qanastek/EMEA-V3 huggingface dataset:
Strength 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 80 mg 5 mg/ 160 mg 5 mg/ 160 mg 5 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 10 mg/ 160 mg 5 mg/ 80 mg 5 mg/ 160 mg 10 mg/ 160 mg
Pharmaceutical Form Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet Film-coated tablet
Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita Pillola miksija b’ rita
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali Użu orali
Packaging Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC) Blister (PVC/ PVDC)
Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC) Folja (PVC/ PVDC)
Package size 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 90 tablets 98 tablets 280 tablets 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 56 x 1 tablet (unit dose) 98 x 1 tablet (unit dose) 280 x 1 tablet (unit dose) 280 tablets (4 x 70) 280 tablets (4 x 70) 280 tablets (4 x 70)
56 pillola 90 pillola 98 pillola 280 pillola 7 pilloli 14- il pillola 28 pillola 30 pillola 56 pillola 90 pillola 98 pillola 280 pillola 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 56 x pillola 1 (doża b’ waħda) 98 x pillola 1 (doża b’ waħda) 280 x pillola 1 (doża b’ waħda) 280 pillola (4 x 70) 280 pillola (4 x 70) 280 pillola (4 x 70)
Copalia 5 mg/ 80 mg film-coated tablets
Copalia 5 mg/ 80 mg pilloli miksija b’ rita
Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate) and 80 mg of valsartan.
Kull pillola miksija b’ rita fiha 5 mg ta ’ amlodipine (bħala amlodipine besylate) u 80 mg valsartan.
Dark yellow, round film-coated tablet with bevelled edges, imprinted with “ NVR” on one side and “ NV” on the other side.
Pillola safra skura, tonda miksija b’ rita b’ xifer imżerżaq, ittimbrata “ NVR ” fuq naħa u “ NV ” fuq l - oħra.
Treatment of essential hypertension.
Kura għall- pressjoni li tkun għolja b’ mod naturali.
Copalia is indicated in patients whose blood pressure is not adequately controlled on amlodipine or valsartan monotherapy.
Copalia huwa indikat f’ pazjenti li jkollhom pressjoni għolja li ma tkunx kontrollata b’ terapija ta ’ amlodipine jew valsartan mogħtija waħidhom.
The recommended dose of Copalia is one tablet per day.
Id- doża ta ’ Copalia rakkomandata hija pillola waħda kuljum.
Copalia 5 mg/ 80 mg may be administered in patients whose blood pressure is not adequately controlled with amlodipine 5 mg or valsartan 80 mg alone.
Copalia 5 mg/ 80 mg jista ’ jingħata lill- pazjenti li ma jkollhomx pressjoni kontrollata tajjeb b’ amlodipine 5 mg jew valsartan 80 mg waħidhom.
Copalia can be used with or without food.
Copalia jista ’ jintuża ma ’ l- ikel jew mingħajr ikel.
It is recommended to take Copalia with some water.
Huwa rakkomandat li Copalia jittieħed ma ’ ftit ilma.
Individual dose titration with the components (i. e. amlodipine and valsartan) is recommended before changing to the fixed dose combination.
Huwa rakkomandat li d- dożi tal- komponenti (i. e. amoldipine u valsartan) ikunu miżjuda b’ mod individwali qabel ma ’ tkun konsidrata l- bidla għal fuq doża- fissa kombinata.
When clinically appropriate, direct change from monotherapy to the fixed-dose combination may be considered.
Meta jkun klinikament xieraq, bidla diretta minn monoterapija għal kombinazzjoni b’ doża fissa tista ’ tiġi konsidrata.
For convenience, patients receiving valsartan and amlodipine from separate tablets/ capsules may be switched to Copalia containing the same component doses.
Għall- konvenjenza, pazjenti li qed jieħdu amlodipine u valsartan minn pilloli/ kapsuli separati jistgħu jinqalbu għal Copalia li fihom l- istess dożi tal- komponenti.
Renal impairment No dosage adjustment is required for patients with mild to moderate renal impairment.
Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment renali ħafif għal moderat.
Monitoring of potassium levels and creatinine is advised in moderate renal impairment.
Meta jkun hemm indeboliment renali moderat, ta ’ min jagħmel monitoraġġ tal- livelli ta ’ potassium u krejatinina.
Hepatic impairment Caution should be exercised when administering Copalia to patients with hepatic impairment or biliary obstructive disorders (see section 4.4).
Indeboliment tal- fwied Għandha tintuża kawtela meta jingħata Copalia lill- pazjenti li jsofru minn indeboliment tal- fwied jew mard ta ’ imblokkar tal- marrara (ara sezzjoni 4. 4).
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
F’ pazjenti b’ indeboliment tal- fwied ħafif jew moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
Elderly (age 65 years or over) In elderly patients, caution is required when increasing the dosage.
2 Pazjenti anzjani (età 65 sena jew aktar) F’ pazjenti anzjani, hija meħtieġa l- kawtela meta tkun qed tiżdied id- doża.
2 Children and adolescents Copalia is not recommended for use in patients aged below 18 years due to a lack of data on safety and efficacy.
Tfal u adolexxenti Copalia mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients.
Sensittività eċċessiva għas- sustanzi attivi, għad- derivati dihydropyridine, jew għal xi sustanzi mhux attivi.
Severe hepatic impairment, biliary cirrhosis or cholestasis.
Indeboliment tal- fwied qawwi, ċirrożi tal- marrara jew kolestażi.
Severe renal impairment (GFR < 30 ml/ min/ 1.73 m2) and patients undergoing dialysis.
Indeboliment renali qawwi (GFR < 30 ml/ min/ 1. 73 m2) u pazjenti b’ dijalisi.
Second and third trimesters of pregnancy (see section 4.4 and 4.6).
It- tieni u t- tielet trimestri tat- tqala (ara sezzjoni 4. 4 u 4. 6).
