natgillin/translations-raw huggingface dataset:
Because no information is available regarding the use of telmisartan during breast-feeding, telmisartan/amlodipine is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while breast-feeding a newborn or preterm infant. 
Prednost imajo alternativna zdravila, pri katerih je varnost uporabe med dojenjem, zlasti novorojenčka ali nedonošenčka, natančneje raziskana.
MARKETING AUTHORISATION NUMBER(S) EU/1/10/648/028 (360 (4 x 90 x 1) tablets) 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/648/028 (360 (4 x 90 x 1) tablet)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/10 mg 
ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 40 mg/10 mg
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg/5 mg 
ZUNANJE OZNAČEVANJE PRI SKUPINSKEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 40 mg/5 mg
Twynsta contains sodium 
Izgled zdravila Twynsta in vsebina pakiranja
EXPIRY DATE 
navzea napenjanje
: the event may be a chance finding or related to a mechanism currently not known : most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. 
Redki povečana raven sečne kisline v krvi zvišana raven kreatinfosfokinaze v krvi, znižana raven hemoglobina dogodek je lahko naključen ali povezan s še neznanim mehanizmom o večini primerov nenormalnega jetrnega delovanja ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih učinkov v obdobju po začetku trženja telmisartana so poročali o primerih intersticijske pljučne bolezni (pretežno intersticijske pljučnice in eozinofilne pljučnice)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 40 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 5 mg amlodipine (as amlodipine besilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 5 mg amlodipina (v obliki amlodipinijevega besilata).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 10 mg amlodipine (as amlodipine besilate). 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 80 mg telmisartana in 10 mg amlodipina (v obliki amlodipinijevega besilata).
Rare hepatic function abnormal, liver disorder 
Bolezni jeter, žolčnika in žolčevodov Redki nenormalno jetrno delovanje, jetrna bolezen
The three main studies involved a total of almost 113,000 people. 
V tri glavne študije je bilo vključenih skupaj skoraj 113 000 ljudi.
The company also presented data from the published literature. 
Družba je predstavila tudi podatke iz objavljene literature.
The European Commission granted a marketing authorisation valid throughout the European Union for Dukoral on 28 April 2004. 
Evropska komisija je dovoljenje za promet z cepivom Dukoral, veljavno po vsej Evropski uniji, izdala 28. aprila 2004.
The course should be completed at least one week before potential exposure to cholera. 
Cepljenje mora biti zaključeno vsaj en teden pred morebitno izpostavitvijo koleri.
Other information about Dukoral: 
Druge informacije o zdravilu Dukoral:
The studies took place in areas where cholera is found. 
Študije so izvajali na območjih, kjer se pojavlja kolera.
Because Dukoral has been in use in Sweden since 1991, the company presented the results of three main studies that had already been carried out in order to support the use of Dukoral. 
Ker je cepivo Dukoral na Švedskem v uporabi že od leta 1991, je družba predstavila rezultate treh glavnih študij, ki so že bile izvedene v podporo uporabi tega cepiva.
Once prepared, the suspension should be drunk within two hours. 
Ko je raztopina pripravljena, jo je treba popiti v dveh urah.
The full EPAR for Dukoral 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 cepivo Dukoral je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
This document is a summary of the European public assessment report (EPAR) for Dukoral. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za cepivo Dukoral.
What benefit has Dukoral shown during the studies? 
Kakšne koristi je zdravilo Dukoral izkazalo med študijami?
Dukoral cholera vaccine (inactivated, oral) 
Dukoral cepivo proti koleri (inaktivirano, peroralno)
The people in the final study also received a booster dose 10 to 12 months later. 
Osebe v zadnji študiji so po 10 do 12 mesecih prejele tudi poživitveni odmerek.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to protect itself against a disease. 
Cepiva delujejo tako, da imunski sistem (naravni obrambni mehanizem telesa) „naučijo“, kako naj se brani pred boleznimi.
For more information about treatment with Dukoral, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju s cepivom Dukoral preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
It is available as a suspension in a bottle together with effervescent granules in a sachet. 
Na voljo je kot suspenzija v steklenički skupaj s šumečimi granulami v vrečki.
What is the risk associated with Dukoral? 
