natgillin/translations-raw huggingface dataset:
Patients co-infected with HIV and HBV who discontinue Truvada should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
Bolnike s hkratno HIV in HBV okužbo, ki prekinejo zdravljenje z zdravilom Truvada, je potrebno pozorneje opazovati in opraviti potrebne klinične in laboratorijske teste še vsaj nekaj mesecev po prenehanju zdravljenja.
If appropriate, resumption of hepatitis B therapy may be warranted.
Če je ustrezno, se lahko ponovno uvede zdravljenje hepatitisa B.
The safety and efficacy of Truvada have not been established in patients with significant underlying liver disorders.
Varnost in učinkovitost zdravila Truvada nista bili ugotavljani pri bolnikih s pomembnejšimi spremljevalnimi jetrnimi motnjami.
The pharmacokinetics of tenofovir have been studied in patients with hepatic impairment and no dose adjustment is required in these patients.
Farmakokinetične lastnosti tenofovirja so proučevali pri bolnikih z motnjami v delovanju jeter in ugotovili, da pri teh bolnikih prilagoditev odmerka ni potrebna.
Based on minimal hepatic metabolism and the renal route of elimination for emtricitabine, it is unlikely that a dose adjustment would be required for Truvada in patients with hepatic impairment (see section 5.2).
Na osnovi minimalne jetrne presnove in izločanja emtricitabina preko ledvic je malo verjetno, da bi bila pri bolnikih z motnjami v delovanju jeter potrebna prilagoditev odmerka zdravila Truvada (glejte poglavje 5. 2).
Patients with pre-existing liver dysfunction, including chronic active hepatitis, have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Bolniki z že obstoječo jetrno disfunkcijo, vključno s kroničnim aktivnim hepatitisom, imajo v času kombinirane protiretrovirusne terapije več anomalij jetrne funkcije in jih je treba nadzirati v skladu s standardno prakso.
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues.
Laktacidoza, običajno povezana s hepatično steatozo, je bila ugotovljena ob uporabi analogov nukleozidov.
Early symptoms (symptomatic hyperlactataemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/ or deep breathing) or neurological symptoms (including motor weakness).
Zgodnji simptomi (simptomatične hiperlaktatemije) vključujejo benigne prebavne simptome (slabost, bruhanje in bolečine v trebuhu), nespecifičen občutek slabosti, izgubo apetita, izgubo teže, respiratorne simptome (naglo in/ ali globoko dihanje) ali nevrološke simptome (vključno z motorično oslabelostjo).
Lactic acidosis has a high mortality and may be associated with pancreatitis, liver failure or renal failure.
Laktacidoza ima za posledico visoko smrtnost in jo lahko spremlja vnetje pankreasa, odpoved delovanja jeter ali ledvic.
Lactic acidosis generally occurred after a few or several months of treatment.
Laktacidoza v splošnem nastopi šele po nekaj ali več mesecih zdravljenja.
Treatment with nucleoside analogues should be discontinued in the setting of symptomatic hyperlactataemia and metabolic/ lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Zdravljenje z analogi nukleozidov se mora prekiniti ob ugotovljeni simptomatični hiperlaktatemiji in presnovni acidozi/ laktacidozi, napredujoči hepatomegaliji ali ob hitro rastočem nivoju aminotransferaz.
Caution should be exercised when administering nucleoside analogues to any patient (particularly obese women) with hepatomegaly, hepatitis or other known risk factors for liver disease and hepatic steatosis (including certain medicinal products and alcohol).
5 Previdnostni ukrepi so potrebni pri uporabi analogov nukleozidov pri vsakemu bolniku (posebno pri debelih ženskah) s hepatomegalijo, hepatitisom ali drugim znanim rizičnim faktorjem obolenja jeter in hepatične steatoze (vključujoč določena zdravila in alkohol).
Patients at increased risk should be followed closely.
Bolniki s povečanim tveganjem morajo biti pod skrbnim nadzorom.
Combination antiretroviral therapy has been associated with the redistribution of body fat (lipodystrophy) in HIV patients.
