natgillin/translations-raw huggingface dataset:
Triatec Start
2, 5 mg/ 5 mg/ 10 mg Triatec Start Švedska
WINTHROP MEDICAMENTS 1-13, Boulevard Romain Roland F-75014 Paris France
WINTHROP MEDICAMENTS 1- 13, Boulevard Romain Roland F- 75014 Pariz Francija
AstraZeneca Sverige SE-151 85 Södertälje Sweden
AstraZeneca Sverige SE- 151 85 Södertälje Švedska
Start pack (1,25 + 2,5 +5 mg)
peroralna uporaba
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling
Trading as:
Trguje kot:
Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK United Kingdom
Sanofi- aventis One Onslow Street Guildford Surrey GU1 4YS Velika Britanija
Capsule
Trguje kot:
Oral
Velika Britanija
Aventis Pharma 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH Or Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS
AVENTIS PHARMA LTD 50 Kings Hill Avenue Kings Hill West Malling Kent ME19 4AH
12 Member State EU/ EEA
12 Država članica
United Kingdom
Surrey GU1 4YS Velika Britanija
Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK United Kingdom
Velika Britanija
Sanofi-aventis One Onslow Street Guildford Surrey GU1 4YS UK
Sanofi- aventis One Onslow Street Guildford Surrey GU1 4YS Velika Britanija Velika Britanija
2.5mg 5.0mg 10mg
2. 5mg 5. 0mg 10 mg
13 Member State EU/ EEA
13 DODATEK II
SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
ZNANSTVENI ZAKLJUČKI IN PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO, KI JIH JE PREDSTAVILA EVROPSKA AGENCIJA ZA ZDRAVILA ZNANSTVENI ZAKLJUČKI
Tritace contains ramipril, a second-generation nonsulfhydryl angiotensin converting enzyme inhibitor (ACE-I).
SPLOŠNI POVZETEK ZNANSTVENEGA VREDNOTENJA ZDRAVILA TRITACE IN Z NJIM POVEZANIH IMEN (GLEJTE DODATEK I) Zdravilo Tritace vsebuje ramipril, nesulfhidrilni zaviralec angiotenzinske konvertaze (ACE- I) druge generacije.
Tritace was included in the list of products for Summary of Products Characteristics (SPC) harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/ 83/ EC, as amended, as the above-mentioned medicinal product does not have the same SPC across EU Member States, Iceland and Norway.
Zdravilo Tritace je bilo vključeno na seznam zdravil za uskladitev povzetka glavnih značilnosti zdravila (SPC), ki ga je pripravil CMD( h), v skladu s členom 30( 2) Direktive 2001/ 83/ ES, kakor je bila spremenjena, saj zgoraj navedeno zdravilo nima enakega povzetka glavnih značilnosti zdravila v državah članicah EU, na Islandiji in Norveškem.
Critical Evaluation A number of areas of disharmony in the product information for Tritace have been evaluated by the CHMP and a revised product information was adopted.
Kritično vrednotenje Odbor za zdravila za uporabo v humani medicini (CHMP) je preučil številna področja neskladnosti glede informacij o zdravilu Tritace in sprejel popravljene informacije o zdravilu.
The main areas for harmonisation were: the sections 4.1, 4.2, 4.3, 4.4 and 4.6 of the summary of product information (SPC).
Uskladiti je bilo treba predvsem naslednje: poglavja 4. 1, 4. 2, 4. 3, 4. 4 in 4. 6 povzetka glavnih značilnosti zdravila (SPC).
4.1 Therapeutic Indication
4. 1 Terapevtske indikacije
The CHMP adopted the harmonised indication: “ Treatment of hypertension”.
„ Zdravljenje hipertenzije “.
Regarding the therapeutic indications for heart failure, the MAH proposed the wording: “ Treatment of congestive heart failure”.
„ Zdravljenje kongestivnega srčnega popuščanja “.
The CHMP, considering the previous harmonisations referrals for enalapril, perindopril and lisinopril, adopted the harmonised indication: “ Treatment of symptomatic heart failure”.
