FrancophonIA/ELRC3.0 huggingface dataset:
English: If vomiting occurs within 1 hour of taking Emtricitabine/Tenofovir disoproxil Zentiva, another tablet should be taken.
Slovenian: Če v roku 1 ure od jemanja zdravila Emtricitabin/dizoproksiltenofovirat Zentiva pride do bruhanja, je potrebno vzeti drugo tableto.
English: Cmin: ↓ 21% (↓ 58 to ↑ 48) Emtricitabine:
Slovenian: Cmin: ↓ 21 % (↓ 58 do↑ 48)
English: AUC: ↑ 26% (↑ 20 to ↑ 32) Cmax: ↓ 5% (↓ 11 to ↑ 1)
Slovenian: AUC: ↑ 26% (↑ 20 do ↑ 32) Cmax: ↓ 5% (↓ 11 do ↑ 1) Cmin: n/i
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 Zentiva 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).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 60 ml/min, je pri vsakem posamezniku, ki prejema zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva za zaščito pred izpostavitvijo, treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: Tenofovir disoproxil 245 mg + Emtricitabine/ tenofovir disoproxil
Slovenian: Dizoproksiltenofovir at 245 mg + emtricitabi n/dizoproksiltenofov irat
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 Zentiva, 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).
Slovenian: Če je vrednost serumskega fosfata < 1,5 mg/dl (0,48 mmol/l) ali se očistek kreatinina zmanjša na < 50 ml/min, je pri vsakem bolniku, ki prejema zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva treba ponovno ovrednotiti ledvično funkcijo v roku enega tedna, vključno z merjenjem koncentracije glukoze in kalija v krvi ter glukoze v urinu (glejte poglavje 4.8, proksimalna tubulopatija).
English: AUC: ↓ 25% (↓ 42 to ↓ 3) Cmax: ↓ 28% (↓ 50 to ↑ 5) Cmin: ↓ 26% (↓ 46 to ↑ 10)
Slovenian: AUC: ↓ 25% (↓ 42 do ↓ 3) Cmax: ↓ 28% (↓ 50 do ↑ 5) Cmin: ↓ 26% (↓ 46 do ↑ 10) tenofovir:
English: Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly with adefovir dipivoxil.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se ne sme sočasno uporabljati z dipivoksiladefoviratom.
English: Emtricitabine/Tenofovir disoproxil Zentiva is not for use in children under 12 years of age.
Slovenian: Otroci in mladostniki Zdravila Emtricitabin/dizoproksiltenofovirat Zentiva ne smejo uporabljati otroci, mlajši od 12 let.
English: As Emtricitabine/Tenofovir disoproxil Zentiva contains emtricitabine and tenofovir disoproxil, any interactions that have been identified with these agents individually may occur with Emtricitabine/Tenofovir disoproxil Zentiva.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje emtricitabin in dizoproksiltenofovirat, zato se pri uporabi zdravila Emtricitabin/dizoproksiltenofovirat Zentiva lahko pojavijo katerekoli interakcije, ki so jih opazili pri uporabi teh posameznih učinkovin.
English: FTC/tenofovir disoproxil groupa
Slovenian: FTC/dizoproksiltenofov irata
English: The pharmacokinetics of emtricitabine / tenofovir disoproxil have not been studied in subjects with hepatic impairment.
Slovenian: Jetrna okvara Farmakokinetike emtricitabina / dizoproksiltenofovirata niso proučevali pri osebah z jetrno okvaro.
English: • The active substances are emtricitabine and tenofovir disoproxil phosphate.
Slovenian: • Učinkovini sta emtricitabin in dizoproksiltenofovirijev fosfat.
English: The co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4 and Table 2).
Slovenian: Sočasna uporaba zdravila Emtricitabin/dizoproksiltenofovirat Zentiva in didanozina ni priporočljiva (glejte poglavje 4.4 in preglednico 2).
