natgillin/translations-raw huggingface dataset:
What Clopidogrel 1A Pharma is and what it is used for Before you take Clopidogrel 1A Pharma 
Kaj je zdravilo Klopidogrel 1A Pharma in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Klopidogrel 1A Pharma Kako jemati zdravilo Klopidogrel 1A Pharma
At very high doses, a poor gastric tolerability (gastritis, gastric erosions and/or vomiting) of Clopidogrel was also reported in rat and baboon. 
Pri zelo visokih odmerkih so pri podganah in pavijanih poročali tudi o slabem želodčnem prenašanju (gastritis, želodčne erozije in/ali bruhanje).
The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the Clopidogrel-treated group and 719 (11.4%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p = 0.00009) for the Clopidogrel-treated group (17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG). 
Delež bolnikov s primarnim opazovanim dogodkom [srčno-žilna (SŽ) smrt, miokardni infarkt (MI) ali kap] je bil 582 (9,3 %) v skupini, zdravljeni s klopidogrelom, in 719 (11,4 %) v skupini, ki je prejemala placebo, to je 20 % zmanjšanje relativnega tveganja (95 % IZ od 10 % - 28 %; p=0,00009) v skupini, zdravljeni s klopidogrelom (17 % zmanjšanje relativnega tveganja, če so bili bolniki zdravljeni konzervativno, 29 % kadar je bila izvedena perkutana transluminalna koronarna angioplastika (PTCA) z ali brez stenta in 10 %, če je bila izvedena premostitvena operacija koronarnih arterij (CABG)).
While taking Clopidogrel 1A Pharma, consult your doctor about the breast-feeding of a baby. 
Med jemanjem zdravila Klopidogrel 1A Pharma se o dojenju posvetujte z zdravnikom.
PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: platelet aggregation inhibitors excl. heparin, ATC Code: B01AC-04. 
Farmakoterapevtska skupina: Zaviralci agregacije trombocitov brez heparina, oznaka ATC: B01AC04.
Subsequent metabolism of the 2-oxo-Clopidogrel intermediate metabolite results in formation of the active metabolite, a thiol derivative of Clopidogrel. 
Nadaljnja presnova vmesnega presnovka 2-oksoklopidogrela povzroči nastanek aktivnega presnovka, ki je tiolski derivat klopidogrela.
The clinical relevance of this interaction is uncertain. 
Klinični pomen te interakcije ni znan in tako zmanjša njegovo klinično učinkovitost.
Overdose following Clopidogrel administration may lead to prolonged bleeding time and subsequent bleeding complications. 
Preveliki odmerki klopidogrela lahko podaljšajo čas krvavitve in posledično povzročijo zaplete s krvavitvijo.
Several polymorphic CYP450 enzymes activate Clopidogrel. 
Klopidogrel aktivira več polimorfnih encimov CYP450.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 75 mg of Clopidogrel (as besilate). 
KAKOVOSTNA IN KOLIČINSKA SESTAVA Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
No antidote to the pharmacological activity of Clopidogrel has been found. 
Antidot farmakološkemu delovanju klopidogrela ni znan.
Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): Clopidogrel treatment should be initiated with a single 300 mg loading dose and then continued at 75 mg once a day (with acetylsalicylic acid (ASA) 75 mg-325 mg daily). 
Pri bolnikih z akutnim koronarnim sindromom: - Akutni koronarni sindrom brez elevacije ST spojnice (nestabilna angina ali miokardni infarkt brez Q zobca): zdravljenje moramo začeti z enkratnim udarnim odmerkom 300 mg klopidogrela in nadaljevati s 75 mg enkrat na dan (s 75 mg do 325 mg acetilsalicilne kisline (ASA) dnevno).
ST segment elevation acute myocardial infarction: Clopidogrel should be given as a single daily dose of 75 mg initiated with a 300 mg loading dose in combination with ASA and with or without thrombolytics. 
- Akutni miokardni infarkt z elevacijo ST spojnice: klopidogrel je potrebno dajati v enkratnem dnevnem odmerku 75 mg, zdravljenje pa je potrebno začeti z udarnim odmerkom 300 mg v kombinaciji z ASA ter z/brez uporabe trombolitikov.
