qanastek/EMEA-V3 huggingface dataset:
16 The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Ipertensjoni 15 Id- doża għandha tkun individwalizzata skont il- profil tal- pazjent (ara sezzjoni 4. 4) u l- kontroll tal - pressjoni tad- demm.
Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
Tritace u ismijiet assoċjati jistgħu jintużaw f’ monoterapija jew f’ kombinazzjoni ma ’ klassijiet oħra ta ’ prodotti mediċinali kontra l- ipertensjoni.
CV prevention The MAH proposed the following wording based on international guidelines: “ Instead of increasing the dose above 5 mg Tritace and associated names daily, the addition of another drug, e. g. of a diuretic or a calcium-antagonist may be considered”.
Prevenzjoni kardjovaskulari Il- MAH ippropona t- test li ġej ibbażat fuq linji gwidi internazzjonali: “ Minflok tiżdied id- doża aktar minn 5 mg Tritace u ismijiet assoċjati kuljum, tista ’ tiġi kkunsidrata ż- żieda ta ’ mediċina oħra, pereżempju, ta ’ dijuretiku jew antagonista tal- kalċju ”.
The CHMP agreed that the correctness of this last sentence is questionable and that no substance specific data were presented and therefore deleted this comment.
Is- CHMP qabel li l- korrettezza ta ’ din l- aħħar sentenza hija diskutibbli u li l- ebda dejta speċifika għas- sustanza ma ġiet ippreżentata u għaldaqstant ħassar dan il- kumment.
The time frame for dose escalation of 2 to 4 weeks appears appropriate based on individual variability.
Il- perjodu ta ’ żmien għaż- żieda fid- doża ta ’ 2 sa 4 ġimgħat jidher li huwa xieraq abbażi tal- varjabbiltà individwali.
The CHMP agreed the following: “ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Is- CHMP qabel fuq dan il ġej: “ Id- doża għandha tkun individwalizzata skont il- profil tal- pazjent (ara sezzjoni 4. 4) u l- kontroll tal - pressjoni tad- demm.
Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products”.
Tritace u ismijiet assoċjati jista ’ jintuża f’ monoterapija jew f’ kombinazzjoni ma ’ klassijiet oħra ta ’ prodotti mediċinali kontra l- ipertensjoni ”.
Treatment of renal disease The CHMP agreed that in patients with diabetes and microalbuminuria the recommended initial dose is 1.25 mg of Tritace once daily.
Trattament ta ’ mard renali Is- CHMP qabel li f’ pazjenti bid- dijabete u b’ mikroalbuminurja, id- doża tal- bidu rakkomandata hija 1. 25 mg Tritace darba kuljum.
In patients with diabetes and at least one cardiovascular risk the initial dose shold be 2.5 mg once a day.
F’ pazjenti bid- dijabete u tal- inqas riskju kardjovaskulari wieħed, id - doża inizjali għandha tkun 2. 5 mg darba kuljum.
And finally, for patients with non diabetic nephropathy macroproteinuria ≥ 3gm/ day, the recommended initial dose is 1.25 mg of Tritace once daily.
U finalment, għall- pazjenti b’ makroproteinurja minn nefropatija mhux dijabetika ≥3 gm/ kuljum, id- doża inizjali rakkomandata hija ta ’ 1. 25 mg Tritace darba kuljum.
Symptomatic Heart failure In all countries where the congestive heart failure indication has been approved the initial recommended dose is 0.25 mg daily and the maximum permitted dose is 10 mg daily.
Insuffiċjenza kardijaka sintomatika Fil- pajjiżi kollha fejn l- indikazzjoni insuffiċjenza kardijaka konġestiva ġiet approvata, id- doża inizjali rakkomandata hija 0. 25 mg kuljum u d- doża massima permessa hija 10 mg kuljum.
In most countries the dose is doubled every 1-2 weeks, except in Hungary where the duration is 2-3 weeks.
Fil- maġġoranza tal- pajjiżi, id- doża hija rdoppjata kull ġimgħa- ġimagħtejn, ħlief fl- Ungerija fejn it- tul ta ’ żmien huwa ġimagħtejn- 3 ġimgħat.
The proposals are acceptable with some improvements.
Il- proposti huma aċċettabbli b’ xi titjib.
In conclusion, the CHMP endorsed the following: “ In patients stabilised on diuretic therapy, the recommended initial dose is 1.25 mg daily Tritace and associated names should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg.
Bħala konklużjoni, is- CHMP awtorizza li ġej: “ F’ pazjenti stabbilizzati fuq terapija dijuretika, id- doża inizjali rakkomandata li hija 1. 25 mg kuljum Tritace u ismijiet assoċjati għandha tiżdied billi d- doża tiġi rdoppjata kull ġimgħa sa gimagħtejn sa doża massima ta ’ 10 mg kuljum.
Two administrations per day are preferable”.
Iż- żewġ għotjiet kuljum huma preferibbli ”.
Secondary prevention after acute myocardial infarction In all countries where the post myocardial infarction indication has been approved the initial recommended dose is 2.5 mg twice daily.
Prevenzjoni sekondarja wara infart mijokardijaku akut Fil- pajjiżi kollha fejn l- indikazzjoni wara infart mijokardijaku ġiet approvata, id- doża inizjali rakkomandata hija 2. 5 mg darbtejn kuljum.
However in 6 countries the starting dose is 1.25 mg to 2.5 mg twice daily.
Madankollu f’ 6 pajjiżi, id- doża inizjali hija 1. 25 mg sa 2. 5 mg darbtejn kuljum.
The maximal dose is 10 mg daily.
Id- doża massima hija 10 mg kuljum.
The dose titration steps and target dose are based on the result of the AIRE study.
Iż- żidiet singoli għat- titolazzjoni tad - doża u d- doża fil- mira huma bbażati fuq ir- riżultat tal- istudju AIRE.
The MAH calls on a high level of evidence for ACE-Is administered in the first 24 hours following acute myocardial infarction (MI) in international recommendations, to justify initiating therapy with 24 hours of MI at the lowest dose of 1.25 mg daily (that used as first dose in the heart failure indication), provided that stable haemodynamic conditions are met and the regulatory precedent with lisinopril wording.
Biex jiġġustifika l- bidu tat - terapija f’ 24 siegħa mill- infart mijokardiku bid- doża minima ta ’ 1. 25 mg/ kuljum (l- istess użata bħala l - ewwel doża għall- indikazzjoni tal- insuffiċjenza kardijaka), diment li jkun hemm il- kundizzjonijiet emodinamiċi stabbli u f’ kunsiderazzjoni tar- regolament preċedenti dwar it- test dwar lisinopril, il - MAH jitlob livell għoli ta ’ provi favur l- ACE- inibituri mogħtija fl- ewwel 24 siegħa wara l- infart mijokardiku (MI) akut fir- rakkomandazzjonijiet internazzjonali.
The CHMP, considered that in the absence of substance specific supportive data in this post myocardial infarction (MI) 24 hour interval, agreed the following: “ After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
Is- CHMP, ikkunsidrata l- assenza ta ’ dejta ta ’ appoġġ tas- sustanza speċifika f’ dan l- intervall ta ’ 24 siegħa ta ’ wara infart mijokardijaku (MI) akut, qabel fuq dan li ġej: “ Wara 48 siegħa, wara infart mijokardijaku f’ pazjent klinikament u emodinamikament stabbli, id - doża inizjali hija 2. 5 mg darbtejn kuljum għal tlett ijiem.
If the initial 2.5 dose in not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day.
Jekk id- doża inizjali mhijiex tollerata għandha tingħata doża ta ’ 1. 25 mg darbtejn kuljum għal jumejn qabel mad- doża tiżdied għal 2. 5 mg u 5 mg darbtejn kuljum.
If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdraw” (See SPC for Titration and maintenance dose)
Jekk id- doża ma tistax tiżdied għal 2. 5 mg darbtejn kuljum, it- trattament għandu jiġi rtirat ” (Ara l- SPC għal Titolazzjoni u doża ta ’ manteniment)
4.3 Contraindications There are contraindications present in one or several local SPCs.
16 4. 3 Kontraindikazzjonijiet Hemm kontraindikazzjonijiet preżenti f’ waħda jew bosta SPCs lokali.
In summary, pregnancy and lactation should be amended in line with PhVWP recommendations on ACE-I The following should be added to the contraindication:
Fil- qosor, is- sezzjoni tqala u treddigħ għandha tiġi emendata f’ konformità mar- rakkomandazzjonijiet PhVWP dwar ACE- inibituri Dan li ġej għandu jiżdied mal- kontraindikazzjoni:
17 Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states The CHMP adopted the following contraindication:
Ramipril ma għandux jintuża f’ pazjenti bi stati ta ’ ipotensjoni jew emodinamikament mhux stabbli Is- CHMP adotta l- kontraindikazzjoni li ġejja:
- “ Hypersensitivity to ramipril, to any of the excipients or any other ACE inhibitors (see section 6.1)
- “ Iperensittività għal ramipril, jew għal xi sustanzi oħra jew għal xi inibituri ACE oħrajn (ara
- History of hereditary or idiopathic angioedema
- Storja ta ’ anġjoedema ereditarja jew idjopatika
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section
- Trattament ekstrakorporali li jwasslu għall- kuntatt tad- demm ma ’ wċuħ iċċarġjati negattivament
4.5)
(ara sezzjoni 4. 5)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Stenożi bilaterali sinifikanti tal- arterja renali jew stenożi tal- arterja renali fl- unika kiljwa li taħdem
-2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6 )”
- it- 2 u t- 3 trimestru tat- tqala (ara s- sezzjonijiet 4. 4 u 4. 6) ”
4.4 Special Warnings and Precautions for Use The CHMP adopted the following wording in order to implement this section: -“ Renal Impairment: the warning should be expanded to include not just treatment in patients with renal impairment but the risk of subsequent renal impairment, risk factors and need for early discontinuation. -Agranulatocytosis: the warning should be expanded to include bone marrow depression and other effects on blood. -Hypotension and renal dysfunction after acute myocardial infarction occurred more frequently with ramipril than placebo in the target population in the AIRE study.
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu Is- CHMP adotta t- test li ġej sabiex jimplimenta din is- sezzjoni: - “ Indeboliment Renali: it- twissija għandha titwessa ’ biex tinkludi mhux biss trattament f’ pazjenti b’ indeboliment renali iżda r- riskju ta ’ indeboliment renali sussegwenti, fatturi ta ’ riskju u ħtieġa ta ’ twaqqif bikri.
