qanastek/EMEA-V3 huggingface dataset:
There is no clinical experience with CoAprovel in patients with hepatic impairment.
Għad m’ hemmx esperjenza klinika b’ CoAprovel f’ pazjenti b’ indeboliment epatiku.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy: as with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Stenożi tal- valv aortiku u mitrali, kardjomijopatija ipertrofika ostruttiva: bħal fil- każ ta ’ vażodilatorji oħra, għandha tingħata attenzjoni speċjali f’ pazjenti li jsofru minn stenożi aortika jew mitrali jew kardjomijopatija ipertrofika ostruttiva.
Primary aldosteronism: patients with primary aldosteronism generally will not respond to anti- hypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Aldosteroniżmu primarju: pazjenti b’ aldosteroniżmu primarju ġeneralment ma jirrispondux għall - prodotti mediċinali ta ’ kontra l- pressjoni li jaħdmu billi jinpedixxu s- sistema tar- renin- angiotensin.
Therefore, the use of CoAprovel is not recommended.
Għalhekk, mhux irrikmandat l- użu ta ’ CoAprovel.
Metabolic and endocrine effects: thiazide therapy may impair glucose tolerance.
Effetti metaboliċi u endokrinali: it- terapija bit- thiazide tista ’ tfixkel it- tolleranza tal- glucose.
In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
F’ pazjenti dijabetiċi jista ’ jkun hemm bżonn ta ’ aġġustar fid- doża ta ’ l- insulina jew mediċini ipogliċemiċi li jittieħdu mill- ħalq.
Latent diabetes mellitus may become manifest during thiazide therapy.
Waqt it- terapija bit- thiazide tista ’ tibda tidher id- dijabete li ma tkunx dehret qabel.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy; however at the 12.5 mg dose contained in CoAprovel, minimal or no effects were reported.
3 Żidiet fil- livelli tal- kolesterol u tat- trigliċeridi ġew assoċjati mat- terapija dijuretika thiazide; madankollu b’ doża ta ’ 12. 5 mg ta ’ CoAprovel, l- effetti li ġew irrapportati kienu minimi jew xejn.
3 Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Tista ’ sseħħ iperuriċemija jew tiħrax gotta ċara f’ xi pazjenti li jirċievu it- terapija thiazide.
Electrolyte imbalance: as for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Żbilanċ ta ’ l- elettroliti: bħal f’ kull pazjent li jirċievi terapija dijuretika, għandhom jiġu determinati perjodikament fi spazju ta ’ żmien xieraq l- elettroliti fis- serum.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia, and hypochloremic alkalosis).
Thiazides, li jinkludu hydrochlorothiazide, jistgħu jikkaġunaw żbilanċ fil- fluwidu jew fl- elettroliti (ipokalimja, iponatremja u alkalożi ipokloremika).
Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting.
Sintomi ta ’ allarm li jindikaw żbilanċ fil- fluwidu jew fl- elettroliti huma nixfa fil- ħalq, għatx, debbulizza, letarġija, ħedla, irrekwitezza, uġigħ fil- muskoli jew bugħawwieġ, għeja kbira muskolari, pressjoni baxxa, oligurja, takikardija, u disturbi gastrointestinali bħal dardir jew rimettar.
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with irbesartan may reduce diuretic-induced hypokalaemia.
Għalkemm ipokalimja tista ’ tiżviluppa bl- użu ta ’ dijuretiċi thiazide, terapija konkorrenti ma ’ irbesartan tista ’ tnaqqas l- ipokalimja ikkaġunata mid- dijuretiċi.
The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH.
Ir- riskju ta ’ l- ipokalimja huwa l- akbar f’ pazjenti b’ ċirrożi fil- fwied, f’ pazjenti li qed ikollhom dijuresi mgħaġġla, f’ pazjenti li mhux qed jirċievu biżżejjed elettroliti orali, u f’ pazjenti li qed jieħdu terapija konkomitanti ta ’ kortikosterojdi jew ACTH.
Conversely, due to the irbesartan component of CoAprovel hyperkalaemia might occur, especially in the presence of renal impairment and/ or heart failure, and diabetes mellitus.
Għal kuntrarju, minħabba li CoAprovel fih irbesartan, jista jkun hemm iperkalimja speċjalment fil - preżenza ta ’ indeboliment renali u/ jew insuffiċenza tal- qalb u dijabete.
Adequate monitoring of serum potassium in patients at risk is recommended.
Hija rrikkmandata osservazzjoni adegwata tal- potassium fis- serum f’ pazjenti li għandhom dan ir- riskju.
Potassium-sparing diuretics, potassium supplements or potassium-containing salts substitutes should be co-administered cautiously with CoAprovel (see section 4.5).
Id - dijuretiċi li ma jnaqqsux il- potassium, supplimenti tal- potassium jew sostituti li fihom il- potassium għandhom jingħataw b’ attenzjoni flimkien ma ’ CoAprovel (ara sezzjoni 4. 5).
There is no evidence that irbesartan would reduce or prevent diuretic-induced hyponatraemia.
M’ hemm l- ebda evidenza li turi li irbesartan inaqqas jew jimpedixxi l- iponatremija kkaġunata mid - dijuretiċi.
Chloride deficit is generally mild and usually does not require treatment.
Ġeneralment, in- nuqqas tal- chloride jkun ħafif u ħafna drabi ma jinħtieġx li tingħata kura.
Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Thiazides jistgħu jnaqqsu t- tneħħija urinarja tal- calcium u jikkaġunaw li l- calcium fis- serum jogħla xi ftit f’ intervalli maqsuma fl- assenza ta ’ mard magħruf fil- metaboliżmu tal- calcium.
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
Iperkalċemja qawwija tista ’ tkun ta ’ evidenza li hemm ipertajrojdiżmu mistoħbi.
Thiazides should be discontinued before carrying out tests for parathyroid function.
Thiazides għandhom jitwaqqfu qabel ma jsiru t- testijiet fuq il- funzjoni tal- paratirojde.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnaesemia.
Ġie muri li thiazides iżidu t- tneħħija urinarja tal- magnesium, li tista ’ twassal f’ ipomagneżimja.
Lithium: the combination of lithium and CoAprovel is not recommended (see section 4.5).
Lithium: mhux irrikmandat l- użu flimkien ta ’ lithium u CoAprovel (ara sezzjoni 4. 5).
