natgillin/translations-raw huggingface dataset:
Effekt og sikkerhed af Tarceva i kombination med gemcitabin som 1. linie behandling blev vurderet i et randomiseret, dobbeltblindt, placebokontrolleret studie hos patienter med lokalt fremskreden inoperabel eller metastaserende pancreas cancer.
The efficacy and safety of Tarceva in combination with gemcitabine as a first-line treatment was assessed in a randomised, double-blind, placebo-controlled trial in patients with locally advanced, unresectable or metastatic pancreatic cancer.
(1000 mg/ m2, serie 1 på dag 1, 8, 15, 22, 29, 36 og 43 i en 8 ugers serie; serie 2 og efterfølgende serier på dag 1, 8 og 15 i en 4 ugers serie [vedr. godkendt dosis og doseringsskema for pancreas cancer se produktresuméet for gemcitabin]).
Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
Bortset fra at der var lidt flere kvinder i erlotinib/ gemcitabin- armen end i placebo/ gemcitabin- armen var demografi og sygdomskarakteristika ved baseline ens for de to behandlingsgrupper, 100 mg Tarceva plus gemcitabin og placebo plus gemcitabin:
Baseline demographic and disease characteristics of the patients were similar between the 2 treatment groups, 100 mg Tarceva plus gemcitabine or placebo plus gemcitabine, except for a slightly larger proportion of females in the erlotinib/gemcitabine arm compared with the placebo/gemcitabine arm:
Samlet overlevelse – alle patienter 1, 0
26 Overall Survival – All Patients 1.0
0, 69; 0, 98), p = 0, 028
0.69, 0.98), p = 0.028
Placebo +
Placebo + gemcitabine (n = 2 60) Median OS = 6.0 months
27 Samlet overlevelse – patienter med fjernmetastaser 1, 0
Overall Survival – Patients with Distant Metastases 1.0
0, 66; 0, 98), p = 0, 029
0.66, 0.98), p = 0.029
0, 1 gemcitabine (n = 197) Median samlet overlevelse = 5, 06 måneder 0, 0
0.1 gemcitabine (n = 197) Median OS = 5.06 months 0.0
5. 2 Farmakokinetiske egenskaber
27 5.2 Pharmacokinetic properties
Absorption:
A bsorption:
4 timer.
After oral administration, erlotinib peak plasma levels are obtained in approximately 4 hours after oral dosing.
Ekstrahepatisk metabolisering af CYP3A4 i tarmen, af CYP1A1 i lungerne og af 1B1 i tumorvæv bidrager potentielt til den metaboliske clearance af erlotinib.
Extrahepatic metabolism by CYP3A4 in intestine, CYP 1A1 in lung, and 1B1 in tumour tissue potentially contribute to the metabolic clearance of erlotinib.
Der er identificeret tre hovedmetaboliske udskillelsesveje:
The re are three main metabolic pathways identified:
I ikke - kliniske in vitro assays og i in vivo tumormodeller har erlotinibs primære metabolitter OSI- 420 og OSI- 413, som dannes ved O- demethylering af sidekæderne, samme effekt som erlotinib.
The primary metabolites OSI-420 and OSI-413 of erlotinib produced by O-demethylation of either side chain have comparable potency to erlotinib in non-clinical in vitro assays and in vivo tumour models.
28 Plasmakoncentrationerne af metabolitterne er < 10% af erlotinibs plasmakoncentrationer, og har samme farmakokinetik som erlotinib.
They are present in plasma at levels that are < 10% of erlotinib and display similar pharmacokinetics as erlotinib.
Rygere havde dog en øget clerance- hastighed.
However, smokers had an increased rate of erlotinib clearance.
I det pivotale fase III- NSCLC- studie opnåede rygere en erlotinibplasmakoncentration ved steady- state på 0, 65 µg/ ml (n=16), hvilket var ca.
In the pivot al Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
I et fase I- dosis - eskaleringsstudie hos NSCLC- patienter, som var rygere, indikerede en farmakokinetisk analyse ved steady- state en dosis- proportional stigning i erlotinibeksponeringen, når Tarceva- dosis blev øget fra 150 mg til den maksimale toleransdosis på 300 mg.
