FrancophonIA/ELRC3.0 huggingface dataset:
English: You or your caregiver should also immediately inform your doctor of any changes in behaviour or mood and of any suicidal thoughts you may have.
Danish: Du eller din plejer skal også straks fortælle din læge, hvis du får humørsvingninger eller ændrer adfærd, eller hvis du får en hvilken som helst form for selvmordstanker.
English: Two six-month supportive studies (M2-127 and M2-128) included patients with a history of COPD for at least 12 months prior to baseline.
Danish: To understøttende 6 måneders-studier (M2-127 og M2-128) inkluderede patienter med KOL af mindst 12 måneders varighed.
English: A similar reduction was achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.77; 95% CI: 0.60 to 0.99) and in the subgroup not treated with LAMA (rate ratio: 0.71; 95% CI: 0.42 to 1.20).
Danish: En tilsvarende reduktion blev opnået i undergruppen af patienter, som var i samtidig behandling med LAMA (risiko ratio: 0,77; 95 % CI: 0,60-0,99) og i undergruppen, som ikke blev behandlet med LAMA (risiko ratio: 0,71; 95 % CI: 0,42-1,20).
English: You may take this medicine with or without food.
Danish: Du kan tage dette lægemiddel sammen med et måltid eller mellem måltiderne.
English: Experience in patients with latent infections such as tuberculosis, viral hepatitis, herpes viral infection and herpes zoster is limited.
Danish: Erfaring med patienter med latente infektioner så som tuberkulose, viral hepatitis, viral herpesinfektion og herpes zoster er begrænset.
English: A total of 1323 patients were randomised to receive roflumilast 500 micrograms once a day for 12 weeks (n=443), roflumilast 500 micrograms every other day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=439), or roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (n=441).
Danish: I alt 1323 patienter blev randomiseret til at få roflumilast 500 mikrogram 1 gang dagligt i 12 uger (n=443), roflumilast 500 mikrogram hver anden dag i 4 uger efterfulgt af roflumilast 500 mikrogram 1 gang dagligt i 8 uger (n=439), eller roflumilast 250 mikrogram 1 gang dagligt i 4 uger efterfulgt af roflumilast 500 mikrogram 1 gang dagligt i 8 uger (n=441).
English: What Daxas is and what it is used for What you need to know before you take Daxas How to take Daxas
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du begynder at tage Daxas Sådan skal du tage Daxas Bivirkninger
English: Muscle spasms and weakness
Danish: Muskelspasmer og muskelsvaghed Myalgi
English: Rare side effects (may affect up to 1 in 1,000 people) - male breast enlargement - decreased sense of taste - respiratory tract infections (excluding pneumonia) - bloody stools, constipation - elevation of liver or muscle enzymes (seen in blood tests) - wheals (urticaria).
Danish: Sjældne bivirkninger (forekommer hos 1 ud af 1.000 personer) - brystforstørrelse hos mænd - nedsat smagssans - infektioner i luftvejene (eksklusive lungebetændelse) - blodig afføring, forstoppelse - forhøjet niveau af lever- eller muskelenzymer (set i blodprøver) - hævelse og kløen i huden (nældefeber).
English: Lactose monohydrate Maize starch Povidone
Danish: Lactosemonohydrat Majsstivelse Povidon
English: Concomitant treatment with long acting muscarinic antagonists (LAMA) A higher incidence of weight decrease, decreased appetite, headache and depression was observed during Study RO-2455-404-RD in patients receiving concomitant roflumilast and long-acting muscarinic antagonists (LAMA) plus concomitant inhaled corticosteroids (ICS) and long acting B2 agonists (LABA) compared to those treated only with concomitant roflumilast, ICS and LABA.
Danish: Samtidig behandling med langtidsvirkende muskarinreceptor-antagonister (LAMA) I studie RO-2455-404-RD blev der observeret en højere forekomst af vægttab, appetitløshed, hovedpine og depression hos patienter, der samtidig fik roflumilast og en langtidsvirkende muskarinreceptor-antagonist (LAMA) plus inhalationskortikosteroid (ICS) og langtidsvirkende beta 2agonist (LABA), sammenlignet med gruppen, som kun fik samtidig behandling med roflumilast, ICS og LABA.