- Transient or persistent heart failure post MI
- Insuffijċenza kardijaka wara MI ta ’ qasir żmien jew persistenti
- Monitoring of renal function
- Sorveljanza tal- funzjoni renali
-Cough has been reported with the use of ACE inhibitors.
- Ġiet irrapportata sogħla bl- użu ta ’ inibituri ACE.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
Karatteristikament, is- sogħla mhijiex produttiva,
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough”.
Sogħla mqanqla minn inibituri ACE għandha titqies bħala parti mid- dijanjożi differenzjali ta ’ sogħla ”.
4.6 Pregnancy and Lactation The CHMP recommended a contraindication only for the second and third trimester of pregnancy in line with PhVWP wording on use of AEC-I in pregnancy.
4. 6 Tqala u Treddigħ Is- CHMP irrakkomanda kontraindikazzjoni biss għat- tieni u t- tielet trimestru tat- tqala f’ konformità mat- test tal- PhVWP fuq l- użu ta ’ AEC- inibituri fit- tqala.
However the company challenged this view and proposed a contraindication through out pregnancy, based on data from the ramipril pregnancy register.
Madankollu, il- kumpanija kkuntestat din l - opinjoni u pproponiet kontraindikazzjoni matul it- tqala kollha, abbażi ta ’ dejta mir- reġistru ta ’ ramipril fit- tqala.
The text agreed in the PhVWP of this warning doesn’ t encourage or propose the use of ACE inhibitors during the first trimester of the pregnancy on the contrary once the pregnancy is detected the prescriber has to stop the use of ACE inhibitors and to change if it is necessary for another anti- hypertensive agent as soon as possible.
It- test aċċettat fil- PhVWP ta ’ din it- twissija la jinkorraġġixxi u lanqas jipproponi l- użu ta ’ inibituri ACE waqt l- ewwel trimestru tat- tqala, bil- kuntrarju, la darba jinduna bit- tqala, it- tabib għandu jwaqqaf l- użu ta ’ inibituri ACE u jekk ikun hemm bżonn, jaqleb għal mediċina oħra kontra l- ipertensjoni mill - iktar fis possibbli.
This change of the text is to ensure it doesn’ t suggest an immediate artificial abortion, which is not justified by the clinical experiences collected till now.
Din il- bidla fit- test hija biex tassigura li ma tissuġġerixxix abort artifiċjali immedjat, li mhuwiex iġġustifikat mill- esperjenzi kliniċi miġburin s’ issa.
In conclusions, the CHMP adopted a harmonised wording in line with PhVWP wording on use of AEC-I in pregnancy.
F’ konklużjoni s- CHMP adotta test armonizzat konformi ma ’ dak tal- PhVWP dwar l- użu tal- ACE - inibituri fit- tqala.
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations.
It- test adottat mis- CHMP huwa wieħed armonizzat abbażi tar- rakkomandazzjonijiet tal- PhVWP.
18 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
17 RAĠUNIJIET GĦALL- EMENDAR TAS- SOMMARJU TAL- KARATTERISTIĊI TAL - PRODOTT, TIKKETTA U FULJETT TA ’ TAGĦRIF
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- l- iskop tar- referenza kien l- armonizzazzjoni tas- Sommarji tal- Karatteristiċi tal- Prodotti, tikketta u
labelling and package leaflet.
fuljett ta ’ tagħrif,
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- is- Sommarji tal- Karatteristiċi tal- Prodotti, tikketti u fuljetti 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 ivvalutati abbażi tad- dokumentazzjoni ppreżentata u tad - diskussjoni 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 Tritace and associated names (see Annex I).
is- CHMP irrakkomanda l- emenda tal- Awtorizzazzjoni( jiet) għat- Tqegħid fis- Suq, li s- Sommarju tal - Karatteristiċi tal- Prodott, it- tikketta u l- fuljett ta ’ tagħrif tagħhom huma stipulati fl- Anness III għal Tritace u ismijiet assoċjati (ara l- Anness I).
19 ANNEX III
18 ANNESS III
20 NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
TRITACE and associated names (see Annex I) 1.25 mg tablets TRITACE and associated names (see Annex I) 2.5 mg tablets TRITACE and associated names (see Annex I) 5 mg tablets TRITACE and associated names (see Annex I) 10 mg tablets
TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 1. 25 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 2. 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) pilloli ta ’ 10 mg
TRITACE and associated names (see Annex I) 1.25 mg hard capsules TRITACE and associated names (see Annex I) 2.5 mg hard capsules TRITACE and associated names (see Annex I) 5 mg hard capsules TRITACE and associated names (see Annex I) 10 mg hard capsules
TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 1. 25 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 2. 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 5 mg TRITACE u ismijiet assoċjati miegħu (Ara Anness I) kapsuli ibsin ta ’ 10 mg
Tablet Hard capsule
Pillola Kapsula iebsa
[To be completed nation ally]
[Biex timtela mill- pajjiż partikolari]
THERAPEUTIC INDICATIONS
4. 1 Indikazzjonijiet terapewtiċi
- Treatment of hypertension.
- Kura tal- ipertensjoni
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
- Prevenzjoni kardjovaskulari: tnaqqis fil- mortalità u morbidità kardjovaskulari f’ pazjenti b ’:
o manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or o diabetes with at least one cardiovascular risk factor (see section 5.1).
dijabete b’ għallinqas fattur wieħed ta ’ riskju kardjovaskulari (ara sezzjoni 5. 1).