English: AUC: ↑ 5% (↓ 2 to ↑ 13) Cmax: ↑ 5% (↓ 3 to ↑ 14)
Slovenian: AUC: ↑ 5% (↓ 2 do ↑ 13) Cmax: ↑ 5% (↓ 3 do ↑ 14) Cmin: n/i
English: AUC: ↓ 4% (↓ 15 to ↑ 8) Cmax: ↑ 102% (↓ 96 to ↑ 108)
Slovenian: AUC: ↓ 4% (↓ 15 do ↑ 8) Cmax: ↑ 102% (↓ 96 do ↑ 108) Cmin: n/i
English: Antimycobacterials Rifampicin/tenofovir disoproxil
Slovenian: Zdravila za zdravljenje okužb z mikobakterijami rifampicin/dizoproksiltenofov irat tenofovir:
English: Use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concurrent or recent use of a nephrotoxic medicinal product (see section 4.5).
Slovenian: Zdravila Emtricitabin/dizoproksiltenofovirat Zentiva naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil (glejte poglavje 4.5).
English: Prevention of HIV in adults and adolescents aged 12 years and older, weighing at least 35 kg One tablet, once daily.
Slovenian: Preprečevanje okužbe z virusom HIV pri odraslih in mladostnikih, starih 12 let in več, s telesno maso vsaj 35 kg
English: • Emtricitabine/Tenofovir disoproxil Zentiva is also used to reduce the risk of getting HIV-1 infection in adults, and adolescents aged 12 years to less than 18 years who weigh at least 35 kg,
Slovenian: • Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja tudi za zmanjšanje tveganja za okužbo z virusom HIV-1 pri odraslih in mladostnikih, starih od 12 do 18 let, ki tehtajo vsaj 35 kg, kadar se jemlje vsakodnevno, ob hkratnem upoštevanju varnega spolnega vedenja: Glejte poglavje 2 za seznam previdnostnih ukrepov proti okužbi z virusom HIV.
English: • diarrhoea, being sick (vomiting), feeling sick (nausea),
Slovenian: • driska, bruhanje, občutek siljenja na bruhanje (navzea),
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to reduce the risk of getting HIV is:
Slovenian: Priporočeni odmerek zdravila Emtricitabin/dizoproksiltenofovirat Zentiva za zmanjšanje tveganja za okužbo s HIV je
English: The recommended dose of Emtricitabine/Tenofovir disoproxil Zentiva to treat HIV is:
Slovenian: Priporočeni odmerek zdravila Emtricitabin/dizoproksiltenofovirat Zentiva za zdravljenje okužbe s HIV je
English: Adefovir dipivoxil and Emtricitabine/Tenofovir disoproxil Zentiva should not be administered concomitantly (see section 4.4).
Slovenian: Dipivoksiladefovirat in zdravilo Emtricitabin/dizoproksiltenofovira t Zentiva se ne sme uporabljati sočasno (glejte poglavje 4.4).
English: Atazanavir/ritonavir/emtricitabine Interaction not studied.
Slovenian: atazanavir/ritonavir/emtricitab in
English: Adherence Substudy Participantsb Placebo
Slovenian: Sodelujoči v podštudiji adherenceb
English: Co-administration of Emtricitabine/Tenofovir disoproxil Zentiva and didanosine is not recommended (see section 4.4).
Slovenian: Sočasna uporaba zdravila Emtricitabin/dizoproksiltenofovira t Zentiva in didanozina ni priporočljiva (glejte poglavje 4.4).
English: • PrEP educational brochure for prescribers entitled ‘Important Safety Information for Prescribers
Slovenian: • izobraževalno gradivo PrEP za predpisujoče zdravnike z naslovom »Pomembne varnostne informacije za predpisujoče zdravnike glede zdravila Emtricitabin/dizoproksiltenofovirat Zentiva pri indikaciji zaščite pred izpostavitvijo (PrEP)«;
English: Consideration should be given to interrupting treatment with Emtricitabine/Tenofovir disoproxil Zentiva in patients with creatinine clearance decreased to < 50 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Slovenian: Pri bolnikih z zmanjšanjem očistka kreatinina na < 50 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi zdravljenja z zdravilom Emtricitabin/dizoproksiltenofovirat Zentiva.
