FrancophonIA/ELRC3.0 huggingface dataset:
English: 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).
Icelandic: Ekki má nota Zomarist hjá sjúklingum með skerta lifrarstarfsemi, þar með talið sjúklingum með þéttni alanin aminotransferasa (ALT) eða aspartat aminotransferasa (AST)
English: Liver enzyme monitoring
Icelandic: Eftirlit með lifrarensímum
English: Dark yellow, ovaloid film-coated tablet with bevelled edge, imprinted with “NVR” on one side and “FLO” on the other side.
Icelandic: Dökkgul, sporöskjulaga filmuhúðuð tafla með sniðbrún, auðkennd með „NVR“ á annarri hliðinni og „FLO“ á hinni hliðinni.
English: Accumulation of foamy alveolar macrophages in the lung was observed in rats and mice.
Icelandic: Uppsöfnun froðukenndra átfrumna í lungnablöðrum sást hjá rottum og músum.
English: The incidence of hypoglycaemia in the overall population was 8.4% and 7.2% in the vildagliptin and placebo groups, respectively.
Icelandic: Tíðni of lágs blóðsykurs í rannsóknarhópnum í heild var 8,4% í vildagliptin hópnum en 7,2% í lyfleysuhópnum.
English: There are no adequate data from the use of Zomarist in pregnant women.
Icelandic: Engar fullnægjandi upplýsingar liggja fyrir um notkun Zomarist á meðgöngu.
English: Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group.
Icelandic: Tveir sjúklingar sem fengu vildagliptin greindu frá alvarlegum tilfellum af of lágum blóðsykri og 6 sjúklingar sem fengu lyfleysu.
English: Metabolism and nutritional disorders Common
Icelandic: Efnaskipti og næring Algengar
English: Body weight change with vildagliptin was -0.2 kg vs +1.6 kg with glimepiride.
Icelandic: Þyngdarbreyting hjá þeim sem fengu vildagliptin var -0,2 kg samanborið við +1,6 kg hjá þeim sem fengu glimepirid.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Icelandic: Vildagliptin hefur litla tilhneigingu til milliverkana við önnur lyf sem gefin eru samhliða.
English: After 1 year mean reductions in HbA1c were -0.4% with vildagliptin added to metformin and -0.5% with glimepiride added to metformin, from a mean baseline HbA1c of 7.3%.
Icelandic: Upphafsgildi HbA1c var að meðaltali 7,3%, eftir 1 ár var meðalminnkun HbA1c -0,4% þegar vildagliptini var bætt við metformin og -0,5% þegar glimepiridi var bætt við metformin.
English: The elimination half-life after oral administration is approximately 3 hours.
Icelandic: Helmingunartími brotthvarfs eftir inntöku er u.þ.b. 3 klukkustundir.
English: Rare cases of angioedema have been reported on vildagliptin at a similar rate to controls.
Icelandic: Mjög sjaldgæf tilfelli ofsabjúgs af vildagliptini hafa verið skráð og var tíðnin svipuð og hjá samanburðarhópi.
English: Liver function test abnormalities or hepatitis** Skin and subcutaneous tissue disorders Very rare
Icelandic: Koma örsjaldan fyrir Óeðlileg lifrarpróf eða lifrarbólga** Húð og undirhúð
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Icelandic: Greint hefur verið frá mjög sjaldgæfum tilvikum um truflun á lifrarstarfsemi (þar með talið lifrarbólgu) í tengslum við notkun vildagliptins.
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Zomarist should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Icelandic: Skammtar blóðsykurslækkandi meðferðar með Zomarist eiga að vera einstaklingsbundnir og byggjast á þeirri meðferðaráætlun sem gildir hjá sjúklingi, verkun og þolanleika, en eiga ekki að vera hærri en ráðlagður hámarksskammtur vildagliptins á sólarhring sem er 100 mg.
English: Component of a multipack.
Icelandic: Hluti af fjölpakkningu sem ekki má selja stakan.
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia or increased weight gain.
Icelandic: Það örvar ekki seyti insúlíns og veldur þar af leiðandi ekki of lágum blóðsykri eða aukinni þyngdaraukningu.