English: The limited experience in patients with latent infections such as tuberculosis, viral hepatitis or herpes infections.
Danish: Der er begrænset erfaring hos patienter med latente infektioner såsom tuberkulose, viral hepatitis og herpesinfektioner.
English: Roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 51 ml (pre-bronchodilator FEV1, p<0.0001), and by 53 ml (post-bronchodilator FEV1, p<0.0001).
Danish: Roflumilast 500 mikrogram 1 gang daglig forbedrede lungefunktionen (FEV1) signifikant med, gennemsnitligt 51 ml før bronkodilatation (p<0,0001) og 53 ml efter bronkodilatation (p<0,0001) sammenlignet med placebo.
English: Reductions were achieved in the subgroup of patients concomitantly treated with LAMA (rate ratio: 0.88; 95% CI: 0.75 to 1.04) and in the subgroup not treated with LAMA (rate ratio: 0.83; 95% CI: 0.62 to 1.12).
Danish: Reduktioner blev opnået i undergruppen af patienter i samtidig behandling med LAMA (risiko ratio: 0,88; 95 % CI: 0,75-1,04) og i undergruppen, som ikke blev behandlet med LAMA (risiko ratio: 0,83; 95 % CI: 0,62-1,12).
English: Uncommon side effects (may affect up to 1 in 100 people) - trembling, sensation of spinning head (vertigo), dizziness - sensation of rapid or irregular heartbeat (palpitations) - gastritis, vomiting - reflux of stomach acid to the gullet (acid regurgitations), indigestion - rash - muscle pain, muscle weakness or cramps - back pain - feeling of weakness or tiredness, feeling unwell.
Danish: Ikke almindelige bivirkninger (forekommer hos 1 ud af 100 personer) - rysten, en fornemmelse af at omgivelserne drejer rundt (vertigo), svimmelhed - fornemmelse af hurtig eller uregelmæssig hjerterytme (hjertebanken) - mavekatar, opkastning - refluks af mavesyre til spiserøret (sure opstød), fordøjelsesbesvær - udslæt - muskelsmerter eller -kramper, kraftesløshed - rygsmerter - følelse af svaghed eller træthed; følelse af utilpashed.
English: The tested dose of fluvoxamine was 50 mg. A combination of roflumilast with these active substances might lead to an increase of exposure and persistent intolerability.
Danish: Derfor kan behandling med roflumilast i kombination med disse aktive substanser føre til øget eksponering og vedvarende intolerans over for behandlingen.
English: While adverse reactions like diarrhoea, nausea, abdominal pain and headache mainly occur within the first weeks of therapy and mostly resolve on continued treatment, roflumilast treatment should be reassessed in case of persistent intolerability.
Danish: Bivirkninger som diarré, kvalme, mavesmerter og hovedpine opstår hovedsageligt inden for de første ugers behandling og aftager for det meste ved fortsat behandling.
English: • After 28 days - the recommended maintenance dose is one 500 micrograms tablet once daily.
Danish: • Efter 28 dage - den anbefalede vedligeholdelsesdosis er 1 tablet med 500 mikrogram en gang dagligt.
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C should not take roflumilast (see section 4.3).
Danish: Patienter med moderat eller svært nedsat leverfunktion klassificeret som Child-Pugh B eller C bør ikke tage roflumilast (se pkt.
English: In a pooled analysis of the one-year studies M2-124 and M2-125, roflumilast 500 micrograms once daily significantly improved lung function compared to placebo, on average by 48 ml (pre-bronchodilator FEV1, primary endpoint, p<0.0001), and by 55 ml (post-bronchodilator FEV1, p<0.0001).
Danish: En poolet analyse af 1-års-studierne M2-124 og M2-125 viste, at roflumilast 500 mg 1 gang daglig forbedrede lungefunktionen signifikant sammenlignet med placebo med gennemsnitligt 48 ml (FEV1 før bronkodilatation, primære endepunkt, p<0,0001) og 55 ml (FEV1 efter bronkodilatation, p<0,0001).
