natgillin/translations-raw huggingface dataset:
Derimod havde patienter, som fik føjet placebo, mindre ændringer i HbA1c- koncentrationerne med en stigning på 0, 23% i forhold til en startkoncentration på 8, 30%.
In contrast, patients adding placebo had smaller changes in HbA1c levels, with a rise of 0.23% from a starting level of 8.30%.
De hyppigste bivirkninger ved Icandra (som optræder hos flere end 1 ud af 10 patienter) er kvalme, opkastning, diarré, mavesmerter og manglende appetit.
The most common side effects with Icandra (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 Icandra fremgår af indlægssedlen.
For the full list of all side effects reported with Icandra, see the Package Leaflet.
Icandra må ikke anvendes til patienter, som kan være overfølsomme (allergiske) over for vildagliptin, metformin eller andre af indholdsstofferne.
Icandra should not be used in people who may be hypersensitive (allergic) to vildagliptin, metformin or any of the other ingredients.
Det må ikke anvendes til patienter, som har diabetisk ketoacidose (høje koncentrationer af ketoner og syrer i blodet), diabetisk præcoma, problemer med nyrer eller lever, tilstande, der kan påvirke nyrerne, eller en sygdom, der medfører reduceret tilførsel af oxygen til kroppens væv såsom hjerte - eller lungeinsufficiens eller et nyligt hjerteanfald.
It must not be used in patients who have diabetic ketoacidosis (high levels of ketones and acids in the blood), diabetic pre-coma, problems with their kidneys or liver, conditions that may affect the kidneys, or a disease that causes a reduced supply of oxygen to the tissues such as failure of the heart or lungs or a recent heart attack.
Det må heller ikke anvendes til patienter med alkoholforgiftning (overdrevet alkoholindtag) eller alkoholisme eller patienter, der ammer.
It must also not be used in patients with alcohol intoxication (excessive alcohol consumption) or alcoholism, or during breast-feeding.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at vildagliptin taget sammen med metformin sænker blodsukkeret, og kombinationen af de to aktive stoffer i én tablet gør det lettere for patienterne at overholde behandlingen.
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.
Udvalget besluttede derfor, at fordelene ved Icandra 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 Icandra 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 Icandra.
The Committee recommended that Icandra be given marketing authorisation.
Andre oplysninger om Icandra:
Other information about Icandra:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Icandra til Novartis Europharm Limited den 20. november 2008.
The European Commission granted a marketing authorisation valid throughout the EU for Vildagliptin/ Metformin Hydrochloride Novartis to Novartis Europharm Limited on 1 December 2008.
Den fuldstændige EPAR for Icandra findes her.
The full EPAR for Icandra can be found here.
EU- nummer EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
EU Number EU/ 1/ 08/ 484/ 001 EU/ 1/ 08/ 484/ 002 EU/ 1/ 08/ 484/ 003 EU/ 1/ 08/ 484/ 004 EU/ 1/ 08/ 484/ 005 EU/ 1/ 08/ 484/ 006 EU/ 1/ 08/ 484/ 007 EU/ 1/ 08/ 484/ 008 EU/ 1/ 08/ 484/ 009 EU/ 1/ 08/ 484/ 010 EU/ 1/ 08/ 484/ 011 EU/ 1/ 08/ 484/ 012 EU/ 1/ 08/ 484/ 013 EU/ 1/ 08/ 484/ 014 EU/ 1/ 08/ 484/ 015 EU/ 1/ 08/ 484/ 016 EU/ 1/ 08/ 484/ 017 EU/ 1/ 08/ 484/ 018
Særnavn Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
Invented name Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra Icandra
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
Strength 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
Pharmaceutical Form 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
Route of Administration 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)
Packaging 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
Package size 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
Icandra 50 mg/ 850 mg filmovertrukne tabletter
Icandra 50 mg/ 850 mg film-coated tablets
Icandra 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.
Icandra 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 Icandra 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, Icandra 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 Icandra, der indeholder de samme doser af hvert af disse indholdsstoffer.
Patients receiving vildagliptin and metformin from separate tablets may be switched to Icandra containing the same doses of each component.
5. 2).
Taking Icandra 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 Icandra 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 Icandra 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 Icandra should have their renal function monitored regularly (see section 4.4).
Icandra er ikke undersøgt til patienter på over 75 år.
Icandra has not been studied in patients older than 75 years.
Derfor bør Icandra ikke anvendes til denne population.