No conclusive data on the pharmacodynamic interaction of Clopidogrel and other PPIs are available. 
Zanesljivih podatkov o farmakodinamskem medsebojnem delovanju klopidogrela in drugih zaviralcev protonske črpalke ni.
The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the Clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p = 0.0005) for the Clopidogrel-treated group. 
Število bolnikov s primarnim opazovanim dogodkom (srčno-žilna smrt, MI, kap ali neodzivna ishemijo) je bilo 1.035 (16,5 %) v skupini zdravljeni s klopidogrelom in 1.187 (18,8 %) v skupini s placebom, to je 14 % zmanjšanje relativnega tveganja (95 % IZ od 6 % - 21 %, p=0,0005) za skupino, zdravljeno s klopidogrelom.
Clopidogrel should be given as a single daily dose of 75 mg with or without food. 
• Odrasli in starostniki Klopidogrel se mora dajati kot enkratni dnevni odmerek 75 mg, s hranoz ali brez nje.hrane.
Fifteen percent (15.0%) of patients in the Clopidogrel group and 21.7% in the placebo group reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favour of Clopidogrel (95% CI: 24, 47%; p < 0.001), mainly related to a reduction in occluded infarct-related arteries. 
Primarni opazovani dogodek je bil opažen pri 15,0 % bolnikov v skupini s klopidogrelom in 21¸7 % bolnikov v skupini s placebom, kar predstavlja absolutno zmanjšanje za 6,7 % in 36 % zmanjšanje verjetnosti v prid klopidogrela (95 % IZ od 24 % do 47 %; p<0,001) v glavnem zaradi zmanjšanja zaradi infarkta zamašenih arterij.
Patients were randomised to Clopidogrel (300 mg loading dose followed by 75 mg/day, N = 6,259) or placebo (N = 6,303), both given in combination with ASA (75-325 mg once daily) and other standard therapies. 
Bolniki so bili naključno razporejeni v skupino, ki je prejemala klopidogrel (začetni odmerek 300 mg, nato 75 mg/dan, n=6.259) ali skupino, ki je prejemala placebo (n=6.303), oboje prejeto v kombinaciji z ASA (75 - 325 mg enkrat na dan) in drugimi standardnimi terapijami.
Do not use Clopidogrel 1A Pharma after the expiry date which is stated on the carton and on the blister after EXP. 
Zdravila Klopidogrel 1A Pharma ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu po oznaki EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
Patients received Clopidogrel (75 mg/day, n = 22,961) or placebo (n = 22,891), in combination with ASA (162 mg/day), for 28 days or until hospital discharge. 
Bolniki so 28 dni oziroma do odpusta dobivali klopidogrel (75 mg na dan, n=22.961) ali placebo (n=22.891) v kombinaciji z ASA (162 mg na dan).
In the intention to treat analysis, 939 events were observed in the Clopidogrel group and 1,020 events with ASA (relative risk reduction (RRR) 8.7%, [95% CI: 0.2 to 16.4]; p = 0.045), which corresponds, for every 1,000 patients treated for 2 years, to 10 [CI: 0 to 20] additional patients being prevented from experiencing a new ischaemic event. 
Pri analizi vključenih bolnikov (“intention to treat analysis”) so v skupini, ki je prejemala klopidogrel, opazili 939 dogodkov in v skupini, ki je prejemala ASA, 1.020 dogodkov (zmanjšanje relativnega tveganja (RT) 8,7 %, [95 % IZ: 0,2 do 16,4]; p=0,045), kar ustreza preprečevanju pojava novega ishemičnega dogodka na vsakih 1.000 bolnikov, zdravljenih 2 leti, dodatnim 10 [IZ: 0 do 20] bolnikom.
