FrancophonIA/ELRC3.0 huggingface dataset:
English: Interaction studies with these active substances have only been performed in adults.
Croatian: Ispitivanja interakcija s tim djelatnim tvarima provedena su samo u odraslih.
English: Decreases in BMD of hip were significantly greater in this group until 96 weeks.
Croatian: Sniženja BMD-a kuka bila su značajno veća u toj skupini do 96. tjedna.
English: [outer packaging only]
Croatian: [Samo vanjsko pakiranje]
English: The E138K substitution emerged most frequently during rilpivirine treatment, commonly in combination with the M184I substitution.
Croatian: Supstitucija E138K pojavljivala se najčešće tijekom liječenja rilpivirinom, obično u kombinaciji sa supstitucijom M184I.
English: It is important not to miss a dose of Eviplera.
Croatian: Važno je da ne propustite dozu Eviplere.
English: Eviplera contains three active substances that are used to treat Human Immunodeficiency Virus (HIV) infection:
Croatian: Eviplera sadrži tri djelatne tvari koje se primjenjuju za liječenje infekcije virusom humane imunodeficijencije (HIV):
English: Interaction with didanosine
Croatian: Interakcije s didanozinom
English: Up to 30% of the emtricitabine dose and approximately 10% of the tenofovir dose can be removed by haemodialysis.
Croatian: Do 30% doze emtricitabina i približno 10% doze tenofovira može se ukloniti hemodijalizom.
English: Carcinogenicity studies with rilpivirine in mice and rats revealed tumorigenic potential specific for these species, but are regarded as of no relevance for humans.
Croatian: Ispitivanja kancerogenosti rilpivirina u miševa i štakora pokazala su tumorogeni potencijal specifičan za te vrste, ali smatra se da to nema nikakvu važnost za ljude.
English: There is not sufficient data to justify the use in patients with prior NNRTI failure.
Croatian: Nema dovoljno podataka da bi se opravdala primjena u bolesnika s prethodnim neuspjehom NNRTI-ja.
English: In dogs cholestasis-like effects were noted.
Croatian: U pasa su zabilježeni učinci slični kolestazi.
English: • Softening of the bones (with bone pain and sometimes resulting in fractures)
Croatian: • omekšavanje kostiju (s bolovima u kostima i ponekad posljedičnim prijelomima)
English: • Use effective contraception while taking Eviplera.
Croatian: • Koristite učinkovitu kontracepciju dok uzimate lijek Eviplera.
English: EU/1/11/737/002 90 (3 bottles of 30) film-coated tablets.
Croatian: EU/1/11/737/002 90 (3 boce s 30) filmom obloženih tableta.
English: Maximum tenofovir concentrations are observed in plasma within 2 hours and maximum plasma concentrations of rilpivirine are generally achieved within 4-5 hours.
Croatian: Maksimalne koncentracije tenofovira primjećuju se u plazmi u roku od 2 sata, a maksimalne koncentracije rilpivirina u plazmi općenito se postižu u roku od 4 do 5 sati.
English: Eviplera contains an NNRTI (rilpivirine) and so Eviplera is not to be combined with other medicines of this type.
Croatian: Eviplera sadrži NNRTI (rilpivirin) pa se tako Eviplera ne smije kombinirati s drugim lijekovima ove vrste.
English: Rilpivirine was well tolerated during pregnancy and postpartum.
Croatian: Rilpivirin se dobro podnosio i tijekom trudnoće i u poslijeporođajnom razdoblju.
English: • If you have taken Eviplera during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Croatian: • Ako ste Evipleru uzimali tijekom trudnoće, postoji mogućnost da liječnik zatraži redovito provođenje pretraga krvi i drugih dijagnostičkih pretraga kako bi pratio razvoj vašega djeteta.
English: • Deep, rapid breathing
Croatian: • duboko, ubrzano disanje
English: • Rifabutin, a medicine to treat some bacterial infections.
Croatian: • Rifabutin, lijek za liječenje nekih bakterijskih infekcija.
English: If you are taking an antacid such as medicines containing magnesium or potassium.
Croatian: Ako uzimate antacid kao što su lijekovi koji sadrže magnezij ili kalij.
English: Interrupting treatment with Eviplera should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja Eviplerom također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok.
English: However, as would be expected in this patient population, elevations in AST and ALT occurred more frequently than in the general HIV infected population.
Croatian: Međutim, kao što se moglo i očekivati, povišenje AST i ALT vrijednosti nastupilo je češće u ove populacije nego u opće populacije zaražene HIV-om.
English: This medicine is not a cure for HIV infection.
Croatian: Ovaj lijek ne može izliječiti HIVinfekciju.
English: If you are taking one of these medicines your doctor will either give you a different medicine for stomach ulcers, heartburn or acid reflux, or recommend how and when you take that medicine.
Croatian: Ako uzimate jedan od tih lijekova, liječnik će Vam dati drugi lijek za čir želuca, žgaravicu ili vraćanje želučane kiseline ili preporučiti kako i kada trebate uzimati taj lijek.
English: Patients had a mean age of 42 years (range 19-73), 88% were male, 77% were White, 17% were Black, and 17% were Hispanic/Latino.
Croatian: Srednja vrijednost dobi bolesnika bila je 42 godine (raspon 19 - 73), 88% bili su muškarci, 77% bijelci, 17% crnci, a 17% bili su hispanskog/latinoameričkog podrijetla.
English: • Breakdown of muscle, muscle pain or weakness
Croatian: • raspad mišića, mišićni bolovi ili slabost
English: b Snapshot analysis.
Croatian: b Analiza snimaka.
English: Your doctor will carefully consider whether to treat you with other medicines used for treating HIV infection (see Other medicines used for HIV infection).
Croatian: Liječnik će pažljivo razmotriti hoće li Vas liječiti drugim lijekovima koji se primjenjuju za liječenje HIV-infekcije (pogledajte Drugi lijekovi za liječenje HIV-infekcije).
English: The absolute bioavailability of emtricitabine from 200 mg hard capsules was estimated to be 93%.
Croatian: Apsolutna bioraspoloživost emtricitabina od 200 mg u tvrdim kapsulama iznosila je približno 93%.
English: The efficacy data from study GS-US-264-0111 (see section 5.1) indicates that the brief period of lower rilpivirine exposure does not impact antiviral efficacy of Eviplera.
Croatian: Podaci o djelotvornosti iz ispitivanja GS-US-264-0111 (vidjeti dio 5.1) pokazuju da kratko razdoblje niže izloženosti rilpivirinu ne utječe na antivirusnu djelotvornost lijeka Eviplera.
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Croatian: Ne smatra se uzročno povezanom s tenofovirdizoproksilom u odsutnosti ovog stanja.
English: • This is because the active substances in this medicine pass into human breast milk.
Croatian: • zato što djelatne tvari iz ovoga lijeka prelaze u majčino mlijeko
English: • Women must not get pregnant while taking Eviplera.
Croatian: • Žene ne smiju zatrudnjeti dok uzimaju lijek Eviplera.
English: If you have a history of liver disease, or chronic hepatitis B infection, your doctor may conduct blood tests in order to monitor liver function.
Croatian: Ako imate povijest bolesti jetre ili kroničnu infekciju hepatitisom B, Vaš će liječnik možda provesti pretrage krvi kako bi pratio funkciju jetre.
English: Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets.
Croatian: Svaka boca sadrži silika gel kao sredstvo za sušenje koji se mora čuvati u boci radi zaštite tableta.
English: Alternatively, switching to another antiretroviral regimen could be considered (see sections 4.4, 4.6, 5.1 and 5.2).
Croatian: Kao alternativa, može se razmotriti prijelaz na neki drugi antiretrovirusni režim (vidjeti dijelove 4.4, 4.6, 5.1 i 5.2).
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Croatian: • Obavijestite liječnika ako imate bolest jetre, uključujući hepatitis.
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: Eviplera may affect your kidneys.
Croatian: Eviplera može utjecati na Vaše bubrege.
English: Eviplera is not usually taken with other medicines that can damage your kidneys (see Other medicines and Eviplera).
Croatian: Eviplera se obično ne uzima s drugim lijekovima koji mogu oštetiti bubrege (pogledajte Drugi lijekovi i Eviplera).
English: Concomitant use where caution is recommended
Croatian: Istovremena primjena pri kojoj se preporučuje oprez
English: The terminal elimination half-life of rilpivirine is approximately 45 hours.
Croatian: Poluvrijeme eliminacije rilpivirina iznosi približno 45 sati.
English: If you have HIV infection and hepatitis B, it is especially important not to stop your Eviplera treatment without talking to your doctor first.
Croatian: Ako imate HIV-infekciju i hepatitis B, osobito je važno da ne prestanete liječenje Eviplerom bez prethodnog razgovora sa svojim liječnikom.
English: In vitro binding of rilpivirine to human plasma proteins is approximately 99.7%, primarily to albumin.
Croatian: In vitro vezanje rilpivirina za proteine ljudske plazme, prvenstveno za albumin, iznosi približno 99,7%.
English: Due to the decline in efavirenz plasma levels, the inductive effect decreased and rilpivirine concentrations started to normalise.
Croatian: Zbog pada razine efavirenza u plazmi, indukcijski učinak se smanjio i koncentracije rilpivirina počele su se normalizirati.
English: The most common mutations were the same in the week 48 and week 96 analyses.
Croatian: Najčešće mutacije bile su iste u analizi iz 48. i onoj iz 96. tjedna.
English: • Increased fatty acids (triglycerides), bilirubin or sugar in the blood
Croatian: • povišene masne kiseline (trigliceridi), bilirubin ili šećer u krvi
English: De novo resistance to emtricitabine/lamivudine was seen in 4 cases, and also to rilpivirine in 2 cases, with a consequent cross-resistance to efavirenz (2/2), nevirapine (2/2) and etravirine (1/2).
Croatian: De novo rezistencija na emtricitabin/lamivudin opažena je u 4 slučaja, a na rilpivirin u 2 slučaja, s posljedičnom križnom rezistencijom na efavirenz (2/2), nevirapin (2/2) i etravirin (1/2).
English: As a precautionary measure, it is preferable to avoid the use of Eviplera during pregnancy.
Croatian: Kao mjera opreza, preporučuje se izbjegavati primjenu lijeka Eviplera tijekom trudnoće.
English: • Tell your doctor immediately and stop taking Eviplera if you develop a skin rash with the following symptoms: fever, blisters, redness in your eyes and swelling of your face, mouth or body.
Croatian: • Odmah obavijestite svog liječnika i prestanite uzimati lijek Eviplera ako razvijete kožni osip sa sljedećim simptomima: vrućicom, mjehurima na koži, crvenilom očiju i oticanjem lica, usta ili tijela.
English: The 50% effective concentration (EC50) values for emtricitabine were in the range of 0.0013 to 0.64 µM.
Croatian: Vrijednosti 50%-tne učinkovite koncentracije (EC50) za emtricitabin kretale su se u rasponu od 0,0013 do 0,64 µM.
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: There was no teratogenicity with rilpivirine in rats and rabbits.
Croatian: Nije dokazana teratogenost s rilpivirinom u štakora i kunića.
English: • Problems with digestion resulting in discomfort after meals, wind (flatulence)
Croatian: • tegobe s probavom koje izazivaju nelagodu nakon obroka, vjetrovi (flatulencija)
English: • Lactic acidosis (see Possible side effects: tell a doctor immediately)
Croatian: • laktacidoza (pogledajte Moguće nuspojave: odmah obavijestite liječnika)
English: In order to avoid transmission of HIV to the infant it is recommended that HIV infected women do not breast-feed their infants under any circumstances.
Croatian: Da bi se izbjegao prijenos HIV-a na dojenče, preporučuje se da žene zaražene HIV-om ne doje svoju dojenčad ni pod kojim okolnostima.
English: There are no adequate and well-controlled studies of Eviplera or its components in pregnant women.
Croatian: Ne postoje odgovarajuća i dobro kontrolirana ispitivanja lijeka Eviplera ili njegovih djelatnih tvari u trudnica.
English: If appropriate, resumption of hepatitis B therapy may be warranted.
Croatian: Ako je prikladno, može biti opravdano nastaviti terapiju hepatitisa B.
English: While taking Eviplera you may still develop infections or other illnesses associated with HIV infection.
Croatian: Dok uzimate lijek Eviplera i dalje možete razvijati infekcije ili druge bolesti povezane s HIV-infekcijom.
English: For the resistance analyses, a broader definition of virologic failure was used than in the primary efficacy analysis.
Croatian: U analizama rezistencije koristila se šira definicija virološkog neuspjeha od one u analizi primarne djelotvornosti.
English: Take the rilpivirine tablet at the same time you take Eviplera.
Croatian: Uzmite tabletu rilpivirina u isto vrijeme kad uzimate lijek Eviplera.
English: However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients.
Croatian: Međutim, preporučuje se klinički nadzor, jer u nekih bolesnika možda bude potrebno prilagoditi terapiju održavanja metadonom.
English: What Eviplera is and what it is used for What you need to know before you take Eviplera How to take Eviplera
Croatian: Što je Eviplera i za što se koristi Što morate znati prije nego počnete uzimati lijek Eviplera
English: • Difficulty with movement
Croatian: • poteškoće pri kretanju
English: Eviplera comes in bottles of 30 tablets and in packs made up of 3 bottles, each containing 30 tablets.
Croatian: Eviplera dolazi u bocama s 30 tableta i pakiranjima od 3 boce, od kojih svaka sadrži 30 tableta.
English:  Tell your doctor if you are taking any of these medicines.
Croatian: Obavijestite liječnika ako uzimate bilo koji od tih lijekova.
English: Other effects that may be seen during HIV treatment
Croatian: Druge moguće nuspojave koje se mogu primijetiti tijekom liječenja HIV-a
English: The EC50 values for tenofovir were in the range of 0.04 to 8.5 µM.
Croatian: Vrijednosti EC50 za tenofovir bile su u rasponu od 0,04 do 8,5 µM.
English: Studies in animals have shown limited placenta passage of rilpivirine.
Croatian: Ispitivanja na životinjama pokazala su ograničenu prolaznost rilpivirina kroz placentu.
English: The pharmacokinetic data demonstrate that total exposure (AUC) to rilpivirine as a part of an antiretroviral regimen was approximately 30% lower during pregnancy compared with postpartum (6-12 weeks).
Croatian: Farmakokinetički podaci pokazuju da je ukupna izloženost (AUC) rilpivirinu, kao dijelu antiretrovirusnog režima, bila približno 30% manja tijekom trudnoće nego u poslijeporođajnom razdoblju (6 - 12 tjedana).
English: In the studies, the presence of the mutations V90I and V189I at baseline did not affect the response.
Croatian: U tim ispitivanjima prisutnost mutacija V90I i V189I na početku ispitivanja nije utjecala na odgovor.
English: Before and during treatment, your doctor may order blood tests to measure kidney function.
Croatian: Prije početka i tijekom liječenja, liječnik može naručiti krvne pretrage da bi izmjerio funkciju Vaših bubrega.
English: This, will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.
Croatian: Vaš imunološki sustav i smanjiti rizik od razvoja bolesti povezanih s HIV-infekcijom.
English: There is limited information available on the potential for a pharmacodynamic interaction between rilpivirine and medicinal products that prolong the QTc interval of the electrocardiogram.
Croatian: Dostupne su tek ograničene informacije o mogućnosti farmakodinamičkih interakcija između rilpivirina i lijekova koji produljuju QTc interval na elektrokardiogramu.
English: The safety and efficacy of Eviplera have not been established for the treatment of chronic HBV infection.
