FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH must agree the content and format of the medical educational pack with the national competent authority in each Member State prior to its distribution in their territory.
Croatian: Nositelj odobrenja mora se složiti sa sadržajem i formatom medicinskog edukacijskog paketa s nacionalnim kompetentnim tijelima u svakoj državi članici prije distribucije materijala na njihovom teritoriju.
English: ATC code: J05AR09
Croatian: ATK oznaka: J05AR09
English: Stopping Stribild can seriously affect your response to future treatment.
Croatian: Prestanak uzimanja Stribilda može ozbiljno utjecati na Vaš odgovor na buduće liječenje.
English: These are mentioned above under the heading “Do not take Stribild - If you are taking one of these medicines”.
Croatian: Ti su lijekovi navedeni pod naslovom „Nemojte uzimati Stribild - ako uzimate jedan od sljedećih lijekova“.
English: Pregnant women should not take Stribild.
Croatian: Trudnice ne smiju uzimati Stridbild.
English: Your doctor will carefully consider whether to treat you with Stribild.
Croatian: Vaš će liječnik pažljivo razmotriti hoće li Vas liječiti Stribildom.
English: b Week 144 window is between Day 967 and 1,050 (inclusive).
Croatian: b Okvir 144. tjedna je između 967. i 1050. dana (uključujući).
English: Talk to your doctor before taking Stribild:
Croatian: Obratite se svom liječniku prije nego uzmete Stribild:
English: Date of first authorisation: 24 May 2013 Date of latest renewal: 19 April 2018
Croatian: Datum posljednje obnove odobrenja: 19. travanj 2018.
English: EU/1/13/830/001 EU/1/13/830/002
Croatian: EU/1/13/830/002
English: As a result, the amounts of Stribild or other medicines in your blood may be affected.
Croatian: Kao rezultat, količine Stribilda ili drugih lijekova u Vašoj krvi mogu biti promijenjene.
English: What Stribild looks like and contents of the pack
Croatian: Kako Stribild izgleda i sadržaj pakiranja
English: The long-term effects of substantial increases in progestogen exposure are unknown.
Croatian: Dugoročni učinci značajnih povećanja izloženosti progestagenu nisu poznati.
English: BMD Z-scores were not adjusted for height and weight.
Croatian: Z-vrijednost BMD-a nije bila prilagođena za tjelesnu visinu i težinu.
English: • contraceptive pill, used to prevent pregnancy
Croatian: • kontracepcijske pilule, primjenjuju se za sprječavanje trudnoće
English: AUC: ↑
Croatian: Drospirenon: AUC: ↑
English: Table 1: Interactions between the individual components of Stribild and other medicinal products
Croatian: Tablica 1: Interakcije između pojedinih komponenti Stribilda i drugih lijekova
English: When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Stribild or by other medicines that you are taking at the same time, or by the HIV disease itself.
Croatian: Kad se liječi HIV-infekcija, nije uvijek moguće odrediti jesu li neki od neželjenih učinaka prouzrokovani Stribildom ili drugim lijekovima koje istodobno uzimate, ili samom HIV-bolešću.
English: It's important not to stop taking Stribild without talking to your doctor: see section 3, Do not stop taking Stribild.
Croatian: Važno je da ne prestanete uzimati Stribild bez prethodnog razgovora sa svojim liječnikom: pogledajte dio 3, Nemojte prestati uzimati Stribild.
English: If appropriate, initiation of hepatitis B therapy may be warranted.
Croatian: Ukoliko je prikladno, početak terapije za hepatitis B može biti opravdan.
English: • low white blood cell count (which can make you more prone to infection)
Croatian: • nizak broj bijelih krvnih stanica (što Vas može činiti sklonijim infekcijama)
English: Demographic characteristics
Croatian: Demografske značajke
English: Adults and adolescents aged 12 years and older weighing at least 35 kg: One tablet, once daily with food.
Croatian: Odrasli i adolescenti u dobi od 12 godina i više, težine najmanje 35 kg: jedna tableta, jedanput na dan s hranom.
