FrancophonIA/ELRC3.0 huggingface dataset:
English: • Treatment of NSAID-associated gastric and duodenal ulcers
Maltese: • Għall-kura ta' ulċeri tad-duwodenu
English: The other ingredients are microcrystalline cellulose, glyceryl monostearate, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid copolymer, sugar spheres, paraffin, macrogol (polyethylene glycol), polysorbate, polyvinylpyrrolidone crosslinked, sodium hydroxide (for pH-adjustment), sodium stearyl fumarate, talc, triethyl citrate, iron oxide, titanium dioxide.
Maltese: Microcrystalline cellulose, glyceryl monostearate, hydroxypropylcellulose, hydroxypropyl methylcellulose, magnesium stearate, methacrylic acid co-polymer, sferi taz-zokkor, paraffin, macrogol (polyethylene glycol), polysorbate, polyvinylpyrrolidone crosslinked, sodium hydroxide (għal aġġustament tal-pH), sodium stearyl fumarate, talc, triethyl citrate, iron oxide, titanium dioxide
English: • Do not store above 30°C.
Maltese: • Taħżinx f'temperatura 'l fuq minn 30°C.
English: Side effects may occur with certain frequencies, which are defined as follows: Very common:
Maltese: Effetti sekondarji jistgħu jseħħu b'ċerti frekwenzi, li huma ddefiniti kif ġej:
English: Oral dosing with omeprazole 20 mg maintains an intragastric pH of ≥ 3 for a mean time of 17 hours of the 24-hour period in duodenal ulcer patients.
Maltese: Għoti ta' dożi ta' omeprazole 20 mg jżomm pH fl-istonku ta' ≥ 3 għal medja ta' 17-il siegħa millperjodu ta' 24-siegħa f'pazjenti b'ulċera fid-duwodenu.
English: wheezing.
Maltese: Losec.
English: • Atazanavir (used to treat HIV infection)
Maltese: • Atazanavir (jintuża biex jikkura l-infezzjoni tal-HIV)
English: This time- and dosedependency is due to a decrease of first pass metabolism and systemic clearance probably caused by an inhibition of the CYP2C19 enzyme by omeprazole and/or its metabolites (e.g. the sulphone).
Maltese: Din id-dipendenza fuq il-ħin u d-doża hija minħabba tnaqqis fil-metaboliżmu first pass u tnaqqis fit-tneħħija sistemika probabbli kkawżata minħabba inibizzjoni tal-enzima CYP2C19 minn omeprazole u/jew il-metaboli tiegħu (eż. is-sulphone).
English: Dry mouth, stomatitis, gastrointestinal candidiasis Hepatobiliary disorders Uncommon:
Maltese: Losec jintuża biex jikkura il-kundizzjonijiet li ġejjin:
English: The recommended dose is Losec 20 mg once daily.
Maltese: Id-doża rrakkomandata hija Losec 20 mg kuljum.
English: o Perforated unit dose blisters (hospital packs) of 25 x 1, 28 x 1, 50 x 1, 56 x 1 tablets.
Maltese: o Folja mtaqqba biex tinqata doża waħda (pakkett għall-isptar) ta' 25 x 1, 28 x 1, 50 x 1, 56 x 1 pillola
English: LIST OF EXCIPIENTS Each vial contains disodium edetate and sodium hydroxide.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Kull kunjett fih disodium edetate u sodium hydroxide.
English: Losec 20 mg gastro-resistant tablets: Pink, oblong, biconvex, film-coated tablets, engraved with or on one side and 20 mg on the other side containing enteric coated pellets.
Maltese: Losec 20 mg pilloli gastroreżistenti: pilloli roża, oblongi, konvessi fuq iż-żewġ naħat, miksijin b'rita, imnaqqxin b' jew fuq naħa waħda u b'20 mg fuq in-naħa l-oħra li fihom pritkuni b'kisja enterika.
