FrancophonIA/ELRC3.0 huggingface dataset:
English: The main metabolite in both serum and urine is desmethylpantoprazole, which is conjugated with sulphate.
Danish: Hovedmetabolitten i både serum og urin er desmethylpantoprazol, der er bundet til sulfat.
English: OUTER CARTON FOR BLISTER OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT
Danish: YDRE KARTON TIL BLISTER YDRE KARTON TIL BLISTER MED KARTONFORSTÆRKNING
English: Influence on Vitamin B12 Absorption
Danish: Indflydelse på absorption af vitamin B12
English: As a result, concentration of pantoprazole in the foetus is increased shortly before birth.
Danish: Som en konsekvens heraf øgedes koncentrationen af pantoprazol i fosteret kort før fødslen.
English: Bilirubin increased
Danish: Forhøjet bilirubin
English: As pantoprazole is extensively protein bound, it is not readily dialysable.
Danish: Da pantoprazol i stor udstrækning er proteinbundet, er det ikke let dialyserbart.
English: Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%.
Danish: Observationsstudier tyder på, at protonpumpehæmmere kan øge den samlede risiko for frakturer med 10-40%.
English: Acid-reflux symptom relief rates were largely independent of the initial GORD stage.
Danish: Lindringsfrekvensen af syrereflukssymptomerne var stort set uafhængig af det initiale GORD-stadie.
English: A previous peri-postnatal study in rats at slightly lower doses found no adverse effects at 3 mg/kg compared with a low dose of 5 mg/kg in this study.
Danish: Et tidligere peri-postnatalt studie med rotter, som fik lidt lavere doser, fandt ingen bivirkninger ved 3 mg/kg sammenlignet med en lav dosis på 5 mg/kg i dette studie.
English: Concomitant intake of food had no influence on bioavailability (AUC or Cmax), but increased the variability of the lag-time (tlag).
Danish: Samtidig fødeindtagelse har ingen indflydelse på biotilgængeligheden (AUC eller Cmax), men øger variationen i lag-time (tlag).
English: The following recommendations for lifestyle and dietary changes may also help to relieve heartburn or acid related symptoms.
Danish: Følgende anbefalinger omkring livsstil og kostændringer kan også hjælpe med at lindre halsbrand og syre-relaterede symptomer.
English: Interstitial nephritis
Danish: Interstitiel nephritis
English: Although the main metabolite has a longer half-life (2-3h), excretion is still rapid and thus accumulation does not occur.
Danish: Selv om hovedmetabolitten har en længere halveringstid (2-3 timer), er udskillelsen stadig hurtig, og akkumulation finder således ikke sted.
English: PANTOLOC Control may stop certain other medicines from working properly.
Danish: PANTOLOC Control kan medføre, at andre lægemidler ikke virker ordentligt.
English: This medicinal product is intended for short-term use (up to 4 weeks) only (Refer to section 4.2).
Danish: Dette medicinske produkt er udelukkende beregnet til kortvarig anvendelse (op til 4 uger) (se pkt.
English: Biotransformation Pantoprazole is almost exclusively metabolized in the liver.
Danish: Biotransformation Pantoprazol bliver næsten udelukkende metaboliseret i leveren.
English: PANTOLOC Control 20 mg gastro-resistant tablets should not be chewed or crushed, and should be swallowed whole with liquid before a meal.
Danish: PANTOLOC Control 20 mg enterotabletter bør ikke tygges eller knuses, men skal sluges hele med væske før et måltid.
English: You should not take it as a preventive measure.
Danish: Du skal ikke tage det som en forebyggende behandling.
English: There were no interactions with concomitantly administered antacids.
Danish: Der var ingen interaktion ved samtidig administration af antacida.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity and genotoxicity.
Danish: De prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: During long-term treatment, gastrin levels double in most cases.
Danish: Under langtidsbehandling fordobles gastrinværdierne i de fleste tilfælde.
English: PANTOLOC Control has no or negligible influence on the ability to drive and use machines.
Danish: PANTOLOC Control påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The slight increase in AUC and Cmax in elderly volunteers compared with younger subjects was not clinically relevant.
Danish: Ældre Den lille stigning i AUC og Cmax hos ældre forsøgspersoner i forhold til yngre har ingen klinisk relevans.
English: These might include: Chocolate, peppermint,
Danish: Det kan foreksempel være: Chokolade,
English: The increased mortality has only been reported in pre-weaning rat pups (up to 21 days age) which is estimated to correspond to infants up to the age of 2 years old.
