FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you are taking either of the following classes of medicines used to treat high blood pressure:
Danish: - hvis du har diabetes eller nedsat nyrefunktion, og du behandles med nogen af følgende typer lægemidler, som bruges til at behandle for højt blodtryk:
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: YDRE KARTON TIL MULTPAKNING (INKLUSIV BLUE BOX) MED PA/ALU/PVCBLISTERKORT
English: Treatment with Sprimeo resulted in an overall incidence of adverse reactions similar to placebo up to 300 mg.
Danish: Behandling med Sprimeo udviste en samlet incidens af bivirkninger svarende til placebo for behandling med op til 300 mg. Bivirkningerne var generelt milde og forbigående og det har kun sjældent været nødvendigt at seponere behandlingen.
English: If co-medication with an agent affecting the level of serum potassium is considered necessary, caution is advisable.
Danish: Der bør udvises forsigtighed, hvis samtidig administration af et stof, som påvirker serumkalium, skønnes nødvendig.
English: 90 film-coated tablets
Danish: 90 filmovertrukne tabletter
English: No adjustment of the initial dose is required for patients with mild to severe hepatic impairment (see section 5.2).
Danish: Der kræves ingen justering af initialdosen for patienter med let til stærkt nedsat leverfunktion (se pkt.
English: Packs containing 98 (2x49) or 280 (20x14) tablets are multi-packs.
Danish: Pakninger indeholdende 98 (2x49) eller 280 (20x14) tabletter er multipakninger.
English: Light-red, biconvex, ovaloid tablet, imprinted “IU” on one side and “NVR” on the other side.
Danish: Lyserød, udadbuet, oval tablet, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Danish: YDRE KARTON TIL MULTPAKNING (INKLUSIV BLÅ BOKS) MED PCTFE/PVCBLISTERKORT
English: Sprimeo 300 mg film-coated tablets
Danish: Sprimeo 300 mg filmovertrukne tabletter
English: Sprimeo is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Danish: Sprimeo anbefales ikke til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationsrate (GFR) < 30 ml/min./1,73 m2).
English: Sprimeo is available in packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Sprimeo er tilgængelig i pakninger, der indeholder 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: Sodium and/or volume depleted patients
Danish: Patienter med natrium- og/eller væskemangel
English: What Sprimeo is and what it is used for Before you take Sprimeo How to take Sprimeo Possible side effects How to store Sprimeo Further information
Danish: Det skal du vide, før du begynder at tage Sprimeo Sådan skal du tage Sprimeo Bivirkninger
English: Multipack comprising 20 packs, each containing 14 tablets.
Danish: Multipakning bestående af 20 pakninger, der hver indeholder 14 tabletter.
English: What Sprimeo looks like and contents of the pack Sprimeo 150 mg film coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Danish: Sprimeo 150 mg filmovertrukne tabletter er lyse pink, udadbuede, runde tabletter, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: Multipack comprising 2 packs, each containing 49 tablets.
Danish: Multipakning bestående af 2 pakninger, der hver indeholder 49 tabletter.
English: Packs containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Danish: Pakninger indeholdende 84 (3x28), 90 (3x30), 98 (2x49) eller 280 (20x14) tabletter er multipakninger.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Danish: KARTON TIL DELPAKNING (UDEN BLÅ BOKS) MED PCTFE/PVC-BLISTERKORT
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: KARTON TIL DELPAKNING (UDEN BLUE BOX) MED PA/ALU/PVC-BLISTERKORT
English: Packs containing 14, 28, 30, 50, 56, 90, 98 or 280 tablets.
Danish: Pakninger indeholdende 14, 28, 30, 50, 56, 90, 98 eller 280 tabletter.
English: Component of a multipack comprising 2 packs, each containing 49 tablets.
Danish: Del af en multipakning bestående af 2 pakninger, der hver indeholder 49 tabletter.
English: Packs containing 7, 14, 28, 30, 50, 56, 84, 90, 98 or 280 tablets.
Danish: Pakninger indeholdende 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter.
English: Component of a multipack comprising 20 packs, each containing 14 tablets.
Danish: Del af en multipakning bestående af 20 pakninger, der hver indeholder 14 tabletter.
English: Sprimeo is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Danish: Sprimeo anbefales ikke til patienter med stærkt nedsat nyrefunktion (GFR < 30 ml/min./1,73 m2).
English: Multipack comprising 3 packs, each containing 28 tablets.
Danish: Multipakning bestående af 3 pakninger, der hver indeholder 28 tabletter.
English: Packs containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets are multi-packs.
Danish: Pakninger, der indeholder 84 (3x28), 98 (2x49) eller 280 (20x14) tabletter er multipakninger.
English: What Sprimeo looks like and contents of the pack Sprimeo 300 mg film coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Danish: Sprimeo 300 mg filmovertrukne tabletter er lyserøde, udadbuede, ovale tabletter, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: Multipack comprising 3 packs, each containing 30 tablets.
Danish: Multipakning bestående af 3 pakninger, der hver indeholder 30 tabletter.
English: Component of a multipack comprising 3 packs, each containing 30 tablets.
Danish: Del af en multipakning bestående af 3 pakninger, der hver indeholder 30 tabletter.
English: Component of a multipack comprising 3 packs, each containing 28 tablets.
Danish: Del af en multipakning bestående af 3 pakninger, der hver indeholder 28 tabletter.
English: FOLDING BOX FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS
Danish: KARTON TIL ENKELTPAKNING MED PCTFE/PVC-BLISTERKORT
English: The concomitant use of aliskiren and ACEIs or ARBs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2).
Danish: Samtidig brug af aliskiren og ACE-hæmmere eller ARB'er er kontraindiceret hos patienter med nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2).
English: No adjustment of the initial dose is required for patients with mild to moderate renal impairment (see sections 4.4 and 5.2).
Danish: Der kræves ingen justering af initialdosen for patienter med let til moderat nedsat nyrefunktion (se pkt.
English: The use of aliskiren in combination with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Danish: Anvendelse af aliskiren i kombination med ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2) (se pkt.
English: FOLDING BOX FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Danish: KARTON TIL ENKELTPAKNING MED PA/ALU/PVC-BLISTERKORT
English: Sprimeo is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m
Danish: Sprimeo frarådes til patienter med stærkt nedsat nyrefunktion (GFR < 30 ml/min./1,73 m
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients
Danish: Kombination af aliskiren med ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2) og frarådes til andre patienter
English: As for other agents acting on the renin-angiotensin system, caution should be exercised when aliskiren is given in the presence of conditions pre-disposing to kidney dysfunction such as hypovolaemia (eg.
Danish: Som for andre stoffer, der virker på renin-angiotensin-systemet, skal der udvises forsigtighed, når aliskiren gives til patienter, der er prædisponerede for renal dysfunktion som hypovolæmi (f.eks. pga. blodtab, alvorlig og vedvarende diarré, vedvarende opkastning), hjertelidelse, leverlidelse, diabetes mellitus eller nyrelidelse.
English: België/Belgique/Belgien Novartis Pharma N.V. Tél/Tel: +32 2 246 16 11
Danish: België/Belgique/Belgien Novartis Pharma N.V.
English: - furosemide, a medicine belonging to the type known as diuretics, or “water” tablets, which is used to increase the amount of urine you produce.
Danish: Kaldes også vanddrivende tabletter og bruges til at øge urinproduktionen.
English: No adjustment of the initial dosage of Sprimeo is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Danish: Det er ikke nødvendigt at justere initialdosen af Sprimeo hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: Concomitant use of Sprimeo with ARBs or ACEIs is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Danish: Samtidig brug af Sprimeo og ARB'er eller ACE-hæmmere er kontraindiceret hos patienter med nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2) (se pkt.
English: The combination of aliskiren with ARBs or ACEIs is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) and is not recommended in other patients (see sections 4.3,
Danish: Kombination af aliskiren med ARB'er eller ACE-hæmmere er kontraindiceret til patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min./1,73 m2) og frarådes til andre patienter (se pkt.
English: Hyperkalaemia
Danish: Mave-tarm-kanalen
English: EU/1/07/407/011 7 film-coated tablets EU/1/07/407/012 14 film-coated tablets EU/1/07/407/013 28 film-coated tablets EU/1/07/407/014 30 film-coated tablets EU/1/07/407/015 50 film-coated tablets EU/1/07/407/016 56 film-coated tablets
Danish: EU/1/07/407/011 EU/1/07/407/012 EU/1/07/407/013 EU/1/07/407/014 EU/1/07/407/015 EU/1/07/407/016
English: EU/1/07/407/001 7 film-coated tablets EU/1/07/407/002 14 film-coated tablets EU/1/07/407/003 28 film-coated tablets EU/1/07/407/004 30 film-coated tablets EU/1/07/407/005 50 film-coated tablets EU/1/07/407/006 56 film-coated tablets EU/1/07/407/008 90 film-coated tablets
Danish: EU/1/07/407/001 EU/1/07/407/002 EU/1/07/407/003 EU/1/07/407/004 EU/1/07/407/005 EU/1/07/407/006 EU/1/07/407/008
English: Pharmaceutical Form Route of Administration
Danish: Lægemiddelform Administration Emballage
English: Invented name
Danish: (Sær)navn Styrke
English: Elimination Following administration of an oral [
Danish: Elimination Efter administration af en oral [
English: Death from any cause
Danish: Død uanset årsag
English: Your body can also make too much sugar.
Danish: Deres krop kan også danne for meget sukker.
English: Date of first authorisation: 15 March 2010 Date of latest renewal: 16 December 2014
Danish: Dato for første markedsføringstilladelse: 15. marts 2010 Dato for seneste fornyelse: 16. december 2014
English: Based on a Cox model stratified by region.
Danish: Baseret på en Cox-model stratificeret ud fra region.
English: Onset of these reactions occurred within the first 3 months after initiation of treatment, with some reports occurring after the first dose.
Danish: Disse reaktioner startede inden for de første 3 måneder efter initiering af behandling, og nogle rapporter kom efter første dosis.
English: You can take this medicine with or without food and drink.
Danish: De kan tage dette lægemiddel med eller uden mad og drikke.
English: You should not stop taking this medicine without talking to your doctor first.
Danish: De bør ikke holde op med at tage dette lægemiddel uden at tale med lægen først.
English: Your doctor may ask you to stop Ristaben.
Danish: Lægen vil måske bede Dem om at stoppe med at tage Ristaben.
English: It is important to stay on the diet and exercise recommended by your doctor while taking Ristaben.
Danish: Det er vigtigt at forblive på den diæt og motion, som lægen anbefaler, mens De tager Ristaben.
English: Frequency not known
Danish: Frekvens ikke kendt
English: Poznańska 12 05-850 Ożarów Mazowiecki Poland
Danish: Poznańska 12 05-850 Ożarów Mazowiecki Polen
English: Common: flu
Danish: Almindelig: Influenza
English: Diet and exercise can help your body use its blood sugar better.
Danish: Diæt og motion kan hjælpe Dem, så kroppen bruger sit blodsukker bedre.
English: You should not take this medicine during pregnancy.
Danish: De bør ikke tage dette lægemiddel under graviditet.
English: Treatment may be administered without regard to the timing of dialysis.
Danish: Behandlingen kan administreres uden at tage hensyn til tidspunktet for dialyse.
English: No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Danish: Dosisjustering er ikke nødvendig på basis af køn, race eller body mass index (BMI).
English: A double dose should not be taken on the same day.
Danish: Patienten bør ikke tage en dobbeltdosis på den samme dag.
English: STOP taking Ristaben and contact a doctor immediately if you notice any of the following serious side effects:
Danish: STOP med at tage Ristaben og kontakt straks lægen, hvis De får nogen af følgende alvorlige bivirkninger:
English: Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Danish: På grund af den høje sikkerhedsmargin (19 gange på dette no-effect niveau), anses disse neoplastiske ændringer ikke relevante for situationen hos mennesker.
English: There was no difference in the incidence of severe hypoglycaemia.
Danish: Der var ingen forskel i incidensen af svær hypoglykæmi.
English: It is not known if this medicine is safe and effective when used in children and adolescents under 18 years of age.
Danish: Det er ikke kendt, om dette lægemiddel er sikkert og effektivt, når det anvendes hos børn og teenagere under 18 år.
English: Approximately 79 % of sitagliptin is excreted unchanged in the urine.
Danish: Ca. 79% af sitagliptin udskilles uændret i urinen.
English: Opaque blisters (PVC/PE/PVDC and aluminum).
Danish: Uigennemsigtig blister (PVC/PE/PVDC og aluminium).
English: No dose adjustment of digoxin is recommended.