CYP2C19*1/*2 or *1/*3 
Srednja presnova: CYP2C19*1/*2 ali *1/*3
What Clopidogrel 1A Pharma looks like and contents of the pack 
Izgled zdravila Klopidogrel 1A Pharma in vsebina pakiranja
• very common: affects more than 1 user in 10 
• zelo pogosti: pojavijo se pri več kot 1 od 10 bolnikov
Do not take Clopidogrel 1A Pharma: 
Ne jemljite zdravila Klopidogrel 1A Pharma:
EU/1/09/542/001 - 007 
ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/09/542/001 - 007
Clopidogrel received a variety of concomitant medicinal products including diuretics, beta blockers, ACEI, calcium antagonists, cholesterol lowering agents, coronary vasodilators, antidiabetic agents (including insulin), antiepileptic agents, and GPIIb/IIIa antagonists without evidence of clinically significant adverse interactions. 
Vendar pa so bolniki, ki so bili vključeni v klinično preskušanje klopidogrela, prejemali sočasno različna zdravila, vključno z diuretiki, zaviralci adrenergičnih receptorjev beta, zaviralci angiotenzinske konvertaze (ACEI), kalcijevimi antagonisti, učinkovinami za zniževanje holesterola, koronarnimi vazodilatatorji, antidiabetiki (vključno z insulinom), antiepileptičnimi učinkovinami in antagonisti glikoproteina IIb/IIIa, brez dokazov o klinično pomembnih neželenih interakcijah.
Patients received Clopidogrel (300 mg loading dose, followed by 75 mg/day, n = 1752) or placebo (n = 1,739), both in combination with ASA (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, 
Bolniki so dobivali klopidogrel (300 mg udarni odmerek, nato pa 75 mg na dan, n=1.752) ali placebo (n=1.739), oboje v kombinaciji z ASA (150 mg do 325 mg kot udarni odmerek, nato 75 mg do 162 mg na dan), fibrinolitičnim sredstvom in po potrebi heparinom.
In a crossover clinical study, Clopidogrel (300-mg loading dose followed by 75 mg/day) alone and with omeprazole (80 mg at the same time as Clopidogrel) were administered for 5 days. 
V navzkrižni klinični študiji so 5 dni uporabljali bodisi klopidogrel sam (polnilni odmerek 300 mg in potem 75 mg/dan) bodisi z omeprazolom (80 mg hkrati s klopidogrelom).
• common: affects 1 to 10 users in 100 
• pogosti: pojavijo se pri 1 do 10 od 100 bolnikov
After repeated doses of 75 mg Clopidogrel per day in subjects with severe renal disease (creatinine clearance from 5 to 15 ml/min), inhibition of ADP-induced platelet aggregation was lower (25%) than that observed in healthy subjects, however, the prolongation of bleeding time was similar to that seen in healthy subjects receiving 75 mg of Clopidogrel per day. 
Po večkratnih odmerkih 75 mg klopidogrela na dan, je bila pri osebah s hudo ledvično boleznijo (očistek kreatinina 5 do 15 ml/min) inhibicija z ADP sprožene agregacije trombocitov manjša (25 %) od tiste, opažene pri zdravih osebah.
Important information about some of the ingredients of Clopidogrel 1A Pharma: Clopidogrel 1A Pharma contains hydrogenated castor oil which may cause stomach upset or diarrhoea. 
Pomembne informacije o nekaterih sestavinah zdravila Klopidogrel 1A Pharma Zdravilo Klopidogrel 1A Pharma vsebuje hidrogenirano ricinusovo olje.
Each tablet contains 75 mg of Clopidogrel (as besilate). 
Ena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
CYP2C19 Phenotype and Genotype Frequency 
Pogostnost fenotipov in genotipov CYP2C19
The exposure to the active metabolite of Clopidogrel was decreased by 45% (Day 1) and 40% (Day 5) when Clopidogrel and omeprazole were administered together. 
Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je izpostavljenost aktivnemu presnovku klopidogrela zmanjšala za 45 % (1. dan) oz. 40 % (5. dan).
Glycoprotein IIb/IIIa inhibitors: Clopidogrel should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4). 
