natgillin/translations-raw huggingface dataset:
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sanofi- aventis, S. A.
sanofi-aventis - Produtos Farmacêuticos, S.A.
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sa til Denne indlægsseddel blev senest godkendt
This leaflet was last approved in
ret De kan finde yderligere information om ZIMULTI på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http: // www. emea. europa. eu /
Detaile d information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu.
ise tor au ere ng læ ke r ik te dle mi ge Læ
d ise or uth ra ge on ol tn duc ro lp ina dic Me
Zomarist er et lægemiddel, som indeholder de aktive stoffer vildagliptin og metformin hydrochlorid.
Zomarist is a medicine containing the active substances vildagliptin and metformin hydrochloride.
50 mg vildagliptin og 1. 000 mg metformin hydrochlorid).
50 mg vildagliptin and 1,000 mg metformin hydrochloride).
Virksomheden, som fremstiller Eucreas, har givet tilladelse til, at dens videnskabelige oplysninger må anvendes for Zomarist.
The company that makes Eucreas has agreed that its scientific data can be used for Zomarist.
Zomarist anvendes til behandling af type 2- diabetes (ikke- insulinkrævende diabetes).
Zomarist is used to treat type 2 diabetes (non-insulin-dependent diabetes).
Den anbefalede dosis Zomarist er én tablet to gange dagligt, hvor den ene tablet tages om morgenen, og den anden om aftenen.
The recommended dose of Zomarist is one tablet twice a day, with one tablet taken in the morning and one in the evening.
Valget af tabletstyrke afhænger af, hvilken dosis metformin patienten allerede tager, men den anbefalede dosis er 50 mg vildagliptin og 1. 000 mg metformin to gange dagligt.
The choice of tablet strength to start with depends on the dose of metformin the patient is currently taking, but the recommended dose is 50 mg vildagliptin and 1,000 mg metformin twice a day.
Patienter, der allerede tager vildagliptin og metformin, bør skifte til Zomarist med samme indhold af begge aktive stoffer.
Patients already taking vildagliptin and metformin should switch to Zomarist containing the same amounts of each active substance.
Indtages Zomarist i forbindelse med eller lige efter mad, kan maveproblemer forårsaget af metformin mindskes.
Taking Zomarist with or just after food may reduce any stomach problems caused by metformin.
Zomarist bør ikke anvendes af patienter, der har moderate eller alvorlige problemer med nyrerne eller problemer med leveren.
Zomarist should not be used in patients who have moderate or severe problems with their kidneys or who have problems with their liver.
Ældre patienter, der tager Zomarist, skal regelmæssigt have deres nyrefunktion undersøgt.
Elderly patients taking Zomarist should have their kidney function monitored regularly.
Zomarist anbefales ikke til patienter, der er over 75 år.
Zomarist is not recommended for use in patients aged over 75 years.
Type 2- diabetes er en sygdom, hvor bugspytkirtlen ikke producerer tilstrækkeligt insulin til at regulere blodets koncentration af glukose (sukker), eller hvor kroppen ikke kan udnytte insulin tilstrækkelig effektivt.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose (sugar) in the blood or when the body is unable to use insulin effectively.
Zomarist indeholder to aktive stoffer, som har hver deres virkningsmåde.
Zomarist contains two active substances, which each have a different mode of action.
Vildagliptin, som er en dipeptidylpeptidase 4 (DPP- 4) - hæmmer, virker ved at blokere nedbrydningen af 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. inkretinhormoner i kroppen.
Reproduction is authorised provided the source is acknowledged. when blood glucose levels are high.
Undersøgelser af Galvus som tillægsbehandling til metformin er brugt til at understøtte brugen af Zomarist ved de samme indikationer.
The studies of Galvus as an add-on to metformin were used to support the use of Zomarist in the same indication.
Ansøgeren fremlagde endvidere resultaterne af to undersøgelser, der viser, at de aktive stoffer i de to styrker af Zomarist blev optaget i kroppen på samme vis, som når de blev taget som enkelttabletter.
