qanastek/EMEA-V3 huggingface dataset:
Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended.
Jekk l - espożizzjoni għall- ACE inibitur tkun seħħet mit- tieni trimestru tat- tqala, huwa rakkomandat kontroll ekografiku [ultrasound] tal- funzjoni renali u tal- kranju.
Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension (see also section 4.3 and 4.4 )”.
It- trabi li ommijiethom ikunu ħadu ACE inibituri għandhom jinżammu f’ osservazzjoni stretta għall- ipotensjoni (ara wkoll is- sezzjonijiet 4. 3 u 4. 4) ”.
11 GROUNDS FOR AMENDMENT OF THE SUMMARYOF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
10 RAĠUNIJIET GĦALL- EMENDA TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT, IT- TIKKETTA U L- FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- refernza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta u l -
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif proposti mid- Detenturi tal -
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Awtorizzazzjoni għat- Tqegħid fis- Suq ġew valutati abbażi tad- dokumenti sottomessi u l- konklużjoni xjentifika fi ħdan il- Kumitat,
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Tritazide and associated names (see Annex I).
is- CHMP irrakkomanda l- emendar tal- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif għaliha/ hom huma stabbiliti fl- Anness III għal Tritazide u ismijiet assoċjati (ara Anness I).
12 ANNEX III
11 ANNESS III
NAME OF THE MEDICINAL PRODUCT TRITAZIDE and associated names (see Annex I) 2.5 mg/ 12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/ 12.5 mg tablets TRITAZIDE and associated names (see Annex I) 5 mg/ 25 mg tablets
TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2. 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 12. 5 mg TRITAZIDE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg / 25 mg
Tablet [To be completed nationally]
Pillola [Biex timtela mill- pajjiż partikolari]
Treatment of hypertension.
Għall- kura tal- ipertensjoni.
This fixed dose combination is indicated in patients whose blood pressure is not adequately controlled with ramipril alone or hydrochlorothiazide alone.
Din id- doża fissa tal- mediċini magħqudin hi indikata f’ pazjenti fejn il- pressjoni tad- demm mhijiex ikkontrollata b’ mod adegwat b’ ramipril waħdu jew b’ hydrochlorothiazide waħdu.
Oral use
Għall- użu orali.
It is recommended that TRITAZIDE is taken once daily, at the same time of the day, usually in the morning.
Hu rakkomandat li TRITAZIDE jittieħed darba kuljum, fl- istess ħin tal- ġurnata, normalment filgħodu.
TRITAZIDE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITAZIDE jista ’ jittieħed qabel, ma ’ jew wara l- ikel peress li t- teħid tal- ikel ma jimmodifikax il - bijodisponibilità tiegħu (ara sezzjoni 5. 2).
TRITAZIDE has to be swallowed with liquid.
TRITAZIDE irid jinbela ’ ma ’ xi likwidu.
Adults The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Adulti Id- doża għandha tkun speċifika għal kull pazjent/ a skont l- istorja medika tiegħu/ tagħha (ara sezzjoni 4. 4) u kemm qiegħda taħt kontroll il- pressjoni tad- demm.
The administration of the fixed combination of ramipril and hydrochlorothiazide is usually recommended after dosage titration with one of the individual components.
Normalment, l- għoti ta ’ din l- għaqda fissa ta ’ ramipril u hydrochlorothiazide tiġi rakkomandata wara aġġustamenti fid- dożaġġ ta ’ wieħed mill - komponenti b’ mod individwali.
TRITAZIDE should be started at the lowest available dosage.
TRITAZIDE għandhom jinbdew bl- inqas doża li hemm.
If necessary, the dose can be progressively increased to achieve target blood pressure; the maximum permitted doses are 10 mg of ramipril and 25 mg of hydrochlorothiazide daily.
Jekk hemm bżonn, id- doża tista tiżdied b’ mod gradwali sabiex tintlaħaq il- mira mixtieqa fil- pressjoni tad- demm; l- ogħla dożi li jistgħu jingħataw huma 10 mg ta ’ ramipril u 25 mg ta ’ hydrochlothiazide kuljum.
Diuretic-treated patients In patients concurrently treated with diuretics, as hypotension may occur following initiation of the treatment, caution is recommended.
Pazjenti taħt kura bid- dijuretiċi F’ pazjenti li fl- istess ħin qed jiġu kkurati bid- dijuretiċi, hi rakkomandata l- kawtela, peress li tista ’ sseħħ l- ipotensjoni meta tinbeda l- kura.
Consideration must be given to reducing the diuretic dose or discontinuing the diuretic before starting treatment with TRITAZIDE.
Wieħed irid jikkunsidra tnaqqis fid- doża tad- dijuretiku jew li jitwaqqaf id- dijuretiku qabel ma tinbeda l- kura b’ TRITAZIDE.
14 Patients with renal impairment TRITAZIDE is contraindicated in severe renal impairment due to the hydrochlorothiazide component (creatinine clearance < 30 ml/ min) (see section 4.3).
13 TRITAZIDE huma kontra- indikati f’ pazjenti b’ indeboliment renali gravi minħabba l- komponent hydrochlorothiazide (tneħħija tal- krejatinina < 30 ml/ min) (ara sezzjoni 4. 3).
Patients with creatinine clearance levels between 30 and 60 ml/ min should only be treated with the lowest fixed dose combination of ramipril and hydrochlorothiazide after administration of ramipril alone.
Pazjenti b’ indeboliment fil- funzjoni renali jistgħu jkollhom bżonn ta ’ tnaqqis fid- doża ta ’ TRITAZIDE. Pazjenti b’ livelli ta ’ tneħħija tal- krejatinina bejn30 u 60 ml/ min għandhom jiġu kkurati biss bl- inqas doża ta ’ din l- għaqda fissa ta ’ ramipril u hydrochlorothiazide wara l- għoti ta ’ ramipril waħdu.
The maximum permitted doses are 5 mg of ramipril and 25 mg of hydrochlorothiazide daily.
L- ogħla dożi li jistgħu jingħataw huma 5 mg ta ’ ramipril u 25 mg ta ’ hydrochlorothiazide kuljum.
Patients with hepatic impairment In patients with mild to moderate hepatic impairment, treatment with TRITAZIDE must be initiated only under close medical supervision and the maximum daily doses are 2.5 mg of ramipril and 12.5 mg of hydrochlorothiazide.
Pazjenti b’ indeboliment epatiku F’ pazjenti b’ indeboliment epatiku ħafif għal moderat, il- kura b’ TRITAZIDE għandha tinbeda biss taħt superviżjoni medika stretta u l- ogħla dożi li jistgħu jingħataw huma 2. 5 mg ta ’ ramipril u 12. 5 mg ta ’ hydrochlorothiazide.
TRITAZIDE is contraindicated in severe hepatic impairment (see section 4.3).