Zaviralci glikoproteina IIb/IIIa: klopidogrel moramo uporabljati previdno pri bolnikih, ki imajo lahko tveganje za povečano krvavitev zaradi poškodbe, kirurškega posega ali drugih patoloških stanj, ko prejemajo sočasno zaviralce glikoproteina IIb/IIIa (glejte poglavje 4.4).
a planned surgery (including dental) in the next seven days if you have had a clot in an artery of your brain (ischaemic stroke) which occurred within the 
nedavna huda poškodba nedaven kirurški poseg (vključno na zobeh) načrtovan kirurški poseg (vključno na zobeh) v naslednjih 7 dneh
• rare: affects 1 to 10 users in 10,000 
• redki: pojavijo se pri 1 do 10 od 10.000 bolnikov
Mean inhibition of platelet aggregation (IPA) with 5 μM ADP was diminished by 39% (24 hours) and 21% (Day 5) when Clopidogrel and omeprazole were administered together. 
Če sta bila klopidogrel in omeprazol uporabljena skupaj, se je povprečno zavrtje agregacije trombocitov (IPA) s 5 μM ADP zmanjšalo za 39 % (24 ur) oz. 21 % (5. dan).
Clopidogrel 1A Pharma 75 mg film-coated tablets Clopidogrel 
Klopidogrel 1A Pharma 75 mg filmsko obložene tablete klopidogrel
Extensive metabolism: CYP2C19*1/*1 Intermediate metabolism: 
Obsežna prenova: CYP2C19*1/*1
You have a condition of hardening of arteries (also known as atherosclerosis), and You have previously experienced a heart attack, stroke or have a condition known as peripheral arterial disease (disturbed blood flow in arms or legs caused by vascular 
Zdravilo Klopidogrel 1A Pharma vam je predpisano za pomoč pri preprečevanju nastajanja krvnih strdkov in za zmanjšanje tveganja teh hudih dogodkov, ker: - imate stanje otrdelih arterij (znano tudi kot ateroskleroza), in - ste predhodno doživeli srčni napad, kap ali imeli stanje, ki je znano kot periferna arterijska bolezen (moten krvni pretok v rokah ali nogah, ki ga povzroči zapora žil) ali - ste doživeli hudo obliko bolečine v prsih, znano kot “nestabilna angina” ali “miokardni infarkt” (srčni napad).
Clopidogrel 1A Pharma 75 mg 
PODATKI V BRAILLOVI PISAVI Klopidogrel 1A Pharma 75 mg
No clinically significant pharmacodynamic interactions were observed when Clopidogrel was co-administered with atenolol, nifedipine, or both atenolol and nifedipine. 
Pri sočasni uporabi klopidogrela z atenololom, nifedipinom, ali z obema - atenololom in nifedipinom -niso opazili nobenih klinično pomembnih farmakodinamičnih interakcij.
In CLARITY, there was an overall increase in bleeding in the Clopidogrel + ASA group (17.4%) vs. the placebo + ASA group (12.9%).The incidence of major bleeding was similar between groups (1.3% versus 1.1% for the Clopidogrel + ASA and the placebo + ASA groups, respectively). 
V študiji CLARITY je v skupini s klopidogrelom in ASA prišlo do splošnega povečanja krvavitev (17,4 %) v primerjavi s skupino s placebom in ASA (12,9 %).
What Clopidogrel 1A Pharma contains The active substance is Clopidogrel. 
Kaj vsebuje zdravilo Klopidogrel 1A Pharma Zdravilna učinkovina je klopidogrel.
NAME OF THE MEDICINAL PRODUCT Clopidogrel 1A Pharma 75 mg film-coated tablets 
IME ZDRAVILA Klopidogrel 1A Pharma 75 mg filmsko obložene tablete
• uncommon: affects 1 to 10 users in 1,000 
• občasni: pojavijo se pri 1 do 10 od 1.000 bolnikov
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 75 mg of Clopidogrel (as besilate). 
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 75 mg klopidogrela v obliki klopidogrelijevega besilata.
Clopidogrel is first metabolised to a 2-oxo-Clopidogrel intermediate metabolite. 
Klopidogrel se najprej presnovi v 2-oksoklopidogrel, ki je vmesen presnovek.
BEFORE YOU TAKE CLOPIDOGREL 1A PHARMA 
Shranjevanje zdravila Klopidogrel 1A Pharma
Take special care with Clopidogrel 1A Pharma: If any of the situations mentioned below apply to you, you should tell your doctor before taking Clopidogrel 1A Pharma: if you have a risk of bleeding such as a medical condition that puts you at risk of internal bleeding (such as a stomach ulcer) a blood disorder that makes you prone to internal bleeding (bleeding inside any tissues, organs or joints of your body) 
• če imate tveganje za krvavitev, kot je: zdravstveno stanje s tveganjem za notranjo krvavitev (kot je rana na želodcu) krvna motnja, zaradi katere ste bolj nagnjeni k notranji krvavitvi (krvavitev v tkivih, organih ali sklepih vašega telesa).
