natgillin/translations-raw huggingface dataset:
lansoprazol + amoxicillin lansoprazol + metronidazol
lansoprazole + amoxicillin lansoprazole + metronidazole
30 mg + 1000 mg 3 gange/ dag i 5 dage Endnu ikke undersøgt
30 mg + 1000 mg 3 times/ day for 5 days Not yet investigated
Nedsætter optagelsen af amoxicillin
Decelerates uptake of amoxicillin
10 lansoprazol + clarithromycin + amoxicillin
10 amoxicillin
30 mg + 500 mg + 1000 mg to gange daglig i 5 dage
levels of a clarithromycin metabolite by 30%
* Virkningerne af clarithromycin på lansoprazols farmakokinetik er sandsynligvis afhængig af patientens CYP2C19 genotype.
*The effects of clarithromycin on the pharmacokinetics of lansoprazole are likely to be dependent on the patient’ s CYP2C19 genotype.
Det anbefales at tage lansoprazol inden måltidet.
The intake of food reduces the bioavailability of lansoprazole: it is recommended to take lansoprazole before the meal.
Dyreundersøgelser indikerer ingen direkte skadelig virkninger med hensyn til graviditet, embryonal/ føtal udvikling, barsel eller postnatal udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development.
En beslutning om at fortsætte/ afbryde amning eller fortsætte/ afbryde behandling med lansoprazol bør foretages, idet fordelen ved amning for barnet og fordelen ved lansoprazolbehandling for kvinden bør tages i betragtning.
A decision on whether to continue/ discontinue breast-feeding or to continue/ discontinue therapy with lansoprazole should be made taking into account the benefit of breast- feeding to the child and the benefit of lansoprazole therapy to the woman.
4. 8 ” Bivirkninger ”).
Adverse drug reactions such as dizziness and fatigue may occur (see section 4.8 undesirable effects).
4. 8 ” Bivirkninger ”).
(see section 4.8 Undesirable effects).
4. 8 Bivirkninger
Undesirable Effects
Almindelige (> 1%)
Common (> 1%)
Ualmindelige (0, 1- 1%)
Uncommon (0.1-1%)
Sjældne (0, 01- 0, 1%)
Rare (0.01-0.1%)
Meget sjældne (< 0, 01%)
Very Rare (< 0.01%)
Gastrointestinalt
Gastrointestinal
kvalme, diaré, mavesmerter, forstoppelse, opkastning, flatulens og dyspepsi.
nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence and dyspepsia.
Tør mund eller hals, glossitis, candidiasis i øsofagus, pancreatitis
dry mouth or throat, glossitis, candidiasis of oesophagus, pancreatitis
colitis, stomatitis og sort tunge.
colitis, stomatitis and black tongue.
Hud og hår
Skin and hair
eksem, urticaria og kløen.
eczema, urticaria and itching.
petechia, purpura, hårtab, erythema multiforme, Stevens - Johnson syndrom og toksisk epidermal nekrolyse.
petechia, purpura, hair loss, erythema multiforme, stevens- Johnson syndrome and toxic epidermal necrolysis.
rastløshed, insomnia, døsighed, depression, hallucination, konfusion, vertigo og paræstesier, somnolens, tremor.
restlessness, insomnia, drowsiness, depression, hallucination, confusion, vertigo and paresthesia, somnolence, tremor.
11 Lever og nyrer
11 Blood
thrombocytopeni, eosinofili, pancytopeni og agranulocytose, anæmi, leucopeni.
thrombocytopenia, eosinophilia, pancytopenia and agranulocytosis, anemia, leucopenia.
perifert ødem, palpitationer og brystsmerter.
peripheral edema, palpitation and chest pain.
Muskuloskeletale og bindevævs - forstyrrelser
Musculoskeletal and connective tissue disorders
muskel - og ledsmerter
muscle and joint pain
Sanser
Senses
smagsforstyrrelser og synsforstyrrelser.
zaste disturbances and visual disturbances.
gynekomasti, galactorrhoea.
gynecomastia, galactorrhoea.
Alment Underøgelser
General
træthed.
fatigue.
feber, hyperhidrose, bronchiekonstriktion, impotens og angiødem.
fever, hyperhidrosis, bronchial constriction, impotence and angioedema.
anafylaktisk shock, almen utilpashed øgning i niveauerne for kolesterol og triglycerid.
Increase in cholesterol and triglyceride levels.
Virkningerne ved overdosering med lansoprazol hos mennesker er ikke kendte (selvom den akutte toksicitet sandsynligvis er lav), og vejledninger for behandling kan derfor ikke gives.
The effects of overdose of lansoprazole in humans are not known (although the acute toxicity is likely to be low) and, consequently, instructions for treatment cannot be given.
Daglig doser på op til 180 mg lansoprazol er imidlertid blevet givet under afprøvninger uden signifikante bivirkninger.
However, daily doses of up to 180 mg of lansoprazole have been administered in trials without significant undesirable effects.
4. 8 ” Bivirkninger ” for mulige symptomer på overdosering med lansoprazol.
Undesirable effects for possible symptoms of lansoprazole overdose.
Farmakoterapeutisk klassifikation: protonpumpe- hæmmere, ACT- kode:
Proton pump inhibitors, ATC code:
Lansoprazol er en gastrisk protonpumpe- hæmmer.
Lansoprazole is a gastric proton pump inhibitor.
Den hæmmer det sidste trin i dannelsen af mavesyre ved at hæmme aktiviteten af H+/ K+ ATPase i mavens parietalceller.
It inhibits the final stage of gastric acid formation by inhibiting the activity of H+/ K+ ATPase of the parietal cells in the stomach.
Hæmningen er dosisafhængig og reversibel, og virkningen gælder for både basal og stimuleret sekretion af mavesyre.
The inhibition is dose- dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.
Lansoprazol er koncentreret i parietalcellerne og aktiveres i det sure miljø, hvorefter det reagerer med sulfydrylgruppen hos H+/ K+ATPase, hvilket medfører hæmning af enzymaktiviteten.
Lansoprazole is concentrated in the parietal cells and becomes active in their acidic environment, whereupon it reacts with the sulphydryl group of H+/ K+ATPase causing inhibition of the enzyme activity.
Lansoprazol er en specifik hæmmer af parietalcellens protonpumpe.
Lansoprazole is a specific inhibitor of the parietal cell proton pump.
En enkelt oral dosis lansoprazol 30 mg hæmmer pentagastrin- stimuleret mavesyresekretion med omkring 80%.
A single oral dose of lansoprazole 30 mg inhibits pentagastrin-stimulated gastric acid secretion by about 80%.
En hurtig
A rapid relief of symptoms
12 lettelse af symptomer nås med 30 mg daglig, og de fleste patienter med duodenalulcus bliver raske inden for 2 uger, patienter med mavesår og reflux øsofagitis inden for 4 uger.
12 is obtained by 30 mg daily, and most patients with duodenal ulcer recover within 2 weeks, patients with gastric ulcer and reflux oesophagitis within 4 weeks.
Lansoprazol bliver hurtigt inaktiveret af mavesyren, og lansoprazol bliver derfor givet som entero- coated granulat i gelatinekapsler.
Lansoprazole is rapidly inactivated by gastric acid and lansoprazole is consequently administered as enteric coated granules in gelatin capsules.
Absorption fra duodenum er hurtig, og plasma peak koncentration opnås inden for 1, 5- 2, 0 timer.
Absorption from the duodenum is rapid and plasma peak concentration is achieved within 1.5-2.0 hours.
Biotilgængelighed efter en enkeltdosis på 30 mg og efter gentagen daglig administration er 80- 90%.
Bioavailability after a single dose of 30 mg and after repeated daily administration is 80-90%.
Metabolismen af lansoprazol er hovedsagelig katalyseret af enzymet CYP2C19.
The metabolism of lansoprazole is mainly catalysed by the enzyme CYP2C19.
Enzymet CYP3A4 medvirker også til metabolismen.
The enzyme CYUP3A4 also contributes to the metabolism.
CYP2C19 er underkastet genetisk polymorfi og 2- 6% af befolkningen, kaldet dårlige metabolikere (PM’ er), er homozygote for en mutant CYP2C19 allele og mangler derfor et funktionelt CYP2C19 enzym.
CYP2C19 is subject to genetic polymorphism and 2-6% of the population, called poor metabolisers (PMs), are homozygote for a mutant CYP2C19 allele and therefore lacks a functional CYP2C19 enzyme.
Eksponeringen af lansoprazol er adskillige gange højere hos PM’ er end hos ekstensive metabolikere (EM’ er).
The exposure of lansoprazole is several-fold higher in PMs than in extensive metabolisers (EMs).
Eliminationshalveringstiden for lansoprazol er 1, 0- 2, 0 timer.
The elimination half-life of lansoprazole is 1.0-2.0 hours.
Sulfonen, 5- hydroxy lansoprazol og sulfiden.
Three metabolites have been identified in the plasma: the sulphone, 5-hydroxy lansoprazole and the sulphide.
Omkring 15- 50% af metabolitterne udskilles i urinen og resten i fæces.
About 15-50% of the metabolites are secreted in the urine and the remainder in the faeces.
Tre metabolitter er blevet identificeret i urinen:
Three metabolites have been identified in the urine:
5- hydroxysulfon, 5- hydroxysulfid og 5 - hydroxylansoprazol.
5-hydroxy sulphone, 5- hydroxy sulphide and 5-hydroxy lansoprazole.
I to undersøgelser over carcinogenicitet hos rotter frembragte lansoprazol dosis- relateret gastrisk ECL cellehyperplasi og ECL cellecarcinoider forbundet med hypergastrinæmi grundet hæmning af syresekretionen og retinal atrofi.
In two rat carcinogenicity studies, lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids associated with hypergastrinaemia due to inhibition of acid secretion and retinal atrophy.
Hos mus udvikledes dosis- relateret ECL cellehyperplasi såvel som levertumorer og adenom af rete testis.
In mice dose-related gastric ECL cell hyperplasia developed as well as liver tumours and adenoma of rete testis.
Fortegnelse over hjælpestoffer
List of Excipients
Sukkerkugler (sukrose og majstivelse) Natriumlaurylsulfat Meglumin Mannitol Hypromellose Macrogol 6000 Talkum Polysorbat 80 Titaniumdioxid (E 171) Metakrylsyre – ethakrylat copolymer, 1: 1, dispersion 30%
Sugar spheres (sucrose and maize starch) Sodium laurilsulphate Meglumine Mannitol Hypromellose Macrogol 6000 Talc Polysorbate 80 Titanium dioxide (E 171) methacrylic acid ethyl acrylate copolymer, 1:1, dispersion 30%
Kapselskal Gelatine Titaniumdioxid (E 171)
Gelatin Titanium dioxide (E 171)
Derudover for Lansoprazol 15 mg:
In addition for Lansoprazole 15 mg:
Quinolin gul (E 104)
Quinoline yellow (E 104)
Særlige opbevaringsforhold
Special Precautions for Storage
Opbevares ved under 25 ºC Opbevares i den oprindelige emballage beskyttet mod fugt.
Store in the original package in order to protect from moisture.
Aluminium/ aluminium blisterpakning (Alu/ OPA/ PVC/ PE)
Aluminium/ Aluminium blister (Alu/ OPA/ PVC/ PE)
Lansoprazol 15 mg:
Lansoprazole 15 mg:
7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 og 250 kapsler
7, 10, 14, 15, 20, 28, 30, 35, 50, 56, 60, 84, 98, 100 and 250 capsules
Lansoprazol 30 mg:
Lansoprazole 30 mg:
DATO FOR FØRSTE TILLADELSE/ FORNYELSE AF TILLADELSEN
DATE OF FIRST AUTHORISATION / RENEWAL OF AUTHORISATION
21. februar 2006 EMEA/ CHMP/ 373083/ 2005
21 February 2006 EMEA/ CHMP/ 373083/ 2005
21, OM Lansoprazol AbZ- Pharma 15 mg og 30 mg Internationalt fællesnavn (INN):
OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol AbZ-Pharma 15 mg and 30 mg International Non-Proprietary Name (INN):
Lansoprazol AbZ- Pharma (lansoprazol) er en protonpumpehæmmer, som hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gastrisk ulcus, reflux øsofagitis, gastro- øsofageal reflukssygdom, behandling og profylakse af NSAID- relaterede gastriske og duodenale ulcera, Zollinger- Ellisons syndrom og i kombination med passende antibakterielle behandlingsregimener til udryddelse af Helicobacter pylori og forebyggelse af recidiv af peptiske ulcera hos patienter med H. pylori- relaterede ulcera.
Lansoprazol AbZ-Pharma (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Det skete den 7. november 2003.
A Marketing Authorisation for Lansoprazol AbZ-Pharma (15 mg and 30 mg) was previously granted to ratiopharm GmbH in Finland on 7 November 2003.
På sit møde i september 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/ risk- forholdet er gunstigt for Lansoprazol AbZ - Pharma.
During its September 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/ risk ratio is favourable for Lansoprazol AbZ-Pharma.
CHMP godkendte ændringerne af afsnit 4. 2 (dosering og indgivelsesmåde) og præciserede den anbefalede dosering for antibiotika i overensstemmelse med ” punkter, der bør overvejes vedrørende ordlyden af Helicobacter pylori- eradikationsbehandlingen i de forskellige afsnit af produktresuméet ” og vedtog en positiv udtalelse den 15. september 2005.
Changes to the SPC section 4.2 (Posology and Methods of Administration) giving a detailed dosing recommendation for antibiotics, in accordance with “ Points to consider on wording of Helicobacter pylori eradication therapy in selected SPC sections”, were agreed by CHMP and a positive opinion was adopted on 15 September 2005.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 86 13 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa- Kommissionen den 21. februar 2006.
(44-20) 74 18 84 00 Fax (44-20) 74 18 86 13 E-mail: mail@emea. eu. int http: / /www. emea. eu. int ©EMEA 2006 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged
gastro- resistent kapsel, hård
Gastro-resistant capsule, hard
30 mg 30 mg
30 mg
FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEER, ETIKETTERING OG INDLÆGSSEDLER FREMLAGT AF EMEA
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA SCIENTIFIC CONCLUSIONS
SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LANSOPRAZOL ABZ- PHARMA 15 MG, 30 MG, GASTRO- RESISTENTE KAPSLER, HÅRDE (se bilag I) Lansoprazol AbZ- Pharma 15 mg, 30 mg, gastro- resistente kapsler, hårde, blev indbragt til voldgiftsafgørelse i henhold til artikel 29 i Rådets direktiv 2001/ 83/ EF, med senere ændringer, efter at Tyskland havde givet udtryk for betænkeligheder under en procedure om gensidig anerkendelse med Finland som referencemedlemsstat.
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF LANSOPRAZOL ABZ- PHARMA 15 MG, 30 MG, GASTRO-RESISTANT CAPSULES, HARD (see Annex I) Lansoprazol AbZ-Pharma 15 mg, 30 mg, gastro-resistant capsules, hard were referred for arbitration according to Article 29 of Council Directive 2001/ 83/ EC, as amended, following concerns raised by Germany during a Mutual Recognition Procedure with Finland acting as Reference Member state.
Udryddelse af H. pyolori og heling af peptisk ulcus Med det formål at harmonisere behandlingerne til udryddelse af Helicobacter pylori blev der offentliggjort retningslinjer for behandling af Helicobacter pylori - infektion af European Helicobacter pylori Study Group.
Eradication of H. pylori and peptic ulcer healing In order to standardise the treatment regimens for H. pylori eradication guidelines on the management of Helicobacter pylori infection were published by the European Helicobacter pylori Study Group.
I anbefalingen ” The Maastricht Consensus ” hedder det, at behandlingerne til udryddelse af H. pylori skal være enkle, godt tolererede og opnå en eradikationsrate på over 80% beregnet efter ” intention- to- treat- princippet ”.
The Maastricht Consensus stated that treatment regimens for eradication of H. pylori should be simple, well tolerated and achieve an eradication rate of over 80% on an intention to treat basis.
De behandlinger, der opfyldte ovenstående kriterier, var følgende:
The treatment regimens that have been shown to satisfy the criteria required above were following:
En standarddosis af protonpumpe- hæmmer to gange dagligt og: • metronidazol, 400 mg (tinidazol, 500 mg) to gange dagligt, + clarithromycin, 250 mg to gange dagligt; • amoxicillin, 1000 mg to gange dagligt, + clarithomycin, 500 mg to gange dagligt (tilrådeligt, når der er sandsynlighed for resistens over for metronidazol); • amoxicillin, 500 mg tre gange dagligt, + metronidazol, 400 mg tre gange dagligt (tilrådeligt, når der er sandsynlighed for resistens over for clarithomycin) Nye oplysninger har siden nødvendiggjort en ajourføring af de oprindelige retningslinjer for at opnå praktiske behandlingsretningslinjer, som kan accepteres i klinisk praksis, både inden for primær pleje og på specialistniveau.
Standard dose proton pump inhibitor, twice daily, and: • metronidazole, 400 mg (tinidazole, 500 mg) twice daily, + clarithromycin, 250 mg twice daily; • amoxicillin, 1000 mg twice daily, + clarithomycin, 500 mg twice daily (advisable when metronidazole resistance is likely); • amoxicillin, 500 mg three times daily, + metronidazole, 400 mg three times daily (advisable when clarithomycin resistance is likely) Since then new data became available that necessitated an update of the original guidelines in order to provide practical management guidelines that would be acceptable across clinical practice, both in primary care and the specialist level.
De ajourførte retningslinjer blev fastlagt på konsensusmødet Maastricht 2 - 2000.
The updated guidelines were established during the Maastricht 2- 2000 Consensus meeting.
Det blev påpeget, at behandlingen var en pakke, som tager hensyn til førstevalgs - og andetvalgseradikationsbehandlinger under et.
It was pointed out that treatment should be thought of as a package, which considers first- and second-line eradication therapies together.
Førstevalgsbehandlingen bør være en tredobbelt behandling med en protonpumpe- hæmmer eller ranitidinvismutsitrat kombineret med clarithromycin (500 mg to gange dagligt) og amoxicillin (1 g to gange dagligt) eller (500 to gange dagligt).
First line therapy should be with triple therapy using a proton pump inhibitor or ranitidine bismuth citrate, combined with clarithromycin (500 mg twice daily) and amoxicillin (1 g twice daily) or metronidazole (500 twice daily).
Andetvalgsbehandlingen med firedobbelt behandling med en protonpumpe- hæmmer kombineret med vismutsubcitrat (subsalicylat) og metronidazol, og tertacyclin i mindst 7 dage er blevet anbefalet.
Second-line therapy with quadruple therapy using proton pump inhibitor combined with bismuth subcitrate (subsalicylate) and metronidazole, and tertacycline for a minimum of 7 days has been recommended.
Hvis vismut ikke er tilgængeligt, skal der anvendes PPI- baserede tredobbelte behandlinger.
If bismuth is not available, PPI-based triple therapies should be used.
Flere på hinanden svigtende resultater håndteres fra tilfælde til tilfælde.
Subsequent failures should be handled on case- by-case basis.
En lavere dosis af clarithromycin i kombinationen clarithromycin- metronidazol understøttes af kliniske oplysninger samt af rapporten Maastricht Consensus, hvori det hedder, at en dosis på 250 mg er tilstrækkelig, selvom den anbefalede dosis er 500 mg.
Reduction of the clarithromycin dose in the clarithromycin-metronidazole combination is supported by clinical data as well as the Maastricht Consensus Report, stating that 250 mg dose is sufficient even if the recommended dose is 500 mg.
En lavere dosis af clarithromycin på 250 mg i den tredobbelte kombinationsbehandling med amoxicillin 1000 mg understøttes dog ikke i rapporten Maastricht 2- 2000 Consensus.
The reduction of clarithromycin to 250 mg in the triple combination therapy with amoxicillin 1000 mg, however, is not supported by the Maastricht 2-2000 Consensus Report.
I en afhandling, som netop er blevet offentliggjort af Bago mfl. i ” Wiener Klinische Wochenschrift 2004 ”, anføres det, at 250 mg to gange dagligt kan være lige så virksomt som 500 mg to gange dagligt til udryddelse af H. pylori hos patienter med dyspepsi, selv om eradikationsraterne var noget lavere.
The paper newly published by Bago et al in Wiener Klinische Wochenschrift 2004, indicates that 250 mg twice daily may be as effective as 500 mg twice daily in eradicating H. pylori in patients with dyspepsia, even if numerically, eradication rates were somewhat lower.
Mens der afventes en bekræftelse af resultaterne af rapporten Maastricht 3- 2005 Consensus, anbefales der dog en dosis på 500 mg to gange dagligt.
However, awaiting confirmation as well as the results of the Maastricht 3-2005 Consensus Report, it is recommended that the dose should be 500 mg clarithromycin twice daily.
De foreliggende data understøtter anvendelse af lansoprazol- amoxicillin- clarithromycin som førstevalgsbehandling.
Benefit/ Risk considerations Available data support the use of lansoprazole-amoxicillin-clarithromycin as a first-line treatment.
I tilfælde af resistens over for clarithromycin eller fejlslagen behandling kan der anvendes en kombination af lansoprazol- amoxicillin- metronidazol, og i tilfælde af allergi over for beta- lactam er det tilrådeligt at anvende en kombination af lansoprazol- clarithromycin- metronidazol.
4 metronidazole may be used, and in case of beta-lactam allergy the combination of lansoprazole- clarithromycin-metronidazole is advisable.
Lansoprazol AbZ- Pharma 15 mg, 30 mg udviser et gunstigt benefit/ risk- forhold, forudsat at der indføjes passende oplysninger vedrørende eradikationsbehandlingen for H. pylori i produktresuméet.
The risk/ benefit ratio of Lansoprazol AbZ-Pharma 15 mg, 30 mg is considered to be favourable provided that appropriate information regarding H. pylori eradication therapy are included in the SPC.
Produktresumé med ændringer fremgår af bilag III.
Whereas, The scope of the referral was to agree on a harmonised dosing schedule for triple therapy for eradication therapy for H. pylori The Summary of Products Characteristic, labelling and package leaflet proposed by the applicant has been assessed based on the documentation submitted and the scientific discussion within the Committee. the CHMP has recommended the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Lansoprazol AbZ- Pharma and associated names (see Annex I).
< Lansoprazol AbZ og tilknyttede navne (se Bilag I) 15 mg gastro- resistent hård kapsel > < Lansoprazol AbZ og tilknyttede navne (se Bilag I) 30 mg gastro- resistent hård kapsel >
< Lansoprazol AbZ and associated names (see Annex I) 15 mg, gastro-resistant capsules, hard > < Lansoprazol AbZ and associated names (see Annex I) 30 mg, gastro-resistant capsules, hard >
[se Bilag I – udfyldes nationalt]
[see Annex I – to be completed nationally]
Hver kapsel indeolder 15 mg eller 30 mg lansoprazol.
Each capsule contains 15 mg or 30 mg lansoprazole.
Indeholder også sucrose (sukker)
Also contains sucrose (sugar).
Gastro- resistent hard kapsel.
Gastro-resistant hard capsule.
4. 1 Terapeutiske indikationer
4.1 Therapeutical indications
- Behandling af duodenalt og gastrisk ulcus bekræftet ved endoskopi eller røntgen
- Treatment of duodenal and gastric ulcer confirmed by endoscopy or radiography
- Behandling af refluks øsofagitis
- Treatment of reflux oesophagitis
- Længerevarende profylakse for refluks øsofagitis
- Long-term prophylaxis of reflux oesophagitis
- Udryddelse af Helicobacter pylori givet samtidig med passende antibiotikabehandling og
- Eradication of Helicobacter pylori concurrently given with appropriate antibiotic therapy and
forhindring af tilbagefald for peptiske ulcera hos patienter med H. pylori forbundne ulcera
prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers
- Zollinger- Ellison syndrom
- Zollinger-Ellison Syndrome
Refluks øsofagitis:
Reflux oesophagitis:
Længerevarende profylakse for refluks øsofagitis:
Long-term prophylaxis of reflux oesophagitis:
8 Udryddelse af Helicobacter pylori:
8 Helicobacter pylori eradication: