FrancophonIA/ELRC3.0 huggingface dataset:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL HEXAL 15 MG, 30 MG GASTRO-RESISTANT CAPSULES, HARD (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LANSOPRAZOL HEXAL 15 MG, 30 MG GASTRO-RESISTENTE KAPSLER, HÅRDE (se bilag I)
English: If the treatment fails the dose 30 mg once daily should be used.
Danish: Hvis behandlingen ikke virker, bør en dosis på 30 mg én gang daglig anvendes.
English: Clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs or diazepam have not been demonstrated.
Danish: Klinisk signifikante interaktioner af lansoprazol med non-steroide antiinflammatoriske lægemidler eller diazpam er ikke blevet påvist.
English: Aluminium/Aluminium blister (Alu/OPA/PVC/PE)
Danish: Aluminium/aluminium blisterpakning (Alu/OPA/PVC/PE) Lansoprazol 15 mg:
English: 7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 and 250 capsules
Danish: 7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 og 250 kapsler Lansoprazol 30 mg:
English: Patients received eradication treatment followed by lansoprazole 30 mg for 4 weeks.
Danish: Patienterne modtog eradikationsbehandling efterfulgt af lansoprazol 30 mg i 4 uger.
English: Ulcer status was determined by endoscopy at week 4, 8, and 12.
Danish: Ulcusstatus blev bestemt efter en endoskopisk undersøgelse i uge 4, 8 og 12.
English: Blood thrombocytopenia, eosinophilia, pancytopenia and agranulocytosis, anemia, leucopenia.
Danish: eosinofili, pancytopeni og agranulocytose, anæmi, leucopeni.
English: Patients with duodenal ulcers (n=3) were treated for 6 weeks and patients with gastric ulcers (n=42) or multiple ulcers (n=5) for 8 weeks.
Danish: Patienter med duodenale ulcera (n=3) blev behandlet i 6 uger og patienter med gastriske ulcera (n=42)
English: At week 4 the healing rates were 44% and 51% for the 15 mg and 30 mg dose, respectively.
Danish: Efter uge 4 var helingsraterne hhv. 44 % og 51 % for dosis på 15 mg og 30 mg.
English: Symptomatic gastro-oesophageal reflux disease:
Danish: Symptomatisk gastro-øsofageal reflux-lidelse:
English: After successful healing of the ulcers and eradication of H. pylori, patients were randomized to treatment with lansoprazole 30 mg or placebo in addition to aspirin 100 mg daily for 12 months.
Danish: Efter vellykket heling af ulcera og eradikation af H. pylori blev der foretaget en randomisering af patienter til behandling med lansoprazol 30 mg eller placebo i tillæg til aspirin 100 mg dagligt i 12 måneder.
English: Patients with healed ulcers and H. pylori eradicated then received naproxen 750 mg daily and were randomized to receive either lansoprazole 30 mg or no treatment for 8 weeks.
Danish: Patienter med helet ulcus og eradikeret H. pylori fik derefter naproxen 750 mg dagligt og blev randomiseret til at få enten lansoprazol 30 mg eller ingen behandling i 8 uger.
English: The proton pump inhibitors, omeprazole, lansoprazole and pantoprazole are all mainly metabolized by the cytochrome P450 isoform CYP2C19.
Danish: De protonpumpehæmmende midler omeprazol, lansoprazol og pantoprazol metaboliseres alle hovedsagelig via cytochrom P450 isoform CYP2C19.
English: 30 mg once daily for four weeks.
Danish: 30 mg én gang daglig i fire uger.
English: Patients were randomized to receive placebo, misoprostol or lansoprazole 15 mg or 30 mg for 12 weeks.
Danish: Patienter blev randomiseret til at modtage placebo, misoprostol eller lansoprazol 15 mg eller 30 mg i 12 uger.
English: Opaque, white hard gelatine capsule, containing pellets with enteric coating.
Danish: Ugennemsigtig, hvid hård gelatinekapsel, indeholdende piller med enterisk belægning.
English: Opaque, yellow hard gelatine capsule, containing pellets with enteric coating.
