natgillin/translations-raw huggingface dataset:
The totality of data submitted does not support the conclusion that the product is therapeutically equivalent. 
Skupni predloženi podatki ne utemeljujejo zaključka, da je zdravilo terapevtsko enakovredno.
Differences in droplets size and their possible effect in tissue penetration were not explained. 
Razlike v velikosti kapljic in njihov možni učinek na prodiranje v tkivo niso bili pojasnjeni.
In addition, the CHMP considered that the preservative efficacy test lacked the methodological details which would allow a correct interpretation. 
CHMP je prav tako menil, da test učinkovitosti konzervansa ni vseboval metodoloških podrobnosti, ki bi omogočile pravilno razlago.
Key pharmaceutical parameters, such as the dissolution of drug substance in the oily phase were not appropriately validated. 
Glavni farmacevtski parametri, kot je raztapljanje zdravilne učinkovine v oljni fazi, niso bili ustrezno preverjeni.
Comparative in vitro microbial tests to investigate the antimicrobial nature of the drug product were not provided. 
Primerjalni mikrobiološki testi in vitro za proučitev antimikrobnih lastnosti zdravila niso bili predloženi.
It was not possible to discuss variability between and within batches of the test and reference products as information on the necessary batches of each product was not provided. 
Razprava o variabilnosti med posameznimi serijami testnega in referenčnega zdravila ter znotraj njih ni bila možna, saj podatki o potrebnih serijah posameznega zdravila niso bili predloženi.
Canazole Clotrimazole Cream 1% w/w is an anti-fungal agent indicated for the treatment of superficial fungal skin and mucous membrane infections, such as candidiasis, dermatophytoses and commensal yeast infections. 
Zdravilo Canazole klotrimazol krema 1 % m/m je zdravilo proti glivicam, namenjeno zdravljenju glivičnih okužb površinske kože in sluznice, kot so kandidiaza, dermatofitoza in okužba s komenzalnimi kvasovkami.
The comparative quality data provided and the preservative efficacy test were, therefore, not considered sufficient to justify a waiver of the need to demonstrate therapeutic equivalence by clinical studies or other validated model, and these were therefore deemed necessary in this case to prove equivalence. 
Predloženi primerjalni podatki o kakovosti in test učinkovitosti konzervansa tako niso zadostovali za utemeljitev opustitve potrebe po kliničnih študijah ali drugih validiranih modelih za dokaz terapevtske enakovrednosti, zato se je štelo, da so v tem primeru potrebni za dokaz enakovrednosti.
At the time of the initial authorisation, the need for therapeutic equivalence studies was waived based on quality data demonstrating that the proposed formulation was similar to the reference product with respect to formulation (except the benzyl alcohol concentration), pH and viscosity of the cream, globule size of the dispersed oil phase and size of the active substance present as particles. 
V času prvotne odobritve je bila na podlagi podatkov o kakovosti, ki so dokazovali, da je predlagana formulacija referenčnemu zdravilu podobna glede formulacije (razen koncentracije benzilalkohola), vrednosti pH in viskoznosti kreme, velikosti globul v fazi razpršenega olja in velikosti zdravilne učinkovine, prisotne v obliki delcev, potreba po študijah terapevtske enakovrednosti opuščena.
The CHMP noted that inconsistent data were provided regarding the state of the drug substance in the drug product and critical quality attributes were not satisfactorily addressed. 
CHMP je menil, da so bili predloženi podatki o stanju zdravilne učinkovine v zdravilu neskladni, kritične kakovostne lastnosti pa niso bile ustrezno obravnavane.
The CHMP considered the comparative quality data and a preservative efficacy test (in vitro) to demonstrate comparable anti-fungal activity provided. 
CHMP je menil, da primerjalni podatki o kakovosti in test učinkovitosti konzervansa (in vitro) kažejo primerljivo delovanje proti glivicam.
However, the need for a therapeutic equivalence study or other validated model for the formulation to prove equivalence was considered essential by the concerned member state and the matter was referred to the CHMP. 
Vendar je zadevna država članica menila, da je za potrditev enakovrednosti formulacije treba predložiti študijo terapevtske enakovrednosti ali druge validirane modele, zato je zadevo napotila na CHMP.
An appropriate skin permeation or similar in vitro studies should have been performed to investigate this matter. 
Za podrobnejšo proučitev tega vprašanja bi morale biti izvedene ustrezne študije kožne prepustnosti ali podobne študije in vitro.
