FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of tenofovir disoproxil with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir has been shown to increase plasma concentrations of tenofovir, especially when used together with an HIV regimen containing tenofovir disoproxil and a pharmacokinetic enhancer (ritonavir or cobicistat).
Croatian: Pokazalo se da istovremena primjena tenofovirdizoproksila s ledipasvirom/sofosbuvirom, sofosbuvirom/velpatasvirom ili ofosbuvirom/velpatasvirom/voksilaprevirom povećava koncentracije tenofovira u plazmi, osobito kad se primjenjuje zajedno s HIV režimom koji sadrži tenofovirdizoproksil i farmakokinetički pojačivač (ritonavir ili kobicistat).
English: Cohort
Croatian: Kohorta
English: Didanosine: The co-administration of emtricitabine/tenofovir disoproxil and didanosine is not recommended (see section 4.4 and Table 2).
Croatian: Didanozin: Ne preporučuje se istovremena primjena emtricitabin/tenofovirdizoproksila i didanozina (vidjeti dio 4.4 i Tablicu 2).
English: In study GS US 104 0321, 87 HIV 1 infected treatment-experienced patients 12 to < 18 years of age were treated with tenofovir disoproxil (n = 45) or placebo (n = 42) in combination with an optimised background regimen (OBR) for 48 weeks.
Croatian: U ispitivanju GS-US-104-0321, 87 prethodno liječenih pacijenata u dobi od 12 do < 18 godina zaraženih virusom HIV-1 primalo je tenofovirdizoproksil (n = 45) ili placebo (n = 42) u kombinaciji s optimiziranom osnovnom terapijom tijekom 48 tjedana.
English: Renal failure, renal impairment, elevated creatinine, hypophosphataemia and proximal tubulopathy (including Fanconi syndrome) have been reported with the use of tenofovir disoproxil (see section 4.8).
Croatian: Pri uporabi tenofovirdizoproksila zabilježeni su zatajenje bubrega, oštećenje funkcije bubrega, povišen kreatinin, hipofosfatemija i proksimalna tubulopatija (uključujući Fanconijev sindrom) (vidjeti dio 4.8).
English: Not recommended for use in individuals under the age of 18 years with renal impairment (see section 4.4).
Croatian: Ne preporučuje se primjena u osoba mlađih od 18 godina koje imaju oštećenje bubrega (vidjeti dio 4.4).
English: Tenofovir disoproxil 245 mg)+Emtricitabine/tenofovir disoproxil
Croatian: Tenofovirdizoproksil 245 mg + emtricitabin/tenofovirdizoproksil
English: It is important not to miss a dose of Emtricitabine/Tenofovir disoproxil Mylan .
Croatian: Važno je da ne propustite uzeti dozu lijeka Emtricitabin/tenofovirdizoproksil Mylan.
English: If a dose of emtricitabine/tenofovir disoproxil is missed within 12 hours of the time it is usually taken, emtricitabine/tenofovir disoproxil should be taken as soon as possible and the normal dosing schedule should be resumed.
Croatian: Ako se propustilo uzeti dozu emtricitabin/tenofovirdizoproksila, a prošlo je manje od 12 sati od uobičajenog vremena uzimanja doze, emtricitabin/tenofovirdizoproksil treba što prije uzeti i potom ga nastaviti uzimati prema uobičajenom rasporedu.
English: Cmin: ↑ 51% (↑ 37 to ↑ 66)
Croatian: Cmin: ↑ 51% (↑ 37 do ↑ 66)
English: Cmin: ↑ 39% (↑ 20 to ↑ 61)
Croatian: Cmin: ↑ 39% (↑ 20 do ↑ 61)
English: • drowsiness
Croatian: • omamljenost
English: Cmin: ↑ 91% (↑ 74 to ↑ 110)
Croatian: Cmin: ↑ 91% (od ↑ 74 do ↑ 110)
English: In the iPrEx clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 after enrolment in the study.
