FrancophonIA/ELRC3.0 huggingface dataset:
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 14, 28, 56, 98 tablets or aluminium/aluminium perforated unit dose blisters (PA/Al/PVC/Al) in a carton containing 30 x 1, 90 x 1 tablets and multipacks containing 360 (4 packs of 90 x 1) tablets.
Maltese: Folji tal-aluminju/aluminju (PA/Al/PVC/Al) f'kaxxa tal-kartun li jkun fiha 14, 28, 56, 98 pillola jew folji perforati tal-aluminju/aluminju bl-unità tad-doża (PA/Al/PVC/Al) f'kaxxa tal-kartun li jkun fiha 30 x 1, 90 x 1 pillola u pakketti multipli li jkun fihom 360 (4 pakketti ta' 90 x 1) pillola.
English: • ACE-inhibitors or aliskiren (see also information under the headings “Do not take Twynsta” and
Maltese: • Inibituri ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux Twynsta” u
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability of telmisartan up to nearly 100 %.
Maltese: Studji dwar il-farmakokinetika f'pazjenti b'indeboliment tal-fwied urew żieda fil-bijodisponibilità assoluta ta' telmisartan bi kważi 100 %.
English: In a subset of 1050 patients with moderate to severe hypertension (DBP ≥100 mmHg) 32.7-51.8 % responded sufficiently to monotherapy of either telmisartan or amlodipine.
Maltese: F'sottosett ta' 1050 pazjent bi pressjoni għolja minn moderata sa severa (DBP ≥100 mmHg) 32.751.8 % irrispondew suffiċjentement għal telmisartan jew amlodipine mogħtija waħidhom.
English: Twynsta is contraindicated in patients with severe hepatic impairment (see section 4.3).
Maltese: Twynsta hu kontraindikat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjoni 4.3).
English: Other medicines and Twynsta
Maltese: Mediċini oħra u Twynsta
English: Nervous system disorders Common dizziness
Maltese: Disturbi fis-sistema nervuża Komuni sturdament
English: Rare syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Maltese: Rari sinkope, newropatija periferali, ipoaestesija, indeboliment fis-sens tattogħma, rogħda
English: Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: Calcium gluconate ġol-vini jista' jkun utli biex ireġġa' lura l-effetti tal-imblokk tal-kanal tal-calcium.
English: Rare nocturia
Maltese: Rari notturnja
English: Progressive scarring of lung tissue (interstitial lung disease [mainly pneumonia of the interstitium and pneumonia with excess eosinophils])
Maltese: Ċikatriċi progressiva tat-tessut tal-pulmun (mard interstizjali tal-pulmun [il-biċċa l-kbira pnewmonja tal-interstizju u pnewmonja b'eosinofili eċċessivi])
English: Twynsta combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: an angiotensin II receptor antagonist, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine.
Maltese: Twynsta jikkombina żewġ komposti kontra l-pressjoni għolja b'mekkaniżmi kumplimentari biex jikkontrolla l-pressjoni tad-demm f'pazjenti bi pressjoni għolja essenzjali: antagonist tar-riċetturi ta' angiotensin II, telmisartan, u imblokkatur dihydropyridinic tal-kanal tal-calcium, amlodipine.
English: The concomitant use of telmisartan/amlodipine 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
Maltese: L-użu fl-istess ħin ta' telmisartan/amlodipine flimkien ma' prodotti li fihom aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m (ara sezzjonijiet 4.5 u 5.1).
English: Co-administration of multiple doses of 10 mg of amlodipine with simvastatin 80 mg resulted in an increase in exposure to simvastatin up to 77 % compared to simvastatin alone.
Maltese: L-għoti flimkien ta' dożi multipli ta' 10 mg ta' amlodipine ma' simvastatin 80 mg irriżulta f'żieda fl-esponiment għal simvastatin ta' sa 77 % meta mqabbel ma' simvastatin waħdu.
English: • Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanzi attivi, għal derivattivi ta' dihydropyridine, jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1
English: Twynsta showed dose-related reductions in systolic/diastolic blood pressure across the therapeutic dose range of 21.8/ 16.5 mmHg (40 mg/5 mg), 22.1/ 18.2 mmHg (80 mg/5 mg), 24.7/ 20.2 mmHg (40 mg/10 mg) and 26.4/ 20.1 mmHg (80 mg/10 mg).
Maltese: Twynsta wera tnaqqis marbut mad-doża fil-pressjoni tad-demm sistolika/dijastolika fil-medda taddoża terapewtika ta' -21.8/-16.5 mmHg (40 mg/5 mg), -22.1/-18.2 mmHg (80 mg/5 mg), -24.
English: The overall incidence of adverse reactions with Twynsta in the clinical trial programme was low with only 12.7 % of patients on treatment experiencing adverse reactions.
Maltese: L-inċidenza totali ta' reazzjonijiet avversi bi Twynsta fil-programm ta' provi kliniċi kienet baxx bi 12.7% biss tal-pazjenti fuq il-kura li kellhom reazzjonijiet avversi.
English: Metabolism and nutrition disorders Uncommon hyperkalaemia
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni iperkalemija
English: S r.o.
Maltese: U L-UŻU C.
English: Reproductive system and breast disorders Uncommon erectile dysfunction gynaecomastia
Maltese: Disturbi fis-sistema riproduttiva u fis-sider Mhux komuni anormalità erettili ġinekomastija
English: The maximum recommended dose is one tablet 80 mg telmisartan/10 mg amlodipine per day.
Maltese: Id-doża massima rakkomandata hi ta' pillola waħda 80 mg telmisartan/10 mg amlodipine kuljum.
English: Amlodipine is a weak CYP3A inhibitor.
Maltese: Amlodipine huwa inibitur dgħajjef ta' CYP3A.
English: When telmisartan is taken with food, the reduction in the area under the plasma concentration-time curve (AUC0-∞) of telmisartan varies from approximately 6 % (40 mg dose) to approximately 19 % (160 mg dose).
Maltese: Meta telmisartan jittieħed mal-ikel, ittnaqqis taż-żona taħt il-kurva tal-konċentrazzjoni tal-plażma-żmien (AUC0-∞) ta' telmisartan ivarja minn madwar 6 % (doża ta' 40 mg) sa madwar 19 % (doża ta' 160 mg).
English: Rare hypoglycaemia (in diabetic patients)
Maltese: Rari ipogliċemija (f'pazjenti dijabetiċi)
English: Rare eczema, erythema, rash angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Maltese: Rari ekżema, eritema, raxx anġjoedema (b'riżultat fatali), eruzzjoni minħabba lmediċina, eruzzjoni tossika talġilda, urtikarja
English: Increased incidence of sepsis has been observed with telmisartan only, however can not be ruled out for Twynsta.
Maltese: Żieda fl-inċidenza ta' sepsis ġiet osservata b'telmisartan biss, madankollu ma tistax tiġi eskluża għal Twynsta.
English: • Telmisartan belongs to a group of substances called “angiotensin-II receptor antagonists”.
Maltese: • Telmisartan jappartjeni għal grupp ta' mediċini li jissejħu “antagonisti tar-riċetturi ta' angiotensin II”.
English: Reproductive toxicology
Maltese: Terapija addizzjonali
English: Common side effects (may affect up to 1 in 10 people): Altered bowel habits, diarrhoea, constipation, visual disturbances, double vision, ankle swelling.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 minn kull 10 min-nies): Bidla fl-ippurgar, dijarea, stitikezza, disturbi fil-vista, vista doppja, nefħa fl-għaksa.
English: Oedema rates were significantly lower with 40 mg/5 mg and 80 mg/5 mg compared to amlodipine 10 mg (4.4 % versus 24.9 %, respectively).
Maltese: Ir-rati ta' edema kienu iktar baxxi b'mod sinifikanti b'40 mg/5 mg u 80 mg/5 mg meta mqabbla ma' amlodipine 10 mg (4.4 % kontra 24.9 %, rispettivament).
English: This medicine contains 337.28 mg sorbitol in each tablet.
Maltese: Din il-mediċina fiha 337.28 mg ta' sorbitol f'kull pillola.
English: Rare blood uric acid increased blood creatine phosphokinase increased, haemoglobin decreased
Maltese: Rari żieda tal-uric acid fid-demm żieda tal-creatine phosphokinase fiddemm, tnaqqis flemoglobina
English: Uncommon arthralgia, muscle spasms (cramps in legs), myalgia
Maltese: Mhux komuni artralġja, spażmi tal-muskoli (bugħawwieġ fir-riġlejn, mijalġja
English: Experimental data indicate that amlodipine binds to both dihydropyridine and nondihydropyridine binding sites.
Maltese: Dejta sperimentali tindika li amlodipine jeħel kemm mas-siti ta' dihydropyridine kif ukoll ta' non-dihydropyridine.
English: As with other blood pressure lowering medicines, the effect of Twynsta may be reduced when you take NSAIDs (non steroidal anti-inflammatory medicines, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.
Maltese: Bħal ma jiġri b'mediċini oħrajn li jbaxxu l-pressjoni tad-demm, l-effetti ta' Twynsta jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti-inflammatory drugs, eż. aspirina jew ibuprofen) jew kortikosterojdi.
English: Skin and subcutaneous tissue disorders Uncommon pruritus hyperhidrosis alopecia, purpura, skin discolouration, hyperhidrosis
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda Mhux komuni ħakk iperidrosi alopeċja, purpura, tibdil fil-kulur talġilda, iperidrosi
English: General disorders and administration site condition Common peripheral oedema
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni edema periferali
English: When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6).
Maltese: Meta ttqala tkun iddijanjostikata, il-kura b'antagonisti tar-riċetturi ta' angiotensin II għandha titwaqqaf immedjatament, u, jekk ikun xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4.3 u 4.6).
English: The observed mean changes in systolic/diastolic blood pressure with a combination therapy containing amlodipine 5 mg ( 22.2/ 17.2 mmHg with 40 mg/5 mg; 22.5/ 19.1 mmHg with 80 mg/5 mg) were comparable to or greater than those seen with amlodipine 10 mg ( 21.0/ 17.6 mmHg) and associated with significant lower oedema rates (1.4 % with 40 mg/5 mg; 0.5 % with 80 mg/5 mg; 17.6 % with amlodipine 10 mg).
Maltese: It-tibdil medju osservat fil-pressjoni tad-demm sistolika/dijastolika b'terapija kombinata li fiha amlodipine 5 mg (-22.2/-17.2 mmHg b'40 mg/5 mg; -22.5/-19.1 mmHg b'80 mg/5 mg) kienu komparabbli ma', jew akbar minn dak li kien osservat b'amlodipine 10 mg (-21.0/-17.6 mmHg) u assoċjat ma' rati iktar baxxi b'mod sinifikanti ta' edema (1.4 % b'40 mg/5 mg; 0.5 % b'80 mg/5 mg; 17.6 % b'amlodipine 10 mg).
English: In an 8-week multicenter, randomised, double-blind, placebo-controlled, parallel group factorial study in 1461 patients with mild to severe hypertension (mean seated diastolic blood pressure ≥95 and ≤119 mmHg), treatment with each combination dose of Twynsta resulted in significantly greater diastolic and systolic blood pressure reductions and higher control rates compared to the respective monotherapy components.
Maltese: Fi studju li dam 8 ġimgħat, multiċentriku, li fih il-pazjenti ntgħażlu b'mod każwali, double-blind, ikkontrollat bil-plaċebo, tat-tip grupp parallel factorial, li sar fuq 1461 pazjent bi pressjoni għolja minn ħafifa sa severa (medja tal-pressjoni tad-demm dijastolika meta pazjent ikun bilqiegħda ta' ≥95 u ≤119 mmHg), il-kura b'kull doża ta' kumbinazzjoni ta' Twynsta rriżultat fi tnaqqis akbar b'mod sinifikanti tal-pressjoni tad-demm dijastolika u sistolika u rati ogħla ta' kontroll meta mqabbla malkomponenti rispettivi tal-mediċini mogħtija waħidhom.
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Twynsta:
Maltese: L-effetti sekondarji li ġejjin kienu osservati bil-komponenti ta' telmisartan jew amlodipine u jistgħu jseħħu wkoll bi Twynsta:
English: In vitro studies have shown that approximately 97.5 % of circulating amlodipine is bound to plasma proteins in hypertensive patients.
Maltese: Studji in vitro wrew li madwar 97.5 % ta' amlodipine li jkun jiċċirkola jeħel mal-proteini fil-plażma f'pazjenti bi pressjoni għolja.
English: The highest dose (for mice, similar to, and for rats twice* the maximum recommended clinical dose of 10 mg on a mg/m2 basis) was close to the maximum tolerated dose for mice but not for rats.
Maltese: L-ogħla doża (għall-ġrieden, simili għal, u għall-firien darbtejn* l-ogħla doża klinika rakkomandata ta' 10 mg bbażata fuq mg/m2) kienet viċin id-doża massima ttollerata għall-ġrieden iżda mhux għall-firien.
English: INFORMATION IN BRAILLE Twynsta 80 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Twynsta 80 mg/5 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets
Maltese: Twynsta 80 mg/5 mg pilloli
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/5 mg tablets
Maltese: Twynsta 40 mg/5 mg pilloli
English: INFORMATION IN BRAILLE Twynsta 40 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Twynsta 40 mg/5 mg
English: INFORMATION IN BRAILLE Twynsta 80 mg/10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Twynsta 80 mg/10 mg
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/10 mg tablets
Maltese: Twynsta 80 mg/10 mg pilloli
English: INFORMATION IN BRAILLE Twynsta 40 mg/10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Twynsta 40 mg/10 mg
English: In animals, lethal ventricular fibrillation and cardiovascular collapse are observed in association with hyperkalemia after administration of verapamil and intravenous dantrolene.
Maltese: Fl-annimali, kienu osservati fibrillazzjoni ventrikulari letali u kollass kardjovaskulari flimkien ma' iperkalimja wara l-għoti ta' verapamil u dantrolene ġol-vini.
English: NAME OF THE MEDICINAL PRODUCT Twynsta 40 mg/10 mg tablets
Maltese: Twynsta 40 mg /10 mg pilloli
English: After 8 weeks of treatment, each of the combinations was statistically significantly superior to both amlodipine monotherapy doses in reducing systolic and diastolic blood pressures ( 13.6/ 9.4 mmHg, 15.0/ 10.6 mmHg with 40 mg/5 mg, 80 mg/5 mg versus 6.2/ 5.7 mmHg, 11.1/ 8.0 mmHg with amlodipine 5 mg and 10 mg and higher diastolic blood pressure control rates compared to the respective monotherapies were achieved (56.7 %, 63.8 % with 40 mg/5 mg and 80 mg/5 mg versus 42 %, 56.7 % with amlodipine 5 mg and 10 mg).
Maltese: 0/10.6 mmHg b'40 mg/5 mg, 80 mg/5 mg kontra -6.2/-5.7 mmHg, -11.1/-8.0 mmHg b'amlodipine 5 mg u 10 mg u nkisbu rati ogħla ta' kontroll ta' pressjoni tad-demm dijastolika meta mqabbla ma' mediċini rispettivi mogħtija waħidhom (56.7 %, 63.8 % b'40 mg/5 mg u 80 mg/5 mg kontra 42 %, 56.7 % b'amlodipine 5 mg u 10 mg).
English: There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system (RAAS).
Maltese: Hemm riskju miżjud ta' pressjoni baxxa severa u insuffiċjenza tal-kliewi meta pazjenti bi stenosi bilaterali fl-arterji tal-kliewi jew bi stenosi tal-arterja għal kilwa waħda li tkun taħdem, ikunu kkurati bi prodotti mediċinali li jaffettwaw is-sistema renin-angiotensin-aldosterone (RAAS).
English: Twynsta 80 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on on Twynsta 40 mg/10 mg or Twynsta 80 mg/5 mg.
Maltese: Twynsta 80 mg/10 mg hu indikat għall-uzu fl-adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat bi Twynsta 40 mg/10 mg jew Twynsta 80 mg/5 mg.
English: Reduced number of white blood cells (leucopenia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), excess sugar in blood , uncontrollable twitching or jerking movements, heart attack, irregular heart beat, inflammation of the blood vessels, inflamed pancreas, inflammation of the stomach lining (gastritis), inflammation of the liver, yellowing of the skin (jaundice), increased levels of hepatic enzymes with jaundice, rapid swelling of skin and mucosa (angioedema), severe skin reactions, hives (urticaria), severe allergic reactions with blistering eruptions of the skin and mucous membranes (exfoliative dermatitis, Stevens-Johnson-Syndrome), increased sensitivity of the skin to sun, increased muscle tension.
Maltese: Tnaqqis fin-numru ta' ċelluli tad-demm bojod (lewkopenija), għadd baxx ta' plejtlits (tromboċitopenija), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa talwiċċ jew pressjoni tad-demm baxxa), zokkor eċċessiv fid-demm, kontrazzjonijiet jew movimenti bliskossi li ma jistgħux jiġu kkontrollati, attakk tal-qalb, taħbit irregolari tal-qalb, infjammazzjoni talvini jew arterji, frixa infjammata, infjammazzjoni fil-kisja tal-istonku (gastrite), infjammazzjoni talfwied, sfura tal-ġilda (suffejra), żieda fil-livelli ta' enzimi tal-fwied flimkien ma' suffejra, nefħa mgħaġġla tal-ġilda u tal-mukuża (anġjoedema), reazzjonijiet severi tal-ġilda, ħorriqija (urtikarja), reazzjonijiet allerġiċi severi b'eruzzjonijiet ta' nfafet tal-ġilda u tal-membrani mukużi (dermatite bilqxur, Sindrome ta' Stevens-Johnson), żieda fis-sensittività tal-ġilda għax-xemx, żieda fit-tensjoni talmuskoli.
English: The increase of the amlodipine dosage should take place with care in the elderly patients (see section 4.2 and 5.2).
Maltese: Pazjenti anzjani Iż-żieda fid-dożaġġ ta' amlodipine għandha ssir b'attenzjoni f'pazjenti anzjani (ara sezzjoni 4.2 u 5.2).
English: A placebo controlled study (PRAISE) designed to evaluate patients in NYHA Class III-IV heart failure receiving digoxin, diuretics and ACE inhibitors has shown that amlodipine did not lead to an increase in risk of mortality or combined mortality and morbidity with heart failure.
Maltese: III-IV li kienu qed jirċievu digoxin, dijuretiċi u inibituri ta' ACE, wera li amlodipine ma wassalx għal żieda fi riskju ta' mortalità jew mortalità u morbożità kombinati ma' insuffiċjenza tal-qalb.
English: Rare malaise influenza-like illness
Maltese: Rari telqa mard qisu influwenza
English: No drug interaction studies have been conducted with cyclosporine and amlodipine in healthy volunteers or other populations with the exception of renal transplant patients, where variable trough concentration increases (average 0% - 40%) of cyclosporine were observed.
Maltese: Ma twettqu l-ebda studji ta' interazzjoni tal-mediċina b'cyclosporine u amlodipine f'voluntiera b'saħħithom jew f'popolazzjonijiet oħrajn, bl-eċċezzjoni ta' pazjenti bi trapjant tal-kliewi, fejn ġew osservati żidiet varjabbli fil-konċentrazzjoni minima (medja ta' 0% - 40%) ta' cyclosporine.
English: Increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), allergic reaction (e.g. rash, itching, difficulty of breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), impaired vision, fast heart beat, upset stomach, abnormal liver function, hives (urticaria), medicine rash, inflammation of the tendons, flu-like illness (for example muscle pain, feeling generally unwell), decreased haemoglobin (a blood protein), increased levels of creatinine phosphokinase in the blood.
Maltese: Żieda f'ċerti ċelluli bojod tad-demm (eosinofilija), għadd baxx ta' plejtlits (tromboċitopenija), reazzjoni allerġika (eż. raxx, ħakk, diffikultà biex tieħu n-nifs, tħarħir, nefħa tal-wiċċ jew pressjoni tad-demm baxxa), livelli baxxi ta' zokkor fid-demm (f'pazjenti dijabetiċi), indeboliment fil-vista, rata mgħaġġla ta' taħbit tal-qalb, stonku mqalleb, funzjoni anormali tal-fwied, ħorriqija (urtikarja), raxx minħabba l-mediċina, infjammazzjoni tat-tendini, mard qisu influwenza (pereżempju uġigħ filmuskoli, sensazzjoni ġenerali li ma tħossokx tajjeb), tnaqqis fl-emoglobina (proteina tad-demm), żieda fil-livelli tal-creatinine phosphokinase fid-demm.
English: In an amlodipine long-term, placebo controlled study in patients with severe heart failure (NYHA class III and IV) the reported incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group (see section 5.1).
Maltese: Fi studju fit-tul, ikkontrollat bi plaċebo, dwar amlodipine f'pazjenti b'insuffiċjenza severa tal-qalb (NYHA klassi III u IV) l-inċidenza rrappurtata ta' edema pulmonari kienet ogħla fil-grupp ittrattat b'amlodipine milli fil-grupp tal-plaċebo (ara sezzjoni 5.1).
English: Concomitant use of amlodipine with strong or moderate CYP3A4 inhibitors (protease inhibitors, azole antifungals, macrolides like erythromycin or clarithromycin, verapamil or diltiazem) may give rise to significant increase in amlodipine exposure resulting in an increased risk of hypotension.
Maltese: (inibituri tal-protease, antifungali azole, makrolidi bħal erythromycin jew clarithromycin, verapamil jew diltiazem) jista' jwassal għal żieda sinifikanti fl-esponiment għal amlodipine li jwassal għal riskju akbar ta' pressjoni baxxa.
English: Rats and mice treated with amlodipine in the diet for two years, at concentrations calculated to provide daily dosage levels of 0.5, 1.25, and 2.5 mg/kg/day showed no evidence of carcinogenicity.
Maltese: Il-firien u l-ġrieden ittrattati b'amlodipine fid-dieta għal sentejn, f'konċentrazzjonijiet ikkalkulati biex jipprovdu livelli ta' dożaġġ ta' kuljum ta' 0.5, 1.25, u 2.5 mg/kg/jum ma wrew l-ebda evidenza ta' karċinoġeniċità.
English: In another multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 947 patients with mild to severe hypertension who were not adequately controlled on amlodipine 10 mg received Twynsta (40 mg/10 mg or 80 mg/10 mg) or amlodipine alone (10 mg).
Maltese: Fi studju ieħor multiċentriku, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat b'mod attiv, grupp parallel, total ta' 947 pazjent bi pressjoni għolja minn ħafifa sa severa, li ma kinux ikkontrollati b'mod adegwat fuq amlodipine 10 mg, irċivew Twynsta (40 mg/10 mg jew 80 mg/ 10 mg) jew amlodipine waħdu (10 mg).
English: In a further multicentre, randomised, double-blind, active-controlled, parallel group study, a total of 1097 patients with mild to severe hypertension who were not adequately controlled on amlodipine 5 mg received Twynsta (40 mg/5 mg or 80 mg/5 mg) or amlodipine alone (5 mg or 10 mg).
Maltese: Fi studju multiċentriku addizzjonali, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat b'mod attiv, grupp parallel, total ta' 1097 pazjent bi pressjoni għolja minn ħafifa sa severa, li ma kinux ikkontrollati b'mod adegwat fuq amlodipine 5 mg, irċivew Twynsta (40 mg/ 5 mg jew 80 mg/5 mg) jew amlodipine waħdu (5 mg jew 10 mg).
English: potassium-sparing diuretics (certain ‘water tablets').
Maltese: żbilanċ ta' diversi minerali fid-demm).
English: Pharmacokinetic of the fixed dose combination
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Twynsta 40 mg/10 mg is indicated in adults whose blood pressure is not adequately controlled on amlodipine 10 mg alone.
Maltese: Twynsta 40 mg/10 mg hu indikat għall-uzu fl-adulti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat b'amlodipine 10 mg waħdu.
English: Non-steroidal anti-inflammatory medicinal products
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/007 (360 (4 x 90 x 1) tablets)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/10/648/007 (360 (4 x 90 x 1) pillola)
English: NAME OF THE MEDICINAL PRODUCT Twynsta 80 mg/5 mg tablets telmisartan/amlodipine
Maltese: Twynsta 80 mg/5 mg pilloli telmisartan/amlodipine
English: Therefore it is not expected to potentiate bradykinin-mediated adverse reactions.
Maltese: Għalhekk mhux mistenni li jsaħħaħ ir-reazzjonijiet avversi medjati minn bradykinin.