FrancophonIA/ELRC3.0 huggingface dataset:
English: The amount of Xagrid that people take can be different, and this depends on your condition.
Maltese: L-ammont ta' Xagrid li persuni jistgħu jieħdu jista' jkun differenti, u dan jiddependi mill-kundizzjoni tiegħek.
English: The effect of two dose levels of anagrelide (0.5 mg and 2.5 mg single doses) on the heart rate and QTc interval was evaluated in a double-blind, randomised, placebo- and active-controlled, cross-over study in healthy adult men and women.
Maltese: Effetti fuq ir-rata ta' taħbit tal-qalb u l-intervall tal-QTc L-effett ta' żewġ livelli ta' doża ta' anagrelide (0.5 mg u 2.5 mg doża waħda) fuq ir-rata ta' taħbit tal-qalb u l-intervall tal-QTc ġie evalwat fi studju double-blind, li fih il-parteċipanti ntgħażlu b'mod każwali, ikkontrollat bi plaċebo u b'mod attiv, tat-tip cross-over, li sar fuq irġiel u nisa adulti b'saħħithom.
English: Available data in animals have shown excretion of anagrelide/metabolites in milk.
Maltese: Dejta flannimali uriet li hemm eliminazzjoni ta' anagrelide/metaboliti fil-ħalib tas-sider.
English: Typically cytoreductive therapy is considered in high risk paediatric patients.
Maltese: Tipikament, terapija ċitoreduttiva tiġi kkunsidrata f'pazjenti pedjatriċi f'riskju għoli.
English: The lowest dose in males (3 mg/kg/day) corresponds to 37 times the human AUC exposure after a 1 mg twice daily dose.
Maltese: Linqas doża f'dawk maskili (3 mg/kg/kuljum) tikkorrispondi għal 37 darba ta' l-espożizzjoni ta' l-AUC
English: In female rats increases in pre- and post-implantation losses and a decrease in the mean number of live embryos was observed at 30 mg/kg/day.
Maltese: F'firien nisa, żidiet fit-telf qabel u wara l-impjantazzjoni u żieda fil-medja tan-numru ta' embriji ħajjin, ġie osservat f'doża ta' 30 mg/kg/jum.
English: In combination with acetylsalicylic acid (a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting, also known as aspirin), there is an increased risk of major haemorrhages (bleeding) (see section “Other medicines and Xagrid”).
Maltese: Flimkien ma' acetylsalicylic acid (sustanza li tinsab f'ħafna mediċini li jintużaw għal-uġigħ u biex jitnaqqas id-deni, kif ukoll għall-prevenzjoni ta' tagħqid tad-demm, magħrufa wkoll bħala aspirina), hemm żieda fir-riskju ta' emorraġiji serji (ħruġ ta' demm) (ara sezzjoni “Mediċini oħra u Xagrid”).
English: Diameter: about 8 mm.
Maltese: Dijametru: madwar 8 mm.
English: INFORMATION IN BRAILLE Lisonorm 10/5 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Lisonorm 10/5 mg
English: Erythema multiforme, Angioedema, Urticaria
Maltese: Erytema multiforme, Anġjoedema, Urtikarja
English: Elderly (> 65 years)
Maltese: Anzjani (> 65 sena)
English: Uncommon Impotence
Maltese: Mhux komuni Impotenza
English: • herbal preparations containing St. John's wort (Hypericum perforatum)
Maltese: John's wort (Hypericum perforatum)
English: Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome, Erythema multiforme.
Maltese: Rari ħafna Nekrolisi Epidermali tossika, Sindromu ta' Stevens-Johnson, Eritema multiforme.
English: Impotence, Gynaecomastia
Maltese: Impotenza, Ginekomastja
English: Lisonorm 10mg/5mg 10 mg/5 mg tablets oral use
Maltese: Lisonorm 10mg/5mg 10 mg/5 mg pilloli
English: The effective half-life of lisinopril is 12.6 hours.