Kakšna tveganja so povezana z zdravilom Dukoral?
Dukoral should not replace standard protective measures against cholera, including advice on diet and hygiene. 
Cepivo Dukoral ne sme nadomestiti standardnih zaščitnih ukrepov proti koleri, ki vključujejo upoštevanje nasvetov glede prehrane in higiene.
The CHMP noted that the risk of cholera for regular tourists is minor, but that Dukoral could be important for certain groups, such as healthcare workers in cholera epidemics. 
Odbor za zdravila za uporabo v humani medicini (CHMP) je ugotovil, da je tveganje okužbe s kolero za običajne turiste zelo majhno, vendar bi lahko bilo cepivo Dukoral zelo pomembno za nekatere skupine, kot so zdravstveni delavci na področjih z epidemijo kolere.
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 Dukoral. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
The Committee decided that Dukoral's benefits are greater than its risks and recommended that it be given marketing authorisation. 
Odbor je zaključil, da so koristi cepiva Dukoral večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
Dukoral is a vaccine. 
Zdravilo Dukoral je cepivo.
Dukoral is used in adults, adolescents and children from two years of age who will be visiting high-risk areas. 
Cepivo Dukoral se uporablja pri odraslih, mladostnikih in otrocih, starih vsaj dve leti, ki nameravajo obiskati zelo tvegana področja.
Dukoral is used to protect against cholera (a very serious disease caused by V. cholerae, which is caught from contaminated food or water and causes severe diarrhoea). 
Cepivo Dukoral se uporablja za zaščito proti koleri (zelo resni bolezni, ki jo povzroča bakterija V. cholerae, s katero se bolnik okuži prek onesnažene hrane ali vode, posledica pa je huda driska).
The length of protection was different for adults and children, lasting for six months in children and for two years in adults. 
Trajanje zaščite je bilo različno pri odraslih in otrocih ter je trajalo šest mesecev pri otrocih in dve leti pri odraslih.
The first study involved over 89,000 people in Bangladesh and compared Dukoral with the same vaccine without the toxin and with placebo. 
Prvo študijo so izvedli v Bangladešu in je vključevala več kot 89 000 oseb, v njej pa so cepivo Dukoral primerjali s istim cepivom brez toksina in s placebom.
Dukoral must not be used in people who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients or to formaldehyde. 
Cepiva Dukoral ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) katero koli zdravilno učinkovino ali katero koli drugo sestavino zdravila ali formaldehid.
When a person is given the vaccine, the immune system recognises the bacteria and the toxin, and makes antibodies against them. 
Ko oseba prejme cepivo, njen imunski sistem prepozna bakterije in toksin ter začne proti njim tvoriti protitelesa.
In adults, two vaccine doses were shown to be as effective as three. 
Odkrili so, da sta pri odraslih dva odmerka enako učinkovita kot trije.
The information presented was not sufficient to support the use of Dukoral in traveller's diarrhoea. 
Predstavljeni podatki niso bili zadostni, da bi bilo mogoče podpreti uporabo cepiva Dukoral za popotniško drisko.
The company also presented information on the use of Dukoral for the prevention of a severe type of traveller's diarrhoea caused by a bacterium called ‘enterotoxigenic Escherichia coli'. 
Družba je prav tako predstavila podatke o uporabi cepiva Dukoral za preprečevanje hude popotniške driske, ki jo povzroča bakterija, imenovana „enterotoksigena Escherichia coli“.
The vaccine contains four different inactivated strains (types) of the bacterium Vibrio cholerae (V. cholerae) serotype O1, and part of a toxin from one of these strains as active substances. 
Cepivo vsebuje kot zdravilno učinkovino štiri različne inaktivirane seve (tipe) bakterij Vibrio cholerae (V. cholerae) serotipa O1 in del toksina iz enega od teh sevov.
Dukoral should be given according to official recommendations, taking into account where cholera is found and the risk of contracting the disease. 
Uporabo cepiva Dukoral je treba določiti na osnovi uradnih priporočil in pri tem upoštevati območja, kjer se kolera pojavlja, in stopnjo tveganja za okužbo.
These antibodies will help to protect against cholera by preventing the bacteria and the toxins from attaching to the walls of the gut and entering the body's cells. 
Ta protitelesa bodo pomagala ščititi osebo pred kolero, tako da bodo preprečevala vezanje bakterij in toksinov na steno črevesja in njihov vstop v celice telesa.
Its use should be postponed in patients with a short-lived illness affecting the stomach or gut, or with a fever. 
Uporabo cepiva je treba prestaviti pri bolnikih s kratkotrajnimi boleznimi, ki prizadenejo želodec ali črevo, ali pri bolnikih s povišano telesno temperaturo.
In this study, Dukoral was made using cholera toxin extracted from cholera bacteria in place of the newer recombinant toxin. 
V tej študiji so cepivo Dukoral izdelali z uporabo toksina kolere, pridobljenega iz bakterije kolere namesto novejšega rekombinantnega toksina.
The course should be repeated in adults who have not been given a booster within two years and in children not given a booster within six months. 
Cikel je treba ponoviti pri odraslih, ki poživitvenega odmerka niso prejeli v dveh letih in pri otrocih, ki ga niso prejeli v šestih mesecih.
However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, diarrhoea, and abdominal (tummy) pain, cramps, gurgling (gas) or discomfort. 
Vendar so bili pri 1 do 10 bolnikih od 1 000 opaženi naslednji neželeni učinki: glavobol, driska in bolečine v trebuhu, krči, vetrovi ali slabo počutje.
The other two studies compared Dukoral (containing recombinant cholera toxin) with placebo in over 22,000 people in Peru. 
V drugih dveh študijah so cepivo Dukoral (ki je vsebovalo rekombinantni toksin kolere) primerjali s placebom pri več kot 22 000 osebah v Peruju.
A further study was carried out to show that Dukoral could produce antibodies in people who do not come from areas where cholera is found. 
Izvedli so še eno študijo, s katero so želeli pokazati, da lahko cepivo Dukoral izzove tvorjenje protiteles tudi pri ljudeh, ki ne izhajajo iz področij, kjer je kolera prisotna.
Side effects with Dukoral are not common. 
Neželeni učinki cepiva Dukoral niso pogosti.
In all three studies, Dukoral, given as either two or three doses, was compared with placebo (a dummy vaccine). 
V vseh treh študijah so cepivo Dukoral, ki so ga dajali bodisi v dveh ali treh odmerkih, primerjali s placebom (cepivom brez zdravilne učinkovine).
In all three studies, the main measure of effectiveness was the ‘protective effectiveness' of the vaccine, calculated by comparing the number of people in the studies who developed cholera after receiving Dukoral and after receiving placebo. 
Glavno merilo učinkovitosti v vseh treh študijah je bila učinkovitost zaščite, ki jo je nudilo cepivo, izračunana na podlagi primerjave števila udeležencev, pri katerih se je po cepljenju s cepivom Dukoral pojavila kolera, s številom tistih, ki so za kolero zboleli po prejemanju placeba.
Why has Dukoral been approved? 
Zakaj je bilo zdravilo Dukoral odobreno?
The vaccine is made up by dissolving the granules in a glass of water to prepare an effervescent (sparkling) solution, and adding the contents of the bottle. 
Cepivo se pripravi z raztapljanjem zrnc v kozarcu vode, s čemer dobimo šumečo raztopino, ki ji dodamo vsebino stekleničke.
For the full list of side effects reported with Dukoral, see the package leaflet. 
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi cepiva Dukoral, glejte navodilo za uporabo.
For continuous protection against cholera, a single booster dose is recommended within two years for people from six years of age, and within six months for children aged between two and six years. 
Za dolgotrajno zaščito proti koleri je priporočen enojni poživitveni odmerek, ki se osebam, starejšim od šest let, daje po dveh letih, otrokom, starim od dveh do šest let, pa po šestih mesecih.
The granules are dissolved in water and mixed with the vaccine before intake. 
Pred jemanjem je treba granule raztopiti v vodi in jih zmešati s cepivom.
Children aged between two and six years should receive three doses, with an interval of one to six weeks between each dose. 
Otroci, stari od dve do šest let, morajo prejeti tri odmerke, med katerimi mora biti eno- do šesttedenski presledek.
Dukoral contains small amounts of inactivated (killed) cholera bacteria and a part of the cholera toxin called the ‘B subunit'. 
