FrancophonIA/ELRC3.0 huggingface dataset:
English: In 16-week studies in which dogs were treated with either metformin alone or a combination of metformin and sitagliptin, no additional toxicity was observed from the combination.
Danish: I 16-ugers undersøgelser, hvor hunde blev behandlet med enten metformin alene eller en kombination af metformin og sitagliptin, sås ikke øget toksicitet med kombinationsbehandlingen.
English: In vitro and clinical data described below suggest that the risk for clinically meaningful interactions following co-administration of other medicinal products is low.
Danish: In vitro og kliniske data, som er beskrevet nedenfor, tyder på, at risikoen for interaktioner af klinisk betydning mellem lægemidler, der administreres samtidigt, er lav.
English: Serious adverse reactions including pancreatitis and hypersensitivity reactions have been reported.
Danish: Alvorlige bivirkninger herunder pankreatitis og overfølsomhedsreaktioner er rapporteret.
English: Pharmacokinetic drug interaction studies with Ristfor have not been performed; however, such studies have been conducted with the individual active substances, sitagliptin and metformin.
Danish: Der er ikke udført farmakokinetiske interaktionsundersøgelser med Ristfor, men sådanne undersøgelser er udført med de enkelte aktive stoffer, sitagliptin og metformin.
English: GFR should be assessed before treatment initiation and regularly thereafter (see section 4.2).
Danish: GFR skal bestemmes inden behandlingsstart og regelmæssigt derefter (se pkt.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Danish: Metformins renale clearance er >400 ml/min, hvilket tyder på, at metformin elimineres ved glomerulær filtration og tubulær sekretion.
English: In studies performed with the individual active substances, both sitagliptin and metformin are excreted in the milk of lactating rats.
Danish: I undersøgelser med de individuelle aktive stoffer udskilles både sitagliptin og metformin i mælken hos diegivende rotter.
English: ACE-inhibitors may decrease the blood glucose levels.
Danish: ACE-hæmmere sænker blodglucoseniveauet.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g., megaloblastic anaemia).
Danish: Langvarig behandling med metformin er blevet associeret med nedsat absorption af B12-vitamin, som meget sjældent medfører klinisk signifikant B12-vitaminmangel (f.eks. megaloblastær anæmi).
English: C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing.
Danish: C] sitagliptindosis til raske forsøgspersoner elimineredes ca. 100% af den administrerede radioaktivitet i fæces (13%) eller urin (87%) inden for en uge efter dosering.
English: Along with diet and exercise, this medicine helps lower your blood sugar.
Danish: Sammen med diæt og motion kan denne medicin hjælpe med at sænke Deres blodsukker.
English: If you forget to take Ristfor
Danish: Hvis De har glemt at tage Ristfor
English: Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Danish: Frekvenserne er baseret på information fra produktresuméer for metformin, der er tilgængelige i EU.
English: Uncommon: dry mouth, headache
Danish: Ikke almindelige: Tør mund, hovedpine
English: What you need to know before you take Ristfor
Danish: Det skal De vide, før De begynder at tage Ristfor
English: If pancreatitis is suspected, Ristfor and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Ristfor should not be restarted.
Danish: Hvis der er mistanke om pankreatitis, bør Ristfor og andre potentielt suspekte lægemidler seponeres, og hvis mistanken om akut pankreatitis bekræftes, må behandlingen med Ristfor ikke genoptages.
English: Ristfor may cause a very rare (may affect up to 1 in 10,000 people), but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Danish: Ristfor kan forårsage en meget sjælden (kan forekomme hos op til 1 ud af 10.000 behandlede), men meget alvorlig bivirkning, der kaldes laktacidose (se punktet ”Advarsler og forsigtighedsregler”).
English: Effects of other medicinal products on sitagliptin
Danish: Andre lægemidlers indvirkning på sitagliptin
English: The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Danish: Sitagliptins farmakokinetik var generelt den samme hos raske personer som hos patienter med type 2diabetes.