English: Tell your doctor or pharmacist if you are taking any other medicines or have recently taken any.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate bilo koje druge lijekove ili ste ih nedavno uzeli.
English: Other effects in children
Croatian: Druge nuspojave u djece
English: For both studies at 48 weeks, the virologic response rate was evaluated in both treatment arms.
Croatian: Za oba ispitivanja u trajanju od 48 tjedana stopa virološkog odgovora procijenjena je u obje skupine liječenja.
English: Stribild should be taken orally, once daily with food (see section 5.2).
Croatian: Stribild se mora uzimati peroralno, jedanput na dan, s hranom (vidjeti dio 5.2).
English: Insufficient safety data are available for children below 12 years of age.
Croatian: Nema dovoljno dostupnih podataka o sigurnosti primjene u djece mlađe od 12 godina.
English: If you are older than this and are prescribed Stribild, your doctor will monitor you carefully.
Croatian: Ako ste stariji od 65 godina, a propisali su Vam Stribild, liječnik će Vas pažljivo nadzirati.
English: Stribild is not to be given with other antiretroviral medicinal products.
Croatian: Stribild se ne smije davati s drugim antiretrovirusnim lijekovima.
English: What Stribild is and what it is used for What you need to know before you take Stribild How to take Stribild
Croatian: Što se nalazi u ovoj uputi Što je Stribild i za što se koristi Što morate znati prije nego počnete uzimati Stribild Kako uzimati Stribild
English: 4 Study conducted using Stribild.
Croatian: 4 Ispitivanje provedeno pomoću Stribilda.
English: Do not stop taking Stribild
Croatian: Nemojte prestati uzimati Stribild
English: Stribild may affect your kidneys.
Croatian: Stribild može utjecati na Vaše bubrege.
English: In some cases, your doctor may need to adjust your dose or check your blood levels.
Croatian: U nekim će Vam slučajevima, liječnik trebati prilagoditi dozu ili provjeriti razine u krvi.
English: While taking Stribild you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate Stribild i dalje možete razvijati infekcije ili druge bolesti povezane s HIV-infekcijom.
English: Stribild reduces the amount of HIV in your body.
Croatian: Stribild smanjuje količinu HIV-a u Vašem tijelu.
English: Stribild may interact with other medicines.
Croatian: Stribild može ući u interakciju s drugim lijekovima.
English: Stribild has no or negligible influence on the ability to drive and use machines.
Croatian: Stribild ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: INR should continue to be monitored during the first weeks following ceasing treatment with Stribild.
Croatian: INR se mora nastaviti pratiti i tijekom prvih tjedana nakon prekida liječenja Stribildom.
English: • lactic acidosis (see Possible serious side effects: tell a doctor immediately)
Croatian: • laktacidoza (pogledajte Moguće ozbiljne nuspojave: odmah obavijestite liječnika)
English: Stribild is a single tablet regimen for the treatment of human immunodeficiency virus (HIV) infection in adults.
Croatian: Stribild je režim s jednom tabletom za liječenje infekcije virusom humane imunodeficijencije (HIV) u odraslih.
English: • difficulty sleeping (insomnia), abnormal dreams
Croatian: • poteškoće sa spavanjem (nesanica), abnormalni snovi
English: Stribild is not usually taken with other medicines that can damage your kidneys (see Other medicines and Stribild).
Croatian: Stribild se obično ne uzima s drugim lijekovima koji Vam mogu oštetiti bubrege (pogledajte Drugi lijekovi i Stribild).
English: Therefore, a multidisciplinary approach is recommended to adequately weigh on a case by case basis the benefit/risk balance of treatment, decide the appropriate monitoring during treatment (including decision for treatment withdrawal) and consider the need for supplementation.
Croatian: Stoga se preporučuje višedisciplinarni pristup kako bi se od slučaja do slučaja odgovarajuće procijenio omjer koristi i rizika od liječenja, odredio način praćenja tijekom liječenja (uključujući i odluku o prekidu liječenja) i razmotrila potreba za suplementima.