English: Patients with moderate or severe hepatic impairment classified as Child-Pugh B or C must not take Daxas (see section 4.3).
Danish: Patienter med moderat eller svært nedsat leverfunktion klassificeret som Child-Pugh B eller C må ikke tage Daxas (se pkt.
English: - The other ingredients are: - Core: lactose monohydrate (see section 2 under “Daxas contains lactose”), maize starch, povidone, magnesium stearate, - Coating: hypromellose, Macrogol 4000, titanium dioxide (E171), and iron oxide yellow (E172).
Danish: Hver filmovertrukken tablet indeholder 500 mikrogram roflumilast - De øvrige indholdsstoffer er: o Tabletkerne: lactosemonohydrat (se punkt 2 under ”Daxas indeholder lactose”), majsstivelse, povidon, magnesiumstearat o Filmovertræk: hypromellose, Macrogol 4000, titandioxid (E171), gul jernoxid (E172)
English: Malaise Asthenia Fatigue
Danish: Utilpashed Asteni Træthed
English: Daxas is indicated for maintenance treatment of severe chronic obstructive pulmonary disease (COPD) (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.
Danish: Daxas anvendes som vedligeholdelsesbehandling hos voksne patienter med svær, kronisk obstruktiv lungesygdom (KOL) (FEV1 efter bronkodilatation mindre end 50% af forventet) associeret med kronisk bronkitis og med tidligere gentagne eksacerbationer.
English: Patients and caregivers should be instructed to notify the prescriber of any suicidal ideation (see also section 4.4).
Danish: Patienter, pårørende og plejere skal informeres om at kontakte ordinerende læge ved enhver tanke om selvmord (se også pkt.
English: The recommended starting dose is one tablet of 250 micrograms roflumilast to be taken once daily, for 28 days.
Danish: Startdosering Den anbefalede startdosis er én tablet på 250 mikrogram roflumilast en gang dagligt i 28 dage.
English: Caution is necessary in Child-Pugh A patients (see section 4.2).
Danish: Forsigtighed er nødvendig hos Child-Pugh A-patienter (se pkt.
English: In Study RO-2455-404-RD when compared with the overall population, the total PDE4 inhibitory activity determined from ex vivo unbound fractions was found to be 15% higher in patients ≥75 years of age, and 11% higher in patients with baseline body weight <60 kg (refer to section 4.4).
Danish: Sammenlignet med den generelle population blev den samlede PDE4-hæmmende aktivitet, bestemt ud fra ex vivo ubundne fraktioner, i studie RO-2455-404-DR fundet at være 15 % højere hos patienter ≥ 75 år og 11 % højere hos patienter med kropsvægt < 60 kg ved baseline (se pkt.
English: The lack of experience in patients with HIV infection or active hepatitis, with severe immunological diseases (e.g.multiple sclerosis, lupus erythematosus, multifocal leukoencephalopathy) or treated with immunosuppressive therapy (other than short-term systemic corticosteroids) and that Daxas should not be initiated or should be stopped in these patients.
Danish: Den manglende erfaring hos patienter med HIV-infektion eller aktiv hepatitis, med alvorlige immunologiske sygdomme (multipel sklerose, lupus erythematosus, multifokal leukoenkefalopati) eller patienter i immunsupprimerende behandling (andre end korttids-systemiske kortikosteroider).
English: All patients should be informed about the risks of Daxas and the precautions for safe use and should be given a patient card before starting Daxas.
Danish: Alle patienter skal informeres om risici forbundet med behandling med Daxas og om forholdsregler for sikker brug.
English: Roflumilast should not be used during breast-feeding.
Danish: Roflumilast må ikke tages i ammeperioden.
English: - a medicine containing fluvoxamine (a medicine to treat anxiety disorders and depression), enoxacin (a medicine to treat bacterial infections) or cimetidine (a medicine to treat stomach ulcers or heartburn).
