qanastek/EMEA-V3 huggingface dataset:
There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system.
Hemm riskju miżjud ta ’ pressjoni baxxa ħafna severa u insuffiċjenza renali meta pazjenti bi stenosi bilaterali fl- arterja renali jew bi stenosi ta ’ l- arterja għal kilwa waħda li tkun taħdem, ikunu kkurati bi prodotti mediċinali li jaffettwaw is- sistema renin- angiotensin - aldosterone.
Kinzalkomb should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/ min) (see section 4.3).
Kinzalkomb m’ għandux jintuża f’ pazjenti b’ indeboliment renali sever (rata ta ’ tneħħija tal- krejatinina ta ’ < 30 ml/ min) (ara sezzjoni 4. 3).
There is no experience regarding the administration of Kinzalkomb in patients with recent kidney transplantation.
M’ hemmx esperjenza dwar l- għoti ta ’ Kinzalkomb f’ pazjenti bi trapjant riċenti tal- kliewi.
Experience with Kinzalkomb is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
L- esperjenza b’ Kinzalkomb hi modesta f’ dawk il- pazjenti b’ indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal- livelli tal- potassium, tal- krejatinina u ta ’ l- uric acid serum hu rakkomandat.
Thiazide diuretic- associated azotaemia may occur in patients with impaired renal function.
Ażotemija assoċjata ma ’ thiazide dijuretiku tista ’ sseħħ f’ pazjenti b’ indeboliment fil- funzjoni renali.
Intravascular hypovolaemia:
Ipovolemija intravaskulari:
Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/ or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting.
Pressjoni baxxa ħafna sintomatika, speċjalment wara l- ewwel doża, tista ’ sseħħ f’ pazjenti li għandhom volum u/ jew sodium li jkun tnaqqas minn terapija dijuretika vigoruża, restrizzjoni tal- melħ fid- dieta, dijarea jew rimettar.
Such conditions should be corrected before the administration of Kinzalkomb.
Dawn il- kundizzjonijiet għandhom ikunu kkoreġuti qabel l- għoti ta ’ Kinzalkomb.
Other conditions with stimulation of the renin-angiotensin-aldosterone system:
Kundizzjonijiet oħrajn bl- istimulazzjoni tas- sistema renin- angiotensin- aldosterone:
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 medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
F’ pazjenti fejn it - ton vaskulari u l- funzjoni renali jiddependu b’ mod predominanti fuq l- attività tas- sistema renin - angiotensin- aldosterone (eż. pazjenti b’ insuffiċjenza konġestiva severa tal- qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi ta ’ l- arterja renali), il- kura bi prodotti mediċinali oħrajn li jaffettwaw din is- sistema kienet assoċjata ma ’ pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew, b’ mod rari, ma ’ insuffiċjenza renali akuta (ara sezzjoni 4. 8).
Primary aldosteronism:
3 Aldosteroniżmu primarju:
Patients with primary aldosteronism generally will not respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin system.
Pazjenti b’ aldosteroniżmu primarju ġeneralment mhux ser jirrispondu għal prodotti mediċinali kontra l- pressjoni għolja li jaġixxu permezz ta ’ l- inibizzjoni tas- sistema renin - angiotensin.
Therefore, the use of Kinzalkomb is not recommended.
Għalhekk, l- użu ta ’ Kinzalkomb mhuwiex rakkomandat.
Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Stenosi tal- valv mitrali u aortiku, kardjomijopatija ipertropika ostruttiva:
As with other vasodilators, special caution is indicated in patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy.
Bħal fil- każ ta ’ mediċini oħrajn li jwessgħu l- arterji/ vini, għandha tingħata attenzjoni speċjali lil pazjenti li jbatu minn stenosi mitrali jew aortika, jew kardjomijopatija ipertropika ostruttiva.
3 Metabolic and endocrine effects:
Effetti metaboliċi u endokrinali:
Thiazide therapy may impair glucose tolerance.
It- terapija b’ thiazide tista ’ tindebolixxi t- tolleranza għal glucose.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
F’ pazjenti dijabetiċi, aġġustamenti fid- doża ta ’ l- insulina jew ta ’ sustanzi ipogliċemiċi orali jistgħu jkunu meħtieġa.
Latent diabetes mellitus may become manifest during thiazide therapy.
Dijabete mellitus moħbija tista ’ toħroġ waqt it- terapija b’ thiazide.
An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Kinzalkomb, minimal or no effects were reported.
Żieda fil- livelli tal- kolesterol u tat- trigliċeridi kienet assoċjata ma ’ terapija dijuretika b’ thiazide; madankollu, bid- doża ta ’ 12. 5 mg li hemm f’ Kinzalkomb, effetti minimi kienu rrappurtati, jew l- ebda effett.
Hyperuricaemia may occur or frank gout may be precipitated in some patients receiving thiazide therapy.
L- iperurikemija tista ’ sseħħ, jew gotta franka tista ’ tiggrava, f’ xi pazjenti li jkunu qed jirċievu terapija b’ thiazide.
Electrolyte imbalance:
Żbilanċ fl- elettroliti:
As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Bħal kull pazjent li jkun qed jirċievi terapija dijuretika, il- livell ta ’ l- elettroliti fis - serum għandu jitkejjel f’ intervalli xierqa.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (including hypokalaemia, hyponatraemia and hypochloraemic alkalosis).
It- thiazides, inkluż hydrochlorothiazide, jistgħu jikkawżaw żbilanċ fil- fluwidu jew żbilanċ fl- elettroliti (li jinkludi ipokalemija, iponatremija u alkalosi ipokloremika).
Warning signs of fluid or electrolyte imbalance are dryness of mouth, thirst, asthenia, lethargy, drowsiness, restlessness, muscle pain or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea or vomiting (see section 4.8).
Sinjali ta ’ twissija ta ’ żbilanċ fil - fluwidu jew fl- elettroliti huma nixfa fil- ħalq, għatx, astenja, letarġija, ngħas, nuqqas ta ’ kwiet f’ ġismek, uġigħ fil- muskoli jew bugħawwieġ, għeja muskolari, pressjoni baxxa, oligurja, takikardja u disturbi gastro- intestinali bħal nawseja u rimettar (ara sezzjoni 4. 8).
- Hypokalaemia
- Ipokalemija
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
Għalkemm l- ipokalemija tista ’ tiżviluppa bl- użu ta ’ dijuretiċi ta ’ thiazide, terapija fl- istess ħin ma ’ telmisartan tista ’ tnaqqas l- ipokalemija li tkun ikkawżata mid- dijuretiku.
The risk of hypokalaemia is greater in patients with cirrhosis of 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 Adrenocorticotropic hormone (ACTH) (see section 4.5).
Ir- riskju ta ’ ipokalemija hu akbar f’ pazjenti biċ- ċirrożi tal- fwied, f’ pazjenti li jkollhom dijuresi attiva, f’ pazjenti li mhumiex jirċievu biżżejjed elettroliti mill- ħalq, u f’ pazjenti li qed jirċievu terapija fl- istess bil- kortikosterojdi jew bl- ormon Adrenokortikotropiku (ACTH) (ara sezzjoni 4. 5).
- Hyperkalaemia
- Iperkalemija
Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Kinzalkomb, hyperkalaemia might occur.
Għal kuntrarju, minħabba l- antaġoniżmu tar- riċetturi ta ’ angiotensin II (AT1) mill- komponent ta ’ telmisartan ta ’ Kinzalkomb, tista ’ sseħħ l- iperkalemija.
Although clinically significant hyperkalaemia has not been documented with Kinzalkomb, risk factors for the development of hyperkalaemia include renal insufficiency and/ or heart failure, and diabetes mellitus.
Għalkemm iperkalemija klinikament sinifikanti ma kinitx dokumentata b’ Kinzalkomb, fatturi ta ’ riskju għall- iżvilupp ta ’ iperkalemija jinkludu insuffiċenzja renali u/ jew insuffiċjenza tal- qalb, u dijabete mellitus.
Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Kinzalkomb (see section 4.5).
Dijuretiċi potassium - sparing, supplimenti tal- potassium jew sostituti tal- potassium li fihom il- melħ, għandhom jingħataw bl- attenzjoni flimkien ma ’ Kinzalkomb (ara sezzjoni 4. 5).
- Hyponatraemia and hypochloraemic alkalosis
- Iponatremija u alkalosi ipokloremika
There is no evidence that Kinzalkomb would reduce or prevent diuretic-induced hyponatraemia.
M’ hemm l- ebda evidenza li Kinzalkomb jista ’ inaqqas jew jimpedixxi iponatremija kkawżata mid - dijuretiċi.
Chloride deficit is generally mild and usually does not require treatment.
In- nuqqas ta ’ chloride ġeneralment ikun ħafif u normalment ma jkollux bżonn ta ’ kura.
- Hypercalcaemia
- Iperkalċemija
Marked hypercalcaemia may be evidence of hidden hyperparathyroidism.
It- thiazides jistgħu jnaqqsu it- tneħħija ta ’ calcium ma ’ l- awrina u jikkawżaw żieda żgħira u intermittenti ta ’ calcium fis- serum fl- assenza ta ’ disturbi magħrufa tal- metaboliżmu tal- calcium.  Iperkalċemja notevoli tista ’ tkun evidenza ta ’ iperparatirojdiżmu moħbi.
Thiazides should be discontinued before carrying out tests for parathyroid function.
It- thiazides għandhom jitwaqqfu qabel ma jsiru t- testijiet għal funzjoni tal- paratirojde.
- Hypomagnesaemia
- Ipomanjesemija
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia (see section 4.5).
Intwera li t- thiazides jistgħu jżidu t- tneħħija urinarja tal- magnesium, li jista ’ jirriżulta f’ ipomanjesemija (ara sezzjoni 4. 5).
Sorbitol and Lactose Monohydrate:
Sorbitol u Lactose Monohydrate:
This medicinal product contains lactose monohydrate and sorbitol.
Dan il- prodott mediċinali fih lactose monohydrate u sorbitol.
Patients with rare hereditary problems of fructose intolerance and/ or with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4 intolleranza għal galactose, bid- defiċjenza ta ’ Lapp lactase jew b’ assorbiment ħażin ta ’ glucose - galactose, m’ għandhomx jieħdu din il- mediċina.
Ethnic differences:
Differenzi etniċi:
As with all other angiotensin II receptor antagonists, telmisartan is apparently less effective in lowering blood pressure in black patients than in non blacks, possibly because of higher prevalence of low renin states in the black hypertensive population.
Bħal fil- każ ta ’ l- antagonisti l- oħrajn kollha tar- riċettur ta ’ angiotensin II, telmisartan jidher li hu inqas effettiv f’ li jbaxxi l- pressjoni tad- demm f’ nies suwed milli f’ nies li mhumiex suwed, possibbilment minħabba l- prevalenza ogħla ta ’ livelli baxxi ta ’ renin fil- popolazzjoni sewda bi pressjoni għolja.
4 Other:
Oħrajn:
As with any antihypertensive agent, excessive reduction of blood pressure in patients with ischaemic cardiopathy or ischaemic cardiovascular disease could result in a myocardial infarction or stroke.
Bħal kull mediċina kontra l- pressjoni għolja, it- tnaqqis eċċessiv fil- pressjoni tad- demm f’ pazjenti b’ kardjopatija iskemika jew b’ mard karjovaskulari iskemiku, jista ’ jirriżulta f’ infart mijokardijaku jew f’ 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 jseħħu f’ pazjenti bi storja medika, jew mingħajrha, ta ’ allerġija jew ażżma tal- bronki, imma huma iktar possibbli f’ pazjenti bi storja medika bħal din.
Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics.
It- tħarrix jew l- attivazzjoni ta ’ lupus erythematosus sistemiku kien irrappurtat bl- użu ta ’ dijuretiċi ta ’ thiazide.
Cases of photosensitivity reactions have been reported with thiazide diuretics (see section 4.8).
Każijiet ta ’ reazzjonijiet ta ’ sensittività għad- dawl kienu rrappurtati b’ dijuretiċi ta ’ thiazide (ara sezzjoni 4. 8).
If a photosensitivity reaction occurs during treatment, it is recommended to stop the treatment.
Jekk matul il- kura sseħħ reazzjoni ta ’ sensittività għad- dawl, hu rakkomandat li twaqqaf il- kura.
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 l- għoti mill- ġdid tad- dijuretiku jkun ikkunsidrat li hu meħtieġ, hu rakkomandat li tipproteġi ż- żoni esposti għax- xemx jew għal UVA artifiċjali.
Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Żidiet riversibbli fil- konċentrazzjonijiet ta ’ lithium fis- serum u t- tossiċità kienu rrappurtati bl- għoti flimkien ta ’ lithium ma ’ inibituri ta ’ l- enzimi li jibdlu l- angiotensin.
Rare cases have also been reported with angiotensin II receptor antagonists (including Kinzalkomb).
Każijiet rari kienu irrappurtati wkoll b’ antagonisti ta ’ riċetturi ta ’ angiotensin II (li jinkludu Kinzalkomb).
Co-administration of lithium and Kinzalkomb is not recommended (see section 4.4).
L- għoti flimkien ta ’ lithium u Kinzalkomb mhuwiex rakkomandat (ara sezzjoni 4. 4).
If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Jekk din it- taħlita turi li hi essenzjali, monitoraġġ bl- attenzjoni tal- livell tas- serum lithium hu rakkomandat matul użu fl- istess ħin.
Medicinal products associated with potassium loss and hypokalaemia (e. g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives):
Prodotti mediċinali marbuta ma ’ telf tal- potassium u ipokalemija (eż. dijuretiċi kaliuretiċi oħrajn, lassattivi, kortikosterojdi, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid u derivattivi tiegħu):
If these substances are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Jekk tkun ser tingħata riċetta għal dawn il- mediċini mat- taħlita hydrochlorothiazide- telmisartan, il- monitoraġġ tal- livelli tal- potassium fil- plażma hu rakkomandat.
These medicinal products may potentiate the effect of hydrochlorothiazide on serum potassium (see section 4.4).
Dawn il- prodotti mediċinali jistgħu jżidu l- effett ta ’ hydrochlorothiazide fuq is- serum potassium (ara sezzjoni 4. 4).
ACE inhibitors, potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, cyclosporin or other medicinal products such as heparin sodium):
Prodotti mediċinali li jistgħu jżidu l- livelli tal- potassium jew jikkaġunaw iperkalemija (eż. inibituri ta ’ ACE, dijuretiċi potassium- sparing, supplimenti tal- potassium, sostituti tal- melħ li fihom il- potassium, cyclosporin jew prodotti mediċinali oħrajn, bħal heparin sodium).
If these medicinal products are to be prescribed with the hydrochlorothiazide-telmisartan combination, monitoring of potassium plasma levels is advised.
Jekk tkun ser tingħata riċetta għal dawn il- prodotti mediċinali mat- taħlita hydrochlorothiazide- telmisartan, il- monitoraġġ tal- livelli tal - potassium fil- plażma hu rakkomandat.
Based on the experience with the use of other medicinal products that blunt the renin- angiotensin system, concomitant use of the above medicinal products may lead to increases in serum potassium and is, therefore, not recommended (see section 4.4).
Ibbażat fuq l- esperjenza ma ’ l- użu ta ’ prodotti mediċinali oħrajn li jnaqqsu l- effett tas- sistema renin- angiotensin, l- użu fl- istess ħin tal- prodotti mediċinali msemmija hawn fuq jista ’ jwassal għal żidiet fis- serum potassium, u għaldaqstant mhuwiex rakkomandat (ara sezzjoni 4. 4).
Medicinal products affected by serum potassium disturbances:
Prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum:
Periodic monitoring of serum potassium and ECG is recommended when Kinzalkomb is administered with these medicinal products affected by serum potassium disturbances (e. g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Monitoraġġ perjodiku tal- livell tal- potassium fis- serum u ECG huma rakkomandati meta Kinzalkomb jingħata ma ’ dawn il - prodotti mediċinali affettwati minn disturbi fil- livell tal- potassium fis- serum (eż. digitalis glycosides, u anti- arritimiċi) u mal- prodotti mediċinali li ġejjin li jinduċu torsades de pointes (li jinkludu xi anti - arritimici), bl- ipokalemija, li hi fattur li jippredisponi t- torsades de pointes.
- class Ia antiarrythmics (e. g. quinidine, hydroquinidine, disopyramide)
- Anti- arritimiċi ta ’ Klassi Ia (eż.: quinidine, hydroquinidine, disopyramide)
- class III antiarrythmics (e. g. amiodarone, sotalol, dofetilide, ibutilide)
- Anti- arritimiċi ta ’ Klassi III (eż. amiodarone, sotalol, dofetilide, ibutilide)
- some antipsychotics (e. g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
(eż. thioridazine, chlorpromazine, levomepromazine,
cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol)
- others (e. g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
(eż. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
Digitalis glycosides:
Digitalis glycosides:
Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Ipokalemija jew ipomanjesemija kkaġunati minn thiazide jiffavorixxu l- bidu ta ’ arritmija kkaġunata minn digitalis (ara sezzjoni 4. 4).
Other antihypertensive agents:
Mediċini oħrajn kontra l- pressjoni għolja:
Telmisartan may increase the hypotensive effect of other antihypertensive agents.
Telmisartan jista ’ jżid l- effett li jbaxxi l- pressjoni ta ’ mediċini oħrajn kontra l- pressjoni għolja.