English: However, more patients in the sitagliptin group discontinued due to lack of efficacy than in the glipizide group.
Danish: Imidlertid ophørte flere patienter i sitagliptingruppen end i glipizidgruppen med behandling på grund af manglende effekt.
English: Lactic acidosis is a medical emergency and must be treated in a hospital.
Danish: Laktacidose er en alvorlig tilstand, der skal behandles på et hospital.
English: • vandetanib, a medicine used to treat a specific type of thyroid cancer (medullary thyroid cancer)
Danish: • Vandetanib, et lægemiddel til behandling af en særlig type kræft i skjoldbruskkirtlen (medullær thyroideacancer).
English: The following data are findings in studies performed with sitagliptin or metformin individually.
Danish: Følgende data er baseret på fund i undersøgelser, der er udført med sitagliptin og metformin hver for sig.
English: The renal clearance of sitagliptin was not meaningfully altered.
Danish: Sitagliptins renale clearance ændredes ikke betydeligt.
English: All patients should continue their recommended diet with an adequate distribution of carbohydrate intake during the day.
Danish: Patienterne bør fortsætte med den anbefalede diæt med et hensigtsmæssigt indtag af kulhydrater i løbet af dagen.
English: Metformin increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Danish: Metformin øger transportkapaciteten for specifikke typer af membranglucosetransportører (GLUT-1 og GLUT
English: GLP-1 also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production.
Danish: Desuden sænker GLP-1 glucagonsekretionen fra pankreatiske alfaceller, som fører til reduceret hepatisk glucoseproduktion.
English: Ketoacidosis is a condition in which substances called ‘ketone bodies' accumulate in the blood and which can lead to diabetic pre-coma.
Danish: Ketoacidose er en tilstand, hvor såkaldte ketonstoffer ophobes i blodet, hvilket kan føre til diabetisk prækoma.
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Danish: De prækliniske data for metformin viser ingen særlig fare for mennesker på basis af traditionelle undersøgelser af sikkerhedsfarmakologi, gentagen dosistoksicitet, genotoksicitet, karcinogenicitet, og toksicitet i forbindelse med reproduktion.
English: • specific medicines for the treatment of bronchial asthma (β-sympathomimetics)
Danish: • Særlig medicin til behandling af bronkial astma (beta-sympatomimetika).
English: • with meals to lower your chance of an upset stomach.
Danish: • sammen med et måltid for at undgå at få problemer med maven.
English: For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Danish: Derfor kan potente CYP3A4-hæmmere (dvs. ketoconazol, itraconazol, ritonavir, clarithromycin) muligvis ændre sitagliptins farmakokinetik hos patienter med svær nyreinsufficiens eller ESRD.
English: Do not take Ristfor if any of the above apply to you and talk with your doctor about other ways of managing your diabetes.
Danish: Tag ikke Ristfor, hvis De mener noget af dette passer på Dem, og drøft andre former for diabetesbehandling med Deres læge.
English: Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see also section 5.3).
Danish: Dyreforsøg med metformin viser ikke skadelige virkninger for graviditet, embryoets eller fostrets udvikling, fødslen eller den postnatale udvikling (se pkt.
English: Sitagliptin and metformin
Danish: Sitagliptin og metformin
English: Prolonged haemodialysis may be considered if clinically appropriate.
Danish: Forlænget hæmodialyse kan overvejes, hvis det er klinisk hensigtsmæssigt.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Danish: Metformin er et biguanid med antihyperglykæmisk virkning, som sænker både basal og postprandial plasmaglucose.
English: If a hypersensitivity reaction is suspected, Ristfor should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Danish: Hvis der er mistanke om en overfølsomhedsreaktion, bør Ristfor seponeres, andre mulige årsager til hændelsen vurderes, og alternativ diabetesbehandling igangsættes (se pkt.
English: However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.
Danish: Svimmelhed og døsighed er dog set i forbindelse med sitagliptin, hvilket kan påvirke Deres evne til at køre bil eller bruge maskiner.