„ Zdravljenje simptomatskega srčnega popuščanja “.
Selective inclusion of one secondary endpoint- all cause mortality- is not recommended.
Selektivno vključevanje enega sekundarnega pokazatelja – nespecifična umrljivost – ni priporočljivo.
The CHMP adopted the following: “ Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with: i) manifest atherothrombotic cardiovascular disease (history of coronary heart disease or stroke, or peripheral vascular disease) or ii) diabetes with at least one cardiovascular risk factor”.
„ Kardiovaskularna preventiva: zmanjšanje kardiovaskularne umrljivosti in umrljivosti pri bolnikih z: i) izraženo aterotrombotsko boleznijo srca in ožilja (anamneza kronične bolezni srca ali infarkta ali periferne žilne bolezni) ali ii) sladkorno boleznijo z vsaj enim kardiovaskularnim dejavnikom tveganja. “
In conclusion, the CHMP agreed the following indication: “ Treatment of renal disease -Incipient glomerular diabetic nephropathy as defined by the presence of microalbuminuria -Manifest glomerular diabetic nephropathy as defined by macroproteinuria in patients with at least one cardiovascular risk factor -Manifest glomerular non-diabetic nephropathy as defined by macroproteinuria ≥ 3g/ da”
- Izražena glomerulna nediabetična nefropatija, kot je opredeljena z makroproteinurijo ≥ 3g/ da “.
The MAH proposed indication “ Secondary prevention after MI in patients with heart failure” has been justified on the basis of the:
Indikacija, ki jo je predlagal imetnik dovoljenja za promet z zdravilom, „ Sekundarna preventiva po miokardnem infarktu pri bolnikih s srčnim popuščanjem “, je bila utemeljena na podlagi:
Acute Infarction Ramipril Efficacy Study (AIRE).
Študije učinkovitosti ramiprila pri akutnem infarktu (AIRE).
Considering the available data the CHMP adopted the following indication: “ Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction”.
„ Sekundarna preventiva po akutnem miokardnem infarktu: zmanjšanje umrljivosti zaradi akutne faze miokardnega infarkta pri bolnikih s kliničnimi znaki srčnega popuščanja, do katerih pride > 48 ur po akutnem miokardnem infarktu “.
16 The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Hipertenzija Odmerek je treba prilagoditi vsakemu bolniku posebej glede na njegov profil (glejte poglavje 4. 4) in uravnavanje krvnega tlaka.
Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products.
15 Zdravilo Tritace in z njim povezana imena se lahko uporabljajo pri monoterapiji ali v kombinaciji z drugimi razredi antihipertenzivnih zdravil.
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”.
„ Namesto povečevanja odmerka nad 5 mg zdravila Tritace in z njim povezanih imen dnevno, je treba preučiti možnost dodajanja drugega zdravila, npr. diuretika ali kalcijevega antagonista “.
The CHMP agreed the following: “ The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
„ Odmerek se prilagaja vsakemu bolniku posebej glede na profil bolnik (glejte poglavje 4. 4) in uravnavanjem krvnega tlaka.
Tritace and associated names may be used in monotherapy or in combination with other classes of antihypertensive medicinal products”.
Zdravilo Tritace in z njim povezana imena se lahko uporabljajo pri monoterapiji ali v kombinaciji z drugimi razredi antihipertenzivnih zdravil “.
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.
Zdravljenje bolezni ledvic CHMP se je strinjal, da je za bolnike s sladkorno boleznijo in mikroalbuminurijo priporočeni začetni odmerek 1, 25 mg zdravila Tritace enkrat dnevno.
And finally, for patients with non diabetic nephropathy macroproteinuria ≥ 3gm/ day, the recommended initial dose is 1.25 mg of Tritace once daily.
Pri bolnikih s sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja znaša začetni odmerek 2, 5 mg enkrat dnevno.
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.