TRITAZIDE huma kontra- indikati f’ pazjenti b’ indeboliment epatiku gravi.
4.3 Contraindications
(ara sezzjoni 4. 3)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
Anzjani Fil- bidu tal- kura d- dożi għandhom ikunu iżgħar u l- aġġustamenti fid- dożi sussegwenti għandhom isiru b’ mod iżjed gradwali minħabba l- possibiltà ikbar ta ’ effetti mhux mixtieqa speċjalment f’ pazjenti debboli u anzjani ħafna.
- Clinically relevant electrolyte disturbances which may worsen following treatment with TRITAZIDE
Popolazzjoni pedjatrika L- użu ta ’ TRITAZIDE fit- tfal u fl- adolexxenti taħt it- 18- il sena mhux rakkomandat peress li m’ hemmx dejta biżżejjed dwar is- sigurtà u l- effikaċja.
(see section 4.4)
4. 3 Kontra- indikazzjonijiet
- Severe impairment of liver function, hepatic encephalopathy
– Sensittività eċċessiva għas- sustanza attiva jew għal xi inibitur ACE ieħor (Enzima li tikkonverti anġjotensin), hydrochlorothiazide, dijuretiċi thiazide oħra, sulfonamides jew għal xi sustanzi mhux attivi ta ’ TRITAZIDE (ara sezzjoni 6. 1). – Passat mediku ta ’ anġjoedima (ereditarja, idjopatika jew minħabba anġjoedima preċedenti b’ inibituri ACE jew AIIRA’ s) – Trattamenti barra mill- ġisem li wasslu għal kuntatt tad- demm ma ’ superfiċji b’ ċarġ elletriku negattiv (ara sezzjoni 4. 5) – djuqija sinifikanti fiż- żewġ arterji renali jew djuqija fl- arterja renali fejn kilwa waħda biss qiegħda tiffunzjona – It- tieni jew t- tielet trimestru tat- tqala (ara sezzjonijiet 4. 4 u 4. 6) – Treddigħ (ara sezzjoni 4. 6) – Indeboliment sever fil- funzjoni renali b’ tneħħija tal- krejatinina taħt it- 30 ml/ min f’ pazjenti mhux taħt dijaliżi – Żbilanċ fl- elettroliti klinikament rilevanti li jista ’ jiħżien wara kura b’ TRITAZIDE (ara sezzjoni 4. 4) – Indeboliment sever fil- funzjoni tal- fwied, enċefalopatija epatika
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
L- inibituri ACE jew l- Antagonisti għar- Riċettur ta ’ Angjotensin II (AIIRA’ s) m’ għandhomx jinbdew waqt it- tqala.
When pregnancy is diagnosed, treatment with ACE inhibitors/ AIIRAs should be stopped immediately, and, if appropriate, alternative therapy should be started (see sections 4.3 and 4.6).
Jekk tiġi dijanjostikata t - tqala, il- kura bl- inibituri ACE/ AIIRAs għandu jitwaqqaf minnufih, u jekk ikun hemm bżonn, tinbeda kura alternattiva (ara sezzjonijiet 4. 3 u 4. 6).
Patients at particular risk of hypotension
Pazjenti b’ riskju partikulari għall- ipotensjoni
15 Patients with strongly activated renin-angiotensin-aldosterone system are at risk of an acute pronounced fall in blood pressure and deterioration of renal function due to ACE inhibition, especially when an ACE inhibitor or a concomitant diuretic is given for the first time or at first dose increase.
Pazjenti bis- sistema renin- anġjotensin- aldosterone attivata ħafna, għandhom riskju ta ’ tnaqqis kbir u ta ’ malajr fil- pressjoni tad- demm u li l- funzjoni renali tmur għall- agħar minħabba l- inibizzjoni ACE,
Significant activation of renin -angiotensin-aldosterone system is to be anticipated and medical supervision including blood pressure monitoring is necessary, for example in:
Għandha tkun mistennija attivazzjoni sinifikanti fis- sistema renin- anġjotensin- aldosterone u tkun neċessarja superviżjoni medika li tinkludi monitoraġġ tal - pressjoni tad- demm, per eżempju f ’:
- patients with haemodynamically relevant left ventricular inflow or outflow impediment
pazjenti b’ ipertensjoni severa pazjenti b’ insuffiċjenza tal- qalb konġestiva ddekompensata pazjenti b’ impediment fid- dħul u fil- ħruġ tad- demm mill- ventriklu tax- xellug li b’ mod emodinamiku jkun rilevanti (eż. djuqija tal- valvola aortika jew mitrali
(e.g. stenosis of the aortic or mitral valve)
– –
- patients in whom fluid or salt depletion exists or may develop (including patients with
pazjenti b’ djuquja f’ arterja renali waħda b’ kilwa l- oħra li tiffunzjona pazjenti fejn jeżisti jew jista ’ jiżviluppa nuqqas ta ’ fluwidu jew melħ (inklużi pazjenti fuq d- dijuretiċi)
- patients with liver cirrhosis and/or ascites
pazjenti b’ ċirrożi tal- fwied jew axxite pazjenti li se jagħmlu xi operazzjoni kbira jew waqt l- anesteżija b’ sustanzi li jikkawża l - ipotensjoni
- patients undergoing major surgery or during anaesthesia with agents that produce
Normalment, qabel ma tinbeda l- kura, hu rakkomandat li tiġi rregolarizzata d- deidratazzjoni, l - ipovolimja u n- nuqqas ta ’ melħ (madankollu, f’ pazjenti b’ insuffiċjenza tal- qalb, trid toqgħod attent li b’ din l- azzjoni korrettiva ma jkunx hemm ir- riskju li l- volum jiżdied iżżejjed).
Generally, it is recommended to correct dehydration, hypovolaemia or salt depletion before initiating treatment (in patients with heart failure, however, such corrective action must be carefully weighed out against the risk of volume overload).
Operazzjoni Fejn ikun possibbli, hu rakkomandat li l- kura bl- inibituri tal- enzima li tikkonverti anġjotensin għandha titwaqqaf ġurnata qabel l- operazzjoni.
Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
– Pazjenti f’ riskju ta ’ iskemija kardijaka jew ċerebrali f’ każ ta ’ ipotensjoni akuta Fil- fażi inizjali tal- kura jkun hemm bżonn ta ’ superviżjoni medika speċjali
- Patients at risk of cardiac or cerebral ischemia in case of acute hypotension
•
The initial phase of treatment requires special medical supervision.
Iperaldosteroniżmu primarju
• Primary Hyperaldosteronism The combination ramipril + hydrochlorothiazide does not represent a treatment of choice for primary hyperaldosteronism.
L- għaqda ramipril + hydrochlorothiazide ma ’ tirrappreżentax l- aħjar kura għall- iperaldosteroniżmu primarju.
If ramipril + hydrochlorothiazide is used in a patient with primary hyperaldosteronism, then careful monitoring of plasma potassium level is required.
