FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will check the phosphate level in your blood and urine and may also do a renal ultrasound during your treatment in order to reduce the risk of hyperphosphataemia (too much phosphate in the blood) and ectopic mineralisation (a build up of calcium in tissues such as the kidneys).
Maltese: It-tabib tiegħek se jiċċekkja l-livell ta' phosphate fid-demm u fl-awrina tiegħek u jista' wkoll jagħmel ultrasound tal-kliewi matul it-trattament tiegħek sabiex jitnaqqas ir-riskju ta' iperfosfatimija (phosphate żejjed fid-demm) u mineralizzazzjoni ektopika (akkumulazzjoni ta' calcium fit-tessuti, bħalma huma l-kliewi).
English: • If you get any side effects, talk to your doctor.
Maltese: • Jekk ikollok aktar mistoqsijiet, staqsi lit-tabib tiegħek.
English: • you are allergic to burosumab or any of the other ingredients of this medicine (listed in section 6)
Maltese: • inti allerġiku għal burosumab jew għal xi sustanza oħra ta' din il-mediċina (imniżżla fissezzjoni 6)
English: Dizziness
Maltese: INDIVIDWALI
English: This conventional therapy was discontinued 2-6 weeks prior burosumab initiation.
Maltese: Din it-terapija konvenzjonali twaqqfet minn ġimagħtejn sa 6 ġimgħat qabel il-bidu ta' burosumab.
English: In the paediatric studies, approximately 57% of the patients had an injection site reaction.
Maltese: Fl-istudji fuq pazjenti pedjatriċi, madwar 57% tal-pazjenti kellhom reazzjoni fis-sit tal-injezzjoni.
English: To decrease the risk for ectopic mineralisation, it is recommended that fasting serum phosphate is targeted in the lower end of the normal reference range for age.
Maltese: Biex tnaqqas ir-riskju għal mineralizzazzjoni ektopika, hu rakkomandat li lphosphate fis-serum waqt is-sawm ikollu mira fit-tarf t'isfel tal-medda normali ta' referenza għall-età.
English: Each vial contains 10 mg burosumab in 1 ml of solution.
Maltese: Kull kunjett fih 10 mg ta' burosumab f'1 ml ta' soluzzjoni.
English: CRYSVITA 10 mg solution for injection
Maltese: U KWANTITATTIVA CRYSVITA 10 mg soluzzjoni għall-injezzjoni
English: LS Mean change (SE) from baseline in total score a
Maltese: SD 1.87) b'XLH, ġew ittrattati għal 64 ġimgħa.
English: The positive change in the RGI-C score reflects resolution of the x-ray appearance of rickets.
Maltese: Impressjoni Globali Radjografika tal-Bidla (RGI-C, Radiographic Global Impression of Change)
English: The European Medicines Agency has deferred the obligation to submit the results of studies with CRYSVITA in one or more subsets of the paediatric population in treatment of X-linked hypophosphataemia.
Maltese: L-għoti flimkien ta' dawn il-prodotti mediċinali ma ġiex studjat fil-provi kliniċi u jista' potenzjalment iħarrax l-ipokalċimija.
English: Do not use CRYSVITA after the expiry date which is stated on the carton and label.
Maltese: Tużax CRYSVITA wara d-data ta' meta tiskadi li tidher fuq il-kartuna u t-tikketta.
English: The maximum dose is 90 mg. All doses should be rounded to the nearest 10 mg.
Maltese: Id-doża massima hija ta' 90 mg.
English: Its metabolism and elimination are expected to follow the immunoglobulin clearance pathways, resulting in degradation to small peptides and individual amino acids.
Maltese: Il-metaboliżmu u leliminazzjoni tiegħu huma mistennija li jsegwu l-passaġġi tat-tneħħija tal-immunoglobulina, li tirriżulta fid-degradazzjoni ta' peptides żgħar u amino acids individwali.
English: Each vial contains 20 mg of burosumab in 1 ml solution.
Maltese: Kull kunjett fih 20 mg ta' burosumab f'soluzzjoni ta' 1 mL.
English: For handling of burosumab before administration, see section 6.6.
Maltese: Għal istruzzjonijiet fuq l-immaniġġjar ta' burosumab qabel jingħata, ara sezzjoni 6.6. 4.3 Kontraindikazzjonijiet
English: Clear to slightly opalescent, colourless to pale brownish-yellowish solution.
