natgillin/translations-raw huggingface dataset:
Den anbefalede dosis af Galvus til voksne er: • en tablet om morgenen og en tablet om aftenen, når det tages sammen med metformin eller et thiazolidindion, • en tablet om morgenen, når det tages sammen med et sulfonylurinstof.
In adults, the recommended dose of Galvus is: • one tablet in the morning and another in the evening when used with metformin or a thiazolidinedione, • one tablet in the morning when taken with a sulphonylurea.
Galvus kan tages sammen med et måltid eller mellem måltiderne.
Galvus can be taken with or without food.
Galvus anbefales ikke til patienter med moderat eller svær nyresygdom, herunder patienter, der er i hæmodialyse (rensning af blodet med en kunstig nyre) og har nyresygdom i sent stadium.
Galvus is not recommended for patients who have moderate or severe problems with their kidneys, including those on haemodialysis (a blood clearance technique) with end-stage renal disease.
Det anbefales heller ikke til patienter med leversygdom.
Galvus is not recommended for patients with liver problems.
Hos patienter over 75 år bør det anvendes med forsigtighed.
It should be used with caution in patients aged over 75 years.
Ved type 2- sukkersyge producerer bugspytkirtlen enten ikke nok insulin til at regulere blodsukkeret, eller også er kroppen ikke i stand til at udnytte insulinet 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.
Det aktive stof i Galvus, vildagliptin, er en dipeptidylpeptidase- IV (DPP- IV) hæmmer.
The active substance in Galvus, vildagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Det virker ved at blokere kroppens nedbrydning af "incretin" - hormoner.
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Incretiner er hormoner, der frigives efter et måltid og får bugspytkirtlen til at producere insulin.
By increasing levels of incretin hormones in the blood, vildagliptin stimulates the pancreas to produce more insulin when blood glucose levels are high.
Vildagliptin øger indholdet af incretiner i blodet.
Vildagliptin does not work when the blood glucose is low.
Det får bugspytkirtlen til at producere mere insulin, når blodsukkeret er højt.
Vildagliptin also reduces the amount of glucose made by the liver, by increasing insulin levels and decreasing the levels of the hormone glucagon.
Vildagliptin virker ikke, når blodsukkeret er lavt.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Vildagliptin nedsætter desuden leverens sukkerproduktion ved at øge 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. insulinindholdet og sænke indholdet af hormonet glukagon.
Reproduction is authorised provided the source is acknowledged.
Virkningerne af Galvus blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Galvus were first tested in experimental models before being studied in humans.
Galvus blev desuden anvendt i syv hovedundersøgelser, der tilsammen omfattede over 4 000 patienter med type 2- sukkersyge, hvis blodsukker ikke var tilfredsstillende reguleret.
Galvus has also been studied in seven main studies involving a total of over 4,000 patients with type 2 diabetes and insufficient control of blood glucose levels.
Det blev her sammenlignet med placebo (virkningsløs behandling), med metformin og med rosiglitazon, der er et thiazolidindion.
Three of these studies looked at the effects of Galvus taken alone in a total of 2,198 patients who had not taken diabetes treatment before, comparing it to placebo (a dummy treatment), metformin or rosiglitazone (a thiazolidinedione).
I de andre fire undersøgelser blev virkningen af Galvus, 50 eller 100 mg dagligt i 24 uger, sammenlignet med placebo som tillægsbehandling til enten metformin (544 patienter), thiazolidindionet pioglitazon (463 patienter), sulfonylurinstoffet glimepirid (515 patienter) eller insulin (296 patienter).
The other four studies compared the effects of Galvus, taken at doses of 50 or 100 mg a day for 24 weeks, with those of placebo, when used as an add-on to existing treatment with metformin (544 patients), pioglitazone (a thiazolidinedione, 463 patients), glimepiride (a sulphonylurea, 515 patients) or insulin (296 patients).
Dette stof fortæller, hvor godt blodsukkeret er reguleret.
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c), which gives an indication of how well blood glucose is controlled.
Galvus sænkede indholdet af HbA1c i alle undersøgelserne.
Galvus reduced levels of HbA1c in all studies.
8% efter 24 uger, men det var ikke lige så effektivt som metformin eller rosiglitazon.
When used alone, it caused a reduction in HbA1c levels by approximately 1% from a starting level of around 8% after 24 weeks, but it was not as effective as metformin or rosiglitazone.
Som tillægsbehandling til anden medicin til behandling af type 2- sukkersyge var Galvus bedre end placebo til at sænke indholdet af HbA1c.