English: Expected
Croatian: Očekivano
English: If you have HIV infection and hepatitis B, it is especially important not to stop your Stribild treatment without talking to your doctor first.
Croatian: Ako imate HIV-infekciju i hepatitis B, naročito je važno da se ne prestanete liječiti Stribildom, a da prije toga niste razgovarali s liječnikom.
English: It is also important to tell your doctor if you are taking any of the following types of medicines:
Croatian: Također je važno obavijestiti liječnika ako uzimate bilo koji od sljedećih vrsta lijekova:
English: Interrupting treatment with Stribild should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja Stribildom također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok.
English: However increased postimplantation loss and decreased foetal weights were observed in rats associated with significant decreases in maternal body weights at 125 mg/kg/day.
Croatian: Međutim, povećani postimplantacijski gubitak i smanjene težine fetusa zabilježeni su u štakora povezanih sa značajnim smanjenjima u tjelesnoj težini majki od 125 mg/kg/dan.
English: e Includes subjects who discontinued for reasons other than an adverse event, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
Croatian: e Obuhvaća ispitanike s prekidom iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti, npr. povučeni pristanak, gubitak mogućnosti praćenja itd.
English: 6 Study conducted with additional voxilaprevir 100 mg to achieve voxilaprevir exposures expected in HCV-infected patients.
Croatian: 6 Ispitivanje provedeno s dodatnom dozom voksilaprevira od 100 mg kako bi se dosegle izloženosti voksilapreviru očekivane u bolesnika zaraženih HCV-om.
English: Stribild can cause dizziness, tiredness or insomnia.
Croatian: Stribild može uzrokovati omaglicu, umor i nesanicu.
English: • suicidal ideation and suicide attempt (in patients who have had depression or mental health problems before), depression
Croatian: • suicidalne ideje i pokušaj samoubojstva (u bolesnika koji su i ranije imali depresiju ili tegobe s mentalnim zdravljem), depresija
English: Lactic acidosis occurs more often in women - particularly if they are overweight and in people with liver disease.
Croatian: Laktacidoza nastaje češće u žena - osobito u onih s prekomjernom tjelesnom težinom i u osoba s bolešću jetre.
English: • One tablet each day by mouth, with food.
Croatian: • Progutajte jednu tabletu svaki dan s hranom.
English: INHALED BETA AGONIST Salmeterol
Croatian: INHALIRAJUĆI BETA-AGONISTI Salmeterol
English: • anaemia (low red blood cell count)
Croatian: • anemiju (nizak broj crvenih krvnih stanica)
English: Each tablet contains 10.9 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 10,9 mg laktoze (u obliku hidrata).
English: Stribild comes in bottles of 30 tablets (with a silica gel desiccant that must be kept in the bottle to help protect your tablets).
Croatian: Stribild dolazi u bocama od 30 tableta (sa sredstvom za sušenje od silika gela koje se mora čuvati u boci radi zaštite tableta).
English: If you have hepatitis B infection liver problems may become worse after you stop taking Stribild.
Croatian: Ako imate infekciju hepatitisom B, tegobe s jetrom mogu se pogoršati nakon što prestanete uzimati Stribild.
English: • constipation, wind (flatulence)
Croatian: • zatvor, vjetrovi (flatulencija)
English: • softening of the bones (with bone pain and sometimes resulting in fractures)
Croatian: • omekšavanje kostiju (uz bolove u kostima i ponekad posljedičnim prijelomom).
English: • If you stopped treatment with any medicine containing tenofovir disoproxil on the advice of your doctor following problems with your kidney function.
Croatian: • ako ste prekinuli liječenje s bilo kojim lijekom koji sadrži tenofovirdizoproksil prema savjetu liječnika koji prati probleme s funkcijom Vaših bubrega
English: Interactions between the components of Stribild and potential co-administered medicinal products are listed in Table 1 below (increase is indicated as “↑”, decrease as “↓”, no change as “↔”).
