natgillin/translations-raw huggingface dataset:
De mest almindelige bivirkninger ved Tyverb i kombination med capecitabin (som optræder hos flere end 1 ud af 10 patienter) er diarré (som kan føre til dehydrering), kvalme, opkastning, udslæt, spiseforstyrrelse med appetitløshed, træthed, fordøjelsesbesvær, tør hud, betændelse i mundslimhinden, forstoppelse, mavesmerter, smertefuld rødme på hænder og fødder, smerter i arme og ben, rygsmerter, betændelse i slimhinderne og søvnbesvær.
The most common side effects with Tyverb in combination with capecitabine (seen in more than 1 patient in 10) are diarrhoea (which may lead to dehydration), nausea (feeling sick), vomiting, rash, anorexia (loss of appetite), fatigue (tiredness), dyspepsia (indigestion), dry skin, stomatitis (inflammation of the lining of the mouth), constipation, abdominal (tummy) pain, palmar-plantar erythrodysaesthesia (redness and pain on the hands and feet), pain in the extremities (hands and feet), back pain, inflammation of the mucous membranes (moist body surfaces) and insomnia (difficulty sleeping).
Den fuldstændige liste over de indberettede bivirkninger ved Tyverb fremgår af indlægssedlen.
For the full list of all side effects reported with Tyverb, see the Package Leaflet.
Tyverb bør ikke anvendes til patienter, der kan være overfølsomme (allergiske) over for lapatinib eller andre af indholdsstofferne.
Tyverb should not be used in people who may be hypersensitive (allergic) to lapatinib or any of the other ingredients.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Tyverb opvejer risiciene i kombination med capecitabin til behandling af patienter med fremskreden eller metastatisk brystkræft, hvis tumorer har en overproduktion af ErbB2 (HER2).
The Committee for Medicinal Products for Human Use (CHMP) decided that Tyverb’ s benefits are greater than its risks, in combination with capecitabine, for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Tyverb.
The Committee recommended that Tyverb be given marketing authorisation.
Der er udstedt ” betinget godkendelse ” for Tyverb.
Tyverb has been given ‘ Conditional Approval’.
Det betyder, at der vil blive tilvejebragt yderligere oplysninger om lægemidlet, især om dets virkning på overlevelsen og spredningen af brystkræft.
This means that there is more evidence to come about the medicine, in particular its effects on survival and on the spread of breast cancer.
Hvert år gennemgår Det Europæiske Lægemiddelagentur (EMEA) alle nye oplysninger, der måtte foreligge, og ajourfører om nødvendigt dette sammendrag.
Every year, the European Medicines Agency (EMEA) will review any new information that may have become available and this summary will be updated as necessary.
Hvilke oplysninger afventes der stadig for Tyverb?
What information is still awaited for Tyverb?
Den virksomhed, der fremstiller Tyverb, skal fremlægge en opdateret analyse af Tyverbs virkning på overlevelsestiden for patienter i hovedundersøgelsen.
The company that makes Tyverb will provide an updated analysis of the effects of Tyverb on survival times of patients in the main study.
Den skal også gennemføre en undersøgelse, hvor virkningen af en behandling, der indeholder Tyverb, og en behandling, der indeholder trastuzumab, sammenlignes med hensyn til kræftens spredning til hjernen.
It will also perform a study comparing the effects of treatment containing Tyverb and a treatment containing trastuzumab on the spread of cancer to the brain.
Andre oplysninger om Tyverb:
Other information about Tyverb:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Tyverb til Glaxo Group Limited den 10. juni 2008.
The European Commission granted a marketing authorisation valid throughout the European Union for Tyverb to Glaxo Group Limited on 10 June 2008.
Den fuldstændige EPAR for Tyverb findes her.
The full EPAR for Tyverb can be found here.
