FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor if any of these side effects get severe or troublesome.
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver alvorlig eller generende.
English: Letrozole 2.5 mg /day + placebo
Danish: 2,5 mg letrozol/dag + placebo
English: • medicines that decrease stomach acidity - used to treat stomach ulcers or indigestion
Danish: • medicin mod mavesyre - bruges til at behandle mavesår eller fordøjelsesbesvær.
English: Rash occurred in approximately 28 % of patients who received lapatinib in combination with capecitabine, in 45 % of patients who received lapatinib in combination with letrozole and in 23 % of patients who received lapatinib in combination with trastuzumab.
Danish: Udslæt opstod hos ca. 28 % af de patienter, der blev behandlet med lapatinib i kombination med capecitabin, hos 45 % af de patienter, som fik lapatinib i kombination med letrozol, og hos 23 % af de patienter, som fik lapatinib i kombination med trastuzumab.
English: Caution should be exercised when dosing lapatinib concurrently with medicinal products with narrow therapeutic windows that are substrates of Pgp, and a reduction in the dose of the Pgp substrate should be considered.
Danish: Der bør udvises forsigtighed ved administration af lapatinib samtidig med lægemidler, der er substrater for Pgp, og som har et smalt terapeutisk vindue.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se. bilag I: Produktresumé, pkt.
English: Lapatinib is predominantly metabolised by CYP3A (see section 5.2).
Danish: Lapatinib metaboliseres hovedsageligt af CYP3A (se pkt.
English: In the prevention of CNS metastases in the metastatic and early breast cancer settings the observed activity was limited.
Danish: I et metastatisk og i et tidligt stadie af brystcancer var effekten til forebyggelse af CNSmetastaser begrænset.
English: Concomitant treatment with strong inhibitors of CYP3A4 should be avoided due to risk of increased exposure to lapatinib (see section 4.5).
Danish: Samtidig behandling med stærke inhibitorer af CYP3A4 bør undgås pga. risiko for øget optagelse af lapatinib (se pkt.
English: Caution is warranted if Tyverb is prescribed to patients with moderate or severe hepatic impairment and to patients with severe renal impairment (see sections 4.2 and 5.2).
Danish: Der skal udvises forsigtighed, hvis Tyverb gives til patienter med moderat eller svært nedsat leverfunktion og til patienter med svært nedsat nyrefunktion (se pkt.
English: • cisapride - a medicine used to treat certain digestive system problems
Danish: • cisaprid - medicin, der bruges til at behandle visse lidelser i fordøjelsessystemet
English: Diarrhoea responds well to proactive management (see section 4.4).
Danish: Diarréen kan afhjælpes med pro-aktiv behandling (se pkt.
English: Lapatinib inhibits the transport proteins BCRP and OATP1B1 in vitro.
Danish: Lapatinib hæmmer transportproteinerne BCRP og OATP1B1 (organisk anion-tranporter) in vitro.
English: Your doctor will review the medicines you are currently taking to make sure you are not taking something that can't be taken with the Tyverb.
Danish: Dette gøres for at sikre, at du ikke tager noget, som ikke må tages samtidig med Tyverb.
English: • repaglinide - a medicine used to treat diabetes
Danish: • repaglinid - medicin, der bruges til at behandle sukkersyge
English: Serious cutaneous reactions, including Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)** Musculoskeletal and connective tissue disorders Very common Pain in extremity*
Danish: Stevens-Johnson syndrom (SJS) og toksisk epidermal nekrolyse (TEN) Knogler, led, muskler og bindevæv Meget almindelig Smerter i ekstremiteter* †, rygsmerter*
English: LVEF decreases were reported in 6.7 % of patients who received lapatinib in combination with trastuzumab, as compared to 2.1 % of patients who received lapatinib alone.
Danish: Fald i LVEF blev rapporteret hos 6,7 % af de patienter, der fik lapatinib i kombination med trastuzumab, sammenlignet med hos 2,1 % af de patienter, der fik lapatinib alene.
English: Tyverb should be discontinued if changes in liver function are severe and patients should not be retreated (see section 4.4).
Danish: Behandlingen med Tyverb bør afbrydes ved alvorlige ændringer i leverfunktionen, og behandlingen bør ikke genoptages hos disse patienter (se pkt.