- Treatment of renal disease:
- Kura ta ’ mard renali:
o Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria, o Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor (see section 5.1), o Manifest glomerular non diabetic nephropathy as defined by macroproteinuria ≥ 3 g/ day (see section 5.1).
nefropatija glomerulari evidenti li mhix ikkawżata mid- dijabete ddeterminata minn makroproteinurja ≥ 3 g/ ġurnata (ara sezzjoni 5. 1).
- Treatment of symptomatic heart failure.
- Kura ta ’ insuffiċjenza tal- qalb sintomatika
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase
- Prevenzjoni sekondarja wara infart mijokardijaku akut: tnaqqis fil- mortalità mill- fażi akuta ta ’ infart
of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
mijokardijaku f’ pazjenti b’ sinjali kliniċi ta ’ insuffiċjenza tal- qalb meta jinbeda > 48 siegħa wara infart mijokardijaku akut.
POSOLOGY AND METHOD OF ADMINISTRATION
20 4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
21 Oral use.
Għall- użu orali.
It is recommended that TRITACE is taken each day at the same time of the day.
Hu rakkomandat li TRITACE jittieħed darba kuljum, fl- istess ħin tal- ġurnata.
TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITACE jista ’ jittieħed qabel, ma ’ jew wara l- ikel peress li t- teħid tal- ikel ma jimmodifikax il - bijodisponibilità tiegħu (ara sezzjoni 5. 2).
TRITACE has to be swallowed with liquid.
TRITACE irid jinbela ’ ma ’ xi likwidu.
It must not be chewed or crushed.
M’ għandekx tomogħdu jew tfarrku.
Diuretic-Treated patients Hypotension may occur following initiation of therapy with TRITACE; this is more likely in patients who are being treated concurrently with diuretics.
Pazjenti taħt kura bid- dijuretiċi Wara li tinbeda l- kura b’ TRITACE tista ’ sseħħ l- ipotensjoni; din tista ’ tiġri iżjed f’ pazjenti li fl- istess ħin qed jiġu kkurati bid- dijuretiċi.
Caution is therefore recommended since these patients may be volume and/ or salt depleted.
Hija għalhekk irrakkomandata l- kawtela peress li dawn il- pazjenti jistgħu jkollhom tnaqqis ta ’ volum u/ jew ta ’ melħ.
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
Jekk ikun possibbli, id- dijuretiku għandu jitwaqqaf jumejn sa tlett ijiem qabel ma tinbeda l- kura b’ TRITACE (ara sezzjoni 4. 4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with TRITACE should be initiated with a 1.25 mg dose.
F’ pazjenti ipertensivi fejn ma twaqqafx id- dijuretiku, il- kura b’ TRITACE għandha tinbeda b’ doża ta ’ 1. 25 mg.
Renal function and serum potassium should be monitored.
Għandhom jiġu ċċekkjati l- funzjoni renali u l- potassju fis- serum.
The subsequent dosage of TRITACE should be adjusted according to blood pressure target.
Id- dożaġġ sussegwenti ta ’ TRITACE għandu jiġi aġġustat skont il- mira ta ’ pressjoni tad- demm li trid tintlaħaq.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Ipertensjoni Id- doża għandha tkun speċifika għal kull pazjent/ a skont il- profil tiegħu/ tagħha (ara sezzjoni 4. 4) u kemm qiegħda taħt kontroll il- pressjoni tad- demm.
TRITACE may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
TRITACE jista ’ jintuża bħal monoterapija jew flimkien ma ’ klassijiet oħra ta ’ prodotti mediċinali antiipertensivi.
Starting dose TRITACE should be started gradually with an initial recommended dose of 2.5 mg daily.
Id- doża tal- bidu TRITACE għandu jinbeda b’ mod gradwali u hu rakkomandat li d- doża inizjali tkun ta ’ 2. 5 mg kuljum.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose.
Pazjenti b’ sistema ta ’ renin- anġjotensin- aldosterone attiva ħafna jistgħu jkollhom tnaqqis qawwi fil - pressjoni tad- demm wara l- ewwel doża.
A starting dose of 1.25 mg is recommended in such patients and the initiation of treatment should take place under medical supervision (see section 4.4).
F’ dawn il- pazjenti hu rakkomandat li d- doża inizjali tkun ta ’ 1. 25 mg u l- bidu tal- kura jsir taħt superviżjoni medika (ara sezzjoni 4. 4).
Titration and maintenance dose The dose can be doubled at interval of two to four weeks to progressively achieve target blood pressure; the maximum permitted dose of TRITACE is 10 mg daily.
Aġġustamenti u doża ta ’ manteniment Id- doża tista ’ tirdoppja f’ intervall ta ’ ġimgħatejn sa erba ’ ġimgħat sakemm b’ mod gradwali tintlaħaq il- mira tal- pressjoni tad- demm mixtieqa.; l- ogħla doża ta ’ TRITACE li tista ’ tingħata hi ta ’ 10 mg kuljum.
Usually the dose is administered once daily.
Normalment id- doża tingħata darba kuljum.
Cardiovascular prevention
Prevenzjoni kardjovaskulari
Starting dose The recommended initial dose is 2.5 mg of TRITACE once daily.
Doża tal- bidu Hu rakkomandat li d- doża inizjali ta’ TRITACE tkun ta ’ 2. 5 mg kuljum.
Titration and maintenance dose Depending on the patient’ s tolerability to the active substance, the dose should be gradually increased.