EU- nummer EU/ 1/ 07/ 440/ 001 EU/ 1/ 07/ 440/ 002
EU Number EU/ 1/ 07/ 440/ 001 EU/ 1/ 07/ 440/ 002
Særnavn Tyverb Tyverb
Invented name Tyverb Tyverb
Styrke 250 mg 250 mg
Strength 250 mg 250 mg
Lægemiddelform Filmovertrukne tabletter Filmovertrukne tabletter
Pharmaceutical Form Film-coated tablet Film-coated tablet
Emballage Blister (PA/ Alu/ PVC/ Alu) Blister (PA/ Alu/ PVC/ Alu)
Packaging Blister (PA/ Alu/ PVC/ Alu) Blister (PA/ Alu/ PVC/ Alu)
Paknings- størrelse 70 tabletter 2x70 tabletter
Package size 70 tablets 2x70 tablets
Hver filmovertrukket tablet indeholder lapatinibditosylatmonohydrat svarende til 250 mg lapatinib.
Each film-coated tablet contains lapatinib ditosylate monohydrate, equivalent to 250 mg lapatinib.
Ovale, bikonvekse, gule, filmovertrukne tabletter, der er præget "GS XJG" på den ene side.
Oval, biconvex, yellow film-coated tablets, with “ GS XJG ” debossed on one side.
Tyverb, i kombination med capecitabine, er indiceret til behandling af patienter med avanceret eller metastatisk brystkræft, hvis tumorer har overekspression af ErbB2 (HER2).
Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2).
5. 1).
Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting (see section 5.1).
Behandling med lapatinib bør kun igangsættes af en læge, der har erfaring i brugen af kræftlægemidler.
Lapatinib treatment should only be initiated by a physician experienced in the administration of anti- cancer agents.
Tumorer med overekspression af ErbB2 er karakteriseret ved IHC3+, eller IHC2+ og gen - amplifikation eller gen- amplifikation alene.
ErbB2 overexpressing tumours are defined by IHC3+, or IHC2+ and gene amplification or gene amplification alone.
Gen- amplifikation skal udføres med en nøjagtig og valideret analyse.
Gene amplification should be performed using an accurate and validated assay.
Lapatinib tages i kombination med capecitabine.
Lapatinib is taken in combination with capecitabine.
Den anbefalede dosis af lapatinib er 1250 mg (fem tabletter) en gang daglig.
The recommended dose of lapatinib is 1250 mg (i. e. five tablets) once daily continuously.
Den daglige dosis bør ikke opdeles.
The daily dose should not be divided.
Lapatinib bør tages enten mindst en time før eller en time efter et måltid.
Lapatinib should be taken either at least one hour before, or at least one hour after food.
4. 5 og 5. 2 for information om absorption).
To minimise variability in the individual patient, administration of lapatinib should be standardised in relation to food intake, for example always be taken before a meal (see sections 4.5 and 5.2 for information on absorption).
4. 9).
Missed doses should not be replaced and the dosing should resume with the next scheduled daily dose (see section 4.9).
5. 1).
The recommended dose of capecitabine is 2000 mg/ m2/ day taken in 2 doses 12 hours apart on days 1- 14 in a 21 day cycle (see section 5.1).
Capecitabine bør tages sammen med mad eller inden for 30 minutter efter et måltid.
Capecitabine should be taken with food or within 30 minutes after food.
Behandlingen med lapatinib skal afbrydes hos patienter, der får symptomer associeret med nedsat uddrivningsfraktion fra venstre ventrikel (Left ventricular ejection fraction (LVEF)), der ifølge ” National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) ” svarer
2 Lapatinib should be discontinued in patients with symptoms associated with decreased left ventricular ejection fraction (LVEF) that are National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grade 3 or greater or if their LVEF drops below the institutions lower limit of normal (see section 4.4).
Behandlingen med lapatinib kan genoptages ved reduceret dosis (1000 mg/ dag) efter minimum to uger, hvis LVEF igen er normal og patienten er symptomfri.