English: The recommended dose of Tyverb is 1000 mg (i.e. four tablets) once daily continuously.
Danish: Den anbefalede dosis af Tyverb er 1000 mg (dvs. fire tabletter) en gang daglig kontinuerligt.
English: Interstitial lung disease / pneumonitis
Danish: Interstitiel lungesygdom/pneumonitis
English: • If you are breast-feeding or planning to breast-feed, tell your doctor.
Danish: • Hvis du ammer eller planlægger at amme, skal du fortælle det til lægen.
English: Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to lapatinib (see section 4.5).
Danish: Samtidig behandling med induktorer af CYP3A4 bør undgås pga. risiko for nedsat optagelse af lapatinib (se pkt.
English: Dosing of lapatinib one hour after a meal results in approximately 2-3 times higher systemic exposure, compared to dosing one hour before a meal (see sections 4.5 and 5.2).
Danish: Ved dosering af lapatinib én time efter et måltid øges den systemiske eksponering ca. 2-3 gange sammenlignet med dosering af lapatinib én time før et måltid (se pkt.
English: Biliary excretion may also contribute to the elimination.
Danish: Der kan også ske udskillelse med galden.
English: • an effect on how your heart works
Danish: • påvirkning af hjertefunktionen.
English: †, cough
Danish: †, hoste
English: Lapatinib inhibits CYP3A4 in vitro at clinically relevant concentrations.
Danish: Lapatinib hæmmer CYP3A4 in vitro ved klinisk relevante koncentrationer.
English: In patients who took up to 5000 mg of lapatinib, symptoms observed include known lapatinib associated events (see section 4.8) and in some cases sore scalp and/or mucosal inflammation.
Danish: Hos patienter, der tog op til 5000 mg lapatinib, sås allerede kendte symptomer relateret til lapatinib (se pkt.
English: Lapatinib, a 4-anilinoquinazoline, is an inhibitor of the intracellular tyrosine kinase domains of both EGFR (ErbB1) and of HER2 (ErbB2) receptors (estimated Ki app values of 3nM and 13nM, respectively) with a slow off-rate from these receptors (half-life greater than or equal to 300 minutes).
Danish: Lapatinib er en 4-anilinoquinazolin-kinase-hæmmer af intracellulær tyrosin-kinase-domæner af både EGFR (ErbB1)- og HER2 (ErbB2)-receptorer (anslåede Ki app
English: Subjects who had not received prior trastuzumab* N
Danish: Forsøgspersoner, der ikke tidligere havde fået trastuzumab* n
English: Lapatinib inhibits the transport protein Pgp in vitro at clinically relevant concentrations.
Danish: Lapatinib hæmmer transportproteinet Pgp in vitro ved klinisk relevante koncentrationer.
English: capecitabine (2500 mg/m2/day, days 1-14 q21 days)
Danish: Capecitabin (2500 mg/m2/dag, dag 1-14 hver 21. dag)
English: Each pack of Tyverb contains 70 film-coated tablets in foil blisters (polyamide / aluminium / polyvinyl chloride / aluminium) of 10 tablets each.
Danish: Tabletterne er pakket i blisterpakninger (polyamid/aluminium/polyvinylchorid/aluminium) med 10 stk.
English: Patients were randomised to either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or trastuzumab (loading dose of 8mg/kg followed by 6mg/kg q3 weekly infusions) plus capecitabine (2500mg/m2/day, days 1-14, every 21 days).
Danish: Patienterne blev enten randomiseret til 1250 mg Tyverb én gang dagligt (kontinuerligt) plus capecitabin (2000 mg/m2/dag på dag 1-14 hver 21. dag) eller trastuzumab (infusion med startdosis på 8 mg/kg efterfulgt af infusion af 6 mg/kg hver 3. uge) plus capecitabin (2500 mg/m2/dag på dag 1-14 hver 21. dag).
English: Diarrhoea, including severe diarrhoea, has been reported with Tyverb treatment (see section 4.8).
Danish: svær diarré ved behandling med Tyverb (se pkt.
English: Lapatinib is a substrate for the transport proteins Pgp and BCRP.
