natgillin/translations-raw huggingface dataset:
Da interaktionen ikke er påvist ved doser af repaglinid, som er højere end 0, 25 mg, skal samtidig brug af ciclosporin med repaglinid undgås.
Since the interaction has not been established with dosages higher than 0.25 mg for repaglinide, the concomitant use of ciclosporin with repaglinide should be avoided.
4. 4).
If the combination appears necessary, careful clinical and blood glucose monitoring should be performed (see section 4.4).
Betablokkere kan maskere symptomerne på hypoglykæmi.
β -blocking agents may mask the symptoms of hypoglycaemia.
Samtidig indtagelse af CYP3A4- substraterne: cimetidin, nifedipin, østrogen eller simvastatin med repaglinid, ændrede ikke væsentligt på repaglinids farmakokinetiske parametre.
Co-administration of cimetidine, nifedipine, oestrogen, or simvastatin with repaglinide, all CYP3A4 substrates, did not significantly alter the pharmacokinetic parameters of repaglinide.
Når patienter, der indtager repaglinid, starter eller ophører med at tage disse stoffer, skal de overvåges
When these medications are administered to or withdrawn from a patient receiving repaglinide, the patient should be observed closely for changes in glycaemic control.
Når repaglinid bruges sammen med andre lægemidler, som hovedsageligt udskilles med galden som repaglinid, bør man overveje eventuel interaktion.
When repaglinide is used together with other drugs that are mainly secreted by the bile, like repaglinide, any potential interaction should be considered.
Repaglinid er ikke klinisk undersøgt i gravide eller ammende kvinder.
There are no studies of repaglinide in pregnant or lactating women.
Sikkerheden ved behandling af gravide med repaglinid kan derfor ikke vurderes.
Therefore the safety of repaglinide in pregnant women cannot be assessed.
Indtil nu har repaglinid ikke vist sig at være teratogent i undersøgelser på dyr.
Up to now repaglinide showed not to be teratogenic in animal studies.
Der er ved høje doser af repaglinid i sidste trimester og under amning observeret en abnorm udvikling af ekstremiteter hos rottefostre og nyfødte rotter.
Embryotoxicity, abnormal limb development in foetuses and new born pups, was observed in rats exposed to high doses in the last stage of pregnancy and during the lactation period.
Repaglinid er målt i mælken hos forsøgsdyrene.
Repaglinide is detected in the milk of experimental animals.
Derfor bør repaglinid ikke bruges til behandling af gravide eller ammende kvinder.
For that reason repaglinide should be avoided during pregnancy and should not be used in lactating women.
På baggrund af erfaringerne med repaglinid og andre hypoglykæmiske lægemidler er følgende bivirkninger set.
Based on the experience with repaglinide and with other hypoglycaemic agents the following adverse events have been seen:
Frekvenser er angivet som følger:
Frequencies are defined as:
Almindelig (≥1/ 100 til < 1/ 10); ikke almindelige (≥1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til ≤1/ 1. 000); meget sjælden (≤1/ 10. 000); ikke kendt (kan ikke estimeres ud fra tilgængeligt data).
Common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Allergi Generaliserede hypersensitive reaktioner (f. eks. anafylaktisk reaktion) eller immunologiske reaktioner såsom vaskulit.
Allergy Generalised hypersensitivity reactions (e. g. anaphylactic reaction), or immunological reactions such as vasculitis.
Hypoglykæmi Ikke kendt:
Hypoglycaemia Not known:
Hypoglykæmisk koma og hypoglykæmisk bevidstløshed Ligesom ved andre hypoglykæmiske lægemidler er der set hypoglykæmiske reaktioner efter indtagelse af repaglinid.
Hypoglycaemic coma and hypoglycaemic unconsciousness As with other hypoglycaemic agents, hypoglycaemic reactions have been observed after administration of repaglinide.
Disse reaktioner er normalt milde og behandles let ved indtagelse af kulhydrater.
These reactions are mostly mild and easily handled through intake of carbohydrates.
Såfremt reaktionerne er så alvorlige, at der kræves hjælp fra tredje mand, kan glucoseinfusion være nødvendig.
If severe, requiring third party assistance, infusion of glucose may be necessary.
4. 4).
The occurrence of such reactions depends, as for every diabetes therapy, on individual factors, such as dietary habits, dosage, exercise and stress (see section 4.4).
4. 5).
Interactions with other medicinal products may increase the risk of hypoglycaemia (see section 4.5).
Efter markedsføring er rapporteret enkelte tilfælde af hypoglykæmi hos patienter, i samtidig behandling med metformin eller thiazolidinedion.
During post marketing experience, cases of hypoglycaemia have been reported in patients treated with repaglinide in combination with metformin or thiazolidinedione.
Mave- tarmkanalen Almindelig:
Gastro-intestinal disorders Common:
Mavesmerter og diarré Meget sjælden:
Abdominal pain and diarrhoea Very rare:
Opkastning og forstoppelse Ikke kendt:
Vomiting and constipation Not known:
Kvalme Gastrointestinale sygdomme som mavesmerter, diarré, kvalme, opkastning og forstoppelse er rapporteret i kliniske forsøg.
Nausea Gastro-intestinal complaints such as abdominal pain, diarrhoea, nausea, vomiting and constipation have been reported in clinical trials.
Incidensen og alvorligheden af disse symptomer var ikke anderledes end for andre β- celle stimulerende orale antidiabetica.
The rate and severity of these symptoms did not differ from that seen with other oral insulin secretagogues.
Hud og subkutane væv Ikke kendt:
Skin and subcutaneous tissue disorders Not known:
Hypersensitivitet Hypersensibilitetsreaktioner på huden i form af erythem, kløe, udslæt og urticaria kan forekomme.
Hypersensitivity Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.
Der er ingen grund til at forvente krydsallergi med sulfonylurinstoffer på grund af forskellen i den kemiske struktur.
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference of the chemical structure.
6 Øjne Meget sjælden:
Eye disorders Very rare:
Synsforstyrrelser Ændringer i blodglucoseniveauer har i nogle tilfælde medført forbigående synsforstyrrelser, især initialt i behandlingen.
6 Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Kardiovaskulær sygdom Type 2- diabetes er forbundet med en forhøjet risiko for kardiovaskulær sygdom.
Cardiovascular disease Type 2 diabetes is associated with an increased risk for cardiovascular disease.
I et epidemiologisk studie blev der rapporteret en højere frekvens af akut koronarsyndrom i repaglinidgruppen.
In one epidemiological study, a higher incidence of acute coronary syndrome was reported in the repaglinide group.
4. 4 og 5. 1).
However, the causality of the relationship remains uncertain (see sections 4.4 and 5.1).
Lever og galdeveje Meget sjælden:
Hepato-biliary disorders Very rare:
Abnormal leverfunktion I meget sjældne tilfælde har der været rapporteret om alvorlig hepatisk dysfunktion.
Hepatic function abnormal In very rare cases, severe hepatic dysfunction has been reported.
Dog er der ikke etableret nogen sammenhængende årsag med repaglinid.
However, a causal relationship with repaglinide has not been established.
Leverenzymstigning Der er rapporteret isolerede tilfælde af leverenzymstigning under behandling med repaglinid.
Increased liver enzymes Isolated cases of increase in liver enzymes have been reported during treatment with repaglinide.
De fleste tilfælde var milde og forbigående, og meget få patienter måtte standse behandlingen på grund af leverenzymstigning.
Most cases were mild and transient, and very few patients discontinued treatment due to increase in liver enzymes.
Da hypoglykæmi i denne undersøgelse blev undgået ved hjælp af forøget kalorieindtagelse, kan en relativ overdosering have kraftig glucosenedsættende virkning og deraf følgende hypoglykæmisymptomer (svimmelhed, øget svedproduktion, rysten, hovedpine o. s. v.).
As hypoglycaemia in this study was avoided through increased calorie intake, a relative overdose may result in an exaggerated glucose-lowering effect with development of hypoglycaemic symptoms (dizziness, sweating, tremor, headache etc.).
