FrancophonIA/ELRC3.0 huggingface dataset:
English: patients were randomised to receive either docetaxel 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclosphosphamide 500 mg/m2 (FAC arm).
Maltese: Wara t-tqassim tal-pazjenti skont in-numru ta' glandoli limfatiċi effettwati (1-3, 4+), 1491 pazjent kienu mqassma mingħajr għażla biex jirċievu jew docetaxel 75 mg/m2 siegħa wara doxorubicin 50 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa TAC), jew doxorubicin 50 mg/m2 segwit minn fluorouracil 500 mg/m2 u cyclophosphamide 500 mg/m2 (il-fergħa FAC).
English: G3/4 Blood bilirubin increased (< 5%);
Maltese: G3/4 Żieda flalkaline phosphatase fid-demm (< 4%);
English: Description of selected adverse reactions in gastric adenocarcinoma cancer for docetaxel 75 mg/m2 in combination with cisplatin and 5-fluorouracil
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari f' kanċer gastriku tat-tip adenokarċinoma għal docetaxel 75 mg/m² użat flimkien ma' cisplatin u 5-fluorouracil
English: Myocardial ischemia
Maltese: OĦRAJN ĊITOTOSSIKU
English: The required volume of Docetaxel Accord concentrate for solution for infusion must be injected via a single injection (one shot) into a 250 ml infusion bag containing either 5% glucose solution or sodium chloride 9 mg/ml (0.9%) solution for infusion.
Maltese: Il-volum meħtieġ ta' Docetaxel Accord konċentrat għal soluzzjoni għall-infużjoni għandu jkun injettat permezz ta' injezzjoni waħda (titqiba waħda) ġol-borża ta' infużjoni ta' 250 ml li jkun fiha 5% soluzzjoni tal-glukosju jew ta' kloridu tas-sodju 9 mg/ml (0.9%) għall-infużjoni.
English: A total of 449 patients were randomised to receive either docetaxel monotherapy 100 mg/m2 as a 1 hour infusion or paclitaxel 175 mg/m2 as a 3 hour infusion.
Maltese: It-total ta' 449 pazjenti kienu mqassma, mingħajr għażla, biex jirċievu jew docetaxel 100 mg/m2 li tingħata bħala infużjoni tul siegha, jew paclitaxel 175 mg/m2
English: Docetaxel as single agent
Maltese: Docetaxel kull tliet ġimgħat
English: The recommended dose of docetaxel is 75 mg/m2 as a 1-hour infusion, followed by cisplatin 75 mg/m2, as a 1- to 3-hour infusion (both on day 1 only), followed by 5-fluorouracil 750 mg/m2 per day given as a 24-hour continuous infusion for 5 days, starting at the end of the cisplatin infusion.
Maltese: Adenokarċinoma ta' l-istonku Id-doża irrakkomandata ta' docetaxel hija 75 mg/m2 mogħtija bħala infużjoni tul siegħa, segwita minn cisplatin 75 mg/m2, bħala infuzjoni tul ta' 1 sa 3 sigħat (it-tnejn fl-ewwel jum biss), segwita minn 5fluorouracil 750 mg/m2kuljum, mogħti bħala infużjoni kontinwa fuq medda ta' 24 siegħa għal 5 ijiem, mibdija fit-tmiem ta' l-infużjoni ta' cisplatin.It-trattament għandu jiġi ripetut kull tlett ġimgħat.
English: Tabulated list of adverse reactions in breast cancer for docetaxel 100 mg/m2 single agent
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari fil-kanċer tas-sider għal docetaxel 100 mg/m2
English: Data from one multicentre, randomised, controlled phase III clinical study support the use of docetaxel in combination with capecitabine for treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy, including an anthracycline.
Maltese: III, ta' studju kliniku, u li sar mingħajr għażla u li kien ikkontrollat, issostni l-użu ta' docetaxel flimkien ma' capecitabine għat-trattament ta' pazjenti b'kanċer tas-sider avvanzat lokalment jew dak metastatiku, wara li falliet il-kimoterapija ċitotossika, inkluża anthracycline.
