FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of erlotinib with omeprazole, a proton pump inhibitor (PPI), decreased the erlotinib exposure [AUC] and maximum concentration [Cmax] by 46% and 61%, respectively.
Danish: Samtidig administration af erlotinib med omeprazol, som er en syrepumpehæmmer, nedsætter erlotinibeksponering [AUC] og maksimumkoncentrationen [Cmax] med henholdsvis 46 % og 61 %.
English: The geometric mean of the C24h was 288 ng/mL in the non-smokers and 34.8 ng/mL in the smokers with a mean ratio of 12.1% (95% CI: 4.82 to 30.2, p = 0.0001).
Danish: Det geometriske middeltal for C24t var 288 ng/ml hos ikke-rygerne og 34,8 ng/ml hos rygerne med en middelratio på 12,1 % (95 % konfidensinterval: 4,82 til 30,2; p= 0,0001).
English: No data are available regarding the influence of severe hepatic dysfunction on the pharmacokinetics of erlotinib.
Danish: Der foreligger ingen data om indvirkningen af alvorlig nedsat leverfunktion på erlotinibs farmakokinetik.
English: • Eyebrow changes
Danish: • Forandringer af øjenbryn
English: INFORMATION IN BRAILLE tarceva 25 mg
Danish: INFORMATION I BRAILLESKRIFT tarceva 25 mg
English: Patients were randomised 2:1 to receive Tarceva 150 mg or placebo orally once daily.
Danish: Patienterne blev randomiserede i forholdet 2:1 til behandling med Tarceva 150 mg eller placebo oralt én gang daglig.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Tarceva 25 mg filmovertrukne tabletter Tarceva 100 mg filmovertrukne tabletter Tarceva 150 mg filmovertrukne tabletter
English: The geometric mean of the AUC0-inf was 18726 ng•h/mL in the non-smokers and 6718 ng•h/mL in the smokers with a mean ratio of 35.9% (95% CI: 23.7 to 54.3, p < 0.0001).
Danish: Det geometriske middeltal for AUC0-inf var 18726 ng•t/ml hos ikke-rygerne og 6718 ng•t/ml hos rygerne med en middelratio på 35,9 % (95 % konfidensinterval: 23,7 til 54,3; p<0,0001).
English: Combination of erlotinib with proton pump inhibitors should be avoided.
Danish: Kombinationen af erlotinib med syrepumpehæmmere bør undgås.
English: Use of Tarceva in patients with severe renal impairment is not recommended.
Danish: Anvendelse af Tarceva til patienter med svær nedsat nyrefunktion anbefales ikke.
English: INFORMATION IN BRAILLE tarceva 150 mg
Danish: INFORMATION I BRAILLESKRIFT tarceva 150 mg
English: Headache, altered skin sensation or numbness in the extremities Difficulty in breathing, cough
Danish: • Hovedpine, ændret fornemmelse i huden eller følelsesløshed i arme og ben
English: Exploratory Analysis (40% OS maturity) (n=173)
Danish: Eksplorativ analyse (40% af data tilgængelige for den samlede overlevelse) (n=173)
English: Confounding factors included pre-existing liver disease or concomitant hepatotoxic medications (see section 4.4).
Danish: Konfunderende faktorer indbefattede tidligere leversygdom eller samtidig administration af hepatotoksiske lægemidler (se pkt.
English: CI of HR
Danish: Konfidensinterval of HR
English: Hepatitis, hepatic failure
Danish: Hepatitis, leverinsufficiens
English: Potent inducers of CYP3A4 activity increase erlotinib metabolism and significantly decrease erlotinib plasma concentrations.
Danish: Potente induktorer af CYP3A4-aktivitet øger metaboliseringen af erlotinib og nedsætter plasmakoncentrationen af erlotinib signifikant.
English: - First-line Non-Small Cell Lung Cancer (NSCLC) therapy for patients with EGFR activating mutations (Tarceva administered as monotherapy)
Danish: - Første-linje-behandling af ikke-småcellet lungecancer (NSCLC) hos patienter med EGFRaktiverende mutationer (administration af Tarceva som monoterapi)
English: INFORMATION IN BRAILLE tarceva 100 mg
Danish: INFORMATION I BRAILLESKRIFT tarceva 100 mg
English: In patients with solid tumours and with moderately impaired hepatic function (Child-Pugh score 7-9), geometric mean erlotinib AUC0-t and Cmax was 27000 ng•h/mL and 805 ng/mL, respectively, as compared to 29300 ng•h/mL and 1090 ng/mL in patients with adequate hepatic function including patients with primary liver cancer or hepatic metastases.