Jekk ramipril + hydrochlorothiazide jintuża f’ pazjent b’ iperaldosteroniżmu primarju, ikun hemm bżonn ta ’ monitoraġġ bir- reqqa tal- livelli tal- pottasium fil- plażma.
• Elderly patients See section 4.2
Pazjenti b’ mard fil- fwied
• Patients with liver disease Electrolyte disturbances due to diuretic therapy including hydrochlorothiazide may cause hepatic encephalopathy in patients with liver disease.
Żbilanċ fl- elettroliti minħabba kura dijuretika li tinkludi hydrochlorothiazide tista ’ tikkawża enċefalopatija epatika f’ pazjenti b’ mard fil- fwied.
There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after renal transplant.
Hemm riskju ta ’ indeboliment fil- funzjoni renali speċjalment f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva jew wara trapjant renali.
Renal impairment In patients with renal disease, thiazides may precipitate uraemia.
Indeboliment renali F’ pazjenti b’ mard renali, thiazides jistgħu b’ ħesrem jikkawża l- urimja.
Cumulative effects of the active substance may develop in patients with impaired renal function.
Jistgħu jiżviluppaw effetti kumulattivi tas- sustanza attiva f’ pazjenti b’ indeboliment fil- funzjoni renali.
If progressive renal impairment becomes evident, as indicated by a rising non-protein nitrogen, careful reappraisal of therapy is necessary, with consideration given to discontinuing diuretic therapy (see section 4.3).
Jekk ikun evidenti li l - indeboliment renali sejjer għall- agħar, kif indikat mil- livelli dejjem jogħlew tan- nitroġenu li mhux ġej mill- proteina, ikun hemm bżonn li din it- tip ta ’ kura tiġi eżaminata sew, bil- ħsieb li titwaqqaf il- kura dijuretika (ara sezzjoni 4. 3).
Electrolyte imbalance As for any patient receiving diuretic therapy, periodic determination of serum electrolytes should be performed at appropriate intervals.
Żbilanċ fl- elettroliti Bħal ma jsir għal kull pazjent li jirċievi kura dijuretika, f’ intervalli xierqa, għandha ssir valutazzjoni perjodika tal- elettroliti fis- serum.
Thiazides, including hydrochlorothiazide, can cause fluid or electrolyte imbalance (hypokalaemia, hyponatraemia and hypochloraemic alkalosis).
Thiazides, inkluż hydrochlorothiazide, jistgħu jikkawża żbilanċ fil - fluwidi jew fl- elettroliti (ipokalimja, iponatrimija u alkalożi ipoklorimika).
Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with ramipril may
Għalkemm l- ipokalimja tista ’ tiżviluppa bl- użu tad- dijuretiċi thiazide, kura fl- istess ħin b’ ramipril tista ’ tnaqqas l- ipokalimja kkawżata mid- dijuretiku. Ir- riskju tal- ipokalimja tkun l- iżjed f’ pazjenti b’ ċirrożi tal- fwied, f’ pazjenti li qed ikollhom dijureżi ta ’ malajr, f’ pazjenti li mhux qed jirċievu biżżejjed elettroliti u f’ pazjenti li fl -
The risk of hypokalaemia is greatest in patients with cirrhosis of the liver, in patients experiencing rapid diuresis, in patients who are receiving inadequate electrolytes and in patients receiving concomitant therapy with corticosteroids or ACTH (see section 4.5).
15 istess ħin qed jirċievu kura b’ kortikosterojdi jew ACTH (ara sezzjoni 4. 5).
The first measurement of plasma potassium levels should be carried out during the first week following the start of treatment.
L- ewwel testijiet tal- livelli tal- potassju fil- plażma għandhom isiru fl- ewwel ġimgħa wara li tinbeda l- kura.
Dilutional hyponatraemia may occur.
Jekk jinsab li l- livell tal- potassju huwa baxx, għandhom jittieħdu miżuri ta ’ korrezzjoni. Tista ’ sseħħ iponatrimja minħabba ilma żejjed.
Reduction in sodium levels can be initially asymptomatic and regular testing is therefore essential.
Fil- bidu t- tnaqqis fil- livell ta ’ sodju jista ’ jkun mingħajr sintomi u għalhekk hu importanti ħafna li jsiru testijiet b’ mod regolari.
Testing should be more frequent in elderly and cirrhotic patients.
It- testijiet għandhom ikun aktar frekwenti f’ pazjenti anzjani u ċirrotiċi.
Thiazides have been shown to increase the urinary excretion of magnesium, which may result in hypomagnesaemia.
Ġie muri li thiazides iżidu t- tneħħija fl- awrina ta ’ magnesium, li jista ’ jirriżulta f’ ipomagnesimja.
Hyperkalaemia Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITAZIDE.
Iperkalimja F’ xi pazjenti kkurati b’ inibituri ACE inkluż TRITAZIDE kellhom l- iperkalimja.
Patients at risk for development of hyperkalaemia include those with renal insufficiency, age (> 70 years), uncontrolled diabetes mellitus, or those using potassium salts, potassium retaining diuretics and other plasma potassium increasing active substances or conditions such as dehydration, acute cardiac decompensation, metabolic acidosis.
Pazjenti f’ riskju li jiżviluppaw l- iperkalimja jinkludi dawk b’ insuffiċjenza renali, età (> 70 sena), dijabete mellitus li mhix ikkontrollata jew dawk li qed jieħdu salts tal- potassju, dijuretiċi li jżommu l- potassju u sustanzi attivi oħra li jżidu l- livell ta ’ potassju fil- plażma jew kundizzjonijiet bħal deidratazzjoni, dekompensazzjoni kardijaka akuta, aċidożi metabolika.
If concomitant use of the above mentioned agents is deemed appropriate, regular monitoring of serum potassium is recommended (see section 4.5).
Jekk ikun ta ’ benefiċċju li dawn is- sustanzi msemmijin hawn fuq jintużaw fl- istess ħin, hu rakkomandat li l- potassju fis- serum jiġi ċċekkjat b’ mod regolari (ara sezzjoni 4. 5).
Hepatic Encephalopathy Electrolyte disturbances due to diuretic therapy including hydrochlorothiazide may cause hepatic encephalopathy in patients with liver disease.
Enċefalopatija epatika Disturbi fl- elettroliti minħabba t- terapija bid- dijuretiċi inkluż hydrochlorthiazide jistgħu jikkawża enċefalopatija epatika f’ pazjenti b’ mard fil- fwied.
Treatment should be immediately discontinued in case of hepatic encephalopathy.
Il- kura għandha titwaqqaf minnufih f’ każ ta ’ enċefalopatija epatika.
Hypercalcaemia Hydrochlorothiazide stimulates renal calcium reabsorption and may cause hypercalcaemia.