English: In GEICAM 9805 study alopecia that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, alopeċja li bdiet matul il-perijodu ta' trattament u li ppersistiet waqt ilperjodu ta' osservazzjoni ġiet osservata li kienet baqgħet għaddejja f'49 pazjent (9.2 %) fil-fergħa ta' TAC u f'35 pazjent (6.7 %) fil-fergħa ta' FAC.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion docetaxel
Maltese: Docetaxel Accord 20 mg/1 ml konċentrat għall-infużjoni docetaxel
English: Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion One vial of 1 ml of concentrate contains 20 mg of docetaxel.
Maltese: Docetaxel Accord 20 mg/1 ml konċentrat għal soluzzjoni għall-infużjoni Kunjett wieħed ta' 1ml ta' konċentrat fih 20mg ta' docetaxel.
English: In the docetaxel plus trastuzumab arm, 64% had received a prior anthracycline as adjuvant therapy compared with 55% in the docetaxel arm alone.
Maltese: Fil-qasam ta' listudji fejn docetaxel intuża flimkien ma' trastuzumab, 64% kienu ħadu qabel anthracycline bħala terapija miżjuda, meta mqabbel ma' 55% tal-fergħa ta' docetaxel biss.
English: In this study, 501 patients, with locally advanced SCCHN, and a WHO performance status of 0 or 1, were randomised to one of two arms.
Maltese: F'dan l-istudju, 501 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miż-żewġ friegħi tat-trattament mingħajr għażla.
English: Rash pruritic;
Maltese: Uġigh fil-parti ta' fuq tażżaqq;
English: Nausea (G3/4: 4%);
Maltese: Astenja (G3/4: 3%);
English: Dyspepsia (G3/4:
Maltese: Stomatite (G3/4:
English: Overall response rate (%):
Maltese: Sopravivenza ta' Sena (%)
English: A multicentre, open-label, randomised study was conducted to evaluate the safety and efficacy of docetaxel for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who had not received prior chemotherapy for metastatic disease.
Maltese: Ġew irrapportati okkorrenzi rari ta' deidrazzjoni bħala konsegwenza ta' ġrajjiet gastro-intestinali, inkluż enterokolite u perforament gastro-intestinali.
English: Patients with hepatic impairment Based on pharmacokinetic data with docetaxel at 100 mg/m2 as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment tal-fwied Ibbażat fuq tagħrif farmakokinetiku bid-docetaxel f'doża ta' 100 mg/m2 meta mogħti waħdu, il pazjenti li għandhom livelli għoljin ta' l-enżimi trasaminażi (ALT u/jew AST) aktar minn 1.5 drabi ta' l-ogħla livell tal-firxa normali (ULN) u l-livell tal-enzima alkaline phosphatase aktar minn 2.5 drabi ta' l-ULN, id-doża irrakkomandata ta' docetaxel hija 75 mg/m2 (ara -sezzjonijiet 4.4 u 5.2).
English: Following the administration of a 100 mg/m2 dose given as a one-hour infusion a mean peak plasma level of 3.7 µg/ml was obtained with a corresponding AUC of 4.6 h.µg/ml.
Maltese: Wara l-għoti ta' doża ta' 100 mg/m2 li ngħatat bħala infużjoni fi żmien siegħa, l-ogħla livell medju fil plażma kien ta' 3.7 μg/ml b'AUC korrispondenti ta' 4.6 sigħat.μg/ml.
English: Ischemia myocardial
Maltese: Kunjett wieħed
English: Tabulated list of adverse reactions in breast cancer for adjuvant therapy with docetaxel 75 mg/m2 in combination with doxorubicin and cyclophosphamide in patients with node-positive (TAX 316) and node-negative (GEICAM 9805) breast cancer - pooled data
Maltese: Deskrizzjoni ta' reazzjonijiet avversi partikulari għat-terapija miżjuda b'Docetaxel 75 mg/m² użat flimkien ma' doxorubicin u cyclophosphamide f'pazjenti b'kanċer tas-sider li nfirex fil-glandoli limfatiċi tas-sider (TAX
English: • at the injection site, skin reactions, phlebitis (inflammation of the vein) or swelling
Maltese: • mard interstizjali tal-pulmun (infjammazzjoni fil-pulmuni li tikkawża sogħla u diffikultà biex tieħu n-nifs.