Simptomatsko srčno popuščanje V vseh državah, v katerih je bila odobrena indikacija srčnega popuščanja, znaša začetni priporočeni odmerek 0, 25 mg dnevno, največji dovoljeni odmerek pa je 10 mg dnevno.
In most countries the dose is doubled every 1-2 weeks, except in Hungary where the duration is 2-3 weeks.
V večini držav se odmerek podvoji vsak 1 do 2 tedna, razen na Madžarskem, kjer je to obdobje dolgo 2– 3 tedne.
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.
„ Pri bolnikih, katerih stanje je stabilno zaradi zdravljenja z diuretiki, znaša priporočeni začetni odmerek 1, 25 mg dnevno, zdravilo Tritace in z njim povezana imena pa se titrirajo s podvajanjem odmerka na en do dva tedna vse do največjega dnevnega odmerka 10 mg.
Two administrations per day are preferable”.
Zaželeno je odmerjanje dvakrat dnevno “.
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.
Sekundarna preventiva po akutnem miokardnem infarktu V vseh državah, v katerih je bila odobrena indikacija po miokardnem infarktu, znaša priporočeni začetni odmerek 2, 5 mg dvakrat dnevno.
However in 6 countries the starting dose is 1.25 mg to 2.5 mg twice daily.
Vendar pa je v 6 državah začetni odmerek od 1, 25 mg do 2, 5 mg dvakrat dnevno.
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.
Imetnik dovoljenja za promet z zdravilom se sklicuje na trdne dokaze v mednarodnih priporočilih za angiotenzinske konvertaze, ki so bili odmerjene v prvih 24 urah po akutnem miokardnem infarktu, da bi utemeljil začetek zdravljenja v 24 urah po miokardnem infarktu pri najnižjem odmerku 1, 25 mg dnevno (ki se uporablja kot prvi odmerek pri indikaciji srčnega popuščanja), če so izpolnjeni stabilni hemodinamični pogoji in na podlagi precedensa z besedilom, ki velja za lizinopril.
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.
„ 48 ur po miokardnem infarktu pri klinično in hemodinamično stabilnem bolniku je začetni odmerek 2, 5 mg dvakrat dnevno v obdobju treh dni.
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.
Če bolnik začetnega odmerka 2, 5 ne prenaša, se mu daje odmerek 1, 25 mg dvakrat dnevno v obdobju dveh dni pred povečanjem na 2, 5 mg in 5 mg dvakrat dnevno.
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)
Če odmerka ni mogoče povečati na 2, 5 mg dvakrat dnevno, je treba zdravljenje prekiniti. “ (Glejte povzetek glavnih značilnosti zdravila glede titracije in vzdrževalnega odmerka)
4.3 Contraindications There are contraindications present in one or several local SPCs.
4. 3 Kontraindikacije V enem ali več lokalnih povzetkih glavnih značilnosti zdravila so navedene kontraindikacije.
In summary, pregnancy and lactation should be amended in line with PhVWP recommendations on ACE-I The following should be added to the contraindication:
Kontraindikacijam je treba dodati naslednje:
17 Ramipril must not be used in patients in patients with hypotensive or haemodynamically unstable states The CHMP adopted the following contraindication:
- „ Preobčutljivost na ramipril, na katero koli pomožno snov ali kateri koli drugi zaviralec ACE (glejte
- “ Hypersensitivity to ramipril, to any of the excipients or any other ACE inhibitors (see section 6.1)
poglavje 6. 1)
- History of hereditary or idiopathic angioedema
- Anamneza dednega ali idiopatskega angioedema
- Extracorporeal treatments leading to contact of blood with negatively charged surfaces (see section
- Zunajtelesno zdravljenje, pri katerem gre za stik krvi z negativno nabitimi površinami (glejte
4.5)
poglavje 4. 5)
- Significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney
- Močna obojestranska stenoza ledvične arterije ali stenoza ledvične arterije pri samo eni delujoči
-2nd and 3rd trimester of pregnancy (see section 4.4 and 4.6 )”
- Drugo in tretje trimesečje nosečnosti (glejte poglavji 4. 4 in 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.
bolnikih z motnjami v delovanju ledvic, temveč tudi tveganje za kasnejše motnje v delovanju ledvic, dejavnike tveganja in potrebo po predčasnem prenehanju jemanja zdravila.