Maltese: Il-half-life effettiv ta' lisinopril hu 12.6 sigħat.
English: Additionally, there was a high incidence of QT prolongation observed in 16.7% subjects (n=8).
Maltese: Barra minn hekk, kien hemm inċidenza għolja ta' prolungament tal-QT osservat f'16.7% tas-suġġetti (n=8).
English: Uncommon Myocardial infarction (see section 4.4), Tachycardia, Palpitations,
Maltese: Mhux komuni Infart mijokardijaku (ara sezzjoni 4.4), Takikardja, Palpitazzjonijiet,
English: Pharmacokinetic parameters (AUC, Cmax, tmax, half-life) were not different from those observed after administration of the individual components separately.
Maltese: Il-parametri farmakokinetiċi (AUC, Cmax, tmax, half-life) ma kinux differenti minn dawk osservati wara l-għoti tal-komponenti individwali mogħtija separatament.
English: 10 mg/5 mg tablets oral use
Maltese: 10 mg/5 mg pilloli
English: In the systemic circulation 95 to 98 % of amlodipine is bound to plasma protein.
Maltese: Fiċ-ċirkolazzjoni sistemika 95 sa 98 % ta' amlodipine huwa marbut ma' proteini fil-plażma.
English: Myocardial infarction, Ventricular tachycardia, Atrial fibrillation, Arrhythmia
Maltese: Infart mijokardijaku, Takikardja ventrikulari, Fibrilazzjoni atrijali, Arritmija
English: The bioavailability of amlodipine is 64 to 80 %; its volume of distribution is approximately 20 l/kg.
Maltese: Il-bijodisponibilità ta' amlodipine hi ta' bejn 64 sa 80 %; il-volum ta' distribuzzjoni hi madwar 20 l/kg.
English: Dyspnoea, Rhinitis
Maltese: Dispnea, Rinite
English: Psoriasis, Urticaria, Alopecia
Maltese: Psorjasi, Urtikarja, Alopeċja
English: • autonomous nervous system stimulants (sympathomimetics), such as ephedrine, phenylephrine,
Maltese: • stimulanti tas-sistema nervuża awtonoma (simpatomimetiċi), bħal ephedrine, phenylephrine,
English: • Unstable angina pectoris (excluding Prinzmetal's angina).
Maltese: • Anġina pectoris instabbli (li teskludi l-anġina ta' Prinzmetal).
English: Acute renal failure, Uraemia
Maltese: Insuffiċjenza renali akuta, Uremja
English: The most common adverse reactions with the combination were headache (8%), cough (5%), and dizziness (3%).
Maltese: L-aktar reazzjonijiet avversi komuni bil-kombinazzjoni kienu uġigħ ta' ras (8%), sogħla (5%), u sturdament (3%).
English: Frequencies are defined as follows: Very common (≥ 1/10), Common (≥ 1/100 to < 1/10), Uncommon (≥ 1/1,000 to < 1/100), Rare (≥ 1/10,000 to <1/1,000), Very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Komuni ħafna (≥ 1/10), Komuni (≥ 1/100 sa < 1/10), Mhux komuni (≥ 1/1,000 sa < 1/100), Rari (≥ 1/10,000 sa <1/1,000), Rari ħafna (< 1/10,000), mhux magħruf (ma jistax jiġi stmat mit-tagħrif disponibbli).
English: The 90% confidence intervals calculated for AUC(0-t), AUC(0-inf) and Cmax were within the range of 0.8-1.25 for both components (lisinopril and amlodipine).
Maltese: L-intervalli ta' kunfidenza ta' 90% ikkalkolati għal AUC(0-t), AUC(0-inf) u Cmax kienu fil-medda ta' 0.8-1.25 għaż-żewġ komponenti (lisinopril u amlodipina).