English: NAME OF THE MEDICINAL PRODUCT Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion docetaxel
Maltese: Docetaxel Accord 80 mg/4 ml konċentrat għall-infużjonidocetaxel
English: Hazard ratio (95% CI) *p-value
Maltese: Il-proporzjon tar-riskju (95%CI) *p-value
English: Lymphoedema (G3/4:
Maltese: Stitikezza (G3/4:
English: Pyrexia (G3/4: 1%);
Maltese: Rimettar (G3/4: 5%);
English: Asthenia; Oedema peripheral; Pyrexia; Fatigue; Mucosal inflammation; Pain; Influenza like illness; Chest pain; Chills
Maltese: Fġir l-imnieħer; Uġigh fil farinġi u l-larinġi; Farinġite tal-parti nażali; Qtugħ ta' nifs; Sogħla; Tnixxija mill-imnieħer
English: After 10 years of follow-up in GEICAM 9805 study acute leukaemia occurred in 1 of 532 (0.2%) patients in TAC arm No cases were reported in patients in FAC arm No patient was diagnosed with myelodysplastic syndrome in either treatment groups.
Maltese: Wara 10 snin ta' osservazzjoni fl-istudju GEICAM 9805, lewkimja akuta seħħet f'pazjent 1 minn 532 pazjent (0.2 %) fil-fergħa TAC.
English: Inflammation of the lungs can also develop when docetaxel therapy is used with radiotherapy)
Maltese: Infjammazzjoni tal-pulmuni tista' tiżviluppa wkoll meta t-terapija b'docetaxel tintuża mar-radjuterapija)
English: Patients with operable node-positive breast cancer (TAX 316) Data from a multicentre open-label randomised study support the use of docetaxel for the adjuvant treatment of patients with operable node-positive breast cancer and KPS ≥ 80%, between 18 and 70 years of age.
Maltese: Id-data minn studju f'ċentri multipli, fejn kemm il-pazjenti kif ukoll l-investigaturi kienu jafu x'mediċini qed jintużaw, u l-pazjenti tqassmu mingħajr għażla, isaħħu l-użu ta' docetaxel għattrattament miżjud f'pazjenti li għandhom kanċer tas-sider li nfirex fil-glandoli limfatiċi u li huwa operabbli b'KPS ta' ≥80%, minn 18 sa 70 sena fl-età.
English: Docetaxel Accord in combination with trastuzumab is indicated for the treatment of patients with metastatic breast cancer whose tumours over express HER2 and who previously have not received chemotherapy for metastatic disease.
Maltese: Docetaxel Accord flimkien ma' trastuzumab huwa indikat għat-trattament ta'pazjenti b'kanċer metastatiku tas-sider, liema tumuri jesprimu bil-qawwa HER2, u li preċedentement ma kienux ħadu kimoterapija għall-mard metastatiku.
English: In study GEICAM 9805 peripheral oedema that started during the treatment period persisted into the follow-up period in 4 patients (0.8%) in TAC arm and in 2 patients (0.4%) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), no patients (0%) in TAC arm had peripheral oedema and it was observed to be ongoing in 1 patient (0.2%) in FAC arm.
Maltese: Fl-istudju GEICAM 9805, l-edima periferika li bdiet matul il-perijodu ta' trattament baqgħet tippersisti fil-perijodu ta' osservazzjoni f'4 pazjenti (0.8 %) fil-fergħa TAC u f'2 pazjenti (0.4 %) filfergħa FAC.
English: CAUTION: Ready to add to infusion solution
Maltese: Preparazzjoni ta' soluzzjoni għall-infużjoni
English: Anaemia (G3/4: 6.9%); Thrombocytopenia (G4: 0.5%)
Maltese: Newtropenija (G3/4: 59.2%); Tromboċitopenija (G3/4:
English: In this study, 358 patients with inoperable locally advanced SCCHN, and WHO perfomance status 0 or 1, were randomised to one of two treatment arms.