Anti-doping test: hydrochlorothiazide contained in this medicinal product could produce a positive analytic result in an anti-doping test.
Testijiet anti- doping: hydrochlorothiazide li jinsab f’ dan il- prodott mediċinali tista ’ tipproduċi riżultat analitiku pożittiv f’ test anti- doping.
General: in patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e. g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with angiotensin converting enzyme inhibitors or angiotensin-II receptor antagonists that affect this system has been associated with acute hypotension, azotemia, oliguria, or rarely acute renal failure.
Ġenerali: f’ pazjenti, li għandhom it- ton vaskulari u l- funzjoni renali jiddependu l- aktar mill- attivita ’ tas- sistema renin- angiotensin- aldosterone (p. e. pazjenti li jbatu minn insuffiċjenza tal- qalb konġestiva jew mard renali, inkluż stenożi ta ’ l- arterja renali), il- kura b’ impedituri ta ’ enzimi li jikkonvertu angiotensin jew b’ riċetturi antagonisti angiotensin- II li jaffetwaw din is- sistema ġew assoċjati ma ’ pressjoni baxxa akuta, ażotemja, oligurja, jew rarament insuffiċjenza renali akuta.
As with any anti-hypertensive agent, excessive blood pressure decrease in patients with ischemic cardiopathy or ischemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħal ma jiġri b’ kull mediċina kontra pressjoni għolja, it- tnaqqis eċċessiv ta ’ pressjoni f’ pazjenti li jbatu minn kardjopatija iskemika jew minn mard kardjovaskulari iskemiku jista ’ jwassal għal infart mijokardijaku jew għal attakk ta ’ puplesija.
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Reazzjonijiet ta ’ sensittività eċċessiva għal hydrochlorothiazide jistgħu jinħassu f’ pazjenti li għandhom jew m’ għandhomx rekord ta ’ allerġija jew ażżma tal- bronki, imma hemm aktar ċans li jiġru f’ pazjenti li kellhom dawn l- attakki.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
L- użu ta ’ dijuretiċi thiazide ġie rrapportat li jaggrava jew jattiva lupus erythematosus sistemiku.
Cases of photosensitivity reactions have been reported with thiazides diuretics (see section 4.8).
Każijiet ta ’ reazzjonijiet ta ’ fotosensittività ġew irrapportati b’ dijuretiċi ta ’ thiazides (ara sezzjoni 4. 8).
If photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Jekk isseħħ reazzjoni ta ’ fotosensittività matul it- trattament, huwa rrakkomandat li t- trattament jitwaqqaf.
If a re- administration of the diuretic is deemed necessary, it is recommended to protect exposed areas to the sun or to artificial UVA.
Jekk jitqies li jkun hemm bżonn l- għoti mill- ġdid ta ’ dijuretiku, huwa rrakkomandat li jiġu protetti partijiet esposti għax- xemx jew għal UVA artifiċjali.
Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
Antagonisti tar- riċettur ta ’ angiotensin II ma għandhomx jinbdew matul it- tqala.
Unless continued AIIRAs 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 terapija b’ AIIRAs ma tkunx meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti ta ’ kontra pressjoni għolja alternattivi li għandhom profil ta ’ sigurtà stabbilit sabiex jintużaw waqt it- tqala.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Meta tiġi ddijanjostikata tqala, trattament b’ AIIRAs għandu jitwaqqaf minnufih, u jekk xieraq, għandha tinbeda terapija alternattiva (ara sezzjonijiet 4. 3 u 4. 6).
4 Lactose: this medicinal product contains lactose.
4 Lactose: dan il- prodott mediċinali fih il- lactose.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Pazjenti bi problemi ereditarji rari ta ’ intolleranza għall- galactose, id- defiċjenza ta ’ Lapp lactase jew assorbiment ħażin tal- glucose- galactose m’ għandhomx jieħdu dan il- prodott mediċinali.
Other antihypertensive agents: the antihypertensive effect of CoAprovel may be increased with the concomitant use of other antihypertensive agents.
Mediċini oħra kontra l- pressjoni għolja: l- effett ta ’ CoAprovel kontra l- pressjoni għolja jista ’ jiżdied meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- pressjoni għolja.
Irbesartan and hydrochlorothiazide (at doses up to 300 mg irbesartan/ 25 mg hydrochlorothiazide) have been safely administered with other antihypertensive agents including calcium channel blockers and beta-adrenergic blockers.
Irbesartan u hydrochlorothiazide (b’ dożi sa 300 mg irbesartan/ 25 mg hydrochlorothiazide) ingħataw mingħajr periklu ma ’ mediċini oħra kontra l- pressjoni għolja inklużi l- imblokkaturi tal- kanali ta ’ calcium u mblokkaturi beta- adrenergic.
Prior treatment with high dose diuretics may result in volume depletion and a risk of hypotension when initiating therapy with irbesartan with or without thiazide diuretics unless the volume depletion is corrected first (see section 4.4).
Kura minn qabel b’ dożi għoljin ta ’ dijuretiċi tista ’ tirriżulta fi tnaqqis ta ’ volum u riskju ta ’ pressjoni baxxa meta tinbeda l- kura b’ irbesartan flimkien jew mingħajr dijuretiċi thiazide jekk it- tnaqqis tal- volum ma jiġix korrett minn qabel (ara sezzjoni 4. 4).
Lithium: reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Lithium: żidiet riversibbli tal- konċentrazzjonijiet ta ’ lithium fis- serum u tossiċità ġew irrapportati waqt l- amministrazzjoni konkomitanti tal- lithium ma ’ l- impedituri ta ’ l- enzimi li jikkonvertu angiontensin.
Similar effects have been very rarely reported with irbesartan so far.
Effetti simili ġew irrapportati rarament ħafna b’ irbesartan sa issa.
Furthermore, renal clearance of lithium is reduced by thiazides so the risk of lithium toxicity could be increased with CoAprovel.
U wkoll, tneħħija renali ta ’ lithium titnaqqas b’ thiazides u għalhekk, ir- riskju ta ’ tossiċita ’ minn lithium tista ’ tiżdied b’ CoAprovel.
Therefore, the combination of lithium and CoAprovel is not recommended (see section 4.4).
Għalhekk, il- kombinazzjoni ta ’ lithium u CoAprovel mhiex irrikkmandata (ara sezzjoni 4. 4).
