FrancophonIA/ELRC3.0 huggingface dataset:
English: 50 mg capsule: Size number 2 capsule with a Swedish orange cap (black imprint “ASK001”) and body (black imprint “50mg”).
Maltese: Kapsula ta' 50 mg: Kapsula b'daqs numru 2 b'għatu u korp ta' lewn Swedish orange (marka sewda "ASK001" u "50mg")..
English: Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid
Maltese: Kolbam 250 mg kapsuli ibsin cholic acid
English: Of 49 patients with a single enzyme defect treated in Study CAC-91-10-10 and included in the safety analysis, 42 had at least one pre- and one post-treatment assessment for urine bile acids and liver function tests; height and weight and were included in the primary efficacy analysis.
Maltese: Minn 49 pazjent b'difett f'enzima waħda li kienu rċevew kura fl-Istudju CAC-91-10-10 u kienu ġew inklużi fl-analiżi tas sigurtà, 42 kellhom mill-inqas valutazzjoni waħda qabel u wara l-kura għall-aċidi biljari fl-awrina u testijiet tal-funzjoni tal-fwied; it-tul u l-piż u kienu nklużi fl-analiżi tal-effikaċja primarja.
English: No formal preclinical safety studies have been conducted; however, data in the literature reveal no special hazard for humans based on studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Maltese: Ma sar l-ebda studju formali qabel l-użu kliniku dwar is-sigurtà; madankollu, dejta fil-letteratura tindika li abbażi ta' studji ta' sigurtà farmakoloġika, tossiċità minn dożi ripetuti, ġenotossiċità, potenzjal karċinoġeniku, tossiċità għar-riproduzzjoni, ma hemm l-ebda periklu speċjali għall-bniedem.
English: - PSURs - Annual Reassessments
Maltese: - PSURs -Valutazzjonijiet mill-ġdid annwali
English: Distribution and pharmacological effects of bile acids such as cholic acid are mainly limited to the enterohepatic circulation, which includes the intestine, portal vein, liver and biliary tract.
Maltese: Id-distribuzzjoni u l-effetti farmakoloġiċi tal-aċidi biljari bħall-aċidu koliku huma prinċipalment limitati għaċ-ċirkolazzjoni enteroepatika, li tinkludi l-musrana, il-vina portali, il-fwied u l-passaġġ biljari.
English: Kolbam 250 mg: Each capsule contains 250 mg of cholic acid.
Maltese: Kolbam 250 mg: Kull kapsula fiha 250 mg ta' aċidu koliku.
English: A total of 79 patients received cholic acid treatment, 49 of these suffered from a primary enzyme defect.
Maltese: Total ta' 79 pazjent irċevew kura bl-aċidu koliku, li 49 minnhom kienu jbatu minn difett primarju f'enzima.
English: Concurrent with the disappearance of atypical bile acid metabolites, there is a consistent reduction and normalization in serum liver enzymes.
Maltese: Flimkien mal-għajbien talmetaboliti atipiċi tal-aċidu biljari, ikun hemm tnaqqis konsistenti u normalizzazzjoni fl-enzimi tal fwied fis-serum.
English: Within the liver, cholic acid is amidated in species-specific proportions, with glycine and/or taurine, into a more hydrophilic, conjugated form.
Maltese: Fil-fwied, l-aċidu koliku jiġi amidat fi proporzjonijiet speċifiċi għall-ispeċi, bil-gliċina u/jew tawrina, f'forma aktar konjugata u idrofilika.
English: The remaining 5 patients were treatment naïve.
Maltese: Il-5 pazjenti li fadal qatt ma kienu ħadu trattament qabel.
English: 250 mg Capsule shell Gelatin
Maltese: Qoxra tal-kapsula ta' 250 mg Gelatin
English: 50 mg Capsule shell Gelatin
Maltese: Qoxra tal-kapsula ta' 50 mg Gelatin
English: NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules cholic acid
Maltese: Kolbam 50 mg kapsuli ibsin cholic acid
English: Ciclosporin alters the pharmacokinetics of cholic acid by inhibition of the hepatic uptake and hepatobiliary secretion of bile acids, as well as via its pharmacodynamics by inhibiting cholesterol 7α-hydroxylase.