Kombinirana protiretrovirusna terapija pri bolnikih s HIV je povezana s prerazporeditvijo telesne maščobe (lipodistrofija).
The long-term consequences of these events are currently unknown.
Dolgoročne posledice teh pojavov trenutno niso poznane.
Knowledge about the mechanism is incomplete.
Mehanizem delovanja še ni pojasnjen.
A connection between visceral 5 lipomatosis and protease inhibitors and lipoatrophy and nucleoside reverse transcriptase inhibitors has been hypothesised.
Postavljena je hipoteza o povezanosti med visceralno lipomatozo in zaviralci proteaze in med lipoatrofijo in nukleozidnimi zaviralci reverzne transkriptaze.
A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances.
Večje tveganje za pojav lipodistrofije je povezano z individualnimi dejavniki, kot je višja starost, ter z dejavniki povezanimi z zdravili, kot so dolgotrajno protiretrovirusno zdravljenje in z njim povezane motnje presnove.
Clinical examination should include evaluation for physical signs of fat redistribution.
Klinična preiskava naj bi vključevala ocenitev fizičnih znakov maščobne prerazporeditve.
Consideration should be given to the measurement of fasting serum lipids and blood glucose.
Potrebno je izmeriti vrednosti serumskih lipidov in glukoze v krvi na tešče.
Lipid disorders should be managed as clinically appropriate (see section 4.8).
Lipidne motnje je potrebno primerno klinično obravnavati (glejte poglavje 4. 8).
Tenofovir is structurally related to nucleoside analogues hence the risk of lipodystrophy cannot be excluded.
Tenofovir je strukturno soroden analogom nukleozidov, zato ni mogoče izključiti tveganja za lipodistrofijo.
However, 144-week clinical data from antiretroviral-naïve patients indicate that the risk of lipodystrophy was lower with tenofovir disoproxil fumarate than with stavudine when administered with lamivudine and efavirenz.
Vendar pa klinični podatki iz 144 tednov pri bolnikih, ki še niso bili zdravljeni s protiretrovirusnimi zdravili, kažejo, da je tveganje za lipodistrofijo manjše, če je bil tenofovirdizoproksil fumarat zaužit z lamivudinom in efavirenzom kot pri stavudinu v kombinaciji z lamivudinom in efavirenzom.
Any child exposed in utero to nucleoside and nucleotide analogues, even HIV negative children, should have clinical and laboratory follow-up and should be fully investigated for possible mitochondrial dysfunction in case of relevant signs or symptoms.
Vse otroke, tudi HIV- negativne, ki so bili in utero izpostavljeni nukleozidnim in nukleotidnim analogom, je treba klinično in laboratorijsko spremljati ter jih v primeru relevantnih znakov ali simptomov glede možne mitohondrijske disfunkcije temeljito preiskati.
Relevant examples are cytomegalovirus retinitis, generalised and/ or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia.
Ustrezni primeri so citomegalovirusni retinitis, generalizirane in/ ali žariščne okužbe z mikobakterijami in s Pneumocystis jiroveci povzročena pljučnica.
Co-administration of tenofovir disoproxil fumarate and didanosine: is not recommended.
Sočasna uporaba tenofovirdizoproksil fumarata in didanozina: ni priporočena.
Co-administration of tenofovir disoproxil fumarate and didanosine results in a 40-60% increase in systemic exposure to didanosine that may increase the risk of didanosine-related adverse events (see section 4.5).
Sočasna uporaba tenofovirdizoproksil fumarata in didanozina povzroča povečanje sistemske izpostavljenosti didanozinu za 40- 60%, kar lahko poveča tveganje pojava neželenih učinkov, povezanih z didanozinom (glejte poglavje 4. 5).
Rare cases of pancreatitis and lactic acidosis, sometimes fatal, have been reported.
Poročali so o redkih primerih pankreatitisa in laktacidoze, ki so bili včasih smrtni.
Co-administration of tenofovir disoproxil fumarate and didanosine at a dose of 400 mg daily has been associated with a significant decrease in CD4 cell count, possibly due to an intracellular interaction increasing phosphorylated (i. e. active) didanosine.
