FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
Croatian: Jedna tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 300,7 mg tenofovirdizoproksilsukcinata ili 136 mg tenofovira).
English: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg film-coated tablets Emtricitabine/Tenofovir disoproxil
Croatian: Emtricitabine/Tenofovir disoproxil Krka 200 mg/245 mg filmom obložene tablete emtricitabin/tenofovirdizoproksil (Emtricitabinum/Tenofovirum disoproxilum)
English: Lactic acidosis (see Possible serious side effects) fatty liver yellow skin or eyes, itching, or pain in the abdomen (tummy) caused by inflammation of the liver inflammation of the kidney, passing a lot of urine and feeling thirsty, kidney failure, damage to kidney tubule cells softening of the bones (with bone pain and sometimes resulting in fractures) back pain caused by kidney problems
Croatian: Rijetke nuspojave (mogu se javiti u do 1 na 1000 osoba) - laktacidoza (pogledajte Moguće ozbiljne nuspojave) - masna jetra - žuta boja kože ili očiju, svrbež ili bol u trbuhu prouzročena upalom jetre - upala bubrega, mokrenje velikih količina mokraće i osjećaj žeđi, zatajenje bubrega, oštećenje stanica bubrežnih kanalića - omekšavanje kostiju (uz bol u kostima i ponekad s posljedičnim prijelomima) - bol u leđima prouzročen tegobama s bubrezima
English: anaemia
Croatian: anemija
English: Emtricitabine/tenofovir disoproxil has not been studied in individuals over the age of 65 years.
Croatian: Emtricitabin/tenofovirdizoproksil se nije ispitivao u osoba starijih od 65 godina.
English: Recommendation concerning coadministration with Emtricitabine/Tenofovir disoproxil Krka (emtricitabine 200 mg, tenofovir disoproxil 245 mg)
Croatian: Preporuka za istovremenu primjenu s lijekom Emtricitabine/Tenofovir disoproxil Krka (emtricitabin 200 mg, tenofovirdizoproksil 245 mg)
English: Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300.7 mg of tenofovir disoproxil succinate or 136 mg of tenofovir).
Croatian: Jedna filmom obložena tableta sadrži 200 mg emtricitabina i 245 mg tenofovirdizoproksila (što odgovara 300,7 mg tenofovirdizoproksilsukcinata ili 136 mg tenofovira).
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: Common side effects (may affect up to 1 in 10 people) pain, stomach pain difficulty sleeping, abnormal dreams problems with digestion resulting in discomfort after meals, feeling bloated, flatulence rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches other allergic reactions, such as wheezing, swelling or feeling light-headed
Croatian: (vjetrovi) - osipi (uključujući crvene točkice ili mrlje, katkada s pojavom mjehurića i oticanjem kože), koji mogu biti alergijske reakcije, svrbež, promjene boje kože, uključujući tamnjenje dijelova kože - druge alergijske reakcije, kao što su piskanje pri disanju, oticanje ili osjećaj omaglice
English: The use of Emtricitabine/Tenofovir disoproxil Krka is not recommended in individuals under the age of 18 years with renal impairment (see section 4.2).
Croatian: Ne preporučuje se primjena lijeka Emtricitabine/Tenofovir disoproxil Krka u osoba s oštećenjem bubrega mlađih od 18 godina (vidjeti dio 4.2).
English: The adverse reactions considered at least possibly related to treatment with the tenofovir disoproxil and emtricitabine 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 bolesnika zaraženih virusom HIV-1 smatra da su barem moguće povezane s liječenjem sastojcima tenofovirdizoproksilom i emtricitabinom, navedene su niže u Tablici 3 po organskim sustavima i učestalosti.
English: - Reminder of the key safety information regarding the use of Emtricitabine/Tenofovir disoproxil Krka for PrEP in adults and adolescents - Reminder of factors to help identify individuals at high risk of acquiring HIV 1 - Reminder on the risk of development of HIV 1 drug resistance in undiagnosed HIV 1
Croatian: - Podsjetnik s ključnim informacijama o sigurnosti primjene Emtricitabine/Tenofovir disoproxil Krka za predekspozicijsku profilaksu u odraslih i adolescenata - Podsjetnik s čimbenicima radi lakšeg utvrđivanja osoba pod visokim rizikom od dobivanja virusa HIV-1 - Podsjetnik o riziku od razvoja rezistencije virusa HIV-1 na lijekove u nedijagnosticiranih osoba zaraženih virusom HIV-1 - Donosi sigurnosne informacije o pridržavanju terapije, testiranju na HIV, bubrežnom, koštanom i HBV statusu.