The proposals are acceptable with some improvements. 
Predlogi so sprejemljivi z nekaj popravki.
The Rapporteurs are of the opinion that amended wording, the lower age limit of 55 years, is recommended. 
Poročevalci menijo, da je uporaba spremenjenega besedila, nižja starostna meja 55 let, priporočena.
Placebo relative risk (95% confidence interval) 
Placebo Relativno tveganje (95 % interval zaupanja)
However the effect of multiple doses is not known. 
Toda učinek večkratnih odmerkov ni znan.
• Sexual inability in men, reduced sexual desire in men or women 
• impotenca pri moških, zmanjšano spolno poželenje pri moških ali ženskah
Both subpopulations were prospectively stratified. 
Obe podpopulaciji sta bili prospektivno stratificirani.
There are differences, however, in the results obtained from various trials (HOPE, EUROPA, PEACE, and PART 2). 
Vendar pa v rezultatih, pridobljenih iz različnih preskušanj (HOPE, EUROPA, PEACE in PART 2), obstajajo razlike.
All patients n=4,645 
Vsi bolniki n = 4.645 n =
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. 
CHMP je soglašal s tem, da je točnost tega zadnjega stavka vprašljiva in da niso bili predstavljeni nobeni podatki, ki bi se nanašali na to snov, zato je to pripombo izbrisal.
The nephroprotection indication presented the major area of disagreement. 
Indikacija nefro zaščite je bila glavno področje nestrinjanja.
The HOPE study: Main results Ramipril 
Študija HOPE: Glavni rezultati Ramipril
The current indication of ramipril in hypertension differs among the EU countries. 
Trenutne indikacije ramiprila pri hipertenziji se med državami članicami EU razlikujejo.
Your doctor will reduce the initial dose and adjust your treatment more slowly. 
Zdravnik bo zmanjšal začetni odmerek in bo bolj počasi prilagajal vaše zdravljenje.
• Do not take a double dose to make up for a forgotten tablet/capsule. 
• Ne vzemite dvojnega odmerka, če ste pozabili vzeti tableto/kapsulo.
Rats, dogs and monkeys tolerated daily doses of 2, 2.5 and 8 mg/kg/d respectively without harmful effects. 
Podgane, psi in opice so prenesli dnevne odmerke 2, 2,5 in 8 mg/kg/dan brez škodljivih učinkov.
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.
08019 Barcelona Spain 
08019 Barcelona Španija
It also reduced neuroendocrine activation. 
Zmanjša tudi nevroendokrino aktivacijo.
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).
• If you are going to receive an anaesthetic. 
• če boste dobili anestetik.
This may be a sign of your body holding onto more water than usual 
To je lahko znak, da se v telesu zadržuje več vode kot po navadi.
Depending on the machine that is used, TRITACE may not be suitable for you 
Odvisno od naprave, ki se za to uporablja, je mogoče, da zdravilo TRITACE ni primerno za vas.
The time frame for dose escalation of 2 to 4 weeks appears appropriate based on individual variability. 
Časovni okvir za povečanje odmerka z dveh na štiri tedne se zdi ustrezen na podlagi individualne spremenljivosti.
The indication for cardiovascular prevention is justified by the results of HOPE study. 
Indikacija za kardiovaskularno preventivo je utemeljena z rezultati študije HOPE.
NO-1325 Lysaker Norway 
NO-1325 Lysaker Norveška
Selective inclusion of one secondary endpoint- all cause mortality- is not recommended. 
Selektivno vključevanje enega sekundarnega pokazatelja - nespecifična umrljivost - ni priporočljivo.
• Severe stomach pain which may reach through to your back. 
• Huda bolečina v želodcu, ki lahko sega v hrbet.
• Difficulty concentrating 
• težave s koncentracijo
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.
A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Lithuania 
A. Juozapavičiaus g. 6/2 LT-09310 Vilnius Litva
- the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee, 
- so bili povzetki glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenja za promet z zdravilom, ocenjeni na podlagi predložene dokumentacije in znanstvene razprave znotraj Odbora,
Raynaud's phenomenon 
Raynaudov pojav
The dose titration steps and target dose are based on the result of the AIRE study. 
Postopna titracija odmerka in ciljni odmerek temeljita na rezultatih študije AIRE.