Croatian: U kliničkom ispitivanju iPrEx nisu bile otkrivene varijante virusa HIV-1 s ekspresijom K65R, K70E, M184V ili M184I u vrijeme serokonverzije u ispitanika koji su se zarazili virusom HIV-1 nakon uključenja u ispitivanje.
English: Treatment of HIV-1 infection
Croatian: Liječenje infekcije virusom HIV-1
English: Hepatitis B virus (HBV) antiviral agents
Croatian: Antivirusni lijekovi za virus hepatitisa B (HBV) Adefovirdipivoksil/ tenofovirdizoproksil
English: (may affect up to 1 in 10 people)
Croatian: (mogu se javiti u do 1 na 10 osoba)
English: No dose adjustment of ribavirin is required.
Croatian: Nije potrebno prilagođivati dozu ribavirina.
English: Mean changes at week 48 (end of double-blind phase) were -0.215 and -0.165 in lumbar spine BMD Z-score, and -0.254 and -0.179 in total body BMD Z-score for the tenofovir disoproxil and placebo groups, respectively.
Croatian: Srednje vrijednosti promjene u 48. tjednu (kraj dvostruko slijepe faze) bile su −0,215 odnosno −0,165 u z-vrijednosti BMD-a u području lumbalne kralježnice te −0,254 odnosno −0,179 u z-vrijednosti ukupnog BMD-a u skupini koja je primala tenofovirdizoproksil, odnosno placebo.
English: once daily.
Croatian: 2 godine.
English: • increased creatine kinase Common side effects
Croatian: • povišenu kreatin kinazu Česte nuspojave
English: No dose adjustment of tacrolimus is required.
Croatian: Nije potrebno prilagođivati dozu takrolimusa.
English: AUC: ↓ 12% (↓ 16 to ↓ 8) Cmax: ↓ 16% (↓ 22 to ↓ 10) Cmin: ↓ 15% (↓ 12 to ↓ 9)
Croatian: AUC: ↓ 12% (od ↓ 16 do ↓ 8) Cmax: ↓ 16% (od ↓ 22 do ↓ 10) Cmin: ↓ 15% (od ↓ 12 do ↓ 9)
English: The combination should be used with caution with frequent renal monitoring (see section 4.4).
Croatian: Tu je kombinaciju potrebno koristiti uz oprez i često praćenje bubrežnih funkcija (vidjeti dio 4.4).
English: Antimycobacterials Rifampicin /Tenofovir disoproxil
Croatian: Antimikobakterijski lijekovi Rifampicin/tenofovirdizoproksil
English: Emtricitabine and tenofovir are phosphorylated by cellular enzymes to form emtricitabine triphosphate and tenofovir diphosphate, respectively.
Croatian: Stanični enzimi fosforiliraju emtricitabin i tenofovir u emtricitabintrifosfat odnosno tenofovir difosfat.
English: anaemia2
Croatian: anemija2
English: • Do not breast-feed during treatment with Emtricitabine/Tenofovir disoproxil Mylan.
Croatian: • Nemojte dojiti tijekom liječenja lijekom Emtricitabin/tenofovirdizoproksil Mylan.
English: AUC: ↓ 29% (↓ 36 to ↓ 22) Cmax: ↓ 41% (↓ 51 to ↓ 29)
Croatian: AUC: ↓ 29% (↓ 36 do ↓ 22) Cmax: ↓ 41% (↓ 51 do ↓ 29)
English: If you vomit less than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan, take another tablet.
Croatian: Ako ste povraćali u razmaku manjem od 1 sata nakon što ste uzeli lijek Emtricitabin/tenofovirdizoproksil Mylan, uzmite drugu tabletu.
English: BATCH NUMBER
Croatian: 13. BROJ SERIJE
English: • Provides information on how to take Emtricitabine/Tenofovir Mylan
Croatian: • pruža informacije o tome kako uzimati lijek Emtricitabin/tenofovirdizoproksil Mylan
English: Studies with tenofovir disoproxil
Croatian: Ispitivanja s tenofovirdizoproksilom
English: Cmin: ↑ 29% (↑ 15 to ↑ 44)
Croatian: Cmin: ↑ 29% (↑ 15 do ↑ 44)
English: Total body bone gain was less in the tenofovir disoproxil treatment group compared to the stavudine or zidovudine treatment group.