When used as an add-on to existing treatment for type 2 diabetes, Galvus was more effective than placebo in reducing HbA1c levels.
Sammen med metformin og med pioglitazon virkede en dosis på 100 mg dagligt bedre end 50 mg dagligt og gav en reduktion i indholdet af HbA1c på mellem 0, 8 og 1, 0%.
With metformin and with pioglitazone, the 100-mg daily dose was more effective than the 50 mg daily dose, with a reduction in HbA1c levels of between 0.8 and 1.0%.
0, 6%.
In combination with glimepiride, both 50 mg and 100 mg daily doses caused a reduction of around 0.6%.
Hos de patienter, der i stedet fik placebo som tillægsbehandling til den medicin, de fik i forvejen, var ændringen i HbA1c- niveauet derimod mindre (mellem et fald på 0, 3% og en stigning på 0, 2%).
In contrast, patients adding placebo to their existing treatment showed smaller changes in HbA1c levels, ranging from a fall of 0.3% to a rise of 0.2%.
Selv om Galvus som tillægsbehandling til insulin gav større fald i HbA1c end placebo, var virkningen for lille til at blive anset for at have klinisk betydning for patienterne.
Although adding Galvus to existing insulin therapy caused a greater reduction in HbA1c levels than placebo, the size of this effect was too small to be considered meaningful for patients.
Firmaet trak under vurderingen af lægemidlet sin ansøgning tilbage om anvendelse af Galvus som selvstændig behandling og som tillægsbehandling til insulin.
The company withdrew its application for the use of Galvus on its own and as an add-on to insulin during the assessment of the medicine.
Den fuldstændige liste over alle de indberettede bivirkninger ved Galvus fremgår af indlægssedlen.
For the full list of all side effects reported with Galvus, see the Package Leaflet.
Galvus bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for vildagliptin eller andre af indholdsstofferne.
Galvus should not be used in people who may be hypersensitive (allergic) to vildagliptin or any of the other ingredients.
Hos patienter med hjertesygdom bør Galvus kun bruges, hvis sygdommen er af lettere grad.
Its use in patients with heart disease should be limited to patients with mild disease.
Da vildagliptin er blevet sat i forbindelse med leverproblemer, skal patienterne undersøges for at kontrollere deres lever inden behandlingen med Galvus og med regelmæssige mellemrum under behandlingen.
Because vildagliptin has been associated with liver problems, patients should have tests to check their liver before treatment with Galvus and at regular intervals during treatment.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Galvus opvejer risiciene til behandling af type 2- sukkersyge, når det anvendes som oral dobbeltbehandling i kombination med metformin, et sulfonylurinstof eller et thiazolidindion.
The Committee for Medicinal Products for Human Use (CHMP) concluded that Galvus’ s benefits in the treatment of type 2 diabetes mellitus are greater than its risks when used as dual oral therapy in combination with metformin, a sulphonylurea or a thiazolidinedione.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Galvus.
The Committee recommended that Galvus be given marketing authorisation.
Andre oplysninger om Galvus:
Other information about Galvus:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Galvus til Novartis Europharm Limited den 26. september 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for Galvus to Novartis Europharm Limited on 26 September 2007.
Den fuldstændige EPAR for Galvus findes her.
The full EPAR for Galvus can be found here.
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet Tablet
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
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)
7 tabletter 14 tabletter 28 tabletter 30 tabletter 56 tabletter 60 tabletter 90 tabletter 112 tabletter 180 tabletter 336 tabletter 336 tabletter (3x112) tabletter
7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets 336 (3x112) tablets
Hver tablet indeholder 47, 82 mg lactose, vandfri.
Each tablet contains 47.82 mg anhydrous lactose.
Den ene side er præget med ” NVR ”, og den anden side er præget med ” FB ”.
One side is debossed with “ NVR”, and the other side with “ FB”.
Vildagliptin er indiceret til behandling af type 2- diabetes mellitus:
Vildagliptin is indicated in the treatment of type 2 diabetes mellitus:
Som oral terapi kombineret med
As dual oral therapy in combination with
- metformin hos patienter med utilstrækkelig glykæmisk kontrol på trods af maksimal tolereret
- metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of
dosis monoterapi med metformin
monotherapy with metformin,
- et sulfonylurea hos patienter med utilstrækkelig glykæmisk kontrol på trods af maksimal
- a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose
tolereret dosis sulfonylurea og til hvem metformin ikke er egnet på grund af kontraindikationer eller intolerance
of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance,
- et glitazon hos patienter med utilstrækkelig glykæmisk kontrol, og til hvem et glitazon er egnet.