English: Table 2: HbA1c results in placebo-controlled combination therapy studies of sitagliptin and metformin*
Danish: Tabel 2: HbA1c resultater i placebokontrollerede undersøgelser af kombinationsbehandling med sitagliptin og metformin*
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Danish: Reproduktive toksicitetsundersøgelser viste en let behandlingsrelateret øget forekomst af føtale ribbensdefekter (manglende, hypoplastiske og takkede ribben) hos rotteafkom ved en systemisk eksponering på mere end 29 gange eksponeringen hos mennesker.
English: If this happens, you must stop taking Ristfor and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Danish: Hvis dette sker for Dem, skal De omgående stoppe med at tage Ristfor og kontakte læge eller nærmeste hospital, da laktacidose kan føre til koma.
English: The apparent terminal t½ following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Danish: Den tilsyneladende terminale halveringstid (t½) efter indgift af en 100 mg oral dosis sitagliptin var ca. 12,4 timer.
English: The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40 % of patients requiring a glipizide dose of  5 mg/day throughout the study.
Danish: Den gennemsnitligt anvendte glipiziddosis i sammenligningsgruppen, var 10 mg dagligt, og ca. 40% af patienterne havde behov for en glipiziddosis på 5 mg/dag i hele undersøgelsesperioden.
English: Lactic acidosis, a rare but serious metabolic complication, most often occurs at acute worsening of renal function or cardiorespiratory illness or sepsis.
Danish: Laktacidose er en meget sjælden, men alvorlig metabolisk komplikation, som oftest indtræder ved akut forværring af nyrefunktionen eller ved kardiopulmonal sygdom eller sepsis.
English: The incidence of hypoglycaemia in the sitagliptin group (4.9 %) was significantly lower than that in the glipizide group (32.0 %).
Danish: Incidensen af hypoglykæmi i gruppen, som blev behandlet med sitagliptin, var signifikant lavere end i glipizidgruppen (4,9% versus 32,0%).
English: In vitro data showed that sitagliptin is not an inhibitor of CYP isoenzymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
Danish: In vitro-data viste, at sitagliptin ikke er en hæmmer af CYP-isozymerne CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 eller 2B6, og det inducerer ikke CYP3A4 og CYP1A2.
English: • certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
Danish: • Visse lægemidler, der nedsætter blodtrykket (ACE-hæmmere og angiotensin II
English: There are no adequate data from the use of sitagliptin in pregnant women.
Danish: Der er utilstrækkelige data for anvendelse af sitagliptin til gravide.
English: - The active substances are sitagliptin and metformin.
Danish: - Aktive stoffer: Sitagliptin og metformin.
English: The incidence of hypoglycaemia was 24.9 % for patients treated with sitagliptin, metformin, and insulin and 37.8 % for patients treated with placebo, metformin, and insulin.
Danish: Incidensen af hypoglykæmi var 24,9% for de patienter, der blev behandlet med sitagliptin, metformin og insulin, og 37,8% for de patienter, der blev behandlet med placebo, metformin og insulin.
English: The effects of potent CYP3A4 inhibitors in the setting of renal impairment have not been assessed in a clinical study.
Danish: Virkningen af potente CYP3A4-hæmmere hos patienter med nyreinsufficiens er ikke vurderet i en klinisk undersøgelse.
English: • iodinated contrast agents or alcohol-containing medicines
Danish: • Jodholdige kontraststoffer eller medicin, der indeholder alkohol.
English: In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Danish: Hos rotter var der en øget forekomst af hepatiske adenomer og carcinomer ved en systemisk eksponering, der var 58 gange højere end eksponeringen hos mennesker.
English: You should continue the diet recommended by your doctor during treatment with this medicine and take care that your carbohydrate intake is equally distributed over the day.
