FrancophonIA/ELRC3.0 huggingface dataset:
English: Effect of pantoprazole on the absorption of other medicinal products Because of profound and long lasting inhibition of gastric acid secretion, pantoprazole may reduce the absorption of drugs with a gastric pH dependent bioavailability, e.g some azole antifungals as ketoconazole, itraconazole, posaconazole and other medicine as erlotinib.
Maltese: L-effett ta' pantoprazole fuq l-assorbiment ta' prodotti mediċinali oħrajn Minħabba l-inibizzjoni profonda u li ddum tat-tnixxija tal-aċidu gastriku, pantoprazole jista' jnaqqas l-assorbiment ta' mediċini b'bijodisponibilità li tiddependi fuq il-pH gastriku, eż. xi antifungali azole bħal ketoconazole, itraconazole, posaconazole u mediċina oħra bħal erlotinib.
English: Hospital pack with 20 (20x1) vials.
Maltese: Pakkett tal-isptar b'20 (20x1) kunjett.
English: Pharmacotherapeutic group: Proton pump inhibitors, ATC code: A02BC02
Maltese: Inibituri tal-pompa tal-proton, Kodiċi ATC:
English: Pantoprazole is converted to its active form in the acidic environment in the parietal cells where it inhibits the H+, K+-ATPase enzyme, i. e. the final stage in the production of hydrochloric acid in the stomach.
Maltese: Pantoprazole jinbidel għall-forma attiva tiegħu fl-ambjent aċidiku fiċ-ċelluli parjetali fejn jinibixxi l-enzima H+, K+-ATPase, i.e. il-fażi finali fil-produzzjoni ta' hydrochloric acid fl-istonku.
English: Detailed information on this medicinal product is available on the website of the Heads of Medicines Agencies (HMA) http://www.hma.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Mexxejja tal-Aġenziji dwar il-Mediċini (HMA) http://www.hma.eu
English: Interaction studies with drugs also metabolized with these pathways, like carbamazepine, diazepam, glibenclamide, nifedipine, and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
Maltese: Studji dwar l-interazzjonijiet b'mediċini li jiġu metabolizzati wkoll b'dawn il-passaġġi, bħal carbamazepine, diazepam, glibenclamide, nifedipine, u kontraċettiv orali li fih levonorgestrel u ethinyl oestradiol, ma żvelaw l-ebda interazzjonijiet klinikament sinifikanti.
English: Pack with 1 vial.
Maltese: Pakkett b'1 kunjett.
English: Thrombocytopenia;
Maltese: Artralġja;
English: Rare (affects 1 to 10 users in 10,000) disturbances in vision such as blurred vision; hives; pain in the joints; muscle pains; weight changes; raised body temperature; swelling of the extremities (peripheral oedema); allergic reactions; depression; breast enlargement in males.
Maltese: - Rari (jaffettwaw minn 1 sa 10 utenti minn kull 10,000) disturbi fil-vista bħal vista mċajpra; urtikarja; uġigħ fil-ġogi; uġigħ fil-muskoli; tibdil fil-piż; temperatura għolja tal-ġisem; nefħa tal-estremitajiet (edema periferali); reazzjonijiet allerġiċi; dipressjoni; tkabbir tas-sider fl-irġiel.
English: PHARMACEUTICAL FORM AND CONTENTS Pack with 5 gastro-resistant tablets.
Maltese: U KONTENUT Pakkett b'5 pilloli gastro-reżistenti.
English: 84 gastro-resistant tablets
Maltese: 84 pillola gastro-reżistenti
English: 7 gastro-resistant tablets 10 gastro-resistant tablets 14 gastro-resistant tablets 15 gastro-resistant tablets 28 gastro-resistant tablets 30 gastro-resistant tablets
Maltese: 7 pilloli gastro-reżistenti 10 pilloli gastro-reżistenti 14-il pillola gastro-reżistenti 15-il pillola gastro-reżistenti 28 pillola gastro-reżistenti 30 pillola gastro-reżistenti
English: The treatment period for reflux oesophagitis is usually between 4 and 8 weeks.
Maltese: Il-perjodu ta' kura għal esofagite riflussa hu normalment bejn 4 u 8 ġimgħat.
English: Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Maltese: Iperlipidimji u żidiet fil-lipidi (triglycerides, kolesterol); Tibdil fil-piż
English: Eradication of Helicobacter pylori (H. pylori) in combination with appropriate antibiotic therapy in patients with H. pylori associated ulcers.
Maltese: Il-qerda ta' Helicobacter pylori (H. pylori) flimkien ma' terapija antibijotika adattata f'pazjenti b'ulċeri assoċjati ma' H. pylori.
English: [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: [Ara Anness I - Biex timtela mill-pajjiż partikolari] {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Pantoprazole is extensively metabolized in the liver via the cytochrome P450 enzyme system.
Maltese: Studji oħrajn dwar l-interazzjonijiet Pantoprazole jiġi metabolizzat b'mod estensiv fil-fwied permezz tas-sistema tal-enzimi ta' ċitokrom P450.
English: 50 gastro-resistant tablets 56 gastro-resistant tablets 84 gastro-resistant tablets 90 gastro-resistant tablets 112 gastro-resistant tablets 140 gastro-resistant tablets 140 (10x14) (5x28) gastro-resistant tablets 150 (10x15) gastro-resistant tablets 280 (20x14), (10x28) gastro-resistant tablets 500 gastro-resistant tablets 700 (5x140) gastro-resistant tablets
Maltese: 50 pillola gastro-reżistenti 56 pillola gastro-reżistenti 84 pillola gastro-reżistenti 90 pillola gastro-reżistenti 112-il pillola gastro-reżistenti 140 pillola gastro-reżistenti 140 (10x14) (5x28) pillola gastro-reżistenti 150 (10x15) pillola gastro-reżistenti 280 (20x14), (10x28) pillola gastro-reżistenti 500 pillola gastro-reżistenti 700 (5x140) pillola gastro-reżistenti
English: Two vials (80 mg pantoprazole) a day.
Maltese: Żewġ kunjetti (80 mg ta' pantoprazole) kuljum.
English: Hospital pack with 10 (10x1) vials.
Maltese: Pakkett tal-isptar b'10 (10x1) kunjetti.
English: Do not take Protium
Maltese: X'INHU PROTIUM
English: PACKAGE LEAFLET
Maltese: Doża rakkomandata
English: Mean peak plasma concentrations were increased by about 60 %.
Maltese: Il-medja tal-konċentrazzjonijiet massimi fil-plażma żdiedu b'madwar 60%.
English: 56 gastro-resistant tablets
Maltese: 56 pillola gastro-reżistenti
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data)
Maltese: Il-frekwenza tal-effetti sekondarji possibbli elenkata hawn taħt hi definita bl-użu tal-konvenzjoni li ġejja: komuni ħafna (jaffettwaw iktar minn utent 1 minn kull 10) komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) mhux komuni (jaffettwaw minn 1 sa 10 utenti minn kull 1,000) rari (jaffettwaw minn 1 sa 10 utenti minn kull 10,000) rari ħafna (jaffettwaw inqas minn utent 1 minn kull 10,000) mhux magħruf (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli)
English: Constipation;
Maltese: Dijarea;
English: The treatment period for stomach ulcers is usually between 4 and 8 weeks.
Maltese: Il-perjodu ta' kura għal ulċeri tal-istonku hu normalment ta' bejn 4 u 8 ġimgħat.
English: 90 gastro-resistant tablets
Maltese: 90 pillola gastro-reżistenti
English: One vial (40 mg pantoprazole) a day.
Maltese: Kunjett wieħed (40 mg ta' pantoprazole) kuljum.
English: Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions patients should start their treatment with a daily dose of 80 mg (2 tablets of Protium 40 mg).
Maltese: Is-Sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn Għall-immaniġġjar fit-tul tas-Sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn, il-pazjenti għandhom jibdew il-kura tagħhom b'doża ta' kuljum ta' 80 mg (2 pilloli ta' Protium 40 mg).
English: The increased risk should be assessed according to individual risk factors, e.g. high age (>65 years), history of gastric or duodenal ulcer or upper gastrointestinal bleeding.
Maltese: Iż-żieda fir-riskju għandha tiġi evalwata skond il-fatturi ta' riskju individwali, eż. età avvanzata (>65 sena), storja medika ta' ulċera gastrika jew duwodenali jew ħruġ ta' demm fil-parti ta' fuq tal-passaġġ gastrointestinali.
English: 49 gastro-resistant tablets
Maltese: 49 pillola gastro-reżistenti
English: 60 gastro-resistant tablets
Maltese: 60 pillola gastro-reżistenti
English: Gastric and duodenal ulcer.
Maltese: Ulċera gastrika u duwodenali.
English: The absolute bioavailability from the tablet was found to be about 77 %.
Maltese: Instab li l-bijodisponibilità assoluta mill-pillola kienet ta' madwar 77%.
English: Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific blockade of the proton pumps of the parietal cells.
Maltese: Pantoprazole hu sostitut ta' benzimidazole li jinibixxi t-tnixxija ta' hydrochloric acid fl-istonku permezz ta' imblokk speċifiku tal-pompi proton taċ-ċelluli parjetali.
English: Gynaecomastia
Maltese: Mijalġja
English: Hospital pack with 5 (5x1) vials.
Maltese: Pakkett tal-isptar b'5 (5x1) kunjetti.
English: Lithuania Luxembourg Netherlands Norway
Maltese: Il-Litwanja Il-Lussemburgu L-Olanda In-Norvegja Il-Polonja Il-Portugall Ir-Rumanija Is-Slovakkja Is-Slovenja Spanja
English: The use of Protium 20 mg as a preventive of gastroduodenal ulcers induced by non-selective non-steroidal anti-inflammatory drugs (NSAIDs) should be restricted to patients who require continued NSAID treatment and have an increased risk to develop gastrointestinal complications.
Maltese: L-użu ta' Protium 20 mg bħala preventiv ta' ulċeri gastroduwodenali kkaġunati minn mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs) mhux selettivi, għandu jiġi ristrett għal pazjenti li jeħtieġu t-tkomplija tal-kura bl-NSAIDs u li għandhom żieda fir-riskju li jiżviluppaw kumplikazzjonijiet gastrointestinali.
English: For storage conditions of the reconstituted and diluted medicinal product see section 6.3.
Maltese: Għall-kundizzjonijiet tal-ħażna tal-prodott mediċinali rikostitwit u dilwit, ara sezzjoni 6.3.
English: The recommended oral dose is one gastro-resistant tablet Protium 20 mg per day.
Maltese: Id-doża orali rakkomandata hi ta' pillola waħda gastro-reżistenti Protium ta' 20 mg kuljum.
English: The main metabolic pathway is demethylation by CYP2C19 and other metabolic pathways include oxidation by CYP3A4.
Maltese: Il-passaġġ metaboliku ewlieni hu demethylation minn CYP2C19 u passaġġi metaboliċi oħrajn jinkludu ossidazzjoni minn CYP3A4.
English: Depression (and all aggravations)
Maltese: Dipressjoni (u laggravamenti kollha)
English: 50 gastro-resistant tablets 90 gastro-resistant tablets 100 gastro-resistant tablets 140 gastro-resistant tablets 140 (10x14) gastro-resistant tablets 150 (10x15) gastro-resistant tablets 700 (5x140) gastro-resistant tablets
Maltese: 50 pillola gastro-reżistenti 90 pillola gastro-reżistenti 100 pillola gastro-reżistenti 140 pillola gastro-reżistenti 140 (10x14) pillola gastro-reżistenti 150 (10x15) pillola gastro-reżistenti 700 (5x140) pillola gastro-reżistenti
English: Treatment of gastric ulcer
Maltese: Kura ta' ulċera gastrika
English: Renal Impairment
Maltese: Nefrite interstizjali
English: 10 gastro-resistant tablets 14 gastro-resistant tablets 15 gastro-resistant tablets
Maltese: 7 pilloli gastro-reżistenti 10 pilloli gastro-reżistenti 14-il pillola gastro-reżistenti 15-il pillola gastro-reżistenti
English: Hospital pack with 1 vial.
Maltese: Pakkett b'kunjett 1.
English: Following administration of single oral doses of 20 or 40 mg pantoprazole to children aged 5 - 16 years AUC and Cmax were in the range of corresponding values in adults.
Maltese: Wara l-għoti ta' dożi orali waħidhom ta' 20 jew 40 mg ta' pantoprazole lil tfal li kellhom 5 - 16-il sena, l-AUC u c-Cmax kienu fil-medda ta' valuri li jikkorrispondu fl-adulti.
English: 98 gastro-resistant tablets
Maltese: 98 pillola gastro-reżistenti
English: If the combination of atazanavir with a proton pump inhibitor is judged unavoidable, close clinical monitoring (e.g virus load) is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
Maltese: Jekk il-kumbinazzjoni ta' mediċina ta' atazanavir ma' inibitur tal-pompa tal-proton tkun iġġudikata li hi inevitabbli, monitoraġġ kliniku mill-qrib (eż. ammont ta' viruses) hu rakkomandat flimkien ma' żieda fid-doża ta' atazanavir għal 400 mg ma' 100 mg ta' ritonavir.
English: Although the main metabolite has a moderately delayed half-life (2 - 3 h), excretion is still rapid and thus accumulation does not occur.
Maltese: Għalkemm il-metabolit ewlieni għandu half-life li hi moderatament itwal (2 - 3 sigħat), it-tneħħija xorta hi mgħaġġla u għaldaqstant l-akkumulazzjoni ma sseħħx.
English: The medicine should be administered intravenously over 2 - 15 minutes.
Maltese: Il-prodott mediċinali għandu jingħata minn ġo vina fuq perjodu 2 - 15-il minuta.
English: A ready-to-use solution is prepared in 10 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection.
Maltese: Soluzzjoni lesta għall-użu tiġi ppreparata f'10 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%).
English: Very Rare (affects less than 1 user in 10,000)
Maltese: - Rari ħafna (jaffettwaw inqas minn utent 1 minn kull 10,000) diżorjentament.
English: Important information about some of the ingredients of Protium This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. is essentially ‘sodium- free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kunjett, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Czech Republic Denmark Estonia
Maltese: L-Estonja Il-Finlandja Franza
English: He will check your liver enzymes more frequently.
Maltese: Jista' jkollok bżonn ta' testijiet addizzjonali.
English: Treatment duration in Zollinger-Ellison syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
Maltese: It-tul ta' żmien tal-kura tas-Sindrome ta' Zollinger-Ellison u kundizzjonijiet ipersekretorji patoloġiċi oħrajn mhijiex limitata u għandha tiġi adattata skond il-ħtiġijiet kliniċi.
English: General pharmacokinetics
Maltese: Pazjenti pedjatriċi
English: - Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for certain types of cancer) because Protium may stop these and other medicines from working properly.
Maltese: - Mediċini bħal ketoconazole, itraconazole u posaconazole (jintużaw għall-kura ta' infezzjonijiet fungali) jew erlotinib (jintuża għal ċerti tipi ta' kanċer) għax Protium jista' ma jħallix lil dawn u lil mediċini oħrajn milli jaħdmu kif suppost.
English: This solution may be administered directly or may be administered after mixing it with 100 ml sodium chloride 9 mg/ml (0.9 %) solution for injection or glucose 55 mg/ml (5 %) solution for injection.
Maltese: Is-soluzzjoni ppreparata tista' tingħata direttament jew tista' tingħata wara li tħallatha ma' 100 ml ta' soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/ml (0.9%) jew soluzzjoni għall-injezzjoni ta' glucose 55 mg/ml (5%).
English: Stevens-Johnson syndrome; Lyell syndrome; Erythema multiforme; Photosensitivity
Maltese: Sindrome ta' Lyell; Eritema multiforme;
English: Adults and adolescents 12 years of age and above:
Maltese: Adulti u adoloxxenti minn 12-il sena 'l fuq:
English: Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria.
Maltese: B12 (cyanocobalamin) minħabba ipo- jew achlorhydria.
English: Hyponatraemia
Maltese: Anġjoedema
English: Take special care with Protium
Maltese: QABEL MA TUŻA PROTIUM
English: Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 40” on one side.
Maltese: Pillola gastro-reżistenti, safra, ovali u bikonvessa, stampata b'“P 40” fuq naħa waħda.
English: Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 20 mg oral dose.
Maltese: Pantoprazole jiġi assorbit malajr u l-konċentrazzjoni massima fil-plażma tintlaħaq anki wara doża orali waħda ta' 20 mg.
English: Yellow, oval, biconvex gastro-resistant tablet imprinted with “P 20” on one side.
Maltese: Pillola gastro-reżistenti, safra, ovali u bikonvessa, stampata b'“P 20” fuq naħa waħda.
English: Soya oil
Maltese: Żejt tas-sojja
English: Interaction studies have also been performed administering pantoprazole concomitantly with the respective antibiotics (clarithromycin, metronidazole, amoxicillin) No clinically relevant interactions were found.
Maltese: Twettqu wkoll studji dwar interazzjonijiet billi pantoprazole ingħata fl-istess ħin mal-antibijotiċi rispettivi (clarithromycin, metronidazole, amoxicillin).
English: Characteristics in patients/special groups of subjects Approximately 3 % of the European population lack a functional CYP2C19 enzyme and are called poor metabolisers.
Maltese: Karatteristiċi f'pazjenti/gruppi speċjali ta' persuni Madwar 3% tal-popolazzjoni Ewropea m'għandhomx enzima CYP2C19 funzjonali u jissejħu persuni b'metaboliżmu batut.
English: Serious skin conditions (frequency not known): blistering of the skin and rapid deterioration of your general condition, erosion (including slight bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson-Syndrome, Lyell-Syndrome, Erythema multiforme) and sensitivity to light.
Maltese: - Kundizzjonijiet serji tal-ġilda (frekwenza mhux magħrufa): infafet tal-ġilda u deterjorament mgħaġġel tal-kundizzjon ġenerali tiegħek, tgħawwir (li jinkludi ħruġ żgħir ta' demm) tal-għajnejn, imnieħer, ħalq/xufftejn jew il-partijiet ġenitali (is-Sindrome ta' Stevens-Johnson, is-Sindrome ta' Lyell, eritema multiforme) u sensittività għad-dawl.
English: Rash / exanthema / eruption;
Maltese: Nawseja/rimettar; Nefħa addominali u gass żejjed;
English: The medicine should be administered intravenously over 2-15 minutes.
Maltese: Il-mediċina għandha tingħata minn ġo vina fuq perjodu 2-15-il minuta.
English: Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Maltese: Kull pillola gastro-reżistenti fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: The main metabolic pathway is demethylation by CYP2C19 with subsequent sulphate conjugation, other metabolic pathway include oxidation by CYP3A4.
Maltese: Il-passaġġ metaboliku ewlieni hu demethylation minn CYP2C19 b'konjugazzjoni sussegwenti ta' sulphate, passaġġ metaboliku ieħor jinkludi ossidazzjoni minn CYP3A4.
English: 168 gastro-resistant tablets
Maltese: 112-il pillola gastro-reżistenti 168 pillola gastro-reżistenti
English: Hospital pack with 50, 56, 84, 90, 112, 140, 140 (10x14 or 5x28), 150 (10x15), 280 (20x14 or 10x28), 500, 700 (5x140) gastro-resistant tablets.
Maltese: Pakketti tal-isptar b'50, 56, 84, 90, 112, 140, 140 (10x14 jew 5x28), 150 (10x15), 280 (20x14 jew 10x28), 500, 700 (5x140) pillola gastro-reżistenti.
English: After a single-dose administration of 40 mg pantoprazole, the mean area under the plasma concentration-time curve was approximately 6 times higher in poor metabolisers than in subjects having a functional CYP2C19 enzyme (extensive metabolisers).
Maltese: Wara l-għoti ta' doża waħda ta' 40 mg ta' pantoprazole, il-medja taż-żona taħt il-kurva konċentrazzjoni fil-plażma-ħin kienet ta' madwar 6 darbiet ogħla f'persuni b'metaboliżmu batut milli f'persuni li kellhom enzima CYP2C19 funzjonali (persuni b'metaboliżmu estensiv).
English: Each gastro-resistant tablet contains 40 mg of pantoprazole (as sodium sesquihydrate).
Maltese: Kull pillola gastro-reżistenti fiha 40 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Pack sizes of 1 vial and 5 (5x1) vials with powder for solution for injection.
Maltese: Daqsijiet tal-pakkett ta' 1 kunjett u 5 (5x1) kunjetti bi trab għal soluzzjoni għall-injezzjoni.
English: Adults: Preventing duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who need to take NSAIDs continuously.
Maltese: - Il-prevenzjoni ta' ulċeri duwodenali u tal-istonku kkawżati minn mediċini mhux sterojdi kontra l-infjammazzjoni (NSAIDs, per eżempju, ibuprofen) f'pazjenti f'riskju li għandhom bżonn jieħdu NSAIDs kontinwament.
English: The other ingredients are: disodium edetate and sodium hydroxide (for pH adjustment).
Maltese: - Is-sustanzi l-oħra huma: disodium edetate u sodium hydroxide (għal aġġustament tal-pH).
English: Adults and adolescents 12 years of age and above
Maltese: Adulti u adoloxxenti minn 12-il sena 'l fuq
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola gastro-reżistenti fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: In the presence of any alarm symptom (e. g. significant unintentional weight loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) and when gastric ulcer is suspected or present, malignancy should be excluded, as treatment with pantoprazole may alleviate symptoms and delay diagnosis.
Maltese: Fil-preżenza ta' kwalunkwe sintomu ta' allarm (e. g. telf ta' piż sinifikanti mhux intenzjonat, rimettar rikorrenti, disfaġja, ematemesi, anemija jew melaena) u meta ulċera gastrika tkun issuspettata jew preżenti, tumur malinn għandu jiġi eskluż, għax il-kura bi pantoprazole tista' ttaffi s-sintomi u tittardja d-dijanjosi.
English: 90 gastro-resistant tablets 100 gastro-resistant tablets 140 gastro-resistant tablets 140 (10x14) gastro-resistant tablets 150 (10x15) gastro-resistant tablets 700 (5x140) gastro-resistant tablets
Maltese: 140 (10x14) pillola gastro-reżistenti 150 (10x15) pillola gastro-reżistenti 700 (5x140) pillola gastro-reżistenti
English: Pantoprazole is rapidly absorbed and the maximal plasma concentration is achieved even after one single 40 mg oral dose.
Maltese: Pantoprazole jiġi assorbit malajr u l-konċentrazzjoni massima fil-plażma tintlaħaq anki wara doża orali waħda ta' 40 mg.
English: Name of Member State
Maltese: Isem tal-Istat Membru
English: Systemic exposure with up to 240 mg administered intravenously over 2 minutes were well tolerated.
Maltese: Espożizzjoni sistemika b'sa 240 mg mogħtija ġol-vini fuq perjodu ta' 2 minuti kienet ittollerata tajjeb.
English: Reflux oesophagitis
Maltese: Il-Belġju Ċipru
English: Coumarin anticoagulants (phenprocoumon or warfarin) Although no interaction during concomitant administration of phenprocoumon or warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in International Normalised Ratio (INR) have been reported during concomitant treatment in the post-marketing period.
Maltese: Anti-koagulanti coumarin (phenprocoumon jew warfarin) Għalkemm ma kienet osservata l-ebda interazzjoni waqt l-għoti fl-istess ħin ta' phenprocoumon jew warfarin fi studji farmakokinetiċi kliniċi, ftit każijiet iżolati ta' tibdil fl-International Normalised Ratio (INR) kienu rrappurtati waqt il-kura fl-istess ħin fil-perjodu ta' wara l-bejgħ.
English: 49gastro-resistant tablets 56 gastro-resistant tablets 60 gastro-resistant tablets 84 gastro-resistant tablets 90 gastro-resistant tablets 98 gastro-resistant tablets 98 (2x49) gastro-resistant tablets 100 gastro-resistant tablets 112 gastro-resistant tablets 168 gastro-resistant tablets
Maltese: 7 pilloli gastro-reżistenti 10 pilloli gastro-reżistenti 14-il pillola gastro-reżistenti 15-il pillola gastro-reżistenti 24 pillola gastro-reżistenti 28 pillola gastro-reżistenti 30 pillola gastro-reżistenti 48 pillola gastro-reżistenti 49 pillola gastro-reżistenti 56 pillola gastro-reżistenti 60 pillola gastro-reżistenti 84 pillola gastro-reżistenti 90 pillola gastro-reżistenti 98 pillola gastro-reżistenti 98 (2x49) pilloli gastro-reżistenti 100 pillola gastro-reżistenti 112-il pillola gastro-reżistenti 168 pillola gastro-reżistenti
English: Other side effects are: - Common (affects 1 to 10 users in 100) inflammation of the wall of the vein and blood clotting (thrombophlebitis) where the medicine is injected.
Maltese: - Komuni (jaffettwaw minn 1 sa 10 utenti minn kull 100) infjammazzjoni tal-ħajt tal-vina u emboli fid-demm (tromboflebite) fejn il-mediċina tkun injettata.