Croatian: Ukupno povećanje BMD-a bilo je manje u skupini koja je primala tenofovirdizoproksil nego u skupini koja je primala stavudin ili zidovudin.
English: If vomiting occurs more than 1 hour after taking Emtricitabine/Tenofovir disoproxil Mylan a second dose should not be taken.
Croatian: Ako povraćanje nastupi nakon više od 1 sata od uzimanja lijeka Emtricitabin/tenofovirdizoproksil Mylan, nije potrebno uzeti drugu dozu.
English: The mean (%CV) tenofovir drug exposure increased from 2,185 (12%) ng•h/mL in subjects with normal renal function, to 3,064 (30%) ng•h/mL, 6,009 (42%) ng•h/mL and 15,985 (45%) ng•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Croatian: Prosječna je vrijednost (%CV) izloženosti tenofoviru porasla s 2185 (12%) ng•h/ml u ispitanika s normalnom bubrežnom funkcijom, na 3064 (30%) ng•h/ml, 6009 (42%) ng•h/ml i 15 985 (45%) ng•h/ml u ispitanika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega.
English: Norgestimate:
Croatian: Norgestimat:
English: • pain, stomach pain
Croatian: • bol, bol u želucu
English: Emtricitabine/Tenofovir disoproxil Mylan contains lactose monohydrate.
Croatian: Emtricitabin/tenofovirdizoproksil Mylan sadržava laktozu hidrat.
English: HIV-1 infection: The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/or tenofovir disoproxil were nausea (12%) and diarrhoea (7%) in an open-label randomised clinical study in adults (GS-01-934, see section 5.1).
Croatian: Infekcija virusom HIV-1: U otvorenom, randomiziranom kliničkom ispitivanju na odraslima (GS-01-934), najčešće zabilježene nuspojave za koje se smatra da su moguće ili vjerojatno povezane s emtricitabinom i/ili tenofovirdizoproksilom, bile su mučnina (12%) i proljev (7%) (vidjeti dio 5.1).
English: If emtricitabine/tenofovir disoproxil is co-administered with an NSAID, renal function should be monitored adequately.
Croatian: Ako se emtricitabin/tenofovirdizoproksil primjenjuje istovremeno s NSAIL-om, potrebno je na odgovarajući način pratiti funkciju bubrega.
English: Do not take Emtricitabine/Tenofovir disoproxil Mylan if you are already taking other medicines that contain the components of this medicine (which are emtricitabine and tenofovir disoproxil), or any other antiviral medicines that contain tenofovir, alafenamide, lamivudine or adefovir dipivoxil.
Croatian: Drugi lijekovi i Emtricitabin/tenofovirdizoproksil Mylan Nemojte uzimati Emtricitabin/tenofovirdizoproksil Mylan ako već uzimate druge lijekove koji sadržavaju sastojke lijeka Emtricitabin/tenofovirdizoproksil Mylan (emtricitabin i tenofovirdizoproksil) ili bilo koje druge antivirusne lijekove koji sadržavaju tenofoviralafenamid, lamivudin ili adefovirdipivoksil.
English: Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least35 kg: One tablet,
Croatian: Sprječavanje HIV-a u odraslih osoba i adolescenata u dobi od 12 godina i starijih, tjelesne težine najmanje 35 kg: jedna tableta, jedanput na dan.
English: Table 8: Study population from study CO-US-104-0380 (Partners PrEP)
Croatian: Tablica 8: Ispitivana populacija u ispitivanju CO-US-104-0380 (Partners PrEP)
English: Emtricitabine/tenofovir disoproxil should not be administered concomitantly with other medicinal products containing emtricitabine, tenofovir disoproxil, tenofovir alafenamide, or other cytidine analogues, such as lamivudine (see section 4.5).