English: • Losec 40 mg capsules have a reddish-brown body marked 40 and a reddish-brown cap marked A/OL.
Maltese: • Kapsuli Losec 40 mg għandhom korp aħamar jagħti fil-kanella immarkat 40 u għatu aħmar jagħti fil-kanella immarkat A/OL.
English: • Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Maltese: • Diazepam (jintuża biex jikkura ansjetà, biex jirrilassa l-muskoli jew għall-epilessija).
English: For instructions on reconstitution of the product before administration, see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni tal-prodott qabel jingħata, ara sezzjoni 6.6.
English: Vial of 10 ml made of colourless borosilicate glass, type I. Stopper made of bromobutyl rubber, cap made of aluminium and a plastic polypropylene lid.
Maltese: Tapp magħmul minn lastku bromobutyl, siġill magħmul mill-aluminju u għatu tal-plastic magħmul mill-plastik tal- polypropylene.
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Maltese: Pazjenti bi problemi eriditarji rari ta' intolleranza għal fructose, malassorbiment tal-glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase m'għandhomx jieħdu din il-mediċina.
English: Break the tablet and disperse it in a spoonful of non-carbonated water - if so wished, mix with some fruit juices or applesauce.
Maltese: Aqsam il-pillola u ferrixha f'mgħarfa ilma mhux bil-gass - jekktixtieq, ħallatha ma' xi meraq tal-frott jew pure tat-tuffieħ.
English: Bioequivalence between Losec capsules and Losec gastro-resistant tablets, based on both area under the omeprazole plasma concentration-time curve (AUC) and maximum plasma concentration (Cmax) of omeprazole, has been demonstrated for all doses, 10 mg, 20 mg and 40 mg.
Maltese: Il-bijoekwivalenza bejn il- kapsuli Losec u l-pilloli gastroreżistenti Losec, ibbażata kemm fuq l-erja taħt il-kuva tal-konċentrazzjoni ta' omeprazole fil-plażma u l-ħin (AUC) kif ukoll fuq l-ogħla konċentrazzjoni ta' omeprazole fil-plażma (Cmax), intweriet bid-dożi kollha, 10 mg, 20 mg u 40 mg.
English: - The other ingredients are disodium edetate and sodium hydroxide.
Maltese: Kull kunjett fih sodium hydroxide.
English: What Losec looks like and contents of the pack
Maltese: Id-Dehra ta' Losec u l-kontenuti tal-pakkett
English: • If you or your child have trouble swallowing the capsules: - Open the capsules and swallow the contents directly with half a glass of water or put the contents into a glass of still (non-fizzy) water, any acidic fruit juice (e.g. apple, orange or pineapple) or apple sauce.
Maltese: • jekk int jew ibnek/bintek għandkom problema biex tibilgħu l-kapsuli: - iftaħ il-kapsuli u ibla' l-kontenut direttament u wara ħu nofs tazza ilma, jew itfa' lkontenut ġo nofs tazza ilma (mhux bil-gass) u ixorbu, kull meraq tal-frott aċiduż (eż. tuffieħ, larinġ u pineapple) jew pure tat-tuffieħ.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder for solution for injection contains omeprazole sodium 42.6 mg, equivalent to omeprazole 40 mg. After reconstitution, 1 ml contains omeprazole sodium 4.26 mg, equivalent to omeprazole 4 mg.
Maltese: Wara r-rikonstituzzjoni, 1 ml ikun fih omeprazole sodium 4.26 mg, ekwivalenti għal omeprazole 4 mg
English: • Spinning feeling (vertigo).
Maltese: • Tħoss rasek iddur bik (vertiġini).
English: • if you are allergic to medicines containing other proton pump inhibitors (eg pantoprazole,
Maltese: • jekk int allerġiku għal mediċini li fihom inibituri tal-pompa tal-proton (eż. pantoprazole,
English: • 10 mg: o HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 or 100 capsules; hospital packs of 140, 280 or 700 capsules.
Maltese: • 10 mg: o Fliexken HDPE ta' 5, 7, 10, 14, 15, 28, 30, 50, 56, 60 jew 100 kapsula; pakketti għallisptar ta' 140, 280 jew 700 kapsula o Folji ta' 7, 14, 15, 28, 30, 35, 50, 60 jew 84 kapsula.
English: Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets Losec and associated names (see Annex I) 40 mg gastro-resistant tablets
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg pilloli gastroreżistenti Losec u ismijiet assoċjati (ara Anness I) 20 mg pilloli gastroreżistenti Losec u ismijiet assoċjati (ara Anness I) 40 mg pilloli gastroreżistenti [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: This medicine is available without prescription.
Maltese: Din il-mediċina tingħata mingħajr riċetta.
English: • 20 mg: o HDPE bottles of 5, 7, 10, 14, 15, 28, 30, 50, 60 or 100 capsules; hospital packs of 140, 280 , or 700 capsules.
Maltese: • 20 mg: o Fliexken HDPE ta' 5, 7, 10, 14, 15, 28, 30, 50, 60 jew 100 kapsula; pakketti għallisptar ta' 140, 280 jew 700 kapsula o Folji ta' 7, 14, 15, 28, 30, 50, 60 jew 84 kapsula.
English: Since omeprazole is metabolised by CYP2C19 and CYP3A4, active substances known to inhibit CYP2C19 or CYP3A4 (such as clarithromycin and voriconazole) may lead to increased omeprazole serum levels by decreasing omeprazole's rate of metabolism.
Maltese: Din iddipendenza mal-ħin u mad-doża sseħħ minħabba li l-metaboliżmu first-pass u t-tneħħija sistemika jonqsu probabbli minħabba inibizzjoni tal-enzima CYP2C19 minn omeprazole u/jew il-metaboli tiegħu (eż is-sulphone).
English: To treat ulcers in the stomach (gastric ulcer):
Maltese: Biex tikkura ulċeri fl-istonku (ulċera gastrika)
English: • You have severe liver problems.
Maltese: • Problemi fid-demm bħal nuqqas ta'ċelloli bojod jew plejtlits.
English: 20 mg: 5, 7, 10, 14, 15, 28, 30, 50, 60, 100 capsules; hospital packs of 140, 280 or 700 capsules.
Maltese: 20 mg: 5, 7, 10, 14, 15, 28, 30, 50, 60, 100 kapsula; pakketti għall-isptar ta' 140, 280 jew 700 kapsula. 40 mg: 5, 7, 14, 15, 28, 30, 60 kapsula; pakketti għall-isptar ta' 140, 280 jew 700 kapsula.
English: • Treatment of symptomatic gastro-esophageal reflux disease
Maltese: • Għall-kura ta' mard ta' rifluss gastro-esofagali bis-sintomi
English: Losec and associated names (see Annex I) 10 mg Losec and associated names (see Annex I) 20 mg Losec and associated names (see Annex I) 40 mg
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg Losec u ismijiet assoċjati (ara Anness I) 20 mg Losec u ismijiet assoċjati (ara Anness I) 40 mg
English: With a syringe draw 5 ml of infusion solution from the 100 ml infusion bottle or bag.
Maltese: B'siringa iġbed 5 ml ta' soluzzjoni tal-infużjoni mill-flixkun jew il-borża tal-infużjoni ta' 100 ml.
English: 5.1 Pharmacodynamic properties
Maltese: Effetti farmakodinamiċi
English: Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg pilloli gastroreżistenti Losec u ismijiet assoċjati (ara Anness I) 20 mg pilloli gastroreżistenti
English: Losec and associated names (see Annex I) 40 mg powder and solvent for solution for injection
Maltese: Losec u ismijiet assoċjati (ara Anness I) 40 mg trab u solvent għal soluzzjoni għall-injezzjoni
English: • An infection called “thrush” which can affect the gut and is caused by a fungus.
Maltese: • Infezzjoni msejjħa “thrush” li tista' taffetwa l-imsaren u hija kkawżata minn fungu.
English: Losec for intravenous use is indicated as an alternative to oral therapy for the following indications:
Maltese: Losec għal użu ġol-vini huwa indikat bħala alternattiva għal terapija orali għall-indikazzjonijiet li ġejjin:
English: Losec and associated names (see Annex I) 10 mg gastro-resistant tablets Losec and associated names (see Annex I) 20 mg gastro-resistant tablets [See Annex I - To be completed nationally] Omeprazole
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg pilloli gastroreżistenti Losec u ismijiet assoċjati (ara Anness I) 20 mg pilloli gastroreżistenti [Ara Anness I - Biex timtela mill-pajjiż partikolari] omeprazole
English: Interstitial nephritis
Maltese: Sustanzi attivi oħra
English: Losec and associated names (see Annex I) 10 mg hard capsules Losec and associated names (see Annex I) 20 mg hard capsules Losec and associated names (see Annex I) 40 mg hard capsules
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg kapsuli Losec u ismijiet assoċjati (ara Anness I) 20 mg kapsuli Losec u ismijiet assoċjati (ara Anness I) 40 mg kapsuli [Ara Anness I - Biex timtela mill-pajjiż partikolari] omeprazole
English: A randomised, double blind clinical study (Héliot study) concluded that omeprazole, in combination with two antibiotics (amoxicillin and clarithromycin), was safe and effective in the treatment of H. pylori infection in children age 4 years old and above with gastritis: H. pylori eradication rate: 74.2% (23/31 patients) with omeprazole + amoxicillin + clarithromycin versus 9.4% (3/32 patients) with amoxicillin + clarithromycin.
Maltese: Studju kliniku randomised, double blind (studju Héliot) ikkonkluda li omeprazole flimkien ma' żewġ antibijotiċi (amoxicillin u clarithromycin), kien sigur u effettiv fil-kura ta' infezzjoni b'H.pylori fi tfal minn 4 snin 'l fuq b'gastrite:
English: Abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting
Maltese: Uġigħ addominali, stitikezza, dijarea, gass, tqalligħ/rimettar
English: H. pylori eradication in peptic ulcer disease
Maltese: II. Solvent għall-injezzjoni
English: • Skin rash, lumpy rash (hives) and itchy skin.
Maltese: • Raxx fil-ġilda, raxx bil-boċċi (ħorriqija) u ħakk fil-ġilda.
English: Draw the omeprazole solution back into the syringe.
Maltese: Iġbed is-soluzzjoni ta' omeprazole lura fis-siringa.
English: Co-administration of omeprazole (40 mg once daily) reduced mean nelvinavir exposure by ca. 40% and the mean exposure of the pharmacologically active metabolite M8 was reduced by ca. 75-90%.
Maltese: 40% u lesponiment medju tal-meabolit attiv b'mod farmakoloġiku M8 tnaqqas b'madwar 75-90%. Linterazzjoni tista' tinvolvi wkoll l-inibizzjoni ta' CYP2C19 inhibition.
English: 20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 tablets; hospital pack of, 560 tablets.
Maltese: 10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 pillola; pakkett għall-isptar ta' 560 tablets. 20 mg: 5, 7, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 98, 100 pillola; pakkett għall-isptar ta' 560 pillola. 40 mg: 5, 7, 14, 15, 28, 30, 50, 56, 60, 100 pillola; pakkett għall-isptar ta' 560 pillola
English: The major part of its metabolism is dependent on the polymorphically expressed CYP2C19, responsible for the formation of hydroxyomeprazole, the major metabolite in plasma.
Maltese: Il-parti l-kbira talmetaboliżmu tiegħu jiddependi fuq CYP2C19 li jiġi espress b'mod polimorfiku, responsabbli għallformazzjoni ta' hydroxyomeprazole, il-metabolu ewlieni fil-plażma.
English: Hard capsules
Maltese: Kapsuli ibsin
English: Losec powder and solvent for solution for injection can be used as an alternative to oral therapy.
Maltese: It-trab Losec u s-solvent għal soluzzjoni għall-injezzjoni jistgħu jintużaw bħala alternattiva għal terapija orali.
English: Total plasma clearance is about 30-40 l/h after a single dose.
Maltese: It-tneħħija totali mill-plażma hija madwar 30-40 l/siegħa wara doża waħda.
English: • Children aged over 4 years may take Losec.
Maltese: • Tfal aktar minn 4 snin jistgħu jieħdu Losec.
English: Losec and associated names (see Annex I) 40 mg powder for solution for infusion [See Annex I - To be completed nationally] Omeprazole
Maltese: Losec u ismijiet assoċjati (ara Anness I) 40 mg trab għall-infużjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari] omeprazole iv
English: 31-40 kg Combination with two antibiotics: Losec 20 mg, amoxicillin 750 mg and clarithromycin 7.5 mg/kg body weight are all administrated two times daily for one week.
Maltese: Losec 20 mg, amoxicillin 750 mg u clarithromycin 7.5 mg/kg piż tal-ġisem jingħataw kollha flimkien darbtejn kuljum għal ġimgħa.
English: 15-30 kg Combination with two antibiotics: Losec 10 mg, amoxicillin 25 mg/kg body weight and clarithromycin 7.5 mg/kg body weight are all administrated together two times daily for one week
Maltese: Losec 10 mg, amoxicillin 25 mg/kg piż tal-ġisem u clarithromycin 7.5 mg/kg piż tal-ġisem jingħataw kollha flimkien darbtejn kuljum għal ġimgħa.
English: Losec and associated names (see Annex I) 10 mg capsules Losec and associated names (see Annex I) 20 mg capsules Losec and associated names (see Annex I) 40 mg capsules [See Annex I - To be completed nationally]
Maltese: Losec u ismijiet assoċjati (ara Anness I) 10 mg kapsuli ibsin Losec u ismijiet assoċjati (ara Anness I) 20 mg kapsuli ibsin Losec u ismijiet assoċjati (ara Anness I) 40 mg kapsuli ibsin [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Treatment of reflux esophagitis
Maltese: TA' PRODOTTI MEDIĊINALI MHUX
English: Perforated unit dose blister (hospital pack):
Maltese: INFORMAZZJONI BIL-BRAILLE Pakkett għall-isptar:
English: • 40 mg: o HDPE bottles of 5, 7, 14, 15, 28, 30 or 60 capsules; hospital packs of 140, 280, or 700 capsules.
Maltese: • 40 mg: o Fliexken HDPE ta' 5, 7, 14, 15, 28, 30, jew 60 kapsula; pakketti għall-isptar ta' 140, 280 jew 700 kapsula o Folji ta' 7, 14, 15, 28, jew 30, 50, 60 jew 84 kapsula.
English: Losec gastro-resistant tablets contains the active substance omeprazole.
Maltese: Id-Dehra ta' Losec u l-kontenuti tal-pakkett:
English: • Muscle weakness.
Maltese: • Dgħufija fil-muskoli.
English: 10 mg: 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 tablets; hospital pack of 560 tablets.
Maltese: • 10 mg: o Fliexken HDPE ta' 7, 14, 15, 28, 30, 50, 100 pillola; pakketti għall-isptar ta' 140 pillola o Folji ta' 5, 7, 10, 14, 15, 25, 28, 30, 50, 56, 60, 84, 90, 100 pillola; pakketti għallisptar ta' 560 pillola.
English: Weight
Maltese: EFFETTI
English: • Losec 40 mg gastro-resistant tablets are dark red-brown with or on one side and 40 mg on the other side.
Maltese: • Il-pilloli gastroreżistenti Losec 40 mg huma pilloli ħomor skuri fil-kannella b' jew fuq naħa waħda u b'40 mg fuq in-naħa l-oħra.