Cepivo Dukoral vsebuje majhno količino neaktiviranih (uničenih) bakterij kolere in del toksina kolere, imenovanega podenota B. Ta podenota sama po sebi ni strupena.
In the future, the immune system will be able to produce antibodies more quickly when it is exposed to cholera bacteria. 
Posledično bo imunski sistem ob vnovični izpostavitvi bakteriji kolere sposoben hitreje tvoriti protitelesa.
In the first of the two studies in Peru, the protective effectiveness of Dukoral was 85% for the first five months of follow-up. 
V prvi od obeh študij, opravljenih v Peruju, je bila učinkovitost zaščite s cepivom Dukoral v prvih petih mesecih sledenja 85─odstotna.
In the study in Bangladesh, the protective effectiveness of Dukoral was 85% over the first six months of follow-up. 
V študiji, ki so jo izvedli v Bangladešu, je bila učinkovitost zaščite s cepivom Dukoral v prvih šestih mesecih sledenja 85─odstotna.
In adults and children from six years of age, Dukoral is given as two doses, one to six weeks apart. 
Pri odraslih in otrocih, starih nad šest let, se cepivo Dukoral daje v dveh odmerkih, med katerima mora biti eno- do šesttedenski presledek.
Food, drink and other medicines taken by mouth should be avoided for one hour before and one hour after each dose of Dukoral. 
Eno uro pred in eno uro po zaužitju odmerka cepiva Dukoral se je treba izogibati hrani, pijači in drugim zdravilom, ki se jih jemlje peroralno.
The other study in Peru showed that after a booster dose, the protective effectiveness of Dukoral during the second year of follow-up was 61%. 
Druga perujska študija je pokazala, da je bila učinkovitost zaščite s cepivom Dukoral med drugim letom sledenja 61 %.
What is Dukoral used for? 
Za kaj se zdravilo Dukoral uporablja?
How has Dukoral been studied? 
Kako je bilo zdravilo Dukoral raziskano?
How is Dukoral used? 
Kako se zdravilo Dukoral uporablja?
Dukoral is a vaccine that is given by mouth. 
Zdravilo Dukoral je cepivo, ki se jemlje peroralno.
How does Dukoral work? 
Kako zdravilo Dukoral deluje?
What is Dukoral? 
Kaj je zdravilo Dukoral?
Further information on Brinavess can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/brinavess. 
Nadaljnje informacije o zdravilu Brinavess so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/brinavess.
The European Medicines Agency decided that Brinavess's benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zaključila, da so koristi zdravila Brinavess večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
What measures are being taken to ensure the safe and effective use of Brinavess? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Brinavess?
If the blood pressure or heart rate suddenly decreases the infusion should be stopped immediately. 
Če se krvni tlak ali srčni utrip nenadoma zniža, je treba infundiranje takoj prekiniti.
The main measure of effectiveness was the proportion of patients whose heart rhythm returned to normal. 
Glavno merilo učinkovitosti je bil delež bolnikov, pri katerih se je srčni utrip vrnil na normalno vrednost.
As for all medicines, data on the use of Brinavess are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Brinavess stalno spremljajo.
The healthcare professional should monitor the patient's blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards. 
Zdravstveni delavec mora spremljati krvni tlak in srčni utrip bolnika med dajanjem zdravila in najmanj 15 minut po njem.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Brinavess have also been included in the summary of product characteristics and the package leaflet. 
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Brinavess upoštevati zdravstveni delavci in bolniki, so vključeni tudi v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
By blocking these channels, vernakalant can prevent abnormal electrical activity that can lead to atrial fibrillation. 
Vernakalant lahko z blokiranjem teh kanalov prepreči nenormalno električno aktivnost, ki lahko povzroči atrijsko fibrilacijo.
What benefits of Brinavess have been shown in studies? 
Kakšne koristi zdravila Brinavess so se pokazale v študijah?
Why has Brinavess been authorised in the EU? 
Zakaj je bilo zdravilo Brinavess odobreno v EU?
For more information about using Brinavess, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Brinavess glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Brinavess must not be used in patients with severe aortic stenosis (narrowing of the aorta), low systolic blood pressure (blood pressure when the heart is contracting), advanced heart failure (when the heart does not pump enough blood around the body), some types of altered electrical activity in the heart or a very slow heart rate. 