Danish: (lægemiddel til behandling af bakterieinfektioner) eller cimetidin (lægemiddel til behandling af mavesår og halsbrand).
English: Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation.
Danish: Patienter, pårørende og plejere skal informeres om at kontakte ordinerende læge ved enhver ændring i adfærd eller humør og ved selvmordslignende tanker.
English: Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. phenobarbital, carbamazepine, phenytoin) may reduce the therapeutic efficacy of roflumilast.
Danish: Derfor kan potente CYP-induktorer (fx phenobarbital, carbamazepin, phenytoin) reducere den terapeutiske effekt af roflumilast, hvorfor roflumilast frarådes til patienter i behandling med potente CYP-induktorer.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller på apotekspersonalet, hvis der er noget, du er i tvivl om.
English: Renal impairment No dose adjustment is necessary.
Danish: Nedsat nyrefunktion Der er ikke behov for dosisjustering.
English: • For the first 28 days - the recommended starting dose is one 250 micrograms tablet once daily.
Danish: • I de første 28 dage - den anbefalede startdosis er 1 tablet med 250 mikrogram en gang dagligt.
English: How to take Daxas
Danish: Sådan skal du tage Daxas
English: Each Daxas 250 micrograms tablet contains 250 micrograms roflumilast.
Danish: Hver Daxas 250 mikrogram tablet indeholder 250 mikrogram roflumilast.
English: The rate of experiencing a TEAE of interest for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.
Danish: Andelen, der oplevede en TEAE af interesse og fik 500 mikrogram hver anden dag i 4 uger efterfulgt af 500 mikrogram 1 gang dagligt i 8 uger, var ikke statistisk signifikant forskellig i forhold til de, der fik 500 mikrogram 1 gang dagligt i 12 uger.
English: The reduction of moderate or severe exacerbations with roflumilast and LABA compared to placebo and LABA was on average 21% (p=0.0011).
Danish: For patienter behandlet med roflumilast og LABA reduceredes antallet af moderate eller svære eksacerbationer gennemsnitligt med 21% (p=0,0011) sammenlignet med patienter behandlet med placebo- og LABA.
English: A higher incidence of sleep disorders (mainly insomnia) in patients ≥75 years or older was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (3.9% vs 2.3%).
Danish: I studie RO-2455-404-RD blev der observeret en højere forekomst af søvnforstyrrelser (hovedsageligt søvnløshed) hos patienter i alderen ≥ 75 år og derover i roflumilast-armen sammenlignet med patienter i placebo-armen (3,9 % kontra 2,3 %).
English: Roflumilast is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Danish: Behandling med roflumilast frarådes til patienter med depression associeret med selvmordslignende tanker eller adfærd i anamnesen.
English: Daxas is not recommended in patients with a history of depression associated with suicidal thinking or behaviour.
Danish: Daxas anbefales ikke til patienter, der tidligere har haft depression forbundet med selvmordstanker eller selvmordslignende adfærd.
English: Simesa S.p.A. Tel: +39 02 9801 1
Danish: Tel: +39 02 9801 1
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Danish: Daxas tabletter indeholder lactose og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form for arvelig lactasemangel (lapp lactase deficiency) eller glucose/galactose malabsorption.
English: The percentage of patients experiencing a Treatment Emergent Adverse Event (TEAE) of interest, defined as diarrhoea, nausea, headache, decreased appetite, insomnia, and abdominal pain (secondary endpoint), was nominally statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (45.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (54.2%, Odds Ratio 0.63, 95% CI [0.47, 0.83], p=0.001).
Danish: Andelen af patienter, der oplevede en bivirkning af interesse, defineret som diarré, kvalme, hovedpine, nedsat appetit, søvnløshed eller mavesmerter (sekundært endepunkt), som følge af behandlingen (Treatment Emergent Adverse Event (TEAE)), var nominelt statistisk signifikant lavere hos patienter, som startede på roflumilast 250 mikrogram 1 gang dagligt i 4 uger efterfulgt af roflumilast 500 mikrogram 1 gang dagligt i 8 uger (45,4%) sammenlignet med de, der fik roflumilast 500 mikrogram 1 gang dagligt i 12 uger (54,2%, odds ratio 0,63; 95% CI [0,47; 0,83], p=0,001).
English: The discontinuation rate for those receiving 500 micrograms every other day for 4 weeks followed by 500 micrograms once a day for 8 weeks was not statistically significantly different to those receiving 500 micrograms once a day for 12 weeks.
Danish: Andelen, der stoppede med behandlingen efter at have fået 500 mikrogram hver anden dag i 4 uger efterfulgt af 500 mikrogram 1 gang dagligt i 8 uger, var ikke statistisk signifikant forskellig fra den andel, der fik 500 mikrogram 1 gang dagligt i 12 uger.
English: This might be the case in special populations that may have higher exposure, such as in black, non-smoking females (see section 5.2) or in patients concomitantly treated with CYP1A2/ 2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or the CYP1A2/3A4 inhibitor enoxacin (see section 4.5).
Danish: 5.2) eller hos patienter, der samtidig behandles med CYP1A2/2C19/3A4-hæmmere (som fluvoxamin og cimetidin) eller CYP1A2/3A4-hæmmeren enoxacin (se pkt.
English: Over the entire study period of 12 weeks, the percentage of patients discontinuing treatment due to any reason was statistically significantly lower in patients initially receiving roflumilast 250 micrograms once a day for 4 weeks followed by roflumilast 500 micrograms once a day for 8 weeks (18.4%) compared to those receiving roflumilast 500 micrograms once a day for 12 weeks (24.6%; Odds Ratio 0.66, 95% CI [0.47, 0.93], p=0.017).
Danish: Gennem hele studieperioden på 12 uger var andelen af patienter, som ophørte med behandlingen af hvilken som helst grund, signifikant lavere i gruppen af patienter, som startede på roflumilast 250 mikrogram 1 gang dagligt i 4 uger efterfulgt af roflumilast 500 mikrogram 1 gang dagligt i 8 uger (18,4%) sammenlignet med de, der fik roflumilast 500 mikrogram 1 gang dagligt i 12 uger (24,6%; odds ratio 0,66; 95% CI [0,47; 0,93], p=0,017).
English: The incidence was 2.5% vs 2.2% in patients with a baseline body weight ≥60 kg, treated with roflumilast when compared to those treated with placebo.
Danish: Hos patienter med en kropsvægt ≥ 60 kg var forekomsten 2,5 % kontra 2,2 % i henholdsvis roflumilast-armen og placebo-armen.
English: Please notify your doctor immediately of any suicidal thoughts you may have.
Danish: Du skal straks kontakte din læge, hvis du oplever noget, der bare minder om selvmordstanker.
English: Gastrointestinal disorders Diarrhoea Nausea
Danish: Mave-tarm-kanalen Diarré Kvalme
English: Driving and using machines Daxas has no influence on the ability to drive and use machines.
Danish: Trafik- og arbejdssikkerhed Daxas påvirker ikke arbejdssikkerheden eller evnen til at færdes sikkert i trafikken.
English: A higher incidence of sleep disorders (mainly insomnia) in patients with a baseline body weight <60 kg was observed in Study RO-2455-404-RD for patients treated with roflumilast when compared to those treated with placebo (6.0% vs 1.7%).
Danish: I studie RO-2455-404-RD blev der hos patienter med en kropsvægt < 60 kg ved baseline observeret en højere forekomst af søvnforstyrrelser (hovedsageligt søvnløshed) i roflumilast-armen sammenlignet med placebo-armen (6,0 % kontra 1,7 %).
English: Daxas is not recommended in patients with a history of depression associated with suicidal ideation or behaviour.
Danish: Daxas anbefales ikke til patienter med tidligere depression og heraf afledte selvmordstanker eller selvmordslignende adfærd.
English: Each tablet contains 500 micrograms roflumilast.
Danish: Hver tablet indeholder 500 mikrogram roflumilast.
English: Exacerbation Category
Danish: Eksacerbationskategori
English: Daxas is not recommended if you have one or more of the following diseases: - severe immunological diseases such as HIV infection, multiple sclerosis (MS), lupus erythematosus (LE) or progressive multifocal leukoencephalopathy (PML) - severe acute infectious diseases such as tuberculosis, or acute hepatitis - cancer (except basal-cell carcinoma, a slow-growing type of skin cancer) - or severe impairment of the heart function
Danish: (LE) eller progressiv multifokal leukoenkefalopati, (PML) - alvorlige akutte infektionssygdomme som tuberkulose eller akut hepatitis - kræft (bortset fra basalcellekarcinom, en langsomt voksende form for hudkræft) - eller alvorlig forringelse af hjertefunktionen.
English: That increased exposure might occur in certain populations and increase the risk of persistent intolerability: o Special populations who have increased PDE4 inhibition such as black non smoking females; o Patients concomitantly treated with CYP1A2/2C19/3A4 inhibitors (such as fluvoxamine and cimetidine) or CYP1A2/3A4 inhibitors (such as enoxacin).
Danish: At øget eksponering kan forekomme i visse befolkningsgrupper og øge risikoen for vedvarende intolerabilitet: o Særlige populationer, der har forøget PDE4 hæmning såsom negroide, ikke-rygende kvinder.
English: Each tablet contains 250 micrograms roflumilast.
Danish: Hver tablet indeholder 250 mikrogram roflumilast.
English: Theophylline
Danish: Theofyllin
English: Daxas 250 micrograms tablets
Danish: Daxas 250 mikrogram tabletter
English: The clinical data with Daxas in patients with mild hepatic impairment classified as Child-Pugh A are insufficient to recommend a dose adjustment (see section 5.2) and therefore Daxas should be used with caution in these patients.
Danish: De kliniske data for patienter med let nedsat leverfunktion klassificeret som Child-Pugh A er utilstrækkelige til at anbefale en dosisjustering (se pkt.
English: Vomiting Gastro-esophageal reflux disease Dyspepsia
Danish: Opkastning Gastroesofagal refluks Dyspepsi
English: Daxas 250 micrograms tablets roflumilast
Danish: Daxas 250 mikrogram tabletter Roflumilast
English: Daxas 500 micrograms tablets roflumilast
Danish: Daxas 500 mikrogram tabletter roflumilast
English: Daxas 500 micrograms film-coated tablets
Danish: Daxas 500 mikrogram filmovertrukne tabletter
English: Daxas 500 micrograms film-coated tablets roflumilast
Danish: Daxas 500 mikrogram filmovertrukne tabletter roflumilast
English: Hepatic impairment
Danish: Psykiske forstyrrelser Insomni
English: Nervous system disorders Headache
Danish: Nervesystemet
English: *A single case with a fatal outcome
Danish: *Et enkelt tilfælde med fatalt udfald
English: 40549 Düsseldorf Germany
Danish: 40549 Düsseldorf Tyskland
English: Just carry on with the next dose at the normal time.
Danish: Du skal blot fortsætte med at tage næste dosis på det normale tidspunkt.
English: Approximately 30% of patients experienced at least one adverse reaction.
Danish: Ca. 30 % af patienterne oplevede mindst én bivirkning.
English: Long-term studies:
Danish: Længerevarende undersøgelser:
English: Tablets should be taken whole.
Danish: Tabletter skal tages hele.
English: Constipation may be a preceding symptom.
Danish: Obstipation kan være et forudgående symptom.
English: Experience from clinical studies in patients above the age of 75 years is very limited.
Danish: Erfaring fra kliniske undersøgelser af patienter over 75 år, er meget begrænset.
English: Intestinal obstruction*
Danish: Intestinal obstruktion*
English: After one year of treatment, a reduction of 1.12% in HbA1c was observed.
Danish: Efter et års behandling sås en reduktion på 1,12 % i HbA1c.
English: Do not take a double dose to make up for forgotten doses.
Danish: Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: BindRen is for oral use.
Danish: BindRen er til oral anvendelse.