English: Immune system disorders Very rare
Maltese: Disturbi tas-sistema immuni Rari ħafna Disturbi awtoimmuni
English: Pancreatitis, Gastritis, Gingival hyperplasia
Maltese: Pankreatite, Gastrite, Iperplasja ġenġivali
English: Amlodipine is a dihydropyridine-type calcium channel blocker.
Maltese: Amlodipine huwa imblokkatur tal-kanali tal-kalċju tat-tip dihydropyridine.
English: Elimination from the plasma is biphasic with a terminal elimination half-life of about 30-50 hours.
Maltese: L-eliminazzjoni mill-plażma hi bifażika b'half-life ta' eliminazzjoni terminali ta' madwar 30-50 siegħa.
English: • Hereditary or idiopathic angioedema (see section 4.4).
Maltese: • Anġjoedema ereditarja jew idjopatika (ara sezzjoni 4.4).
English: Fixed dose combination
Maltese: Kombinazzjoni ta' doża fissa
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolo-skeletriċi u tat-tessut konnettiv
English: Pharmacotherapeutic group: ACE inhibitors and calcium channel blockers, ATC code: not yet assigned.
Maltese: Kategorija farmakoterapewtika: impedituri ta' l-ACE u imblokkaturi għal kanali tal-kalċju, Kodiċi ATC:
English: - The other ingredients are cellulose microcrystalline, sodium starch glycolate (type A) and magnesium stearate.
Maltese: - Is-sustanzi l-oħra huma cellulose microcrystalline, sodium starch glycolate (tip A) u magnesium stearate.
English: • anticonvulsants (such as carbamazepine, phenobarbital and phenytoin), used to treat epilepsy
Maltese: • mediċini antikonvulsanti (bħal carbamazepine, phenobarbital u phenytoin), użati biex jittrattaw l-epilessija
English: ADRs with amlodipine
Maltese: ADR b'amlodipine
English: 6.4 Special precautions for storage Store below 25°C
Maltese: 6.4 Prekawzjonijiet speċjali għall-ħażna Aħżen f'temperatura taħt 25°C
English: 6.5 Nature and contents of container 30 tablets in white, opaque PVC/PE/PVDC/Aluminium blisters.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 30 pillola f'folji bojod-opaki tal-PVC/PE/PVDC/Aluminju.
English: Amlodipine is extensively metabolized by the liver to inactive metabolites with 10 % of the unchanged parent compound and 60 % of metabolites are excreted in the urine.
Maltese: Amlodipine huwa metabolizzat estensivament mill-fwied għal metaboliti inattivi b'10% tas-sustanza originali mhux mibdula u 60% tal-metaboliti eliminati fl-awrina.
English: Adverse reaction Lisonorm (n=64)
Maltese: Reazzjoni avversa Lisonorm (n=64)
English: Interactions related to amlodipine
Maltese: Interazzjonijiet relatati ma' amlodipine
English: Lisonorm is a fixed dose combination containing the active substances lisinopril and amlodipine.
Maltese: Lisonorm huwa kombinazzjoni ta' dożi fissi bis-sustanzi attivi lisinopril u amlodipine.
English: • allupurinol, used to treat gout
Maltese: • allupurinol, użat biex jittratta l-gotta
English: • Hypersensitivity to amlodipine or to any other dihydropyridine derivatives.
Maltese: • Sensittività eċċessiva għal amlodipine jew kull derivat ieħor ta' dihydropyridine.
English: Therefore, the Applicant acknowledged the limitations arising from the product selection in the initial pivotal BE study and performed a study (Protocol No 67289) to investigate bioequivalence of LISONORM FORTE (fixed-combination of amlodipine 10 mg and lisinopril 20 mg), co-administration of NORVASC 10 mg (containing amlodipine 10 mg) and PRINIVIL 20 mg (containing lisinopril 20 mg), and LISONORM (fixed-combination of amlodipine 5 mg and lisinopril 10 mg) under fasting conditions.
Maltese: Għaldaqstant, l-Applikant għaraf il-limiti li jirriżultaw mill-għażla tal-prodotti fl-istudju BE inizjali ta' importanza fundamentali u wettaq studju (Protokoll Nru 67289) sabiex jeżamina l-bijoekwivalenza ta' LISONORM FORTE (kombinazzjoni fissa ta' amlodipina 10 mg u lisinopril 20 mg), amministrazzjoni fl-istess ħin ta' NORVASC 10 mg (li fih amlodipina 10 mg) u PRINIVIL 20 mg (li fih lisinopril 20 mg), u LISONORM (kombinazzjoni fissa ta' amlodipina 5 mg u lisinopril 10 mg) taħt kundizzjonijiet ta' sawm.
English: Renal dysfunction
Maltese: Indeboliment fil-funzjoni renali
English: Pharmacokinetic parameters were calculated for amlodipine and lisinopril by the means of Bioequiv 3.5 software using a model independent approach.
Maltese: Il-parametri farmakokinetiċi ġew ikkalkolati għal amlodipina u lisinopril permezz ta' softwer Bioequiv 3.5 li juża approċċ mudell-indipendenti.
English: Uncommon Hypersensitivity/angioedem a of the face, extremities, lips, tongue, glottis and/or larynx (see section 4.4), Rash, Pruritus
Maltese: Mhux komuni Sensittività eċċessiva/anġjoedema tal-wiċċ, estremitajiet, xofftejn, ilsien, glottide u/jew tal-larinġi (ara sezzjoni 4.4), Raxx, Ħakk
English: Others: In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, antiacid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non-steroidal antiinflammatory medicines, antibiotics and oral hypoglycaemic medicines.
Maltese: Oħrajn: Fil-monoterapija, amlodipine ngħata b'mod sikur ma' dijuretiċi ta' thiażide, imblokkaturi tarriċetturi beta, impedituri tal-ACE, nitrati li jaġixxu fuq perijodu ta' żmien twil, nitrogliċerina għal taħt l-ilsien, digoxin, warfarina, atorvastatin, sildenafil, mediċini kontra l-aċidu (ġel ta' aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti-infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi li jittieħdu mill-ħalq.
English: • diuretics (used to reduce fluid retention)
Maltese: • dijuretiċi (użati biex inaqqsu l-akkumulazzjoni ta' fluwidu)
English: Do not take Lisonorm
Maltese: Tieħux Lisonorm
English: Alopecia, Rash, Purpura, Skin discolouration, Diaphoresis, Pruritus
Maltese: Alopeċja, Raxx, Purpura, Tibdil fil-kulur tal-ġilda, Dijaforesi, Ħakk
English: Frequencies are defined as follows: very common: affects more than 1 user in 10 common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000 rare: affects 1 to 10 users in 10,000 very rare: affects less than 1 user in 10,000 not known: frequency cannot be estimated from the available data.
Maltese: Il-frekwenzi huma mfissra kif ġej: komuni ħafna: jaffettwa aktar minn persuna 1 minn kull 10 komuni: jaffettwa minn 1 sa 10 persuni minn kull 100 mhux komuni: jaffettwa minn 1 sa 10 persuni minn kull 1,000 rari: jaffettwa minn 1 sa 10 persuni minn kull 10,000 rari ħafna: jaffettwa inqas minn persuna 1 minn kull 10,000 mhux magħruf: il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli.
English: Interactions related to lisinopril
Maltese: Interazzjonijiet relatati ma' lisinopril
English: Packs contain 30 tablets in white, opaque PVC/PE/PVDC-aluminium blisters.
Maltese: Il-pakketti fihom 30 pillola f'folji tal-aluminju opaki tal-PVC/PE/PVDC.
English: Hepatic failure, Hepatitis, Cholestatic jaundice, (see section 4.4)
Maltese: Rari ħafna Insuffiċjenza epatika, Epatite, Suffejra kolestatika, (ara sezzjoni 4.4)
English: Hepatitis, Jaundice, Cholestasis
Maltese: Epatite, Suffejra, Kolestasi
English: • Heart failure after acute myocardial infarction (during the first 28 days).
