FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma AUC of sitagliptin was increased approximately 2-fold in patients with moderate renal impairment (GFR ≥ 30 to < 45 mL/min), and approximately 4-fold in patients with severe renal impairment (GFR < 30 mL/min), including patients with ESRD on haemodialysis.
Danish: Sitagliptins plasma-AUC steg med ca. det dobbelte hos patienter med moderat nyreinsufficiens (GFR ≥30 til <45 ml/min) og med ca. det firdobbelte hos patienter med svær nyreinsufficiens (GFR <30 ml/min), inklusive patienter med ESRD i hæmodialyse.
English: In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
Danish: I en 24-ugers placebokontrolleret faktoriel undersøgelse af initialbehandling gav sitagliptin 50 mg to gange dagligt i kombination med metformin (500 mg eller 1.000 mg to gange dagligt) en signifikant forbedring af glykæmiske parametre sammenlignet med begge former for monoterapi.
English: Very rare: decreased vitamin B12 levels, hepatitis (a problem with your liver), hives, redness of the skin (rash) or itching
Danish: Meget sjældne: Nedsat niveau af B12-vitamin, leverbetændelse (hepatitis), nældefeber, rødme af huden (udslæt) eller kløe.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Danish: Symptomerne på laktacidose omfatter: - opkastning - mavesmerter - muskelkramper - almen utilpashed med udpræget træthed - vejrtrækningsbesvær - nedsat kropstemperatur og langsommere puls
English: INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/850 mg film-coated tablets
Danish: INDRE KARTON til multipakninger (2 pakninger) - uden Blue Box 50 mg/850 mg filmovertrukne tabletter
English: These included hypoglycaemia (frequency very common with sulphonylurea or insulin), constipation (common with sulphonylurea), peripheral oedema (common with pioglitazone), and headache and dry mouth (uncommon with insulin).
Danish: Disse omfattede hypoglykæmi (frekvens: meget almindelig med sulfonylurinstoffer eller insulin), obstipation (almindelig med sulfonylurinstoffer), perifert ødem (almindelig med pioglitazon) og hovedpine og mundtørhed (ikke almindelig med insulin).
English: Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight (-1.5 kg) compared to a significant weight gain in patients administered glipizide (+1.1 kg).
Danish: De patienter, der blev behandlet med sitagliptin, udviste et signifikant gennemsnitligt fald i kropsvægt i forhold til baseline sammenlignet med en signifikant vægtøgning hos patientgruppen, der fik glipizid (-1,5 versus +1,1 kg).
English: Ristfor is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Danish: Ristfor er også indiceret som tillægsbehandling til insulin (dvs. tripel kombinationsbehandling) som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, når stabil dosering af insulin og metformin alene ikke giver tilstrækkelig glykæmisk kontrol.
English: When Ristfor is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Ristfor anvendes sammen med et sulfonylurinstof, kan en lavere dosis af sulfonylurinstoffet være nødvendig for at reducere risikoen for hypoglykæmi (se pkt.
English: Ristfor combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Danish: Ristfor er en kombination af to antihyperglykæmiske lægemidler med komplementære virkningsmekanismer til forbedring af glykæmisk kontrol hos patienter med type 2-diabetes: sitagliptinphosphat, en dipeptidylpeptidase-4-hæmmer (DPP-4), og metforminhydrochlorid, der tilhører biguanidklassen.
English: When Ristfor is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Danish: Når Ristfor anvendes sammen med insulin, kan det være nødvendigt at nedsætte insulindosis for at reducere risikoen for hypoglykæmi (se pkt.
English: The expiry date refers to the last day of the month.
Danish: Brug ikke Ristfor efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
Danish: Ved akut forværring af nyrefunktionen akkumuleres metformin, hvilket øger risikoen for laktacidose.
English: No treatment related effects on fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Danish: Der blev ikke observeret behandlingsrelaterede bivirkninger i fertiliteten hos han- og hunrotter, der blev behandlet med sitagliptin før og under parringsperioden.
English: If you are not sure, talk to your doctor, pharmacist or nurse before taking Ristfor.
Danish: Er De i tvivl, så spørg lægen, apotekspersonalet eller sundhedspersonalet, før De tager Ristfor.
English: Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Danish: Ristfor er indiceret som supplement til diæt og motion til forbedring af den glykæmiske kontrol hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin alene eller hos de patienter, som allerede er i behandling med kombinationen af sitagliptin og metformin.
English: Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget dette lægemiddel sammen med pioglitazon:
English: • ranolazine, a medicine used to treat angina
Danish: • Ranolazin, et lægemiddel til behandling af brystsmerter (angina pectoris).
English: - The other ingredients are: In the tablet core: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauril sulfate, and sodium stearyl fumarate.
Danish: - Øvrige indholdsstoffer: I tabletkernen: Mikrokrystallinsk cellulose (E460), povidon K 29/32 (E1201), natriumlaurilsulfat, og natriumstearylfumarat.
English: Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Danish: Ristfor er indiceret som tripel kombinationsbehandling sammen med en peroxisom proliferatoraktiveret receptor-gamma (PPAR)-agonist (dvs. et glitazon) som supplement til diæt og motion hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og en PPAR-agonist.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEERØRENDE UDLEVERING OG ANVENDELSE
English: The dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Danish: Dosis bør doseres som sitagliptin 50 mg to gange dagligt (100 mg i alt pr. dag), og metformin bør gives i en dosis svarende til den, som allerede tages.
English: Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
Danish: Når nyrefunktionen er nedsat, er renal clearance nedsat i forhold til kreatinins, og derfor er halveringstiden for elimination forlænget, hvilket fører til øget plasmakoncentration af metformin.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER
English: Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride:
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget dette lægemiddel sammen med et sulfonylurinstof, fx glimepirid:
English: If you take more than the prescribed dosage of this medicine, contact your doctor immediately.
Danish: Kontakt straks Deres læge, hvis De har taget mere end den foreskrevne dosis af dette lægemiddel.
English: Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Danish: Kapselformet, rød filmovertrukken tablet med "577" præget på den ene side.
English: Uncommon upper abdominal pain
Danish: Øvre abdominalsmerter
English: In this study there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
Danish: I denne undersøgelse var incidensen af hypoglykæmi den samme, som blev rapporteret for patienter, der var blevet behandlet med sitagliptin eller placebo.
English: 84 film-coated tablets.
Danish: 84 filmovertrukne tabletter.
English: Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Danish: Ændring i kropsvægt i forhold til baseline var den samme for patienter, der blev behandlet med sitagliptin i forhold til placebo.
English: Capsule-shaped, pink film-coated tablet with “515” debossed on one side.
Danish: Kapselformet, lyserød filmovertrukken tablet med "515" præget på den ene side.
English: Studies of sitagliptin in combination with metformin In a 24-week, placebo-controlled clinical study to evaluate the efficacy and safety of the addition of sitagliptin 100 mg once daily to ongoing metformin, sitagliptin provided significant improvements in glycaemic parameters compared with placebo.
Danish: Undersøgelser af sitagliptin i kombination med metformin I en 24-ugers placebokontrolleret klinisk undersøgelse til vurdering af effekt og sikkerhed ved sitagliptin 100 mg en gang dagligt som supplement til metformin gav sitagliptin signifikant forbedring af glykæmiske parametre sammenlignet med placebo.
English: 98 film-coated tablets.
Danish: 98 filmovertrukne tabletter.
English: 196 film-coated tablets
Danish: 196 filmovertrukne tabletter
English: Hepatic impairment Ristfor must not be used in patients with hepatic impairment (see section 5.2).
Danish: Nedsat leverfunktion Ristfor må ikke anvendes til patienter med nedsat leverfunktion (se pkt.
English: For the different doses on metformin, Ristfor is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Danish: Til de forskellige metformindoser findes Ristfor i styrker på 50 mg sitagliptin og 850 mg metforminhydrochlorid eller 1.000 mg metforminhydrochlorid.
English: There have been no therapeutic clinical trials conducted with Ristfor tablets however bioequivalence of Ristfor with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Danish: Der er ikke udført behandlingsmæssige kliniske undersøgelser med Ristfor-tabletter, men Ristfors bioækvivalens er blevet påvist, når det gives sammen med sitagliptin og metformin (se pkt.
English: 112 film-coated tablets
Danish: 112 filmovertrukne tabletter
English: Ristfor should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and
Danish: Behandlingen med Ristfor skal afbrydes forud for eller på tidspunktet for billeddiagnostiske procedurer og først genoptages mindst 48 timer herefter, forudsat at nyrefunktionen er blevet vurderet og fundet stabil (se pkt.
English: • medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
Danish: • Lægemidler mod smerter og betændelseslignende tilstande (NSAID'er og COX-2-hæmmere,
English: The addition of sitagliptin to glimepiride and metformin provided significant improvements in glycaemic parameters.