If the combination proves necessary, careful monitoring of serum lithium levels is recommended.
Jekk tinħass il- ħtieġa ta ’ din il- kombinazzjoni, hija rrikmandata osservazzjoni bir- reqqa tal- livelli tal - lithium fis- serum.
Medicinal products affecting potassium: the potassium-depleting effect of hydrochlorothiazide is attenuated by the potassium-sparing effect of irbesartan.
Prodotti mediċinali li jaffettwaw il- potassium: l- effett fit- tnaqqis ta ’ potassium ikkaġunat minn hydrochlorothiazide jonqos minħabba l- effett potassium- sparing ta’ irbesartan.
However, this effect of hydrochlorothiazide on serum potassium would be expected to be potentiated by other medicinal products associated with potassium loss and hypokalaemia (e. g. other kaliuretic diuretics, laxatives, amphotericin, carbenoxolone, penicillin G sodium).
Madankollu, dan l- effett ta ’ hydrochlorothiazide fuq il- potassium fis- serum, huwa mistenni li jiżdied bi prodotti mediċinali oħra assoċjati ma ’ telf ta ’ potassium u ipokalimja (p. e. dijuretiċi kalijuretiċi oħra, lassativi, amphotericin, carbenoxolone, penicillin G sodium).
Conversely, based on the experience with the use of other medicinal products that blunt the renin-angiotensin system, concomitant use of potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products that may increase serum potassium levels (e. g. heparin sodium) may lead to increases in serum potassium.
Minn naħa l- oħra, ibbażat fuq l- esperjenza bl- użu ta ’ prodotti mediċinali oħra li jostakolaw is- sistema ta ’ renin- angiotensin, użu konkomitanti ta ’ dijuretiċi potassium- sparing, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium u mediċini oħra li jistgħu jżidu l- livelli tal- potassium fis- serum (p. e. heparin sodium) jistgħu jwasslu għal żidied tal - potassium fis- serum.
Adequate monitoring of serum potassium in patients at risk is recommended (see section 4.4).
Monitoraġġ adegwat tal- potassium fis- serum f’ pazjenti f’ riskju huwa rakkomandat (ara sezzjoni 4. 4).
Medicinal products affected by serum potassium disturbances: periodic monitoring of serum potassium is recommended when CoAprovel is administered with medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics).
Prodotti mediċinali affettwati b’ tibdil tal- potassium fis- serum: osservazzjoni perjodika tal - potassium fis- serum hija rrikmandata meta CoAprovel jiġi mogħti flimkien ma ’ prodotti mediċinali oħra affettwati b’ disturbi tal- potassium fis- serum (p. e. digitalis glycosides, antiarritmiċi).
Non-steroidal anti-inflammatory drugs: when angiotensin II antagonists are administered simultaneously with non-steroidal anti- inflammatory drugs (i. e. selective COX-2 inhibitors, acetylsalicylic acid (> 3 g/ day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Mediċini anti- infjammatorji mhux sterojdi: meta antagonisti ta ’ angiotensin II jingħataw simultanjament ma ’ mediċini anti- infjammatorji mhux sterojdi (jiġifieri inibituri COX- 2 selettivi, acetylsalicylic acid (> 3 g/ ġurnata) u NSAIDs mhux selettivi), jista ’ jkun hemm tnaqqis ta ’ l- effett kontra l- pressjoni għolja.
As with ACE inhibitors, concomitant use of angiotensin II antagonists and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Bħal fil- każ ta ’ l- inibituri ACE, l- użu konkomitanti ta ’ antagonisti ta ’ angiotensin II u NSAIDs jista ’ jwassal għal riskju akbar ta ’ deterjorament tal- funzjoni renali, inkluża l- possibbilità ta 'insuffiċjenza renali akuta, u żieda ta ’ potassium fis- serum, speċjalment f’ pazjenti li diġà kellhom funzjoni renali ħażina.
The combination should be administered with caution, especially in the elderly.
It- taħlita għandha tingħata b’ attenzjoni, speċjalment fl- anzjani.
Patients should be adequately hydrated and consideration should be given to monitoring renal function after initiation of concomitant therapy, and periodically thereafter.
Il- pazjenti għandhom jiġu idratati sewwa, u għandha tingħata konsiderazzjoni għall- monitoraġġ tal- funzjoni renali wara l- bidu ta ’ terapija konkomitanti, u perjodikament wara.
Additional information on irbesartan interactions: in clinical studies, the pharmacokinetic of irbesartan is not affected by hydrochlorothiazide.
Tagħrif addizzjonali dwar l- effetti ta ’ irbesartan ma ’ mediċini oħra: fi studji kliniċi, il- farmakokinetiċi ta ’ irbesartan ma kinux affettwati minn hydrochlorothiazide.
Irbesartan is mainly metabolised by CYP2C9 and to a lesser extent by glucuronidation.
Irbesartan jiġi metabolizzat prinċipalment b’ CYP2C9 u b’ mod anqas estensiv bi glukuronidazzjoni.
No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was coadministered with warfarin, a medicinal product metabolised by CYP2C9.
Ma kienu osservati ebda interazzjonijiet farmakokinetiċi jew farmakodinamiċi sinifikanti meta irbesartan ingħata ma ’ warfarin, prodott mediċinali metabolizzat b’ CYP2C9.
The effects of CYP2C9 inducers such as rifampicin on the pharmacokinetic of irbesartan have not been evaluated.
L- effetti ta ’ indutturi ta ’ CYP2C9 bħal rifampicin fuq il - farmakokinetika ta ’ irbesartan ma ġewx evalwati.
The pharmacokinetic of digoxin was not altered by co-administration of irbesartan.
Il- farmakokinetika ta ’ digoxin ma nbidlitx meta ngħata ma ’ irbesartan.