Croatian: Emtricitabin/tenofovirdizoproksil se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil (u obliku tenofovirdizoproksila), tenofoviralafenamid ili s drugim analozima citidina, kao što je lamivudin (vidjeti dio 4.5).
English: AUC: ↓ 28% (↓ 34 to ↓ 20) Cmax: ↓ 38% (↓ 46 to ↓ 29)
Croatian: AUC: ↓ 28% (↓ 34 do ↓ 20) Cmax: ↓ 38% (↓ 46 do ↓ 29)
English: The safety of tenofovir disoproxil when co-administered with ledipasvir/sofosbuvir, sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir and a pharmacokinetic enhancer has not been established.
Croatian: Sigurnost tenofovirdizoproksila kad se primjenjuje istovremeno s ledipasvirom/sofosbuvirom, sofosbuvirom/velpatasvirom ili sofosbuvirom/velpatasvirom/voksilaprevirom i farmakokinetičkim pojačivačem nije ustanovljena.
English: • aminoglycosides (for bacterial infection)
Croatian: • aminoglikozide (za bakterijsku infekciju)
English: Cmax: ↑ 38% (↑ 14 to ↑ 67)
Croatian: Cmax: ↑ 38% (↑ 14 do ↑ 67)
English: In the Partners PrEP clinical study, no HIV-1 variants expressing K65R, K70E, M184V, or M184I were detected at the time of seroconversion among subjects who became infected with HIV-1 during the study.
Croatian: U kliničkom ispitivanju Partners PrEP nisu bile otkrivene varijante virusa HIV-1 s ekspresijom K65R, K70E, M184V ili M184I u vrijeme serokonverzije u ispitanika koji su se zarazili virusom HIV-1 tijekom ispitivanja.
English: Table 7: Efficacy and adherence in study CO-US-104-0288 (iPrEx, matched case-control analysis)
Croatian: Tablica 7: Djelotvornost i pridržavanje terapije u ispitivanju CO-US-104-0288 (iPrEx, analiza usklađenih parova)
English: Among 28 patients receiving 96 weeks of treatment with tenofovir disoproxil, BMD Z scores declined by -0.341 for lumbar spine and -0.458 for total body.
Croatian: U 28 pacijenata koji su primali tenofovirdizoproksil tijekom 96 tjedana, z-vrijednosti BMD-a u području lumbalne kralježnice smanjile su se za −0,341, a vrijednosti za cijelo tijelo za
English: Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Croatian: Emtricitabin/tenofovirdizoproksil nije ispitivan u osoba starijih od 65 godina.
English: The mean (%CV) emtricitabine drug exposure increased from 12 (25%) μg•h/mL in subjects with normal renal function, to 20 (6%) μg•h/mL, 25 (23%) μg•h/mL and 34 (6%) μg•h/mL, in subjects with mild, moderate and severe renal impairment, respectively.
Croatian: Prosječna je vrijednost (% koeficijenta varijacije, CV) izloženosti emtricitabinu porasla s 12 (25%) µg•h/ml u ispitanika s normalnom funkcijom bubrega, na 20 (6%) µg•h/ml, 25 (23%) µg•h/ml i 34 (6%) µg•h/ml, u ispitanika s blagim, umjerenim odnosno teškim oštećenjem funkcije bubrega.
English: Do not stop taking Emtricitabine/Tenofovir disoproxil Mylan
Croatian: Nemojte prestati uzimati lijek Emtricitabin/tenofovirdizoproksil Mylan
English: • The importance of regular monitoring of renal function during Emtricitabine/Tenofovir disoproxil Mylan therapy
Croatian: • Važno je redovito praćenje funkcije bubrega tijekom terapije lijekom Emtricitabin/tenofovirdizoproksil Mylan.
English: • That if serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving tenofovir disoproxil, renal function should be re-evaluated within one week.
Croatian: • Ako su u bilo kojeg pedijatrijskog pacijenta koji prima tenofovirdizoproksil fosfati u serumu < 3,0 mg/dL (0,96 mmol/l), unutar jednoga tjedna treba ponovno procijeniti funkciju bubrega.
