FrancophonIA/ELRC3.0 huggingface dataset:
English: Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Danish: Selv om der ikke er set interaktion ved samtidig anvendelse af phenprocoumon eller warfarin i kliniske farmakokinetiske studie, er der rapporteret om få isolerede tilfælde af ændringer i INR ved samtidig behandling efter markedsføringen.
English: For patients expected to be on prolonged treatment or who take PPIs with digoxin or medicinal products that may cause hypomagnesaemia (e.g. diuretics), health care professionals should consider measuring magnesium levels before starting PPI treatment and periodically during treatment.
Danish: Hos patienter, der forventedes at være på en forlænget behandling, eller som tager protonpumpehæmmere sammen med digoxin eller lægemidler, der kan være årsag til hypomagnesiæmi (f.eks. vanddrivende midler), bør de behandlende læger overveje at måle magnesiumniveauet, før de påbegynder en behandling med protonpumpehæmmere og regelmæssigt under behandlingen.
English: Penetration of the placenta was investigated in the rat and was found to increase with advanced gestation.
Danish: Passagen over placenta hos rotter blev undersøgt og fandtes at stige med fremskreden graviditet.
English: Do not exceed this recommended dose of 20 mg pantoprazole daily.
Danish: Overskrid ikke den anbefalede daglige dosis på 20 mg pantoprazol.
English: Do not use this medicine after the expiry date, which is stated on the carton and the blister after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato (EXP), der står på pakningen.
English: - Avoid large meals - Eat slowly - Stop smoking - Reduce alcohol and caffeine consumption - Reduce weight (if overweight) - Avoid tight-fitting clothing or belts - Avoid eating less than three hours before bedtime - Elevate bedhead (if you suffer from nocturnal symptoms) - Reduce intake of food that can cause heartburn.
Danish: - undgå store måltider - spis langsomt - hold op med at ryge - reducer indtaget af alkohol og koffein - vægttab (ved overvægt) - undgå tætsiddende tøj eller bælte - undgå at spise tre timer før sengetid - hæv hovedgærdet (hvis du lider af natlige symptomer) - reducer indtaget af madvarer, som kan medføre halsbrand.
English: Do not take this product for longer than 4 weeks without consulting your doctor.
Danish: Tag ikke dette produkt i længere tid end 4 uger uden at tale med din læge.
English: This medicine may not bring immediate relief.
Danish: Medicinen er ikke beregnet til at give øjeblikkelig lindring.
English: In the 2-year rodent studies an increased number of liver tumors was observed in rats (in one rat study only) and in female mice and was interpreted as being due to pantoprazole's high metabolic rate in the liver.
Danish: I toårs studierne med gnavere blev der observeret et øget antal af levertumorer hos rotter (kun i et rottestudie) og hos hunmus, hvilket blev tolket som en konsekvens af pantoprazols høje metaboliske omsætning i leveren.
English: After 7 days the percentage of patients experiencing complete relief from acid regurgitation was between 61.5% and 84.4%, after 14 days between 67.7% and 90.4%, and after 28 days between 75.2% and 94.5%, respectively.
Danish: Efter 7 dage var procentdelen af patienter, som opnåede fuldstændig lindring af syreregurgitation mellem 61,5% og 84,4%, efter 14 dage mellem 67,7% og 90,4%, og efter 28 dage mellem 75,2% og
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Sodium laurilsulfate
Danish: Methacrylsyre-ethylacrylat copolymer (1:1) Natriumlaurilsulfat
English: Do not exceed this dose.
Danish: Dosis bør ikke overskrides.
English: Sodium carbonate, anhydrous Mannitol (E421) Crospovidone
Danish: Natriumcarbonat, vandfrit Mannitol (E 421) Crospovidon
English: • They have unintentional weight loss, anaemia, gastrointestinal bleeding, dysphagia, persistent vomiting or vomiting with blood, since it may alleviate symptoms and delay diagnosis of a severe condition.
Danish: • de har utilsigtet vægttab, anæmi, gastrointestinal blødning, dysphagi, vedvarende opkastninger eller opkastning med blod, da det kan sløre symptomerne og derved forsinke en diagnose af en alvorlig lidelse.
English: It may be necessary to take the tablets for 2-3 consecutive days to relieve the symptoms.
Danish: Det kan være nødvendigt at tage tabletter i 2-3 dage i træk for at lindre symptomerne.
