FrancophonIA/ELRC3.0 huggingface dataset:
English: The following changes, observed in rats and macaques receiving the irbesartan/hydrochlorothiazide combination at 10/10 and 90/90 mg/kg/day, were also seen with one of the two medicinal products alone and/or were secondary to decreases in blood pressure (no significant toxicologic interactions were observed): - kidney changes, characterized by slight increases in serum urea and creatinine, and hyperplasia/hypertrophy of the juxtaglomerular apparatus, which are a direct consequence of the interaction of irbesartan with the renin-angiotensin system; - slight decreases in erythrocyte parameters (erythrocytes, haemoglobin, haematocrit); - stomach discoloration, ulcers and focal necrosis of gastric mucosa were observed in few rats in a 6 months toxicity study at irbesartan 90 mg/kg/day, hydrochlorothiazide 90 mg/kg/day, and irbesartan/hydrochlorothiazide 10/10 mg/kg/day.
Maltese: It-tibdiliet li ġejjin, osservati f'firien u f'makakki li rċevew il-kombinazzjoni ta' irbesartan/hydrochlorothiazide f'dożi ta' 10/10 u 90/90 mg/kg/jum, dehru wkoll b'wieħed minn dawn iż-żewġ mediċini waħidhom u/jew kienu sekondarji għal tnaqqis tal-pressjoni (ma ġewx osservati interazzjonijiet tossikoloġiċi sinifikanti): - tibdil fil-kliewi, ikkaratterizzat minn żidiet ħfief fl-urea fis-serum u tal-kreatinina, u iperplażja/ ipertrofija tal-apparat ġukstaglomerulari, li huma konsegwenza diretta tal-interazzjoni ta' irbesartan mas-sistema renin-angiotensin; - tnaqqis żgħir fil-parametri tal-eritroċiti (eritroċiti, emoglobina, ematokrit); - telf ta' kulur fl-istonku, ulċeri, nekrożi fokali tal-mukoża gastrika ġew osservati fi ftit firien fi studju ta' 6 xhur fuq it-tossiċità b'irbesartan 90 mg/kg/jum, hydrochlorothiazide 90 mg/kg/jum u irbesratan/hydrochlorothiazide 10/10 mg/kg/jum.
English: Irbesartan AUC and Cmax values were also somewhat greater in older subjects (≥ 65 years) than those of young subjects (18-40 years).
Maltese: Il-valuri ta' AUC u Cmax ta' irbesartan kienu pjuttost ogħla f'pazjenti anzjani (≥ 65 sena) milli individwi iżgħar (18-40 sena).
English: Not known: anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
Maltese: Reazzjonijiet anafilattiċi, nekrolisi epidermali tossika, anġite nekrotizzanti (vaskulite, vaskulite kutanea), reazzjonijiet tal-ġilda bħal ta' lupus eritematożi, reazzjonijiet ' fotosensittivi, raxx, urtikarja
English: Following oral administration of Ifirmacombi, the absolute oral bioavailability is 6080% and 50-80% for irbesartan and hydrochlorothiazide, respectively.
Maltese: Wara li jingħata mill-ħalq irbesartan/hydrochlorothiazide, il-bijotrasformazzjoni hi ta' 60-80% u 50-80% għal irbesartan u hydrochlorothiazide, rispettivament.
English: Common:
Maltese: Tqala:
English: Renal artery stenosis - Renovascular hypertension:
Maltese: Stenożi tal-arterja renali-Pressjoni renovaskulari għolja:
English: Ifirmacombi should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.3).
Maltese: Ifirmacombi m'għandhiex tingħata lil pazjenti li għandhom indeboliment renali sever (tneħħija ta' kreatinina < 30 ml/min) (ara sezzjoni 4.3).
English: Thiazides may increase the risk of adverse effects caused by amantadine.
