FrancophonIA/ELRC3.0 huggingface dataset:
English: Results of 17 randomized controlled clinical studies (i.e. two pivotal and 15 supportive studies), in which pantoprazole 20mg was investigated with regard to relief of reflux symptoms as a primary or secondary endpoint, have been presented.
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: • Post marketing experience
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
English: Heartburn was defined as burning feeling rising from the stomach or lower chest up towards the neck.
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: BACKGROUND INFORMATION ON THE PROCEDURE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: Clinical trial data did not indicate any specific safety issue in this patient population and the oral prescriptiononly product is approved for adolescent patients.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: No dose adjustment is required in the elderly.
Danish: Dosis bør ikke overskrides.
English: 2.8 Overall conclusions, risk/benefit assessment and recommendation
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: Table 5 Relief rate of acid eructation in study BGI022
Danish: Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC02
English: n
Danish: Kerne
English: Concomitant intake of food has no influence on the bioavailability of pantoprazole.
Danish: Samtidig fødeindtagelse har ingen indflydelse på biotilgængeligheden (AUC eller Cmax), men øger variationen i lag-time (tlag).
English: • Clinical studies in special populations
Danish: Særlige patientgrupper
English: Relief of key symptoms in GORD after 14 days
Danish: Lindring af de vigtigste GORD-symptomer efter 14 dage
English: A continuously high level of quality can therefore be guaranteed.
Danish: En usædvanlig stor forøgelse forekommer imidlertid kun i enkeltstående tilfælde.
English: The effect increases with dose and over time and reaches steady state after a few days.
Danish: Tag den næste dosis næste dag til sædvanlig tid.
English: Outcomes and estimation
Danish: Virkning og anvendelse
English: 1.1 Submission of the dossier
Danish: DATO FOR ÆNDRING AF TEKSTEN
English: • Adverse events
Danish: • ANDRE BETINGELSER
English: CH2
Danish: Batch
English: CONTROLOC Control is available in film coated tablets containing 20 mg pantoprazole.
Danish: INFORMATION I BRAILLE-SKRIFT CONTROLOC Control 20 mg
English: These studies, which reflect the use of the product in medical practice as compared to the scientific setting of clinical studies with strict inclusion and exclusion criteria, contributed to the safety profile of pantoprazole.
Danish: Bivirkninger, der er observeret ved brug af pantoprazol i kliniske studier og efter markedsføringen.
English: Allocation
Danish: Absorption
English: Active Substance
Danish: Nedsat leverfunktion
English: Introduction
Danish: Indgivelsesmåde
English: symptoms after 7 and 28 days of
Danish: Lindring af GORDsymptomer efter 7 og 28 dages behandling
English: In this trial, patients were entered based on the presence of reflux symptoms without endoscopic examination.
Danish: Patienterne bør konsultere deres læge inden de tager dette lægemiddel, hvis de skal have foretaget en endoskopi eller urea udåndingstest.
English: Subjects by arm entered/ completed
Danish: Synsforstyrrelser/ sløret syn
English: Outcomes/endpoints
Danish: Resultater Bemærkninger
English: Patients with conditions for whom a nonprescription use of pantoprazole would not be appropriate, like patients with current erosive lesions of the upper gastrointestinal tract (e.g. reflux esophagitis stage I-V, erosive gastritis, were excluded.
Danish: Derfor bør patienter, der er i behandling med kumarinantikoagulantia (f.eks. phenprocoumon eller warfarin), have foretaget ekstra analyser af prothrombintid/INR ved behandlingsstart og -ophør samt ved uregelmæssig brug af pantoprazol.
English: Pharmacodynamics
Danish: Hypromellose
English: Since the elimination half-life in these patients is still shorter than the dosing interval of 24 hours, no accumulation of pantoprazole was observed following multiple dosing.
Danish: Selv om hovedmetabolitten har en længere halveringstid (2-3 timer), er udskillelsen stadig hurtig, og akkumulation finder således ikke sted.
English: No further information on the contraindicated symptoms or the consequences of the treatment is available.
Danish: Der er ingen kendte symptomer på overdosering hos mennesker.
English: The claimed indication at time of application read as follows: “Treatment of reflux symptoms (e.g. heartburn, acid regurgitation)”
Danish: CONTROLOC Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
English: Placebocontrolled, multicenter, randomized, double blind, parallel group comparison
Danish: Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad,
English: Risk Management Plan
Danish: Virkningsmekanisme
English: The initial application was submitted by Nycomed GmbH (EMEA/H/C/1013).
Danish: Indehaver af markedsføringstilladelsen Nycomed GmbH
English: 2.6 Legal Status
Danish: 6.3 Opbevaringstid
English: Since in patients with liver cirrhosis the elimination half-life, the AUC and the maximum serum concentration is increased compared to healthy subjects, patients with liver disease should not be supplied with non-prescription pantoprazole without consulting a doctor.
Danish: Specielt patienter over 55 år, som dagligt tager ikkereceptpligtige lægemidler mod fordøjelsesbesvær og halsbrand, bør informere deres apotek eller læge.
English: Thrombocytopenia very rare
Danish: Trombocytopeni, leukopeni,
English: 74.3% to 92.3% H2RA (Ranitidine 300mg, Ranitidine 2x150 mg, Nizatidine 2x150 mg)
Danish: Rød jernoxid (E 172) Sort jernoxid (E 172) Gul jernoxid (E 172) Sojalecithin Titandioxid (E 171) Antifoam DC 1510
English: ITT
Danish: ANDET
English: Indirect danger may arise by masking any serious underlying conditions such as an upper gastrointestinal tumour or myocardial infarction if the patient erroneously assesses his or her symptoms (with the help of the pharmacist as appropriate) as caused by gastro-oesophageal reflux.
Danish: - hvis du tidligere har haft et mavesår eller har fået foretaget en maveoperation - hvis du har leverproblemer eller gulsot (gulfarvning af huden og øjnene) - hvis du regelmæssigt tager til læge på grund af alvorlige sygdomme eller lidelser
English: from prescription to non-prescription.
Danish: Du kan få CONTROLOC Control uden recept.
English: The synthesis of the drug substance is performed without optically active reagents and results in a racemate.
Danish: Virkningen er den samme, uanset om det aktive stof gives oralt eller intravenøst.
English: The results of clinical studies where symptomatic relief of GORD was investigated show that pantoprazole provides relief of heartburn and acid regurgitation during a short-term treatment course (2-4 weeks).
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: No increased risk of the treatment with pantoprazole in patients with renal impairment or impaired liver function has been detected in the post-marketing period.
Danish: Selv om der ikke er set interaktion ved samtidig anvendelse af phenprocoumon eller warfarin i kliniske farmakokinetiske forsøg, er der rapporteret om få isolerede tilfælde af ændringer i INR ved samtidig behandling efter markedsføringen.
English: Reflux of gastric acid into the oesophagus is mediated by different mechanisms such as transient lower oesophageal sphincter relaxations or reduced pressure, impaired oesophageal clearance and hiatus hernia.
Danish: Tag ikke CONTROLOC Control samtidigt med anden medicin, som begrænser mængden af syre i din mave, så som andre syrepumpehæmmere (omeprazol, lansoprazol eller rabeprazol) eller en H2antagonist (f.eks. ranitidin, famotidin).
English: It involves conventional chemical operations (alkylation, oxidation, formation of salt), which were transferred from laboratory to production batches during the development.
Danish: Dannelse af carcinoide forstadier (atypisk hyperplasi) og ventrikelcarcinoider, som er fundet i dyreforsøg, er ikke set hos mennesker i langtidsbehandling i de hidtil udførte studier (se pkt.
English: Additionally, patients with symptoms related to conditions other than GORD will not experience improvement after 2 weeks of treatment or they will need longer than 4-week treatment and therefore will see a doctor.
Danish: Du skal kontakte lægen, hvis du ikke oplever symptomlindring efter 2 hele ugers behandling med medicinen.
English: 7.3% to 44.1% 6/7
Danish: 4/8 uger 331
English: Patients with chest pain will be excluded from non-prescription supply.
Danish: Patienterne bør rådgives om, at tabletterne ikke er beregnet til at give øjeblikkelig lindring.
English: Randomised (n=361)
Danish: Titandioxid (E 171)
English: Pantoprazole-containing products are currently licensed throughout the European community for the treatment of conditions such as gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, acid reflux disease, dyspepsia and duodenal or gastric ulcers.
Danish: Du må gerne tage CONTROLOC Control samtidig med syreneutraliserende medicin (f.eks. magaldrat, alginsyre, natriumbicarbonat, aluminiumhydroxid, magnesiumcarbonat eller kombinationer heraf), hvis det er nødvendigt.
