FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) rari (≥1/10,000 sa <1/1,000), rari ħafna
English: In vitro data indicate that this is predominantly mediated by the cytochrome P450 3A4 isoform (CYP3A4).
Maltese: Dejta in vitro tindika li dan huwa medjat prinċipalment mill iżoforma 3A4 taċ-ċitokromju P450 (CYP3A4).
English: 84 tablets
Maltese: 28 pillola 30 pillola 84 pillola
English: • Educational material for pathologists which contains o Pathologist's guide o USB stick or CD ROM with images of digital specimens (digital library with high resolution images) o SmPC
Maltese: • Materjal edukattiv għal patoloġisti li fih o Gwida għall-patoloġisti o USB stick jew CD ROM bi stampi ta' kampjuni diġitali (librerija diġitali bi stampi ta' riżoluzzjoni għolja)
English: Headache Mild or moderate severity headache was reported in 5.8% of patients.
Maltese: Uġigħ ta' ras minn ħafifa sa moderata kienet irrapportata f'5.8% tal-pazjenti.
English: In study 4, 61.9% and 72.7% of patients were in amenorrhea at the end of both treatment course 1 and 2 combined (5 mg dose and 10 mg dose, respectively, p=0.032); 48.7 % and 60.5 % were in amenorrhea at the end of all four treatment courses combined (5 mg dose and 10 mg dose,
Maltese: Fi studju 4, 61.9% u 72.7% tal-pazjenti kienu f'amenorrea kemm fi tmiem il-kors ta' kura 1 kif ukoll 2 ikkombinati (doża ta' 5 mg u doża ta' 10 mg, rispettivament, p=0.032). 48.7% u 60.5% kienu f'amenorreja fl-aħħar tal-erba' korsijiet ta' kura kkombinati kollha (doża ta' 5 mg u doża ta' 10 mg, rispettivament, p=0.027).
English: Pharmacotherapeutic group: Sex hormones and modulators of the genital system, progesterone receptor modulators.
Maltese: Ormoni sesswali u modulaturi tas-sistema ġenitali, modulaturi tar riċettur tal-proġesteron.
English: Administration of the potent CYP3A4 inducer rifampicin (300 mg twice daily for 9 days) to healthy female volunteers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite by 90% or more and decreased ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure.
Maltese: L-għoti tal-induttur ta' CYP3A4 qawwi rifampicin (300 mg darbtejn kuljum għal 9 ijiem) lil voluntiera nisa b'saħħithom naqqas b'mod sinifikanti is-Cmax u l-AUC ta' ulipristal acetate u l metabolit attiv tiegħu b'90% jew aktar u naqqas il-half-life ta' ulipristal acetate bi 2.2 drabi u dan jikkorrespondi għal tnaqqis ta' madwar 10 darbiet tal-espożizzjoni ta' ulipristal acetate.
English: • key effects of Ulipristal Acetate Gedeon Richter on Progesterone Receptor Modulator Associated Endometrial Changes (PAEC) and how they differ from those of unopposed oestrogen.
Maltese: • effetti ewlenin ta' Ulipristal Acetate Gedeon Richter fuq Tibdil Endometrijali Assoċjat ma' Modulatur tar-Riċettur tal-Progesterone (Progesterone Receptor Modulator Associated Endometrial Changes (PAEC)) u kif dawn huma differenti minn dawk ta' estroġenu mhux oppost.
English: • patients with alanine transaminase (ALT) or aspartate aminotransferase (AST) > 2 x ULN (isolated or in combination with bilirubin >2 x ULN) must not be treated.
Maltese: • pazjenti b'alanine transaminase (ALT) jew aspartate aminotransferase (AST) > 2 x ULN
English: Headache*
Maltese: FEJN MA
English: INFORMATION IN BRAILLE Ulipristal Acetate Gedeon Richter
Maltese: INFORMAZZJONI BIL-BRAILLE Ulipristal Acetate Gedeon Richter
English: Ulipristal Acetate Gedeon Richter 5 mg tablets Ulipristal acetate
Maltese: Ulipristal Acetate Gedeon Richter 5 mg pilloli Ulipristal acetate
English: In the first 3-month treament course of the two long term Phase III trials, the frequency was 5.3% and 5.8% for ulipristal acetate, respectively.
Maltese: III, il frekwenza kienet 5.3% u 5.8% għal ulipristal acetate, rispettivament.
English: Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.