The applicant also presented the results of two studies showing that the active substances in the two strengths of Zomarist were absorbed in the body in the same way as when they were taken as separate tablets.
Hvilken risiko er der forbundet med Zomarist?
What is the risk associated with Zomarist?
De hyppigste bivirkninger ved Zomarist (som optræder hos flere end 1 ud af 10 patienter) er kvalme, opkastning, diaré, mavesmerter og manglende appetit.
The most common side effects with Zomarist (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain and loss of appetite.
Den fuldstændige liste over alle de indberettede bivirkninger ved Zomarist fremgår af indlægssedlen.
For the full list of all side effects reported with Zomarist, see the Package Leaflet.
Zomarist må ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for vildagliptin, metformin eller nogen af indholdsstofferne.
Zomarist should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Udvalget besluttede derfor, at fordelene ved Zomarist er større end risiciene ved behandling af patienter med type 2 - diabetes mellitus, hvor der ikke kan opnås tilstrækkelig glykæmisk kontrol trods indtagelse af den maksimale daglige orale dosis af metformin alene, eller som allerede behandles med en kombination af vildagliptin og metformin som enkelttabletter.
Therefore, the Committee decided that the benefits of Zomarist 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 Zomarist.
The Committee recommended that Zomarist be given marketing authorisation.
Andre oplysninger om Zomarist:
Other information about Zomarist:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Zomarist til Novartis Europharm Limited den 1. december 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Zomarist to Novartis Europharm Limited on 1 December 2008.
Den fuldstændige EPAR for Zomarist findes her.
The full EPAR for Zomarist can be found here.
EU- nummer EU/ 1/ 08/ 483/ 001 EU/ 1/ 08/ 483/ 002 EU/ 1/ 08/ 483/ 003 EU/ 1/ 08/ 483/ 004 EU/ 1/ 08/ 483/ 005 EU/ 1/ 08/ 483/ 006 EU/ 1/ 08/ 483/ 007 EU/ 1/ 08/ 483/ 008 EU/ 1/ 08/ 483/ 009 EU/ 1/ 08/ 483/ 010 EU/ 1/ 08/ 483/ 011 EU/ 1/ 08/ 483/ 012 EU/ 1/ 08/ 483/ 013 EU/ 1/ 08/ 483/ 014 EU/ 1/ 08/ 483/ 015 EU/ 1/ 08/ 483/ 016 EU/ 1/ 08/ 483/ 017 EU/ 1/ 08/ 483/ 018
EU/ 1/ 08/ 483/ 001 EU/ 1/ 08/ 483/ 002 EU/ 1/ 08/ 483/ 003 EU/ 1/ 08/ 483/ 004 EU/ 1/ 08/ 483/ 005 EU/ 1/ 08/ 483/ 006 EU/ 1/ 08/ 483/ 007 EU/ 1/ 08/ 483/ 008 EU/ 1/ 08/ 483/ 009 EU/ 1/ 08/ 483/ 010 EU/ 1/ 08/ 483/ 011 EU/ 1/ 08/ 483/ 012 EU/ 1/ 08/ 483/ 013 EU/ 1/ 08/ 483/ 014 EU/ 1/ 08/ 483/ 015 EU/ 1/ 08/ 483/ 016 EU/ 1/ 08/ 483/ 017 EU/ 1/ 08/ 483/ 018
Særnavn Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist
Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist Zomarist
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
Zomarist 50 mg/ 850 mg filmovertrukne tabletter
Zomarist 50 mg/ 850 mg film-coated tablets
Zomarist 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.
Zomarist 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 Zomarist 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, Zomarist 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.
Patienter, der modtager vildagliptin og metformin i separate tabletter, kan gå over til Zomarist, der indeholder de samme doser af hvert af disse indholdsstoffer.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Zomarist containing the same doses of each component.
5. 2).
Taking Zomarist 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 Zomarist 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).
2 Hepatic impairment Zomarist 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).
Ældre patienter (≥ 65 år)
Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see section 4.4).
Zomarist er ikke undersøgt til patienter på over 75 år.