English: Cellulose, microcrystalline Hydroxypropyl cellulose, low substituted Iron oxide red (E172) Silica, colloidal anhydrous Lactose monohydrate Magnesium stearate
Croatian: crveni željezov oksid (E172) silicijev dioksid, koloidni, bezvodni laktoza hidrat magnezijev stearat
English: • That use of Emtricitabine/Tenofovir disoproxil Mylan should be avoided with concomitant or recent use of nephrotoxic medicinal products.
Croatian: • Treba izbjegavati istovremenu ili nedavnu primjenu lijeka Emtricitabin/tenofovirdizoproksil Mylan i nefrotoksičnih lijekova.
English: Cmax: ↑ 55% (↑ 43 to ↑ 68) Cmin: ↑ 39% (↑ 31 to ↑ 48)
Croatian: Cmax: ↑ 55% (↑ 43 do ↑ 68) Cmin: ↑ 39% (↑ 31 do ↑ 48)
English: • decreases in potassium in the blood
Croatian: • smanjenu razinu kalija u krvi
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Croatian: AUC: ↓ 25% (↓ 42 do ↓ 3) Cmax: ↓ 28% (↓ 50 do ↑ 5) Cmin: ↓ 26% (↓ 46 do ↑ 10)
English: Lopinavir/Ritonavir/Tenofovir disoproxil (400 mg b.i.d./100 mg b.i.d/245 mg q.d.)
Croatian: Lopinavir/ritonavir/ tenofovirdizoproksil (400 mg b.i.d./100 mg b.i.d/245 mg q.d.)
English: No dose adjustment is recommended.
Croatian: Nema preporučene prilagodbe doziranja.
English: See also under Use with ledipasvir and sofosbuvir or sofosbuvir and velpatasvir below.
Croatian: Vidjeti također niže pod Primjena s ledipasvirom i sofosbuvirom ili sofosbuvirom i velpatasvirom.
English: a Relative risk reduction calculated on incident (post-baseline) seroconversion from the double-blind treatment period and through the 8-week follow-up period.
Croatian: HIV-pozitivni ispitanici HIV-negativni podudarni kontrolni ispitanici a Smanjenje relativnog rizika izračunato po incidentnoj serokonverziji (nakon početka ispitivanja) iz dvostruko slijepog razdoblja liječenja i tijekom 8-tjednog razdoblja praćenja.
English: Cmax: ↑ 42% (↑ 27 to ↑ 57) Cmin: ↔
Croatian: Cmax: ↑ 42% (↑ 27 do ↑ 57) Cmin: ↔
English: lactic acidosis
Croatian: NARKOTIČKI ANALGETICI
English: Also contains: lactose monohydrate.
Croatian: Sadržava i laktozu hidrat.
English: • back pain caused by kidney problems
Croatian: • bol u leđima prouzročen tegobama s bubrezima
English: • You must be HIV negative before you start to take this medicine to reduce the risk of getting HIV.
Croatian: • Prije nego što počnete uzimati ovaj lijek radi smanjenja rizika od dobivanja HIV-a, morate biti HIV-negativni.
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Croatian: • Edukacijska brošura o predekspozicijskoj profilaksi za propisivače, s naslovom „Važne informacije za propisivače o sigurnosti primjene lijeka Emtricitabin/tenofovirdizoproksil Mylan u indikaciji predekspozicijske profilakse (PrEP)”
English: Table 9: Efficacy in study CO-US-104-0380 (Partners PrEP)
Croatian: Tablica 9: Djelotvornost u ispitivanju CO-US-104-0380 (Partners PrEP)
English: AUC: ↑ 32% (↑ 25 to ↑ 38) Cmax: ↔
Croatian: AUC: ↑ 32% (↑ 25 do ↑ 38) Cmax: ↔
English: • Talk to your doctor if you have a history of liver disease, including hepatitis.