Danish: Hos patienter med solide tumorer og med moderat nedsat leverfunktion (Child-Pugh score 7-9) var det geometriske middeltal for erlotinib-AUC0-t og Cmax på henholdsvis 27000 ng•t/ml og 805 ng/ml.
English: Liver or kidney disease
Danish: Sygdomme i lever og nyrer
English: Erlotinib and P-glycoprotein inhibitors
Danish: Erlotinib og P-glykoproteinhæmmere
English: Each film-coated tablet contains 25 mg, 100 mg or 150 mg of erlotinib (as erlotinib hydrochloride) depending on the strength.
Danish: Hver filmovertrukken tablet indeholder 25 mg, 100 mg eller 150 mg erlotinib (som erlotinibhydrochlorid), afhængigt af styrke.
English: The geometric mean of the Cmax was 1056 ng/mL in the non-smokers and 689 ng/mL in the smokers with a mean ratio for smokers to non-smokers of 65.2% (95% CI: 44.3 to 95.9, p = 0.031).
Danish: Det geometriske middeltal af Cmax var 1056 ng/ml hos ikke-rygerne og 689 ng/ml hos rygerne med en middelratio for rygerne i forhold til ikke-rygerne på 65,2 % (95 % konfidensinterval: 44,3 til 95,9; p= 0,031).
English: Tarceva 25 mg film-coated tablets Tarceva 100 mg film-coated tablets Tarceva 150 mg film-coated tablets Erlotinib
Danish: Tarceva 25 mg filmovertrukne tabletter Tarceva 100 mg filmovertrukne tabletter Tarceva 150 mg filmovertrukne tabletter Erlotinib
English: Interaction with coumarin-derived anticoagulants including warfarin leading to increased International Normalized Ratio (INR) and bleeding events, which in some cases were fatal, have been reported in patients receiving Tarceva.
Danish: Hos patienter, som får Tarceva, er der blevet rapporteret interaktion med coumarin-antikoagulantia (inklusive warfarin), som har medført forhøjet International Normalized Ratio (INR) og blødninger, som i visse tilfælde var letale.
English: Tiredness, fever, rigors
Danish: • Træthed, feber, kulderystelser
English: Each 25 mg film-coated tablet contains 27.43 mg Lactose monohydrate.
Danish: Hver 25 mg filmovertrukken tablet indeholder 27,43 mg lactosemonohydrat.
English: Dose reduction for rash and diarrhoea was needed in 6% and 1% of patients, respectively.
Danish: Udslæt og diarré nødvendiggjorde reduktion af dosis hos hhv. 6 % og 1 % af patienterne.
English: Gastrointestinal disorders
Danish: - Gastrointestinale perforationer
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and 1B1 in tumour tissue potentially contribute to the metabolic clearance of erlotinib.
Danish: Ekstrahepatisk metabolisering af CYP3A4 i tarmen, af CYP1A1 i lungerne og af 1B1 i tumorvæv bidrager potentielt til den metaboliske clearance af erlotinib.
English: Extrahepatic metabolism by CYP3A4 in intestine, CYP1A1 in lung, and CYP1B1 in tumour tissue also potentially contribute to the metabolic clearance of erlotinib.
Danish: Ekstrahepatisk metabolisme ved hjælp af CYP3A4 i tarmen, af CYP1A1 i lungerne og af CYP1B1 i tumorvæv bidrager også potentielt til den metaboliske clearance af erlotinib.
English: Eye irritation due to conjunctivitis/keratoconjunctivitis (very common: may affect more than 1 out of 10 people) and keratitis (common: may affect up to 1 in 10 people).
Danish: • Øjenirritation på grund af betændelse i øjets bindehinde, både bindehinde og hornhinde (meget almindelig: kan påvirke flere end 1 ud af 10 behandlede) eller kun hornhinde (almindelig: kan påvirke op til 1 ud af 10 behandlede).
English: Gastrointestinal perforations have been observed (uncommon: may affect up to 1 in 100 people).
Danish: • Hul i mave-tarm-kanalen er blevet observeret (ikke almindelig: kan påvirke op til 1 ud af 100 behandlede).
English: Potent inhibitors of CYP3A4 activity decrease erlotinib metabolism and increase erlotinib plasma concentrations.
Danish: Potente hæmmere af CYP3A4-aktivtet nedsætter metaboliseringen af erlotinib og øger plasmakoncentrationerne af erlotinib.