28 current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg.
29 populationsfarmakokinetiske analyser ledsagedes øgede serumkoncentrationer af total bilirubin af en langsommere hastighed af erlotinib- clearance.
In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Lactosemonohydrat Cellulose, mikrokrystallinsk (E460) Natriumstivelsesglycolat type A Natriumlaurylsulfat Magnesiumstearat (E470 b)
Lactose monohydrate Cellulose, microcrystalline (E460) Sodium starch glycolate Type A Sodium laurilsulfate Magnesium stearate (E470 b)
Gråt påtrykt blæk:
Printing ink grey:
Shellac (E904) Gul jernoxid (E172) Sort jernoxid (E172) Titandioxid (E171)
Shellac (E904) Iron oxide yellow (E172) Iron oxide black (E172) Titanium dioxide (E171)
30 6. 3 Opbevaringstid
3 years.
Tarceva 150 mg En filmovertrukken tablet indeholder 150 mg erlotinib (som erlotinibhydroklorid).
Tarceva 150 mg One film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).
Filmovertrukken tablet Hvide til gullige, runde, bikonvekse tabletter påtrykt ‘ Tarceva 150 ’ og logo i brunt på den ene side.
Film-coated tablet White to yellowish, round, biconvex tablets with ‘Tarceva 150’ and logo printed in brown on one side.
Tarceva er indiceret til behandling af patienter med lokalt fremskreden eller metastatisk ikke- småcellet lungecancer efter behandlingssvigt af mindst et tidligere kemoterapiregime.
No n-small cell lung cancer (NSCLC):Tarceva is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Den anbefalede dosis af Tarceva er 150 mg, som tages mindst en time før eller to timer efter indtagelse af føde.
The recommended daily dose of Tarceva is 150 mg taken at least one hour before or two hours after the ingestion of food.
32 Hvis dosisjustering er nødvendig, skal dosis reduceres med 50 mg ad gangen (se pkt.
When dose adjustment is necessary, reduce in 50 mg steps (see section 4.4).
Tarceva findes i styrker på 25 mg, 100 mg og 150 mg.
32 Tarceva is available in strengths of 25 mg, 100 mg and 150 mg.
33 Afhængig af den diagnostiske evaluering skal behandling med Tarceva stoppes hos patienter, som udvikler akutte nye og/ eller progredierende, uforklarlige lungesymptomer, som f. eks. dyspnø, hoste og feber.
33 In patients who develop acute onset of new and/or progressive unexplained pulmonary symptoms such as dyspnoea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation.
Hos disse patienter bør det derfor overvejes at teste leverfunktionen periodisk.
The refore, in such patients, periodic liver function testing should be considered.
Tabletterne indeholder lactose og må ikke gives til patienter med arvelig galactoseintolerans, Lapp lactase deficit eller glucose- galactosemalabsorption.
The tablets contain lactose and should not be administered to patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Erlotinibs pløselighed reduceres ved en pH over 5.
Erlotinib is characterised by a decrease in solubility at pH above 5.
Lægemidler, der ændrer pH i den øvre del af mave - tarmkanalen, som eksempelvis protonpumpehæmmere, H2- antagonister og antacida, kan ændre erlotinibs opløselighed og derved dets biotilgængelighed.
Drugs that alter the pH of the upper GI tract, like proton pump inhibitors, H2 antagonists and antacids, may alter the solubility of erlotinib and hence its bioavailability.
Virkningen af samtidig administration af erlotinib med H2- antagonister kendes ikke; men det er sandsynligt, at biotilgængelighed vil være mindsket.
The effects of concomitant administration of erlotinib with H2 antagonists and antacids are unknown; however, reduced bioavailability is likely.
34 Forbehandling eller samtidig administration af Tarceva ændrede ikke clearance af de prototypiske CYP3A4- substrater, midazolam og erythromycin, men nedsatte tilsyneladende den orale biotilgængelighed af midazolam med op til 24%.
34 of the concomitantly administered CYP3A4/2C8 substrate paclitaxel.
