskuloskeletale smerter, blødning, hovedpine, transaminaseforhøjelser, trombocytopeni og perifer neuropati.
· the most common adverse drug reactions (ADRs) (≥25%) with trastuzumab emtansine were nausea, fatigue, musculoskeletal pain, haemorrhage, headache, transaminases increased, thrombocytopenia, and peripheral neuropathy.
Hos patienter med svære infusionsrelaterede reaktioner bør behandlingen afbrydes, indtil symptomerne er forsvundet.
Treatment should be interrupted in patients with a severe IRR until signs and symptoms resolve.
ASAT/ALAT forbedres til Grad ≤2; herefter nedsættes dosis med 1 dosisniveau
AST/ALT recovers to Grade ≤ 2, and then reduce one dose level
Baseret på farmakokinetiske populationsanalyser er clearance af trastuzumabemtansin 0,68 l/dag og halveringstiden (t1/2) ca. 4 dage efter intravenøs administration af trastuzumabemtansin til patienter med HER2-positiv metastatisk brystkræft.
Based on population pharmacokinetic (PK) analysis, following intravenous administration of trastuzumab emtansine in patients with HER2-positive metastatic breast cancer, the clearance of trastuzumab emtansine was 0.68 L/day and the elimination half-life (t1/2) was approximately 4 days.
Størstedelen af patienterne havde grad 1 eller 2 bivirkninger (≥50.000/mm3) med laveste værdi omkring dag 8.
The majority of the patients had Grade 1 or 2 events (≥ 50,000/mm3), with the nadir occurring by day 8 and generally improving to Grade 0 or 1 (≥ 75,000/mm3) by the next scheduled dose.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 160 mg
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 160 mg
Denne tilstand gør, at levercellerne ændres, og der dannes mange små knuder i leveren, som kan ændre leverfunktionen.
Patients develop multiple nodules in the liver that can change how the liver functions.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Pulver til koncentrat til infusionsvæske, opløsning 1 hætteglas med 100 mg
PHARMACEUTICAL FORM AND CONTENTS Powder for concentrate for solution for infusion 1 vial of 100 mg
Nodulær regenerativ hyperplasi er en sjælden leversygdom karakteriseret ved udbredt benign omdannelse af leverparenkym til små regenerative noduli.
NRH is a rare liver condition characterised by widespread benign transformation of hepatic parenchyma into small regenerative nodules; NRH may lead to non-cirrhotic portal hypertension.
Kadcyla leveres i type I-hætteglas, indeholdende 15 ml (100 mg), med fluororesinbelagt grå butylgummi-prop og forseglet med aluminium med hvidt flip-off-låg.
Kadcyla 100 mg powder for concentrate for solution for infusion Kadcyla is provided in 15 mL (100 mg) Type 1 glass vial closed with a grey-butyl rubber stopper coated with fluoro-resin laminate, and sealed with an aluminium seal with a white plastic flip-off cap.
Absorption Trastuzumabemtansin administreres intravenøst.
Trastuzumab emtansine is administered intravenously.
● Kadcyla (trastuzumabemtansin) produktresumé ● Information til sundhedspersonale
· Kadcyla (trastuzumab emtansine) SPC · Health care professional information The HCP information shall contain the following key messages:
Fortsæt behandling med trastuzumabemtansin
Continue treatment with trastuzumab emtansine
Trastuzumabemtansin må ikke administreres i kombination med kemoterapi.
Do not administer trastuzumab emtansine in combination with chemotherapy 5.
Grad 2-3 på dag for planlagt behandling (25.000 til <75.000/mm3)
Thrombocytopenia Grade 2-3 on day of scheduled treatment (25,000 to <
Beregn, hvor meget rekonstitueret koncentrat der er behov for, til en dosis på 3,6 mg trastuzumabemtansin/kg kropsvægt (se pkt.
Determine the volume of the reconstituted solution required based on a dose of 3.6 mg trastuzumab emtansine/kg body weight (see section 4.2):
Grad 3 (>5 til ≤20 ´ øvre normalgrænse)
Grade 3 (> 5 to ≤ 20´ the ULN)
Trombocytopeni eller lave trombocytværdier var en hyppigt indberettet bivirkning ved behandling med trastuzumabemtansin og var i kliniske studier den bivirkning, der hyppigst medførte seponering, dosisreduktion og afbrydelse af dosis (se pkt.
Thrombocytopenia, or decreased platelet counts, was commonly reported with trastuzumab emtansine and was the most common adverse reaction leading to treatment discontinuation, dose reduction, and dose interruption (see section 4.8).
Ved en livstruende infusionsrelateret reaktion skal behandlingen seponeres permanent (se pkt.
Treatment must be permanently discontinued in the event of a life threatening infusionrelated reaction (see section 4.2).
Hvis der anvendes 0,9% natriumchlorid til fortynding, kan der ved opbevaring fremkomme udfældning (se pkt.
Particulates may be observed on storage if diluted in 0.9% sodium chloride (see section 6.6).
Total bilirubin >2 ´ øvre normalgrænse på hvilket som helst tidspunkt
TBILI > 2´ ULN at any time
Metastatisk brystkræft (mBC) Patienterne skal behandles indtil der er sygdomsrecidiv eller toksicitet, der ikke kan behandles.
Patients should receive treatment until disease progression or unmanageable toxicity.
Blod og lymfesystem Trombocytopeni, anæmi
Thrombocytopenia, Anaemia
Forhøjet alanintransaminase (ALAT)
Increased Alanine Transaminase (ALT)
Ved første infusion vil lægen eller sundhedspersonalet overvåge dig for eventuelle bivirkninger, mens du får infusionen og i mindst 90 minutter efter.
You will be observed by a doctor or nurse while it is being given and for at least 90 minutes following the initial dose, in case you have any side effects.
Giv ikke trastuzumabemtansin før totalbilirubin forbedres til Grad ≤1; herefter behandles ved samme dosisniveau
Do not administer trastuzumab emtansine until total bilirubin recovers to Grade ≤ 1, and then treat at the same dose level.
Hos patienter i alderen 65-74 år (n=113) var hazard ratio for progressionsfri overlevelse og samlet overlevelse, baseret på vurderinger fra en uafhængig komité, henholdsvis 0,88 (95% konfidensinterval 0,53; 1,45) og 0,74 (95% konfidensinterval 0,37; 1,47).
In patients 65 to 74 years old (n=113), based on IRC assessments, the hazard ratios for PFS and OS were 0.88 (95% CI: 0.53, 1.45) and 0.74 (95% CI: 0.37, 1.47), respectively.
● Hætteglas med 160 mg trastuzumabemtansin: Brug en steril sprøjte og injicér langsomt 8 ml sterilt vand til injektionsvæsker i hætteglasset.
· 160 mg trastuzumab emtansine vial: Using a sterile syringe, slowly inject 8 mL of sterile water for injection into the vial.