FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of bleomycin, vindesine, mitomycin C and cisplatin in patients with recurrent and/or metastatic squamous cell carcinoma of the cervix was recently shown to be of benefit with regards to survival and a phase II study showed bleomycin to be part of a clinically relevant alternative treatment regimen for cisplatin, in patients with recurrent cervical cancer.
Maltese: Għalkemm l-bleomiċina, bħalissa, mhijiex meqjusa bħala komponent essenzjali fit-trattament sistemiku tal-ewwel linja ta' SCCHN, hija xorta tikkostitwixxi għażla ta' trattament għall-kemjoterapija (konkomittanti), jew flimkien ma' RT, u għaldaqstant ma jistax jiġi kkunsidrat li din l-indikazzjoni saret obsoleta.
English: The CHMP therefore considered the indication to be acceptable.
Maltese: Għaldaqstant, is-CHMP qies li l-indikazzjoni hija aċċettabbli.
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES
Maltese: TAL-PRODOTT MEDIĊINALI, MNEJN JINGĦATA, APPLIKANTI FL-ISTATI
English: Regarding the indication in Head and Neck cancer, the CHMP is of the opinion that although bleomycin has obvious disadvantages related to its toxicity (pulmonitis, pulmonary fibrosis, stomatitis and skin changes), there is still a role for bleomycin in (neoadjuvant) treatment of the disease.
Maltese: Rigward l-indikazzjoni ta' kanċer tar-ras u tal-għonq, is-CHMP huwa tal-opinjoni li għalkemm l-bleomiċina għandha żvantaġġi evidenti relatati mat-tossiċità tagħha (pulmonite, fibrożi pulmonari, stomatite u bidliet fil-ġilda), għad hemm rwol għall-bleomiċina fit-trattament (neoadjuvant) tal-marda.
English: In the Netherlands bleomycin is currently approved for the following indications:
Maltese: Fl-Olanda, il-bleomiċina bħalissa hija approvata għallindikazzjonijiet li ġejjin:
English: Intramuscular injection Subcutaneous injection Intravenous administration Intra-arterial administration Intra-pleural injection Intraperitoneal administration
Maltese: Is-CHMP jikkunsidra li għalkemm il-bleomiċina mhijiex komponent tal-ewwel linja evidenti għat-trattament sistemiku ta' kanċer taċ-ċerviċi, il-bleomiċina tibqa' mediċina ċitostatika li għandha tibqa' disponibbli għall-pazjenti għal din l-indikazzjoni.
English: - (Non-)Hodgkin´s lymphoma and other malignant lymphomas - Testis carcinoma - Intrapleural therapy of malignant pleural effusion.
Maltese: Is-Sommarju tal-Karatteristiċi tal-Prodott, tikketta u l-fuljett tat-tagħrif huma l-verżjonijiet finali miksuba waqt il-proċedura tal-grupp ta' Koordinazzjoni.
English: • The active substance is irbesartan.
Maltese: • Is-sustanza attiva hi irbesartan.
English: Av. Camí Reial, 51-57
Maltese: Camí Reial, 51-57
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first Authorization: 13 April 2012
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel Awtorizzazzjoni: 13 ta' april 2012
English: The volume of distribution is 53 - 93 litres.
Maltese: Il-volum ta' distribuzzjoni huwa 53-93 litru.
English: Rodopi Prefecture, Block No 5, Rodopi 69300, Greece
Maltese: Rodopi Prefecture, Block No 5, Rodopi 69300, Il-Greċja
English: (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Maltese: (≥1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000).
English: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Silica colloidal anhydrous Hypromellose Magnesium stearate.
Maltese: Lactose monohydrate Microcrystalline cellulose Croscarmellose sodium Anidru kollojdali silika Hypromellose Magnesium stearate.
English: (serum creatinine ≤ 1.5 mg/dl in males and < 1.1 mg/dl in females).
Maltese: (krejatinina fis-serum ≤ 1.5 mg/dl fl-irġiel u < 1.1 mg/dl fin-nisa).
English: Cartons of 28, 56, 90 or 98 film-coated tablets in PVC/PVDC-aluminium/PVDC blisters.