Aġġustamenti u doża ta ’ manteniment Skont it- tollerabilità tal- pazjent għas- sustanza attiva, id- doża għandha tiżdied b’ mod gradwali.
It is recommended to double the dose after one or two weeks of treatment and - after another two to three weeks - to increase it up to the target maintenance dose of 10 mg TRITACE once daily.
Hu rakkomandat li d- doża tirdoppja wara ġimgħa jew ġimgħatejn ta ’ kura u wara ġimgħatejn sa tliet ġimgħat oħra – li tiżdied sad- doża mixtieqa ta ’ manteniment ta ’ 10 mg ta ’ TRITACE kuljum.
See also posology on diuretic treated patients above.
Ara wkoll id- dożaġġ tal- pazjenti taħt kura bid- dijuretiċi aktar ’ il fuq.
Treatment of renal disease
Kura tal- mard renali
In patients with diabetes and microalbuminuria:
F’ pazjenti bid- dijabete u l- mikroalbuminurja
The recommended initial dose is 1.25 mg of TRITACE once daily.
Doża tal- bidu Hu rakkomandat li d- doża inizjali ta’ TRITACE tkun ta ’ 1. 25 mg kuljum.
22 Titration and maintenance dose Depending on the patient's tolerability to the active substance, the dose is subsequently increased.
21 Aġġustamenti u doża ta ’ manteniment Skont it- tollerabilità tal- pazjent għas- sustanza attiva, id- doża tista ’ sussegwentement tiżdied.
Doubling the once daily dose to 2.5 mg after two weeks and then to 5 mg after a further two weeks is recommended.
Id- doża ta ’ darba kuljum tista ’ tirdoppja għal 2. 5 mg wara ġimgħatejn u mbagħad hu rakkomandat titla ’ għal 5 mg wara ġimgħatejn oħra.
In patients with diabetes and at least one cardiovascular risk
F’ pazjenti bid- dijabete u għallinqas riskju wieħed kardjovaskulari
The recommended initial dose is 2.5 mg of TRITACE once daily.
Doża tal- bidu Hu rakkomandat li d- doża inizjali ta’ TRITACE tkun ta ’ 2. 5 mg kuljum.
Titration and maintenance dose Depending on the patient’ s tolerability to the active substance, the dose is subsequently increased.
Aġġustamenti u doża ta ’ manteniment Skont it- tollerabilità tal- pazjent għas- sustanza attiva, id- doża tista ’ sussegwentement tiżdied.
The target daily dose is 10 mg.
Id- doża ta ’ darba kuljum tista ’ tirdoppja għal 5 mg TRITACE wara ġimgħa jew ġimgħatejn u mbagħad hu rakkomandat titla ’ għal 10 mg wara ġimgħatejn jew tliet ġimgħat oħra.
In patients with non- diabetic nephropathy as defined by macroproteinuria ≥ 3 g/ day.
F’ pazjenti b’ nefropatija li mhix ikkawżata mid- dijabete, iddeterminata minn makroproteinurja ≥ 3 g/ ġurnata.
Symptomatic heart failure
Insuffiċjenza tal- qalb sintomatika
Starting dose In patients stabilized on diuretic therapy, the recommended initial dose is 1.25 mg daily.
Doża tal- bidu F’ pazjenti stabbilizzati fuq kura dijuretika, id- doża rakkomandata inizjali hi ta ’ 1. 25 mg kuljum.
Titration and maintenance dose TRITACE should be titrated by doubling the dose every one to two weeks up to a maximum daily dose of 10 mg.
Aġġustamenti u doża ta ’ manteniment Aġġustamenti f’ TRITACE għandhom isiru billi d- doża tirdoppja kull ġimgħa jew ġimgħatejn sa doża massima ta ’ kuljum ta ’ 10 mg.
Two administrations per day are preferable.
Ikun aħjar jekk jingħata darbtejn kuljum.
Secondary prevention after acute myocardial infarction and with heart failure
Prevenzjoni sekondarja wara infart mijokardijaku akut u b’ insuffiċjenza tal- qalb
Starting dose After 48 hours, following myocardial infarction in a clinically and haemodynamically stable patient, the starting dose is 2.5 mg twice daily for three days.
Doża tal- bidu 48 siegħa wara infart mijokardijaku f’ pazjent klinikament u emodinamikament stabbli, id- doża tal - bidu hi ta ’ 2. 5 mg darbtejn kuljum għal tlett ijiem.
If the initial 2.5 mg dose is not tolerated a dose of 1.25 mg twice a day should be given for two days before increasing to 2.5 mg and 5 mg twice a day.
Jekk id- doża inizjali ta ’ 2. 5 mg ma tkunx tollerata, għandha tingħata doża ta ’ 1. 25 mg darbtejn kuljum għal jumejn qabel ma tiżdied għal 2. 5 mg u 5 mg darbtejn kuljum.
If the dose cannot be increased to 2.5 mg twice a day the treatment should be withdrawn.
Jekk id- doża ma tistax tiżdied għal 2. 5 mg darbtejn kuljum, il- kura għandha titwaqqaf.
Titration and maintenance dose The daily dose is subsequently increased by doubling the dose at intervals of one to three days up to the target maintenance dose of 5 mg twice daily.
