FrancophonIA/ELRC3.0 huggingface dataset:
English: - muscle or joint pain - general feelings of illness - abdominal pain - hypersensitivity (allergic) reactions - inflammation of the liver (hepatitis) - if you have severe liver disease - if you have had to stop nevirapine treatment in the past because of changes in your liver function - if you are taking a medicine containing the herbal substance St John's Wort (Hypericum perforatum).
Danish: - hvis du tidligere har taget Nevirapin Teva og måtte stoppe behandlingen, fordi du har fået: - alvorligt hududslæt - hududslæt og samtidig andre symptomer som feber blærer mundsår øjenbetændelse hævelser i ansigtet hævelser generelt åndenød muskelsmerter eller ledsmerter en følelse af at være syg mavesmerter - overfølsomhedsreaktioner (allergiske) - leverbetændelse (hepatitis) - hvis du tidligere har været nødt til at stoppe behandling med Nevirapin Teva på grund af ændringer i din leverfunktion - hvis du tager naturmedicin, som indeholder perikon (Hypericum perforatum).
English: Nevirapine AUC ↑ 1.14 (1.05-1.24)
Danish: Nevirapin AUC ↑ 1,14 (1,05-1,24)
English: How to take Nevirapine Teva
Danish: Sådan skal du tage Nevirapin Teva
English: Both, the primary (p = 0.92) and secondary endpoints showed no statistically significant differences between efavirenz and nevirapine 200 mg twice daily.
Danish: Der var ingen statistisk signifikant forskel mellem efavirenz og ”nevirapin 200 mg 2 gange daglig” for hverken det primære (p = 0,92) eller det sekundære endepunkt.
English: Nevirapine AUC ↑ 1.29 (1.19-1.40)
Danish: Nevirapin AUC ↑ 1,29 (1,19-1,40)
English: Nevirapine Cmin ↑ 1.34 (1.21-1.49) Nevirapine Cmax ↑ 1.25 (1.14-1.37)
Danish: Nevirapin Cmin ↑ 1,34 (1,21-1,49) Nevirapin Cmax ↑ 1,25 (1,14-1,37)
English: These adverse reactions are commonly associated with other antiretroviral agents and may be expected to occur when nevirapine is used in combination with other agents; however it is unlikely that these adverse reactions are due to nevirapine treatment.
Danish: Disse bivirkninger er ofte forbundet med andre antiretrovirale midler og kan muligvis forventes at opstå, når nevirapin anvendes i kombination med disse midler.
English: By stopping reverse transcriptase from working, Nevirapine Teva helps control HIV-1 infection.
Danish: Nevirapin hjælper med at kontrollere hiv-1-infektion ved at forhindre enzymet i at arbejde.
English: Nevirapine AUC ↑ 1.25 (1.17-1.34)
Danish: Nevirapin AUC ↑ 1,25 (1,17-1,34)
English: - The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone K25, sodium starch glycolate (Type A), colloidal silicon dioxide and magnesium stearate.
Danish: - Øvrige indholdsstoffer: Mikrokrystallinsk cellulose, lactosemonohydrat, povidon K25,
English: Nevirapine Teva belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection.
Danish: Nevirapin Teva tilhører en gruppe af lægemidler, som kaldes antiretrovirale lægemidler.
English: Telbivudine is not a substrate, inducer or inhibitor of the cytochrome P450 (CYP450) enzyme system.
Danish: Telbivudin er ikke substrat, inducer eller hæmmer af CYPenzymsystemet.
English: Nevirapine Teva may be taken with or without food.
Danish: Nevirapin Teva kan tages både sammen med mad og alene.
English: Stavudine: 30/40 mg BID
Danish: Stavudin 30/40 mg 2 gange daglig
English: It is not recommended to coadminister ketoconazole and Nevirapine Teva (see section 4.4).
Danish: Det anbefales ikke at coadministrere ketoconazol og Nevirapin Teva (se pkt.