Danish: Den øgede mortalitet er kun blevet rapporteret for rotteunger inden afvænning (op til 21 dage gamle), hvilket anslås at korrespondere med spædbørn op til 2 år.
English: To avoid this interference, PANTOLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Danish: For at undgå denne interferens bør PANTOLOC Control seponeres mindst 5 dage inden måling af CgA (se pkt.
English: Pharmacokinetics do not vary after single or repeated administration.
Danish: De farmakokinetiske parametre er ens efter enkelt eller gentagen administration.
English: Patients may start to experience symptomatic relief after approximately one day of treatment with pantoprazole, but it might be necessary to take it for 7 days to achieve complete heartburn control.
Danish: Patienterne kan begynde at opleve symptomatisk lindring efter en dags behandling med pantoprazol, men det kan være nødvendigt at tage det i 7 dage for at opnå fuldstændig kontrol af halsbranden.
English: The treatment should not exceed 4 weeks without consulting a doctor.
Danish: Behandlingen bør ikke overstige 4 uger uden at konsultere en læge.
English: Severe hypomagnesaemia has been reported in patients treated with PPIs like pantoprazole for at least three months, and in most cases for a year.
Danish: Der er rapporteret om svær hypomagnesiæmi hos patienter, der er blevet behandlet med protonpumpehæmmere som f.eks. pantoprazol i mindst tre måneder og i de fleste tilfælde i et år.
English: Within the following table, adverse reactions are ranked under the MedDRA frequency classification: Very common (≥ 1/10); 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).
Danish: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 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 forhåndenværende data).
English: After administration of pantoprazole to patients with liver impairment (Child-Pugh classes A, B and C) the half-life values increased to between 3 and 7 h and the AUC values increased by a factor of 3-6, whereas the Cmax only increased slightly by a factor of 1.3 compared with healthy subjects.
Danish: Efter administration af pantoprazol til patienter med leverinsufficiens (Child-Pugh klasse A, B og C) stiger halveringstiden til mellem 3 og 7 timer og AUC-værdierne stiger med en faktor 3-6, mens Cmax kun stiger lidt med en faktor 1,3 sammenlignet med raske forsøgspersoner.
English: If your reflux symptoms (heartburn or acid regurgitation) persist for longer than 2 weeks, consult your doctor who will decide about the need for long-term intake of this medicinal product.
Danish: Hvis dine reflukssymptomer (halsbrand eller opgylpning af syre) varer ved længere end 2 uger, skal du tale med din læge, som vil træffe beslutning om behovet for langvarig indtagelse af dette lægemiddel.
English: The occurrence of these neoplasms is associated with the pantoprazole-induced changes in the breakdown of thyroxine in the rat liver.
Danish: Forekomsten af disse neoplastiske ændringer hænger sammen med de pantoprazol-inducerede forandringer i nedbrydning af thyroxin i rotteleveren.
English: Patients should not take another proton pump inhibitor or H2 antagonist concomitantly.
Danish: Patienter bør ikke tage andre protonpumpehæmmere eller H2-antagonister samtidigt.
English: The half-life of the main metabolite (about 1.5 h) is not much longer than that of pantoprazole.
Danish: Hovedmetabolitternes halveringstid (ca. 1,5 time) er ikke meget længere end pantoprazols.
English: If no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Danish: Hvis der ikke er opnået symptomlindring indenfor 2 ugers kontinuerlig behandling, bør patienten instrueres om at kontakte lægen.
English: Especially, patients over 55 years taking any non-prescription indigestion or heartburn remedy on a daily basis should inform their pharmacist or doctor.
Danish: Specielt patienter over 55 år, som dagligt tager ikke-receptpligtige lægemidler mod fordøjelsesbesvær og halsbrand, bør informere deres apotek eller læge.
English: You should take this medicine for at least 2-3 consecutive days.
Danish: Du bør tage denne medicin i mindst 2-3 dage i træk.
English: This leaflet was last revised in { mm/yyyy}
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ}
English: This should be considered in patients with reduced body stores or risk factors for reduced vitamin B12 absorption on long-term therapy or if respective clinical symptoms are observed.
Danish: Dette bør overvejes i forbindelse med patienter med reducerede depoter i kroppen eller risikofaktorer for reduceret absorption af vitamin B12 ved behandling i længere tid, eller hvis de pågældende kliniske symptomer observeres.
