FrancophonIA/ELRC3.0 huggingface dataset:
English: - History of angioedema associated with previous ACE inhibitor therapy - Hereditary or idiopathic angioedema - Renal impairment (creatinine clearance <30 ml/min/1.73 m2) or anuria - Second and third trimesters of pregnancy (see sections 4.4 and 4.6)
Maltese: - Passat ta' anġjoedima assoċjata ma' terapija preċedenti b'inibitur ta' ACE - Anġjoedima ereditarja jew idjopatika - Indeboliment tal-kliewi (tneħħija tal-krejatinina < 30 ml/min/1.73 m2) jew anurja - It-tieni u t-tielet trimestri tat-tqala (ara sezzjonijiet 4.4 u 4.6)
English: Plasma protein binding is approximately 25 to 30%.
Maltese: Ittwaħħil mal-proteini tal-plażma huwa madwar 25 % sa 30 %.
English: Estimates of frequency are based on the proportion of patients reporting each adverse reaction during Vascace Plus clinical trials that included a total combined population of 1'097 patients.
Maltese: Stimi ta' frekwenza huma bbażati fuq il-proporzjon ta' pazjenti li rappurtaw kull reazzjoni avversa waqt il-provi kliniċi b'Vascace Plus li nkludew popolazzjoni kombinata totali ta' 1,097 pazjent.
English: Hypokalaemia, hyponatraemia, hypochloraemia, hypomagnesaemia, hypercalcaemia, hypocalciuria, hypovolaemia/dehydration, metabolic alkalosis, hyperglycaemia, hyperuricaemia, gout, hypercholesterolaemia (increased total, LDL and VLDL cholesterol) hypertriglyceridaemia.
Maltese: Ipokalimja, iponatrimija, ipoklorimja, ipomanjesimja, iperkalċimija, ipokalċurja, ipovolimja/deidrazzjoni, alkalożi metabolika, ipergliċemija, iperuriċimja, gotta, iperkoleserolimja (żjieda fil-kolesterol totali, LDL u VLDL), ipertrigliċeridimja.
English: (It is also better to avoid Vascace Plus in early pregnancy - see the sections on “Pregnancy” and “Breastfeeding”.)
Maltese: (Ikun aħjar ukoll li tevita' Vascace Plus fi tqala bikrija ara s-sezzjonijiet dwar “Tqala” u “Treddigħ”).
English: The dose of Vascace Plus is one tablet (5.0 mg cilazapril and 12.5 mg hydrochlorothiazide) administered once daily.
Maltese: Id-doża ta' Vascace Plus huwa pillola waħda (5.0 mg cilazapril u 12.5 mg hydrochlorothiazide) mogħtija darba kuljum.
English: Rash, photosensitivity, pseudoporphyria, cutaneous vasculitis Musculoskeletal and connective tissue disorders Uncommon
Maltese: Raxx, fotosensittività, psewdoporfirja, vaskulite kutanja Disturbi muskolu-skeletrali u tat-tessut konnettiv
English: Reasons may include (i) differences between the target populations treated with Vascace Plus and Vascace, (ii) differences in cilazapril dose, and (iii) specific effects of combination therapy.
Maltese: Ir-raġunijiet jistgħu jinkludu (i) differenzi bejn ilpopolazzjonijiet immirati biex jiġu kkurati b'Vascace Plus u Vascace, (ii) differenzi fid-doża ta' cilazapril, u (iii) effetti speċifiċi ta' terapija kombinata.
English: (desensitization).
Maltese: ray).
English: Hydrochlorothiazide is eliminated largely unchanged by the kidney, with a half-life of 7 to 11 hours.
Maltese: Hydrochlorothiazide huwa eliminat fil-biċċa l-kbira mhux mibdul mill-kliewi, b'half-life ta' 7 sa 11-il siegħa.
English: Cilazapril did no show any mutagenic or genotoxic effect in various mutagenicity tests, performed in vitro and in vivo.