Maltese: Pakketti ta' 28, 56, 90 jew 98-il pillola miksija b'rita f' folji tal-PVC/PVDC-Aluminju/PVDC.
English: Titanium dioxide (E171)
Maltese: Hypromellose Titanium dioxide (E171) Macrogol 400
English: Luxe mbourg/Luxemburg Portfarma ehf.
Maltese: Luxembourg/Luxemburg Portfarma ehf.
English: The predefined blood pressure goal was ≤ 135/85 mmHg.
Maltese: L-għan predefinit kien għall-pressjoni ta' ≤135/85 mmHg.
English: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare
Maltese: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari
English: Similar effects have been very rarely reported with irbesartan so far.
Maltese: Effetti simili ġew irrapportati rarament ħafia b'irbesartan s'issa.
English: The terminal elimination half-life of irbesartan is 11 - 15 hours.
Maltese: Il-half-life t'eliminazzjoni terminali t'irbesartan hija 11-15 sigħat.
English: • potassium-sparing medicines (such as certain diuretics)
Maltese: • mediċini potassium-sparing (bħal ċerti dijuretiċi)
English: 6, Dervenakion str., 15351 Pallini Attiki, Greece Tel.: +30 210 66 65 067
Maltese: 6, Dervenakion str., 153 51 Pallini Attiki, Il-Greċja Tel.: +30 210 66 65 067
English: Unite d Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527
Maltese: United Kingdom Aspire Pharma Limited Tel: +44(0)1730 234527
English: Immune system disorders:
Maltese: Disturbi tas-sistema immuni:
English: B e lgië/Belgique/Belgien Pharmathen S.A.
Maltese: België/Belgique/Belgien Pharmathen S.A.
English: 08184 - Palau-solità i Plegamans, Barcelona, Spain
Maltese: - Palau-solità i Plegamans, Barcelona, Spanja
English: The total body and renal clearance are 157 - 176 and 3 - 3.5 ml/min, respectively.
Maltese: It-tneħħija mill ġisem kollu u renali huma 157-176 u 3-3.5 ml/min, rispettivament.
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 f 590 pazjenti b'tip 2 ta' dijabete, mikroalbuminuria (30-300 mg/jum) u funzjoni renali normali (krejatinina fis-serum ≤ 1.5 mg/dl fl-irġiel u < 1.1 mg/dl fin-nisa).
English: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki Greece
Maltese: Pharmathen S.A. 6 Dervenakion str. 15351 Pallini Attiki
English: Other medicines and Sabervel
Maltese: Mediċini oħra u Sabervel
English: INFORMATION IN BRAILLE Sabervel 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sabervel 75 mg
English: INFORMATION IN BRAILLE Sabervel 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sabervel 300 mg
English: Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti-inflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Maltese: mediċini anti-infjammatorji mhux sterojdi (i.e. inibituri COX-2 selettivi, acetylsalicylic acid (> 3 g/kuljum) u NSAIDs mhux selettivi), jista' jkun hemm attenwazzjoni 'tal-effett kontra l-pressjoni għolja.
English: 15351 Pallini, Attiki, Greece
Maltese: 15351 Pallini Attiki, Il-Greċja
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
Maltese: IRMA 2 kien studju double blind ikkontrollat bil-plaċebo ta' morbożità f 590 pazjenti b'tip 2 ta' dijabete, mikroalbuminuria (30-300 mg/jum) u funzjoni renali normali
English: Sabervel is used in adult patients
Maltese: Sabervel jintuża f pazjenti adulti
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 adoloxxenti ta' bejn is-6 u s-16-il sena bi pressjoni għolja jew f riskju (dijabetiċi, passat ta' pressjoni għolja fil-familja) fuq perjodu ta' tliet ġimgħat.
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing irbesartan, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, ikkontrollata, ta' morbożità u mortalità li qabblet irbesartan, amlodipine u plaċebo.
English: INFORMATION IN BRAILLE Sabervel 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Sabervel 150 mg
English: Excipients: also contains lactose monohydrate.
Maltese: Sustanzi mhux attivi: fih ukoll lactose monohydrate.
English: Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, silica colloidal anhydrous, hypromellose, magnesium stearate, Film-coating: hypromellose, titanium dioxide (E171), macrogol 400
Maltese: Qalba tal-pillola: Lactose monohydrate , Microcrystalline cellulose, Croscarmellose sodium, Anidru kollojdali silika, Hypromellose, Magnesium stearate.