English: Rigors very common very common very common
Danish: Meget almindelig Meget almindelig Meget almindelig
English: Very rare side effects (may affect up to 1 in 10,000 people):
Danish: Meget sjældne bivirkninger (kan påvirke op til 1 ud af 10.000 behandlede):
English: Pancreatic cancer (Tarceva administered concurrently with gemcitabine)
Danish: Pancreascancer (samtidig administration af Tarceva og gemcitabin)
English: In summary, the combination of erlotinib with proton pump inhibitors should be avoided.
Danish: Kombinationen af erlotinib med syrepumpehæmmere bør derfor undgås.
English: • The active substance of Tarceva is erlotinib.
Danish: • Aktivt stof: erlotinib.
English: • This medicine has been prescribed for you only.
Danish: • Lægen har ordineret Tarceva til dig personligt.
English: Contact lens use is also a risk factor for keratitis and ulceration.Very rare cases of corneal perforation or ulceration have been reported during use of Tarceva (see section 4.8).
Danish: Meget sjældne tilfælde af corneaperforation eller -ulceration er rapporteret ved brug af Tarceva (se pkt.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: 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:
Danish: 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:
English: The primary endpoint of the study included progression free survival (PFS) in all patients.
Danish: Studiets primære endepunkt inkluderede progressionsfri overlevelse (PFS) hos alle patienter.. Demografiske karakteristika og sygdomskarakteristika ved basislinje var afbalancerede mellem de to behandlingsarme.
English: Tarceva 100 mg film-coated tablets
Danish: Tarceva 100 mg filmovertrukne tabletter
English: Flatulence very common very common very common very common very common very common very common
Danish: Meget almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig Meget almindelig
English: -Paronychia -Folliculitis -Acne/
Danish: - Alopeci - Tør hud1 - Paronykie - Follikulitis - Acne/dermatitis acneiformis - Hudfissurer
English: Tarceva 150 mg film-coated tablets
Danish: Tarceva 150 mg filmovertrukne tabletter
English: • If you have further questions, ask your doctor or pharmacist.
Danish: Er du i tvivl, så spørg lægen eller på apoteket.
English: Stomach pain, indigestion and flatulence
Danish: • Mavesmerter, fordøjelsesbesvær, luftafgang
English: - Maintenance NSCLC therapy after first-line chemotherapy (Tarceva administered as monotherapy)
Danish: - Vedligeholdelsesbehandling af NSCLC efter første-linje kemoterapi (administration af Tarceva som monoterapi)
English: 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.
Danish: I ikkekliniske in vitro assays og i in vivo tumormodeller har erlotinibs primære metabolitter OSI-420 og OSI-413, som dannes ved O-demetylering af sidekæderne, samme virkning som erlotinib.
English: Respiratory, thoracic and mediastinal disorders Dyspnoea Cough very common very common
Danish: Luftveje, thorax og mediastinum Dyspnø Hoste
English: Table 2: Summary of ADRs per frequency category: Body System Very common
Danish: Opsummering af bivirkninger pr. frekvensgruppe:
English: NAME OF THE MEDICINAL PRODUCT Tarceva 25 mg film-coated tablets Erlotinib
Danish: LÆGEMIDLETS NAVN Tarceva 25 mg filmovertrukne tabletter Erlotinib
English: Infections and infestations Infection*
Danish: MedDRA termer Infektioner og parasitære sygdomme
English: Tarceva 25 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 25' engraved on one side and is available in pack sizes of 30 tablets.
Danish: Tarceva 25 mg leveres som hvide til gullige, runde, filmovertrukne tabletter præget med ”T 25" på den ene side og fås i pakninger med 30 tabletter.
English: -Liver function test abnormalities
Danish: - Abnorme leverfunktionstests 5
English: 3 Including fatalities, in patients receiving Tarceva for treatment of NSCLC or other advanced solid tumours (see section 4.4).
Danish: 2 Inklusive indadgroende øjenvipper, forøget vækst og fortykkelse af øjenvipper Inklusive dødsfald hos patienter, som fik Tarceva som behandling af NSCLC eller andre fremskredne solide tumorer (se pkt.
English: Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 100' engraved on one side and is available in pack sizes of 30 tablets.
Danish: Tarceva 100 mg leveres som hvide til gullige, runde, filmovertrukne tabletter præget med ”T 100" på den ene side og fås i pakninger med 30 tabletter.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 100 mg film-coated tablets Erlotinib
Danish: LÆGEMIDLETS NAVN Tarceva 100 mg filmovertrukne tabletter Erlotinib
English: Tarceva 150 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 150' engraved on one side and is available in pack sizes of 30 tablets.
Danish: Tarceva 150 mg leveres som hvide til gullige, runde, filmovertrukne tabletter præget med ”T 150" på den ene side og fås i pakninger med 30 tabletter.
English: The primary endpoint was investigator assessed PFS.
Danish: Det primære endepunkt var investigatorvurderet PFS. Effektresultaterne er vist i tabel 3.
English: Tarceva 25 mg film coated tablets
Danish: Tarceva 25 mg filmovertrukne tabletter
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 behandlede):
English: Use of Tarceva in paediatric patients is not recommended.
Danish: Anvendelse af Tarceva til børn anbefales ikke.
English: NAME OF THE MEDICINAL PRODUCT Tarceva 150 mg film-coated tablets Erlotinib
Danish: LÆGEMIDLETS NAVN Tarceva 150 mg filmovertrukne tabletter Erlotinib
English: Metabolism and nutrition disorders Anorexia Weight decreased very common very common
Danish: Metabolisme og ernæring Anoreksi
English: demonstrating a substantial PFS benefit (HR=0.10, 95% CI, 0.04 to 0.25; p<0.0001) and an overall survival HR of 0.83 (95% CI, 0.34 to 2.02).
Danish: Den største fordel blev dog observeret i den prædefinerede eksplorative analyse af patienter med EGFR-aktiverende mutationer (n= 49), som viste en substantiel fordel med hensyn til progressionsfri overlevelse (hazard ratio=0,10; 95 % konfidensinterval 0,04-0,25; p<0,0001) og en hazard ratio for samlet overlevelse på 0,83 (95 % konfidensinterval 0,34-2,02).
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 behandlede):
English: General disorders and administration site conditions Fatigue
Danish: Almene symptomer og reak tioner på administrationsstedet Træthed Pyreksi Rigor
English: Stomatitis
Danish: Kløe
English: White to yellowish, round, biconvex tablets with ‘T 25' engraved on one side.
Danish: Hvide til gullige, runde, bikonvekse tabletter præget med ‘T 25' på den ene side.
English: White to yellowish, round, biconvex tablets with ‘T 100' engraved on one side.
Danish: Hvide til gullige, runde, bikonvekse tabletter præget med ‘T 100' på den ene side.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/05/311/001
English: Renal and urinary disorders insufficiency1 -Nephritis1 -Proteinuria1
Danish: - Nefrit1 - Proteinuri1
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/311/002
English: Each film-coated tablet contains 25 mg erlotinib (as erlotinib hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 25 mg erlotinib (som erlotinibhydrochlorid).
English: White to yellowish, round, biconvex tablets with ‘T 150' engraved on one side.
Danish: Hvide til gullige, runde, bikonvekse tabletter præget med ‘T 150' på den ene side.
English: 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.
Danish: 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.
English: Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 100 mg erlotinib (som erlotinibhydrochlorid).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/05/311/003
English: Each film-coated tablet contains 150 mg erlotinib (as erlotinib hydrochloride).
Danish: Hver filmovertrukken tablet indeholder 150 mg erlotinib (som erlotinibhydrochlorid).
English: Mouth irritation
Danish: • Irritation i munden
English: 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.
Danish: 6 % af de Tarceva-behandlede patienter, og hver af dem medførte afbrydelse af behandlingen hos 1 % af patienterne.
English: • if you develop acute or worsening redness and pain in the eye, increased eye watering, blurred vision and/or sensitivity to light, please tell your doctor or nurse immediately as you may need urgent treatment (see Possible Side Effects below).
Danish: • hvis du oplever akut eller forværret rødme og smerte i øjet, øget tåreflåd, slørret syn og/eller lysfølsomhed.
English: Erlotinib and proteasome inhibitors
Danish: Erlotinib og proteasomhæmmere
English: No studies on the effects on the ability to drive and use machines have been performed; however erlotinib is not associated with impairment of mental ability.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj og betjene maskiner.
English: Hazard Ratio (95% CI)
Danish: Hazard ratio konfidensinterval)
English: Pruritus
Danish: Flatulens
English: What Tarceva is and what it is used for What you need to know before you take Tarceva How to take Tarceva
Danish: Det skal du vide, før du begynder at tage Tarceva Sådan skal du tage Tarceva Bivirkninger
English: Abdominal pain Dyspepsia
Danish: Opkastning Stomatitis Mavesmerter Dyspepsi
English: The degree of reduction is likely to be clinically significant (see sections 4.2, 4.5, 5.1 and 5.2).
Danish: Graden af reduktion er sandsynligvis klinisk signifikant (se pkt.
English: The efficacy results are summarized in Table 3.
Danish: Andre bivirkninger, inklusiv dem fra andre studier, er listet i tabel 2.
English: Eye disorders
Danish: - Ændringer i øjenvipperne
English: Current smokers should be advised to stop smoking (see sections 4.4, 4.5, 5.1 and 5.2).
Danish: Rygere skal derfor rådes til at stoppe med at ryge (se pkt.
English: What is alfacalcidol?
Danish: Hvad er alfacalcidol?
English: [This section should be amended to reflect the following wording]
Danish: [Dette punkt skal ændres, så det afspejler følgende ordlyd]
English: [The following wording should be deleted] “whilst alfacalcidol significantly reduces the frequency of falls in the elderly” [The following wording should be added]
Danish: [Følgende ordlyd skal slettes] ”mens alfacalcidol reducerer faldhyppigheden hos ældre i signifikant grad” [Følgende ordlyd skal tilføjes]
English: Combination of alendronic acid and alfacalcidol (Valebo):
Danish: Kombination af alendronsyre og alfacalcidol (Valebo):
English: Amendments to be included in the relevant sections of the summary of product characteristic and package leaflet
Danish: Ændringer, der skal inkluderes i de relevante punkter i produktresuméet og indlægssedlen
English: Section 5.1: Pharmacodynamic properties [This section should be amended to reflect the following wording]
Danish: 5.1: Farmakodynamiske egenskaber [Dette punkt skal ændres, så det afspejler følgende ordlyd]
English: In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Danish: I nogle kliniske studier er det påvist, at alfacalcidol reducerer faldrisikoen hos ældre.
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
Danish: Den gældende indlægsseddel er den endelige version, der blev nået til enighed om under koordinationsgruppens procedure med de følgende ændringer:
English: Alendronic acid reduces the risk of vertebral and hip fractures.
Danish: Alendronsyre reducerer risikoen for vertebrale frakturer og hoftefrakturer.
English: The valid summary of product characteristics is the final version achieved during the Coordination group procedure with the following amendments:
Danish: Det gældende produktresumé er den endelige version, der blev nået til enighed om under koordinationsgruppens procedure med følgende ændringer:
English: Section 4.1: Therapeutic indications [The wording of this section should be read as below] Treatment of postmenopausal osteoporosis.
Danish: 4.1: Terapeutiske indikationer [Ordlyden i dette punkt skal være som nedenfor]
English: Summary of product characteristic
Danish: Produktresumé
English: - if you are more than 3 months pregnant.
Danish: - hvis du er gravid og mere end 3 måneder henne i din graviditet.
English: Try to take a tablet at the same time each day.
Danish: Det er bedst at indtage tabletten på samme tid hver dag.
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og blisterkort efter ”EXP”.
English: In some cases you may have to stop taking one of the medicines.
Danish: I nogle tilfælde må du stoppe med at tage noget af medicinen.
English: This can lead to permanent vision impairment, if not treated.
Danish: Dette kan føre til permanent nedsat syn, hvis det ikke behandles.
English: Sepsis including fatal outcome
Danish: Sepsis inklusive sepsis med fatalt udfald
English: Terminal elimination half-life was >20 hours.
Danish: Den terminale eliminationshalveringstid var >20 timer.
English: - Medicines to increase blood pressure, such as noradrenaline.
Danish: - Medicin til at øge blodtrykket, såsom noradrenalin.
English: Therefore, it is not expected to potentiate bradykinin-mediated adverse effects.
Danish: Derfor forventes det ikke, at bradykininmedierede bivirkninger potenseres.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data):
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (Hyppigheden kan ikke bestemmes ud fra forhåndenværende data):
English: The recommended dose of Tolucombi is one tablet a day.
Danish: Den anbefalede dosis af Tolucombi er én tablet dagligt.
English: - Calcium supplements and/or vitamin D supplements.
Danish: - Kalktilskud og/eller D-vitamintilskud.
English: - If you have had skin cancer or if you develop an unexpected skin lesion during the treatment.
Danish: - Hvis du har haft hudkræft, eller hvis du udvikler en uventet hudlæsion under behandlingen.
English: See also information under the heading “Do not take Tolucombi”.
Danish: Se også information under overskriften ”Tag ikke Tolucombi”.
English: It is important that you take Tolucombi every day until your doctor tells you otherwise.
Danish: Det er vigtigt, at du tager Tolucombi hver dag, så længe din læge ikke siger andet.
English: - Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Danish: - Amantadin (medicin til behandling af Parkinsons sygdom, som også bruges til at behandle eller forebygge visse sygdomme forårsaget af virus).