natgillin/translations-raw huggingface dataset:
No information is available in patients with severe hepatic impairment (Child-Pugh class C). 
Za bolnike z resno okvaro jeter (razred C po Child-Pughu) podatkov ni na voljo.
The signs and symptoms of an acute overdose can be anticipated to be those of excessive pharmacologic effect: a rise in serum sodium concentration, polyuria, thirst and dehydration/hypovolemia (profuse and prolonged aquaresis). 
Specifičnega antidota za zastrupitev s tolvaptanom ni. Pričakovati je, da bodo znaki in simptomi akutnega prevelikega odmerjanja pretirani farmakološki učinki: zvišanje koncentracij natrija v serumu, poliurija, žeja in dehidracija/hipovolemija
• patchy bleeding in the skin 
• krvavenje kože v obliki zaplat
Co-administration of Samsca with other treatments for hyponatremia, and medicinal products that increase serum sodium concentration, is not recommended during initial treatment or for other patients with very low baseline serum sodium concentrations (see section 4.5). 
Sočasna uporaba zdravila Samsca z drugimi oblikami zdravljenja hiponatriemije ali zdravili, ki povečujejo koncentracije natrija v serumu, ni priporočljiva med začetnim zdravljenjem ali za druge bolnike z zelo nizko koncentracijo natrija v serumu ob izhodišču (glejte poglavje 4.5).
In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of tolvaptan. 
V izkušnjah iz obdobja trženja so zelo redko po dajanju tolvaptan poročali o anafilaksi (vključno z anafilaktičnim šokom in generaliziranim izpuščanjem).
This effect continued as on Day 30, when more tolvaptan than placebo patients still had normal concentrations (60 % vs. 27 %). 
Ta učinek se je nadaljeval do 30. dneva, ko je še vedno imelo normalne koncentracije več bolnikov, zdravljenih s tolvaptanom, kot zdravljenih s placebom
Each tablet contains 7.5 mg tolvaptan. 
Ena tableta vsebuje 7,5 mg tolvaptana.
Hyponatremia 
Hiponatriemija
• raised levels of creatinine in the blood. 
• zvišana koncentracija kreatinina v krvi
• Hypernatremia 
• hipernatriemija
Patients with known hypersensitivity reactions to benzazepine or benzazepine derivatives (e.g. benazepril, conivaptan, fenoldopam mesylate or mirtazapine) may be at risk for hypersensitivity reaction to tolvaptan (see section 4.3 Contraindications). 
(npr. benazepril, konivaptan, fenoldopamijev mesilat ali mirtazapin) obstaja nevarnost za pojav preobčutljivostnih reakcij na tolvaptan (glejte poglavje 4.3 Kontraindikacije).
Liver function tests must be promptly performed in patients taking tolvaptan who report symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine or jaundice. 
Pri bolnikih, ki uporabljajo tolvaptan, in ki poročajo o simptomih, ki lahko nakazujejo na poškodbo jeter, vključno z utrujenostjo, anoreksijo, nelagodjem v zgornjem desnem predelu trebuha, temnim urinom ali zlatenico, je treba takoj opraviti teste delovanja jeter.
There is no experience from controlled clinical trials with concomitant use of Samsca and other treatments for hyponatremia such as hypertonic sodium chloride solution, oral sodium formulations, and medicinal products that increase serum sodium concentration. 
Izkušenj iz kontroliranih kliničnih preskušanj sočasne uporabe zdravila Samsca in drugih oblik zdravljenja hiponatriemije, kot so hipertonična raztopina natrijevega klorida, peroralne oblike natrija in zdravila, ki povečajo koncentracije natrija v serumu, ni. Tudi zdravila z visoko vsebnostjo natrija, kot so šumeči protibolečinski pripravki in nekatere oblike zdravil proti dispepsiji, lahko povečajo koncentracije natrija v serumu.
In 2 pivotal, double-blind, placebo-controlled, clinical trials, a total of 424 patients with euvolemic or hypervolemic hyponatremia (serum sodium < 135 mEq/L) due to a variety of underlying causes (heart failure [HF], liver cirrhosis, SIADH and others) were treated for 30 days with tolvaptan (n = 216) or placebo (n = 208) at an initial dose of 15 mg/day. 
V 2 osrednjih, dvojno slepih, s placebom nadziranih kliničnih preskušanjih so v obdobju 30 dni s tolvaptanom (n = 216) ali placebom (n = 208) z začetnim odmerkom 15 mg/dan zdravili skupno
How to store Samsca 
Shranjevanje zdravila Samsca
10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters 
10 × 1 tableta v perforiranih pretisnih omotih za enkratni odmerek PVC/Al 30 × 1 tableta v perforiranih pretisnih omotih za enkratni odmerek PVC/Al
No teratogenic effects were seen in rabbits at 300 mg/kg/day (up to 5 times the exposure in humans at the 60 mg dose, based on AUC). 
Pri kuncih niso opazili teratogenega učinka pri 300 mg/kg/dan (do 5-krat večja izpostavljenost kot pri ljudeh pri odmerku
How to take Samsca 
Kako jemati zdravilo Samsca
Clearance of tolvaptan is not significantly affected by age. 
Starost Starost nima pomembnega vpliva na očistek tolvaptana.
Hepatic disorders2 Acute hepatic failure3 
žolčnika in žolčevodov bolezni jeter2, akutna odpoved jeter3
Samsca is contraindicated during breast-feeding (see section 4.3). 
Zdravilo Samsca je kontraindicirano med dojenjem (glejte poglavje 4.3).
This effect was seen in all patients, the severe (serum sodium: < 130 mEq/L) and mild (serum sodium: 130 -< 135 mEq/L) subsets and for all disease aetiology subsets (e.g. HF, cirrhosis, SIADH/other). 
Ta učinek so opazili pri vseh bolnikih, v podskupini s hudimi znaki (natrij v serumu: < 130 mEq/l) in blagimi znaki (natrij v serumu:
Generalised rash 
generalizirani izpuščaj
Samsca 7.5 mg tablets EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet) 
Samsca 7,5 mg tablete EU/1/09/539/005 (10 tablet) EU/1/09/539/006 (30 tablet) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
Samsca 7.5 mg tablets Each tablet contains 7.5 mg tolvaptan. 
Samsca 7,5 mg tablete Ena tableta vsebuje 7,5 mg tolvaptana.
Samsca 7.5 mg tablets 5 years 
Samsca 7,5 mg tablete 5 let
Contents of the pack and other information 
Shranjevanje zdravila Samsca Vsebina pakiranja in dodatne informacije
Samsca contains lactose 
Zdravilo Samsca vsebuje laktozo.
Due to the need for a dose titration phase with close monitoring of serum sodium and volume status (see section 4.4), treatment with Samsca has to be initiated in hospital. 
(glejte poglavje 4.4) skrbno nadzirati, je treba zdravljenje z zdravilom Samsca začeti v bolnišnici.
Administration of tolvaptan may cause too rapid increases in serum sodium (≥ 12 mmol/L per 24 hours, please see below); therefore, monitoring of serum sodium in all patients must start no later than 4-6 hours after treatment initiation. 
glejte spodaj); zato je treba z nadziranjem natrija v serumu pri vseh bolnikih začeti najkasneje 4-6 ur po uvedbi zdravljenja.
• other products which increase the salt in your blood or which contain large amounts of salt. 
• diltiazem (zdravljenje visokega krvnega tlaka in bolečine v prsih), • druga zdravila, ki povečujejo koncentracijo soli v krvi ali ki vsebujejo velike količine soli.
Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. 
Modre, okrogle, plitko konveksne tablete z dimenzijami Ø8 × 3,0 mm z vtisnjenim napisom „OTSUKA“ in „30“ na eni strani.
{MM/YYYY} 
• če dojite
Samsca 30 mg: Blue, round, shallow-convex tablets with dimensions of Ø8 × 3.0 mm, debossed with “OTSUKA” and “30” on one side. 
Zdravilo Samsca 30 mg: modre, okrogle, plitko konveksne tablete z dimenzijami Ø8 × 3,0 mm, z vtisnjenim napisom „OTSUKA“ in „30“ na eni strani.