Danish: Lapatinib er et substrat for transportproteinerne p-glykoprotein (Pgp) og brystcancer-resistent protein (BCRP).
English: even if their signs of illness seem the same as yours.
Danish: Det kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
English: LVEF decreases were reported in 2.5 % of patients who received lapatinib in combination with capecitabine, as compared to 1.0 % with capecitabine alone.
Danish: LVEF-fald blev rapporteret hos 2,5 % af de patienter, der fik lapatinib i kombination med capecitabin sammenlignet med 1,0 % ved capecitabin alene.
English: • if you have inflammation of the lung
Danish: • hvis du har betændelse/irritation i lungerne
English: In the HER2-overexpressing population, only 2 patients were enrolled who had received prior trastuzumab, 2 patients had received prior aromatase inhibitor therapy, and approximately half had received tamoxifen.
Danish: To af patienterne havde tidligere fået behandling med en aromatasehæmmer, og ca. halvdelen havde fået tamoxifen.
English: Interstitial lung disease and pneumonitis
Danish: Interstitiel lungesygdom og pneumonitis
English: • if you have any kidney problems
Danish: • hvis du har nyreproblemer
English: Tell your doctor if you have any heart problems before you take Tyverb.
Danish: Hvis du har problemer med hjertet, skal du fortælle det til lægen, inden du begynder behandling med Tyverb.
English: Do not breast-feed while taking Tyverb and for at least 5 days after the last dose.
Danish: Du må ikke amme, mens du er i behandling med Tyverb og i mindst 5 dage efter den sidste dosis.
English: Combination treatment with Tyverb and capecitabine
Danish: Kombinationsbehandling med Tyverb og capecitabin
English: Please refer to the full prescribing information of capecitabine.
Danish: Se endvidere capecitabins produktinformation.
English: Deaths (%)
Danish: Median follow-up (år) Døde (%)
English: LVEF decreases were reported in 3.1 % of patients who received lapatinib in combination with letrozole as compared to 1.3 % of patients receiving letrozole plus placebo.
Danish: Der blev rapporteret om fald i LVEF hos 3,1 % af de patienter, som fik lapatinib i kombination med letrozol, sammenlignet med 1,3 % af de patienter, som fik letrozol og placebo.
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 and /or CYP2C8 should be avoided (see section 4.5).
Danish: Samtidig indgift af Tyverb med oralt administrerede lægemidler med et smalt terapeutisk vindue, som er substrater for CYP3A4 og/eller CYP2C8, bør undgås (se pkt.
English: Concomitant treatment with substances that increase gastric pH should be avoided, as lapatinib solubility and absorption may decrease (see section 4.5).
Danish: Samtidig behandling med stoffer, der øger gastrisk pH, bør undgås, idet opløseligheden og absorptionen af lapatinib kan reduceres (se pkt.
English: Each pack of Tyverb contains 70 or 84 tablets in aluminium foil blisters of 10 or 12 tablets each.
Danish: Hver pakning med Tyverb indeholder 70 eller 84 tabletter.
English: • diarrhoea (which may make you dehydrated and lead to more severe complications) Tell your doctor immediately at the first sign of diarrhoea (loose stool), as it is important that this is treated right away.
Danish: Tal straks med lægen ved de første tegn på diarré (tynd mave), da det er vigtigt, at dette bliver behandlet rigtigt.
English: Tyverb should be discontinued in patients who experience pulmonary symptoms which are NCI CTCAE grade 3 or greater (see section 4.4).
Danish: Behandlingen med Tyverb skal afbrydes hos patienter, der får pulmonale symptomer, der ifølge NCI CTCAE svarer til eller er større end grad 3 (se pkt.
English: In the evaluable population (n=37), the maximum mean ΔΔQTcF (90% CI) of 8.75 ms (4.08, 13.42) was observed 10 hours after ingestion of the third dose of lapatinib 2000 mg.
Danish: I den evaluérbare population (n=37) blev det maksimale gennemsnit ΔΔQTcF (90 % CI) på 8,75 ms (4,08; 13,42) observeret 10 timer efter indtagelse af den tredje dosis lapatinib på 2000 mg. ΔΔQTcF oversteg tærsklen på 5 ms og de øvre 90 % CI-grænser oversteg tærsklen på 10 ms på adskillige tidspunkter.