Pregnancy Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Tqala L- antagonoisti tar- Riċetturi ta ’ Angiotensin II (AIIRAs) m’ għandhomx jinbdew waqt it- tqala.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm ma jkunx ikkunsidrat bħala meħtieġ li l- kura b’ AIIRA titkompla, pazjenti li qed jippjanaw tqala għandha titbiddlilhom il- kura kontra l- pressjoni għolja għal oħra alternattiva b’ mediċini kontra l - pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għall- użu fit- tqala.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see section 4.3 and 4.6).
Meta t- tqala tkun iddijanjostikata, kura b’ AIIRAs għandha titwaqqaf immedjatament, u, jekk xieraq, għandha tinbeda kura alternattiva (ara sezzjoni 4. 3 u 4. 6).
Sodium- and/ or volume-depleted patients Excessive hypotension was seen in 0.4% of patients with uncomplicated hypertension treated with Copalia in placebo-controlled studies.
Pazjenti nieqsa mis- sodium u/ jew volum Pressjoni baxxa eċċessiva dehret f’ 0. 4% tal- pazjenti b’ pressjoni għolja mingħajr kumplikazzjonijiet li kienet kurata b’ Copalia fi studji kontrollati bi plaċebo.
In patients with an activated renin-angiotensin system (such as volume- and/ or salt-depleted patients receiving high doses of diuretics) who are receiving angiotensin receptor blockers, symptomatic hypotension may occur.
F’ pazjenti b’ sistema ta ’ renin- angiotensin attivata (bħall pazjenti nieqsa mill- melħ u/ jew volum li qed jirċievu dożi ta ’ dijuretiċi għoljin) li qed jirċievu imblokkaturi tar- riċetturi ta ’ angiotensin, tista ’ taqa ’ l- pressjoni b’ mod sintomatiku.
Correction of this condition prior to administration of Copalia or close medical supervision at the start of treatment is recommended.
Qabel tibda l- kura b’ Copalia huwa rakkomandat li din tiġi korretta jew inkella jkun hemm sorveljanza medika mill- qrib meta tibda l- kura.
If hypotension occurs with Copalia, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline.
Jekk taqa ’ l- pressjoni b’ Copalia, il- pazjent għandu jitqiegħed mindud wiċċu ‘ l fuq u jekk ikun meħtieġ, jingħata infużjoni fil- vina b’ ilma bil- melħ.
Treatment can be continued once blood pressure has been stabilised.
Il- kura tista ’ titkompla meta l- pressjoni tkun stabbli.
Hyperkalaemia Concomitant use with potassium supplements, potassium-sparing diuretics, salt substitutes containing potassium, or other medicinal products that may increase potassium levels (heparin, etc.) should be undertaken with caution and with frequent monitoring of potassium levels.
Iperkalimja L- użu fl- istess ħin ma ’ sustanzi li fihom potassium, dijuretiċi li- jfaddlu potassium, sustanzi li jittieħdu flok il- melħ li fihom il- potassium, jew prodotti mediċinali oħrajn li jistgħu jgħollu l- livelli ta ’ potassium (eparina, eċċ) għandhom jintużaw bil- kawtela u b’ monitoraġġ frekwenti tal- livelli ta ’ potassium.
Renal artery stenosis No data are available on the use of Copalia in patients with bilateral renal artery stenosis or stenosis to a solitary kidney.
Stenożi ta ’ l- arterja renali M’ hemmx tagħrif dwar l- użu ta ’ Copalia f’ pazjenti b’ stenożi bilaterali ta ’ l- arterji renali jew stenożi ta ’ kilwa waħda.
Kidney transplantation To date there is no experience of the safe use of Copalia in patients who have had a recent kidney transplantation.
Trapjant tal- kliewi Sa ’ llum għad m’ hemmx esperjenza bl- użu ta ’ Copalia f’ pazjenti li riċentement ħadu trapjant tal - kliewi.
Hepatic impairment Valsartan is mostly eliminated unchanged via the bile, whereas amlodipine is extensively metabolised by the liver.
Indeboliment tal- fwied Valsartan, fil- parti l- kbira jiġi eliminat mhux mibdul permezz tal- bajl, filwaqt li amlodipine jiġi metabolizzat b’ mod estensiv fil- fwied.
Particular caution should be exercised when administering Copalia to patients with mild to moderate hepatic impairment or biliary obstructive disorders.
Għandha ssir attenzjoni partikolari meta Copalia jingħata lill - pazjenti li jsofru minn indeboliment ħafif jew moderat jew mard ta ’ imblokkar tal- marrara.
In patients with mild to moderate hepatic impairment without cholestasis, the maximum recommended dose is 80 mg valsartan.
3 F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat mingħajr kolestażi, l- ogħla doża rakkomandata ta ’ valsartan hija 80 mg.
Renal impairment No dosage adjustment of Copalia is required for patients with mild to moderate renal impairment (GFR > 30 ml/ min/ 1.73 m2).
Indeboliment renali M’ hemmx bżonn ta ’ tibdil fid- dożaġġ għall- pazjenti li għandhom indeboliment ħafif għal moderat (GFR > 30 ml/ min/ 1. 73 m2).
3 Primary hyperaldosteronism Patients with primary hyperaldosteronism should not be treated with the angiotensin II antagonist valsartan as their renin-angiotensin system is affected by the primary disease.
Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone Pazjenti b’ kondizzjoni primarja b’ livelli għoljin ta ’ aldosterone m’ għandhomx jiġu kurati b’ valsartan li hu antagonist ta ’ angiotensin II peress li s- sistema ta ’ renin- angiotensin tagħħom hija effettwata mill- marda naturali.
Heart failure As a consequence of the inhibition of the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Insuffiċjenza tal- qalb Bħala konsegwenza ta ’ l- inibizzjoni tas- sistema renin- angiotensin- aldosterone, tibdil fil- funzjoni renali tista ’ tkun mistennija f’ indvidwi li huma suxxettibli.
