FrancophonIA/ELRC3.0 huggingface dataset:
English: • Reducing the dosage of obeticholic acid to: ▪ 5 mg once weekly, for patients intolerant to 5 mg twice weekly ▪ 10 mg once weekly, for patients intolerant to 10 mg twice weekly
Croatian: • Smanjenje doze obetikolatne kiseline na: 5 mg jedanput tjedno, za bolesnike koji ne podnose 5 mg dvaput tjedno 10 mg jedanput tjedno, za bolesnike koji ne podnose 10 mg dvaput tjedno
English: Warnings and precautions Talk to your doctor or pharmacist before taking OCALIVA.
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek OCALIVA.
English: Based on population pharmacokinetic analysis, renal function did not have a meaningful effect on the pharmacokinetics of obeticholic acid.
Croatian: Na temelju analize populacijske farmakokinetike bubrežna funkcija nije imala značajnog učinka na farmakokinetiku obetikolatne kiseline.
English: 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).
Croatian: U odnosu na bolesnike koji su započeli s 10 mg jedanput dnevno u skupini koja je primala lijek OCALIVA u dozi u 10 mg, bolesnici u skupini u kojoj se titrirala doza lijeka OCALIVA imali su manju incidenciju svrbeža (70 % u odnosu na 56 %) i manju stopu prekida liječenja zbog svrbeža (10 % u odnosu na 1 %).
English: If you forget to take OCALIVA
Croatian: Ako ste zaboravili uzeti lijek OCALIVA
English: • pain in your joints
Croatian: • bol u zglobovima
English: Microcrystalline cellulose (E460) Sodium starch glycolate (Type A) Magnesium stearate
Croatian: Jezgra tablete mikrokristalična celuloza (E460) natrijev škroboglikolat, vrsta A magnezijev stearat
English: The metabolite-to -parent ratios of the glycine and taurine conjugates of obeticholic acid were 13.8 and 12.3, respectively, after daily administration.
Croatian: Nakon svakodnevne primjene, omjer metabolita i izvornog lijeka za glicinske konjugate obetikolatne kiseline iznosio je 13,8 odnosno za taurinske 12,3.
English: There is little information about the effects of OCALIVA in pregnancy.
Croatian: O učincima lijeka OCALIVA na trudnoću postoji malo informacija.
English: Adverse reactions leading to discontinuation were 1% in the OCALIVA titration arm and 11% in the OCALIVA 10 mg arm.
Croatian: Nuspojave koje su dovele do prekida liječenja iznosile su 1 % u skupini u kojoj se titrirala doza lijeka OCALIVA i 11 % u skupini koja je primala lijek OCALIVA u dozi od 10 mg.
English: Population pharmacokinetic analysis indicated that gender does not influence obeticholic acid pharmacokinetics.
Croatian: Analiza populacijske farmakokinetike ukazuje da spol ne utječe na farmakokinetiku obetikolatne kiseline.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/16/1139/001
English: In general itching of the skin is a very common side effect that begins within the first month following the start of treatment with OCALIVA and usually becomes less severe over time..
Croatian: Općenito se svrbež kože, što je vrlo česta nuspojava, javlja tijekom prvog mjeseca od početka liječenja lijekom OCALIVA te se njegova jačina smanjuje tijekom vremena.
English: For Non-Cirrhotic or Child-Pugh Class A patients:
Croatian: Za bolesnike koji nemaju cirozu ili imaju Child-Pugh stadij A:
English: Population pharmacokinetic analysis indicated that race is not expected to influence obeticholic acid pharmacokinetics.
Croatian: Analiza populacijske farmakokinetike ukazuje da se ne očekuje da će rasa utjecati na farmakokinetiku obetikolatne kiseline.
English: • swelling in the hands and feet
Croatian: • oticanje šaka i stopala
English: 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").
Croatian: Ako uzimate smole koje vežu žučne kiseline, ovaj lijek uzmite najmanje 4 do 6 sati prije ili najmanje 4 do 6 sati nakon uzimanja smola koje vežu žučne kiseline (pogledajte dio „Drugi lijekovi i OCALIVA“).
English: Tell your doctor or pharmacist if you experience itching of the skin (pruritus) or if the itch gets worse while on this medicine.
Croatian: Recite svom liječniku ili ljekarniku ako se u Vas javi svrbež kože (pruritus) ili se svrbež pogoršava tijekom uzimanja ovog lijeka.
English: Obeticholic acid is conjugated with glycine or taurine in the liver and secreted into bile.
Croatian: Obetikolatna kiselina se konjugira s glicinom ili taurinom u jetri te se izlučuje u žuč.
English: No dose adjustment is required for patients with renal impairment (see section 5.2).
Croatian: Za bolesnike s oštećenjem bubrega nije potrebna prilagodba doze (vidjeti dio 5.2).
English: 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).
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja obetikolatnom kiselinom uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu (vidjeti dio 5.3).
English: - 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.
Croatian: - OCALIVA 10 mg žuta je, filmom obložena tableta, trokutastog oblika s utisnutim „INT“ s jedne strane i „10“ s druge strane filmom obložene tablete.
English: 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.
Croatian: Nemojte prestati uzimati lijek bez savjetovanja s liječnikom.
English: Abdominal pain and discomfort
Croatian: Poremećaji probavnog sustava bol i nelagoda u abdomenu konstipacija
English: In the post marketing setting, serious liver injury and death have been reported with more frequent dosing of obeticholic acid than recommended in patients with moderate to severe decreases in liver function.
Croatian: U periodu nakon stavljanja lijeka u promet kod učestalijeg doziranja obetikolatne kiseline nego što je preporučeno u bolesnika s umjereno do jako smanjenom jetrenom funkcijom zabilježeni su ozbiljno oštećenje jetre i smrtni ishod.
English: 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.
Croatian: c Bolesnici su randomizirani (1:1:1) kako bi primili lijek OCALIVA od 10 mg jedanput dnevno tijekom ukupnog trajanja ispitivanja od 12 mjeseci ili titriranu dozu lijeka OCALIVA (5 mg jedanput dnevno tijekom početnih 6 mjeseci, s opcijom povećanja na 10 mg jedanput dnevno tijekom zadnjih 6 mjeseci, ako je bolesnik podnosio lijek OCALIVA, ali je imao ALP 1,67 puta GGN ili veći i/ili ukupni bilirubin iznad GGN-a ili smanjenje ALP-a manje od 15 %) ili placebo. dSkupina u kojoj je titrirana doza lijeka OCALIVA i skupina koja je primala 10 mg lijeka OCALIVA naspram skupine na placebu.
English: The volume of distribution of obeticholic acid is 618 L. The volume of distributions of glyco- and tauro-obeticholic acid has not been determined.
Croatian: Volumen distribucije gliko- i tauro-obetikolatne kiseline nije utvrđen.
English: See table 1 for dose recommendations.
Croatian: Bolesnici s oštećenjem jetre Vidjeti tablicu 1 za preporučene doze.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva svrbež ekcem, osip
English: 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).
Croatian: Bolesnici koji uzimaju smole koje vežu žučne kiseline, obetikolatnu kiselinu trebaju uzimati najmanje 4 do 6 sati prije ili 4 do 6 sati poslije uzimanja smole koja veže žučne kiseline, ili u što je moguće većem intervalu (vidjeti dio 4.5).
English: 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.
Croatian: Ako uzimate bilo koji od tih lijekova, lijek OCALIVA uzmite najmanje 4 do 6 sati prije ili 4 do 6 poslije uzimanja smole koja veže žučne kiseline, u što je moguće većem razmaku.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION OCALIVA 5 mg film-coated tablets Each film-coated tablet contains 5 mg of obeticholic acid.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV OCALIVA 5 mg filmom obložene tablete Jedna filmom obložena tableta sadržava 5 mg obetikolatne kiseline.
English: EU/1/16/1139/004
Croatian: EU/1/16/1139/003 EU/1/16/1139/004
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/002 30 film-coated tablets EU/1/16/1139/004 100 film-coated tablets
Croatian: EU/1/16/1139/002 30 filmom obloženih tableta EU/1/16/1139/004 100 filmom obloženih tableta
English: OCALIVA 10 mg film-coated tablets
Croatian: OCALIVA 10 mg filmom obložene tablete
English: The impact of mild hepatic impairment (Child-Pugh Class A) on the pharmacokinetics of obeticholic acid was negligible, therefore, no dose adjustment is necessary for patients with mild hepatic impairment.
Croatian: Utjecaj blagog oštećenja jetre (Child-Pugh stadij A) na farmakokinetiku obetikolatne kiseline bio je zanemariv.
English: 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.
Croatian: Teški je svrbež prijavljen u 23 % bolesnika u skupini koja je primala lijek OCALIVA od 10 mg dnevno, u 19 % bolesnika u skupini u kojoj je titrirana doza lijeka OCALIVA te u 7 % bolesnika u skupini koja je primala placebo.
English: Components of primary endpointe
Croatian: Komponente primarnog ishodae
English: Poly(vinyl alcohol), partially hydrolysed (E1203) Titanium dioxide (E171)
Croatian: Ovojnica tablete poli(vinilni alkohol), djelomično hidroliziran (E1203) titanijev dioksid (E171) makrogol 3350 (E1521) talk (E553b) željezov oksid, žuti (E172)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1139/001 30 film-coated tablets EU/1/16/1139/003 100 film-coated tablets
Croatian: EU/1/16/1139/001 30 filmom obloženih tableta EU/1/16/1139/003 100 filmom obloženih tableta
English: Pharmacotherapeutic group: Bile and liver therapy, Bile acid preparations.
Croatian: Farmakoterapijska skupina: lijekovi za liječenje žuči i jetre, pripravci žučnih kiselina, ATK oznaka: A05AA04
English: 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.
Croatian: Kako OCALIVA izgleda i sadržaj pakiranja - OCALIVA 5 mg žuta je, okrugla, filmom obložena tableta s utisnutim „INT“ s jedne strane i
English: 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.
Croatian: Ako se istodobno primjenjuju smole koje vežu žučne kiseline, obetikolatnu kiselinu treba uzeti najmanje 4 do 6 sati prije ili 4 do 6 sati poslije uzimanja smole koja veže žučne kiseline ili u što je moguće većem intervalu.
English: Intercept Pharma International Ltd. Ormond Building 31 - 36 Ormond Quay Upper Dublin 7
Croatian: Ormond Building 31 - 36 Ormond Quay Upper Dublin 7
English: Liver related adverse events
Croatian: Nuspojave povezane s jetrom
English: 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.
Croatian: Medijan vremena do nastupa teškog svrbeža iznosio je 11 dana za bolesnike u skupini koja je primala lijek OCALIVA u dozi od 10 mg, 158 dana za skupinu u kojoj se titrirala doza lijeka OCALIVA te 75 dana za skupinu koja je primala placebo.
English: Intercept Pharma International Ltd. Ιρλανδία
Croatian: Intercept Pharma International Ltd.
English: Frequency of adverse reactions in PBC patients*
Croatian: Tablica 2. Učestalost nuspojava u bolesnika s PBC-om*
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja orofaringealna bol
English: OCALIVA 5 mg film-coated tablets Yellow, 8 mm round tablet debossed with ‘INT' on one side and ‘5' on the other side.
Croatian: Žuta, okrugla tableta promjera 8 mm s utisnutim „INT“ na jednoj strani i „5“ na drugoj strani.
English: Other medicines and OCALIVA
Croatian: Drugi lijekovi i OCALIVA
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA 10 mg
English: b In the trial there were 16 patients (7%) who were intolerant and did not receive concomitant UDCA: 6 patients
Croatian: b U ispitivanju je bilo 16 bolesnika (7 %) koji nisu podnosili i nisu istodobno primiliUDCA: 6 bolesnika (8 %) u skupini koja je primala lijek OCALIVA od 10 mg, 5 bolesnika (7 %) u skupini u kojoj je titrirana doza lijeka OCALIVA i 5 bolesnika (7 %) u skupini koja je primala placebo.
English: Intercept Pharma International Ltd. Ireland
Croatian: Intercept Pharma UK & Ireland Ltd.
English: OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets obeticholic acid
Croatian: OCALIVA 5 mg filmom obložene tablete OCALIVA 10 mg filmom obložene tablete obetikolatna kiselina
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE 5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU BOCA 5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 5 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 5 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 10 mg
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA 10 mg
English: OCALIVA 5 mg film-coated tablets: Each film-coated tablet contains 5 mg of obeticholic acid.
Croatian: OCALIVA 5 mg filmom obložene tablete: Jedna filmom obložena tableta sadržava 5 mg obetikolatne kiseline.
English: Severe pruritus
Croatian: Teški svrbež
English: NA
Croatian: A
English: Oedema peripheral, Pyrexia
Croatian: Opći poremećaji i reakcije na mjestu primjene umor periferni edem, pireksija
English: Tel: +39 0236026571
Croatian: Intercept Italia S.r.l. Tel: +39 0236026571
English: Starting Dosage
Croatian: Početna doza
English: OCALIVA 10 mg film-coated tablets: Each film-coated tablet contains 10 mg of obeticholic acid.
Croatian: OCALIVA 10 mg filmom obložene tablete: Jedna filmom obložena tableta sadržava 10 mg obetikolatne kiseline.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg of obeticholic acid.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadržava 5 mg obetikolatne kiseline.
English: B. PACKAGE LEAFLET
Croatian: Ιρλανδία
English: Maximum Dosage
Croatian: Makismalna doza
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 10 mg of obeticholic acid.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI Jedna filmom obložena tableta sadržava 10 mg obetikolatne kiseline.
English: OCALIVA 10 mg film-coated tablets Each film-coated tablet contains 10 mg of obeticholic acid.
Croatian: OCALIVA 10 mg filmom obložene tablete Jedna filmom obložena tableta sadržava 10 mg obetikolatne kiseline.
English: Oropharyngeal pain
Croatian: Prijavljivanje nuspojava
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets OCALIVA 10 mg film-coated tablets
Croatian: OCALIVA 5 mg filmom obložene tablete OCALIVA 10 mg filmom obložene tablete
English: Final report: 2020
Croatian: Završno izvješće:
English: Bile acid binding resins
Croatian: Smole koje vežu žučne kiseline
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 5 mg film-coated tablets obeticholic acid
Croatian: OCALIVA 5 mg filmom obložene tablete obetikolatna kiselina
English: • stomach pain
Croatian: • bol u trbuhu
English: NAME OF THE MEDICINAL PRODUCT OCALIVA 10 mg film-coated tablets obeticholic acid
Croatian: OCALIVA 10 mg filmom obložene tablete obetikolatna kiselina
English: These findings were maintained at 48 weeks.
Croatian: Ti su nalazi održani i nakon 48 tjedana.
English: Intelence (etravirine)
Croatian: Intelence (etravirin)
English: Further information on Intelence can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Više informacija o lijeku Intelence možete nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Intelence
Croatian: Ostale informacije o lijeku Intelence
English: Intelence is available as tablets (25, 100 and 200 mg) to be swallowed whole with a glass of water.
Croatian: Intelence je dostupan u obliku tableta (25, 100 i 200 mg) koje se gutaju cijele s čašom vode.
English: Intelence received a marketing authorisation valid throughout the EU on 28 August 2008.
Croatian: Lijek Intelence dobio je odobrenje za stavljanje u promet koje je na snazi u Europskoj uniji od 28. kolovoza 2008.
English: 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.
Croatian: U odraslih je preporučena doza lijeka Intelence 200 mg dvaput dnevno nakon obroka, dok u djece doza ovisi o tjelesnoj težini i kreće se od 100 mg dvaput dnevno do 200 mg dvaput dnevno.
English: Patients who cannot swallow can disperse the tablets in a glass of water and then drink the solution immediately.
Croatian: Bolesnici koji ne mogu progutati tabletu mogu je otopiti u čaši vode i odmah popiti tu otopinu.
English: The European Medicines Agency therefore decided that its benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove stoga je zaključila da njegove koristi nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u Europskoj uniji.
English: What measures are being taken to ensure the safe and effective use of Intelence?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Intelence?
English: What is Intelence and what is it used for?
Croatian: Što je Intelence i za što se koristi?
English: HIV-1 is a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: HIV-1 je virus koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: Intelence is a medicine for treating human immunodeficiency virus type 1 (HIV-1) in adults and children from 6 years of age.
Croatian: Intelence je lijek za liječenje virusa humane imunodeficijencije 1 (HIV-1) u odraslih i djece u dobi od 6 godina.
English: An overview of Intelence and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Intelence i zašto je odobren u EU-u
English: The active substance in Intelence, etravirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Croatian: Djelatna tvar lijeka Intelence, etravirin, jest nenukleozidni inhibitor povratne transkriptaze (NNRTI).
English: The most common side effects with Intelence (which may affect more than 1 in 10 people) are rash, diarrhoea, nausea (feeling sick) and headache.
Croatian: Najčešće nuspojave lijeka Intelence (koje se mogu javiti u više od 1 na 10 osoba) jesu osip, proljev, mučnina (slabost) i glavobolja.
English: Intelence (etravirine) EMA/440123/2019
Croatian: Intelence (etravirin) EMA/514667/2018
English: Side effects reported with Intelence are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Intelence pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: What are the risks associated with Intelence?
Croatian: Koji su rizici povezani s lijekom Intelence?
English: 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.
Croatian: Lijekom Intelence ne liječi se infekcija HIV-om ni AIDS, no njegovom primjenom može se odgoditi narušavanje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: Why is Intelence authorised in the EU?
Croatian: Zašto je lijek Intelence odobren u EU-u?
English: 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.
Croatian: Preporuke i mjere opreza kojih se zdravstveni djelatnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Intelence nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: As for all medicines, data on the use of Intelence are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Intelence kontinuirano se prate.
English: 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.
Croatian: U glavnom ispitivanju u kojem je sudjelovalo 101 dijete u dobi od 6 do 17 godina približno polovica ispitanika imala je nemjerljive razine HIV-a 24 tjedna nakon uzimanja lijeka Intelence u kombinaciji s drugim lijekovima, a udio djece s nemjerljivim razinama HIV-a neznatno se povećao nakon 48 tjedana.
English: Studies have shown that Intelence, in combination with other medicines, is effective at reducing the level of HIV in the blood (viral load) to undetectable levels (below 50 copies/ml) in many patients with HIV-1 infection.
Croatian: Ispitivanja su pokazala da Intelence u kombinaciji s drugim lijekovima djelotvorno smanjuje razinu HIV-a u krvi (virusno opterećenje) na nemjerljivu razinu (ispod 50 jedinica/ml) u mnogih bolesnika s infekcijom HIV-1.
English: 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'.
Croatian: Intelence se primjenjuje samo u bolesnika koji su već primali liječenje za infekciju HIV-om te se mora koristiti zajedno s drugim lijekovima za HIV koji sadrže „pojačan inhibitor proteaze”.
English: 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.
Croatian: U dvama glavnim ispitivanjima u kojima je sudjelovalo 1203 odraslih ispitanika prosječno virusno opterećenje iznosilo je 70 000 jedinica/ml na početku liječenja.
English: After 24 weeks, 59% of the patients taking Intelence together with other HIV medicines had undetectable levels of HIV, compared with 41% of those taking placebo (a dummy treatment) plus the other HIV medicines.
Croatian: Nakon 24 tjedna, 59 % bolesnika koji su uzimali lijek Intelence u kombinaciji s drugim lijekovima protiv HIV-a imalo je nemjerljive razine HIV-a, u usporedbi s 41 % ispitanika koji su uzimali placebo (prividno liječenje) i druge lijekove protiv HIV--a.
English: How does Intelence work?
Croatian: Kako djeluje Intelence?
English: Intelence is effective at reducing viral load to undetectable levels in both adults and children and its side effects are considered manageable.
Croatian: Intelence je djelotvoran za smanjenje virusnog opterećenja na nemjerljive razine u odraslih i djece, a njegovim se nuspojavama može lako upravljati.