Antidiabetic medicinal products (oral agents and insulin):
Prodotti mediċinali kontra kontra d- dijabete (mediċini li jittieħdu mill- ħalq u insulina):
Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Aġġustament fid- doża ta ’ prodotti mediċinali kontra d- dijabete jista ’ jkun meħtieġ (ara sezzjoni 4. 4).
Metformin should be used with precaution: risk of lactic acidosis induced by a possible functional renal failure linked to hydrochlorothiazide.
Metformin għandu jintuża bl- attenzjoni: hemm riskju ta ’ aċidożi lattikali kkaġunata minn insuffiċjenza funzjonali renali marbuta ma ’ hydrochlorothiazide.
Cholestyramine and colestipol resins:
Cholestyramine u colestipol resins:
Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
L- assorbiment ta ’ hydrochlorothiazide hu indebolit fil- preżenza ta ’ reżini ta ’ l- iskambju enajoniċi.
Non-steroidal anti-inflammatory medicinal products:
Prodotti mediċinali mhux sterojdi kontra l- infjammazzjoni:
NSAIDs (i. e. acetylsalicylic acid at anti- inflammatory dosage regimens, COX-2 inhibitors and non-selective NSAIDs) may reduce the diuretic, natriuretic and antihypertensive effects of thiazide diuretics and the antihypertensive effects of angiotensin II receptor antagonists.
NSAIDs (i. e. acetylsalicylic acid f’ korsijiet ta ’ dożaġġ kontra l- infjammazzjoni, inibituri ta ’ COX- 2 u NSAIDs mhux selettivi) jistgħu jnaqqsu l- effetti dijuretiċi, natriuretiċi u kontra l- pressjoni għolja ta ’ thiazide, u l- effetti kontra l - pressjoni għolja ta ’ l- antagonisti tar- riċettur ta ’ angiotensin II.
In some patients with compromised renal function (e. g. dehydrated patients or elderly patients with compromised renal function) the co-administration of angiotensin II receptor antagonists and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible.
F’ xi pazjenti li għandhom il- funzjoni renali kompromessa (eż. pazjenti deidratati jew pazjenti anzjani b’ funzjoni renali kompromessa), l- għoti flimkien ta ’ antagonisti tar- riċettur ta ’ angiotensin II u mediċini li jinibixxu cyclo- oxygenase, jista ’ jirriżulta f’ deterjorament addizzjonali tal- funzjoni renali, li jinkludi l- possibbiltà ta ’ insuffiċjenza akuta renali, li normalment tkun riversibbli.
Therefore the combination should be administered with caution, especially in the elderly.
Għalhekk, it - taħlita għandha tingħata bl- attenzjoni, speċjalment lil persuni anzjani.
Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter.
Il- pazjenti għandhom jingħataw l- ilma b’ mod adegwat u għandha tingħata konsiderazzjoni lill- monitoraġġ tal- funzjoni renali wara l - bidu ta ’ terapija fl- istess ħin u perjodikament wara dan.
Pressor amines (e. g. noradrenaline):
Pressor amines (eż. noradrenaline):
The effect of pressor amines may be decreased.
L- effett ta ’ pressor amines jista ’ jitnaqqas.
Nondepolarizing skeletal muscle relaxants (e. g. tubocurarine):
Rilassanti tal- muskoli skeletriċi li mhumiex depolarizzanti (eż. tubocurarine):
The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
L- effett tar- rilassanti tal- muskoli skeletriċi li mhumiex depolarizzanti jista ’ jissaħħaħ b’ hydrochlorothiazide
Medicinal products used in the treatment for gout (e. g. probenecid, sulfinpyrazone and allopurinol):
Prodotti mediċinali użati fil- kura għal gotta (eż. probenecid, sulfinpyrazone u allopurinol):
Dosage adjustment of uricosuric medications may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Aġġustament fid- dożaġġ ta ’ mediċini urikosuriċi jista ’ jkun meħtieġ għax hydrochlorothiazide jista ’ jżid il- livell ta ’ uric acid fis- serum.
Increase in dosage of probenecid or sulfinpyrazone may be necessary.
Żieda fid- dożaġġ ta ’ probenecid jew ta ’ sulfinpyrazone tista ’ tkun meħtieġa.
Co- administration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.
L- għoti flimkien ta ’ thiazide jista ’ jżid l- inċidenza ta ’ reazzjonijiet minħabba sensittività eċċessiva għal allupurinol.
Calcium salts:
Calcium salts:
Thiazide diuretics may increase serum calcium levels due to the decreased excretion.
Dijuretiċi thiazide jistgħu jżidu l- livelli tal- calcium fis- serum minħabba tnaqqis fit - tneħħija.
If calcium supplements must be prescribed, serum calcium levels should be monitored and calcium dosage adjusted accordingly.
Jekk tkun ser tingħata riċetta għal supplimenti tal- calcium, il- livelli tal- calcium fis- serum għandu jkun immonitorat u d- dożaġġ tal- calcium għandu jkun aġġustata b’ mod xieraq.
Beta-blockers and diazoxide:
Imblokkaturi beta u diazoxide:
The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
L- effett ipergliċemiku ta ’ imblokkaturi beta u ta ’ diazoxide jista ’ jiżdied bit- thiazides.
Anticholinergic agents (e. g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Mediċini anti- kolinerġiċi (eż. atropine u biperiden) jistgħu jżidu l- bijodisponibilità ta ’ dijuretiċi tat- tip thiazide billi jnaqqsu moviment spontanju gastrointestinali u r- rata tat- tbattil ta ’ l- istonku.
Thiazides may increase the risk of adverse effects caused by amantadine.
It- thiazides jistgħu jżidu r- riskju ta ’ effetti avversi ikkawżati minn amantadine.
Cytotoxic agents (e. g. cyclophosphamide, methotrexate):
6 Mediċini ċitotossiċi (eż. cyclophosphamide, methotrexate):
Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Thiazides jistgħu jnaqqsu t- tneħħija renali ta ’ prodotti mediċinali ċitotossiċi u jsaħħu l- effetti majelosuppressivi tagħhom.
Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan:
Ibbażat fuq il- proprjetajiet farmakoloġiċi tagħhom, jista ’ jkun mistenni li l- prodotti mediċinali li ġejjin jistgħu jżidu l- effetti ipotensivi tal- mediċini kollha kontra l- pressjoni għolja, li jinkludu telmisartan:
Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Flimkien ma ’ dan, pressjoni tad- demm baxxa ħafna meta wieħed ikun bilwieqfa tista ’ tiggrava permezz ta ’ l- alkoħol, barbiturates, mediċini narkotiċi jew anti- dipressanti.
The use of angiotensin II receptor antagonists is not recommended during the first trimester of pregnancy (see section 4.4).
L- użu ta ’ antagonisti tar- riċetturi ta ’ angiotensin II mhuwiex rakkomandat matul l- ewwel trimestru tat - tqala (ara sezzjoni 4. 4).
The use of angiotensin II receptor antagonists is contraindicated during the second and third trimester of pregnancy (see sections 4.3 and 4.4).
L- użu ta ’ antagonisti tar- riċetturi ta ’ angiotensin II hu kontra- indikat matul it - tieni u t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 3 u 4. 4).
6 Pregnancy (see section 4.3):
Tqala (ara sezzjoni 4. 3):
There are no adequate data from the use of Kinzalkomb in pregnant women.
M’ hemmx tagħrif biżżejjed mill- użu ta ’ Kinzalkomb f’ nisa tqal.
Studies in animals have shown reproductive toxicity (see section 5.3).
Studji fuq l - annimali wrew tossiċità riproduttiva (ara sezzjoni 5. 3).
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 matul l- ewwel trimestru tat- tqala ma kinitx 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, similar risks may exist for this class of drugs.
Filwaqt li m’ hemm l- ebda dejta epidemjoloġika kkontrollata dwar ir- riskju b’ antagonisti tar - riċetturi ta ’ angiotensin II, riskji simili jistgħu jkunu jeżistu għal din il- klassi ta ’ mediċini.
Unless continued angiotensin II receptor antagonist 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.
Ħlief jekk it- tkomplija tal- kura bl- antagonisti tar- riċetturi ta ’ angiotensin II tkun ikkunsidrata li hi essenzjali, il - pazjenti li jkunu qed jippjanaw li joħorġu tqal għandha tinbidlilhom il- kura għal waħda b’ kura alternattiva b’ mediċini kontra l- pressjoni għolja li għandhom profil tas- sigurtà stabbilit għall- użu fit - tqala.
When pregnancy is diagnosed, treatment with angiotensin II receptor antagonists should be stopped immediately, and, if appropriate, alternative therapy should be started.
Meta t- tqala tkun iddijanjostikata, il- kura b’ antagonisti tar- riċetturi ta ’ angiotensin II għandha titwaqqaf immedjatament, u, jekk ikun xieraq, għandha tinbeda kura alternattiva.
Angiotensin II receptor antagonist therapy exposure during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Espożizzjoni għall- kura b’ antagonisti tar- riċetturi ta ’ angiotensin II matul it- tieni u t- tielet trimestri hu magħruf li tikkaġuna fetotossiċità (tnaqqis fil- funzjoni renali, oligoidramnios, ittardjar fl - ossifikazzjoni tal- kranju) u tossiċità fit- trabi tat- twelid (insuffiċjenza renali, pressjoni baxxa, iperkalemija).
(See also section 5.3).
(Ara wkoll sezzjoni 5. 3).
Should exposure to angiotensin II receptor antagonists have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk tkun seħħet espożizzjoni għal antagonisti tar- riċetturi ta ’ angiotensin II mit- tieni trimestru tat - tqala, hu rakkomandat li jsir kontroll bl- ultrasound tal- funzjoni renali u tal- kranju.
Infants whose mothers have taken angiotensin II receptor antagonists should be closely observed for hypotension (see also sections 4.3 and 4.4).
Trabi li ommijiethom ikunu ħadu antagonisti tar- riċetturi ta ’ angiotensin II, għandhom ikunu osservati mill- qrib għal pressjoni baxxa (ara wkoll sezzjonijiet 4. 3 u 4. 4).
Thiazides cross the placental barrier and appear in cord blood.
Thiazides jaqsmu l- ostakolu tal- plaċenta u jidhru fid- demm tal- kurdun.
They may cause foetal electrolyte disturbances and possibly other reactions that have occurred in the adults.
Jistgħu jikkawżaw disturbi fl - elettroliti tal- fetu u possibbilment reazzjonijiet oħrajn li ġraw f’ persuni adulti.
Cases of neonatal thrombocytopenia, of foetal or neonatal jaundice have been reported with maternal thiazide therapy.
Kienu rrappurtati każijiet ta ’ tromboċitopenija ta ’ trabi tat- twelid, ta ’ suffejra fil- feti jew trabi ta ’ twelid meta l- omm kienet qed tuża terapija b’ thiazide.
Lactation (see section 4.3):
Treddigħ (ara sezzjoni 4. 3):
Kinzalkomb is contraindicated during lactation since it is not known whether telmisartan is excreted in human milk.
Kinzalkomb hu kontra- indikat matul it- treddigħ għax mhux magħruf jekk telmisartan jitneħħiex fil- ħalib tal- bniedem.
Thiazides appear in human milk and may inhibit lactation.
It- thiazides jidhru fil- ħalib tal- bniedem u jistgħu jinibixxu t- treddigħ.
No studies on the effect on the ability to drive and use machines have been performed.
Ma saru l- ebda studji dwar l- effett fuq il- ħila biex issuq jew tħaddem magni.
However, when driving vehicles or operating machinery it should be taken into account that dizziness or drowsiness may occasionally occur when taking antihypertensive therapy.