In patients with severe heart failure whose renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor antagonists has been associated with oliguria and/ or progressive azotaemia and (rarely) with acute renal failure and/ or death.
F’ pazjenti b’ insuffiċjenza severa tal- qalb li jkollhom funzjoni renali li tiddependi mill- attività tas- sistema renin- angiotensin- aldosterone, kura b ’ inibituri ta ’ angiotensin- converting enzyme (ACE) u antagonisti tar- riċettur ta ’ angiotensin kienet assoċjata ma ’ oligurja u/ jew ażotemja li tavvanza u (rarament) insuffiċjenza akuta renali u/ jew mewt.
Similar outcomes have been reported with valsartan.
Konsegwenzi simili kienu rappurtati b’ valsartan.
In a long-term, placebo-controlled study (PRAISE-2) of amlodipine in patients with NYHA (New York Heart Association Classification) III and IV heart failure of non-ischaemic aetiology, amlodipine was associated with increased reports of pulmonary oedema despite no significant difference in the incidence of worsening heart failure as compared to placebo.
Fi studju fit- tul, kontrollat bi plaċebo (PRAISE- 2) b’ amlodipine f’ pazjenti b’ NYHA (Klassifikazzjoni ta ’ l- Assoċjazzjoni tal- Qalb Ta ’ New York) III u IV, insuffiċjenza tal- qalb b’ etjoloġija mhux iskemika, amlodipine kien assoċjat ma ’ numru akbar ta ’ rapporti ta ’ edima fil- pulmun minkejja li ma kienx hemm differenza sinifikanti fin- numru ta ’ pazjenti li l- insuffiċjenza tal- qalb marret għall- agħar meta mqabbla mal- plaċebo.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with all other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenożi tal- valv ta ’ l- aorta u mitrijali, kardjomijopatija ipertrofika ostruttiva Bħall ma jiġri bis- sustanzi vażodilataturi l- oħrajn kollha, kawtela speċjali hi indikata f’ pazjenti li jsofru minn stenożi ta ’ l- aorta jew tal- mitrija, jew kardjomijopatija ipertrofika ostruttiva.
Copalia has not been studied in any patient population other than hypertension.
Copalia ma kienx studjat f’ ebda popolazzjoni ta ’ pazjenti oħrajn apparti dawk li jsofru minn pressjoni għolja.
Interactions linked to amlodipine Caution required with concomitant use 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).
Nuqqas ta ’ qbil marbut ma ’ amlodipine Kawtela meħtieġa bl- użu fl- istess ħin Inibituri ta ’ CYP3A4 Studju b’ pazjenti anzjani wera li diltiazem jinibixxi l- metaboliżmu ta ’ amlodipine, probabbli permezz ta ’ CYP3A4 (livelli tal- konċentrazzjoni fil- plażma jiżdiedu b’ 50% u l- effett ta ’ amlodipine jiżdied).
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.
Il - possibilità li inibituri li huma aktar qawwija ta ’ CYP3A4 (eż ketoconazole, itraconazole, ritonavir) jistgħu jżidu l- konċentrazzjoni ta ’ amlodipine fil- plażma b’ mod aktar qawwi minn diltiazem ma tistax tiġi eskluża.
CYP3A4 inducers (anticonvulsant agents [e. g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) Co-administration may lead to reduced plasma concentrations of amlodipine.
Sustanzi li jinduċu CYP3A4 (sustanzi kontra l- konvulżjonijiet [eż carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone], rifampicin, Hypericum perforatum) L- użu fl- istess ħin jista ’ jwassal għal konċentrazzjonijiet ta ’ amlodipine fil- plażma aktar baxxi.
Clinical monitoring is indicated, with possible dosage adjustment of amlodipine during the treatment with the inducer and after its withdrawal.
Monitoraġġ kliniku huwa indikat, bil- possibiltà ta ’ tibdil fid- dożaġġi ta ’ amlodipine waqt il- kura bis - sustanza li tinduċi u wara li titwaqqaf.
To be taken into account with concomitant use Others In monotherapy, amlodipine has been safely administered with thiazide diuretics, beta blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, digoxin, warfarin, atorvastatin, sildenafil, anti-acid medicines (aluminium hydroxide gel, magnesium hydroxide, simeticone), cimetidine, non- steroidal anti-inflammatory medicines, antibiotics and oral hypoglycaemic medicines.
4 mediċini antaċidi (ġel ta ’ l- aluminium hydroxide, magnesium hydroxide, simeticone), cimetidine, mediċini anti- infjammatorji mhux sterojdi, antibijotiċi u mediċini ipogliċemiċi orali.
Interactions linked to valsartan Concomitant use not recommended Lithium Reversible increases in serum lithium concentrations and toxicity have been reported during concurrent use of ACE inhibitors.
Nuqqas ta ’ qbil marbut ma ’ valsartan L- użu fl- istess ħin mhux rakkomandat Lithium Żiediet riversibbli tal- konċentrazzjonijiet ta ’ lithium fis- serum u tossiċità kienu rappurtati bl- użu fl - istess ħin ta ’ inibituri ACE.
Despite the lack of experience with concomitant use of valsartan and lithium, this combination is not recommended.
Minkejja nuqqas ta ’ esperjenza bl- użu fl- istess ħin ta ’ valsartan u lithium, din it- taħlita mhix rakkomandata.
If the combination proves necessary, careful monitoring of serum lithium levels is recommended (see section 4.4).
Jekk il- kombinazzjoni tkun inevitabbli, huwa rakkomandat li jsir monitoraġġ bir- reqqa tal- livelli ta ’ lithium fis- serum (ara sezzjoni 4. 4).
4 Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium and other substances that may increase potassium levels If a medicinal product that affects potassium levels is to be prescribed in combination with valsartan, monitoring of potassium plasma levels is advised.