- a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a
4. 2 Dosering og indgivelsesmåde
thiazolidinedione is appropriate.
Voksne Når Galvus anvendes i kombination med metformin eller et glitazon, er den anbefalede daglige dosis af vildagliptin 100 mg, administreret som én dosis på 50 mg om morgenen og én dosis på 50 mg om aftenen.
Adults When used in dual combination with metformin or a thiazolidinedione, the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Når Galvus kombineres med et sulfonylurea, er den anbefalede dosis af vildagliptin 50 mg én gang daglig om morgenen.
When used in dual combination with a sulphonylurea, the recommended dose of vildagliptin is 50 mg once daily administered in the morning.
Der er ingen dokumentation for vildagliptins sikkerhed og virkning ved oral behandling kombineret med både metformin og et glitazon eller med metformin og et sulfonylurea.
The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione or with metformin and a sulphonylurea has not been established.
5. 2).
Galvus can be administered with or without a meal (see also section 5.2).
2 Supplerende information vedr. specielle populationer Nedsat nyrefunktion Der kræves ingen dosisjustering for patienter med let nedsat nyrefunktion (kreatininclearance ≥ 50 ml/ min).
2 Additional information on special populations Renal impairment No dose adjustment is required in patients with mild renal impairment (creatinine clearance ≥ 50 ml/ min).
4. 4 og 5. 2).
The use of Galvus is not recommended in patients with moderate or severe renal impairment or in haemodialysis patients with end-stage renal disease (ESRD) (see also sections 4.4 and 5.2).
4. 4 og 5. 2).
Hepatic impairment Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3x the upper limit of normal (ULN) (see also sections 4.4 and 5.2).
Ældre patienter (≥ 65 år) Der kræves ingen dosisjustering til ældre patienter.
Elderly (≥ 65 years) No dose adjustments are necessary in elderly patients.
5. 1 og 5. 2).
Experience in patients aged 75 years and older is limited and caution should be exercised when treating this population (see also sections 5.1 and 5.2).
Børn og unge (< 18 år) Galvus bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Galvus is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Generelt Galvus kan ikke erstatte insulin hos insulinkrævende patienter.
General Galvus is not a substitute for insulin in insulin-requiring patients.
Galvus bør ikke anvendes til patienter med type 1- diabetes eller til behandling af diabetisk ketoacidose.
Galvus should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Nedsat nyrefunktion Der er begrænsede erfaringer med patienter med moderat til svær nyreinsufficiens eller med patienter med nyresygdom i sidste stadie (ESRD) på hæmodialyse.
Renal impairment There is limited experience in patients with moderate to severe renal impairment or in patients with ESRD on haemodialysis.
Derfor frarådes Galvus til disse patienter.
Therefore, the use of Galvus is not recommended in these patients.
Nedsat leverfunktion Galvus må ikke anvendes til patienter med nedsat leverfunktion, inklusive patienter der før behandlingstidspunktet har ALAT eller ASAT > 3x ULN.
Hepatic impairment Galvus should not be used in patients with hepatic impairment, including patients with pre-treatment ALT or AST > 3x ULN.
Monitorering af leverenzymer Der er rapporteret sjældne tilfælde af leverdysfunktion (inklusive hepatitis).
Liver enzyme monitoring Rare cases of hepatic dysfunction (including hepatitis) have been reported.
Leverfunktionstest skal udføres før initiering af behandling med Galvus for at kende patientens baselineværdi.
Liver function tests should be performed prior to the initiation of treatment with Galvus 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 leverfunktionstest, 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 liver function tests until the abnormality(ies) return(s) to normal.
3 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.
3 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 bør derfor ikke anvendes 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.
5. 3).
Skin disorders Skin lesions, including blistering and ulceration have been reported in extremities of monkeys in non- clinical toxicology studies (see section 5.3).
Det anbefales derfor, i overensstemmelse med rutinekontrollen af diabetespatienten, at monitorere for hudlæsioner, såsom blære - og sårdannelse.
Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Hjælpestoffer Tabletterne indeholder lactose.
Excipients The tablets contain lactose.
Bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af hereditær lactasemangel (Lapp Lactase deficiency) eller glucose/ galactosemalabsorption.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
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 inducere 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.
Kombination med pioglitazon, metformin og glyburid Resultaterne af studier med disse orale antidiabetika har ikke vist nogen klinisk relevante farmakokinetiske interaktioner.
Combination with pioglitazone, metformin and glyburide Results from studies conducted with these oral antidiabetics have shown no clinically relevant pharmacokinetic interactions.
Digoxin (Pgp- substrat), warfarin (CYP2C9- substrat) Kliniske studier med raske forsøgspersoner har ikke vist nogen klinisk relevante farmakokinetiske interaktioner.
Digoxin (Pgp substrate), warfarin (CYP2C9 substrate) Clinical studies performed with healthy subjects have shown no clinically relevant pharmacokinetic interactions.
Kombination med amlodipin, ramipril, valsartan eller simvastatin Der er udført lægemiddel- lægemiddel- interaktionsstudier på raske forsøgspersoner med amlodipin, ramipril, valsartan og simvastatin.
Combination with amlodipine, ramipril, valsartan or simvastatin Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Der foreligger ikke tilstrækkelige data om brugen af vildagliptin hos gravide kvinder.
There are no adequate data from the use of vildagliptin in pregnant women.
På grund af de manglende data for mennesker bør Galvus ikke anvendes under graviditet.
Due to lack of human data, Galvus should not be used during pregnancy.
Det vides ikke, om vildagliptin udskilles i human modermælk.
It is not known whether vildagliptin is excreted in human breast milk.
Dyreforsøg har vist, at vildagliptin udskilles i mælken.
Animal studies have shown excretion of vildagliptin in milk.
Galvus må ikke anvendes under amning.
Galvus should not be used during lactation.
Patienter, som oplever svimmelhed som en bivirkning, bør derfor undgå at køre bil eller betjene maskiner.
Patients who experience dizziness as an undesirable effect should avoid driving vehicles or using machines.
Der er indhentet sikkerhedsdata fra i alt 3. 784 patienter, som blev eksponeret for vildagliptin med en daglig dosis på 50 mg (én gang daglig) eller 100 mg (50 mg to gange daglig eller 100 mg én gang daglig) i kontrollerede forsøg på mindst 12 ugers varighed.
Safety data were obtained from a total of 3,784 patients exposed to vildagliptin at a daily dose of 50 mg (once daily) or 100 mg (50 mg twice daily or 100 mg once daily) in controlled trials of at least 12 weeks duration.
Af disse patienter modtog 2. 264 patienter vildagliptin som monoterapi, og 1. 520 patienter modtog vildagliptin kombineret med et andet lægemiddel.
Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product.
2. 682 patienter blev behandlet med 100 mg vildagliptin daglig (50 mg to gange daglig eller 100 mg én gang daglig) og 1. 102 patienter blev behandlet med 50 mg vildagliptin én gang daglig.
2,682 patients were treated with vildagliptin 100 mg daily (either 50 mg twice daily or 100 mg once daily) and 1,102 patients were treated with vildagliptin 50 mg once daily.
I data fra kontrollerede monoterapi - og tillægsbehandlingsstudier af 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) 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.
Disse transaminaseforhøjelser var generelt asymptomatiske, ikke - progredierende og ikke associeret med kolestase eller gulsot.
These elevations in transaminases were generally asymptomatic, non-progressive in nature and not associated with cholestasis or jaundice.
En større andel af tilfælde blev rapporteret, når vildagliptin blev administreret i kombination med en ACE- hæmmer (angiotensin converting enzyme hæmmer).
A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
De bivirkninger, der blev rapporteret hos patienter, der modtog Galvus som monoterapi i dobbeltblindede studier og tillægsbehandlinger er opført nedenfor for hver indikation efter organsystemklasse og absolut hyppighed.
Adverse reactions reported in patients who received Galvus in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Hyppighederne defineres som meget almindelige (≥1/ 10), almindelige (≥1/ 100 til < 1/ 10), ikke almindelige (≥1/ 1. 000 til < 1/ 100), sjælden (≥1/ 10. 000 til < 1/ 1. 000), meget sjældne (< 1/ 10. 000), ikke kendte (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 to < 1/ 1,000), very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
Kombination med metformin I kontrollerede studier af kombinationen af vildagliptin 100 mg daglig + metformin, blev der ikke rapporteret nogen udtræden af studierne på grund af bivirkninger, hverken i gruppen, der fik vildagliptin 100 mg daglig + metformin, eller i gruppen, der fik placebo + metformin.
Combination with metformin In controlled clinical trials with the combination of vildagliptin 100 mg daily + metformin, no withdrawal due to adverse reactions was reported in either the vildagliptin 100 mg daily + metformin or the placebo + metformin treatment groups.