English: AUC: ↓ 1% (↓ 8 to ↑ 6) Cmax: ↑ 7% (↓ 6 to ↑ 22)
Slovenian: AUC: ↓ 1% (↓ 8 do ↑ 6) Cmax: ↑ 7% (↓ 6 do ↑ 22) Cmin: n/i
English: How to store Emtricitabine/Tenofovir disoproxil Zentiva
Slovenian: Kako jemati zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva
English: Emtricitabine/ tenofovir disoproxil/ efavirenz
Slovenian: Emtricitabin/diz oproksiltenofovi rat/ efavirenz
English: Emtricitabine/Tenofovir disoproxil Zentiva [outer packaging only]
Slovenian: PODATKI V BRAILLOVI PISAVI Emtricitabin/dizoproksiltenofovirat Zentiva [samo na zunanji ovojnini]
English: AUC: ↓ 7% (↓ 13 to ↓ 1) Cmax: ↓ 11% (↓ 20 to ↑ 1)
Slovenian: AUC: ↓ 7% (↓ 13 do ↓ 1) Cmax: ↓ 11% (↓ 20 do ↑ 1) Cmin: n/i
English: Consideration should be given to interrupting use of Emtricitabine/Tenofovir disoproxil Zentiva in individuals with creatinine clearance decreased to < 60 ml/min or decreases in serum phosphate to < 1.0 mg/dl (0.32 mmol/l).
Slovenian: Pri posameznikih z zmanjšanjem očistka kreatinina na < 60 ml/min ali z zmanjšanjem serumskega fosfata na < 1,0 mg/dl (0,32 mmol/l) je treba razmisliti o prekinitvi uporabe zdravila Emtricitabin/dizoproksiltenofovirat Zentiva.
English: HIV-1 RNA < 400 copies/ml (TLOVR)
Slovenian: HIV-1 RNA < 400 kopij/ml (TLOVR) Vrednost p Razlika v % (95% IZ)
English: • pain in the abdomen (tummy) caused by inflammation of the pancreas,
Slovenian: • bolečine v trebuhu zaradi vnetja trebušne slinavke,
English: If you have HBV, there is a serious risk of liver problems when you stop taking Emtricitabine/Tenofovir disoproxil Zentiva, whether or not you also have HIV.
Slovenian: Če imate hepatitis B, obstaja resno tveganje za jetrne težave, ko prenehate jemati zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva, ne glede na to, ali imate HIV ali ne. Pomembno je, da zdravila Emtricitabin/dizoproksiltenofovirat Zentiva ne prenehate jemati, ne da bi se posvetovali s svojim zdravnikom: glejte poglavje 3.
English: Indigo carmine aluminum lake (E 132)
Slovenian: Filmska obloga polivinilalkohol titanov dioksid makrogol smukec indigotin (E 132)
English: If Emtricitabine/Tenofovir disoproxil Zentiva is coadministered with an NSAID, renal function should be monitored adequately.
Slovenian: Pri sočasnem jemanju zdravila Emtricitabin/dizoproksiltenofovirat Zentiva z NSAID je potrebno spremljati ledvično funkcijo.
English: No dose adjustment of ribavirin is required.
Slovenian: Prilagoditev odmerka ribavirina ni potrebna
English: General disorders and administration site conditions Very common asthenia
Slovenian: Splošne težave in spremembe na mestu aplikacije Zelo pogosto astenija
English: the BMD Z-scores observed in subjects who switched to tenofovir disoproxil were lower than those observed in subjects who remained on their stavudine- or zidovudine-containing regimen (see sections 4.4 and 5.1).