Dijuretiċi li jfaddlu potassium, sustanzi ta ’ potassium, sustanzi li jintużaw flok il- melħ u sustanzi oħra li jistgħu jgħollu l- livelli ta ’ potassium Jekk prodott mediċinali li jeffettwa l- livelli ta ’ potassium se jkollu jiġi ordnat f’ taħlita ma ’ valsartan, aħjar isir monitoraġġ tal- livelli ta ’ potassium fil- plażma.
Caution required with concomitant use Non-steroidal anti-inflammatory medicines (NSAIDs), including selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day), and non-selective NSAIDs When angiotensin II antagonists are administered simultaneously with NSAIDs attenuation of the antihypertensive effect may occur.
Kawtela meħtieġa bl- użu fl- istess ħin Mediċini anti- infjammatorji mhux sterojdi (NSAID’ s), inklużi inibituri silettivi COX- 2, acetylsalicylic acid (> 3 g/ jum), u NSAID’ s mhux silettivi Meta antagonisti ta ’ angiotensin II jingħataw fl- istess ħin ma ’ NSAID’ s, jista ’ jitnaqqas l- effett ta ’ kontra l- pressjoni għolja.
Furthermore, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function and an increase in serum potassium.
Minbarra hekk, l- użu fl- istess ħin ta ’ antagonisti ta ’ angiotensin II u NSAID’ s jista ’ jżid ir- riskju li l- funzjoni renali tiħżien u potassium fis- serum jogħla.
Therefore, monitoring of renal function at the beginning of the treatment is recommended, as well as adequate hydration of the patient.
Għaldaqstant monitoraġġ tal- funzjoni renali fil- bidu tal- kura huwa rakkomandat, kif ukoll li l- pazjenti jkun idratat sew.
Others In monotherapy with valsartan, no interactions of clinical significance have been found with the following substances: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Oħrajn L- użu ta ’ valsartan waħdu ma weriex nuqqas ta ’ qbil ta ’ sinifikat kliniku b’ dawn is- sustanzi li ġejjin: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.
Interactions common to the combination No drug interaction studies were performed with Copalia and other medicinal products.
Interazzjonijiet komuni għall- kombinazzjoni Ma sarux studji dwar nuqqas ta ’ qbil b’ Copalia u prodotti mediċinali oħrajn.
To be taken into account with concomitant use Other antihypertensive agents Commonly used antihypertensive agents (e. g. alpha blockers, diuretics) and other medicinal products which may cause hypotensive adverse effects (e. g. tricyclic antidepressants, alpha blockers for treatment of benign prostate hyperplasia) may increase the antihypertensive effect of the combination.
Li għandu jitqies bl- użu fl- istess ħin Sustanzi oħrajn li jbaxxu l- pressjoni Sustanzi oħrajn li jbaxxu l- pressjoni li jintużaw ta ’ spiss (eż alpha blockers, dijuretiċi) u prodotti mediċinali oħrajn li jista ’ jkollhom effetti avversi li jbaxxu l- pressjoni (eż mediċini triċikliċi kontra d - depressjoni, alpha blockers għall- kura ta ’ iperplażja beninna tal- prostata) jistgħu jżidu l- effett kontra l - pressjoni għolja tal- kombinazzjoni.
The use of Angiotensin II Receptor Antagonists (AIIRAs) is not recommended during the first trimester of pregnancy (see section 4.4).
L’ użu ta Antagonisti tar- Riċetturi ta ’ Angiotensin II (AIIRAs) mhuwhiex rakkomandat fl- ewwel trimestru tat- tqala (ara sezzjoni 4. 4).
The use of AIIRAs is contraindicated during the second and third trimesters of pregnancy (see section 4.3 and 4.4).
L’ uzu ta ’ AIIRAs huwa kontraindikat fit- tieni u it- tielet trimestri tat- tqala (ara sezzjoni 4. 3 u 4. 4).
Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Evidenza epidemjoloġika dwar ir- riskju ta ’ teratoġeniċità wara espożizzjoni għal inibituri ACE waqt l - ewwel trimestru tat- tqala ma kinetx konklussiva; madankollu, żieda żgħira fir- riskju ma tistax tiġi eskluża.
Whilst there is no controlled epidemiological data on the risk with Angiotensin II Receptor Antagonists (AIIRAs), similar risks may exist for this class of drugs.
Filwaqt li m’ hemmx dejta epidemjoloġika kkontrollata dwar ir- riskju b’ Antagonisti tar - Riċetturi ta ’ Angiotensin II (AIIRAs), riskji jixtiebhu jistgħu jeżistu għal din il- klassi ta ’ prodott mediċinali.
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm kura b’ AIIRA kontinwata hija ikkunsidrata essenzjali, pazjenti li qed jippjanaw għal tqala għandhom jinqalbu għal kura alternattiva kontra l- pressjoni għolja li għandha profil ta ’ sigurtà stabbilit qћall- uzu fit- tqala.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, an, if appropriate, alternative therapy should be started.
Meta t- tqala tkun iddijanjostikata, il- kura b’ AIIRAs għandha titwaqqaf mill- aktar fis possibli, u jekk approprjat, kura alternattiva għandha tinbeda.
AIIRAs 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) (see also section 5.3).
5 Espożizzjoni għall- kura ta ’ AIIRAs fit- tieni u it- tielet trimestri huwa magħruf li jinduċi tossiċità tal - fetu uman (funzjoni renali mnaqqsa, oligoidramnios, ittardjar ta 'l- ossifikazzjoni tal- kranju) u tossiċità fit- trabi wara it- twelid (indeboliment renali, pressjoni baxxa, iperkalemia) (ara ukoll sezzjoni 5. 3).
Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk kien hemm espożizzjoni għal AIIRAs mit- tieni trimestru tat- tqala, huwa rakkomandat jsir kontroll bl- ultrasound tal- funzjoni renali u l- kranju.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see section 4.3 and 4.4).
Trabi li ommhom ħadet AIIRAs għandhom jkunu taħt osservazzjoni mill- qrib għal pressjoni baxxa (ara ukoll sezzjoni 4. 3 and 4. 4).