Additional information on hydrochlorothiazide interactions: when administered concurrently, the following medicinal products may interact with thiazide diuretics:
5 Tagħrif addizzjonali dwar l- effetti ta ’ hydrochlorothiazide ma ’ mediċini oħra: meta jingħataw flimkien, il- prodotti mediċinali segwenti jistgħu jinteraġixxu ma ’ dijuretiċi thiazide:
5 Alcohol: potentiation of orthostatic hypotension may occur;
Alkoħol: jista ’ jkun hemm żieda fil- pressjoni baxxa ortostatika;
Antidiabetic medicinal products (oral agents and insulins): dosage adjustment of the antidiabetic medicinal product may be required (see section 4.4);
Mediċini kontra d- dijabete (mediċini li jittieħdu mill- ħalq u insulina): jista ’ jkun hemm bżonn aġġustar tad- doża tal- prodott mediċinali kontra d- dijabete (ara sezzjoni 4. 4);
Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins;
Cholestyramine u Colestipol resins: l- assorbiment ta ’ hydrochlorothiazide jiġi imfixkel fil- preżenza ta ’ anionic exchange resins;
Corticosteroids, ACTH: electrolyte depletion, particularly hypokalaemia, may be increased;
Kortikosterojdi, ACTH: tnaqqis fl- elettroliti, speċjalment ipokalemija, jista ’ jiżdied;
Digitalis glycosides: thiazide induced hypokalaemia or hypomagnaesemia favour the onset of digitalis-induced cardiac arrhythmias (see section 4.4);
Digitalis glycosides: ipokalemija jew ipomagneżemja ikkaġunati minħabba thiazide jistgħu jiffavorixxu l- bidu ta ’ arritmiji kardijaċi kkawżati minn digitalis (ara sezzjoni 4. 4);
Non-steroidal anti-inflammatory drugs: the administration of a non-steroidal anti-inflammatory drug may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics in some patients;
Mediċini anti- infjammatorji mhux sterojdi: l- amministrazzjoni ta ’ mediċini anti- infjammatorji mhux sterojdi jistgħu jnaqqsu l- effetti dijuretiċi, natrijuretiċi u ta ’ kontra l- pressjoni għolja tat- thiazide f’ xi pazjenti;
Pressor amines (e. g. noradrenaline): the effect of pressor amines may be decreased, but not sufficiently to preclude their use;
Pressor amines (p. e. noradrenaline): l- effetti tal- pressor amines jistgħu jonqsu, iżda mhux biżżejjed biex teskludi l- użu tagħhom;
Nondepolarizing skeletal muscle relaxants (e. g. tubocurarine): the effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide;
Rilassanti Nondepolarizing tal- muskolu skeletali (p. e. tubocurarine): l- effetti ta ’ rilassanti nondepolarizing tal- muskolu skeletali jistgħu jiżdiedu b’ hydrochlorothiazide;
Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Mediċini kontra l- gotta: jista ’ jkun hemm il- bżonn ta ’ aġġustar tad- dożi ta ’ mediċini kontra l- gotta minħabba li hydrochlorothiazide jista ’ jgħolli l- livell ta ’ serum uric acid.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Jista ’ jkun hemm bżonn żieda fid- doża ta ’ probenecid jew sulfinpyrazone.
Co-administration of thiazide diuretics may increase the incidence of hypersensitivity reactions to allopurinol;
L- użu flimkien ta ’ dijuretiċi thiazide jistgħu jżidu l - inċidenza ta ’ reazzjonijiet ta ’ sensittività eċċessiva għal- allopurinol;
Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Calcium salts: dijuretiċi thiazide jistgħu jgħollu l- livelli ta ’ calcium fis- serum calcium minħabba tnaqqis ta ’ eskrezzjoni.
If calcium supplements or calcium sparing medicinal products (e. g. vitamin D therapy) must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly;
Jekk jinħtieġ li jingħataw supplimenti tal- calcium jew mediċini calcium sparing (p. e. kura bil- Vitamina D), il- livelli ta ’ serum ta ’ calcium għandhom jiġu osservati u d- doża tal- calcium aġġustata kif meħtieġ;
Other interactions: the hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Interazzjonijiet oħra: thiazides jistgħu jżidu l- effet ipergliċemiku tal- beta- blockers u ta ’ diazoxide.
Anticholinergic agents (e. g. atropine, beperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Il - mediċini antikolinerġiċi (p. e atropine, beperiden) jistgħu jżidu l- biodisponibilità tad- dijuretiċi tat- tip thiazide billi jnaqqsu l- motilità` gastro- intestinali u r- rata ta ’ tbattil ta ’ l- istonku.
Thiazides may increase the risk of adverse effects caused by amantadine.
Thiazides jistgħu jżidu r- riskju ta ’ effetti avversi ikkaġunati b’ amantadine.
Thiazides may reduce the renal excretion of cytotoxic medicinal products (e. g. cyclophosphamide, methotrexate) and potentiate their myelosuppressive effects.
Thiazides jistgħu jnaqqsu l- eskrezzjoni renali tal- mediċini ċitotossiċi (p. e cyclophosphamide, methotrexate) u jżidu l- effetti majolosoppressivi tagħhom.
Pregnancy: the use of AIIRAs is not recommended during the first trimester of pregnancy (see section 4.4).
L- użu ta ’ AIIRAs mhuwiex rakkomandat matul l- ewwel tliet xhur tat- tqala (ara sezzjoni 4. 4).
The use of AIIRAs is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
L- użu ta ’ AIIRAs huwa kontra- indikat matul it- tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 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 tat- teraġenoċità wara espożizzjoni għal inibituri ACE matul l - ewwel tliet xhur tat- tqala ma kienitx 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 ma hemm ebda data epidemijoloġika dwar ir- riskji b’ Antagonisti ta ’ Reċetturi ta ’ Angiotensin II (AIIRAs), jistgħu jeżistu riskji simili għal din il- klassi ta ’ mediċini.
Unless continued AIIRAs 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 terapija AIIRAs kontinwa mhijiex meqjusa essenzjali, il- pazjenti li jkunu qegħdin jippjanaw li joħorġu tqal għandhom jinqalbu għal trattamenti alternattivi ta ’ kontra l- pressjoni għolja li għandhom profil ta ’ sigurtà stabbilit għal użu waqt tqala.
When pregnancy is diagnosed, treatment with AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta tiġi dijanjostikata tqala, trattament b ’ AIIRAs għandu jitwaqqaf minnufih, u, jekk xieraq, għandha tinbeda terapija alternattiva.
(see section 5.3).
6 Espożizzjoni għal terapija AIIRAs matul it- tieni u t- tielet trimestri hija magħrufa li twassal għal tossiċità tal- fetu uman (tnaqqis fil- funzjoni tal- kliewi, oligohydramnios, tnaqqis fl- ossifikazzjoni tal - għadam tar- ras) u tossiċità neonatali (nuqqas fil- funzjoni tal- kliewi, pressjoni baxxa, iperkalemija) (ara sezzjoni 5. 3).