Samtidig administration af P - glycoproteinhæmmere, f. eks. cyclosporin og verapamil kan medføre ændret distribution og/ eller
Concomitant administration of inhibitors of Pgp, e.g. cyclosporine and verapamil, may lead to altered distribution and/or altered elimination of erlotinib.
Samtidig administration af erlotinib med omeprazol, som er en syrepumpehæmmer, nedsætter erlotinibeksponering [AUC] og maksimumkoncentrationen [Cmax] med henholdsvis 46% og 61%.
35 erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Der foreligger ingen studier om anvendelsen af erlotinib hos gravide kvinder.
The re are no studies in pregnant women using erlotinib.
Behandlingen bør kun fortsættes hos gravide, hvis fordelen hos moderen opvejer risikoen for fostret.
Treatment should only be continued in pregnant women if the potential benefit to the mother outweighs the risk to the foetus.
36 6% af de Tarceva- behandlede patienter, og hver af dem medførte afbrydelse af behandlingen hos 1% af patienterne.
Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1% of patients.
De bivirkninger, som i det pivotale studie BR. 21 optrådte hyppigere (≥3%) hos Tarceva- behandlede patienter end hos patienter, som fik placebo, og som optrådte hos mindst 10% af patienterne i Tarceva- gruppen, er sammenfattet i henhold til National Cancer Institute- Common Toxicity Criteria (NCI- CTC) Grade i tabel 1.
36 Adverse events occurring more frequently (≥3%) in Tarceva-treated patients than in the placebo group in the pivotal study BR.21, and in at least 10% of patients in the Tarceva group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 1.
Svære infektioner, med eller uden neutropeni, har omfattet pneumoni, sepsis og cellulitis.. ** Kan føre til dehydrering, hypokaliæmi og nyreinsufficiens. *** Udslæt herunder dermatitis acneiform.
* Severe infections, with or without neutropenia, have included pneumonia, sepsis, and cellulitis. ** Can lead to dehydration, hypokalemia and renal failure. *** Rash included dermatitis acneiform.
37 tid til starten af udslæt og diarré var hhv.
The median time to onset of rash and diarrhoea was 10 days and 15 days, respectively.
Bivirkninger, som i det pivotale studie PA. 3 optrådte hyppigere (≥ 3%) hos patienter behandlet med Tarceva 100 mg plus gemcitabin end hos patienter behandlet med placebo plus gemcitabin, og som optrådte hos mindst 10% af patienterne i gruppen, som fik Tarceva 100 mg plus gemcitabin, er sammenfattet i tabel 2 i henhold til National Cancer Institute Common Toxicity Criteria (NCI- CTC).
37 Adverse events occurring more frequently (≥3%) in Tarceva 100 mg plus gemcitabine-treated patients than in the placebo plus gemcitabine group in the pivotal study PA.3, and in at least 10% of patients in the Tarceva 100 mg plus gemcitabine group, are summarised by National Cancer Institute-Common Toxicity Criteria (NCI-CTC) Grade in Table 2.
NCI- CTC Grad
NCI-CTC
MedDRA termer Totalt antal patienter med bivirkninger Infektioner og parasitære sygdomme
MedDRA Preferred Term Total patients with any AE Infections and infestations
10 10
< 1 1
Pyreksi Træthed Rigor *
Pyrexia Fatigue Rigors
38 A248- 1003 (hoved- halskræft) og OSI2288g (metastatisk brystkræft) og fra 285 patienter, som fik Tarceva 100 eller 150 mg plus gemcitabin i fase III pancreas cancer- studiet PA. 3.
248-101 (ovarian cancer), A248-1003 (head and neck cancer), and OSI2288g (metastatic breast cancer) and the 285 patients who received Tarceva 100 or 150 mg plus gemcitabine in the phase III pancreatic cancer study PA.3.
Følgende betegnelser anvendes for at graduere bivirkningerne efter hyppighed: meget almindelig (> 1/ 10); almindelig (> 1/ 100, < 1/ 10); ikke almindelig (> 1/ 1. 000, < 1/ 100); sjælden (> 1/ 10. 000, < 1/ 1. 000); meget sjælden (< 1/ 10. 000), herunder enkeltstående indberetninger.