Maltese: Inti tista' tgħin billi tirrapporta kwalunkwe effett sekondarju li jista' jkollok.
English: The active substance in Duloxetine Sandoz, duloxetine, is a serotonin-noradrenaline re-uptake inhibitor.
Maltese: Is-sustanza attiva f'Duloxetine Sandoz, duloxetine, hija inibitur tal-assorbiment mill-ġdid ta' serotonin u ta' noradrenaline.
English: What is Duloxetine Sandoz?
Maltese: X'inhu Duloxetine Sandoz?
English: Duloxetine Sandoz is a medicine that contains the active substance duloxetine.
Maltese: Duloxetine Sandoz huwa mediċina li fiha s-sustanza attiva duloxetine.
English: On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Maltese: Fit-8 ta' April 2015, Sandoz GmbH għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni tagħha għall-awtorizzazzjoni għat-tqegħid fis-suq għal Duloxetine Sandoz, għall-kura ta' dipressjoni, uġigħ fin-nervituri dijabetiċi u disturb ta' ansjetà ġeneralizzata.
English: It was to be available as gastroresistant capsules (capsules whose contents are not broken down in the stomach and release the medicine in the intestine) containing 30 or 60 mg of duloxetine.
Maltese: Kellu jkun disponibbli bħala kapsuli gastroreżistenti (kapsuli li l-kontenut tagħhom ma jitkissirx fl-istonku u li jerħu l-mediċina filmusrana) li fihom 30 jew 60 mg ta' duloxetine.
English: Duloxetine Sandoz was developed as a ‘generic medicine'.
Maltese: Duloxetine Sandoz kien żviluppat bħala "mediċina ġenerika".
English: Because Duloxetine Sandoz is a generic medicine, the company had presented results of tests to determine that Duloxetine Sandoz is bioequivalent to the reference medicine, Cymbalta.
Maltese: Peress li Duloxetine Sandoz huwa mediċina ġenerika, il-kumpanija kienet ippreżentat riżultati ta' testijiet biex tiddetermina li Duloxetine Sandoz huwa bijoekwivalenti għall-mediċina ta' referenza, Cymbalta.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns about whether the two studies conducted to show bioequivalence between the medicine and the reference product had been carried out in accordance with guidelines for Good Clinical Practice (GCP) and was of the provisional opinion that Duloxetine Sandoz could not have been approved for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.
Maltese: Abbażi tar-reviżjoni tad-dejta, meta sar l-irtirar, is-CHMP kellu xi tħassib dwar jekk iż-żewġ studji li saru biex juru bijoekwivalenza bejn il-mediċina u l-prodott ta' referenza twettqux skont il-linji gwida għall-Prassi Klinika Tajba (PKT) u kien tal-opinjoni provviżorja li Duloxetine Sandoz ma setax jiġi approvat għall-kura ta' dipressjoni, uġigħ fin-nervituri dijabetiċi u disturb ta' ansjetà ġeneralizzata.
English: This means that Duloxetine Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Cymbalta.
Maltese: Dan ifisser li Duloxetine Sandoz jixbah lill‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) magħrufa bħala Cymbalta.
English: Duloxetine Sandoz was to be used to treat major depression, pain due to diabetic peripheral neuropathy (damage to the nerves in the extremities that can occur in patients with diabetes) and generalised anxiety disorder (long-term anxiety or nervousness about everyday matters).
Maltese: Duloxetine Sandoz kellu jintuża biex jikkura dipressjoni maġġuri, uġigħ minħabba newropatija dijabetika periferika (ħsara fin-nervituri fl-estremitajiet li tista' sseħħ f'pazjenti bid-dijabete) u disturb ta' ansjetà ġeneralizzata (ansjetà fit-tul jew nervożiżmu minħabba kwistjonijiet ta' kuljum).
English: How is Duloxetine Sandoz expected to work?
Maltese: Għal xiex kien mistenni li jintuża Duloxetine Sandoz?
English: ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ & ΥΙΟΣ Ε.Π.Ε.
