natgillin/translations-raw huggingface dataset:
Treatment with OCALIVA 10 mg or OCALIVA titration (5 mg to 10 mg) resulted in clinically and statistically significant increases (p < 0.0001) relative to placebo in the number of patients achieving the primary composite endpoint at all study time points (see Table 3). 
Pri zdravljenju z 10 mg zdravila OCALIVA in pri titriranju odmerka OCALIVA (s 5 mg na 10 mg) se je število bolnikov, ki so pri vseh časovnih točkah v študiji dosegli primarni sestavljeni opazovani dogodek, klinično in statistično pomembno zvečal (p < 0,0001) glede na placebo (glejte preglednico 3).
In subjects with mild, moderate and severe hepatic impairment (Child-Pugh Class A, B, and C, respectively), mean AUC of total obeticholic acid, the sum of obeticholic acid and its two active conjugates, increased by 1.13-, 4- and 17-fold, respectively, compared to subjects with normal hepatic function following single-dose administration of 10 mg obeticholic acid. 
Po enkratnem odmerku 10 mg obetiholne kisline se je pri preskušancih z blago, zmerno in hudo jetrno okvaro (razred A, B in C po Child-Pughovi lestvici) povprečna vrednost AUC skupne obetiholne kisline in njenih dveh aktivnih konjugatov povečala za faktor 1,13 (razred A), 4 (razred B) in 17 (razred C) glede na preskušance z normalnim delovanjem jeter.
The metabolite-to -parent ratios of the glycine and taurine conjugates of obeticholic acid were 13.8 and 12.3, respectively, after daily administration. 
Po dnevni uporabi je razmerje presnovka in osnovne učinkovine pri glicinskih konjugatih obetiholne kisline 13,8, pri tavrinskih pa 12,3.
If you stop taking OCALIVA 
Če ste prenehali jemati zdravilo OCALIVA
b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients 
Za izračun 95-odstotnih intervalov zaupanja (IZ) so uporabili Fisherjev eksaktni test. b V preskušanju, v katerem je imelo 16 bolnikov (7 %) intoleranco in niso prejeli sočasnega UDCA: 6 bolnikov
• Temporarily interrupting obeticholic acid dosing for up to 2 weeks followed by restarting at a reduced dosage. 
• začasna 2-tedenska prekinitev odmerjanja obetiholne kisline, ki ji sledi vnovično zdravljenje z zmanjšanim odmerkom;
If you take bile acid binding resins, take this medicine at least 4-6 hours before or at least 4-6 hours after the bile acid binding resin (see section "Other medicines and OCALIVA"). 
Če jemljete smole za vezavo žolčnih kislin, vzemite to zdravilo najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem (glejte poglavje »Druga zdravila in zdravilo OCALIVA«).
Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid pharmacokinetics. 
Populacijska farmakokinetična analiza je pokazala, da spol ne vpliva na farmakokinetiko obetiholne kisline.
dOCALIVA titration and OCALIVA 10 mg versus placebo. 
d Primerjava titracije zdravila OCALIVA in 10 mg zdravila OCALIVA s placebom.
Obeticholic acid is conjugated with glycine or taurine in the liver and secreted into bile. 
Obetiholna kislina se konjugira z glicinom ali tavrinom v jetrih in se izloča v žolč.
Severe pruritus was reported in 23% of patients treated with OCALIVA 10 mg arm, 19% of patients in the OCALIVA titration arm, and 7% of patients in the placebo arms. 
O hudem pruritusu so poročali pri 23 % bolnikov, zdravljenih z 10 mg zdravila OCALIVA na dan, 19 % bolnikov v skupini, ki so ji odmerek zdravila OCALIVA titrirali, in pri 7 % bolnikov v skupini,
For Non-Cirrhotic or Child-Pugh Class A patients: 
Bolniki brez jetrne ciroze ali bolniki razreda A po Child-Pughovi lestvici:
Respiratory, thoracic and mediastinal disorders 
Bolezni dihal, prsnega koša in mediastinalnega prostora orofaringealne bolečine
After daily administration of obeticholic acid, there was accumulation of the glycine and taurine conjugates of obeticholic acid which have in vitro pharmacological activities similar to the parent drug. 
Po dnevni uporabi obetiholne kisline se akumulirajo njeni glicinski in tavrinski konjugati, pri katerih so farmakološki učinki in vitro podobni učinkom prvotne učinkovine.
Relative to patients who started on 10 mg once daily in the OCALIVA 10 mg arm, patients in the OCALIVA titration arm had a lower incidence of pruritus (70% and 56% respectively) and a lower discontinuation rate due to pruritus (10% and 1%, respectively). 
