natgillin/translations-raw huggingface dataset:
Lindring af de vigtigste GORD-symptomer og andre gastrointestinale symptomer
Relief of leading GORD symptoms and other GI symptoms
Dosering Den anbefalede dosering er 20 mg pantoprazol (en tablet) daglig.
The recommended dose is 20 mg pantoprazole (one tablet) per day.
Hvis der ikke er opnået symptomlindring indenfor 2 ugers kontinuerlig behandling, bør patienten instrueres om at kontakte lægen.
Overall treatment duration without consultation of a doctor is limited to 4 weeks; if no symptom relief is obtained within 2 weeks of continuous treatment, the patient should be instructed to consult a doctor.
Vurdering af gastrointestinale symptomer på dag 14 og dag 28
Assessment of GI symptoms at day 14 and
Livskvalitet, tid, der går, inden halsbrand lindres
Quality of life, Time to heartburn relief
Enterotabletterne er gule, ovale, bikonvekse filmovertrukne tabletter præget med ”P20” på den ene side.
Tablets are yellow, oval, biconvex, film-coated and imprinted with “P20” in brown ink on one side.
I denne undersøgelse sammenlignedes virkningen af omeprazol 10 mg med virkningen af pantoprazol 20 mg efter en og to ugers behandling.
This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg after one and two weeks or treatment.
FARMACEUTISKE OPLYSNINGER
Medicinal Product
Pan 20, 40, Niz 150 bid
Pan 20, 40, Niz 150 bid weeks
Desuden var virkningen af pantoprazol blevet sammenlignet med andre PPI'er (lansoprazol, esomeprazol) i andre undersøgelser, og man fandt, at det ikke var dårligere end disse PPI'er med hensyn til at lindre symptomer på halsbrand og sure opstød (undersøgelse VMG305 og M3-320).
Additionally, in other studies efficacy of pantoprazole was compared to other PPIs (lansoprazole, esomeprazole) and it was found to be non-inferior to these PPIs in relieving symptoms of heartburn and acid regurgitation (Study VMG305 and M3-320).
421 Pantoprazol var virkningsfuldtog tolereredes godt
Pantoprazole was effective and well tolerated
Lindring af symptomer i GORD Fase 0/I efter 4 ugers behandling
Relief of symptoms in GORD Stage 0/I after 4 weeks of treatment
Den sædvanlige startdosis for omeprazol ved reflukssygdom er 20 mg. 10 mg omeprazol svarer ikke behandlingsmæssigt til 20 mg pantoprazol.
The usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
Derudover er den sædvanlige startdosis for omeprazol ved reflukssygdom 20 mg. 10 mg omeprazol svarer behandlingsmæssigt ikke til 20 mg pantoprazol.
Additionally, the usual starting dose for omeprazole in reflux disease is 20 mg; 10 mg omeprazole is not therapeutically equivalent to 20 mg pantoprazole.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
- Marketing authorisation number:
603 Pantoprazol var væsentlig mere virkningsfuldt end placebo
Pantoprazole was significantly more effective than placebo
KLINISKE OPLYSNINGER
Clinical safety
243 Pantoprazol var væsentlig mere virkningsfuldt end nizatidin
Pantoprazole was significantly more effective than nizatidine
I denne undersøgelse sammenlignedes virkningen og tolerabiliteten af pantoprazol 20 mg, 40 mg eller 80 mg til behandling af øsofagitis og sikring af, at der ikke opstår GORD-symptomer.
This study compared the efficacy and tolerability of pantoprazole 20 mg, 40 mg, or 80 mg in healing of oesophagitis and freedom from GORD symptoms.
I denne undersøgelse blev virkningen af pantoprazol 20 mg sammenlignet med omeprazol 10 mg på dag 28 hos patienter med refluks-øsofagitis.
In this study the efficacy of 20 mg pantoprazole was compared to 10 mg omeprazole at day 28 in patients with reflux oesophagitis.
Endoskopisk helbredelse af GORD Fase II/III efter 4 og 8 ugers behandling
Endoscopic healing of GORD Stage II/III after 4 and 8 weeks of treatment
Lindring af GORDrelaterede symptomer efter 14 dage og 28 dage
Relief of GORD-related symptoms after 14 and 28 days
Der blev opnået tilsvarende resultater for fuldstændig lindring af syre-regurgitation som for halsbrand.
Results for the relief of acid regurgitation showed similar results.
I denne undersøgelse sammenlignedes virkningen af omeprazol 10 mg med virkningen af pantoprazol 20 mg på dag 28 hos patienter uden øsofagitis fastslået ved endoskopi.
This study compared the efficacy of omeprazole 10 mg versus pantoprazole 20 mg at day 28 in patients without oesophagitis established by endoscopy.
Pharmacovigilancesystemet
2.5 Pharmacovigilance
Endoskopisk helbredelse af GORD Fase I efter 8 uger, forbedring af GORDsymptomer efter 2-4 uger
Endoscopic healing of GORD Stage I after 8 weeks, Improvement of GORD symptoms after 2 and 4 weeks
CONTROLOC Control findes i aluminim/aluminium-blister med eller uden kartonforstærkning.
Tablets are packed in Alu/Alu blisters without cardboard reinforcement or Alu/Alu blisters with cardboard reinforcement (blister wallet).
Korttidsbehandling af reflukssymptomer (fx halsbrand, syreregurgitation) hos voksne.
“Short-term treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.”
Lindring af de vigtigste symptomer efter 2 ugers behandling
Leading symptom relief after 2 weeks of treatment
344 Pantoprazol var bedre end ranitidin til at lindre GORDsymptomer
344 Pantoprazole was superior to ranitidine in the relief of GORD symptoms
219 Pantoprazol var bedre end placebo
Pantoprazole was superior to placebo
Endoskopisk helbredelse af GORD Fase I
Endoscopic healing of GORD Stage I
327 Pantoprazol og omeprazol var lige virknings-fulde
Pantoprazole and omeprazole were similarly effective
I denne undersøgelse sammenlignedes virkningen af pantoprazol 20 mg en gang dagligt med 150 mg ranitidin to gange dagligt til behandling af øsofagitis og sikring af, at der ikke opstår GORDsymptomer efter behandling.
This study compared the efficacy of 20 mg pantoprazole once daily with 150 mg twice daily ranitidine in healing of oesophagitis and freedom from GORD symptoms after treatment.
Ud fra følgende betragtninger:
The approved indication is:
Den absolutte biotilgængelighed for en tablet er omkring 77%.
The absolute bioavailability of pantoprazole in healthy subjects is 77% and does not change at multiple dosing.
Lindring af halsbrand i GORD Fase 0/I på dag 28
Relief of heartburn in GORD Stage 0/I at day 28
Lindring af halsbrand i GORD Fase 0/I på dag 14
Relief of heartburn in GORD Stage 0/I at day 14
A. ETIKETTERING
• Manufacture
529 De to PPI'er var lige virkningsfulde; pantoprazol var ikke dårligere end esomeprazol
Both PPIs were comparably effective; pantoprazole was noninferior to esomeprazole
Patienterne bør ikke tage pantoprazol som et forebyggende lægemiddel.
There are no direct safety issues that preclude pantoprazole being available as a non-prescription medicine.
Publicerede undersøgelser viste, at pantoprazol ikke er dårligere end andre PPI'er (undersøgelse VMG305 og M3
Published studies showed noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF TILLADELSEN
- Date of authorisation: - Marketing authorisation granted by:
Publicerede undersøgelser tyder på, at pantoprazol ikke er dårligere end andre PPI'er (undersøgelse VMG305 og M3
Published studies suggest noninferiority of pantoprazole compared to other PPIs (Study VMG305 and M3
Enterotablet
Enrolment
4.8 Bivirkninger
2.4 Clinical aspects
CONTROLOC Control indeholder: - Aktivt stof: Pantoprazol.
CONTROLOC Control is presented in form of gastro-resistant tablets containing pantoprazole as an active substance.
Hovedpine; svimmelhed; diaré; kvalme, opkastning; oppustethed og luftafgang fra tarmen; forstoppelse; mundtørhed; smerter og ubehag i maven; hududslæt og eksem; kløe; svaghedsfornemmelse, udmattet eller generelt utilpas; søvnforstyrrelser; forøgede leverenzymtal ved blodprøve.
Diarrhoea Headache Nausea / Vomiting Abdominal distension and bloating Abdominal pain and discomfort Constipation Dizziness Liver enzymes increased (transaminases, γ-GT) Rash / Exanthema / Eruption Pruritus Sleep disorders Dry mouth Asthenia, fatigue and malaise Hyperlipidaemias and lipid increases Disturbances in vision / Blurred vision Hypersensitivity (incl.
GORDdiagnosen i disse studier er baseret på endoskopisk vurdering, med undtagelse af et enkelt studie, hvor inkluderingen af patienter alene var baseret på symptomatologi.
The CHMP noted that in the majority of the studies patients were included based on endoscopic examination rather than symptoms alone.
Hovedmetabolitten i både serum og urin er desmethylpantoprazol, der er bundet til sulfat.
The main serum metabolite is formed by demethylation at the 4-position of the pyridine ring, followed by conjugation with sulphate.
De mest almindeligt rapporterede bivirkninger er diaré og hovedpine, som begge forekommer hos ca. 1 % af patienterne.
The most frequent adverse events (≥5%) included diarrhoea, headache, and nausea.
Dyreforsøg har påvist reproduktionstoksicitet.
It has been proven that the drug substance can be reproducibly manufactured.
Vigtig information om nogle af de øvrige indholdsstoffer i CONTROLOC Control
ASSESSMENT REPORT FOR CONTROLOC Control
Lindring af GORDsymptomer efter 2 ugers behandling
Relief of GORD symptoms after 2 weeks of treatment
KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver enterotablet indeholder 20 mg pantoprazol (som natriumsesquihydrat).
Each gastro-resistant tablet contains 20 mg pantoprazole (equivalent of 22.6 mg of pantoprazole sodium sesquihydrate).
4/8 uger 270 Pantoprazol var bedre end ranitidin
270 Pantoprazole was superior to ranitidine
GENEREL KLASSIFIKATION FOR UDLEVERING Ikke receptpligtigt lægemiddel.
The application concerns the supply as non-prescription medicine.
Dosisjustering er ikke nødvendig hos ældre patienter, eller hos patienter med nedsat nyre- eller leverfunktion.
Clinical trials have been performed in special patient populations, such as children, the elderly and renal- or liver-impaired patients.
Lindring af halsbrand i GORD Fase 0
Relief of heartburn in GORD Stage 0
Overtræk: hypromellose, povidon K25, titandioxid (E 171), gul jernoxid (E 172), propylenglycol, methacrylsyre-ethylacrylat copolymer (1:1), natriumlaurilsulfat, polysorbat 80, triethylcitrat.
The excipients used in the formulation of the finished product are well known excipients used for preparation of tablets such as sodium carbonate, mannitol, crospovidone, povidone K90, calcium stearate (present in tablet core), hypromellose, povidone K25, titanium dioxide, yellow iron oxide, methacrylic acid-ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, triethyl citrate (present in film-coating, including enteric coating and undercoating), shellac, red iron oxide, black iron oxide, yellow iron oxide, soya lecithin, titanium dioxide and antifoam DC 1510 (present in printing ink).
Lindring af GORDsymptomer tid, der går, inden halsbrand lindres
Relief of GORD symptoms, Time to heartburn relief
Pantoprazol var bedre til behandling af de vigtigste GORDsymptomer end ranitidin.
Pantoprazole was superior to ranitidine in the treatment of key GORD symptoms.
201 Pantoprazol var væsentlig mere virkningsfuldt end ranitidin
Pantoprazole was significantly more effective than ranitidine
Oversigt over indlægssedlen:
Pantoprazole: Omeprazole:
4.5 Interaktion med andre lægemidler og andre former for interaktion
Number of patients with this adverse drug reaction
Pantoprazol er en substitueret benzimidazol, som hæmmer sekretionen af saltsyre i maven ved en specifik virkning på parietalcellernes protonpumper.
It acts by inhibiting the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Pantoprazol har konstant vist sig at være bedre end placebo og H2-receptor-antagonister og ikke mindre effektive end andre PPI'er.
These studies showed that pantoprazole 20mg was superior to placebo and histamine2-receptor antagonist in the complete relief from heartburn and was non-inferior to other proton pump inhibitors.
CONTROLOC Control kan reducere absorptionen af aktive stoffer, hvis biotilgængelighed er pHafhængig (fx. ketoconazol).
There are potential interactions with anticoagulants and with drugs, which bioavailability is pH dependent such as atanazavir.
Symptomlindrin g efter 2 og 4 ugers behandling
Symptom relief at 2 and 4 weeks of treatment
Det forventes, at der i gennemsnit er 5 % af patienterne, som oplever bivirkninger.
There were only 2% of patients who took the study medication longer than 4 weeks.
Diaré kvalme/opkastning, udspilet abdomen og oppustethed, forstoppelse, tørhed i munden, abdominale smerter og ubehag
These included diarrhoea, abdominal pain, headache, nausea, chest pain and rash.
For at opnå den bedste behandling skal du være omhyggelig med at følge anvisningerne for CONTROLOC Control.
In-process controls performed during the synthesis are suitable to control the reaction progress.
FARMAKOLOGISKE EGENSKABER
Pharmacokinetics
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.
In these studies between 57 and 78% of patients reported relief from heartburn at day 7 and 73-83% at day 14.
Endoskopisk helbredelse af GORD Fase I efter 8 ugers behandling
Endoscopic healing of GORD Stage I after 8 weeks of treatment
Methacrylsyre-ethylacrylat copolymer (1:1) Natriumlaurilsulfat
The gastro-resistant coating consists of methacrylic acid - ethyl acrylate copolymer 1:1; triethyl citrate is added as a plasticizer.
• BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG
• Risk and consequences of incorrect use
- Meget sjældne bivirkninger:
Serious adverse drug reactions have therefore been rare.
Lindring af de vigtigste GORD-symptomer efter 28 dage
Relief of key symptoms in GORD after 28 days
INFORMATION I BRAILLE-SKRIFT
Baseline data
Derfor bør pantoprazol ikke gives sammen med atazanavir (se pkt.
The co-administration with atazanavir is contra-indicated in the SPC and the Package Leaflet.
Lindring af halsbrand i GORD Fase I efter 1 og 2
Relief of heartburn in GORD Stage I after 1 and 2 weeks of treatment
Det kan foreksempel være:
Whereas:
Overtræk
Comparator
4/8 uger 346 Pantoprazol og omeprazol var lige effektive
346 Pantoprazole and omeprazole
Endoskopisk helbredelse af GORD Fase I efter 4 uger
Endoscopic healing of GORD Stage I after 4 weeks
Endoskopisk helbredelse af GORD Fase I efter 4 ugers behandling
Endoscopic healing of GORD Stage I after 4 weeks of treatment
Pantoprazol omdannes til dets aktive form, en cyklisk sulfonamid, i det sure miljø i parietalcellerne, hvor det hæmmer H+/K+-ATPase enzymet, dvs. det sidste stadie i produktionen af saltsyre i maven.
It inhibits basal and stimulated acid secretion in animals and man via the covalent binding H+/K+ ATP-ase, also known as the “gastric proton pump” located in the secretory membrane of the parietal cell.
6.4 Særlige opbevaringsforhold
2.7 Data exclusivity
Patienter med langvarige tilbagevendende symptomer på fordøjelsesbesvær eller halsbrand bør se deres læge med regelmæssige intervaller.
Typically a patient with GORD symptoms sees a pharmacist in the first instance.
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN
• User consultation
338 Pantoprazol var bedre end ranitidin
Pantoprazole was superior to ranitidine
CONTROLOC Control 20 mg enterotabletter Pantoprazol
Pantozol 20 mg gastro-resistant tablets
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
The results also show an early onset of the clinical effect, with rates of complete relief of heartburn between 54.0% and 80.6% achieved after 7 days of treatment with pantoprazole 20 mg. A further improvement in the symptom relief rates was observed after 14 days and 28 days of treatment, respectively.
Povidon K90
WA300
Lever og galdeveje
Relief of GORD
SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale pakning for at beskytte mod fugt.
The tablets stored in primary packaging materials as described in the dossier were in compliance with the shelf-life specifications at all tested time points.
Amning
Randomisation
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.
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.
B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN
• Post marketing experience
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).
Heartburn was defined as burning feeling rising from the stomach or lower chest up towards the neck.
INSTRUKTIONER VEDRØRENDE ANVENDELSEN
BACKGROUND INFORMATION ON THE PROCEDURE
De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
Clinical trial data did not indicate any specific safety issue in this patient population and the oral prescriptiononly product is approved for adolescent patients.
Dosis bør ikke overskrides.
No dose adjustment is required in the elderly.
4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
2.8 Overall conclusions, risk/benefit assessment and recommendation
Farmakoterapeutisk klassifikation: Protonpumpehæmmere, ATC-kode: A02BC02
Table 5 Relief rate of acid eructation in study BGI022
Kerne
n
Samtidig fødeindtagelse har ingen indflydelse på biotilgængeligheden (AUC eller Cmax), men øger variationen i lag-time (tlag).
Concomitant intake of food has no influence on the bioavailability of pantoprazole.
Særlige patientgrupper
• Clinical studies in special populations
Lindring af de vigtigste GORD-symptomer efter 14 dage
Relief of key symptoms in GORD after 14 days
En usædvanlig stor forøgelse forekommer imidlertid kun i enkeltstående tilfælde.
A continuously high level of quality can therefore be guaranteed.
Tag den næste dosis næste dag til sædvanlig tid.
The effect increases with dose and over time and reaches steady state after a few days.
Virkning og anvendelse
Outcomes and estimation
DATO FOR ÆNDRING AF TEKSTEN
1.1 Submission of the dossier
• ANDRE BETINGELSER
• Adverse events
Batch
CH2
INFORMATION I BRAILLE-SKRIFT CONTROLOC Control 20 mg
CONTROLOC Control is available in film coated tablets containing 20 mg pantoprazole.
Bivirkninger, der er observeret ved brug af pantoprazol i kliniske studier og efter markedsføringen.
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.
Absorption
Allocation
Nedsat leverfunktion
Active Substance
Indgivelsesmåde
Introduction
Lindring af GORDsymptomer efter 7 og 28 dages behandling
symptoms after 7 and 28 days of
Patienterne bør konsultere deres læge inden de tager dette lægemiddel, hvis de skal have foretaget en endoskopi eller urea udåndingstest.
In this trial, patients were entered based on the presence of reflux symptoms without endoscopic examination.
Synsforstyrrelser/ sløret syn
Subjects by arm entered/ completed
Resultater Bemærkninger
Outcomes/endpoints
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.
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.
Hypromellose
Pharmacodynamics
Selv om hovedmetabolitten har en længere halveringstid (2-3 timer), er udskillelsen stadig hurtig, og akkumulation finder således ikke sted.
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.
Der er ingen kendte symptomer på overdosering hos mennesker.
No further information on the contraindicated symptoms or the consequences of the treatment is available.
CONTROLOC Control bruges til korttidsbehandling af reflukssymptomer (f.eks. halsbrand og sure opstød) hos voksne.
The claimed indication at time of application read as follows: “Treatment of reflux symptoms (e.g. heartburn, acid regurgitation)”
Chokolade, pebermynte, spearmint, fed og friturestegt mad, syreholdig mad, krydret mad,
Placebocontrolled, multicenter, randomized, double blind, parallel group comparison
Virkningsmekanisme
Risk Management Plan
Indehaver af markedsføringstilladelsen Nycomed GmbH
The initial application was submitted by Nycomed GmbH (EMEA/H/C/1013).
6.3 Opbevaringstid
2.6 Legal Status
Specielt patienter over 55 år, som dagligt tager ikkereceptpligtige lægemidler mod fordøjelsesbesvær og halsbrand, bør informere deres apotek eller læge.
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.
Trombocytopeni, leukopeni,
Thrombocytopenia very rare
Rød jernoxid (E 172) Sort jernoxid (E 172) Gul jernoxid (E 172) Sojalecithin Titandioxid (E 171) Antifoam DC 1510
74.3% to 92.3% H2RA (Ranitidine 300mg, Ranitidine 2x150 mg, Nizatidine 2x150 mg)
ANDET
ITT
- 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
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.
Du kan få CONTROLOC Control uden recept.
from prescription to non-prescription.
Virkningen er den samme, uanset om det aktive stof gives oralt eller intravenøst.
The synthesis of the drug substance is performed without optically active reagents and results in a racemate.
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.
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).
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.
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.
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).
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.
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.
It involves conventional chemical operations (alkylation, oxidation, formation of salt), which were transferred from laboratory to production batches during the development.