Iperkalċimja Hydrochlorothiazide jistimula l- assorbiment mill- ġdid tal- kalċju renali u jista ’ jikkawża l- iperkalċimja.
It may interfere with test for parathyroid function.
Jista ’ jfixkel it- test tal- funzjoni tal- paratirojde.
In case of angioedema TRITAZIDE must be discontinued.
F’ każ ta ’ anġjoedima, TRITAZIDE għandu jitwaqqfu.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITAZIDE (see section 4.8).
Ġiet irrapportata anġjoedima intestinali f’ pazjenti kkurati b’ inibituri ACE inkluż TRITAZIDE (ara sezzjoni 4. 8).
A temporary discontinuation of TRITAZIDE should be considered prior to desensitization.
Qabel it- tneħħija ta ’ sensittività għandu jiġi kkunsidrat it- twaqqif temporanju ta ’ TRITAZIDE.
Neutropenia/agranulocytosis Neutropenia/agranulocytosis have been rarely seen and bone marrow depression has also been reported.
Newtropinja/ agranuloċitosi Newtropinja/ agranuloċitosi dehru b’ mod rari ħafna u tnaqqis fl- attività tal- mudullun ġie rrapportat ukoll.
More frequent monitoring is advised in the initial phase of treatment and in patients with impaired renal function, those with concomitant collagen disease (e.g. lupus erythematosus or scleroderma), and all those treated with other medicinal products that can cause changes in the blood picture (see sections 4.5 and 4.8).
Hu rakkomandat li l- għadd taċ- ċelluli bojod tad- dejjem ikun iċċekkjat sabiex wieħed ikun jista ’ jinduna jekk hemmx xi lewkopinja. Ikun aħjar jekk fil- fażi inizjali tal- kura u f’ pazjenti b’ indeboliment fil- funzjoni renali, dawk li fl- istess ħin għandhom mard fil- collagen (eż. lupus erythematosus jew skleroderma) u dawk kollha kkurati b’ prodotti mediċinali oħra li jistgħu jikkawża tibdil f’ dak li għandu x’ jaqsam mad- demm (ara sezzjonijiet 4. 5 u 4. 8).
17 Athletes Hydrochlorothiazide may produce a positive analytic result in the anti-doping test.
Atleti Hydrochlorothiazide jista ’ jipproduċi riżultat pożittiv fl- analiżi tat- test ta ’ l- anti- doping.
Metabolic and endocrine effects Thiazide therapy may impair glucose tolerance.
16 It- terapija bit- thiazides tista ’ tnaqqas it- toleranza għal glucose.
In diabetic patients dosage adjustments of insulin or oral hypoglycaemic agents may be required.
F’ pazjenti dijabetiċi jista ’ jkun hemm bżonn ta ’ aġġustamenti fid- dożaġġ tal- insulina jew tas- sustanzi ipogliċemiċi orali.
Increases in cholesterol and triglyceride levels have been associated with thiazide diuretic therapy.
Dijabete mellitus li mhix żviluppata tista ’ tiżviluppa ruħha waqt terapija bit- thiazides Żidiet fil- livelli tal - kolesterol u tat- trigliċeridi ġew assoċjati ma ’ terapija dijuretika bit- thiazides.
Hyperuricaemia may occur or frank gout may be precipitated in certain patients receiving thiazide therapy.
Tista ’ sseħħ l- iperuriċemija jew il- gotta b’ mod ħesrem u għall- għarrieda f’ xi pazjenti li qed jirċievu t - terapija bit- thiazides.
Other Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
Oħrajn Jistgħu jseħħu reazzjonijiet ta ’ sensittività f’ pazjenti b’ passat mediku jew le ta ’ allerġija jew ażma bronkjali.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Ġiet irrapportata l- possibiltà ta ’ aggravar jew attivazzjoni ta ’ systemic lupus erythematosus.
Extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (e.g. polyacrylonitril membranes) and low density lipoprotein apheresis with dextran sulphate due to increased risk of severe anaphylactoid reactions (see section 4.3).
Trattamenti barra mill- ġisem li wasslu għal kuntatt tad- demm ma ’ superfiċji b’ ċarġ elletriku negattiv bħad- dijaliżi jew l- emofiltrazzjoni b’ xi membrana ‘ high- flux ’ (eż. membrana tal- polyacrylnitril) u afereżi tal- lipoproteina b’ densità baxxa b’ dextran sulphate minħabba ż- żieda fir- riskju ta ’ reazzjonijiet gravi li jixbħu dawk anafilattiċi (ara sezzjoni 4. 3).
Hyperkalaemia may occur; therefore close monitoring of serum potassium is required.
Tista ’ sseħħ l- iperkalimja; għalhekk ikun hemm bżonn ta ’ monitoraġġ tajjeb tal- potassium fis- serum.
Antihypertensive agents (e.g. diuretics) and other substances that may decrease blood pressure (e.g. nitrates, tricyclic antidepressants, anaesthetics, acute alcohol intake, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
Sustanzi antiipertensivi (eż. dijuretiċi) u sustanzi oħra li jistgħu jnaqqsu l- pressjoni tad- demm (eż. nitrati, antidipressivi triċikli, anestetiċi, teħid akkut tal- alkoħol, baclofen, alfuzosin, doxazosin, prazosin, tamsulosin, terazosin):
Potentiation of the risk of hypotension is to be anticipated (see section 4.2 for diuretics).
Għandu jkun mistenni żieda fir- riskju ta ’ ipotensjoni (ara sezzjoni 4. 2 għad- dijuretiċi).
Vasopressor sympathomimetics and other substances (epinephrine) that may reduce the antihypertensive effect of ramipril:
Simpatomimetiċi vasopressor u sustanzi oħra (epinephrine) li jistgħu jnaqqsu l- effett antiipertensiv ta ’ ramipril:
Blood pressure monitoring is recommended.
Hu rakkomandat monitoraġġ tal- pressjoni tad- demm
Allopurinol, immunosuppressants, corticosteroids, procainamide, cytostatics and other substances that may change the blood cell count.
Allopurinol, sustanzi li jbaxxu l- immunità, kortikosterojdi, procainamide, ċitostatiċi u sustanzi oħra li jistgħu jbidlu l- għadd taċ- ċelluli tad- demm:
Lithium levels must be monitored.
Għandu jkun hemm monitoraġġ tal- livelli ta ’ lithium.
Concomitant use of thiazide diuretics may increase the risk of lithium toxicity and enhance the already increased risk of lithium toxicity with ACE inhibitors.
L- użu fl - istess ħin tad- dijuretiċi thiazide jista ’ jżid ir- riskju ta ’ tossiċità mil- lithium u tkabbar ir- riskju diġà miżjud ta ’ tossiċità mil- lithium minħabba l- inibituri ACE.
The combination of ramipril and hydrochlorothiazide with lithium is therefore not recommended.
