FrancophonIA/ELRC3.0 huggingface dataset:
English: Onduarp 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),
Maltese: Onduarp 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: INFORMATION IN BRAILLE Onduarp 40 mg/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Onduarp 40 mg/5 mg
English: INFORMATION IN BRAILLE Onduarp 40 mg/10 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Onduarp 40 mg/10 mg
English: The mean steady state apparent volume of distribution (Vdss) is approximately 500 l.
Maltese: Il-volum apparenti tad-distribuzzjoni fl-istat fiss (Vdss) hu ta' madwar 500 l.
English: Onduarp 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: Onduarp 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: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/5 mg tablets
Maltese: Onduarp 40 mg/5 mg pilloli
English: Aluminium/aluminium blisters (PA/Al/PVC/Al) in a carton containing 28 tablets.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folji tal-aluminju/aluminju (PA/Al/PVC/Al) f'kaxxa tal-kartun li jkun fiha 28 pillola.
English: The main risk factors for hyperkalaemia to be considered are: - Diabetes mellitus, renal impairment, age (>70 years) - Combination with one or more other medicinal products that affect the renin-angiotensin-aldosterone system and/or potassium supplements.
Maltese: - Dijabete mellitus, indeboliment tal-kliewi, età (> 70 sena) - Kumbinazzjoni ma' prodott mediċinali wieħed jew aktar li jaffettwaw is-sistema renin-angiotensin-aldosterone u/jew is-supplimenti tal-potassium.
English: Steady-state plasma levels are reached after continuous administration for 7-8 days.
Maltese: Il-livelli fil-plażma fl-istat fiss jintlaħqu wara għoti kontinwu għal 7-8 ijiem.
English: • Obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
Maltese: • Ostruzzjoni tal-fluss 'il barra tal-ventriklu tax-xellug (eż. stenosi aortika ta' grad għoli)
English: Therefore it is not expected to potentiate bradykininmediated adverse reactions.
Maltese: Għalhekk mhux mistenni li jsaħħaħ ir-reazzjonijiet avversi medjati minn bradykinin.
English: Pharmacokinetic of the fixed dose combination (FDC) The rate and extent of absorption of Onduarp are equivalent to the bioavailability of telmisartan and amlodipine when administered as individual tablets.
Maltese: Il-farmakokinetika tal-kumbinazzjoni ta' doża (FDC) Ir-rata u l-grad ta' assorbiment ta' Onduarp huma ekwivalenti għall-bijodisponibilità ta' telmisartan u amlodipine meta jingħataw bħala pilloli individwali.
English: Vasculitis Respiratory, thoracic and mediastinal disorders Uncommon:
Maltese: Disturbi respiratorji, toraċiċi u medjastinali:
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 Onduarp 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' Onduarp 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: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain ‘water tablets').
Maltese: • Mediċini li jistgħu jżidu l-livelli tal-potassium fid-demm bħal sostituti tal-melħ li fihom il potassium, dijuretiċi li ma jneħħux potassium (ċerti ‘pilloli tal-awrina').
English: Infections and infestations cystitis
Maltese: Disturbi gastro-intestinali
English: NAME OF THE MEDICINAL PRODUCT Onduarp 40 mg/10 mg tablets
Maltese: Onduarp 40 mg/10 mg pilloli
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 liperkalemija.
English: Onduarp is available in a folding box containing 28 tablets in aluminium/aluminium blisters.
Maltese: Onduarp hu disponibbli f'kaxxa li tintewa li fiha 28 pillola f'folji tal-aluminju/aluminju.
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 talqalb.
English: Haemodynamic studies and exercise based controlled clinical trials in NYHA Class II-IV heart failure patients have shown that amlodipine did not lead to clinical deterioration as measured by exercise tolerance, left ventricular ejection fraction and clinical symptomatology.
Maltese: II-IV, urew li amlodipine ma wassalx għal deterjorament kliniku kif imkejjel permezz ta' tolleranza għall-eżerċizzju, porzjon ta' tfigħ 'il barra ventrikulari tax-xellug u sintomatoloġija klinika.
English: This has been confirmed in a subchronic (13-week) toxicology study in rats, in which dose levels of 3.2/0.8, 10/2.5 and 40/10 mg/kg of telmisartan and amlodipine were tested.
Maltese: Dan ġie kkonfermat fi studju dwar it-tossikoloġija sottokronika fil-firien, li dam 13-il ġimgħa, li fih livelli ta' doża ta' 3.2/0.8, 10/2.5 u 40/10 mg/kg ta' telmisartan u amlodipine kienu ttestjati.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/5 mg tablets
Maltese: Onduarp 80 mg/5 mg pilloli
English: - The other ingredients are colloidal anhydrous silica, brilliant blue FCF (E 133), ferric oxide black (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine,
Maltese: (E172), ferric oxide yellow (E172), magnesium stearate, maize starch, meglumine,
English: Separate reproductive toxicity studies with the combination of telmisartan and amlodipine have not been conducted.
Maltese: Ma sarux studji separati dwar it-tossiċità riproduttiva bil-kombinazzjoni ta' telmisartan u amlodipine.
English: • if you are allergic to other medicines of the dihydropyridine type (one type of calcium channel blocker).
Maltese: • jekk inti allerġiku għal mediċini oħra tat-tip dihydropyridine (tip wieħed ta' imblokkatur talkanal tal-calcium).
English: There was no effect on the fertility of rats treated orally with amlodipine maleate (males for 64 days and females for 14 days prior to mating) at doses of up to 10 mg amlodipine/kg/day (about 10 times the Maximum Recommended Human Dose of 10 mg/day on an mg/m2 basis).
Maltese: Ma kien hemm l-ebda effett fuq ilfertilità ta' firien ikkurati mill-ħalq b'amlodipine maleate (irġiel għal 64 jum u nisa għal 14-il jum qabel it-tgħammir) f'dożi ta' sa 10 mg ta' amlodipine/kg/kuljum (madwar 10 darbiet tad-Doża Massima Rakkomandata għall-Bniedem ta' 10 mg/kuljum fuq bażi ta' mg/m2).
English: Nervous system disorders somnolence, migraine, headache, paraesthesia syncope, peripheral neuropathy, hypoaesthesia, dysgeusia, tremor
Maltese: Disturbi fis-sistema nervuża sturdament ngħas, migranja, uġigħ ta' ras, parestesija sinkope, newropatija periferali, ipoestesija, indeboliment fis-sens tat-togħma, rogħda
English: Telmisartan does not inhibit human plasma renin or block ion channels.
Maltese: Telmisartan ma jinibixxix ir-renin fil-plażma umana jew jimblokka l-kanali tal-joni.
English: NAME OF THE MEDICINAL PRODUCT Onduarp 80 mg/10 mg tablets
Maltese: Onduarp 80 mg/10 mg pilloli
English: Investigations hepatic enzymes increased blood uric acid increased
Maltese: Investigazzjonijiet żieda fl-enzimi talfwied żieda tal-uric acid fiddemm
English: Pharmacotherapeutic group: Agents acting on the renin-angiotensin system, angiotensin II antagonists and calcium channel blockers; ATC Code: C09DB04.
Maltese: Mediċini li jaġixxu fuq is-sistema renin-angiotensin, antagonisti ta' angiotensin II u imblokkaturi tal-kanal tal-calcium;
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: In both species, increased plasma renin activity and hypertrophy/hyperplasia of the renal juxtaglomerular cells were observed.
Maltese: Fiż-żewġ speċi, kienet osservata żieda fl-attività ta' renin fil-plażma u ipertrofija/iperplasija taċ-ċelluli juxtaglomerular.
English: Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG
Maltese: Boehringer Ingelheim RCV GmbH & Co
English: Nervous system disorders Very rare:
Maltese: Disturbi fis-sistema nervuża Rari ħafna:
English: The volume of distribution of amlodipine is approximately 21 l/kg.
Maltese: Il-volum tad-distribuzzjoni ta' amlodipine hu ta' madwar 21 l/kg.
English: In this respect data concerning diastolic blood pressure (DBP) are inconsistent.
Maltese: F'dan irrigward, id-dejta dwar pressjoni dijastolika tad-demm (DBP) hi inkonsistenti.
English: Signs and symptoms of overdose are expected to be in line with exaggerated pharmacological effects.
Maltese: Sinjali u sintomi ta' doża eċċessiva huma mistennija li jikkorrispondu ma' effetti farmakoloġiċi esaġerati.
English: Musculoskeletal and connective tissue disorders Rare:
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi Rari:
English: Interactions linked to telmisartan
Maltese: Interazzjonijiet marbuta ma' telmisartan
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: Change of bowel habit Pancreatitis, gastritis
Maltese: Pankreatite, gastrite
English: Read the package leaflet for further information.
Maltese: Hemm ftit informazzjoni disponibbli f'pazjenti anzjani ħafna.
English: Onduarp 80 mg/10 mg may be administered in patients whose blood pressure is not adequately controlled on Onduarp 40 mg/10 mg or Onduarp 80 mg/5 mg.
Maltese: Onduarp 80 mg/10 mg jista' jingħata lil pazjenti li l-pressjoni tad-demm tagħhom ma tkunx ikkontrollata b'mod adegwat fuq Onduarp 40 mg/10 mg jew Onduarp 80 mg/5 mg.
English: Micturition disorder, pollakiuria Reproductive system and breast disorders Uncommon:
Maltese: Sensittività eċċessiva, reazzjoni anafilattika Disturbi fil-metaboliżmu u n-nutrizzjoni Mhux komuni: Rari:
English: Immune system disorders Rare:
Maltese: Disturbi fis-sistema immune Rari ħafna:
English: • Haemodynamically unstable heart failure after acute myocardial infarction
Maltese: • Insuffiċjenza emodinamikament instabbli tal-qalb wara infart mijokardijaku akut
English: As with other blood pressure lowering medicines, the effect of Onduarp 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' Onduarp jistgħu jitnaqqsu meta tieħu NSAIDs (non steroidal anti-inflammatory drugs, eż. aspirina jew ibuprofen) jew kortikosterojdi.
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.
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.
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.
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 bl iskossi 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.
English: S r.o.
Maltese: U L-UŻU
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: Telmisartan and amlodipine are not dialysable.
Maltese: Telmisartan u Amlodipine mhumiex dijalizzabbli.
English: Angioedema (with fatal outcome), drug eruption, toxic skin eruption, urticaria
Maltese: Anġjoedema (b'riżultat fatali), eruzzjoni minħabba l-mediċina, eruzzjoni tossika tal-ġilda, urtikarja
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 Onduarp (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 Onduarp (40 mg/ 5 mg jew 80 mg/5 mg) jew amlodipine waħdu (5 mg jew 10 mg).
English: Musculoskeletal and connective tissue disorders arthralgia, muscle spasms (cramps in legs), myalgia back pain, pain in extremity (leg pain)
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja, spażmi tal-muskoli (bugħawwieġ firriġlejn), majalġja uġigħ fid-dahar, uġigħ fl-estremitajiet (uġigħ fir-riġlejn)
English: Onduarp tablets contain two active substances called telmisartan and amlodipine.
Maltese: X'fih Onduarp - Is-sustanzi attivi huma telmisartan u amlodipine.
English: Amlodipine should be used with caution together with CYP3A4 inhibitors.
Maltese: Ma jistax jiġi eskluż li inibituri qawwija ta' CYP3A4
English: - Intercurrent events, in particular dehydration, acute cardiac decompensation, metabolic acidosis, worsening of renal function, sudden worsening of the renal condition (e.g. infectious diseases), cellular lysis (e.g. acute limb ischemia, rhabdomyolysis, extensive trauma).
Maltese: - Avvenimenti interkurrenti, b'mod partikulari d-deidrazzjoni, dikumpensazzjoni akuta kardijaka, aċidożi metabolika, funzjoni tal-kliewi li tmur għall-agħar, kundizzjoni tal-kliewi li tmur għallagħar għal għarrieda (eż. mard infettiv), lisi ċellulari (eż. iskemija akuta fir-riġlejn jew fiddirgħajn, rabdomijolisi, trawma estensiva).
English: Dual blockade of the renin-angiotensin-aldosterone system The use of telmisartan in combination with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: Imblokk doppju tas-sistema renin-angiotensin-aldosterone L-użu fl-istess ħin ta' telmisartan flimkien ma' aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.2, 4.4, 4.5).
Maltese: L-użu fl-istess ħin ta' telmisartan flimkien ma' aliskiren huwa kontraindikat f'pazjenti b'dijabete mellitus jew b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.2, 4.4, 4.5).
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 Onduarp (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 Onduarp (40 mg/10 mg jew 80 mg/ 10 mg) jew amlodipine waħdu (10 mg).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/729/004 (360 (4 x 90 x 1) tablets)
Maltese: EU/1/11/729/004 (360 (4 x 90 x 1) pillola)
English: Amlodipine is relatively vessel-selective, with a greater effect on vascular smooth muscle cells than on cardiac muscle cells.
Maltese: Amlodipine hu relattivament selettiv għal vini/arterji, b'effett akbar fuq ċelluli vaskulari tal-muskoli lixxi milli fuq iċċelluli tal-muskoli kardijaċi.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/5 mg
Maltese: Folja b'unità tad-doża ta' 10 pilloli - 80 mg/5 mg
English: Animal reproductive toxicity studies with Onduarp have not been performed.
Maltese: Ma sarux studji dwar tossiċità riproduttiva fl-annimali b'Onduarp.
English: The most common adverse reactions include dizziness and peripheral oedema.
Maltese: L-iktar reazzjonijiet avversi komuni jinkludu sturdament u edema periferali.
English: The concomitant use of CYP3A4 inducers (i.e. rifampicin, Hypericum perforatum) may lead to a lower plasma concentration of amlodipine.
Maltese: (i.e. rifampicin, Hypericum perforatum) jista' jwassal għal konċentrazzjoni iktar baxxa ta' amlodipine fil-plażma.
English: The following side effects have been observed with the components telmisartan or amlodipine and may occur also with Onduarp:
Maltese: L-effetti sekondarji li ġejjin kienu osservati bil-komponenti ta' telmisartan jew amlodipine u jistgħu jseħħu wkoll b'Onduarp:
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors, and with angiotensin II receptor antagonists, including telmisartan.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet tal-lithium fis-serum u t-tossiċità kienu rrappurtati waqt lgħoti fl-istess ħin ta' lithium ma' inibituri ta' enzimi li jibdlu angiotensin, u ma' antagonisti tarriċetturi ta' angiotensin II, li jinkludu telmisartan.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister of 10 tablets - 80 mg/10 mg
Maltese: Folja b'unità tad-doża ta' 10 pilloli - 80 mg/10 mg
English: Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 80 mg ta' telmisartan u 10 mg ta' amlodipine (bħala besylate).
English: Concomitant use of telmisartan with aliskiren is contraindicated in patients with renal impairment (GFR < 60 ml/min/1.73 m2) (see section 4.3).
Maltese: L-użu fl-istess ħin ta' telmisartan flimkien ma' aliskiren huwa kontraindikat f'pazjenti b'indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjoni 4.3).
English: Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 80 mg ta' telmisartan u 5 mg ta' amlodipine (bħala besylate).
English: Children and adolescents The use of Onduarp in children and adolescents up to the age of 18 years is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Onduarp fit-tfal u fl-adolexxenti sal-età ta' 18-il sena mhuwiex rakkomandat.
English: Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as besylate).
Maltese: Kull pillola fiha 40 mg ta' telmisartan u 5 mg ta' amlodipine (bħala besylate).
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: Ittibdil 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: • Medicines used for HIV/AIDS (e.g. ritonavir) or for treatment of fungal infections (e.g.
Maltese: • Mediċini li jintużaw għall-kura tal-HIV/AIDS (eż. ritonavir) jew għall-kura ta' infezzjonijiet fungali (eż. ketoconazole).