English: Biotransformation Metformin is excreted unchanged in the urine.
Icelandic: Metformin skilst út á óbreyttu formi með þvagi.
English: In the subgroups treated with insulin with or without concomitant metformin the placebo-adjusted mean reduction in HbA1c was -0.63% and -0.84%, respectively.
Icelandic: Í undirhópnum sem fékk meðferð með insúlíni og metformini var lyfleysuaðlöguð meðallækkun HbA1c -0,63% og hjá undirhópnum sem fékk meðferð með insúlíni án samhliða meðferðar með metformini var lyfleysuaðlöguð meðallækkun HbA1c -0,84%.
English: • Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Icelandic: Einkennin geta verið gulnun húðar og augna, ógleði, minnkuð matarlyst eða dökkleitt þvag, en þetta getur bent til lifrarsjúkdóms (lifrarbólgu).
English: Combinations not recommended
Icelandic: Ekki er mælt með samhliða notkun
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Zomarist may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Icelandic: Zomarist getur valdið aukaverkun sem kemur örsjaldan fyrir, en er mjög alvarleg, og kallast mjólkursýrublóðsýring (sjá kaflann „Varnaðarorð og varúðarreglur“).
English: Cationic active substances
Icelandic: Katjónísk virk efni
English: Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Icelandic: Meðferð með vildagliptini, 50-100 mg á sólarhring hjá sjúklingum með sykursýki af tegund 2 bætti marktækt vísa um starfsemi betafrumna þ.á m.
English: - For patients switching from co-administration of vildagliptin and metformin as separate tablets: Zomarist should be initiated at the dose of vildagliptin and metformin already being taken.
Icelandic: - Hjá sjúklingum sem eru að skipta yfir af samhliða meðferð með vildagliptini og metformini í sitthvorri töflunni:
English: Dizziness, tremor Skin and subcutaneous tissue disorders Common
Icelandic: Ógleði, uppköst, niðurgangur, kviðverkir og minnkuð matarlyst
English: Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
Icelandic: Tafla 4 Aukaverkanir sem greint var frá hjá sjúklingum sem fengu vildagliptin 100 mg á sólarhring, eitt sér í tvíblindum rannsóknum (N=1.855)
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08
Icelandic: Sykursýkilyf, blóðsykurslækkandi lyf til inntöku í blöndum, ATC-flokkur:
English: In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.
Icelandic: Í þessum rannsóknum komu ekki fram neinar milliverkanir af klínískri þýðingu m.t.t. lyfjahvarfa eftir samhliða gjöf vildagliptins.
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Icelandic: Gjöf vildagliptins leiðir til hraðrar og algjörrar hömlunar á DPP-4 virkni, sem leiðir til hækkaðra innlægra (endogenous) gilda innkirtlahormónanna GLP-1 (glucagon-like peptide 1) og GIP (glucosedependent insulinotropic polypeptide), við föstu og eftir máltíðir.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Icelandic: Aukaverkanir settar upp í töflu
English: 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).
Icelandic: Í klínískum rannsóknum varð ekki breyting á líkamsþyngd frá upphaflegri þyngd þegar vildagliptin 100 mg á sólarhring var gefið eitt sér (-0,3 kg fyrir vildagliptin og -1,3 kg fyrir lyfleysu).
English: • Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.
Icelandic: Einkennin eru m.a. slæmur og þrálátur kviðverkur (magasvæðið), sem gæti leitt yfir í bakið, sem og ógleði og uppköst.
English: Additional information on the individual active substances of the fixed combination
Icelandic: Viðbótarupplýsingar um hvort virka efnið í samsetningunni fyrir sig
English: Vildagliptin in combination with insulin significantly decreased HbA1c compared with placebo.
Icelandic: Vildagliptin í samsettri meðferð með insúlíni lækkaði HbA1c marktækt samanborið við lyfleysu.
English: Dizziness
Icelandic: Máttleysi
English: When starting or using such products in combination with metformin, close monitoring of renal function is necessary.
Icelandic: Nauðsynlegt er að fylgjast náið með nýrnastarfsemi þegar notkun slíkra lyfja samhliða metformini er hafin eða við samhliða notkun þeirra og metformins.