Therefore the use of Icandra is not recommended in this population.
Pædiatriske patienter (< 18 år) Icandra bør ikke anvendes til børn og unge p. g. a. manglende dokumentation for sikkerhed og virkning.
Paediatric population (< 18 years) Icandra is not recommended for use in children and adolescents due to a lack of data on safety and efficacy.
Generelt Icandra er ikke en erstatning for insulin til insulinkrævende patienter og må ikke anvendes til patienter med type 1- diabetes.
General Icandra is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
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 Icandra (see sections 4.2, 4.3 and 4.8).
LFTs skal udføres før initiering af behandling med Icandra for at kende patientens baselineværdi.
LFTs should be performed prior to the initiation of treatment with Icandra in order to know the patient’s baseline value.
4. 3).
Metformin is contraindicated in patients with heart failure, therefore Icandra is contraindicated in this patient population (see section 4.3).
Operation Da Icandra indeholder metformin, skal behandlingen seponeres 48 timer før elektiv operation med helbedøvelse og må normalt først genoptages tidligst 48 timer efter operationen.
Surgery As Icandra 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, Icandra 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. 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 Icandra (see section 4.4).
5 4. 6 Graviditet og amning
5 4.6 Pregnancy and lactation
Der foreligger ikke tilstrækkelige data om brugen af Icandra hos gravide kvinder.
There are no adequate data from the use of Icandra in pregnant women.
4. 3).
Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Icandra should not be used during lactation (see section 4.3).
5. 2).
However, bioequivalence of Icandra with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
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)
Bivirkninger rapporteret hos patienter, der modtog vildagliptin 100 mg som monoterapi i dobbeltblindede studier (N=1855)
Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
En langsom stigning i dosis kan også forbedre den gastrointestinale tolerabilitet.
To prevent them, it is recommended that metformin be taken in 2 daily doses during or after meals.
Icandra 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.
Icandra 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.
9 Metformin kan udøve den glucosesænkende effekt via tre mekanismer:
9 Metformin may exert its glucose -lowering effect via three mechanisms:
Icandra Absorption Bioækvivalens er påvist mellem Icandra 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.
Icandra Absorption Bioequivalence has been demonstrated between Icandra 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 Icandra.
Food does not affect the extent and rate of absorption of vildagliptin from Icandra.
Absorptionshastighed og - omfang for metformin fra Icandra 50 mg/ 1000 mg blev reduceret ved indgivelse med mad, som er afspejlet af en reduktion i Cmax på 26%, AUC på 7% og forsinket Tmax (2, 0 til 4, 0 t).
The rate and extent of absorption of metformin from Icandra 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Fordeling Vildagliptins plasmaproteinbinding er lav (9, 3%), og vildagliptin fordeles ligeligt mellem plasma og erytrocytter.
10 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
10 Biotransformation Metabolisering er den vigtigste eliminationsvej for vildagliptin hos mennesker, idet den udgør 69% af dosis.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Ved de normale metformindoser og doseringsplaner nås steady- state plasmakoncentrationer inden for 24- 48 timer og er generelt mindre end 1 µg/ ml.
11 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
11 Mad forsinker og reducerer omfanget af absorptionen af metformin en smule.
Food slightly delays and decreases the extent of the absorption of metformin.
Der blev observeret en stigning i incidensen af mammært adenokarcinom og hæmangiosarkom med en NOEL på henholdsvis 500 mg/ kg (59 gange den humane eksponering) og 100 mg/ kg (16 gange den humane eksponering).
An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and
12 mennesker på grund af vildagliptins og dets hovedmetabolits manglende genotoksicitet, forekomsten af tumorer hos kun én art og de høje systemiske eksponeringsratioer, som tumorerne blev observeret ved.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
I et 13- ugers toksikologistudie på cynomolgusaber er der registreret hudlæsioner ved doser ≥ 5 mg/ kg/ dag.
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
13 6. 6 Regler for destruktion og anden håndtering
13 6.6 Special precautions for disposal
Icandra 50 mg/ 1000 mg filmovertrukne tabletter
Icandra 50 mg/1000 mg film-coated tablets
Voksne Baseret på patientens nuværende dosis af metformin, kan Icandra 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, Icandra 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 Icandra should not be used in patients with creatinine clearance < 60 ml/min (see sections 4.3, 4.4 and 5.2).
4. 4).
