natgillin/translations-raw huggingface dataset:
Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum, Taenia spp., Echinococcus multilocularis and Echinococcus granulosus. 
Prazikvantel je derivat pirazinoizokinolina, ki uspešno deluje proti trakuljam, kot so: Dipylidium caninum, Taenia spp., Echinococcus multilocularis in Echinococcus granulosus.Prazikvantel hitro prehaja skozi celotno zajedavčevo telesno površino in vpliva predvsem na prepustnost zajedavčeve membrane za kalcij (Ca++).
Profender 96 mg/24 mg spot-on solution for large cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 96 mg/ 24 mg kožni nanos, raztopina za velike mačke
Profender is to be administered at a minimum dose of 1 mg/kg body weight emodepside and 5 mg/kg body weight praziquantel, according to the following dosage table. 
Najmanjši odmerek je 1 mg emodepsida/kg telesne mase in 5 mg prazikvantela/kg telesne mase.
Profender 50 mg / 10 mg modified-release Tablets for Medium Dogs 
Profender 50 mg/10 mg tablete za srednje velike pse Pretisni omot
Each 0.35 ml pipette contains: Active substances: 7.5 mg emodepside, 30 mg praziquantel 
Zdravilni učinkovini: 7,5 mg emodepsida, 30,0 mg prazikvantela
Profender 85.8 mg/ml / 21.4 mg/ml spot-on solution for cats Praziquantel/Emodepside 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 85.5 mg/ml / 21.4 mg/ml kožni nanos, raztopina za mačke Prazikvantel / Emodepsid
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 6 (24 or 102) tablets 
PODATKI NA ZUNANJI OVOJNINI Profender 50 mg/10 mg tablete za srednje velike pse Zunanji karton z 6 (24 ali 102) tabletami
Profender 15 mg/3 mg modified-release Tablets for Small Dogs Profender 50 mg/10 mg modified-release Tablets for Medium Dogs Profender 150 mg/30 mg modified-release Tablets for Large Dogs Praziquantel / Emodepside 
Profender 15 mg/3 mg tablete s prirejenim sproščanjem za majhne pse Profender 50 mg/10 mg tablete s prirejenim sproščanjem za srednje velike pse Profender 150 mg/30 mg tablete s prirejenim sproščanjem za velike pse Emodepsid / Prazikvantel
Profender 30 mg / 7.5 mg spot-on solution for small cats Profender 60 mg / 15 mg spot-on solution for medium cats Profender 96 mg / 24 mg spot-on solution for large cats Praziquantel / Emodepside 
Profender 30 mg/ 7.5 mg kožni nanos, raztopina za majhne mačke Profender 60 mg/ 15 mg kožni nanos, raztopina za srednje velike mačke Profender 96 mg/ 24 mg kožni nanos, raztopina za velike mačke Prazikvantel / Emodepsid
Profender 15 mg/3 mg modified-release Tablets for Small Dogs Profender 50 mg/10 mg modified-release Tablets for Medium Dogs Profender 150 mg/30 mg modified-release Tablets for Large Dogs 
NAVODILO ZA UPORABO Profender 15 mg/ 3 mg tablete s prirejenim sproščanjem za male pse Profender 50 mg/ 10 mg tablete s priprejenim sproščanjem za srednje velike pse Profender 150 mg/ 30 mg tablete s prirejenim sproščanje za velike pse
Pipette label 
Pljučni črvi
For medium cats > 2.5 kg - 5 kg 
CILJNE ŽIVALSKE VRSTE Za srednje velike mačke >2,5 - 5 kg
EU/2/05/054/012 2 pipettes EU/2/05/054/013 4 pipettes 
EU/2/05/054/012 2 merilni kapalki EU/2/05/054/013 4 merilne kapalke
EU/2/05/054/014 12 pipettes EU/2/05/054/015 20 pipettes EU/2/05/054/016 40 pipettes 
EU/2/05/054/014 12 merilnih kapalk EU/2/05/054/015 20 merilnih kapalk EU/2/05/054/016 40 merilnih kapalk
PACKAGE LEAFLET Profender 85.8 mg/ml / 21.4 mg/ml spot-on solution for cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 85.8 mg/ml/ 21.4 mg/ml kožni nanos, raztopina za mačke
For animal treatment only. 
BESEDILO “SAMO ZA ŽIVALI” Samo za živali.