Danish: Ugennemsigtig, gul hård gelatinekapsel, indeholdende piller med enterisk belægning.
English: Simple healing rates (independent of H. pylori status) were at 8 weeks, 66%, 74% and 50% in the lansoprazole 15 mg, 30 mg and ranitidine groups, respectively; P<0.001).
Danish: Simple helingsrater (uafhængig af H. pylori- status) var efter uge 8 hhv. 66 %, 74 % og 50 % i grupperne med lansoprazol 15 mg, 30 mg og ranitidin; P<0.001).
English: Patients were randomized to treatment with either ranitidine 150 mg twice daily or lansoprazole, 15 mg or 30 mg once daily for 8 weeks.
Danish: Der blev randomiseret patienter til behandling med enten ranitidin 150 mg to gange dagligt eller lansoprazol, 15 mg eller 30 mg én gang dagligt i 8 uger.
English: Agrawal et al conducted a double-blind RCT in 353 patients with gastric ulcer and who continued to receive stable doses of NSAIDs.
Danish: Agrawal m.fl. gennemførte en dobbeltblind RCT-undersøgelse af 353 patienter med gastrisk ulcus, som fortsatte med at få konstante doser af NSAID.
English: Concomitantly taken food slows down and reduces the absorption of lansoprazole.
Danish: Samtidig idtagelse af mad nedsætter hastigheden af og reducerer absoptionen af lansoprazol.
English: Healing was assessed endoscopically at 4 and 8 weeks.
Danish: Helingen blev vurderet ved en endoskopisk undersøgelse efter uge 4 og 8 uger.
English: By week 12, the percentages of gastric ulcer-free patients were 51%, 93%, 80% and 82% for the placebo, misoprostol, lansoprazole 15 mg and lansoprazole 30 mg group, respectively.
Danish: Procenttallene for gastrisk ulcusfri patienter var 51 %, 93 %, 80 % og 82 % for hhv. placebo, misoprostol, lansoprazol 15 mg og lansoprazol 30 mg-gruppen.
English: The recommended dose is 15 mg or 30 mg once daily.
Danish: Den anbefalede dosis er 15 mg eller 30 mg én gang daglig.
English: Lansoprazole should be used with caution in patients with severe hepatic dysfunction.
Danish: Lansoprazol bør anvendes med forsigtighed hos patienter med svær hepatisk funktionsvigt (se pkt.
English: The rate of S2-healing (good healing) was
Danish: S2-helingsraten (god heling) var 35 %.
English: During follow-up, 9/61 patient (14.8%) in the placebo group had recurrence of ulcer complications compared with 1/62 patients
Danish: Under opfølgningen havde 9/61 patienter (14,8 %) i placebo-gruppen recidiverende ulcuskomplikationer i forhold til 1/62 patients (1,6 %) i lansoprazol-gruppen (P=0,008).
English: Absorption and distribution: Lansoprazole is rapidly inactivated by gastric acid and lansoprazole is consequently administered as enteric coated granules in gelatin capsules.
Danish: Lansoprazol bliver hurtigt inaktiveret af mavesyren, og lansoprazol bliver derfor givet som entero-coated granulat i gelatinekapsler.
English: 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
Danish: En enkelt oral dosis lansoprazol 30 mg hæmmer pentagastrin-stimuleret mavesyresekretion med omkring 80%.
English: Lai et al studied 43 patients who presented with peptic ulcer and were found to be infected with H. pylori while receiving NSAIDs.
Danish: Lai m. fl. undersøgte 43 patienter med peptisk ulcus, som var blevet smittet med H. pylori, mens de fik NSAID.
English: Formal interaction studies with lansoprazole and NSAIDs have not been conducted.
Danish: Formelle interaktionundersøgelser med lansoprazol og NSAID'er er ikke blevet gennemført.
English: Gastric acid is central in the pathogenesis of gastroduodenal ulcers and acid inhibition has been shown to effectively heal NSAID induced ulcers.
Danish: Mavesyre er en vigtig faktor for opståen af gastroduodenale ulcera, og det er påvist, at hæmning af syre er effektiv til heling af NSAID- inducerede ulcera.