Għalhekk l- għaqda ta ’ ramipril u hydrochlorothiazide ma ’ lithium mhijiex irrakkomandata.
18 Antidiabetic agents including insulin:
Sustanzi antidijabetiċi inkluża l- insulina:
Hydrochlorothiazide may attenuate the effect of antidiabetic medicines.
Hydrochlorothiazide jista ’ jnaqqas l- effett tal- mediċini antidijabetiċi.
Particularly close blood glucose monitoring is therefore recommended in the initial phase of co-administration.
Għalhekk, hu rakkomandat monitoraġġ verament bir- reqqa tal- glucose fid- demm fil- fażi inizjali tal- għoti ta ’ dawn iż- żewġ mediċini flimkien.
Nonsteroidal anti-inflammatory drugs and acetylsalicylic acid:
17 Mediċini antiinfjammatorji li mhumiex sterojdi u acetylsalicylic acid:
Reduction of the antihypertensive effect of TRITAZIDE is to be anticipated.
Għandu jkun mistenni tnaqqis fl- effett antiipertensiv ta ’ TRITAZIDE.
Oral anticoagulants: anticoagulant effect may be decreased due to concomitant use of hydrochlorothiazide.
Antikoagulanti orali: l- effett antikoagulanti jista ’ jonqos minħabba l- użu fl- istess ħin ta ’ hydrochlorothiazide.
Corticosteroids, ACTH, amphotericin B, carbenoxolone, large amounts of liquorice, laxatives (in case of a prolonged use), and other kaliuretic or plasma potassium decreasing agents: increased risk of hypokalaemia.
Kortikosterojdi, ACTH, amphotericin B, carbenoxolone, ammonti kbar ta ’ likorizja, lassattivi (f’ każ ta ’ użu għal żmien twil) u sustanzi oħra kaljuretiċi jew li jnaqqsu l- pottasium fil- plażma: żieda fir - riskju ta ’ ipokalimja.
Digitalis preparations, active substances known to prolong the QT interval and antiarrhythmics: their proarrhythmic toxicity may be increased or their antiarrhythmic effect decreased in the presence of electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia).
Preparazzjonijiet ta ’ digitalis, sustanzi attivi magħrufa li jtawlu l- intervall QT u antiarritmiċi: it - tossiċità proarritmika tagħhom tista ’ tiżdied jew l- effett antiarritmiku tagħhom jonqos fil- presenza ta ’ disturbi elettrlitiċi (eż. ipokalimja, ipomagnesimja).
Haemolysis possible.
Possibbiltà ta ’ emoliżi
Colestyramine or other enterally administered ion exchangers: reduced absorption of hydrochlorothiazide.
Colestyramine jew sustanzi oħra li jbidlu l- ijonji (ion exchangers) mogħtija b’ mod enteriku: tnaqqis fl - assorbiment ta ’ hydrochlorothiazide.
Sulphonamide diuretics should be taken at least one hour before or four to six hours after these medications.
Dijuretiċi sulfonamidi għandhom jittieħdu mill- anqas siegħa qabel jew bejn erba ’ sa sitt sigħat wara dawn il- medikazzjonijiet.
Possible intensification and prolongation of the muscular relaxing effect.
Rilassant muskolari tat- tip curare: possibbiltà li l- effett rilassanti fuq il- muskoli jiżdied u jittawwal.
Calcium salts and plasma calcium increasing medicinal products:
Imluħa tal- kalċju u prodotti mediċinali li jżidu l- kalċju fil- plażma:
Rise in serum calcium concentration is to be anticipated in case of concomitant administration of hydrochlorothiazide; therefore close monitoring of serum calcium is required.
Għandu jkun mistenni li l - konċentrazzjoni tal- kalċju fis- serum jogħla f’ każ ta ’ teħid fl- istess ħin ta ’ hydrochlorothiazide; għalhekk hemm bżonn ta ’ monitoraġġ tajjeb tal- kalċju fis- serum
Carbamazepine: risk of hyponatraemia due to additive effect with hydrochlorothiazide.
Carbamazepine: riskju ta ’ iponatrimja minħabba l- effett addittiv ta ’ hydrochlorothiazide.
Iodine containing contrast media: in case of dehydration induced by diuretics including hydrochlorothiazide, there is increased risk of acute renal impairment, in particular when use of important doses of iodine containing contrast media.
Midja ta ’ kuntrast li fihom il- jodju: f’ każ ta ’ deidratazzjoni kawża tad- dijuretiċi inkluż hydrochlorothiazide, hemm żieda fir- riskju ta ’ indeboliment renali akut speċjalment meta jkun hemm l- użu ta ’ dożi importanti ta ’ midja ta ’ kuntrast li fihom il- jodju.
Penicillin: hydrochlorothiazide is excreted in the distal tubulus, and reduces excretion of penicillin.
Penicillin: hydrochlorthizide jiġi mneħħi mit- tubulu distali u jnaqqas it- tneħħija ta ’ penicillin
Quinine: hydrochlorothiazide reduces quinine excretion.
Quinine: hydrochlorothiazide inaqqas it- tneħħija ta ’ quinine.
TRITAZIDE is not recommended during the first trimester of pregnancy (see section 4.4) and contraindicated during the second and third trimesters of pregnancy (see section 4.3).
TRITAZIDE mhux rakkomandat waqt l- ewwel trimestru ta ’ tqala (ara sezzjoni 4. 4) u kontra- indikat waqt it- tieni u t- tielet trimestru ta ’ tqala (ara sezzjoni 4. 3).
When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.
Jekk tiġi dijanjostikata t- tqala, il- kura b’ TRITAZIDE għandu jitwaqqaf minnufih, u jekk ikun hemm bżonn, tinbeda kura alternattiva.
ACE inhibitor/ Angiotensin II Receptor Antagonist (AIIRA) 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 għat - terapija bl- inibituri ACE / Antagonisti għar- Riċettur ta ’ AnġjotensinII waqt it- tieni u t- tielet trimestri ta ’ tqala hu magħruf li jikkawża fetotossiċità umana (tnaqqis fil- funzjoni renali, nuqqas fl- ammont ta ’ fluwidu amnjotiku, dewmien fl- ossifikazzjoni tal- kranju) u tossiċità tat- tarbija tat- twelid (insuffiċjenza renali, ipotensjoni, iperkalimja).
(See 19 also 5.3'Preclinical safety data').
(Ara wkoll sezzjoni 5. 3 ‘ Tagħrif ta 'qabel l- użu kliniku dwar is - sigurtà tal- mediċina ’).
Hydrochlorothiazide, in cases of prolonged exposure during the third trimester of pregnancy, may cause a foeto-placental ischaemia and risk of growth retardation.
18 F’ każijiet ta ’ espożizzjoni għal żmien twil waqt it- tielet trimestru, hydrochlorothiazide jista ’ jikkawża iskemija fetu- plaċentali u riskju ta ’ nuqqas ta ’ żvilupp tal- fetu.