Maltese: Cilazapril ma wera l-ebda effett mutaġeniku jew ġenotossiku f'diversi testijiet ta' mutaġeniċità, imwettqa in vitro u in vivo.
English: Simultaneous administration of amantidine and hydrochlorothiazide may increase possible adverse effects of amantidine.
Maltese: L-għoti ta' amantidine flimkien ma' hydrochlorothiazide jista' jżid l-effetti avversi possibbli ta' amantidine.
English: - Calcium supplements and vitamin D. - Cholestyramine/colestipol (used for reducing the amount of fat in your blood).
Maltese: - Supplimenti tal-kalċju u vitamina D. - Cholestyramine/colestipol (użati biex inaqqsu l-ammont ta' xaħam fid-demm tiegħek).
English: Angioedema (may involve the face, lips, tongue, larynx or gastrointestinal tract) (see section 4.4), anaphylaxis (see section 4.4), lupus-like syndrome (symptoms may include vasculitis, myalgia, arthralgia/arthritis, positive antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis)
Maltese: Anġjoedima (tista' tinvolvi l-wiċċ, xufftejn, ilsien, larinġi jew apparat gastro-intestinali) (ara sezzjoni 4.4), anafilassi (ara sezzjoni 4.4), sindrome li tixbaħ lil-lupus (sintomi jistgħu jinkludu vaskulite, uġigħ fil-muskoli, uġigħ fil-ġogi/artrite, antikorpi antinukleari pożittiv, żjidiet fir-rata ta' sedimentazzjoni taleritroċiti, esinofilja u lewkoċitosi)
English: A variant form is angioedema of the intestine, which tends to occur within the first 24-48 hours of treatment.
Maltese: Forma differenti hija anġjoedima tal-musrana, li għandha tendenza li sseħħ fl-ewwel 24-48 siegħa ta' kura.
English: The mean lethal doses in rats, mice, and cynomolgus monkeys were higher than 2000 mg/kg body weight.
Maltese: Dożi letali medji fil-firien, ġrieden, u xadini cynomolgus kienu ogħla minn 2000 mg/kg ta' piż tal-ġisem.
English: For cilazaprilat, the volume of distribution has been determined to be approximately 0.5 to 0.7 l/kg.
Maltese: Għall cilazaprilat, il-volum ta' distribuzzjoni kien iddeterminat li huwa madwar 0.5 sa 0.7 l/kg.
English: Treatment-related adverse events resulting in treatment withdrawal occur in around 0.1% of patients receiving thiazide monotherapy.
Maltese: Avvenimenti avversi relatati mal-kura li jwasslu għal waqfien tal-kura jseħħu f'madwar 0.1 % tal-pazjenti li jirċievu thiazide bħala monoterapija.
English: Hydrochlorothiazide is rapidly absorbed following oral administration of Vascace Plus.
Maltese: Hydrochlorothiazide huwa assorbit malajr wara għoti orali ta' Vascace Plus.
English: Hydrochlorothiazide belongs to a group of medicines called ‘thiazide diuretics' or ‘water tablets'.
Maltese: Hydrochlorothiazide jagħmel parti minn grupp ta' mediċini msejħa ‘dijuretiċi thiazide' jew ‘pilloli talawrina'.
English: Vascace Plus is a combination of cilazapril and hydrochlorothiazide.
Maltese: Vascace Plus huwa taħlita ta' cilazapril u hydrochlorothiazide.
English: Arrhythmia
Maltese: Arritmija
English: Symptoms associated with overdosage of ACE inhibitors may include hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough.
Maltese: Sintomi assoċjati ma' doża eċċessiva ta' inibituri ta' ACE jistgħu jinkludu pressjoni baxxa, xokk ċirkolatorju, disturbi fl-elettroliti, insuffiċjenza tal-kliewi, iperventilazzjoni, takikardija, palpitazzjonijiet, bradikardija, sturdament, ansjetà u sogħla.