English: No formal interaction studies with lansoprazole and NSAIDs have been performed.
Danish: Der er ingen formelle interaktionsundersøgelser foretaget med lansoprazol og NSAID.
English: Campell et al evaluated the effect of pre-treatment of Helicobacter pylori (H. pylori) infection on gastric ulcer healing rates in patients receiving NSAIDs and antisecretory medication in pooled analyses of two identical double-blind RCT comparing lansoprazole with ranitidine.
Danish: Campell m. fl. undersøgte i samlede analyser af to identiske dobbeltblinde RCT-undersøgelser, hvori lansoprazol blev sammenlignet med ranitidine, indvirkningen af forudgående behandling for Helicobacter pylori - (H. pylori) infektion på helingsraterne for gastrisk ulcus hos patienter, der fik NSAID og sekrethæmmende medicin.
English: In patients who continue to take NSAID medication healing is delayed.
Danish: Hos patienter, som fortsætter med at tage NSAID'er,
English: In patients not fully healed the treatment may be continued for another four weeks.
Danish: Hos patienter, der ikke er helt ophelede, kan behandlingen fortsætte i endnu 4 uger.
English: Mannitol Hypromellose Macrogol 6000 Talc
Danish: Macrogol 6000
English: The Summary of Products Characteristic proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee.
Danish: Ud fra følgende betragtninger: Hensigten med henvisningen var at opnå enighed om et produktresumé med henblik på indikationen, det af ansøgeren foreslåede produktresumé er blevet vurderet på grundlag af den forelagte dokumentation og den faglige drøftelse i udvalget anbefaler CHMP , at der udstedes markedsføringstilladelser med ændringer af produktresuméet for
English: confusion, vertigo and paresthesia, somnolence, tremor.
Danish: svimmelhed rastløshed, insomnia, døsighed, depression, hallucination, konfusion, vertigo og paræstesier, somnolens, tremor.
English: Titanium dioxide (E 171) In addition for Lansoprazole 15 mg: Quinoline yellow (E 104) [To be completed nationally] 6.2.
Danish: Quinolin gul (E 104) [Udfyldes nationalt]
English: 81 (69%) of 118, and 85 (73%) of 117 patients receiving ranitidine, lansoprazole 15 mg, and lansoprazole 30 mg, respectively (P<0.05 for ranitidine vs. both lansoprazole doses).
Danish: Efter 8 ugers behandling blev der observeret heling hos 61 (53 %) af 115, 81 (69 %) af 118 og 85 (73 %) af 117 patienter, som modtog henholdsvis ranitidin, lansoprazol 15 mg og lansoprazol 30 mg
English: Due to the lack of data in patients with severely impaired hepatic function, these patients should not be treated with lansoprazole (see section 4.4 “Special warning and precautions for use”).
Danish: bør disse patienter ikke behandles med lansoprazol (se pkt.
English: There is no need to change the dose in patients with impaired renal function.
Danish: Nedsat lever- eller nyrefunktion: Der er intet behov for at ændre dosis hos patienter med nedsat nyrefunktion.
English: • Treatment of benign gastric and duodenal ulcers associated with the use of anti-inflammatory analgesics in patients requiring continued anti-inflammatory analgesic treatment.
Danish: • behandling af godartede gastriske og duodenale ulcera i tilknytning til anvendelse af anti inflammatoriske analgetika hos patienter, som kræver løbende antiinflammatorisk, analgetisk behandling.
English: • Prophylaxis of gastric and duodenal ulcer associated with the use of anti-inflammatory agents and relief of symptoms in patients requiring continuous anti-inflammatory therapy
Danish: • Profylakse af gastriske og duodenale ulcera i tilknytning til anvendelse af anti-inflammatoriske midler samt lindring af symptomer hos patienter, der kræver fortsat anti-inflammatorisk behandling.
English: Lai et al studied 123 patients with ulcer complications relating to the use of low dose aspirin and who were infected by H. pylori.
Danish: Lai m. fl. undersøgte 123 patienter smittet med H. pylori og med ulcerkomplikationer,
English: among 537 patients without H. pylori infection who were long-term users of NSAIDs with a history of endoscopically documented gastric ulcer.