15 Elderly (≥ 65 years) As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Icandra should have their renal function monitored regularly (see section 4.4).
18 4. 6 Graviditet og amning
18 4.6 Pregnancy and lactation
22 Metformin kan udøve den glucosesænkende effekt via tre mekanismer:
22 Metformin may exert its glucose-lowering effect via three mechanisms:
Fordeling Vildagliptins plasmaproteinbinding er lav (9, 3%), og vildagliptin fordeles ligeligt mellem plasma og erytrocytter.
23 Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
23 Biotransformation Metabolisering er den vigtigste eliminationsvej for vildagliptin hos mennesker, idet den udgør 69% af dosis.
Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Ved de normale metformindoser og doseringsplaner nås steady- state plasmakoncentrationer inden for 24- 48 timer og er generelt mindre end 1 µg/ ml.
24 schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
24 Mad forsinker og reducerer omfanget af absorptionen af metformin en smule.
Food slightly delays and decreases the extent of the absorption of metformin.
25 mennesker på grund af vildagliptins og dets hovedmetabolits manglende genotoksicitet, forekomsten af tumorer hos kun én art og de høje systemiske eksponeringsratioer, som tumorerne blev observeret ved.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed.
26 6. 6 Regler for destruktion og anden håndtering
26 6.6 Special precautions for disposal
Pharmacovigilancesystem Indehaveren af markedsføringstilladelsen skal sikre, at pharmacovigilancesystemet, som beskrevet i version 3. 0 præsenteret i Modul 1. 8. 1. af ansøgningen om markedsføringstilladelse, er på plads og fungerer, før og mens produktet er på markedet.
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
PSUR PSUR- cyklussen af Icandra vil stemme overens med den, der gælder for kryds- reference- produktet Eucreas, indtil andet specificeres.
PSURs The PSUR cycle of Icandra will correspond to the one attributed to the cross-referred product, Eucreas, until otherwise specified.
Icandra 50 mg/ 850 mg filmovertrukne tabletter vildagliptin/ metforminhydrochlorid
Icandra 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 1000 mg filmovertrukne tabletter vildagliptin/ metforminhydrochlorid
Icandra 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Icandra 50 mg/ 850 mg filmovertrukne tabletter Icandra 50 mg/ 1000 mg filmovertrukne tabletter
Icandra 50 mg/850 mg film-coated tablets Icandra 50 mg/1000 mg film-coated tablets
- Lægen har ordineret Icandra til dig personligt.
- This medicine has been prescribed for you.
Virkning og anvendelse 2.
What Icandra is and what it is used for 2.
Det skal du vide, før du begynder at tage Icandra 3.
Before you take Icandra 3.
Sådan skal du tage Icandra 4.
How to take Icandra 4.
Opbevaring 6.
How to store Icandra 6.
VIRKNING OG ANVENDELSE
WHAT ICANDRA IS AND WHAT IT IS USED FOR
De aktive stoffer i Icandra tilhører en gruppe lægemidler, der kaldes ” orale antidiabetika ”.
The active substances of Icandra belong to a group of medicines called “oral antidiabetics”.
Icandra bruges til at behandle patienter med type 2- diabetes (sukkersyge).
Icandra is used to treat patients with type 2 diabetes.
Icandra indeholder to aktive stoffer kaldet vildagliptin og metformin.
Icandra contains two active substances called vildagliptin and metformin.
DET SKAL DU VIDE, FØR DU BEGYNDER AT TAGE ICANDRA
BEFORE YOU TAKE ICANDRA
Tag ikke Icandra
Do not take Icandra
indholdsstoffer (opført under afsnit 6).
Icandra (listed in section 6).
Se også information omkring dette i afsnittet ” Vær ekstra forsigtig med at tage Icandra ”.
Please also see information about this in section “Take special care with Icandra”.
Vær ekstra forsigtig med at tage Icandra Hold op med at tage dette lægemiddel og tal med din læge, hvis du oplever et eller flere af følgende symptomer, som kan være tegn på en tilstand kaldet ” laktatacidose ”:
Take special care with Icandra Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called “lactic acidosis”:
Du skal ikke tage Icandra igen, hvis du tidligere har taget Galvus (vildagliptin) eller Icandra, men blev nødt til at stoppe på grund af bivirkninger (leversygdom).
If you have previously taken Galvus (vildagliptin) or Icandra but had to stop taking it because of side effects (liver disease), you should not take Icandra again.