English: Hypersensitivity (angioedema, anaphylaxis), lupus-like syndrome Metabolism and nutrition disorders
Maltese: Sensittività eċċessiva (anġjoedima, anafilassi), sindrome jixbaħ lil-lupus Disturbi fil-metaboliżmu u n-nutrizzjoni
English: Austria: Inhibace Plus “Roche” Belgium, Luxembourg: Co-Inhibace Cyprus, Greece: Vascace Plus Czech Republic, Hungary, Poland, Spain: Inhibace Plus Germany: Dynorm Plus
Maltese: Inhibace Plus “Roche” Il-Belġju, il-Lussemburgu:
English: - Steroid medicines (such as hydrocortisone, prednisolone and dexamethasone) or other medication which suppress the immune system.
Maltese: - Sterojdi (bħal hydrocortisone, prednisolone u dexamethasone) jew xi medikazzjoni oħra li tissopprimi s-sistema immuni.
English: Thiazides may increase serum uric acid levels and may precipitate acute gout.
Maltese: Thiazides jistgħu jżidu l-livelli ta' uric acid fis-serum u jistgħu jikkawżaw gotta akuta.
English: Non-depolarizing muscle relaxants
Maltese: Rilassanti tal-muskoli mhux depolarizzanti
English: Cilazapril belongs to a group of medicines called ‘ACE inhibitors' (Angiotensin Converting Enzyme Inhibitors).
Maltese: Cilazapril jagħmel parti minn grupp ta' mediċini msejħa ‘inibituri ta' ACE' (Inibituri tal-Enżima li Tittrasforma lill-Angiotensin).
English: - Hypersensitivity to cilazapril, other ACE inhibitors, hydrochlorothiazide, other thiazide diuretics, sulphonamides or any excipients of Vascace Plus
Maltese: - Sensittività eċċessiva għal cilazapril, inibituri oħra ta' ACE, hydrochlorothiazide, dijuretiċi thiazide oħra, sulphonamides jew għal xi sustanzi mhux attivi ta' Vascace Plus
English: Routine monitoring of potassium and creatinine is part of normal medical practice for patients with renal impairment.
Maltese: Monitoraġġ ta' rutina tal-potassju u tal-krejatinina huwa parti mill-prattika medika normali għall-pazjenti b'indeboliment fil-kliewi.
English: HOW TO TAKE VASCACE PLUS
Maltese: X'fih Vascace Plus
English: If indicated, cilazaprilat, the active form of cilazapril, may be removed from the general circulation by haemodialysis (see section 4.4).
Maltese: Għalhekk, it-taħlita ta' cilazapril mal-mediċini msemmija fuq mhux irrakkomandata (ara sezzjoni 4.4).
English: Glucose levels should be carefully monitored during initiation of treatment with each component of Vascace Plus.
Maltese: Il-livelli tal-glukosju għandhom jiġu ssorveljati b'attenzjoni waqt il-bidu tal-kura b'kull komponent ta' Vascace Plus.
English: Vascace Plus and associated names (see Annex I) 5 mg/12.5 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: Vascace Plus u ismijiet assoċjati (Ara Anness I) 5 mg/12.5 mg mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Concomitant use of anticholinergics (e.g. atropine, biperiden) may increase the bioavailability of hydrochlorothiazide due to reduced gastrointestinal mobility and decreased gastric emptying.
Maltese: L-użu flimkien ta' antikolinerġiċi (eż. atropine, biperiden) jista' jżid il-bijodisponibbiltà ta' hydrochlorothiazide minħabba t-tnaqqis ta' mobilità gastro-intestinali u żvujtjar tal-istonku imnaqqas.
English: The effect is usually not significant in patients with normal renal function.
Maltese: L-effett normalment ma jkunx sinifikanti f'pazjenti b'funzjoni tal-kliewi normali.