Moreover, rare cases of hypoglycaemia and thrombocytopenia in neonates have been reported in case of exposure near term.
Barra minn hekk, ġew irrapportati każijiet rari ta ’ ipogliċemija u tromboċitopinja fit- trabi tat- twelid minħabba espożizzjoni lejn l- aħħar tat- tqala.
Hydrochlorothiazide can reduce plasma volume as well as the uteroplacental blood flow.
Hydrochlorothiazide jista ’ jnaqqas il- volum tal- plażma u l- fluss tad- demm uteroplaċentali.
TRITAZIDE is contraindicated during breast-feeding.
TRITAZIDE huma kontra- indikati waqt it- treddigħ.
Insufficient information is available regarding the use of ramipril during breast-feeding and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Jekk nisa li qed irredgħu jingħataw dożi terapewtiċi ta ’ ramipril u hydrochlorothiazide, l- ammonti ta ’ ramipril u hydrochlorothiazide li joħorġu fil- ħalib tas- sider huma tali li probabbilment ikollhom effetti fuq it- tarbija li qeda terda ’. M’ hemmx tagħrif biżżejjed dwar l- użu ta ’ ramipril waqt it- treddigħ u jkunu preferibbli kuri alternattivi b’ passat stabbilit aħjar ta ’ sikurezza għal waqt it- treddigħ specjalment waqt it- treddigħ ta ’ tarbija tat- twelid jew ta ’ tarbija li twieldet qabel iż- żmien.
Hydrochlorothiazide is excreted in human milk.
Hydrochlorothiazide jiġi mneħħi fil- ħalib uman.
Hypersensitivity to sulphonamide-derived active substances, hypokalaemia and nuclear icterus might occur.
Waqt it- treddigħ minn ommijiet li qed jipproduċi ħalib, thiazides ġew assoċjati ma ’ tnaqqis jew anki twaqqif ta ’ produzzjoni ta ’ ħalib. Jistgħu jseħħu sensittività eċċessiva għas - sustanzi attivi ġejjin mis- sulfonamidi, ipokalimja u ikterus nukleari.
Because of the potential for serious reactions in nursing infants from both active substances, a decision should be made whether to discontinue nursing or to discontinue therapy taking account of the importance of this therapy to the mother.
Minħabba l- possibbiltà ta ’ reazzjonijiet serji miż- żewġ sustanzi attivi fit- trabi li qed jiġu mredda ’, deċisjoni għandha tittieħed dwar jekk għandux jieqaf it- treddigħ jew titwaqqaf il- kura, waqt li tqis l- importanza ta ’ din it- terapija għall- omm.
Some adverse effects (e.g. symptoms of a reduction in blood pressure such as dizziness) may impair the patient’s ability to concentrate and react and, therefore, constitute a risk in situations where these abilities are of particular importance (e.g. operating a vehicle or machinery).
Xi effetti avversi (eż. sintomi ta ’ tnaqqis fil- pressjoni tad- demm bħal l- isturdament) jistgħu jnaqqsu l - abbiltà tal- pazjenti li jikkonċentra u jirreaġixxi u għalhekk ikunu ta ’ riskju f’ sitwazzjonijiet fejn dawn l- abbiltajiet ikunu ta ’ importanza partikulari (eż. tħaddem karozza jew magni).
After the first dose or subsequent increases in dose it is not advisable to drive or operate machinery for several hours.
Hu rakkomandat li wara l - ewwel doża jew wara żidiet sussegwenti fid- doża, m’ għandekx issuq jew tħaddem magni għal bosta sigħat.
The ramipril active substance may induce persistent dry cough, while the hydrochlorothiazide active substance may lead to worsening of glucose, lipid and uric acid metabolism.
L- analiżi tas- siġurtà ta ’ ramipril + hydrochlorothiazide jinkludi reazzjonijiet avversi li seħħew fil - kuntest tal- ipotensjoni u/ jew nuqqas ta ’ fluwidu minħabba ż- żieda fid- djuresi. Is- sustanza attiva ramipril tista ’ tikkawża sogħla niexfa persistenti, waqt li s- sustanza attiva hydrochlorothiazide tista ’ twassal biex imur għall- agħar il- metaboliżmu tal- glucose, tal- lipidi tal- aċidu uriku.
The two active substances have inverse effects on plasma potassium.
Iż- żewġ sustanzi attivi għandhom effetti bil- maqlub fuq il- potassju fil- plażma.
Serious adverse reactions include angioedema or anaphylactic reaction, renal or hepatic impairment, pancreatitis, severe skin reactions and neutropenia/agranulocytosis.
Reazzjonijiet avversi serji jinkludu anġjoedima jew reazzjoni anafilattika, indeboliment renali jew epatiku, pankreatite, reazzjonijiet severi fil- ġilda u newtropinja/ agranuloċitosi
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).