Maltese: • Insuffiċjenza kardijaka wara infart mijokardijaku akut (matul l-ewwel 28 jum).
English: • lithium, antipsychotics, used to treat mental disorders
Maltese: • lithium, antipsikotiċi, użati biex jittrattaw disturbi mentali
English: Mental disorders
Maltese: Disturbi mentali
English: Teratogenic or other embrio/fetotoxic effects were not found in rats and rabbits given up to 10 mg/kg amlodipine (8 times and 23 times, respectively, the maximum recommended human daily dose of 10 mg on a mg/m2 basis) during gestation.
Maltese: Effetti teratoġeniċi jew effetti fuq l-embrijo/fetu ma nstabux fuq firien u fniek li ngħataw sa 10 mg/kg amlodipine (8 darbiet u 23 darba, rispettivament id doża massima rakkomandata kuljum għall-bniedem ta' 10 mg fuq bażi ta' mg/m2) waqt it-tqala.
English: Bronchospasm, Allergic alveolitis/Eosinophilic pneumonia, Sinusitis
Maltese: Rari ħafna Bronkospażmu, Alveolite allerġika/Pnewmonja
English: The geometric mean ratios, 90% confidence intervals and corresponding intra-individual CVs for Cmax, AUC0-t and AUC0-∞ for amlodipine and lisinopril were also presented.
Maltese: Ġew ippreżentati wkoll il-proporzjonijiet medji ġeometriċi, l-intervalli ta' kunfidenza ta' 90% u CVs intraindividwi korrispondenti għal Cmax, AUC0-t u AUC0-∞ ta' amlodipina u lisinopril.
English: Overall, the CHMP considered that the applicant had responded adequately by providing the results of an additional study, BES No.67289, and had demonstrated formal proof of bioequivalence.
Maltese: Kumplessivament, is-CHMP ikkunsidra li l-Applikant wieġeb b'mod adegwat billi pprovda r-riżultati ta' studju addizzjonali, BES Nru 67289, u wera prova formali ta' bijoekwivalenza.
English: CYP3A4 inducers: Co-administration with anticonvulsant agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, herbal preparations containing St. John's wort/Hypericum perforatum) may lead to reduced plasma concentrations of amlodipine.
Maltese: It-teħid konġunt ta' sustanzi antikonvulsanti (eż. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone), rifampicin, preparazzjonijiet bil-ħxejjex li fihom St.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA Kull pillola fiha 10 mg lisinopril (bħala dihydrate) u 5 mg amlodipine (bħala besilate).
English: Uncommon Vertigo, Paraesthesia, Taste disturbance
Maltese: Mhux komuni Vertigo, Paraestesija, Disturbi fit-togħma
English: Pancreatitis, Intestinal angioedema
Maltese: Rari ħafna Pankreatite, Anġjoedema intestinali
English: The applicant, Gideon Richter, sought a Marketing Authorisation in several member states (CZ, EE, LT, LV, PL, RO, and SK,) through the Mutual Recognition Procedure with Hungary acting as the reference member state.
Maltese: Lapplikant, Gideon Richter, ippreżenta applikazzjoni għal Awtorizzazzjoni għat-Tqegħid fis-Suq f'bosta Stati Membri (CZ, EE, LT, LV, PL, RO, u SK,) permezz tal-Proċedura ta' Rikonoxximent Reċiproku bl-Ungerija taġixxi bħala l-Istat Membru ta' referenza.
English: No teratogenic effects of lisinopril were seen in mice, rats and rabbits given doses that were 55 times, 33 times and 0.15 times, respectively, the maximum recommended human daily dose.
Maltese: Ma dehru ebda effetti teratoġeniċi ta' lisinopril fil-ġrieden, il-firien u l-fniek meta dawn ingħataw 55 darba, 33 darba u 0.15 darbiet, rispettivament, id-doża massima ta' kuljum rakkomandata għal bniedem.
English: Each tablet contains 10 mg lisinopril (as dihydrate) and 5 mg amlodipine (as besilate).
Maltese: Kull pillola fiha 10 mg lisinopril (bħala dihydrate) u 5 mg amlodipine (bħala besilate).
English: A syndrome has been reported that may include one or more of the following symptoms: fever, vasculitis, myalgia, arthralgia/arthritis, positive ANA, elevated ESR value, eosinophilia and leucocytosis, rash, photosensitivity or other dermatological manifestations.
Maltese: Sindromu ġie rapportat li jista' jinkludi wieħed jew aktar mis-sintomi li ġejjin: deni, vaskulite, uġigħ filmuskoli, artralġja/artrite, ANA pożittiva, valur ta' ESR elevat, eosinofilja u lewkoċitosi, raxx, fotosensittività u manifestazzjonijiet oħra tal-ġilda.
English: No pharmacokinetic interactions have been described between the active substances of Lisonorm .
Maltese: M'hemmx interazzjonijiet farmakokinetiċi deskritti bejn is-sustanzi attivi ta' Lisonorm.
English: Allopurinol, procainamide, cytostatics or immunosuppressive agents (systemic corticosteroids) may lead to an increased risk of leukopenia when administered concomitantly with ACE inhibitors.
Maltese: Allopurinol, procainamide, ċitostatiċi jew sustanzi immunosuppressivi (kortikosterojdi sistemiċi) jistgħu jwasslu għal riskju ogħla ta' lewkopenja meta jingħataw flimkien ma' impedituri ta' l-ACE.
English: • anaesthetics, used in surgery or some dental procedures.
Maltese: • anestetiċi, użati fil-kirurġija jew f'xi proċeduri dentali.
English: What LISONORM contains - The active substances are lisinopril and amlodipine.
Maltese: - Is-sustanzi attivi huma lisinopril u amlodipine.
English: Anaphylactoid reactions during low-density lipoproteins (LDL) apheresis Rarely, patients receiving ACE inhibitors during low-density lipoproteins (LDL) apheresis with dextran sulphate have experienced life-threatening anaphylactoid reactions.
Maltese: Reazzjonijiet anafilattojdi waqt aferesi ta' liunpoproteini ta' densità baxxa (LDL)) F'każijiet rari, pazjenti li rċevew impedituri ta' l-ACE waqt aferesi ta' lipoproteini ta' densità baxxa (LDL) b'dextran sulphate kellhom reazzjonijiet anafilattojdi li kienu ta' periklu għal ħajja.
English: Amlodipine is transformed into inactive metabolites in the liver primarily, with 10 % of the unchanged parent compound excreted in the urine.
Maltese: Amlodipine jiġi trasformat f'metaboliti mhux attivi prinċipalment filfwied, b'10 % tas-sustanza oriġinali mhux mibdula eliminata fl-awrina.
English: Overdose can result in excessive peripheral vasodilatation with marked hypotension, circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, and cough.
Maltese: Doża eċċessiva tista' tirriżulta f'vażodilazzjoni periferali eċċessiva bi pressjoni baxxa sostanzjali, xokk ċirkolatorju, disturbi fl-elettroliti, insuffiċjenza renali, iperventilazzjoni, takikardja, palpitazzjonijiet, bradikardja, sturdamenti, ansjetà, u sogħla.
English: Adverse reactions were usually mild, transient and rarely warranted the discontinuation of treatment with Lisonorm .
Maltese: Reazzjonijiet avversi kienu ġeneralment ħfief, għaddiena u rarement kienu jeħtieġu li t-trattament b'Lisonorm jitwaqqaf.
English: • non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid (used to treat for arthritis,
Maltese: • mediċini anti-infjammatorji mhux sterojdi (NSAID) bħal acetylsalicylic acid (użati fit-trattament ta' artrite, uġigħ muskolari, uġigħ ta' ras, infjammazzjoni, deni)
English: Intestinal oedema has been reported rarely in patients treated with ACE inhibitors.
Maltese: Edema intestinali ġiet rapportata rarement f'pazjenti ttrattati b'impedituri ta' l-ACE.
English: Lisinopril mitigates the kaliuretic effect of diuretics.
Maltese: Lisinopril jimmitiga l-effetti kaliuretiċi tad-dijuretiċi.
English: The following adverse drug reactions (ADRs) have been reported during the treatment with lisinopril and amlodipine independently :
Maltese: Ir-reazzjonijiet avversi għal mediċina li ġejjin (ADR) ġew irrapportati waqt it-trattament b'lisinopril u amlodipine independentement:
English: ADRs with lisinopril
Maltese: Frekwenza ADR b'lisinopril
English: • Hypersensitivity to lisinopril or to any other angiotensin converting enzyme (ACE) inhibitor.
Maltese: • Sensittività eċċessiva għal lisinopril jew għal kull impeditur ieħor għal enżimi li jikkonvertu angiotensin (ACE).
English: Surgery/general anaesthesia
Maltese: Kirurġija/loppju ġenerali
English: Name approval pending
Maltese: 1 L-approvazzjoni tal-isem għadha pendenti
English: The appearance of QT prolongation was similar in all 3 different treatment options, and there were no statistically significant differences between predose and post-dose QTc values.
Maltese: Il-feġġa tal-prolungament tal-QT irriżultat simili fit-3 għażliet ta' trattament differenti kollha, u ma kien hemm ebda differenza statistikament sinifikanti bejn il-valuri tal-QTc ta' qabel id-doża u ta' wara d-doża.
English: Lisinopril is an angiotensin converting enzyme (ACE) inhibitor, which results in reduction of plasma angiotensin II and consequently aldosterone levels and elevates those of vasodilatory bradykinin.
Maltese: Lisinopril huwa impeditur għall-enżimi li jikkonvertu angiotensin, li jikkaġuna tnaqqis ta'angiotensin II fil-plażma u sussegwentement tal-livelli ta' aldosterone u jgħolli dawk tal-vażodilatur bradykinin.
English: Patients with renal impairment
Maltese: Pazjenti b'indeboliment Renali
English: CYP3A4 inhibitors: A study in elderly patients has shown that diltiazem inhibits the metabolism of amlodipine, probably via CYP3A4 (plasma concentration increases by approximately 50% and the effect of amlodipine is increased).
Maltese: Studju f'pazjenti anzjani wera li diltiazem jimpedixxi l-metaboliżmu ta' amlodipine, probabilment permezz ta' CYP3A4
English: Appropriate measures include the subcutaneous administration of 0.3-0.5 mg adrenaline epinephrine or the slow intravenous administration of 0.1 mg adrenaline, followed by glucocorticoids and antihistamines, with simultaneous monitoring of vital functions.
Maltese: Miżuri xierqa jinkludu l-għoti taħt il-ġilda ta' 0.3-0.5 mg adrenaline epinephrine jew l-għoti bil-mod fil-vina ta' 0.1 mg adrenaline, segwita b'glukokortikojdi u antistamini, b'monitoraġġ simultaneju tal-funzjonijiet vitali.
English: The elimination of lisinopril is prolonged in renal impairment and therefore, dose reduction may be necessary (see section 4.2).
Maltese: L-eliminazzjoni ta' lisinopril hi mtawwla b'indeboliment tal-kliewi u għalhekk, tnaqqis fid-doża jista' jkun meħtieġ (ara sezzjoni 4.2).
English: NAME OF THE MEDICINAL PRODUCT Lisonorm (see Annex I) 10/5 mg tablets [See Annex I - To be completed nationally] lisinopril/amlodipine
Maltese: TAL-PRODOTT MEDIĊINALI Lisonorm (Ara Anness I) 10/5 mg pilloli [Ara Anness I - Għandu jitlesta fil-pajjiż stess] lisinopril/amlodipine