English: In the dose range of 10 to 80 mg, the plasma kinetics of pantoprazole are linear after both oral and intravenous administration.
Danish: Inden for dosisintervallet 10-80 mg er pantoprazols plasmakinetik lineær efter både oral og intravenøs administration.
English: Hallucination; Confusion (especially in pre-disposed patients, as well as the aggravation of these symptoms in case of pre-existence)
Danish: Hallucinationer, forvirring (især hos prædisponerede patienter, samt forværring af allerede eksisterende symptomer)
English: In a retrospective analysis of 17 studies in 5960 patients with gastro-oesophageal reflux disease (GORD) who were treated with 20 mg pantoprazole monotherapy, the symptoms associated with acid reflux e.g. heartburn and acid regurgitation were evaluated according to a standardised methodology.
Danish: I en retrospektiv analyse af 17 studier med 5960 patienter med gastroøsofageal refluks (GORD), som blev behandlet med 20 mg pantoprazol som monoterapi, blev de symptomer, der er forbundet med syre refluks, f.eks halsbrand og syre regurgitation, evalueret i henhold til en standardiseret metode.
English: Do not take PANTOLOC Control: - if you are allergic to pantoprazole, or to any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke PANTOLOC Control: - hvis du er allergisk over for pantoprazol eller et af de øvrige indholdsstoffer (angivet i afsnit 6
English: The following adverse reactions have been reported with pantoprazole.
Danish: Følgende bivirkninger er blevet rapporteret ved brug af pantoprazol.
English: Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist have told you.
Danish: Tag altid dette lægemiddel nøjagtigt som beskrevet i denne indlægsseddel eller efter de anvisninger lægen eller apotekspersonalet har givet dig.
English: Studies selected had to have at least one acid reflux symptom recording point at 2 weeks.
Danish: I de udvalgte studier skulle der være registreret mindst ét syrereflukssymptom inden for 2 uger.
English: Microscopic colitis
Danish: Mikroskopisk colitis
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Indenfor hver frekvensgruppe er bivirkningerne opstillet efter faldende alvorlighed.
English: Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
Danish: Interaktionsstudier med carbamazepin, caffein, diazepam, diclofenac, digoxin, ethanol, glibenclamid, metoprolol, naproxen, nifedipin, phenytoin, piroxicam, theofyllin og et oralt kontraceptivum indeholdende levonorgestrel og ethinylestradiol viste ikke klinisk betydningsfulde interaktioner.
English: No dose reduction is recommended when pantoprazole is administered to patients with impaired renal function (including patients on dialysis, which removes only negligible amounts of pantoprazole).
Danish: Der kræves ingen dosisreduktion, når pantoprazol gives til patienter med nedsat nyrefunktion (inklusiv patienter i dialyse, som kun fjerner ubetydelige mængder af pantoprazol).
English: Special populations No dose adjustment is necessary in elderly patients or in those with impaired renal or liver function.
Danish: Dosisjustering er ikke nødvendig hos ældre patienter, eller hos patienter med nedsat nyre- eller leverfunktion.
English: PANTOLOC Control should not be used by children and adolescents under 18 years of age due to a lack of safety information in this younger age group.
Danish: PANTOLOC Control må ikke bruges af børn og unge under 18 år pga. manglende dokumentation for sikkerhed i denne aldersgruppe.
English: As a result, a mild to moderate increase in the number of specific endocrine (ECL) cells in the stomach is observed in a minority of cases during long-term treatment (simple to adenomatoid hyperplasia).
Danish: Som resultat heraf er en svag til moderat forøgelse af antallet af specifikke endokrine (ECL) celler i maven set hos et mindretal af patienterne under langtidsbehandling (simpel til adenomatoid hyperplasi).
English: As with healthy subjects, the half-life of pantoprazole is short.
Danish: Som hos raske forsøgspersoner er pantoprazols halveringstid kort.
English: Available published evidence suggests that proton pump inhibitors should be discontinued between 5 days and 2 weeks prior to CgA measurements.
Danish: Den foreliggende publicerede dokumentation antyder, at protonpumpehæmmere bør seponeres mellem 5 dage og 2 uger før måling af CgA.
English: In the 2-year carcinogenicity studies in rats, neuroendocrine neoplasms were found.
Danish: I et toårigt karcinogenitetsstudie på rotter fandt man neuroendokrin neoplasi.