6 Should exposure to AIIRAs have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk seħħet espożizzjoni għall- AIIRAs mit- tieni trimestru tat- tqala, huwa rrakkomandat kontroll bl - ultrasound tal- funzjoni renali u tal- kranju.
Infants whose mothers have taken AIIRAs should be closely observed for hypotension (see also sections 4.3 and 4.4).
Trabi li ommijiethom ħadu AIIRAs għandhom jiġu osservati mill- qrib għal pressjoni baxxa (ara wkoll is- sezzjonijiet 4. 3 u 4. 4).
Thiazides cross the placental barrier and appear in cord blood.
Thiazides jgħaddu mill- plaċenta u jsibu ruħhom fid- demm tal- kurdun.
They may cause a decrease in placental perfusion, foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.
Jistgħu iġibu nuqqas fil - perfużjoni tal- plaċenta, disturbi fl- elettroliti tal- fetu u possibilment reazzjonijiet oħra li ġraw fl- adulti.
Cases of neonatal thrombocytopenia, or foetal or neonatal jaundice have been reported with maternal thiazide therapy.
Ġew irrapportati każijiet ta ’ tromboċitopenja fi trabi tat- twelid jew suffejra fil- fetu jew fit- trabi tat - twelid meta l- omm ingħatat il- kura bit- thiazide.
Since CoAprovel contains hydrochlorothiazide, it is not recommended during the first trimester of pregnancy.
Billi CoAprovel fih hydrochlorothiazide, mhux irrikkmandat waqt l- ewwel trimestru tat- tqala.
A switch to a suitable alternative treatment should be carried out in advance of a planned pregnancy.
Jinħtieġ li tingħata kura alternattiva qabel ma jkun hemm il- ħsieb ta ’ tqala.
CoAprovel is contraindicated during breast-feeding.
CoAprovel huwa kontra- indikat waqt it- treddigħ.
Based on its pharmacodynamic properties, CoAprovel is unlikely to affect this ability.
Skond il- kwalitajiet farmakodinamiċi tiegħu, CoAprovel mhux suppost li jkollu effett fuq din il- ħila.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or weariness may occur during treatment of hypertension.
Waqt is- sewqan jew tħaddim ta ’ magni wieħed għandu joqgħod attent għax xi kultant jista ’ jħoss xi sturdament jew għejja waqt il- kura kontra l- pressjoni għolja.
Irbesartan/ hydrochlorothiazide combination:
L- għoti ta ’ irbesartan/ hydrochlorothiazide flimkien:
Table 1 gives the adverse reactions observed from spontaneous reporting and in placebo-controlled trials in which 898 hypertensive patients received various doses (range:
It- Tabella 1 tagħti r- reazzjonijiet avversi osservati minn rapportaġġ spontanju u fi provi kkontrollati bi plaċebo li fihom 898 pazjent bi pressjoni għolja rċievew għadd ta ’ dożi (medda:
37.5 mg/ 6.25 mg to 300 mg/ 25 mg irbesartan/ hydrochlorothiazide).
37. 5 mg/ 6. 25 mg sa 300 mg/ 25 mg irbesartan/ hydrochlorothiazide) u reazzjonijiet avversi minn rapportaġġ spontanju.
The frequency of adverse reactions listed below is defined using the following convention: 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).
Il- frekwenza tar- reazzjonijiet avversi hija definita permezz tal- konvenzjoni li ġejja: 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).
Adverse Reactions in Placebo-Controlled Trials and Spontaneous Reports* Investigations:
Reazzjonijiet Avversi fi Provi Kkontrollati bi Plaċebo u Rapporti Spontaneji * Investigazzjonijiet:
increases in blood urea nitrogen (BUN), creatinine and creatine kinase
żidiet fin- nitroġenu ta ’ l- urea tad- demm (BUN), kreatinina u creatine kinase
decreases in serum potassium and sodium
tnaqqis fil- potassium u fis- sodium tas- serum
syncope, hypotension, tachycardia, oedema
sinkope, pressjoni baxxa, takikardija, edema
Uncommon:
sturdament
Not known:
Mhux komuni:
Ear and labyrinth disorders:
sturdament ortostatiku
Not known:
Mhux magħrufa:
tinnitus cough
uġigħ ta ’ ras
Gastrointestinal disorders:
Disturbi fil- widnejn u fis- sistema labirintika:
Uncommon:
Mhux magħrufa:
nausea/ vomiting diarrhoea dyspepsia, dysgeusia
Disturbi respiratorji, toraċiċi u medjastinali:
Renal and urinary disorders:
Mhux magħrufa:
Common:
sogħla
Metabolism and nutrition
Disturbi gastro- intestinali:
Not known:
Komuni:
disorders:
dardir/ rimettar
Vascular disorders:
Mhux magħrufa:
General disorders and administration site conditions:
Mhux magħrufa:
flushing fatigue
għeja kbira
Immune system disorders:
Disturbi fis- sistema immuni:
Not known:
Mhux
cases of hypersensitivity reactions such as angioedema, rash, urticaria
każijiet rari ta ’ reazzjonijiet ta ’ sensittività
hepatitis, abnormal liver function
eċċessiva bħal anġjoedema, raxx, urtikarja epatite, funzjoni anormali tal- fwied
Reproductive system and breast Uncommon: disorders:
Disturbi fis- sistema riproduttiva Mhux komuni: u fis- sider:
sexual dysfunction, libido changes
disfunzjoni sesswali, tibdil fil- libidu
* Frequency for adverse reactions detected by spontaneous reports is described as “ not known”
* Il- frekwenza għal reazzjonijiet avversi mikxufin minn rapporti spontaneji hija deskritta bħala “ mhux magħrufa ”
Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with CoAprovel.
Aktar tagħrif fuq komponenti individwali: minbarra r- reazzjonijiet avversi msemmijin hawn fuq għal dan il- prodott kombinat, reazzjonijiet avversi oħrajn li ġew irrapportati ma ’ wieħed minn dawn il - komponenti individwali jistgħu jkunu reazzjonijiet avversi potenzjali ma ’ CoAprovel.
Tables 2 and 3 below detail the adverse reactions reported with the individual components of CoAprovel.