38 The following terms are used to rank the undesirable effects by frequency: very common (> 1/10); common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1000); very rare (< 1/10,000) including isolated reports.
Almindelig (i PA. 3):
Common:
Almindelig:
Uncommon
Erlotinib er en epidermal vækstfaktorreceptor/ human epidermal vækstfaktorreceptor type 1 (EGFR også kendt som HER1) tyrosinkinase- hæmmer.
39 Erlotinib is an epidermal growth factor receptor/human epidermal growth factor receptor type 1 (EGFR also known as HER1) tyrosine kinase inhibitor.
I non- kliniske modeller medfører hæmning af EGFR phosphortyrosin cellestase og/ eller celledød.
In non-clinical models, inhibition of EGFR phosphotyrosine results in cell stasis and/or death.
Studieendepunkterne omfattede samlet overlevelse, progressionsfri overlevelse (PFS), responsrate, varighed af respons, tid indtil forværring af lungecancerrelaterede symptomer (hoste, dyspnø og smerter), og sikkerhed.
Study endpoints included overall survival, progression-free survival (PFS), response rate, duration of response, time to deterioration of lung cancer-related symptoms (cough, dyspnoea and pain), and safety.
Hazard ratio for patienter med EGFR- positive tumorer var 0, 68 (konfidensinterval 0, 49- 0, 94) og 0, 93 (konfidensinterval (0, 63- 1, 36) for patienter med EGFR- negative tumorer (defineret ved IHC under anvendelse af EGFR pharmDx kit og definerende EGFR- negativ som farvning af mindre end 10% tumorcellerne).
In the 45% of patients with known EGFR-expression status, the hazard ratio was 0.68 (CI 0.49-0.94) for patients with EGFR-positive tumours and 0.93 (CI 0.63-1.36) for patients with EGFR-negative tumours (defined by IHC using EGFR pharmDx kit and defining EGFR-negative as less than 10% tumour cells staining).
Hos de resterende 55% af patienterne med ukendt EGFR- ekspressionsstatus var hazard ratio 0, 77 (konfidensinterval 0, 61 - 0, 98).
In the remaining 55% of patients with unknown EGFR-expression status, the hazard ratio was 0.77 (CI 0.61-0.98).
40 Den mediane PFS var 9, 7 uger i Tarceva- gruppen (95% konfidensinterval; 8, 4 til 12, 4 uger) sammenlignet med 8, 0 uger i placebo- gruppen (95% konfidensinterval; 7, 9 til 8, 1 uger).
The median PFS was 9.7 weeks in the Tarceva group (95% CI, 8.4 to 12.4 weeks) compared with 8.0 weeks in the placebo group (95% CI, 7.9 to 8.1 weeks).
RECIST).
40 A survival benefit of Tarceva was also observed in patients who did not achieve an objective tumour response (by RECIST).
(1000 mg/ m2, serie 1 på dag 1, 8, 15, 22, 29, 36 og 43 i en 8 ugers serie; serie 2 og efterfølgende serier på dag 1, 8 og 15 i en 4 ugers serie [vedr. godkendt dosis og doseringsskema for pancreas- cancer se produktresuméet for gemcitabin]).
Patients were randomised to receive Tarceva or placebo once daily on a continuous schedule plus gemcitabine IV (1000 mg/m2, Cycle 1 - Days 1, 8, 15, 22, 29, 36 and 43 of an 8 week cycle; Cycle 2 and subsequent cycles - Days 1, 8 and 15 of a 4 week cycle [approved dose and schedule for pancreatic cancer, see the gemcitabine SPC]).
Samlet overlevelse – alle patienter 1, 0
41 Overall Survival – All Patients 1.0
42 Samlet overlevelse – patienter med fjernmetastaser 1, 0
Overall Survival – Patients with Distant Metastases 1.0
5. 2 Farmakokinetiske egenskaber
42 5.2 Pharmacokinetic properties
Erlotinib metaboliseres i leveren af de hepatiske, humane cytokromer, primært af CYP3A4 og i mindre udstrækning af CYP1A2.