English: Normal oesophagus on endoscopy History of reflux symptoms (heartburn, acid eructation, pain on swallowing)
Danish: Hyperlipidæmi og forhøjede lipider (triglycerider, cholesterol), ændring i kropsvægt
English: Numbers analysed
Danish: BATCHNUMMER
English: formulations of pantoprazole have equipotent effect on intragastric pH.
Danish: Pantoprazol metaboliseres i leveren via cytokrom P450 enzymsystemet.
English: The safety profile of pantoprazole is established and allows the assessment according to the applicable criteria for non-prescription medicines.
Danish: MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet er ikke receptpligtigt.
English: Non-responders to acid suppression could indicate the role of other factors.
Danish: CONTROLOC Control kan medføre, at andre lægemidler ikke virker ordentligt.
English: Unlike other proton pump inhibitors, pantoprazole has linear pharmacokinetics in a dose range of 10 - 80mg.
Danish: Inden for dosisintervallet 10-80 mg er pantoprazols plasmakinetik lineær efter både oral og intravenøs administration.
English: Patients with new symptoms will be referred to a doctor.
Danish: Patienter bør instrueres i at kontakte lægen, hvis:
English: PP (N=268)
Danish: Gul jernoxid (E 172)
English: Studies
Danish: Fremstiller
English: Tablet cores are produced by wet granulation.
Danish: Desuden blev der fundet planocellulære papillomer i formaven på rotter.
English: The efficacy of pantoprazole in the proposed indication and posology has been demonstrated.
Danish: De følgende bivirkninger er blevet rapporteret ved brug af pantoprazol.
English: This was considered acceptable.
Danish: Denne indlægsseddel blev senest godkendt
English: Visit
Danish: Øjne
English: Rapporteur:
Danish: Telefon:
English: anaphylactic reaction and anaphylactic shock) Depression (and all aggravations) Urticaria Weight changes Arthralgia Myalgia Bilirubin increased Oedema peripheral Body temperature increased Angioedema Leukopenia very rare
Danish: Synsforstyrrelser så som sløret syn; ledsmerter; muskelsmerter; ændringer i kropsvægt; forhøjet kropstemperatur; hævelse af hænder og fødder; allergiske reaktioner; depression; forhøjede værdier af bilirubin og fedt i blodet (kan ses i blodprøver).
English: The dissolution test is the same as the one used during drug development.
Danish: Udløbsdatoen (Exp) er den sidste dag i den nævnte måned.
English: 4 weeks Rather severe heartburn, acid regurgitation, pain on swallowing
Danish: Hepatocellulær skade, gulsot, leversvigt
English: All analytical methods, except for particle size and residual solvents, are compendial and validation of these methods was not deemed necessary.
Danish: I tilfælde af overdosering med kliniske tegn på forgiftning, bortset fra symptomatisk og understøttende behandling, kan der ikke gives nogle særlige terapeutiske anbefalinger.
English: Tablets cores covered with subcoating are subsequently covered with the second coating layerenteric coating.
Danish: I nedenstående tabel er bivirkningerne ordnet efter følgende frekvensklassifikation:
English: Pantoprazole: Esomeprazole:
Danish: Arthralgi, Myalgi
English: • Patient exposure
Danish: Pædiatrisk anvendelse
English: Pantoprazole is indicated for a range of acid-related gastrointestinal disorders.
Danish: Behandling med syrehæmmende midler medfører en let forøget risiko for gastrointestinale infektioner forårsaget af bakterier, som f.eks.
English: Placebo Relief Rate of Acid Eructation (N/Total N)
Danish: Forhøjede leverenzymer (transaminaser, γ-GT)
English: Given that there are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine this supply classification is considered of benefit to the patients.
Danish: Da pantoprazol i stor udstrækning er proteinbundet, er det ikke let dialyserbart.
English: The chosen reference product is:
Danish: - Øvrige indholdsstoffer:
English: The majority of patients with reflux symptoms can be controlled at the self-care level or a primary care level.
Danish: De fleste patienter vil opnå symptomfrihed af halsbrand og sure opstød indenfor en uge.
English: All patients who received at least one study medication dose were included into the safety analysis.
Danish: I de udvalgte studier skulle der være registreret mindst ét syrereflukssymptom inden for 2 uger.
English: The level of significance adopted was 0.05 and the test power was 90% for a two-tailed test.