English: PANTOLOC Control is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Danish: PANTOLOC Control bør ikke anvendes til børn og unge under 18 år på grund af utilstrækkelige data vedrørende sikkerhed og virkning.
English: By the end of the recovery phase, bone parameters were similar across groups and body weights were also trending toward reversibility after a drug-free recovery period.
Danish: Ved udgangen af rekonvalescensperioden var knogleparametrene ens i alle grupper, og der var desuden en tendens mod reversabilitet for legemsvægt efter en rekonvalescensperiode uden lægemidler.
English: If CgA and gastrin levels have not returned to reference range after initial measurement, measurements should be repeated 14 days after cessation of proton pump inhibitor treatment.
Danish: Hvis indholdet af CgA og gastrin ikke er returneret til referenceområdet ved den første måling, bør målingen gentages 14 dage efter seponering af protonpumpehæmmeren.
English: Renal elimination represents the major route of excretion (about 80%) for the metabolites of pantoprazole; the rest is excreted with the faeces.
Danish: Udskillelsen gennem nyrerne repræsenterer den største del af udskillelsen (omkring 80%) for metabolitterne af pantoprazol, mens resten udskilles med fæces.
English: If you take more PANTOLOC Control than you should Tell your doctor or pharmacist if you have taken more than the recommended dose.
Danish: Hvis du har taget for meget PANTOLOC Control Fortæl det til lægen eller apoteket hvis du har taget mere end den anbefalede dosis.
English: • They have had previous gastric ulcer or gastrointestinal surgery.
Danish: • de tidligere har haft mavesår eller fået foretaget gastrointestinale indgreb.
English: Pantoprazole was consistently shown to be superior to placebo and H2RA and non-inferior to other PPIs.
Danish: Pantoprazol har konstant vist sig at være bedre end placebo og H2-receptor-antagonister og ikke mindre effektive end andre PPI'er.
English: On average, at about 2.0 h - 2.5 h post administration (tmax) of a single 20 mg oral dose, the maximum serum concentrations (Cmax) of about 1-1.5 µg/ml are achieved, and these values remain constant after multiple administration.
Danish: 2-2,5 timer efter administration (tmax) af en enkelt oral dosis på 20 mg, opnås i gennemsnit en maksimal serumkoncentration (Cmax) på omkring 1-1,5 µg/ml, og disse værdier forbliver konstante ved gentagne doseringer.
English: It might be necessary to take the tablets for 2-3 consecutive days to achieve improvement of symptoms.
Danish: Det kan være nødvendigt at tage tabletterne i 2-3 på hinanden følgende dage for at opnå en forbedring af symptomerne.
English: Stop taking PANTOLOC Control when you are completely symptom-free.
Danish: Stop med at tage PANTOLOC Control, når du er symptomfri.
English: Due to the specific binding of pantoprazole to the proton pumps within the parietal cell, the elimination half-life does not correlate with the much longer duration of action (inhibition of acid secretion).
Danish: På grund af den specifikke binding af pantoprazol til protonpumperne i de parietale celler svarer halveringstiden for udskillelsen ikke til den meget længere virkningsvarighed (hæmning af syresekretionen).
English: PANTOLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Danish: PANTOLOC Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
English: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
Danish: Forhøjet chromogranin A (CgA) kan interferere med undersøgelser for neuroendokrine tumorer.
English: After 14 and 28 days, complete heartburn relief was experienced in 62.9% to 88.6% and 68.1% to 92.3% of the patients, respectively.
Danish: Efter 14 og 28 dage oplevede henholdsvis 62,9% til 88,6% og 68,1% til 92,3% af patienterne fuldstændig lindring af halsbranden.
English: Also CgA increases due to decreased gastric acidity.
Danish: Også indholdet af CgA stiger på grund af den nedsatte gastriske aciditet.
English: Patients with long-term recurrent symptoms of indigestion or heartburn should see their doctor at regular intervals.
Danish: Patienter med langvarige tilbagevendende symptomer på fordøjelsesbesvær eller halsbrand bør se deres læge med regelmæssige intervaller.
English: Pantoprazole reduces acidity in the stomach and thereby increases gastrin in proportion to the reduction in acidity.
Danish: Pantoprazol reducerer surhedsgrad i maven og øger derved gastrin i forhold til reduktionen af surhedsgraden.
English: In these studies, the percentage of patients experiencing complete relief from heartburn after 7 days was between 54.0% and 80.6% in the pantoprazole group.