Croatian: Interakcije između komponenti Stribilda i potencijalno istodobno primijenjenih lijekova navedene su u sljedećoj Tablici 1 (povećanje je označeno kao „↑”, smanjenje kao „↓”, bez promjene kao „↔”).
English: If this is unavoidable, your doctor will monitor your kidney function more frequently.
Croatian: Ako se to ne može izbjeći, liječnik će češće pratiti funkciju Vaših bubrega.
English: Co-administration of tenofovir disoproxil and didanosine is not recommended as it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions.
Croatian: Ne preporučuje se istodobna primjena tenofovirdizoproksila i didanozina, jer rezultira 40-60%-tnim povećanjem sistemske izloženosti didanozinu što može povećati rizik od nuspojava povezanih s didanozinom.
English: No antagonism was observed for any of these combinations.
Croatian: Ni za jednu navedenu kombinaciju nisu zabilježeni antagonisti.
English: • increased levels of creatine kinase in the blood that may result in muscle pain and weakness
Croatian: • povišene razine kreatin kinaze u krvi, što može rezultirati mišićnim bolovima i slabošću.
English: It is important not to miss a dose of Stribild.
Croatian: Važno je da ne propustite uzeti dozu Stribilda.
English: Before starting treatment, your doctor will order blood tests to assess your kidney function.
Croatian: Prije početka liječenja, Vaš liječnik će zatražiti krvne pretrage kako bi procijenio funkciju Vaših bubrega.
English: The transporters that cobicistat inhibits include P-gp, BCRP, OATP1B1 and OATP1B3.
Croatian: Prijenosnici koje kobicistat inhibira uključuju P-gp, BCRP, OATP1B1 i OATP1B3.
English: As the effect of cationic complexation of elvitegravir cannot be excluded when Stribild is co-administered with multivitamin supplements, it is recommended to separate Stribild and multivitamin supplements dosing by at least 4 hours.
Croatian: Kako se učinak kationske kompleksacije elvitegravira ne može isključiti kada se Stribild istodobnu primjenjuje s multivitaminskim dodacima, preporučuje se razdvajanje doziranja Stribilda i multivitaminskih dodataka za najmanje 4 sata.
English: 2 Studies performed with ritonavir boosted elvitegravir.
Croatian: 2 Ispitivanja provedena s ritonavirom pojačanim elvitegravirom.
English: • increased sugar, fatty acids (triglycerides), bilirubin in your blood
Croatian: • povišene razine šećera, masnih kiselina (triglicerida), bilirubin u krvi
English: Aromatic and aliphatic hydroxylation or glucuronidation metabolites are present in very low levels, display considerably lower anti-HIV activity and do not contribute to the overall antiviral activity of elvitegravir.
Croatian: Aromatski i alifatski metaboliti hidroksilacije i glukuronidacije prisutni su u vrlo niskim razinama, pokazuju znatno niže anti-HIV djelovanje i ne pridonose ukupnom antivirusnom djelovanju elvitegravira.
English: Inhibition of integrase prevents the integration of HIV-1 DNA into host genomic DNA, blocking the formation of the HIV-1 provirus and propagation of the viral infection.
Croatian: Inhibicija integraze sprječava integraciju HIV-1 DNK u genomski DNK domaćina, blokirajući formiranje provirusa HIV-1 i propagaciju virusne infekcije.
English: If you vomit less than 1 hour after taking Stribild, take another tablet with food.
Croatian: Ako povraćate kad je prošlo manje od 1 sata od uzimanja Stribilda, uzmite drugu tabletu s hranom.
English: 2 Anaemia was common and skin discolouration (increased pigmentation) was very common when emtricitabine was administered to paediatric patients.
Croatian: 2 Anemija je bila česta, a promjena boje kože (pojačana pigmentacija) vrlo česta kad se emtricitabin primjenjivao u pedijatrijskih bolesnika.
English: If you forget to take Stribild
Croatian: Ako ste zaboravili uzeti Stribild
English: Reductions in BMD have been reported in paediatric patients.
Croatian: Zabilježena su smanjenja BMD-a u pedijatrijskih bolesnika.
English: The interactions described are based on studies conducted with the components of Stribild as individual agents and/or in combination, or are potential drug interactions that may occur with Stribild.
Croatian: Opisane interakcije temelje se na ispitivanjima koja su provedena na komponentama Stribilda kao pojedinačnim tvarima i/ili u kombinaciji, ili su potencijalne interakcije lijekova koje se mogu pojaviti sa Stribildom.
English: Rarely, cases of pancreatitis and lactic acidosis, sometimes fatal, have been reported.
Croatian: U rijetkim su slučajevima zabilježeni pankreatitis i laktacidoza, ponekad sa smrtnim ishodom.
English: Seven patients had estimated glomerular filtration rate (GFR) values between 70 and 90 mL/min/1.73 m2.
Croatian: Sedam bolesnika imalo je procijenjene brzine glomerularne filtracije (GFR) između 70 i 90 ml/min/1,73 m2.
English: An assessment of benefit/risk ratio is recommended to justify use of voriconazole with Stribild.
Croatian: Procjena omjera koristi/rizika preporučuje se radi opravdanja primjene vorikonazola sa Stribildom.
English: • Lactic acidosis (excess lactic acid in the blood) is a rare but potentially life-threatening side effect of some HIV medicines.
Croatian: • Laktacidoza (suvišak mliječne kiseline u krvi) rijetka je, ali potencijalno po život opasna nuspojava nekih lijekova protiv HIV-a.
English: In case of concomitant antiviral therapy for hepatitis B or C, please refer also to the relevant Summary of Product Characteristics for these medicinal products.
Croatian: U slučaju istodobne antivirusne terapije za hepatitis B ili C, molimo da također pročitate sažetak opisa svojstava lijeka za te lijekove.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary.
Croatian: U slučaju predoziranja bolesnik mora biti pod nadzorom zbog znakova toksičnosti (vidjeti dio 4.8) te mu se, prema potrebi, mora pružiti standardno potporno liječenje.
English: Limited data from population pharmacokinetic analysis (n = 24) indicated that hepatitis B and/or C virus infection had no clinically relevant effect on the exposure of boosted elvitegravir.
Croatian: Ograničeni podaci iz populacijske farmakokinetičke analize (n = 24) pokazala je da istodobna infekcija virusom hepatitisa B i/ili C nema klinički značajan učinak na izloženost pojačanom elvitegraviru.
English:  If any of these applies to you, talk to your doctor before taking Stribild.
Croatian: Ako se išta od ovog odnosi na Vas, razgovarajte sa svojim liječnikom prije nego uzmete Stribild.
English: Long term oral carcinogenicity studies with elvitegravir and cobicistat did not show any carcinogenic potential in mice and rats.
Croatian: Dugoročna ispitivanja kancerogenosti peroralne primjene elvitegravira i kobicistata nisu pokazala kancerogeni potencijal u miševa i štakora.
English: Of the 18 patients with viral resistance development, 13 occurred through Week 48, 3 occurred between Week 48 to Week 96, and 2 occurred between Week 96 to Week 144 of treatment.
Croatian: Od 18 bolesnika s razvojem virusne rezistencije, 13 ju je razvilo do 48. tjedna, 3 su je razvila između 48. i 96. tjedna, a 2 između 96. i 144. tjedna.
English: In an in vitro chromosomal aberration test, elvitegravir was negative with metabolic activation; however, an equivocal response was observed without activation.
Croatian: U in vitro pretrazi kromosomske aberacije elvitegravir je bio negativan s metaboličkim djelovanjem; međutim, neodređeni odgovor zapažen je bez djelovanja.
English: Bone toxicity was diagnosed as osteomalacia (monkeys) and reduced bone mineral density (rats and dogs).
Croatian: Toksičnost za kost dijagnosticirala se kao osteomalacija (majmuni) i smanjena mineralna gustoća kostiju (štakori i psi).
English: Tenofovir disoproxil should be avoided in patients with HIV-1 harbouring the K65R substitution.
Croatian: Tenofovirdizoproksil se mora izbjegavati u bolesnika s HIV-1 koji nose supstituciju K65R.
English: osteomalacia (manifested as bone pain and infrequently contributing to fractures)1,3,5, myopathy1,3
Croatian: osteomalacija (koja se očituje bolovima u kostima i rijetko pridonosi prijelomima)1,3,5, miopatija1,3
English: Tenofovir disoproxil had no effect on any of the CYP450 isoforms, except CYP1A1/2, where a small (6%) but statistically significant reduction in metabolism of a CYP1A1/2 substrate was observed.
Croatian: Tenofovirdizoproksil nije imao učinka na ni jedan od izooblika CYP450, osim na CYP1A1/2, gdje je zapaženo malo (6%), no statistički značajno smanjenje metabolizma supstrata CYP1A1/2.
English: Tenofovir is primarily excreted by the kidney by both filtration and an active tubular transport system (human organic anion transporter [hOAT1]) with approximately 70-80% of the dose excreted unchanged in urine following intravenous administration.
Croatian: Tenofovir se prvenstveno izlučuje putem bubrega filtracijom i aktivnim tubularnim transportnim sustavom (humanim organskim anionskim prijenosnikom [hOAT1]), pri čemu se oko 70-80% doze izlučuje u nepromijenjenom obliku u mokraći nakon intravenske primjene.
English: Stribild has not been studied in patients over 65 years of age.
Croatian: Stribild nije ispitan u bolesnika starijih od 65 godina.
English:  Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection (such as yellowing of your skin or the white part of your eyes, dark “tea-coloured” urine, light-coloured stools, loss of appetite for several days or longer, feeling or being sick, or stomach-area pain).
Croatian: Odmah obavijestite Vašeg liječnika o novim ili neobičnim simptomima nakon što se prestanete liječiti, osobito o simptomima koje dovodite u vezu s infekcijom hepatitisom B (kao što su žuta boja kože ili bjeloočnica, tamna boja mokraće, stolice svijetle boje, gubitak apetita tijekom nekoliko dana ili dulje, mučnina ili povraćanje te bol u predjelu trbuha).
English: d Includes patients who discontinued due to adverse event or death at any time point from day 1 through the time window if this resulted in no virologic data on treatment during the specified window.
Croatian: d Obuhvaća bolesnike koji su prekinuli zbog nuspojava ili smrti u bilo kojem trenutku od 1. dana tijekom vremenskog okvira ako virološki podaci o liječenju tijekom određenog okvira nisu bili dostupni.
English: neutropenia1
Croatian: neutropenija1
English: Following intravenous administration the volume of distribution of emtricitabine and tenofovir was approximately 1,400 mL/kg and 800 mL/kg, respectively.
Croatian: Nakon intravenske primjene volumen distribucije emtricitabina i tenofovira bio je približno 1400 ml/kg, odnosno 800 ml/kg.
English: Do not stop taking Stribild without talking to your doctor.
Croatian: Nemojte prestati uzimati Stribild bez prethodnog razgovora sa svojim liječnikom.
English: (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000
Croatian: Učestalost je definirana kao vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100) ili rijetko (≥ 1/10 000 i < 1/1000).
English:  If you think you may have lactic acidosis, tell your doctor immediately.
Croatian:  Ako mislite da možda imate laktacidozu, odmah o tome obavijestite Vašeg liječnika.
English: This may stop your medicines from working properly, or may make any side effects worse.
Croatian: To može spriječiti ispravno djelovanje lijekova, ili pogoršati nuspojave.
English: The recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment.
Croatian: Preporučeni raspored za praćenje funkcije bubrega s obzirom na prisutnost ili odsutnost dodatnih čimbenika rizika za oštećenje bubrega.