Syncope1, Headache1, Dizziness1 
Bolezni živčevja sinkopa1, glavobol1,
• Anuria 
• anurija
Each Samsca 30 mg tablet contains 30 mg tolvaptan. 
Ena tableta zdravila Samsca 30 mg vsebuje 30 mg tolvaptana.
Each Samsca 15 mg tablet contains 15 mg tolvaptan. 
Ena tableta zdravila Samsca 15 mg vsebuje 15 mg tolvaptana.
Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side. 
Modre, trikotne, plitko konveksne tablete z dimenzijami 6,58 × 6,2 × 2,7 mm z vtisnjenim napisom „OTSUKA“ in „15“ na eni strani.
For the full list of excipients, see section 6.1. 
70 mg laktoze (v obliki monohidrata) na tableto Za celoten seznam pomožnih snovi glejte poglavje 6.1.
Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side. 
Modre, pravokotne, plitko konveksne tablete z dimenzijami 7,7 × 4,35 × 2,5 mm z vtisnjenim napisom „OTSUKA“ in „7.5“ na eni strani.
Samsca 15 mg tablets and Samsca 30 mg tablets 4 years 
Samsca 15 mg tablete in Samsca 30 mg tablete 4 leta
Samsca 7.5 mg: Blue, rectangular, shallow-convex tablets with dimensions of 7.7 × 4.35 × 2.5 mm, debossed with “OTSUKA” and “7.5” on one side. 
Zdravilo Samsca 7,5 mg: modre, pravokotne, plitko konveksne tablete z dimenzijami 7,7 × 4,35 × 2,5 mm, z vtisnjenim napisom „OTSUKA“ in „7.5“ na eni strani.
Samsca contains lactose as an excipient. 
Zdravilo Samsca vsebuje laktozo kot pomožno snov.
• diltiazem (treatment for high blood pressure and chest pain), 
• desmopresin (uporablja se za zvišanje ravni faktorjev strjevanja krvi).
Rapid correction of hyponatremia 
Opis izbranih neželenih učinkov Hiter popravek hiponatriemije
EU/1/09/539/005 (10 tablets) EU/1/09/539/006 (30 tablets) EU/1/09/539/007 (10 × 1 tablet) EU/1/09/539/008 (30 × 1 tablet) 
EU/1/09/539/005 (10 tablet) EU/1/09/539/006 (30 tablet) EU/1/09/539/007 (10 × 1 tableta) EU/1/09/539/008 (30 × 1 tableta)
• ketoconazole (against fungal infections), 
Naslednja zdravila lahko povečajo učinek tega zdravila: • ketokonazol (proti glivičnim okužbam),
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS AND PERFORATED UNIT DOSE BLISTERS 
PRETISNI OMOTI IN PERFORIRANI PRETISNI OMOTI ZA ENKRATNI ODMEREK
Samsca 15 mg: Blue, triangular, shallow-convex tablets with dimensions of 6.58 × 6.2 × 2.7 mm, debossed with “OTSUKA” and “15” on one side. 
Zdravilo Samsca 15 mg; modre, trikotne, plitko konveksne tablete z dimenzijami 6,58 × 6,2 × 2,7 mm, z vtisnjenim napisom „OTSUKA“ in „15“ na eni strani.
Package leaflet: Information for the user Samsca 7.5 mg tablets Samsca 15 mg tablets Samsca 30 mg tablets tolvaptan 
Navodilo za uporabo Samsca 7,5 mg tablete Samsca 15 mg tablete Samsca 30 mg tablete tolvaptan
You have been prescribed this medicine because you have a lowered sodium level in your blood as a result of a disease called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH) where the kidneys retain too much water. 
„sindrom neustreznega izločanja antidiuretičnega hormona“ (SIADH), pri kateri ledvice zadržujejo preveč vode.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PERFORATED UNIT DOSE BLISTERS 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Samsca 7.5 mg tablets are available as 10 tablets in PP/Alu blisters 30 tablets in PP/Alu blisters 10 × 1 tablet in PVC/Alu perforated unit dose blisters 30 × 1 tablet in PVC/Alu perforated unit dose blisters 
Samsca 7,5 mg tablete so na voljo kot 10 tablet v pretisnih omotih PP/Al
Excipient with known effect 51 mg lactose (as monohydrate) per tablet 
51 mg laktoze (v obliki monohidrata) na tableto Samsca 15 mg tablete
Samsca 15 mg and Samsca 30 mg tablets 
Samsca 15 mg tablete in Samsca 30 mg tablete
Rapid correction of hyponatremia, sometimes leading to neurological symptoms observed in clinical trials investigating other indications from post-authorisation safety study in hyponatremia secondary to SIADH observed in post-marketing with tolvaptan in ADPKD. 
Iz varnostne študije v obdobju po izdaji dovoljenja za promet z zdravilom pri hiponatriemiji, sekundarni k SIADH.
Excipient with known effect 35 mg lactose (as monohydrate) per tablet 
35 mg laktoze (v obliki monohidrata) na tableto Samsca 30 mg tablete
Ecchymosis, Pruritus 
Bolezni sečil polakiurija, poliurija okvara ledvic
• constipation 
• omotičnost
Asthenia, Pyrexia, Malaise1 
Bolezni kože in podkožja ehimoza, pruritus srbeč izpuščaj1
• Volume depletion 
• zvišana telesna temperatura
• The active substance is tolvaptan Each Samsca 7.5 mg tablet contains 7.5 mg tolvaptan. 
Ena tableta zdravila Samsca 7,5 mg vsebuje 7,5 mg tolvaptana.
• find it difficult to urinate 
• težko odvajate vodo,
It must not be used in women who are more than three months pregnant. 
Ne smejo ga uporabljati nosečnice, ki so noseče več kot tri mesece.
The company presented information from scientific literature as well as results from studies with the medicine. 
Družba je predstavila podatke iz objavljene znanstvene literature in rezultate študij z zdravilom.
This medicine is the same as Twynsta, which is already authorised in the European Union (EU). 
To zdravilo je enako zdravilu Twynsta, ki je že odobreno v Evropski uniji (EU).
The European Commission granted a marketing authorisation valid throughout the European Union for Onduarp on 24 November 2011. 
Evropska komisija je dovoljenje za promet z zdravilom Onduarp, veljavno po vsej Evropski uniji, odobrila dne 24. novembra 2011.
The maximum dose is one tablet of the highest strength (80/10 mg) once a day. 
Največji odmerek je ena tableta največje jakosti (80/10 mg) enkrat na dan.
The full EPAR for Onduarp can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Onduarp je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
It is available as tablets (40 mg telmisartan/10 mg amlodipine, 40 mg telmisartan/5 mg amlodipine, 80 mg telmisartan/10 mg amlodipine and 80 mg telmisartan/5 mg amlodipine). 
Na voljo je v obliki tablet (40 mg telmisartana/10 mg amlodipina, 40 mg telmisartana/5 mg amlodipina, 80 mg telmisartana/10 mg amlodipina in 80 mg telmisartana/5 mg amlodipina).
Both are medicines to lower the blood pressure that have been available in the European Union (EU) since the 1990s. 
Obe zdravili sta namenjeni zniževanju krvnega tlaka in sta v Evropski uniji (EU) na voljo od 1990-ih.
Other information about Onduarp 
Druge informacije o zdravilu Onduarp
This is a summary of the European public assessment report (EPAR) for Onduarp. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Onduarp.
For more information about treatment with Onduarp, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Onduarp preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte s svojim zdravnikom ali farmacevtom.
EPAR summary for the public telmisartan / amlodipine 
Povzetek EPAR za javnost telmisartan/amlodipin
The main measure of effectiveness in the three studies was the fall in diastolic blood pressure (blood pressure measured between two heartbeats) after eight weeks. 
Glavno merilo učinkovitosti v teh treh študijah je bilo znižanje diastoličnega krvnega tlaka (krvnega tlaka, izmerjenega med dvema srčnim utripoma) po osmih tednih.
Onduarp is used to treat essential hypertension (high blood pressure) in adults (aged 18 years or over). 
Zdravilo Onduarp se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih (starih 18 let ali več).
What is the risk associated with Onduarp? 
Kakšna tveganja so povezana z zdravilom Onduarp?
Onduarp is taken by mouth as one tablet once a day and is used for long-term treatment. 
Zdravilo Onduarp se jemlje peroralno, in sicer ena tableta enkrat na dan, uporablja pa se za dolgotrajno zdravljenje.
When appropriate, direct switch to Onduarp may be considered. 
Če je primerno, se lahko presodi o neposrednem prehodu na zdravljenje z zdravilom Onduarp.
The company that makes Twynsta has agreed that its scientific data can be used for Onduarp (‘informed consent') 
Družba, ki proizvaja zdravilo Twynsta, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Onduarp („privolitev po pojasnilu“).
By lowering the blood pressure, the risks associated with high blood pressure, such as having a stroke, are reduced. 
Z znižanjem krvnega tlaka se zmanjšajo tveganja, ki jih povzroča visok krvni tlak, kot je na primer kap.
Onduarp must also not be used in patients who have severe liver or bile problems, shock (a steep fall in blood pressure), severe hypotension (low blood pressure), obstruction to blood flow from the left side of their heart or in patients with heart failure after having a myocardial infarction (heart attack). 
Zdravila Onduarp ne smejo uporabljati bolniki s hudimi obolenji jeter ali žolčnika, bolniki v šoku (velik padec krvnega tlaka), s hudo hipotenzijo (nizkim krvnim tlakom), oviranim krvnim pretokom iz leve strani srca ali s srčnim popuščanjem po miokardnem infarktu (srčna kap).
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Onduarp. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Onduarp, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
What benefit has Onduarp shown during the studies? 
Kakšne koristi je zdravilo Onduarp izkazalo med študijami?
The most common side effects with Onduarp (seen in between 1 and 10 patients in 100) are dizziness and peripheral oedema (swelling, especially of the ankles and feet). 
Najpogostejši neželeni učinki zdravila Onduarp (opaženi pri 1 do 10 bolnikov od 100) so omotica in periferni edem (otekanje, zlasti gležnjev in stopal).
Onduarp must not be used in people who are hypersensitive (allergic) to telmisartan, amlodipine, other medicines in the ‘dihydropyridine derivatives' class or to any of the other ingredients. 
Zdravila Onduarp ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) telmisartan, amlodipin, druga zdravila iz razreda „derivatov dihidropiridina“ ali katero koli drugo sestavino zdravila.
The Committee decided that Onduarp's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zaključil, da so koristi zdravila Onduarp večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
In the two other studies, Onduarp was more effective at reducing diastolic blood pressure than continued treatment with amlodipine alone: depending on the strengths of Onduarp and amlodipine, the fall in diastolic blood pressure was greater in patients taking Onduarp by between 1.4 mmHg and 4.9 mmHg. 
V dveh drugih študijah je bilo zdravilo Onduarp učinkovitejše pri zniževanju diastoličnega krvnega tlaka kot nadaljnje zdravljenje z amlodipinom kot samostojnim zdravilom: odvisno od jakosti zdravila Onduarp in amlodipina, se je diastolični krvni tlak bolj znižal pri bolnikih, ki so jemali zdravilo Onduarp, in sicer za 1,4 mmHg do 4,9 mmHg.
Studies were also carried to show that Onduarp tablets are absorbed in the same way in the body as separate tablets of amlodipine and telmisartan. 
Izvedene so bile tudi študije, s katerimi so želeli dokazati, da telo tablete zdravila Onduarp absorbira na enak način kot ločene tablete amlodipina in telmisartana.
In two other main studies, 1,978 adults whose hypertension had not responded adequately to amlodipine were either given Onduarp or continued to take amlodipine at the same or a higher dose. 
V dveh drugih glavnih študijah, v katerih je sodelovalo 1 978 odraslih s hipertenzijo, ki se niso ustrezno odzvali na amlodipin, so bolniki prejemali zdravilo Onduarp ali pa so nadaljevali zdravljenje z enakim ali večjim odmerkom amlodipina kot samostojnega zdravila.
Onduarp can also be used in place of treatment with telmisartan and amlodipine in patients who are taking both medicines as separate tablets. 
Zdravilo Onduarp lahko nadomesti zdravljenje s telmisartanom in amlodipinom pri bolnikih, ki jemljejo obe zdravili z dvema ločenima tabletama.