English: Psychiatric disorders:
Croatian: Psihijatrijski poremećaji: Često:
English: Placebo Tenofovir disoproxil 245 mg +Emtricitabine/tenofovir disoproxil
Croatian: Tenofovirdizoproksil u dozi od 245 mg + Emtricitabin/tenofovirdizoproksil
English: Antimycobacterials Rifampicin/Tenofovir disoproxil
Croatian: Antimikobakterijski lijekovi Rifampicin/Tenofovirdizoproksil
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Krka to treat HIV is:
Croatian: Preporučena doza lijeka Emtricitabine/Tenofovir disoproxil Krka za liječenje HIV-a je:
English: AUC: ↑ 65% (↑ 59 to ↑ 71) Cmax: ↑ 61% (↑ 51 to ↑ 72) Cmin: ↑ 115% (↑ 105 to ↑ 126)
Croatian: AUC: ↑ 65% (↑ 59 do ↑ 71) Cmax: ↑ 61% (↑ 51 do ↑ 72) Cmin: ↑ 115% (↑ 105 do ↑ 126)
English: Concomitant administration of sofosbuvir/velpatasvir and efavirenz is
Croatian: Sofosbuvir/Velpatasvir
English: No dose adjustment of tacrolimus is required.
Croatian: Nije potrebna prilagodba doziranja takrolimusa.
English: Cmax: ↑ 25% (↑ 8 to ↑ 45) Cmin: ↔
Croatian: Cmax: ↑ 25% (↑ 8 do ↑ 45) Cmin: ↔
English: AUC: ↑ 142% (↑ 123 to ↑ 164) Cmax: ↑ 55% (↑ 41 to ↑ 71) Cmin: ↑ 301% (↑ 257 to ↑ 350)
Croatian: AUC: ↑ 142% (↑ 123 do ↑ 164) Cmax: ↑ 55% (↑ 41 do ↑ 71) Cmin: ↑ 301% (↑ 257 do ↑ 350)
English: Bone problems.
Croatian: - Tegobe s kostima.
English: Other medicines and Emtricitabine/Tenofovir disoproxil Krka
Croatian: Drugi lijekovi i Emtricitabine/Tenofovir disoproxil Krka
English: AUC: ↑ 6% (↓ 1 to ↑ 13) Cmax: ↑13% (↑ 1 to ↑ 27) Cmin: NC
Croatian: AUC: ↑ 6% (↓ 1 do ↑ 13) Cmax: ↑ 13% (↑ 1 do ↑ 27) Cmin: NI
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10) Tenofovir:
Croatian: AUC: ↓ 25% (↓ 42 do ↓ 3) Cmax: ↓ 28% (↓ 50 do ↑ 5) Cmin: ↓ 26% (↓ 46 do ↑ 10)
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/velpatasvirom.
English: Signs of osteonecrosis are: joint stiffness joint aches and pains (especially of the hip, knee and shoulder) difficulty with movement → If you notice any of these symptoms tell your doctor.
Croatian: Znakovi osteonekroze su: - ukočenost zglobova - bol u zglobovima (osobito u kuku, koljenu i ramenu) - otežana pokretljivost
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Krka should not be administered concomitantly (see section 4.4).
Croatian: Adefovirdipivoksil i Emtricitabine/Tenofovir disoproxil Krka ne smiju se primjenjivati istovremeno (vidjeti dio 4.4).
English: Tenofovir disoproxil 245 mg
Croatian: Tenofovirdizoproksi l 245 mg)
English: The same recommendations apply as in adults (see Co-administration of other medicinal products below).
Croatian: Istovremena primjena i rizik od toksičnosti za bubrege Vrijede iste preporuke kao za odrasle (vidjeti dio Istovremena primjena drugih lijekova, u nastavku).
English: expected to decrease plasma concentrations of velpatasvir.
Croatian: Očekuje se da će istovremena primjena sofosbuvira/velpatasvira i efavirenza smanjiti koncentracije velpatasvira u plazmi.
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1) Cmin: NC
Croatian: AUC: ↑ 26% (↑ 20 do ↑ 32) Cmax: ↓ 5% (↓ 11 do ↑ 1) Cmin: NI
English: Emtricitabine/Tenofovir disoproxil Krka should not be administered concomitantly (see section 4.4).
Croatian: Emtricitabine/Tenofovir disoproxil Krka ne smiju se primjenjivati istovremeno (vidjeti dio 4.4).
English: It is preferable that Emtricitabine/Tenofovir disoproxil Krka is taken with food.
Croatian: Lijek Emtricitabine/Tenofovir disoproxil Krka je najbolje uzimati s hranom.
English: Emtricitabine/Tenofovir disoproxil Krka can cause dizziness.
Croatian: Emtricitabine/Tenofovir disoproxil Krka može uzrokovati omaglicu.
English: AUC: ↑ 50% (↑ 42 to ↑ 59) Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Croatian: AUC: ↑ 50% (↑ 42 do ↑ 59) Cmax: ↑ 64% (↑ 54 do ↑ 74) Cmin: ↑ 59% (↑ 49 do ↑ 70)
English: Emtricitabine/Tenofovir disoproxil Krka should only be used in individuals with creatinine clearance (CrCl) <80 mL/min if the potential benefits are considered to outweigh the potential risks.
Croatian: < 80 mL/min ako se smatra da su moguće koristi veće od mogućih rizika.
English: Sofosbuvir: AUC: ↔
Croatian: Velpatasvir: AUC: ↔
English: If renal abnormalities are detected or suspected then consultation with a nephrologist should be obtained to consider interruption of Emtricitabine/Tenofovir disoproxil Krka treatment - That Emtricitabine/Tenofovir disoproxil Krka may cause a reduction in BMD and the effects of Emtricitabine/Tenofovir disoproxil Krka associated changes in BMD on long term bone health and future fracture risk are currently unknown in paediatric patients - That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Croatian: - Emtricitabine/Tenofovir disoproxil Krka može izazvati smanjenje BMD-a, a učinci promjena BMD-a povezanih s lijekom Emtricitabine/Tenofovir disoproxil Krka na dugoročno zdravlje kosti i rizik od budućih lomova u pedijatrijskih bolesnika trenutno nisu poznati.
English: AUC: ↓ 34% (↓ 41 to ↓ 25) Cmax: ↓ 34% (↓ 41 to ↑ 25) Cmin: ↓ 34% (↓ 43 to ↑ 24) Sofosbuvir:
Croatian: AUC: ↓ 34% (↓ 41 do ↓ 25) Cmax: ↓ 34% (↓ 41 do ↑ 25) Cmin: ↓ 34% (↓ 43 do ↑ 24)
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5) Cmin: NC
Croatian: AUC: ↓ 5% (↓ 9 do ↓ 1) Cmax: ↓ 11% (↓ 17 do ↓ 5) Cmin: NI
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24) Cmin: NC
Croatian: AUC: ↓ 4% (↓ 32 do ↑ 34) Cmax: ↓ 5% (↓ 27 do ↑ 24) Cmin: NI
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9) Cmin: NC
Croatian: AUC: ↑ 4% (↓ 3 do ↑ 11) Cmax: ↑ 3% (↓ 3 do ↑ 9) Cmin: NI
English: - HIV renal educational brochure - HIV pediatric renal educational brochure - PrEP educational brochure for prescribers entitled ‘Important Safety Information for
Croatian: - Edukacijska brošura o HIV-u i renalnoj funkciji u djece - Edukacijska brošura o predekspozicijskoj profilaksi za propisivače, s naslovom „Važne informacije za propisivače o sigurnosti primjene lijeka Emtricitabine/Tenofovir disoproxil Krka u indikaciji predekspozicijske profilakse (PrEP)” - Lista provjere kod predekspozicijske profilakse za propisivača - Edukacijska brošura o predekspozicijskoj profilaksi za osobu pod rizikom, s naslovom „Važne informacije o lijeku Emtricitabine/Tenofovir disoproxil Krka radi smanjenja rizika od dobivanja infekcije virusom humane imunodeficijencije (HIV)” - Kartica-podsjetnik kod predekspozicijske profilakse
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14) Cmin: NC
Croatian: AUC: ↑ 5% (↓ 2 do ↑ 13) Cmax: ↑ 5% (↓ 3 do ↑ 14) Cmin: NI
English: Only samples from subjects randomized to emtricitabine/tenofovir disoproxil were evaluated for detectable plasma or intracellular tenofovir disoproxil-DP levels.
Croatian: Mjerljive razine tenofovirdizoproksila-DP-a u plazmi ili unutar stanica bile su procijenjene samo u uzorcima ispitanika randomiziranih na primanje emtricitabin/tenfovitdizoproksila.
English: Co-administration of Emtricitabine/Tenofovir disoproxil Krka and didanosine is not recommended (see section 4.4).
Croatian: Emtricitabine/Tenofovir disoproxil Krka i didanozina (vidjeti dio 4.4).
English: The pharmacokinetics of emtricitabine has not been studied in patients with hepatic impairment.
Croatian: Farmakokinetika emtricitabina nije ispitana u bolesnika s oštećenjem funkcije jetre.
English: Emtricitabine/Tenofovir disoproxil Krka may affect your kidneys.
Croatian: - Emtricitabine/Tenofovir disoproxil Krka može utjecati na bubrege.
English: Emtricitabine/Tenofovir disoproxil Krka should not be given to adolescents with existing kidney problems.
Croatian: Emtricitabine/Tenofovir disoproxil Krka se ne smije propisati adolescentima koji imaju tegobe s bubrezima.
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: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 50 mL/min in any patient receiving Emtricitabine/Tenofovir disoproxil Krka, renal function should be reevaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako su u bilo kojeg bolesnika koji prima Emtricitabine/Tenofovir disoproxil Krka fosfati u serumu < 1,5 mg/dL (0,48 mmol/L) ili se klirens kreatinina smanji na < 50 mL/min, unutar jednoga tjedna treba ponovno procijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u urinu (vidjeti dio 4.8, proksimalna tubulopatija).
English: No dose adjustment of efavirenz is required.
Croatian: Nije potrebna prilagodba doziranja efavirenza.
English: Atazanavir/Ritonavir/Emtricitabine Interaction not studied.
Croatian: Atazanavir/Ritonavir/Emtricitabin
English: Ribavirin/Tenofovir disoproxil
Croatian: Ribavirin/Tenofovirdizoproksil
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NC
Croatian: AUC: ↓ 4% (↓ 7 do ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2) Cmin: NI
English: Darunavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Croatian: Darunavir/Ritonavir/Tenofovirdizoproksil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Krka, another tablet should be taken.
Croatian: Ako nastupi povraćanje, a prošlo je manje od 1 sata od uzimanja lijeka Emtricitabine/Tenofovir disoproxil Krka, treba uzeti drugu tabletu.
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1) Cmin: NC
Croatian: AUC: ↓ 7% (↓ 13 do ↓ 1) Cmax: ↓ 11% (↓ 20 do ↑ 1) Cmin: NI
English: This adverse reaction may occur as a consequence of proximal renal tubulopathy.
Croatian: Ova nuspojava može nastati kao posljedica proksimalne bubrežne tubulopatije.
English: If serum phosphate is confirmed to be < 3.0 mg/dl (0.96 mmol/l) in any paediatric patient receiving Emtricitabine/Tenofovir disoproxil Krka, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako su u bilo kojeg pedijatrijskog bolesnika koji prima Emtricitabine/Tenofovir disoproxil Krka fosfati u serumu < 3,0 mg/dL (0,96 mmol/L), unutar jednog tjedna treba ponovno procijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: If serum phosphate is < 1.5 mg/dL (0.48 mmol/L) or creatinine clearance is decreased to < 60 mL/min in any individual receiving Emtricitabine/Tenofovir disoproxil Krka for pre-exposure prophylaxis, renal function should be re-evaluated within one week, including measurements of blood glucose, blood potassium and urine glucose concentrations (see section 4.8, proximal tubulopathy).
Croatian: Ako su u bilo koje osobe koja prima Emtricitabine/Tenofovir disoproxil Krka za predekspozicijsku profilaksu fosfati u serumu < 1,5 mg/dL (0,48 mmoL/l) ili se klirens kreatinina smanji na < 60 mL/min, unutar jednoga tjedna treba ponovno ocijeniti funkciju bubrega, kao i izmjeriti koncentracije glukoze u krvi, kalija u krvi i glukoze u mokraći (vidjeti dio 4.8, proksimalna tubulopatija).
English: AUC: ↑ 96% (↑ 74 to ↑ 121) Cmax: ↑ 68% (↑ 54 to ↑ 84) Cmin: ↑ 118% (↑ 91 to ↑ 150) Sofosbuvir:
Croatian: AUC: ↑ 96% (↑ 74 do ↑ 121) Cmax: ↑ 68% (↑ 54 do ↑ 84) Cmin: ↑ 118% (↑ 91 do ↑ 150)
English: Before taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV:
Croatian: Prije uzimanja lijeka Emtricitabine/Tenofovir disoproxil Krka radi smanjenja rizika od dobivanja HIV-a:
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV is:
Croatian: Preporučena doza lijeka Emtricitabine/Tenofovir disoproxil Krka za smanjivanje rizika od dobivanja HIV-a:
English: No dose adjustment of famciclovir is required.
Croatian: Nije potrebna prilagodba doziranja famciklovira.
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22) Cmin: NC
Croatian: AUC: ↓ 1% (↓ 8 do ↑ 6) Cmax: ↑ 7% (↓ 6 do ↑ 22) Cmin: NI
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6) Cmin: NC
Croatian: AUC: ↓ 2% (↓ 5 do ↑ 0) Cmax: ↓ 1% (↓ 7 do ↑ 6) Cmin: NI
English: Efavirenz/Emtricitabine/Tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Croatian: Efavirenz/Emtricitabin/Tenofovirdizoproksil (600 mg/200 mg/245 mg q.d.)
English: Uncommon side effects (may affect up to 1 in 100 people) pain in the abdomen (tummy) caused by inflammation of the pancreas swelling of the face, lips, tongue or throat anaemia (low red blood cell count) breakdown of muscle, muscle pain or weakness which may occur due to damage to the kidney tubule cells
Croatian: - oticanje lica, usana, jezika ili grla - anemija (nizak broj crvenih krvnih stanica) - propadanje mišića, bolovi u mišićima ili slabost mišića, koji mogu nastati zbog oštećenja stanica bubrežnih kanalića
English: Atazanavir/Ritonavir/Tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Croatian: Atazanavir/Ritonavir/Tenofovirdizoproksil (300 mg q.d./100 mg q.d./245 mg q.d.)
English: While taking Emtricitabine/Tenofovir disoproxil Krka to treat HIV or to reduce the risk of getting HIV:
Croatian: Dok uzimate lijek Emtricitabine/Tenofovir disoproxil Krka za liječenje HIV-a ili za smanjivanje rizika od dobivanja HIV-a:
English: Darunavir/Ritonavir/Emtricitabine Interaction not studied.
Croatian: Darunavir/Ritonavir/Emtricitabin
English: No dose adjustment is required.
Croatian: Nije potrebna prilagodba doziranja.
English: How to store Emtricitabine/Tenofovir disoproxil Krka
Croatian: Kako uzimati Emtricitabine/Tenofovir disoproxil Krka
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11) Cmin: NC
Croatian: AUC: ↓ 9% (↓ 16 do ↓ 1) Cmax: ↓ 7% (↓ 22 do ↑ 11) Cmin: NI
English: Co-administration is not recommended because it results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse reactions (see section 4.5).
Croatian: Istovremena primjena tenofovirdizoproksila i didanozina Ne preporučuje se njihova istovremena primjena zato što rezultira 40−60%-tnim povećanjem sistemske izloženosti didanozinu, što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
English: AUC: ↓ 27% (↓ 35 to ↓ 18) Cmax: ↓ 37% (↓ 48 to ↓ 25) GS-331007
Croatian: Cmax: ↓ 37% (↓ 48 do ↓ 25) GS-331007
English: Tablet core
Croatian: Praćenje funkcije bubrega
English: AUC: ↓ 4% (↓ 9 to ↑ 0) Cmax: ↓ 6% (↓ 13 to ↑ 0) Cmin: ↓ 2% (↓ 9 to ↑ 6)
Croatian: AUC: ↓ 4% (↓ 9 do ↑ 0) Cmax: ↓ 6% (↓ 13 do ↑ 0)
English: Emtricitabine/tenofovir disoproxil
Croatian: Emtricitabinum/Tenofovirum disoproxilum
English: Emtricitabine/Tenofovir disoproxil (200 mg/245 mg q.d.)
Croatian: Emtricitabin/Tenofovirdizoproksil (200 mg/245 mg q.d.)
English: Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV infection - Reminder on the importance of strict adherence to the recommended dosing regimen - Provides information on how to take Emtricitabine/Tenofovir disoproxil Krka - Provides information on the possible side effects - Provides information on how to store Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Emtricitabine/Tenofovir disoproxil Krka radi smanjenja rizika od dobivanja infekcije HIV-om - Podsjetnik o važnosti strogog pridržavanja preporučenog režima doziranja
English: These may be signs of HIV infection: - tiredness - fever - joint or muscle aches - headache - vomiting or diarrhoea - rash - night sweats - enlarged lymph nodes in the neck or groin → Tell your doctor about any flu-like illness - either in the month before starting Emtricitabine/Tenofovir disoproxil Krka, or at any time while taking Emtricitabine/Tenofovir disoproxil Krka.
Croatian: Ovo mogu biti znakovi infekcije virusom HIV-a: - umor - vrućica - bolovi u zglobovima ili mišićima - glavobolja - povraćanje ili proljev - osip - noćno znojenje - povećani limfni čvorovi na vratu ili u preponama
English: Other effects in children Children given emtricitabine very commonly experienced changes in skin colour including darkening of the skin in patches Children commonly experienced low red blood cell count (anaemia) - this may cause the child to be tired or breathless → If you notice any of these symptoms tell your doctor.
Croatian: Ostali učinci u djece - Djeca liječena emtricitabinom vrlo su često imala promjene boje kože, uključujući
English: Cmin: ↑ 48% (↑ 34 to ↑ 63) Emtricitabine:
Croatian: Cmin: ↑ 48% (↑ 34 do ↑ 63)
English: Cmax: ↑ 79% (↑ 56 to ↑ 104) Cmin: ↑ 163% (↑ 137 to ↑ 197)
Croatian: AUC: ↑ 98% (↑ 77 do ↑ 123) Cmax: ↑ 79% (↑ 56 do ↑ 104) Cmin: ↑ 163% (↑ 137 do ↑ 197)
English: Cmin: ↑ 45% (↑ 27 to ↑ 64) Emtricitabine:
Croatian: Cmin: ↑ 45% (↑ 27 do ↑ 64)
English: Detection Versus No Detection of Tenofovir
Croatian: Procjena rizika za zaštitu od virusa HIV-1: Detektiran naspram nedetektiran tenofovir
English: Renal and bone effects in adults
Croatian: Učinci na bubrege i kosti u odraslih
English: Difference (95%CI) 32 (9 to 55)
Croatian: 32 (9 do 55)
English: ORAL CONTRACEPTIVES Norgestimate/Ethinyl oestradiol/Tenofovir disoproxil
Croatian: Norgestimat/Etinilestradiol/Tenofovirdizopro ksil
English: + Emtricitabine/Rilpivirine/ Tenofovir disoproxil (200 mg/25 mg/245 mg q.d.)
Croatian: Emtricitabin/Rilpivirin/Tenofovirdizoproksil (200 mg/25 mg/245 mg q.d.)
English: While taking Emtricitabine/Tenofovir disoproxil Krka to reduce the risk of getting HIV:
Croatian: Dok uzimate Emtricitabine/Tenofovir disoproxil Krka za smanjenje rizika od dobivanja HIV-a:
English: Lopinavir/Ritonavir/Emtricitabine Interaction not studied.
Croatian: Lopinavir/Ritonavir/Emtricitabin
English: Individuals should be re-confirmed to be HIV-negative at frequent intervals (e.g. at least every 3 months) using a combined antigen/antibody test while taking Emtricitabine/Tenofovir disoproxil Krka for pre-exposure prophylaxis.
Croatian: Dok uzimaju Emtricitabine/Tenofovir disoproxil Krka zbog predekspozicijske profilakse, te se osobe trebaju često testirati (npr. najmanje svaka 3 mjeseca) pomoću kombiniranog testa antigen-protutijelo kako bi se potvrdilo da su i dalje HIV-negativne.
English: A higher risk of renal impairment has been reported in HIV-1 infected patients receiving tenofovir disoproxil in combination with a ritonavir or cobicistat boosted protease inhibitor.
Croatian: U bolesnika zaraženih virusom HIV-1 koji su primali tenofovirdizoproksil u kombinaciji s ritonavirom ili kobicistatom pojačanim inhibitorom proteaze zabilježen je veći rizik od oštećenja funkcije bubrega.