Erlotinib is metabolised in the liver by the hepatic cytochromes in humans, primarily CYP3A4 and to a lesser extent by CYP 1A2.
43 Plasmakoncentrationerne af metabolitterne er < 10% af erlotinibs plasmakoncentrationer, og har samme farmakokinetik som erlotinib.
They are present in plasma at levels that are < 10% of erlotinib and display similar pharmacokinetics as erlotinib.
Denne virkning var ledsaget af en 24% stigning i erlotinibs tilsyneladende plasmaclearance.
In a phase I dose escalation study in NSCLC patients who were current smokers, pharmacokinetic analyses at steady-state indicated a dose proportional increase in
I et fase I- dosis - eskaleringsstudie hos NSCLC- patienter, som var rygere, indikerede en farmakokinetisk analyse ved steady- state en dosis- proportional stigning i erlotinibeksponeringen, når Tarceva- dosis blev øget fra 150 mg til den maksimale toleransdosis på 300 mg.
43 erlotinib exposure when the Tarceva dose was increased from 150 mg to the maximum tolerated dose of 300 mg.
44 populationsfarmakokinetiske analyser ledsagedes øgede serumkoncentrationer af total bilirubin af en langsommere hastighed af erlotinib- clearance.
In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
De røde blodlegemeparametre var nedsat og antallet af hvide blodlegemer, primært neutrofile, var forøget.
Red blood cell parameters were decreased and white blood cells, primarily neutrophils, were increased.
Data fra reproduktionstoksikologiske tests på rotter og kaniner i doser i nærheden af maksimum tolererbar dosis og/ eller maternale toksiske doser viste reproduktionstoksiske (embryotoksicitet hos rotter, embryoresorption og foetotoksicitet hos kanin) og udviklingstoksiske (nedsat vækst af unger og nedsat overlevelse hos rotter) virkninger, men ingen teratogenicitet og ingen påvirkning af fertiliteten.
Data from reproductive toxicology tests in rats and rabbits at doses near the maximum tolerated dose and/or maternally toxic doses showed reproductive (embryotoxicity in rats, embryo resorption and foetotoxicity in rabbits) and developmental (decrease in pup growth and survival in rats) toxicity, but was not teratogenic and did not impair fertility.
Shellak (E904) Rød jernoxid (E172)
Printing ink brown Shellac (E904) Iron oxide red (E172)
45 6. 3 Opbevaringstid
6.3 Shelf life
46 BILAG II
46 ANNEX II
48 BILAG III
48 ANNEX III
50 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Hver tablet indeholder 25 mg erlotinib (som erlotinibhydrochlorid).
Each tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).
Til oral anvendelse Læs indlægssedlen inden brug
For oral use Read the package leaflet before use
52 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
53 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Hver tablet indeholder 100 mg erlotinib (som erlotinibhydrochlorid).
Each tablet contains 100 mg of erlotinib (as erlotinib hydrochloride).
56 MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG DEN INDRE EMBALLAGE
56 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Hver tablet indeholder 150 mg erlotinib (som erlotinibhydrochlorid).
Each tablet contains 150 mg of erlotinib (as erlotinib hydrochloride).
58 MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS
58 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
Tarceva 25 mg filmovertrukne tabletter Tarceva 100 mg filmovertrukne tabletter Tarceva 150 mg filmovertrukne tabletter Erlotinib
Tarceva 25 mg Film-Coated Tablets Tarceva 100 mg Film-Coated Tablets Tarceva 150 mg Film-Coated Tablets Erlotinib
kan være skadeligt for andre, selvom de har de samme symptomer, som du har.
may harm them, even if their symptoms are the same as yours.
Virkning og anvendelse 2.
What Tarceva is and what it is used for 2.
Det skal du vide, før du begynder at tage Tarceva 3.
Before you take Tarceva 3.
Sådan skal du tage Tarceva 4.
How to take Tarceva 4.
Opbevaring 6.