Danish: Der anbefales ingen dosisjustering af digoxin.
English: Continue to take this medicine as long as your doctor prescribes it so you can continue to help control your blood sugar.
Danish: Fortsæt med at tage Ristaben, så længe Deres læge ordinerer det, så De fortsat kan få hjælp til at kontrollere Deres blodsukker.
English: In particular, tell your doctor if you are taking digoxin (a medicine used to treat irregular heart beat and other heart problems).
Danish: Fortæl det især til lægen, hvis De tager digoxin (et lægemiddel til behandling af uregelmæssig hjerterytme og andre hjerteproblemer).
English: Adverse reactions are listed below (Table 1) by system organ class and frequency.
Danish: Bivirkningerne ses nedenfor (tabel 1) inddelt i systemorganklasse og frekvens.
English: Your doctor may prescribe a medicine to treat your allergic reaction and a different medicine for your diabetes.
Danish: Lægen kan ordinere et lægemiddel til behandling af Deres allergiske reaktion og et andet lægemiddel til Deres diabetes.
English: Your doctor may prescribe this medicine alone or with certain other medicines that lower blood sugar.
Danish: Deres læge kan ordinere dette lægemiddel alene eller sammen med visse andre lægemidler, der sænker blodsukkeret.
English: Sitagliptin accumulates only minimally with multiple doses.
Danish: Sitagliptin akkumuleres kun minimalt efter flere doser.
English: Method of administration Ristaben can be taken with or without food.
Danish: Administration Ristaben kan tages med eller uden mad.
English: For composite endpoints, the p-values correspond to a test of non-inferiority seeking to show that the hazard ratio is less than 1.3.
Danish: For sammensatte endepunkter svarer p-værdierne til en test af noninferioritet, der tilstræber at vise, at hazard ratio er mindre end 1,3.
English: Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Danish: Frekvenserne defineres som: Meget almindelig (1/10); almindelig (1/100 til <1/10); ikke almindelig (1/1.000 til <1/100); sjælden (1/10.000 til <1/1.000); meget sjælden (<1/10.000) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Due to lack of human data, Ristaben should not be used during pregnancy.
Danish: På grund af mangel på humane data bør Ristaben ikke anvendes under graviditet.
English: Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Danish: På grund af de høje sikkerhedsmargener tyder disse fund ikke på en relevant risiko for reproduktionen hos mennesker.
English: The renal clearance was approximately 350 ml/min.
Danish: Den renale clearance var ca. 350 ml/min.
English: Ristaben should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Danish: Ristaben bør ikke anvendes til patienter med type 1-diabetes eller til behandling af diabetisk ketoacidose.
English: Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Ristaben and periodically thereafter.
Danish: Da der er dosisjustering på baggrund af nyrefunktionen, anbefales det at vurdere nyrefunktionen før initiering af Ristaben og med mellemrum derefter.
English: There are no adequate data from the use of sitagliptin in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af sitagliptin til gravide kvinder.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Danish: Type 2-diabetes er en tilstand, hvor Deres krop ikke danner nok insulin, samtidig med at det insulin, som Deres krop danner, ikke virker så godt, som det burde.
English: However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported.
Danish: Ved bilkørsel og betjening af maskiner bør der dog tages hensyn til, at svimmelhed og søvnighed er rapporteret.
English: This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Danish: Dette lægemiddel vil ikke forårsage lavt blodsukker, fordi det ikke virker, når Deres blodsukker er lavt.
English: Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion.
Danish: Elimination af sitagliptin foregår primært via renal udskillelse og omfatter aktiv tubulær sekretion.
English: See TECOS Cardiovascular Safety Study below.
Danish: Se det kardiovaskulære sikkerhedsstudie TECOS nedenfor.
English: However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Danish: Patienter, der har risiko for digoxinforgiftning, bør dog monitoreres for dette, når sitagliptin og digoxin administreres samtidigt.
English: Following a [
Danish: Efter en [
English: Cardiovascular death
Danish: Kardiovaskulær død
English: The relevance of these findings for humans is unknown.
Danish: Relevansen af dette fund for mennesker er ukendt.
English: The incretins are part of an endogenous system involved in the physiologic regulation of glucose homeostasis.
Danish: Inkretinerne er en del af et endogent system, som er involveret i den fysiologiske regulering af glucosehomøostase.
English: Hospitalization for unstable angina
Danish: Hospitalsindlæggelse pga. ustabil angina
English: For all other endpoints, the p-values correspond to a test of differences in hazard rates.
Danish: For alle andre endepunkter svarer p-værdierne til en test af forskellene i hazard ratio.
English: Elderly subjects (65 to 80 years) had approximately 19 % higher plasma concentrations of sitagliptin compared to younger subjects.
Danish: Ældre patienter (65-80 år) havde ca. 19% højere sitagliptin-plasmakoncentrationer sammenlignet med yngre patienter.
English: The level of digoxin in your blood may need to be checked if taking with Ristaben.
Danish: Det kan være nødvendigt at kontrollere indholdet af digoxin i Deres blod, hvis De tager Ristaben.
English: If you have kidney problems, your doctor may prescribe lower doses (such as 25 mg or 50 mg).
Danish: Hvis De har nyreproblemer, kan Deres læge ordinere en lavere dosis (såsom 25 mg eller 50 mg).
English: This can lead to serious medical problems like heart disease, kidney disease, blindness, and amputation.
Danish: Dette kan føre til alvorlige helbredsproblemer som hjertesygdom, nyresygdom, blindhed og amputation.
English: Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.
Danish: Det skal vurderes, om der er andre potentielle årsager til hændelsen, og alternativ diabetesbehandling skal indledes.
English: * Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Danish: * Incidensrate pr. 100 patientår er beregnet som 100 × (samlet antal patienter med ≥ 1 hændelse i løbet af en egnet eksponeringsperiode pr. samlet antal patientår med opfølgning).
English: (see section 4.2 and 5.2).
Danish: 4.2 og 5.2).
English: Number of patients
Danish: Antal patienter
English: - an allergic reaction to Ristaben (see section 4).
Danish: - Allergisk reaktion over for Ristaben (se punkt 4).
English: Sitagliptin is not a substrate for OCT2 or OAT1 or PEPT1/2 transporters.
Danish: Sitagliptin er ikke et substrat for OCT2, OAT1 eller PEPT1/2 transportere.
English: Both treatments were added to usual care targeting regional standards for HbA1c and CV risk factors.
Danish: Begge behandlinger blev givet som supplement til standardbehandling målrettet de regionale standarder for HbA1c og kardiovaskulære risikofaktorer.
English: If you stop taking Ristaben
Danish: Hvis De holder op med at tage Ristaben
English: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Danish: Hyppighed af sammensatte kardiovaskulære endepunkter og vigtige sekundære endepunkter
English: Effects of sitagliptin on other medicinal products
Danish: Sitagliptins indvirkning på andre lægemidler
English: Your doctor has prescribed this medicine to help lower your blood sugar, which is too high because of your type 2 diabetes.
Danish: Deres læge har foreskrevet dette lægemiddel som en hjælp til at sænke Deres blodsukker, som er for højt på grund af Deres type 2-diabetes.
English: This medicine helps to increase the levels of insulin produced after a meal and decreases the amount of sugar made by the body.
Danish: Dette lægemiddel hjælper med at øge mængden af insulin, der frigives efter et måltid, og nedsætter mængden af sukker, der dannes af kroppen.
English: When this happens, sugar (glucose) builds up in the blood.
Danish: Når dette sker, øges sukkerindholdet (glucose) i blodet.
English: p<0.001 compared to placebo or placebo + combination treatment.
Danish: p<0,001 sammenlignet med placebo eller placebo + kombinationsbehandling.
English: 2031 BN Haarlem The Netherlands
Danish: 2031 BN Haarlem Holland
English: Rare: reduced number of platelets
Danish: Sjælden: Nedsat antal blodplader.
English: Dose-proportionality was not established for Cmax and C24hr (Cmax increased in a greater than dose-proportional manner and C24hr increased in a less than dose-proportional manner).
Danish: Dosisproportionaliteten blev ikke fastslået for Cmax og C24t (Cmax øgedes mere end dosisproportionalt og C24t øgedes mindre end dosisproportionalt).
English: Human data are lacking.
Danish: Der findes ikke humane data.
English: Sitagliptin, but not metformin, increased active GIP concentrations.
Danish: Sitagliptin, men ikke metformin, øgede den aktive GIP-koncentration.