FrancophonIA/ELRC3.0 huggingface dataset:
English: Aluminium-Aluminium blisters : pack size of 30 tablets
Maltese: Folji tal-aluminju-aluminju : id-daqs tal-pakkett ta' 30 pillola
English: Cardiovascular prevention
Maltese: Prevenzjoni kardjovaskulari
English: When telmisartan was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed.
Maltese: Meta telmisartan kien mogħti flimkien ma' digoxin, ġew osservati żidiet medji fl-ogħla konċentrazzjonijiet fil-plażma (49%) u fil-konċentrazzjonijiet l-aktar baxxi (20%) ta' digoxin.
English: Telmisartan is metabolised by conjugation to the glucuronide of the parent compound.
Maltese: Telmisartan hu metabolat permezz ta' konjugazzjoni għal glucuronide.
English: Therefore it is not expected to potentiate bradykinin-mediated adverse effects.
Maltese: Għalhekk mhux mistenni li ssaħħaħ l-effetti avversi medjati minn bradykinin.
English: The concomitant use of Telmisartan Teva 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' Telmisartan Teva flimkien ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).
English: VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Maltese: NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: Ελλάδα Teva Ελλάς Α.Ε.
Maltese: M'hemmx dejta dwar l-użu ta' Telemisartan Teva f'nisa tqal.
English: Investigations Uncommon:
Maltese: Investigazzjonijiet Mhux komuni:
English: Plasma aldosterone levels are decreased by telmisartan.
Maltese: Il-livelli ta' aldosterone fil-plażma jitnaqqsu minn telmisartan.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Maltese: Telmisartan ma jinibixxix l-enzima li tibdel angiotensin (kininase II), l-enzima li tiddegrada wkoll bradykinin.
English: The antihypertensive efficacy of telmisartan is comparable to that of agents representative of other classes of antihypertensive medicinal products (demonstrated in clinical trials comparing telmisartan to amlodipine, atenolol, enalapril, hydrochlorothiazide, and lisinopril).
Maltese: dik ta' mediċini li jirrappreżentaw kategoriji oħrajn ta' mediċini anti-ipertensivi (dan intwera fi provi kliniċi li qabblu telmisartan ma' amlodipine, atenolol, enalapril, hydrochlorothiazide, u lisinopril).
English: A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate
Maltese: A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420) u magnesium stearate Kif jidher Telmisartan Teva u l-kontenut tal-pakkett
English: Sepsis including fatal outcome1
Maltese: Sepsis li tinkludi riżultat fatali1
English: TRANSCEND randomized ACE-I intolerant patients with otherwise similar inclusion criteria as ONTARGET to telmisartan 80 mg (n=2954) or placebo (n=2972), both given on top of standard care.
Maltese: TRANSCEND għażel b'mod każwali pazjenti li kienu intolleranti għal ACE-I u li mill-bqija kellhom kriterji tal-inklużjoni li kienu simili bħal dawk ta' ONTARGET għal telmisartan 80 mg (n=2954) jew plaċebo (n=2972), it-tnejn mogħtija b'mod addizzjonali mal-kura standard.
English: Povidone (PVP K-30) Sorbitol (E420)
Maltese: Povidone (PVP K-30) sorbitol (E420), magnesium stearate
English: Cmax and to a lesser extent AUC increase disproportionately at doses above 40 mg.
Maltese: Is-Cmax u, fi grad anqas l-AUC, jiżdiedu b'mod sproporzjonat f'dożi ta' aktar minn 40 mg.
English: The safety data from this study in patients aged 6 to < 18 years appeared generally similar to that observed in adults.
Maltese: Id-dejta tas-sigurtà minn dan l-istudju f'pazjenti ta' bejn 6 u < 18-il sena dehret li kienet ġeneralment simili għal dik osservati fl-adulti.
English: Corticosteroïds (systemic route) Reduction of the antihypertensive effect.
Maltese: Kortikosterojdi (rotta sistemika)
English: Hepatic function abnormal/liver disorder3
Maltese: Funzjoni epatika anormali/disturb fil-fwied3
English: • Amifostine (a protective medicine during radiotherapy for cancer treatment)
Maltese: • Amisofine (mediċina protettiva li tingħata waqt ir-radjuterapija għal pazjenti bil-kanċer) • Alkoħol
English: Muscoloskeletal and connective tissue disorders
Maltese: Disturbi muskolu-skelettriċi u tat-tessuti konnettivi
English: Tel: +(44) 1977 628 500
Maltese: United Kingdom Teva UK Limited Tel: +(44) 1977 628 500
English: By inclusion the presence of secondary hypertension was not investigated.