Madankollu, meta ssuq il- vetturi jew tħaddem il- makkinarju, għandek tikkunsidra l- fatt li l- isturdament jew in- ngħas jistgħu xi kultant iseħħu meta wieħed ikun qed jieħdu terapija kontra l- pressjoni għolja.
Fixed Dose Combination The overall incidence of adverse events reported with Kinzalkomb was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Taħlita Fissa tad- Doża L- inċidenza totali ta ’ avvenimenti avversi rrappurtati b’ Kinzalkomb kienet komparabbli ma ’ dawk irrappurtati b’ telmisartan waħdu fi provi kkontrollati u randomised li saru fuq 1471 pazjent li kienu randomised biex jirċievu telmisartan flimkien ma ’ hydrochlorothiazide (835) jew telmisartan biss
Dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients.
Ir- relazzjoni ta ’ l- effetti mhux mixtieqa assoċjati mad- doża ma ’ kinitx stabbilita, u l- effetti ma wrew l- ebda korrelazzjoni mas- sess, ma ’ l- età, jew mar- razza tal- pazjenti.
Adverse reactions reported in all clinical trials and occurring more frequently (p ≤ 0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Reazzjonijiet avversi rrappurtati fil- provi kliniċi kollha u li seħħew b’ mod iktar frekwenti (p ≤0. 05) meta ngħata telmisartan flimkien ma ’ hydrochlorothiazide milli meta ngħata l- plaċebo, qed jintwerew hawn taħt skond il- klassi tas- sistema ta ’ l- organi.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Kinzalkomb.
Reazzjonijiet avversi li huma magħrufa li jseħħu meta kull komponent jingħata waħdu, iżda li ma kinux osservati fil- provi kliniċi, jistgħu jseħħu matul il- kura b’ Kinzalkomb.
Adverse reactions have been ranked under headings of frequency 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), not known (cannot be estimated from the available data).
Ir- reazzjonijiet avversi ġew ikklassifikati skond kategoriji ta ’ frekwenza bl- użu 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), mhux magħrufa (ma jistgħux ikunu stmati mid- dejta disponibbli)
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
F’ kull sezzjoni ta ’ frekwenza, ir- reazzjonijiet avversi huma mniżżla skond is- serjetà tagħhom, bl- aktar serji jitniżżlu l- ewwel.
Bronchitis Pharyngitis, sinusitis
Bronkite Farinġite, sinusite
and nutrition disorders
Disturbi fil- metaboliżmu u n- nutrizzjoni
Hypokalaemia, Hyperuricaemia, hyponatraemia
Ipokalemija, Iperurikemija, ipernatremija
Anxiety Depression
Ansjetà Dipressjoni
Dizziness Syncope, paraesthesia Insomnia, sleep disorders
Sturdament Sinkope, parestesija Nuqqas ta ’ rqad, disturbi fl- irqad
Visual disturbance, vision blurred
Disturbi tal- vista, vista mċajpra
Tachycardia, arrhythmias
Takikardija, arritmiji
Hypotension, orthostatic hypotension
Pressjoni tad- demm baxxa, pressjoni tad- demm baxxa meta wieħed ikun bilwieqfa
Dyspnoea Respiratory distress (including pneumonitis and pulmonary oedema)
Dispneja Problemi respiratorji (li jinkludu pnewmonite u edima pulmonari)
Diarrhoea, dry mouth, flatulence, Abdominal pain, constipation, dyspepsia, vomiting Gastritis
Dijarea, ħalq xott, gass, Uġigħ addominali, stitikezza, dispepsja, rimettar Gastrite
Hepatobiliary disorders
8 Disturbi fil- fwied u fil- marrara
Abnormal hepatic function/ liver disorder
Funzjoni epatika anormali/ disturb fil- fwied
Angioedema, erythema, pruritus, rash, hyperhidrosis, urticaria
Anġjoedima, eritema, ħakk, raxx, iperidrosi, urtikarja
Muscoloskeletal, connective tissue and bone disorders
Disturbi muskolu- skeltrali, tal- connective tissue u tal- għadam
Back pain, muscle spasms myalgia Arthralgia, muscle cramps, pain in limb
Uġigħ fid- dahar, spażmi fil- muskoli, majalġja Artralġja, bugħawwieġ fil- muskoli, uġigħ fir- riġlejn jew fid - dirgħajn
Erectile dysfunction
Disfunzjoni erettili
Chest pain Influenza-like illness, pain
Uġigħ fis- sider Mard bħal dak ta ’ l- influwenza, uġigħ
Blood uric acid increased Blood creatinine increased, blood creatine phosphokinase increased, hepatic enzyme increased
Żieda tal- uric acid fid- demm Żieda fil- krejatinina fid- demm, żieda fil- creatine phosphokinase fid- demm, żieda fl- enzimi epatiċi fid- demm
8 Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
Informazzjoni addizzjonali dwar komponenti individwali L- effetti mhux mixtieqa li kienu rrappurtati qabel b’ wieħed mill- komponenti individwali jistgħu jsaħħu l- effetti mhux mixtieqa b’ Kinzalkomb, anki jekk dawn ma kinux osservati fil- provi kliniċi li saru fuq dan il- prodott.
Undesirable effects occurred with similar frequency in placebo and telmisartan treated patients.
L- effetti mhux mixtieqa seħħew bi frekwenza simili f’ pazjenti li kieku kkurati bil- plaċebo u b’ telmisartan.
The overall incidence of adverse events reported with telmisartan (41.4%) was usually comparable to placebo (43.9%) in placebo controlled trials.
L- inċidenza totali ta ’ avvenimenti avversi rrappurtati b’ telmisartan (41. 4%) kienet ġeneralment komparabbli mal- plaċebo (43. 9%) fil- provi li saru li kienu kkontrollati bil- plaċebo.
The following adverse drug reactions listed below have been accumulated from all clinical trials including 5788 hypertensive patients treated with telmisartan.
Ir- reazzjonijiet avversi għall- mediċina li ġejjin, elenkati hawn taħt, inġabru mill- provi kliniċi kollha, li jinkludu 5788 pazjent bil- pressjoni għolja kkurati b’ telmisartan.