Komuni ħafna (≥1/ 10); Komuni (≥1/ 100 sa < 1/ 10); Mhux komuni (≥1/ 1, 000 sa < 1/ 100); Rari (≥1/ 10, 000 sa < 1/ 1, 000); Rari ħafna (< 1/ 10, 000), mhux magħruf (ma tistax tittieħed stima mid- data disponibbli) >
Cardiac disorders
Disturbi fil - qalb
Uncommon Myocardial ischaemia including angina pectoris, tachycardia, arrhythmia, palpitations, oedema peripheral
Mhux komuni Iskemija mijokardjali li tinkludi angina pectoris, takikardija, arritmja, palpitazzjonijiet, edima periferali
Not known Myocardial infarction
Mhux magħruf Infart mijokardjali
20 Blood and lymphatic system disorders
19 sistema limfatika
White blood cell count decreased, red blood cell count decreased, haemoglobin decreased, haemolytic anaemia, platelet count decreased
tad- demm, tnaqqis fl- għadd taċ- ċelluli ħomor tad- demm, tnaqqis fl - emoglobina, anemija emolitika, tnaqqis fl - għadd tal- plejtlits
Bone marrow failure, neutropenia including agranulocytosis, pancytopenia, eosinophilia Haemoconcentration in the context of fluid depletion
li tinkludi agranuloċitosi, panċitopenj a, eosinofilja, żieda fil - konċentrazzjoni tal - emoglobina f’ kuntest ta ’ nuqqas ta ’ fluwidu
Vertigo, paraesthesia, tremor, balance disorder, burning sensation, dysgeusia, ageusia
Vertigo, parestiżja, tregħid, disturbi fil - bilanċ, sensazzjoni ta ’ ħruq, disgewżja, agewżja
Cerebral ischaemia including ischaemic stroke and transient ischaemic attack, psychomotor skills impaired, parosmia
Iskemija ċerbrali li tinkludi puplesija iskemika u attakk iskemiku ta ’ qasir żmien, tnaqqis fl - abbiltajiet psikomotorji, parosmja
Visual disturbance including blurred vision, conjunctivitis
Disturbi fil- viżta li tinkludi viżta mċajpra, konġuntivite
Xanthopsia, lacrimation decreased due to hydrochlorothiazide
Ksantopsja, nuqqas ta ’ dmugħ minħabba hydrochlorothiazide
Hearing impaired
Diffikultà fis- smigħ
Non-productive tickling cough, bronchitis
Sogħla niexfa b’ tagħrix fil - griżmejn, bronkite
Sinusitis, dyspnoea, nasal congestion
Sinusite, diffikultà biex tieħu n- nifs, konġestjoni nażali
Bronchospasm including asthma aggravated Alveolitis allergic, non cardiogenic pulmonary oedema due to hydrochlorothiazide
Bronkospażmu li tinkludi l- aggravar tal- ażma Alveolite allerġika, edima pulmonarja mhux kardjoġenika kkawżata minn hydrochlorothiazide
Gastrointestinal inflammation, digestive disturbances, abdominal discomfort, dyspepsia, gastritis, nausea, constipation
Infjammazzjoni gastro- intestinali, disturbi diġestivi, dwejjaq addominali, dispepsja, gastrite, dardir, stitikezza Ġinġivite minħabba
Vomiting, aphtous stomatitis, glossitis, diarrhoea, abdominal pain upper, dry mouth
Rimettar, ulċeri fil - ħalq, glossite, dijarea, uġigħ fin - naħa ta ’ fuq tal -
Pancreatitis (cases of fatal outcome have been very exceptionally reported with ACE inhibitors), pancreatic enzymes increased, small bowel angioedema
Pankreatite (bl- inibituri ACE, b’ mod eċċezzjonali ħafna ġew irrapportati xi każijiet li kellhom eżitu fatali), żieda fl- enzimi pankreatiċi, anġjoedima fl - intestin iż- żgħir
Gingivitis due to hydrochlorothiazide
addome, ħalq xott
Sialoadenitis due to hydrochlorothiazide
Infjammazzjoni tal - glandoli tal- bżieq minħabba hydrochlorothiazide
Renal impairment including renal failure acute, urine output increased, blood urea increased, blood creatinine increased 21
Indeboliment renali li tinkludi insuffiċjenza renali akuta, żieda fl - ammont tal- awrina, żieda fl- ammont ta ’ urea fid- demm, żieda fl- ammont ta ’ krejatinina fid - demm
Worsening of a pre- existing proteinuria Interstitial nephritis due to hydrochlorothiazide
Jiżdied l- ammont li diġa ’ kien hemm ta ’ proteina fl - awrina Nefrite interstizjali minħabba hydrochlorothiazide
Skin and subcutaneous tissue disorders
Anġjoedima: b’ mod eċċezzjonali ħafna,
Angioedema: very exceptionally, the airway obstruction resulting from angioedema may have a fatal outcome; dermatitis psoriasiform, hyperhidrosis, rash, in particular maculo-papular, pruritus, alopecia
l- ostrużżjoni fil- pajp tan- nifs minħabba l - anġjoedima jista ’ jkollu riżultat fatali; dermatite psorjasiforme, iperidrożi, raxx b’ mod partikulari makulo- papulari, prurite, alopeċja
Toxic epidermal necrolysis, Stevens- Johnson syndrome, erythema multiforme, pemphigus, psoriasis aggravated, exfoliative dermatitis, photosensitivity reaction, onycholysis, pemphigoid or lichenoid exanthema or enanthema, urticaria
Johnson, eritema multiforme, pemfigus, psorjasi li tmur għall - agħar, dermatite esfoljattiva, reazzjoni ta ’ fotosensittività, onikolożi (jinqala ’ d- difer minn postu), pemfigojd jew eksantema liċenojde jew enantema, urtikarja
Systemic lupus erythematosus due to hydrochlorothiazide
Lupus erythematosus sistemika minħabba hydrochlorothiazide
Musculoskeletal and connective tissue disorders
Disturbi muskolu - skeltrali u tal -
Arthralgia, muscle spasms Muscular weakness, musculoskeletal stiffness, tetany due to hydrochlorothiazide
Debbulizza fil - muskoli, ebusija muskolu - skeltrali, tetanja minħabba hydrochlorothiazide
Diabetes mellitus inadequate control, glucose tolerance
Kontroll inadegwat tad- dijabete mellitus, tonqos it -
Anorexia, decreased appetite
Anoressija, tnaqqis fl- aptit
Blood potassium increased due
Żieda fil - livell ta ’ potassju
decreased, blood glucose increased, blood uric acid increased, gout aggravated, blood cholesterol and/or triglycerides increased due to hydrochlorothiazide
tollerabilità għal - glucose, jiżdied il - livell ta ’ glucose fid- demm, jiżdied il- livell tal- aċidu uriku fid- demm, il - gotta tmur għall - agħar, il- livell tal - kolesterol u/ jew tat- trigliċerdi fid - demm jiżdied minħabba hydrochlorothiazid e
Blood potassium decreased, thirst due to hydrochlorothiazide
Tnaqqis fil- livell ta ’ pottasium fid- demm, għatx minħabba hydrochlorothiazide
to ramipril
fid- demm minħabba ramipril
Glycosuria, metabolic alkalosis, hypochloraemia, hypomagnesaemia, hypercalcaemia, dehydration due to hydrochlorothiazide
Glikosurja, alkalożi metabolika, ipoklorimja, ipomagnesimja, iperkalċimja, deidratazzjoni minħabba hydrochlorothiazide
Hypotension, orthostatic blood pressure decreased, syncope, flushing
Ipotensjoni, tnaqqis fil- pressjoni tad - demm ortostatika, sinkope, ħmura fil - wiċċ
Thrombosis in the context of severe fluid depletion, vascular stenosis, hypoperfusion, Raynaud’s phenomenon, vasculitis
Tromożi f’ kuntest ta ’ nuqqas gravi ta ’ fluwidi, stenożi vaskulari, ipoperfużjoni, fenomenu ta ’ Raynaud, vaskulite
22 General disorders and administration site conditions
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Fatigue, asthenia
Gheja, astinja
Chest pain, pyrexia
Uġigħ fis- sider, deni
Anaphylactic or anaphylactoid reactions to either ramipril or anaphylactic reaction to hydrochlorothiazide, antinuclear antibody increased
Reazzjonijiet anafilattiċi jew li jixbħuhom għal jew ramipril jew reazzjoni anafilattika għal hydrochlorothiazide, żieda fl- antikorpi antinukleari
Cholestatic or cytolytic hepatitis (fatal outcome has been very exceptional), hepatic enzyme and /or bilirubin conjugated increased
Epatite kolestatika jew ċitolitika (każijiet b’ eżitu fatali kienu eċċeżżjonali ħafna) żieda fl- enzimi epatiċi u/ jew żieda fil- bilirubin konġjugat
Acute hepatic failure, jaundice cholestatic, hepatocellular damage
Insuffiċjenza epatika akuta, suffejra kolestatika, dannu epatoċellulari
Calculous cholecystitis due to hydrochlorothiazide
Koleċistite kawża tal- formazzjoni ta ’ kalkli minħabba hydrochlorothiazide
Transient erectile impotence
Impotenza erettili għal żmien qasir
Libido decreased, gynaecomastia
Tnaqqis fil- libido, gajnikomastja (żvilupp eċċessiv tas- sider fir- raġel)
Depressed mood, apathy, anxiety, nervousness, sleep disorders including somnolence,
Tħossok imdejjaq, apatija, ansjetà, nervożità, disturbi fl- irqad inkluż ħedla ta ’ ngħas
Confusional state, restlessness, disturbance in attention
Stat konfużjonarju, irrekwitezza, disturbi fl - attenzjoni
Symptoms associated with overdosage of ACE inhibitors may include excessive peripheral vasodilatation (with marked hypotension, shock), bradycardia, electrolyte disturbances, renal failure, cardiac arrhythmia, impairment of consciousness including coma, cerebral convulsions, pareses, and paralytic ileus.