Maltese: Thiazides jistgħu jżidu r-riskju ta' effetti avversi kkaġunati b'amantadine.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets EU/1/11/673/009-016
Maltese: Ifirmacombi 300 mg/12.5 mg pilloli miksija b'rita EU/1/11/673/009-016
English: Uncommon syncope, hypotension, tachycardia, oedema
Maltese: Mhix komuni sinkope, pressjoni baxxa, takikardija, edema
English: Side effects associated with hydrochlorothiazide alone Skin and lip cancer (non-melanoma skin cancer); loss of appetite; stomach irritation; stomach cramps; constipation; jaundice (yellowing of the skin and/or whites of the eyes); inflammation of the pancreas characterised by severe upper stomach pain, often with nausea and vomiting; sleep disorders; depression; blurred vision; lack of white blood cells, which can result in frequent infections, fever; decrease in the number of platelets (a blood cell essential for the clotting of the blood), decreased number of red blood cells (anaemia) characterised by tiredness, headaches, being short of breath when exercising, dizziness and looking pale; kidney disease; lung problems including pneumonia or buildup of fluid in the lungs; increased sensitivity of the skin to the sun; inflammation of blood vessels; a skin disease characterized by the peeling of the skin all over the body; cutaneous lupus erythematosus, which is identified by a rash that may appear on the face, neck, and scalp; allergic reactions; weakness and muscle spasm; altered heart rate; reduced blood pressure after a change in body position; swelling of the salivary glands; high sugar levels in the blood; sugar in the urine; increases in some kinds of blood fat; high uric acid levels in the blood, which may cause gout.
Maltese: Effetti sekondarji assoċjati ma' hydrochlorothiazide waħdu Kanċer tal-ġilda u tax-xoffa (Kanċer tal-ġilda mhux melanoma), nuqqas t'aptit; irritazzjoni fl-istonku, bugħawwieġ fl-istonku, stitikezza, suffejra (sfurija tal-ġilda u/jew l-abjad tal-għajnejn); infjammazzjoni tal-frixa ikkaraterizzata b'uġigħ sever fin-naħa ta' fuq tal-istonku, xi kultant b'dardir u remettar, disturbi fl-irqad; depressjoni, vista mxekkla; nuqqas ta' ċelluli bojod tad-demm li jistgħu jirriżultaw f'infezzjonijiet ta' spiss, deni, tnaqqis fl-għadd ta' plejtlits fid-demm (ċellula tad-demm meħtieġa biex jgħaqqad id-demm), tnaqqis sever fiċ-ċelluli l-ħomor tad-demm (anemija) li jistgħu jikkawżaw għeja, uġigħ ta' ras, ma jkollokx nifs meta tagħmel l-eżerċizzji, sturdament u tidher pallidu; mard tal-kliewi; problemi fil-pulmun li tinkludi pnewmonja jew akkumulazzjoni ta' fluwidi fil-pulmun; sensibilizzazzjoni ogħla tal-ġilda għax-xemx; infjammazzjoni tal-vażi tad-demm; mard tal-ġilda karatterizzat fi tqaxxir tal-ġilda madwar il-ġisem kollu; lupus eritematosi kutanea, li hija identifikata b'raxx li jidher fuq il-wiċċ, l-għonq jew ir-ras; reazzjonijiet allerġiċi; dgħufija u spażmi muskolari; tibdil fit-taħbit tal-qalb; tnaqqis fil-pressjoni tad-demm wara bidla fil-pożizzjoni tal-ġisem, il-glandoli tal-bżieq jintefħu; livelli ogħla ta' zokkor fid-demm; zokkor fl-awrina, żidiet f'xi tipi ta' grass fid-demm; livelli ta' uric acid ogħla fid-demm li jistgħu jikkaġunaw il-gotta.
English: The terminal elimination half-life of irbesartan is 11-15 hours.
Maltese: Il-half-life tal-eliminazzjoni terminali ta' irbesartan hija ta' 11 - 15-il siegħa.