Danish: Sitagliptin som supplement til glimepirid og metformin gav signifikante forbedringer af glykæmiske parametre.
English: Some medicinal products can adversely affect renal function, which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Danish: Kombinationsbehandlinger, der kræver forholdsregler før anvendelse Visse lægemidler kan påvirke nyrefunktionen negativt, hvilket kan øge risikoen for laktacidose, f.eks. NSAID'er, herunder selektive cyklooxygenase (COX) II-hæmmere, ACE-hæmmere, angiotensin IIreceptorantagonister og diuretika, især loop-diuretika.
English: Talk to your doctor or pharmacist before taking Ristfor: - if you have or have had a disease of the pancreas (such as pancreatitis) - if you have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Danish: Kontakt lægen, apoteket eller sundhedspersonalet, før De tager Ristfor: - Hvis De har eller har haft en sygdom i bugspytkirtlen (f.eks. pankreatitis).
English: The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
Danish: Reduktionen i kropsvægt ved en kombination af sitagliptin og metformin var den samme som den, der blev observeret med metformin alene eller placebo.
English: Tel: +39 06 361911 medicalinformation.it@merck.com
Danish: Tel: +39 06 361911 doccen@merck.com
English: Therapy may be restarted no earlier than 48 hours following surgery or resumption of oral nutrition and provided that renal function has been re-evaluated and found to be stable.
Danish: Behandling med Ristfor skal afbrydes på tidspunktet for kirurgi under generel, spinal eller epidural anæstesi og må tidligst genoptages 48 timer efter kirurgi eller genoptagelse af oral ernæring og under forudsætning af, at nyrefunktionen er blevet vurderet og fundet stabil.
English: However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Danish: Der er ingen klinisk erfaring fra patienter med svær leverinsufficiens (ChildPugh score >9), men da sitagliptin primært elimineres renalt, forventes svær leverinsufficiens ikke at påvirke sitagliptins farmakokinetik.
English: Renal function
Danish: Nyrefunktionen
English: In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Danish: Desuden indeholder filmovertrækket: Poly(vinylalkohol), macrogol 3350, talcum (E553b), titandioxid (E171), rød jernoxid ((E172) og sort jernoxid (E172).
English: Study of sitagliptin in combination with metformin and insulin A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Danish: Undersøgelse af sitagliptin i kombination med metformin og insulin En 24-ugers placebokontrolleret undersøgelse blev designet til at evaluere effekt og sikkerhed af sitagliptin (100 mg en gang dagligt) som supplement til insulin (ved stabil dosis i mindst 10 uger) med eller uden metformin (mindst 1500 mg).
English: Gastrointestinal disorders diarrhoea
Danish: Mave-tarm-kanalen Diarré
English: The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Danish: Incidensen af hypoglykæmi hos patienter, der blev behandlet med sitagliptin, var den samme som for placebo.
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 litres.
Danish: Det gennemsnitlige fordelingsvolumen ved steady state efter en enkelt intravenøs dosis på 100 mg sitagliptin til raske forsøgspersoner er ca. 198 l. Den fraktion af sitagliptin, som er reversibelt bundet til plasmaproteiner, er lav (38%).
English: The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Danish: Patienterne fik sitagliptin (7.332) 100 mg dagligt (eller 50 mg dagligt, hvis eGFR ved baseline var ≥ 30 og < 50 ml/min/1,73 m2) eller placebo (7.339) som supplement til standardbehandling målrettet de regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
English: Study of sitagliptin in combination with metformin and a PPAR agonist A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Danish: Undersøgelse af sitagliptin i kombination med metformin og en PPAR-agonist Et 26-ugers placebokontrolleret studie blev designet til at evaluere sitagliptins effekt og sikkerhed (100 mg en gang dagligt) som supplement til kombinationen pioglitazon plus metformin.
English: In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Danish: Patienterne skal informeres om at stoppe med at tage metformin og øjeblikkeligt søge lægehjælp ved symptomer, der kan give mistanke om laktacidose.
English: Sitagliptin 100 mg once daily added to ongoing insulin + metformin therapy (N=223)
Danish: Sitagliptin 100 mg en gang dagligt som supplement til igangværende insulin- + metforminbehandling (N=223)
English: Study of sitagliptin in combination with metformin and a sulphonylurea A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride (alone or in combination with metformin).
Danish: Undersøgelse af sitagliptin i kombination med metformin og et sulfonylurinstof En 24-ugers placebokontrolleret undersøgelse blev designet til at vurdere effekt og sikkerhed af sitagliptin (100 mg en gang dagligt) som supplement til glimepirid (alene eller i kombination med metformin).
English: Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately 23 times the clinical exposure level.
Danish: Nogle af disse tyder på neural toksicitet: Vejrtrækning med åben mund, spytafsondring, hvid skummende opkastning, ataksi, skælven, nedsat aktivitet og/eller krum stilling.
English: For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Danish: Til patienter, der ikke er tilstrækkeligt kontrolleret på metformin alene, bør den normale startdosis doseres som 50 mg sitagliptin to gange dagligt (100 mg i alt pr. dag) plus den dosis metformin, som allerede tages.
English: (pancreatitis).
Danish: hæmmere).
English: EU/1/10/620/002 EU/1/10/620/003 EU/1/10/620/004 EU/1/10/620/005 EU/1/10/620/006 EU/1/10/620/007 EU/1/10/620/008 EU/1/10/620/017 EU/1/10/620/019 EU/1/10/620/020
Danish: EU/1/10/620/001 EU/1/10/620/002 EU/1/10/620/003 EU/1/10/620/004 EU/1/10/620/005 EU/1/10/620/006 EU/1/10/620/007 EU/1/10/620/008 EU/1/10/620/017 EU/1/10/620/019 EU/1/10/620/020
English: Maximum daily dose is 25 mg.
Danish: Den maksimale daglige dosis er 25 mg.
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 M•hr, Cmax was 950 nM.
Danish: Peak-plasmakoncentrationer (median Tmax) forekom 1-4 timer efter dosering, gennemsnitlig plasmaAUC for sitagliptin var 8,52 µM•hr, Cmax var 950 nM. Sitagliptins absolutte biotilgængelighed er ca. 87%.
English: Ristfor 50 mg/850 mg film-coated tablets
Danish: Ristfor 50 mg/850 mg filmovertrukne tabletter.
English: Maximum daily dose is 100 mg.
Danish: Den maksimale daglige dosis er 100 mg.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Danish: Analyse af resultaterne for overvægtige patienter, der blev behandlet med metformin efter svigt af diæt alene, viste: - signifikant reduktion af den absolutte risiko for diabetesrelaterede komplikationer i metformingruppen (29,8 hændelser/1.000 patientår) versus diæt alene (43,3 hændelser/1.000 patientår), p=0,0023, og versus den kombinerede sulfonylurinstof/insulinmonoterapigruppe (40,1 hændelser/1.000 patientår), p=0,0034.
English: After an oral dose of metformin, Tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60 % in healthy subjects.
Danish: Absolut biotilgængelighed for en 500 mg metformintablet er ca. 50-60% hos raske forsøgspersoner.
English: EU/1/10/620/010 EU/1/10/620/011 EU/1/10/620/012 EU/1/10/620/013 EU/1/10/620/014 EU/1/10/620/015 EU/1/10/620/016 EU/1/10/620/018 EU/1/10/620/021 EU/1/10/620/022
Danish: EU/1/10/620/009 EU/1/10/620/010 EU/1/10/620/011 EU/1/10/620/012 EU/1/10/620/013 EU/1/10/620/014 EU/1/10/620/015 EU/1/10/620/016 EU/1/10/620/018 EU/1/10/620/021 EU/1/10/620/022
English: Sitagliptin 100 mg once daily added to ongoing pioglitazone + metformin therapy (N=152)
Danish: Sitagliptin 100 mg en gang dagligt som supplement til igangværende behandling med pioglitazon + metformin (N=152)
English: Maximum daily dose is 50 mg.
Danish: Den maksimale daglige dosis er 50 mg.
English: Ristfor is indicated in combination with a sulphonylurea (i.e., triple combination therapy) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.
Danish: Ristfor er indiceret som supplement til diæt og motion i kombination med et sulfonylurinstof (dvs. tripel kombinationsbehandling) hos patienter, der ikke er tilstrækkeligt kontrolleret på den maksimalt tolererede dosis metformin og sulfonylurinstof.
English: - if you have a severe infection or are dehydrated - if you are going to have an X-ray where you will be injected with a dye.
Danish: - Hvis De har en alvorlig infektion eller har væskemangel.
English: Ristfor 50 mg/1,000 mg film-coated tablets
Danish: Ristfor 50 mg/1.000 mg filmovertrukne tabletter.