English: The recommended dose of Tyverb is 1250 mg (i.e. five tablets) once daily continuously.
Danish: Den anbefalede dosis af Tyverb er 1250 mg (fem tabletter) en gang daglig kontinuerligt.
English: Tyverb is also supplied in high density polyethylene bottles (HDPE) with a child resistant polypropylene closure containing 70, 84, 105 or 140 film-coated tablets.
Danish: Beholderen har en børnesikret lukke af polypropylen og indeholder enten 70, 84, 105 eller 140 filmovertrukne tabletter.
English: Lapatinib inhibits CYP2C8 in vitro at clinically relevant concentrations.
Danish: Lapatinib hæmmer CYP2C8 in vitro ved klinisk relevante koncentrationer.
English: Tyverb 1500 mg / day + Letrozole 2.5 mg /day
Danish: 1500 mg Tyverb/dag + 2,5 mg letrozol/dag
English: • unusual hair loss or thinning
Danish: • usædvanligt hårtab eller tyndere hår.
English: tyverb 250 mg [folding box only]
Danish: tyverb 250 mg [kun på ydre karton]
English: Combination treatment with Tyverb and letrozole
Danish: Kombinationsbehandling med Tyverb og letrozol
English: Co-administration of Tyverb with orally administered medicinal products with narrow therapeutic windows that are substrates of CYP3A4 (e.g. cisapride, pimozide and quinidine) should be avoided (see sections 4.4 and 5.2).
Danish: Samtidig administration af Tyverb med oralt administrerede lægemidler, der har et smalt terapeutisk vindue, og som er substrater for CYP3A4 (f.eks. cisaprid, pimozid og kinidin), bør undgås (se pkt.
English: • sore mouth/mouth ulcers
Danish: • mundsmerter/mundsår
English: If you are prescribed Tyverb in combination with trastuzumab, the usual dose is 4 Tyverb tablets a day, as a single dose.
Danish: Hvis du får Tyverb i kombination med trastuzumab, er den sædvanlige dosis 4 Tyverb-tabletter om dagen.
English: Decreased left ventricular ejection fraction (see section 4.2 - dose reduction - cardiac events and section 4.4).
Danish: 4.2 - midlertidig afbrydelse af behandling og nedsættelse af dosis - kardielle hændelser og pkt.
English: Combination treatment with Tyverb and trastuzumab
Danish: Kombinationsbehandling med Tyverb og trastuzumab
English: Tyverb is also available in multipacks containing 140 tablets that comprise 2 packs, each containing 70 tablets.
Danish: Multipakningen består af 2 pakninger, der hver indeholder 70 tabletter.
English: Very common Insomnia*
Danish: Meget almindelig Søvnmangel* Nervesystemet
English: Tyverb 250 mg tablets lapatinib
Danish: Tyverb 250 mg tabletter lapatinib
English: Hyperbilirubinaemia, hepatotoxicity (see section 4.4).
Danish: Hyperbilirubinæmi, levertoksicitet (se pkt.
English: Tyverb (1250 mg/day) + capecitabine (2000 mg/m2/day, days 1-14 q21 days)
Danish: Tyverb (1250 mg/dag) + capecitabin (2000 mg/m2/dag, dag 1-14 hver 21. dag)
English: How to take Tyverb
Danish: Sådan skal du tage Tyverb
English: The recommended dose of Tyverb is 1500 mg (i.e. six tablets) once daily continuously.
Danish: Den anbefalede dosis af Tyverb er 1500 mg (seks tabletter) en gang daglig kontinuerligt.
English: If you are prescribed Tyverb in combination with capecitabine, the usual dose is 5 Tyverb tablets a day, as a single dose.
Danish: Hvis du får Tyverb i kombination med capecitabin, er den sædvanlige dosis 5 Tyverb-tabletter om dagen.
English: Administration of lapatinib in patients with hepatic impairment should be undertaken with caution (see sections 4.2 and 4.4).
Danish: Indgift af lapatinib til patienter med nedsat leverfunktion bør ske med forsigtighed (se pkt.