English: In a peri-postnatal rat reproduction study designed to assess bone development, signs of offspring toxicity (mortality, lower mean body weight, lower mean body weight gain and reduced bone growth) were observed at exposures (Cmax) approximately 2x the human clinical exposure.
Danish: I et peri-postnatalt reproduktionsstudie med rotter, der var designet til at vurdere knogleudvikling, blev der observeret tegn på toksicitet hos afkommet (mortalitet, lavere gennemsnitlig legemsvægt, lavere gennemsnitlig øgning af legemsvægt og reduceret knoglevækst) ved eksponeringer (Cmax) på omtrent 2 gange den menneskelige kliniske eksponering.
English: Investigations revealed no evidence of impaired fertility or teratogenic effects.
Danish: Studierne viste intet tegn på nedsat fertilitet eller teratogen effekt.
English: If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping PANTOLOC Control.
Danish: Hvis sådanne hudreaktioner optræder, navnlig på hudområder udsat for sol, og er ledsaget af artralgi, bør patienten straks søge læge, og lægen bør overveje at seponere PANTOLOC Control.
English: StevensJohnson syndrome; Lyell syndrome;
Danish: Stevens-Johnson syndrom, Lyell syndrome, erythema multiforme, lysfølsomhed.
English: You may need further blood tests - methotrexate (used to treat rheumatoid arthritis, psoriasis, and cancer) - if you are taking methotrexate your doctor may temporarily stop your PANTOLOC Control treatment because pantoprazole can increase levels of methotrexate in the blood.
Danish: - methotrexat (bruges til behandling af reumatoid artrit, psoriasis og cancer) - hvis du tager methotrexat, kan din læge midlertidigt stoppe din behandling med PANTOLOC Control, da Pantoloc Control kan forøge niveauet af methotrexat i blodet.
English: PANTOLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Danish: PANTOLOC Control indeholder det aktive stof pantoprazol, som blokerer den ”pumpe”, der producerer mavesyre.
English: Do not take PANTOLOC Control with other medicines which limit the amount of acid produced in your stomach, such as another proton pump inhibitor (omeprazole, lansoprazole or rabeprazole) or an H2 antagonist (e.g. ranitidine, famotidine).
Danish: Tag ikke PANTOLOC Control samtidigt med anden medicin, som begrænser mængden af syre i din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H2-antagonist (f.eks. ranitidin, famotidin).
English: Marketing Authorisation Holder Takeda GmbH
Danish: Indehaver af markedsføringstilladelsen Takeda GmbH
English: The increased CgA level may interfere with investigations for neuroendocrine tumours.
Danish: Det forhøjede indhold af CgA kan interferere med undersøgelser for neuroendokrine tumorer.
English: - You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
Danish: - Du skal kontakte din læge, hvis du får det værre, eller hvis du ikke har det bedre efter 2 uger.
English: If affected, patients should not drive or use machines.
Danish: Påvirkede patienter bør udvise forsigtighed og bør ikke føre motorkøretøjer eller betjene maskiner.
English: Disturbances in vision / blurred vision
Danish: Synsforstyrrelser/ sløret syn
English: Your doctor may decide that you need some tests.
Danish: Din læge kan beslutte at henvise dig til yderligere undersøgelser.
English: Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Danish: Pantoprazol er en substitueret benzimidazol, som hæmmer sekretionen af saltsyre i maven ved en specifik virkning på parietalcellernes protonpumper.
English: You may experience relief from your acid reflux and heartburn symptoms after just one day of treatment with PANTOLOC Control, but this medicine is not meant to bring immediate relief.
Danish: Du kan opleve lindring af dine symptomer på sure opstød og halsbrand efter kun en dags behandling med PANTOLOC Control, men denne medicin har ikke til hensigt at give øjeblikkelig lindring.
English: - falling magnesium levels in your blood (potential symptoms: fatigue, involuntary muscle contractions, disorientation, convulsions, dizziness, increased heart rate).
Danish: - Faldende magnesiumniveauer i blodet (mulige symptomer: træthed, ufrivillige muskelsammentrækninger, desorientering, kramper, svimmelhed, øget hjertefrekvens).
English: Packs containing 7 or 14 gastro-resistant tablets.
Danish: Pakningerne indeholder 7 eller 14 enterotabletter.
English: D-78467 Konstanz Germany
Danish: D-78467 Konstanz
English: In addition, squamous cell papillomas were found in the forestomach of rats in one study.
Danish: Desuden blev der fundet planocellulære papillomer i formaven på rotter.
English: The mechanism leading to the formation of gastric carcinoids by substituted benzimidazoles has been carefully investigated and allows the conclusion that it is a secondary reaction to the massively elevated serum gastrin levels occurring in the rat during chronic high-dose treatment.
Danish: Den mekanisme, der fører til, at substituerede benzimidazoler giver ventrikelcancer er undersøgt nøje og konklusionen er, at ventrikelcancer er en sekundær reaktion til den kraftige forøgelse af serumgastrinniveauet hos rotter i kronisk højdosisbehandling.
English: Liver enzymes increased (transamina ses, γ-GT)
Danish: Forhøjede leverenzymer (transaminaser, γ-GT)
English: However, you may take PANTOLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Danish: Du må gerne tage PANTOLOC Control samtidig med syreneutraliserende medicin (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller kombinationer heraf), hvis det er nødvendigt.
English: Therefore in settings where high-dose methotrexate is used, for example cancer and psoriasis, a temporary withdrawal of pantoprazole may need to be considered.
Danish: Ved anvendelse af højdosis-methotrexat fx ved cancer og psoriasis, bør det derfor overvejes at seponere pantoprazol midlertidigt.
English: Ask your pharmacist how to throw away medicines you no longeruse.
Danish: Spørg på apoteket, hvordan du skal bortskaffe medicinrester.
English: In most affected patients, hypomagnesaemia improved after magnesium replacement and discontinuation of the PPI.
Danish: Hos de fleste berørte patienter bedredes deres hypomagnesiæmi efter magnesiumerstatning og ophør med protonpumpehæmmere.
English: You must talk to a doctor if you do not feel better or if you feel worse after 2 weeks.
Danish: Du skal kontakte din læge, hvis du får det værre, eller hvis du ikke har det bedre efter 2 uger.
English: Urticaria; Angioedema
Danish: Urticaria, angioødem
English: PANTOLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Danish: PANTOLOC Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pH-afhængig (fx. ketoconazol).
English: Therefore, in patients treated with coumarin anticoagulants (e.g. phenprocoumon or warfarin), monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.
Danish: Derfor bør patienter, der er i behandling med kumarin-antikoagulantia (f.eks. phenprocoumon eller warfarin), have foretaget ekstra analyser af prothrombintid/INR ved behandlingsstart og -ophør samt ved uregelmæssig brug af pantoprazol.
English: You must not use PANTOLOC Control if you are taking HIV protease inhibitors.
Danish: Du må ikke tage PANTOLOC Control, hvis du tager HIV-proteasehæmmere.
English: On short-term use, in most cases they do not exceed the upper limit of normal.
Danish: Ved anvendelse af pantoprazol i kort tid overskrider gastrinværdierne i de fleste tilfælde ikke normalområdet.
English: What PANTOLOC Control contains - The active substance is pantoprazole.
Danish: PANTOLOC Control indeholder: - Aktivt stof: Pantoprazol.
English: Hyponatraemia, Hypomagnesaemia
Danish: Hyponatræmi, hypomagnesæmi Hypokalcæmi
English: mm/yyyy
Danish: MM/ÅÅÅÅ
English: If you forget to take PANTOLOC Control
Danish: Hvis du har glemt at tage PANTOLOC Control
English: If you have been suffering from repetitive heartburn or indigestion symptoms for some time, remember to see your doctor regularly.
Danish: Hvis du gennem den seneste tid har lidt af halsbrand- eller fordøjelsesbesværsymptomer, skal du huske at gå til læge regelmæssigt.
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Danish: - du skal have taget en særlig blodprøve (chromogranin A) - hvis du tager HIV-proteasehæmmere såsom atazanavir; nelfinavir (til behandling af
English: Typical symptoms are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
Danish: Typiske symptomer er: Hævelse af ansigt, læber, mund, tunge og/eller hals, hvilket kan give problemer med at synke eller trække vejret, udslæt (nældefeber), alvorlig svimmelhed med hurtig hjertebanken og kraftige svedeture.
English: Do not take PANTOLOC Control tablets for more than 4 weeks without consulting your doctor.
Danish: Tag ikke PANTOLOC Control-tabletter i mere end 4 uger uden at kontakte lægen.
English: spearmint, fatty and fried food, acidic food, spicy food, citrus fruits and fruit juices, tomatoes.
Danish: pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad, citrusfrugter,
English: Fracture of wrist, hip and spine.
Danish: Fraktur af håndled, hofte og rygsøjle
English: Asthenia, fatigue and malaise
Danish: Asteni, træthed, utilpashed
English: Adverse reactions with pantoprazole in clinical trials and post-marketing experience
Danish: Bivirkninger, der er observeret ved brug af pantoprazol i kliniske studier og efter markedsføringen.
English: Yellow, oval biconvex film-coated tablets imprinted with “P20” in brown ink on one side.
Danish: Gul, oval, bikonveks filmovertrukken enterotablet påtrykt ”P20” med brunt blæk på den ene side.
English: - Ask your pharmacist if you need more information or advice.
Danish: - Spørg på apoteket, hvis der er mere, du vil vide.
English: For the complete relief from acid regurgitation, similar results were obtained as for heartburn.
Danish: Der blev opnået tilsvarende resultater for fuldstændig lindring af syre-regurgitation som for halsbrand.
English: - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Danish: - Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172), propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat, polysorbat 80, triethylcitrat.
English: Driving and using machines If you experience side effects like dizziness or disturbed vision, you should not drive or use machines.
Danish: Hvis du oplever bivirkninger som svimmelhed og synsforstyrrelser, må du ikke føre motorkøretøj eller betjene maskiner.
English: Clearance is about 0.1 l/h/kg, and terminal half-life (t1/2) about 1 h. There were a few cases of subjects with delayed elimination.
Danish: Clearance er ca. 0,1 l/t/kg, og den terminale halveringstid (t½) er ca. 1 time.
English: Pantoprazole should not be used during pregnancy.
Danish: PANTOLOC Control bør ikke anvendes under graviditet.
English: - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Danish: - Øvrige indholdsstoffer : - Kerne: Natriumcarbonat, vandfrit; mannitol (E 421), crospovidon, povidon K90, calciumstearat.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere information om PANTOLOC Control på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Posology The recommended dose is 20 mg pantoprazole (one tablet) per day.
Danish: Dosering Den anbefalede dosering er 20 mg pantoprazol (en tablet) daglig.
English: There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).
Danish: Fertilitet I dyrestudier var der ingen tegn på nedsat fertilitet efter administration af pantoprazol (se pkt.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRRINGSTILLADELSEN
English: - Printing ink: shellac, red, black and yellow iron oxide (E172), and ammonia solution, concentrated.
Danish: - Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); koncentreret ammoniakopløsning.
English: Bone Fracture
Danish: Knoglefraktur
English: - warfarin and phenprocoumon (used to thin blood and prevent clots).
Danish: - ketoconazol (bruges ved svampeinfektion) - warfarin og phenprocoumon (medicin som virker blodfortyndende og forebygger blodpropper).
English: Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Germany
Danish: Takeda GmbH Byk-Gulden-Str. 2 D-78467 Konstanz Tyskland
English: As the therapeutic dose in man is low, no side effects on the thyroid glands are expected.
Danish: Der forventes ingen bivirkninger i skjoldbruskkirtlen, da den terapeutiske dosis hos mennesker er lav.
English: Tell your doctor immediately, before or after taking this medicine, if you notice any of the following symptoms, which could be a sign of another, more serious, disease: - an unintentional loss of weight (not related to a diet or an exercise programme) - vomiting, particularly if repeated - vomiting blood; this may appear as dark coffee grounds in your vomit - you notice blood in your stools; which may be black or tarry in appearance - difficulty in swallowing or pain when swallowing - you look pale and feel weak (anaemia) - chest pain - stomach pain - severe and/or persistent diarrhoea, because this medicine has been associated with a small increase in infectious diarrhoea.
Danish: Fortæl det straks til lægen før eller efter du har taget medicinen, hvis du oplever nogle af følgende symptomer, som kan være et tegn på en anden, mere alvorlig, sygdom: - uventet vægttab (som ikke er relateret til diæt eller et motionsprogram) - opkastning, især ved gentagelse - blodigt opkast, dette kan ses som mørkt kaffegrums i dit opkast - du opdager blodig afføring, som kan være sort eller tjærefarvet - synkebesvær eller smerte i forbindelse med synkning - du ser bleg ud eller føler dig sløj (blodmangel) - brystsmerter - mavesmerter - kraftig og/eller vedvarende diaré, da dette lægemiddel er forbundet med en let øget risiko for infektiøs diaré - hvis du får udslæt, især på de dele af huden, der er udsat for sol, skal du snarest muligt sige det til lægen, da du kan være nødt til at holde op med at tage PANTOLOC Control.
English: PANTOLOC Control should not be used during breast-feeding.
Danish: PANTOLOC Control bør ikke anvendes under amning.
English: Preclinical studies revealed no evidence of impaired fertility or teratogenic effects (see section 5.3).
Danish: Prækliniske studier viste ikke tegn på nedsat fertilitet eller teratogen effekt (se pkt.
English: anaphylactic reactions and anaphylactic shock)
Danish: Hypersensitivitet (inklusive anafylaktiske reaktioner og anafylaktisk chok)
English: Decreased gastric acidity, due to any means - including proton pump inhibitors - increases gastric counts of bacteria normally present in the gastrointestinal tract.
Danish: Gastrointestinale infektioner forårsaget af bakterier Alle faktorer, der nedsætter surhedsgraden i maven, - inklusiv protonpumpehæmmere - øger antallet af de bakterier, der normalt findes i mavetarmkanalen.
English: Body temperature increased;
Danish: Forhøjet kropstemperatur, perifert ødem
English: • They have jaundice, hepatic impairment, or liver disease.
Danish: • de har gulsot, leverinsufficiens eller anden leversygdom.
English: HIV Protease Inhibitors
Danish: HIV-proteasehæmmere
English: Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Danish: Hyperlipidæmi og forhøjede lipider (triglycerider, cholesterol), ændring i kropsvægt
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Danish: Lehnitzstraße 70-98 D-16515 Oranienburg Tyskland
English: This is to allow CgA levels that might be spuriously elevated following PPI treatment to return to reference range.
Danish: Dette er for at eventuelle falskt forhøjede værdier af CgA i forbindelse med behandling med protonpumpehæmmere kan vende tilbage til referenceområdet.
English: What you need to know before you take PANTOLOC Control
Danish: Det skal du vide, før du begynder at tage PANTOLOC Control
English: Rash / exanthema / eruption;
Danish: Udslæt/eksantem/ eruptioner, Kløe
English: Doses up to 240 mg administered intravenously over 2 minutes were well tolerated.
Danish: Doser op til 240 mg indgivet i.v.
English: - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Danish: - hvis du tager HIV-proteasehæmmere som f.eks. atazanavir, nelfinavir (til behandling af
English: Relieves heartburn.
Danish: Lindrer halsbrand.
English: However, according to the studies conducted so far, the formation of carcinoid precursors (atypical hyperplasia) or gastric carcinoids as were found in animal experiments (see section 5.3) have not been observed in humans.
Danish: Dannelse af carcinoide forstadier (atypisk hyperplasi) og ventrikelcarcinoider, som er fundet i dyrestudier, er ikke set hos mennesker i langtidsbehandling i de hidtil udførte studier (se pkt.
English: Fundic gland polyps (benign)
Danish: Polypper på fundus (godartede
English: 7 gastro-resistant tablets 14 gastro-resistant tablets
Danish: 7 enterotabletter 14 enterotabletter
English: Co-administration of Pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.5).
Danish: Samtidig behandling med Pantoprazol anbefales ikke sammen med HIV protease-hæmmere, hvor optagelsen er afhængig af surt intragastrisk pH som f.eks. atazanavir, nelfinavir, på grund af en signifikant reduktion i deres biotilgængelighed (se pkt.
English: Byk-Gulden-Straße 2, 78467 Konstanz Germany
Danish: Byk-Gulden-Str. 2 D-78467 Konstanz Tyskland
English: See ‘Other medicines and PANTOLOC Control'.
Danish: Se brug af andet medicin sammen med Pantoloc control.
English: Hypocalcaemia
Danish: Hypomagnesiæmi
English: What PANTOLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Danish: Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
English: PANTOLOC Control is used for the short-term treatment of reflux symptoms (for example heartburn, acid regurgitation) in adults.
Danish: PANTOLOC Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.