English: EU/1/11/673/017 (14 film-coated tablets) EU/1/11/673/018 (28 film-coated tablets) EU/1/11/673/019 (30 film-coated tablets) EU/1/11/673/020 (56 film-coated tablets) EU/1/11/673/021 (56 x 1 film-coated tablets) EU/1/11/673/022 (84 film-coated tablets) EU/1/11/673/023 (90 film-coated tablets) EU/1/11/673/024 (98 film-coated tablets)
Maltese: EU/1/11/673/017 (14 pillola mikisija b'rita) EU/1/11/673/018 (28 pillola mikisija b'rita) EU/1/11/673/019 (30 pillola mikisija b'rita) EU/1/11/673/020 (56 pillola mikisija b'rita) EU/1/11/673/021 (56 x 1 pillola mikisija b'rita) EU/1/11/673/022 (84 pillola mikisija b'rita) EU/1/11/673/023 (90 pillola mikisija b'rita) EU/1/11/673/024 (98 pillola mikisija b'rita)
English: EU/1/11/673/001 (14 film-coated tablets) EU/1/11/673/002 (28 film-coated tablets) EU/1/11/673/003 (30 film-coated tablets) EU/1/11/673/004 (56 film-coated tablets) EU/1/11/673/005 (56 x 1 film-coated tablets) EU/1/11/673/006 (84 film-coated tablets) EU/1/11/673/007 (90 film-coated tablets) EU/1/11/673/008 (98 film-coated tablets)
Maltese: EU/1/11/673/001 (14 pillola mikisija b'rita) EU/1/11/673/002 (28 pillola mikisija b'rita) EU/1/11/673/003 (30 pillola mikisija b'rita) EU/1/11/673/004 (56 pillola mikisija b'rita) EU/1/11/673/005 (56 x 1 pillola mikisija b'rita) EU/1/11/673/006 (84 pillola mikisija b'rita) EU/1/11/673/007 (90 pillola mikisija b'rita) EU/1/11/673/008 (98 pillola mikisija b'rita)
English: Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Maltese: Irbesartan huwa antagonista qawwi, attiv mill-ħalq, antagonista selettiv tar-riċettatur angiotensin-II (tip AT1).
English: EU/1/11/673/009 (14 film-coated tablets) EU/1/11/673/010 (28 film-coated tablets) EU/1/11/673/011 (30 film-coated tablets) EU/1/11/673/012 (56 film-coated tablets) EU/1/11/673/013 (56 x 1 film-coated tablets) EU/1/11/673/014 (84 film-coated tablets) EU/1/11/673/015 (90 film-coated tablets) EU/1/11/673/016 (98 film-coated tablets)
Maltese: EU/1/11/673/009 (14 pillola mikisija b'rita) EU/1/11/673/010 (28 pillola mikisija b'rita) EU/1/11/673/011 (30 pillola mikisija b'rita) EU/1/11/673/012 (56 pillola mikisija b'rita) EU/1/11/673/013 (56 x 1 pillola mikisija b'rita) EU/1/11/673/014 (84 pillola mikisija b'rita) EU/1/11/673/015 (90 pillola mikisija b'rita) EU/1/11/673/016 (98 pillola mikisija b'rita)
English: C irbesartan, 80-85% of the circulating plasma radioactivity is attributable to unchanged irbesartan.
Maltese: C irbesartan, 80-85% tar-radjuattività li tiċċirkola fil-plażma hi attribwita għal irbesartan mhux mibdul.
English: Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Maltese: Irbesartan u hydrochlorothiazide (b'dożi sa 300 mg irbesartan/25 mg hydrochlorothiazide) ingħataw mingħajr periklu ma' mediċini oħra kontra l-pressjoni għolja inklużi l-imblokkaturi tal-kanali ta' calcium u imblokkaturi beta-adrenergic.
English: Ifirmacombi 150 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Maltese: Ifirmacombi 150 mg/12.5 mg mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, żejt ir-riġnu idroġenat fil-qalba tal-pillola u polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) u red iron oxide (E172) fil-kisi tal-pillola.
English: Ifirmacombi 300 mg/25 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) and red iron oxide (E172) in the film-coating.
Maltese: Ifirmacombi 300 mg/25 mg mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, żejt ir-riġnu idroġenat fil-qalba tal-pillola u polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172) u red iron oxide (E172) fil-kisi tal-pillola.
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Maltese: Rilassanti nondepolarizing tal-muskoli skeletriċi (eż. tubocurarine): l-effett ta' mediċini mhux depolarizzanti li jtaffu l-effett ta' muskoli skeletriċi jista' jiħrax b'hydrochlorothiazide;
English: While this is not documented with Ifirmacombi, a similar effect should be anticipated.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Ifirmacombi, effetti simili għandhom ikunu mistennija.
English: Efficacy and safety of the combination of irbesartan and hydrochlorothiazide as initial therapy for severe hypertension (defined as SeDBP ≥ 110 mmHg) was evaluated in a multicentre, randomized, double-blind, active-controlled, 8-week, parallel-arm study.
Maltese: L-effikaċja u s-sigurtà ta' irbesartan/hydrochlorothiazide bħala terapija inizjali għal pressjoni għolja severa (definita bħala SeDBP ≥ 110 mmHg) ġew evalwati fi studju b'aktar minn ċentru wieħed, b'mod każwali, double-blind, ikkontrollat b'mod attiv ta' 8 ġimgħat, parallel-arm.
English: Ifirmacombi 300 mg/12.5 mg: mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, hydrogenated castor oil in the tablet core and polyvinyl alcohol, titanium dioxide (E171), macrogol, talc in the film-coating.
Maltese: Ifirmacombi 300 mg/12.5 mg mannitol, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, sodium starch glycolate, talc, macrogol 6000, żejt ir-riġnu idroġenat fil-qalba tal-pillola u polyvinyl alcohol, titanium dioxide (E171), macrogol, talc fil-kisi tal-pillola.
English: Ifirmacombi is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
Maltese: Ifirmacombi huwa kombinazzjoni ta' antagonist ta' riċettur angiotensin-II, irbesartan, u dijuretiku ta' thiazide, hydrochlorothiazide.
English: Not known: cardiac arrhythmias
Maltese: Arritmiji kardijaċi
English: Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Maltese: Interazzjonijiet oħra: thiazides jistgħu jżidu l-effett ipergliċemiku tal-beta-blockers u ta' diazoxide.
English: There was no evidence of mutagenicity or clastogenicity with the irbesartan/hydrochlorothiazide combination.
Maltese: Ma kienx hemm evidenza ta' mutaġeniċità jew klastoġeniċità bil-kombinazzjoni ta' irbesartan/hydrochlorothiazide.
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Maltese: Reżina tal-colestyramine u Colestipol: impediment tal-assorbiment ta' hydrochlorothiazide fil-preżenza ta' reżini ta' skambju anijoniku;
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially "sodium-free".
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: In addition increases in blood urea nitrogen (BUN) (2.3%), creatine kinase (1.7%) and creatinine (1.1%) were also commonly observed in the trials.
Maltese: Dardir/remettar (1.8%), u tgħaddi awrina mhix normali (1.4%) u kreatinina (1.1%) kienu wkoll osservati fil-provi.
English: increases in blood urea nitrogen (BUN), creatinine and creatine kinase decreases in serum potassium and sodium
Maltese: Komuni Żidiet fin-nitroġenu tal-urea tad-demm (BUN), kreatinina u creatine kinase
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: Medicinal products affecting potassium:
Maltese: Prodotti mediċinali li jaffettwaw il-potassium:
English: Dose titration with the individual components (i.e. irbesartan and hydrochlorothiazide) may be recommended.
Maltese: It-titrazzjoni tad-doża bis-komponenti individwali (i.e. irbesartan u hydochlorothiazide) jista' jiġi rakkomandat.
English: Not known: weakness, muscle spasm
Maltese: Debulizza, spażmu muskolari
English: The trough to peak effects measured by cuff during office visits were 68% and 76% for Ifirmacombi 150 mg/12.5 mg and Ifirmacombi 300 mg/12.5 mg, respectively.
Maltese: L-effetti mill-inqas għall-aktar għolja mkejla mid-dirgħajn waqt viżiti fl-uffiċċju kienu 68% u 76% għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg u irbesartan/hydrochlorothiazide 300 mg/12.5 mg, rispettivament.
English: Medicinal products affected by serum potassium disturbances:
Maltese: Prodotti mediċinali affettwati b'tibdil tal-potassium fis-serum:
English: A cumulative doseresponse relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Maltese: Studju ieħor wera assoċjazzjoni possibbli bejn il-kanċer tax-xoffa (SCC) u lesponiment għal HCTZ: 633 każ ta' kanċer tax-xoffa tqabblu ma' 63,067 kontroll tal-popolazzjoni, blużu ta' strateġija ta' teħid ta' kampjuni b'riskju ssettjat Intweriet relazzjoni għar-rispons tad-doża kumulattiva b'OR aġġustata ta' 2.1 (95 % CI: 1.7-2.6) li tiżdied għal OR 3.9 (3.0-4.9) għal użu kbir (~25,000 mg) u OR 7.7 (5.7-10.5) għall-ogħla doża kumulattiva (~100,000 mg) (ara wkoll issezzjoni 4.4)
English: Dosage of Ifirmacombi 300 mg/25 mg
Maltese: Dożaġġ ta' Ifirmacombi 300 mg/25 mg
English: Table 1: Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports Investigations
Maltese: Reazzjonijiet Avversi fi Provi Kkontrollati bi Plaċebo u Rapporti Spontaneji Sistema tal-klassifika talorgani
English: Lithium: The combination of lithium and Ifirmacombi is not recommended (see section 4.5).
Maltese: Il-kombinazzjoni ta' litju u Ifirmacombi mhix rakkomandata (ara sezzjoni 4.5).
English: It is known that side effects associated with hydrochlorothiazide may increase with higher doses of hydrochlorothiazide.
Maltese: Huwa magħruf li effetti sekondarji assoċjati ma' hydrochlorothiazide jistgħu jgħollu ma' dożi ogħla ta' hydrochlorothiazide.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli miksija b'rita Ifirmacombi 300 mg/12.5 mg pilloli miksija b'rita Ifirmacombi 300 mg/25 mg pilloli miksija b'rita
English: Tables 2 and 3 below detail the adverse reactions reported with the individual components of Ifirmacombi.
Maltese: ItTabelli 2 u 3 hawn taħt jiddeskrivi fid-dettall ir-reazzjonijiet avversi marbuta mal-komponenti individwali ta' Iffirmasta rapportati.
English: Periodic monitoring of serum potassium is recommended when Ifirmacombi is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics).
Maltese: Monitoraġġ perjodiku tal-potassju fis-serum huwa rrikmandat meta Ifirmacombi jiġi mogħti flimkien ma' prodotti mediċinali oħra li jaffettwaw disturbi marbuta mal-potassju fis-serum (eż. digitalis glycosides, antiarritmiċi).
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/12.5 mg film-coated tablets Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli miksija b'rita Ifirmacombi 300 mg/12.5 mg pilloli miksija b'rita Ifirmacombi 300 mg/25 mg pilloli miksija b'rita Irbesartan/Hydrochlorothiazide
English: Among 898 hypertensive patients who received various doses of irbesartan/hydrochlorothiazide (range: 37.5 mg/6.25 mg to 300 mg/25 mg) in placebo-controlled trials, 29.5% of the patients experienced adverse reactions.
Maltese: It-Tabella 1 tagħti r-reazzjonijiet avversi osservati minn rapportaġġ spontanju u fi provi kkontrollati bi plaċebo li fihom 898 pazjent bi pressjoni għolja rċievew għadd ta' dożi (medda: 37.5 mg/6.25 mg sa 300 mg/25 mg irbesartan/hydrochlorothiazide) u li fihom 29.5% tal-pazjenti kellhom reazzjonijiet avversi.
English: Other medicines and Ifirmacombi
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Ifirmacombi 300 mg/25 mg film-coated tablets Pale pink, biconvex, capsule shaped, film-coated tablets.
Maltese: Ifirmacombi 300 mg/25 mg pilloli miksija b'rita Pilloli roża ċari, mżaqqin fuq żewġ naħat, f'għamla ta' kapsula, miksijin b'rita.
English: Anticholinergic agents (e.g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Maltese: Il-mediċini antikolinerġiċi (eż. atropine, beperiden) jistgħu jżidu l-bijodisponibilità tad-dijuretiċi tat-tip thiazide billi jnaqqsu l-motilità gastrointestinali u r-rata ta' tbattil tal-istonku.
English: Additional information on hydrochlorothiazide interactions: When administered concurrently, the following medicinal products may interact with thiazide diuretics:
Maltese: Tagħrif addizzjonali dwar l-effetti ta' hydrochlorothiazide ma' mediċini oħra: Meta jingħataw flimkien, il-prodotti mediċinali segwenti jistgħu jirreaġixxu ma' dijuretiċi ta' thiazide:
English: When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/diastolic reductions of 15.8/10.0 mmHg.
Maltese: Meta ġiet assessjata permezz ta' osservazzjoni ta' pressjoni ambulatorja, il-kombinazzjoni ta' 150 mg irbesartan u 12.5 mg hydrochlorothiazide darba kuljum, ikkawżat tnaqqis konsisteneti fil-pressjoni matul perijodu ta' 24 siegħa bi tnaqqis medju f'24 siegħa tal-pressjoni sistolika/dijastolika ta' 15.
English: No teratogenic effects were seen in rats given irbesartan and hydrochlorothiazide in combination at doses that produced maternal toxicity.
Maltese: Ma deherx li kien hemm effetti teratoġeniċi f'firien li ngħataw irbesartan u hydrochlorothiazide flimkien b'dożi li kienu jipproduċu tossiċità materna.
English: Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli Irbesartan/Hydrochlorothiazide
English: Not known: transient blurred vision, xanthopsia, acute myopia and secondary acute angle-closure glaucoma
Maltese: Vista mċajpra li tgħaddi, xantopsja, mijopija akuta u glawkoma akuta sekondarja ta' għeluq tal-angolu
English: Hydrochlorothiazide is 68% protein-bound in the plasma, and its apparent volume of distribution is 0.83-1.14 l/kg.
Maltese: Hydrochlrothiazide jeħel mal-proteini tal-plażma bi 68%, u l-volum ta' distibuzzjoni apparenti huwa
English: Most of the above mentioned effects appear to be due to the pharmacological activity of irbesartan (blockade of angiotensin-II-induced inhibition of renin release, with stimulation of the renin-producing cells) and occur also with angiotensin converting enzyme inhibitors.
Maltese: Il-parti l-kbira mill-effetti msemmija hawn fuq jidhru li ġraw minħabba l-attività farmakoloġika ta' irbesartan (imblokk tal-inibizzjoni stimulata minn angiotensin II tal-ħelsien ta' renin, b'stimulazzjoni ta' ċelluli li jipproduċu renin) u jseħħu wkoll b'impedituri ta' enzimi li jikkonvertu angiotensin.
English: The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mmHg.
Maltese: Iż-żieda ta' 12.5 mg hydrochlorothiazide ma' 300 mg ta' irbesartan darba kuljum f'pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f'aktar tnaqqis fil-pressjoni dijastolika korreġuta bil-plaċebo fl-inqas livelli (24 siegħa wara li tingħata d-doża) ta' 6.1 mmHg.
English: In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mmHg, respectively).
Maltese: F'dawn il-pazjenti, kien osservat tnaqqis inkrementali fil-pressjoni tad-demm kemm għal pressjoni sistolika tad-demm (SBP) kif ukoll għal pressjoni dijastolika tad-demm (DBP) (13.3 u 8.3 mmHg, rispettivament).
English: Ifirmacombi is a combination of two active substances, irbesartan and hydrochlorothiazide.
Maltese: Ifirmacombi hu kombinazzjoni ta' żewġ mediċini, irbesartan u hydrochlorothiazide.
English: Ifirmacombi 300 mg/25 mg tablets Irbesartan/Hydrochlorothiazide
Maltese: Ifirmacombi 300 mg/25 mg pilloli Irbesartan/Hydrochlorothiazide
English: In patients with creatinine clearance < 20 ml/min, the elimination half-life of hydrochlorothiazide was reported to increase to 21 hours.
Maltese: F'pazjenti bi tneħħija ta' kreatinina < 20 ml/min, l-half-life tal-eliminazzjoni ta' hydrochlorothiaze ġiet irrapportata li tiżdied għal 21 siegħa.