Slovenian: Pri otrocih, okuženih s HIV 1 (starih od 2 do 15 let), so opazili manjše Z-vrednosti MKG pri osebah, ki so prešle na zdravljenje z dizoproksiltenofoviratom, kot pri osebah, ki so ostale na režimu zdravljenja, ki je vključeval stavudine ali zidovudine (glejte poglavji 4.4 in 5.1).
English: AUC: ↓ 2% (↓ 5 to ↑ 0) Cmax: ↓ 1% (↓ 7 to ↑ 6)
Slovenian: AUC: ↓ 2% (↓ 5 do ↑ 0) Cmax: ↓ 1% (↓ 7 do ↑ 6) Cmin: n/i
English: • back pain caused by kidney problems.
Slovenian: • bolečine v križu zaradi ledvične okvare.
English: infected patients.
Slovenian: * Bolniki,
English: Cmax: ↔ Cmin: ↑ 42% (↑ 37 to ↑ 49)
Slovenian: Cmin: ↑ 42 % (↑ 37 do ↑ 49)
English: Rarely, inflammation of the pancreas and lactic acidosis (excess lactic acid in the blood), which sometimes causes death, have been reported when medicines containing tenofovir disoproxil and didanosine were taken together.
Slovenian: Pri sočasnem jemanju zdravil, ki vsebujejo dizoproksiltenofovirat in didanozin, so redko poročali o vnetju trebušne slinavke in laktoacidozi (zvišanju mlečne kisline v krvi), ki je včasih smrtna.
English: BMD Z-scores declined by -0.012 for lumbar spine and by -0.338 for total body in the 64 subjects who were treated with tenofovir disoproxil for 96 weeks.
Slovenian: Z-vrednosti MGK so se pri 64 osebah, ki so se 96 tednov zdravile z dizoproksiltenofoviratom, zmanjšale za -0,012 za ledveno hrbtenico in za -0,338 za celo telo.
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.
Slovenian: Povzetek neželenih učinkov, prikazan v preglednici Spodaj v preglednici 3 so po organskih sistemih in pogostnosti navedeni neželeni učinki, ki so vsaj možno povezani z zdravljenjem z učinkovinama emtricitabin/dizoproksiltenofovirat pri bolnikih s HIV-1 na podlagi kliničnih študij in izkušenj po prihodu zdravila na tržišče.
English: AUC: ↓ 11% (↓ 14 to ↓ 7) Cmax: ↓ 7% (↓ 13 to ↓ 0)
Slovenian: AUC: ↓ 11% (↓ 14 do ↓ 7) Cmax: ↓ 7% (↓ 13 do ↓ 0) Cmin: n/i tenofovir:
English: AUC: ↓ 5% (↓ 9 to ↓ 1) Cmax: ↓ 11% (↓ 17 to ↓ 5)
Slovenian: AUC: ↓ 5% (↓ 9 do ↓ 1) Cmax: ↓ 11% (↓ 17 do ↓ 5) Cmin: n/i tenofovir:
English: What Emtricitabine/Tenofovir disoproxil Zentiva is and what it is used for Emtricitabine/Tenofovir disoproxil Zentiva contains two active substances, emtricitabine and tenofovir disoproxil.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva vsebuje dve učinkovini, emtricitabin in dizoproksiltenofovirat.
English: AUC: ↑ 45% Cmax: ↑ 60% Cmin: ↔
Slovenian: Cmax: ↑ 60% Cmin: ↔
English: Darunavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./
Slovenian: darunavir/ritonavir/dizoproksi ltenofovirat (300 mg enkrat dnevno/100 mg enkrat dnevno/245 mg enkrat dnevno)
English: Efavirenz/tenofovir disoproxil
Slovenian: efavirenz/dizoproksiltenofovir at efavirenz:
English: A single 245 mg dose of tenofovir disoproxil was administered to non-HIV infected subjects with varying degrees of hepatic impairment defined according to Child-Pugh-Turcotte (CPT) classification.
Slovenian: Osebam brez okužbe s HIV, ki so imele različne stopnje jetrne okvare po klasifikaciji Child-PughTurcotte (CPT), so vzeli enkratni 245 mg odmerek dizoproksiltenofovirata.