Lapatinib may be restarted at a reduced dose (1000 mg/ day) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Interstitiel lungesygdom/ pneumonitis
Interstitial lung disease / pneumonitis
4. 4).
Lapatinib should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Det bør overvejes at ophøre eller midlertidigt afbryde behandlingen med lapatinib, hvis en patient udvikler toksicitet, der ifølge NCI CTCAE svarer til eller er større end grad 2.
Discontinuation or interruption of dosing with lapatinib may be considered when a patient develops toxicity greater than or equal to grade 2 on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE).
Når toksiciteten bedres til grad 1 eller mindre, kan behandlingen med lapatinib genoptages med 1250 mg/ dag.
Dosing can be restarted at 1250 mg/ day when the toxicity improves to grade 1 or less.
Hvis toksiciteten kommer igen, bør behandlingen med lapatinib genoptages med en lavere dosis (1000 mg/ dag).
If the toxicity recurs, then lapatinib should be restarted at a lower dose (1000 mg/ day).
Læs produktinformationen for capecitabine for vejledning i midlertidig afbrydelse og om nedsat dosis af capecitabine.
The prescribing information for capecitabine must be consulted for guidance on dose delay and dose reduction recommendations for capecitabine.
Det er ikke nødvendigt med dosisændringer til patienter med mildt til moderat nedsat nyrefunktion.
No dose adjustment is necessary in patients with mild to moderate renal impairment.
5. 2).
Caution is advised in patients with severe renal impairment as there is no experience of lapatinib in this population (see section 5.2),
4. 4).
Lapatinib should be discontinued if changes in liver function are severe and patients should not be retreated (see section 4.4).
Indgift af lapatinib til patienter med moderat til svært nedsat leverfunktion bør ske med forsigtighed pga. øget optagelse af lægemidlet.
Administration of lapatinib to patients with moderate to severe hepatic impairment should be undertaken with caution due to increased exposure to the medicinal product.
5. 2).
Insufficient data are available in patients with hepatic impairment to provide a dose adjustment recommendation (see section 5.2).
Tyverb bør ikke anvendes til børn pga. utilstrækkelig dokumentation for sikkerhed og virkning.
Tyverb is not recommended for use in paediatrics due to insufficient data on safety and efficacy.
Der er begrænset information om brugen af lapatinib hos patienter på 65 år og ældre.
There are limited data of the use of lapatinib in patients aged 65 years and older.
Der henvises til produktinformationen for capecitabine for relevante kontraindikationer og sikkerheds - informationer, når lapatinib administreres i kombination med capecitabine.
Please refer to the capecitabine prescribing information for relevant contraindications and safety information when administering lapatinib in combination with capecitabine.
Lapatinib har været associeret med rapporter om fald i venstre ventrikels uddrivningsfraktion (LVEF) (se pkt.
3 Lapatinib has been associated with reports of decreases in left ventricular ejection fraction (LVEF) (see section 4.8).
Der skal udvises forsigtighed, hvis lapatinib gives til patienter med tilstande, der kan hæmme venstre ventrikels funktion.
Caution should be taken if lapatinib is to be administered to patients with conditions that could impair left ventricular function.
LVEF skal evalueres hos alle patienter før initiering af behandling med lapatinib for at sikre, at patienten har en baseline- LVEF, der ligger inden for institutionens
LVEF should be evaluated in all patients prior to initiation of treatment with lapatinib to ensure that the patient has a baseline LVEF that is within the institutions normal limits.
4. 2).
LVEF should continue to be evaluated during treatment with lapatinib to ensure that LVEF does not decline to an unacceptable level (see section 4.2).
4. 8).
Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8).
4. 2).
Patients should be monitored for symptoms of pulmonary toxicity (see section 4.2).
Levertoksicitet er forekommet ved brug af lapatinib og kan i sjældne tilfælde være fatalt.
Hepatotoxicity has occurred with lapatinib use and may in rare cases be fatal.
Leverfunktionen (transaminaser, bilirubin og alkalin fosfatase) bør monitoreres før behandlingen påbegyndes og månedligt derefter, eller som klinisk indiceret.
Liver function (transaminases, bilirubin and alkaline phosphatase) should be monitored before initiation of treatment and monthly thereafter, or as clinically indicated.
Behandlingen med lapatinib bør afbrydes ved alvorlige ændringer i leverfunktionen, og behandlingen bør ikke genoptages hos disse patienter.
Lapatinib dosing should be discontinued if changes in liver function are severe and patients should not be retreated.
4. 2 og 5. 2).
Caution is warranted if lapatinib is prescribed to patients with moderate or severe hepatic impairment (see sections 4.2 and 5.2).
4. 2 og 5. 2).
Caution is advised if lapatinib is prescribed to patients with severe renal impairment (see sections 4.2 and 5.2).
Der er rapporteret om diarre inkl. svær diarre ved behandling med lapatinib (se pkt.
Diarrhoea, including severe diarrhoea, has been reported with lapatinib treatment (see section 4.8).
Pro- aktiv behandling af diarre med obstipantia er vigtigt.
Proactive management of diarrhoea with anti-diarrhoeal agents is important.
4. 2 – midlertidig afbrydelse af behandling og nedsættelse af dosis – anden toksicitet).
Severe cases of diarrhoea may require administration of oral or intravenous electrolytes and fluids, and interruption or discontinuation of lapatinib therapy (see section 4.2 – dose delay and dose reduction – other toxicities).
4. 5).
Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
4. 5).
Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to lapatinib (see section 4.5).
4. 5).
Grapefruit juice should be avoided during treatment with lapatinib (see section 4.5).
4. 5).
Coadministration of lapatinib with medicinal product with narrow therapeutic windows that are substrates of CYP3A4 or CYP2C8 should be avoided (see section 4.5).
4. 5).
Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease (see section 4.5).
5. 2).
Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
3, 6 gange og halveringstiden øgedes 1, 7 gange.
In healthy volunteers receiving ketoconazole, a strong CYP3A4 inhibitor, at 200 mg twice daily for 7 days, systemic exposure to lapatinib (100 mg daily) was increased approximately 3.6– fold, and half- life increased 1.7 – fold.
Indgift af lapatinib samtidig med stærke inhibitorer af CYP3A4 (fx ritonavir, saquinavir, telithromycin, ketoconazol, itraconazol, voriconazol, posaconazol, nefazodin) bør undgås.
Coadministration of lapatinib with strong inhibitors of CYP3A4 (e. g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) should be avoided.
Indgift af lapatinib samtidig med moderate inhibitorer af CYP3A4 bør ske med forsigtighed, og kliniske bivirkninger bør monitoreres omhyggeligt.
Coadministration of lapatinib with moderate inhibitors of CYP3A4 should proceed with caution and clinical adverse reactions should be carefully monitored.
72%.
4 In healthy volunteers receiving carbamazepine, a CYP3A4 inducer, at 100 mg twice daily for 3 days and 200 mg twice daily for 17 days, systemic exposure to lapatinib was decreased approximately 72%.
Indgift af lapatinib samtidig med kendte induktorer af CYP3A4 (fx rifampicin, rifabutin, carbamazepin, phenytoin eller perikum (hypericum perforatum)) bør undgås.
Coadministration of lapatinib with known inducers of CYP3A4 (e. g. rifampicin, rifabutin, carbamazepine, phenytoin or Hypericum perforatum [St John’ s wort]) should be avoided.
4 Lapatinib er et substrat for transportproteinerne Pgp og BCRP.
Lapatinib is a substrate for the transport proteins Pgp and BCRP.
5. 2).
Inhibitors (ketoconazole, itraconazole, quinidine, verapamil, cyclosporine, erythromycin) and inducers (rifampin, St John’ s Wort) of these proteins may alter the exposure and/ or distribution of lapatinib (see section 5.2).
Opløseligheden af lapatinib er pH- afhængig.
The solubility of lapatinib is pH-dependent.
Lapatinib hæmmer CYP3A4 og CYP2C8 in vitro ved klinisk relevante koncentrationer.
Lapatinib inhibits CYP3A4 and CYP2C8 in vitro at clinically relevant concentrations.
4. 4 og 5. 2).
Coadministration of lapatinib with medicines with narrow therapeutic windows that are substrates of CYP3A4 (e. g. cisapride, pimozide and quinidine) or CYP2C8 (e. g. repaglinide) should be avoided (see sections 4.4 and 5.2).
Hvis lapatinib gives i kombination med paclitaxel (175 mg/ m2 hver 3. uge), kan svær neutropeni indtræffe sammen med diarre.
If lapatinib is administered in combination with paclitaxel (175 mg/ m2 every three weeks), severe neutropenia may coincide with diarrhoea.
Dette kræver monitorering og tidlig behandling af diarre.
This warrants monitoring and early treatment of diarrhoea.
Lapatinib hæmmer transportproteinerne Pgp, BCRP og OATP1B1 in vitro.
Lapatinib inhibits the transport proteins Pgp, BCRP and OATP1B1 in vitro.
5. 2).
It cannot be excluded that lapatinib will affect the pharmacokinetics of substrates of Pgp (e. g. digoxin), BCRP (e. g. topotecan) and OATP1B1 (e. g. rosuvastatin) (see section 5.2).
Samtidig administration af lapatinib og capecitabine eller trastuzumab ændrede ikke farmakokinetikken for disse midler (eller metabolitterne af capecitabine) eller lapatinib i betydelig grad.
Concomitant administration of lapatinib with capecitabine or trastuzumab did not meaningfully alter the pharmacokinetics of these agents (or the metabolites of capecitabine) or lapatinib.
4. 2 og 5. 2).
The bioavailability of lapatinib is increased up to about 4 times by food, depending on e. g. the fat content in the meal (see sections 4.2 and 5.2).
Grapefrugtjuice bør derfor ikke indtages under behandling med lapatinib.
Grapefruit juice may inhibit CYP3A4 in the gut wall and increase the bioavailability of lapatinib and should therefore be avoided during treatment with lapatinib.
Der foreligger ikke tilstrækkelige data om brugen af lapatinib hos gravide kvinder.
There are no adequate data from the use of lapatinib in pregnant women.
Lapatinib bør ikke anvendes under graviditet, medmindre det er absolut nødvendigt.
Lapatinib should not be used during pregnancy unless clearly necessary.
Kvinder i den fødedygtige alder skal anvende effektiv antikonception og undgå at blive gravide under behandlingen med lapatinib.
Women of childbearing potential should be advised to use adequate contraception and avoid becoming pregnant while receiving treatment with lapatinib.
Sikker anvendelse af lapatinib under amning er ikke etableret.
The safe use of lapatinib during lactation has not been established.
Det vides ikke, om lapatinib udskilles i modermælken.
It is not known whether lapatinib is excreted in human milk.
Kvinder, der behandles med lapatinib, skal ophøre med amning.
Breast feeding must be discontinued in women who are receiving therapy with lapatinib.
Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene ma - skiner.
No studies on the effects on the ability to drive and use machines have been performed.
En negativ påvirkning af sådanne aktiviteter kan ikke forudsiges ud fra lapatinibs farmakologi.
The clinical status of
Patientens kliniske tilstand og lapatinibs bivirkningsprofil skal tages i betragtning, når patientens evne til at udføre opgaver, der kræver dømmekraft, motoriske eller kognitive færdigheder, skal vurderes.
5 the patient and the adverse event profile of lapatinib should be borne in mind when considering the patient's ability to perform tasks that require judgement, motor or cognitive skills.
5. 1).
Safety of lapatinib has been evaluated as monotherapy or in combination with other chemotherapies for various cancers including patients who received lapatinib in combination with capecitabine (see section 5.1).
De mest almindelige bivirkninger (> 25%) undervejs i behandlingen med lapatinib plus capecitabine var gastro- intestinale (diarre, kvalme og opkastning) eller dermatologiske (palmo- plantar erytrodysæstesi (PPE) samt udslæt).
The most common adverse reactions (> 25%) during therapy with lapatinib plus capecitabine were gastrointestinal (diarrhoea, nausea, and vomiting) or dermatologic (palmar-plantar erythrodysesthesia [PPE] and rash).
Forekomsten af PPE var den samme i grupperne med både lapatinib plus capecitabine og capecitabine alene.
The incidence of PPE was similar in both lapatinib plus capecitabine and capecitabine alone treatment arms.
Diarre var den mest almindelige bivirkning, der gav anledning til ophør med behandlingen, og denne havde den samme forekomst i begge grupper (lapatinib plus capecitabine:
Diarrhoea was the most common adverse reaction resulting in discontinuation of treatment and this had a similar incidence in both treatment groups (lapatinib plus capecitabine:
5%, capecitabine:
5%, capecitabine:
Følgende konvention er anvendt til klassifikation af frekvenserne:
The following convention has been utilised for the classification of frequency:
Meget almindelig (≥ 1/ 10), Almin - delig (≥ 1/ 100, < 1/ 10), Ikke almindelig (≥ 1/ 1. 000, < 1/ 100), Sjælden (≥ 1/ 10. 000, < 1/ 1. 000) og Meget sjælden (< 1/ 10. 000), Ikke kendt (kan ikke estimeres ud fra de tilgængelige data).
Very common ((≥ 1/ 10), Common (≥ 1/ 100 to < 1/ 10), Uncommon (≥ 1/ 1,000 to < 1/ 100), Rare (≥ 1/ 10,000 to < 1/ 1,000) and Very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
De alvor - ligste bivirkninger er anført først.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Følgende bivirkninger er rapporteret i forbindelse med lapatinib:
The following adverse reactions have been reported to be associated with lapatinib:
4. 2 – nedsættelse af dosis – kardielle hændelser og 4. 4)
Decreased left ventricular ejection fraction (see section 4.2 - dose reduction – cardiac events and section 4.4)
Luftveje, thorax og mediastinum Ikke almindelig Mave- tarmkanalen
Respiratory, thoracic and mediastinal disorders Uncommon
Interstitiel lungesygdom/ pneumonitis
Interstitial lung disease/ pneumonitis
Meget almindelig Hud og subkutane væv
Gastrointestinal disorders Very common
4. 2 - midlertidig afbrydelse af behandling og nedsættelse af dosis – anden toksicitet og 4. 4).
Diarrhoea, which may lead to dehydration (see section 4.2 - dose delay and dose reduction – other toxicities and section 4.4).
Meget almindelig
Skin and subcutaneous tissue disorders Very common
4. 2 - midlertidig afbrydelse af behandling og nedsættelse af dosis – anden toksicitet)
Rash (including dermatitis acneiform) (see section 4.2 - dose delay and dose reduction – other toxicities)
Almene symptomer og reaktioner på administrationsstedet Meget almindelig Lever og galdeveje
General disorders and administration site conditions Very common
Hyperbilirubinæmi, levertotoksicitet
Hepatobiliary disorders Common
Følgende bivirkninger
Hyperbilirubinaemia, hepatotoxicity
en forskel i frekvensen på mere end 5% sammenlignet med capecitabine alene.
The following additional adverse reactions have been reported to be associated with lapatinib in combination with capecitabine with a frequency difference of greater than 5% compared to capecitabine alone.
Mave- tarmkanalen Meget almindelig
Gastrointestinal disorders Very common Skin and subcutaneous Very common
Hud og subkutane væv Meget almindelig
Dyspepsia tissue disorders Dry skin