Danish: De bør fortsætte med den diæt, som blev anbefalet af Deres læge under behandlingen med Ristfor, og sørge for, at indtagelsen af kulhydrater fordeles jævnt over dagen.
English: Stop taking Ristfor for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal.
Danish: Stop med at tage Ristfor i en kort periode, hvis De har en tilstand, som kan være forbundet med dehydrering (betydeligt tab af kropsvæsker), såsom alvorlig opkastning, diarré, feber, udsættelse for varme eller indtagelse af mindre væske end normalt.
English: Change in clinical status of patients with previously controlled type 2 diabetes A patient with type 2 diabetes previously well controlled on Ristfor who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Danish: Ændring i klinisk status hos patienter med tidligere velbehandlet type 2-diabetes En patient med type 2-diabetes, der tidligere var velbehandlet på Ristfor, og som udvikler unormale laboratorieværdier eller klinisk sygdom (især vagt eller uklart defineret sygdom) bør vurderes hurtigt med henblik på tegn på ketoacidose eller laktacidose.
English: Among these patients, adverse events reported regardless of causal relationship to medicinal product occurring in at least 5 % included upper respiratory tract infection and nasopharyngitis.
Danish: De bivirkninger, som forekom hos mindst 5% af disse patienter, og som blev rapporteret uanset kausal sammenhæng, inkluderede infektion i øvre luftveje og nasopharyngitis.
English: A large overdose of metformin (or co-existing risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Danish: En stor overdosis metformin (eller samtidigt forekommende risiko for laktacidose) kan føre til laktacidose, som kræver akut lægehjælp og behandling på hospital.
English: These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Danish: Disse reaktioner omfatter anafylaksi, angioødem og eksfoliative hudsygdomme, herunder Stevens-Johnsons syndrom.
English: This medicine can be used alone or with certain other medicines for diabetes (insulin, sulphonylureas, or glitazones).
Danish: Lægemidlet kan bruges alene eller sammen med visse andre lægemidler til behandling af diabetes (insulin, sulfonylurinstof eller glitazoner).
English: Avoid excessive alcohol intake while taking Ristfor since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Danish: De skal undgå at indtage store mængder alkohol, mens De er i behandling med Ristfor, da det kan øge risikoen for laktacidose (se punktet ”Advarsler og forsigtighedsregler”).
English: If you have a serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing, stop taking this medicine and call your doctor right away.
Danish: Hvis De får en alvorlig allergisk reaktion (hyppighed ikke kendt) herunder udslæt, nældefeber, blærer på huden/hudafskalning og hævelse af ansigt, læber, tunge eller svælg, som kan medføre vejtræknings- eller synkebesvær, skal De stoppe med at tage dette lægemiddel og straks kontakte lægen.
English: Therefore, a reduction in the dose of the sulphonylurea or insulin may be necessary.
Danish: Derfor kan det være nødvendigt at reducere dosis af sulfonylurinstof eller insulin.
English: Stop taking Ristfor and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Danish: Stop med at tage Ristfor og kontakt omgående læge eller nærmeste hospital, hvis De får et eller flere af nedenstående symptomer på laktacidose, da denne tilstand kan føre til koma.
English: Some adverse reactions were observed more frequently in studies of combination use of sitagliptin and metformin with other anti-diabetic medicinal products than in studies of sitagliptin and metformin alone.
Danish: Nogle bivirkninger blev observeret hyppigere i undersøgelser med sitagliptin i kombination med metformin og andre antidiabetika end i undersøgelser med sitagliptin og metformin-monoterapi.
English: Some patients have experienced the following side effects while taking metformin alone: Very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite.
Danish: Nogle patienter har oplevet følgende bivirkninger, når de har taget metformin alene: Meget almindelige: Kvalme, opkastning, diarré, mavesmerter og tab af appetit.
English: In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
Danish: I en klinisk undersøgelse havde sitagliptin en lille effekt på digoxinkoncentrationerne i plasma, hvilket tyder på, at sitagliptin kan være en svag hæmmer af p-glykoprotein.
English: Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Danish: Intravaskulær administration af iodholdige kontrastmidler kan medføre kontrastinduceret nefropati, resulterende i akkumulation af metformin og en øget risiko for laktacidose.
English: For patients switching from co-administration of sitagliptin and metformin For patients switching from co-administration of sitagliptin and metformin, Ristfor should be initiated at the dose of sitagliptin and metformin already being taken.
Danish: Til patienter, der skifter fra samtidig administration af sitagliptin og metformin Til patienter, der skifter fra samtidig administration af sitagliptin og metformin, bør Ristfor initieres med den dosis af sitagliptin og metformin, som allerede tages.
English: Improvements in surrogate markers of beta cell function, including HOMA-β (Homeostasis Model Assessment-β), proinsulin to insulin ratio, and measures of beta cell responsiveness from the frequently-sampled meal tolerance test were observed.
Danish: Forbedring af surrogatmarkører for betacellefunktionen, inklusive HOMA-β (homøostatisk modelvurdering af βcellefunktionen), proinsulin/insulin-ratio samt resultater fra en frequently sampled meal tolerance test blev observeret.
English: Some patients have experienced the following side effects during clinical studies while taking sitagliptin alone (one of the medicines in Ristfor) or during post-approval use of Ristfor or sitagliptin alone or with other diabetes medicines:
Danish: Nogle patienter har oplevet følgende bivirkninger i kliniske studier, når de har taget sitagliptin alene (et af de aktive stoffer i Ristfor) eller ved anvendelse af Ristfor eller sitagliptin efter markedsføring alene eller sammen med anden diabetesmedicin:
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Ristfor (see section 4).
Danish: Der er indberettet tilfælde af betændelse i bugspytkirtlen (pankreatitis) hos patienter, der får Ristfor (se punkt 4).
English: Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment.
Danish: Sitagliptin forbedrede totalt set den glykæmiske kontrol, når det blev givet som monoterapi eller som kombinationsbehandling.
English: In clinical trials, sitagliptin as monotherapy improved glycaemic control with significant reductions in haemoglobin A1c (HbA1c) and fasting and postprandial glucose.
Danish: I kliniske undersøgelser forbedrede sitagliptin som monoterapi den glykæmiske kontrol ved signifikant reduktion af hæmoglobin A1c (HbA1c) samt faste- og postprandial glucose.
English: Ristfor contains two different medicines called sitagliptin and metformin.
Danish: Ristfor indeholder to slags medicin, sitagliptin og metformin.
English: It is not known whether sitagliptin is excreted in human milk.
Danish: Det vides ikke, om sitagliptin udskilles i modermælk hos mennesker.
English: These symptoms may happen when you start taking metformin and usually go away Common: a metallic taste
Danish: Disse symptomer kan opstå, når De starter med at tage metformin og forsvinder som regel.
English: No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR]  60 mL/min).
Danish: Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (glomerulær filtrationsrate [GFR] ≥ 60 ml/min).
English: Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis.
Danish: Samtidig anvendelse af lægemidler, der påvirker det fælles tubulære transportsystem involveret i den renale elimination af metformin (f.eks organisk kationtransportør-2 [OCT2] / multidrug og toksin ekstrusion [MATE]-hæmmere såsom ranolazin, vandetanib, dolutegravir og cimetidin), kan øge den systemiske eksponering for metformin og kan øge risikoen for laktacidose.
English: The DPP-4 inhibitors are a class of agents that act as incretin enhancers.
Danish: DPP-4-hæmmerne er en klasse af præparater, der virker som inkretinenhancers.
English: This medicine has no or negligible influence on the ability to drive and use machines.
Danish: Dette lægemiddel påvirker ikke eller kun i ubetydelig grad evnen til at køre bil eller bruge maskiner.
English: Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Danish: Glukokortikoider (givet systemisk og lokalt), beta-2-agonister og diuretika har en selvstændig hyperglykæmisk virkning.