FrancophonIA/ELRC3.0 huggingface dataset:
English: Omeprazole is a substituted benzimidazole belonging to the therapeutic group of proton pump inhibitors (PPIs).
Maltese: Omeprazole huwa benzimidazole sostitut li jagħmel parti mill-grupp terapewtiku tal-inibituri talpompa tal-proton (PPIs).
English: Harmonisation of the SPC and PL for the OTC product
Maltese: Armonizzazzjoni tal-SPC u l-PL għall-prodott OTC
English: Concomitant use with posaconazol and erlotinib should be avoided.
Maltese: L-użu konkomitanti ma' posaconazol u erlotinib għandu jiġi evitat.
English: i) Patients considered to be at risk of aspiration of gastric contents during general anaesthesia/Acid aspiration prophylaxis
Maltese: i) Pazjenti kkunsidrati li qegħdin f'riskju ta' aspirazzjoni ta' kontenuti gastriċi waqt anestesija ġenerali/Profilassi kontra l-aspirazzjoni tal-aċidu
English: Adult posology: capsule and tablet
Maltese: Pożoloġija fl-adulti: kapsula u pillola
English: • In combination with appropriate antibiotics, Helicobacter pylori (H. pylori) eradication in peptic ulcer disease
Maltese: • F'kombinazzjoni ma' antibijotiċi xierqa, il-qerda tal-Helicobacter pylori (H. pylori) fil-mard tal-ulċeri peptiċi
English: g) Acid-related dyspepsia
Maltese: ġ) Dispepsja relatata mal-aċidu
English: In children over 1 year of age and ≥ 10 kg
Maltese: Fi tfal ta' iżjed minn sena u ≥ 10 kg
English: The CHMP considered this indication to be approvable.
Maltese: IsCHMP qies li din l-indikazzjoni tista' tiġi approvata.
English: • Treatment of gastric ulcers
Maltese: • Trattament ta' ulċeri gastriċi
English: The interaction with tacrolimus and phenytoin were retained and monitoring was recommended but an interaction with methotrexate was considered unwarranted.
Maltese: Inżammet l-interazzjoni ma' tacrolimus u phenytoin u kien rakkomandat monitorġġ iżda l-interazzjoni ma' methotrexate ma tqisitx ġustifikata.
English: Section 4.1 - Therapeutics indications in paediatric patients - capsules and tablets
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi f'pazjenti pedjatriċi - kapsuli u pilloli
English: The CHMP considered the IV formulations to be alternatives to oral therapy in adult patients where the use of oral medicinal products is inappropriate.
Maltese: Is-CHMP qies li l-formulazzjonijiet IV huma alternattivi għat-terapija orali f'pazjenti adulti fejn l-użu ta' prodotti mediċinali orali ma jkunux addattat.
English: For the prevention of NSAID-associated gastric ulcers or duodenal ulcers in patients at risk (age> 60, previous history of gastric and duodenal ulcers, or of upper GI bleeding) the recommended dose is 20 mg once daily.
Maltese: Għallprevenzjoni tal-ulċeri gastriċi jew l-ulċeri duwodenali assoċjati man-NSAIDs f'pazjenti li huma f' riskju (età> 60, storja preċedenti ta' ulċeri gastriċi u duwodenali, jew ta' fsada fil-parti ta' fuq talapparat gastro-intestinali), id-doża rakkomandata hija 20 mg darba kuljum.
English: Regarding the prevention of relapse of H. pylori negative duodenal ulcers, the available literature was reviewed.
Maltese: Rigward it-tfaċċar mill-ġdid ta' ulċeri duwodenali negattivi H. pylori, ġiet eżaminata l letteratura disponibbli.
English: • Treatment of duodenal ulcers
Maltese: • Trattament ta' ulċeri duwodenali
English: The likelihood of developing reflux symptoms or oesophageal epithelial injury is a function of a quantitative abnormality of the number of reflux events and/or oesophageal acid exposure.
Maltese: Il-probabbiltà li jiġu żviluppati sintomi ta' rifluss jew korriment tal-epitelju esofagali hija funzjoni ta' abnormalità kwantitattiva tan-numru ta' episodji ta' rifluss u/jew esponiment għall-aċidu tal-esofagu.
English: There are currently 4 separate formulations of Losec on the market: gastro-resistant tablets, capsules, powder for solution for infusion and powder for solution for injection.
Maltese: Attwalment hemm 4 formulazzjonijiet differenti ta' Losec fis-suq: pilloli gastro-reżistenti, kapsuli, trab għal soluzzjoni għal infużjoni u trab għal soluzzjoni għal injezzjoni.
English: Commitments by the MAH were agreed, as listed in the Letter of Undertaking dated 14 December 2009.
Maltese: Ġew miftiehma l-impenji mill-MAH, kif elenkati fl-Ittra ta' Impenn datata 14 ta' Diċembru 2009.
English: The CHMP noted data showing that omeprazole does not increase the incidence or seriousness of the side effects in the poor metaboliser population and considered that although poor metabolisers show 5 to 10 times higher mean AUC than subjects having a functional CYP2C19 enzyme, there is no evidence that patients who are poor CYP2C19 metabolisers are at increased risk when treated with omeprazole at recommended doses..
Maltese: Is-CHMP innota informazzjoni li turi li omeprazole ma jżidx l-inċidenza jew il-gravità tal-effetti sekondarji fil-popolazzjoni b'metabolizzazzjoni ħażina u kkunsidra li għalkemm il-metabolizzaturi ħżiena juru AUC medja ta' 5 sa 10 darbiet ogħla mill-individwi li jkollhom enzima CYP2C19 funzjonali, m'hemmx evidenza li l-pazjenti li huma metabolizzaturi ħżiena ta' CYP2C19 huma f'riskju akbar meta jiġu ttrattati b'omeprazole fid-dożi rakkomandati.
English: c) “Treatment of duodenal ulcers” and “Prevention of relapse of duodenal ulcers” The indication in H. pylori negative ulcers was split from the indication with concomitant H. pylori infection.
Maltese: ċ) “Trattament tal-ulċeri duwodenali” u “Prevenzjoni tal-ħruġ mill-ġdid ta' ulċeri duwodenali” L-indikazzjoni f'ulċeri negattivi H. pylori kienet mifruda mill-indikazzjoni b'infezzjoni minn H. pylori simultanja.
English: However, peptic ulcers and erosions are different clinical entities.
Maltese: Madankollu, l-ulċeri u l-erużjonijiet peptiċi huma entitajiet kliniċi differenti.
English: After discussing the various existing texts in the national SPCs and noting that experience on use of intravenous formulations of Losec in paediatric patients is limited, the CHMP adopted the following harmonised indications in adults for Losec for intravenous use, as an alternative to oral therapy:
Maltese: Wara li ddiskuta d-diversi testi eżistenti fl-SPCs nazzjonali u nnota li l-esperjenza dwar l-użu ta' formulazzjonijiet għal ġol-vina ta' Losec f'pazjenti pedjatriċi hija limitata, is-CHMP adotta l-indikazzjonijiet armonizzati segwenti f'persuni adulti għal Losec għal użu fil-vini, bħala alternattiva għat-terapija orali:
English: The SPC therefore states that omeprazole is a CYP2C19 inhibitor and that inconsistent data has been reported from observational and clinical studies on the clinical implications of the PK/PD interaction in terms of major cardiovascular events.
Maltese: L-SPC għalhekk isostni li omeprazole huwa inibitur ta' CYP2C19 u li kienet irrappurtata dejta inkonsistenti minn studji ta' osservazzjoni u kliniċi dwar l-implikazzjonijiet kliniċi tal-interazzjoni farmakokinetika/farmakodinamika f'termini ta' episodji kardjovaskulari maġġuri.
English: Section 4.1 - Therapeutics indications in adults - powder for injection and powder for infusion
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi f'persuni adulti - trab għal injezzjoni u trab għal infużjoni
English: The recommended initial dose is 60 mg daily.
Maltese: Id-doża tal-bidu rakkomandata hija 60 mg kuljum.
English: Regarding the eradication of H. pylori in peptic ulcer disease, a number of triple-regimen therapies (Losec plus two antibiotics) are proposed.
Maltese: Rigward il-qerda tal-H. pylori fil-mard tal-ulċeri peptiċi, huma proposti numru ta' terapiji ta' reġim triplu (Losec flimkien ma' żewġ antibijotiċi).
English: a) “Treatment of symptomatic gastro-oesophageal reflux disease (GERD)” The MAH proposed that both duodenal and gastric ulcers be presented in individual indications separate from the GERD indication.
Maltese: a) “Trattament ta' mard ta' rifluss gastroesofagali sintomatiku (GERD)” Il-MAH ippropona li kemm l-ulċeri duwodenali kif ukoll l-ulċeri gastriċi jkunu ppreżentati f'indikazzjonijiet individwali separati mill-indikazzjoni ta' GERD.
English: In patients with impaired hepatic function, however, a daily dose of 10-20 mg may be sufficient.
Maltese: Madankollu, f'pazjenti b'indeboliment fil-funzjoni tal-fwied, tista' tkun suffiċjenti doża ta' 10-20 mg kuljum.
English: “Losec gastro-resistant tablets are indicated for the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults”
Maltese: “Il-pilloli gastro-intestinali Losec huma indikati għat-trattament ta' sintomi ta' rifluss (eż. qrusa flistonku, rigurġitazzjoni tal-aċidu) f'persuni adulti”
English: Losec (omeprazole) was included in the list of products for SPC harmonisation and a referral was triggered in order to resolve divergences and harmonise the nationally authorised SPCs across Europe.
Maltese: Losec (omeprazole) ġie inkluż fil-lista ta' prodotti għall-armonizzazzjoni tal-SPC u nbeda riferiment sabiex jiġu solvuti d-diverġenzi u jiġu armonizzati l-SPCs awtorizzati fuq livell nazzjonali madwar lEwropa.
English: • Treatment of symptomatic gastro-esophageal reflux disease
Maltese: • Trattament ta' mard ta' rifluss esofaġali sintomatiku
English: Initial GERD treatment is managed by a symptom-based approach; an empiric trial of acid suppression can be used.
Maltese: It-trattament inizjali ta' GERD huwa ġestit b'approċċ ibbażat fuq is-sintomi; tista' tintuża prova empirika tat-trażżin tal-aċidu.
English: For the treatment of symptomatic gastro-oesophageal reflux disease, the recommended dose is 20 mg daily.
Maltese: Għat-trattament tal-mard ta' rifluss gastro-intestinali sintomatiku, id-doża rakkomandata hija 20 mg kuljum.
English: Omeprazole has been reported to interact with some antiretroviral drugs.
Maltese: Omeprazole kien irrappurtat li jinteraġixxi ma' xi mediċini antiretrovirali.
English: d) “Treatment of gastric ulcers” and “Prevention of relapse of gastric ulcers” The gastric ulcer indications were separated from the duodenal ulcer indications as well as from the NSAID-related and H. pylori positive ulcers.
Maltese: d) “Trattament tal-ulċeri gastriċi” u “Prevenzjoni tal-ħruġ mill-ġdid ta' ulċeri gastriċi” L-indikazzjonijiet fl-ulċeri gastriċi kienu separate mill-indikazzjonijiet tal-ulċeri duwodenali kif ukoll mill-ulċeri relatati man-NSAID u l-ulċeri H. pylori pożittivi.
English: It is administered as a prodrug and specifically and dose-proportionally inhibits the gastric H+/K+-ATPase (proton pump) and thereby inhibits H+ ion transfer into the gastric lumen, which is responsible for acid secretion in the parietal cells of the stomach.
Maltese: Huwa jingħata bħala promediċina u jimpedixxi speċifikament u b'mod proporzjonali mad-doża l-H+/K+-ATPase gastriku (pompa tal-proton) u b'hekk jimpedixxi ttrasferiment ta' joni H+ fil-lumen gastriku, li huwa responsabbli għas-sekrezzjoni tal-aċidu fiċ-ċelloli parjetali tal-istonku.
English: • Treatment of NSAID-associated gastric and duodenal ulcers
Maltese: • Trattament ta' ulċeri gastriċi u ulċeri duwodenali assoċjati man-NSAIDs
English: Prevention of ulcers is currently started on a regular basis in a considerable number of patients using NSAIDs and the superior efficacy PPIs over H2 antagonists in the healing of gastroduodenal ulcers associated with NSAIDs when NSAIDs cannot be discontinued has been demonstrated.
Maltese: Il-prevenzjoni tal-ulċeri attwalment tinbeda fuq bażi regolari f'numru konsiderevoli ta' pazjenti li jużaw NSAIDs u ġiet dimostrata l-effikaċja akbar tal-PPIs fuq lantagonisti H2 fil-fejqan ta' ulċeri gastroduwodenali assoċjati man-NSAIDs meta n-NSAIDs ma jkunux jistgħu jitwaqqfu.
English: While literature data strongly indicates that there is no cross-reactivity between the various substituted benzimidazoles, there is data indicating suspected cross-reactivity.
Maltese: Filwaqt li d-dejta mil-letteratura tindika b'mod qawwi li m'hemmx cross-reattività bejn id-diversi benzimidazoles sostituti, teżisti dejta li tindika suspett ta' cross-reattività.
English: A statement on the potential increased or decreased absorption of active substances with a gastric pH dependent absorption due to decreased intragastric acidity was inserted.
Maltese: Ġiet inkluża dikjarazzjoni dwar iż-żieda jew ittnaqqis potenzjali fl-assorbiment tas-sustanzi attivi b'assorbiment dipendenti fuq il-pH gastriku minħabba tnaqqis fl-aċidità intragastrika.
English: PPIs are also effective for primary prevention of NSAID-associated ulcers.
Maltese: Il-PPIs huma effettivi wkoll għall-prevenzjoni primarja ta' ulċeri assoċjati man-NSAIDs.
English: The CHMP considered that dual therapies are less effective than triple therapies, but that they could be considered in cases where known hypersensitivity precludes use of any triple combination.
Maltese: Is-CHMP qies li t-terapiji doppji huma inqas effettivi mit-terapiji tripli, iżda li huma jistgħu jiġu kkunsidrati f'każijiet fejn sensittività eċċessiva magħrufa ma tippermettix l-użu ta' kwalunkwe kombinazzjoni tripla.
English: After consultation of the Cardiovascular subgroup of the Efficacy Working Party, the CHMP confirmed that a PK and PD interaction between CYP2C19 inhibitors and clopidogrel is observed, although the clinical implication of this finding is not clear.
Maltese: Wara konsultazzjoni tas-sottogrupp Kadjovaskulari tal-Grupp ta' Ħidma dwar l-Effikaċja, is-CHMP ikkonferma li hija osservata interazzjoni farmakokinetika u interazzjoni farmakodinamika bejn l-inibituri ta' CYP2C19 u clopidogrel, għalkemm mhix ċara l-implikazzjoni klinika ta' din is-sejba.
English: The indication and the associated posology were removed from the harmonised SPC.
Maltese: L-indikazzjoni u l-pożoloġija assoċjata ġew imneħħija mill-SPC armonizzat.
English: The CHMP considered that this indication is similar to chemical pneumonia (among others caused by gastric acid aspiration).
Maltese: Is-CHMP ħass li din l-indikazzjoni hija simili għall-pulmonite kimika (ikkawżata fost l-oħrajn millaspirazzjoni tal-aċidu gastriku).
English: Salmonella and Campylobacter are mentioned; however the mention of C. difficile infections was removed, as the available data did not establish a possible causal relationship between C. difficile infection and the use of PPIs.
Maltese: Is-Salmonella u l-Campylobacter huma msemmija; madankollu tneħħiet ir-referenza għal-infezzjonijiet mill-C. difficile, billi l-informazzjoni disponibbli ma stabbilietx relazzjoni kawżali possibbli bejn infezzjoni mill-C. difficile u l-użu tal-PPIs.
English: • Treatment of reflux esophagitis
Maltese: • Trattament tal-esofaġite ta' rifluss
English: Section 4.6: Pregnancy and lactation - all formulations
Maltese: Sezzjoni 4.6: Tqala u treddigħ - il-formulazzjonijiet kollha
English: The CHMP noted that heartburn was not included in the definition of dyspepsia agreed upon by an international committee of clinical investigators (Rome III Committee).
Maltese: Is-CHMP innota li l-qrusa tal-istonku ma kinitx inkluża fid-definizzjoni ta' dispepsja kif maqbula minn kumitat internazzjonali ta' investigaturi kliniċi (Kumitat III ta' Ruma).
English: Increased gastric pH during omeprazole treatment may affect absorption, while other possible interaction mechanisms are via CYP2C19.
Maltese: Iż-żieda fil-pH gastriku waqt trattament b'omeprazole tista' taffettwa l-assorbiment, waqt li mekkaniżmi ta' interazzjoni possibbli oħra huma permezz tal-CYP2C19.
English: All patients with severe disease and inadequate response to other therapies have been effectively controlled and more than 90% of the patients maintained on doses of 20-120 mg daily.
Maltese: Il-pazjenti kollha b'mard sever u rispons inadegwat għal terapiji oħra ġew ikkontrollati b'mod effettiv u iżjed minn 90% tal-pazjenti nżammu fuq dożi ta' 20-120 mg kuljum.
English: Whilst definition of what constitutes typical reflux disease may differ, in general terms, GERD is applied to patients with symptoms suggestive of reflux or complications thereof, but not necessarily with oesophageal inflammation.
Maltese: Filwaqt li d-definizzjoni ta' x'jikkostitwixxi mard tipiku ta' rifluss tista' tvarja, f'termini ġenerali, GERD huwa applikat għal pazjenti b'sintomi li jissuġġerixu rifluss jew kumplikazzjonijiet tiegħu, iżda mhux neċessarjament b'infjammazzjoni tal-esofagu.
English: • In combination with antibiotics in treatment of duodenal ulcer caused by H. pylori
Maltese: • F'kombinazzjoni ma' antibijotiċi fit-trattament ta' ulċera duwodenali kkawżata mill-H. pylori
English: • Prevention of NSAID-associated gastric and duodenal ulcers in patients at risk
Maltese: • Prevenzjoni ta' ulċeri gastriċi u ulċeri duwodenali assoċjati man-NSAIDs f'pazjenti f'riskju
English: The CHMP discussed the association of omeprazole with the occurrence of bone fracture/hip fracture in the elderly, especially osteoporosis affected population.
Maltese: Is-CHMP iddiskuta l-assoċjazzjoni ta' omeprazole mas-seħħ ta' ksur tal-għadam/ksur tal-ġenbejn flanzjani, speċjalment il-popolazzjoni affettwata mill-osteoporożi.
English: PRESCRIPTION-ONLY PRESENTATIONS
Maltese: IPPREŻENTATI
English: The CHMP assessed the potential omeprazole-clopidogrel interaction and considered that a warning is warranted, given the potential seriousness of the observed adverse events.
Maltese: Is-CHMP ivvaluta l-interazzjoni potenzjali bejn omeprazole u clopidogrel u ħass li twissija hija ġustifikata, minħabba s-serjetà potenzjali tal-episodji avversi li kienu osservati.
English: The indication for the treatment of Zollinger Ellison syndrome is already harmonised throughout the EU and the CHMP considered this indication to be approvable.
Maltese: L-indikazzjoni għat-trattament tas-sindrome ta' Zollinger Ellison hija diġà armonizzata madwar l-UE u s-CHMP qies li din l-indikazzjoni tista' tiġi approvata.
English: • Symptomatic treatment of heartburn and acid regurgitation in gastro-esophageal reflux disease In children and adolescents over 4 years of age
Maltese: • Trattament sintomatiku tal-qrusa fl-istonku u r-rigurġitazzjoni tal-aċidu f'mard ta' rifluss gastro-esofagali
English: The most common and effective treatment of peptic oesophagitis or symptomatic GERD is to reduce gastric acid secretion with either H2 blockers or a PPI and the CHMP therefore considered this indication approvable.
Maltese: L-iżjed trattament komuni u effettiv ta' esofaġite peptika jew GERD sintomatiku huwa li titnaqqas is-sekrezzjoni tal-aċidu gastriku b'imblokkaturi H2 jew PPI u għalhekk is-CHMP qies li din l-indikazzjoni tista' tiġi approvata.
English: The proposed harmonisations mainly concern the drug product and the MAH provided satisfactory information on the appearance, polymorphisms, specifications and stability of the drug substances (omeprazole magnesium for the MUPS tablets, omeprazole for the capsules and omeprazole sodium for the injection and infusion formulations).
Maltese: Il-MAH issottometta proposta għall-armonizzazzjoni tal-modulu dwar il-Kwalità. Larmonizzazzjonijiet proposti jirrigwardaw prinċipalment il-prodott mediċinali u l-MAH ipprovda informazzjoni sodisfaċenti dwar id-dehra, il-polimorfiżmi, l-ispeċifikazzjonijiet u l-istabilità tassustanzi tal-mediċina (omeprazole magnesium għall-pilloli MUPS, omeprazole għall-kapsuli u omeprazole sodium għall-formulazzjonijiet tal-injezzjoni u tal-infużjoni).
English: The CHMP noted that study data showed that 20 mg once daily produces a more pronounced and consistent inhibition than the lower doses and therefore agreed on a maximum daily dose of 20 mg. Selftreatment should be limited to a maximum period of 14 days, and the patient should be instructed to consult a doctor if symptoms persist.
Maltese: Jekk ma jinkisibx kontroll tas-sintomi wara erba' ġimgħat ta' trattament b'20 mg kuljum, hija rakkomandata aktar investigazzjoni.
English: For most indications, a 40 mg daily dose is recommended, although in patients with Zollinger-Ellison Syndrome the recommended initial dose is 60 mg daily.
Maltese: Għall-maġġoranza tal-indikazzjonijiet, hija rakkomandata doża ta' 40 mg kuljum, għalkemm f'pazjenti bis-Sindrome ta' Zollinger-Ellison, iddoża tal-bidu rakkomandata hija 60 mg kuljum.
English: For the treatment of Zollinger-Ellison syndrome, the dose should be individually adjusted and treatment continued as long as clinically indicated.
Maltese: Għat-trattament tas-sindrome ta' Zollinger-Ellison, id-doża għandha tiġi aġġustata b'mod individwali u t-trattament jitkompla sakemm ikun klinikament indikat.
English: It is in the so-called “idiopathic ulcers” that the prevention of relapse of H. pylori negative duodenal and gastric ulcer indications are indicated.
Maltese: Huwa fl-hekk imsejħa “ulċeri idjopatiċi” li hemm indikati l-indikazzjonijietdwar il-prevenzjoni tal-ħruġ mill-ġdid tal-ulċeri duwodenali negattivi H. pylori u l-ulċeri gastriċi.
English: Based on the review of data and taking into account the commitments provided by the MAH to submit an update of Module 3 in May 2010, the CHMP adopted a harmonised Module 3.
Maltese: Abbażi tal-eżami tad-dejta u wara li kkunsidra l-impenji mogħtija mill-MAH sabiex jipprovdi aġġornament tal-Modulu 3 f'Mejju 2010, is-CHMP adotta Modulu 3 armonizzat.
English: Based on the above, the CHMP considers the benefit/risk ratio of Losec to be favourable and the harmonised Product Information documents to be approvable.
Maltese: Fuq il-bażi ta' dan ta' hawn fuq, is-CHMP iqis ilproporzjon tal-benefiċċju/riskju ta' Losec bħala wieħed favorevoli u d-dokumenti armonizzati ta' Informazzjoni dwar il-Prodott bħala approvabbli.
English: The CHMP was of the opinion that prolonged acid inhibition by PPIs may promote vitamin B12 malabsorption and inserted a warning stating that omeprazole may reduce the absorption of vitamin B12 and that this should be considered in patients on long-term therapy.
Maltese: Is-CHMP kien tal-opinjoni li l-inibizzjoni prolungata tal-aċidu mill-PPIs tista' tippromwovi lassorbiment ħażin tal-vitamina
English: The SPC therefore states that co-administration of atazanavir and nelfinavir with proton pump inhibitors is not recommended and that if co-administration is judged unavoidable, close clinical monitoring is recommended together with an increase of the anti-retroviral drug dose, as plasma levels of nelfinavir and atazanavir are decreased in case of co-administration with omeprazole.
Maltese: L-SPC għalhekk jgħid li l-għoti ta' atazanavir u nelfinavir fl-istess ħin ma' inibituri tal-pompa tal-proton mhuwiex rakkomandat u li jekk l-għoti fl-istess ħin ikun ikkunsidrat bħala mhux evitabbli, huwa rakkomandat monitoraġġ kliniku mill-qrib flimkien ma' żieda fid-doża tal-mediċina antiretrovirali, billi l-livelli ta' nelfinavir u atazanavir fil-plażma jitbaxxew filkaż ta' għoti fl-istess ħin ma' omeprazole.
English: Regarding the method of administration of the capsules and tablets, with regards to patients with swallowing difficulties, the CHMP agreed that the capsule can be opened and the contents swallowed based on the in-vivo (bioequivalence) as well as in-vitro studies on the intake as dispersed/suspended tablets/granules of the oral pharmaceutical forms.
Maltese: Dwar il-metodu ta' kif għandhom jingħataw il-kapsuli u l-pilloli, fir-rigward ta' pazjenti b'diffikultajiet biex jibilgħu, is-CHMP qabel li l-kapsula tista' tinfetaħ u jinbelgħu l-kontenuti fuq ilbażi tal-istudji in-vivo (bijoekwivalenza) kif ukoll tal-istudji in-vivo dwar it-teħid bħala pilloli/granijiet imxerrda/sospiżi tal-forom farmaċewtiċi orali.
English: Regarding the prevention of non-steroidal anti-inflammatory drug (NSAID) -associated gastric ulcers, duodenal ulcers or gastroduodenal erosions in patients at risk, prevention of ulcer formation in at risk NSAID users is a reasonable course of action, given the high and increasing incidence.
Maltese: e) “Trattament ta' ulċeri gastriċi u ulċeri duwodenali assoċjati ma' NSAIDs” u “Prevenzjoni ta' ulċeri gastriċi u ulċeri duwodenali assoċjati ma' NSAIDs f'pazjenti f'riskju” Rigward il-prevenzjoni ta' ulċeri gastriċi, ulċeri duwodenali jew erużjonijiet gastroduwodenali assoċjati ma' mediċini anti-infjammatorji mhux sterojdi (NSAID) f'pazjenti f'riskju, il-prevenzjoni tal-ħolqien ta' ulċeri f'utenti ta' NSAIDs li jkunu f'riskju hija kors ta' azzjoni raġonevoli, minħabba linċidenza għolja u dejjem tiżdied.
English: For the treatment of NSAID-associated gastric and duodenal ulcers, the recommended dose is 20 mg once daily.
Maltese: Għat-trattament tal-ulċeri gastriċi, id-doża rakkomandata hija 20 mg darba kuljum.