AstraZeneca Sverige SE-151 85 Södertälje Sweden 
AstraZeneca Sverige SE-151 85 Södertälje Švedska
• Fainting, hypotension (abnormally low blood pressure), especially when you stand or sit up quickly 
• omedlevica, nenormalno nizek krvni tlak (hipotenzija), zlasti če hitro vstanete ali sedete
This means an absolute mortality reduction of 5.7 % and a relative risk reduction of 27 % (95 % CI 
To pomeni absolutno zmanjšanje umrljivosti za 5,7 % in zmanjšanje relativnega tveganja za 27 % (95 % IZ [od 11 do 40 %]).
You must tell your doctor if you think that you are (or might become) pregnant You should not take TRITACE in the first 12 weeks of pregnancy, and you must not take them at all after the 13th week as their use during pregnancy may possibly be harmful to the baby. 
Zdravniku morate povedati, če se vam zdi, da ste noseči (ali bi lahko zanosili) Zdravila TRITACE ni dobro jemati v prvih 12 tednih nosečnosti, od 13. tedna naprej pa ga sploh ne smete jemati, ker lahko njegova uporaba med nosečnostjo škoduje otroku.
Empreendimento Lagoas Park, Edifício 7 - 3º Piso 2740-244 Porto Salvo Portugal 
Empreendimento Lagoas Park, Edifício 7 - 3ş Piso 2740-244 Porto Salvo Portugalska
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. 
Epidemiološke ugotovitve o tveganju za teratogene učinke po izpostavljenosti zaviralcem ACE v prvem trimesečju nosečnosti niso dokončne, toda majhnega povečanja tveganja ni mogoče izključiti.
• Decreasing your body's production of substances that could raise your blood pressure 
• v telesu zmanjša nastajanje snovi, ki lahko zvišajo krvni tlak
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).
The CHMP adopted the harmonised indication: “Treatment of hypertension”. 
CHMP je sprejel usklajeno indikacijo: „Zdravljenje hipertenzije“.
The subsequent dosage of TRITACE should be adjusted according to blood pressure target. 
Nadaljnje odmerjanje TRITACE je treba prilagoditi glede na ciljni krvni tlak.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
Antihypertensive properties: 
Antihipertenzivne lastnosti:
It is recommended to monitor the white blood cell count to permit detection of a possible leucopoenia. 
Priporočljive so kontrole bele krvne slike, da bi odkrili morebitno levkopenijo.
• Sweating more than usual 
• močnejše znojenje kot po navadi
United Kingdom HOECHST MARION ROUSSEL LTD. 
Velika Britanija HOECHST MARION ROUSSEL LTD.
81105 Bratislava 
81105 Bratislava Slovaška
• Red and swollen tongue 
• rdeč in otekel jezik
This could be a sign of a severe allergic reaction to TRITACE 
To je lahko znak hude alergijske reakcije na zdravilo TRITACE.
TRITACE has to be swallowed with liquid. 
TRITACE je treba zaužiti s tekočino.
Titration and maintenance dose 
Titracija in vzdrževalni odmerek
In conclusion, the CHMP adopted a harmonised wording according to the PhVWP recommendations. 
Na koncu je CHMP sprejel usklajeno besedilo v skladu s priporočili skupine PhVWP.
TRITACE is not recommended for use in children and adolescents below 18 years of age because there is no information available in this population. 
Zdravila TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih, mlajših od 18 let, ker za to populacijo ni informacij.
Very rare (affects less than 1 in 10,000 people) • Being more sensitive to the sun than usual. 
Zelo redki (pojavijo se pri manj kot 1 od 10.000 bolnikov) • večja občutljivost za sončno svetlobo, kot po navadi.
• Headache or feeling tired 
• glavobol ali utrujenost
o Patients at particular risk of hypotension 
o Bolniki s posebnim tveganjem za hipotenzijo
• Your doctor may then decide to increase the amount you take. 
• Zdravnik se nato lahko odloči in poveča odmerek, ki ga jemljete.
Taking TRITACE with food and alcohol 
Jemanje zdravila TRITRACE skupaj s hrano in alkoholom
The study showed that after an average follow-up time of 15 months the mortality in ramipril-treated patients was 16.9 % and in the placebo treated patients was 22.6 %. 
Študija je pokazala, da je bila umrljivost po povprečno 15 mesecih spremljanja med bolniki, zdravljenimi z ramiprilom 16,9 %, in med bolniki, ki so dobivali placebo 22,6 %.
A preventive placebo-controlled study (the HOPE-study), was carried out in which ramipril was added to standard therapy in more than 9,200 patients. 
Izvedena je bila preventivna, s placebom kontrolirana študija (študija HOPE), v kateri so ramipril dodali standardnemu zdravljenju več kot 9.200 bolnikov.
• To reduce the risk or delay the worsening of kidney problems (whether or not you have diabetes) 
• za zmanjšanje tveganja ali upočasnitev poslabšanja težav z ledvicami (ne glede na to, ali imate sladkorno bolezen ali ne)
• TRITACE may be taken with or without food. 
• Zdravilo TRITACE lahko vzamete s hrano ali brez nje.
4.1 Therapeutic Indication 
4.1 Terapevtske indikacije
• Cramps or pain in your muscles 
• krči ali bolečine v mišicah
Treatment to reduce or delay the worsening of kidney problems 
Zdravljenje za zmanjšanje ali upočasnitev slabšanja težav z ledvicami
Adverse reactions frequency is defined using the following convention: Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
Zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), ni znano (ni mogoče oceniti na podlagi podatkov, ki so na voljo).
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).
Swallow the tablets/capsules whole with liquid. 
Tablete/kapsule pogoltnite cele in s tekočino.
• If you are allergic (hypersensitive) to ramipril, any other ACE inhibitor medicine or any of the ingredients of TRITACE listed in section 6. 
• če ste alergični (preobčutljivi) na ramipril, katerikoli drug zaviralec ACE ali katerokoli sestavino zdravila TRITACE, navedeno v poglavju 6.
Treatment of high blood pressure 
Zdravljenje visokega krvnega tlaka
Characteristically, the cough is nonproductive, persistent and resolves after discontinuation of therapy. 
Značilno je, da je ta kašelj neproduktiven, trdovraten in po prekinitvi zdravljenja izgine.
Sufficient experience is still lacking in the treatment of patients with severe (NYHA IV) heart failure immediately after myocardial infarction. 
Še vedno ni dovolj izkušenj z zdravljenjem bolnikom s hudim srčnim popuščanjem (NYHA IV) neposredno po miokardnem infarktu.
In patients with diabetes and at least one cardiovascular risk 
Bolniki s sladkorno boleznijo in vsaj enim kardiovaskularnim dejavnikom tveganja
• Blood tests showing too few blood cells in your blood 
• preiskave krvi, ki kažejo premalo krvnih celic v krvi
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES 
4.7 Vpliv na sposobnost vožnje in upravljanja s stroji
In patients with diabetes and microalbuminuria: 
Bolniki s sladkorno boleznijo in mikroalbuminurijo:
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).
If you forget to take TRITACE 
Če ste pozabili vzeti zdravilo TRITACE
Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bulgaria 
Alexandar Stamboliyski blvd. 103 office building Sofia Tower, fl. 8, Sofia 1303 Bolgarija
You may need to stop your TRITACE treatment one day beforehand; ask your doctor for advice 
Morda boste morali en dan pred tem nehati jemati zdravilo TRITACE; posvetujte se o tem s svojim zdravnikom.
• An increased number of certain white blood cells (eosinophilia) found during a blood test 
• večje število določenih belih krvnih celic (eozinofilija) na preiskavah krvi
The AIRE study included more than 2,000 patients with transient/persistent clinical signs of heart failure after documented myocardial infarction. 
Študija AIRE je vključila več kot 2.000 bolnikov s prehodnimi ali trajnimi kliničnimi znaki srčnega popuščanja po dokumentiranem miokardnem infarktu.
• If you have collagen vascular disease such as scleroderma or systemic lupus erythematosus 
• če imate kolagensko žilno bolezen, npr. sklerodermo ali sistemski eritematozni lupus.
TRITACE can be used: 
Zdravilo TRITACE se lahko uporablja:
This could be a sign of pancreatitis (inflammation of the pancreas). 
To je lahko znak pankreatitisa (vnetja trebušne slinavke).
Secondary endpoints Death from any cause Need for Revascularisation Hospitalisation for unstable angina 
Sekundarne končne točke Smrt zaradi kateregakoli vzroka 10,4 Potreba po revaskularizaciji Hospitalizacija zaradi nestabilne angine pektoris
The ramipril treatment was started 3 to 10 days after the acute myocardial infarction. 
Zdravljenje z ramiprilom se je začelo od 3 do 10 dni po akutnem miokardnem infarktu.
They can increase the chance of getting side effects if you take them with TRITACE: 
Povečajo lahko možnost neželenih učinkov, če jih jemljete skupaj z zdravilom TRITACE:
Do not take TRITACE if any of the above apply to you. 
Ne vzemite zdravila TRITACE, če kaj od naštetega velja za vas.
UNDESIRABLE EFFECTS 
MOŽNI NEŽELENI UČINKI
• Disturbed hearing and ringing in your ears 
• motnje sluha ali zvonjenje v ušesih
• Blocked nose, difficulty breathing or worsening of asthma 
• zamašen nos, težko dihanje ali poslabšanje astme
Latvia sanofi-aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvia 
Latvija sanofi-aventis Latvia SIA Kr.Valdemara 33-8 LV1010 - Riga Latvija
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.
These patients presented with abdominal pain (with or without nausea or vomiting). 
Bolniki so imeli bolečine v trebuhu (z navzeo in bruhanjem ali brez njiju).
SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Greece 
SANOFI-AVENTIS AEBE 348, Syngrou Av. - Building A 176 74 Kallithea Grčija
Extensive mutagenicity testing using several test systems has yielded no indication that ramipril possesses mutagenic or genotoxic properties. 
Obsežno testiranje mutagenosti z uporabo več testnih sistemov ni pokazalo mutagenega ali genotoksičnega delovanja ramiprila.
• To treat high blood pressure (hypertension) 
• za zdravljenje visokega krvnega tlaka (hipertenzije)
Take this medicine by mouth at the same time of the day each day. 
Jemanje tega zdravila Zdravilo zaužijte vsak dan ob istem času.
Népfürdo u.22 1138 Budapest Hungary 
Zentiva HU Kft Népfürdo u.22 1138 Budapest Madžarska
Studies involving chronic oral administration have been conducted in rats, dogs and monkeys. 
Študije kronične peroralne uporabe so bile izvedene pri podganah, psih in opicah.
Fertility was not impaired either in male or in female rats. 
Plodnost ni bila prizadeta ne pri podganjih samcih ne pri samicah.
TRITACE may increase the amount of lithium in your blood. 
Zdravilo TRITACE lahko poveča količino litija v krvi.
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. 
CHMP je sprejel naslednje besedilo, da bi omogočil izvajanje tega poglavja: - „Motnje v delovanju ledvic: opozorilo je treba razširiti tako, da ne vključuje le zdravljenja pri bolnikih z motnjami v delovanju ledvic, temveč tudi tveganje za kasnejše motnje v delovanju ledvic, dejavnike tveganja in potrebo po predčasnem prenehanju jemanja zdravila.
4.4 Special Warnings and Precautions for Use 
4.4 Posebna opozorila in previdnostni ukrepi
DK-2970 Hoersholm Denmark 
DK-2970 Hoersholm Danska
• Your doctor will adjust the amount you take until your blood pressure is controlled. 
• Zdravnik vam bo prilagajal količino zdravila, dokler vaš krvni tlak ne bo urejen.
Taking TRITACE with other medicines 
Jemanje z drugimi zdravili
Like all medicines, TRITACE can cause side effects, although not everybody gets them. 
Kot vsa zdravila ima lahko tudi zdravilo TRITACE neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
What TRITACE is and what it is used for Before you take TRITACE How to take TRITACE Possible side effects 
Kaj je zdravilo TRITACE in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo TRITACE Kako jemati zdravilo TRITACE Možni neželeni učinki
The CHMP, considering the previous harmonisations referrals for enalapril, perindopril and lisinopril, adopted the harmonised indication: “Treatment of symptomatic heart failure”. 
Odbor CHMP je ob upoštevanju prejšnjih napotitev glede usklajevanja za enalapril, perindopril in lizinopril sprejel usklajeno indikacijo: „Zdravljenje simptomatskega srčnega popuščanja“.
Usually the dose is administered once daily. 
Po navadi se odmerek uporabi enkrat na dan.
TRITACE is not recommended for use in children and adolescents below 18 years of age due to insufficient data on safety and efficacy. 
TRITACE ni priporočljivo uporabljati pri otrocih in mladostnikih do 18. leta starosti, ker o njegovi varnosti in učinkovitosti v tej skupini ni dovolj podatkov.
There is a risk of impairment of renal function, particularly in patients with congestive heart failure or after a renal transplant. 
Obstaja tveganje za okvaro delovanja ledvic, zlasti pri bolnikih s kongestivnim srčnim popuščanjem ali po presaditvi ledvice.
In case of angioedema, TRITACE must be discontinued. 
V primeru angioedema je treba prenehati uporabljati zdravilo TRITACE.