Zomarist has not been studied in patients older than 75 years.
Derfor bør Zomarist ikke anvendes til denne population.
Therefore the use of Zomarist is not recommended in this population.
Pædiatriske patienter (< 18 år) Zomarist bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Zomarist 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. 6)
 Hepatic impairment (see sections 4.2, 4.4 and 4.8)  Acute alcohol intoxication, alcoholism  Lactation (see section 4.6)
Generelt Zomarist er ikke en erstatning for insulin til insulinkrævende patienter og må ikke anvendes til patienter med type 1- diabetes.
General Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
4. 9).
Renal impairment
Nedsat nyrefunktion Da metformin udskilles af nyrerne, skal kreatininkoncentrationerne i serum monitoreres regelmæssigt:
3 As metformin is excreted by the kidney, serum creatinine concentrations should be monitored regularly:
Der skal udvises særlig forsigtighed i situationer, hvor nyrefunktionen kan blive svækket, f. eks. ved start på
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 Zomarist (see sections 4.2, 4.3 and 4.8).
LFTs skal udføres før initiering af behandling med Zomarist for at kende patientens baselineværdi.
LFTs should be performed prior to the initiation of treatment with Zomarist in order to know the patient’s baseline value.
4. 3).
Metformin is contraindicated in patients with heart failure, therefore Zomarist is contraindicated in this patient population (see section 4.3).
Operation Da Zomarist indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med helbedøvelse og må normalt først genoptages tidligst 48 timer efter operationen.
Surgery As Zomarist 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.
4. 5).
Therefore, due to the metformin active substance, Zomarist 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).
Der er ikke udført nogen formelle interaktionsstudier med Zomarist.
4 There have been no formal interaction studies for Zomarist.
Vildagliptin Vildagliptin har lavt potentiale for interaktioner med samtidigt administrerede lægemidler.
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
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.
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 Zomarist (see section 4.4).
Der foreligger ikke tilstrækkelige data om brugen af Zomarist hos gravide kvinder.
5 There are no adequate data from the use of Zomarist in pregnant women.
5 Studier i dyr har vist udskillelse i mælk af både metformin og vildagliptin.
Studies in animals have shown excretion of both metformin and vildagliptin in milk.
4. 3).
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Zomarist should not be used during lactation (see section 4.3).
5. 2).
However, bioequivalence of Zomarist with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
6 Tabel 1
Table 1
Almindelig Almindelig Almindelig Ikke almindelig
Common Common
Tremor Hovedpine Svimmelhed Træthed
Tremor Headache
I kliniske forsøg ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev administreret som monoterapi (- 0, 3 kg og - 1, 3 kg for henholdsvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
og ernæring sjælden Reduktion af vitamin B 12 - absorption og laktatacidose *
Decrease of vitamin B 12 absorption and lactic acidosis*
FARMAKOLOGISKE EGENSKABER 8 5. 1 Farmakodynamiske egenskaber
5.1 Pharmacodynamic properties
Zomarist kombinerer to antihyperglykæmiske midler med komplementære virkningsmekanismer for at forbedre den glykæmiske kontrol hos patienter med type 2- diabetes: vildagliptin, der tilhører klassen af ø- celle- forstærkere, og metformin- hydrochlorid, der tilhører klassen af biguanider.
Zomarist combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Vildagliptin, der tilhører klassen af ø- celle- forstærkere, er en potent og selektiv dipeptidyl- peptidase- 4 (DPP- 4) - hæmmer.
8 Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Når vildagliptin blev administreret til patienter, hvis glykæmiske kontrol ikke var tilfredsstillende trods behandling med metformin monoterapi, forekom der yderligere statistisk signifikante middelreduktioner i HbA 1c efter 6 måneders behandling sammenlignet med placebo (der var en forskel mellem grupperne på - 0, 7% til - 1, 1% for vildagliptin ved henholdsvis 50 mg og 100 mg).
Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA 1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively).
Andelen af patienter, der opnåede en reduktion i HbA 1c på ≥ 0, 7% fra baseline, var statistisk signifikant højere i gruppen, der modtog vildagliptin og metformin (henholdsvis 46% og 60%) i forhold til gruppen, der modtog metformin plus placebo (20%).
The proportion of patients who achieved a decrease in HbA 1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%).
Metformin kan udøve den glucosesænkende effekt via tre mekanismer:
Metformin may exert its glucose -lowering effect via three mechanisms:
Det prospektive, randomiserede studie UKPDS (UK Prospective Diabetes Study) har fastslået den langsigtede fordel ved intensiv styring af blodsukker ved type 2- diabetes.
9 The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long- term benefit of intensive blood glucose control in type 2 diabetes.
Zomarist Absorption Bioækvivalens er påvist mellem Zomarist ved tre dosisstyrker (50 mg/ 500 mg, 50 mg/ 850 mg og 50 mg/ 1000 mg) i forhold til fri kombination af vildagliptin - og metforminhydrochloridtabletter ved de tilsvarende doser.
Zomarist Absorption Bioequivalence has been demonstrated between Zomarist at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Mad påvirker ikke absorptionsomfang og - hastighed for vildagliptin fra Zomarist.
Food does not affect the extent and rate of absorption of vildagliptin from Zomarist.
Absorptionshastighed og - omfang for metformin fra Zomarist 50 mg/ 1000 mg blev reduceret ved indgivelse med mad, som er afspejlet af en reduktion i C max på 26%, AUC på 7% og forsinket T max (2, 0 til 4, 0 t).
The rate and extent of absorption of metformin from Zomarist 50 mg/1000 mg were decreased when given with food as reflected by the decrease in C max by 26%, AUC by 7% and delayed T max (2.0 to 4.0 h).
Administration af vildagliptin sammen med mad resulterede i et fald i C max (19%) sammenlignet med dosering i den fastende tilstand.
Administration of vildagliptin with food resulted in a decreased C max (19%) compared to dosing in the fasting state.
Vildagliptins gennemsnitlige fordelingsvolumen ved steady state efter intravenøs administration (V ss) er 71 liter, hvilket indikerer ekstravaskulær fordeling.
The mean volume of distribution of vildagliptin at steady-state after intravenous administration (V ss) is 71 litres, suggesting extravascular distribution.
85% af dosis udskilt i urinen, og 15% af dosis genfindes i fæces.
10 Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion var den systemiske eksponering for vildagliptin øget (C max 8- 66%, AUC 32- 134%), og den totale body - clearance var reduceret sammenlignet med forsøgspersoner med normal nyrefunktion.
In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (C max 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Metformin Absorption Efter en oral dosis metformin nås den maksimale plasmakoncentration C max efter ca.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (C max) is achieved after about 2.5 h..
I kontrollerede kliniske forsøg oversteg de maksimale metformin plasmaværdier (C max) ikke 4 µg/ ml, selv ikke ved maksimumdoser.
In controlled clinical trials, maximum metformin plasma levels (C max) did not exceed 4 µg/ml, even at maximum doses.
Det gennemsnitlige fordelingsvolumen (V d) varierede mellem 63- 276 liter.
The mean volume of distribution (V d) ranged between 63-276 litres.
Udskillelse Metformin udskilles gennem nyrerne.
11 Metformin is eliminated by renal excretion.
Vildagliptin Der blev observeret intrakardielle impulsledningsforsinkelser hos hunde med en NOEL (No Observed Effect Level) på 15 mg/ kg (7 gange human eksponering baseret på C max).
Vildagliptin Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7- fold human exposure based on C max).
Metformin Ikke- kliniske data vedrørende metformin viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet, carcinogenicitet og reproduktionstoksicitet.
12 Non-clinical data on metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Zomarist 50 mg/ 1000 mg filmovertrukne tabletter
Zomarist 50 mg/1000 mg film-coated tablets
Voksne Baseret på patientens nuværende dosis af metformin, kan Zomarist 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, Zomarist 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.
4. 3, 4. 4 og 5. 2).
Additional information on special populations Renal impairment Zomarist 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).
15 Hepatic impairment Zomarist 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).