Sočasna uporaba tenofovirdizoproksil fumarata in didanozina pri odmerku 400 mg dan je bila
A decreased dosage of 250 mg didanosine co-administered with tenofovir disoproxil fumarate therapy has been associated with reports of high rates of virological failure within several tested combinations.
Sočasna uporaba zmanjšanega odmerka didanozina (250 mg) in zdravljenje z tenofovirdizoproksil fumaratom je bilo v več preizkušenih kombinacijah povezano s poročili o visoki stopnji virološke odpovedi.
Consequently, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Zato bolniki z redko dedno intoleranco za galaktozo, laponsko obliko zmanjšane aktivnosti laktaze ali malabsorpcijo glukoze/ galaktoze ne smejo jemati tega zdravila.
6 The steady-state pharmacokinetics of emtricitabine and tenofovir were unaffected when emtricitabine and tenofovir disoproxil fumarate were administered together versus each medicinal product dosed alone.
Farmakokinetične lastnosti emtricitabina in tenofovirja se v stanju dinamičnega ravnovesja niso spremenile, če sta bila emtricitabin in tenofovirdizoproksil fumarat vzeta sočasno ali vsak posamezno.
In vitro and clinical pharmacokinetic interaction studies have shown the potential for CYP450 mediated interactions involving emtricitabine and tenofovir disoproxil fumarate with other medicinal products is low.
In vitro in klinične študije farmakokinetičnih interakcij so pokazale, da je možnost za s CYP450 posredovane interakcije emtricitabina in tenofovirdizoproksil fumarata z drugimi zdravili majhna.
Interactions relevant to emtricitabine:
Interakcije, pomembne za emtricitabin:
There are no clinically significant interactions when emtricitabine is co-administered with indinavir, zidovudine, stavudine or famciclovir.
Ni klinično pomembnih interakcij, ko se emtricitabin uporablja skupaj z indinavirjem, zidovudinom, stavudinom ali famciklovirom.
With the exception of famciclovir and tenofovir disoproxil fumarate, the effect of co-administration of emtricitabine with medicinal products that are excreted by the renal route, or other medicinal products known to affect renal function, has not been evaluated.
Z izjemo famciklovirja in tenofovirdizoproksil fumarata niso bili ovrednoteni učinki sočasne uporabe emtricitabina z zdravili, ki se izločajo po ledvični poti, ali z drugimi zdravili, za katera je znano, da vplivajo na ledvično funkcijo.
Co-administration of Truvada with medicinal products that are eliminated by active tubular secretion may lead to an increase in serum concentrations of either emtricitabine or a co-administered medicinal product due to competition for this elimination pathway.
Sočasna uporaba zdravila Truvada z zdravili, ki se izločajo z aktivno tubularno sekrecijo, lahko vodi v povišanje serumskih koncentracij emtricitabina ali sočasno uporabljenih zdravil zaradi kompeticije za to pot izločanja.
There is no clinical experience with the co-administration of emtricitabine and cytidine analogues.
Ni kliničnih izkušenj o sočasni uporabi emtricitabina in analogov citidina.
Consequently, Truvada should not be administered in combination with lamivudine or zalcitabine for the treatment of HIV infection (see section 4.4).
Zaradi tega se zdravila Truvada ne sme jemati v kombinaciji z lamivudinom ali zalcitabinom za zdravljenje okužbe z virusom HIV (glejte poglavje 4. 4).
Interactions relevant to tenofovir:
Interakcije, pomembne za tenofovir:
Co-administration of lamivudine, indinavir, efavirenz, nelfinavir or saquinavir (ritonavir boosted) with tenofovir disoproxil fumarate did not result in any clinically relevant interaction.
Sočasno jemanje lamivudina, indinavirja, efavirenza, nelfinavirja ali sakvinavirja (okrepljen z učinkom ritonavirja) s tenofovirdizoproksil fumaratom ni privedlo do klinično pomembnih interakcij.
When tenofovir disoproxil fumarate was administered with lopinavir/ ritonavir, no changes were observed in the pharmacokinetics of lopinavir and ritonavir.
Pri sočasnem jemanju tenofovirdizoproksil fumarata z lopinavirjem/ ritonavirjem niso opazili nobenih sprememb v farmakokinetiki lopinavirja in ritonavirja.
Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Pri sočasnem jemanju tenofovirdizoproksil fumarata z lopinavirjem/ ritonavirjem je bila AUC tenofovirja povišana za približno 30%. Večje koncentracije tenofovirja bi lahko okrepile neželene učinke, povezane s tenofovirjem, vključno z ledvičnimi bolezni.
When didanosine gastro-resistant capsules were administered 2 hours prior to or concurrently with tenofovir disoproxil fumarate, the AUC for didanosine was on average increased by 48% and 60% respectively.
Pri jemanju didanozin gastrorezistentnih kapsul do dve uri pred oziroma sočasno s tenofovirdizoproksil fumaratom se je AUC za didanozin v povprečju povečala za 48% oziroma 60%.
The mean increase in the AUC of didanosine was 44% when the buffered tablets were administered 1 hour prior to tenofovir.
Srednje povišanje AUC za didanozin je bilo 44% pri vnosu puferskih tablet eno uro pred tenofovirjem.
In both cases the pharmacokinetic parameters for tenofovir administered with a light meal were unchanged.
V obeh primerih so farmakokinetični parametri tenofovirja zaužitega ob lahkem obroku ostali nespremenjeni.
The co-administration of tenofovir disoproxil fumarate and didanosine is not recommended (see section 4.4).
Sočasno jemanje tenofovirdizoproksil fumarata in didanozina ni priporočljivo (glejte poglavje 4. 4).
When tenofovir disoproxil fumarate was administered with atazanavir, a decrease in concentrations of atazanavir was observed (decrease of 25% and 40% of AUC and Cmin respectively compared to atazanavir 400 mg).
Če je bil
When ritonavir was added to atazanavir, the negative impact of tenofovir on atazanavir Cmin was significantly reduced, whereas the decrease of AUC was of the same magnitude (decrease of 25% and 26% of AUC and Cmin respectively compared to atazanavir/ ritonavir 300/ 100 mg).
7 atazanavirju dodan ritonavir, se je negativni učinek tenofovirja na Cmin atazanavirja pomembno zmanjšal, medtem ko je bila stopnja znižanja AUC enaka (znižanje AUC za 25% in Cmin za 26% v primerjavi s 300/ 100 mg atazanavirja/ ritonavirja).
The co-administration of atazanavir/ ritonavir with tenofovir resulted in increased exposure to tenofovir.
Sočasna uporaba atazanavirja/ ritonavirja in tenofovirja je povečala izpostavljenost tenofovirju.
Higher tenofovir concentrations could potentiate tenofovir associated adverse events, including renal disorders.
Večje koncentracije tenofovirja bi lahko okrepile neželene učinke, povezane s tenofovirjem, vključno z ledvičnimi bolezni.
Co-administration of tenofovir disoproxil fumarate with other medicinal
Tenofovir se izloča preko ledvic s filtracijo in z aktivno sekrecijo preko humanega prenašalca organskih anionov 1 (hOAT1, human organic anion transporter 1).
7 products that are also actively secreted via the anion transporter (e. g. cidofovir) may result in increased concentrations of tenofovir or of the co-administered medicinal product.
Sočasno jemanje tenofovirdizoproksil fumarata z drugimi zdravili, ki se prav tako izločajo preko prenašalca anionov (npr. cidofovir), se lahko odrazi v povišanju koncentracije tenofovirja oziroma drugih sočasno jemanih zdravil.
Tenofovir disoproxil fumarate has not been evaluated in patients receiving nephrotoxic medicinal products (e. g. aminoglycosides, amphotericin B, foscarnet, ganciclovir, pentamidine, vancomycin, cidofovir or interleukin-2).
Tenofovirdizoproksil fumarat ni bil ovrednoten pri bolnikih, ki so prejemali nefrotoksična zdravila (npr. aminoglikozide, amfotericin B, foskarnet, ganciklovir, pentamidin, vankomicin, cidofovir ali interlevkin- 2).