Profender 15 mg / 3 mg modified-release Tablets for Small Dogs 
Profender 15 mg/3 mg tablete za majhne pse
EU/2/05/054/018 - 031 
ŠTEVILKA DOVOLJENJA ZA PROMET EU/2/05/054/018 - 031
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 50 mg / 10 mg Tablets for Medium Dogs Outer carton, pack size of 2 (or 4) tablets 
PODATKI NA ZUNANJI OVOJNINI Profender 50 mg/10 mg tablete za srednje velike pse Zunanji karton z 2 (ali 4) tabletami
Replace screw cap after use. 
Po uporabi namestite navojno zaporko.
EU/2/05/054/006 2 pipettes EU/2/05/054/007 4 pipettes 
EU/2/05/054/006 2 merilni kapalki EU/2/05/054/007 4 merilne kapalke
Pack sizes 
Pretisni omot
3 mg emodepside, 15 mg praziquantel. 
NAVEDBA UČINKOVIN(E) emodepsid 3 mg, prazikvantel 15 mg
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 150 mg / 30 mg Tablets for Large Dogs Outer carton, pack size of 2 tablets 
PODATKI NA ZUNANJI OVOJNINI Profender 150 mg/30 mg tablete za velike pse Zunanji karton z 2 tabletama
Profender 150 mg / 30 mg modified-release Tablets for Large Dogs 
Profender 150 mg/30 mg tablete za velike pse
6 tablets 24 tablets 102 tablets 
102 tableti
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 10 (24 or 50) tablets 
PODATKI NA ZUNANJI OVOJNINI Profender 15 mg/3 mg tablete za majhne pse Zunanji karton z 10 (24 ali 50) tabletami
PACKAGE SIZES 
Velikosti pakiranj:
EU/2/05/054/023 2 tablets EU/2/05/054/024 4 tablets 
EU/2/05/054/023 za 2 tableti EU/2/05/054/024 za 4 tablete
10 mg emodepside, 50 mg praziquantel. 
NAVEDBA UČINKOVIN(E) emodepsid 10 mg, prazikvantel 50 mg
EU/2/05/054/003 12 pipettes EU/2/05/054/004 20 pipettes EU/2/05/054/005 40 pipettes 
EU/2/05/054/003 12 merilnih kapalk EU/2/05/054/004 20 merilnih kapalk EU/2/05/054/005 40 merilnih kapalk
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender 15 mg / 3 mg Tablets for Small Dogs Outer carton, pack size of 2 (or 4) tablets 
PODATKI NA ZUNANJI OVOJNINI Profender 15 mg/3 mg tablete za majhne pse Zunanji karton z 2 (ali 4) tabletami
EU/2/05/054/001 2 pipettes EU/2/05/054/002 4 pipettes 
EU/2/05/054/001 2 merilni kapalki EU/2/05/054/002 4 merilne kapalke
Marketing authorisation holder: Bayer Animal Health GmbH 51368 Leverkusen Germany 
Imetnik dovoljenja za promet z zdravilom: Bayer Animal Health GmbH 51368 Leverkusen
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for small cats Outer carton, pack size of 12 (20 or 40) pipettes 
PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za majhne mačke Škatla z 12 (20 ali 40) merilnimi kapalkami
Avoid direct contact with application area while it is wet. 
Ne dotikajte se mesta nanosa, ko je še vlažno.
In this product, emodepside is responsible for the efficacy against Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala and Trichuris vulpis. 
Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala in Trihuris vulpis.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 12 (20 or 40) pipettes 
PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za velike mačke Škatla z 12 (20 ali 40) merilnimi kapalkami
PACKAGE LEAFLET Profender 30 mg / 7.5 mg spot-on solution for small cats Profender 60 mg / 15 mg spot-on solution for medium cats Profender 96 mg / 24 mg spot-on solution for large cats 
NAVODILO ZA UPORABO Profender 30 mg/ 7.5 mg kožni nanos, raztopina za majhne mačke Profender 60 mg/ 15 mg kožni nanos, raztopina za srednje velike mačke Profender 96 mg/ 24 mg kožni nanos, raztopina za velike mačke
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
B. POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE Na veterinarski recept.
Transient mild neurological disorders (e.g. tremors, incoordination) were observed in very rare cases. 
Zelo redko se lahko pojavijo lažje in prehodne nevrološke motnje, kot so nekoordiniranost gibov in mišično drgetanje.
Each 0.70 ml pipette contains: Active substances: 15 mg emodepside, 60 mg praziquantel 
Zdravilni učinkovini: 15,0 mg emodepsida, 60,0 mg prazikvantela
Each 1.12 ml pipette contains: Active substances: 24 mg emodepside, 96 mg praziquantel 
Zdravilni učinkovini: 24,0 mg emodepsida, 96,0 mg prazikvantela
Tapeworms (Cestodes): 
INDIKACIJA(E) