FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor or nurse should perform tests to check the levels of your blood potassium, calcium, magnesium, and thyroid-stimulating hormone (TSH) as well as the electrical activity of your heart with a test called an electrocardiogram (ECG).
Maltese: kalċjum, magnesjum u l-ormon li jistimula t-tirojde (TSH) kif ukoll l-attività elettrika ta' qalbek b'test li jissejjaħ elettrokardjogramma (ECG). Għandu jkollok dawn it-testijiet:
English: Tlf: + 47 67 10 71 00
Maltese: Norge sanofi-aventis Norge AS Tlf: + 47 67 10 71 00
English: • Decreased levels of potassium in your blood.
Maltese: • Tnaqqis fil-livelli ta' potassium fid-demm tiegħek.
English: Duration
Maltese: Tqala
English: In the event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval, dosing with vandetanib should be at least temporarily stopped and resumed at a reduced dose when toxicity has resolved or improved to CTCAE grade 1 (see section 4.4).
Maltese: F'każ ta' kriterju tatterminoloġija komuni għal-każijiet avversi (CTCAE) ta' grad 3 jew tossiċità aktar qawwija jew titwil tal-intervall QTc tal-elettrokardjogramma (ECG) , id-dożaġġ b'vandetanib għandu jitwaqqaf għal lanqas temporanjament u jerġa jinbeda b'doża aktar baxxa meta tkun għaddiet it-tossiċità għal CTCAE ta' grad 1 (ara sezzjoni 4.4).
English: In consideration of the high intra-individual variability of the response to anticoagulation, and the possibility of interaction between vitamin K antagonists and chemotherapy, an increased frequency of the INR (International Normalised Ratio) monitoring is recommended, if it is decided to treat the patient with vitamin K antagonists.
Maltese: Meta wieħed iqis li hemm varjabilità għolja bejn l-individwi għar-rispons bl-antikoagulanti, u l-possibilità li jkun hemm interazzjoni bejn antagonisti tal-vitamina K u kimoterapija, huwa rakkomandat li l frekwenza tal-monitoraġġ tal-INR (Proporzjon Internazzjonali Normalizzat), jekk ikun deċiż li lpazjenti jingħataw kura b'antagonisti tal-vitamina K.
English: For patients in whom Rearranged during Transfection (RET) mutation is not known or is negative, a possible lower benefit should be taken into account before individual treatment decision (see important information in sections 4.4 and 5.1).
Maltese: Pazjenti fejn ma jkunx magħruf jekk għandhomx il-mutazzjoni Irranġata mill-ġdid waqt itTransfezzjoni (RET) jew ikun negattiv, il-fatt li jista' jkun hemm anqas benefiċċju għandu jitqies qabel id-deċiżjoni dwar il-kura individwali (ara tagħrif importanti f'sezzjonijiet 4.4 u 5.1).
English: NAME OF THE MEDICINAL PRODUCT Caprelsa 300 mg tablets vandetanib
Maltese: Caprelsa 300 mg pilloli miksijin b'rita vandetanib
English: Caprelsa 300 mg is a white oval-shaped film-coated tablet with “Z300” imprinted on one side.
Maltese: Caprelsa 300 mg hija pillola bajda ovali miksija b'rita b' “Z300” imnaqqxa fuq naħa waħda.
English: The pharmacokinetics of vandetanib at the 300 mg dose in MTC patients are characterised by a clearance of approximately 13.2 l/h.
Maltese: Il-farmakokinetika ta' vandetanib b'doża ta' 300 mg f'pazjenti MTC hija karatterizzata bi tneħħija ta'
English: Breast-feeding is contraindicated while receiving vandetanib therapy.
Maltese: It-treddigħ huwa kontra-indikat waqt li tkun qed tirċievi terapija b'vandetanib.
English: How to store Caprelsa
Maltese: L-AWTORIZZAZJONI JIĠU KOMPLUTI
English: If another event of common terminology criteria for adverse events (CTCAE) grade 3 or higher toxicity or prolongation of the ECG QTc interval occurs, dosing with Caprelsa should be at least temporarily stopped and resumed at a reduced dose (c in Table 1) when toxicity has resolved or improved to CTCAE grade 1.
Maltese: Jekk iseħħ avveniment ieħor ta' kriterju tat-terminoloġija komuni għal każijiet avversi (CTCAE) ta' grad 3 jew tossiċità aktar qawwija jew ikun hemm titwil tal intervall QTc tal-ECG, id-dożaġġ b'Caprelsa għandu mill-inqas jitwaqqaf b'mod temporanju u jerġa' jinbeda b'doża mnaqqsa (c f'Tabella 1) meta tkun għaddiet it-tossiċità jew tjiebet għal
English: Reduction in dose may be necessary (see section 4.8).
Maltese: (ara sezzjoni 4.8).
English: Colitis, dry mouth, stomatitis, dysphagia, constipation, gastritis, gastrointestinal haemorrhage
Maltese: influwenza, ċestite, sinusite, larinġite,
English: A single dose pharmacokinetic study in volunteers indicated that hepatic impairment did not affect exposure to vandetanib.
Maltese: Studju farmakokinetiku b'doża waħda f'voluntiera b'saħħithom indika li l-indeboliment tal-fwied ma effettwax l-esponiment għal vandetanib.
English: Dose increase (mg)b when tolerated well after 8 weeks at starting dose
Maltese: Żieda fid-doża (mg)b meta tkun ittollerata sew wara 8 ġimgħat bid-doża tal-bidu
English: Medicinal products known to prolong QTc interval Vandetanib has been shown to prolong the ECG QTc interval; Torsades de pointes have been uncommonly reported.
Maltese: • L-użu ta' vandetanib flimkien mal-prodotti mediċinali li ġejjin magħrufin ukoll li jtawwlu l intervall QTc u/jew jikkawżaw Torsades de pointes:
English: After having well tolerated the first 1 or 2 cycles of therapy (1 cycle = 28 days), the remaining patients continued on 100 mg/m2 of treatment.
Maltese: Wara li kienu ttolleraw sew l-ewwel 1 jew 2 ċikli ta' terapija (ċiklu 1 = 28 ġurnata), il-pazjenti li kien fadal baqgħu fuq 100 mg/m2 ta'
English: Fourteen of the 28 patients (50%) who stopped vandetanib for an adverse event discontinued without a dose reduction.
Maltese: Erbatax minn 28 pazjent (50%) li waqqfu vandetanib minħabba episodju avvers (AE) komplew mingħajr ma naqqsu d-doża.
English: ECG QTc prolongation appears to be dose-dependent.
Maltese: It-titwil tal-QTc fl-elettrokardjogramma jidher li jiddependi mid-doża.
English: • Patients who develop a single value of corrected ECG QTc interval of at least 500 msec should stop taking CAPRELSA.
Maltese: • Pazjenti li jiżviluppaw valur wieħed ta' QTc ta' mill-anqas 500 ms għandhom jieqfu jieħdu CAPRELSA.
English: There is no experience with Caprelsa in patients 5-8 years of age in this study.
Maltese: F'dan l-istudju ma kien hemm ebda esperjenza b'Caprelsa f'pazjenti b'etajiet minn 5-8 snin.
English: Pharmacokinetic data from volunteers, suggests that no change in starting dose is required in patients with mild, moderate or severe hepatic impairment (see sections 4.2 and 5.2).
Maltese: Dejta farmakokinetika minn voluntiera, tindika li mhux meħtieġ tibdil fid-doża tal-bidu f'pazjenti b'indeboliment tal-fwied ħafif, moderat jew sever (ara sezzjoni 4.2 u 5.2).
English: Frequency System Organ Class
Maltese: Sistema tal-Klassifika tal-Organi
English: - Coating: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
Maltese: - Kisja: hypromellose, povidone, titanium dioxide (E171), yellow iron oxide (E172), propylene glycol, methacrylic acid-ethyl acrylate copolymer, sodium lauril sulfate, polysorbate 80, triethyl citrate.
English: StevensJohnson syndrome; Lyell syndrome;
Maltese: Sindrome ta' StevensJohnson;
English: • They have had previous gastric ulcer or gastrointestinal surgery.
Maltese: • Kellhom ulċera gastrika jew operazzjoni gastrointestinali fil-passat.
English: Disturbances in vision / blurred vision
Maltese: Disturbi filvista / vista mċajpra
English: Microscopic colitis
Maltese: Kolite mikroskopika
English: Production site Oranienburg Lehnitzstraße 70-98, 16515 Oranienburg
Maltese: Sit tal-produzzjoni Oranienburg Lehnitzstraße 70-98, 16515
English: Interaction studies with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline and an oral contraceptive containing levonorgestrel and ethinyl oestradiol did not reveal clinically significant interactions.
Maltese: Studji ta' interazzjoni ma' carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline u kontraċettiv orali li fih levonorgestrel u ethinyl oestradiol ma wrewx interazzjonijiet klinikament sinifikanti.
English: Byk-Gulden-Straße 2, 78467 Konstanz Germany
Maltese: Byk-Gulden-Straße 2, 78467 Konstanz Il-Ġermanja
English: Takeda GmbH Production site Oranienburg Lehnitzstraße 70-98
Maltese: Sit tal-produzzjoni Oranienburg Lehnitzstraße 70-98
English: Interference with Laboratory Tests
Maltese: Interferenza mat-testijiet tal-laboratorju
English: What PANTOLOC Control contains - The active substance is pantoprazole.
Maltese: X'fih PANTOLOC Control - Is-sustanza attiva hi pantoprazole.
English: Telephone: 0800 825332 4 Telefax:
Maltese: Telefown: 0800 852332 4 Telefaks: 0800 825332 9
English: Hyperlipidaemias and lipid increases (triglycerides, cholesterol);
Maltese: Iperlipidimji u żidiet fil-lipidi (triglycerides, kolesterol);
English: Gastro-resistant tablet.
Maltese: Pillola gastro-reżistenti.
English: Body temperature increased;
Maltese: Żieda fit-temperatura tal-ġisem;
English: Depression (and all aggravations)
Maltese: Depressjoni (u l-aggravamenti kollha)
English: After 7 days the percentage of patients experiencing complete relief from acid regurgitation was between 61.5% and 84.4%, after 14 days between 67.7% and 90.4%, and after 28 days between 75.2% and 94.5%, respectively.
Maltese: 4%, wara 14-il jum bejn 67.7% u 90.4%, u wara 28 jum bejn 75.2% u 94.5%, rispettivament.
English: Within the following table, adverse reactions are ranked under the MedDRA frequency classification: 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), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħrufa (ma tistax tittieħed stima mid-data disponibbli).
English: After 14 and 28 days, complete heartburn relief was experienced in 62.9% to 88.6% and 68.1% to 92.3% of the patients, respectively.
Maltese: Wara 14 u 28 jum, solliev totali mill-qrusa fl-istonku seħħ fi 62.9% sa 88.6% u 68.1% sa 92.3% tal-pazjenti, rispettivament.
English: België/Belgique/Belgien
Maltese: Suomi/Finland
English: - The other ingredients are: - Core: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
Maltese: - Is-sustanzi l-oħra huma: - Qalba: sodium carbonate (anhydrous), mannitol, crospovidone, povidone K90, calcium stearate.
English: 7 gastro-resistant tablets 14 gastro-resistant tablets
Maltese: 7 pilloli gastro-reżistenti 14-il pillola gastro-reżistenti
English: Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system.
Maltese: Pantoprazole jiġi metabolizzat fil-fwied permezz tas-sistema tal-enzimi ta' ċitokrom P450.
English: Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Ammonia solution, concentrated
Maltese: Red iron oxide (E172) Black iron oxide (E172) Yellow iron oxide (E172) Soluzzjoni tal-ammonja, ikkonċentrata
English: D-78467 Konstanz Germany
Maltese: D-78467 Konstanz Il-Ġermanja
English: Jaundice;
Maltese: Dijarea;
English: Observational studies suggest that proton pump inhibitors may increase the overall risk of fracture by 10-40%.
Maltese: Studji ta' osservazzjoni jissuġġerixxu li l-impedituri tal-pompa tal-proton jistgħu jżidu globalment ir-riskju ta' ksur b'10-40%.
English: - Printing ink: shellac, red, black and yellow iron oxide (E172), and ammonia solution, concentrated.
Maltese: - Linka tal-istampar: shellac, red, black and yellow iron oxide (E172), u soluzzjoni tal-ammonja, ikkonċentrata.
English: PANTOLOC Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: PANTOLOC Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: PANTOLOC Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Maltese: PANTOLOC Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.
English: Liver enzymes increased (transamina ses, γ-GT)
Maltese: Żieda flenzimi talfwied (transaminas es, γ-GT)
English: Rash / exanthema / eruption;
Maltese: Nawseja / rimettar;
English: HIV Protease Inhibitors
Maltese: Impedituri tal-Protease tal-HIV
English: Agranulocytosis Thrombocytopenia; Leukopenia,
Maltese: Agranuloċitosi Tromboċitopenj a; Lewkopenja,
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 benzimidazole sostitut li jinibixxi t-tnixxija ta' hydrochloric acid fl-istonku permezz ta' imblokk speċifiku tal-pompi proton taċ-ċelluli parjetali.
English: Influence on Vitamin B12 Absorption
Maltese: B12, u nuqqas ta' Vitamina
English: Pantoprazole/metabolites have been identified in human milk.
Maltese: Pantoprazole/metaboliti ġew identifikati fil-ħalib tas-sider uman.
English: PANTOLOC Control 20 mg gastro-resistant tablets
Maltese: PANTOLOC Control 20 mg pilloli gastro-reżistenti
English: Fundic gland polyps (benign)
Maltese: Polipi tal-glandola fundika (beninni)
English: However, you may take PANTOLOC Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Maltese: Madankollu, tista' tieħu PANTOLOC Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: Pharmacotherapeutic group: Drugs for acid related disorders, Proton pump inhibitors, ATC code: A02BC02
Maltese: Mediċini għal disturbi relatati mal-aċidu, Inibituri tal-pompa tal-proton, Kodiċi ATC:
English: Marketing Authorisation Holder Takeda GmbH
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Takeda GmbH
English: In a retrospective analysis of 17 studies in 5960 patients with gastro-oesophageal reflux disease (GORD) who were treated with 20 mg pantoprazole monotherapy, the symptoms associated with acid reflux e.g. heartburn and acid regurgitation were evaluated according to a standardised methodology.
Maltese: F'analiżi retrospettiva ta' 17-il studju fuq 5,960 pazjent bil-marda tar-rifluss gastro-esofagali (GORD) li kienu kkurati b'monoterapija ta' 20 mg ta' pantoprazole, is-sintomi marbuta mar-rifluss tal-aċidu, eż. qrusa fl-istonku u rigurġitazzjoni tal-aċidu kienu evalwati skond metodoloġija standardizzata.
English: Pantoprazole is converted to its active form, a cyclic sulphenamide, 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, sulphenamide ċikliku, 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: Investigations revealed no evidence of impaired fertility or teratogenic effects.
Maltese: L-investigazzjonijiet ma żvelaw l-ebda evidenza ta' indeboliment fil-fertilità jew effetti teratoġeniċi.
English: Constipation ; Dry mouth;
Maltese: Ferita epatoċellulari; Suffejra;
English: Increased Chromogranin A (CgA) level may interfere with investigations for neuroendocrine tumours.
Maltese: Il-livell ta' Kromogranin A (CgA) miżjud jista' jinterferixxi mal-investigazzjonijiet għal tumuri newroendokrinali.
English: Hyponatraemia, Hypomagnesaemia
Maltese: Iponatrimija, Ipomanjesemija Ipokalċemija
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: OUTER CARTON FOR BLISTER OUTER CARTON FOR BLISTER WITH CARDBOARD REINFORCEMENT
Maltese: KARTUNA TA' BARRA GĦAL FOLJA KARTUNA TA' BARRA GĦAL FOLJA B'CARDBOARD REINFORCEMENT
English: Doses up to 240 mg administered intravenously over 2 minutes were well tolerated.
Maltese: Dożi sa 240 mg mogħtija ġol-vini fuq perjodu ta' 2 minuti kienu ttollerati tajjeb.
English: To avoid this interference, PANTOLOC Control treatment should be stopped for at least 5 days before CgA measurements (see section 5.1).
Maltese: Biex din l-interferenza tiġi evitata, il-kura bi PANTOLOC Control għandha titwaqqaf għal mill-inqas 5 ijiem qabel il-kejl ta' CgA (ara sezzjoni 5.1).
English: Each gastro-resistant tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Maltese: Kull pillola gastro-reżistenti fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Talk to your doctor before taking PANTOLOC Control - if you have been treated for heartburn or indigestion continuously for 4 or more weeks - if you are over 55 years old and taking non-prescription indigestion treatment on a daily basis - if you are over 55 years old with any new or recently changed reflux symptoms - if you have previously had a gastric ulcer or stomach surgery - if you have liver problems or jaundice (yellowing of skin or eyes) - if you regularly see your doctor for serious complaints or conditions - if you are due to have an endoscopy or a breath test called a C-urea test. - if you have ever had a skin reaction after treatment with a medicine similar to PANTOLOC
Maltese: Kellem lit-tabib tiegħek qabel tieħu PANTOLOC Control - jekk kont ikkurat/a għal qrusa fl-istonku jew indiġestjoni kontinwament għal 4 ġimgħat jew iktar - jekk għandek iktar minn 55 sena u qed tieħu kura ta' kuljum għall-indiġestjoni mingħajr riċetta tat-tabib - jekk għandek iktar minn 55 sena u għandek sintomi tar-rifluss ġodda jew sintomi li nbidlu dan l-aħħar - jekk kellek operazzjoni minħabba ulċera gastrika jew tal-istonku - jekk għandek problemi tal-fwied jew suffejra (sfura tal-ġilda jew fl-għajnejn) - jekk regolarment tara lit-tabib tiegħek għal problemi jew kundizzjonijiet serji - jekk ser ikollok endoskopija jew test tan-nifs imsejjaħ C-urea test - jekk qatt kellek reazzjoni fil-ġilda wara kura b'mediċina simili għal PANTOLOC Control li tnaqqas l-aċtu fl-istonku.
English: PANTOLOC Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Maltese: PANTOLOC Control jista' jnaqqas l-assorbiment ta' sustanzi attivi li l-bijodisponibiltà tagħhom tiddependi fuq il-pH gastrika (eż. ketoconazole).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeletri ċi u tat-tessuti konnettivi
English: Gynaecomastia
Maltese: Ginekomastija
English: Tél/Tel: + 32 2 464 06 11 takeda-belgium@takeda.com
Maltese: België/Belgique/Belgien Takeda Belgium Tél/Tel: + 32 2 464 06 11 takeda-belgium@takeda.com
English: The absolute bioavailability from the tablet was found to be about 77%.
Maltese: Instab li l-bijodisponibiltà assoluta mill-pillola kienet ta' madwar 77%.
English: Date of first authorisation: 12 June 2009 Date of latest renewal: 21 February 2014
Maltese: 12 ta' Ġunju 2009 Data tal-aħħar tiġdid: 21 ta' Frar 2014
English: On average, at about 2.0 h - 2.5 h post administration (tmax) of a single 20 mg oral dose, the maximum serum concentrations (Cmax) of about 1-1.5 µg/ml are achieved, and these values remain constant after multiple administration.
Maltese: Bħala medja, bejn wieħed u ieħor wara 2.0-2.5 sigħat wara l-għoti (tmax) ta' doża orali waħda ta' 20 mg, jinkisbu konċentrazzjonijiet massimi fis-serum (Cmax) ta' madwar 1-1.5 µg/ml, u dawn il-valuri jibqgħu kostanti wara għoti multiplu.
English: Pantoprazole is completely and rapidly absorbed after oral administration.
Maltese: Pantoprazole ikun assorbit totalment u malajr wara l-għoti orali.
English: What PANTOLOC Control looks like and contents of the pack The gastro-resistant tablets are yellow, oval, biconvex film-coated tablets imprinted with “P20” on one side.
Maltese: Kif jidher PANTOLOC Control u l-kontenut tal-pakkett Il-pilloli gastro-reżistenti huma pilloli sofor, ovali, bikonvessi, miksija b'rita u stampati bi “P20” fuq naħa waħda.
English: Do not use this medicine after the expiry date, which is stated on the carton and the blister after ‘EXP'.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-folja wara ‘EXP'.
English: Hypersensitivity to the active substance, or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1).
English: Yellow, oval biconvex film-coated tablets imprinted with “P20” in brown ink on one side.
Maltese: Pilloli miksija b'rita, sofor, ovali u bikonvessi stampati b'“P20” b'linka kannella fuq naħa waħda.
English: In these studies, the percentage of patients experiencing complete relief from heartburn after 7 days was between 54.0% and 80.6% in the pantoprazole group.
Maltese: F'dawn l-istudji, il-perċentwali ta' pazjenti li kellhom solliev totali mill-qrusa fl-istonku wara 7 ijiem kienet bejn 54.0% u 80.6% fil-grupp ta' pantoprazole.
English: After administration of pantoprazole to patients with liver impairment (Child-Pugh classes A, B and C) the half-life values increased to between 3 and 7 h and the AUC values increased by a factor of 3-6, whereas the Cmax only increased slightly by a factor of 1.3 compared with healthy subjects.
Maltese: Wara l-għoti ta' pantoprazole lil pazjenti b'indebolimenti tal-fwied (Child-Pugh klassijiet A, B u Ċ), il-valuri tal-half-life żdiedu għal bejn 3 u 7 sigħat, u l-valuri tal-AUC żdiedu b'fattur ta' 3-6, filwaqt li s-Cmax żdied ftit biss b'fattur ta' 1.3 meta mqabbel ma' persuni b'saħħithom.
English: However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.
Maltese: Madanakollu, interazzjoni ta' pantoprazole ma' sustanzi oħrajn li jkunu metabolizzati mill-istess sistema ta' enzimi ma tistax tiġi eskluża.
English: Take one tablet (20 mg) per day.
Maltese: Ħu pillola waħda (20 mg) kuljum.
English: Each tablet contains 20 mg pantoprazole (as sodium sesquihydrate).
Maltese: Kull pillola fiha 20 mg ta' pantoprazole (bħala sodium sesquihydrate).
English: Gastrointestinal infections caused by bacteria
Maltese: Infezzjonjiet gastrointestinali kkaġunati minn batterja
English: You should take this medicine for at least 2-3 consecutive days.
Maltese: Għandek tieħu din il-mediċina għal mill-inqas 2-3 ijiem konsekuttivi.
English: Renal impairment
Maltese: Nefrite interstizjali
English: PANTOLOC Control contains the active substance pantoprazole, which blocks the ‘pump' that produces stomach acid.
Maltese: PANTOLOC Control fih is-sustanza attiva pantoprazole, li timblokka l-'pompa' li tipproduċi l-aċidu fl-istonku.
English: During treatment with antisecretory medicinal products, serum gastrin increases in response to the decreased acid secretion.
Maltese: Matul kura bi prodotti mediċinali antisekretorji, il-gastrin fis-serum jiżdied b'rispons għal sekrezzjoni mnaqqsa ta' aċidu.
English: Pharmacokinetics do not vary after single or repeated administration.
Maltese: Il-farmakokinetika ma tvarjax wara għoti wieħed jew għoti ripetut.
English: Headache; Dizziness
Maltese: DATA TA' SKADENZA
English: Clearance is about 0.1 l/h/kg, and terminal half-life (t1/2) about 1 h. There were a few cases of subjects with delayed elimination.
Maltese: It-tneħħija hi ta' madwar 0.1 l/siegħa/kg, u l-half-life terminali(t1/2) hi ta' madwar siegħa.
English: Stop taking PANTOLOC Control when you are completely symptom-free.
Maltese: Għandek tieqaf tieħu PANTOLOC Control meta ma jkollokx aktar sintomi.
English: How to store PANTOLOC Control
Maltese: Kif taħżen PANTOLOC Control
English: - if you are due to have a specific blood test (Chromogranin A) - if you are taking HIV protease inhibitors such as atazanavir, nelfinavir (for the treatment of
Maltese: - inti wasalt biex ikollok test tad-demm speċifiku (Kromogranin A) - jekk qed tieħu impedituri ta' protease ta' HIV bħal atazanavir; nelfinavir (għat-trattament ta'