Adverse reactions of unknown frequency reported with the use of telmisartan alone include:
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ telmisartan waħdu jinkludu:
Upper respiratory tract infection, urinary tract infection including cystitis
Infezzjoni fil- parti ta ’ fuq tal- apparat respiratorju, infezzjoni fl - apparat tal- awrina li tinkludi ċistite
Eosinophilia, anaemia, thrombocytopenia
Eosinofilja, anemija, tromboċitopenija
Hypersensitivity, anaphylactic reactions
Sensittività eċċessiva, reazzjonijiet anafilattiċi
Hyperkalaemia
Iperkalemija
Stomach discomfort
Skonfort fl- istonku
Eczema, drug eruption, toxic skin eruption
Ekżema, eruzzjoni minħabba l- mediċina, eruzzjoni tossika tal - ġilda
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu- skeltrali, tal- connective tissue u tal- għadam
Arthrosis, tendon pain
Artosi, uġigħ fit- tendini
Renal dysfunction, renal impairment (including acute renal failure)
Disfunzjoni renali, indeboliment renali (li jinkludi insuffiċjenza renali akuta)
Asthenia, drug ineffective
Astenja, il- mediċina ma tkunx effettiva
Haemoglobin decreased
Tnaqqis fl- emoglobina
Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).
Hydrochlorothiazide jista ’ jikkaġuna jew iżid l- ipovolemija li tista ’ twassal għal żbilanċ fl- elettroliti (ara sezzjoni 4. 4).
Adverse reactions of unknown frequency reported with the use of hydrochlorothiazide alone include:
Reazzjonijiet avversi ta ’ frekwenza mhux magħrufa rrappurtati bl- użu ta ’ hydrochlorothiazide waħdu jinkludu:
9 Blood and lymphatic system disorders
Disturbi tad- demm u tas- sistema limfatika
Anaemia aplastic, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis, thrombocytopenia
Anemija aplastika, anemija emolitika, insuffiċjenza fil - funzjoni tal- mudullun, lewkopenija, newtropenija, agranuloċitosi, tromboċitopenija
Anaphylactic reactions, hypersensitivity
Reazzjonijiet anafilattiċi, sensittività eċċessiva
Diabetes mellitus inadequate control
Kontroll inadegwat ta ’ dijabete mellitus
Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia
Anoreksja, tnaqqis fl- aptit, żbilanċ fl- elettroliti, iperkolesterolemija, ipergliċemija, ipovolemija
Restlessness
Nuqqas ta ’ kwiet f’ ġismek
Light-headedness
Sturdament
Not known
Mhux magħrufa
Vasculitis necrotizing
Vaskulite nekrotizzanti
Gastrointestinal disorders
10 Disturbi gastro- intestinali
Pancreatitis, stomach discomfort
Pankreatite, skonfort fl- istonku
Jaundice hepatocellular, jaundice cholestatic
Suffejra epatoċellulari, suffejra kolestatika
Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis
Sindrome qisu tal- lupus, reazzjonijiet ta ’ sensittività għad - dawl, vaskulite fil- ġilda, nekrolisi epidermali tossika
Musculoskeletal, connective tissue and bone disorders
Disturbi muskolu- skeltrali, tal - connective tissue u tal- għadam
Weakness
Dgħjufija
Nephritis interstitial, renal dysfunction, glycosuria
Nefrite interstizjali, disfunzjoni renali, glikosurja
Triglycerides increased
Żieda fit- triglycerides
There is limited information available for telmisartan with regard to overdose in humans.
Hemm informazzjoni limitata disponibbli għal telmisartan fir- rigward ta ’ doża eċċessiva fil- bnedmin.
The degree to which hydrochlorothiazide is removed by haemodialysis has not been established.
Il- grad sa fejn hydrochlorothiazide jitneħħa permezz ta ’ l- emodijalisi ma kienx stabbilit.
The most prominent manifestations of telmisartan overdose were hypotension and tachycardia; bradycardia, dizziness, vomiting, increase in serum creatinine, and acute renal failure have also been reported.
L- iktar sintomi prominenti ta ’ doża eċċessiva ta ’ telmisartan kienu pressjoni tad- demm baxxa ħafna u takikardja; bradikardja, sturdament, rimettar, żieda fil- livell tal- krejatinina fis- serum, u insuffiċjenza renali akuta kienu wkoll irrappurtati.
Overdose with hydrochlorothiazide is associated with electrolyte depletion
Doża eċċessiva b’ hydrochlorothiazide hi marbuta ma ’ tnaqqis fl- elettroliti (ipokalemija, ipokloremija) u ipovolemija li tirriżulta minn dijuresi eċċessiva.
The most common signs and symptoms of overdose are nausea and somnolence.
L- iktar sinjali u sintomi komuni ta ’ doża eċċessiva huma nawseja u ngħas.
Hypokalaemia may result in muscle spasms and/ or accentuate arrhythmia associated with the concomitant use of digitalis glycosides or certain anti-arrhythmic medicinal products.
L- ipokalemija tista ’ tirriżulta fi spażmi tal- muskoli u/ jew iżżid l- arritmija marbuta ma ’ l- użu fl- istess ħin ta ’ digitalis glycosides jew ċerti prodotti mediċinali anti- arritmijaċi.
Telmisartan is not removed by haemodialysis.
Telmisartan ma jitneħħiex permezz tal- emodijalisi.
The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Il- pazjent għandu jkun immonitorjat mill - qrib, u l- kura għandha tkun sintomatika u ta ’ appoġġ.
Management depends on the time since ingestion and the severity of the symptoms.
L- immaniġġjar jiddependi fuq il- ħin minn meta d- doża tkun ittieħdet, u fuq is- severità tas- sintomi.
Suggested measures include induction of emesis and/ or gastric lavage.