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' irbesartan, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skont kemm felħu.
English: Currently available data are described in section 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: 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' irbesartan 300 mg (34%) milli fil-grupp tal-plaċebo (21%).
English: Mechanism of action: Irbesartan is a potent, orally active, selective angiotensin-II receptor (type AT1) antagonist.
Maltese: Irbesartan huwa antagonista qawwi, attiv mill-ħalq, antagonista selettiv tarriċettur angiotensin-II (tip AT1).
English: Fertility and reproductive performance were not affected in studies of male and female rats even at oral doses of irbesartan causing some parental toxicity (from 50 to 650 mg/kg/day), including mortality at the highest dose.
Maltese: Il-fertilità u l-prestazzjoni riproduttiva ma ġewx affettwati fl-istudji ta' firien irġiel u nisa anki f dożi orali ta' irbesartan li jikkawżaw xi tossiċità parentali (minn 50 sa 650 mg/kg/kuljum), inkluż mortalità fl-ogħla doża.
English: 28 film-coated tablets 56 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 28 pilloli miksijin b'rita 56 pilloli miksijin b'rita 90 pilloli miksijin b'rita 98 pilloli miksijin b'rita
English: In placebo-controlled trials in patients with hypertension, the overall incidence of adverse events did not differ between the irbesartan (56.2%) and the placebo groups (56.5%).
Maltese: Fi studji kliniċi kkontrollati bi plaċebo f pazjenti bi pressjoni għolja, l-inċidenza totali ta' effetti avversi ma kinetx differenti bejn dawk li ħadu irbesartan (56.2%) u l-grupp li ħa l-plaċebo (56.5%).
English: While this is not documented with Sabervel, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Sabervel, effetti simili għandhom ikunu antiċipati b'antagonisti tar-riċetturi angiotensin-II.
English: irbesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells (in rats at ≥ 90 mg/kg/day, in macaques at ≥ 10 mg/kg/day).
Maltese: Barra minn hekk, irbesartan ikkaġuna iperplasja/ipertrofija taċ-ċelluli ġukstaglomerulari (f firien ≥ 90 mg/kg/jum, f'makakki ≥ 10 mg/kg/jum).
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 filkliewi (bħal nefrite interstizja, nefħa tubulari, tubi basofiliċi, żidiet fil-konċentrazjonijiet fil-plażma 'tal-urea u krejatinina) 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: 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: 5.5 mEq/l) ġrat f 46.3% tal-pazjenti fil-grupp ta' irbesartan u f 26.
English: hypersensitivity reactions such as angioedema, rash, urticaria
Maltese: reazzjonijiet ta' sensittività eċċessiva bħal anġjoedema, raxx, urtikarja
English: Paediatric population: the safety and efficacy of Sabervel in children aged 0 to 18 has not been established.
Maltese: Popolazzjonipedjatrika: is-sigurtà u l-effikaċja ta' Sabervel fit-tfal ta' bejn 0 sa 18-il sena ma ġewx determinati s'issa.
English: In 1.7% of hypertensive patients with advanced diabetic renal disease treated with irbesartan, a decrease in haemoglobin*, which was not clinically significant, has been observed.
Maltese: F' 1.7% tal-pazjenti bi pressjoni għolja b'mard dijabetiku avanzat renali kkurati b'irbesartan, kien osservat tnaqqis fl-emoglobina*, li ma kienx klinikament sinifikanti.
English: M anufacture r:
Maltese: Kisja b'rita:
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' proteinuria li tidher,
English: jaundice
Maltese: JINTUŻA
English: Hypromellose
Maltese: iperkalemija
English: significant increases in plasma creatine kinase were commonly observed (1.7%) in irbesartan treated subjects.
Maltese: żidiet sinifikanti tal-krejatina kinazi fil-plażma ġew osservati frekwentement (1.7%) findividwi li ħadu l-kura b'irbesartan.
English: The incidence of adverse events was not related to dose (in the recommended dose range), gender, age, race, or duration of treatment.
