natgillin/translations-raw huggingface dataset:
Lansoprazol 30 mg kombineret med clarithromycin 250 mg eller 500 mg og amoxicillin 1 g eller kombineret med clarithromycin 250 mg og metronidazol 400- 500 mg to gange dagligt blev forbundet med eradikationsrater, der lå over de ovenfor beskrevne krav.
Lansoprazole 30 mg combined with clarithromycin 250 or 500 mg and amoxicillin 1g, or clarithromycin 250 and metronidazole 400-500 mg twice daily was associated with eradication rates meeting the above described requirements.
Anvendelse af et regimen, der omfatter lansoprazol 30 mg to gange dagligt, amoxicillin 1 g to gange dagligt og metronidazol 400- 500 mg to gange dagligt, er også blevet undersøgt.
The use of a regimen including lansoprazole 30mg twice daily, amoxicillin 1g twice daily and metronidazole 400-500mg twice daily has also been examined.
Eradikation og forebyggelse af tilbagefald af gastriske og duodenale ulcera
4.1 Therapeutic indications • Eradication and prevention of relapse of gastric ulcer and duodenal Two studies to support the indication prevention of duodenal ulcers were provided.
Der var ingen baselinestratifikation af H. pylori- status, hvilket afspejlede den kliniske praksis på daværende tidspunkt.
There was no baseline stratification for H. pylori status, reflecting clinical practice at the time.
Andelen af evaluerbare patienter, som forblev raske efter 12 måneder, var 39% ved placebo i forhold til 84% ved vedligeholdelsesbehandling med lansoprazol 15 mg.
84% on lansoprazole15 mg maintenance.
Den anden undersøgelse så nærmere på anvendelsen af lansoprazol som vedligeholdelsesbehandling af helede gastriske ulcera eller duodenale ulcera (forebyggelse af tilbagefald), der var resistente mod H2 - blokkere.
The second study examined the use of lansoprazole in the maintenance of healed ulcer (prevention of relapse) of duodenal or gastric ulcer disease resistant H2 blockers.
Formålet med denne undersøgelse var at sammenligne virkningen af og sikkerheden ved lansoprazol 15/ 30 mg med placebo i forbindelse med forebyggelse af duodenale ulcera hos patienter, der tidligere havde haft duodenale ulcera, eller i forbindelse med forebyggelse af gastriske ulcera hos patienter, der tidligere havde haft gastriske ulcera.
The objective of this trial was to compare the efficacy /safety or lansoprazole 15/30mg to placebo in the prevention of duodenal ulcers in those with a history of duodenal, or gastric ulcer disease in those with a history of gasric ulcers.
10 Indehaveren af markedsføringstilladelsen har fremlagt tre undersøgelser vedrørende bioækvivalens som baggrundsdokumentation for indvirkningen af fødeindtagelse på lansoprazols biotilgængelighed.
4.2 Posology and methods of administration • Food interaction The MAH has provided three bioequivalence studies as background documentation on the effect of food intake on the bioavailability of lansoprazole.
AUC blev reduceret med cirka 50%.
The AUC was reduced by about 50%.
Der er blevet gennemført undersøgelser, som undersøger effekten af at blande lansoprazolgranulaterne med fødevarer.
This is reflected in the SPC. • Mixing the content of the “opened capsules” with food Studies have been performed investigating the effect of mixing the granules of lansoprazole with food.
Selvom alle behandlinger resulterede i ækvivalente AUC- værdier af lansoprazol, skal det bemærkes, at undersøgelserne blev udført med bestemte produktmærker inden for de forskellige blandemidler.
Although all treatments resulted in equivalent AUC of lansoprazole, it has to be noted that the studies were performed with certain brands of the different vehicles.
Den faktor, der ville påvirke biotilgængeligheden mest, ville være, hvis granulaterne blev blandet med et blandemiddel med en pH > 7.
The factor that would influence the bioavailability the most would be if the granules were mixed with a vehicle of pH > 7.
Dette er afspejlet i produktresuméet under punkt 4. 2 og 5. 2.
This is reflected in the SPC under section 4.2 and 5.2.
En angivelse af, hvor stor erfaring der foreligger med administration af lægemidlet til børn, er påkrævet under punkt 4. 2 i produktresuméet.
4.2 Posology (in special populations) • Use in children A statement indicating the experience with the medicinal product in children is required under section 4.2 of the SPC.
Ansøgeren besvarede spørgsmålet vedrørende de pædiatriske data ved at indsende en komplet dokumentationspakke for disse.
10 The evaluation of the pharmacokinetics in children aged 10 weeks and above showed similar exposures in comparison to healthy adult volunteers receiving a 30 mg dose either with a body weight or body surface based dosing for babies.
Evalueringen af farmakokinetikken hos børn i alderen 10 uger og opefter viste eksponeringer af samme størrelsesorden som hos raske voksne frivillige, der fik en dosis på 30 mg med enten en kropsvægt - eller kropsoverfladebaseret dosis for spædbørn.
However, higher values for exposure will be expected in children below 1 year of age with the pharmaceutical forms that are commercially available.
Højere eksponering for lansoprazol blev også set hos nyfødte og spædbørn i alderen op til cirka 10 uger.
10 weeks.
Suboptimale resultater blev opnået for børn i alderen 1- 11 år, og resultaterne vedrørende farmakodynamik samt virkning gør det vanskeligt at anbefale doseringer.
Sub-optimal results were obtained for children 1-11 years of age and pharmacodynamic as well as the efficacy results make dosing recommendations difficult.
Dette er afspejlet i produktresuméet under punkt 4. 2.
This is reflected in the SPC under 4.2.
Det blev påvist, at den samlede lansoprazoleksponering mangedobles hos patienter med svær nedsat leverfunktion.
The pharmacokinetic data of children and adolescents are summarised under section 5.2. • Liver impairment Three studies were submitted addressing the pharmacokinetics in lansoprazole in patients with different levels of (mild, moderate and severe) liver impairment It was demonstrated that the total lansoprazole exposure is many-fold increased in patients with severe hepatic impairment.
Sikkerheden ved PPI’ er anses generelt for at være høj.
The safety of PPIs is generally considered high.
Medmindre ansøgeren kan fremvise overbevisende data om tilfredsstillende sikkerhed i forbindelse med de opnåede eksponeringer, anbefales en reduktion af dosis på 50%.
Unless the applicant can show convincing data on satisfactory safety with the exposures obtained, it is recommended that a dose reduction of 50% is made.
Yderligere reduktioner er ikke praktisk mulige, og data vil måske ikke muliggøre simuleringer af farmakokinetikken/ farmakodynamikken med hensyn til øgningen af dosisintervallet.
Further reductions are not practically possible and data may not allow simulations of PK/PD regarding the increase the dose-interval.
Dette fremgår også af produktresuméet for lansoprazol.
This is reflected in section 4.2, 4.4 and 5.2 of the SPC. • 4.3 Contraindication Due to a marked reduction in atazanavir trough concentrations observed during concomitant use of omeprazole, use of PPIs is contraindicated in the SPC for Rayataz (atazanavir).
En undersøgelse vedrørende interaktion med phenytoin er blevet fremlagt.
This is also reflected in the SPC for lansoprazole. • 4.5 Interaction with other medicinal products and other forms of interaction One study of the interaction with phenytoin has been submitted.
Indvirkningen af lansoprazol 60 mg qd i 9 dage på phenytoins farmakokinetik efter en intravenøs dosis på 250 mg blev undersøgt.
The effect of lansoprazole 60 mg q.d. for 9 days on the pharmacokinetics of phenytoin after a 250 mg i.v. dose was investigated.
Der foreligger ingen data vedrørende brug af lansoprazol under graviditet og amning.
For the complete wording of section 4.5 please see attched SPC. • 4.6 Pregnancy and lactation No data regarding of the use of lanzoprazole during preganancy and lactation has been provided.
Undersøgelser hos dyr viser ikke nogen direkte eller indirekte skadelige virkninger på graviditet, embryonal/ føtal udvikling, fødsel eller postnatal udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Betragtninger vedrørende benefit/ risk- forholdet
Therefore, the use of lansoprazole during pregnancy is not recommended.
12 • behandling af NSAID- relaterede godartede gastriske og duodenale ulcera hos patienter, der kræver fortsat NSAID- behandling • profylakse af NSAID- relaterede gastriske og duodenale ulcera hos risikopatienter (se punkt 4. 2), der kræver fortsat behandling • symptomatisk gastroøsofageal reflukssygdom • Zollinger- Ellisons syndrom.
11 Benefit/Risk consideration Based on the documentation submitted by the MAH and the scientific discussion within the Committee, the CHMP considered that the benefit/risk ratio of Agopton and associated names is favourable for use relating to: • Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome.
Produktresuméet, etiketteringen og indlægssedlen fremgår af bilag III til udtalelsen.
GROUNDS FOR AMENDMENTS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS LABELLING AND PACKAGE LEAFLET Whereas, • the scope of the referral was the harmonisation of the Summary of Products Characteristics, • the Summary of Products Characteristic, Labelling and Package Leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, Labelling and Package Leaflet is set out in Annex III of the CHMP Opinion for Agopton and associated names (see Annex I of the opinion).
Dette produktresumé og denne etikettering og indlægsseddel er de samme som dem, der var vedlagt Kommissionens afgørelse af denne artikel 30- indbringelse vedrørende lægemidler indeholdende lansoprazol.
This SPC, labelling and package leaflet is the version that was annexed to the Commission Decision on this Article 30 referral for lansoprazole containing medicinal products.
14 PRODUKTRESUMÉ
13 SUMMARY OF PRODUCT CHARACTERISTICS
[Se Bilag I – Udfyldes nationalt]
[See Annex I - To be completed nationally]
Hver kapsel indeholder 30 mg lansoprazol.
Each capsule contains 15 mg of lansoprazole Each capsule contains 30 mg of lansoprazole
Hver 30 mg kapsel indeholder 59, 8 mg saccharose.
Each 15 mg capsule contains 29.9 mg of sucrose Each 30 mg capsule contains 59 .8 mg of sucrose
Agopton 15 mg: < farve > enterokapsler.
Agopton 15 mg: < colour > capsules.
Hver kapsel indeholder < hvide til lysebrune enterogranulater >.
Each capsule contains < white to pale brownish white enteric- coated granules >.
Agopton 30 mg: < farve > enterokapsler.
Agopton 30 mg: < colour > capsules.
4. 2) • Symptomatisk gastroøsofageal reflukssygdom • Zollinger- Ellisons syndrom.
• Treatment of duodenal and gastric ulcer • Treatment of reflux oesophagitis • Prophylaxis of reflux oesophagitis • Eradication of Helicobacter pylori (H. pylori) concurrently given with appropriate antibiotic therapy for treatment of H.pylori-associated ulcers • Treatment of NSAID-associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment • Prophylaxis of NSAID-associated gastric ulcers and duodenal ulcers in patients at risk (see section 4.2) requiring continued therapy • Symptomatic gastroesophageal reflux disease • Zollinger-Ellison syndrome.
5. 2).
Agopton should be taken at least 30 minutes before food (see section 5.2).
Til patienter, der har svært ved at synke medicinen, anbefales det på grundlag af forsøg og klinisk praksis, at enterokapslerne åbnes, og granulaterne blandes med lidt vand eller æble - / tomatjuice eller drysses ud over en lille smule flydende mad (f. eks. yoghurt eller æblemos) for at gøre 16 administrationen lettere.
15 For patients with difficulty swallowing; studies and clinical practice suggest that the capsules may be opened and the granules mixed with a small amount of water, apple/tomato juice or sprinkled onto a small amount of soft food (e.g. yoghurt, apple puree) to ease administration.
5. 2).
Capsules may also be opened and granules mixed with 40 ml of apple juice for administration through a nasogastric tube (see section 5.2).
Refluksøsofagitis:
Reflux oesophagitis:
Profylakse af refluksøsofagitis:
Prophylaxis of reflux oesophagitis:
Når der skal vælges en passende kombinationsbehandling, er det vigtigt at tage officielle lokale retningslinjer i betragtning med hensyn til bakteriel resistens, varighed af behandling (normalt 7 dage, men nogle gange op til 14 dage) og hensigtsmæssig brug af antibakterielle midler.
When selecting appropriate combination therapy consideration should be given to official local guidance regarding bacterial resistance, duration of treatment, (most commonly 7 days but sometimes up to 14 days), and appropriate use of antibacterial agents.
250- 500 mg clarithromycin to gange dagligt + 1 g amoxicillin to gange dagligt 250 mg clarithromycin to gange dagligt + 400- 500 mg metronidazol to gange dagligt.
The recommended dose is 30 mg of Agopton twice daily for 7 days in combination with one of the following: clarithromycin 250-500 mg twice daily + amoxicillin 1 g twice daily clarithromycin 250 mg twice daily + metronidazole 400-500 mg twice daily
Eradikation af H. pylori på op til 90% opnås, når clarithromycin kombineres med Agopton og amoxicillin eller metronidazol.
H. pylori eradication rates of up to 90%, are obtained when clarithromycin is combined with Agopton and amoxicillin or metronidazole.
Anvendelse af et regimen, der omfatter 30 mg lansoprazol to gange dagligt, 1 g amoxicillin to gange dagligt og 400- 500 mg metronidazol to gange dagligt, er også blevet undersøgt.
Use of a regimen including lansoprazole 30 mg twice daily, amoxicillin 1 g twice daily and metronidazole 400-500 mg twice daily has also been examined.
Behandling af NSAID- associeret godartet ulcus ventriculi og ulcus duodeni hos patienter, der kræver fortsat NSAID- behandling:
Treatment of NSAID associated benign gastric and duodenal ulcers in patients requiring continued NSAID treatment:
Risikopatienter eller patienter med mavesår, der er vanskelige at få til at hele, skal sandsynligvis behandles i længere tid og/ eller have en højere dosis.
For patients at risk or with ulcers that are difficult to heal, a longer course of treatment and/or a higher dose should probably be used.
Profylakse af NSAID- associeret ulcus ventriculi og ulcus duodeni hos risikopatienter (som for eksempel alder > 65 eller ulcus ventriculi eller ulcus duodeni i anamnesen), der kræver forlænget NSAID- behandling:
Prophylaxis of NSAID associated gastric and duodenal ulcers in patients at risk (such as age > 65 or history of gastric or duodenal ulcer) requiring prolonged NSAID treatment:
Symptomatisk gastroøsofageal reflukssygdom:
16 Symptomatic gastro-oesophageal reflux disease:
17 Zollinger- Ellisons syndrom:
Zollinger-Ellison syndrome:
Nedsat lever - eller nyrefunktion:
Impaired hepatic or renal function:
4. 4 og 5. 2).
Patients with moderate or severe liver disease should be kept under regular supervision and a 50% reduction of the daily dose is recommended (see section 4.4 and 5.2).
5. 2).
The use of Agopton is not recommended in children as clinical data are limited (see also section 5.2).
4. 5).
Lansoprazole should not be administered with atazanavir (see section 4.5).
4. 2 og 5. 2).
Lansoprazole should be used with caution in patients with moderate and severe hepatic dysfunction (see sections 4.2 and 5.2).
På grund af de begrænsede sikkerhedsdata for patienter, der har været i vedligeholdelsesbehandling i mere end 1 år, skal der regelmæssigt foretages en gennemgang af behandlingen og en grundig afvejning af risici/ fordele for disse patienter.
Because of limited safety data for patients on maintenance treatment for longer than 1 year, regular review of the treatment and a thorough risk/benefit assessment should regularly be performed in these patients.
Der er rapporteret om meget sjældne tilfælde af colitis hos patienter, der tager lansoprazol.
17 Very rarely cases of colitis have been reported in patients taking lansoprazole.
I tilfælde af svær og/ eller vedvarende diarré skal det derfor overvejes at seponere behandlingen.
Therefore, in the case of severe and/or persistent diarrhoea, discontinuation of therapy should be considered.
Den forebyggende behandling af peptisk ulceration hos patienter, der kræver fortsat NSAID - behandling, skal begrænses til højrisikopatienter (f. eks. tidligere gastrointestinal blødning, perforation eller ulcus, fremskreden alder, samtidig brug af medicin, der er kendt for at øge sandsynligheden for
The treatment for the prevention of peptic ulceration of patients in need of continuous NSAID treatment should be restricted to high risk patients (e.g. previous gastrointestinal bleeding, perforation or ulcer, advanced age, concomitant use of medication known to increase the likelihood of upper GI adverse events [e.g. corticosteroids or anticoagulants], the presence of a serious co-morbidity factor or the prolonged use of NSAID maximum recommended doses).
< Da Agopton indeholder saccharose, må patienter med sjældne arvelige problemer med fructoseintolerans, glucose- galactosemalabsorption eller sucrase- isomaltase- insufficiens ikke anvende dette lægemiddel. >
< As Agopton contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose- galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. >
Lægemidler med pH- afhængig absorption Lansoprazol kan påvirke absorptionen af lægemidler, for hvilke gastrisk pH er vigtig for biotilgængeligheden.
Medicinal products with pH dependent absorption Lansoprazole may interfere with the absorption of drugs where gastric pH is critical to bioavailability.
Et forsøg har vist, at samtidig administration af lansoprazol (60 mg én gang dagligt) og atazanavir 400 mg til raske frivillige medførte en væsentlig reduktion af atazanavireksponeringen (en reduktion af AUC og Cmax på cirka 90%).
A study has shown that co-administration of lansoprazole (60 mg once daily) with atazanavir 400 mg to healthy volunteers resulted in a substantial reduction in atazanavir exposure (approximately 90% decrease in AUC and Cmax).
4. 3).
Lansoprazole should not be co-administered with atazanavir (see section 4.3).
Lægemidler, der metaboliseres af P450- enzymer Lansoprazol kan øge plasmakoncentrationerne af lægemidler, der metaboliseres af CYP3A4.
Medicinal products metabolised by P450 enzymes Lansoprazole may increase plasma concentrations of drugs that are metabolised by CYP3A4.
Samtidig administration af lansoprazol øger plasmakoncentrationerne af tacrolimus (et CYP3A - og P - gp- substrat).
Co-administration of lansoprazole increases the plasma concentrations of tacrolimus (a CYP3A and P- gp substrate).
Eksponering for lansoprazol forhøjede gennemsnitseksponeringen for tacrolimus med op til 81%.
Lansoprazole exposure increased the mean exposure of tacrolimus by up to 81%.
Lægemidler, der transporteres af P- glycoprotein Det er observeret, at lansoprazol hæmmer transportproteinet P- glycoprotein (P- gp) in vitro.
Medicinal products transported by P-glycoprotein Lansoprazole has been observed to inhibit the transport protein, P-glycoprotein (P-gp) in vitro.
Andre lægemidlers effekt på lansoprazol
18 Effects of other drugs on lansoprazole
Lægemidler, der hæmmer CYP2C19 Fluvoxamin:
Drugs which inhibit CYP2C19 Fluvoxamine:
19 En reduktion af dosis kan overvejes, når lansoprazol kombineres med CYP2C19- hæmmeren fluvoxamin.
A dose reduction may be considered when combining lansoprazole with the CYP2C19 inhibitor fluvoxamine.
Lægemidler, der inducerer CYP2C19 og CYP3A4 Enzyminducere, der påvirker CYP2C19 og CYP3A4, som for eksempel rifampicin og prikbladet perikum (hypericum perforatum), kan reducere plasmakoncentrationerne af lansoprazol markant.
Drugs which induces CYP2C19 and CYP3A4 Enzyme inducers affecting CYP2C19 and CYP3A4 such as rifampicin, and St John´s wort (Hypericum perforatum) can markedly reduce the plasma concentrations of lansoprazole.
Andet Sukralfat/ antacider:
Others Sucralfate/Antacids:
Sukralfat/ antacider kan nedsætte lansoprazols biotilgængelighed.
Sucralfate/Antacids may decrease the bioavailability of lansoprazole.
Der er dog ikke udført nogen formelle interaktionsforsøg.
No clinically significant interactions of lansoprazole with nonsteroidal anti-inflammatory drugs have been demonstrated, although no formal interactions studies have been performed.
Dyreforsøg indikerer ingen direkte eller indirekte skadelige effekter på graviditet, den embryonale/ føtale udvikling, fødsel eller den postnatale 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, hvorvidt amning skal fortsættes/ afbrydes, eller om behandling med lansoprazol skal fortsættes/ afbrydes, skal tages under hensyntagen til barnets fordel af amning og kvindens fordel af behandling med lansoprazol.
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 breastfeeding to the child and the benefit of lansoprazole therapy to the woman.
Hyppighederne er defineret som almindelige (> 1/ 100, < 1/ 10), ikke almindelige (> 1/ 1. 000, < 1/ 100), sjældne (> 1/ 10. 000, < 1/ 1. 000) og meget sjældne (< 1/ 10. 000).
Frequencies are defined as common (> 1/100, < 1/10); uncommon (> 1/1,000, < 1/100); rare (> 1/10,000, < 1/1,000); very rare (< 1/10,000).
Lidelser i blod og lymfe Psykiatriske lidelser
19 Blood and lymphatic system disorders
Ikke almindelige Trompocytopeni, eosinofili, leukopeni Depression
Uncommon Thrombocytopenia, eosinophilia, leucopenia
Sjældne Anæmi Søvnmangel, hallucinationer, konfusion
Very rare Agranulocytosis, pancytopenia
Meget sjældne Agranulocytose, pancytopeni
Insomnia, hallucination, confusion
Lidelser i det centrale og perifere nervesystem Lidelser i øjne
Nervous system disorders
Rastløshed, vertigo, paræstesi, somnolens, tremor Synsforstyrrelser
Restlessness, vertigo, paresthesia, somnolence, tremor
Kvalme, diarré, abdominalsmerter, obstipation, opkastning, flatulens, mund - og halstørhed
Nausea, diarrhoea, stomach ache, constipation, vomiting, flatulence, dry mouth or throat
Colitis, stomatitis
Colitis, stomatitis
Lever - og galdevejslidelser
Hepatobiliary disorders
Dermatologiske lidelser Muskuloskeletale -, bindevævs - og knoglelidelser
Skin and subcutaneous tissue disorders Musculoskeletal and connective tissue disorders
Urtikaria, kløe, udslæt
Urticaria, itching, rash
Stevens- Johnson - syndrom, toksisk epidermal nekrolyse
Steven-Johnson syndrome, toxic epidermal necrolysis
Stigning i kolesterol - og triglyceridniveaue r, hyponatriæmi
Increase in cholesterol and triglyceride levels, hyponatremia
4. 8 for at få yderligere oplysninger om mulige symptomer på overdosering med lansoprazol.
Please refer to section 4.8 for possible symptoms of lansoprazole overdose.
Protonpumpehæmmere, ATC- kode:
Proton pump inhibitors, ATC code:
Den hæmmer den sidste fase af mavesyreproduktionen 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 effekten gælder både den basale og den stimulerede sekretion af mavesyre.
The inhibition is dose- dependent and reversible, and the effect applies to both basal and stimulated secretion of gastric acid.