Alvorligere hypoglykæmi med krampeanfald, bevidstløshed eller koma behandles med intravenøs glucose.
More severe hypoglycaemia with seizure, loss of consciousness or coma should be treated with IV glucose.
Farmako- terapeutisk gruppe:
Pharmaco-therapeutic group:
Carbamoylmethyl benzoesyre derivat ATC- kode:
Carbamoylmethyl benzoic acid derivative, ATC code:
Repaglinid er et nyt oralt β- celle stimulerende korttidsvirkende antidiabeticum.
Repaglinide is a novel short-acting oral secretagogue.
Denne effekt er afhængig af fungerende β- celler i de Langerhanske øer.
Repaglinide lowers the blood glucose levels acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning β -cells in the pancreatic islets.
Repaglinid lukker de ATP- afhængige kaliumkanaler i β- cellens membran ved at binde sig til bindingssteder, der er forskellige fra andre β- celle stimulerende antidiabeticas bindingssteder.
Repaglinide closes ATP-dependent potassium channels in the β -cell membrane via a target protein different from other secretagogues.
Dermed depolariseres β- cellen, hvilket medfører en åbning af calciumkanalerne.
This depolarises the β -cell and leads to an opening of the calcium channels.
Den medfølgende stigning af calciumindløb stimulerer insulin sekretionen fra β- cellen.
The resulting increased calcium influx induces insulin secretion from the β -cell.
Hos patienter med type 2- diabetes indtraf det insulinotrope respons på et måltid inden for 30 minutter efter oral dosering af repaglinid.
In type 2 diabetic patients, the insulinotropic response to a meal occurred within 30 minutes after an oral dose of repaglinide.
Plasma repaglinid koncentrationen faldt hurtigt og 4 timer efter administration var der kun lave stofkoncentrationer i plasma hos type 2- diabetes patienter.
Plasma repaglinide levels decreased rapidly, and low drug concentrations were seen in the plasma of type 2 diabetic patients 4 hours post-administration.
Et dosisafhængigt blodglucosefald blev påvist hos patienter med type 2- diabetes, der indtog doser på 0, 5 til 4 mg repaglinid.
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
Resultater af kliniske undersøgelser har vist, at repaglinid doseres optimalt i forbindelse med
Clinical study results have shown that repaglinide is optimally dosed in relation to main meals (preprandial dosing).
Et epidemiologisk studie indikerede, at de repaglinidbehandlede patienter havde en lettere forhøjet risiko for akut koronarsyndrom sammenlignet med de sulfonylureabehandlede patienter (se pkt.
One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide
4. 4 og 4. 8).
7 treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
Repaglinid absorberes hurtigt fra mave- tarmkanalen, hvilket medfører hurtig stigning i plasmakoncentrationen af lægemidlet.
Repaglinide is rapidly absorbed from the gastrointestinal tract, which leads to a rapid increase in the plasma concentration of the drug.
Efter at maksimum er nået, falder plasmakoncentrationen hurtigt, og repaglinid elimineres i løbet af 4 til 6 timer.
After reaching a maximum, the plasma level decreases rapidly, and repaglinide is eliminated within 4 - 6 hours.
1 time.
The plasma elimination half-life is approximately one hour.
Farmakokinetikken for repaglinid er karakteriseret ved en gennemsnitlig absolut biotilgængelighed på 63% (CV 11%), et lavt fordelingsvolumen på 30 liter (svarende til fordeling i intracellulær- væsken) og en hurtig elimination fra blodet.
Repaglinide pharmacokinetics are characterised by a mean absolute bioavailability of 63% (CV 11%), low volume of distribution, 30 L (consistent with distribution into intracellular fluid), and rapid elimination from the blood.
Der er set en høj inter- individuel variation (60%) af repaglinid- plasma koncentration i de kliniske undersøgelser.
A high interindividual variability (60%) in repaglinide plasma concentrations has been detected in the clinical trials.
Den intra- individuelle variation er lav til moderat (35%) og da repaglinid doseres under optrapning til den ønskede effekt, er effekten ikke påvirket af den inter- individuelle variation.
Intraindividual variability is low to moderate (35%) and as repaglinide should be titrated against the clinical response, efficacy is not affected by interindividual variability.
AUC (SD) efter en enkeltdosis på 2 mg (4 mg i patienter med lever insufficiens) var 31, 4 ng/ ml x time (28, 3) i raske frivillige, 304, 9 ng/ ml x time (228, 0) i patienter med lever insufficiens, og 117, 9 ng/ ml x time (83, 8) i ældre type 2 diabetiske patienter.
The AUC (SD) after 2 mg single dose exposure (4 mg in patients with hepatic insufficiency) was 31.4 ng/ ml x hr (28.3) in healthy volunteers, 304.9 ng/ ml x hr (228.0) in patients with hepatic insufficiency, and 117.9 ng/ ml x hr (83.8) in the elderly type 2 diabetic patients.
Efter en 5 dages behandling med repaglinid (2 mg x 3/ dag) i patienter med svær nyredysfunktion (kreatinin clearance:
After a 5 day treatment of repaglinide (2 mg x 3/ day) in patients with a severe impaired renal function (creatinine clearance:
20- 39 ml/ min.), viste resultaterne en signifikant stigning til det dobbelte i eksponering (AUC) og halveringstid (t1/ 2) i sammenligning med personer med normal nyrefunktion.
20-39 ml/ min.), the results showed a significant 2-fold increase of the exposure (AUC) and half-life (t1/ 2) as compared to subjects with normal renal function.
Repaglinid har høj bindingsaffinitet til plasmaproteiner i mennesker (over 98%).
Repaglinide is highly bound to plasma proteins in humans (greater than 98%).
Repaglinid og stoffets metabolitter udskilles primært via galden.
Repaglinide and its metabolites are excreted primarily via the bile.
Under 1% af det oprindelige lægemiddel udskilles med afføringen.
Less than 1% of the parent drug is recovered in faeces.
8 Glycerol 85% Magnesiumstearat Meglumin Poloxamer
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer
Blisterpakningerne (aluminium/ aluminium) indeholder henholdsvis 30, 90, 120 eller 270 tabletter.
The blister pack (aluminium/ aluminium) contains 30, 90, 120 or 270 tablets, respectively.
17. august 1998 Dato for seneste fornyelse:
17 August 1998 Date of last renewal:
23. juli 2008
23 July 2008
Repaglinid tabletter er gule, runde og konvekse og er præget med Novo Nordisk logo (Apis- tyren).
Repaglinide tablets are yellow, round and convex and engraved with Novo Nordisk logo (Apis bull).
4. 4 og 4. 5 for at bestemme dosis.
In the case of concomitant use with other active substances refer to sections 4.4 and 4.5 to assess dosage.
10 Hvis patientens behandling ændres ved skift fra et andet oralt antidiabeticum, er den anbefalede startdosis 1 mg.
If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is
4. 4)
No clinical studies have been conducted in patients > 75 years of age or in patients with hepatic insufficiency (see section 4.4).
11 Repaglinid virker via et specifikt bindingsted med en kort virkning på β - celler.
11 performed.
Kombinationsbehandling med Neutral Protamin Hagedorn (NPH) insulin eller thiazolidinedioner er ikke undersøgt klinisk.
Trials of combination therapy with Neutral Protamine Hagedorn (NPH) insulin or thiazolidinediones have been performed.
Samtidig indtagelse af gemfibrozil (600 mg 2 gange dagligt), en CYP2C8- hæmmer, og repaglinid (en enkelt dosis på 0, 25 mg) øgede repaglinidoptagelsen (AUC) med 8, 1 gange og Cmax med 2, 4 gange hos frivillige raske personer.
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
12 mulig øgning og forlængelse af repaglinids blodglucosesænkende effekt og plasmarepaglinidkoncentrationen efter 7 timer øgedes 28, 6 gange af gemfibrozil.
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
Samtidig indtagelse af 100 mg itraconazol, en CYP3A4- hæmmer, er også undersøgt hos frivillige raske personer og øgede repaglinidoptagelsen (AUC) 1, 4 gange.
Co-administration of 100 mg itraconazole, an inhibitor of CYP3A4, has also been studied in healthy volunteers, and increased the AUC by 1.4-fold.
13 grundigt for ændring i blodglucoseregulering.
13 4.6 Pregnancy and lactation
Almindelig (≥1/ 100 til < 1/ 10); ikke almindelige (≥1/ 1. 000 til < 1/ 100); sjælden (≥ 1/ 10. 000 til ≤ 1/ 1. 000) og meget sjælden (≤ 1/ 10. 000); ikke kendt (kan ikke estimeres ud fra tilgængelig data).
Common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Der er ingen grund til at forvente krydsallergi med sulfonylurinstoffer på grund af forskellen i den kemiske struktur.
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference in chemical structure.
Almene hypersensitive eller immunologiske reaktioner såsom vaskulitis kan meget sjældent forekomme.
Visual disturbances
14 Øjne Meget sjælden:
14 Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
Synsforstyrrelser Ændringer i blodglucoseniveauer har i nogle tilfælde medført forbigående synsforstyrrelser, især initialt i behandlingen.
Such disturbances have only been reported in very few cases after initiation of repaglinide treatment.
15 Resultater af kliniske undersøgelser har vist, at repaglinid doseres optimalt i forbindelse med hovedmåltiderne (præprandial dosering).
Clinical study results have shown that repaglinide is optimally dosed in relation to main meals (preprandial dosing).
4. 4 og 4. 8).
15 treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
16 Povidone (polyvidon) Glycerol 85% Magnesiumstearat Meglumin Poloxamer Jern oxid, gul (E172)
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer Iron oxide, yellow (E172)
Ikke relevant.
16 Not applicable.
Repaglinid tabletter er ferskenfarvede, runde og konvekse og er præget med Novo Nordisk logo (Apis- tyren).
Repaglinide tablets are peach-coloured, round and convex and engraved with Novo Nordisk logo (Apis bull).
18 Der bør gå en eller to uger mellem hver titrering af dosis (alt efter blodglucoserespons).
One to two weeks should elapse between titration steps (as determined by blood glucose response).
Hvis patientens behandling ændres ved skift fra et andet oralt antidiabeticum, er den anbefalede startdosis 1 mg.
18 If patients are transferred from another oral hypoglycaemic agent the recommended starting dose is 1 mg.
Hos svækkede eller fejlernærede patienter bør initial - og vedligeholdelsesdosis være konservativ og der kræves en omhyggelig optrapning af dosis for at undgå hypoglykæmiske reaktioner.
In debilitated or malnourished patients the initial and maintenance dosage should be conservative and careful dose titration is required to avoid hypoglycaemic reactions.
19 Repaglinid virker via et specifikt bindingsted med en kort virkning på β- celler.
Repaglinide acts through a distinct binding site with a short action on the β -cells.
Kombinationsbehandling med andre β- celle stimulerende orale antidiabetica og acarbose er ikke undersøgt klinisk.
19 Trials investigating the combination with other insulin secretagogues and acarbose have not been performed.
Behandling af disse patient grupper anbefales derfor ikke.
Therefore, treatment is not recommended in these patient groups.
Samtidig indtagelse af gemfibrozil (600 mg 2 gange dagligt), en CYP2C8- hæmmer, og repaglinid (en
Co-administration of gemfibrozil (600 mg twice daily), an inhibitor of CYP2C8, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC 8.1-fold and Cmax 2.4-fold in healthy volunteers.
Halveringstiden blev forlænget fra 1, 3 til 3, 7 timer, som resulterede i en mulig øgning og forlængelse af repaglinids blodglucosesænkende effekt og plasmarepaglinidkoncentrationen efter 7 timer øgedes 28, 6 gange af gemfibrozil.