English: Thrombocytopaenia, haemolytic anaemia, bone marrow failure, neutropenia Immune system disorders
Maltese: Newtropenija, agranuloċitosi, tromboċitopenija, anemija Disturbi fis-sistema immuni
English: Administration of cilazapril and hydrochlorothiazide in the presence of food delays cilazaprilat Tmax by 1.5 hours and reduces Cmax by 24%.
Maltese: L-għoti ta' cilazapril u hydrochlorothiazide fil-preżenza tal-ikel jittardja Tmax ta' cilazaprilat b'1.5 sigħat u jnaqqas Cmax b'24%.
English: It delays hydrochlorothiazide Tmax by 1.4 hours and reduces Cmax by 14% with no effect on overall bioavailability of both molecules as assessed by AUC0-24-value.
Maltese: Tmax ta' hydrochlorothiazide b'1.4 sigħat u jnaqqas Cmax b'14 % bl-ebda effett fuq il-bijodisponibilità totali taż-żewġ molekoli kif evalwat mill-valur ta' AUC0-24.
English: What Vascace Plus contains - The active substances are cilazapril and hydrochlorothiazide - The other ingredient(s) is (are)...
Maltese: - Is-sustanzi attivi huma cilazapril u hydrochlorothiazide - Is-sustanza(i) l-oħra hi (huma) ....
English: Renal impairment, acute renal failure (see section 4.4), blood creatinine increased, blood urea increased, hyperkalaemia, hyponatraemia, proteinuria, nephrotic syndrome, nephritis Reproductive system and breast disorders
Maltese: Indeboliment tal-kliewi, insuffiċjenza akuta tal-kliewi (ara sezzjoni 4.4), żjieda tal-krejatinina fiddemm, żjieda tal-urea fid-demm, iperkalimja, iponatrimija, protenurja, sindrome nefrotiku, nefrite Disturbi fis-sistema riproduttiva u fis-sider
English: Digoxin
Maltese: Anzjani
English: Treatment-related adverse events resulting in treatment withdrawal occur in less than 5% of patients receiving ACE inhibitor monotherapy.
Maltese: Avvenimenti avversi relatati mal-kura li jwasslu għal waqfien tal-kura jseħħu f'inqas minn 5 % tal-pazjenti li qed jirċievu inibitur ta' ACE bħala monoterapija.
English: Vascace Plus is a combination of two medicines called cilazapril and hydrochlorothiazide.
Maltese: Vascace Plus huwa taħlita ta' żewġ mediċini msejħa cilazapril u hydrochlorothiazide.
English: Dysgeusia, cerebral ischaemia, transient ischaemic attack, ischaemic stroke, peripheral neuropathy Cardiac disorders
Maltese: Disġewsja, iskemija ċerebrali, attakk iskemiku temporanju, puplesija iskemika, newropatija periferali
English: When driving and operating machines, it should be taken into account that occasionally dizziness and fatigue may occur during treatment with Vascace Plus (see sections 4.4 and 4.8).
Maltese: Meta ssuq u tħaddem magni, għandu jittieħed f'kunsiderazzjoni li xi kultant jista' jkun hemm sturdament u għeja waqt kura b'Vascace Plus (ara sezzjonijiet 4.4 u 4.8).
English: Abnormal liver function test (including transaminases, bilirubin, alkaline phosphatase, gamma GT), cholestatic hepatitis with or without necrosis
Maltese: Test tal-funzjoni tal-fwied mhux normali (inkluż transaminases, bilirubin, alkaline phosphatase, gamma GT), epatite kolestatika bi jew mingħajr nekrosi Disturbi fil-ġilda u fit-tessuti ta' taħt il-ġilda
English: Dyspnoea, bronchospasm, rhinitis, interstitial lung disease, bronchitis, sinusitis Gastrointestinal disorders
Maltese: Qtugħ ta' nifs, bronkospażmu, rinite, marda tal-interstizju tal-pulmun, bronkite, sinożite
English: Italy, Portugal: Inibace Plus
Maltese: Inibace Plus
English: Interstitial pneumonitis, acute pulmonary oedema Gastrointestinal disorders
Maltese: Pulmonite tal-interstizju, edima pulmonari akuta
English: Angioedema has been associated with ACE inhibitors, with a reported incidence of 0.1-0.5%.
