FrancophonIA/ELRC3.0 huggingface dataset:
English: Consideration should be given to interrupting use of with emtricitabine/tenofovir disoproxil in individuals with creatinine clearance decreased to < 60 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Croatian: Treba razmotriti mogućnost prekida primjene emtricitabin/tenofovirdizoproksila u osoba u kojih je klirens kreatinina smanjen na < 60 ml/min ili su fosfati u serumu sniženi na < 1,0 mg/dL (0,32 mmol/l).
English: Assessment of adverse reactions related to emtricitabine is based on experience in three paediatric studies (n = 169) where treatment-naïve (n = 123) and treatment-experienced (n = 46) paediatric HIV infected patients aged 4 months to 18 years were treated with emtricitabine in combination with other antiretroviral agents.
Croatian: Procjena nuspojava povezanih s emtricitabinom temelji se na iskustvu triju ispitivanja provedenih na pedijatrijskim pacijentima u dobi od 4 mjeseca do 18 godina zaraženima HIV-om (n = 169), u kojima su pacijenti koji prethodno nisu bili liječeni (n = 123) i prethodno liječeni pacijenti (n = 46) primali emtricitabin u kombinaciji s drugim antiretrovirusnim lijekovima.
English: Relative Risk Reduction (95% CI)
Croatian: Smanjenje relativnog rizika (95 % CI)
English: • Emtricitabine/tenofovir disoproxil may affect your kidneys.
Croatian: • Emtricitabin/tenofovirdizoproksil može utjecati na bubrege.
English: PrEP reminder card for the individual at risk (to be provided by HCP):
Croatian: Kartica-podsjetnik za osobe pod rizikom kod predekspozicijske profilakse (osobi je daje zdravstveni radnik):
English: pancreatitis
Croatian: pankreatitis
English: Cmax: ↓ 23% (↓ 30 to ↑ 16)
Croatian: Cmax: ↓ 23% (od ↓ 30 do ↑ 16)
English: Rarely, pancreatitis and lactic acidosis, sometimes fatal, have been reported.
Croatian: U rijetkim su slučajevima zabilježeni pankreatitis i laktacidoza, ponekad sa smrtnim ishodom.
English: • fatty liver
Croatian: • masna jetra
English: angioedema
Croatian: angioedem
English: • PrEP Checklist for prescribers
Croatian: • Lista provjere za propisivače kod predekspozicijske profilakse
English: No dose adjustment is required in patients with hepatic impairment (see sections 4.4 and 5.2).
Croatian: U pacijenata s oštećenjem funkcije jetre nije potrebno prilagođavati dozu (vidjeti dijelove 4.4 i 5.2).
English: The adverse reactions observed in paediatric patients who received treatment with tenofovir disoproxil were consistent with those observed in clinical studies of tenofovir disoproxil in adults (see section 4.8 Tabulated summary of adverse reactions and 5.1).
Croatian: Nuspojave zabilježene u pedijatrijskih pacijenata liječenih tenofovirdizoproksilom u skladu su s onima dobivenim u kliničkim ispitivanjima tenofovirdizoproksila u odraslih (vidjeti dio 4.8, Tablični prikaz nuspojava i dio 5.1).
English: HIV-1 infected patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Croatian: Pacijenti zaraženi virusom HIV-1 i s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
English: • The other ingredients are cellulose microcrystalline, hydroxypropyl cellulose, low-substituted, iron oxide red (E172), silica colloidal anhydrous, lactose monohydrate (see section 2 ‘Emtricitabine/Tenofovir disoproxil Mylan contains lactose'), magnesium stearate, hypromellose,
Croatian: • Drugi sastojci su mikrokristalična celuloza, hidroksipropilceluloza, djelomično supstituirana, crveni željezov oksid (E172), koloidni, bezvodni silicijev dioksid, laktoza hidrat (pogledajte dio 2 „Emtricitabin/tenofovirdizoproksil Mylan sadrži laktozu”), magnezijev stearat, hipromeloza, titanijev dioksid (E171), triacetin, boja brilliant blue FCF Aluminum lake (E133), žuti željezov oksid (E172).
English: Emtricitabine/tenofovir disoproxil has not been studied in patients over 65 years of age.
Croatian: Emtricitabin/tenofovirdizoproksil nije ispitan u pacijenata starijih od 65 godina.
English: Interaction with didanosine: 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 (see section 4.5).
Croatian: Interakcija s didanozinom: Ne preporučuje se istovremena primjena tenofovirdizoproksila i didanozina, jer rezultira 40-60%-tnim povećanjem sistemske izloženosti didanozinu što može povećati rizik od nuspojava povezanih s didanozinom (vidjeti dio 4.5).
English: Pharmacokinetic parameters were mainly determined following administration of single doses of emtricitabine 200 mg or tenofovir disoproxil 245 mg to non-HIV infected subjects with varying degrees of renal impairment.
Croatian: Farmakokinetički parametri određeni su uglavnom nakon primjene jednokratnih doza od 200 mg emtricitabina ili 245 mg tenofovirdizoproksila kod ispitanika koji nisu bili zaraženi virusom HIV-a, a imali su različiti stupanj oštećenja funkcije bubrega.
English: • dizziness, headache
Croatian: • omaglica, glavobolja
English: Emtricitabine
Croatian: Emtricitabin
English: After oral administration of emtricitabine or tenofovir disoproxil, emtricitabine and tenofovir are widely distributed throughout the body.
Croatian: Nakon peroralne primjene emtricitabina illi tenofovirdizoproksila, emtricitabin i tenofovir se široko distribuiraju po tijelu.
English: Use with ledipasvir and sofosbuvir, sofosbuvir and velpatasvir or sofosbuvir, velpatasvir and voxilaprevir
Croatian: Primjena s ledipasvirom i sofosbuvirom, sofosbuvirom i velpatasvirom ili sofosbuvirom, velpatasvirom i voksilaprevirom
English: hypophosphataemia1
Croatian: hipofosfatemija1
English: Renal impairment: Emtricitabine and tenofovir are eliminated by renal excretion and the exposure to emtricitabine and tenofovir increases in individuals with renal dysfunction (see sections 4.4 and 5.2).
Croatian: Oštećenje funkcije bubrega: Emtricitabin i tenofovir eliminiraju se izlučivanjem putem bubrega i izloženost emtricitabinu i tenofoviru povećava se u osoba s poremećenom funkcijom bubrega (vidjeti dijelove 4.4 i 5.2).
English: The pharmacokinetics of tenofovir has been studied in patients with hepatic impairment and no dose adjustment is required.
Croatian: Farmakokinetika tenofovira ispitana je u pacijenata s oštećenjem funkcije jetre i u tih pacijenata nije potrebno prilagođavati dozu.
English: No dose adjustment of efavirenz is required.
Croatian: Nije potrebno prilagođivati dozu efavirenza.
English: uninfected individuals should be counselled at frequent intervals to strictly adhere to the recommended Emtricitabine/tenofovir disoproxil daily dosing schedule.
Croatian: Osobama koje nisu zaražene virusom HIV-1 treba opetovano savjetovati da se strogo pridržavaju preporučenog dnevnog rasporeda doziranja emtricitabin/tenofovirdizoproksila.
English: What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for 2.
Croatian: Što je Emtricitabin/tenofovirdizoproksil Mylan i za što se koristi 2.
English: (may affect up to 1 in 100 people)
Croatian: (mogu se javiti u do 1 na 100 osoba)
English: • cidofovir (for viral infection)
Croatian: • cidofovir (za virusnu infekciju)
English: Emtricitabine/Tenofovir disoproxil Mylan should be initiated by a physician experienced in the management of HIV infection.
Croatian: Terapiju lijekom Emtricitabin/tenofovirdizoproksil Mylan mora započeti liječnik s iskustvom u liječenju infekcije HIV-om.
English: Tenofovir pharmacokinetics were not substantially altered in subjects with hepatic impairment suggesting that no dose adjustment is required in these subjects.
Croatian: Farmakokinetika tenofovira nije se bitno izmijenila u ispitanika s oštećenjem funkcije jetre, što navodi na zaključak da u tih ispitanika nije potrebno prilagođavati dozu.
English: Cmax: ↓ 19% (↓ 40 to ↑ 10)
Croatian: Cmax: ↓ 19% (od ↓ 40 do ↑ 10)
English: • That Emtricitabine/Tenofovir disoproxil Mylan is not recommended for use in paediatric patients with renal impairment
Croatian: • Primjena lijeka Emtricitabin/tenofovirdizoproksil Mylan ne preporučuje se u pedijatrijskih pacijenata s oštećenjem bubrega.
English: The Partners PrEP clinical study (CO-US-104-0380) evaluated emtricitabine/tenofovir disoproxil, tenofovir disoproxil 245 mg, or placebo in 4,758 HIV-uninfected subjects from Kenya or Uganda in serodiscordant heterosexual couples.
Croatian: Kliničko ispitivanje Partners PrEP (CO-US-104-0380) procijenilo je emtricitabin/tenofovirdizoproksil u dozi od 245 mg ili placebo u 4758 ispitanika koji nisu bili zaraženi HIV-om iz Kenije ili Ugande koji su bili u heteroseksualnom odnosu s partnerom drugačijeg serološkog statusa.
English: vesiculobullous rash, pustular rash, maculopapular rash, rash, pruritus, urticaria, skin discolouration (increased pigmentation)2
Croatian: vezikulobulozni osip, pustulozni osip, makulopapularni osip, osip, svrbež, urtikarija, promjena boje kože (pojačana pigmentacija)2
English: Multipack: 90 (3 bottle packs of 30) film-coated tablets
Croatian: 4. FARMACEUTSKI OBLIK I SADRŽAJ Višestruko pakiranje: 90 (3 boce po 30) filmom obloženih tableta 5. NAČIN I PUT PRIMJENE LIJEKA
English: As emtricitabine/tenofovir disoproxil fixed-dose combination tablets contains emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with the fixed-dose combination.
Croatian: Emtricitabin/tenofovirdizoproksil je tableta s kombinacijom fiksnih doza emtricitabina i tenofovirdizoproksila, pa sve interakcije koje su utvrđene u zasebnoj primjeni tih lijekova mogu nastupiti i pri kombinaciji fiksnih doza.
English: • If you notice within 12 hours of the time you usually take Emtricitabine/Tenofovir disoproxil Mylan, take the tablet preferably with food as soon as possible.
Croatian: • Ako ste to primijetili prije nego je proteklo 12 sati od vremena kada obično uzimate lijek Emtricitabin/tenofovirdizoproksil Mylan, uzmite dozu čim prije, po mogućnosti s hranom.
English: In patients who received treatment with tenofovir disoproxil, or stavudine or zidovudine, mean lumbar spine BMD Z score was 1.034 and 0.498, and mean total body BMD Z-score was 0.471 and 0.386, respectively, at baseline.
Croatian: U pacijenata koji su primili tenofovirdizoproksil, odnosno stavudin ili zidovudin, početna srednja z-vrijednost BMD-a u području lumbalne kralježnice bila je −1,034 odnosno −0,498, a ukupnog BMD-a −0,471 odnosno −0,386.
English: Individuals with renal impairment: Since tenofovir disoproxil can cause renal toxicity, close monitoring of renal function is recommended in any adults with renal impairment receiving emtricitabine/tenofovir disoproxil (see sections 4.2, 4.4 and 5.2).
Croatian: Osobe s oštećenjem funkcije bubrega: Tenofovirdizoproksil može prouzročiti bubrežnu toksičnost, pa se preporučuje pomno praćenje funkcije bubrega u svih odraslih osoba s oštećenom funkcijom bubrega koje se liječi emtricitabin/tenofovirdizoproksilom (vidjeti dijelove 4.2, 4.4 i 5.2).
English: Treatment of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg: One tablet,
Croatian: Liječenje 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: Overall HIV-1 infection prevention strategy
Croatian: Ukupna strategija sprječavanja infekcije virusom HIV-1
English: Renal impairment: As emtricitabine/tenofovir disoproxil may cause renal damage, monitoring of renal function is recommended (see section 4.4).
Croatian: Oštećenje funkcije bubrega: Emtricitabin/tenofovirdizoproksil može prouzročiti oštećenje bubrega, pa se preporučuje praćenje funkcije bubrega (vidjeti dio 4.4).
English: • Bone problems.
Croatian: • Tegobe s kostima.
English: Cmax: ↓ 30% (↓ 41 to ↓ 17) Cmin: ↑ 63% (↑ 43 to ↑ 85)
Croatian: Cmax: ↓ 30% (↓ 41 do ↓ 17) Cmin: ↑ 63% (↑ 43 do ↑ 85)
English: The mean (%CV) tenofovir Cmax and AUC0-∞ values were 223 (34.8%) ng/mL and 2,050 (50.8%) ng•h/mL, respectively, in normal subjects compared with 289 (46.0%) ng/mL and 2,310 (43.5%) ng•h/mL in subjects with moderate hepatic impairment, and 305 (24.8%) ng/mL and 2,740 (44.0%) ng•h/mL in subjects with severe hepatic impairment.
Croatian: U normalnih ispitanika prosječne vrijednosti (%CV) Cmax i AUC0-∞ tenofovira bile su 223 (34,8%) ng/ml odnosno 2050 (50,8%) ng•h/ml, u usporedbi s 289 (46,0%) ng/ml i 2310 (43,5%) ng•h/ml u ispitanika s umjerenim oštećenjem funkcije jetre, te 305 (24,8%) ng/ml i 2740 (44,0%) ng•h/ml u ispitanika s teškim oštećenjem funkcije jetre.
English: Emtricitabine/tenofovir disoproxil can cause dizziness.
Croatian: Emtricitabin/tenofovirdizoproksil može uzrokovati omaglicu.
English: In HIV-1 infected patients with renal risk factors, the co-administration of tenofovir disoproxil with a boosted protease inhibitor should be carefully evaluated.
Croatian: U pacijenata zaraženih virusom HIV-1 s bubrežnim čimbenicima rizika potrebno je pažljivo procijeniti istovremenu primjenu tenofovirdizoproksila s pojačanim inhibitorom proteaze.
English: Treatment of HIV-1 infection:
Croatian: Liječenje infekcije virusom HIV-1:
English: NAME OF THE MARKETING AUTHORISATION HOLDER MYLAN S.A.S
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET MYLAN S.A.S
English: Ethnicity
Croatian: Etnička pripadnost
English: Mean changes at week 48 (end of randomised phase) were 0.032 and 0.087 in lumbar spine BMD Z score, and 0.184 and 0.027 in total body BMD Z score for the tenofovir disoproxil and stavudine or zidovudine groups, respectively.
Croatian: Srednje vrijednosti promjene u 48. tjednu (kraj randomizirane faze) bile su 0,032 odnosno 0,087 u z-vrijednostima BMD-a u području lumbalne kralježnice te −0,184 odnosno −0,027 u z-vrijednostima ukupnog BMD-a za skupinu koja je primila tenofovirdizoproksil, odnosno skupinu koja je primila stavudin ili zidovudin.
English: • That if bone abnormalities are detected or suspected then consultation with an endocrinologist and/or nephrologist should be obtained
Croatian: • Ako se otkriju abnormalnosti kosti ili se na njih posumnja, potrebno je savjetovati se s endokrinologom i/ili nefrologom.
English: Clinical efficacy and safety of emtricitabine/tenofovir disoproxil was established from studies conducted with emtricitabine and tenofovir disoproxil when given as single agents.
Croatian: Klinička djelotvornost i sigurnost emtricitabin/tenofovirdizoproksila utvrđene su na temelju ispitivanja provedenih s emtricitabinom i tenofovirdizoproksilom kao pojedinačnim lijekovima.
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan
Croatian: Što morate znati prije nego počnete uzimati Emtricitabin/tenofovirdizoproksil Mylan
English: Patients receiving ledipasvir/sofosbuvir sofosbuvir/velpatasvir or sofosbuvir/velpatasvir/voxilaprevir concomitantly with tenofovir disoproxil and a boosted HIV protease inhibitor should be monitored for adverse reactions related to tenofovir disoproxil.
Croatian: Pacijente koji primaju ledipasvir/sofosbuvir, sofosbuvir/velpatasvir ili sofosbuvir/velpatasvir/voksilaprevir istovremeno s tenofovirdizoproksilom i pojačanim inhibitorom HIV-proteaze potrebno je pratiti zbog mogućih nuspojava povezanih s tenofovirdizoproksilom.
English: • HIV paediatric renal educational brochure
Croatian: • Edukacijska brošura o HIV-u i renalnoj funkciji u djece
English: If bone abnormalities are detected or suspected during use of emtricitabine/tenofovir disoproxil in any paediatric patient, consultation with an endocrinologist and/or nephrologist should be obtained.
Croatian: Ako se tijekom primjene emtricitabin/tenofovirdizoproksila u pedijatrijskih pacijenata otkriju abnormalnosti kosti ili se na njih posumnja, potrebno je konzultirati se s endokrinologom i/ili nefrologom.
English: Separate preparations of emtricitabine and tenofovir disoproxil are available for treatment of HIV-1 infection if it becomes necessary to discontinue or modify the dose of one of the components of
Croatian: Za liječenje infekcije virusom HIV-1 postoje odvojeni pripravci emtricitabina i tenofovirdizoproksila ako postane neophodno prekinuti primjenu ili prilagoditi dozu jedne od djelatnih tvari lijeka Emtricitabin/tenofovirdizoproksil Mylan.
English: dizziness headache
Croatian: omaglica glavobolja
English: Table 5: Study population from study CO-US-104-0288 (iPrEx)
Croatian: Tablica 5: Ispitivana populacija u ispitivanju CO-US-104-0288 (iPrEx)
English: What you need to know before you take Emtricitabine/Tenofovir disoproxil Mylan 3.
Croatian: Što morate znati prije nego počnete uzimati lijek Emtricitabin/tenofovirdizoproksil Mylan 3.
English: What Emtricitabine/Tenofovir disoproxil Mylan looks like and contents of the pack
Croatian: Kako Emtricitabin/tenofovirdizoproksil Mylan izgleda i sadržaj pakiranja
English: In patients who received treatment with tenofovir disoproxil or placebo, mean lumbar spine BMD Z score was -1.004 and -0.809, and mean total body BMD Z-score was -0.866 and -0.584, respectively, at baseline.
Croatian: U pacijenata koji su primili tenofovirdizoproksil, odnosno placebo, početna srednja z-vrijednost BMD-a u području lumbalne kralježnice bila je −1,004 odnosno −0,809, a početna srednja z-vrijednost ukupnog BMD-a bila je −0,866 odnosno −0,584.
English: • amphotericin B (for fungal infection)
Croatian: • amfotericin B (za gljivičnu infekciju)
English: IMMUNOSUPPRESSANTS
Croatian: IMUNOSUPRESIVI
English: What Emtricitabine/Tenofovir disoproxil Mylan is and what it is used for
Croatian: Što je Emtricitabin/tenofovirdizoproksil Mylan i za što se koristi
English: Voxilaprevir: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
Croatian: Voksilaprevir: AUC: ↑ 143% Cmax:↑ 72% Cmin: ↑ 300%
English: Emtricitabine+ tenofovir disoproxil +efavirenz*
Croatian: Emtricitabin+ tenofovirdizoproksil +efavirenz*
English: Emtricitabine:
Croatian: Emtricitabin:
English: The steady-state pharmacokinetics of emtricitabine and tenofovir were unaffected when emtricitabine and tenofovir disoproxil were administered together versus each medicinal product dosed alone.
Croatian: Farmakokinetika emtricitabina i tenofovira u stanju dinamičke ravnoteže nije se promijenila kada su emtricitabin i tenofovirdizoproksil primijenjeni zajedno, u odnosu na primjenu svakoga lijeka posebno.
English: The pharmacokinetics of emtricitabine and tenofovir (administered as tenofovir disoproxil) in paediatric patients with renal impairment have not been studied.
Croatian: Nije ispitana farmakokinetika emtricitabina i tenofovira (primijenjenog u obliku tenofovirdizoproksila) u pedijatrijskih pacijenata s oštećenjem bubrega.
English: • vancomycin (for bacterial infection)
Croatian: • vankomicin (za bakterijsku infekciju)
English: Pre-exposure prophylaxis: No new adverse reactions to emtricitabine/tenofovir disoproxil were identified from two randomised placebo-controlled studies (iPrEx, Partners PrEP) in which 2,830 HIV-1 uninfected adults received emtricitabine/tenofovir disoproxil once daily for pre-exposure prophylaxis.
Croatian: Predekspozicijska profilaksa: U dva randomizirana, placebom kontrolirana ispitivanja (iPrEx, Partners PrEP) u kojima je 2830 odraslih koji nisu bili zaraženi virusom HIV-1 primalo emtricitabin/tenofovirdizoproksil jedanput na dan za predekspozicijsku profilaksu nisu bile utvrđene nove nuspojave emtricitabin/tenofovirdizoproksila.
English: GS-3310072: AUC: ↔ Cmax:↔ Cmin: N/A
Croatian: GS-3310072: AUC: ↔ Cmax:↔ Cmin: N/P
English: Use of emtricitabine/tenofovir disoproxil should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Croatian: Potrebno je izbjegavati primjenu emtricitabin/tenofovirdizoproksila uz istovremenu ili nedavnu primjenu nefrotoksičnih lijekova (vidjeti dio 4.5).
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Croatian: AUC: ↓ 53% (↓ 61 do ↓ 43) Cmax: ↓ 47% (↓ 57 do ↓ 36) Cmin: ↓ 57% (↓ 64 do ↓ 48)
English: Consideration should be given to interrupting treatment with emtricitabine/tenofovir disoproxil in patients with creatinine clearance decreased to < 50 mL/min or decreases in serum phosphate to < 1.0 mg/dL (0.32 mmol/L).
Croatian: Također treba razmotriti mogućnost prekida liječenja emtricitabin/tenofovirdizoproksilom u pacijenata u kojih je klirens kreatinina smanjen na < 50 ml/min ili u kojih su fosfati u serumu sniženi na < 1,0 mg/dL (0,32 mmol/l).
English: The use of emtricitabine/tenofovir disoproxil is not recommended in individuals under the age of 18 years with renal impairment (see sections 4.2 and 4.4).
Croatian: Ne preporučuje se primjena emtricitabin/tenofovirdizoproksila u osoba s oštećenjem bubrega mlađih od 18 godina (vidjeti dijelove 4.2 i 4.4).
English: Study Drug Quantification
Croatian: Kvantifikacija ispitivanog lijeka
English: Renal function should be closely monitored (see section 4.4).
Croatian: Funkciju bubrega treba pomno pratiti (vidjeti dio 4.4).
English: Emtricitabine/tenofovir disoproxil should not be administered concomitantly with adefovir dipivoxil.
Croatian: Emtricitabin/tenofovirdizoproksil se ne smije primjenjivati istovremeno s adefovirdipivoksilom.
English: Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for emtricitabine/tenofovir disoproxil in patients with hepatic impairment (see sections 4.2 and 5.2).
Croatian: S obzirom na minimalni jetreni metabolizam i eliminaciju emtricitabina putem bubrega, malo je vjerojatno da bi u pacijenata s oštećenjem funkcije jetre bilo potrebno prilagođavati dozu emtricitabin/tenofovirdizoproksila (vidjeti dijelove 4.2 i 5.2).
English: If you forget to take Emtricitabine/Tenofovir disoproxil Mylan
Croatian: Ako ste zaboravili uzeti Emtricitabin/tenofovirdizoproksil Mylan
English: titanium dioxide (E171), triacetin, brilliant blue FCF aluminum lake (E133) and iron oxide yellow (E172).
Croatian: laktoza hidrat hipromeloza titanijev dioksid (E171) triacetin boja brilliant blue FCF Aluminium lake (E133)
English: • Provides information on how to store Emtricitabine/Tenofovir Mylan.
Croatian: • pruža informacije o tome kako čuvati lijek Emtricitabin/tenofovirdizoproksil Mylan.
English: Table 6: Efficacy in study CO-US-104-0288 (iPrEx)
Croatian: Tablica 6: Djelotvornost u ispitivanju CO-US-104-0288 (iPrEx)
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Mylan therapy
Croatian: • U pedijatrijskih pacijenata potrebno je odrediti početnu funkciju bubrega prije započinjanja liječenja lijekom Emtricitabin/tenofovirdizoproksil Mylan.
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 4.4).
Croatian: Emtricitabin/tenofovirdizoproksil se ne smije primjenjivati istovremeno s drugim lijekovima koji sadrže emtricitabin, tenofovirdizoproksil, tenofoviralafenamid ili druge analoge citidina, kao što je lamivudin (vidjeti dio 4.4).
English: Very common:
Croatian: Vrlo često:
English: In study GS US 104 0352, 97 treatment-experienced patients 2 to < 12 years of age with stable, virologic suppression on stavudine- or zidovudine-containing regimens were randomised to either replace stavudine or zidovudine with tenofovir disoproxil (n = 48) or continue on their original regimen (n = 49) for 48 weeks.
Croatian: U ispitivanju GS-US-104-0352, 97 prethodno liječenih pacijenata u dobi od 2 do < 12 godina sa stabilnom supresijom virusa, liječenih lijekovima koji sadrže stavudin ili zidovudin, randomizirani su u skupinu u kojoj je tenofovirdizoproksil zamijenio stavudin ili zidovudin (n = 48) ili u skupinu koja je nastavila primati svoje prvotne lijekove (n = 49) tijekom 48 tjedana.