natgillin/translations-raw huggingface dataset:
The following events have also been reported when VIRAMUNE has been used in combination with other antiretroviral agents:
Med jemanjem zdravila VIRAMUNE v kombinaciji z drugimi protivirusnimi zdravili so poročali še o naslednjih pojavih:
- decrease in or abnormal skin sensations.
- zmanjšani ali spremenjeni občutljivosti kože.
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however, it is unlikely that these events are due to a treatment with VIRAMUNE.
Ta stanja so večinoma povezana z drugimi protivirusnimi zdravili in se lahko pojavijo, kadar jemljete zdravilo VIRAMUNE v kombinaciji z drugimi zdravili, ni pa verjetno, da jih povzroča samo zdravljenje z zdravilom VIRAMUNE.
The expiry date refers to the last day of that month.
VIRAMUNA ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in pretisnem omotu za oznako EXP.
VIRAMUNE should be used within 6 months of opening the bottle.
Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
What VIRAMUNE contains
Kaj vsebuje zdraviloVIRAMUNE
Each ml contains 10 mg of the active substance nevirapine
En milliliter vsebuje 10 mg zdravilne učinkovine nevirapina
(as nevirapine hemihydrate).
(v obliki nevirapinijevega hemihidrata).
- The other ingredients are carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
- Pomožne snovi so karbomer, metilparahidroksibenzoat, propilparahidroksibenzoat, sorbitol,
sorbitol, sucrose, polysorbate 80, sodium hydroxide and water.
saharoza, polisorbat 80, natrijev hidroksid in voda.
What VIRAMUNE looks like and contents of pack
Izgled zdravilaVIRAMUNA in vsebina pakiranja
VIRAMUNE oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
75 Peroralna suspenzija VIRAMUNE je na voljo v plastenkah po 240 ml.
For measuring the correct dose a plastic measuring syringe is included.
Za pravilno odmerjanje je priložena plastična merilna brizga.
VIRAMUNE is also supplied as 200 mg tablets for older children and adults.
VIRAMUNE je na voljo tudi v obliki tablet po 200 mg za starejše otroke in odrasle.
78 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
76 Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništvo imetnika dovoljenja za promet z zdravilom.
Eesti Österreich Boehringer Ingelheim Pharma GmbH Eesti Filiaal Tel: +372 60 80 940
Eesti Filiaal Tel: +372 60 80 940
Slovenská republika Boehringer Ingelheim RCV GmbH & Co KG organizač ná zlož ka Tel: +421 2 5810 1211
organizačná zložka Tel: +421 2 5810 1211
79 Italia Boehringer Ingelheim Italia S. p. A.
77 Italia Boehringer Ingelheim Italia S. p. A.
This leaflet was last approved in {MM/ YYYY}
Navodlo je bilo odobreno {MM/ LLLL}
80
78
Viread is a medicine containing the active substance tenofovir disoproxil, available as light blue almond-shaped tablets.
Viread je zdravilo, ki vsebuje zdravilno učinkovino tenofovirdizoproksilat in je na voljo v obliki svetlo modrih tablet mandljaste oblike.
Viread is an antiviral medicine.
Viread je protivirusno zdravilo.
It is used in combination with other antiviral medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Uporablja se v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje odraslih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV- 1), virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (AIDS).
For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus ’ s response to antiviral medicines.
Bolnikom, ki so predhodno že jemali zdravila za zdravljenje okužbe s HIV, smejo zdravniki predpisati zdravilo Viread šele potem, ko se seznanijo s protivirusnimi zdravili, ki jih je bolnik jemal prej, oziroma ko ocenijo kakšna je verjetnost, da se bo virus odzval na protivirusna zdravila.
Treatment with Viread should be initiated by a doctor who has experience in the treatment of HIV infection.
Zdravljenje z zdravilom Viread mora uvesti zdravnik z izkušnjami pri zdravljenju okužb s HIV.
The recommended dose of Viread is one tablet taken once a day with food.
Priporočen odmerek zdravila Viread je ena tableta enkrat dnevno s hrano.
In exceptional cases, patients who have particular difficulty swallowing can crush the tablet in at least 100 ml of water, orange juice or grape juice, and drink the resulting suspension.
V izjemnih primerih lahko bolniki, ki imajo težave pri požiranju, tableto strejo v najmanj 100 ml vode, pomarančnega ali grozdnega soka in popijejo nastalo suspenzijo.
The dose may need to be adjusted in patients who have problems with their kidneys.
Pri bolnikih, ki imajo težave z ledvicami, je odmerek morda treba prilagoditi.
The active substance in Viread, tenofovir disoproxil, is a ‘ prodrug ’ that is converted into tenofovir in the body.
Zdravilna učinkovina zdravila Viread, tenofovirdizoproksilat, je „ predzdravilo “, ki se v telesu pretvori v tenofovir.
Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI) that blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Tenofovir je nukleotidni zaviralec reverzne transkriptaze (NRTI), ki zavira aktivnost reverzne transkriptaze, encima, ki ga proizvaja virus HIV in ki omogoča okužbo celic in nastajanje novih virusov.
Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Zdravilo Viread, če ga jemljemo v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in ga ohranja na nizki ravni.
Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Viread ne ozdravi okužbe s HIV ali AIDS- a, vendar pa lahko upočasni slabšanja imunskega sistema in razvoj okužb in bolezni, povezanih z AIDS- om.
Viread has been studied in three main studies involving 1,343 HIV-infected adults.
Zdravilo Viread so preučevali v treh glavnih kliničnih študijah s 1343 odraslimi, okuženimi s HIV.
They had been taking HIV treatments for at least 4 years, but were not
V prvih dveh raziskavah so primerjali učinke dodajanja zdravila Viread z učinki dodajanja placeba (zdravila brez zdravilne učinkovine) pri 741 bolnikih.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
To bolniki so jemali zdravila proti HIV vsaj 4 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged responding to them.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged leta, vendar se nanje niso odzivali.
The main measure of effectiveness was the change in the level of HIV in the blood (viral load), after 4 or 24 weeks of treatment.
Glavno merilo učinkovitosti je bila sprememba koncentracije virusa HIV v krvi (virusne obremenitve) po 4 oziroma 24 tednih zdravljenja.
The effects of Viread were also assessed in a study of 602 treatment-naïve patients (who had not taken HIV treatment before).
Učinke zdravila Viread so preučevali tudi v študiji s 602 predhodno nezdravljenima bolnikoma (ki prej še niso jemali zdravil proti okužbi s HIV).
The study compared the effects of either Viread with those of stavudine (another antiviral medicine) when they were taken together with lamivudine and efavirenz (other antiviral medicines).
V študiji so primerjali učinke zdravila Viread z učinki stavudina (drugega protivirusnega zdravila), pri čemer so bolniki obe zdravili jemali skupaj z lamivudinom in efavirenzom (drugima protivirusnima zdraviloma).
The main measure of effectiveness was the number of patients with viral loads below 400 copies/ ml after 48 weeks.
Glavno merilo učinkovitosti je bilo število bolnikov, katerih virusna obremenitev je bila po 48 tednih manj kot 400 kopij/ ml.
What benefit has Viread shown during the studies?
Kakšne koristi je zdravilo Viread izkazalo med raziskavami?
Viread, taken in combination with other antiviral medicines, caused a reduction in viral load.
Zdravilo Viread, dajano v kombinaciji z drugimi protivirusnimi zdravili, je povzročilo zmanjšanje virusne obremenitve.
In the first study of treatment-experienced patients, those adding Viread to their existing treatment had a fall in viral load of 76% after 4 weeks, compared to a rise of 4% in the placebo group.
V prvi študiji s predhodno zdravljenimi bolniki je pri bolnikih, pri katerih so k obstoječemu zdravljenju dodali zdravilo Viread, prišlo do 76- odstotnega zmanjšanje virusne obremenitve po 4 tednih, v skupini s placebom pa do 4- odstotnega povečanja.
Similar results were seen after 24 weeks.
Podobne rezultate so ugotovili po 24 tednih.
The second study showed the same effect, with a 75% fall in the Viread group, compared to a fall 7% in those adding placebo, after 24 weeks.
V drugi raziskavi je bil učinek enak: po 24 tednih je bilo v skupini z zdravilom Viread opaženo 75- odstotno zmanjšanje, v skupini, v kateri so dodali placebo, pa 7- odstotno zmanjšanje.
In treatment-naïve patients, Viread was as effective as stavudine, with similar numbers of patients in the Viread and stavudine groups having viral loads below 400 copies/ ml after 48 weeks.
Pri predhodno nezdravljenih bolnikih je bilo zdravilo Viread enako učinkovito kot stavudin, saj je bilo v skupinah z zdravilom Viread in stavudinom podobno število bolnikov, ki so imeli po 48 tednih virusne obremenitve pod 400 kopij/ ml.
The most common side effects when taking Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, and hypophosphataemia (low levels of phosphate in the blood).
Najpogostejši neželeni učinki pri jemanju zdravila Viread (opaženi pri več kot 1 od 10 bolnikov) so navzeja (slabost), bruhanje, driska, omotica in hipofosfatemija (nizke ravni fosfata v krvi).
For the full list of side effects reported with Viread, see the Package Leaflet.
Celoten seznam neželenih stranskih učinkov, o katerih so poročali pri uporabi zdravila Viread, najdete v Navodilu za uporabo.
Viread should not be used in people who may be hypersensitive (allergic) to tenofovir, to tenofovir disoproxil fumarate, or to any of the other ingredients.
Zdravila Viread ne smejo jemati osebe, ki utegnejo biti preobčutljive za (alergične na) tenofovir, tenofovirdizoproksil fumarat ali katero drugo sestavino.
As with other anti-HIV medicines, patients taking Viread may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Enako kot pri drugih zdravilih proti virusu HIV obstaja pri bolnikih, ki jemljejo zdravilo Viread, nevarnost lipodistrofije (sprememb v porazdelitvi telesne maščobe), osteonekroze (odmiranja kostnega tkiva) ali sindroma imunske reaktivacije (simptomov okužbe, ki jih povzroči imunski sistem, medtem ko se zdravi).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Viread.
Pri bolnikih, ki imajo težave z jetri (vključno z okužbo s hepatitisom B ali C), obstaja pri jemanju zdravila Viread povečano tveganje za poškodbe jeter.
As with all other NRTIs, Viread may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Viread during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Enako kot vsi drugi NRTI- ji lahko zdravilo Viread povzroči tudi laktacidozo (kopičenje mlečne kisline v telesu), pri dojenčkih mater, ki so med nosečnostjo jemale zdravilo Viread, pa mitohondrijsko disfunkcijo (poškodbo komponent za proizvajanje energije v celicah, kar se lahko odraža v težavah s krvjo).
The Committee for Medicinal products for Human Use (CHMP) decided that Viread’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients over 18 years of age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Viread v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje bolnikov nad 18 let, okuženih s HIV - 1, večje od z njim povezanih tveganj.
The committee noted that the benefit of Viread is based on one study of patients with high viral loads who had not received any antiviral treatment before, and studies in which Viread was added to existing HIV treatment that was not working.
Odbor je ugotovil, da so koristi zdravila Viread utemeljene z eno študijo z bolniki z visokimi virusnimi obremenitvami, ki predhodno niso prejemali protivirusnih zdravil, in raziskavah, v katerih so zdravilo Viread dodajali k obstoječemu zdravljenju HIV, ki ni bilo učinkovito.
The committee recommended that Viread be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Viread odobri dovoljenje za promet.
Viread was originally authorised under “ Exceptional Circumstances”, because, for scientific reasons, limited information was available at the time of approval.
Zdravilo Viread je bilo prvotno odobreno „ v izjemnih okoliščinah “, saj so bile zaradi znanstvenih razlogov ob odobritvi na voljo le omejene informacije.
As the company had supplied the additional information requested, the “ Exceptional Circumstances ” ended on 8 July 2005.
Ker je podjetje posredovalo zahtevane dodatne informacije, so „ izjemne okoliščine “ prenehale 8. julija 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Viread to Gilead Sciences International Limited on 5 February 2002.
Evropska komisija je dovoljenje za promet z zdravilom Viread, veljavno po vsej Evropski uniji, odobrila družbi Gilead Sciences International Limited dne 5. februarja 2002.
The marketing authorisation was renewed on 5 February 2007.
Dovoljenje za promet z zdravilom je bilo podaljšano 5. februarja 2007.
The full EPAR for Viread is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Viread je na voljo tukaj.
bottle (HDPE) bottle (HDPE)
Plastenka (HDPE)
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as fumarate), equivalent to 300 mg of tenofovir disoproxil fumarate, or 136 mg of tenofovir.
Ena filmsko obložena tableta vsebuje 245 mg tenofovirdizoproksila (v obliki fumarata), kar je ekvivalentno 300 mg tenofovirdizoproksil fumarata ali 136 mg tenofovirja.
Each tablet contains 153.33 mg lactose monohydrate.
Vsaka tableta vsebuje 153, 33 mg laktoze monohidrata.
Light blue, almond-shaped, film-coated tablets, debossed on one side with the markings “ GILEAD” and “ 4331” and on the other side with the marking “ 300”.
Svetlo modre, mandljaste oblike, filmsko obložene tablete z vtisnjenima znakoma “ GILEAD ” in “ 4331 ” na eni strani ter znakom “ 300 ” na drugi strani.
HIV-1 infection:
Okužba z virusom HIV- 1:
Viread is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults over 18 years of age.
Viread je indiciran v kombinaciji z drugimi protiretrovirusnimi zdravili za zdravljenje odraslih oseb, starejših od 18 let, okuženih s HIV- 1.
The demonstration of benefit of Viread in HIV-1 infection is based on results of one study in treatment-naïve patients, including patients with a high viral load (> 100,000 copies/ ml) and studies in which Viread was added to stable background therapy (mainly tritherapy) in antiretroviral pre-treated patients experiencing early virological failure (< 10,000 copies/ ml, with the majority of patients having < 5,000 copies/ ml).
Dokaz uspešnosti Vireada za zdravljenje okužbe z virusom HIV- 1 temelji na rezultatih študije zdravljenja še nezdravljenih bolnikov, vključujoč bolnike z visoko virusno obremenitvijo (> 100. 000 kopij/ ml) in na študijah v katerih so Viread dodali k stabilni osnovni terapiji (večinoma tritirno zdravljenje) predhodno že zdravljenim bolnikom, ki so izkusili zgodnji virološki neuspeh in niso več reagirali na terapijo (< 10. 000 kopij/ ml, večina bolnikov je imela vrednost < 5. 000 kopij/ ml).
The choice of Viread to treat antiretroviral experienced patients with HIV-1 infection should be based on individual viral resistance testing and/ or treatment history of patients.
Pri odločanju o Vireadu za zdravljenje bolnikov z okužbo z virusom HIV- 1, ki so že bili zdravljeni s protiretrovirusnimi zdravili, je potrebno upoštevati posamezne teste virusne rezistence in/ ali predhodno zdravljenje bolnikov.
Hepatitis B infection:
Okužba z virusom hepatitisa B:
Viread is indicated for the treatment of chronic hepatitis B in adults with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/ or fibrosis.
Zdravilo Viread je indicirano za zdravljenje kroničnega hepatitisa B pri odraslih s kompenzirano jetrno boleznijo z dokazano aktivno replikacijo virusov, vztrajno zvišano vrednostjo alanin- aminotransferaze (ALT) v serumu in s histološko dokazano aktivnim vnetjem in/ ali fibrozo.
This indication is based on histological, virological, biochemical and serological responses mainly in adult nucleoside-naïve patients with HBeAg positive and HBeAg negative chronic hepatitis B with compensated liver function.
Ta indikacija temelji na histoloških, viroloških, biokemijskih in seroloških odzivih zlasti pri odraslih bolnikih, ki še niso bili zdravljeni z nukleozidi, s kroničnim hepatitisom B, pozitivnim na HBeAg in negativnim na HBeAg, s kompenziranim delovanjem jeter.
Therapy should be initiated by a physician experienced in the management of HIV infection and/ or treatment of chronic hepatitis B.
Terapijo mora izvajati zdravnik, ki že ima izkušnje z zdravljenjem okužbe z virusom HIV in/ ali z zdravljenjem kroničnega hepatitisa B.
In exceptional circumstances in patients having particular difficulty in swallowing, Viread can be administered following disintegration of the tablet in at least 100 ml of water, orange juice or grape juice.
V izjemnih primerih, ko ima bolnik hujše težave s požiranjem, se lahko Viread zaužije razdrobljen v najmanj 100 ml vode, pomarančnega ali grozdnega soka.
2 Adults:
2 Odrasli:
The recommended dose for the treatment of HIV or for the treatment of chronic hepatitis B is 245 mg (one tablet) once daily taken orally with food.
Priporočen odmerek za zdravljenje okužbe z virusom HIV ali za zdravljenje kroničnega hepatitisa B je 245 mg (ena tableta) enkrat dnevno, peroralno, s hrano.
- In HBeAg positive patients without cirrhosis, treatment should be administered for at least
- Pri na HBeAg pozitivnih bolnikih brez ciroze naj zdravljenje traja najmanj 6- 12 mesecev po
6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with anti-HBe detection) is confirmed or until HBs seroconversion or there is loss of efficacy (see section 4.4).
potrditvi HBe serološke konverzije (izguba HBeAg in izguba HBV DNA z detekcijo anti- HBe) ali do HBs serološke konverzije ali dokler ne pride do izgube učinkovitosti (glejte poglavje 4. 4).
- In HBeAg negative patients without cirrhosis, treatment should be administered at least until
- Pri na HBeAg negativnih bolnikih brez ciroze naj zdravljenje traja najmanj do HBs serološke
HBs seroconversion or there is evidence of loss of efficacy.
konverzije ali do dokazane izgube učinkovitosti.
Viread is not recommended for use in children below the age of 18 years due to insufficient data on safety and efficacy (see section 5.2).
Zaradi nezadostnih podatkov o varnosti in učinkovitosti uporaba Vireada pri otrocih pod 18 let ni priporočljiva (glejte poglavje 5. 2).
No data are available on which to make a dose recommendation for patients over the age of 65 years (see section 4.4).
Podatkov, na osnovi katerih bi lahko priporočili odmerke za bolnike starejše od 65 let, ni na voljo (glejte poglavje 4. 4).
There are limited data on the safety and efficacy of tenofovir disoproxil fumarate in patients with moderate and severe renal impairment (creatinine clearance < 50 ml/ min) and long term safety data has not been evaluated for mild renal impairment (creatinine clearance 50-80 ml/ min).
Podatki o varnosti in učinkovitosti tenofovirdizoproksil fumarata pri bolnikih z zmernimi in hudimi motnjami v delovanju ledvic (očistek kreatinina < 50 ml/ min) so nezadostni, dolgoročni podatki o varnosti pri bolnikih z blagimi motnjami v delovanju ledvic (očistek kreatinina 50- 80 ml/ min) niso bili ovrednoteni.
Therefore, in patients with renal impairment tenofovir disoproxil fumarate should only be used if the potential benefits of treatment are considered to outweigh the potential risks.
Zato se sme pri vseh bolnikih z motnjami v delovanju ledvic tenofovirdizoproksil fumarat uporabljati samo, če se oceni, da morebitne koristi zdravljenja odtehtajo morebitna tveganja.
Dose interval adjustments are recommended for patients with creatinine clearance < 50 ml/ min.
Intervale med odmerki je priporočljivo prilagoditi pri bolnikih, ki imajo očistek kreatinina < 50 ml/ min.
Limited data from clinical studies support once daily dosing of tenofovir disoproxil fumarate in patients with mild renal impairment.
Pomankljivi podatki iz kliničnih študij podpirajo odmerjanje tenofovirdizoproksil fumarata enkrat dnevno pri bolnikih z blagimi motnjami v delovanju ledvic.
Moderate renal impairment (creatinine clearance 30-49 ml/ min):
Zmerne motnje v delovanju ledvic (očistek kreatinina od 30- 49 ml/ min):
Administration of 245 mg tenofovir disoproxil (as fumarate) every 48 hours is recommended based on modelling of single-dose pharmacokinetic data in non-HIV and non-HBV infected subjects with varying degrees of renal impairment, including end-stage renal disease requiring haemodialysis, but has not been confirmed in clinical studies.
Priporočljiv je odmerek 245 mg tenofovirdizoproksila (v obliki fumarata) vsakih 48 ur, ki temelji na podatkih o farmakokinetiki enkratnih odmerkov pri bolnikih, ki niso okuženi z virusom HIV ali virusom HBV, z različnimi stopnjami motenj v delovanju ledvic, vključno s končno fazo ledvične bolezni, zaradi katere je potrebna hemodializa, toda v kliničnih študijah ni bil potrjen.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients (see sections 4.4 and 5.2).
Zato je potrebno pri teh bolnikih skrbno nadzorovati klinični odziv na zdravljenje in delovanje ledvic (glejte poglavji 4. 4 in 5. 2).
Severe renal impairment (creatinine clearance < 30 ml/ min) and haemodialysis patients:
Hude motnje v delovanju ledvic (očistek kreatinina < 30 ml/ min) in bolniki na hemodializi:
Adequate dose adjustments cannot be applied due to lack of alternative tablet strengths, therefore use in this group of patients is not recommended.
Zaradi tega uporaba zdravila pri tej skupini bolnikov ni priporočljiva.
If no alternative treatment is available, prolonged dose intervals may be used as follows:
Če alternativne oblike zdravljenja ni na razpolago, se lahko uporabijo naslednji podaljšani odmerni intervali:
Severe renal impairment:
Hude motnje v delovanju ledvic:
245 mg tenofovir disoproxil (as fumarate) may be administered every 72-96 hours (dosing twice a week).
245 mg tenofovirdizoproksila (v obliki fumarata) vsakih 72- 96 ur (odmerjanje dvakrat na teden).
245 mg tenofovir disoproxil (as fumarate) may be administered every 7 days following completion of a haemodialysis session*.
245 mg tenofovirdizoproksila (v obliki fumarata) vsakih 7 dni po končani hemodializi *.