Aġġustamenti u doża ta ’ manteniment Id- doża ta ’ kuljum għandha sussegwentement tiżdied billi tirdoppja d- doża f’ intervalli ta ’ bejn ġurnata sa tlett ijiem sad- doża mixtieqa ta ’ manteniment ta ’ 5 mg darbtejn kuljum.
The maintenance dose is divided in 2 administrations per day where possible.
Fejn ikun possibbli d- doża ta ’ manteniment għandha titqassam f’ darbtejn.
If the dose cannot be increased to 2.5 mg twice a day treatment should be withdrawn.
Jekk id- doża ma tistax tiżdied għal 2. 5 mg darbtejn kuljum, il- kura għandha titwaqqaf.
Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction.
Għad m’ hemmx biżżejjed esperjenza fil- kura ta ’ pazjenti b’ insuffiċjenza tal- qalb gravi (NYHA IV) eżattament wara infart mijokardijaku.
Should the decision be taken to treat these patients, it is recommended that therapy be started at 1.25 mg once daily and that particular caution be exercised in any dose increase.
Jekk tittieħed id- deċiżjoni li dawn il- pazjenti jiġu kkurati, hu rakkomandat li l- kura tinbeda b’ doża ta ’ 1. 25 mg kuljum u kull żieda fid- doża għandha tittieħed taħt kawtela partikulari.
23 Special populations
Popolazzjonijiet speċjali
Patients with renal impairment Daily dose in patients with renal impairment should be based on creatinine clearance (see section 5.2):
22 Pazjenti b’ indeboliment renali Id- doża ta ’ kuljum f’ pazjenti b’ indeboliment renali għandha tkun ibbażata fuq it- tneħħija tal - krejatinina (ara sezzjoni 5. 2):
- if creatinine clearance is ≥ 60 ml/ min, it is not necessary to adjust the initial dose (2.5 mg/ day);
- jekk it- tneħħija tal- krejatinina hi ta ’ ≥ 60 ml/ mim, m’ hemmx bżonn ta ’ aġġustament fid- doża
the maximal daily dose is 10 mg;
inizjali (2. 5 mg/ kuljum); id- doża massima ta ’ kuljum hi ta ’ 10 mg;
- if creatinine clearance is between 30-60 ml/ min, it is not necessary to adjust the initial dose
- jekk it- tneħħija tal- krejatinina hi bejn 30- 60 ml/ min, m’ hemmx bżonn ta ’ aġġustament fid- doża
(2.5 mg/ day); the maximal daily dose is 5 mg;
inizjali (2. 5 mg/ kuljum); id- doża massima ta ’ kuljum hi ta ’ 5 mg;
- if creatinine clearance is between 10-30 ml/ min, the initial dose is 1.25 mg/ day and the maximal
- jekk it- tneħħija tal- krejatinina hi bejn 10- 30 ml/ min, id- doża inizjali hi ta ’ 1. 25 mg/ kuljum u d -
daily dose is 5 mg;
doża massima ta ’ kuljum hi ta ’ 5 mg;
- in haemodialysed hypertensive patients: ramipril is slightly dialysable; the initial dose is
- f’ pazjenti ipertensivi bl- emodijaliżi: ramipril jiġi daqsxejn dijalizzat; id- doża inizjali hi ta ’
1.25 mg/ day and the maximal daily dose is 5 mg; the medicinal product should be administered few hours after haemodialysis is performed.
1. 25 mg/ kuljum u d- doża massima ta ’ kuljum hi ta ’ 5 mg; il- prodott mediċinali għandu jingħata ftit sigħat wara li ssir l- emodijaliżi.
Patients with hepatic impairment (see section 5.2) In patients with hepatic impairment, treatment with TRITACE must be initiated only under close medical supervision and the maximum daily dose is 2.5 mg TRITACE.
Pazjenti b’ indeboliment epatiku (ara sezzjoni 5. 2) F’ pazjenti b’ indeboliment epatiku, il- kura b’ TRITACE għandha tinbeda biss taħt superviżjoni medika stretta u l- ogħla doż ta ’ kuljum hi ta ’ 2. 5 mg TRITACE.
A reduced initial dose of 1.25 mg ramipril should be considered.
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. Għandha tiġi kkunsidrata doża inizjali mnaqqsa ta ’ 1. 25 mg ramipril.
Paediatric population TRITACE is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Popolazzjoni pedjatrika L- użu ta ’ TRITACE fit- tfal u fl- adolexxenti taħt it- 18- il sena mhux rakkomandat peress li m’ hemmx dejta biżżejjed dwar is- sigurtà u l- effikaċja.
CONTRAINDICATIONS
4. 3 Kontra- indikazzjonijiet
- Hypersensitivity to the active substance, to any of the excipients or any other ACE (Angiotensin
– Sensittività eċċessiva għas- sustanza attiva, għal xi sustanzi mhux attivi jew għal xi inibitur ACE ieħor (Enzima li Tikkonverti Anġjotensin) (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)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Ramipril m’ għandux jintuża f’ pazjenti ipotensivi jew li mhumiex f’ stat emodinamikament stabbli..
- 2nd and 3rd trimester of pregnancy (see sections 4.4 and 4.6)
4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Popolazzjonijiet speċjali
Special populations Pregnancy:
Tqala:
ACE inhibitors such as ramipril, or Angiotensin II Receptor Antagonists (AIIRAs) should not be initiated during pregnancy.