When calcium ions enter the cells in the muscles of blood vessel walls, this causes contraction. 
Ko kalcijevi ioni vstopijo v celice mišic v stenah žil, se začnejo te krčiti.
By blocking the receptors to which angiotensin II normally attaches, Telmisartan stops the hormone having an effect, allowing the blood vessels to widen. 
Ker telmisartan zavira receptorje, na katere se angiotenzin II običajno veže, hormonu prepreči delovanje, zaradi česar se krvne žile lahko razširijo.
Onduarp is used in patients whose blood pressure is not adequately controlled by amlodipine alone. 
Zdravilo Onduarp se uporablja pri bolnikih, pri katerih se krvni tlak ne uravnava ustrezno samo z amlodipinom.
In one main study, 1,461 adults with hypertension were treated with combinations of telmisartan and amlodipine, with telmisartan or amlodipine alone, or with placebo (a dummy treatment). 
V eni glavni študiji je bilo 1 461 odraslih bolnikov s hipertenzijo zdravljenih s kombinacijo telmisartana in amlodipina, s telmisartanom ali amlodipinom kot samostojnim zdravilom ali s placebom (zdravilom brez zdravilne učinkovine).
Why has Onduarp been approved? 
Zakaj je bilo zdravilo Onduarp odobreno?
In the first study, the falls in diastolic blood pressure seen in patients taking combinations of telmisartan and amlodipine were greater than those seen in patients taking only one of the active substances or placebo. 
V prvi študiji so opazili, da je bilo znižanje diastoličnega krvnega tlaka pri bolnikih, ki so jemali kombinacijo telmisartana in amlodipina, večje kot znižanje pri bolnikih, ki so jemali samo eno od zdravilnih učinkovin ali placebo.
For the full list of all side effects reported with Onduarp, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Onduarp, glejte navodilo za uporabo.
The CHMP noted that patients already taking the two active substances in separate tablets may be more likely to adhere to their treatment if prescribed Onduarp. 
CHMP je menil, da bi bolniki, ki že jemljejo obe zdravilni učinkovini z ločenima tabletama, pri prehodu na zdravljenje z zdravilom Onduarp, lažje upoštevali režim zdravljenja.
Onduarp is a medicine that contains two active substances, telmisartan and amlodipine. 
Onduarp je zdravilo, ki vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
For a patient who has been taking telmisartan and amlodipine as separate tablets, the dose of Onduarp to be taken depends on the doses of telmisartan and amlodipine that he or she was taking before. 
Pri bolnikih, ki so jemali telmisartan in amlodipin v dveh ločenih tabletah, se odmerek zdravila Onduarp določi na podlagi odmerka telmisartana in amlodipina, ki ga je ta oseba jemala pred tem.
In addition, studies showed that the medicine was effective in patients whose blood pressure is not adequately controlled by amlodipine alone. 
Študije so tudi pokazale, da je zdravilo učinkovito pri bolnikih, pri katerih se krvni tlak ustrezno ne uravnava z amlodipinom kot samostojnim zdravilom.
By reducing the flow of calcium into the cells, amlodipine prevents the cells from contracting and this helps the blood vessels to relax. 
Amlodipin zmanjša pretok kalcija v celice in tako prepreči njihovo krčenje ter pomaga pri sproščanju napetosti žil.
For a patient whose blood pressure is not adequately controlled by amlodipine, separate tablets of amlodipine and telmisartan should be used to adjust the doses before switching to Onduarp. 
Bolniki, pri katerih se krvni tlak ustrezno ne uravnava samo z amlodipinom, naj najprej pričnejo jemati ločeni tableti amlodipina in telmisartana za prilagoditev odmerkov pred uporabo zdravila Onduarp.
Onduarp contains two active substances, telmisartan and amlodipine. 
Zdravilo Onduarp vsebuje dve zdravilni učinkovini, telmisartan in amlodipin.
They work in similar ways to reduce blood pressure by allowing the blood vessels to relax. 
Obe na podoben način sproščata napetost žil in tako nižata krvni tlak.
How has Onduarp been studied? 
Kako je bilo zdravilo Onduarp raziskano?
How does Onduarp work? 
Kako zdravilo Onduarp deluje?