Maltese: F'dan l-istudju, 358 pazjent li kellhom SCCHN inoperabbli u lokalment avvanzat u b'performance status ta' WHO ta' 0 jew 1, tqassmu lil waħda miżżewġ friegħi tat-trattament mingħajr għażla.
English: Lethargy (G3/4: 3.4%); Pyrexia (G3/4: 0.6%); Fluid retention;
Maltese: Tqalligħ (G3/4: 9.6%); Rimettar (G3/4: 7.6%); Dijarea
English: Two randomised phase III comparative studies, involving a total of 326 alkylating or 392 anthracycline failure metastatic breast cancer patients, have been performed with docetaxel at the recommended dose and regimen of 100 mg/m2 every 3 weeks.
Maltese: III, t'għamla komparattiva u magħmula mingħajr għażla, fejn kien hemm total ta' 326 suġġetti fejn it-trattament oriġinali kien b'sustanzi ċitotossiċi alkylating u 392 oħra li kienu ittrattati oriġinarjament b'sustanza anthracycline, b'falliment tal-kura fiż-żewġ gruppi u li t-tnejn kellhom kanċer tas-sider metastatiku.
English: MARKETING AUTHORISATION NUMBER EU/1/12/769/003
Maltese: EU/1/12/769/001 EU/1/12/769/002 EU/1/12/769/003
English: Note that this is likely to be an underestimate since docetaxel alone at a dose of 100 mg/m2 is known to result in neutropenia in 97% of patients, 76% grade 4, based on nadir blood counts.
Maltese: Innota li din hija probabbli stima baxxa għax docetaxel waħdu f'doża ta'100 mg/m2 hu magħruf li jġib in-newtropenija f'97%tal-pazjenti, 76% fi grad 4, meta ibbażata fuq in-nadir ta' l-għadd taċċelluli fid-demm.
English: Best overall response (CR + PR) to chemotherapy (%) (95% CI) ***p-value
Maltese: L-aħjar rizultat sħiħ bil-kimoterapija (%) (95%CI) ***p-value
English: Syncope (G3/4: 0%); Neurotoxicity (G3/4: Somnolence (G3/4: 0%)
Maltese: Newrotossiċità (G3/4:0 %) Ħedla ta' ngħas (G3/4: 0%)
English: Nausea (G3/4: 5%); Stomatitis (G3/4:
Maltese: (G3/4: 6.4%); Stomatite (G3/4:
English: Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with capecitabine
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal docetaxel 75 mg/m² użat flimkien ma' capecitabine
English: • nasal drainage; inflammation of the throat and nose; cough
Maltese: Disturbi fis-sistema nervuża Parasteżija; Ugigħ ta' ras; Disgewżja;
English: • pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath).
Maltese: • fibrożi tal-pulmuni (titrabba bħal qoxra u r-rita tal-pulmun teħxien b'konsegwenza li jkun hemm qtugħ ta' nifs)
English: Locoregional therapy with radiation was delivered either with a conventional fraction (1.8 Gy - 2.0 Gy once a day, 5 days per week for a total dose of 66 to 70 Gy), or accelerated/hyperfractionated regimens of radiation therapy (twice a day, with a minimum interfraction interval of 6 hours, 5 days per week).
Maltese: Gy darba kuljum, 5 ijiem fil-ġimgħa sa doża totali ta' 66 to 70 Gy), jew bħala terapija ta' radjazzjoni mgħaġġla/iperfrazzjonata (darbtejn kuljum, b'intervall minimu ta' interfraction ta' 6 sigħat, 5 ijiem fil-ġimgħa).
English: Tabulated list of adverse reactions in breast cancer for docetaxel 75 mg/m2 in combination with doxorubicin
Maltese: Lista f'forma tabulari tar-reazzjonijiet avversi fil-kanċer tas-sider għal docetaxel 75 mg/m² użat flimkien ma' doxorubicin:
English: Docetaxel Accord in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Maltese: Docetaxel Accord flimkien ma' doxorubicin huwa indikat għat-trattament ta' pazjenti b'kanċer tassider lokalment avvanzat jew dak metastatiku, li ma kienux ħadu qabel terapija ċitotossika għal din ilmarda.
English: Onycholysis (G3/4: 1%)
Maltese: Deni (G3/4: 1%);
English: Gastric adenocarcinoma
Maltese: Adenokarċinoma ta' l-istonku
English: Dysgeusia (G3/4:
Maltese: Newtropenija (G3/4:
English: Dyspepsia; Abdominal pain
Maltese: Pressjoni baxxa; Pressjoni għolja; Emoraġija
English: Pharyngolaryngeal pain (G3/4:
Maltese: Reazzjonijiet tal-ġilda (G3/4:
English: A hazard ratio of less than 1 favours docetaxel + cisplatin + fluorouracil *un-adjusted log-rank test **un-adjusted log-rank test, not adjusted for multiple comparisons ***Chi square test, not adjusted for multiple comparisons NA-not applicable
Maltese: (95%CI) ***p-value L-aħjar rizultat sħiħ (CR + PR) bit-trattament studjat [kimoterapija +/- kimoradjuterapija] (%) (95%CI) ***p-value Proporzjon ta' riskju ta' anqas minn 1 huwa favur docetaxel + cisplatin + fluorouracil *Log-rank test mhux aġġustat **Logrank test mhux aġġustat, mhux aġġustat għal paraguni multipli ***Chi-square test, mhux aġġustat għal paraguni multipli NA - Ma jgħoddx f'dan il-każ.
English: Thrombocytopenia (G3/4: 3%)
Maltese: Tromboċitopenija (G3/4: 5.2%)
English: 1Full analysis set (intent-to-treat)
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Docetaxel Accord 80 mg/4 ml is supplied in a 5 ml clear glass vial with fluorotec plus rubber stopper and aluminium seal and a red flip-off cap.
Maltese: Docetaxel Accord 80 mg/4 ml huwa fornut minn kunjett ta' 5 ml magħmul minn ħġieġ ċar , b'tapp talgomma fluorotec plus u siġill tal-aluminju u kappa li tista' tgħolliha biex tiftaħha kulur oranġjo dan.
English: Esophagitis/dysphagia/ odynophagia (G3/4:
Maltese: Esofaġite/disfaġja/ odinofaġja (G3/4:0.6%);
English: Frequency System Organ Class
Maltese: Frekwenza Sistema tal-Klassifika tal-Organi
English: D-78467 Konstanz Germany
Maltese: 2 D-78467 Konstanz
English: België/Belgique/Belgien Takeda Belgium Tél/Tel: + 32 2 464 06 11 takeda-belgium@takeda.com
Maltese: Luxembourg/Luxemburg Takeda Belgium Tél/Tel: + 32 2 464 06 11 takeda-belgium@takeda.com
English: Methacrylic acid-ethyl acrylate copolymer (1:1) Sodium laurilsulfate
Maltese: Methacrylic acid-ethyl acrylate copolymer (1:1)
English: Diarrhoea;
Maltese: Urtikarja;
English: Date of first authorisation:12 June 2009
Maltese: 12 ta' Ġunju 2009
English: 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: 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,
English: In animal studies (rats) 5 mg/kg was the observed NOAEL (No Observed Adverse Effect Level) for embryotoxicity.
Maltese: Fi studji fuq l-annimali (firien) 5 mg/kg kien l-NOAEL (No Observed Adverse Effect Level) osservat għall-embrijotossiċità.
English: It has been shown that co-administration of atazanavir 300 mg/ritonavir 100 mg with omeprazole (40 mg once daily) or atazanavir 400 mg with lansoprazole (60 mg single dose) to healthy volunteers resulted in a substantial reduction in the bioavailability of atazanavir.
Maltese: Intwera li l-għoti flimkien ta' atazanavir 300 mg/ritonavir 100 mg ma' omeprazole (40 mg darba kuljum) jew atazanavir 400 mg ma' lansoprazole (doża waħda ta' 60 mg) lil voluntiera b'saħħithom, irriżulta fi tnaqqis sostanzjali fil-bijodisponibiltà ta' atazanavir.
English: The absorption of atazanavir is pH-dependent.
Maltese: L-assorbiment ta' atazanavir hu dipendenti fuq il-pH.
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 flistonku seħħ fi 62.9% sa 88.6% u 68.1% sa 92.3% tal-pazjenti, rispettivament.
English: What PANTECTA Control contains - The active substance is pantoprazole.
Maltese: X'fih PANTECTA Control - Is-sustanza attiva hi pantoprazole.
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%,
English: 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: 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
English: Takeda France S.A.S.
Maltese: Takeda Italia S.p.A.
English: PANTECTA Control is available in Alu/Alu blisters with or without cardboard reinforcement.
Maltese: PANTECTA Control hu disponibbli f'folji Alu/Alu bi jew mingħajr cardboard reinforcement.
English: ‘Other medicines and PANTECTA Control'.
Maltese: Ara “Mediċini oħra u PANTECTA Control).
English: PANTECTA Control 20 mg gastro-resistant tablets Pantoprazole
Maltese: PANTECTA Control 20 mg pilloli gastro-reżistenti Pantoprazole
English: PANTECTA Control 20 mg gastro-resistant tablets
Maltese: PANTECTA Control 20 mg pilloli gastro-reżistenti
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza talUnjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il
English: However, you may take PANTECTA Control with antacids (e.g. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, or combinations thereof), if needed.
Maltese: Madankollu, tista' tieħu PANTECTA Control ma' antaċidi (eż. magaldrate, alginic acid, sodium bicarbonate, aluminium hydroxide, magnesium carbonate, jew kumbinazzjonijiet tagħhom), jekk ikun meħtieġ.
English: Constipation; Dry mouth;
Maltese: bilirubina epatoċellulari; Suffejra;
English: PANTECTA Control may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).
Maltese: PANTECTA Control jista' jnaqqas l-assorbiment ta' sustanzi attivi li l-bijodisponibiltà tagħhom tiddependi fuq il-pH gastrika (eż. ketoconazole).
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: Pharmacotherapeutic group: : Drugs for acid related disorders,Proton pump inhibitors, ATC code: A02BC02
Maltese: Mediċini għal disturbi relatati mal-aċidu, Inibituri tal-pompa talproton, Kodiċi ATC:
English: Urticaria; Angioedema
Maltese: Tromboċitopenja; Lewkopenja, Panċitopenija
English: Liver enzymes increased (transaminases, γ-GT)
Maltese: Mhux magħrufa fil-marrara tal-fwied (transaminases, γ-GT)
English: Ελλάδα
Maltese: Mekkaniżmu ta' azzjoni
English: - warfarin and phenprocoumon (used to thin blood and prevent clots).
Maltese: - ketoconazole (użat għal infezzjonijiet fungali). - warfarin u phenprocoumon (jintużaw biex iraqqu d-demm u għall-prevenzjoni tal-emboli).
English: Pruritus
Maltese: FEJN
English: Calcium stearate
Maltese: Mhux komuni
English: Hepatic impairment
Maltese: Nefrite interstizjali
English: Hyponatraemia, Hypomagnesaemia
Maltese: Iponatrimija, Ipomanjesemija
English: Co-administration with atazanavir (see section 4.5).
Maltese: L-għoti flimkien ma' atazanavir (ara sezzjoni 4.5).
English: 7 gastro-resistant tablets 14 gastro-resistant tablets
Maltese: Il-pakketti fihom 7 jew 14-il pillola gastro-reżistenti.
English: Stop taking PANTECTA Control when you are completely symptom-free.
Maltese: Għandek tieqaf tieħu PANTECTA Control meta ma jkollokx aktar sintomi.
English: Approximately 5% of patients can be expected to experience adverse reactions .
Maltese: Madwar 5% tal-pazjenti huma mistennija li jkollhom reazzjonijiet avversi.
English: What PANTECTA 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 PANTECTA Control u l-kontenut tal-pakkett Il-pilloli gastro-reżistenti huma pilloli sofor, ovali, bikonvessi, miksija b'rita u stampati bi “P20” fuq