natgillin/translations-raw huggingface dataset:
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at vildagliptin taget med metformin nedsætter blokglukoseniveauerne, og at kombinationen af de to aktive stoffer i en tablet kan medvirke til, at patienterne overholder deres behandling.
The Committee for Medicinal Products for Human Use (CHMP) concluded that vildagliptin taken with metformin reduces blood glucose levels and the combination of the two active substances in one tablet may help patients to stick to their treatment.
Derfor var udvalget af den opfattelse, at fordelene ved Eucreas er større end risiciene ved behandling af type 2- diabetes mellitus- patienter, som ikke opnår tilstrækkelig glykæmisk regulering på deres maksimalt tolererede dosis oral metformin alene, eller som allerede behandles med kombinationen af vildagliptin og metformin som særskilte tabletter.
Therefore, the Committee decided that the benefits of Eucreas are greater than its risks for the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Eucreas.
The Committee recommended that Eucreas be given marketing authorisation.
Andre oplysninger om Eucreas:
Other information about Eucreas:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Eucreas til Novartis Europharm Limited den 14. november 2007.
The European Commission granted a marketing authorisation valid throughout the EU for Eucreas to Novartis Europharm Limited on 14 November 2007.
Den fuldstændige EPAR for Eucreas findes her.
The full EPAR for Eucreas can be found here.
EU- nummer EU/ 1/ 07/ 425/ 001 EU/ 1/ 07/ 425/ 002 EU/ 1/ 07/ 425/ 003 EU/ 1/ 07/ 425/ 004 EU/ 1/ 07/ 425/ 005 EU/ 1/ 07/ 425/ 006 EU/ 1/ 07/ 425/ 007 EU/ 1/ 07/ 425/ 008 EU/ 1/ 07/ 425/ 009 EU/ 1/ 07/ 425/ 010 EU/ 1/ 07/ 425/ 011 EU/ 1/ 07/ 425/ 012 EU/ 1/ 07/ 425/ 013 EU/ 1/ 07/ 425/ 014 EU/ 1/ 07/ 425/ 015 EU/ 1/ 07/ 425/ 016 EU/ 1/ 07/ 425/ 017 EU/ 1/ 07/ 425/ 018
EU/ 1/ 07/ 425/ 001 EU/ 1/ 07/ 425/ 002 EU/ 1/ 07/ 425/ 003 EU/ 1/ 07/ 425/ 004 EU/ 1/ 07/ 425/ 005 EU/ 1/ 07/ 425/ 006 EU/ 1/ 07/ 425/ 007 EU/ 1/ 07/ 425/ 008 EU/ 1/ 07/ 425/ 009 EU/ 1/ 07/ 425/ 010 EU/ 1/ 07/ 425/ 011 EU/ 1/ 07/ 425/ 012 EU/ 1/ 07/ 425/ 013 EU/ 1/ 07/ 425/ 014 EU/ 1/ 07/ 425/ 015 EU/ 1/ 07/ 425/ 016 EU/ 1/ 07/ 425/ 017 EU/ 1/ 07/ 425/ 018
Særnavn Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas
Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas Eucreas
Styrke 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 850 mg 50 mg / 1000 mg 50 mg / 1000 mg 50 mg / 1000 mg
Lægemiddelform Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter Filmovertrukne tabletter
Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Indgivelsesvej Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Emballage Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al) Blister (PA/ Al/ PVC/ Al)
blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al) blister (PA/ Al/ PVC/ Al)
Pakningsstørrelse 10 tabletter 30 tabletter 60 tabletter 120 tabletter 180 tabletter 360 tabletter 10 tabletter 30 tabletter 60 tabletter 120 tabletter 180 tabletter 360 tabletter 120 (2x60) tabletter 180 (3x60) tabletter 360 (6x60) tabletter 120 (2x60) tabletter 180 (3x60) tabletter 360 (6x60) tabletter
10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 10 tablets 30 tablets 60 tablets 120 tablets 180 tablets 360 tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets 120 (2x60) tablets 180 (3x60) tablets 360 (6x60) tablets
Eucreas 50 mg/ 850 mg filmovertrukne tabletter
Eucreas 50 mg/ 850 mg film-coated tablets
Gul, oval, filmovertrukket tablet med skrå kant, præget med ” NVR ” på den ene side og ” SEH ” på den anden side.
Yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “ NVR” on one side and “ SEH” on the other side.
Eucreas er indiceret til behandling af patienter med type 2- diabetes mellitus, der ikke opnår tilstrækkelig glykæmisk kontrol med deres maksimalt tålte dosis oral metformin alene, eller som allerede behandles med kombinationen af vildagliptin og metformin i form af separate tabletter.
Eucreas is indicated in the treatment of type 2 diabetes mellitus patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Voksne Baseret på patientens nuværende dosis af metformin, kan Eucreas påbegyndes med en tablet á enten 50 mg/ 850 mg eller 50 mg/ 1000 mg to gange daglig, én tablet om morgenen og én om aftenen.
Adults Based on the patient’ s current dose of metformin, Eucreas may be initiated at either the 50 mg/ 850 mg or 50 mg/ 1000 mg tablet strength twice daily, one tablet in the morning and the other in the evening.
Den anbefalede daglige dosis er 100 mg vildagliptin plus 2000 mg metforminhydrochlorid.
The recommended daily dose is 100 mg vildagliptin plus 2000 mg metformin hydrochloride.
Patienter, der modtager vildagliptin og metformin i separate tabletter, kan gå over til Eucreas, der indeholder de samme doser af hvert af disse indholdsstoffer.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Eucreas containing the same doses of each component.
Doser på over 100 mg vildagliptin frarådes.
Doses higher than 100 mg of vildagliptin are not recommended.
Der er ingen klinisk erfaring med vildagliptin og metformin i triple- kombination med andre midler mod diabetes.
There is no clinical experience of vildagliptin and metformin in triple combination with other antidiabetic agents.
5. 2).
Taking Eucreas with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
4. 3, 4. 4 og 5. 2).
Additional information on special populations Renal impairment Eucreas should not be used in patients with creatinine clearance < 60 ml/ min (see sections 4.3, 4.4 and 5.2).
4. 3, 4. 4 og 4. 8).
Hepatic impairment Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
4. 4).
2 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see section 4.4).
Eucreas er ikke undersøgt til patienter på over 75 år.
Eucreas has not been studied in patients older than 75 years.
Derfor bør Eucreas ikke anvendes til denne population.
Therefore the use of Eucreas is not recommended in this population.
Pædiatriske patienter (< 18 år) Eucreas bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Eucreas is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
4. 4).
− Hypersensitivity to the active substances or to any of the excipients − Diabetic ketoacidosis or diabetic pre-coma − Renal failure or renal dysfunction defined as creatinine clearance < 60 ml/ min (see section 4.4) − Acute conditions with the potential to alter renal function, such as:
4. 4)
dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
- - -
−
4. 2, 4. 4 og 4. 8)
Acute - - -
- Akut alkoholforgiftning, alkoholisme
or chronic disease which may cause tissue hypoxia, such as: cardiac or respiratory failure, recent myocardial infarction, shock.
4. 6)
− Hepatic impairment (see sections 4.2, 4.4 and 4.8) − Acute alcohol intoxication, alcoholism − Lactation (see section 4.6)
Generelt Eucreas er ikke en erstatning for insulin til insulinkrævende patienter og må ikke anvendes til patienter med type 1- diabetes.
General Eucreas is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Laktatacidose Laktatacidose er en meget sjælden men alvorlig stofskiftekomplikation, der kan forekomme på grund af ophobning af metformin.
Lactic acidosis Lactic acidosis is a very rare but serious metabolic complication that can occur due to metformin accumulation.
4. 3 og 4. 5).
The incidence of lactic acidosis can and should be reduced by also assessing other associated risk factors, such as poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, hepatic insufficiency and any conditions associated with hypoxia (see also sections 4.3 and 4.5).
Diagnosticering af laktatacidose Laktatacidose er kendetegnet ved acidotisk dyspnø, mavesmerter og hypotermi efterfulgt af koma.
Diagnosis of lactic acidosis Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain and hypothermia followed by coma.
Diagnostiske laboratorieresultater er reduceret pH- værdi i blodet, plasma laktatværdier over 5 mmol/ l og øget aniongab og laktat/ pyruvat- ratio.
Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/l and increased anion gap and lactate/pyruvate ratio.