Danish: fl. gennemførte en prospektiv, dobbeltblind RCT- undersøgelse af 537 patienter uden H. pylori infektion med langtidsbrug af NSAID og endoscopisk bekræftet gastrisk ulcus.
English: pancreatitis colitis, stomatitis and black tongue
Danish: Tør mund eller hals, glossitis, candidiasis i øsofagus, pancreatitis colitis, stomatitis og sort tunge.
English: Adverse drug reactions such as dizziness and fatigue may occur (see section 4.8 undesirable effects).
Danish: Virkninger på evnen til at føre motorkøretøj eller betrjene maskiner Bivirkningsreaktioner såsom svimmelhed og træthed kan forekomme (se pkt.
English: Matsukawa et al evaluated in an uncontrolled study the efficacy of lansoprazole 15 mg and 30
Danish: Matsukawa m.fl. undersøgte i en ukontrolleret undersøgelse virkningen af lansoprazol 15 mg og 30 mg hos 47 patienter med NSAID- inducerede gastroduodenale ulcera.
English: • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continuous NSAID-treatment
Danish: • Behandling af NSAID-relaterede benigne gastriske og duodenale ulcera hos patienter, der kræver løbende behandling med NSAID
English: glossitis,
Danish: bronchiekonstriktion,
English: In a study published as an abstract (Goldstein et al), the healing rates were 64% and 76% for the 15 mg and 30 mg dose, respectively, at week 8.
Danish: 64% og 76% for dosis på 15 mg og 30 mg efter uge 8.
English: the CHMP has recommended the granting of the Marketing Authorisations with amendments of the Summary of Product Characteristics as set out in Annex III for Lansoprazol HEXAL and associated names (see Annex I).
Danish: Produktresumé med ændringer fremgår af bilag III.
English: • Prophylaxis of NSAID-associated benign gastric and duodenal ulcers patients at risk requiring continuous NSAID-treatment”.
Danish: • Profylakse mod NSAID-relaterede benigne gastriske og duodenale ulcera hos risikopatienter , der kræver løbende behandling med NSAID.
English: (See Section 4.2 “
Danish: (se bilag I).
English: Common
Danish: Styrke
English: bronchial constriction, impotence and angioedema.
Danish: impotens og angiødem.
English: Prophylaxis of NSAID-associated gastric and duodenal ulcers in patients requiring continuous NSAIDtreatment:
Danish: Profylakse mod NSAID-relaterede gastriske og duodenale ulcera hos patienter, de kræver løbende behandling med NSAID: 15 mg én gang daglig.
English: Incompatibilities Not applicable
Danish: Ikke relevant
English: Nervous system headache, dizziness restlessness,
Danish: Gastrointestinalt kvalme, diaré,
English: Furthermore, interaction studies performed with omeprazole and several
Danish: Endvidere er der i interaktionsundersøgelser med omeprazol og flere NSAID'er ingen interaktion påvist.
English: General fatigue.
Danish: galactorrhoea.
English: EU (MA) Number
Danish: EU (MT) nummer
English: Bottle (glass type III)
Danish: Flaske (type IIIglas)
English: Packaging Content Package size
Danish: Særnavn Styrke Lægemiddelform Dyrearter Indgivelsesvej Emballage Indhold Pakning sstørrelse
English: In the MRP United Kingdom is the Reference Member State (RMS) and Austria, Belgium, Denmark, Finland, France, Greece, Germany, Italy, Ireland, Iceland, Luxembourg, The Netherlands, Portugal, Spain and Sweden are Concerned Member States (CMS).
Danish: I proceduren for gensidig anerkendelse er Det Forenede Kongerige referencemedlemsstaten, og Østrig, Belgien, Danmark, Finland, Frankrig, Grækenland, Tyskland, Italien, Irland, Island, Luxembourg, Nederlandene, Portugal, Spanien og Sverige er de berørte medlemsstater.
English: SERETIDE EVOHALER and associated names (See Annex I)
Danish: SERETIDE EVOHALER og tilknyttede navne (se bilag I)
English: In several EU Member States Seretide Evohaler and associated names are approved through the Mutual Recognition Procedure (MRP).