English: • drowsiness,
Slovenian: • izpuščaj,
English: In a study of 498 men, the mean changes from baseline to week 24 in BMD ranged from 0.4% to 1.0% across hip, spine, femoral neck and trochanter in men who received daily emtricitabine/tenofovir disoproxil prophylaxis (n = 247) vs. placebo (n = 251).
Slovenian: Pri moških, ki so vsak dan prejemali zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva za zaščito (n = 247) v primerjavi s placebom (n = 251) so bile povprečne spremembe MKG od izhodišča do 24. tedna na kolkih, hrbtenici, vratu in trohantru stegnenice od 0,4 % do 1,0 %.
English: AUC: ↑ 4% (↓ 3 to ↑ 11) Cmax: ↑ 3% (↓ 3 to ↑ 9)
Slovenian: AUC: ↑ 4% (↓ 3 do ↑ 11) Cmax: ↑ 3% (↓ 3 do ↑ 9) Cmin: n/i emtricitabin:
English: Use of Emtricitabine/Tenofovir disoproxil Zentiva should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Slovenian: Zdravila Emtricitabin/dizoproksiltenofovirat Zentiva naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
English: Protease inhibitors Atazanavir / ritonavir / tenofovir disoproxil (300 mg q.d./100 mg q.d./245 mg q.d.)
Slovenian: ZDRAVILA ZA ZDRAVLJENJE INFEKCIJ Protiretrovirusne učinkovine Zaviralci proteaz atazanavir/ritonavir/dizoproks iltenofovirat (300 mg enkrat dnevno/100 mg enkrat dnevno/245 mg enkrat dnevno)
English: AUC: ↓ 4% (↓ 7 to ↓ 1) Cmax: ↓ 4% (↓ 9 to ↑ 2)
Slovenian: AUC: ↓ 4% (↓ 7 do ↓ 1) Cmax: ↓ 4% (↓ 9 do ↑ 2) Cmin: n/i tenofovir:
English: Ribavirin/tenofovir disoproxil
Slovenian: ribavirin/dizoproksiltenofovir at ribavirin:
English: AUC: ↓ 9% (↓ 16 to ↓ 1) Cmax: ↓ 7% (↓ 22 to ↑ 11)
Slovenian: AUC: ↓ 9% (↓ 16 do ↓ 1) Cmax: ↓ 7% (↓ 22 do↑ 11) Cmin: n/i emtricitabin:
English: Emtricitabine/Tenofovir disoproxil Zentiva contains sodium
Slovenian: Kaj vsebuje zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva
English: Cmin: N/A GS-3310072:
Slovenian: sofosbuvir: AUC: ↔ Cmax: ↔ GS-3310072:
English: • That paediatric patients should have their baseline renal function assessed prior to initiating Emtricitabine/Tenofovir disoproxil Zentiva therapy
Slovenian: • da je pred začetkom zdravljenja z zdravilom Emtricitabin/dizoproksiltenofovirat Zentiva pri pediatričnih bolnikih treba oceniti začetne vrednosti delovanja ledvic;
English: AUC: ↓ 3% (↓ 8% to ↑ 15) Cmax: ↓ 24% (↓ 44 to ↓ 12)
Slovenian: AUC: ↓ 3% (↓ 8% do ↑ 15) Cmax: ↓ 24% (↓ 44 do↓ 12) Cmin: n/i tenofovir:
English: Cmax: ↑ 64% (↑ 54 to ↑ 74) Cmin: ↑ 59% (↑ 49 to ↑ 70)
Slovenian: AUC: ↑ 50 % (↑ 42 do ↑ 59) Cmax: ↑ 64 % (↑ 54 do ↑ 74) Cmin: ↑ 59 % (↑ 49 do ↑ 70)
English: AUC: ↓ 4% (↓ 32 to ↑ 34) Cmax: ↓ 5% (↓ 27 to ↑ 24)
Slovenian: AUC: ↓ 4% (↓ 32 do ↑ 34) Cmax: ↓ 5% (↓ 27 do ↑ 24) Cmin: n/i etinilestradiol:
English: Whenever possible, Emtricitabine/Tenofovir disoproxil Zentiva should be taken with food.