Danish: Distribution Fordelingsvolumet er på omkring 0,15 l/kg og serumproteinbindingen er ca. 98%.
English: Although spontaneous abortions and premature births did not occur with higher frequency, because animal studies have shown reproductive toxicity (signs of slight fetotoxicity were observed at doses above 5 mg/kg), patients are advised not to use pantoprazole during pregnancy.
Danish: I dyreforsøg (rotter) var den observerede NOAEL (intet bivirkningsniveau observeret) 5 mg/kg for embryotoksicitet.
English: Pantoprazole: Ranitidine:
Danish: Urticaria, angioødem
English: The majority of these studies were performed in mild reflux disease and investigated the efficacy of pantoprazole either in the symptomatic relief or in the endoscopic healing of GORD.
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: The eligibility for this multiple application to the centralised procedure was agreed upon by the EMEA/CHMP.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs (EMEAs) hjemmeside http://www.emea.europa.eu/.
English: The printed tablets are put into the container closure systems.
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE KARTONFORSTÆRKNING
English: Stable salts are only formed with bases, due to rapid conversion to the cyclic sulphenamide on pyridyl protonation.
Danish: Forekomsten af disse neoplastiske ændringer hænger sammen med de pantoprazol-inducerede forandringer i nedbrydning af thyroxin i rotteleveren.
English: 1 FENDRICK AM et al., Self-Selection and Use Patterns of Over-the-Counter Omeprazole for Frequent Heartburn, Clinical Gastroenterology and Hepatology 2004;2:17-21
Danish: Blæk til prægning: Shellac; rød, sort og gul jernoxid (E 172); sojalecithin, titandioxid (E 171), antifoam DC 1510.
English: The manufacturing process of pantoprazole sodium sesquihydrate is a four step synthesis.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder sojalecithin.
English: In the final step the gastro-resistant tablets are printed on one side [“P20”] with brown printing ink using an offset printing machine.
Danish: Gul, oval, bikonveks filmovertrukken enterotablet påtrykt ”P20” med brunt blæk på den ene side.
English: Time to freedom from key GORD symptoms
Danish: Tid, der går, inden de vigtigste GORDsymptomer er forsvundet
English: Clinical studies in elderly patients and in patients with liver or kidney disease did not identify any concerns.
Danish: Den lille stigning i AUC og Cmax hos ældre forsøgspersoner i forhold til yngre har ingen klinisk relevans.
English: It is noted that specific aspects of the national implementation of a nonprescription status vary amongst Member States.
Danish: Det er uvist, om pantoprazol udskilles i modermælk hos mennesker.
English: Test product and placebo tablets were of identical appearance, and were packed in identical bottles and cartons.
Danish: Passagen over placenta hos rotter blev undersøgt og fandtes at stige med fremskreden graviditet.
English: randomized, doubleblind, multicenter, parallel group comparison
Danish: Stevens-Johnson syndrom, Lyell syndrome, erythema multiforme, lysfølsomhed
English: The product specification is standard for tablets (modified release) and contains tests with suitable limits for appearance, mean mass, disintegration time, loss on drying, identification, dissolution (UV determination), content uniformity, assay (HPLC), purity - impurities and degradation products (HPLC), microbial limits.
Danish: Der er i specifikke undersøgelser ikke fundet klinisk betydningsfulde interaktioner med carbamazepin, caffein, diazepam, diclofenac, digoxin, ethanol, glibenclamid, metoprolol, naproxen, nifedipin, phenytoin, piroxicam, theofyllin og et oralt kontraceptivum indeholdende levonorgestrel og ethinylestradiol.
English: As reflux symptoms are common and can affect the quality of life of the majority of sufferers a proton pump inhibitor is usually used as a first-line treatment.
Danish: Alle faktorer, der nedsætter surhedsgraden i maven, - inklusiv protonpumpehæmmere - øger antallet af de bakterier, der normalt findes i mavetarmkanalen.
English: Placebo
Danish: Triethylcitrat
English: Mild symptoms occurring 2 or more days per week or moderate to severe symptoms occurring more than 1 day per week are often considered troublesome for patients.
Danish: Det kan være nødvendigt at tage tabletterne i 2-3 på hinanden følgende dage for at opnå en forbedring af symptomerne.