Maltese: L-inċidenza ta' effetti avversi ma kinetx relatata mad-doża (doża li ngħatat fil-firxa rrikmandata), sess, età, razza, jew mat-tul tal-kura.
English: • Patients with high blood pressure and type 2 diabetes with kidney disease
Maltese: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints)
English: Respiratory, thoracic and mediastinal disorders: Uncommon:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
English: In patients insufficiently controlled with 150 mg once daily, the dose of Sabervel 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' Sabervel 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: Metabolism and nutrition disorders: Not known:
Maltese: Disturbi _fil-metaboliżmu u n-nutrizzjoni:
English: Sabervel at a dose of 150 mg once daily generally provides a better 24 hour blood pressure control than 75 mg.
Maltese: Sabervel b'doża ta' 150 mg darba kuljum ġeneralment jipprovdi kontroll aħjar matul l24 siegħa għall-pressjoni tad-demm minn 75 mg.
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly subjects (≥ 65 years) than those of young subjects (18 - 40
Maltese: Il-valuri ta' irbesartan AUC u Cmax kienu xi ftit ogħla f individwi anzjani (≥ 65 sena) milli findividwi żgħar (18-40 sena).
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 ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/
English: Common: at least 1 in 100 and less than 1 in 10 patients Uncommon: at least 1 in 1000 and less than 1 in 100 patients Side effects reported in clinical studies for patients treated with Irbesartan were:
Maltese: Mhux komuni: talanqas 1 minn kull 1000 pazjent u anqas minn 1 minn kull 100 pazjent L-effetti sekondarji rrappurtati fl-istudji kliniċi għall-pazjenti kkurati b'irbesartan kienu:
English: What Sabervel looks like and contents of the pack Sabervel 75 mg film-coated tablets are white, concave, round, film-coated tablets with 7 mm diameter.
Maltese: Id-dehra ta' Sabervel u l-kontenuti tal-pakkett Il-pilloli Sabervel 75 mg huma bojod, konkavi, tondi, pilloli miksija b'rita b'dijametru ta' 7 mm.
English: The study examined the long-term effects (2 years) of irbesartan on the progression to clinical (overt) proteinuria (urinary albumin excretion rate (UAER) > 300 mg/day, and an increase in UAER of at least 30% from baseline).
Maltese: (sentejn) ta' irbesartan fuq il-progressjoni għal proteinuria klinikali (li tidher) (ir-rata ta' tneħħija t'albumina ma'l-urina (UAER) > 300 mg/jum, u żjieda f' UAER 'tal-inqas 30% mill-linja bażi).
English: Sabervel 75 mg film-coated tablets irbesartan
Maltese: Sabervel 75 mg pilloli miksijin b'rita irbesartan
English: Terms marked with a star (*) refer to the adverse reactions that were additionally reported in > 2% of diabetic hypertensive patients with chronic renal insufficiency and overt proteinuria and in excess of placebo.
Maltese: It-termini mmarkati bi stilla (*) jirreferu għar-reazzjonijiet avversi li ġew irrappurtati b'mod addizzjonali f> 2% tal-pazjenti dijabetiċi bi presssjoni għolja b'insuffiċjenza renali kronika u proteinurja ċara u iżjed milli fil-grupp tal-plaċebo.
English: The concomitant use of Sabervel 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' Sabervel 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: Each tablet of Sabervel 300 mg contains 300 mg irbesartan.
Maltese: Kull pillola ta' Sabervel 300 mg fiha 300 mg ta' irbesartan.
English: Each tablet of Sabervel 75 mg contains 75 mg irbesartan.
Maltese: Kull pillola ta' Sabervel 75 mg fiha 75 mg ta' irbesartan.
English: orthostatic hypotension*
Maltese: sturdament, sturdament ortostatiku*
English: Sabervel belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Sabervel jappartjeni għall-grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: EU/1/12/765/003 EU/1/12/765/004 EU/1/12/765/008 EU/1/12/765/011
Maltese: EU/1/12/765/008 EU/1/12/765/011
English: Hypersensitivity to the active substance, or to any of the excipients (see section 6.1).
Maltese: Sensittività eċċessiva għas-sustanza attiva, jew għal xi sustanzi mhux attivi (ara sezzjoni 6.1).