Maltese: esomeprazole (20 mg kuljum għal 6 ijiem) irriżulta f'Cmax bejn wieħed u ieħor 65% aktar baxx, tmax ittardjat (minn medjan ta' 0.75 sigħat għal 1.0 sigħat) u AUC medja 13% ogħla.
English: Ulipristal Acetate Gedeon Richter may cause mild dizziness (see section 4 “Possible side effects”).
Maltese: Ulipristal Acetate Gedeon Richter jista' jikkawża sturdament ħafif (ara sezzjoni 4 “Effetti sekondarji li jista' jkollu”).
English: In all Phase III studies including repeated intermittent treatment studies, a total of 7 cases of hyperplasia were observed out of 789 patients with adequate biopsies (0.89%).
Maltese: 7 każijiet ta' iperplażja minn 789 pazjent b'bijopsiji adegwata (0.89%).
English: Amenorrhea Endometrial thickening*
Maltese: Tħaxxin tal endometriju*
English: In vitro data indicate that ulipristal acetate and its active metabolite do not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, or induce CYP1A2 at clinically relevant concentrations.
Maltese: 2C9, 2C19, 2D6, 2E1, u 3A4, jew jinduċu lil CYP1A2 f'konċentrazzjonijiet klinikament rilevanti.
English: Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively; the AUC of the active metabolite of ulipristal acetate increased 2.4 fold while the Cmax of the active metabolite decreased (0.53 fold change).
Maltese: Wara l-għoti tal-inibitur qawwi ta' CYP3A4 ketoconazole (400 mg darba kuljum għal 7 ijiem) lil voluntiera nisa b'saħħithom, is-Cmax u l-AUC ta' ulipristal acetate żdiedu b'2 u 5.9 darbiet, rispettivament; l-AUC tal-metabolit attiv ta' ulipristal acetate żdied b'2.4 darbiet filwaqt li s-Cmax tal metabolit attiv naqas (bidla ta' 0.53 drabi).
English: What Ulipristal Acetate Gedeon Richter contains - The active substance is ulipristal acetate.
Maltese: X'fih Ulipristal Acetate Gedeon Richter - Is-sustanza attiva hija ulipristal acetate.
English: ULIPRISTAL ACETATE GEDEON RICHTER 5 mg TABLETS PATIENT CARD
Maltese: Ulipristal Acetate Gedeon Richter 5 mg pilloli
English: If, during repeated intermittent treatment, after the initial reduction in bleeding or amenorrhea, an altered persistent or unexpected bleeding pattern occurs, such as inter-menstrual bleeding, investigation of the endometrium including endometrial biopsy should be performed in order to exclude other underlying conditions, including endometrial malignancy.
Maltese: Jekk, matul kura intermittenti ripetuta, wara t-tnaqqis inizjali fil-fsada jew amenorreja, isseħħ fsada mhux mistennija jew persistenti mibdul, bħal fsada matul il-mestrwazzjoni, għandha titwettaq investigazzjoni tal-endometriju inkluż bijopsija endometrijali sabiex jiġu esklużi l-kundizzjonijiet sottostanti l-oħra, inkluż tumur malinn endometrijali.
English: Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.
Maltese: Ulipristal acetate għandu struttura ta' sterojdi u jaġixxi bħala modulatur selettiv tar-riċettur tal proġesteron b'effetti inibitorji predominanti fuq ir-riċettur tal-proġesteron.
English: - If you are currently taking hormonal contraception (for example birth control pills) (see “Other medicines and Ulipristal Acetate Gedeon Richter”) you should use an alternative reliable barrier contraceptive method (such as a condom) while taking Ulipristal Acetate Gedeon Richter.
Maltese: (ara “Mediċini oħra u Ulipristal Acetate Gedeon Richter”), inti għandek tuża metodu kontraċettiv b'barriera affidabbli alternattiv (bħal kondom) waqt li tieħu Ulipristal Acetate
English: Ulipristal Acetate Gedeon Richter is used in adult women (over 18 years of age) before they reach the menopause.
Maltese: Ulipristal Acetate Gedeon Richter jintuża f'nisa adulti (akbar minn 18-il sena) qabel ma jaslu għall menopawża.
English: Median PBAC at baseline
Maltese: toraċiċi u medjastinali
English: Potential for other medicinal products to affect ulipristal acetate:
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Il-potenzjal li prodotti mediċinali oħra jaffettwaw lil ulipristal acetate:
English: Batch
Maltese: PBAC
English: Therefore, hormonal contraceptives are not recommended and you should use an alternative reliable barrier contraceptive method, such as a condom, during Ulipristal Acetate Gedeon Richter treatment.
Maltese: Għaldaqstant, il kontraċettivi ormonali mhumiex rakkomandati u inti għandek tuża metodu kontraċettiv b'barriera affidabbli alternattiv, bħal kondom, waqt li tkun fuq kura b'Ulipristal Acetate Gedeon Richter.
English: 4.6 Fertility, pregnancy and lactation
Maltese: .6 Fertilità, tqala u treddigħ Kontraċezzjoni fin-nisa
English: Underlying hepatic disorder.
Maltese: Disturbi respiratorji,
English: At the end of treatment course 4, 158 (69.6%) subjects and 164 (74.5%) subjects were assessed as being in amenorrhea, in the 5 mg dose and 10 mg dose respectively (p=0.290).
Maltese: Fl-aħħar tal-kors ta' kura 4, 158 (69.6%) individwu u 164 (74.5%)
English: Dizziness
Maltese: Komuni
English: In subsequent treatment courses, endometrial thickening was less frequently observed (4.9% and 3.5% of patients by the end of second and fourth treatment course, respectively).
Maltese: kura sussegwenti, it-tħaxxin endometrijali kien osservat b'mod inqas frekwenti (4.9% u 3.5% tal pazjenti sat-tmiem it-tieni u r-raba' kors ta' kura, rispettivament).
English: Ulipristal Acetate Gedeon Richter is contraindicated in patients with hepatic disorder (see section 4.3 and 4.4).
Maltese: Richter huwa kontraindikat f'pazjenti b'disturb tal-fwied (ara sezzjoni 4.3 u 4.4).
English: Mannitol
Maltese: Stitikezza
English: PHARMACEUTICAL FORM AND CONTENTS 28 tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Hot flush* Pelvic pain Ovarian cyst* Breast tenderness/pain
Maltese: - skumdità fis-sider - nefħa minħabba żamma ta' fluwidu (edema)
English: Common (may affect up to 1 in 10 people) side effects: - headache - spinning sensation (vertigo) - stomach ache, feeling sick (nausea) - acne - muscle and bone (musculoskeletal) pain - sac of fluid within the ovaries (ovarian cyst), breast tenderness/pain, lower abdominal (pelvic)
Maltese: - borża ta' fluwidu fi ħdan l-ovarji (ċista fl-ovarji), sensittività/uġigħ fis-sider, uġigħ fin-naħa t'isfel tal-addome (fil-pelvis), fwawar
English: Therefore concomitant administration of medicinal products containing progestagen is not recommended (see section 4.4 and 4.6).
Maltese: Għalhekk l-għoti konkomittanti ta' prodotti mediċinali li fihom proġestaġen mhuwiex irrakkomandat (ara sezzjoni 4.4 u 4.6).
English: What Ulipristal Acetate Gedeon Richter is and what it is used for What you need to know before you take Ulipristal Acetate Gedeon Richter How to take Ulipristal Acetate Gedeon Richter Possible side effects
Maltese: Tiħux Ulipristal Acetate Gedeon Richter - jekk inti allerġiku għal ulipristal acetate jew għal xi sustanza oħra ta' Ulipristal Acetate Gedeon Richter (elenkati fis-sezzjoni 6). jekk għandek disturb tal-fwied sottostanti. jekk inti tqila jew jekk qed tredda'.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Microcrystalline cellulose
Maltese: Microcrystalline cellulose Mannitol
English: Pre-operative use:
Maltese: Data tal-ewwel awtorizzazzjoni:
English: Ulipristal Acetate Gedeon Richter should not be taken by children under 18 years of age since safety and efficacy of ulipristal acetate has not been established in this age group.
Maltese: Ulipristal Acetate Gedeon Richter ma għandux jittieħed minn tfal li għandhom inqas minn 18-il sena peress li s-sigurtà u l-effikaċja ta' ulipristal acetate ma ġewx determinati f'dan il-grupp tal-età.
English: What Ulipristal Acetate Gedeon Richter looks like and contents of the pack Ulipristal Acetate Gedeon Richter is white to off-white, round curved tablet of 7 mm engraved with code “ES5” on one face.
Maltese: Il-kura b'Ulipristal Acetate Gedeon Richter normalment twassal għal tnaqqis sinifikanti jew saħansitra tista' twaqqaf il-fsada mestrwali tiegħek (il-‘pirjid' tiegħek) fi żmien l-ewwel 10 ijiem tal-kura.
English: For further treatment courses, liver function must be tested once before each new treatment course and when clinically indicated.
Maltese: trattament, u wara dan meta jiġi indikat klinikament.
English: • inform the patients about potential adverse reactions related to liver that could be caused by the use of Ulipristal Acetate Gedeon Richter.
Maltese: • tgħarraf lill-pazjenti dwar reazzjonijiet avversi potenzjali relatati mal-fwied li jistgħu jiġu kkawżati mill-użu ta' Ulipristal Acetate Gedeon Richter.
English: How to store Ulipristal Acetate Gedeon Richter
Maltese: Mediċini oħra u Ulipristal Acetate Gedeon Richter
English: If a patient during treatment shows signs or symptoms compatible with liver injury (fatigue, asthenia, nausea, vomiting, right hypochondrial pain, anorexia, jaundice), treatment should be stopped and the patient should be investigated immediately, and liver function tests performed.
Maltese: Jekk pazjent waqt it-trattament juri sinjali jew sintomi kompatibbli ma' ħsara fil-fwied (għeja, astenja, dardir, rimettar, uġigħ ipokondrijali fin-naħa tal-lemin, anoreksja, suffejra), it-trattament għandu jitwaqqaf u l-pazjent għandu jiġi investigat immedjatament, u għandhom isiru testijiet tal-funzjoni tal fwied.
English: In study 1, a statistically significant difference was observed in reduction in menstrual blood loss in favour of the patients treated with ulipristal acetate compared to placebo (see Table 1 below), resulting in faster and more efficient correction of anaemia than iron alone.
Maltese: Fl-istudju 1, kienet osservata differenza statistikament sinifikanti fit-tnaqqis ta' telf ta' demm mestrwali favur il-pazjenti li kienu rċevew kura bi ulipristal acetate meta mqabbla ma' plaċebo (ara Tabella 1 hawn taħt), li rriżulta f'korrezzjoni aktar mgħaġġla u aktar effiċjenti tal-anemija milli bil ħadid waħdu.
English: Ovarian cyst ruptured* Breast swelling
Maltese: Ċisti fl-ovarji*
English: Ulipristal Acetate Gedeon Richter is likely to make some hormonal contraceptives less effective.
Maltese: Ulipristal Acetate Gedeon Richter huwa mistenni li jagħmel xi kontraċettivi ormonali inqas effettivi.
English: • Educational material for prescribers (gynaecologists) which contains: o Cover letter o SmPC o Physician's guide to prescribing Ulipristal Acetate Gedeon Richter
Maltese: • Materjal edukattiv għal dawk li jagħtu l-prodott fuq riċetta (ġinekologi) li huwa magħmul minn:
English: How to take Ulipristal Acetate Gedeon Richter
Maltese: Ulipristal Acetate Gedeon
English: The treatment consists of one tablet of 5 mg to be taken once daily for treatment courses of up to 3 months each.
Maltese: Id-doża rakkomandata hija pillola waħda ta' 5 mg kuljum, għal korsijiet ta' kura sa massimu ta' 3 xhur kull wieħed.
English: If you stop taking Ulipristal Acetate Gedeon Richter Ulipristal Acetate Gedeon Richter is to be taken daily during treatment courses of up to 3 months continuously.
Maltese: Ulipristal Acetate Gedeon Richter għandu jittieħed kuljum matul il-korsijiet ta' kura sa massimu ta' 3 xhur b'mod kontinwu.
English: Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and
Maltese: Wara l-għoti tal-inibitur moderat ta' CYP3A4 erythromycin propionate (500 mg darbtejn kuljum għal 9 ijiem) lil voluntiera nisa b'saħħithom, kien hemm żieda fis-Cmax u l-AUC ta' ulipristal acetate ta' 1.2 u 2.9 darbiet, rispettivament; l-AUC tal-metabolit attiv ta' ulipristal acetate żdied b'1.5 drabi filwaqt li s-Cmax tal-metabolit attiv naqas (bidla ta' 0.52 drabi).
English: Rare (may affect up to 1 in 1,000 people) side effects: - nosebleed - indigestion, bloating - break of sac of fluid within the ovaries (ovarian cyst ruptured) - breast swelling.
Maltese: Effetti sekondarji rari (jistgħu jaffettwaw sa persuna 1 minn kull 1,000): - fsada mill-imnieħer
English: The terminal half-life of ulipristal acetate in plasma following a single dose of 5 or 10 mg is estimated to be about 38 hours, with a mean oral clearance (CL/F) of about 100 l/h.
Maltese: Il-half-life terminali ta' ulipristal acetate fil-plażma wara doża unika ta' 5 jew 10 mg huwa stmat li huwa ta' madwar 38 siegħa, bi tneħħija orali medja
English: A daily dose of ulipristal acetate 5 mg partially suppresses FSH levels but serum oestradiol levels are maintained in the mid-follicular range in the majority of patients and are similar to levels in patients who received placebo.
Maltese: Doża ta' ulipristal acetate ta' 5 mg kuljum trażżan parzjalment il-livelli tal-FSH iżda fil-maġġoranza tal-pazjenti, il-livelli ta' estradajol fis-serum jinżammu fil-medda mid-follikulari u huma simili għal livelli f'pazjenti li rċevew plaċebo.
English: If hysterectomy or endometrial biopsy specimens are sent for histology, then the pathologist should be informed that the patient has taken ulipristal acetate (see sections 4.4 and 5.1).
Maltese: Jekk kampjuni miġbura minn bijopsiji endometrijali jew minn isterektomiji jintbagħtu għall-istoloġija, allura l-patologu għandu jkun infurmat li l-pazjenta kienet ħadet ulipristal acetate (ara sezzjonijiet 4.4 u 5.1).
English: Ulipristal Acetate Gedeon Richter passes into the breast milk.
Maltese: Acetate Gedeon Richter milli suppost.
English: • the need to inform the pathologist that patients were treated with Ulipristal Acetate Gedeon Richter if biopsy/surgical samples are to be sent for analysis.
Maltese: • il-ħtieġa li l-patoloġista jiġi infurmat li l-pazjenti ġew ikkurati b'Ulipristal Acetate Gedeon Richter jekk kampjuni ta' bijopsija/kirurġiċi jkollhom jintbagħtu għal analiżi.
English: • the contraindications of pregnancy and breastfeeding, genital bleeding of unknown aetiology or for reasons other than uterine fibroids, and uterine, cervical, ovarian or breast cancer as well as underlying hepatic disorder.
Maltese: • il-kontra-indikazzjonijiet tat-tqala u t-treddigħ, fsada ġenitali ta' etjoloġija mhux magħrufa jew għal raġunijiet oħra li mhumiex fibrojdi uterini, u kanċer tal-utru, ċervikali, tal-ovarji jew tas-sider kif ukoll disturb tal-fwied sottostanti.
English: Ulipristal Acetate Gedeon Richter contains the active substance ulipristal acetate.
Maltese: X'inhu Ulipristal Acetate Gedeon Richter u għalxiex jintuża Ulipristal Acetate Gedeon Richter fih is-sustanza attiva ulipristal acetate.
English: The lining of the uterus may thicken or change as a result of taking Ulipristal Acetate Gedeon Richter.
Maltese: Għaldaqstant, treddax lit-tarbija tiegħek waqt li tkun qed tieħu Ulipristal Acetate Gedeon Richter.
English: Due to the CYP-mediated metabolism, hepatic impairment is expected to alter the elimination of ulipristal acetate, resulting in increased exposure.
Maltese: Minħabba l-metaboliżmu medjat minn CYP, l-indeboliment tal-fwied huwa mistenni li jbiddel l-eliminazzjoni ta' ulipristal acetate, li jwassal għal żieda fl-esponiment.
English: Ulipristal acetate is readily converted to its mono-N-demethylated and subsequently to its di-N-demethylated metabolites.
Maltese: Bijotrasformazzjoni/Eliminazzjoni Ulipristal acetate jiġi kkonvertit malajr fil-metaboliti mono-N-demethylated u sussegwentement fil metaboliti di-N-demethylated tiegħu.
English: Patients in this study were required to be anaemic at Study entry (Hb < 10.2 g/dl) and all patients were to receive oral iron 80 mg Fe++ in addition to study medicinal product.
Maltese: Il-pazjenti f'dan l-istudju kienu meħtieġa li jkunu anemiċi fid-dħul tal-Istudju (Hb < 10.2 g/dl) u l-pazjenti kollha kellhom jirċievu ħadid orali ta' 80 mg Fe++ apparti lprodott mediċinali tal-istudju.
English: The MAH shall ensure that, at launch and thereafter, all prescribers of Ulipristal Acetate Gedeon Richter and pathologists who review samples from Ulipristal Acetate Gedeon Richter-treated patients, as well as patients treated with Ulipristal Acetate Gedeon Richter, are provided with educational material.
