FrancophonIA/ELRC3.0 huggingface dataset:
English: Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Ifirmacombi 300 mg/25 mg fiha 300 mg irbesartan (bħala irbesartan hydrochloride) u 25 mg hydrochlorothiazide.
English: The types and incidences of adverse events reported for patients treated with the combination were similar to the adverse event profile for patients on monotherapy.
Maltese: It-tipi u l-inċidenzi ta' episodji avversi rrapportati għal pazjenti ttrattati bil-kombinazzjoni kienu simili għall-profil tal-episodju avvers għal pazjenti fuq monoterapija.
English: As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Maltese: Bħal fil-każ tal-inibituri ACE, l-użu konkomitanti ta' antagonisti ta' angiotensin II u NSAIDs jista' jwassal għal riskju akbar ta' deterjorament tal-funzjoni renali, inkluża l-possibilità ta' insuffiċjenza renali akuta, u żieda ta' potassium fis-serum, speċjalment f'pazjenti li diġà kellhom funzjoni renali ħażina.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Żidiet riversibbli tal-konċentrazzjonijiet ta' litju fis-serum u tossiċità ġew irrapportati waqt l-amministrazzjoni konkomitanti tal-litju mal-impedituri tal-enzimi li jikkonvertu angiontensin.
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotaemia, oliguria, or rarely acute renal failure (see section 4.5).
Maltese: F'pazjenti, li għandhom it-ton vaskulari u l-funzjoni renali jiddependu l-aktar mill-attivita' tas-sistema renin-angiotensin-aldosterone (eż. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenożi tal-arterja renali), il-kura b'impedituri ta' enzimi li jikkonvertu angiotensin jew b'riċetturi antagonisti angiotensin-II li jaffetwaw din is-sistema ġew assoċjati ma' pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza renali akuta (ara sezzjoni 4.5).
English: You may need to have blood checks if you take: - potassium supplements - salt substitutes containing potassium - potassium sparing medicines or other diuretics (water tablets) - some laxatives - medicines for the treatment of gout - therapeutic vitamin D supplements - medicines to control heart rhythm - medicines for diabetes (oral agents or insulins) - carbamazepine (a medicine for the treatment of epilepsy).
Maltese: Għandu mnejn ikollok bżonn tagħmel testijiet tad-demm jekk qed tieħu: - supplimenti tal-potassju - sostituti tal-melħ li fihom il-potassju - mediċini li ma jqanqlux it-tnixxija tal-potassju jew xi dijuretiċi oħra (pilloli tal-ilma) - xi porog - mediċina għall-kura tal-gotta - supplimenti terapewtiċi tal-vitamina D - mediċini li jikkontrollaw it-taħbit tal-qalb - mediċini tad-dijabete (sustanzi orali jew insulini) - carbamazepine (mediċina għall-kura tal-epilessija).
English: The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
Maltese: L-antagoniżmu selettiv tar-riċetturi ta' angiotensin-II (AT1) jirriżulta f'żidiet fillivelli fil-plażma ta' renin u fil-livelli ta' angiotensin-II u fi tnaqqis fil-konċentrazzjoni tal-plażma aldosterone.
English: Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials.
Maltese: Tabella 1 tagħti l-frekwenza ta' reazzjonijiet avversi osservati minn raportaġġ spontaneju fi provi kontrollati bi plaċebo
English: Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Maltese: Ifirmacombi 300 mg/12.5 mg pilloli Irbesartan/Hydrochlorothiazide
English: Dosage of Ifirmacombi 300 mg/12.5 mg
Maltese: Dożaġġ ta' Ifirmacombi 300 mg/12.5 mg
English: Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Ifirmacombi 150 mg/12.5 mg fiha 150 mg irbesartan (bħala irbesartan hydrochloride) u 12.5 mg hydrochlorothiazide.
English: Not known: vertigo, paraesthesia, light-headedness, restlessness
Maltese: Vertiġini, paraestesja, rasek fl-arja, irrikwitezza
English: swelling extremity arthralgia, myalgia
Maltese: Mhix magħrufa Dispepsja, disgewsja
English: Table 3: Adverse reactions reported with the use of hydrochlorothiazide alone Investigations
Maltese: Tabella 3. Reazzjonijiet avversi rapportati bl-użu ta' hydrochorothiazide waħdu System Organ Class
English: Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita ta' Ifirmacombi 300 mg/12.5 mg fiha 300 mg irbesartan (bħala irbesartan hydrochloride) u 12.5 mg hydrochlorothiazide.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Maltese: Fi studji kliniċi, il-farmakokinetiċi ta' irbesartan ma kinux affettwati minn hydrochlorothiazide.
English: Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in Ifirmacombi, minimal or no effects were reported.
Maltese: Żidiet fil-livelli tal-kolesterol u tat-trigliċeridi ġew assoċjati mat-terapija dijuretika thiazide; madankollu b'doża ta' 12.5 mg li tinsab fil-kombinazzjoni ta' irbesartan u hydrochlorothiazide, ġew rapporttati effetti minimi jew xejn.
English: BLISTER
Maltese: Suffejra
English: - Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg.
Maltese: Ifirmacombi 300 mg/12.5 mg jista' jingħata lil pazjenti meta l-pressjoni tad-demm tagħhom mhix qed tiġi kontrollata b'mod xieraq b'irbesartan 300 mg jew b'Ifirmacombi 150 mg/12.5 mg.
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Maltese: B'kollox 697 pazjent intagħżlu b'mod każwali fi proporzjon ta' 2:1 jew għal irbesartan/hydrochlorothiazide 150 mg/12.5 mg jew għal irbesartan 150 mg u ġew tittrati bil-forza b'mod sistematiku (qabel ma r-rispons tagħhom għal doża iktar baxxa ġie vvalutat) wara ġimgħa għal irbesartan/hydrochlorothiazide 300 mg/25 mg jew irbesartan 300 mg, rispettivament.
English: Dosage of Ifirmacombi 150 mg/12.5 mg
Maltese: Dożaġġ ta' Ifirmacombi 150 mg/12.5 mg
English: You should also tell your doctor: - if you are on a low-salt diet - if you have signs such as abnormal thirst, dry mouth, general weakness, drowsiness, muscle pain or cramps, nausea, vomiting, or an abnormally fast heart beat which may indicate an excessive effect of hydrochlorothiazide (contained in Ifirmacombi) - if you experience an increased sensitivity of the skin to the sun with symptoms of sunburn (such as redness, itching, swelling, blistering) occurring more quickly than normal - if you are going to have an operation (surgery) or be given anaesthetics - if you have changes in your vision or pain in one or both of your eyes while taking Ifirmacombi.
Maltese: Inti għandek tgħid lit-tabib tiegħek ukoll: - jekk qegħda fuq dieta ta' low-salt - jekk għandek sinjali ta' għatx mhux normali, ħalq xott, dgħufija ġenerali, ħedla, uġigħ muskolari jew bugħawwieġ, dardir, rimettar, jew il-qalb li qed tħabbat b'mod mgħaġġel li jista' jindika effett eċċessiv ta' hydrochlorothiazide (li jinsab f'Ifirmacombi) - jekk tesperjenza żieda fis-sensittività tal-ġilda għax-xemx b'sintomi ta' xemxata (bħal ħmura, ħakk, nefħa, infafet) li sseħħ aktar malajr mis-soltu - jekk ser ikollok intervent kirurġiku (operazzjoni) jew ser tingħata l-loppju - jekk ikollok tibdil fil-viżta jew uġigħ f'waħda mill-għajnejk jew fiż-żewġ għajnejn meta tkun qed tieħu Ifirmacombi.
English: Not known: Anaphylactic reaction including anaphylactic shock
Maltese: Reazzjoni anafilattika inkluż xokk anafilattiku
English: Ifirmacombi 150 mg/12.5 mg and 300 mg/25 mg film-coated tablets Film coating:
Maltese: Ifirmacombi 150 mg/12.5 mg u 300 mg/25 mg pilloli miksija b'rita Kisi tar-rita:
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Pale pink, biconvex, oval, film-coated tablets.
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli miksija b'rita Pilloli ovali ta' lewn roża ċari, miksijin b'rita.