English: Metformin accumulation occurs at acute worsening of renal function and increases the risk of lactic acidosis.
Icelandic: Þegar bráð versnun nýrnastarfsemi á sér stað safnast metformin upp og eykur hættuna á mjólkursýrublóðsýringu.
English: Headache, chills
Icelandic: Sundl, skjálfti
English: Infections and infestations Very rare
Icelandic: Lifrarsjúkdómur (lifrarbólga) (mjög sjaldgæft):
English: After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h.. Absolute bioavailability of a 500 mg metformin tablet is approximately 50-60% in healthy subjects.
Icelandic: Eftir inntöku metformins, næst hámarks plasmaþéttni (Cmax) eftir um það bil 2,5 klst.
English: Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Icelandic: Hver tafla inniheldur 50 mg vildagliptin og 850 mg metformin hýdróklóríð (sem samsvarar 660 mg af metformini).
English: Nausea, gastro-oesophageal reflux disease
Icelandic: Ógleði, bakflæðissjúkdómur í vélinda
English: Each film-coated tablet contains 50 mg of vildagliptin and 850 mg of metformin hydrochloride (corresponding to 660 mg of metformin).
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg vildagliptin og 850 mg metformin hýdróklóríð (samsvarar 660 mg af metformini).
English: 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 sections 4.4 and 5.2).
Icelandic: Því skal hafa reglulegt eftirlit með nýrnastarfsemi hjá öldruðum sjúklingum í meðferð með Zomarist (sjá kafla 4.4 og 5.2).
English: Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by comedications that are CYP 450 inhibitors and/or inducers.
Icelandic: Af þeirri ástæðu er ekki gert ráð fyrir að samhliða gjöf lyfja sem eru CYP 450 hemlar og/eða hvatar hafi áhrif á úthreinsun vildagliptins vegna umbrota.
English: Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Icelandic: Hver tafla inniheldur 50 mg vildagliptin og 1000 mg metformin hýdróklóríð (sem samsvarar 780 mg af metformini).
English: Each film-coated tablet contains 50 mg of vildagliptin and 1000 mg of metformin hydrochloride (corresponding to 780 mg of metformin).
Icelandic: Hver filmuhúðuð tafla inniheldur 50 mg vildagliptin og 1000 mg metformin hýdróklóríð (samsvarar 780 mg af metformini).
English: In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Icelandic: Óháð verkun þess á sykursblóðsykur, hefur metformin jákvæð áhrif á umbrot fitu hjá mönnum.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Icelandic: Metformin er biguaníð með blóðsykurslækkandi áhrif.
English: - Store in the original package (blister) in order to protect from moisture.
Icelandic: - Geymið við lægri hita en 30°C. - Geymið í upprunalegum umbúðum (þynnu) til varnar gegn raka.
English: Metformin acts primarily by decreasing endogenous hepatic glucose production.
Icelandic: Meginverkun metformins er að draga úr framleiðslu glúkósa í lifur.
English: A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose).
Icelandic: Tveggja ára rannsókn á krabbameinsvaldandi áhrifum var gerð á rottum með skömmtum til inntöku sem voru allt að 900 mg/kg (u.þ.b.
English: GFR ml/min Metformin
Icelandic: Gaukulsíunarhraði ml/mín.
English: No metabolites have been identified in humans.
Icelandic: Ekki hefur verið gerð grein fyrir neinum umbrotsefnum hjá mönnum.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Icelandic: Eftirfarandi niðurstöður sýna lyfjahvörf hvors virka efnisins í Zomarist fyrir sig.
English: Tablet core
Icelandic: Vöðvaverkir
English: Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.
Icelandic: Læknirinn kann að ávísa minni skammti ef þú ert með skerta nýrnastarfsemi Ef þú tekur sykursýkislyf úr flokki lyfja sem kallast sulfonylurea getur einnig verið að læknirinn ávísi minni skammti.
English: Medicinal products that can acutely impair renal function (such as antihypertensives, diuretics and NSAIDs) should be initiated with caution in metformin-treated patients.