English: Statistical methods
Danish: Organsystem
English: Comparison of clinical safety and efficacy of 20mg, 40mg pantoprazole QD and nizatidine 150mg BID in symptomatic erosive oesophagitis
Danish: Det er vist, at samtidig anvendelse af atazanavir 300 mg/ ritonavir 100 mg og omeprazol (40 mg én gang daglig) eller atazanavir 400 mg og lanzoprazol (60 mg givet som enkeltdosis) hos raske forsøgspersoner har medført en betydelig reduktion i atazanavirs biotilgængelighed.
English: However, patients with alarming symptoms indicative of gastrointestinal malignancy (such as unintentional weight loss, bleeding, dysphagia, abdominal pain etc.) will normally see a physician.
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: METHODS
Danish: Frekvens
English: The null hypothesis that no difference in efficacy exists between the two treatments was tested one-sided versus the alternative that such a difference exists (superiority of pantoprazole).
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: However, in the nonprescription setting the presence of oesophageal erosions cannot be ruled out because treatment will be performed without prior endoscopic examination.
Danish: Der forventes ingen bivirkninger i skjoldbruskkirtlen, da den terapeutiske dosis hos mennesker er lav.
English: Pantozol 40 mg gastro-resistant tablets
Danish: LÆGEMIDLETS NAVN CONTROLOC Control 20 mg, enterotabletter
English: There may be local guidelines for disposal.
Danish: Der kan være lokale retningslinjer for bortskaffelse.
English: Thousand Oaks, California
Danish: Thousand Oaks, Californien
English: Not known (frequency cannot be estimated from available data)
Danish: Ikke kendt (hyppigheden kan ikke vurderes ud fra tilgængelige data)
English: CI 95% for HRa
Danish: HRa CI 95% for HRa
English: Your injection could take about 10 seconds.
Danish: Injektionen tager cirka 10 sekunder.
English: Call your doctor immediately.
Danish: Kontakt straks din læge.
English: - The expiration date printed on the label has passed.
Danish: - Udløbsdatoen, der er trykt på etiketten, er passeret.
English: Keep pushing down on your skin.
Danish: Bliv ved med at trykke ned på huden.
English: Component of a multipack, can't be sold separately.
Danish: En del af en multipakning; kan ikke sælges separat.
English: - Any part appears cracked or broken.
Danish: - En eller flere dele ser ud til at være revnede eller ødelagte.
English: ● Talk with your doctor or pharmacist about proper disposal.
Danish: ● Tal med din læge eller apotekspersonalet om korrekt bortskaffelse.
English: AMGEVITA can also be given alone.
Danish: AMGEVITA kan også anvendes alene.
English: The decision to stop using AMGEVITA should be discussed with your doctor.
Danish: Beslutningen om at stoppe med at bruge AMGEVITA skal diskuteres med din læge.
English: Dun Laoghaire, Co Dublin Ireland
Danish: Dun Laoghaire, Co Dublin Irland
English: Results from the overall UC-II study population are shown in table 28.
Danish: Resultater fra den samlede UC-II studiespopulation er vist i tabel 28.
English: Tell your healthcare provider if you are allergic to latex.
Danish: Fortæl det til din læge, hvis du er allergisk over for latex.
English: Side effects may occur at least up to 4 months after the last AMGEVITA injection.
Danish: Bivirkninger kan forekomme op til 4 måneder efter den sidste AMGEVITA injektion.
English: Instructions for use:
Danish: Instruktioner til anvendelsen:
English: ● It is important that you do not try to give the injection unless you or your caregiver has received training.
Danish: ● Det er vigtigt, at du ikke forsøger at give injektionen, medmindre du eller din plejer har fået undervisning i det.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Danish: Du kan også overveje selv at skrive disse oplysninger ned for det tilfælde, at du i fremtiden bliver bedt om dem.
English: Always take the outer carton of this medicine with you, even if it is empty.
Danish: Tag altid den ydre karton eller hætteglasset fra dette lægemiddel med, også selvom den er tom.
English: Mean exposure in all adalimumab population was 762 days.
Danish: Den gennemsnitlige eksponering i hele adalimumabpopulationen var 762 dage.
English: BCVA was either improved or maintained (< 5 letters deterioration) in 88.4% of the eyes at week 78.
Danish: BCVA blev enten forbedret eller vedligeholdt (< 5 forringelse i forhold til bogstaver) i 88,4 % af øjnene i uge 78.
English: Disease flares at the end of 32 weeksa (n/N)
Danish: Opblussen af sygdom i slutningen af de 32 ugera (n/N)