- Transient or persistent heart failure post MI
- Začasno ali trajno popuščanje srca po miokardnem infarktu
- Monitoring of renal function
- Spremljanje delovanja ledvic
-Cough has been reported with the use of ACE inhibitors.
- Pri uporabi zaviralcev ACE so poročali o kašljanju.
Characteristically, the cough is non- productive, persistent and resolves after discontinuation of therapy.
Značilen je suh, trdovraten kašelj, ki izzveni po
ACE inhibitor-induced cough should be considered as part of the differential diagnosis of cough”.
Kašelj, ki nastane zaradi uporabe zaviralcev ACE, je treba obravnavati kot del diferencialne diagnoze kašlja “.
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 Nosečnost in dojenje CHMP je priporočil kontraindikacijo le za drugo in tretje trimesečje nosečnosti v skladu z besedilom skupine PhVWP o uporabi ACE- I med nosečnostjo.
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.
Besedilo tega opozorila, ki ga je sprejela skupina PhVWP, ne priporoča ali predlaga uporabe zaviralcev ACE v prvem trimesečju nosečnosti, nasprotno, ko je nosečnost ugotovljena, mora zdravnik, ki predpisuje zdravilo, prenehati predpisovati zaviralce ACE in jih po potrebi čim prej zamenjati z drugim zdravilom proti hipertenziji.
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.
Namen te spremembe je zagotoviti, da v besedilu ne bi bil predlagan takojšen umetni splav, saj to ni utemeljeno z dosedanjimi kliničnimi izkušnjami.
In conclusions, the CHMP adopted a harmonised wording in line with PhVWP wording on use of AEC-I in pregnancy.
CHMP je sprejel usklajeno besedilo v skladu z besedilom skupine PhVWP o uporabi ACE- I med nosečnostjo.
18 GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
17 PODLAGA ZA DOPOLNILO POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA, OZNAČEVANJA IN NAVODILA ZA UPORABO
- the scope of the referral was the harmonisation of the Summaries of Products Characteristics,
- je bil namen napotitve uskladitev povzetkov glavnih značilnosti zdravila, označevanja in navodila za
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing
- so bili povzetki glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali
Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
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).
je CHMP priporočil dopolnitev dovoljenj( a) za promet z zdravilom, za katera so povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo določeni v Dodatku III za zdravilo Tritace in z njim povezana imena (glejte Dodatek I).
19 ANNEX III
18 DODATEK III
20 NAME OF THE MEDICINAL PRODUCT
19 1 IME ZDRAVILA
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 in povezana imena (glejte Dodatek I) 1. 25 mg tablete TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 5 mg tablete TRITACE in povezana imena (glejte Dodatek I) 10 mg tablete
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 in povezana imena (glejte Dodatek I) 1. 25 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 2. 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 5 mg trde kapsule TRITACE in povezana imena (glejte Dodatek I) 10 mg trde kapsule
Tablet Hard capsule
Tableta Trda kapsula
[To be completed nation ally]
[Izpolni država članica]
THERAPEUTIC INDICATIONS
4. 1 Terapevtske indikacije
- Cardiovascular prevention: reduction of cardiovascular morbidity and mortality in patients with:
- Kardiovaskularna preventiva: zmanjšanje kardiovaskularne obolevnosti in umrljivosti pri bolnikih z:
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).
o manifestno aterotrombotično kardiovaskularno boleznijo (anamnezo koronarne srčne bolezni ali možganske kapi ali z boleznijo perifernih žil), ali o sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja (glejte poglavje 5. 1).