English: How to store Ifirmacombi
Maltese: Kif taħżen Ifirmacombi
English: Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/6.9 mmHg in patients with mild-to-moderate hypertension.
Maltese: Doża darba kuljum ta' 150 mg irbesartan u 12.5 mg ta' hydrochlorothiazide tat tnaqqis tal-pressjoni sistolika/dijastolika fil-punt medjan ta' 12.9/6.9 mmHg aġġustat għal plaċebo (24 siegħa wara li ngħatat id-doża) f'pazjenti bi pressjoni għolja bejn ħafifa għal moderata.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Maltese: Ifirmacombi 150 mg/12.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 150 mg ta' irbesartan (bħala irbesartan hydrochloride) u 12.5 mg ta' hydrochlorothiazide.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets White, biconvex, capsule shaped, film-coated tablets.
Maltese: Ifirmacombi 300 mg/12.5 mg pilloli miksija b'rita Pilloli bojod, mżaqqin fuq żewġ naħat, f'għamla ta' kapsula, miksijin b'rita.
English: Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
Maltese: L-użu flimkien ta' dijuretiċi ta' thiazide jistgħu jżidu l-inċidenza ta' reazzjonijiet ta' sensittività eċċessiva għal allopurinol;
English: When Ifirmacombi is used in patients with impaired renal function, a periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: Meta Ifirmacombi tingħata lil pazjenti li għandhom indeboliment fil-funzjoni renali, monitoraġġ perijodiku tal-potassju, kreatinina u aċidu uriku hu rakkomandat.
English: Renal impairment and kidney transplantation:
Maltese: Indeboliment renali u trapjant tal-kliewi:
English: Uncommon side effects (may affect up to 1 in 100 people): - diarrhoea - low blood pressure - fainting - heart rate increased - flushing - swelling - sexual dysfunction (problems with sexual performance) - blood tests may show lowered levels of potassium and sodium in your blood.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100) - dijarea - pressjoni tad-demm baxxa - ħass ħażin - il-qalb tħabbat b'mod mgħaġġel - fwawar - nefħa - impotenza sesswali (problemi ta' prestazzjoni sesswali) - it-testijiet tad-demm juru livelli mnaqqsa ta' potassju u sodju fid-demm tiegħek.
English: Tablet core:
Maltese: Tabella 1.
English: Exposure to AIIRA therapy during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia) (see section 5.3).
Maltese: Espożizzjoni għal terapija AIIRAs matul it-tieni u t-tielet trimestri hija magħrufa li twassal għal tossiċità tal-fetu uman (tnaqqis fil-funzjoni tal-kliewi, oligohydraminjos, tnaqqis fl-ossifikazzjoni tal-kranju) u tossiċità neonatali (nuqqas fil-funzjoni tal-kliewi, pressjoni baxxa, iperkalemija)
English: The effects of the irbesartan/hydrochlorothiazide combination on fertility have not been evaluated in animal studies, as there is no evidence of adverse effect on fertility in animals or humans with either irbesartan or hydrochlorothiazide when administered alone.
Maltese: L-effetti tal-kombinazzjoni ta' irbesartan/hydrocholorhiazide fuq il-fertilità għadhom ma ġewx evalwati fi studji fl-annimali, għax m'hemmx evidenza ta' effetti avversi fuq il-fertilità fl-annimali jew fil-bniedem b'irbesartan jew b'hydrochlorothiazide meta jingħataw waħidhom.
English: Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone-system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).
Maltese: Dejta minn provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta'
English: OTHER
Maltese: C
English: When measured by ambulatory blood pressure monitoring, the trough to peak effects of Ifirmacombi 150 mg/12.5 mg were 100%.
Maltese: Meta mkejla permezz ta' osservazzjoni tal-pressjoni ambulatorja l-effetti mill-inqas għal aktar effetti għoljin ta' irbesartan/hydrochlorothiazide 150 mg/12.5 mg kienu 100%.
English: There is no clinical experience with Ifirmacombi in patients with hepatic impairment.
Maltese: Għad m'hemmx esperjenza klinika b'Ifirmacombi f'pazjenti b'indeboliment epatiku.
English: No dosage adjustment is necessary in patients with renal impairment whose renal creatinine clearance is ≥ 30 ml/min (see sections 4.3 and 4.4).
Maltese: L-ebda aġġustament fid-doża mhu meħtieġ f'pazjenti b'indeboliment renali li t-tneħħija ta' kreatinina tagħhom hi ≥ 30 ml/min (ara sezzjonijiet 4.3 u 4.4).
English: The potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Maltese: - Indeboliment epatiku sever, ċirrożi biljari u kolestażi.
English: Peak plasma concentration occurs at 1.5-2 hours after oral administration for irbesartan and 1-2.5 hours for hydrochlorothiazide.
Maltese: Il-konċentrazzjoni fil-plażma tilħaq l-ogħla livell 1.5 - 2 sigħat wara li tingħata mill-ħalq għal irbesartan u 1 - 2.5 sigħat għal hydrochlorothiazide.
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Maltese: Ifirmacombi 300 mg/12.5 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 300 mg ta' irbesartan (bħala irbesartan hydrochloride) u 12.5 mg of hydrochlorothiazide.
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 300 mg irbesartan (bħala irbesartan hydrochloride) u 25 mg hydrochlorothiazide.
English: During the 8-week treatment period, there were no reported cases of syncope in either treatment group.
Maltese: Matul il-perjodu ta' trattament ta' 8 ġimgħat, ma kien hemm ebda każ ta' sinkope rrapportat f'xi grupp tat-trattament.
English: Not known: cases of hypersensitivity reactions such as angioedema, rash, urticaria
Maltese: Mhix magħrufa Każijiet ta' reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja
English: These lesions were not observed in macaques; - decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Maltese: Dawn il-leżjonijiet ma ġewx osservati filmakakki; - tnaqqis tal-potassium fis-serum minħabba hydrochlorothiazide u mfixkla parzjalment meta hydrochlorothiazide ngħata flimkien ma' irbesartan.
English: Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Maltese: Kull pillola miksija b'rita fiha 150 mg irbesartan (bħala irbesartan hydrochloride) u 12.5 mg hydrochlorothiazide.
English: What Ifirmacombi contains - The active substances are irbesartan and hydrochlorothiazide.
Maltese: X'fih Ifirmacombi - Is-sustanzi attivi huma irbesartan u hydrochlorothiazide.
English: Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Maltese: Mediċini kontra d-dijabete (mediċini li jittieħdu mill-ħalq u insulini): jista' jkun hemm bżonn aġġustar tad-doża tal-prodott mediċinali kontra d-dijabete (ara sezzjoni 4.4);
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Severe renal impairment (creatinine clearance < 30 ml/min) - Refractory hypokalaemia, hypercalcaemia - Severe hepatic impairment, biliary cirrhosis and cholestasis - The concomitant use of Ifirmacombi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5
Maltese: - L-użu fl-istess ħin ta' Ifirmacombi ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u
English: The full EPAR for Hepsera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (10 mg).
Maltese: Jiġi f'pilloli (10 mg).
English: This summary was last updated in 05-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi'05-2013.
English: Adefovir is an antiviral belonging to the class ‘nucleoside analogues'.
Maltese: Adefovir hu sustanza antivirali li tappartjeni għall-klassi tal-‘analogi nukleosidiċi'.
English: Among those who took Hepsera, 53% of the HBeAg-positive and 64% of the HBeAg-negative patients had an improvement in liver damage as assessed in a biopsy, compared with 25% and 33%, respectively, in the patients who took placebo.
Maltese: Fost dawk li ħadu Hepsera, 53% tal-pazjenti pożittivi għall-HBeAg u 64% ta' dawk negattivi għall-HBeAg kellhom titjib fil-ħsara fil-fwied valutata b'bijopsija, meta mqabbla ma' 25% u 33%, rispettivament, fost pazjenti li kienu ħadu l-plaċebo.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera on 6 March 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Hepsera valida fl-Unjoni Ewropea kollha fis-6 ta' Marzu 2003.
English: The active substance in Hepsera, adefovir dipivoxil, is a ‘prodrug' that is converted into adefovir in the body.
Maltese: Is-sustanza attiva f'Hepsera, adefovir dipivoxil, hi 'promediċina' li tinbidel f'adefovir fil-ġisem.
English: The first study included 511 patients who were ‘HBeAg positive' (infected with the common type of the hepatitis B virus) and the second included 184 patients who were ‘HBeAg negative' (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Maltese: Fl-ewwel studju ħadu sehem 511-il pazjent li kienu 'pożittivi għall-HBeAg' (infettati bit-tip komuni ta' vajrus talepatite B) u fit-tieni wieħed ħadu sehem 184 pazjent li kienu 'negattivi għall-HBeAg' (infettati b'vajrus mutat [mibdul], li jwassal għal forma ta' epatite B kronika iktar diffiċli biex tiġi ttrattata).
English: • compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Maltese: • mard tal-fwied ikkompensat (meta l-fwied ikollu ħsara iżda jibqa' jaħdem sew), li jkollhom ukoll sinjali li l-vajrus ikun għadu qed jimmultiplika, u li jkollhom sinjali ta' ħsara fil-fwied (żieda fil-livelli tal-enzim tal-fwied 'alanina aminotransferażi' [ALT - alanine aminotransferase] u sinjali ta' ħsara meta t-tessut tal-fwied jiġi analizzat taħt il-mikroskopju).
English: Hepsera is a medicine that contains the active substance adefovir dipivoxil.
Maltese: Hepsera huwa mediċina li fiha s-sustanza attiva adefovir dipivoxil.
English: This is a summary of the European public assessment report (EPAR) for Hepsera.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Hepsera.
English: Hepsera is used to treat adults with chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Maltese: Hepsera jintuża fit-trattament ta' pazjenti adulti bl-epatite B kronika (fuq tul ta' żmien) (marda talfwied ikkawżata minn vajrus tal-epatite B).
English: Why has Hepsera been approved?
Maltese: Għaliex ġie approvat Hepsera?
English: Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Maltese: Hepsera ġie studjat f'żewġ studji ewlenin, li fihom tqabbel mal-plaċebo (trattament finta).
English: The most common side effects with Hepsera (seen in more than 1 patient in 10) are raised creatinine (a marker of kidney problems) and asthenia (weakness).
Maltese: L-effetti sekondarji l-iktar komuni b'Hepsera (li dehru f'iktar minn pazjent wieħed minn kull 10) huma żieda fil-kreatinina (markatur tal-problemi tal-kliewi) u l-astenija (dgħufija).
English: What is Hepsera?
Maltese: X'inhu Hepsera?
English: What is the risk associated with Hepsera?
Maltese: Għal xiex jintuża Hepsera?
English: Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
Maltese: Adefovir ma jħallix lill-vajrus jipproduċi DNA u ma jħallihx jimmultiplika ruħu u jinfirex.
English: How has Hepsera been studied?
Maltese: Kif ġie studjat Hepsera?
English: Hepsera was more effective than placebo in slowing down the progression of liver disease.
Maltese: Hepsera kien iktar effikaċi mill-plaċebo biex ibatti l-progressjoni tal-mard tal-fwied.
English: Hepsera is not recommended for use in patients with severe kidney disease or who are on dialysis (a blood clearing technique) - its use should only be considered in these patients if its potential benefits are greater than its potential risks.
Maltese: Hepsera mhuwiex rakkomandat għall-użu minn pazjenti b'mard gravi fil-kliewi jew li qegħdin f'dijaliżi (teknika ta' purifikazzjoni tad-demm) - l-użu tiegħu għandu jiġi kkunsidrat f'dawn il-pazjenti jekk ilbenefiċċji potenzjali tiegħu huma ogħla mir-riskji potenzjali.
English: Adefovir interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Maltese: Adefovir jinterferixxi malazzjoni ta' enzima virali msejjaħ polimerażi tad-DNA , li għandha x'taqsam mal-formazzjoni ta' DNA virali.
English: Patients who have problems with their kidneys should take Hepsera less frequently.
Maltese: Pazjenti bi problemi fil-kliewi għandhom jieħdu Hepsera inqas spiss.