FrancophonIA/ELRC3.0 huggingface dataset:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each coated tablet contains 5 mg olanzapine
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola miksija fiha 5 mg olanzapine
English: Concomitant injection of olanzapine and parenteral benzodiazepine is not recommended (see sections 4.4 and 6.2).
Maltese: Injezzjoni ta' olanzapine flimkien ma' benzodijazepin parenterali ma kinietx studjata u għalhekk m'hijiex rakkomandata (ara taqsimiet 4.4 u 6.2).
English: EU/1/96/022/012 28 coated tablets EU/1/96/022/027 35 coated tablets EU/1/96/022/021 56 coated tablets EU/1/96/022/033 70 coated tablets EU/1/96/022/039 98 coated tablets
Maltese: EU/1/96/022/012 28 pillola miksija EU/1/96/022/027 35 pillola miksija EU/1/96/022/021 56 pillola miksija EU/1/96/022/033 70 pillola miksija EU/1/96/022/039 98 pillola miksija
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 15 mg coated tablets Olanzapine
Maltese: ZYPREXA 15 mg pilloli miksija olanzapine
English: EU/1/96/022/002 28 coated tablets EU/1/96/022/023 35 coated tablets EU/1/96/022/019 56 coated tablets EU/1/96/022/029 70 coated tablets EU/1/96/022/035 98 coated tablets
Maltese: EU/1/96/022/002 28 pillola miksija EU/1/96/022/023 35 pillola miksija EU/1/96/022/019 56 pillola miksija EU/1/96/022/029 70 pillola miksija EU/1/96/022/035 98 pillola miksija
English: ZYPREXA 15 mg coated tablets
Maltese: ZYPREXA 15 mg pilloli miksija
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 5 mg coated tablets Olanzapine
Maltese: ZYPREXA 5 mg pilloli miksija olanzapine
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 5 mg coated tablets olanzapine
Maltese: ZYPREXA 5 mg pilloli miksija Olanzapine
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 20 mg coated tablets Olanzapine
Maltese: ZYPREXA 20 mg pilloli miksija olanzapine
English: Weight gain1
Maltese: Żieda filpiż1
English: Reconstitute ZYPREXA Powder for Solution for Injection using standard aseptic techniques for reconstitution of parenteral products.
Maltese: Ħallat ZYPREXA Trab jinħall f'soluzzjoni għall-injezzjoni billi tuża metodu asettiku tas-soltu għattaħlit ta' prodotti parenterali.
English: ZYPREXA 7.5 mg coated tablets Round, white, coated tablets imprinted with “LILLY” and a numeric identicode “4116”.
Maltese: Pilloli, tondi, bojod u miksijin, stampati b' "LILLY" u b'kodiċi tal-identità numeriku "4116".
English: In a pharmacokinetic study in healthy volunteers, a dose of 5 mg of ZYPREXA powder for solution for injection produced a maximum plasma concentration (Cmax) approximately 5 times higher than that seen with the same dose of olanzapine administered orally.
Maltese: Fi studju farmakokinetiku f'voluntiera b'saħħithom, doża ta' 5 mg ta' ZYPREXA trab jinħall f'soluzzjoni għall-injezzjoni wasslet għal konċentrazzjoni massima tal-plażma (Cmax) bejn wieħed u ieħor 5 darbiet ogħla minn dik li dehret bl-istess doża ta' olanzapine meħuda mill-ħalq.
English: ZYPREXA powder for solution for injection should be reconstituted in accordance with the recommendation in section 6.6.
Maltese: ZYPREXA trab għal soluzzjoni għall-injezzjoni għandha titħallat skond ir-rakkomandazzjonijiet f'taqsima 6.6.