It- Tabelli 2 u 3 taħt jiddeskrivu fid- dettall ir- reazzjonijiet avversi rrapportati mal- komponenti individwali ta ’ CoAprovel.
Adverse reactions reported with the use of irbesartan alone General disorders and administration site conditions:
Reazzjonijiet avversi rrapportati ma ’ l- użu ta ’ irbesartan waħdu Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata:
chest pain
uġigħ fis- sider
Adverse reactions (regardless of relationship to medicinal product) reported with the use of hydrochlorothiazide alone Investigations:
Reazzjonijiet avversi (minkejja r- relazzjoni mal- prodott mediċinali) rapportati ma ’ l- użu ta ’ hydrochlorothiazide waħdu Investigazzjonijiet:
electrolyte imbalance (including hypokalaemia and hyponatraemia, see section 4.4), hyperuricaemia, glycosuria, hyperglycaemia, increases in cholesterol and triglycerides
ipokalemija u l- iponatremja, ara sezzjoni 4. 4), iperuriċemija glikożurja, ipergliċemija, żieda fil- kolesterol u trigliċeridi
Cardiac disorders:
Mhux magħrufa:
Blood and lymphatic system disorders:
arritmji kardijaċi
Not known:
Disturbi tad- demm u tas- sistema Mhux magħrufa: limfatika:
cardiac arrhythmias aplastic anaemia, bone marrow depression, neutropenia/ agranulocytosis, haemolytic anaemia, leucopenia, thrombocytopenia
anemija aplastika, dipressjoni tal - mudullun ta ’ l- għadam, newtropenja/ agranuloċitożi, anemija emolitika, lewkopenja, tromboċitopenja
Nervous system disorders:
Mhux Disturbi fis- sistema nervuża:
Not known:
Mhux Disturbi fl- għajnejn: magħrufa:
vertigo, paraesthesia, light-headedness, restlessness
irrekwitezza vista mċajpra li tgħaddi, xanthopsia
Respiratory, thoracic and mediastinal disorders:
Mhux Disturbi respiratorji, toraċiċi u
Not known:
diffikultà respiratorja (inkluż pulmonite u
transient blurred vision, xanthopsia respiratory distress (including pneumonitis and pulmonary oedema)
magħrufa: medjastinali:
Gastrointestinal disorders:
edema pulmonari)
Not known:
Mhux Disturbi gastro- intestinali:
pancreatitis, anorexia, diarrhoea, constipation, gastric irritation, sialadenitis, loss of appetite
pankrejatite, anoressja, dijarea, stitikezza,
Renal and urinary disorders:
magħrufa:
Skin and subcutaneous tissue disorders:
irritazzjoni fl- istonku, sijaladenite, nuqqas ta ’ aptit
Not known:
Mhux Disturbi fil- kliewi u fis- sistema magħrufa: urinarja:
interstitial nephritis, renal dysfunction anaphylactic reactions, toxic epidermal necrolysis, necrotizing angitis (vasculitis, cutaneous vasculitis), cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, photosensitivity reactions, rash, urticaria
nefrite interstizjali, disfunzjoni renali
Musculoskeletal and connective tissue disorders:
Mhux Disturbi fil- ġilda u fit- tessuti ta ’
Not known:
reazzjonijiet anafilattiċi, nekroliżi
weakness, muscle spasm
magħrufa: taħt il- ġilda:
Vascular disorders:
Mhux Disturbi muskolu- skeltrali u tal - magħrufa: connective tissue:
General disorders and administration site conditions:
għeja, spażmu tal- muskoli
Not known:
Mhux Disturbi vaskulari: magħrufa:
postural hypotension fever
pressjoni baxxa tal- qagħda
Hepatobiliary disorders:
Mhux Disturbi ġenerali u magħrufa: kondizzjonijiet ta 'mnejn jingħata:
Not known:
deni
jaundice (intrahepatic cholestatic jaundice)
Mhux Disturbi fil- fwied u fil- marrara: magħrufa:
Psychiatric disorders:
suffejra (suffejra intraepatika kolestatika)
Not known:
Mhux Disturbi psikjatriċi: magħrufa:
depression, sleep disturbances
dipressjoni, disturbi fl- irqad
8 The dose dependent adverse events of hydrochlorothiazide (particularly electrolyte disturbances) may increase when titrating the hydrochlorothiazide.
L- episodji avversi dipendenti fuq id- doża ta 'hydrochlorothiazide (b' mod partikolari disturbi elettrolitiċi) jistgħu jiżdiedu meta jkun qed jiġi ttitrat il- hydrochlorothiazide.
No specific information is available on the treatment of overdose with CoAprovel.
M’ hemmx biżżejjed informazzjoni speċifika fuq il- kura ta ’ doża eċċessiva ta ’ CoAprovel.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Il- pazjent għandu jkun osservat mill- viċin u l- kura għandha tkun sintomatika u ta ’ support.
Management depends on the time since ingestion and the severity of the symptoms.
L- immaniġġjar jiddependi fuq iż- żmien minn meta tittieħed u minn kemm huma qawwija s- sintomi.
Suggested measures include induction of emesis and/ or gastric lavage.
Miżuri ssuġġeriti jinkludu induzzjoni tar- rimettar u/ jew tal- ħasil gastriku.
Activated charcoal may be useful in the treatment of overdose.
Il- faħam attivat jista ’ jkun utli fit- trattament ta ’ doża eċċessiva.
Serum electrolytes and creatinine should be monitored frequently.
L- elettroliti u l- kreatinina fis- serum għandhom jiġu mkejlin ta ’ spiss.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Jekk titbaxxa l- pressjoni, il- pazjent għandu joqgħod mimdud, u jingħata sostituzzjoni tal- melħ u volum malajr.
The most likely manifestations of irbesartan overdose are expected to be hypotension and tachycardia; bradycardia might also occur.
Is- sintomi l- iktar ċari ta ’ doża eċċessiva ta ’ irbesartan huma mistennija li jkunu pressjoni baxxa, u takikardija; bradikardija tista ’ tiġri wkoll.
Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloremia, hyponatraemia) and dehydration resulting from excessive diuresis.
Doża eċċessiva ta ’ hydrochlorothiazide hija assoċjata ma ’ tnaqqis fl- elettroliti (ipokalemija, ipokloremija, iponatremija) u deidrazzjoni minħabba dijureżi eċċessiva.
The most common signs and symptoms of overdose are nausea and somnolence.
L- iktar sinjali u sintomi komuni ta ’ doża eċċessiva huma dardir u ngħas.
Hypokalaemia may result in muscle spasms and/ or accentuate cardiac arrhythmias associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
Ipokalemija tista ’ tikkaġuna spażmi tal- muskoli u/ jew arritmiji kardijaċi aċċentwati minħabba l- użu flimkien ta ’ glikosidi diġitali jew minħabba ċerti mediċini antiarritmiċi.
Irbesartan is not removed by haemodialysis.
Irbesartan ma jitneħħiex bl- emodijaliżi.
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Ma ġiex stabbilit kemm jitneħħa hydrochlorothiazide bid - dijaliżi tad- demm.
C09DA04.
Kategorija farmakoterapewtika: antagonisti ta ’ angiotensin- II, kombinati Kodiċi ATC C09DA04.
CoAprovel is a combination of an angiotensin-II receptor antagonist, irbesartan, and a thiazide diuretic, hydrochlorothiazide.
9 CoAprovel huwa kombinazzjoni ta ’ antagonist ta ’ riċettur angiotensin- II, irbesartan u dijuretiku thiazide, hydrochlorothiazide.
The combination of these ingredients has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.
Il- kombinazzjoni ta ’ dawn l- ingredjenti għandha effett anti- ipertensiv miżjud, inaqqas il- pressjoni tad- demm fi grad aktar minn kull ingredjent waħdu.
Irbesartan is a potent, orally active, selective angiotensin-II receptor (AT1 subtype) antagonist.
Irbesartan huwa antagonist qawwi, attiv mill- ħalq, antagonist selettiv tar- riċettur angiotensin- II (sub tip AT1).
It is expected to block all actions of angiotensin-II mediated by the AT1 receptor, regardless of the source or route of synthesis of angiotensin-II.
Huwa mistenni li jimblokka l- azzjonijiet kollha ta ’ l- angiotensin- II medjati mir- riċettur AT1, mingħajr m’ għandu x’ jaqsam ma ’ l- oriġini jew rotta ta ’ sinteżi ta ’ l- angiotensin- II.
The selective antagonism of the angiotensin-II (AT1) receptors results in increases in plasma renin levels and angiotensin-II levels, and a decrease in plasma aldosterone concentration.
L- antagoniżmu selettiv tar- riċetturi ta ’ l- angiotensin- II (AT1), jirriżulta f’ żidiet fil- livelli fil- plażma ta ’ renin u fil - livelli ta ’ angiotensin- II, u fi tnaqqis fil- konċentrazzjoni tal- plażma aldosterone.
Serum potassium levels are not significantly affected by irbesartan alone at the recommended doses in patients without risk of electrolyte imbalance (see sections 4.4 and 4.5).
Il- livelli tal- potassium fis- serum mhumiex affettwati b’ mod sinifikanti b’ irbesartan waħdu f’ dożi rrikmandati lill- pazjenti li m’ għandhomx riskju ta ’ żbilanċ ta ’ l- elettroliti (ara sezzjonijiet 4. 4 u 4. 5).
Irbesartan does not inhibit ACE (kininase-II), an enzyme which generates angiotensin-II and also degrades bradykinin into inactive metabolites.
Irbesartan ma jinpedixxix l- ACE (kinase- II), enzima li tiġġenera l- angiotensin- II u tiddiżintegra ukoll il- bradikinina f’ metaboliti inattivi.
Irbesartan does not require metabolic activation for its activity.
Irbesartan m’ għandux bżonn ta ’ attivazzjoni metabolika biex ikun attiv.
Hydrochlorothiazide is a thiazide diuretic.
Hydrochlorothiazide huwa dijuretiku thiazide.
The mechanism of antihypertensive effect of thiazide diuretics is not fully known.
Għad mhux magħruf għal kollox il- mekkaniżmu ta ’ l - effett anti- ipertensiv tad- dijuretiċi tat- tip thiazide.
Thiazides affect the renal tubular mechanisms of electrolyte reabsorption, directly increasing excretion of sodium and chloride in approximately equivalent amounts.
Thiazides jaffettwaw il- mekkaniżmu tubulari renali tar- riassorbiment ta ’ l- elettroliti u jżidu direttament l- eskrezzjoni tas- sodium u tal- chloride f’ ammonti kważi ekwivalenti.
The diuretic action of hydrochlorothiazide reduces plasma volume, increases plasma renin activity, increases aldosterone secretion, with consequent increases in urinary potassium and bicarbonate loss, and decreases in serum potassium.
L- azzjoni dijuretika ta ’ hydrochlorothiazide tnaqqas il- volum tal- plażma, iżżid l - attività tar- renin fil- plażma, u żżid it- tmexxija ta ’ l- aldosterone, bil- konsegwenza li żżid it- telf ta ’ potassium u bicarbonate fl- awrina u tnaqqas il- potassium fis- serum.
Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of irbesartan tends to reverse the potassium loss associated with these diuretics.
Preżumibbilment minħabba l - inblukkar fis- sistema renin- angiotensin- aldosterone, meta hydrochlorothiazide jingħata flimkien ma ’ irbesartan jista ’ jinqaleb bil- kontra t- telf tal- potassium assoċjat ma ’ dawn id- dijuretiċi.
With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6-12 hours.
Bil - hydrochlorothiazide, id- dijureżi tibda ’ fi żmien 2 sigħat, u l- ogħla effett ikun wara madwar 4 sigħat, waqt li l- azzjoni ddum madwar 6- 12- il siegħa.
9 The combination of hydrochlorothiazide and irbesartan produces dose-related additive reductions in blood pressure across their therapeutic dose ranges.
Il- kombinazzjoni ta ’ hydrochlorothiazide u irbesartan tipproduċi tnaqqis addittiv relatat mad- doża fil - pressjoni tad- demm tul il- firxa terapewtika tad- doża.
The addition of 12.5 mg hydrochlorothiazide to 300 mg irbesartan once daily in patients not adequately controlled on 300 mg irbesartan alone resulted in further placebo-corrected diastolic blood pressure reductions at trough (24 hours post-dosing) of 6.1 mm Hg.
Iż- żieda ta ’ 12. 5 mg hydrochlorothiazide ma ’ 300 mg ta ’ irbesartan darba waħda kuljum f’ pazjenti li ma kinux ikkontrollati sew meta ħadu 300 mg irbesartan waħdu irriżulta f’ aktar tnaqqis fil- pressjoni dijastolika korreta bil- plaċebo fl- inqas livelli (24 siegħa wara li tingħata d- doża) ta ’ 6. 1 mmHg.
The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/ diastolic reductions of up to 13.6/ 11.5 mm Hg.
Il- kombinazzjoni ta ’ 300 mg irbesartan u 12. 5 mg hydrochlorothiazide irriżultaw fi tnaqqis fuq kollox tal- pressjoni sistolika/ dijastolika, mnaqqsa għal plaċebo, sa 13. 6/ 11. 5 mm Hg.
Limited clinical data (7 out of 22 patients) suggest that patients not controlled with the 300 mg/ 12.5 mg combination may respond when uptitrated to 300 mg/ 25 mg.
Dejta klinika limitata (7 minn 22 pazjent) tissuġġerixxi li l- pazjenti mhux ikkontrollati bil - kombinazzjoni ta ’ 300 mg/ 12. 5 mg jistgħu jiġu titrati ’ l fuq għal 300 mg/ 25 mg.
In these patients, an incremental blood pressure lowering effect was observed for both systolic blood pressure (SBP) and diastolic blood pressure (DBP) (13.3 and 8.3 mm Hg, respectively).
F’ dawn il- pazjenti, kien osservat tnaqqis inkrementali fil- pressjoni tad- demm kemm għal pressjoni sistolika tad- demm (SBP) kif ukoll għal pressjoni dijastolika tad- demm (DBP) (13. 3 u 8. 3 mm Hg, rispettivament).
Once daily dosing with 150 mg irbesartan and 12.5 mg hydrochlorothiazide gave systolic/ diastolic mean placebo-adjusted blood pressure reductions at trough (24 hours post-dosing) of 12.9/ 6.9 mm Hg in patients with mild-to-moderate hypertension.
Doża darba kuljum ta ’ 150 mg irbesartan u 12. 5 mg ta ’ hydrochlorothiazide tat- tnaqqis tal- pressjoni sistolika/ dijastolika fil- punt medjan ta ’ 12. 9/ 6. 9 mmHg aġġustat għal plaċebo (24 siegħa wara li ngħatat id- doża) f’ pazjenti bi pressjoni għolja bejn ħafifa għal moderata.
Peak effects occurred at 3-6 hours.
L- ogħla effetti jseħħu f ’ 3 - 6 sigħat.
When assessed by ambulatory blood pressure monitoring, the combination 150 mg irbesartan and 12.5 mg hydrochlorothiazide once daily produced consistent reduction in blood pressure over the 24 hours period with mean 24-hour placebo-subtracted systolic/ diastolic reductions of 15.8/ 10.0 mm Hg.
Meta ġiet assessjata permezz ta ’ osservazzjoni ta ’ pressjoni ambulatorja, il- kombinazzjoni ta ’ 150 mg irbesartan u 12. 5 mg hydrochlorothiazide darba kuljum, ikkawżat tnaqqis konsisteneti fil - pressjoni matul perijodu ta ’ 24 siegħa bi tnaqqis medju f’ 24 siegħa tal- pressjoni sistolika/ dijastolika ta ’ 15. 8/ 10. 0 mmHg mnaqqsa għall- plaċebo.
When measured by ambulatory blood pressure monitoring, the trough to peak effects of CoAprovel 150 mg/ 12.5 mg were 100%.
Meta mkejla permezz ta ’ osservazzjoni tal- pressjoni ambulatorja l- effetti mill- inqas għal aktar ta ’ CoAprovel 150 mg/ 12. 5 mg kienu 100%.
The trough to peak effects measured by cuff during office visits were 68% and 76% for CoAprovel 150 mg/ 12.5 mg and CoAprovel 300 mg/ 12.5 mg, respectively.
L- effetti mill - inqas għal aktar mkejla mid- dirgħajn waqt il- viżti għand it- tabib kienu 68% u 76% għal CoAprovel 150 mg/ 12. 5 mg u CoAprovel 300 mg/ 12. 5 mg, rispettivament.
These 24-hour effects were observed without excessive blood pressure lowering at peak and are consistent with safe and effective blood-pressure lowering over the once-daily dosing interval.
Dawn l- effetti tul 24 siegħa kienu osservati mingħajr ma sar tnaqqis eċċessiv tal- pressjoni fl- ogħla effett u huma konsistenti mat- tnaqqis sigur u effettiv tal- pressjoni tul l- intervall ta ’ doża waħda kuljum.
In patients not adequately controlled on 25 mg hydrochlorothiazide alone, the addition of irbesartan gave an added placebo-subtracted systolic/ diastolic mean reduction of 11.1/ 7.2 mm Hg.
F’ pazjenti li ma kinux ikkontrollati sew meta ħadu 25 mg hydrochlorothiazide waħdu, meta ngħataw irbesartan ukoll kellhom tnaqqis miżjud medju fil- pressjoni sistolika/ dijastolika ta ’ 11. 1/ 7. 2 mm Hg meta mnaqqsa għal plaċebo.
The blood pressure lowering effect of irbesartan in combination with hydrochlorothiazide is apparent after the first dose and substantially present within 1-2 weeks, with the maximal effect occurring by 6-8 weeks.
10 L- effett li għandu irbesartan f’ kombinazzjoni ma ’ hydrochlorothiazide fit- tnaqqis tal- pressjoni jitfaċċa wara l- ewwel doża u jibqa ’ preżenti sostanzjalment f’ 1- 2 ġimgħat, bl- effett massimu jseħħ fi żmien 6 - 8 ġimgħat.
In long-term follow-up studies, the effect of irbesartan/ hydrochlorothiazide was maintained for over one year.
Waqt studji li saru b’ kontinwazzjoni fit- tul, l- effett ta ’ irbesartan/ hydrochlorothiazide inżamm għal aktar minn sena.
Although not specifically studied with the CoAprovel, rebound hypertension has not been seen with either irbesartan or hydrochlorothiazide.
Għalkemm ma ġiex speċifikament studjat b’ CoAprovel, il- pressjoni ma reġgħetx għoliet kemm b’ irbesartan jew b’ hydrochlorothiazide.