L- inibituri ACE bħal ramipril jew l- Antagonisti għar- Riċettur ta ’ Angjotensin II (AIIRA’ s) m’ għandhomx jinbdew waqt it- tqala.
Unless continued ACE inhibitor/ AIIRAs therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm l- użu kontinwu bl- inibituri ACE / AIIRAs mhux ikkusnidrat essenzjali, pazjenti li qed jippjanaw li joħorġu tqal għandhom jingħataw kuri antiipertensivi alternattivi li għandhom passat stabbilit ta ’ siġurtà għall- użu 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). o Patients at particular risk of hypotension
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 with strongly activated renin-angiotensin-aldosterone system
- Pazjenti bis- sistema renin- anġjotensin- aldosterone attivata ħafna
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.
23 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, speċjalment meta inibitur ACE jew xi dijuretiku mogħti fl- istess ħin jingħta għall- ewwel darba jew meta tiżdied id- doża għall- ewwel darba.
24 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 severe hypertension
– – –
- patients with haemodynamically relevant left ventricular inflow or outflow impediment (e. g.
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
stenosis of the aortic or mitral valve)
– –
- patients with unilateral renal artery stenosis with a second functional kidney
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)
diuretics)
– –
- patients undergoing major surgery or during anaesthesia with agents that produce
pazjenti b’ ċirrożi tal- fwied jew axxite pazjenti li se jagħmlu xi operazzjoni kbira jew waqt l- anesteżija b’ sustanzi li jikkawża l - ipotensjoni
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).
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).
- Transient or persistent heart failure post MI
- Insuffiċjenza tal- qalb momentanja jew persistenti wara infart mijokardijaku
The initial phase of treatment requires special medical supervision.
Il- fażi inizjali tal- kura għandha bżonn ta ’ superviżjoni medika partikulari
o Elderly patients See section 4.2.
○ Pazjenti Anzjani Ara sezzjoni 4. 2
Surgery It is recommended that treatment with angiotensin converting enzyme inhibitors such as ramipril should be discontinued where possible one day before surgery.
Operazzjoni Fejn ikun possibbli, hu rakkomandat li l- kura bl- inibituri tal- enzima li tikkonverti anġjotensin għandha titwaqqaf ġurnata qabel l- operazzjoni.
Particularly careful monitoring is required in patients with renal impairment (see section 4.2).
Monitoraġġ tal- funzjoni renali Il- funzjoni renali għandu jiġu valutat qabel u waqt il- kura u d- dożaġġ aġġustat speċjalment fl- ewwel ġimgħat ta ’ kura. Hemm bżonn ta ’ monitoraġġ bir- reqqa speċjalment f’ pazjenti b’ indeboliment renali (ara sezzjoni 4. 2).
There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant.
Hemm riskju ta ’ indeboliment fil- funzjoni renali speċjalment f’ pazjenti b’ insuffiċjenza tal- qalb konġestiva jew wara trapjant renali.
Angioedema Angioedema has been reported in patients treated with ACE inhibitors including ramipril (see section 4.8).
Anġjoedima L- anġjoedima giet irrapportata f’ pazjenti kkurati b’ inibituri ACE inkluż ramipril (ara sezzjoni 4. 8).
In case of angioedema, TRITACE must be discontinued.
F’ każ ta ’ anġjoedima, TRITACE għandu jitwaqqfu.
Emergency therapy should be instituted promptly.
Terapija ta ’ emerġenza għandha tinbeda minnufih.
Patient should be kept under observation for at least 12 to 24 hours and discharged after complete resolution of the symptoms.
Il- pazjent għandu jinżamm taħt osservazzjoni għal mill- anqas 12 sa 24 siegħa u jitħalla joħroġ wara li s- sintomi ikun marru għal kollox.
Intestinal angioedema has been reported in patients treated with ACE inhibitors including TRITACE (see section 4.8).
Ġiet irrapportata anġjoedima intestinali f’ pazjenti kkurati b’ inibituri ACE inkluż TRITACE (ara sezzjoni 4. 8).
These patients presented with abdominal pain (with or without nausea or vomiting).
Dawn il- pazjenti kellhom uġigħ addominali (bid- dardir jew rimettar jew mingħajr).
Anaphylactic reactions during desensitization The likelihood and severity of anaphylactic and anaphylactoid reactions to insect venom and other allergens are increased under ACE inhibition.
Reazzjonijiet anafilattiċi waqt it- tneħħija ta ’ sensittività Il- possibiltà u s- severità ta ’ reazzjonijiet anafilattiċi u dawk li jixbħuhom għall- velenu tal- insetti u allerġeni oħra jiżdiedu meta wieħed ikun qed jieħu l- inibituri ACE.
A temporary discontinuation of TRITACE should be considered prior to desensitization.
Qabel it- tneħħija ta ’ sensittività għandu jiġi kkunsidrat it- twaqqif temporanju ta ’ TRITACE.
Hyperkalaemia Hyperkalaemia has been observed in some patients treated with ACE inhibitors including TRITACE.
Iperkalimja F’ xi pazjenti kkurati b’ inibituri ACE inkluż TRITACE 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
25 Neutropenia/ agranulocytosis Neutropenia/ agranulocytosis, as well as thrombocytopenia and anaemia, have been rarely seen and bone marrow depression has also been reported.
24 msemmijin hawn fuq jintużaw fl- istess ħin, hu rakkomandat li l- potassju fis- serum jiġi ċċekkjat b’ mod regolari (ara sezzjoni 4. 5).