Danish: I disse studier var procentdelen af de patienter, som opnåede fuldstændig lindring af halsbranden efter 7 dage, mellem 54,0% og 80,6% i gruppen som blev behandlet med pantoprazol.
English: During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion.
Danish: Under behandling med sekretionshæmmende lægemidler stiger indholdet af gastrin i serum som reaktion på den nedsatte syresekretion.
English: Concomitant use of high dose methotrexate (e.g. 300 mg) and proton-pump inhibitors has been reported to increase methotrexate levels in some patients.
Danish: Samtidig brug af høje doser methotrexat (fx 300 mg) og protonpumpehæmmere er blevet rapporteret at øge methotrexat-koncentrationen hos nogle patienter.
English: Alu/Alu blisters with or without cardboard reinforcement containing 7 or 14 gastro-resistant tablets.
Danish: Aluminium/aluminiumblister, med eller uden kartonforstærkning, der indeholder 7 eller 14 enterotabletter.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutant væv
English: Proton pump inhibitors, especially if used in high doses and over long durations (> 1 year), may modestly increase the risk of hip, wrist and spine fracture, predominantly in older people or in presence of other recognised risk factors.
Danish: Protonpumpehæmmere kan, især hvis de anvendes i høje doser og over længere tid (> 1 år), i beskeden grad øge risikoen for frakturer i hofte, håndled og rygsøjle, primært hos ældre, eller hvis der er andre kendte risikofaktorer.
English: Since pantoprazole binds to the enzyme distal to the receptor level, it can inhibit hydrochloric acid secretion independently of stimulation by other substances (acetylcholine, histamine, gastrin).
Danish: Da pantoprazol bindes til enzymet distalt for cellereceptorniveauet, kan stoffet påvirke saltsyresekretionen uafhængigt af stimulationen fra andre stoffer (acetylcholin, histamin, gastrin).
English: • They are on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Danish: • de er under kontinuerlig symptomatisk behandling af fordøjelsesbesvær eller halsbrand i mere end
English: This may cause you symptoms such as a painful burning sensation in the chest rising up to the throat (heartburn) and a sour taste in the mouth (acid regurgitation).
Danish: Det kan give symptomer som smertefuld brændende fornemmelse i brystet, som stiger op i halsen (halsbrand) og giver en sur smag i munden (sure opstød).
English: Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Danish: Pantoprazol kan i lighed med alle syreblokerende midler reducere absorptionen af vitamin B12 (cyanocobalamin) på grund af hypochlorhydri eller achlorhydri.
English: Reflux is the backflow of acid from the stomach into the gullet (“foodpipe”), which may become inflamed and painful.
Danish: Refluks er tilbageløb af syre fra maven til spiserøret, som kan blive betændt og smertefuldt.
English: The inhibition is dose-dependent and affects both basal and stimulated acid secretion.
Danish: Hæmningen er dosisafhængig og indvirker både på den basale og den stimulerede syresekretion.
English: Pharmacotherapeutic group: Drugs for acid related disorders, Proton pump inhibitors, ATC code: A02BC02
Danish: Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC02
English: A slight increase of neoplastic changes of the thyroid was observed in the group of rats receiving the highest dose (200 mg/kg) in one 2-year study.
Danish: En beskeden forøgelse af neoplastiske forandringer af thyreoidea blev set i et toårigt studie i den gruppe rotter, der fik den højeste dosis (200 mg/kg).
English: Arthralgia; Myalgia
Danish: Artralgi, Myalgi
English: Serious manifestations of hypomagnesaemia such as fatigue, tetany, delirium, convulsions, dizziness, and ventricular arrhythmia can occur but they may begin insidiously and be overlooked.
Danish: Alvorlige manifestationer af hypomagnesiæmi såsom træthed, tetani, delirium, kramper, svimmelhed og ventrikulær arytmi kan forekomme, men de kan starte snigende og blive overset.
English: CARDBOARD REINFORCEMENT
Danish: KARTONFORSTÆRKNING
English: Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system.
Danish: Pantoprazol metaboliseres i leveren via CYP-enzymsystemet (cytokrom P450).
English: The fasting gastrin values increase under pantoprazole.
Danish: Fastende gastrinværdier stiger under pantoprazolbehandling.
English: In most patients, freedom from heartburn and acid reflux symptoms is achieved in 1 week.
Danish: De fleste patienter vil opnå symptomfrihed af halsbrand og sure opstød indenfor en uge.