English: Tyverb is prescribed in combination with capecitabine, for patients who have had treatment for advanced or metastatic breast cancer before.
Danish: • I kombination med capecitabin til patienter med avanceret eller metastatisk brystcancer.
English: Median (95%
Danish: Median (95 % CI)
English: • trouble sleeping
Danish: • søvnbesvær
English: If you are prescribed Tyverb in combination with an aromatase inhibitor, the usual dose is 6 Tyverb tablets a day, as a single dose.
Danish: Hvis du får Tyverb i kombination med en aromatasehæmmer, er den sædvanlige dosis 6 Tyverbtabletter om dagen.
English: 15.4 wks (8.4, 16.9)
Danish: 15,4 uger (8,4; 16,9)
English: If the toxicity recurs, then Tyverb should be restarted at a lower dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor).
Danish: Hvis toksiciteten kommer igen, bør behandlingen med Tyverb genoptages med en lavere dosis (750 mg daglig ved kombination med trastuzumab, 1000 mg daglig ved kombination med capecitabin eller 1250 mg daglig ved kombination med en aromatasehæmmer).
English: Tyverb 250 mg film-coated tablets lapatinib
Danish: Tyverb 250 mg filmovertrukne tabletter lapatinib
English: Tyverb may be restarted at a reduced dose (750 mg/day when administered with trastuzumab, 1000 mg/day when administered with capecitabine or 1250 mg/day when administered with an aromatase inhibitor) after a minimum of 2 weeks and if the LVEF recovers to normal and the patient is asymptomatic.
Danish: Behandlingen med Tyverb kan genoptages med reduceret dosis (750 mg daglig ved kombination med trastuzumab, 1000 mg daglig ved kombination med capecitabin eller 1250 mg daglig ved kombination med en aromatasehæmmer) efter minimum to uger, hvis LVEF igen er normal, og patienten er symptomfri.
English: Tyverb / trastuzumab combination posology
Danish: Dosering ved kombinationen Tyverb / trastuzumab
English: Tyverb is prescribed in combination with an aromatase inhibitor, for patients with hormone sensitive metastatic breast cancer (breast cancer that is more likely to grow in the presence of hormones), who are not currently intended for chemotherapy.
Danish: Patienter med hormonfølsom metastatisk brystkræft (brystkræft, der har større tendens til at vokse, når der er hormoner til stede), som det ikke på nuværende tidspunkt er hensigtsmæssigt at behandle med kemoterapi, skal tage Tyverb i kombination med en aromatasehæmmer.
English: Bottles
Danish: Beholdere
English: Co-administration of Tyverb with medicinal products with narrow therapeutic windows that are substrates of CYP2C8 (e.g. repaglinide) should be avoided (see sections 4.4 and 5.2).
Danish: Samtidig administration af Tyverb med lægemidler med et smalt terapeutisk vindue, som er substrater for CYP2C8 (f.eks. repaglinid), bør undgås (se pkt.
English: Progression-free survival (PFS) was the primary endpoint of the study with response rate and overall survival (OS) as secondary endpoints.
Danish: Studiets primære endepunkt var progressionsfri overlevelse (PFS).
English: Subjects who had received prior trastuzumab* N
Danish: Forsøgspersoner, der tidligere havde fået trastuzumab* n
English: • use fragrance free, hypoallergenic beauty products
Danish: • brug plejeprodukter uden parfume og allergifremkaldende stoffer
English: • rash, dry skin, itching
Danish: • udslæt, tør hud, kløe.
English: Breast-feeding must be discontinued in women who are receiving therapy with Tyverb and for at least 5 days after the last dose.
Danish: Kvinder, der behandles med Tyverb, skal ophøre med at amme og i mindst 5 dage efter den sidste dosis.
English: Lapatinib is not significantly renally excreted and is highly bound to plasma proteins, therefore haemodialysis would not be expected to be an effective method to enhance the elimination of lapatinib.
Danish: Lapatinib udskilles ikke væsentligt via nyrerne og bindes i høj grad til plasmaproteiner.
English: Tyverb can cause skin rash
Danish: Tyverb kan forårsage udslæt
English: PFS = progression-free survival; CI = confidence interval.