Danish: Seretide Evohaler og tilknyttede navne er godkendt i en række EU-medlemsstater gennem proceduren for gensidig anerkendelse.
English: 4 July 2006 EMEA/306351/2006
Danish: 4. juli 2006 EMEA/306351/2006
English: Seretide Evohaler and associated names (see Annex I) contain salmeterol and fluticasone propionate, a fixed dose combination of the long acting β-agonist salmeterol and the inhaled corticosteroid fluticasone propionate and is indicated for the regular treatment of asthma where use of a combination product (long-acting beta-2-agonist and inhaled corticosteroid) is appropriate: - patients not adequately controlled with inhaled corticosteroids and ‘as needed' inhaled short acting beta-2-agonist or - patients already adequately controlled on both inhaled corticosteroid and long-acting beta-2-agonist.
Danish: Seretide Evohaler og tilknyttede navne (se bilag I) indeholder salmeterol og fluticasonpropionat, som er en fastdosiskombination af den langtidsvirkende beta-agonist salmeterol og det inhalerede corticosteroid fluticasonpropionat, og er indiceret til standardbehandling af astma, når det er hensigtsmæssigt at anvende et kombinationsprodukt (langtidsvirkende beta-2-agonist og inhaleret corticosteroid): - hos patienter, som ikke kan kontrolleres tilstrækkeligt med inhalerede corticosteroider og inhaleret korttidsvirkende beta-2-agonist givet efter behov, eller - hos patienter, der allerede kontrolleres tilstrækkeligt med både inhaleret corticosteroid og langtidsvirkende beta-2agonist.
English: *Note: the information given in this document and Annexes reflect only the CHMP Opinion dated 27 April 2006.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 4. juli Bemærkning: Oplysningerne i dette dokument og bilagene afspejler udelukkende CHMP's udtalelse af 27. april 2006.
English: Do not take this medicine if you are under 18 years of age.
Danish: Tag ikke dette lægemiddel hvis du er under 18 år.
English: Be aware that the desired effect is not achieved if you stop taking Prandin.
Danish: Vær opmærksom på, at den ønskede virkning ikke opnås, hvis du stopper med at tage Prandin.
English: Prandin should be taken with caution.
Danish: Prandin skal tages med forsigtigthed.
English: • If you have an infection or a fever
Danish: • Hvis du har en infektion eller feber
English: Prandin may not be suitable for you.
Danish: Prandin er måske ikke den rigtige løsning for dig.
English: Possible interactions should therefore be taken into account by the physician:
Danish: Derfor bør lægen overveje mulige interaktioner:
English: The amount of Prandin, food or exercise may need to be adjusted.
Danish: Mængden af Prandin, mad eller motion skal muligvis justeres.
English: If your blood sugar gets too high
Danish: Hvis dit blodsukker bliver for højt
English: • If you have type 1 diabetes.
Danish: • Hvis du har type 1-diabetes.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
English: ANNEX II A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARDS TO SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: Do not take more Prandin than your doctor has recommended.
Danish: Tag aldrig en større mængde Prandin, end lægen har anbefalet.
English: Your body's response to Prandin may change if you take other medicines, especially these:
Danish: Din krops reaktion på Prandin kan ændres, hvis du tager anden medicin, især følgende:
English: Warnings and precautions Talk to your doctor before taking Prandin:
Danish: Advarsler og forsigtighedsregler Kontakt lægen før du tager Prandin:
English: EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET
English: Polacrilin potassium Povidone (polyvidone) Glycerol 85%
Danish: Povidon (polyvidon) Glycerol 85%
English: • Diabetic ketoacidosis, with or without coma.
Danish: • Diabetisk ketoacidose, med eller uden koma.
English: Your ability to drive or use a machine may be affected if your blood sugar is low or high.
Danish: Din evne til at køre bil eller arbejde med maskiner, kan muligvis være påvirket, hvis dit blodsukker er for lavt eller for højt.
English: In case a Risk Management Plan is submitted to any regulatory authority the MAH must inform the Rapporteur.