There is no experience on the use of Copalia in pregnant women.
M’ hemmx esperjenza bl- użu ta ’ Copalia waqt it- tqala.
Data on a limited number of exposed pregnancies
Studji bl- annimali wrew li hemm tossiċità għas - sistema riproduttiva b’ valsartan/ amlodipine simili ma ’ dik li ġiet deskritta għal valsartan u antagonisti oħra ta ’ angiotensin II (ara sezzjoni 5. 3).
5 indicate no adverse effects of amlodipine and other calcium receptor antagonists on the health of the foetus.
Tagħrif dwar numru limitat ta ’ esponimenti waqt it- tqala ma jurux effetti avversi ta ’ amlodipine jew antagonisti tar- riċetturi ta ’ calcium fuq is- saħħa tal- fetu.
However, there may be a risk of prolonged delivery.
Madankollu jista ’ jkun hemm riskju li l- ħlas jitwal.
It is not known whether valsartan and/ or amlodipine are excreted in human milk.
Mhux magħruf jekk valsartan u/ jew amlodipine joħorġux mal- ħalib tas- sider tal- bniedem.
Valsartan was excreted in the milk of lactating rats.
Valsartan ħareġ fil- ħalib ta ’ firien li kienu qed ireddgħu.
Because of the potential adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue therapy, taking into account the importance of this therapy for the mother.
Minħabba reazzjonijiet avversi li jista ’ jkun hemm fi trabi li qed jitreddgħu, għandha ssir deċizjoni jekk għandux jitwaqqaf it- treddigħ jew it- terapija, filwaqt li tkun konsidrata l- importanza ta ’ din it- terapija għall- omm.
When driving vehicles or using machines it should be taken into account that occasionally dizziness or weariness may occur.
Waqt is- sewqan jew l- użu ta ’ magni, għandu jitqies li kultant jista ’ jkun hemm sturdament jew għejja.
The safety of Copalia has been evaluated in five controlled clinical studies with 5,175 patients, 2,613 of whom received valsartan in combination with amlodipine.
Is- sigurtà ta ’ Copalia ġiet meqjusa f’ ħames studji kliniċi kontrollati b’ 5, 175 pazjent, li 2, 613 minnhom irċevew valsartan kombinat ma ’ amlodipine.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100, < 1/ 10); uncommon (≥ 1/ 1,000, < 1/ 100); rare (≥ 1/ 10,000, < 1/ 1,000); very rare (< 1/ 10,000), including isolated reports.
Reazzjonijiet avversi kienu klassifikati taħt titli ta ’ frekwenzi bil- konvenzjoni li ġejja: komuni ħafna (≥1/ 10); komuni (≥1/ 100, < 1/ 10); mhux komuni (≥1/ 1, 000, < 1/ 100); rari (≥1/ 10, 000, < 1/ 1, 000); rari ħafna (< 1/ 10, 000), inklużi rapporti iżolati.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull grupp ta ’ frekwenza, l- effetti mhux mixtieqa għandhom jitniżżlu skond is- serjetà tagħhom.
Cardiac disorders
Disturbi tal- qalb
Tachycardia, palpitations Syncope
Takikardja, palpitazzjonijiet Sinkope
Nervous system disorders
Disturbi tas- sistema nervuża
Headache Dizziness, somnolence, dizziness postural, paraesthesia
Sturdament, ngħas, tistordi kif tiċċaqlaq, parasteżija
Eye disorders
Disturbi ta ’ l- għajnejn
Visual disturbance
Ma tarax tajjeb
Ear and labyrinth disorders
Disturbi tal- widnejn u tas- sistema labirintika
Vertigo Tinnitus
Vertigo Żanżin tal- widnejn
Respiratory, thoracic and mediastinal disorders
Disturbi gastro- intestinali
Cough, pharyngolaryngeal pain
Dijarea, tqallih, uġigħ addominali, stitikezza, ħalq xott
Gastrointestinal disorders Renal
Disturbi renali u tas- sistema urinarja
Uncommon: and urinary disorders Rare:
Pollakisurja, tgħaddi volum kbir ta ’ awrina
Diarrhoea, nausea, abdominal pain, constipation, dry mouth Pollakisuria, polyuria
6
Skin and subcutaneous tissue disorders
Disturbi tal- ġilda u tat- tessuti ta ’ taħt il- ġilda
Rash, erythema Hyperhidrosis, exanthema, pruritus
Raxx, ħmura tal- ġilda Iperidrożi, mard b’ raxx tal- ġilda, ħakk
Musculoskeletal and connective tissue disorders
Disturbi muskolu- skeltriċi u tat- tessut konnettiv
Joint swelling, back pain, arthralgia Muscle spasm, sensation of heaviness
Nefħa fil- ġogi, uġigħ fid- dahar, artralġja Spażmi fil- muskoli, sensazzjoni ta ’ toqol
Nasopharyngitis, influenza
Nasofarinġite, influwenza
Orthostatic hypotension Hypotension
Taqa ’ l- pressjoni kif tqum Pressjoni baxxa
Oedema, pitting oedema, facial oedema, oedema peripheral, fatigue, flushing, asthenia, hot flush
Edima, edima li titgħattan, edima tal- wiċċ, edima periferali, għeja, issir ruxxan, astenja, fawra
Immune system disorders
Disturbi tas- sistema immuni
Hypersensitivity
Sensitività eċċessiva
Reproductive system and breast disorders
Disturbi tas- sistema riproduttiva u tas- sider
Erectile dysfunction
Ma jkunx hemm erezzjoni normali
Additional information on the combination Peripheral oedema, a recognised side effect of amlodipine, was generally observed at a lower incidence in patients who received the amlodipine/ valsartan combination than in those who received amlodipine alone.
Aktar tagħrif dwar il- kombinazzjoni Edima periferali, effett sekondarju magħruf ta ’ amlodipine, kien osservat b’ mod ġenerali b’ frekwenza aktar baxxa f’ pazjenti li rċevew il- kombinazzjoni amlodipine/ valsartan milli f’ dawk li rċevew amlodipine waħdu.