Miżuri ssuġġeriti jinkludu li l- pazjent jiġi mġiegħel jirremetti u/ jew il- ħasil ġastriku.
Activated charcoal may be useful in the treatment of overdose.
Il- faħam attivat jista ’ jkun utli fil- kura ta ’ doża eċċessiva.
Serum electrolytes and creatinine should be monitored frequently.
Il- livelli ta ’ l- elettroliti u tal- krejatinina fis- serum għandhom ikunu mmonitorjati ta ’ spiss.
If hypotension occurs, the patient should be placed in a supine position, with salt and volume replacements given quickly.
Jekk isseħħ pressjoni baxxa, il- pazjent għandu jinżamm mimdud fuq dahru, u jingħata malajr sostitut tal- melħ u tal- volum.
Angiotensin II receptor antagonists and diuretics, ATC code:
Antagonisti tar- riċettur ta ’ angiotensin II u dijuretiċi, Kodiċi ATC:
Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Kinzalkomb hu taħlita ta ’ antagonist tar- riċetturi ta ’ angiotensin II, telmisartan, 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.
Din it- taħlita ta ’ dawn l- ingredjenti għandha effett miżjud kontra l- pressjoni
Kinzalkomb once daily produces effective and smooth reductions in blood pressure across the therapeutic dose range.
Kinzalkomb mogħti darba kuljum jipproduċi tnaqqis effettiv u stabbli fil- pressjoni tad- demm fil - medda kollha tad- doża terapewtika.
Telmisartan is an orally effective and specific angiotensin II receptor subtype 1 (AT1) antagonist.
Telemisartan hu antagonist effettiv li jingħata mill- ħalq, tar- riċetturi ta ’ angiotensin II (tip AT1).
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Telmisartan jieħu post angiotensin II b’ affinità għolja ħafna mis- sit fejn jeħel fis- sottotip tar- riċettur AT1, li hu responsabbli għall- azzjonijiet magħrufa ta ’ angiotensin II.
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Telmisartan ma jesibixxi l- ebda attività agonista parzjali fir- riċettur AT1.
Telmisartan selectively binds the AT1 receptor.
Telmisartan jeħel b’ mod selettiv mar- riċettur AT1.
The binding is long-lasting.
It- twaħħil idum ħafna.
Telmisartan does not show affinity for other receptors, including AT2 and other less characterised AT receptors.
Telmisartan ma jurix affinità għal riċetturi oħrajn, li jinkludu AT2 u riċetturi AT oħrajn inqas karatterizzati.
The functional role of these receptors is not known, nor is the effect of their possible overstimulation by angiotensin II, whose levels are increased by telmisartan.
Il- rwol funzjonali ta ’ dawn ir- riċetturi mhuwiex magħruf, kif lanqas hu magħruf l - effett ta ’ l- istimulazzjoni żejda possibbli tagħhom minn angiotensin II, li l- livelli tiegħu jiżdiedu permezz ta ’ telmisartan.
Plasma aldosterone levels are decreased by telmisartan.
Il- livelli ta ’ aldosterone fil- plażma jitnaqqsu minn telmisartan.
Telmisartan does not inhibit human plasma renin or block ion channels.
Telmisartan ma jinibixxix ir- renina fil- plażma umana jew jimblokka l- kanali tal- joni.
Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Telmisartan ma jinibixxix l - enzima li tibdel angiotensin (kininase II), l- enzima li tiddegrada wkoll bradykinin.
Therefore, it is not expected to potentiate bradykinin- mediated adverse effects.
Għalhekk mhux mistenni li jsaħħaħ l- effetti avversi medjati minn bradykinin.
An 80 mg dose of telmisartan administered to healthy volunteers almost completely inhibits the angiotensin II evoked blood pressure increase.
Doża ta ’ 80 mg ta ’ telmisartan mogħtija lill- voluntiera b’ saħħithom, kważi tinibixxi kompletament iż - żieda fil- pressjoni tad- demm ikkawżata minn angiotensin II.
The inhibitory effect is maintained over 24 hours and still measurable up to 48 hours.
Dan l- effett inibitorju jinżamm għal 24 siegħa u jista ’ jibqa ’ jitkejjel sa 48 siegħa.
After the first dose of telmisartan, the antihypertensive activity gradually becomes evident within 3 hours.
Wara l- ewwel doża ta ’ telmisartan, l- attività kontra l- pressjoni għolja ssir evidenti gradwalment fi żmien 3 sigħat.
The maximum reduction in blood pressure is generally attained 4-8 weeks after the start of treatment and is sustained during long-term therapy.
It- tnaqqis massimu fil- pressjoni tad- demm ġeneralment jinkiseb wara 4- 8 ġimgħat mill- bidu tal- kura, u jinżamm matul terapija fit- tul.
The antihypertensive effect persists constantly over 24 hours after dosing and includes the last 4 hours before the next dose as shown by ambulatory blood pressure measurements.
L- effett kontra l- pressjoni tad- demm jippersisti l - ħin kollu għal 24 siegħa wara li jingħata d- dożaġġ, u jinkludi l- aħħar 4 sigħat qabel id- doża li jkun imiss, kif muri mill- kejl tal- pressjoni tad- demm ambulatorja.
This is confirmed by measurements made at the point of maximum effect and immediately prior to the next dose (through to peak ratios consistently above 80% after doses of 40 and 80 mg of telmisartan in placebo controlled clinical studies).
Dan hu kkonfermat mill- kejl li jsir fil - punt ta ’ l- effett massimu u immedjatament qabel id- doża li jmiss (sal- proporzjonijiet massimi li kienu ogħla minn 80% b’ mod konsistenti, wara li ngħataw dożi ta ’ 40 u 80 mg ta ’ telmisartan fi provi kliniċi b’ telmisartan ikkontrollati bil- plaċebo.
In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
F’ pazjenti bi pressjoni għolja, telmisartan inaqqas kemm il- pressjoni sistolika kif ukoll dik dijastolika, mingħajr ma jaffettwa r- rata tal- polz.