Maltese: ΑΚΗΣ ΠΑΝΑΓΙΩΤΟΥ &
English: 56 x 1 tablets:
Maltese: 56 x 1 pillola:
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION Date of first authorisation: 19 January 2007
Maltese: DATA TA' L-EWWEL AWTORIZZAZZJONI/TIĠDID TA' L-AWTORIZZAZZJONI Data ta' l-ewwel awtorizzazzjoni: 19 ta' Jannar 2007
English: Uxbridge UB8 1DH - United Kingdom
Maltese: Uxbridge UB8 1DH - Ir-Renju Unit
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - United Kingdom
Maltese: Newcastle Upon Tyne, Tyne & Wear NE3 3TT - Ir-Renju Unit
English: very common (≥ 1/10); common (≥ 1/100, < 1/10); uncommon (≥ 1/1,000, < 1/100); rare (≥ 1/10,000, < 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, < 1/10); mhux komuni (≥ 1/1,000, < 1/100); rari (≥ 1/10,000, < 1/1,000); rari ħafna (< 1/10,000).
English: SANOFI SYNTHELABO LIMITED Edgefield Avenue - Fawdon
Maltese: SYNTHELABO LIMITED Edgefield Avenue - Fawdon
English: Newcastle Upon Tyne, Tyne & Wear NE3 3TT United Kingdom
Maltese: Newcastle Upon Tyne, Tyne & Wear NE3 3TT Ir-Renju Unit
English: IDNT was a double blind, controlled, morbidity and mortality trial comparing Irbesartan BMS, amlodipine and placebo.
Maltese: IDNT kienet prova double blind, ikkontrollata, ta' morbożità u mortalità li qabblet Irbesartan BMS, amlodipine u plaċebo.
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: 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: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 84 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 56 pillola 56 X 1 pilloli 84 pillola 98 pillola
English: 14 tablets 28 tablets 56 tablets 56 x 1 tablets 98 tablets
Maltese: 14-il pillola 28 pillola 56 pillola 56 X 1 pillola 98 pillola
English: The total body and renal clearance are 157-176 and 3-3.5 ml/min, respectively.
Maltese: It-tneħħija millġisem kollu u renali huma 157-176 u 3-3.5 ml/min, rispettivament.
English: The other ingredients are lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
Maltese: Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, hypromellose, silicon dioxide, magnesium stearate, titanium dioxide, macrogol 3000, carnauba wax.
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, disa' t-itfal ta' bejn 6 u 12-il sena).
English: INFORMATION IN BRAILLE Irbesartan BMS 75 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan BMS 75 mg
English: Lithium: the combination of lithium and Irbesartan BMS is not recommended (see section 4.5).
Maltese: Lithium: it-taħlit ta' litju u Irbesartan BMS mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Regression to normoalbuminuria (< 30 mg/day) was more frequent in the Irbesartan BMS 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 BMS 300 mg (34%) milli filgrupp tal-plaċebo (21%).
English: Uncommon: flushing
Maltese: Mhux komuni: fwawar
English: INFORMATION IN BRAILLE Irbesartan BMS 300 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan BMS 300 mg
English: Paediatric patients: in a randomised trial of 318 hypertensive children and adolescents aged 6 to 16 years, the following related adverse events occurred in the 3-week double-blind phase: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%).
Maltese: Pazjenti pedjatriċi: fi prova randomised ta' 318-il tifel u tifla bi pressjoni għolja u adoloxxenti ta' bejn is-6 u s-16-il sena, dawn l-effetti avversi relatati li ġejjin ġraw fil-fażi ta' tliet ġimgħat doubleblind: uġigħ ta' ras (7.9%), pressjoni baxxa (2.2%), sturdament (1.9%), sogħla (0.9%).
English: INFORMATION IN BRAILLE Irbesartan BMS 150 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Irbesartan BMS 150 mg
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 it-tnaqqis tal-pressjoni kien 60%-70% ta' logħla rispons fid-diastolika u sistolika bid-dożi rrikmandati.
English: LIST OF EXCIPIENTS Excipients: also contains lactose monohydrate.
Maltese: LISTA TA' SUSTANZI MHUX ATTIVI Sustanzi mhux attivi: fih ukoll lactose monohydrate.
English: BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI KFT.
Maltese: BRISTOL-MYERS SQUIBB GYÓGYSZERKERESKEDELMI
English: Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website ta' l-Aġenzija Ewropea dwar ilmediċini (EMEA) http://www.emea.europa.eu/
English: Patients were titrated from 75 mg to a maintenance dose of 300 mg Irbesartan BMS, 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 BMS, minn 2.5 mg għal 10 mg ta' amlodipine, jew plaċebo skond kemm felħu.