In double-blind, controlled clinical trials, the incidence of peripheral oedema by dose was as follows:
Fi provi kliniċi double- blind b’ kontroll, l- edima periferali li seħħet mad- doża kienet kif ġej:
% of patients who experienced peripheral oedema
% ta ’ pazjenti li kellhom edima periferali
0 2.5 Amlodipine 5 (mg) 10
0 2. 5 Amlodipine 5 (mg) 10
3.0 5.5 8.0 2.3 3.1 4.8 10.3 NA
3. 0 5. 5 8. 0 2. 3 3. 1 4. 8 10. 3 NA
2.4 5.4 2.3 NA
2. 4 5. 4 2. 3 NA
1.6 2.4 2.1 9.0
1. 6 2. 4 2. 1 9. 0
0.9 3.9 2.4 9.5
0. 9 3. 9 2. 4 9. 5
The mean incidence of peripheral oedema evenly weighted across all doses was 5.1% with the amlodipine/ valsartan combination.
Il- medja ta ’ l- edima periferali li seħħet, meqjusa b’ mod ugwali fil- medda tad- dożi kollha kienet 5. 1% bil- kombinazzjoni amlodipine/ valsartan.
Additional information on the individual components Adverse drug reactions previously reported with one of the individual components (amlodipine or valsartan) may be potential undesirable effects with Copalia as well, even if not observed in clinical trials or during the post-marketing period.
Aktar tagħrif dwar il- komponenti individwali Reazzjonijiet avversi għall- medicina li kienu rappurtati qabel b’ wieħed mill- komponenti (amlodipine jew valsartan) jistgħu jkunu effetti mhux mixtieqa b’ Copalia ukoll, anki jekk ma dehrux waqt il- provi kliniċi jew waqt il- perjodu ta ’ wara t- tqegħid fis- suq.
Amlodipine Common Uncommon
Amlodipine Amlodipine Komuni Mhux komuni
Vomiting.
Rimettar.
Alopecia, altered bowel habits, dyspepsia, dyspnoea, rhinitis, gastritis, gingival hyperplasia, gynaecomastia, hyperglycaemia, impotence, increased urinary frequency, leucopenia, malaise, mood changes, myalgia, peripheral neuropathy, pancreatitis, hepatitis, thrombocytopenia, vasculitis, angioedema and erythema multiforme.
Alopeċja, ippurgar mhux bħas- soltu, dispepsja, qtugħ ta ’ nifs, rinite, gastrite, iperplasja tal- ħanek, ġinekomastja, ipergliċemija, impotenza, tgħaddi l- awrina aktar frekwenti, lewkopenja, telqa tal- ġisem, tibdil fil- burdata, majalġja, newropatija periferali, pankrejatite, epatite, tromboċitopenja, vaskulite, anġjoedima u eritema multiforme.
Rarely, patients, particularly those with severe obstructive coronary artery disease, have developed increased frequency, duration or severity of angina or acute myocardial infarction on starting calcium channel blocker therapy or at the time of dosage increase.
Arritmija, infart mijokardijaku, B’ mod rari, il- pazjenti, l- aktar dawk li għandhom mard sever ta ’ mblokk tal- arterja koronarja, żviluppaw żieda fil- frekwenza, fit- tul ta ’ ħin jew fil- qawwa tal- anġina jew tal- infart mijokardijaku akut meta bdew kura
Arrhythmia (including ventricular tachycardia and atrial fibrillation) has also been reported.
Arritmija (inkluż takikardija ventrikolari u fibrillazzjoni atrijali) kienu wkoll irrappurtati.
These adverse events may not be distinguishable from the natural history of the underlying disease.
Dawn il- każijiet avversi jistgħu ma jkunux jingħarfu mill- istorja naturali tal- istess marda li qed tiġi kkurata.
Very rare
Rari ħafna
Cholestatic jaundice, AST and ALT increase, purpura, rash and pruritus.
Suffejra kolestatika, żieda fl- AST u l- ALT, purpura, raxx u ħakk.
Exceptional cases of extrapyramidal syndrome have been reported.
Każijiet ta ’ eċċezzjoni ta ’ sindrome ekstrapiramidali kienu rrappurtati.
Valsartan
Valsartan Mhux Tnaqqis fl- emoglobina, tnaqqis fl- ematocrit, newtropenja, tromboċitopenja, żieda fil - magħruf
Decrease in haemoglobin, decrease in haematocrit, neutropenia, thrombocytopenia, increase of serum potassium, elevation of liver function values including increase of serum bilirubin, renal failure and impairment, elevation of serum creatinine, angioedema, myalgia, vasculitis, hypersensitivity including serum sickness.
potassium tas- serum, żieda fil- valuri tal- funzjoni tal- fwied inkluż żieda fil- bilirubin tas- serum, insuffiċjenza u indeboliment tal- kliewi, livell ogħla ta ’ kreatinina fis - serum, anġjoedima, majalġja, vaskulite, sensittività eċċessiva inkluż mard tas- serum.
Symptoms There is no experience of overdose with Copalia.
Sintomi M’ hemmx esperjenza ta ’ doża eċċessiva b’ Copalia.
The major symptom of overdose with valsartan is possibly pronounced hypotension with dizziness.
L- aktar sintomu ta ’ doża eċċessiva b’ valsartan hija pressjoni baxxa li tinħass bil- qawwa flimkien ma ’ sturdament.
Overdose with amlodipine may result in excessive peripheral vasodilation and, possibly, reflex tachycardia.
Doża eċċessiva b’ amlodipine tista ’ twassal għal vażodilatazzjoni periferali eċċessiva u, possibilment, reflex takikardja.
Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported.
Pressjoni baxxa ħafna li tista ’ ddum sa ma twassal għall xokk li jista ’ jwassal għall- mewt kien rappurtat.
Treatment If ingestion is recent, induction of vomiting or gastric lavage may be considered.
Kura Jekk id- doża tkun għada kif ittieħdet, il- pazjent jista ’ jew jiġi mġiegħel jirremetti jew issirlu lavanda gastrika.
Administration of activated charcoal to healthy volunteers immediately or up to two hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
L- użu ta ’ faħam attivat f’ voluntiera b’ saħħithom eżatt wara jew sa sagħtejn wara li tkun ittieħdet doża ta ’ amlodipine intweriet li naqset b’ mod sinifikanti l- assorbiment ta ’ amlodipine.
Clinically significant hypotension due to Copalia overdose calls for active cardiovascular support, including frequent monitoring of cardiac and respiratory function, elevation of extremities, and attention to circulating fluid volume and urine output.
Meta taqa l- pressjoni b’ Copalia b’ mod li jkun hemm sintomi kliniċi, għandu jkun hemm support għall- qalb, inklużi monitoraġġ frekwenti tal- funzjoni tal- qalb u tas- sistema respiratorja, jittellgħu d- driegħ, u għandha ssir attenzjoni għall- volum ta ’ fluwidi li jiċċirkolaw u l- volum ta ’ awrina.
A vasoconstrictor may be helpful in restoring vascular tone and blood pressure, provided that there is no contraindication to its use.
Mediċina li ddejjaq il- vini tista ’ tgħin sabiex jiġi ristabilit it- ton tal- vini u l- pressjoni tad- demm, sakemm ma jkunx hemm kontra- indikazzjoni għall- użu tagħha.
Intravenous calcium gluconate may be beneficial in reversing the effects of calcium channel blockade.
Calcium gluconate mogħti minn ġol vina jista ’ jgħin biex ireġġa ’ lura l- effetti ta ’ l- imblukkar tal- kanali tal- calcium.
Both valsartan and amlodipine are unlikely to be removed by haemodialysis.
Kemm valsartan u amlodipine mhux probabbli li jitneħħew bid- dijalisi tad- demm.
Pharmacotherapeutic group: angiotensin II antagonists, plain (valsartan), combinations with dihydropyridine derivatives (amlodipine), ATC code:
Antagonisti ta ’ angiotensin II, sempliċi (valsartan), kombinazzjonijiet ma ’ derivati ta ’ dihydropyridine (amlodipine), Kodiċi ATC:
Copalia combines two antihypertensive compounds with complementary mechanisms to control blood pressure in patients with essential hypertension: amlodipine belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class of medicines.
Copalia jikkombina żewġ sustanzi kontra l- pressjoni għolja ma ’ mekkaniżmi kumplimentari sabiex tkun kontrollata l- pressjoni tad- demm f’ pazjenti b’ pressjoni għolja naturali: amlodipine huwa membru ta ’ klassi li huma antagonisti ta ’ calcium u valsartan ta ’ klassi ta ’ mediċini li huma antagonisti ta angiotensin II.
The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Il- kombinazzjoni ta ’ dawn iż- żewġ sustanzi twassal għal effett kontra l- pressjoni għolja adittiv, b’ mod li l- pressjoni titbaxxa aktar milli kieku jingħataw il- mediċini waħidhom.
Amlodipine The amlodipine component of Copalia inhibits the transmembrane entry of calcium ions into cardiac and vascular smooth muscle.
Amlodipine Il- komponent amlodipine f’ Copalia jinibixxi id- dħul mill- membrana ta ’ joni ta ’ calcium fil- muskoli tal- qalb u tal- muskoli lixxi tal- vini.
The mechanism of the antihypertensive action of amlodipine is due to a direct relaxant effect on vascular smooth muscle, causing reductions in peripheral vascular resistance and in blood pressure.
Il- mekkaniżmu ta ’ l- azzjoni kontra l- pressjoni għolja ta ’ amlodipine ġej mill- effett dirett u rilassant fuq il- muskoli lixxi tal- vini, li jikkawżaw tnaqqis fir - reżistenza fil- vini periferali u fil- pressjoni tad- demm.
Experimental data suggest that amlodipine binds to both dihydropyridine and non-dihydropyridine binding sites.
Tagħrif sperimentali jindika li amlodipine jintrabat kemm ma ’ siti ta ’ twaħħil ta ’ dihydropyridine kif ukoll ma ’ oħrajn li mhumhiex dihydropyridine.
The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels.
8 tnejn marbuta mal- moviment ta ’ joni ta ’ calcium barra miċ- ċelluli għal ġo fihom minn kanali ta ’ joni speċifiċi.
Following administration of therapeutic doses to patients with hypertension, amlodipine produces vasodilation, resulting in a reduction of supine and standing blood pressures.
Wara li jingħataw dożi terapewtiċi lill- pazjenti li jsofru minn pressjoni għolja, amlodipine inaqqas il - vażodilatazzjoni, li jwassal għall- tnaqqis fil- pressjonijiet tad- demm kemm meta l- pazjent ikun mindud kif ukoll wieqaf.
These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
Dawn it- tnaqqis fil- pressjoni tad- demm ma jkunux akkompanjati b’ tibdil sinifikanti fir- rata tal- qalb jew fil- livelli ta ’ catecholamine fil- plażma ma ’ dożaggi fuq tul ta ’ żmien.
Plasma concentrations correlate with effect in both young and elderly patients.
Hemm korrelazzjoni diretta bejn il- konċentrazzjonijiet fil- plażma u l- effett f’ kemm pazjenti żgħażagħ kif ukoll dawk anzjani.
In hypertensive patients with normal renal function, therapeutic doses of amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow, without change in filtration fraction or proteinuria.
F’ pazjenti bil- pressjoni għolja b’ funzjoni renali normali, dożi terapewtiċi ta ’ amlodipine wasslu għall - tnaqqis fir- resistenza fil- vini renali u żieda fir- rata ta ’ filtrazzjoni fil- glomeruli u ċirkolazzjoni effettiva tal- plażma renali, mingħajr ma tinbidel il- frazzjoni ta ’ filtrazzjoni jew proteina fl- awrina.
As with other calcium channel blockers, haemodynamic measurements of cardiac function at rest and during exercise (or pacing) in patients with normal ventricular function treated with amlodipine have
Hekk kif jiġri b’ mediċini oħra li jinblukkaw il- kanali tal- calcium, il- kejl emodinamiku tal- funzjoni tal - qalb waqt is- serħan u waqt l- eżerċizzju (jew mixi) f’ pazjenti b’ funzjoni ventrikulari normali kurati b’ amlodipine wrew b’ mod ġenerali żieda żgħira fl- indiċi kardijaku mingħajr influwenza sinifikanti fid- dP/ dt jew fil- pressjoni jew volum fil- ventrikolu tax- xellug fi tmiem id- dijastoli.
In haemodynamic studies, amlodipine has not been associated with a negative inotropic effect when administered in the therapeutic dose range to intact animals and humans, even when co-administered with beta blockers to humans.
Fi studji imodinamiċi, amlodipine ma kienx assoċjat ma ’ effett inotropiku negattiv meta ingħata fil- medda ta ’ dożi terapewtiċi lill- annimali u bnedmin b’ saħħithom, anki meta ingħata ma ’ beta blockers fil - bnedmin.
Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or humans.
Amlodipine ma jibdilx il- funzjoni tan- nodu sino- atrijali jew tal- passaġġ atrijoventrikulari f’ annimali jew f’ bnedmin b’ saħħithom.
In clinical studies in which amlodipine was administered in combination with beta blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed.
Fi studji kliniċi li fihom amlodipine ingħata flimkien ma ’ beta blockers lill- pazjenti li kellhom jew pressjoni għolja jew anġina, ma deherx li kien hemm effetti avversi fuq parametri ta ’ l- elektrokardjogramma.
Valsartan Valsartan is an orally active, potent and specific angiotensin II receptor antagonist.
Valsartan Valsartan huwa sustanza attiva meta jittieħed mill- ħalq, potenti u jaħdem bħala antagonist speċifiku tar- riċettur ta ’ angiotensin II.
It acts selectively on the receptor subtype AT1, which is responsible for the known actions of angiotensin II.
Jaħdem b’ mod silettiv fuq ir- ricettur tas- sottotip AT1, li huwa risponsabbli mill- effetti magħrufa ta ’ angiotensin II.
The increased plasma levels of angiotensin II following AT1 receptor blockade with valsartan may stimulate the unblocked receptor subtype AT2, which appears to counterbalance the effect of the AT1 receptor.
Iż- żieda fil- livelli ta ’ angiotensin II fil- plażma li sseħħ meta valsartan jinblokka r- riċetturi AT1 tista ’ tistimula r- riċettur tas- sottotip AT2, li milli jidher għandu l- effett oppost għal dak tar- riċettur AT1.
Valsartan does not exhibit any partial agonist activity at the AT1 receptor and has much (about 20,000-fold) greater affinity for the AT1 receptor than for the AT2 receptor.
Valsartan ma jidhirx li għandu effett parzjali ta ’ agonist tar- riċettur AT1 u għandu affinità ħafna akbar (b’ madwar 20, 000 darba) għar- riċettur AT1 milli għar- riċettur AT2.
Valsartan does not inhibit ACE, also known as kininase II, which converts angiotensin I to angiotensin II and degrades bradykinin.
Valsartan ma jaħdimx bħala impeditur ta ’ ACE, magħruf ukoll bħala kininase II, li jaqleb angiotensin I f’ angiotensin II u jkisser bradykinin.
Since there is no effect on ACE and no potentiation of bradykinin or substance P, angiotensin II antagonists are unlikely to be associated with coughing.
Peress li m’ għandux effett fuq ACE u ma jqawwix lil bradykinin jew is- sustanza P, antagonisti ta ’ angiotensin II mhux probabbli li jwasslu għas- sogħla.
In clinical trials where valsartan was compared with an ACE inhibitor, the incidence of dry cough was significantly (p < 0.05) lower in patients treated with valsartan than in those treated with an ACE inhibitor (2.6% versus 7.9%, respectively).
Fi provi kliniċi fejn valsartan kien imqabbel ma ’ impedituri ACE, il- pazjenti kurati b’ valsartan kellhom frekwenza anqas b’ mod sinifikanti (p < 0. 05) ta ’ sogħla xotta minn dawk kurati b’ impedituri ACE (2. 6% kontra 7. 9% rispettivament).
In a clinical trial of patients with a history of dry cough during ACE inhibitor therapy, 19.5% of trial subjects receiving valsartan and 19.0% of those receiving a thiazide diuretic experienced coughing, compared to 68.5% of those treated with an ACE inhibitor (p < 0.05).
Fi prova klinika b’ pazjenti li kienu sofrew minn sogħla xotta waqt terapija b’ impeditur ACE, 19. 5% tal- pazjenti tal- prova li kienu qed jirċievu valsartan u 19. 0% ta ’ dawk li kienu qed jirċievu dijuretiċi thiazide kellhom sogħla, imqabbla ma ’ 68. 5% ta ’ dawk ikkurati b’ impedituri ACE (p < 0. 05%).
Valsartan does not bind to or block other hormone receptors or ion channels known to be important in cardiovascular regulation.
Valsartan la jintrabat ma ’ u lanqas jinblokka riċetturi ta ’ ormoni oħrajn jew kanali ta ’ joni magħrufin għall- importanza tagħhom fir- regolazzjoni kardjovaskulari.
Administration of valsartan to patients with hypertension results in a drop in blood pressure without affecting pulse rate.
L- għotja ta ’ valsartan lill- pazjenti li jsofru minn pressjoni għolja twassal għal waqa ’ fil- pressjoni tad - demm mingħajr ma jkun hemm effett fuq ir- rata tal- polz.