English: (0.2 %), angioedema, urticaria
Danish: anafylaktisk reaktion, angioødem, urticaria)
English: Nevirapine Cmin ↑ 1.22 (1.10-1.35) Nevirapine Cmax ↑ 1.13 (1.03-1.24)
Danish: Nevirapin Cmin ↑ 1,22 (1,10-1,35) Nevirapin Cmax ↑ 1,13 (1,03-1,24)
English: For patients who are unable to swallow tablets or who weigh less than 50 kg or whose body surface area is below 1.25 m2
Danish: Til patienter, som ikke er i stand til at synke tabletterne eller som vejer mindre end 50 kg eller hvis legemsoverfladeareal er mindre end 1,25 m² i henhold til Mosteller formlen, kan andre orale formuleringer af nevirapin anvendes, hvis det skønnes hensigtsmæssigt.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN • Periodiske sikkerhedsopdateringer (PSURs)
English: It is not recommended to coadminister boceprevir and Nevirapine Teva (see section 4.4).
Danish: Det anbefales ikke at coadministrere boceprevir og Nevirapin Teva (se pkt.
English: What Nevirapine Teva is and what it is used for What you need to know before you take Nevirapine Teva How to take Nevirapine Teva Possible side effects
Danish: Det skal du vide, før du begynder at tage Nevirapin Teva Sådan skal du tage Nevirapin Teva Bivirkninger
English: It is very important that you take only one Nevirapine Teva tablet a day for the first 14 days (”lead-in” period) If you have any rash during this period, do not increase the dose but consult your doctor.
Danish: Det er meget vigtigt, at du kun tager 1 Nevirapin Teva tablet om dagen i de første 14 dage af behandlingen (optrapningsfasen).
English: Such reactions may appear in the form of anaphylaxis (a severe form of allergic reaction) with symptoms such as: - rash - swelling of the face - difficulty breathing (bronchial spasm) - anaphylactic shock
Danish: Sådanne reaktioner kan opstå i form af anafylaksi (en alvorlig form for allergisk reaktion) med symptomer som:
English: Clinical hepatitis reported as clinical adverse event occurred in 10 (2.6%) and 2 (0.5%) patients in the nevirapine twice daily and efavirenz groups respectively.
Danish: Hos 10 (2,6 %) og 2 (0,5 %) patienter i henholdsvis ”nevirapin 2 gange daglig”- og efavirenzgrupperne blev klinisk hepatitis rapporteret som en klinisk bivirkning.
English: Itraconazole 200 mg QD
Danish: Itraconazol 200 mg 4 gange daglig
English: It is not recommended to coadminister rifampicin and Nevirapine Teva (see section 4.4).
Danish: Det anbefales ikke at coadministrere rifampicin og Nevirapin Teva (se pkt.
English: Saquinavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments.
Danish: Saquinavir/ritonavir og Nevirapin Teva kan coadministreres uden dosisjustering.
English: Fosamprenavir/ritona vir 700/100 mg BID
Danish: Fosamprenavir/ ritonavir 700/100 mg 2 gange daglig
English: Nevirapine Cmin ↑ 1.32 (1.22-1.43) Nevirapine Cmax ↑ 1.17 (1.09-1.25)
Danish: Nevirapin Cmin ↑ 1,32 (1,22-1,43) Nevirapin Cmax ↑ 1,17 (1,09-1,25)
English: Uncommon Stevens-Johnson syndrome/toxic epidermal necrolysis (which may be fatal)
Danish: Stevens-Johnsons syndrom/ toksisk epidermal nekrolyse (som kan være letal) (0,2 %), angioødem, urticaria
English: For children, increase of the dose of lopinavir/ritonavir to 300/75 mg/m2 twice daily with food should be considered when used in combination with Nevirapine Teva, particularly for patients in whom reduced susceptibility to lopinavir/ritonavir is suspected.
Danish: Hos børn bør det overvejes at øge dosis af lopinavir/ritonavir til 300/75 mg/m2 2 gange daglig gange daglig
English: Nevirapine Teva and abacavir may be co-administered without dose adjustments.