Maltese: Ciclosporin ibiddel il-farmakokinetika tal-aċidu koliku permezz tal-inibizzjoni tat-teħid epatiku u s sekrezzjoni epatobiljari tal-aċidi biljari, kif ukoll permezz tal-farmakodinamika tiegħu billi jinibixxi lkolesterol 7α-hydroxylase.
English: Cholic acid down-regulates bile acid biosynthesis via activation of farnesoid X receptor, which represses transcription of the CYP7A1 gene encoding cholesterol 7α-hydroxylase, the rate-limiting enzyme of bile acid synthesis.
Maltese: L-aċidu koliku jirregola 'l isfel il-bijosintesi tal-aċidu biljari permezz tal-attivazzjoni tar-riċettur farnesoid X, li jrażżan it-traskrizzjoni tal-ġene CYP7A1 li jikkodifika l-kolesterol 7αhydroxylase, l-enzima li tillimita r-rata tas-sintesi tal-aċidu biljari.
English: Kolbam 50 mg: Each capsule contains 50 mg of cholic acid.
Maltese: Kolbam 50 mg: Kull kapsula fiha 50 mg ta' aċidu koliku.
English: Mild peripheral neuropathy
Maltese: Newropatija periferali ħafifa
English: Printing ink
Maltese: Dijarea moderata
English: Other medicines and Kolbam
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Maltese: Peress li din hi approvazzjoni taħt ċirkostanzi ta' eċċezzjoni u skont l-Artikolu 14(8) tar-Regolament (KE) 726/2004, l-MAH għandu jwettaq, fiż-żmien stipulat, il-miżuri li ġejjin:
English: In Study CAC-002-01 for patients overall with single-enzyme defects, urinary bile acids and serum transaminases did not change significantly from baseline to worst post-baseline value.
Maltese: Fl-Istudju CAC-002-01 għall-pazjenti globali b'difetti f'enzima waħda, l-aċidi biljari fl-awrina u ttransaminases fis-serum ma nbidlux b'mod sinifikanti mil-linja bażi sal-agħar valur ta' wara l-linja bażi.
English: The pharmacodynamic action of cholic acid is feedback inhibition of the synthesis of toxic partial bile acid biosynthetic products that result from blockages in the normal bile acid synthetic pathway.
Maltese: L-azzjoni farmakodinamika tal-aċidu koliku hija l-inibizzjoni tal-feedback tas-sintesi ta' prodotti tossiċi mill-bijosintesi parzjali tal-aċidu biljari b'riżultat ta' imblukkar fil-passaġġ sintetiku normali tal-aċidu biljari.
English: Elderly patients (older than 65 years)
Maltese: Pazjenti anzjani ('il fuq minn 65 sena)
English: • feeling of pins and needles (mild peripheral neuropathy)
Maltese: • dardir (nawżja ħafifa) • sensazzjoni ta' pinnijiet u labar (newropatija periferali ħafifa)
English: Oestrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering substances) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of cholic acid.
Maltese: Estroġeni, kontraċettivi orali, u clofibrate (u forsi sustanzi oħra li jbaxxu l-lipidi) jżidu s-sekrezzjoni tal-kolesterol fil-fwied u jinkoraġġixxu l-formazzjoni ta' ġebla tal-kolesterol fil-marrara u għalhekk jistgħu jinnewtralizzaw l-effikaċja tal-aċidu koliku.
English: Reduction of the dose led to resolution of the clinical signs and correction of abnormal laboratory parameters.
Maltese: It-tnaqqis tad-doża wassal għar-riżoluzzjoni tas-sinjali kliniċi u l-korrezzjoni tal-parametri anormali tal-laboratorju.
English: Patients with familial hypertriglyceridaemia
Maltese: Pazjenti b'ipertrigliċeridemija familjali
English: Mild nausea Mild reflux Moderate diarrhoea
Maltese: Il-professjonisti dwar il-kura tassaħħa huma mitluba jirrappurtaw kwalunkwe reazzjoni avversa suspettata.
English: Statistically significant improvements were also observed in the baseline to best postbaseline analyses of serum transaminases.
Maltese: Titjib statistikament sinifikanti kien osservat ukoll fil-linja bażi sal-aħjar analiżi ta' wara l-linja bażi ta' transaminases fis-serum.
English: Study CAC-002-01, (an open-label, single-centre, nonrandomized continuation study of cholic acid capsules in subjects with inborn errors of bile acid synthesis), was the continuation of study CAC-9110-10 and started on 1 Jan 2010.
Maltese: L-istudju CAC-002-01, (studju ta' kontinwazzjoni b'tikketta miftuħa, b'ċentru uniku, mhux randomizzat tal-kapsuli tal-aċidu koliku f'individwi b'difetti konġeniti fis-sintesi tal-aċidu biljari),
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10)
English: The 250 mg capsules are white (black imprint “ASK002” and “250mg”).
Maltese: (marka sewda "ASK002" u "250mg")
English: Of all the patients treated in Study CAC-91-10-10, 49 patients presented with a single enzyme defect.
Maltese: Mill-pazjenti kollha li rċevew kura fl-Istudju CAC-91-10-10, 49 pazjent ippreżentaw b'difett f'enzima waħda.
English: Efficacy was demonstrated in two ways: (a) treatment with cholic acid leads to an improvement in liver function as demonstrated by improved liver function test values, (b) Fast Atom Bombardment-Mass Spectrometry (FAB-MS) data demonstrated efficacy by showing that cholic acid treatment led to a suppression of the abnormal urine bile acids that initially led to the diagnosis.
Maltese: (a) kura bl-aċidu koliku twassal għal titjib fil-funzjoni tal-fwied kif tidher minn titjib fil-valuri tat test tal-funzjoni tal-fwied, (b) dejta minn Fast Atom Bombardment-Mass Spectrometry (FAB-MS) uriet effikaċja billi wriet li kura bl-aċidu koliku wasslet għal trażżin tal-aċidi biljari anormali fl-awrina li inizjalment kienu wasslu għad-dijanjosi.
English: Therefore use of phenobarbital in patients treated with cholic acid is contraindicated (see section 4.3).
Maltese: Għalhekk l-użu ta' phenobarbital f'pazjenti li qed jirċievu kura bl-aċidu koliku huwa kontra-indikat (ara sezzjoni 4.3).
English: Therapeutic efficacy and safety of cholic acid treatment in patients with inborn errors of bile acid metabolism were evaluated.
Maltese: L-effikaċja terapewtika u s-sigurtà tal-kura bl-aċidu koliku f'pazjenti b'difetti konġeniti fil-metaboliżmu tal-aċidu biljari kienu vvalutati.
English: White 185 ml HDPE bottle induction-sealed with a 38 mm white, child-resistant closure consisting of a HDPE grooved screw cap and induction seal (cardboard, wax and aluminium foil) liner.
Maltese: Flixkun abjad tal-HDPE ta' 185 ml issiġillat permezz ta' induzzjoni b'għeluq abjad, reżistenti għat-tfal ta' 38 mm li jikkonsisti minn tapp imħaffer bil-kamin tal-HDPE u folja ssiġillata permezz ta'
English: Medicines for lowering cholesterol levels in the blood, such as cholestyramine, colestipol or colesevelam, and certain antacids which contain aluminium (e.g. indigestion relief products) may affect the absorption of cholic acid.
Maltese: Mediċini li jbaxxu l-livelli tal-kolesterol fid-demm, bħal cholestyramine, colestipol jew colesevelam, u ċerti antiaċidi li fihom l-aluminju (eż. prodotti għas-serħan mill-indiġestjoni) jistgħu jaffettwaw lassorbiment tal-aċidu koliku.
English: There are no data on the effects of cholic acid on fertility.
Maltese: Ma hemm l-ebda dejta dwar l-effetti tal-aċidu koliku fuq il-fertilità.
English: Phenobarbital may stop cholic acid from working.
Maltese: Il-parametri tal-fwied għandhom ukoll jiġu mmonitorjati.
English: In repeated dose studies, frequently reported effects of cholic acid have included decreased body weight, diarrhoea and liver damage with elevated transaminases although are considered to be associated with the pharmacological effects of bile acid metabolism.
Maltese: fosthom indeboliment tas-CNS, li mhux se jkunu ttrattati billi jiġu indirizzati l-effetti tad-difetti filbili.
English: Slightly increased blood pressure was evident in rats after 30 days of cholic acid at approximately 4-fold therapeutic dose with increased vasoconstrictor responses to noradrenaline, together with decreased levels of aldosterone and increased corticosterone, but no adverse clinical signs were observed.
Maltese: 4 darbiet id-doża terapewtika b'żieda fir-rispons vażokostrittur għal noradrenaline, flimkien ma' tnaqqis fil-livelli ta' aldosterone u żieda fil-corticosterone, iżda ma ġie osservat l-ebda sinjal kliniku avvers.
English: Statistically significant changes were seen in the baseline to the best post-baseline analysis of urinary bile acids, with substantial decreases in marked, significant, and slight abnormalities as well as increases in normal spectra.
Maltese: Bidliet statistikament sinifikanti kienu osservati fil-linja bażi sal-aħjar analiżi ta' wara l-linja bażi ta' aċidi biljari fl-awrina, bi tnaqqis sostanzjali f'anormalitajiet ovvji, sinifikanti u ħfief kif ukoll żidiet fl-ispettri normali.
English: NAME OF THE MEDICINAL PRODUCT Kolbam 50 mg hard capsules.
Maltese: Kull kapsula iebsa fiha 50 mg ta' aċidu koliku.
English: NAME OF THE MEDICINAL PRODUCT Kolbam 250 mg hard capsules.
Maltese: Kull kapsula iebsa fiha 250 mg ta' aċidu koliku.
English: In patients with CTX (N=3), urinary bile acids at baseline were normal for 1 patient and elevated for 2 patients, elevated for all patients in the worst post-treatment analysis, and normal in the best postbaseline assessment for all 3 patients.
Maltese: F'pazjenti b'CTX (N=3), aċidi biljari fl-awrina fil-linja bażi kienu normali għal pazjent wieħed u elevati għal 2 pazjenti, elevati għall-pazjenti kollha fl-agħar analiżi ta' wara t-trattament, u normali fl-aħjar valutazzjoni ta' wara l-linja bażi għat-3 pazjenti kollha.
English: Of the 52 patients described above that were included in Study CAC-91-10-10 during the 17-year study period, 6 died, 3 had no evidence of treatment, 4 terminated the study, 10 were lost to follow-up, and for 1 data retrieval was unsuccessful.
Maltese: Mit-52 pazjent deskritti fuq li ħadu sehem fl-Istudju CAC-91-10-10 matul il-perjodu tal-istudju ta' 17il sena, 6 mietu, 3 ma kellhom l-ebda evidenza ta' kura, 4 temmew l-istudju, 10 ma kienux disponibbli għal segwitu, u għal wieħed l-irkupru tad-dejta ma kienx ta' suċċess.
English: Ciclosporin may affect the levels of cholic acid.
Maltese: Ciclosporin jista' jaffettwa l-livelli tal-aċidu koliku.
English: In each of the primary bile acid deficiencies due to enzyme defects in the biosynthetic pathway, absence of primary bile acids leads to cholestasis and unregulated accumulation of toxic bile acid precursors.
Maltese: F'kull defiċjenza tal-aċidu biljari primarju minħabba difetti fl-enzimi fil-passaġġ bijosintetiku, in-nuqqas ta' aċidi biljari primarji jwassal għal kolestasi u l-akkumulazzjoni mhux ikkontrollata ta' prekursuri ta' aċidi biljari tossiċi.
English: The purpose of substituting missing cholic acid is to restore the main functions of this bile acid consisting of lipid transport in the form of mixed micelles, the activation of co-lipase and fat digestion and absorption, the absorption of fat-soluble vitamins, and the induction of bile flow, thus preventing cholestasis.
Maltese: L-għan tas-sostituzzjoni tal-aċidu koliku li jkun nieqes huwa sabiex jiġu restawrati l-funzjonijiet ewlenin ta' dan l-aċidu biljari li jikkonsistu fit-trasport tal-lipidi fil-forma ta' miċelli mħallta, l-attivazzjoni tal-ko-lipażi u d-diġestjoni u l-assorbiment tax-xaħam, l-assorbiment ta' vitamini li jinħallu fix-xaħam, u l-induzzjoni tal-fluss talbili, biex b'hekk tiġi evitata l-kolestasi.
English: HOW TO STORE KOLBAM
Maltese: Tiħux Kolbam
English: Serum transaminases were below the ULN for most patients (71-100%) at baseline and for most patients (86%) at the worst post-baseline assessment and for all patients (100%) at the best post-baseline assessment.
Maltese: It-transaminases fis-serum kienu taħt l-ULN għall-biċċa l-kbira tal-pazjenti (71-100%) fil-linja bażi u għall-biċċa l-kbira tal-pazjenti (86%) fl-agħar valutazzjoni ta' wara l-linja bażi u għall-pazjenti kollha (100%) fl-aħjar valutazzjoni ta' wara l-linja bażi.
English: Elderly Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
Maltese: Anzjani L-aċidu koliku ma ġiex studjat għas-sigurtà u l-effikaċja fuq persuni 'l fuq minn 65 sena.
English: Anti-doping test:
Maltese: Testijiet anti-doping:
English: Metabolic and endocrine effects:
Maltese: Effetti metaboliċi u endokrinali:
English: See section 2 "Ifirmacombi contains sodium".
Maltese: Ara sezzjoni 2 "Ifirmacombi fih sodium".
English: Castor oil, hydrogenated
Maltese: Castor oil, idroġenat
English: The volume of distribution for irbesartan is 53-93 litres.
Maltese: Il-volum ta' distribuzzjoni għal irbesartan huwa 53 - 93 litru.
English: Primary aldosteronism:
Maltese: Aldosteroniżmu primarju:
English: Date of first authorisation: 04 March 2011 Date of latest renewal: 19 November 2015
Maltese: Data tal-aħħar tiġdid: 19 ta' Novembru 2015
English: The mean age of patients was 52.5 years, 13% were ≥ 65 years of age, and just 2% were ≥ 75 years of age.
Maltese: L-età medja kienet ta' 52.5 sena, 13% kienu ≥ 65 sena, u 2% biss kienu ≥ 75 sena.
English: Peak effects occurred at 3-6 hours.
Maltese: L-ogħla effetti jseħħu fi 3-6 sigħat.
English: Blister (OPA/Aluminium/PVC//Aluminium): 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets, in a box.
Maltese: Folji (OPA/Aluminju/PVC/Aluminju) - 14, 28, 30, 56, 56 x 1, 84, 90 u 98 pillola miksija b'rita f'kaxxa.
English: Ifirmacombi contains sodium
Maltese: Ifirmacombi fih sodium
English: Not known: respiratory distress (including pneumonitis and pulmonary oedema)
Maltese: Diffikultà respiratorja (li tinkludi pnewmonite u edem pulmonari)
English: Pharmacotherapeutic group: angiotensin II antagonists and diuretics, ATC code: C09DA04.
Maltese: antagonisti ta' angiotensin-II u dijuretiċi Kodiċi ATC: C09DA04
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II.
English: Dual blockade of the renin-angiotensin-aldosterone system (RAAS):
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS):
English: Angiotensin II Receptor Antagonists (AIIRAs):
Maltese: Antagonisti ta' Reċetturi ta' Angiotensin II (AIIRAs):
English: The total body and renal clearance are 157-176 and 3.0-3.5 ml/min, respectively.
Maltese: It-tneħħija mill-ġisem kollu u renali hija 157 - 176 u 3.0 - 3.5 ml/min, rispettivament.
English: Electrolyte imbalance:
Maltese: Żbilanċ elettrolitiku:
English: Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;
Maltese: Kortikosterojdi, ACTH: tnaqqis fl-elettroliti, speċjalment ipokalemija, jista' jiżdied;
English: Boxes of 14, 28, 30, 56, 56 x 1, 84, 90 and 98 film-coated tablets in blisters are available.
Maltese: Jiġu f'kaxxi ta' 14, 28, 30, 56, 56 x 1, 84, 90 u 98 pillola miksija b'rita ġo folji.
English: The frequency of adverse reactions listed below is defined using the following convention: - 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: - mhux komuni (1/1,000 sa <1/100) - rari (1/10,000 sa <1/1,000) - rari ħafna (<1/10,000) - mhux magħruf (ma jistax jiġi stimat mid-data disponibbli`).
English: Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Maltese: Stenożi tal-valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva:
English: Lithium:
Maltese: Litju:
English: Not known: aplastic anaemia, bone marrow depression, neutropenia/agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
Maltese: Anemija aplastika, depressjoni tal-mudullun, newtropenja/agranuloċitosi, anemija emolitika, lewkopenja, tromboċitopenja
English: jaundice hepatitis, abnormal liver function
Maltese: Epatite, funzjoni anormali talfwied
English: Reporting of suspected adverse reactions
Maltese: Adverse Reaction
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola mikisija b'rita 30 pillola mikisija b'rita 56 pillola mikisija b'rita 56 x1 pillola mikisija b'rita 84 pillola mikisija b'rita 90 pillola mikisija b'rita 98 pillola mikisija b'rita
English: Not known: electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
Maltese: Żbilanċ fl-elettroliti (li jinkludu ipokalemja u iponatremja, ara sezzjoni 4.4), iperurikemja, glikosurja, ipergliċemija, żieda fiil-kolesterol u trigliċeridi
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skeltriċi u tat-tessut konnettiv
English: Ifirmacombi 300 mg/25 mg film-coated tablets EU/1/11/673/017-024
Maltese: Ifirmacombi 300 mg/25 mg pilloli miksija b'rita EU/1/11/673/017-024
English: When necessary, Ifirmacombi may be administered with another antihypertensive medicinal product (see section 4.3, 4.4, 4.5 and 5.1).
Maltese: Meta jkun meħtieġ, Ifirmacombi jista' jiġi amministrat bi prodott mediċinali ieħor ta' kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Not known: pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
Maltese: Pankreatite, anoreksja, dijarea, stitikezza, irritazzjoni gastrika,
English: Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Maltese: Digitalis glycosides: ipokalemija jew ipomagneżemja ikkaġunati minn thiazides jistgħu jiffavorixxu l-bidu ta' arritmiji kardijaċi kkawżati minn digitalis (ara sezzjoni 4.4);
English: Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP < 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
Maltese: Erbgħa u sebgħin fil-mija (47.2%) tal-pazjenti fuq il-kombinazzjoni laħqu livell minimu ta' SeDBP < 90 mmHg meta mqabbel ma' 33.2% tal-pazjenti fuq irbesartan (p = 0.0005).
English: When angiotensin II antagonists are administered simultaneously with non-steroidal antiinflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Meta antagonisti ta' angiotensin II jingħataw flimkien ma' mediċini antinfjammatorji mhux sterojdi (i.e. inibituri silettivi ta' COX-2, acetylsalicylic acid (> 3 g/jum) u NSAIDs mhux silettivi), jista' jkun hemm tħarrix tal-effett kontra t-tlugħ tal-pressjoni.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets EU/1/11/673/001-008
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli miksija b'rita EU/1/11/673/001-008