FrancophonIA/ELRC3.0 huggingface dataset:
English: You must not take this medicine: - if you are allergic (hypersensitive) to the active substances or any of the other ingredients of Lisonorm - if you are allergic to other ACE inhibitors (such as enalapril, captopril and ramipril) or other calcium channel blockers (such as nifedipine, felodipine or nimodipine) - if you have had an angioedema (symptoms such as itching, nettle rash, wheezing and swelling of the hands, throat, mouth or eyelids), related or not to treatment with an ACE-inhibitor - if your blood pressure is too low (severe hypotension) - if you have a narrowing of the aorta (aortic stenosis), of a heart valve (mitral stenosis), an increase in the thickness of the heart muscle (hypertrophic cardiomyopathy) or cardiogenic shock (not enough blood supply to your tissues) - if you have unstable angina (except Prinzmetal's angina) - if you have suffered a heart attack (myocardial infarction) within the last 28 days - if you are pregnant or think you may be pregnant - if you are breast-feeding
Maltese: Lisonorm, - jekk inti allerġiku għal impedituri oħra ta' l-ACE (bħal enalapril, captopril u ramipril) jew imblokkaturi oħra tal-kanal tal-kalċju (bħal nifedipine, felodipine jew nimodipine), - jekk kellek anġjoedema (sintomi bħal ħakk, urtikarja, tħarħir u nefħa tal-idejn, tal-griżmejn jew tat-tbieqi tal-għajnejn), relatati jew le ma' trattament b'impeditur ta'l-ACE, - jekk il-pressjoni tad-demm tiegħek hija baxxa wisq (pressjoni baxxa severa), - jekk għandek tidjiq tal-aorta (stenosi aortika), tal-valv tal-qalb (stenosi mitrali), żieda fil-ħxuna fil-muskolu tal-qalb (kardjomijopatija ipertrofika) jew xokk kardjoġeniku (m'hemmx biżżejjed forniment ta' demm fit-tessuti tiegħek), - jekk għandek anġina li mhix stabbli (ħlief anġina ta' Prinzmetal), - jekk kellek attakk ta' qalb (infart mijokardjali) fl-aħħar 28 jum, - jekk inti tqila jew taħseb li inti tqila, - jekk qed tredda'
English: Lisonorm tablet is a combination product of amlodipine, which belongs to a group of medicines called calcium channel blockers, and lisinopril, which belongs to a group of medicines called angiotensinconverting enzyme (ACE) inhibitors.
Maltese: Il-pillola Lisonorm hija prodott ikkombinat ta' amlodipine, li jappartjeni għal grupp ta' mediċini msejħa imblokkaturi tal-kanal tal-kalċju, u lisinopril, li jappartjeni għal grupp ta' mediċini msejħa impedituri ta' enżimi li jikkonvertu angiotensin (ACE).
English: Based on the data provided, bioequivalence for both amlodipine 10 mg and lisinopril 20 mg after administration of single oral doses of LISONORM FORTE, co-administration of NORVASC 10 mg and PRINIVIL 20 mg, or administration of LISONORM (fixed-combination of amlodipine 5 mg and lisinopril 10 mg) could be concluded.
Maltese: Abbażi tad-dejta pprovduta, kien possibbli li jiġi konkluż favur il-bijoekwivalenza kemm għal amlodipina 10 mg kif ukoll għal lisinopril 20 mg wara l-għoti ta' dożi orali singoli ta' LISONORM FORTE, l-għoti fl-istess ħin ta' NORVASC 10 mg u PRINIVIL 20 mg, jew l-għoti ta' LISONORM (kombinazzjoni fissa ta' amlodipina 5 mg u lisinopril 10 mg).
English: Very rarely, neutropenia, agranulocytosis, thrombocytopenia and anaemia have been reported in patients receiving ACE inhibitors (see section 4.8).
Maltese: B'mod rari ħafna, newtropenja, agranuloċitosi u anemija ġew rapportati f'pazjenti li qed jieħdu impedituri ta' l-ACE (ara sezzjoni 4.8).
English: Oliguria/Anuria
Maltese: Rari ħafna Oligurja/Anurja
English: Lisonorm is a new fixed-dose combination containing 10mg lisinopril (an ACE inhibitor) and 5mg amlodipine (a calcium antagonist), indicated for patients with blood pressure adequately controlled with lisinopril and amlodipine given concurrently at the same dose level.
Maltese: Lisonorm huwa kombinazzjoni ġdida ta' doża fissa li fih 10mg lisinopril (inibitur ta' ACE) u 5mg amlodipina (amlodipine, antagonista tal-kalċju), indikat għal pazjenti bi pressjoni tad-demm ikkontrollata b'mod adegwat b'lisinopril u amlodipina mogħtijin fl-istess ħin fl-istess dożaġġ.
English: Pruritus
Maltese: Iperkalemja
English: Lisinopril can be removed from the plasma by dialysis.
Maltese: Lisinopril jista' jiġi eliminat mill-plażma waqt id-dijaliżi.
English: Respiratory, thoracic and mediastinal disorders
Maltese: Disturbi respiratorji, toraċiċi Komuni
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-tqegħid fis-Suq u l-Manifattur [Ara Anness I - Għandu jitlesta fil-pajjiż stess]
English: • Pregnancy and lactation (see section 4.6).
Maltese: • Tqala u treddigħ (ara sezzjoni 4.6).
English: Infections are more likely.
Maltese: Infezzjonijiet huma aktar probabbli.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients Cellulose, microcrystalline Sodium starch glycolate (Type A) Magnesium stearate
Maltese: Sodium starch glycolate (TIp A)
English: A total of 96 post-dose adverse events were reported by 35 of the 48 subjects who received at least one dose of the study medication.
Maltese: Total ta' 96 episodju avvers ta' wara d-doża ġew irrapportati minn 35 mit-48 suġġett li rċevew għall-inqas doża waħda tal-mediċina tal-istudju.
English: Amlodipine may dilate coronary vessels (arteries and arterioles); it improves oxygen supply to the myocardium both in intact and in ischaemic regions.
Maltese: Amlodipine jista' jwessa' l-vażi koronarji (arterji i arterjoli); ittejjeb il-forniment ta' ossiġnu lil mijokardjum kemm fir-reġjuni intatti u iskemiċi.
English: Bone marrow depression, Agranulocytosis, Leucopenia, Neutropenia, Thrombocytopenia, Haemolytic anaemia Anaemia,
Maltese: Lewkopenja, Newtropenja, Tromboċitopenija, Anemija emolitika
English: Renal function, serum potassium and sodium levels should be monitored during therapy with Lisonorm .
Maltese: Il-funzjoni renali, il-livelli ta' potassju u sodju fis-serum għandhom jiġu mmonitorati waqt it-terapija b'Lisonorm.
English: Lisonorm is not recommended for breast-feeding mothers, as lisinopril may be excreted in human milk (see section 4.3).
Maltese: Lisonorm mhux rakkomandat għal ommijiet li qed ireddgħu, peress li lisinopril jista' jiġi eliminat filħalib tal-bniedem (ara sezzjoni 4.3).
English: In hyperglycaemic patients, lisinopril contributes to the restoration of impaired endothelial function.
Maltese: F'pazjenti ipergliċemiċi, lisinopril jikontribwixxi sabiex ilfunzjoni endoteljali indebolita tiġi restorata.
English: Common side effects in a clinical trial with Lisonorm tablets were: headache, cough, dizziness, palpitations (a quicker or irregular heart beat), and pruritus.
Maltese: Effetti sekondarji komuni fi prova klinika bil-pilloli Lisonorm kienu: uġigħ ta' ras, sogħla, stordament, palpitazzjonijiet (taħbit ta' qalb aktar mgħaġġel jew irregolari), u ħakk.
English: Angioedema accompanied by laryngeal oedema is potentially fatal.
Maltese: Anġjoedema akkumpanjata minn edema larinġeali hi potenzjalment fatali.
English: An Article 29 referral procedure was initiated due to concerns raised by the CZ and LV on the potential serious risk to public health regarding insufficient proof of bioequivalence since the Applicant did not use the originator´s products (Aulin Gel) as reference treatments but used monocomponent-containing generics in the originally submitted bioequivalence study.
Maltese: Minħabba tħassib imqajjem minn CZ u LV firrigward tar-riskji gravi potenzjali għas-saħħa pubblika relatati ma' prova insuffiċjenti ta' bijoekwivalenza minħabba li l-Applikant, fl-istudju ta' bijoekwivalenza sottomessi oriġinarjament, ma użax il-prodotti tal-oriġinatur (Aulin Gel) bħala trattament ta' referenza iżda uża mediċini ġeneriċi li fihom monokomponenti, inbdiet proċedura ta' referenza skont l-Artikolu 29.
English: Hyperkalaemia
Maltese: Magnesium stearate
English: In line with the regulatory requirements (CHMP/EWP/191583/2005), a formal proof of bioequivalence, evidence of a wide therapeutic experience, and an adequately established benefit/risk ratio should be demonstrated for new fixed dose combination products claiming substitution indication.
Maltese: Għall-prodotti ġodda ta' kombinazzjoni ta' doża fissa li juru l-indikazzjoni bħala terapija sostituttiva, ir-rekwiżiti regolatorji (CHMP/EWP/191583/2005) jipprevedu li l-bijoekwivalenza tkun formalment ppruvata, li jiġu ppreżentati provi ta' esperjenza terapewtika mifruxa u murija l-eżistenza ta' relazzjoni ta' riskju/benefiċċju stabbilita adegwatament.
English: Substances affecting potassium levels: Potassium-sparing diuretics (e.g. spironolactone, amiloride, and triamterene), potassium supplements, or potassium-containing salt substitutes and other substances that may increase potassium levels (e.g. heparin) can lead to hyperkalaemia in combination with ACE inhibitors, particularly in patients with renal impairment and other pre-existing conditions (see section 4.4).
Maltese: Sustanzi li jaffettwaw il-livelli ta' potassju: dijuretiċi li ma jħallux il-potassju joħroġ fl-awrina (eż. spironolactone, amiloride, u triamterene), supplimenti tal-potassju, jew mluħa sostituti li jkun fihom il-potassju u sustanzi oħra li jistgħu jżidu l-livelli ta' potassju (eż. heparin) jistgħu jwasslu għal iperkalemja f'kombinazzjoni mal-impedituri ta' l-ACE, b'mod partikolari f'pazjenti b'indeboliment fil-kliewi u kundizzjonijiet oħra li kienu jeżistu qabel (ara sezzjoni 4.4).
English: Bee/wasp venom desensitization
Maltese: Disturbi tad-demm u tas-sistema limfatika
English: ACE inhibitors therapy exposure during the second and third trimesters is known to induce human foetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Maltese: L-espożizzjoni għat-terapija b'impedituri ta' l-ACE waqt it-tieni u t-tielet trimestru hi magħrufa li tinduċi tossiċità fil-fetu uman (tnaqqis fil-funzjoni renali, oligohidramnijosi, dewmien flossifikazzjoni tal-kranju) u tossiċità għal tarbija li għadha titwieled (insuffiċjenza renali, pressjoni baxxa, iperkalemja).
English: In this leaflet:
Maltese: Dijuretiċi:
English: Mood changes, angioedema (hypersensitivity reaction with sudden swelling of the lips, face and neck, and occasionally of the feet and hands; higher rate of angioedema in black patients than in non-black patients), change of colour (pale blue followed by redness) and/or numbness or tingling in the fingers or toes (Raynaud's phenomenon), changes in the way things taste, fatigue, feeling sleepy or difficulty in going to sleep, strange dreams, rapid heartbeat, runny nose, nausea, stomach pain or indigestion, skin rash, itching, impotence, tiredness, muscle weakness).
Maltese: Bidliet fil-burdata, anġjoedema (sensittività eċċessiva b'nefħa f'daqqa tax-xofftejn, il-wiċċ, l-għonq, u kultant tas-saqajn u l-idejn; Rata ogħla ta' anġjoedema f'pazjenti suwed milli f'pazjenti mhux suwed), bidla fil-kulur (ikħal blu ċar segwit bi ħmura) u/jew tirżih jew tnemnim tas-swaba tal-idejn jew tassaqajn (il-fenomenu ta' Raynaud), bidliet fil-mod kif l-affarijiet jintegħmu, tħossok maħlub, bi ngħas jew diffikultà biex torqod, ħolm stramb, taħbit ta' qalb mgħaġġel, imnieħer iqattar, tqalligħ, uġigħ flistonku jew indiġestjoni, raxx tal-ġilda, ħakk, impotenza, għeja, debolezza tal-muskoli).
English: Skin rash, itchy skin, indigestion, shortness of breath, muscle cramps, altered bowel habit, muscle or joint pain, back pain, chest pain, mood changes, tremor, visual disturbances, tinnitus, hypotension, difficulty in breathing, taste perversion, runny nose, increased need to urinate, dry mouth, thirst, loss of pain sensation, increased sweating, fainting, weakness, enlargement of breasts in men, impotence, weight increase, weight decrease.
Maltese: Raxx tal-ġilda, ħakk, indiġestjoni, qtugħ ta' nifs, bugħawwieġ, tibdil fid-drawwiet tal-imsaren, uġigħ fil-muskoli jew fil-ġogi, uġigħ fid-daħar, uġigħ fis-sider, bidliet fil-burdata, rogħda, disturbi fil-vista, tinnite, pressjoni baxxa, diffikultà biex tieħu nifs sew, bidla fit-togħma, imnieħer iqattar, bżonn biex tgħaddi l-awrina aktar ta' spiss, ħalq xott, għatx, nuqqas ta' sensazzjoni għal uġigħ, żieda fil-ħruġ ta' lgħaraq ,ħass ħażin, debolezza, tkabbir tas-sider fl-irġiel, impotenza, żieda fil-piż, tnaqqis fil-piż.
English: In some patients with bilateral renal artery stenosis or with a stenosis of the artery to a solitary kidney, who have been treated with angiotensin converting enzyme inhibitors, increases in blood urea and serum creatinine, usually reversible upon discontinuation of therapy, have been seen.
Maltese: F'xi pazjenti bi stenosi bilaterali tal-arterja renali jew bi stenosi tal-arterja għal kilwa solitarja, li ġew ittrattati b'impedituri għal enżimi li jikkonvertu angiotensin, dehru żidiet fil-livelli ta' urea fid-demm u ta' kreatinina fis-serum, ġeneralment riversibbli malli twaqqfet it-terapija.
English: These life-threatening reactions can be avoided by temporary withdrawal of ACE inhibitor therapy.
Maltese: Dawn irreazzjonijiet kienu evitati billi t-terapija b'impeditur ta' l-ACE ġiet temporanjament miżmuma qabel kull aferesi.
English: Hungary.
Maltese: L-Ungerija.
English: Diuretics: When a diuretic is added to the therapy of a patient receiving Lisonorm the antihypertensive effect is usually additive (see section 4.4).
Maltese: Meta dijuretiku jiġi miżjud mat-terapija ta' pazjent li qed jirċievi Lisonorm l-effett kontra l-pressjoni għolja huwa ġeneralment magħdud (ara sezzjoni 4.4).
English: Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin converting enzyme inhibitors, including lisinopril.
Maltese: Anġjoedema tal-wiċċ, ta' l-estremitajiet, tax-xofftejn, ta' l-ilsien, tal-glottide u/jew tal-larinġi ġew rapportati f'pazjenti trattati b'impedituri għal enżimi li jikkonvertu angiotensin, li jinkludu lisinopril.
English: Adverse reactions were consistent with those reported previously with amlodipine and/or lisinopril.
Maltese: Reazzjonijiet avversi kienu konsistenti ma' dawk rapportati qabel b'amlodipine u/jew lisinopril.
English: Allergic reactions, abnormal liver function test, inflammation of the liver (hepatitis), yellowing of the skin (jaundice), elevation of blood glucose, heart attack (myocardial infarction), irregular heartbeat (arrhythmia), cough, severe skin reactions, swelling or soreness of the gums, red patches on skin.
Maltese: Reazzjonijiet allerġiċi, riżultati ta' funzjoni abnormali tal-fwied, infjammazzjoni tal-fwied (epatite), sfurija tal-ġilda (suffejra), livelli ogħla tal-glukosju fid-demm, attakk tal-qalb (infart mijokardjali), taħbit ta' qalb irregolari (arritmija), sogħla, reazzjonijiet severi tal-ġilda, nefħa jew uġigħ fil-ħanek, dbabar ħomor fuq il-ġilda.
English: • medicines used to treat bacterial (rifampicin), HIV (ritonavir) or fungal infections (ketoconazole).
Maltese: (ritonavir) jew minn fungi (ketoconazole).
English: Accordingly, amlodipine is contraindicated during pregnancy.
Maltese: Għalhekk, amlodipine hu kontraindikat waqt it-tqala.
English: Confusion, acute kidney problems, dry mouth, hair loss, psoriasis, enlargement of breasts in men.
Maltese: Effetti sekondarji rari Konfużjoni, problemi akuti tal-kliewi, ħalq xott, telf ta' xahar, psorjasi, tkabbir tas-sider fl-irġiel.
English: Lisonorm and associated names (see Annex I) 10 mg/5mg tablets [See Annex I - To be completed nationally] Lisinopril/Amlodipine
Maltese: Lisonorm u ismijiet assoċjati (Ara Anness I) pilloli ta' 10 mg/5mg [Ara Anness I - Għandu jitlesta fil-pajjiż stess] Lisinopril/Amlodipine
English: The possibility that more potent inhibitors of CYP3A4 (i.e. ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine to a greater extent than diltiazem cannot be excluded.
Maltese: (i.e. ketoconazole, itraconazole, ritonavir) jistgħu jżidu l-konċentrazzjoni fil-plażma ta' amlodipine aktar minn diltiazem ma jistax jiġi eskluż.
English: - have kidney problems - have liver problems - are under dialysis - are about to have a treatment called LDL apheresis for removal of cholesterol - are older than 65 years - if you are on a low-salt diet and you use potassium containing salt substitutes or supplements - have diarrhoea or vomiting - desensitisation treatment to reduce allergy to bee or wasp stings - are taking any medicines listed below
Maltese: - problemi fil-fwied - ikollok id-dijalisi - ser ikollok trattament imsejjaħ aferesi ta' LDL għat-tneħħija ta' kolesterol - aktar minn 65 sena - jekk inti fuq dieta ta' melħ baxx u qed tuża melħ li fih il-potassju bħala sostitut jew supplimenti - għandek id-dijarea jew qed tirrimetti - trattament biex tnaqqas is-sensittività għal allerġija minn ġdim tan-naħal jew żunżan - qed tieħu mediċini elenkati hawn taħt
English: Pemphigus, Diaphoresis.
Maltese: Tfal u adoloxxenti
English: Whereas - the Applicant has submitted a bioequivalence study, No. 67289, which shows that the test product induces comparable PK profiles for amlodipine and lisinopril in the fixed dose combination to those of the reference products (monocomponents).
Maltese: Billi - l-Applikant ippreżenta studju ta' bijoekwivalenza, Nru 67289, li juri li l-prodott prova jwassal għal profili farmakokinetiċi komparabbli għal amlodipina u lisinopril fil-kombinazzjoni ta' doża fissa għal dawk tal-prodotti ta' referenza (monokomponenti); - il-bijoekwivalenza mal-prodotti monokomponenti ntweriet b'mod adegwat; - il-profil tas-sigurtà tal-prodott tal-prova ma juri ebda differenza fir-rigward tal-episodji avversi assoċjati mat-teħid ta' amlodipina u lisinopril meta mqabbla mat-trattament ta' referenza rispettivi;
English: [To be completed nationally]
Maltese: [Lott]
English: Lisonorm is indicated only for patients in whom the optimal maintenance dose of lisinopril and amlodipine has been titrated to 10 mg and 5 mg, respectively (see section 4.4).
Maltese: Lisonorm hu indikat biss għal pazjenti li għalihom l-aħjar doża ta' manteniment ta' lisinopril u amlodipine ġiet ittittrata għal 10 mg u 5 mg, rispettivament (ara sezzjoni 4.4).
English: Orthostatic hypotension Flushing Uncommon Cerebrovascular accident (see section 4.4), Raynaud's phenomenon
Maltese: Pressjoni ortostatika baxxa Fwawar Mhux komuni Aċċident ċerebrovaskulari (ara sezzjoni 4.4),
English: For Lisonorm (new lisinopril 10mg/ amlodipine 5mg combination), a positive benefit/risk ratio had not been established given that the initial bioequivalence study submitted was not conducted with the appropriate control, and that preliminary results of a new bioequivalence study (No.67289) did not allow a full assessment of the benefit risk ratio.
Maltese: Għal Lisonorm (kombinazzjoni ġdida ta' lisinopril 10mg/ amlodipina 5mg), ma kinitx ġiet stabbilita relazzjoni ta' riskju/benefiċċju favorevoli meta wieħed jikkunsidra li l-istudju ta' bijoekwivalenza inizjalment ippreżentat ma sarx b'kontroll xieraq, u rriżultati preliminari ta' studju ta' bijoekwivalenza ġdid (Nru 67289) ma ppermettewx valutazzjoni sħiħa tar-relazzjoni riskju/benefiċċju.
English: Dry mouth
Maltese: Tqala u treddigħ
English: Oedema, Fatigue
Maltese: Edema, Għeja
English: Compensatory activation of the renin-angiotensin-aldosterone system (RAAS) should be expected and therefore, counter-regulatory mechanisms activated by ACE inhibitors may contribute to the restoration of physiological responses to increased salt intake.
Maltese: Attivazzjoni kompensatorja tas-sistema renin-angiotensin-aldosterone (RAAS) hija mistennija u għalhekk, mekkaniżmi kontraregolatorji attivati minn impedituri tal-ACE jistgħu jikontribwixxu għar-restorazzjoni ta' risponsi fiżjoloġiċi għal żieda fit-teħid ta' mluħa.
English: Anaphylactic shock has been reported in patients dialysed with polyacrylonitrile (e.g. AN 69) membrane and treated concomitantly with an ACE inhibitor, therefore, this combination must be avoided.
Maltese: Xokk anafilattiku ġie rapportat f'pazjenti dijalizzati b'membrana ta' polyacrylonitrile (eż. AN 69) u trattati fl-istess ħin b'impeditur ta' l-ACE, u għalhekk, din il-kombinazzjoni għandha tiġi evitata.
English: Cough Uncommon Rhinitis
Maltese: AKTAR TAGĦRIF
English: Consequently, Lisonorm is contraindicated in pregnancy (see section 4.3).
Maltese: Sussegwentement, Lisonorm hu kontraindikat fit-tqala (ara sezzjoni 4.3).
English: In addition to its direct blood pressure lowering effect, lisinopril mitigates albuminuria by modifying the haemodynamic conditions and tissue structure in the renal glomeruli.
Maltese: Għalkemm l-effett ewlieni huwa stimulat peremzz tas-sistema renin-angiotensin-aldosterone.
English: In controlled clinical trials, the following adverse reactions were reported in ≥ 1% of patients with either concomitantly administered amlodipine plus lisinopril or with amlodipine and lisinopril monotherapies (see Table below):
Maltese: Fi provi kliniċi b'kontrolli, ir-reazzjonijiet avversi li ġejjin ġew rapportati f'≥ 1% ta' pazjenti kemm meta amlodipine u lisinopril ġew mogħtija flimkien jew meta amlodipine u lisinopril ġew moħtija bħala monoterapija (ara Tabella taħt):
English: Amlodipine is slowly and almost completely absorbed from the gastrointestinal tract following oral administration.
Maltese: Amlodipine huwa assorbit bil-mod u kważi b'mod sħiħ mill-passaġġ gastrointestinali wara t-teħid orali.
English: Concomitant use with glyceryl trinitrate and other nitrates, or other vasodilators, may further reduce blood pressure.
Maltese: L-użu konkomitanti ta' glyceryl trinitrate u nitrati oħra, jew vażodilaturi oħra, jista' jnaqqas aktar il-pressjoni tad-demm.
English: In clinical studies, there was no age-related change in the efficacy or safety profile of amlodipine or lisinopril.
Maltese: Fi studji kliniċi, ma kienx hemm bidla relatata ma' l-età fl-effikaċja jew il-profil tas-sigurtà ta' amlodipine jew lisinopril.
English: Intravenous administration of calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Maltese: L-għoti ġol-vina ta' calcium gluconate jista' jkun ta' siwi sabiex jreġġa' lura l-effetti tal-imblokk tal-kanali tal-kalċju.
English: Arthralgia, Myalgia, Muscle cramps, Back pain
Maltese: Sinkope, Tregħid, bidla fit-togħma, Ipoestesja, Paraestesja
English: Non-steroidal anti-inflammatory drugs (NSAIDs): Chronic administration of NSAIDs, including high-dosed acetylsalicylic acid ≥ 3 g/day, may reduce the antihypertensive effect of an ACE inhibitor.
Maltese: L-għoti b'mod kroniku ta' NSAIDs, li jinkludu dożi għoljin ta' acetylsalicylic acid ≥ 3 g/kuljum, jista' jnaqqas l-effett ta' kontra l-pressjoni għolja ta' impeditur ta' l-ACE.
English: Lisonorm is indicated only for patients with titrated optimal maintenance dose of lisinopril and amlodipine of 10 mg and 5 mg, respectively.
Maltese: Lisonorm hu indikat biss għal pazjenti li għalihom l-aħjar doża ta' manteniment ta' lisinopril u amlodipine ġiet ittittrata għal 10 mg u 5 mg, rispettivament.
English: Amlodipine exerts antianginal effect through the dilation of peripheral arterioles as well as through reduction of cardiac afterload, without resulting in reflex tachycardia, and accordingly, energy consumption and oxygen demand of cardiac muscle decrease.
Maltese: Amlodipine jeżerċita effett antianġinali permezz tat-twessiegħ ta' l-arterjoli periperali kif ukoll permezz ta' tnaqqis ta' afterload kardijaku, mingħajr ma jirriżulta f'takikardja riflessiva, u b'riżultat t'hekk, il-konsum ta' l-enerġija u d-domanda għall-ossiġnu tal-muskolu kardijaku jonqsu.
English: Calcium channel blocking activity, for example elicits direct arterial dilation accompanied by sodium and water retention.
Maltese: L-attività ta' imblokk tal-kanali tal-kalċju, pereżempju teliċita twessiegħ arterjali dirett akkumpanjat b'żamma ta' sodju u ilma.
English: Peak plasma concentration (Cmax) occurs 6 to 10 hours after dosing.
Maltese: Il-konċentrazzjoni massima filplażma (Cmax) isseħħ bejn 6 sa 10 sigħat wara li tingħata d-doża.
English: • insulin and oral antidiabetics
Maltese: • insulina u mediċini ta' kontra d-dijabete li jittieħdu mill-ħalq