Danish: Nevirapin Teva og abacavir kan co-administreres uden dosisjustering.
English: The concomitant administration of Nevirapine Teva with NNRTIs is not recommended (see section
Danish: Det anbefales ikke at coadministrere Nevirapin Teva og NNRTI (se pkt.
English: NNRTIs Efavirenz 600 mg QD
Danish: NNRTI'ere Efavirenz 600 mg 4 gange daglig
English: versus 0.9 %).
Danish: 4.4 og 4.5).
English: Nevirapine levels may increase on stopping St John‘s Wort.
Danish: Nevirapinniveauet kan stige ved ophør med perikon.
English: Tenofovir and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Tenofovir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: You may take Nevirapine Teva with or without food.
Danish: Du kan tage Nevirapin Teva-tabletter sammen med mad og drikke eller uden mad og drikke.
English: Ritonavir 600 mg BID
Danish: Ritonavir 600 mg 2 gange daglig
English: Didanosine Cmin ND Didanosine Cmax ↔ 0.98 (0.79-1.21)
Danish: Didanosin AUC ↔ 1,08 (0,92-1,27) Didanosin Cmin ND Didanosin Cmax ↔ 0,98 (0,79-1,21)
English: The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system and higher body mass index may be some of the many risk factors for developing this disease.
Danish: Risikofaktorer for udvikling af denne sygdom er blandt mange: Længden af den tidsperiode, hvor du er blevet behandlet med flere antiretrovirale lægemidler, anvendelse af kortikosteroider, alkoholforbrug, alvorligt nedsat immunforsvar samt højere BMI (body-mass-index).
English: Methadone Cmin ND Methadone Cmax ↓ 0.58 (0.50 - 0.67)
Danish: Methadon AUC ↓ 0,40 (0,31 - 0,51) Methadon Cmin ND Methadon Cmax ↓ 0,58 (0,50 - 0,67)
English: Results of in vitro studies showed a weak antagonism of nevirapine by adefovir (see section 5.1), this has not been confirmed in clinical trials and reduced efficacy is not expected.
Danish: Resultater fra in vitro studier viste en svag antagonisme fra adefovir på nevirapin (se pkt.
English: Due to the metabolic pathway of raltegravir no interaction is expected.
Danish: Der forventes ingen interaktion på grund af mekanisme ved raltegravirmetabolisme.
English: anaphylactic reaction, angioedema, urticaria) Uncommon anaphylactic reaction Rare drug reaction with eosinophilia and systemic symptoms Nervous system disorders
Danish: Lægemiddelreaktion med eosinofili og systemiske symptomer
English: Maraviroc and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Maraviroc og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Fluconazole 200 mg QD
Danish: Fluconazol 200 mg 4 gange daglig
English: Nevirapine Cmin ↑ 1.47 (1.20-1.82) Nevirapine Cmax ↑ 1.18 (1.02-1.37)
Danish: Nevirapin AUC ↑ 1,27 (1,12-1,44) Nevirapin Cmin ↑ 1,47 (1,20-1,82) Nevirapin Cmax ↑ 1,18 (1,02-1,37)
English: Didanosine and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Didanosin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Nevirapine Teva and emtricitabine may be co-administered without dose adjustments.
Danish: Nevirapin Teva og emtricitabin kan co-administreres uden dosisjustering.
English: Nevirapine Cmin ↓ 0.32
Danish: Nevirapin Cmin ↓ 0,32 Nevirapin Cmax ↓ 0,50
English: Entecavir and Nevirapine Teva may be co-administered without dose adjustments.
Danish: Entecavir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Atazanavir/ritonavir 300/100 mg QD 400/100 mg QD
Danish: Atazanavir/ritonavir 300/100 mg 4 gange daglig
English: Adefovir and Nevirapine Teva may be co-administered without dose adjustments.
Danish: Adefovir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: ANTACIDS
Danish: Anæmi
English: Raltegravir and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Raltegravir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Rifabutin and Nevirapine Teva can be coadministered without dose adjustments.
Danish: Rifabutin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Nevirapine Cmax ↑ 1.24 compared to historical controls.
Danish: Nevirapin: Plasmakoncentrationer: ↑ 1,15-1,28 sammenlignet med historiske kontroller.
English: Ritonavir and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Ritonavir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Interferons and Nevirapine Teva may be co-administered without dose adjustments.
Danish: Interferoner og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Tipranavir and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Tipranavir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: You should not use Nevirapine Teva on its own.
Danish: Du må ikke tage Nevirapin Teva som den eneste behandling.
English: Only take Nevirapine Teva tablets by mouth.
Danish: Nevirapin Teva tabletter skal sluges.
English: INTEGRASE INHIBITORS
Danish: INTEGRASEHÆMMERE
English: Stavudine Cmin ND Stavudine Cmax ↔ 0.94 (0.86-1.03)
Danish: Stavudin AUC ↔ 0,96 (0,89-1,03) Stavudin Cmin ND Stavudin Cmax ↔ 0,94 (0,86-1,03)
English: Lamivudine and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Lamivudin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Cimetidine and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Cimetidin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Telbivudine and Nevirapine Teva may be co-administered without dose adjustments.
Danish: Telbivudin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: ANTIFUNGALS
Danish: SVAMPEMIDLER
English: In human liver microsomes, abacavir did not inhibit cytochrome P450 isoforms.
Danish: Abacavir hæmmer ikke CYPisoformer i humane levermikrosomer.
English: ANTITHROMBOTICS
Danish: ANTITROMBOTIKA
English: DMPA and Nevirapine Teva can be coadministered without dose adjustments.
Danish: DMPA og Nevirapin Teva kan coadministreres uden dosisjustering.
English: Each tablet contains 200 mg of nevirapine (as anhydrous)
Danish: En tablet indeholder 200 mg nevirapin (vandfri)
English: Darunavir and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Darunavir og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Stavudine and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Stavudin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Ribavirin and Nevirapine Teva may be co-administered without dose adjustments.
Danish: Ribaverin og Nevirapin Teva kan co-administreres uden dosisjustering.
English: Treatment initiation pack
Danish: Startpakning
English: Immune system disorders Common hypersensitivity (incl.
Danish: Overfølsomhed (inkl.
English: If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking Nevirapine Teva.
Danish: Hvis du nogensinde får udslæt i mild grad uden nogle af de andre bivirkninger, skal du straks informere lægen om det.
English: Fosamprenavir/ritonavir and Nevirapine Teva can be coadministered without dose adjustments
Danish: Fosamprenavir/ritonavir og Nevirapin Teva kan coadministreres uden dosisjustering.
English: Enfuvirtide and Nevirapine Teva can be co-administered without dose adjustments.
Danish: Enfuvirtid og Nevirapin Teva kan co-administreres uden dosisjustering.
English: (women more than 250 cells/mm³, men more than 400 cells/mm³) - pre-treated patients with detectable HIV-1 plasma viral load and higher CD4 cell counts at the start of nevirapine therapy (women more than 250 cells/mm³, men more than 400 cells/mm³)
Danish: Nevirapin Teva (kvinder med over 250 celler/mm3, mænd med over 400 celler/mm3) - tidligere behandlede patienter med påviselig hiv-1-virusbelastning i plasma og forhøjede
English: Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy.
Danish: Før behandlingen med nevirapin igangsættes samt med passende mellemrum undervejs i behandlingen, skal der udføres biokemiske tests, herunder test af leverfunktion.
English: Zidovudine Cmin ND Zidovudine Cmax ↓ 0.70 (0.49-1.04)
Danish: Zidovudin AUC ↓ 0,72 (0,60-0,96) Zidovudin Cmin ND Zidovudin Cmax ↓ 0,70 (0,49-1,04)
English: NRTIs
Danish: Gulsot
English: These measures will help protect the environment.