English: Each tablet contains 150 mg irbesartan
Maltese: Kull pillola fiha 150 mg irbesartan
English: In the female and black subgroups which represented 32% and 26% of the overall study population respectively, a renal benefit was not evident, although the confidence intervals do not exclude it. As for the secondary endpoint of fatal and non-fatal cardiovascular events, there was no difference among the three groups in the overall population, although an increased incidence of non-fatal MI was seen for women and a decreased incidence of non-fatal MI was seen in males in the irbesartan group versus the placebobased regimen.
Maltese: Għall-endpoint sekondarju ta' każijiet kardjovaskulari fatali u mhux fatali, ma kienx hemm differenza bejn it-tlett gruppi tal-pazjenti fil-popolazzjoni totali, għalkemm inċidenza akbar ta' MI mhux fatali ġiet murija f nisa u inċidenza inqas ta' MI mhux fatali ġiet murija firġiel fil-grupp t'irbesartan kontra l-grupp ibbażat fuq il-plaċebo.
English: Lithium: the combination of lithium and Sabervel is not recommended (see section 4.5).
Maltese: Għaldaqstant, din it-taħlita mhix rakkomandata (ara sezzjoni 4.4).
English: Do not use Sabervel after the expiry date which is stated on the carton and on the blister after EXP.
Maltese: Tużax Sabervel wara d-data ta' skadenza li tidher fuq il-kartuna u fuq il-folja wara EXP.
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 tarriċetturi ta' angiotensin-II (AT1) jirriżulta f żidiet fil-livelli fil-plażma ta' renin u fil-livelli ta'
English: White, concave, round, film-coated tablet with 11 mm diameter.
Maltese: Bajda, konkavu, tonda, pillola miksija b'rita b'dijametru ta' 11mm.
English: Hypertension and type 2 diabetes with renal disease The “Irbesartan Diabetic Nephropathy Trial (IDNT)” shows that irbesartan decreases the progression of renal disease in patients with chronic renal insufficiency and overt proteinuria.
Maltese: L-istudju "Irbesartan u n-Nefropatija bid-Diabete (IDNT)" juri li irbesartan inaqqas il-progressjoni talmard renali fil-pazjenti b'insuffiċjenza renali kronika u b'proteinuria li tidher.
English: - an ACE-inhibitor (for example enalapril, lisinopril, ramipril), in particular if you have diabetes-related kidney problems.
Maltese: - inibitur ta' ACE (pereżempju enalapril, lisinopril, ramipril), b'mod partikulari jekk għandek problemi tal-kliewi relatati mad-dijabete. - aliskiren
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Sabervel” and “Warnings and precautions”).
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux> <Tużax> Sabervel” u “Twissijiet u prekawzjonijiet”)
English: 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 il-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: Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Maltese: Aktar informazzjoni dwar l-interazzjonijiet ta' irbesartan: fi studji kliniċi, il-farmakokinetika ta'
English: White, concave, round, film-coated tablet with 7 mm diameter.
Maltese: Bajda, konkavu, tonda, pillola miksija b'rita b'dijametru ta' 7mm.
English: - aliskiren
Maltese: takikardija
English: 6, Dervenakion str., 153 51 Pallini Attiki, Greece
Maltese: 6 Dervenakion str. 15351 Pallini Attiki
English: What Sabervel looks like and contents of the pack Sabervel 150 mg film-coated tablets are white, concave, round, film-coated tablets with 9 mm diameter.
Maltese: Id-dehra ta' Sabervel u l-kontenuti tal-pakkett Il-pilloli Sabervel 150 mg huma bojod, konkavi, tondi, pilloli miksija b'rita b'dijametru ta' 9 mm.
English: In diabetic hypertensive patients with microalbuminuria and normal renal function, orthostatic dizziness and orthostatic hypotension were reported in 0.5% of the patients (i.e., uncommon) but in excess of placebo.
Maltese: F'pazjenti dijabetiċi bi pressjoni għolja b'mikroalbuminuria u funzjoni normali tal-kliewi, sturdament ortostatiku u pressjoni baxxa ortostatika ġew irrapportati f0.5% tal-pazjenti (jiġifieri mhux komuni) iżda iżjed milli fil-grupp tal-plaċebo.