English: Losec and associated names (see Annex I) 40 mg powder and solvent for solution for injection (I+II) [See Annex I - To be completed nationally] omeprazole
Maltese: Losec u ismijiet assoċjati (ara Anness I) 40 mg trab u solvent għal soluzzjoni għall-injezzjoni [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Losec and associated names (see Annex I) 10 mg Losec and associated names (see Annex I) 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Losec u ismijiet assoċjati (ara Anness I) 10 mg Losec u ismijiet assoċjati (ara Anness I) 20 mg
English: Losec 10 mg gastro-resistant tablets: Light-pink, oblong, biconvex, film-coated tablets engraved with or on one side and 10 mg on the other side containing enteric coated pellets.
Maltese: Losec 10 mg pilloli gastroreżistenti: pilloli roża ċari, oblongi, konvessi fuq iż-żewġ naħat, miksijin b'rita imnaqqxin b' jew fuq naħa waħda u b'10 mg fuq in-naħa l-oħra li fihom pritkuni b'kisja enterika.
English: Omeprazole is a weak base and is concentrated and converted to the active form in the highly acidic environment of the intracellular canaliculi within the parietal cell, where it inhibits the enzyme H+ K+-ATPase - the acid pump.
Maltese: Omeprazole huwa bażi dgħajjef u jiġi kkonċentrat u mibdul fil-forma attiva fl-ambjent aċiduż ħafna tal-kanalikuli fiċ-ċelluli ta' ġoċ-ċelluli parjetali, fejn jinibixxi l-enzima H+ K+-ATPase - il-pompa tal aċidu.
English: • Changes in blood count including agranulocytosis (lack of white blood cells)
Maltese: • Saquinavir (jintuża biex jikkura infezzjoni bl-HIV)
English: • 20 mg: o HDPE bottles of 7, 14, 15, 28, 30, 50, 56, 100 tablets; hospital packs of 140 , 200, 280 tablets.
Maltese: • 20 mg: o Fliexken HDPE ta' 7, 14, 15, 28, 30, 50, 56, 100 pillola; pakketti għall-isptar ta' 140, 200, 280 pillola o Folji ta' 5,7, 14, 15, 25,28, 30, 50, 56, 60, 84 90, 98, 100 pillola.
English: 40 mg: hard gelatine capsules with an opaque reddish-brown body, marked 40 and an opaque reddishbrown cap marked A/OL, containing enteric coated pellets.
Maltese: 40 mg: kapsuli ibsin tal-ġelatina b'korp opak aħmar jagħti fil-kanella, immarkat 40 u għatu opak aħmar jagħti fil-kanella mmarkat A/OM li fihom pritkuni b'kisja enterika.
English: Other side effects include:
Maltese: Disturbi psikjatriċ Mhux komuni:
English: Chemical and physical in-use stability has been demonstrated for 4 hours at 25oC after reconstitution.
Maltese: Stabbilità kimika u fiżika waqt l-użu kienet pruvata għal 4 sigħat f'temperatura ta' 25°C wara rrikostuzzjoni.
English: After reconstitution the injection should be given slowly over a period of at least 2.5 minutes at a maximum rate of 4 ml per minute.
Maltese: Wara r-rikostituzzjoni l-injezzjoni għandha tingħata bilmod fuq perjodu ta' mill-anqas żewġ minuti u nofs b'rata massima ta' 4 ml kull minuta.
English: If needed, the dose can be increased to Losec 20-40 mg once daily.
Maltese: Jekk ikun hemm bżonn, id-doża tista' tiżdied għal Losec 20-40 mg darba kuljum.
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 Losec 20-120 mg daily.
Maltese: Il-pazjenti kollha b'mard sever u li ma kellhomx rispons xieraq għal terapiji oħrajn kienu kontrollati b'mod effettiv u aktar minn 90% tal-pazjenti mmantna fuq dożi ta' Losec 20-120 mg kuljum.
English: Treatment of gastric ulcers
Maltese: Trab għall-injezzjoni
English: Alternative preparation for infusions in flexible containers Use a double-ended transfer needle and attach to the injection membrane of the infusion bag.
Maltese: Peparazzjoni alternattiva ta' infużjonijiet ġo kontenituri flessibbli Uża labra li ttaqqab miż-żewġ naħat u titrasferixxi u waħħalha mal-membrana tal-injezzjoni talborża tal-infużjoni.
English: In patients with Zollinger-Ellison syndrome the dose should be individually adjusted and treatment continued as long as clinically indicated.
Maltese: Madankollu, ma kienx hemm evidenza ta' xi benefiċċju kliniku rigward is-sintomi ta' indiġestjoni.
English: • Losec 10 mg gastro-resistant tablets are light-pink with or on one side and 10 mg on the other side.
Maltese: • Il-pilloli gastroreżistenti Losec 10 mg huma pilloli roża ċari b' jew fuq naħa waħda u b'10 mg fuq in-naħa l-oħra
English: • The usual dose is 20 mg Losec twice a day for one week.
Maltese: • Id-doża li s-soltu tingħata hija 20 mg Losec darbtejn kuljum għal ġimgħa.
English: Treatment of duodenal ulcers
Maltese: Kura ta' ulċeri tad-duwodenu
English: • Clopidogrel (used to prevent blood clots (thrombi))
Maltese: • Digoxin (jintuża biex jikkura problemi tal-qalb).
English: Annex I List of medicinal products and presentations
Maltese: Lista ta 'prodotti mediċinali u preżentazzjonijiet
English: Date of latest renewal 24.04.2011
Maltese: Data ta' l-aħħar tiġdid: 24.04.2011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/335/001
Maltese: FIS-SUQ EU/1/06/335/001
English: INFORMATION IN BRAILLE Valtropin 5 mg/1.5 ml
Maltese: INFORMAZZJONI BIL-BRAILLE Valtropin 5 mg/1.5 ml
English: Name and address of the manufacturer of the biological active substance LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, South Korea Name and address of the manufacturer responsible for batch release BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany
Maltese: Isem u indirizz tal-manifattur tas-sustanza bijoloġika attiva LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, Korea t'Isfel Isem u indirizz tal-manifattur responsabbli għall-ħruġ tal-lott BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, il-Ġermanja
English: Subcutaneous administration of 0.073 mg/kg body weight of Valtropin resulted in a Cmax of 43.97 ng/ml and an AUC0-24 h of 369.90 ng·h/ml.
Maltese: L-għoti taħt ġilda ta' 0.073 mg/kg tal-piż tal-ġisem ta' Valtropin irriżulta f'Cmax ta' 43.97 ng/ml u AUC0-24 h ta' 369.90 ng h/ml.
English: Sensitivity to metacresol
Maltese: Sensittività għal metacresol
English: It has 191 amino acid residues and a molecular weight of 22,125 daltons.
Maltese: Huwa għandu 191 residwu ta' aċidu amminiku u piż molekulari ta' 22,125 daltons.
English: Powder: - The active substance is somatropin.
Maltese: - Is-sustanza attiva hija somatropin.
English: The cut-off point of the dynamic test should be strict.
Maltese: Il-punt ta' qtugħ il-linja tat-test dinamiku għandu jkun strett.
English: The clinical significance of this is unknown.
Maltese: Ir-rilevanza klinika ta' dan it-tnaqqis mhuwiex magħruf.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation 24.04.2006
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 24.04.2006
English: Personality disorder
Maltese: Disturbi fil-personalità
English: Cmax was reached at 4 h and t½ was 3 h.
Maltese: Cmax intlaħaq wara 4 sigħat u t-t½ kien 3 sigħat.
English: Somatropin is a polypeptide hormone of recombinant DNA origin.
Maltese: Somatropin huwa ormon polipeptide ta' oriġini ta' DNA rikombinanti.