Danish: (95 % CI) Hazard ratio (95 % CI) p-værdi PFS = progressionsfri overlevelse; CI = konfidensinterval.
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 5 tablets.
Danish: Hvert blisterkort er perforeret på midten og kan deles i daglige doser med 5 tabletter.
English: Skin and subcutaneous tissue disorders Very common Rash (including dermatitis acneiform) (see section 4.2 - dose delay and dose reduction - other toxicities), dry skin* †, palmar-plantar erythrodysaesthesia*, alopecia †, pruritus
Danish: - midlertidig afbrydelse af behandling og nedsættelse af dosis - anden toksicitet), tør hud* palmoplantar erytrodysæstesi (PPE) (hånd-fod-syndrom)*, alopeci pruritus
English: Tyverb 250 mg film-coated tablets
Danish: Tyverb 250 mg filmovertrukne tabletter
English: Lapatinib was not clastogenic or mutagenic in a battery of assays including the Chinese hamster chromosome aberration assay, the Ames assay, human lymphocyte chromosome aberration assay and an in vivo rat bone marrow chromosome aberration assay.
Danish: kromosomafvigelser hos kinesiske hamstre, Ames' test, kromosomafvigelser i humane lymfocytter og in vivokromosomafvigelser i knoglemarv hos rotter.
English: Each foil has a perforation down the middle to allow the blisters to be separated into a daily dose of 6 tablets.
Danish: Hvert blisterkort er perforeret på midten og kan deles i daglige doser med 6 tabletter.
English: In oral carcinogenicity studies with lapatinib, severe skin lesions were seen at the highest doses tested which produced exposures based on AUC up to 2-fold in mice and male rats, and up to 15-fold in female rats, compared to humans given 1250 mg of lapatinib once daily.
Danish: De resulterede i en påvirkning, som baseret på AUC var op til 2 gange større hos mus og hanrotter og op til 15 gange større hos hunrotter sammenlignet med mennesker, som fik 1250 mg lapatinib en gang daglig.
English: Investigator assessment Tyverb (1250 mg/day)+ capecitabine (2000 mg/m2/day,
Danish: Investigators vurdering Tyverb (1250 mg/dag) + capecitabin (2000 mg/m2/dag, dag 1-14 hver 21. dag)
English: This includes herbal medicines and other medicines you bought without a prescription.
Danish: Dette gælder også medicin, som ikke er købt på recept, f.eks. naturlægemidler og vitaminer og mineraler.
English: Patients were randomised to receive either Tyverb 1250 mg once daily (continuously) plus capecitabine (2000 mg/m2/day on days 1-14 every 21 days), or to receive capecitabine alone
Danish: Patienterne blev randomiseret til enten Tyverb 1250 mg en gang om dagen (kontinuerligt) og capecitabin (2000 mg/m2/døgn på dag 1-14 hver 21. dag) eller til capecitabin alene (2500 mg/m2/døgn på dag 1-14 hver 21. dag).
English: Other medicines and Tyverb
Danish: Brug af anden medicin sammen med Tyverb
English: Blister packs
Danish: BLISTERKORT
English: • Your doctor will also carry out tests to check your heart and liver function before and during treatment with Tyverb.
Danish: • Før og under behandlingen med Tyverb vil lægen tage prøver for at tjekke din hjerte- og leverfunktion.
English: What Tyverb is and what it is used for What you need to know before you take Tyverb How to take Tyverb
Danish: Det skal du vide, før du begynder at tage Tyverb Sådan skal du tage Tyverb Bivirkninger
English: Tell your doctor if you get a skin rash.
Danish: Fortæl det til lægen, hvis du får udslæt.
English: Caution is advised if lapatinib is co-administered with paclitaxel.
Danish: Der bør udvises forsigtighed ved samtidig administration af lapatinib og paclitaxel.
English: Lapatinib has been associated with reports of pulmonary toxicity including interstitial lung disease and pneumonitis (see section 4.8).
Danish: Lapatinib har været associeret med rapporter om pulmonal toksicitet inkl.
English: Hypersensitivity reactions including anaphylaxis (see section 4.3) Metabolism and nutrition disorders Very common Anorexia
Danish: Overfølsomhedsreaktioner, herunder anafylaksi (se pkt.