Croatian: Nije utvrđena sigurnost i djelotvornost primjene lijeka Eviplera za liječenje kronične HBV-infekcije.
English: At a dose of 25 mg of rilpivirine, no dose adjustment is required.
Croatian: Pri dozi od 25 mg rilpivirina nije potrebna prilagodba doze.
English: The combination of Eviplera and dabigatran etexilate should be used with caution.
Croatian: Kombinaciju lijeka Eviplera i dabigatran eteksilata potrebno je primjenjivati s oprezom.
English: Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping emtricitabine or tenofovir disoproxil (two of the three active substances of Eviplera).
Croatian: Neki su bolesnici imali krvne nalaze ili simptome koji su pokazivali da im se hepatitis pogoršao nakon prestanka uzimanja emtricitabina ili tenofovirdizoproksila (dvije od tri djelatne tvari Eviplere).
English: e Includes patients who discontinued for reasons other than an AE, death or lack or loss of efficacy, e.g., withdrew consent, loss to follow-up, etc.
Croatian: e Obuhvaća bolesnike s prekidom iz razloga koji nisu posljedica nuspojave, smrti ili nedostatka ili gubitka djelotvornosti, npr., povučeni pristanak, gubitak mogućnosti praćenja, itd.
English: Eviplera contains lactose monohydrate.
Croatian: Eviplera sadrži laktozu monohidrat.
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 istovremene antivirusne terapije za hepatitis B ili C, molimo pročitajte također odgovarajuće Sažetke opisa svojstava lijeka za te lijekove.
English: Insufficient safety data are available for children under the age of 18 years.
Croatian: Nema dovoljno podataka o sigurnosti primjene za djecu mlađu od 18 godina.
English: The decrease in the unbound free fraction of rilpivirine exposure (i.e. active) during pregnancy compared to postpartum was less pronounced than for total exposure of rilpivirine.
Croatian: Smanjenje nevezane slobodne frakcije izloženosti rilpivirinu (tj. djelatne) tijekom trudnoće u usporedbi s poslijeporođajnim razdobljem, bilo je manje izraženo nego kod ukupne izloženosti rilpivirinu.
English: Rilpivirine inhibits P-glycoprotein (P-gp) in vitro (IC50 is 9.2 µM).
Croatian: Rilpivirin inhibira P-glikoprotein (P-gp) in vitro (IC50 je 9,2 µM).
English: • If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Croatian: • Ako Vam je liječnik rekao da ne podnosite neke šećere, obratite se liječniku prije uzimanja ovog lijeka.
English: Population pharmacokinetic analysis indicated that hepatitis B and/or C virus co-infection had no clinically relevant effect on the exposure to rilpivirine.
Croatian: Populacijska farmakokinetička analiza pokazala je da istovremena infekcija virusom hepatitisa B i/ili C nema klinički značajan učinak na izloženost rilpivirinu.
English: If overdose occurs the patient must be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary including observation of the clinical status of the patient and monitoring of vital signs and ECG (QT interval).
Croatian: U slučaju predoziranja, bolesnika se mora nadzirati zbog znakova toksičnosti (vidjeti dio 4.8), a standardno potporno liječenje primijeniti po potrebi uključujući promatranje kliničkog stanja bolesnika i nadziranje vitalnih znakova i EKG-a (QT interval).
English: • Medicines containing didanosine (for HIV infection): Taking Eviplera with other antiviral medicines that contain didanosine can raise the levels of didanosine in your blood and may reduce CD4+ cell counts.
Croatian: • Lijekovi koji sadrže didanozin (protiv HIV-infekcije): Uzimanje lijeka Eviplera s drugim antivirusnim lijekovima koji sadrže didanozin može povisiti razine didanozina u krvi i smanjiti broj stanica CD4+.
English: Both emtricitabine and tenofovir have activity that is specific to HIV-1, HIV-2 and, HBV.
Croatian: I emtricitabin i tenofovir imaju aktivnost koja je specifična za HIV-1, HIV-2 i HBV.
English: Talk to your doctor about an alternative regimen (see section 3, How to take Eviplera).