V primerjavi z bolniki, ki so zdravljenje začeli z odmerkom 10 mg enkrat na dan v skupini, ki je prejemala 10 mg zdravila OCALIVA, je bila pri bolnikih v skupini, kjer so odmerek zdravila OCALIVA titrirali, pogostnost pruritusa manjša (70 % v primerjavi s 56 %), stopnja prekinitev zdravljenja pa je bila manjša (10 % v primerjavi z 1 %).
You should continue to take OCALIVA for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first. 
Ne prenehajte uporabe tega zdravila, ne da bi se prej posvetovali z zdravnikom.
No dose adjustment is required for elderly patients (see section 5.2). 
Odmerka pri njih ni treba prilagajati (glejte poglavje 5.2).
Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid pharmacokinetics. 
Populacijska farmakokinetična analiza je pokazala, da ni pričakovati, da bi rasa vplivala na farmakokinetiko obetiholne kisline.
Liver related adverse events 
Neželeni učinki, povezani z jetri
OCALIVA 10 mg film-coated tablets 
OCALIVA 10 mg filmsko obložene tablete
QUALITATIVE AND QUANTITATIVE COMPOSITION OCALIVA 5 mg film-coated tablets Each film-coated tablet contains 5 mg of obeticholic acid. 
KAKOVOSTNA IN KOLIČINSKA SESTAVA OCALIVA 5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 5 mg obetiholne kisline.
INR should be monitored and the dose of warfarin adjusted, if needed, to maintain the target INR range when co-administering obeticholic acid and warfarin. 
Pri sočasni uporabi obetiholne kisline in varfarina je treba spremljati vrednost INR in po potrebi prilagoditi odmerek varfarina, da se ohrani ciljni razpon vrednosti INR.
Mean reductions in ALP were observed as early as Week 2 and were maintained through Month 12 for patients who were maintained on the same dosage throughout 12 months. 
Pri bolnikih, ki so vseh 12 mesecev prejemali isti odmerek, so se tudi ohranila vseh 12 mesecev.
If you take any of these medicines, take OCALIVA at least 4-6 hours before or 4-6 hours after taking bile acid binding resin, giving as much time as possible. 
Če jemljete katero koli izmed teh zdravil, vzemite zdravilo OCALIVA najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem, tako da bo čas med jemanjem obeh zdravil čim daljši.
For patients taking bile acid binding resins, obeticholic acid should be administered at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible (see section 4.5). 
Bolniki, ki jemljejo smole za vezavo žolčnih kislin, morajo obetiholno kislino vzeti najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem (glejte poglavje 4.5).
or OCALIVA titration (5 mg once daily for the initial 6 months, with the option to increase to 10 mg once daily for the last 6 months, if the patient was tolerating OCALIVA but had ALP 1.67-times the ULN or greater, and/or total bilirubin above the ULN, or less than 15% ALP reduction) or placebo. 
c Bolnike so randomizirali (1:1:1), tako da so v eni skupini prejemali 10 mg zdravila OCALIVA enkrat na dan vseh 12 mesecev preskušanja, v drugi so odmerek zdravila OCALIVA titrirali (5 mg enkrat na dan prvih 6 mesecev, z možnostjo zvečanja na 10 mg enkrat na dan zadnjih 6 mesecev, če je bolnik zdravilo OCALIVA prenašal, a je bila vrednost ALP 1,67-kratna vrednost ULN ali večja in/ali skupni bilirubin nad vrednostjo ULN ali se je vrednost ALP zmanjšala za manj kot 15 %), v tretji pa placebo.
Severe pruritus 
Hudi pruritus
The systemic exposure of obeticholic acid, its active conjugates, and endogenous bile acids is increased in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C, respectively) when compared to healthy controls. 
Pri bolnikih z zmerno do hudo jetrno okvaro (razred B oziroma C po Child-Pughovi lestvici) je sistemska izpostavitev obetiholni kislini, njenim aktivnim konjugatom in endogenim žolčnim kislinam večja kot pri zdravih kontrolnih preskušancih.
Based on animal studies and intended pharmacology, obeticholic acid is not expected to interfere with breast-feeding or the growth or development of a breast-fed child. A decision should be made whether to discontinue breast-feeding or to discontinue/abstain from obeticholic acid therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman (see section 5.3). 
Ob upoštevanju koristi dojenja za otroka in koristi zdravljenja za mater se je treba odločiti, ali se prekine dojenje ali opusti/prekine zdravljenje z obetiholno kislino (glejte poglavje 5.3).
OCALIVA 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT' on one side and ‘5' on the other side. 