It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia.
Newtropinja/ agranuloċitosi Newtropinja/ agranuloċitosi kif ukoll tromboċitopenja u anemija 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).
Ethnic differences ACE inhibitors cause higher rate of angioedema in black patients than in non black patients.
Differenzi etniċi L- inibituri ACE jikkawżaw rata ogħla ta ’ anġjoedima f’ pazjenti suwed mill f’ pazjenti mhux suwed.
As with other ACE inhibitors, ramipril may be less effective in lowering blood pressure in black people than in non black patients, possibly because of a higher prevalence of hypertension with low renin level in the black hypertensive population.
Bħall- inibituri ACE l- oħra, ramipril jista jkun inqas effettiv biex inaqqas il- pressjoni tad- demm f’ nies suwed milli f’ nies mhux suwed, probabilment għaliex f’ popolazzjoni ipertensiva sewda hemm inċidenza ogħla ta ’ ipertensjoni b’ livell baxx ta ’ renin.
Cough Cough has been reported with the use of ACE inhibitors.
Sogħla Ġiet irrapportata s- sogħla bl- użu tal- inibituri ACE.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
Karateristika ta ’ dan il- grupp ta ’ mediċini, is - sogħla hija niexfa, persistenti u tgħaddi wara li twaqqaf il- kura.
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough.
Sogħla kkawżata mill- inibituri ACE għandha tiġi kkunsidrata bħala parti mid- dijanjosi differenzjata tas- sogħla.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Contra-indicated combinations
L- għoti ta ’ kombinazzjonijiet flimkien huwa kontra- indikat
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).
If such treatment is required, consideration should be given to using a different type of dialysis membrane or a different class of antihypertensive agent.
Jekk ikun hemm bżonn ta ’ din it- tip ta ’ kura, wieħed irid jaħseb biex juża ’ tip differenti ta ’ membrana għad- dijaliżi jew juża klassi differenti ta ’ sustanza antiipertensiva.
Potassium salts, heparin, potassium-retaining diuretics and other plasma potassium increasing active substances (including Angiotensin II antagonists, trimethoprim, tacrolimus, ciclosporin):
Potassium salts, eparina, dijuretiċi li jżommu l- pottasium u sustanzi attivi oħra li jżidu l- plażma pottasium (inklużi antagonisti ta ’ Anġjotensin II, trimethoprim, tacrolimus, ciclosporin):
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 (e. g. isoproterenol, dobutamine, dopamine, epinephrine) that may reduce the antihypertensive effect of TRITACE:
Simpatomimetiċi vasopressor u sustanzi oħra (eż. isoprotenerol, dobutamine, dopamine, epinephrine) li jistgħu jnaqqsu l- effett antiipertensiv ta ’ TRITACE:
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:
Increased likelihood of haematological reactions (see section 4.4).
Żieda fil- possibilità ta ’ reazzjonijiet ematoloġiċi (ara sezzjoni 4. 4).
Lithium salts:
Lithium salts:
Excretion of lithium may be reduced by ACE inhibitors and therefore lithium toxicity may be increased.
It- tneħħija mill- ġisem ta ’ lithium tista ’ titnaqqas minħabba l- inibituri ACE u għalhekk tista ’ tiżdied it- tossiċità mil- lithium.
Lithium level must be monitored.
Għandu jkun hemm monitoraġġ tal- livelli ta ’ lithium.
Antidiabetic agents including insulin:
25 Sustanzi antidijabetiċi inkluża l- insulina:
Hypoglycaemic reactions may occur.
Jistgħu jseħħu reazzjonijiet ipogliċemiċi.
Blood glucose monitoring is recommended.
Hu rakkomandat monitoraġġ taz- zokkor fid- demm.
26 Non-steroidal anti-inflammatory drugs and acetylsalicylic acid:
Mediċini antiinfjammatorji li mhumiex sterojdi u acetylsalicylic acid:
Reduction of the antihypertensive effect of TRITACE is to be anticipated.
Għandu jkun mistenni tnaqqis fl- effett antiipertensiv ta ’ TRITACE.
Furthermore, concomitant treatment of ACE inhibitors and NSAIDs may lead to an increased risk of worsening of renal function and to an increase in kalaemia.
Barra minn hekk, kura fl- istess ħin ta ’ inibituri ACE u NSAIDs jista ’ jwassal għal żieda fir- riskju ta ’ aggravar fil- funzjoni renali u għal żieda f’ kalimja.
PREGNANCY AND LACTATION
4. 6 Tqala u treddigħ
TRITACE 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).
TRITACE 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).
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 għall- inibituri ACE waqt l- ewwel trimestru ta ’ tqala ma kinitx konklużiva; madankollu ma tistax tiġi eskluża żieda żgħira fir - riskju.
Unless continued ACE inhibitor therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Sakemm l- użu kontinwu tal- inibituri ACE mhux ikkusnidrat essenzjali, pazjenti li qed jippjanaw li joħorġu tqal għandhom jingħataw kuri antiipertensivi alternattivi li għandhom passat stabbilit ta ’ siġurtà għall- użu waqt it- tqala.
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’ TRITACE 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 also 5.3'Preclinical safety data ').
(Ara wkoll sezzjoni 5. 3 ‘ Tagħrif ta 'qabel l- użu kliniku dwar is- sigurtà tal - mediċina ’).