FrancophonIA/ELRC3.0 huggingface dataset:
English: Rash and diarrhoea resulted in discontinuation of Tarceva in 1% and <1% of patients, respectively, in study BO18192, while no patients discontinued for rash or diarrhoea in BO25460.
Maltese: Fl-istudju BO18192, raxx u dijarea wasslu għal waqfien ta' Tarceva f'1% u <1% tal-pazjenti, rispettivament, filwaqt li f'BO25460, l-ebda pazjent ma waqaf minħabba raxx jew dijarea.
English: In a clinical study, the concomitant use of erlotinib with carboplatin and paclitaxel led to an increase of total platinum AUC0-48 of 10.6%.
Maltese: 6% fl-AUC0-48 totali ta' platinum.
English: Each film-coated tablet contains 100 mg erlotinib (as erlotinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 100 mg erlotinib (bħala erlotinib hydrochloride).
English: Patient factors, which correlated with erlotinib pharmacokinetics, were serum total bilirubin, AAG and current smoking.
Maltese: Fatturi tal-pazjent, li jikkorrelaw mal-farmakokinetika ta' erlotinib, kienu total tal-bilirubina fis-serum,
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/311/001
English: • Periodic Safety Update Reports
Maltese: • Testijiet tad-demm tal-funzjoni tal-fwied mhux normali
English: Tarceva 100 mg is supplied as a white to yellowish, round, film-coated tablet with ‘T 100' engraved on one side and is available in pack sizes of 30 tablets.
Maltese: Tarceva 100 mg huwa pprovdut bħala pillola miksija b'rita, tonda, ta' kulur abjad għal safrani b'‘T 100' minquxa fuq naħa waħda u huwa disponibbli f'pakketti ta' 30 pillola.
English: The listed ADRs were those reported in at least 10% (in the Tarceva group) of patients and occurred more frequently (≥3%) in patients treated with Tarceva than in the comparator arm. Other ADRs including those from other studies are summarized in Table 2.
Maltese: L-ADRs elenkati kienu dawk irrappurtati f'mill-inqas 10% (fil-grupp ta' Tarceva) tal-pazjenti u seħħew b'mod aktar frekwenti (≥3%) f'pazjenti ttrattati b'Tarceva milli fil-grupp ta' paragun.
English: Based on the data from these studies, severe adverse reactions such as diarrhoea, rash and possibly increased activity of liver aminotransferases may occur above the recommended dose.
Maltese: Ibbażat fuq dejta minn dawn l-istudji, reazzjonijiet avversi serji bħal dijarea, raxx u possibilment żieda fl-attività ta' aminotransferases talfwied jistgħu jseħħu b'dożi aktar mid-doża rrakkomandata.
English: In the remaining 55% of patients with unknown EGFR-expression status, the hazard ratio was 0.77 (95% CI 0.61-0.98).
Maltese: 77 (95% CI 0.61-0.98).
English: If a plasma-based cfDNA test is used and the result is negative for activating mutations, perform a tissue test wherever possible due to the potential for false negative results from a plasma-based test.
Maltese: Jekk jintuża test ta' cfDNA bbażat fuq il-plażma u r-riżultat ikun negattiv għall-mutazzjonijiet li jattivaw, wettaq test tat-tessut fejn possibbli minħabba l-potenzjal ta' riżultati negattivi foloz minn test ibbażat fuq il-plażma.
English: demonstrating a substantial PFS benefit (HR=0.10, 95% CI, 0.04 to 0.25; p<0.0001) and an overall survival HR of 0.83 (95% CI, 0.34 to 2.02).
Maltese: (HR= 1.02, CI ta' 95%, 0.85 sa 1.22, p=0.82).
English: -Hepatic failure 6
Maltese: Insuffiċjenza tal-fwied6
English: MARKETING AUTHORISATION NUMBER(S) EU/1/05/311/002
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/05/311/002
English: Eye disorders Keratoconjunctivitis sicca Conjunctivitis very common very common
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna
English: Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk.
Maltese: Pazjenti li qed jirċievu flistess waqt sustanzi anti-anġjoġeniċi, kortikosterojdi, NSAIDs, u/jew kimoterapija bbażata fuq taxane, jew li għandhom passat ta' ulċerazzjoni peptika jew marda divertikulari huma f'riskju ikbar.
English: Medicinal products that alter the pH of the upper Gastro-Intestinal (GI) tract may alter the solubility of erlotinib and hence its bioavailability.
Maltese: Prodotti mediċinali li jbiddlu l-pH tal-parti ta' fuq tas-sistema Gastro-Intestinali (GI) jistgħu jbiddlu s-solubilità ta' erlotinib u b'hekk il-bijodisponibiltà tiegħu.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Maltese: Kontenut tal-pakkett u informazzjoni oħra X'fih Tarceva:
English: This disease can also be linked to the natural progression of your medical condition and can have a fatal outcome in some cases.
Maltese: Din il-marda tista' tkun marbuta wkoll mal-progressjoni naturali tal-kundizzjoni medika tiegħek u f'xi każijiet jista' jkollha riżultat fatali.
English: In population pharmacokinetic analysis, increased serum concentrations of total bilirubin were associated with a slower rate of erlotinib clearance.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni, żieda fil-konċetrazzjonijiet fis-serum tat-total ta' bilirubina kienet assoċjata ma' rata ta'tneħħija aktar bil-mod ta' erlotinib.
English: In the pivotal Phase III NSCLC trial, current smokers achieved erlotinib steady state trough plasma concentration of 0.65 µg/mL (n=16) which was approximately 2-fold less than the former smokers or patients who had never smoked (1.28 µg/mL, n=108).
Maltese: III dwar NSCLC, dawk li kienu qed ipejpu f'dak iż-żmien laħqu l-inqas konċentrazzjoni ta' erlotinib fil-plażma fi stat fiss b'valur ta' 0.65 µg/mL (n=16) li kien madwar darbtejn inqas minn dak ta' pazjenti li qabel kienu jpejpu iżda waqfu jew pazjenti li qatt ma pejpu (1.28 µg/mL, n=108).
English: In rare cases liver failure was observed (rare: may affect up to 1 in 1,000 people).
Maltese: • F'każijiet rari kienet osservata insuffiċjenza tal-fwied (rari: jistgħu jaffettwaw sa persuna waħda minn kull 1,000).
English: In the event of severe or persistent diarrhoea, nausea, anorexia, or vomiting associated with dehydration, Tarceva therapy should be interrupted and appropriate measures should be taken to treat the dehydration (see section 4.8).
Maltese: F'każ ta' dijarea qawwija jew persistenti, dardir, anoressija, jew rimettar assoċjat ma' deidrazzjoni, terapija b'Tarceva trid titwaqqaf u miżuri xierqa jittieħdu għall-kura tad-deidrazzjoni (ara sezzjoni 4.8).
English: Safety evaluation of Tarceva is based on the data from more than 1500 patients treated with at least one 150 mg dose of Tarceva monotherapy and more than 300 patients who received Tarceva 100 or 150 mg in combination with gemcitabine.
Maltese: L-evalwazzjoni tas-sigurtà ta' Tarceva hija bbażata fuq id-data minn aktar minn 1500 pazjent ittrattati b'mill-inqas doża waħda ta' 150 mg ta' Tarceva bħala monoterapija u aktar minn 300 pazjent li rċevew Tarceva 100 jew 150 mg flimkien ma' gemcitabine.
English: Two-year carcinogenicity studies with erlotinib conducted in rats and mice were negative up to exposures exceeding human therapeutic exposure (up to 2-fold and 10-fold higher, respectively, based on Cmax and/or AUC).
Maltese: Studji ta' sentejn dwar ilkarċinoġeniċità b'erlotinib li twettqu fuq il-firien u l-ġrieden kienu negattivi sa esponimenti li jaqbżu lesponiment terapewtiku fil-bniedem (sa darbtejn u 10 darbiet ogħla, rispettivament, ibbażat fuq Cmax u/jew l-AUC).
English: Tablet coat
Maltese: PAKKETT TA' BARRA
English: In the Tarceva plus gemcitabine arm, Grade 3/4 rash and diarrhoea were each reported in 5% of patients.
Maltese: Fil-grupp ta' Tarceva flimkien ma' gemcitabine, raxx u dijarea ta' Grad 3/4 it-tnejn kienu rrappurtati f'5% tal pazjenti.
English: What Tarceva looks like and contents of the pack:
Maltese: Kif jidher Tarceva u l-kontenut tal-pakkett:
English: See also below “Other medicines and Tarceva”
Maltese: Ara wkoll taħt “Mediċini oħra u Tarceva”.
English: In study BR.21, the median time to onset of rash was 8 days, and the median time to onset of diarrhoea was 12 days.
Maltese: Fi studju BR.21, il-ħin medjan sakemm deher ir-raxx kien ta' tmint ijiem, u il-ħin medjan sakemm deheret id-dijarrea kien ta' 12-il ġurnata.
English: In population pharmacokinetic analysis, no clinically significant relationship was observed between erlotinib clearance and creatinine clearance, but there are no data available for patients with creatinine clearance <15 ml/min.
Maltese: F'analiżi tal-farmakokinetika tal-popolazzjoni, ma ġiet osservata lebda relazzjoni klinikament sinnifikanti bejn it-tneħħija ta' erlotinib u t-tneħħija ta' kreatinina, iżda m'hemmx dejta disponibbli dwar pazjenti li għandhom tneħħija ta' kreatinina <15 ml/min.
English: Common
Maltese: Kull
English: Glucuronidation disorder like Gilbert's syndrome Your doctor must treat you with caution if you have a glucuronidation disorder like Gilbert's syndrome.
Maltese: Disturb fil-glukuronidazzjoni bħas-sindrome ta' Gilbert It-tabib tiegħek għandu jikkurak b'kawtela jekk għandek disturb fil-glukuronidazzjoni bħas-sindrome ta' Gilbert.
English: • if you have diarrhoea because your doctor may need to treat you with anti-diarrhoeal (for example loperamide);
Maltese: • jekk għandek dijarea, għax it-tabib tiegħek jista' jkollu bżonn jikkurak b'mediċini kontra ddijarea (per eżempju loperamide);
English: For patients who require concomitant treatment with Tarceva and a potent CYP3A4 inducer such as rifampicin an increase in dose to 300 mg should be considered while their safety (including renal and liver functions and serum electrolytes) is closely monitored, and if well tolerated for more than 2 weeks, further increase to 450 mg could be considered with close safety monitoring.
Maltese: Għall-pazjenti li jinħtieġu kura b'Tarceva flimkien ma' induttur qawwi ta' CYP3A4 bħal rifampicin, għandha tiġi kkunsidrata żieda fid-doża għal 300 mg filwaqt li s-sigurtà tagħhom (inkluż il-funzjonijiet renali u tal-fwied u l-elektroliti fis-serum) tiġi sorveljata mill-viċin, u jekk ittollerat tajjeb għal aktar minn ġimagħtejn, aktar żieda sa 450 mg tista' tkun ikkunsidrata b'sorveljanza tas-sigurtà mil-viċin.
English: Grade 3/4 rash and diarrhoea occurred in 9% and 6%, respectively in Tarceva-treated patients and each resulted in study discontinuation in 1% of patients.
Maltese: Raxx u dijarea ta' Grad 3/4 seħħew f'9% u 6%, rispettivament tal-pazjenti kkurati b'Tarceva u f'kull każ kien hemm 1% tal-pazjenti li waqqfu l-istudju minħabba f'dan.
English: Patients were randomised 1:1 to receive Tarceva 150 mg or placebo orally once daily until disease progression.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu Tarceva 150 mg jew plaċebo mill-ħalq darba kuljum sal-progressjoni tal-marda.
English: Based on the mode of action, erlotinib has the potential to be a teratogen.
Maltese: Ibbażat fuq il-mod ta' azzjoni, erlotinib għandu l-potenzjal li jkun teratoġeniku.
English: In the clinical studies doses were reduced by 50 mg steps.
Maltese: Fi studji kliniċi id-doża kienet imnaqqsa bi kwantitajiet ta' 50 mg.
English: Rash and diarrhoea each resulted in dose reductions in 2% of patients, and resulted in study discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Maltese: Raxx u dijarea t-tnejn wasslu għal tnaqqis fid-doża fi 2% tal-pazjenti, u wasslu għal waqfien talistudju f'sa 1% tal-pazjenti li kienu qed jirċievu Tarceva flimkien ma' gemcitabine.
English: This study was conducted in Caucasian patients with metastatic or locally advanced NSCLC (stage IIIB and IV) who have not received previous chemotherapy or any systemic antitumour therapy for their advanced disease and who present mutations in the tyrosine kinase domain of the EGFR (exon 19 deletion or exon 21 mutation).
Maltese: Dan l-istudju sar fuq pazjenti Kawkasi b'NSCLC metastatiku jew avanzat lokalment (stadju IIIB u IV) li ma kienux ħadu kimoterapija jew xi terapija sistemika kontra t-tumuri minn qabel għal marda avanzata tagħhom u li kellhom mutazzjonijiet fid-dominju ta' tyrosine kinase ta' EGFR (tneħħija ta' exon 19 jew mutazzjoni ta' exon 21).
English: Less than 2% of the orally administered dose is excreted as parent substance.
Maltese: Anqas minn 2% tad-doża mogħtija millħalq titneħħa bħala s-sustanza oriġinali.
English: Confounding factors included pre-existing liver disease or concomitant hepatotoxic medications (see section 4.4).
Maltese: Fatturi li aggravaw inkludew mard tal-fwied eżistenti minn qabel jew medikazzjonijiet epatotossiċi fl-istess waqt (ara sezzjoni 4.4).
English: Although erlotinib exposure was similar in patients with moderately impaired hepatic function (Child-Pugh score 7-9) compared with patients with adequate hepatic function, caution should be used when administering Tarceva to patients with hepatic impairment.
Maltese: Għalkemm esponiment għal erlotinib kien simili f'pazjenti b'indeboliment moderat tal-funzjoni tal-fwied (punteġġ ChildPugh 7-9) meta mqabbel ma' pazjenti b'funzjoni adegwata tal-fwied, għandha tintuża attenzjoni meta Tarceva jingħata lill-pazjenti b'indeboliment tal-fwied.
English: These findings were observed at clinically relevant exposures.
Maltese: Dawn is-sejbiet ġew osservati f'espożizzjonijiet klinikament rilevanti.
English: - First-line Non-Small Cell Lung Cancer (NSCLC) therapy for patients with EGFR activating mutations (Tarceva administered as monotherapy)
Maltese: - Terapija primarja għall-Kanċer tal-pulmun mhux taċ-ċellula żgħira (NSCLC) għall-pazjenti b'mutazzjonijiet li jattivaw lil EGFR (Tarceva mogħti bħala monoterapija)
English: Norge
Maltese: Nisa
English: In the pivotal study BR.21 in NSCLC, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva groups.
Maltese: BR.21 f'NSCLC, l-inċidenża ta' ILD (0.8%) kienet l-istess kemm fil-grupp tal-plaċebo kif ukoll f'dak ta' Tarceva.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 25 mg of erlotinib (as erlotinib hydrochloride).
Maltese: Kull pillola miksija b'rita fiha 25 mg ta' erlotinib (bħala erlotinib hydrochloride).
English: Combination of alendronic acid and alfacalcidol (Valebo):
Maltese: Kombinazzjoni ta' alendronic acid u alfacalcidol (Valebo):
English: What is alfacalcidol?
Maltese: X'inhu alfacalcidol?
English: Package leaflet
Maltese: Anness
English: In some clinical studies, alfacalcidol has been shown to reduce the risk of falls in the elderly.
Maltese: F'xi studji kliniċi, alfacalcidol intwera li jnaqqas ir-riskju ta' waqgħat fl-anzjani.
English: Section 5.1: Pharmacodynamic properties [This section should be amended to reflect the following wording]
Maltese: Sezzjoni 5.1: Proprjetajiet farmakodinamiċi
English: WHAT VALEBO IS AND WHAT IT IS USED FOR
Maltese: X'INHU VALEBO
English: [This section should be amended to reflect the following wording]
Maltese: [Din is-Sezzjoni għandha tiġi emendata biex tirrifletti l-formolazzjoni tal-kliem li ġejja]
English: [The following wording should be deleted] “whilst alfacalcidol significantly reduces the frequency of falls in the elderly” [The following wording should be added]
Maltese: [Din is-sezzjoni għandha tiġi emendata biex tirrifletti l-formolazzjoni tal-kliem li ġejja]
English: Section 4.1: Therapeutic indications [The wording of this section should be read as below] Treatment of postmenopausal osteoporosis.
Maltese: Sezzjoni 4.1: Indikazzjonijiet terapewtiċi
English: The valid package leaflet is the final version achieved during the Coordination group procedure with the following amendments:
Maltese: Is-sommarju tal-karatteristiċi tal-prodott validu huwa l-verżjoni finali miksuba matul il-proċedura talgrupp ta' Koordinazzjoni bl-emendi li ġejjin:
English: Date of first authorisation: 13 March 2013 Date of latest renewal: 8 January 2018
Maltese: Data tal-ewwel awtorizzazzjoni: 13 ta' Marzu 2013 Data tal-aħħar tiġdid: 8 ta' Jannar 2018
English: Równoległa 5, 02-235 Warszawa, Poland TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany KRKA - FARMA d.o.o.,V.
Maltese: Równoległa 5, 02-235 Warszawa, Il-Polonja TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Il-Ġermanja KRKA - FARMA d.o.o.,V.
English: Blisters (OPA/Al/PVC foil//Al foil): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 and 100 x 1 tablet in a box.
Maltese: Folji (fojl ta' OPA/tal-Al/PVC//fojl tal-Al): 14 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 84 x 1, 90 x 1, 98 x 1 u 100 x 1 pillola f'kaxxa.
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Maltese: Il-bijodisponibilità assoluta ta' telmisartan f'doża ta' 40 mg u 160 mg kienet ta' 42 % u 58 %, rispettivament.
English: Lactose , sorbitol and sodium
Maltese: Lactose, sorbitol u sodium
English: - Severe renal impairment (creatinine clearance <30 ml/min).
Maltese: - Indeboliment renali sever (rata ta' tneħħija ta' kreatinina ta' < 30 ml/min).
English: LYFIS ehf.
Maltese: Ísland LYFIS ehf.
English: KRKA-POLSKA Sp. z o.o.
Maltese: KRKA-POLSKA Sp. z. o.o. ul.
English: Possible side effects of Tolucombi:
Maltese: Effetti sekondarji possibbli ta' Tolucombi:
English: See section 2 "Tolucombi contains lactose, sorbitol and sodium".
Maltese: Ara sezzjoni 2 "Tolucombi fih lactose, sorbitol u sodium".
English: Exacerbation or activation of systemic lupus erythematosus
Maltese: Aggravament jew attivazzjoni ta' lupus erythematosus sistemiku
English: Povidone (K30) Red ferric oxide (E172) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420)
Maltese: Povidone (K30) Red ferric oxide (E172) Silica, anidru kollojdali Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420)
English: Holjevca 20/E, 10 450 Jastrebarsko, Croatia
Maltese: Holjevca 20/E, 10450
English: Visual disturbance, vision blurred
Maltese: Disturbi tal-vista, vista mċajpra
English: - Muscle relaxing medicines, such as tubocurarine.
Maltese: - Mediċini li jirrilassaw il-muskoli, bħal tubocurarine.
English: Telmisartan is highly bound to plasma proteins (>99.5 %) mainly albumin and alpha l-acid glycoprotein.
Maltese: Telmisartan jeħel ħafna mal-proteini fil-plażma (>99.5 %), l-aktar ma' l-albumina u alpha1-acid glycoprotein.
English: Blisters (OPA/Al/PVC foil//Al foil): 3 years Blisters (OPA/Al/PE foil with desiccant//Al foil): 2 years
Maltese: Folji (fojl ta' OPA tal-Al/PVC//fojl tal-Al): 3 snin Folji (fojl tal-OPA/Al/PE b'dessikant//fojl tal-Al): Sentejn
English: Eosinophilia, thrombocytopenia
Maltese: Anemija Eosinofilja, tromboċitopenija
English: - Refractory hypokalaemia, hypercalcaemia.
Maltese: - Ipokalemija refrattarja, iperkalċemija.
English: - The other ingredients are: hydroxypropylcellulose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone (K30), red ferric oxide (E172) - only in 40 mg/12.5 mg and 80 mg/12.5 mg tablets, silica colloidal anhydrous, sodium hydroxide (E524), sodium stearyl fumarate, sorbitol (E420) and yellow ferric oxide (E172) - only in 80 mg/25 mg tablets.
Maltese: - Is-sustanzi l-oħra huma hydroxypropylcellulose, lactose monohydrate, magnesium stearate, mannitol, meglumine, povidone (K30), red ferric oxide (E172) - fil-pilloli ta' 40 mg/12.5 mg u 80 mg/12.5 mg biss, silica anidru kollojdali, sodium hydroxide (E524), sodium stearyl fumarate, sorbitol (E420) u yellow ferric oxide (E172) - fil-pilloli ta' 80 mg/25 mg biss.
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system; angiotensin II antagonists and diuretics, ATC code:C09DA07.
Maltese: Sustanzi li jaġixxi fuq is-sistema renin-angiotensin, antagonisti tarriċettur ta' angiotensin II u dijuretiċi, Kodiċi ATC: C09DA07
English: Tolucombi 40 mg/12.5 mg tablets EU/1/13/821/001
Maltese: Tolucombi 40 mg/12.5 mg pilloli EU/1/13/821/001
English: Tolucombi 80 mg/12.5 mg tablets EU/1/13/821/011
Maltese: Tolucombi 80 mg/12.5 mg pilloli EU/1/13/821/011
English: - Second and third trimesters of pregnancy (see sections 4.4 and 4.6).
Maltese: - It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6).
English: Povidone (K30) Silica, colloidal anhydrous Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420) Yellow ferric oxide (E172)
Maltese: Sodium hydroxide (E524) Sodium stearyl fumarate Sorbitol (E420) Yellow ferric oxide (E172)
English: Pressor amines (e.g. noradrenaline) The effect of pressor amines may be decreased.
Maltese: Pressor amines (eż. noradrenaline)
English: See also information under the heading “Do not take Tolucombi”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Tolucombi”.
English: Beta-blockers and diazoxide The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Maltese: Imblokkaturi beta u diazoxide L-effett ipergliċemiku ta' imblokkaturi beta u ta' diazoxide jista' jiżdied bit-thiazides.
English: - Cholestyramine and colestipol, medicines for lowering blood fat levels.
Maltese: - Cholestyramine u colestipol, mediċini biex ibaxxu l-livelli tax-xaħam fid-demm.
English: The overall incidence of adverse reactions reported with telmisartan (41.4 %) was usually comparable to placebo (43.9 %) in placebo controlled trials.
Maltese: L-inċidenza totali ta' avvenimenti avversi rrappurtati b'telmisartan (41.4%) kienet ġeneralment komparabbli mal-plaċebo (43.9%) fil-provi li saru li kienu kkontrollati bil-plaċebo.
English: The cytochrome P450 isoenzymes are not involved in the metabolism of telmisartan.
Maltese: L-isoenzimi ta' ċitokrom P450 mhumiex involuti fil-metaboliżmu ta' telmisartan.
English: 3: For further description, please see sub-section “Description of selected adverse reactions”
Maltese: 3: Għal deskrizzjoni addizzjonali, jekk jogħġbok ara s-sottosezzjoni, “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: Hydrochlorothiazide is 68 % protein bound in the plasma and its apparent volume of distribution is 0.83 - 1.14 l/kg.
Maltese: Hydrochlorothiazide jeħel mal-proteini fil-plażma f'ammont ta' 68 %, u l-volum apparenti taddistribuzzjoni hu ta' 0.83-1.14 l/kg.
English: Tolucombi is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Tolucombi hu taħlita ta' antagonist tar-riċettur ta' angiotensin II, telmisartan, u dijuretiku thiazide, hydrochlorothiazide.
English: Blister (OPA/Al/PVC foil//Al foil): 14 x 1 tablet
Maltese: Folja (fojl ta' OPA tal-Al/PVC//fojl tal-Al) 14 x 1 pillola
English: Renal and urinary disorders Uncommon: Renal impairment (including acute renal failure)
Maltese: Indeboliment renali (li jinkludi insuffiċjenza renali akuta)
English: Arthrosis, tendon pain
Maltese: Artosi, uġigħ fit-tendini
English: How to store Tolucombi
Maltese: Tieħux Tolucombi
English: The effect of Tolucombi may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicyl acid or ibuprofen).
Maltese: L-effett ta' Tolucombi jista' jitnaqqas meta tieħu NSAIDs (non steroidal antiinflammatory drugs, eż. acetylsalicyl acid jew ibuprofen).
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Maltese: 1: Ibbażat fuq esperjenza ta' wara t-tqegħid fis-suq 2: Għal deskrizzjoni addizzjonali, jekk jogħġbok ara s-sottosezzjoni, “Deskrizzjoni ta' reazzjonijiet avversi magħżula”.
English: Hypersensitivity, anaphylactic reactions
Maltese: Sensittività eċċessiva, reazzjonijiet anafilattiċi
English: Epidemiological studies have shown that long-term treatment with hydrochlorothiazide reduces the risk of cardiovascular mortality and morbidity.
Maltese: Studji epidemjoloġiċi wrew li kura fit-tul b'hydrochlorothiazide tnaqqas ir-riskju ta' mortalità u l-morbożità kardjovaskulari.
English: Renal and urinary disorders Not known: Nephritis interstitial, renal dysfunction, glycosuria
Maltese: Nefrite interstizjali, disfunzjoni renali, glikosurja
English: Amantadine Thiazides may increase the risk of adverse reactions caused by amantadine.
Maltese: Amantadine It-thiazides jistgħu jżidu r-riskju ta' reazzjonijiet avversi ikkawżati minn amantadine.