Use of tenofovir disoproxil fumarate should be avoided with concurrent or recent use of a nephrotoxic medicinal product.
Tenofovirdizoproksil fumarata naj ne bi uporabljali sočasno oziroma neposredno po uporabi nefrotoksičnih zdravil.
If concomitant use of Truvada and nephrotoxic agents is unavoidable, renal function should be monitored weekly (see section 4.4).
Če je sočasna uporaba zdravila Truvada in nefrotoksičnega zdravila neizogibna, je potrebno tedensko nadzorovati ledvično funkcijo (glejte poglavje 4. 4).
Co-administration of tenofovir disoproxil fumarate and methadone, ribavirin, rifampicin, adefovir dipivoxil or the hormonal contraceptive norgestimate/ ethinyl oestradiol did not result in any pharmacokinetic interaction.
Sočasno jemanje tenofovirdizoproksil fumarata in metadona, ribavirina, rifampicina, adefovirdipivoksila oziroma hormonskega kontraceptiva norgestimat/ etinilestradiola ni povzročilo farmakokinetičnih interakcij.
Interactions relevant to Truvada:
Interakcije, pomembne za zdravilo Truvada:
Co-administration of tacrolimus with the combination product emtricitabine/ tenofovir disoproxil fumarate did not result in any clinically significant interactions.
Sočasno jemanje takrolimusa s kombiniranim zdravilom z emtricitabinom/ tenofovirdizoproksil fumaratom ni privedlo do klinično pomembnih interakcij.
For emtricitabine and tenofovir disoproxil fumarate, insufficient data on exposed pregnancies are available.
Za emtricitabin in tenofovirdizoproksil fumarat ni na voljo dovolj podatkov od nosečnic, ki so bile izpostavljene zdravilu.
Animal studies do not indicate direct or indirect harmful effects of emtricitabine or tenofovir disoproxil fumarate with respect to pregnancy, embryonal/ foetal development, parturition or postnatal development (see section 5.3).
Študije na živalih ne kažejo na neposredne ali posredne škodljive vplive emtricitabina ali tenofovirdizoproksil fumarata na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte poglavje 5. 3).
However, Truvada should not be used during pregnancy unless no other alternative is available.
Vendar zdravila Truvada ne smete uporabljati med nosečnostjo, razen če ni na voljo druge možnosti.
The use of Truvada must be accompanied by the use of effective contraception.
Med zdravljenjem z zdravilom Truvada je treba uporabljati učinkovito kontracepcijo.
It is not known whether emtricitabine or tenofovir are excreted in human milk.
Ni znano ali emtricitabin ali tenofovirdizoproksil fumarat prehajata v materino mleko.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV to the infant.
Splošno priporočljivo je, naj s HIV okužene ženske v nobenem primeru ne dojijo, da se prepreči prenos HIV na dojenčka.
However, patients should be informed that dizziness has been reported during treatment with both emtricitabine and tenofovir disoproxil fumarate.
Vendar je bolnike potrebno opozoriti, da se lahko v času zdravljenja z emtricitabinom in tenofovirdizoproksil fumaratom pojavi omotičnost.
In an open-label randomised clinical study in antiretroviral-naïve patients (GS-01-934; see section 5.1), patients received emtricitabine, tenofovir disoproxil fumarate and efavirenz for 144 weeks (administered as the combination formulation Truvada, plus efavirenz from week 96).
V odprti, randomizirani klinični študiji so bolniki, ki še niso bili zdravljeni s protiretrovirusnimi zdravili (GS- 01- 934, glejte poglavje 5. 1), 144 tednov prejemali emtricitabin, tenofovirdizoproksil fumarat in efavirenz (v obliki kombinirane formulacije zdravila Truvada in efavirenza od 96. tedna
The safety profile of emtricitabine and tenofovir disoproxil fumarate was consistent with the previous experience with these agents when each was administered with other antiretroviral agents.
Varnostni profil emtricitabina in tenofovirdizoproksil fumarata je bil skladen s predhodnimi izkušnjami s tema učinkovinama, ko so bolniki vsako od njiju prejemali z drugimi protiretrovirusnimi zdravili.