POSSIBLE SIDE EFFECTS 
Pomožne snovi
If you forget to take Clopidogrel 1A Pharma 
KAKO JEMATI ZDRAVILO KLOPIDOGREL 1A PHARMA
Clopidogrel is extensively metabolised by the liver. 
Klopidogrel je predzdravilo.
Not applicable 
peroralna uporaba
Always take Clopidogrel 1A Pharma exactly as your doctor has told you. 
Pri jemanju zdravila Klopidogrel 1A Pharma natančno upoštevajte zdravnikova navodila.
While you are taking Clopidogrel 1A Pharma: 
Bodite posebno pozorni pri jemanju zdravila Klopidogrel 1A Pharma:
This summary was last updated in August-2014. 
Povzetek je bil nazadnje posodobljen avgusta 2014.
Data from this study collected until week 96 showed that this effect was maintained over time. 
Podatki iz te študije, ki so jih zbrali do 96. tedna, so pokazali, da se je učinek ohranil dlje časa.
It is used in patients from 12 years of age and weighing at least 40 kg. 
Uporablja se pri bolnikih, ki so stari 12 let ali več in tehtajo najmanj 40 kg.
The European Commission granted a marketing authorisation valid throughout the European Union for Triumeq on 1 September 2014. 
Evropska komisija je dovoljenje za promet z zdravilom Triumeq, veljavno po vsej Evropski uniji, izdala 1. septembra 2014.
After 48 weeks, 88% of the patients given the combination found in Triumeq (364 out of 414) responded to treatment, compared with 81% of the patients who were given Atripla (338 out of 419). 
Po 48 tednih se je na zdravljenje odzvalo 88 % bolnikov, ki so prejemali kombinacijo, ki jo vsebuje zdravilo Triumeq (364 od 414), v primerjavi z 81 % bolnikov, ki so prejemali zdravilo Atripla (338 od 419).
Giving the combined medicine rather than the single medicines reduces the number of tablets patients have to take, helping them to adhere to their treatment. 
Dajanje kombiniranega zdravila namesto posameznih zdravil zmanjša število tablet, ki jih morajo bolniki jemati, zaradi česar se lažje držijo predpisanega zdravljenja.
This is a summary of the European public assessment report (EPAR) for Triumeq. 
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Triumeq.
Triumeq reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Triumeq zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
The full EPAR and risk management plan summary for Triumeq 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) in povzetek načrta obvladovanja tveganj za zdravilo Triumeq sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Before starting treatment with Triumeq, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'. 
Pred začetkom zdravljenja z zdravilom Triumeq je treba pri vseh bolnikih opraviti preiskavo, s katero se ugotovi, ali imajo gen, imenovan „HLA-B (tip 5701)“.
What measures are being taken to ensure the safe and effective use of Triumeq? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Triumeq?
The main measure of effectiveness was the response rate, which was the proportion of patients with a reduction of the levels of virus in the blood (viral load) to fewer than 50 copies of HIV RNA per ml. 
Glavno merilo učinkovitosti je bila stopnja odziva, opredeljena kot delež bolnikov, pri katerih se je koncentracija virusa v krvi (virusno breme) zmanjšala na manj kot 50 kopij HIV RNA na ml.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Triumeq's benefits are greater than its risks and recommended that it be approved for use in the EU. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da so koristi zdravila Triumeq večje od z njim povezanih tveganj, in priporočil, da se odobri za uporabo v EU.
Other information about Triumeq 
Druge informacije o zdravilu Triumeq
The CHMP concluded that the medicine had demonstrated its effectiveness in previously untreated patients, and that similar benefits are expected in patients who have received previous treatment. 
Odbor CHMP je zaključil, da je bila dokazana učinkovitost zdravila pri predhodno nezdravljenih bolnikih in da je podobne koristi mogoče pričakovati tudi pri predhodno že zdravljenih bolnikih.
Triumeq dolutegravir / abacavir / lamivudine 
Triumeq dolutegravir/abakavir/lamivudin
Results from this study showed that Triumeq was absorbed into the body in the same way as the separate medicines. 
Rezultati iz te študije so pokazali, da se zdravilo Triumeq v telesu absorbira na enak način kot ločeni zdravili.
Triumeq is available as tablets (50 mg dolutegravir / 600 mg abacavir /300 mg lamivudine) and the recommended dose is one tablet a day, taken with or without food. 
Zdravilo Triumeq je na voljo v obliki tablet (50 mg dolutegravirja/600 mg abakavirja/300 mg lamivudina), priporočeni odmerek pa je ena tableta na dan, ki se vzame s hrano ali brez nje.
The CHMP also considered the fact that Triumeq can be taken with or without food as an additional advantage compared with other similar medicines which have to be taken strictly either with food or on an empty stomach. 
Odbor CHMP je prav tako menil, da je dejstvo, da se lahko zdravilo Triumeq jemlje s hrano ali brez nje, dodatna prednost v primerjavi z drugimi podobnimi zdravili, ki se morajo obvezno jemati bodisi s hrano ali na prazen želodec.
The combination of abacavir and lamivudine has been authorised as Kivexa since 2004. 
Kombinacija abakavirja in lamivudina je odobrena od leta 2004 kot zdravilo Kivexa.
The most common side effects with Triumeq (which may affect more than 1 in 10 people) are insomnia (difficulty sleeping), headache, nausea (feeling sick), diarrhoea and fatigue (tiredness). 
Najpogostejši neželeni učinki zdravila Triumeq (ki lahko prizadenejo več kot 1 osebo od 10) so nespečnost (težave s spanjem), glavobol, navzeja (slabost), driska in utrujenost.
Data from this study had already been used in the authorisation of Tivicay. 
Podatke iz te študije so že predložili v postopku za pridobitev dovoljenja za promet z zdravilom Tivicay.
All three active substances in Triumeq are already available in the European Union (EU) as singlecomponent medicines: abacavir has been authorised as Ziagen since 1999, lamivudine as Epivir since 1996, and dolutegravir as Tivicay since January 2014. 
Vse tri zdravilne učinkovine v zdravilu Triumeq so v Evropski uniji (EU) že na voljo kot enokomponentna zdravila: abakavir je odobren od leta 1999 kot zdravilo Ziagen, lamivudin od leta 1996 kot zdravilo Epivir, dolutegravir pa od januarja 2014 kot zdravilo Tivicay.
The combination of dolutegravir, abacavir and lamivudine (as found in Triumeq) was evaluated in one main study involving 833 previously untreated patients. 
Kombinacijo dolutegravirja, abakavirja in lamivudina (ki jo vsebuje zdravilo Triumeq) so ovrednotili v eni glavni študiji, v kateri je sodelovalo 833 bolnikov, ki se pred tem še niso zdravili.
A risk management plan has been developed to ensure that Triumeq is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Triumeq je bil pripravljen načrt obvladovanja tveganj.
Triumeq does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Triumeq ne ozdravi okužbe z virusom HIV ali aidsa, vendar lahko upočasni slabšanje imunskega sistema in razvoj okužb ter bolezni, povezanih z aidsom.
What is Triumeq and what is it used for? 
Kaj je zdravilo Triumeq in za kaj se uporablja?
The CHMP also noted that giving the combination of dolutegravir, abacavir and lamivudine as a single tablet is an additional treatment option for patients with HIV infection and without the HLA-B (type 5701) gene. 
Odbor CHMP je prav tako izpostavil, da je dajanje kombinacije dolutegravirja, abakavirja in lamivudina v eni tableti dodatna možnost zdravljenja za bolnike, ki so okuženi z virusom HIV in nimajo gena HLAB (tip 5701).
What benefits of Triumeq have been shown in studies? 
Kakšne koristi je zdravilo Triumeq izkazalo v študijah?
What are the risks associated with Triumeq? 
Kakšna tveganja so povezana z zdravilom Triumeq?