Rumena, okrogla tableta s premerom 8,0 mm, z vtisnjeno oznako »INT« na eni in »5« na drugi strani.
(8%) in the OCALIVA 10 mg arm, 5 patients (7%) in the OCALIVA titration arm, and 5 patients (7%) in the placebo arm. c Patients were randomized (1:1:1) to receive OCALIVA 10 mg once daily for the entire 12 months of the trial, 
(8 %) v skupini z 10 mg zdravila OCALIVA, 5 bolnikov (7 %) v skupini s titracijo zdravila OCALIVA in 5 bolnikov (7 %) v skupini s placebom.
The median time to onset of severe pruritus was 11, 158, and 75 days for patients in the OCALIVA 10 mg, OCALIVA titration, and placebo arms, respectively. 
Pri bolnikih, ki so prejemali 10 mg zdravila OCALIVA, je bila mediana časa do nastopa hudega pruritusa 11 dni, pri bolnikih, ki so jim odmerek zdravila OCALIVA titrirali 158 dni, pri bolnikih, ki so prejemali placebo, pa 75 dni.
Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on the pharmacokinetics of obeticholic acid. 
Populacijska farmakokinetična analiza je pokazala, da delovanje ledvic nima bistvenega učinka na farmakokinetiko obetiholne kisline.
Your doctor may need to monitor how well your blood clots when taking medicines such as warfarin (a medicine to help your blood flow) with OCALIVA. 
Pri jemanju zdravil, kot je varfarin (zdravilo, ki pomaga pri pretoku krvi), skupaj z zdravilom OCALIVA bo zdravnik morda moral spremljati, kako se strjuje vaša kri.
Abdominal pain and discomfort 
Bolezni prebavil bolečine in neprijeten občutek v trebuhu obstipacija
No dose adjustment of concomitant UDCA is required in patients receiving obeticholic acid. 
Pri bolnikih, ki prejemajo obetiholno kislino, ni treba prilagajati odmerka UDCA, ki se jemlje sočasno.
Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171) 
Obloga tablete polivinilnialkohol, delno hidroliziran (E1203) titanov dioksid (E171) makrogol 3350 (E1521) smukec (E553b) rumeni železov oksid (E172)
OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets obeticholic acid 
OCALIVA 5 mg filmsko obložene tablete OCALIVA 10 mg filmsko obložene tablete obetiholna kislina
International normalised ratio (INR) is decreased following co-administration of warfarin and obeticholic acid. 
Po sočasni uporabi varfarina in obetiholne kisline se internacionalno normalizirano razmerje (INR) zmanjša.
Mean baseline total bilirubin values ranged from 10 μmol/L to 12 μmol/L across treatment arms, with 92% of patients within normal range. 
Povprečne izhodiščne vrednosti skupnega bilirubina v vseh skupinah so bile v razponu od 10 μmol/l do 12 μmol/l.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu. 
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu kjer so na voljo tudi povezave do drugih spletnih strani o redkih boleznih in zdravljenju.
When concomitant bile acid binding resins are administered, obeticholic acid should be taken at least 4-6 hours before or 4-6 hours after taking a bile acid binding resin, or at as great an interval as possible. 
Bolniki, ki sočasno uporabljajo smole za vezavo žolčnih kislin, morajo obetiholno kislino vzeti najmanj 4-6 ur pred jemanjem smole za vezavo žolčnih kislin ali 4-6 ur po tem.
Skin and subcutaneous tissue disorders 
Bolezni kože in podkožja pruritus ekcem, izpuščaj
Oedema peripheral, Pyrexia 
Splošne težave in spremembe na mestu aplikacije utrujenost periferni edem, pireksija
What OCALIVA looks like and contents of the pack - OCALIVA 5 mg is a yellow, round film-coated tablet with ‘INT' on one side and ‘5' on the other side of the film-coated tablet. 
Izgled zdravila OCALIVA in vsebina pakiranja - Zdravilo OCALIVA 5 mg je rumena, okrogla filmsko obložena tableta z vtisnjeno oznako »INT«
Tablet core 
Začetni odmerek
OCALIVA 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic acid. 
OCALIVA 5 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 5 mg obetiholne kisline.
Obeticholic acid has minimal renal elimination with less than 3% of the dose recovered in urine. 
V urinu so ugotovili manj kot 3 % odmerka.
Your doctor may adjust your dose depending on your liver function or if you experience itching that is difficult to tolerate. 
Priporočeni odmerek je ena 5-miligramska filmsko obložena tableta, enkrat na dan, ki jo pogoltnete.Zdravnik vam bo morda prilagodil odmerek glede na vašo jetrno funkcijo ali če se je pri vas pojavilo srbenje, ki ga težko prenašate.
Pharmacotherapeutic group: Bile and liver therapy, Bile acid preparations. 
Farmakoterapevtska skupina: zdravila za bolezni žolča in jeter, žolčne kisline, oznaka ATC: A05AA04
Adverse reactions leading to discontinuation were 1% in the OCALIVA titration arm and 11% in the OCALIVA 10 mg arm. 
Pogostnost neželenih učinkov, zaradi katerih so prekinili zdravljenje, je bila pri bolnikih v skupini, ki so ji odmerek zdravila OCALIVA titrirali, 1 %, pri bolnikih v skupini, ki je prejemala 10 mg zdravila OCALIVA na dan, pa 11 %.
Thyroid function abnormality 
Bolezni endokrinega sistema nenormalno delovanje ščitnice
OCALIVA 10 mg film-coated tablets Each film-coated tablet contains 10 mg of obeticholic acid. 
OCALIVA 10 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 10 mg obetiholne kisline.
OCALIVA 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic acid. 
OCALIVA 10 mg filmsko obložene tablete: Ena filmsko obložena tableta vsebuje 10 mg obetiholne kisline.
Consider discontinuing treatment with obeticholic acid for patients who continue to experience persistent, intolerable pruritus. 
Pri bolnikih, pri katerih pruritus, ki ga ne morejo prenašati, vztraja, razmislite o opustitvi zdravljenja z obetiholno kislino.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 5 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 10 mg 
PODATKI NA ZUNANJI OVOJNINI ŠKATLA 10 mg
For patients who have not achieved an adequate reduction in ALP and/or total bilirubin after 3 months of treatment and the patient is tolerating obeticholic acid, titrate up to 5 mg twice weekly (at least 3 days apart) and subsequently to 10 mg twice weekly (at least 3 days apart) based on response and tolerability 
Na podlagi odziva in prenašanja se titrira do 5 mg dvakrat na teden (z razmikom vsaj 3 dni med odmerkoma) in nato do 10 mg dvakrat na teden (z razmikom vsaj 3 dni med odmerkoma).
Oropharyngeal pain 
Ledvična okvara
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription. 
A. IZDELOVALEC , ODGOVOREN ZA SPROŠČANJE SERIJ B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA ZA PROMET Z ZDRAVILOM D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO ZDRAVILA E. SPECIFIČNE ZAHTEVE ZA IZPOLNITEV UKREPOV PO PRIDOBITVI POGOJNEGA DOVOLJENJA ZA PROMET Z ZDRAVILOM
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg of obeticholic acid. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 5 mg obetiholne kisline.
• thyroid hormone irregularity 
• Načrt za obvladovanje tveganj (RMP)
STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg of obeticholic acid. 
NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg obetiholne kisline.
NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets 
OCALIVA 5 mg filmsko obložene tablete OCALIVA 10 mg filmsko obložene tablete
Other medicines and OCALIVA 
Druga zdravila in zdravilo OCALIVA
Medicinal products that affect obeticholic acid 
Smole, ki vežejo žolčne kisline
- OCALIVA 10 mg is a yellow, triangular film-coated tablet with ‘INT' on one side and ‘10' on the other side of the film-coated tablet. 
- Zdravilo OCALIVA 10 mg je rumena, trikotna filmsko obložena tableta z vtisnjeno oznako »INT«
What OCALIVA contains The active substance is obeticholic acid. 
Učinkovina je obetiholna kislina.
NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets obeticholic acid 
OCALIVA 5 mg filmsko obložene tablete obetiholna kislina
Decrease in ALP of at least 15%, n (%) Total bilirubin less than or equal to 1-times ULNf, n a Percentage of subjects achieving a response, defined as an ALP less than 1.67-times the ULN, total bilirubin within the normal range, and an ALP decrease of at least 15%. 
ULN, skupni bilirubin znotraj normalnega razpona in zmanjšanje vrednosti ALP za vsaj 15 %.
NAME OF THE MEDICINAL PRODUCT OCALIVA 10 mg film-coated tablets obeticholic acid 
OCALIVA 10 mg filmsko obložene tablete obetiholna kislina
These findings were maintained at 48 weeks. 
Te ugotovitve so veljale tudi v 48. tednu.
Further information on Intelence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Nadaljnje informacije o zdravilu Intelence so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
What measures are being taken to ensure the safe and effective use of Intelence? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intelence?
Other information about Intelence 
Druge informacije o zdravilu Intelence
The European Medicines Agency therefore decided that its benefits are greater than its risks and it can be authorised for use in the EU. 
Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Intelence večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Intelence received a marketing authorisation valid throughout the EU on 28 August 2008. 
Za zdravilo Intelence je bilo 28. avgusta 2008 izdano dovoljenje za promet, veljavno po vsej EU.
Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately. 
Bolniki, ki tablete ne morejo pogoltniti, jo lahko raztopijo v kozarcu vode in raztopino takoj popijejo.
As for all medicines, data on the use of Intelence are continuously monitored. 
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Intelence stalno spremljajo.
In adults, the recommended dose of Intelence is 200 mg twice a day after a meal while in children the dose depends on body weight and ranges from 100 mg twice a day to 200 mg twice a day. 
Pri odraslih je priporočeni odmerek zdravila Intelence 200 mg dvakrat dnevno po obroku, pri otrocih pa je odmerek odvisen od telesne mase in znaša od 100 mg dvakrat dnevno do 200 mg dvakrat dnevno.
What benefits of Intelence have been shown in studies? 
Kakšne koristi zdravila Intelence so se pokazale v študijah?
An overview of Intelence and why it is authorised in the EU 
Pregled zdravila Intelence in zakaj je odobreno v EU
Intelence is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water. 
Zdravilo Intelence je na voljo v obliki tablet (25 mg, 100 mg in 200 mg), ki jih je treba pogoltniti cele s kozarcem vode.
In two main studies in a total of 1,203 adults, the average viral load was 70,000 copies/ml at the start of treatment. 
V dveh glavnih študijah, v kateri so bili vključeni 1 203 odrasli, je bilo povprečno virusno breme ob začetku zdravljenja 70 000 kopij/ml.
What is Intelence and what is it used for? 
Kaj je zdravilo Intelence in za kaj se uporablja?
Why is Intelence authorised in the EU? 
Zakaj je bilo zdravilo Intelence odobreno v EU?
What are the risks associated with Intelence? 
Kakšna tveganja so povezana z zdravilom Intelence?
Side effects reported with Intelence are carefully evaluated and any necessary action taken to protect patients. 
Neželeni učinki, o katerih so poročali pri zdravilu Intelence, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intelence have 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 Intelence upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 6 years of age. 
Zdravilo Intelence je zdravilo za zdravljenje okužb s humanim virusom imunske pomanjkljivosti tipa 1 (HIV-1) pri odraslih in otrocih, starejših od šest let.
It contains the active substance etravirine. 
Zdravilo vsebuje učinkovino etravirin.
The most common side effects with Intelence (which may affect more than 1 in 10 people) are rash, diarrhoea, nausea (feeling sick) and headache. 
Najpogostejši neželeni učinki zdravila Intelence (ki se lahko pojavijo pri več kot 1 bolniku od 10) so izpuščaj, driska, navzeja (slabost) in glavobol.
The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI). 
Učinkovina v zdravilu Intelence, etravirin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
In a main study of 101 children aged between 6 and 17 years, about half of them had undetectable levels of HIV after 24 weeks of taking Intelence in combination with other medicines, and the proportion of children with undetectable levels of HIV increased slightly after 48 weeks. 
V glavni študiji, ki je vključevala 101 otroka, starega od šest do 17 let, je imela približno polovica po 24 tednih jemanja zdravila Intelence v kombinaciji z drugimi zdravili nezaznavno raven virusa HIV, delež otrok z nezaznavno ravnijo virusa HIV pa se je po 48. tednu rahlo povečal.
For further information about using Intelence, see the package leaflet or contact your doctor or pharmacist. 
Za več informacij glede uporabe zdravila Intelence glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Intelence does not cure HIV infection or AIDS, but it may delay damage to the immune system and the development of infections and diseases associated with AIDS. 
Zdravilo Intelence ne ozdravi okužbe z virusom HIV ali aidsa, lahko pa podaljša čas do nastopa poškodb imunskega sistema in razvoja okužb ter bolezni, povezanih z aidsom.
Intelence is only used in patients who have been treated for their HIV infection before and it must be used together with other HIV medicines that include a ‘boosted protease inhibitor'. 
Zdravilo Intelence se uporablja samo pri bolnikih, pri katerih je bila okužba z virusom HIV že zdravljena, in ga je treba uporabljati skupaj z drugimi zdravili za zdravljenje okužbe z virusom HIV, ki vključujejo „okrepljeni zaviralec proteaze“.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses. 
Ta zavira delovanje reverzne transkriptaze, encima, ki ga tvori virus HIV ter ki omogoča okužbo celic v telesu in nastajanje novih virusov.
The medicine can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of HIV infection. 
Predpisovanje in izdaja zdravila je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.