Croatian: • Ako ste imali bolest jetre, uključujući hepatitis, razgovarajte s liječnikom.
English: • PrEP reminder card
Croatian: • Kartica-podsjetnik kod predekspozicijske profilakse
English: Emtricitabine+ tenofovir disoproxil +efavirenz
Croatian: Emtricitabin+ tenofovirdizoproksil +efavirenz
English: Marketing Authorisation Holder MYLAN S.A.S.
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MYLAN S.A.S.
English: • ganciclovir (for viral infection)
Croatian: • ganciklovir (za virusnu infekciju)
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Croatian: Treba izbjegavati primjenu emtricitabin/tenofovirdizoproksila istovremeno s primjenom ili nakon nedavne primjene nefrotoksičnih lijekova.
English: Tacrolimus/Tenofovir disoproxil /Emtricitabine
Croatian: Takrolimus/tenofovirdizoproksil/ emtricitabin
English: Emtricitabine/tenofovir disoproxil should be avoided in antiretroviral-experienced patients with HIV-1 harbouring the K65R mutation (see section 5.1).
Croatian: Primjenu lijeka Emtricitabin/tenofovirdizoproksil Mylan treba izbjegavati u pacijenata s HIV-1 koji nosi mutaciju K65R, a koji su već bili liječeni antiretrovirusnim lijekovima (vidjeti dio 5.1).
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Mylan treatment
Croatian: Ako se posumnja na abnormalnosti funkcije bubrega ili ih se otkrije, potrebno je konzultirati se s nefrologom o mogućnosti prekida liječenja lijekom Emtricitabin/tenofovirdizoproksil Mylan.
English: Co-administration of other medicinal products
Croatian: Istovremena primjena drugih lijekova
English: • inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells
Croatian: • upala bubrega, mokrenje velikih količina mokraće i osjećaj žeđi, zatajenje bubrega, oštećenje stanica bubrežnih kanalića
English: If renal abnormalities are suspected or detected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/tenofovir disoproxil use.
Croatian: Ako se posumnja na abnormalnosti funkcije bubrega ili ih se otkrije, potrebno je konzultirati se s nefrologom o mogućnosti prekida primjene emtricitabin/tenofovirdizoproksila.
English: Cmin: ↑ 63% (↑ 45 to ↑ 84)
Croatian: Cmin: ↑ 63% (od ↑ 45 do ↑ 84)
English: AUC: ↑ 40% (↑ 31 to ↑ 50) Cmax: ↔
Croatian: AUC: ↑ 40% (od ↑ 31 do ↑ 50) Cmax: ↔
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25)
Croatian: AUC: ↓ 27% (od ↓ 35 do ↓ 18) Cmax: ↓ 37% (od ↓ 48 do ↓ 25)
English: • foscarnet (for viral infection)
Croatian: • foskarnet (za virusnu infekciju)
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Croatian: Ne preporučuje se primjena emtricitabin/tenofovirdizoproksila u osoba s oštećenjem bubrega mlađih od 18 godina (vidjeti dio 4.2).
English: Cmin: ↑ 42% (↑ 37 to ↑ 49)
Croatian: Cmin: ↑ 42% (↑ 37 do ↑ 49)
English: NAME OF THE MEDICINAL PRODUCT Emtricitabine/Tenofovir disoproxil Mylan 200 mg/245 mg film-coated tablets
Croatian: NAZIV LIJEKA Emtricitabin/tenofovirdizoproksil Mylan 200 mg/245 mg filmom obložene tablete
English: Drug Not Detected
Croatian: Lijek otkriven
English: Cmax: ↑ 47% (↑ 37 to ↑ 58) Cmin: ↑ 47% (↑ 38 to ↑ 57)
Croatian: Cmax: ↑ 47% (od ↑ 37 do ↑ 58) Cmin: ↑ 47% (od ↑ 38 do ↑ 57)
English: The adverse reactions considered at least possibly related to treatment with the components of emtricitabine/tenofovir disoproxil from clinical study and post-marketing experience in HIV-1 infected patients are listed in Table 3, below, by body system organ class and frequency.
Croatian: Nuspojave za koje se na temelju kliničkog ispitivanja i iskustva nakon stavljanja lijeka u promet u pacijenata zaraženih virusom HIV-1 smatra da su barem moguće povezane s liječenjem sastojcima emtricitabin/tenofovirdizoproksila, navedene su niže u Tablici 3 po organskim sustavima i učestalosti.
English: Tacrolimus:
Croatian: Takrolimus:
English: Table 10: Efficacy and adherence in study CO-US-104-0380 (Partners PrEP)
Croatian: Tablica 10: Djelotvornost i pridržavanje terapije u ispitivanju CO-US-104-0380 (Partners PrEP)
English: Once opened use within 90 days.
Croatian: Iskoristiti unutar 90 dana od prvog otvaranja.
English: Interrupting treatment with emtricitabine/tenofovir disoproxil should also be considered in case of progressive decline of renal function when no other cause has been identified.
Croatian: Prekid liječenja emtricitabin/tenofovirdizoproksilom također treba razmotriti u slučaju progresivnog slabljenja funkcije bubrega ako se nije utvrdio niti jedan drugi uzrok.
English: In vivo --pre-exposure prophylaxis: Plasma samples from 2 clinical studies of HIV-1 uninfected subjects, iPrEx and Partners PrEP, were analysed for 4 HIV-1 variants expressing amino acid substitutions (i.e. K65R, K70E, M184V, and M184I) that potentially confer resistance to tenofovir or emtricitabine.
Croatian: PrEP, bili su analizirani na 4 varijante virusa HIV-1 s ekspresijom supstitucije aminokiselina (tj. K65R, K70E, M184V i M184I) koje potencijalno nose rezistenciju na tenofovir ili emtricitabin.
English: No human data on the effect of emtricitabine/tenofovir disoproxil are available.
Croatian: Nema dostupnih podataka o učinku emtricitabin/tenofovirdizoproksila na plodnost u čovjeka.
English: Ribavirin/Tenofovir disoproxil
Croatian: Ribavirin/tenofovirdizoproksil
English: Recommendation concerning co-administration with emtricitabine/tenofovir disoproxil (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Croatian: Preporuka za istovremenu primjenu s emtricitabin/ tenofovirdizoproksilom (emtricitabin 200 mg, tenofovirdizoproksil 245 mg)
English: It is not considered to be causally associated with tenofovir disoproxil in the absence of this condition.
Croatian: Ne smatra se da je uzročno povezana s tenofovirdizoproksilom ako tubulopatija nije prisutna.
English: The increased exposure of tenofovir could potentiate adverse reactions associated with tenofovir disoproxil, including renal disorders.
Croatian: Povećano izlaganje tenofoviru moglo bi pojačati nuspojave povezane s tenofovirdizoproksilom, uključujući poremećaje bubrega.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24)
Croatian: AUC: ↓ 34% (od ↓ 41 do ↓ 25) Cmax: ↓ 34% (od ↓ 41 do ↑ 25) Cmin: ↓ 34% (od ↓ 43 do ↑ 24)
English: • Reminder of the key safety information regarding the use of Emtricitabine/Tenofovir Mylan for
Croatian: • podsjetnik s ključnim informacijama o sigurnosti primjene lijeka Emtricitabin/tenofovirdizoproksil Mylan za predekspozicijsku profilaksu
English: Antiretrovirals
Croatian: ORALNI KONTRACEPTIVI
English: It is preferable that Emtricitabine/Tenofovir disoproxil Mylan is taken with food.
Croatian: Emtricitabin/tenofovirdizoproksil Mylan je najbolje uzimati s hranom.
English: What Emtricitabine/Tenofovir disoproxil Mylan contains
Croatian: Što Emtricitabin/tenofovirdizoproksil Mylan sadrži
English: The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Croatian: Farmakokinetika emtricitabina nije ispitana u pacijenata s oštećenjem funkcije jetre.