- Treatment of renal disease:
- Zdravljenje bolezni ledvic:
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).
o začetne glomerularne diabetične nefropatije, opredeljene kot prisotnost mikroalbuminurije, o manifestne glomerularne diabetične nefropatije, opredeljene kot prisotnost makroproteinurije pri bolnikih z vsaj enim kardiovaskularnim dejavnikom tveganja (glejte poglavje 5. 1), o manifestne glomerularne nediabetične nefropatije, opredeljene kot prisotnost makroproteinurije ≥ 3 g/ dan (glejte poglavje 5. 1).
- Secondary prevention after acute myocardial infarction: reduction of mortality from the acute phase
- Sekundarna preventiva po akutnem miokardnem infarktu: zmanjšanje umrljivosti v akutni fazi
of myocardial infarction in patients with clinical signs of heart failure when started > 48 hours following acute myocardial infarction.
miokardnega infarkta pri bolnikih s kliničnimi znaki srčnega popuščanja z začetkom > 48 ur po akutnem miokardnem infarktu.
POSOLOGY AND METHOD OF ADMINISTRATION
20 4. 2 Odmerjanje in način uporabe
21 Oral use.
Peroralna uporaba
TRITACE can be taken before, with or after meals, because food intake does not modify its bioavailability (see section 5.2).
TRITACE je mogoče vzeti pred obroki, med njimi ali po njih, ker uživanje hrane ne vpliva na biološko uporabnost (glejte poglavje 5. 2).
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.
Bolniki, ki dobivajo diuretike Po uvedbi zdravljenja z zdravilom TRITACE se lahko pojavi hipotenzija; verjetnejša je pri bolnikih, ki se sočasno zdravijo z diuretiki.
Caution is therefore recommended since these patients may be volume and/ or salt depleted.
Pri takšnih bolnikih je zato potrebna previdnost, ker jim lahko primanjkuje tekočine in/ ali soli.
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with TRITACE (see section 4.4).
Če je mogoče, je treba uporabo diuretika prekiniti 2 ali 3 dni pred začetkom zdravljenja s TRITACE (glejte poglavje 4. 4).
In hypertensive patients in whom the diuretic is not discontinued, therapy with TRITACE should be initiated with a 1.25 mg dose.
Pri hipertenzivnih bolnikih, ki jim diuretika ni mogoče ukiniti, je treba zdravljenja s TRITACE začeti z odmerkom 1, 25 mg.
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure control.
Odmerek je treba prilagoditi posameznemu bolniku glede na njegove značilnosti (glejte poglavje 4. 4) in urejenost krvnega tlaka.
Starting dose TRITACE should be started gradually with an initial recommended dose of 2.5 mg daily.
Začetni odmerek Zdravljenje s TRITACE je treba začeti postopoma; priporočeni začetni odmerek je 2, 5 mg na dan.
Patients with a strongly activated renin-angiotensin-aldosterone system may experience an excessive drop in blood pressure following the initial dose.
Bolnikom z močno aktiviranim sistemom renin- angiotenzin- aldosteron se lahko krvni tlak po prvem odmerku čezmerno zniža.
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).
Za takšne bolnike je priporočljiv začetni odmerek 1, 25 mg, uvedba zdravljenja pa mora potekati pod zdravniškim nadzorom (glejte poglavje 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.
Največji dovoljeni odmerek TRITACE je 10 mg na dan.
Starting dose The recommended initial dose is 2.5 mg of TRITACE once daily.
Začetni odmerek Priporočeni začetni odmerek je 2, 5 mg TRITACE enkrat na dan.
Titration and maintenance dose Depending on the patient’ s tolerability to the active substance, the dose should be gradually increased.
Titracija in vzdrževalni odmerek Odmerek je treba postopoma povečevati, odvisno od bolnikovega prenašanja zdravilne učinkovine.
The recommended initial dose is 1.25 mg of TRITACE once daily.
Priporočeni začetni odmerek je 1, 25 mg TRITACE enkrat na dan.
22 Titration and maintenance dose Depending on the patient's tolerability to the active substance, the dose is subsequently increased.
21 Titracija in vzdrževalni odmerek Odvisno od bolnikovega prenašanja zdravilne učinkovine se odmerek nato povečuje.