Maltese: B'inklużjoni, il-preżenza ta' pressjoni għolja sekondarja ma ġietx investigata.
English: Serious adverse drug reactions include anaphylactic reaction and angioedema which may occur rarely (≥1/10,000 to <1/1,000), and acute renal failure.
Maltese: Reazzjonijiet avversi serji tal-mediċina jinkludu reazzjoni anafilattika u anġjoedema li tista' sseħħ rarament (≥1/10,000 sa <1/1,000), u insuffiċjenza akuta tal-kliewi.
English: This is confirmed by trough to peak ratios consistently above 80 % seen after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies.
Maltese: 80% b'mod konsistenti, osservati wara li ngħataw dożi ta' 40 u 80 mg ta' telmisartan fi provi kliniċi b'telmisartan ikkontrollati bi plaċebo.
English: There was no evidence for benefit on cardiovascular mortality (hazard ratio 1.03, 95 % CI 0.85 - 1.24).
Maltese: Ma kien hemm l-ebda evidenza ta' benefiċċju fuq mortalità kardjovaskulari (proporzjon ta' periklu ta' 1.03, 95% CI 0.85
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Maltese: Uġigħ addominali, dijarea, dispepsja, gass, rimettar
English: Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara “EXP”.
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets 30 tablets
Maltese: 14x1 pilloli 28x1 pilloli 30x1 pilloli 40x1 pilloli 56x1 pilloli 60x1 pilloli 84x1 pilloli 90x1 pilloli 98x1 pilloli 100x1 pilloli 30 pillola
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for peelable perforated blisters.
Maltese: Daqsijiet tal-pakketti ta' 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 pillola għal folji perforati li jistgħu jitqaxxru.
English: Whilst there is no controlled epidemiological data on the risk with angiotensin II receptor antagonists, similar risks may exist for this class of drugs.
Maltese: Filwaqt li m'hemm l-ebda dejta epidemjoloġika kkontrollata fuq ir-riskju b'antagonisti tar-riċetturi ta' angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il-klassi ta' mediċini.
English: Total plasma clearance (Cltot) is high (approximately 1,000 ml/min) compared with hepatic blood flow (about 1,500 ml/min).
Maltese: It-tneħħija totali mill-plażma (Cltot) hi għolja (madwar 1,000 ml/min) meta mqabbla mal-fluss tad-demm epatiku (madwar 1,500 ml/min).
English: Telmisartan Teva is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Telmisartan Teva hu kontraindikat f'pazjenti b'indeboliment serju tal-fwied (ara sezzjoni 4.3).
English: LIST OF EXCIPIENTS Contains sorbitol (E420).
Maltese: TA' EĊĊIPJENTI Fih sorbitol (E420).
English: Telmisartan does not inhibit human plasma renin or block ion channels.
Maltese: Telmisartan ma jinibixxix ir-renina fil-plażma umana jew jimblokka l-kanali tal-joni.
English: Each Telmisartan Teva tablet contains 40 mg telmisartan.
Maltese: Kull pillola ta' Telmisartan Teva fiha, 40 mg telmisartan.
English: Pharmacokinetic objectives included the determination of the steady-state of telmisartan in children and adolescents, and investigation of age-related differences.
Maltese: L-objettivi farmakokinetiċi inkludew id-determinazzjoni tal-istat fiss ta' telmisartan fit-tfal u l-adoloxxenti, u investigazzjoni tad-differenzi relatati mal-età.
English: INFORMATION IN BRAILLE Telmisartan Teva 20 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Telemisartan Teva 20 mg
English: 14x1 tablets 28x1 tablets 30x1 tablets 40x1 tablets 56x1 tablets 60x1 tablets 84x1 tablets 90x1 tablets 98x1 tablets 100x1 tablets
Maltese: 14x1 pilloli 28x1 pilloli 30x1 pilloli 40x1 pilloli 56x1 pilloli 60x1 pilloli 84x1 pilloli 90x1 pilloli 98x1 pilloli 100x1 pilloli
English: INFORMATION IN BRAILLE Telmisartan Teva 40 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Telemisartan Teva 40 mg
English: Pack sizes of 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 tablets for perforated blisters.
Maltese: Daqsijiet tal-pakketti ta' 14x1, 28x1, 30x1, 40x1, 56x1, 60x1, 84x1, 90x1, 98x1, 100x1 pillola għal folji perforati.
English: Concomitant use requiring caution
Maltese: Rappurtar ta' reazzjonijiet avversi suspettati
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 filfunzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Maltese: Studji farmakokinetiċi f'pazjenti b'indeboliment epatiku juru żieda fil-bijodisponibilità assoluta sa kważi
English: Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
Maltese: Dejta disponibbli hi deskritta fis-sezzjoni 5.1 u 5.2 imma l-ebda rakkomandazzjoni dwar il-pożoloġija ma tista' tingħata.
English: INFORMATION IN BRAILLE Telmisartan Teva 80 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Telemisartan Teva 80 mg
English: Telmisartan Teva 40 mg Tablets Telmisartan
Maltese: Telmisartan Teva 40 mg pilloli telmisartan
English: Telmisartan Teva 20 mg Tablets Telmisartan
Maltese: Telmisartan Teva 20 mg pilloli telmisartan
English: Telmisartan Teva 80 mg Tablets Telmisartan
Maltese: Telmisartan Teva 80 mg pilloli telmisartan
English: At the beginning of the preventive therapy with Telmisartan Teva 80 mg, blood pressure should be frequently monitored.
Maltese: Fil-bidu tat-terapija preventiva b'Telmisartan Teva 80mg, il-pressjoni tad-demm għandha tiġi mmonitorjata ta' spiss.
English: • manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke, or peripheral arterial disease) or
Maltese: • mard kardjovaskulari aterotrombotiku sintomatiku (storja medika ta' mard koronarju tal-qalb, puplesija, jew mard arterjali periferali) jew
English: ONTARGET (ONgoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial) compared the effects of telmisartan, ramipril and the combination of telmisartan and ramipril on cardiovascular outcomes in 25620 patients aged 55 years or older with a history of coronary artery disease, stroke, TIA, peripheral arterial disease, or type 2 diabetes mellitus accompanied by evidence of end-organ damage (e.g. retinopathy, left ventricular hypertrophy, macro- or microalbuminuria), which is a population at risk for cardiovascular events.
Maltese: qabbel l-effetti ta' telmisartan, ramipril u t-taħlita ta' telmisartan u ramipril fuq riżultati kardjovaskulari f'25620 pazjent li kellhom 55 sena jew aktar, ma' storja medika ta' mard arterjali koronarju, puplesija, TIA, mard arterjali periferali, jew dijabete mellitus ta' tip 2 akkompanjat minn evidenza ta' ħsara fl-organi fil-mira (eż. retinopatija, ipertrofija ventrikulari tax-xellug, makro- jew mikroalbuminurija), li hi popolazzjoni f'riskju għal avvenimenti kardjovaskulari.
English: The listing also takes into account serious adverse reactions and adverse reactions leading to discontinuation reported in three clinical long-term studies including 21,642 patients treated with telmisartan for the reduction of cardiovascular morbidity for up to six years.
Maltese: Il-lista tikkunsidra wkoll reazzjonijiet avversi serji u reazzjonijiet avversi li jwasslu għal twaqqif tal-mediċina rrappurtat fi tliet studji kliniċi fit-tul li kienu jinkludu 21,642 pazjent ikkurati b'telmisartan għat-tnaqqis ta' morbożità kardjovaskulari għal sa sitt snin.
English: NSAIDs (i.e. acetylsalicylic acid at anti-inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the antihypertensive effect of angiotensin II receptor antagonists.
Maltese: NSAIDs (i.e. acetylsalicylic acid f'korsijiet tad-dożaġġ kontra l-infjammazzjoni, inibituri COX-2 u NSAIDs mhux selettivi) jistgħu jnaqqsu l-effett kontra l-pressjoni għolja tal-antagonisti ta' angiotensin II.
English: Haemoglobin decreased, blood uric acid increased, hepatic enzyme increased, blood creatine phosphokinase increased
Maltese: żieda fil-livelli tal-uric acid, żieda fl-enzimi epatiċi jew ta' creatine phosphokinase fid-demm.
English: Potassium sparing diuretics e.g. spironolactone, eplerenone, triamterene, or amiloride, potassium supplements, or potassium-containing salt substitutes may lead to a significant increase in serum potassium.
Maltese: Dijuretiċi li jirristringu t-tnixxija ta' potassju, eż. spironolactone, eplerenone, triamterene, jew amiloride, supplimenti tal-potassju, jew sostituti tal-melħ li fihom il-potassju jistgħu jwasslu għal żieda sinifikanti fil potassju fis-serum.
English: There was no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Maltese: Ma kien hemm l-ebda evidenza ta' mutaġeniċità u ta' attività klastoġenika rilevanti fi studji in vitro, u l-ebda evidenza ta' karċinoġeneċità fil-firien u fil-ġrieden.
English: Hepato-biliary disorders Rare:
Maltese: Disturbi fil-fwied u fil-marrara Rari:
English: Vascular disorders Uncommon:
Maltese: Disturbi vaskulari Mhux komuni:
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Maltese: Il-medja tal-istat fiss apparenti tal-volum tad-distribuzzjoni (Vdss) hija ta' madwar 500 l.
English: Telmisartan Teva contains sorbitol.
Maltese: Telmisartan Teva fih is-sorbitol
English: • if you are taking digoxin.
Maltese: • jekk qed tieħu digoxin.
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience these side effects), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Maltese: tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi, tħossok ansjuż/a, ngħas, indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb (takikardija), ħalq xott, stonku mqalleb, disturb fis-sens tat-togħma (disgwesja), funzjoni anormali tal-fwied, (hemm aktar ċans li pazjenti Ġappuniżi jkollhom dawn l-effetti sekondarji), ekżema (disturb tal-ġilda), ħmura talġilda, urtikarja (ħorriqija), raxx sever minħabba l-mediċina, uġigħ fil-gogi (artralġja), uġigħ fl estremitajiet, uġigħ fit-tendini, mard li jixbah l-influwenza, tnaqqis fl-emoglobina (proteina fid-demm),
English: This medicinal product contains sorbitol (E420).
Maltese: Dan il-prodott mediċinali fih sorbitol (E420).
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
Maltese: Dijuretiċi (thiazide jew dijuretiċi loop) Trattament minn qabel b'dożi qawwija ta' dijuretiċi bħal furosemide (dijuretiku loop) u hydrochlorothiazide (dijuretiku tat-thiazide) jista' jirriżulta fi tnaqqis tal-volum, u f'riskju ta' pressjoni tad-demm baxxa ħafna meta tinbeda t-terapija b'telmisartan.
English: In some of the investigated patients the doses used were higher than those recommended in the treatment of hypertension in the adult population, reaching a daily dose comparable to160 mg, which was tested in adults.
Maltese: F'xi pazjenti investigati, id-dożi użati kienu ogħla minn dawk rakkomandati fil-kura tal pressjoni għolja fil-popolazzjoni adulta, li laħqu doża ta' kuljum komparabbli għal 160 mg, li ġiet ittestjata fl-adulti.
English: Hypotension
Maltese: Fertilità
English: In the “Prevention Regimen For Effectively avoiding Second Strokes” (PRoFESS) trial in patients 50 years and older, who recently experienced stroke, an increased incidence of sepsis was noted for telmisartan compared with placebo, 0.70 % vs. 0.49 % [RR 1.43 (95 % confidence interval 1.00 - 2.06)]; the incidence of fatal sepsis cases was increased for patients taking telmisartan (0.33 %) vs. patients taking placebo (0.16 %) [RR 2.07 (95 % confidence interval 1.14 - 3.76)].
Maltese: [RR 1.43 (95 % interval ta' kunfidenza 1.00 - 2.06)]: l-inċidenza ta' każijiet fatali ta' sepsis żdiedet għal pazjenti li kienu qed jieħdu telmisartan (0.33 %) kontra pazjenti li kienu qed jieħdu l-plaċebo (0.16 %)
English: Urinary tract infections, upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Maltese: (dipressjoni), ħass ħażin (sinkope), diffikultà biex torqod, sensazzjoni li kollox qed idur bik (sturdament), taħbit tal-qalb bil-mod (bradikardija), pressjoni tad-demm baxxa (ipotensjoni) f'persuni kkurati għal pressjoni tad-demm għolja, sturdament meta wieħed iqum bilwieqfa (ipotensjoni ortostatika), qtugħ ta' nifs, sogħla, uġigħ ta' żaqq, dijarea, skonfort fiż-żaqq, nefħa fiż-żaqq, rimettar, ħakk, żieda fl-għaraq, ħakk, raxx minħabba l-mediċina, uġigħ fid-dahar, bugħawwieġ fil-muskoli, uġigħ fil-muskoli (majalġja), uġigħ fid-dahar, bugħawwieġ fil-muskoli, indeboliment fil-kliewi li jinkludi insuffiċjenza akuta tal-kliewi, uġigħ fis-sider, sensazzjoni ta' dgħufija, u żieda fil-livell ta' krejatinina fid-demm.
English: Metabolism and nutrition disorders Uncommon
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni:
English: The pharmacokinetics of two doses of telmisartan were assessed as a secondary objective in hypertensive patients (n = 57) aged 6 to < 18 years after taking telmisartan 1 mg/kg or 2 mg/kg over a four-week treatment period.
Maltese: Il-farmakokinetiċi taż-żewġ dożi ta' telmisartan ġew ivvalutati bħala objettiv sekondarju f'pazjenti bi pressjoni għolja (n = 57) li kellhom bejn 6 snin sa < 18-il sena, wara li ħadu telmisartan 1 mg/kg jew 2 mg/kg fuq perjodu ta' kura ta' erba' ġimgħat.
English: Each Telmisartan Teva tablet contains 20 mg telmisartan.
Maltese: Kull pillola ta' Telmisartan Teva fiha 20 mg telmisartan.
English: In preclinical safety studies, doses producing exposure comparable to that in the clinical therapeutic range caused reduced red cell parameters (erythrocytes, haemoglobin, haematocrit), changes in renal haemodynamics (increased blood urea nitrogen and creatinine), as well as increased serum potassium in normotensive animals.
Maltese: emoglobina, ematokrit), u bidliet fl-emodinamiċi renali (żieda fin-nitrogen tal-urea u l-kreatinina fiddemm), kif ukoll żieda tal-potassju fis-serum f'annimali normotensivi.
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41.4% vs 43.9 %) in controlled trials in patients treated for hypertension.
Maltese: L-inċidenza ta' reazzjonijiet avversi rrappurtati b'telmisartan kienet ġeneralment komparabbli mal-plaċebo (41.4% vs 43.9%) fil-provi kkontrollati f'pazjenti kkurati għal pressjoni għolja .
English: The use of medicinal products that affect the renin-angiotensin-aldosterone system may cause hyperkalaemia.
Maltese: L-użu ta' prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone, jista' jikkawża iperkalemija.
English: • Barbiturates (strong sleeping tablets)
Maltese: • Barbiturati (pilloli tal-irqad qawwija)
English: In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function), the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
Maltese: F'xi pazjenti li għandhom il-funzjoni renali kompromessa (eż. pazjenti deidratati jew pazjenti anzjani b'funzjoni renali kompromessa), l-għoti flimkien ta' antagonisti ta' angiotensin II u mediċini li jinibixxu cyclo-oxygenase, jista' jirriżulta f'deterjorament addizzjonali tal-funzjoni renali, li jinkludi l-possibbiltà ta' insuffiċjenza akuta renali, li normalment tkun riversibbli.
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Maltese: Prodotti mediċinali jew klassi terapewtika ta' prodotti mediċinali li jistgħu jikkawżaw l-iperkalemija: sostituti tal-melħ li fihom il-potassju, dijuretiċi li ma jneħħux potassju, inibituri ta' ACE, antagonisti tar-riċetturi ta' angiotensin II, mediċini mhux sterojdi kontra l-infjammazzjoni (li jinkludu inibituri COX-2 selettivi), eparina, immunosoppressur (cyclosporin jew tacrolimus), trimethoprim.
English: As with other medicinal products acting on the renin-angiotensin-aldosterone system, telmisartan may provoke hyperkalaemia (see section 4.4).
Maltese: telemisartan jista' jipprovoka iperkalemija (ara sezzjoni 4.4).
English: The other side of the tablet is debossed with the number "7458".
Maltese: Fuq naħa oħra hemm intaljat il-kodiċi ”7458”.
English: • Narcotics (strong pain killers)
Maltese: • Narkotiċi (pilloli qawwija kontra l-uġigħ)