Slovenian: Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva skupaj s hrano in pijačo Kadar je mogoče, je treba zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva jemati s hrano.
English: AUC: ↔ Cmax: ↓ 30%
Slovenian: AUC: ↔ Cmax: ↓ 30% Cmin: N/A
English: • Provides information on how to take Emtricitabine/Tenofovir disoproxil Zentiva
Slovenian: • nudi informacije o morebitnih neželenih učinkih zdravila Emtricitabin/dizoproksiltenofovirat
English: Emtricitabine/ tenofovir disoproxil
Slovenian: Emtricitabin/ dizoproksilten ofovirat
English: • Reminder of the key safety information regarding the use of Emtricitabine/Tenofovir disoproxil
Slovenian: • opozorilo na ključne varnostne informacije v zvezi z uporabo zdravila
English: Lopinavir/ritonavir/emtricitabine Interaction not studied.
Slovenian: lopinavir/ritonavir/emtricitabi n
English: Emtricitabine/Tenofovir disoproxil Zentiva can cause dizziness.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva lahko povzroči omotičnost.
English: + raltegravir (400 mg b.i.d) + emtricitabine/tenofovir disoproxil (200 mg/245 mg q.d.)
Slovenian: ledipasvir/sofosbuvir (90 mg/400 mg enkrat dnevno) + emtricitabin/rilpivirin/ dizoproksiltenofovirat (200 mg/25 mg/245 mg enkrat dnevno)
English: Uncommon pancreatitis
Slovenian: Občasno pankreatitis
English: Tenofovir disoproxil groupa
Slovenian: Skupina dizoproksiltenofovirata
English: Outer carton / bottle label
Slovenian: PODATKI NA ZUNANJI OVOJNINI IN PRIMARNI OVOJNINI Škatla / nalepka na plastenki
English: + efavirenz/emtricitabine/tenofovir disoproxil (600 mg/200 mg/245 mg q.d.)
Slovenian: sofosbuvir (400 mg enkrat dnevno) + efavirenz/emtricitabin/dizopro ksiltenofovirat (600 mg/200 mg/245 mg enkrat dnevno)1
English: It is important not to stop taking Emtricitabine/Tenofovir disoproxil Zentiva without talking to your doctor: see section 3, Do not stop taking Emtricitabine/Tenofovir disoproxil Zentiva.
Slovenian: Če ste pozabili vzeti zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva Pomembno je, da ne izpustite nobenega odmerka zdravila Emtricitabin/dizoproksiltenofovirat Zentiva.
English: Darunavir/ritonavir/emtricitabine Interaction not studied.
Slovenian: darunavir/ritonavir/emtricitabi n
English: AUC: ↓ 53% (↓ 61 to ↓ 43) Cmax: ↓ 47% (↓ 57 to ↓ 36) Cmin: ↓ 57% (↓ 64 to ↓ 48)
Slovenian: Cmin: ↓ 57 % (↓ 64 do ↓ 48)
English: PV-Poland@zentiva.com
Slovenian: PV-Hungary@zentiva.com
English: P-valuea, b mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b URAI Within 12 Weeks Prior to Screening, mITT Analysis Seroconversions / N Relative Risk Reduction (95% CI)b a P-values by logrank test. P-values for URAI refer to the null hypothesis that efficacy differed between subgroup strata (URAI, no URAI).
Slovenian: Relativno zmanjšanje tveganja (95-odstotni IZ)b a P-vrednosti po log-rank testu.
English: • Emtricitabine/Tenofovir disoproxil Zentiva is used to treat Human Immunodeficiency
Slovenian: • Zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva se uporablja za zdravljenje okužbe z virusom HIV-1 (virus človeške imunske pomanjkljivosti 1) pri odraslih.