Croatian: Porazgovarajte s liječnikom o alternativnom načinu uzimanja (vidjeti dio 3 Kako uzimati Evipleru).
English: It is important not to stop taking Eviplera without talking to your doctor: see section 3, Do not stop taking Eviplera.
Croatian: Važno je da ne prestanete uzimati lijek Eviplera bez prethodnog razgovora sa svojim liječnikom: pogledajte dio 3, Nemojte prestati uzimati lijek Eviplera.
English: The safety and efficacy of Eviplera in children under the age of 18 years have not been established.
Croatian: Sigurnost i djelotvornost primjene lijeka Eviplera u djece mlađe od 18 godina nisu ustanovljene.
English: There was no difference in the change from baseline in whole body BMD or BMC for rilpivirine compared with control, in the overall population or in those patients treated with a backbone regimen including tenofovir disoproxil.
Croatian: Nije bilo razlike u promjeni vrijednosti BMD-a cijelog tijela ili BMC-a u odnosu na početne za rilpivirin u usporedbi s kontrolnom skupinom, u ukupnoj populaciji ili u bolesnika liječenih temeljnim režimom uključujući tenofovirdizoproksil.
English: The virologic response was generally preserved throughout the study: of the 12 patients that completed the study, 10 patients were suppressed at the end of the study; in the other 2 patients an increase in viral load was observed only postpartum, for at least 1 patient due to suspected suboptimal adherence.
Croatian: Virološki odgovor bio je uglavnom očuvan tijekom trajanja ispitivanja: od 12 bolesnica koje su završile ispitivanje, 10 bolesnica bilo je suprimirano na kraju ispitivanja; u druge 2 bolesnice opažen je porast virusnog opterećenja samo u poslijeporođajnom razdoblju, a u najmanje 1 bolesnice zbog sumnje na neodgovarajuće pridržavanje terapije.
English: Population pharmacokinetic analysis in HIV infected patients showed that rilpivirine pharmacokinetics is not different across the age range (18 to 78 years) evaluated, with only 2 patients aged 65 years of age or older.
Croatian: Populacijska farmakokinetička analiza u bolesnika zaraženih HIV-om pokazala je da se farmakokinetika rilpivirina ne razlikuje unutar procijenjenog dobnog raspona (18 do 78 godina), s time da su samo 2 bolesnika bila u dobi od 65 ili više godina.
English: Macrolide antibiotics Clarithromycin Erythromycin
Croatian: Makrolidni antibiotici Klaritromicin Eritromicin
English: Eviplera has not been evaluated in patients with previous virologic failure to any other antiretroviral therapy.
Croatian: Eviplera nije procijenjena u bolesnika s prethodnim virološkim neuspjehom na neku od antiretrovirusnih terapija.
English: Eviplera is not recommended in this population (see section 4.2).
Croatian: Eviplera se ne preporučuje u ove populacije (vidjeti dio 4.2).
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje potrebno je provoditi sukladno kliničkoj indikaciji ili preporukama nacionalnog centra za kontrolu otrovanja, ako on postoji.
English: Two of the active substances in Eviplera (tenofovir disoproxil and emtricitabine) show some activity against hepatitis B virus.
Croatian: Dvije djelatne tvari u Evipleri (tenofovirdizoproksil i emtricitabin) pokazuju određenu aktivnost protiv virusa hepatitisa B.
English: It is recommended that CrCl is calculated in all patients prior to initiating therapy with Eviplera and renal function (CrCl and serum phosphate) is also monitored after two to four weeks of treatment, after three months of treatment and every three to six months thereafter in patients without renal risk factors.
Croatian: Preporučuje se, prije nego se započne terapija lijekom Eviplera, izračunati CrCl u svih bolesnika te također pratiti funkciju bubrega (CrCl i fosfate u serumu) nakon dva do četiri tjedna liječenja, nakon tri mjeseca liječenja i svakih tri do šest mjeseci nakon toga u bolesnika bez bubrežnih čimbenika rizika.