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 ta' l-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: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 75 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha: irbesartan 75 mg
English: Reproductive system and breast disorders: Uncommon: sexual dysfunction
Maltese: Disturbi fis-sistema riproduttiva u fis-sider: Mhux komuni: disfunzjoni sesswali
English: Irbesartan significantly reduced the relative risk in the primary combined endpoint of doubling serum creatinine, end-stage renal disease (ESRD) or all-cause mortality.
Maltese: Irbesartan b'mod sinifikattiv naqqas ir-riskju relattiv fl-endpoint primarju kombinat fejn il-krejatinina fis-serum tirdoppja, mard renali fl-aħħar stadju (ESRD) jew mortalità millkawżi kollha.
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) talpazjenti fil-grupp li ħadu 300 mg ta' irbesartan u fi 22% tal-pazjenti fil-grupp talplaċebo.
English: Excipient: 102.00 mg of lactose monohydrate per film-coated tablet.
Maltese: 102.00 mg ta' lactose monohydrate kull pillola.
English: BRISTOL-MYERS SQUIBB GMBH & CO. KGAA
Maltese: BRISTOL-MYERS SQUIBB GMBH & CO.
English: HOW TO TAKE IRBESARTAN BMS
Maltese: X'fih Irbesartan BMS
English: Excipient: 30.75 mg of lactose monohydrate per tablet.
Maltese: Sustanza mhux attiva: 30.75 mg ta' lactose monohydrate kull pillola.
English: The other ingredients are microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, and poloxamer 188.
Maltese: Is-sustanzi l-oħra huma microcrystalline cellulose, croscarmellose sodium, lactose monohydrate, magnesium stearate, colloidal hydrated silica, pregelatinised maize starch, u poloxamer 188.
English: The study examined the long-term effects (2 years) of Irbesartan BMS 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: L-istudju eżamina l-effetti fit-tul (sentejn) ta' Irbesartan BMS 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 ta' l-inqas 30% mill-linja bażi).
English: Irbesartan BMS belongs to a group of medicines known as angiotensin-II receptor antagonists.
Maltese: Irbesartan BMS jappartjeni għall-grupp ta' mediċini magħrufa bħala antagonisti tar-riċetturi angiotensin-II.
English: While this is not documented with Irbesartan BMS, a similar effect should be anticipated with angiotensin-II receptor antagonists.
Maltese: Għalkemm m'hemm xejn dokumentat li dan isir b'Irbesartan BMS, effetti simili għandhom ikunu antiċipati b'antagonisti tar-riċetturi angiotensin-II.
English: Thu
Maltese: KFT.
English: Uncommon: diarrhoea, dyspepsia/heartburn
Maltese: Mhux komuni: dijarea, dispepsja/qrusa fl-istonku
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 150 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha: irbesartan 150 mg
English: The following additional adverse reactions have been reported during post-marketing experience; they are derived from spontaneous reports and therefore, the frequency of these adverse reactions is not known:
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew irrappurtati waqt l-esperjenza ta' wara t-tqegħid fis-suq; ittieħdu minn rapporti spontanji u għalhekk, il-frekwenza ta' dawn ir-reazzjonijiet avversi mhix magħrufa:
English: Renal and urinary disorders: Impaired renal function including cases of renal failure in patients at risk (see section 4.4)
Maltese: Indeboliment renali li jinkudi każijiet ta' insuffiċjenza renali f'pazjenti f'riskju (ara sezzjoni 4.4)
English: Irbesartan AUC and Cmax values were also somewhat greater in elderly 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 anzjani (≥ 65 -il sena) milli f'individwi żgħar (18-40 sena).
English: Excipient: 61.50 mg of lactose monohydrate per tablet.
Maltese: Sustanza mhux attiva: 61.50 mg ta' lactose monohydrate kull pillola.
English: Metabolism and nutrition disorders: Hyperkalaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains: irbesartan 300 mg
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha: irbesartan 300 mg
English: Cardiac disorders: Uncommon: tachycardia
Maltese: Disturbi fil-qalb: Mhux komuni: takikardija
English: Paediatric patients: irbesartan is not recommended for use in children and adolescents due to insufficient data on safety and efficacy (see sections 4.8, 5.1 and 5.2).
Maltese: Pazjenti pedjatriċi: irbesartan mhux irrakkomandat għall-użu fit-tfal u l-addoloxxenti peress li m'hemmx biżżejjed informazzjoni dwar is-sigurtà u l-effikaċja (ara sezzjonijiet 4.8, 5.1 u 5.2).
English: Diuretics and other antihypertensive agents: other antihypertensive agents may increase the hypotensive effects of irbesartan; however Irbesartan BMS has been safely administered with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics.
Maltese: Dijuretiċi u mediċini oħra kontra l-pressjoni għolja: mediċini oħra kontra l-pressjoni għolja jistgħu jżidu l-effetti ta' tnaqqis fil-pressjoni ta' irbesartan; madankollu Irbesartan BMS ingħata mingħajr periklu ma' mediċini oħra ta' kontra l-pressjoni għolja, bħal beta-blockers, imblokkaturi tal-kanali ta' calcium li jaħdmu fit-tul, u dijuretiċi thiazides.
English: General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-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.
Maltese: Ġenerali: f'pazjenti li għandhom it-ton vaskulari u l-funzjoni renali tagħhom jiddependu l-aktar millattività tas-sistema renin-angiotesin-aldosterone (p.e. pazjenti li jbatu minn insuffiċjenza tal-qalb konġestiva jew mard renali, inkluż stenosi ta' l-arterja renali), il-kura b'inibituri ta' enzimi li jikkonvertu angiotensin jew antagonisti tar-riċetturi t' angiotensin-II li jaffettwaw din is-sistema ġew assoċjati ma' pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza akuta renali.
English: Common: dizziness, feeling sick/vomiting, fatigue and blood tests may show raised levels of an enzyme that measures the muscle and heart function (creatine kinase enzyme).
Maltese: Komuni: sturdament, dardir/rimettar u għeja u testijiet tad-demm jistgħu juru livelli ogħla ta' enzim li jkejjel il-funzjoni tal-muskolu u tal-qalb (enzim ta' creatine kinase).
English: Cartons of 56 x 1 film-coated tablet; 7 blister cards of 8 x 1 film-coated tablet each in PVC/PVDC/Aluminium perforated unit dose blisters.
Maltese: Pakketti ta' 56 x 1 pillola; 7 kards ta' folji ta' 8 x 1 pilloli kull waħda f'folji perforati talPVC/PVDC/Aluminju ta' doża waħda.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 75 mg tablets.
Maltese: Irbesartan BMS 75 mg pilloli.
English: NAME OF THE MARKETING AUTHORISATION HOLDER BRISTOL-MYERS SQUIBB PHARMA EEIG
Maltese: FIS-SUQ BRISTOL-MYERS SQUIBB PHARMA EEIG
English: Hyperkalaemia: as with other medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur during the treatment with Irbesartan BMS, especially in the presence of renal impairment, overt proteinuria due to diabetic renal disease, and/or heart failure.
Maltese: Iperkalimja: bħalma jiġri bi prodotti mediċinali oħra li jaffettwaw is-sistema ta' renin-angiotensinaldosterone, iperkalimja tista' sseħħ waqt il-kura b'Irbesartan BMS, speċjalment fil-preżenza t'indeboliment renali, proteinuria ovvja minħabba mard renali dovut għad-dijabete, u/jew insuffiċjenza tal-qalb.
English: These undesirable effects are: headache, taste disturbance, ringing in the ears, muscle cramps, pain in joints and muscles, abnormal liver function, increased blood potassium levels, impaired kidney function, and inflammation of small blood vessels mainly affecting the skin (a condition known as leukocytoclastic vasculitis).
Maltese: Dawn l-effetti mhux mixtieqa huma: uġigħ ta' ras, disturbi fit-togħma, żarżir fil-widnejn, bugħawwieġ, uġigħ fil-ġogi u fil-muskoli, funzjoni tal-fwied anormali, livelli għoljin ta' potassium fid-demm, funzjoni tal-kliewi indebolita, u infjammazzjoni tal-vini ż-żgħar li taffettwa l-ġilda (kundizzjoni magħrufa bħala leukocytoclastic vasculitis).
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 150 mg tablets irbesartan
Maltese: Irbesartan BMS 150 mg pilloli irbesartan
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: Each tablet of Irbesartan BMS 300 mg contains 300 mg irbesartan.
Maltese: Kull pillola ta' Irbesartan BMS 300 mg fiha 300 mg ta' irbesartan.
English: NAME OF THE MEDICINAL PRODUCT Irbesartan BMS 300 mg tablets.
Maltese: Irbesartan BMS 300 mg pilloli.