English: If you forget to take Emtricitabine /Tenofovir disoproxil Zentiva
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Emtricitabin/dizoproksiltenofovirat Zentiva
English: Cmax: ↑ 77% (↑ 53 to ↑ 104) Cmin: ↑ 121% (↑ 100 to ↑ 143)
Slovenian: Cmax: ↑ 77 % (↑ 53 do ↑ 104)
English: Increased plasma concentrations of tenofovir resulting from coadministration of tenofovir disoproxil, ledipasvir/sofosbuvir and darunavir/ritonavir may increase adverse reactions related to tenofovir disoproxil, including renal disorders.
Slovenian: Povečane koncentracije tenofovirja v plazmi zaradi sočasnega dajanja dizoproksiltenofovirata, sofosbuvirja/velpatasvirja/voksilap revirja in darunavirja/ritonavirja lahko povečajo neželene učinke, povezane z dizoproksiltenofoviratom, vključno z motnjami delovanja ledvic .
English: Posology
Slovenian: Skupina
English: Invented name Strength Pharmaceutical Form Route of administration Packaging Content (concentration) Package sizes EU/1/01/173/001 Vaniqa
Slovenian: Številka EU Zaščiteno ime ime Jakost Farmacevtska oblika Pot uporabe
English: EU-Numbers
Slovenian: Ovojnina
English: This overview was last updated in 06-2018
Slovenian: Pregled je bil nazadnje posodobljen 06-2018.
English: The starting dose is 15 mg once a day.
Slovenian: Začetni odmerek je 15 mg enkrat na dan.
English: Further information on Samsca can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije za zdravilo Samsca so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The only major safety concerns seen with this medicine came from animal studies suggesting it could be harmful to unborn babies.
Slovenian: Edini glavni varnostni pomisleki pri tem zdravilu izhajajo iz raziskav na živalih, ki kažejo, da bi lahko bilo škodljivo za še nerojene otroke.
English: The European Medicines Agency concluded that Samsca's benefits are greater than its risks and that it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zaključila, da so koristi zdravila Samsca večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: This means that it blocks one type of receptor (target) to which the hormone vasopressin normally attaches itself.
Slovenian: To pomeni, da zavira eno vrsto receptorja (tarčo), na katerega se običajno veže hormon vazopresin.
English: What measures are being taken to ensure the safe and effective use of Samsca?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Samsca?
English: Samsca is available as tablets (7.5, 15 and 30 mg).
Slovenian: Zdravilo Samsca je na voljo v obliki tablet (7,5 mg, 15 mg in 30 mg).
English: Normal sodium levels are between 135 and 145 mmol/l.
Slovenian: Normalna raven natrija je med 135 in 145 mmol/l.
English: It must not be used in patients who are allergic to tolvaptan or medicines that are similar to tolvaptan, so-called benzazepines or their derivatives.
Slovenian: Zdravilo se ne sme uporabljati pri bolnikih, ki so alergični na tolvaptan ali zdravila, podobna tolvaptanu, tako imenovane benzazepine ali njihove derivate.
English: A dose of 7.5 mg once a day can be used for patients at risk of excessively quick rise in blood sodium.
Slovenian: Odmerek 7,5 mg enkrat na dan se lahko uporablja pri bolnikih, ki jih ogroža čezmerno hiter porast natrija v krvi.
English: This may be increased to a maximum of 60 mg once a day to achieve an appropriate level of blood sodium and blood volume.
Slovenian: Ta se lahko poveča do največ 60 mg enkrat na dan, da se doseže primerna raven natrija v krvi in krvni volumen.
English: Other information about Samsca
Slovenian: Druge informacije o zdravilu Samsca
English: By blocking this receptor, Samsca prevents vasopressin's effect.
Slovenian: Z zaviranjem tega receptorja zdravilo Samsca prepreči učinek vazopresina.
English: As for all medicines, data on the use of Samsca are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Samsca stalno spremljajo.