Maltese: L-MAH għandu jiżgura li, mat-tnedija u minn hemm ‘il quddiem, dawk kollha li jagħtu Ulipristal Acetate Gedeon Richter fuq riċetta u l-patoloġisti li jirrevedu kampjuni minn pazjenti kkurati b'Ulipristal Acetate Gedeon Richter, kif ukoll pazjenti ttrattati b'Ulipristal Acetate Gedeon Richter,
English: Dr. Ondřej Slanař (Czech Republic)
Maltese: Dr. Ondřej Slanař (ir-Repubblika Ċeka)
English: The final agreed wording describes some possible combinations.
Maltese: Il-formulazzjoni finali li ġiet aċċettata tiddeskrivi xi kombinazzjonijiet possibbli.
English: • Zollinger-Ellison syndrome.
Maltese: • sindromu ta' Zollinger-Ellison.
English: 27 February 2009, 24 August 2009 ,19 October 2009 and 23 December 2009
Maltese: 27 ta' Frar 2009, 24 ta' Awwissu 2009 ,19 ta' Ottubru 2009 u 23 ta' Diċembru 2009
English: 20 January 2010
Maltese: 20 ta' Jannar 2010
English: Dr. Barbara van Zwieten-Boot (the Netherlands)
Maltese: Dr. Barbara van Zwieten-Boot (il-Pajjiżi l-Baxxi)
English: 24 July 2008
Maltese: 24 ta' Lulju 2008
English: 10 June 2010
Maltese: 10 ta' Ġunju 2010
English: What is Losec?
Maltese: X'inhu Losec?
English: The active substance in Losec, omeprazole, is a proton pump inhibitor (PPI).
Maltese: Is-sustanza attiva f'Losec, omeprazole, hija inibitur tal-pompa tal-proton (PPI).
English: Losec is also available in the EU under other trade names: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca and Zoltum.
Maltese: Losec jinsab ukoll fl-UE b'ismijiet kummerċjali oħrajn: Antra, Logastric, Losec Forte, Mopral, Omeprazen, Omeprazole AstraZeneca u Zoltum.
English: Losec is authorised in the EU via national procedures.
Maltese: Losec huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: • In combination with antibiotics in the treatment of duodenal ulcer caused by H. pylori.
Maltese: • F'kombinazzjoni ma' antibijotiċi fil-kura ta' ulċeri duwodenali kkawżati minn H. pylori.
English: Questions and answers on Losec and associated names (omeprazole, 10, 20 or 40 mg capsules and tablets, and 40 mg solution for injection and solution for infusion)
Maltese: Mistoqsijiet u tweġibiet dwar Losec u l-ismijiet assoċjati (omeprazole, 10, 20 u 40 mg kapsuli u pilloli, u 40 mg soluzzjoni għal injezzjoni u soluzzjoni għal infużjoni)
English: • symptomatic gastro-oesophageal reflux disease,
Maltese: • mard ta' rifluss gastroesofagali sintomatiku,
English: In children:
Maltese: Fl-adulti:
English: • duodenal ulcers (treatment and prevention of relapse),
Maltese: • ulċeri duwodenali (kura u prevenzjoni ta' rikaduta),
English: When used as an OTC medicine, the CHMP recommended that the indication be the treatment of reflux symptoms (e.g. heartburn, acid regurgitation) in adults.
Maltese: Meta użat bħala mediċina OTC, is-CHMP irrakkomanda li l-indikazzjoni tkun il-kura ta' sintomi ta' rifluss (eż. ħruq ta' stonku, regurġitazzjoni ta' aċidu) fl-adulti.
English: Losec has been identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Losec ġie identifikat mill-Grupp ta' Koordinazzjoni għal Proċeduri Reċiproċi u Deċentralizzati - Bnedmin (CMD(h)) li jeħtieġ armonizzazzjoni.
English: The 10 and 20 mg tablets may be available as non-prescription medicines (over-the-counter, OTC) in some Member States.
Maltese: F'xi Stati Membri, il-pilloli ta' 10 u 20 mg jistgħu jinstabu bħala mediċini li ma għandhomx bżonn ta' riċetta ta' tabib (over-the-counter, OTC).
English: On 27 June 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Losec in the EU.
Maltese: Fis-27 ta' Ġunju 2008, il-Kummissjoni Ewropea rriferiet il-kwistjoni lis-CHMP biex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Losec fl-UE.