Half-life was prolonged from 1.3 hr to 3.7 hr, resulting in possibly enhanced and prolonged blood glucose-lowering effect of repaglinide, and plasma repaglinide concentration at 7 hr was increased 28.6-fold by gemfibrozil.
Samtidig anvendelse af trimetoprim (160 mg 2 gange dagligt), en moderat CYP2C8- hæmmer, og repaglinid (en enkelt dosis på 0, 25 mg) øger repaglinid AUC, Cmax og t½ (henholdsvis 1, 6, 1, 4 og 1, 2 gange) uden statistisk signifikans på blodglucoseniveauerne.
20 Co-administration of trimethoprim (160 mg twice daily), a moderate CYP2C8 inhibitor, and repaglinide (a single dose of 0.25 mg) increased the repaglinide AUC, Cmax and t½ (1.6-fold, 1.4-fold and 1.2-fold respectively) with no statistically significant effects on the blood glucose levels.
21 Når patienter, der indtager repaglinid, starter eller ophører med at tage disse stoffer, skal de overvåges grundigt for ændring i blodglucoseregulering.
21 repaglinide, any potential interaction should be considered.
Almindelig (≥1/ 100 til < 1/ 10); ikke almindelige (≥1/ 1. 000 til < 1/ 100); sjælden (≥ 1/ 10. 000, ≤ 1/ 1. 000) og meget sjælden (≤ 1/ 10. 000); ikke kendt (kan ikke estimeres ud fra tilgængeligt data).
Common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000); not known (cannot be estimated from the available data).
Hypersensitivitet Hypersensibilitetsreaktioner på huden i form af erythema, kløe, udslæt og urticaria kan forekomme.
Hypersensitivity Hypersensitivity reactions of the skin may occur as erythema, itching, rashes and urticaria.
Der er ingen grund til at forvente krydsallergi med sulfonylurinstoffer på grund af forskellen i den
There is no reason to suspect cross-allergenicity with sulphonylurea drugs due to the difference in chemical structure.
22 kemiske struktur.
22 Very rare:
Synsforstyrrelser Ændringer i blodglucoseniveauer har i nogle tilfælde medført forbigående synsforstyrrelser, især initialt i behandlingen.
Visual disturbances Changes in blood glucose levels have been known to result in transient visual disturbances, especially at the commencement of treatment.
23 Et dosisafhængigt blodglucosefald blev påvist hos patienter med type 2- diabetes, der indtog doser på 0, 5 til 4 mg repaglinid.
A dose-dependent decrease in blood glucose was demonstrated in type 2 diabetic patients when administered in doses from 0.5 to 4 mg repaglinide.
4. 4 og 4. 8).
23 One epidemiological study suggested an increased risk of acute coronary syndrome in repaglinide treated patients as compared to sulfonylurea treated patients (see sections 4.4 and 4.8).
24 Majsstivelse Amberlite (kaliumpolacrilin) Povidone (polyvidon) Glycerol 85% Magnesiumstearat Meglumin Poloxamer Jern oxid, rød (E172)
Microcrystalline cellulose (E460) Calcium hydrogen phosphate, anhydrous Maize starch Amberlite (polacrilin potassium) Povidone (polyvidone) Glycerol 85% Magnesium stearate Meglumine Poloxamer Iron oxide, red (E172)
Ikke relevant.
24 Not applicable.
NovoNorm 0, 5 mg tabletter Repaglinid
NovoNorm 0.5 mg tablets Repaglinide
Repaglinid 0, 5 mg;
Repaglinide 0.5 mg;
Glycerol 85% er et af hjælpestofferne
Glycerol 85% is one of the excipients
EU/ 1/ 98/ 076/ 004 30 tabletter EU/ 1/ 98/ 076/ 005 90 tabletter EU/ 1/ 98/ 076/ 006 120 tabletter EU/ 1/ 98/ 076/ 023 270 tabletter
EU/ 1/ 98/ 076/ 004 EU/ 1/ 98/ 076/ 005 EU/ 1/ 98/ 076/ 006 EU/ 1/ 98/ 076/ 023