English: Unstable medical conditions
Maltese: IL-PRODOTT MEDIĊINALI
English: NAME OF THE MEDICINAL PRODUCT ZYPREXA 10 mg powder for solution for injection olanzapine
Maltese: ZYPREXA 10 mg olanzapine trab għal soluzzjoni għall-injezzjoni
English: Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dyskinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in males and females or erectile dysfunction in males.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa 1 minn kull 10 persuni) jinkludu tibdil fil-livelli ta' xi ċelluli tad-demm, ta' xaħmijiet fiċ-ċirkolazzjoni u kmieni fil-kura, żidiet temporanji tal-enzimi tal fwied; żidiet fil-livelli ta' zokkor fid-demm u fl-awrina; żidiet fil-livelli tal-aċidu uriku u tal-creatine phosphokinase fid-demm; tħossok aktar bil-ġuħ; sturdament; irrekwitezza; rogħda; movimenti mhux tas-soltu (diskajnisjas); stitikezza; ħalq xott; raxx; titlef il-forzi;għeja estrema; retenzjoni tal-ilma li twassal għal nefħa fl-idejn, għekiesi jew saqajn; deni; uġigħ fiġ-ġogi u disfunzjonijiet sesswali bħal tnaqqis fil-libido fl-irġiel u fin-nisa jew disfunzjoni erettili fl-irġiel.
English: Gynaecomastia/breast enlargement in males
Maltese: Ginekomastija/tkabbir żejjed tas-sider fl-irġiel
English: • Whenever the risk management system is modified,especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċju u r-riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: If the patient's medical history with regard to these unstable medical conditions cannot be determined, the risks and benefits of IM olanzapine should be considered in relation to other alternative treatments.
Maltese: dawn il-kundizzjonijiet mediċi mhux stabbli ma jistax jiġi determinat, għandhom jiġu kkunsidrati rriskji u l-benefiċji ta' IM olanzapine f'relazzjoni ma' trattamenti oħra alternattivi.
English: Each coated tablet contains 5 mg olanzapine.
Maltese: Kull pillola miksija għandha 10 mg olanzapine.
English: Clinically significant weight gain was observed across all baseline Body Mass Index (BMI) categories.
Maltese: 1 Ġiet osservata żieda fil-piż klinikament sinifikanti fil-kategoriji kollha fil-linja bażi ta' l-Indiċi talMassa tal-Ġisem (BMI).
English: A lower dose (5 mg or 7.5 mg) may be given, on the basis of individual clinical status, which should also include consideration of medicinal products already administered either for maintenance or acute treatment (see section 4.4).
Maltese: Tista' tingħata doża anqas (5 mg jew 7.5 mg), skond l-istat kliniku individwali li għandu jagħti kas tal-prodotti mediċinali li diġà ngħataw jew bħala manteniment tal-kura jew bħala kura akuta (ara taqsima 4.4).
English: In placebocontrolled clinical trials (6-12 weeks duration) of elderly patients (mean age 78 years) with dementiarelated psychosis and/or disturbed behaviours, there was a 2-fold increase in the incidence of death in olanzapine-treated patients compared to patients treated with placebo (3.5 % vs. 1.5 %, respectively).
Maltese: darbtejn akbar fl-inċidenza ta' mwiet fil-pazjenti ttrattati b'olanzapine, mqabbla ma' pazjenti ttrattati bil-plaċebo (3.5% kontra 1.5%, rispettivament).
English: • High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking ZYPREXA.
Maltese: • Livell għoli ta' zokkor fid-demm u livelli għolja ta' xaħmijiet (trigliċeridi u kolesterol) instabu f'pazjenti li qed jieħdu ZYPREXA.
English: After reconstitution each ml of the solution contains 5 mg olanzapine
Maltese: Wara r-rikostituzzjoni kull ml ta' soluzzjoni fih 5 mg olanzapine
English: What Ifirmasta contains - The active substance is irbesartan.
Maltese: X'fih Ifirmasta - Is-sustanza attiva hi irbesartan.
English: Date of first authorisation: 1 December 2008 Date of latest renewal: 26 August 2013
Maltese: Data tal-aħħar tiġdid: 26 ta'Awissu 2013
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).
