FrancophonIA/ELRC3.0 huggingface dataset:
English: No studies were conducted to evaluate daclizumab beta pharmacokinetics in patients with renal or hepatic impairment.
Croatian: Nisu provedena ispitivanja za procjenu farmakokinetike daklizumaba beta u bolesnika s oštećenjem bubrega ili jetre.
English: Within the studied regimens of daclizumab beta 150 mg and 300 mg administered subcutaneous every 4 weeks in MS patients, there was no clear relationship between daclizumab beta exposure and clinical efficacy endpoints (ARR, T2 lesions and Gd-enhancing lesions) or safety endpoints of interest (serious infection status, moderate or severe cutaneous adverse reaction, and AST/ALT > 5 times the ULN).
Croatian: Unutar ispitivanih režima daklizumaba beta od 150 mg i 300 mg primijenjenih supkutano svaka 4 tjedna u bolesnika s MS-om, nije bilo jasnog odnosa između izloženosti daklizumabu beta i ishoda kliničke djelotvornosti (godišnje stope relapsa, lezije na T2-mjerenoj snimci i lezije imbibirane gadolinijem) ili ishoda sigurnosti od interesa (stanje ozbiljne infekcije, umjerene ili teške kožne nuspojave, i AST/ALT > 5 puta GGN).
English: • your skin or the whites of your eyes turn yellow
Croatian: • da su Vaša koža ili bjeloočnice požutjele
English: The causal relationship between daclizumab beta and sarcoidosis is considered possible.
Croatian: Uzročna povezanost između daklizumaba beta i sarkoidoze smatra se mogućom.
English: Sodium succinate, succinic acid, sodium chloride, polysorbate 80, water for injections
Croatian: Natrijev sukcinat, sukcinatna kiselina, natrijev klorid, polisorbat 80, voda za injekcije
English: • the pen has been dropped or is visibly damaged.
Croatian: • je brizgalica pala ili je vidljivo oštećena.
English: • the solution is any other colour than colourless to slightly yellow
Croatian: • je otopina bilo koje druge boje osim bezbojne do blago žute
English: Daclizumab beta is not expected to undergo renal elimination or metabolism by hepatic enzymes (see section 4.2).
Croatian: Ne očekuje se da se daklizumab beta eliminira putem bubrega ili metabolizira jetrenim enzimima (vidjeti dio 4.2).
English: Let your injection site dry on its own before injecting your dose.
Croatian: Pustite da se mjesto injiciranja samo osuši prije injiciranja doze.
English: The exact metabolic pathway for daclizumab beta has not been characterised.
Croatian: Točan metabolički put daklizumaba beta nije razjašnjen.
English: The active substance in Zinbryta is daclizumab beta.
Croatian: Djelatna tvar Zinbryte je daklizumab beta.
English: Daclizumab beta is not expected to undergo metabolism by hepatic enzymes such as CYP isoenzymes (see section 4.5).
Croatian: Ne očekuje se da se daklizumab beta metabolizira jetrenim enzimima kao što su CYP izoenzimi (vidjeti dio 4.5).
English: Cumulatively, 24 cases of colitis have been retrieved from clinical trials.
Croatian: U kliničkim ispitivanjima kumulativno su zabilježena 24 slučaja kolitisa.
English: There is also a plausible mechanism of action for the development of sarcoidosis due to the immunomodulatory effects of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Croatian: Vjerojatan mehanizam djelovanja za razvoj sarkoidoze postoji i zbog imunomodulirajućih učinaka daklizumaba beta i uključenosti daklizumaba beta u nastanak drugih imunološki posredovanih događaja.
English: • Check that the Zinbryta medicine is colourless or slightly yellow (See Figure syringe if the liquid is cloudy, or has
Croatian: • Provjerite da je lijek Zinbryta bezbojan ili blago žut (vidjeti sliku E).
English: • The importance of detecting signs and symptoms which might indicate hepatic injury, and if any of these occur, to promptly contact their physician;
Croatian: • navesti važnost otkrivanja znakova i simptoma koji mogu ukazivati na oštećenje jetre, i ako se bilo što od toga pojavi, odmah se obratiti liječniku • podatke o bolesniku, potpis i datum
English: Following subcutaneous administration of daclizumab beta 150 mg every 4 weeks, steady-state serum daclizumab beta concentrations were achieved by the 4th dose and daclizumab beta accumulated to a level approximately 2.5-fold compared to a single dose.
Croatian: Nakon supkutane primjene daklizumaba beta od 150 mg svaka 4 tjedna, koncentracije daklizumaba beta u serumu u stanju dinamičke ravnoteže postignute su do 4. doze te se daklizumab beta akumulirao do razine približno 2,5 puta veće u usporedbi s jednom dozom.
English: Step 8: Disposing of the used Zinbryta Pre-filled Syringe
Croatian: 9. korak: Odlaganje iskorištenih Zinbryta brizgalica
English: There is a plausible mechanism of action for the development of this colitis due to immunomodulatory properties of daclizumab beta and involvement of daclizumab beta in the origin of other immune-mediated events.
Croatian: Za razvoj tog kolitisa postoji vjerojatan mehanizam djelovanja zbog imunomodulirajućih svojstava daklizumaba beta i uključenosti daklizumaba beta u nastanak drugih imunološki posredovanih događaja.
English: In the DECIDE study subgroup analysis, there was a statistically significant reduction observed compared to interferon beta-1a (intramuscular) on ARR and the number of new or newly enlarging T2 hyperintense lesions across subgroups (gender, age, prior MS DMT therapy, and disease activity levels).
Croatian: postojalo je statistički značajno smanjenje u usporedbi s interferonom beta-1a (intramuskularno) za godišnju stopu relapsa i broj novih ili novoprogredirajućih hiperintenzivnih lezija na T2-mjerenoj snimci za sve podskupine (spol, dob, prethodno liječenje MS-a terapijom koja modificira tijek bolesti i razine aktivnosti bolesti).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for daclizumab beta, the scientific conclusions of CHMP are as follows:
Croatian: (PSUR) za daklizumab beta, znanstveni zaključci CHMP-a su sljedeći: Sarkoidoza
English: At steady state, daclizumab beta mean maximum serum concentration (Cmax), minimum serum concentration (Cmin) and area under the serum concentration-time curve over the dosing interval (AUCtau) values were approximately 30 micrograms/mL, 15 micrograms/mL and 640 day*micrograms/mL, respectively, with inter-patient variability (% CV) of approximately 40%.
Croatian: U stanju dinamičke ravnoteže, srednja maksimalna koncentracija daklizumaba beta u serumu (Cmax) iznosila je približno 30 mikrograma/ml, minimalna koncentracija u serumu (Cmin) iznosila je približno 15 mikrograma/ml, a površina ispod krivulje ovisnosti serumske koncentracije o vremenu tijekom intervala doziranja (AUCtau) približno
English: Elimination As an IgG1 monoclonal antibody, daclizumab beta is not expected to undergo renal elimination.
Croatian: Budući da je IgG1 monoklonsko protutijelo, za daklizumab beta se ne očekuje eliminacija putem bubrega.
English: Carcinogenicity studies with daclizumab beta have not been conducted.
Croatian: Kancerogeneza Nisu provedena ispitivanja kancerogenosti s daklizumabom beta.
English: The active substance is daclizumab beta.
Croatian: Djelatna tvar je daklizumab beta.
English: • If needed, Zinbryta may be stored in the closed original carton without refrigeration up to 30°C
Croatian: • Ako bude potrebno, Zinbryta se može čuvati u zatvorenoj originalnoj kutiji bez rashlađivanja na temperaturi do 30°C do 30 dana.
English: The causal relationship between daclizumab beta and colitis is possible.
Croatian: Uzročna povezanost između daklizumaba beta i kolitisa je moguća.
English: • However, if it is more than 2 weeks from your missed dose, skip the missed dose and take your
Croatian: • Međutim, ako je prošlo više od 2 tjedna od propuštene doze, preskočite propuštenu dozu i primijenite sljedeću dozu na Vaš uobičajen dan.
English: • The liquid is cloudy or contains floating
Croatian: • tekućina je zamućena ili sadrži
English: These symptoms may suggest problems with your liver.
Croatian: • tamnu (boje čaja) mokraću Ovi simptomi mogu ukazivati na probleme s jetrom.
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL Each pre-filled pen contains 150 mg of daclizumab beta in 1 mL
Croatian: Jedna napunjena štrcaljka sadrži 150 mg daklizumaba beta u 1 ml Jedna napunjena brizgalica sadrži 150 mg daklizumaba beta u 1 ml
English: Events - CTCAE] Grade 2; at least one measurement) occurred in 4% of placebo-treated and 5% of Zinbryta-treated patients in the SELECT study, and 9% of the interferon beta-1a (intramuscular)-treated and 8% of Zinbryta-treated patients in the DECIDE study.
Croatian: Ukupni broj limfocita <0,8x109 stanica/L ([Zajednički kriteriji terminologije za nuspojave (Common Terminology Criteria for Adverse EventsCTCAE)] 2. stupnja; pri najmanje jednom mjerenju) zabilježen je u 4% bolesnika kojima je davan placebo i 5% bolesnika liječenih Zinbrytom u ispitivanju SELECT te u 9% bolesnika liječenih interferonom beta-1a (intramuskularno) i 8% bolesnika liječenih Zinbrytom u ispitivanju DECIDE.
English: Inflammation of the bowel (colitis): (Common - may affect up to 1 in 10 people)
Croatian: Upala crijeva (kolitis): (Često - mogu se javiti u manje od 1 na 10 osoba)
English: • dark (tea-coloured) urine
Croatian: • tamna (boje čaja) mokraća
English: • If you see blood at your injection site, wipe it off with the gauze pad and apply an
Croatian: • Ako vidite krv na mjestu injiciranja,
English: Section 4.8 of the SmPC has been reviewed to add the adverse reaction sarcoidosis with a frequency uncommon and the adverse reaction colitis with a frequency common.
Croatian: Dio 4.8 sažetka opisa svojstava lijeka izmijenjen je tako da je dodana nuspojava sarkoidoze s učestalošću „manje često“ te nuspojava kolitisa s učestalošću „često“.
English: Sarcoidosis
Croatian: Sarkoidoza
English: Choose an injection site and wipe the skin
Croatian: Odaberite mjesto za injiciranje i obrišite kožu vatom natopljenom alkoholom.
English: Do not re-cap the pen.
Croatian: Nemojte povlačiti klip natrag.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zinbryta 150 mg injection daclizumab beta
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Zinbryta 150 mg injekcija daklizumab beta s.c.
English: Do not touch or blow on this area again
Croatian: Nemojte ponovno dirati ili puhati na to područje prije davanja injekcije.
English: How to inject Zinbryta
Croatian: Kako primjenjivati Zinbrytu
English: Quickly insert the needle straight into the skin fold until the needle is fully
Croatian: Brzo ubodite iglu ravno u nabor kože tako da je igla potpuno pod kožom (vidjeti sliku I).
English: Daclizumab beta has not been studied in patients with hepatic impairment.
Croatian: Daklizumab beta nije ispitivan u bolesnika s oštećenjem jetre.
English: • Prior to treatment (re)start, confirmation of: o A discussion between the physician and the patient about the risk of serious and potentially fatal hepatic injury and the unpredictable nature of such reactions and about the possibility of having to switch treatment in case of levels of ALT or o Patient understanding of the risk information provided; o Receipt of a copy of the acknowledgement form;
Croatian: o da je liječnik upoznao bolesnika s rizikom od ozbiljnog i potencijalno smrtonosnog oštećenja jetre i o nepredvidljivosti takvih reakcija te o mogućoj potrebi promjene liječenja u slučaju da vrijednosti ALT-a ili AST-a budu > 3 puta GGN
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Jedna napunjena štrcaljka sadrži 150 mg daklizumaba beta u 1 ml otopine za injekciju.
English: Autoimmune haemolytic anaemia was reported in < 1% of patients treated with Zinbryta in clinical studies.
Croatian: Autoimuna hemolitična anemija Autoimuna hemolitična anemija zabilježena je u kliničkim ispitivanjima u < 1% bolesnika liječenih
English: Choose an injection site in your thigh, abdomen, or the back of your upper arm (See
Croatian: Odaberite mjesto za injiciranje na bedru, trbuhu ili stražnjoj strani nadlaktice (vidjeti označena područja na slici D).
English: Infections, some serious (e.g. pneumonia and bronchitis), have been reported with Zinbryta.
Croatian: Infekcije Pri liječenju Zinbrytom prijavljene su infekcije od kojih su neke ozbiljne (npr. upala pluća i bronhitis).
English: Table 2.
Croatian: Pogledajte dio 4.
English: Daclizumab beta has not been studied in patients with renal impairment.
Croatian: Daklizumab beta nije ispitivan u bolesnika s oštećenjem bubrega.
English: and C. If your blood test shows that you have some liver problems, your doctor will decide
Croatian: Ako razvijete probleme s jetrom, liječnik koji
English: Green Stripes Visible
Croatian: Trebali biste vidjeti zelene trake.
English: Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Croatian: Zinbryta 150 mg otopina za injekciju u napunjenoj štrcaljki Zinbryta 150 mg otopina za injekciju u napunjenoj brizgalici daklizumab beta
English: There was limited exposure in patients over 55 years of age in clinical studies with daclizumab beta.
Croatian: U kliničkim ispitivanjima s daklizumabom beta bila je ograničena izloženost u bolesnika starijih od
English: Each pre-filled pen contains a pre-filled syringe, containing 150 mg of daclizumab beta in 1 mL solution for injection.
Croatian: Jedna napunjena brizgalica sadrži napunjenu štrcaljku koja sadrži 150 mg daklizumaba beta u 1 ml otopine za injekciju.
English: SCIENTIFIC CONCLUSIONS AND GROUNDS FOR THE VARIATION TO THE TERMS
Croatian: I RAZLOZI ZA IZMJENU UVJETA ODOBRENJA
English: In patients with neutralising antibodies, daclizumab beta clearance was increased on average by 19% (see section 5.2).
Croatian: U bolesnika s neutralizirajućim protutijelima, klirens daklizumaba beta bio je povišen u prosjeku za
English: You will hear the
Croatian: I DOHVATA DJECE
English: Each pre-filled syringe contains 150 mg of daclizumab beta in 1 mL solution for injection.
Croatian: Jedna napunjena brizgalica sadrži 150 mg daklizumaba beta u 1 ml otopine za injekciju.
English: NAME OF THE MEDICINAL PRODUCT Zinbryta 150 mg solution for injection in pre-filled syringe Zinbryta 150 mg solution for injection in pre-filled pen daclizumab beta
Croatian: Uputa o lijeku: Informacije za korisnika Zinbryta 150 mg otopina za injekciju u napunjenoj štrcaljki Zinbryta 150 mg otopina za injekciju u napunjenoj brizgalici daklizumab beta
English: You may be tested for TB before starting Zinbryta
Croatian: Možda ćete se morati testirati na tuberkulozu prije početka liječenja Zinbrytom i biti praćeni tijekom liječenja.
English: • gauze pad
Croatian: • bljedilo
English: physical score (≥7.5 point)
Croatian: 19% (vidjeti dio 5.2).
English: Solution for injection
Croatian: Otopina za injekciju.
English: Bandage
Croatian: Flaster
English: • adhesive bandage or plaster
Croatian: • pojava žutila kože ili bjeloočnica
English: Pad
Croatian: Kolitis
English: SC
Croatian: ZA
English: The recommended dose of Atripla is one tablet once a day.
Croatian: Preporučena doza lijeka Atripla je jedna tableta jednom dnevno.
English: What is Atripla and what is it used for?
Croatian: Što je Atripla i za što se koristi?
English: Atripla keeps the amount of HIV in the blood at a low level.
Croatian: Atripla održava količinu HIV-a u krvi na niskoj razini.
English: Further information on Atripla can be found on the Agency's website ema.europa.eu/en/medicines/human/EPAR/Atripla.
Croatian: Više informacija o lijeku Atripla nalazi se na internetskim stranicama Agencije ema.europa.eu/en/medicines/human/EPAR/Atripla.
English: Other information about Atripla
Croatian: Ostale informacije o lijeku Atripla
English: After 48 weeks, 89% of the patients taking Atripla (181 out of 203) and 88% of those remaining on previous treatment (85 out of 97) had viral loads below 200 copies/ml.
Croatian: Nakon 48 tjedana u 89 % bolesnika koji su uzimali lijek Atripla (181 od 203) i 88 % bolesnika koji su ostali na prijašnjoj terapiji (85 od 97) virusna opterećenja iznosila su manje od 200 kopija/ml.
English: Patients should take the medicine regularly and not miss doses.
Croatian: Bolesnici trebaju redovito uzimati lijek i ne smiju preskakati doze.
English: • certain medicines whose breakdown is blocked or accelerated by Atripla;
Croatian: • određene lijekove kojima Atripla blokira ili ubrzava razgradnju
English: • medicines that cause QT prolongation;
Croatian: • lijekove koji uzrokuju produljenje QT intervala
English: • voriconazole (used to treat fungal infections).
Croatian: • vorikonazol (upotrebljava se za liječenje gljivičnih infekcija).
English: Atripla must also not be used in patients who are taking any of the following:
Croatian: Atripla se također ne smije primjenjivati u bolesnika koji uzimaju nešto od sljedećeg:
English: Side effects reported with Atripla are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Atripla pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: It does not cure HIV infection or AIDS, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.
Croatian: Lijek ne liječi infekciju HIV-om ili AIDS, ali privremeno zaustavlja narušavanje imunosnog sustava i razvoj infekcija i bolesti povezanih s AIDS-om.
English: Atripla received a marketing authorisation valid throughout the EU on 13 December 2007.
Croatian: Lijek Atripla dobio je odobrenje za stavljanje lijeka u promet koje je na snazi u Europskoj uniji od 13. prosinca 2007.
English: Atripla (efavirenz / emtricitabine / tenofovir disoproxil)
Croatian: Atripla (efavirenz / emtricitabin / tenofovirdizoproksil)
English: All three active substances block the activity of reverse transcriptase, an enzyme produced by HIV that allows the virus to infect cells and make more viruses.
Croatian: Sve tri djelatne tvari blokiraju djelovanje reverzne transkriptaze, enzima koji HIV stvara, a koji virusu omogućuje da zarazi stanice i stvori veći broj virusa.
English: Why is Atripla authorised in the EU?
Croatian: Zašto je lijek Atripla odobren u EU-u?
English: The main study of Atripla included 300 patients whose HIV infection was already being successfully treated with various combinations of antiviral medicines.
Croatian: Glavno ispitivanje lijeka Atripla uključivalo je 300 bolesnika u kojih se infekcija HIV-om već uspješno liječila različitim kombinacijama antivirusnih lijekova.
English: In the European Union (EU), efavirenz has been approved since 1999, emtricitabine has been approved since 2003, and tenofovir disoproxil has been approved since 2002.
Croatian: U Europskoj Uniji (EU) efavirenz je odobren od 1999., emtricitabin od 2003., a tenofovirdizoproksil od
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Atripla have also been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Atripla nalaze se također u sažetku opisa svojstava i u uputi o lijeku.
English: What are the risks associated with Atripla?
Croatian: Koji su rizici povezani s lijekom Atripla?
English: An overview of Atripla and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Atripla i zašto je odobren u EU-u
English: The European Medicines Agency noted that Atripla needs to be taken on an empty stomach to prevent certain side effects of one of its components, efavirenz.
Croatian: Europska agencija za lijekove napominje da lijek Atripla treba uzimati na prazan želudac kako bi se spriječile određene nuspojave jedne od njegovih komponenti, efavirenza.
English: What measures are being taken to ensure the safe use of Atripla?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna primjena lijeka Atripla?
English: Because taking the medicine on an empty stomach could result in the component tenofovir being less effective, the Agency could not recommend Atripla for general use in patients with HIV and with high viral loads.
Croatian: Budući da zbog uzimanja lijeka na prazan želudac može doći do smanjene učinkovitosti komponente tenofovira, Agencija ne može preporučiti lijek Atripla za opću primjenu u bolesnika s HIV-om i s visokim virusnim opterećenjem.
English: The company that markets Atripla will ensure that all doctors expected to prescribe the medicine are provided with an educational pack that includes information on the increased risk of kidney disease with medicines containing tenofovir disoproxil such as Atripla.
Croatian: Tvrtka koja stavlja lijek Atripla u promet osigurat će da svi liječnici od kojih se očekuje da će propisivati lijek prime edukacijski paket koji obuhvaća informacije o povećanom riziku od bolesti bubrega kod primjene lijekova koji sadrže tenofovirdizoproksil, kao što je Atripla.
English: It must not be used in patients in whom previous HIV treatment combinations have not worked or have stopped working.
Croatian: Lijek se ne smije primjenjivati u bolesnika u kojih prethodne kombinirane terapije za liječenje HIV-a nisu djelovale ili su prestale djelovati.
English: Atripla must not be used in patients with severe liver disease and patients with a family member who has had QT prolongation (an alteration of the electrical activity of the heart) or has died unexpectedly.
Croatian: Atripla se ne smije primjenjivati u bolesnika s teškom bolešću jetre i u bolesnika čiji je član obitelji imao produljenje QT intervala (promjena električne aktivnosti srca) ili je neočekivano preminuo.
English: The most common side effects with Atripla (which may affect more than 1 patient in 10) are dizziness, headache, diarrhoea, nausea (feeling sick), vomiting, rash, asthenia (weakness), hypophosphataemia (low blood levels of phosphates) and elevated levels of creatine kinase (an enzyme found in muscles).
Croatian: Najčešće nuspojave lijeka Atripla (koje se mogu pojaviti u više od 1 na 10 bolesnika) jesu omaglica, glavobolja, proljev, mučnina, povraćanje, osip, astenija (slabost), hipofosfatemija (niske razine fosfata u krvi) i povišene razine kreatin kinaze (enzim koji se nalazi u mišićima).
English: Atripla is an antiviral medicine used to treat adults infected with human immunodeficiency virus-1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Croatian: Atripla je antivirusni lijek koji se primjenjuje za liječenje bolesnika zaraženih virusom humane imunodeficijencije tipa 1 (HIV-1), virusom koji uzrokuje sindrom stečene imunodeficijencije (AIDS).
English: The three active substances in Atripla are: efavirenz (600 mg), emtricitabine (200 mg) and tenofovir disoproxil (245 mg).
Croatian: Tri djelatne tvari lijeka Atripla jesu: efavirenz (600 mg), emtricitabin (200 mg) i tenofovirdizoproksil (245 mg).
English: Another study, which looked at how the combined tablet was absorbed in the body, showed that the combination tablet was absorbed in the same way as the separate medicines, when they were taken on an empty stomach.
Croatian: Drugo ispitivanje u kojem se ispitivalo kako se kombinirane tablete apsorbiraju u tijelu, pokazalo je da se kombinirana tableta, kada je uzeta na prazan želudac, apsorbira na jednaki način kao i svaki od tih lijekova zasebno.
English: As for all medicines, data on the use of Atripla are continuously monitored.
Croatian: Kao za sve lijekove, podatci o primjeni lijeka Atripla kontinuirano se prate.
English: For more information about using Atripla, see the package leaflet or contact a doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Atripla pročitajte u uputi o lijeku, odnosno obratite se liječniku ili ljekarniku.
English: It is recommended that Atripla is taken on an empty stomach, preferably at bedtime.
Croatian: Preporučuje se da se lijek Atripla uzima na prazan želudac, po mogućnosti prije spavanja.