Nedsat nyrefunktion Da metformin udskilles af nyrerne, skal kreatininkoncentrationerne i serum monitoreres regelmæssigt:
Renal impairment As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
- mindst en gang om året for patienter med normal nyrefunktion
- at least once a year in patients with normal renal function
- mindst to til fire gange årligt hos patienter med serumkreatininværdier ved øverste grænse for
- at least two to four times a year in patients with serum creatinine levels at the upper limit of
normalområdet og hos ældre patienter.
normal and in elderly patients.
3 Nedsat nyrefunktion hos ældre patienter forekommer hyppigt og er asymptomatisk.
3 Renal impairment in elderly patients is frequent and asymptomatic.
Der skal udvises særlig forsigtighed i situationer, hvor nyrefunktionen kan blive svækket, f. eks. ved start på antihypertensiv behandling eller behandling med diuretikum, eller når behandling med et NSAID påbegyndes.
Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with an NSAID.
4. 2, 4. 3 og 4. 8).
Hepatic impairment Patients with hepatic impairment, including those with pre-treatment ALT or AST > 3x ULN, should not be treated with Eucreas (see sections 4.2, 4.3 and 4.8).
Monitorering af leverenzymer Der er rapporteret sjældne tilfælde af leverdysfunktion med vildagliptin (inklusive hepatitis).
Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
LFTs skal udføres før initiering af behandling med Eucreas for at kende patientens baselineværdi.
LFTs should be performed prior to the initiation of treatment with Eucreas in order to know the patient’s baseline value.
Patienter, som udvikler forhøjede transaminaseniveauer, skal monitoreres med en sekundær evaluering af leverfunktionen for at bekræfte resultatet og skal derefter følges med hyppige LFTs, indtil abnormaliteten / - erne er tilbage på normalen.
Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal.
Hjertesvigt Der er begrænsede erfaringer med vildagliptinbehandling hos patienter med hjertesvigt, New York Heart Association (NYHA) - funktionsklasse I- II, og derfor skal vildagliptin anvendes med forsigtighed til disse patienter.
Cardiac failure Experience with vildagliptin therapy in patients with congestive heart failure of New York Heart Association (NYHA) functional class I-II is limited and therefore vildagliptin should be used cautiously in these patients.
Der er ingen erfaringer med anvendelse af vildagliptin i kliniske forsøg med patienter med NYHA- funktionsklasse III- IV, og vildagliptin anbefales derfor ikke til disse patienter.
There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class III-IV and therefore use is not recommended in these patients.
4. 3).
Metformin is contraindicated in patients with heart failure, therefore Eucreas is contraindicated in this patient population (see section 4.3).
Hudsygdomme Hudlæsioner, herunder blære - og sårdannelse, er rapporteret for vildagliptin på abers ekstremiteter i non- kliniske toksikologi- undersøgelser (se pkt.
Skin disorders Skin lesions, including blistering and ulceration have been reported with vildagliptin in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Det anbefales derfor - i overensstemmelse med rutinekontrol af diabetespatienten - at monitorere for hudlæsioner, såsom blære - eller sårdannelse.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Operation Da Eucreas indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med helbedøvelse og må normalt først genoptages tidligst 48 timer efter operationen.
Surgery As Eucreas contains metformin, the treatment should be discontinued 48 hours before elective surgery with general anaesthesia and should not usually be resumed earlier than 48 hours afterwards.
Administration af jodholdigt kontraststof Intravaskulær administration af jodholdigt kontraststof ved radiologiske undersøgelser kan medføre nyresvigt.
Administration of iodinated contrast agent The intravascular administration of iodinated contrast agents in radiological studies can lead to renal failure.
4. 5).
Therefore, due to the metformin active substance, Eucreas should be discontinued prior to, or at the time of, the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.5).
4 Vildagliptin Vildagliptin har lavt potentiale for interaktioner med samtidigt administrerede lægemidler.
4 Vildagliptin Vildagliptin has a low potential for interactions with co-administered medicinal products.
Vildagliptin er ikke et cytokrom P (CYP) 450- enzymsubstrat og hæmmer eller inducerer ikke CYP 450- enzymer, og der vil derfor være lav risiko for interaktion med aktive stoffer, som er substrater, hæmmere eller induktorer af disse enzymer.
Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Studier af lægemiddel- lægemiddel interaktioner med digoxin (P- glycoproteinsubstrat) og warfarin (CYP2C9- substrat) hos raske forsøgspersoner har ikke vist nogen klinisk relevante farmakokinetiske interaktioner efter samtidig administration med vildagliptin.
Drug-drug interaction studies with digox in (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after co- administration with vildagliptin.
Der er udført lægemiddel- lægemiddel- interaktionsstudier på raske forsøgspersoner med amlodipin, ramipril, valsartan og simvastatin.
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
4. 4).
Metformin Combinations not recommended There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Eucreas (see section 4.4).
Kationisk aktive stoffer, der elimineres ved tubulær sekretion (f. eks. cimetidin) kan interagere med metformin ved at konkurrere om fælles tubulære transportsystemer og dermed forsinke eliminationen af metformin, hvilket kan forhøje risikoen for laktatacidose.
Cationic active substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems and hence delay the elimination of metformin, which may increase the risk of lactic acidosis.
Et studie med raske frivillige forsøgspersoner viste, at cimetidin, administreret som 400 mg daglig, øgede den systemiske eksponering af metformin (AUC) med 50%.
A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
4. 4).
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Intravaskulær administration af jodholdige kontraststoffer kan medføre nyresvigt med deraf følgende metformin- akkumulation med risiko for laktatacidose.
Intravascular administration of iodinated contrast media may lead to renal failure, resulting in metformin accumulation with the risk of lactic acidosis.
Kombinationer, der kræver sikkerhedsforanstaltninger Glukokortikoider, beta- 2- agonister og diuretika har indbygget hyperglykæmisk aktivitet.
Combinations requiring precautions for use Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
ACE- hæmmere (angiotensin converting enzyme hæmmere) kan reducere blodsukkerniveauet.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Der foreligger ikke tilstrækkelige data om brugen af Eucreas hos gravide kvinder.
There are no adequate data from the use of Eucreas in pregnant women.
For metformin viser dyreforsøg ikke
For metformin, studies in animals have not
5 reproduktionstoksicitet.
5 shown reproductive toxicity.
5. 3).
Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3).
Det vides ikke, om vildagliptin udskilles i modermælk hos mennesker, men metformin udskilles i små mængder i modermælken.
It is not known whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts.
4. 3).
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Eucreas should not be used during lactation (see section 4.3).
Patienter, der oplever svimmelhed som en bivirkning, skal undgå at føre motorkøretøj eller betjene maskiner.
Patients who may experience dizziness as an undesirable effect should avoid driving vehicles or using machines.
5. 2).
However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
I data fra kontrollerede monoterapi - og tillægsbehandlingsstudier i op til 24- ugers varighed var incidensen af ALAT - eller ASAT- forhøjelser > 3x ULN (klassificeret som til stede ved mindst 2 fortløbende målinger eller ved det sidste behandlingsbesøg) var 0, 2% for vildagliptin 50 mg en gang daglig, 0, 3% for vildagliptin 50 mg to gange daglig og 0, 2% for alle sammenligningsstofferne.
In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations ≥ 3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
En større andel af tilfælde blev rapporteret, når vildagliptin blev administreret i kombination med en ACE- hæmmer.
A greater proportion of cases were reported when vildagliptin was administered in combination with an ACE inhibitor.
De fleste hændelser var milde og forsvandt ved fortsat vildagliptin- behandling.
The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.
De bivirkninger, der blev rapporteret hos patienter, der modtog vildagliptin i dobbeltblindede studier som tillægsbehandling til metformin (tabel 1) og som monoterapi (tabel 2) er opført nedenfor efter organsystemklasse og absolut hyppighed.
Adverse reactions reported in patients who received vildagliptin in double-blind studies as add-on therapy to metformin (Table 1) and as monotherapy (Table 2) are listed below by system organ class and absolute frequency.
De bivirkninger, der er anført i tabel 3, er baseret på oplysninger, der er til rådighed i det produktresume for metformin, der er tilgængeligt i EU.
Adverse reactions listed in Table 3 are based on information available from the metformin Summary of Product Characteristics available in the EU.
Hyppigheden 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), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
Frequencies are defined as very common (≥1/10); common (≥1/100, < 1/10); uncommon (≥1/1,000, < 1/100); rare (≥1/10,000, < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
6 Tabel 1
6 Table 1
Bivirkninger, der blev rapporteret hos patienter, der modtog vildagliptin 100 mg daglig som tillægsbehandling til metformin, sammenlignet med placebo plus metformin i dobbeltblindede studier (N=208)
Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)