Maltese: Il-frekwenza ta' l-effetti avversi msemmija hawn taħt hija definita bl-użu ta' din il-konvenzjoni: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni Tar-Riskju (RMP)
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Maltese: It-tneħħija totali mill-ġisem u mill-kliewi huma ta' 157-176 u 3-3.5 ml/min, rispettivament.
English: ELOGIS PHARMA Τηλ: + 30 210 4101670
Maltese: Τηλ: + 30 210 4101670
English: IRMA 2 was a placebo-controlled double blind morbidity study in 590 patients with type 2 diabetes, microalbuminuria (30-300 mg/day) and normal renal function (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Maltese: IRMA 2 kien studju double blind ikkontrollat bil-plaċebo ta' morbożità li sar fuq 590 pazjent b'dijabete ta' tip 2, mikroalbuminurja (30-300 mg/jum) u funzjoni renali normali (kreatinina fis-serum ≤ 1.5 mg/dl fl-irġiel u < 1.1 mg/dl fin-nisa).
English: When angiotensin II antagonists are administered simultaneously with non-steroidal antiinflammatory medicinal products (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: Meta jingħataw antagonisti ta' angiotensin II flimkien ma' mediċini anti-infjammatorji mhux sterojdi (i.e. inibituri COX-2 selettivi, acetylsalicylic acid (> 3 g/kuljum) u NSAIDs mhux selettivi), jista' jkun hemm attenwazzjoni ta' l-effett kontra l-pressjoni għolja.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, b'kontrolli, b'morbożità u mortalità li qabblet Ifirmasta, amlodipine u plaċebo.
English: Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Maltese: Filwaqt li ma hemm ebda data epidemijoloġika dwar ir-riskji b'Antagonisti ta' Reċetturi ta' Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il-klassi ta' mediċini.
English: - The other ingredients are mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, castor oil, hydrogenated in the core of tablet and polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 and talc in film-coating.
Maltese: - Is-sustanzi l-oħra huma mannitol, hydroxypropylcellulose, low-substituted hydroxypropyl cellulose (LH-21), low-substituted hydroxypropyl cellulose (LH-11), talc, macrogol 6000, castor oil, hydrogenated fil-qalba tal-pillola u polyvinyl alcohol, titanium dioxide (E171), macrogol 3000 u talc fil-kisi tar-rita.
English: See also information under the heading “Do not take Ifirmasta”.
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux Ifirmasta”.
English: Additional information on irbesartan interactions:
Maltese: Aktar informazzjoni dwar l-interazzjonijiet ta' irbesartan:
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoniiiet 4.8, 5.1 u 5.2 imma l'ebda rakkomandazzjoni fuq il-pożoloġija ma tista' tingħata.
English: Of those 23 children, 21 were evaluable for comparison of pharmacokinetics with adults (twelve children over 12 years, nine children between 6 and 12 years).
Maltese: Minn dawn it-23 tifel u tifla, 21 setgħu jiġu evalwati għal taqbil ta' farmakokinetiċi ma' adulti (tnax-il tifel u tifla 'l fuq minn 12-il sena, disat itfal ta' bejn 6 u 12-il sena).
English: Reduction of blood pressure with 0.5 mg/kg (low), 1.5 mg/kg (medium) and 4.5 mg/kg (high) target titrated doses of irbesartan was evaluated in 318 hypertensive or at risk (diabetic, family history of hypertension) children and adolescents aged 6 to 16 years over a three week period.
Maltese: Tnaqqis tal-pressjoni tad-demm b'0.5 mg/kg (baxx), 1.5 mg/kg (medju) u 4.5 mg/kg (għoli) livelli mixtieqa ddożati ta' irbesartan kienu evalwati fi 318-il tifel u tifla u adoloxxent ta' bejn 6 u 16-il sena bi pressjoni għolja jew f'riskju (dijabete, storja ta' pressjoni għolja fil-familja) fuq perjodu ta' tliet ġimgħat.
English: Lithium The combination of lithium and Ifirmasta is not recommended (see section 4.5).
Maltese: Lithium It-taħlit ta' litju u Ifirmasta mhuwiex rakkomandat (ara sezzjoni 4.5).
English: At 24 hours the reduction of blood pressure was 60-70% of the corresponding peak diastolic and systolic responses at the recommended doses.
Maltese: F'24 siegħa t-tnaqqis tal-pressjoni kien 60%-70% ta' logħla rispons fid-dijastolika u sistolika bid-dożi rrikmandati.
English: Marketing Authorisation Holder and Manufacturer KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
English: hypersensitivity reactions such as angioedema, rash, urticaria, anaphylactic reaction, anaphylactic shock
Maltese: reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja, reazzjoni anafilattika, xokk anafilattiku
English: A limited accumulation of irbesartan (18%) in plasma was observed upon repeated once daily dosing.
Maltese: Akkumulazzjoni limitata t'irbesartan (< 20%) giet osservata fil-plażma meta doża ta' darba kuljum kienet ripetuta.
English: thrombocytopenia
Maltese: tromboċitopenija
English: While similar blood pressure was achieved in all treatment groups, fewer subjects in the irbesartan 300 mg group (5.2%) than in the placebo (14.9%) or in the irbesartan 150 mg group (9.7%) reached the endpoint of overt proteinuria, demonstrating a 70% relative risk reduction versus placebo (p = 0.0004) for the higher dose.
Maltese: Waqt li pressjoni simili ġiet milħuqa fil-gruppi kollha tal-kura, inqas individwi fil-grupp t'irbesartan 300 mg (5.2%) minn dawk bil-plaċebo (14.9%) jew fil-grupp t'irbesartan 150 mg (9.7%) laħqu l-endpoint ta' protejnurja li tidher, li jfisser 70% ta' tnaqqis fir-risku relattiv meta mqabbel mal-plaċebo (p = 0.0004) għal doża l-għolja.
English: In clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Maltese: Fi studji kliniċi, il-farmakokinetika ta' irbesartan mhix affettwata minn hydrochlorothiazide.
English: Ifirmasta 75 mg film-coated tablets Ifirmasta 150 mg film-coated tablets Ifirmasta 300 mg film-coated tablets
Maltese: Ifirmasta 75 mg pilloli miksija b'rita Ifirmasta 150 mg pilloli miksija b'rita Ifirmasta 300 mg pilloli miksija b'rita
English: Patients in all treatment groups typically received between 2 and 4 antihypertensive agents (e.g., diuretics, beta blockers, alpha blockers) to reach a predefined blood pressure goal of ≤ 135/85 mmHg or a 10 mmHg reduction in systolic pressure if baseline was > 160 mmHg.
Maltese: Il-pazjenti fil-gruppi ta' kura kollha tipikament irċevew bejn 2 u 4 mediċini kontra l-pressjoni għolja (p.e. dijuretiċi, beta blockers, alpha blockers) biex laħqu l-livell imfassal minn qabel ta' pressjoni ta' ≤ 135/85 mmHg jew tnaqqis ta' 10 mmHg fil-pressjoni sistolika jekk il-linja bażi kienet > 160 mmHg.
English: Tablet core:
Maltese: 14-il pillola:
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the irbesartan 300 mg group (34%) than in the placebo group (21%).
Maltese: Rigressjoni għal albuminuria normali (< 30 mg/jum) kienet iktar frekwenti fil-grupp ta' Ifirmasta 300 mg (34%) milli fil-grupp tal-plaċebo (21%).
English: Adjusted mean change of trough seated diastolic blood pressure (SeDBP) was as follows: 3.8 mmHg (low dose), 3.2 mmHg (medium dose), 5.6 mmHg (high dose).
Maltese: Il-bidla medja aġġustata fil-pressjoni dijastolika tad-demm meħuda meta pazjent ikun bil-qiegħda (SeDBP) kienet kif ġej: 3.8 mmHg (doża baxxa), 3.2 mmHg (doża medja), 5.6 mmHg (doża għolja).
English: While this is not documented with Ifirmasta, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Ifirmasta, effetti simili għandhom ikunu antiċipati b'antagonisti tar-riċetturi angiotensin-II.
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg irbesartan, from 2.5 mg to 10 mg amlodipine, or placebo as tolerated.
Maltese: Il-pazjenti ngħataw doża aġġustata minn 75 mg għal doża ta' manteniment ta' 300 mg ta' Ifirmasta, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skond kemm felħu.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, hyperkalaemia (≥ 5.5 mEq/L) occurred in 29.4% of the patients in the irbesartan 300 mg group and 22% of the patients in the placebo group.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'mikroalbuminurja u b'funzjoni renali normali, iperkalimja (≥ 5.5mEq/L) ġrat f'29.4% (jiġifieri komuni ħafna) tal- pazjenti fil-grupp li ħadu 300 mg ta' irbesartan u fi 22% tal-pazjenti filgrupp tal- plaċebo.
English: The following table presents the adverse medicinal product reactions that were reported in placebocontrolled trials in which 1,965 hypertensive patients received irbesartan.
Maltese: It-tabella li ġejja tippreżenta r-reazzjonijiet avversi tal-mediċina li ġew irrappurtati fi provi kliniċi kkontrollati bi plaċebo li fihom 1,965 pazjent bi pressjoni għolja rċevew irbesartan.
English: The safety and efficacy of Ifirmasta in children aged 0 to 18 has not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Ifirmasta fit-tfal ta' bejn 0 sa 18-il sena ma ġewx determinati s'issa.
English: At very high doses (≥ 500 mg/kg/day) degenerative changes in the kidney (such as interstitial nephritis, tubular distension, basophilic tubules, increased plasma concentrations of urea and creatinine) were induced by irbesartan in the rat and the macaque and are considered secondary to the hypotensive effects of the medicinal product which led to decreased renal perfusion.
Maltese: B'dożi għoljin ħafna (≥ 500 mg/kg/jum) tibdil diġenerattiv fil-kliewi (bħal nefrite interstizjali, nefħa tubulari, tubi basofiliċi, żidiet fil-konċentrazjonijiet fil-plażma ta' l-urea u kreatinina) ġew stimulati b'irbesartan f'firien u f'makakki u huma meqjusa bħala sekondarji għall-effetti ipotensivi tal-mediċina li kkaġunat tnaqqis fil-perfużjoni renali.
English: The concomitant use of Ifirmasta 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 and 5.1).
Maltese: L-użu fl-istess ħin ta' Ifirmasta 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 5.1).
English: Non-steroidal anti-inflammatory medicinal products:
Maltese: Mediċini anti-infjammatorji mhux sterojdi:
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' irbesartan AUC u Cmax kienu xi ftit ogħla f'individwi akbar fl-età (≥ 65 -il sena) milli f'individwi żgħar (18-40 sena).
English: Pharmacotherapeutic group: angiotensin II antagonist, plain, ATC code: C09CA04.
Maltese: Kodiċi ATC: C09CA04.
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Maltese: żidiet sinifikanti tal-kreatina kinazi fil-plażma ġew osservati frekwentement (1.7%) f'individwi li ħadu l-kura b'irbesartan.
English: Hepatic impairment
Maltese: disfunzjoni sesswali
English: After oral administration, irbesartan is well absorbed: studies of absolute bioavailability gave values of approximately 60-80%.
Maltese: Wara li jingħata mill-ħalq, irbesartan jiġi assorbit sew: studji ta' bijodisponibiltà assoluta wrew valuri ta' madwar 60%-80%.
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 56x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 56 pillola miksija b'rita 56 x 1 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita
English: Undesirable effects where the frequency is not known are: feeling of spinning, headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, reduced number of platelets, abnormal liver function, increased blood potassium levels, impaired renal function, inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis) and severe allergic reactions (anaphylactic shock).
Maltese: Effetti mhux mixtieqa, fejn il-frekwenza mhijiex magħrufa huma: tħoss rasek iddur bik, uġigħ ta' ras, disturbi fit-togħma, żarżir fil-widnejn, bugħawwieġ, uġigħ fil-ġogi u fil-muskoli, tnaqqis fin-numru tal-plejtlits, funzjoni tal-fwied anormali, livelli għoljin ta' potassium fid-demm, funzjoni tal-kliewi indebolita, infjammazzjoni tal-vini ż-żgħar li taffettwa l-ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis) u reazzjonijiet allerġiċi severi (xokk anafilattiku).
English: hepatitis, abnormal liver function
Maltese: epatite, funzjoni anormali tal-fwied
English: In 1,715 hypertensive patients with type 2 diabetes, proteinuria ≥ 900 mg/day and serum creatinine ranging from 1.0-3.0 mg/dl, the long-term effects (mean 2.6 years) of irbesartan on the progression of renal disease and all-cause mortality were examined.
Maltese: F'1,715-il pazjent bi pressjoni għolja u b'dijabete ta' tip 2, protejnurja ≥ 900 mg/jum u kreatinina fis-serum li tvarja minn 1.0 - 3.0 mg/dl, ġew eżaminati l-effetti fit-tul (medja ta' 2.6 snin) ta' Ifirmasta fuq lavvanz ta' mard renali u l-kawżi kollha ta' mortalità.
English: Irbesartan exhibits linear and dose proportional pharmacokinetics over the dose range of 10 to 600 mg. A less than proportional increase in oral absorption at doses beyond 600 mg (twice the maximal recommended dose) was observed; the mechanism for this is unknown.
Maltese: Inqas minn żieda proporzjonali t'assorbiment orali b'dożi 'il fuq minn 600 mg (id-doppju taddoża massima rrikmandata) ġie osservat;
English: White, oval tablets.
Maltese: Pilloli ovali, bojod.
English: In patients insufficiently controlled with 150 mg once daily, the dose of Ifirmasta can be increased to 300 mg, or other antihypertensive agents can be added (see sections 4.3, 4.4, 4.5 and 5.1).
Maltese: F'pazjenti li mhumiex ikkontrollati biżżejjed b'150 mg darba kuljum, id-doża ta' Ifirmasta tista' tiżdied għal 300 mg, jew jistgħu jiġu miżjudin mediċini oħrajn ta' kontra l-pressjoni għolja (ara sezzjonijiet 4.3, 4.4, 4.5 u 5.1).
English: Vascular disorders: Common:
Maltese: Disturbi vaskulari:
English: In diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria, hyperkalaemia (≥ 5.5 mEq/L) occurred in 46.3% of the patients in the irbesartan group and 26.3% of the patients in the placebo group.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'insuffiċenzja renali kronika u bi protejnurja li tidher, iperkalimja (≥ 5.5 mEq/L) ġrat f'46.3% talpazjenti fil-grupp ta' irbesartan u f'26.3% tal-pazjenti fil-grupp tal-plaċebo.
English: Metabolism and nutrition disorders: Not known:
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: Other medicines and Ifirmasta
Maltese: Mediċini oħra u Ifirmasta
English: Blister (PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 or 98 film-coated tablets in box are available.
Maltese: Folji(PVC/PE/PVDC/Alu): 14, 28, 30, 56, 84, 90 jew 98 pillola miksija b'ritaf'kaxxa. Folja (PVC/PE/PVDC/Alu): 56 x 1 pillola ta' doża waħda miksija b'rita ġo folji pperforati f'kaxxa.
English: Available pharmacodynamic/toxicological data in rats have shown excretion of irbesartan or its metabolites in milk (for details see 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fil-firien uriet li kien hemm eliminazzjoni ta' irbesartan jew il-metaboliti tiegħu fil-ħalib tas-sider (gћad-dettalji ara 5.3).