Icelandic: Gæta skal varúðar hjá sjúklingum sem fá metformin þegar hefja á meðferð með lyfjum sem geta valdið bráðri skerðingu á nýrnastarfsemi (t.d. blóðþrýstingslækkandi lyf, þvagræsilyf og bólgueyðandi verkjalyf).
English: • Common (may affect up to 1 in 10 people): dizziness, headache, trembling that cannot be controlled, metallic taste, low blood glucose.
Icelandic: sundl, höfuðverkur, skjálfti sem ekki er hægt að hafa stjórn á, málmbragð í munni, lágur blóðsykur.
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Icelandic: Aukin hækkun á insúlín/glúkagon hlutfallinu við blóðsykurshækkun vegna hækkunar innkirtlahormónagilda leiðir til minnkunar á framleiðslu glúkósa í lifur, við föstu og eftir máltíðir, sem leiðir til lækkunar blóðsykurs.
English: Maximum daily dose is 2000 mg.
Icelandic: Hámarksskammtur á dag er 2000 mg Upphafsskammturinn er í það mesta helmingur af hámarksskammtinum.
English: Store in the original package (blister) in order to protect from moisture.
Icelandic: Geymið við lægri hita en 30°C. Geymið í upprunalegum umbúðum (þynnu) til varnar gegn raka.
English: • Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called “angioedema”.
Icelandic: Einkennin geta verið þroti í andliti, á tungu eða í koki, kyngingarerfiðleikar, öndunarerfiðleikar, skyndileg útbrot eða ofsakláði en þetta getur bent til viðbragða sem nefnast „ofsabjúgur“.
English: What you need to know before you take Zomarist
Icelandic: Áður en byrjað er að nota Zomarist
English: Supportive management is recommended.
Icelandic: Stuðningsmeðferð er ráðlögð.
English: 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.
Icelandic: Vildagliptin tilheyrir flokki lyfja sem bæta virkni briseyja og metformin hýdróklóríð tilheyrir flokki biguaníða.
English: EU/1/08/483/016 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/017 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/018 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/034 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/035 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/036 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: 360 filmuhúðaðar töflur (PA/Ál/PVC/Ál) EU/1/08/483/034 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/035 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/036 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: EU/1/08/483/001 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/002 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/003 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/004 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/005 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/006 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/019 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/020 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/021 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/022 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/023 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/024 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: EU/1/08/483/019 10 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/020 30 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/021 60 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/022 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/023 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/024 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: Fertility
Icelandic: Ofsviti
English: EU/1/08/483/007 10 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/008 30 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/009 60 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/010 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/011 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/012 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/025 10 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/026 30 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/027 60 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/028 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/029 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/030 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: 10 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/026 30 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/027 60 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/028 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/029 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/030 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: No data are available with regard to overdose of Zomarist.
Icelandic: Engar upplýsingar liggja fyrir um ofskömmtun Zomarist.
English: A slow increase in the dose may also improve gastrointestinal tolerability.
Icelandic: Einnig má bæta þol meltingarfæranna með því að auka skammtana smám saman.
English: EU/1/08/483/013 120 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/014 180 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/015 360 film-coated tablets (PA/Alu/PVC/Alu) EU/1/08/483/031 120 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/032 180 film-coated tablets (PCTFE/PVC/Alu) EU/1/08/483/033 360 film-coated tablets (PCTFE/PVC/Alu)
Icelandic: 360 filmuhúðaðar töflur (PA/Ál/PVC/Ál) EU/1/08/483/031 120 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/032 180 filmuhúðaðar töflur (PCTFE/PVC/Ál) EU/1/08/483/033 360 filmuhúðaðar töflur (PCTFE/PVC/Ál)
English: The mean elimination half-life after intravenous administration is approximately 2 hours.
Icelandic: Helmingunartími brotthvarfs eftir gjöf í æð var að meðaltali u.þ.b. 2 klukkustundir.
English: In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to glimepiride (up to 6 mg/day - mean dose at 2 years: 4.6 mg) in patients treated with metformin (mean daily dose: 1894 mg).
Icelandic: Í klínískri rannsókn sem stóð yfir í 2 ár var vildagliptin (50 mg tvisvar á sólarhring) borið saman við glimepirid (allt að 6 mg/sólarhring - meðalskammtur eftir 2 ár:
English: Nausea
Icelandic: Umbrot
English: Metformin partitions into erythrocytes.