Sintomi assoċjati ma ’ doża eċċessiva ta ’ inibituri ACE jistgħu jinkludu vasodilatazzjoni periferali eċċessiva (b’ ipotensjoni kbira, xokk), bradikardija, disturbi fl- elettroliti, insuffiċjenza renali, arritmja kardijaka, nuqqas ta ’ koxjenza li tinkludi koma, konvulżjonijiet ċerebrali, pareżi, u iljus paralitiku.
In predisposed patients (e.g. prostatic hyperplasia) hydrochlorothiazide overdose may induce acute urinary retention.
F’ pazjenti predisposti (eż. iperplażja prostatika), doża eċċessiva ta ’ hydrochlorothiazide tista ’ tikkawża żamma tal- awrina b’ mod akut.
Suggested measures include primary detoxification (gastric lavage, administration of adsorbents) and measures to restore haemodynamic stability, including administration of alpha 1 adrenergic agonists or angiotensin II (angiotensinamide) administration.
Miżuri rakkomandati jinkludu detossifikazzjoni primarja (lavaġ gastriku, l- għoti ta ’ assorbenti) u miżuri biex jerġgħu jġibu lura l- istabbilità emodinamika li jinkludu l- għoti ta ’ agonisti adrenerġiċi alfa 1 jew l - għoti ta ’ anġjotensin II (anġjotensinamid).
Ramipril Ramiprilat, the active metabolite of the prodrug ramipril, inhibits the enzyme dipeptidylcarboxypeptidase I (synonyms: angiotensin-converting enzyme; kininase II).
Ramipril Ramiprilat, il- metabolit attiv tal- prodrug ramipril jinibixxi l- enzima dipeptidylcarboxypeptidase I (sinonimi: enzima li tikkonverti anġjotensin; kininase II).
In plasma and tissue, this enzyme catalyses the conversion of angiotensin I to the active vasoconstrictor substance angiotensin II, as well as the breakdown of the active vasodilator bradykinin.
Fil- plażma u fit- tessuti, din l- enzima tikkatalizza l- konverżjoni ta ’ anġjotensin I fil- vasoristrettatur attiv anġjotensin II, kif ukoll tikkawża d- dekomponiment tal- vasodilatatur attiv bradykinin.
Since angiotensin II also stimulates the release of aldosterone, ramiprilat causes a reduction in aldosterone secretion.
22 Peress li anġjotensin II jistimula l- ħruġ ta ’ aldosterone, ramiprilat jikkawża tnaqqis fis- sekrezzjoni ta ’ aldosterone.
Hydrochlorothiazide Hydrochlorothiazide is a thiazide diuretic.
Hydrochlorothiazide Hydrochlorothiazide hu dijuretiku thiazide.
It inhibits the reabsorption of sodium and chloride in the distal tubule.
Mhux magħruf għal kollox il- mod kif id- dijuretiċi thiazide għandhom effett antiipertensiv. Jinibixxi l- assorbiment mill- ġdid ta ’ sodju u klorju mit- tubulu distali.
The increased renal excretion of these ions is accompanied by increased urine output (due to osmotic binding of water).
Iż- żieda fit- tneħħija renali ta ’ dawn l- ijonji tiġi segwita minn żieda fl- ammont tal- awrina (minħabba l - irbit osmotiku tal- ilma).
Potassium and magnesium excretion are increased, uric acid excretion is decreased.
It- tneħħija ta ’ potassju u magnesju tiżdied, it- tneħħija tal- aċidu uriku tonqos.
Possible mechanisms of the antihypertensive action of hydrochlorothiazide could be: the modified sodium balance, the reduction in extracellular water and plasma volume, a change in renal vascular resistance as well as a reduced response to norepinephrine and angiotensin II.
Il- modi possibbli ta ’ kif hydrochlorothiazide ikollu effett antiipertensiv jistgħu jkunu: it- tibdil fil - bilanċ ta ’ sodju, it- tnaqqis fil- volum ekstraċellulari tal- ilma u tal- plażma, tnaqqis fir- reżistenza vaskulari tal- kliwi kif ukoll tnaqqis fir- rispons għal norepinephrine u anġjotensin II
Generally, there are no major changes in renal plasma flow and glomerular filtration rate.
Ramipril L- għoti ta ’ ramipril jikkawża tnaqqis kbir fir- reżistenza arterjali periferali. Normalment, ma jkunx hemm tibdil kbir fil- fluss tad- demm fil- kliewi u fir- rata tal- filtrazzjoni glomerulari.
Hydrochlorothiazide With hydrochlorothiazide, onset of diuresis occurs in 2 hours, and peak effect occurs at about 4 hours, while the action persists for approximately 6 to 12 hours.
Hydrochlorothiazide B’ hydrochlorothiazide, il- bidu tad- djuresi sseħħ wara sagħtejn, u l- massimu tal- effett iseħħ wara xi 4 sigħat waqt li l- azzjoni tibqa ’ għal kważi 6 sa 12- il siegħa.
The onset of the antihypertensive effect occurs after 3 to 4 days and can last up to one week after discontinuation of therapy.
Il- bidu tal- effett antiipertensiv iseħħ wara 3 sa 4 ijiem u jista jdum sa ġimgħa wara li titwaqqaf il- kura.
The blood-pressure-lowering effect is accompanied by slight increases in the filtration fraction, renal vascular resistance and plasma renin activity.
L- effett ta ’ tnaqqis fil- pressjoni tad- demm jiġi flimkien ma ’ żidiet żgħar fl- ammont li jiġi ffiltrat, fir - reżistenza vaskulari renali u fl- attività ta ’ renin fil- plażma.