Danish: Disse forholdsregler bidrager til at beskytte miljøet.
English: Can't be sold separately.
Danish: Sælges ikke separat.
English: Patients are not required to drink more fluid than they normally would.
Danish: Patienterne behøver ikke drikke mere væske, end de normalt gør.
English: Component of a multipack.
Danish: Del af multipakke.
English: Maximum tolerated daily dose
Danish: Maksimalt tolereret daglig dosis
English: It may be harmful to the teeth.
Danish: Det kan skade tænderne.
English: Elderly population (≥65 years of age)
Danish: Geriatrisk population (≥ 65 år)
English: The safety and efficacy of Velphoro in children and adolescents below the age of 18 years has not yet been established.
Danish: Velphoros sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Subjects were continued on their study medication from week 12 to week 55.
Danish: Forsøgspersonerne fortsatte på deres studiemedicinering fra uge 12 til uge 55.
English: Carcinogenicity studies were performed in mice and rats.
Danish: Studier af karcinogenicitet blev udført i mus og rotter.
English: Diarrhoea occurred in 11.6% of patients in clinical trials.
Danish: Diarré opstod hos 11,6 % af patienterne i kliniske forsøg.
English: - Push the tablet through the aluminium foil.
Danish: - Tryk tabletten ud gennem aluminiumfolien.
English: The reporting rate is classified as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Danish: Rapporteringshyppigheden er klassificeret som meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100).
English: From week 12 to 24, dose titrations were allowed for both tolerability and efficacy reasons.
Danish: Fra uge 12 til 24 var dosistitrering tilladt af hensyn til både tolerabilitet og virkning.
English: These compounds can be absorbed in the blood.
Danish: Disse stoffer kan absorberes i blodet.
English: Blood levels of radiolabelled iron were very low and confined to the erythrocytes.
Danish: Blodniveauerne for radioaktivt mærket jern var meget lave og begrænset til erytrocytterne.
English: Non-inferiority to sevelamer carbonate was determined at week 12.
Danish: Noninferioritet over for sevelamer-karbonat blev fastlagt ved uge 12.
English: No special dose and administration guidelines were applied to seniors in these studies and the dosing schedules were not associated with any significant concerns.
Danish: Der blev ikke anvendt særlige retningslinjer for dosering og administration hos ældre i disse studier, og dosisplanerne var ikke forbundet med væsentlig bekymring.
English: There is no information on the effects of this medicine if taken during pregnancy or breastfeeding.
Danish: Der foreligger ikke oplysninger om virkningen af dette lægemiddel, hvis det tages under graviditet eller amning.
English: This study was an open-label, randomised, activecontrolled (sevelamer carbonate), parallel group study for up to 55 weeks.
Danish: Dette studie var et open-label, randomiseret, aktivt kontrolleret (sevelamer-karbonat), parallelgruppe-studie på op til 55 uger.
English: DO NOT swallow it whole.
Danish: Den MÅ IKKE sluges hel.
English: Do not stop taking the medicine before talking to your doctor or pharmacist as the phosphorus level in your blood may increase (see section 1).
Danish: Stop ikke med at tage medicinen, før du har talt med din læge eller apotekspersonalet, da fosformængden i dit blod kan øges (se punkt 1).
English: Velphoro has been administered to over 248 seniors (≥65 years of age) according to the approved dosing regimen.
Danish: Velphoro blev administreret til mere end 248 ældre (i alderen ≥ 65 år) i henhold til det godkendte dosisregimen.
English: Therefore Velphoro is not recommended for use in children and adolescents.
Danish: Brug af Velphoro anbefales derfor ikke til børn og unge.
English: Vitamin D and 1,25-dihydroxy Vitamin D levels remained unchanged.
Danish: Koncentrationerne af vitamin D og 1,25-dihydroxyvitamin D forblev uændrede.
English: - Peel back the paper foil at the corner.
Danish: - Træk papirfolien i hjørnet tilbage.
English: The serum phosphorus reduction was maintained over 55 weeks.