Danish: I tilfælde af at et Risikostyringsprogram er indsendt til en hvilken som helst regulatorisk myndighed skal indehaveren af markedsføringstilladelsen informere Rapporteuren.
English: • If you are about to have major surgery or you have recently suffered a severe illness or infection.
Danish: • Hvis du står over for en stor operation eller lige har overstået en alvorlig sygdom eller infektion.
English: Prandin is not recommended in patients with moderate liver disease.
Danish: Prandin anbefales ikke til patienter med moderat leversygdom.
English: Prandin has no direct influence on the ability to drive and use machines but may cause hypoglycaemia.
Danish: Prandin har ingen direkte indflydelse på evnen til at føre motorkøretøj eller betjene maskiner, men kan medføre hypoglykæmi.
English: Your blood sugar may get too high (hyperglycaemia).
Danish: Dit blodsukker kan blive for højt (hyperglykæmi).
English: • If the acid level in your blood is raised (diabetic ketoacidosis).
Danish: • Hvis syreniveauet i dit blod er forhøjet (diabetisk ketoacidose).
English: • If severe hypoglycaemia is not treated, it can cause brain damage (temporary or permanent)
Danish: • Hvis alvorlig hypoglykæmi ikke behandles, kan det forårsage hjerneskade (midlertidig eller permanent) og endog død.
English: Cardiovascular disease Rare
Danish: Kardiovaskulær sygdom Sjælden
English: • If you take other medicines or suffer from liver or kidney problems (see other sections of 2.
Danish: • Hvis du tager anden medicin eller lider af lever- eller nyreproblemer (se andre afsnit under punkt 2.
English: Prandin with alcohol
Danish: Brug af Prandin sammen med alkohol
English: • Have few or no warning signs of hypos.
Danish: • Har få eller ingen advarselstegn på hypoglykæmi.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Novo Nordisk A/S
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Novo Nordisk A/S
English: • Obligation to conduct post-authorisation measures The MAH shall complete, within the stated timeframe, the following measures: Description
Danish: • Forpligtelse til at udføre foranstaltninger efter udstedelse af markedsføringstilladelse Indehaveren af markedsføringstilladelsen skal inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Denmark.
Danish: Novo Nordisk A/S Novo Allé, DK-2880 Bagsværd, Danmark.
English: Prandin should not be taken if you have a severe liver disease (see Do not take Prandin).
Danish: Du må ikke tage Prandin, hvis du har en alvorlig leversygdom (se Tag ikke Prandin).
English: If you miss a dose, take the next dose as usual - do not double the dose.
Danish: Hvis du glemmer at tage en dosis, skal du tage den næste dosis som sædvanligt - Du må ikke tage en dobbeltdosis som erstatning for den glemte dosis.
English: Do not take Prandin
Danish: Tag ikke Prandin
English: Date of last renewal: 23 July 2008
Danish: Dato for første markedsføringstilladelse: 29. januar 2001 Dato for seneste fornyelse: 23. juli 2008
English: Alcohol can change the ability of Prandin to reduce the blood sugar.
Danish: Alkohol kan ændre den virkning, som Prandin har til at sænke blodsukkeret.
English: They include: increased urination; feeling thirsty; dry skin and dry mouth.
Danish: De inkluderer: øget vandladningstrang, tørstfornemmelse, tør hud og tør mund.
English: • Diabetes mellitus type 1, C-peptide negative.
Danish: • C-peptid negativ type 1-diabetes mellitus.
English: 30 tablets 90 tablets 120 tablets 270 tablets
Danish: 30 tabletter 90 tabletter 120 tabletter 270 tabletter
English: Swallow the tablets with a glass of water immediately before or up to 30 minutes before each main meal.
Danish: Tabletterne sluges sammen med et glas vand umiddelbart før eller op til 30 minutter før hvert hovedmåltid.
English: Rare (may affect up to 1 in 1,000 patients) • Acute coronary syndrome (but it may not be due to the medicine).
Danish: Sjældne bivirkninger (kan forekomme hos færre end 1 ud af 1.000 behandlede) • Akut koronarsyndrom (men det behøver ikke være forårsaget af lægemidlet).