Zdravilo Brinavess se ne sme uporabljati pri bolnikih s hudo aortno stenozo (zoženjem aorte), nizkim sistoličnim krvnim tlakom (krvnim tlakom, ko se srce skrči), napredovalim srčnim popuščanjem (ko srce ne zmore prečrpati dovolj krvi po telesu), določenimi spremembami električne aktivnosti srca ali zelo počasnim srčnim utripom.
Side effects reported with Brinavess are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Brinavess, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
An overview of Brinavess and why it is authorised in the EU 
Pregled zdravila Brinavess in zakaj je odobreno v EU
The most common side effects with Brinavess (which may affect more than 1 person in 10) are dysgeusia (taste disturbances) and sneezing. 
Najpogostejša neželena učinka zdravila Brinavess (ki se lahko pojavita pri več kot 1 bolniku od 10) sta disgevzija (motnje okušanja) in kihanje.
Brinavess received a marketing authorisation valid throughout the European Union on 01 September 
Za zdravilo Brinavess je bilo 1. septembra 2010 izdano dovoljenje za promet, veljavno po vsej EU.
It restores normal heart rhythm by blocking channels through which charged particles of potassium and sodium move in and out of the muscle cells in the atria. 
Ta obnovi normalen srčni utrip z blokiranjem kanalov, skozi katere potujejo nabiti delci kalija in natrija v mišične celice preddvora in iz njih.
What is Brinavess and what is it used for? 
Kaj je zdravilo Brinavess in za kaj se uporablja?
Brinavess must not be given within 30 days of having acute coronary syndrome (a group of heart problems that include unstable angina and heart attacks). 
Ne sme se dajati v 30 dneh po akutnem koronarnem sindromu (skupini težav s srcem, ki vključujejo nestabilno angino pektoris in srčne infarkte).
Brinavess is to be used for atrial fibrillation that has started within the last seven days, or within the last three days if the patient had recently had heart surgery. 
Zdravilo Brinavess naj bi se uporabljalo pri atrijski fibrilaciji, ki se je začela v zadnjih sedmih dneh ali v zadnjih treh dneh, če je bil bolnik nedavno operiran na srcu.
Brinavess can only be obtained with a prescription and should be given by a qualified healthcare professional in a setting where the patient's heart can be properly monitored. 
Predpisovanje in izdaja zdravila Brinavess je le na recept, dati pa ga mora usposobljeno zdravstveno osebje v okolju, kjer je mogoče bolnikovo srce ustrezno spremljati.
Other information about Brinavess 
Druge informacije o zdravilu Brinavess
Brinavess contains vernakalant, a type of substance known as an anti-arrhythmic. 
Zdravilo Brinavess vsebuje vernakalant, vrsto snovi, znano kot antiaritmik.
The company that markets Brinavess will ensure that healthcare professionals expected to use the medicine are provided with educational material explaining how the medicine should be used. 
Podjetje, ki trži zdravilo Brinavess, bo zagotovilo, da bodo zdravstveni delavci, ki naj bi uporabljali to zdravilo, prejeli izobraževalno gradivo o njegovi uporabi.
The dose of Brinavess depends on the patient's body weight. 
Odmerek zdravila Brinavess je odvisen od bolnikove telesne mase.
In the first two studies, among patients who had recently started having atrial fibrillation, heart rhythm returned to normal in 51% of those receiving Brinavess (118 out of 231) compared with 4% (6 out of 159) of those taking placebo. 
V prvih dveh študijah se je pri bolnikih z nedavnim pojavom atrijske fibrilacije srčni utrip normaliziral pri 51 % (118 od 231) prejemnikov zdravila Brinavess in pri 4 % (6 od 159) prejemnikov placeba.
In the third study, heart rhythm returned to normal in 47% of the patients receiving Brinavess compared with 14% of those receiving placebo. 
V tretji študiji se je srčni utrip normaliziral pri 47 % bolnikov, ki so prejemali zdravilo Brinavess, in pri 14 % prejemnikov placeba.
What are the risks associated with Brinavess? 
Kakšna tveganja so povezana z zdravilom Brinavess?