Maltese: Anġjoedima ġiet assoċjata ma' inibituri ta' ACE, b'inċidenza rrappurtata ta' 0.1 %-0.5 %.
English: NAME OF THE MEDICINAL PRODUCT Vascace Plus and associated names (see Annex I) 5 mg/12.5 mg film-coated tablets [See Annex I - To be completed nationally]
Maltese: TAL-PRODOTT MEDIĊINALI Vascace Plus u ismijiet assoċjati (Ara Anness I) 5 mg/12.5 mg pilloli miksija b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari]
English: Cilazapril was not teratogenic in rats and cynomolgus monkeys.
Maltese: Cilazapril ma kienx teratoġeniku fil-firien u x-xadini cynomolgus.
English: The use of ACE inhibitors such as cilazapril is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
Maltese: L-użu ta' inibituri ta' ACE bħal cilazapril huwa kontra-indikat matul it-tieni u t-tielet trimester tat-tqala (ara sezzjonijiet 4.3 u 4.4).
English: Lithium
Maltese: Anafilassi
English: The overall risk of adverse effects due to treatment with Vascace Plus is similar to that observed in patients receiving cilazapril monotherapy.
Maltese: Ir-riskju globali ta' avvenimenti avversi kkawżati minn kura b'Vascace Plus huwa simili għal dak osservat f'pazjenti li jirċievu cilazapril bħala monoterapija.
English: Take special care with Vascace Plus
Maltese: Oqgħod attent ħafna b'Vascace Plus
English: Rarely, neutropenia and agranulocytosis have been associated with both thiazides and ACE inhibitors, especially in patients with renal failure or collagen vascular disease, and those receiving immunosuppressive therapy.
Maltese: Rarament, newtropenija u agranuloċitosi kienu assoċjati kemm ma' thiazides kif ukoll ma' inibituri ta' ACE, speċjalment f'pazjenti b'insuffiċjenza renali jew mard tal-collagen vaskulari, u dawk li qed jirċievu terapija immunosoppressiva.
English: In clinical studies, the efficacy and tolerability of cilazapril and hydrochlorothiazide administered concomitantly was similar in both elderly and younger hypertensive patients, although pharmacokinetic data show that clearance of both components in elderly patients was reduced (see section 5.2).
Maltese: Fi studji kliniċi, l-effikaċja u t-tollerabilità ta' l-għoti flimkien ta' cilazapril u hydrochlorothiazide kienu simili f'pazjenti bi pressjoni għolja anzjani u f'pazjenti iżgħar, għalkemm dejta farmakokinetika turi li t-tneħħija taż-żewġ komponenti f'pazjenti anzjani kienet imnaqqsa (ara sezzjoni 5.2).
English: Others
Maltese: da
English: Dry mouth, aphthous stomatitis, decreased appetite, diarrhoea, vomiting, glossitis, pancreatitis Hepatobiliary disorders
Maltese: Ħalq xott, stomatite bl-ulċeri, tnaqqis fl-aptit, dijarea, rimettar, glossite, pankreatite Disturbi fil-fwied u fil-marrara
English: The pharmacokinetic parameters of cilazaprilat are not altered in the presence of increasing doses of the hydrochlorothiazide component.
Maltese: Il-parametri farmakokinetiċi ta' cilazaprilat ma jinbidlux fil-preżenza ta' dożi akbar tal-komponent hydrochlorothiazide.
English: In predisposed patients (e.g. prostatic hyperplasia) hydrochlorothiazide overdose may induce acute urinary retention.
Maltese: F'pazjenti predisposti (eż. iperplażja tal-prostata) doża eċċessiva ta' hydrochlorothiazide tista' tikkawża żamma akuta tal-awrina.
English: Interactions mainly related to hydrochlorothiazide
Maltese: Reazzjonijiet avversi għal hydrochlorothiazide
English: Do not use Vascace Plus after the expiry date which is stated on the pack after EXP.
Maltese: Tużax Vascace Plus wara d-data ta' skadenza li tidher fuq il-kartuna wara EXP.
English: There is limited experience with hydrochlorothiazide during pregnancy.
Maltese: Hemm esperjenza limitata b'hydrochlorothiazide waqt it-tqala.
English: The frequency of adverse reactions attributable to cilazapril, occurring in patients receiving combination therapy (cilazapril + hydrochlorothiazide), may differ from that seen in patients receiving cilazapril monotherapy.
Maltese: Il-frekwenza ta' reazzjonijiet avversi attribwibbli għal cilazapril, li jseħħu f'pazjenti li qed jirċievu terapija kombinata (cilazapril + hydrochlorothiazide), tista' tkun differenti minn dik osservata f'pazjenti li qed jirċievu monoterapija ta' cilazapril.
English: Muscle cramp
Maltese: Elettroliti fis-serum
English: Combination studies with cilazapril and hydrochlorothiazide caused similar findings as observed with cilazapril alone.
Maltese: Studji ta' taħlita ta' cilazapril u hydrochlorothiazide wasslu għall-sejbiet simili kif osservati b'cilazapril waħdu.
English: The combination of cilazapril and hydrochlorothiazide caused no relevant signs of a mutagenic potential for the case of therapeutic treatment.
Maltese: It-taħlita ta' cilazapril u hydrochlorothiazide ma kkawżat l-ebda sinjali rilevanti ta' potenzjal mutaġeniku għall-każ ta' kura terapewtika.
English: Safety and efficacy in children and adolescents below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja fi tfal u adoloxxenti b'età inqas minn 18-il sena ma ġewx stabbiliti.
English: Studies performed with Vascace Plus have demonstrated that the combination of cilazapril and hydrochlorothiazide administered once daily at various doses reduces systolic and diastolic blood pressure compared to placebo 24 hours after dosing, to an extent that is both statistically significant and clinically meaningful.
Maltese: Studji mwettqa b'Vascace Plus urew li t-taħlita ta' cilazapril u hydrochlorothiazide mogħtija darba kuljum f'dożi varji naqqsu il-pressjoni tad-demm sistolika u dijastolika meta mqabbel mal-plaċebo 24 siegħa wara li ngħatat id-doża sa punt li huwa sinifikanti kemm statistikament kif ukoll klinikament.
English: Cilazapril is converted to its active metabolite, cilazaprilat, a specific long-acting angiotensinconverting enzyme (ACE) inhibitor which suppresses the renin-angiotensin-aldosterone system and thereby the conversion of the inactive angiotensin I to angiotensin II, which is a potent vasoconstrictor.
Maltese: Cilazapril jinbidel għall-metabolit attiv tiegħu, cilazaprilat, inibitur speċifiku tal-enżima li tittrasforma lill-angiotensin (ACE), li jaħdem fit-tul u li jrażżan is-sistema renin-angiotensin-aldosterone u b'hekk il-bidla ta' angiotensin I mhux attiv għal angiotensin II, li huwa vażokostrittur qawwi.
English: (anemia, neutropenia, agranulocytosis and thrombocytopenia) - Blood tests showing abnormal electrolyte levels (sodium, potassium, chloride, magnesium,
Maltese: - Għaraq aktar mis-soltu - Fwawar - Problemi biex torqod - Testijiet tad-demm li juru tnaqqis fl-għadd ta' ċelluli ħomor tad-demm, ċelluli bojod tad-demm jew plejtlets (anemija, newtropenija, agranuloċitosi u tromboċitopenija) - Testijiet tad-demm li juru livelli mhux normali ta' elettroliti (sodium, potassium, chloride,
English: Interstitial nephritis, renal impairment
Maltese: Nefrite tal-interstizju, indeboliment tal-kliewi
English: There was no evidence of teratogenicity with the combination of cilazapril and hydrochlorothiazide in rats and mice.
Maltese: Ma kien hemm l-ebda evidenza ta' teratoġeniċità bit-taħlita ta' hydrochlorothiazide u cilazapril fil-firien u l-ġrieden.
English: Adverse reactions that were not observed during Vascace Plus clinical trials but have been reported in association with monotherapy with either component or with other ACE inhibitors or thiazide diuretics, or derived from post-marketing case reports, are classified as `uncommon' (<1/100).
Maltese: Ir-reazzjonijiet avversi li ma kinux osservati waqt il-provi kliniċi b'Vascace Plus iżda kienu rrappurtati f'assoċjazzjoni ma' monoterapija b'xi wieħed mill-komponenti jew b'inibituri ta' ACE jew dijuretiċi thiazide oħra, jew derivati minn rapporti ta' każijiet ta' wara t-tqegħid fis-suq huma klassifikati bħala “mhux komuni” (< 1/100).
English: AUC values increase proportionally for cilazaprilat and hydrochlorothiazide with increasing doses of cilazapril and hydrochlorothiazide in the combination dosage form.
Maltese: Il-valuri tal-AUC jiżdiedu b'mod proporzjonali għal cilazaprilat u hydrochlorothiazide b'żjieda fiddożi ta' cilazapril u hydrochlorothiazide fil-forma mħallta tad-dożaġġ.
English: - Cyclosporine (used to stop the rejection of organs after transplantation).
Maltese: - Cyclosporine (użat biex iwaqqaf il-rifjut ta' organi wara trapjant).
English: In elderly patients whose renal function is normal for age, plasma concentrations of cilazaprilat may be up to 40% higher, and clearance 20% lower, than in younger patients.
Maltese: F'pazjenti anzjani li għandhom funzjoni tal-kliewi normali għall-età tagħhom, il-konċentrazzjonijiet ta' cilazaprilat fil-plażma jistgħu jkunu sa 40% ogħla, u t-tneħħija 20% aktar baxxa, minn f'pazjenti iżgħar.
English: Hepatic disease does not significantly affect the pharmacokinetics of hydrochlorothiazide.
Maltese: Mard tal-kliewi ma jaffetwax il-farmakokinetika ta' hydrochlorothiazide b'mod sinifikanti.
English: No clinically significant interactions were observed when cilazapril and digoxin, nitrates, coumarin anticoagulants, and H2-receptor blockers were concomitantly administered.
Maltese: Meta cilazapril u digoxin, nitrati, antikoagulanti coumarin u imblukkaturi tar-riċettur H2 ingħataw flimkien, ma kienux osservati interazzjonijiet ta' sinifikanza klinika.
English: Cholestatic jaundice
Maltese: Karċinoġeniċità
English: The following list of adverse reactions is derived from clinical trials and post-marketing data, and includes adverse drug reactions seen in patients receiving treatment with cilazapril and/or other ACE inhibitors alone, hydrochlorothiazide and/or other thiazide-type diuretics alone, and in those receiving combined therapy.
Maltese: Il-lista ta' reazzjonijiet avversi li ġejja hija derivata minn provi kliniċi u dejta ta' wara t-tqegħid fissuq, u tinkludi reazzjonijiet avversi tal-mediċina li kienu osservati f'pazjenti li kienu qed jirċievu kura b'cilazapril u/jew inibituri oħra ta' ACE waħedhom, hydrochlorothiazide u/jew dijuretiċi tat-tip thiazide oħra waħedhom, u f'dawk li kienu qed jirċievu terapija kombinata.
English: Thiazides cross the placenta and may be associated with neonatal jaundice, thrombocytopenia and electrolyte abnormalities.
Maltese: Thiazides jgħaddu mill-plaċenta u jistgħu jkunu assoċjati ma' suffejra, tromboċitopenija u anormalitajiet fl-elettroliti fi trabi tat-twelid.