The most frequently reported adverse reactions considered possibly or probably related to emtricitabine and/ or tenofovir disoproxil fumarate were nausea (12%) and diarrhoea (7%).
Najpogostejši neželeni reakciji, o katerih so poročali in ki sta bili verjetno oziroma morda povezani z emtricitabinom in/ ali tenofovirdizoproksil fumaratom, sta bili navzea (12%) in driska (7%).
The adverse reactions considered at least possibly related to treatment with the components of Truvada from clinical trial and post-marketing experience are listed below by body system organ class and absolute frequency.
Spodaj so po organskih sistemih in absolutni pogostosti navedene neželene reakcije, ki so vsaj možno povezane z zdravljenjem z učinkovinami zdravila Truvada na podlagi kliničnih preskušanj in izkušenj po izdaji v promet.
8 uncommon (≥ 1/ 1,000, < 1/ 100), rare (≥ 1/ 10,000, < 1/ 1,000) or very rare (< 1/ 10,000) including isolated reports, or not known (identified through post-marketing safety surveillance and the frequency cannot be estimated from the available data).
Pogostost je definirana kot zelo pogosto (≥ 1/ 10), pogosto (≥ 1/ 100, < 1/ 10), občasno (≥ 1/ 1. 000, < 1/ 100), redko (≥ 1/ 10. 000, < 1/ 1. 000), zelo redko (< 1/ 10. 000), vključno s posameznimi primeri, ali ni znana (ugotovljeni z nadzorovanjem varnosti po pridobitvi dovoljenja za promet in trženju in ni mogoče določiti pogostosti iz razpoložljivih podatkov).
Common: neutropenia Uncommon: anaemia
Pogosto: nevtropenija Občasno: anemija
Common: allergic reaction
Pogosto: alergijska reakcija
Very common: hypophosphataemia Common: hyperglycaemia, hypertriglyceridaemia Rare: lactic acidosis Not known: hypokalaemia
Zelo pogosto: hipofosfatemija Pogosto: hiperglikemija, hipertrigliceridemija Redko: laktacidoza Pogostost ni znana: hipokaliemija
Lactic acidosis, usually associated with hepatic steatosis, has been reported with the use of nucleoside analogues (see section 4.4).
Ob uporabi analogov nukleozidov je bil opažen pojav laktacidoze, običajno povezane s hepatično steatozo (glejte poglavje 4. 4).
Very common: headache, dizziness
Zelo pogosto: glavobol, omotičnost
Very rare: dyspnoea
Zelo redko: dispneja
Very common: diarrhoea, vomiting, nausea Common: elevated serum lipase, elevated amylase including elevated pancreatic amylase, abdominal pain, dyspepsia, flatulence Rare: pancreatitis
Zelo pogosto: driska, bruhanje, navzea Pogosto: povišanje serumske lipaze, zvišana amilaza vključno z zvišano pankreasno amilazo, bolečine v trebuhu, dispepsija, flatulenca Redko: pankreatitis
Common: increased transaminases, hyperbilirubinaemia Very rare: hepatitis Not known: hepatic steatosis
Pogosto: povišane transaminaze, hiperbilirubinemija Zelo redko: hepatitis Pogostost ni znana: hepatična steatoza
Common: urticaria, vesiculobullous rash, pustular rash, maculopapular rash, pruritus, rash and skin discolouration (increased pigmentation)
Pogosto: koprivnica, vezikulobulozni izpuščaj, pustulozni izpuščaj, makulopapulozni izpuščaj, srbečica, rdečica in sprememba obarvanosti kože (hiperpigmentacija)
Very common: elevated creatine kinase Not known: rhabdomyolysis, osteomalacia (manifested as bone pain and infrequently contributing to fractures), muscular weakness, myopathy
Zelo pogosto: povišanje kreatinske kinaze Pogostost ni znana: rabdomioliza, osteomalacija (ki se kaže kot bolečine v kosteh in redko prispeva k zlomom), mišična oslabelost, miopatija
Renal and urinary disorders:
9 Bolezni sečil: