FrancophonIA/ELRC3.0 huggingface dataset:
English: Decreased or sudden hearing loss has been noted in some patients taking tadalafil.
Danish: Der er registreret hørenedsættelse eller høretab hos nogle patienter, som tager tadalafil.
English: In dogs given tadalafil daily for 6 to 12 months at doses of 25 mg/kg/day (resulting in at least a 3-fold greater exposure [range 3.7 - 18.6] than seen in humans given a single 20 mg dose) and above, there was regression of the seminiferous tubular epithelium that resulted in a decrease in spermatogenesis in some dogs.
Danish: Hos hunde, som fik tadalafil dagligt i 6 til 12 måneder i doser på 25 mg/kg/dag (hvilket resulterer i en mindst 3 gange større eksponering (fra 3,7 - 18,6) end den, som ses hos mennesker ved en enkelt dosis på 20 mg) og højere, sås regression af det seminiferøse tubulære epithel, som medførte nedsat spermatogenese hos nogle hunde.
English: If you take more Tadalafil Mylan than you should Contact your doctor.
Danish: Hvis du har taget for meget Tadalafil Mylan Kontakt din læge.
English: PDE5 inhibitors, such as Tadalafil Mylan, have been shown to increase the hypotensive effects of this medicine.
Danish: PDE5-hæmmere, så som Tadalafil Mylan, har vist sig at øge den blodtrykssænkende virkning af denne medicin.
English: The European Medicines Agency has waived the obligation to submit the results of studies in all subsets of the paediatric population in the treatment of the erectile dysfunction.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med tadalafil i alle undergrupper af den pædiatriske population med erektil dysfunktion (se pkt.
English: Tadalafil Mylan 10 mg and 20 mg film-coated tablets cannot be divided and should be swallowed whole.
Danish: Tadalafil Mylan 10 mg og 20 mg filmovertrukne tabletter kan ikke deles og skal synkes hele.
English: Do not take Tadalafil Mylan more than once a day.
Danish: Tag ikke Tadalafil Mylan mere end én gang om dagen.
English: The improvements in the erectile function domain of the international index of erectile function and the total international prostate symptom score in this study were 6.5 and -6.1 with tadalafil 5 mg compared to 1.8 and -3.8 with placebo, respectively.
Danish: Forbedringerne i scoren for erektil funktion i international index of erectile function og den totale international prostate symptom score i dette studie var henholdsvis 6,5 og -6,1 med tadalafil 5 mg sammenlignet med henholdsvis 1,8 og -3,8 for placebo.
English: Tadalafil has negligible influence on the ability to drive or use machines.
Danish: Tadalafil påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Mylan Denmark ApS Tel: + 45 28 11 69 32
Danish: Mylan Denmark ApS Tlf: +45 28 11 69 32
English: In a subsequent study, 217 patients who were treatment-naïve to PDE5 inhibitors were randomised to tadalafil 5 mg once a day vs. placebo.
Danish: I et efterfølgende studie blev 217 patienter, som var behandlingsnaive med hensyn til PDE5-inhibitorer, randomiseret til tadalafil 5 mg en gang dagligt versus placebo.
English: Tadalafil is also > 10,000-fold more potent for PDE5 than for PDE7 through PDE10.
Danish: Tadalafil er også > 10.000 gange mere potent over for PDE5 end for PDE7-PDE10.
English: Less than 0.0005% of the administered dose appeared in the semen of healthy subjects.
Danish: Hos raske forsøgspersoner genfandtes mindre end 0,0005 % af den administrerede dosis i sperma.
English: If you forget to take Tadalafil Mylan
Danish: Hvis du har glemt at tage Tadalafil Mylan
English: The maintenance of the effect was evaluated in an open-label extension to one of the studies, which showed that the improvement in total international prostate symptom score seen at 12 weeks was maintained for up to 1 additional year of treatment with tadalafil 5 mg.
Danish: Dette viste, at den forbedring i den totale international prostate symptom score, som blev set ved 12 uger, blev opretholdt i op til 1 år yderligere ved behandling med tadalafil 5 mg.
English: These include: - migraine, swelling of the face, serious allergic reaction which causes swelling of the face or throat,
Danish: Disse bivirkninger omfatter: - Migræne, hævelse i ansigtet, alvorlige allergiske reaktioner, som medfører hævelse i ansigtet eller svælget, alvorligt hududslæt, lidelser, der påvirker blodforsyningen til øjnene,
English: Gastro-oesophageal reflux,
Danish: Gastro-øsofageal refluks
English: Stevens-Johnson syndrome Exfoliative dermatitis Hyperhydrosis (sweating)
Danish: Exfoliativ dermatitis Hyperhydrose (sveden)
English: When tadalafil 10 mg was administered with theophylline (a non-selective phosphodiesterase inhibitor) in a clinical pharmacology study, there was no pharmacokinetic interaction.
Danish: Når tadalafil 10 mg blev administreret med theophyllin (en non-selektiv phosphodiesterase inhibitor) i en klinisk farmakologisk undersøgelse, var der ingen farmakokinetisk interaktion.
English: In the two primary efficacy studies of general populations, the mean per-subject proportion of successful intercourse attempts were 57 and 67% on tadalafil 5 mg, 50% on tadalafil 2.5 mg as compared to 31 and 37% with placebo.
Danish: I de to primære undersøgelser af effekt hos den generelle population var den gennemsnitlige andel af vellykkede forsøg på samleje per patient 57 % og 67 % på tadalafil 5 mg og 50 % på tadalafil 2,5 mg sammenlignet med 31 og 37 % med placebo.
English: Tadalafil Mylan 10 mg and 20 mg is intended for use prior to anticipated sexual activity and is not recommended for continuous daily use.
Danish: Tadalafil Mylan 10 mg og 20 mg er beregnet til brug før forventet seksuel aktivitet og anbefales ikke til vedvarende daglig brug.
English: Retinal vascular occlusion
Danish: Retinal vaskulær okkusion
English: - removal of all or part of the prostate gland in which nerves of the prostate are cut (radical non -nerve sparing prostatectomy).
Danish: - Har fået fjernet hele eller dele af blærehalskirtlen, og nerverne til blærehalskirtlen derved er blevet skåret over (radikal ikke-nervebevarende prostatektomi).
English: Tadalafil Mylan is a treatment for adult men with erectile dysfunction.
Danish: Tadalafil Mylan er en behandling til voksne mænd med erektil dysfunktion.
English: Tadalafil Mylan tablets are for oral use in men only.
Danish: Tadalafil Mylan tabletterne er til oral brug og kun til mænd.
English: Ketoconazole (400 mg daily) increased tadalafil (20 mg) exposure (AUC) 4-fold and Cmax by 22%.
Danish: Ketoconazol (400 mg dagligt) øgede tadalafil (20 mg dosis) eksponeringen (AUC) 4 gange og Cmax med 22 %.
English: Tadalafil does not treat prostate cancer.
Danish: Tadalafil kan ikke anvendes til behandling af kræft i blærehalskirtlen.
English: It is not known if tadalafil is effective in patients who have had: - pelvic surgery.
Danish: Det vides ikke, om tadalafil virker hos patienter, som: - Er blevet opereret i bækkenet.
English: Tadalafil and other treatments for erectile dysfunction
Danish: Tadalafil og andre behandlinger for erektil dysfunktion
English: Thus, in a patient prescribed any dose of tadalafil (2.5 mg-20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered.
Danish: Derfor bør der hos en patient med hvilken som helst ordineret dosis af tadalafil (2,5 mg - 20 mg), hvor administration af nitrat skønnes som en medicinsk nødvendighed i en livstruende situation, mindst være gået 48 timer efter den sidste dosis tadalafil før administration af nitrat overvejes.
English: Croscarmellose sodium Magnesium stearate Sodium laurilsulfate Silica, colloidal anhydrous
Danish: Croscarmellosenatrium Magnesiumstearat Natriumlaurilsulfat Silica, kolloid vandfri
English: If the effect of this dose is too weak your doctor may increase the dose to 20 mg. Tadalafil Mylan is for oral use.
Danish: Hvis effekten af denne dosis er for svag, kan din læge øge dosis til 20 mg.
English: In the study in patients with erectile dysfunction secondary to diabetes, the mean per-subject proportion of successful attempts were 41 and 46% on tadalafil 5 mg and 2.5 mg, respectively, as compared to 28% with placebo.
Danish: I studiet med patienter, der havde erektil dysfunktion sekundært til diabetes, var den gennemsnitlige andel af vellykkede forsøg per patient henholdsvis 41 og 46 % på tadalafil 5 mg og 2,5 mg, sammenlignet med 28 % med placebo.
English: You should not take Tadalafil Mylan more than once a day.
Danish: Du må ikke tage Tadalafil Mylan mere end én gang dagligt.
English: Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (ritonavir, saquinavir, ketoconazole, itraconazole, and erythromycin) as increased tadalafil exposure (AUC) has been observed if the medicinal products are combined (see section 4.5).
Danish: Der bør udvises forsigtighed ved ordination af tadalafil til patienter, som er i behandling med potente CYP3A4 inhibitorer (ritonavir, saquinavir, ketoconazol, itraconazol og erythromycin), idet øget tadalafil eksponering (AUC) er blevet observeret, hvis lægemidlerne kombineres (se pkt.
English: Tell your doctor or pharmacist if you are already taking: - an alpha blocker (used to treat high blood pressure or urinary symptoms associated with benign prostatic hyperplasia).
Danish: Fortæl lægen eller apotekspersonalet hvis du allerede tager: - Alfa-blokkere(bruges til behandling af for højt blodtryk eller urinvejssymptomer forbundet med godartet forstørrelse af blærehalskirtlen).
English: As a precautionary measure, it is preferable to avoid the use of Tadalafil Mylan during pregnancy.
Danish: Undgåelse af brug af Tadalafil Mylan under graviditet er at foretrække som en forholdsregel.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 56 filmovertrukne tabletter 84 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Prolonged erections Priapism, Penile haemorrhage, Haematospermia
Danish: Langvarige erektioner Priapisme, Blødning fra penis, Hæmatosmermia
English: What Tadalafil Mylan contains - The active substance is tadalafil.
Danish: Tadalafil Mylan indeholder: - Aktivt stof: Tadalafil.
English: The mean persubject proportion of successful sexual intercourse attempts was 71.9% with tadalafil 5 mg compared to 48.3% with placebo.
Danish: Den gennemsnitlige andel af vellykkede samlejer pr. forsøgsperson var 71,9 % for tadalafil 5 mg sammenlignet med 48,3 % for placebo.
English: 28 film-coated tablets 56 film-coated tablets
Danish: 28 filmovertrukne tabletter 56 filmovertrukne tabletter
English: Sodium content
Danish: Natrium indhold
English: Other medicines and Tadalafil Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Tadalafil Mylan Fortæl det til lægen eller apotekspersonalet, hvis du bruger anden medicin eller for nylig har brugt anden medicin eller planlægger at bruge anden medicin.
English: Tadalafil Mylan is not indicated for use by women.
Danish: Tadalafil Mylan er ikke indiceret til anvendelse hos kvinder.
English: The table below lists the adverse reactions observed from spontaneous reporting and in placebo controlled clinical trials (comprising a total of 8022 patients on tadalafil and 4422 patients on placebo) for on-demand and once-a-day treatment of erectile dysfunction and the once-a-day treatment of benign prostatic hyperplasia.
Danish: Nedenstående tabel angiver observerede bivirkninger fra spontane indberetninger samt fra placebokontrollerede kliniske studier (der omfatter i alt 8.022 patienter, der har modtaget tadalafil og 4.422 patienter, der har modtaget placebo) ved behandling af erektil dysfunktion (dosering ved behov eller én gang daglig) og benign prostatahyperplasi (dosering én gang daglig).
English: A selective inhibitor of CYP3A4, ketoconazole (200 mg daily), increased tadalafil (10 mg) exposure (AUC) 2-fold and Cmax by 15%, relative to the AUC and Cmax values for tadalafil alone.
Danish: En selektiv inhibitor af CYP3A4, ketoconazol (200 mg dagligt), øgede tadalafil (10 mg dosis) eksponeringen (AUC) 2 gange og Cmax med 15 % i forhold til AUC- og Cmax-værdierne for tadalafil alene.
English: If you get any side effects, talk to your doctor or pharmacist.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge ellerapotektspersonalet .
English: Ear and labyrinth disorders
Danish: Lidelser i øre- og labyrint
English: Major classes of antihypertensive medicinal products were studied, including calcium channel blockers (amlodipine), angiotensin converting enzyme (ACE) inhibitors (enalapril), beta-adrenergic receptor blockers (metoprolol), thiazide diuretics (bendroflumethiazide), and angiotensin II receptor blockers (various types and doses, alone or in combination with thiazides, calcium channel blockers, beta-blockers, and/or alpha-blockers).
Danish: Væsentlige klasser af antihypertensiva blev undersøgt, heriblandt calciumantagonister (amlodipin), angiotensinkonverterende enzym (ACE) hæmmere (enalapril), betablokkere (metoprolol), thiazid diuretika (bendrofluazid) og angiotensin II blokkere (forskellige typer og doser, alene eller i kombination med thiazider, calciumantagonister, betablokkere og/eller alfablokkere).
English: 5-alpha reductase inhibitors
Danish: 5-alfa-reduktase-hæmmere
English: In the primary efficacy studies, 75% of intercourse attempts were successful in tadalafil treated patients as compared to 32% with placebo.
Danish: I de primære undersøgelser af effekt var 75 % af samlejeforsøgene vellykkede hos patienter, som blev behandlet med tadalafil, sammenlignet med 32 % for placebo.
English: Tadalafil Mylan contains lactose.
Danish: Tadalafil Mylan indeholder lactose.
English: Therefore, administration of tadalafil to patients who are using any form of organic nitrate is contraindicated (see section 4.3).
Danish: Derfor er administration af tadalafil kontraindiceret til patienter, som bruger enhver form for organisk nitrat (se pkt.
English: Tadalafil improves blood flow to, and relaxes the muscles of, the prostate and bladder which may reduce symptoms of benign prostatic hyperplasia.
Danish: Tadalafil forbedrer blodgennemstrømningen til og afslapper muskulaturen i blærehalskirtlen og blæren, hvilket kan reducere symptomerne på godartet forstørret blærehalskirtel.
English: Lactose monohydrate Hypromellose (E464) Titanium dioxide (E171) Iron oxide yellow (E172) Triacetin
Danish: Lactosemonohydrat Hypromellose (E464) Titandioxid (E171) Gul jernoxid (E172) Triacetin
English: See also section 5.1.
Danish: 5.1 og 5.3).
English: Visual field defect, Swelling of eyelids, Conjunctival hyperaemia, Non-arteritic anterior ischemic optic neuropathy (NAION)
Danish: Hævelse af øjenlåg, Konjunktival hyperæmi, Non-arteritis anterior iskæmisk opticusneuropati (NAION)
English: Lactose, anhydrous Poloxamer 188
Danish: Poloxamer 188
English: Gastrointestinal disorders Dyspepsia
Danish: Gastrointestinale lidelser
English: Tadalafil exposure (AUC) in subjects with mild and moderate hepatic impairment (Child-Pugh Class A and B) is comparable to exposure in healthy subjects when a dose of 10 mg is administered.
Danish: Eksponeringen for tadalafil (AUC) hos forsøgspersoner med mild og moderat leverfunktionsnedsættelse (Child-Pugh klasse A og B) er sammenlignelig med eksponeringen hos raske forsøgspersoner ved administration af en dosis på 10 mg. Der er begrænsede kliniske data vedrørende sikkerheden af tadalafil hos patienter med svær leverinsufficiens (Child-Pugh klasse C).
English: The most commonly reported adverse reactions in patients taking tadalafil for the treatment of erectile dysfunction or benign prostatic hyperplasia were headache, dyspepsia, back pain and myalgia, in which the incidences increase with increasing dose of tadalafil.
Danish: De hyppigst rapporterede bivirkninger hos patienter, som tog tadalafil til behandling af erektil dysfunktion eller benign prostatahyperplasi, var hovedpine, dyspepsi, rygsmerter og myalgi, hvor hyppigheden steg ved øget dosis af tadalafil.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) per tablet, og er derfor i det væsentligste natrium frit.
English: Tadalafil Mylan should not be used during breast feeding.
Danish: Tadalafil Mylan bør ikke anvendes under amning.
English: The mean per-subject proportion of successful sexual intercourse attempts was 68% for tadalafil patients compared to 52% for patients on placebo.
Danish: Den gennemsnitlige andel af vellykkede forsøg på samleje var 68 % for tadalafilpatienter sammenlignet med 52 % for patienter på placebo.
English: Icepharma hf Tel: + 354 540 8000
Danish: Icepharma nf Tel: +354 540 8000
English: Grapefruit juice may affect how well Tadalafil Mylan will work and should be taken with caution.
Danish: Brug af Tadalafil Mylan sammen med drikke og alkohol Grapefrugtjuice kan påvirke virkningen af Tadalafil Mylan og bør indtages med forsigtighed.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side affects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Tadalafil Mylan is available as 2.5, 5, 10, and 20 mg film-coated tablets for oral use.
Danish: Tadalafil Mylan er tilgængeligt i tabletstyrker på 2,5, 5, 10 og 20 mg til oral brug.
English: For the treatment of erectile dysfunction using on-demand tadalafil the recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Danish: Når tadalafil bruges til behandling efter behov af erektil dysfunktion, er den anbefalede dosis af tadalafil 10 mg, som tages før forventet seksuel aktivitet, enten med eller uden mad.
English: 2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Danish: 2 filmovertrukne tabletter 4 filmovertrukne tabletter 8 filmovertrukne tabletter 12 filmovertrukne tabletter 24 filmovertrukne tabletter
English: Tadalafil Mylan 5 mg is available in blister packs containing 14, 28, 30, 56, 84 and 98 tablets.
Danish: Tadalafil Mylan 5 mg fås i blisterpakninger, der indeholder 14, 28, 30, 56, 84 og 98 tabletter..
English: Tadalafil Mylan is not intended for use by women.
Danish: Tadalafil Mylan er ikke beregnet til kvinder.
English: 4 film-coated tablets 12 film-coated tablets 24 film-coated tablets
Danish: 4 filmovertrukne tabletter 12 filmovertrukne tabletter 24 filmovertrukne tabletter
English: What you need to know before you take Tadalafil Mylan
Danish: Det skal du vide, før du begynder at tage Tadalafil Mylan
English: General disorders and administration site conditions Chest pain
Danish: Generelle symptomer og forstyrrelser ved applikationssted Brystsmerter
English: Although it is not known if the event is directly related to tadalafil, if you experience decreased or sudden hearing loss, stop taking Tadalafil Mylan and contact your doctor immediately.
Danish: Selvom det ikke er kendt, om dette er direkte relateret til tadalafil, skal du stoppe med at tage Tadalafil Mylan og omgående kontakte din læge, hvis du oplever hørenedsættelse eller et pludseligt høretab.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Tadalafil Mylan bør ikke anvendes til patienter med arvelig galactoseintolerans, total lactasemangel eller glucose/galactosemalabsorption.
English: Tadalafil Mylan contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Tadalafil Mylan indeholder under 1 mmol natrium (23 mg) per tablet og er derfor i det væsentligste natrium frit.
English: Tadalafil Mylan 2.5 mg is available in blister packs containing 28 and 56 tablets.
Danish: Tadalafil Mylan 2,5 mg fås i blisterpakninger med 28 og 56 tabletter.
English: There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Danish: Der er begrænsede kliniske data vedrørende sikkerheden af tadalafil hos patienter med svær leverinsufficiens (Child-Pugh klasse C).
English: Some additional rare side effects have been reported in men taking tadalafil that were not seen in clinical trials.
Danish: Andre sjældne bivirkninger, som ikke blev set i afprøvninger på patienter, er set hos mænd, der tog tadalafil.
English: There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Danish: Der er begrænsede kliniske data omkring sikkerheden af enkelt-dosis administration af tadalafil hos patienter med svær leverinsufficiens (Child-Pugh klasse C).
English: - if you ever had loss of vision because of non-arteritic anterior ischemic optic neuropathy (NAION), a condition described as “stroke of the eye”.
Danish: - hvis du på noget tidspunkt tidligere har haft tab af synet på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION).
English: Tachycardia, Palpitations
Danish: Takykardi, Hjertebanken
English: Nervous system disorders Headache
Danish: Lidelser i det centrale og perifere nervesystem Hovedpine
English: Film-coat: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), iron oxide yellow (E172), triacetin.
Danish: Filmovertræk: lactosemonohydrat, hypromellose (E464), titandioxid (E171), gul jernoxid (E172), triacetin.
English: Excipient with known effect: Each film-coated tablet contains 118.96 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 118,96 mg lactose.
English: Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil.
Danish: Der blev udført tre kliniske studier med 1054 patienter i hjemlige omgivelser for at bestemme virkningsperioden for tadalafil.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://ema.europa.eu.
English: - a 5-alpha reductase inhibitor (used to treat benign prostatic hyperplasia).
Danish: - En 5-alfa reduktase-hæmmer (bruges til behandling af godartet forstørrelse af blærehalskirtlen).
English: Three clinical studies were conducted in 1054 patients in an at-home setting to define the period of responsiveness to tadalafil on demand.
Danish: Der blev udført tre kliniske studier med 1054 patienter i hjemlige omgivelser for at bestemme virkningsperioden for tadalafil taget efter behov.
English: The recommended dose of tadalafil is 10 mg taken prior to anticipated sexual activity and with or without food.
Danish: Den anbefalede dosis af tadalafil er 10 mg, som tages før forventet seksuel aktivitet, enten med eller uden mad.
English: Tadalafil has been shown to significantly improve the ability of obtaining a hard erect penis suitable for sexual activity.
Danish: Evnen til at få en hård, rejst penis egnet til seksuel aktivitet har vist sig at blive væsentligt forbedret med tadalafil.
English: Hypotension Hypertension Respiratory, thoracic and mediastinal disorders Nasal congestion
Danish: Respiratoriske lidelser, lidelser i thorax og mediastinum Tilstoppet næse
English: Tadalafil Mylan 20 mg is available in blister packs containing 2, 4, 8, 12 and 24 tablets.
Danish: Tadalafil Mylan 20 mg fås i blisterpakninger, der indeholder 2, 4, 8, 12 og 24 tabletter.
English: Excipient with known effect: Each film-coated tablet contains 59.48 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 59,48 mg lactose.