Danish: Faldet i serumphosphat blev opretholdt over 55 uger.
English: See section 2 for further information on sucrose and starches.
Danish: Se punkt 2 for at få mere information om saccharose og stivelse.
English: - Take the tablet during a meal and chew it (if necessary, the tablet may be crushed to make this easier for you).
Danish: - Tag tabletten i forbindelse med et måltid, og tyg den (tabletten kan om nødvendigt knuses, hvis det gør det nemmere).
English: In 2 Phase 1 studies, it was concluded that the potential for iron overload is minimal and no dose dependent effects were observed in healthy volunteers.
Danish: I 2 fase 1-studier blev det konkluderet, at potentialet for jernoverbelastning er minimal, og der er ikke observeret dosisafhængige virkninger hos raske frivillige.
English: Drug-drug interaction studies have only been performed in healthy volunteers.
Danish: Der er kun udført interaktionsstudier mellem lægemidler hos raske frivillige.
English: Of the total number of subjects in clinical studies of Velphoro, 29.7% were aged 65 and over, while 8.7% were aged 75 and over.
Danish: Ud af det samlede antal forsøgspersoner i kliniske studier med Velphoro var 29,7 % 65 år og derover, mens 8,7 % var 75 år og derover.
English: Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med fructoseintolerans, glucose-galactose malabsorption eller sucrase-isomaltase insufficiens må ikke tage dette lægemiddel.
English: - The amount of tablets taken per day should be divided across the meals of the day.
Danish: - Antallet af tabletter, der tages dagligt, skal fordeles mellem dagens måltider.
English: Clinical studies have demonstrated that the systemic absorption of iron from Velphoro is low.
Danish: Kliniske studier har påvist, at den systemiske absorbering af jern fra Velphoro er lav.
English: Table 1 Adverse reactions detected in clinical trials System Organ Class
Danish: Tabel 1 Bivirkninger registreret i kliniske forsøg Systemorganklasse
English: This can result in stiffening of the blood vessels, making it harder for the blood to be pumped around the body.
Danish: Dette kan gøre dine blodårer stive og gøre det vanskeligere at pumpe blodet rundt i kroppen.
English: Concomitant administration of Velphoro did not affect the bioavailability of these medicinal products as measured by the area under the curve (AUC).
Danish: Samtidig administration af Velphoro påvirkede ikke biotilgængeligheden af disse lægemidler i henhold til målingen af området under kurven (AUC).
English: The following side effects have also been reported in patients taking this medicine: Very common (may affect more than 1 in 10 people): diarrhoea (generally occurring early on in the treatment, and improving over time).
Danish: Følgende bivirkninger er rapporteret hos patienter, der tager denne medicin: Meget almindelig (forekommer hos mere end 1 ud af 10 personer): diarré (opstår normalt tidligt i behandlingsforløbet og bliver bedre med tiden).
English: Description of selected adverse reactions *Diarrhoea
Danish: Beskrivelse af udvalgte bivirkninger *Diarré
English: The absolute absorption studies in humans were not performed.
Danish: Der blev ikke udført absolutte absorptionsstudier hos mennesker.
English: (rats and dogs) showed that systemic absorption was very low (≤1% of the administered dose).
Danish: Prækliniske studier i flere arter (rotter og hunde) viste, at den systemiske absorption var meget lav (≤ 1 % af den administrerede dosis).
English: It is unlikely that this medicine would pass into the mother's milk.
Danish: Det er usandsynligt, at dette lægemiddel udskilles i human mælk.
English: There was no clear evidence of a carcinogenic effect in mice.
Danish: Der var ingen tydelige tegn på karcinogen virkning hos mus.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Vifor Fresenius Medical Care Renal Pharma France
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Vifor Fresenius Medical Care Renal Pharma France
English: METHOD AND ROUTE(S) OF ADMINISTRATION Tablets must be chewed or crushed and taken with meals.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Tabletterne skal tygges eller knuses og tages i forbindelse med måltider.