Icelandic: Metformin fer inn í rauðu blóðkornin.
English: BLISTERS
Icelandic: Brisbólga
English: Lactic acidosis is characterised by acidotic dyspnoea, abdominal pain, muscle cramps, asthenia and hypothermia followed by coma In case of suspected symptoms, the patient should stop taking metformin and seek immediate medical attention.
Icelandic: Mjólkursýrublóðsýring einkennist af mæði (acidotic dyspnoea), kviðverkjum, sinadrætti og hitalækkun sem síðan fylgir dá.
English: - For patients inadequately controlled on dual combination with metformin and a sulphonylurea: The doses of Zomarist should provide vildagliptin as 50 mg twice daily (100 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Icelandic: Skammtur Zomarist skal gefa vildagliptin sem 50 mg tvisvar á sólarhring (100 mg heildar sólarhringsskammtur) ásamt skammti af metformini sem er svipaður því sem þegar er verið að taka.
English: Asthenia
Icelandic: Lyfjagjöf
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Icelandic: Því er mælt með því að fylgst sé með húðvandamálum s.s. blöðrumyndun og sáramyndun i hefðbundnu eftirliti með sykursýkisjúklingum.
English: Upper respiratory tract infection
Icelandic: 16. UPPLÝSINGAR MEÐ BLINDRALETRI
English: ExtractumPharma zRt.
Icelandic: Ungverjaland ExtractumPharma zRt.
English: Teva Magyarország Zrt Repülőtéri út 5.
Icelandic: Ungverjaland Teva Magyarország Zrt Repülőtéri út 5.
English: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa Portugal
Icelandic: Actavis A/S Sucursal Rua Virgílio Correia, 11 - A 1600-219 Lisboa
English: MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
Icelandic: Frakkland MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France
English: Meda Pharma Hungary Kft Váci út 91.
Icelandic: Ungverjaland Meda Pharma Hungary Kft Váci út 91.
English: EGIS Gyógyszergyár Nyrt.
Icelandic: Ungverjaland EGIS Gyógyszergyár Nyrt.
English: Belgium TEVA PHARMA BELGIUM NV Laarstraat 16
Icelandic: TEVA PHARMA BELGIUM NV Laarstraat 16
English: Co. Tipperary Ireland
Icelandic: Tipperary Ireland
English: Meda Oy Vaisalantie 4 02130 Espoo Finland
Icelandic: Oy Vaisalantie 4 02130 Espoo Finland
English: Chiswick Park London W4 5YE United Kingdom
Icelandic: Park London W4 5YE United Kingdom
English: ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
Icelandic: Frakkland ZYDUS FRANCE 25, rue des Peupliers ZAC Les Hautes Pâtures - Parc d'Activités des Peupliers 92000 Nanterre FRANCE
English: Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
Icelandic: GENERFARMA, S.L. Ronda Isaac Peral, 6 Parque Tecnológico 46980 Paterna (Valencia) SPAIN
English: Hexal Aktiengesellschaft Industriestr.
Icelandic: Þýskaland Hexal Aktiengesellschaft Industriestr.
English: IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564 Greece
Icelandic: IOULIA AND IRENE TSETI PHARMACEUTICAL LABORATORIES ABEE, INTERMED ABEE, Kalyftaki 27, Kifissia 14564
English: Poligono Industrial Areta .Huarte-Pamplona (Navarra)
Icelandic: Huarte-Pamplona (Navarra)
English: SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
Icelandic: Grikkland SANOFI-AVENTIS AEBE 348 SYNGROU AVENUE, BUILDING A, KALLITHEA 17674
English: Latvia sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
Icelandic: Lettland sanofi-aventis Latvia SIA, Kr.Valdemara 33-8 Riga, LV 1010, Latvia
English: ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France
Icelandic: Frakkland ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France
English: 90449 Nürnberg Germany
Icelandic: 90449 Nürnberg
English: Sweden sanofi-aventis AB Box 14142
Icelandic: Svíþjóð sanofi-aventis AB Box 14142