How to store Tarceva 6.
VIRKNING OG ANVENDELSE
WHAT IS TARCEVA AND WHAT IT IS USED FOR
Tarceva er et lægemiddel som anvendes til behandling af kræft ved at forhindre aktiviteten af et protein, som kaldes epidermal vækstfaktor.
Tarceva is a medicinal product used to treat cancer by preventing the activity of a protein called epidermal growth factor receptor.
Du kan få ordineret dette lægemiddel, hvis du har ikke- småcellet lungekræft i et fremskredent stadium, og fordi kemoterapi ikke har kunnet stoppe sygdommen.
This medicine can be prescribed to you if you have non-small cell lung cancer at an advanced stage and chemotherapy has not helped to stop your disease.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE TARCEVA
BEFORE YOU TAKE TARCEVA
Tag ikke Tarceva
You should not take Tarceva:
- hvis du er overfølsom (allergisk) overfor erlotinib eller et af de øvrige indholdsstoffer i Tarceva.
- if you are allergic (hypersensitive) to erlotinib or to any of the ingredients of Tarceva.
Vær ekstra forsigtig med at tage Tarceva
Take special care during treatment with Tarceva:
- hvis du tager andre lægemidler, som kan øge eller nedsætte mængden af erlotinib i dit blod
- if you are taking other medicines that may increase or decrease the amount of erlotinib in your
(f. eks. svampemidler som ketoconazol, proteasehæmmere, erytromycin, claritromycin, phenytoin, carbamazepin, barbiturater, rifampicin, ciprofloxacin, omeprazol, ranitidin eller prikbladet perikon).
blood (for example antifungals like ketoconazole, protease inhibitors, erythromycin, clarithromycin, phenytoin, carbamazepine, barbiturates, rifampicin, ciprofloxacin, omeprazole, ranitidine or St.
Disse lægemidler kan i nogle tilfælde nedsætte virkningen eller øge bivirkningerne af Tarceva, og din læge må måske justere din behandling.
In some cases these medicines may reduce the efficacy or increase the side effects of Tarceva and your doctor may need to adjust your treatment.
- hvis du tager blodfortyndende medicin (som f. eks. warfarin eller andre coumarinderivater),
- if you take blood thinners (like warfarin or other coumarin-derivatives) because Tarceva may
I så fald vil din læge kontrollere dig regelmæssigt ved hjælp af blodprøver.
increase your risk of bleeding and your doctor will need to regularly monitor you with blood tests.
Se også ” Indtagelse af anden medicin ” nedenfor.
See also below “Taking other medicines”.
61 Du skal fortælle din læge:
61 You should tell your doctor:
- hvis du pludseligt får vanskeligheder med at trække vejret, ledsaget af hoste eller feber, fordi
- if you have sudden difficulty in breathing associated with cough or fever because your doctor
din læge måske får brug for at behandle dig med andre lægemidler og at stoppe behandlingen med Tarceva.
may need to treat you with other medicines and interrupt your Tarceva treatment;
- hvis du får diarré, fordi din læge måske vil behandle dig med midler mod diarré (f. eks.
- if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for
loperamid).
example loperamide);
- omgående hvis du får svær eller vedvarende diarré, kvalme, appetittab eller opkastning, fordi
- immediately, if you have severe or persistent diarrhoea, nausea, loss of appetite, or vomiting
din læge måske vil stoppe behandlingen med Tarceva og måske får behov for at behandle dig på hospitalet.
because your doctor may need to interrupt your Tarceva treatment and may need to treat you in the hospital.
4 ” Mulige bivirkninger ”.
See also section 4 “Possible side effects”.
Behandling med denne medicin anbefales ikke, hvis du har en svær lever - eller nyresygdom.
The treatment with this medicine is not recommended if you have a severe liver disease or severe kidney disease.
Din læge vil behandle dig med forsigtighed, hvis du lider af en glukoronidiseringssygdom som Gilberts syndrom.
Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert’s syndrome.
Brug af Tarceva sammen med mad og drikke Tag ikke Tarceva sammen med mad.
Do not take Tarceva with food.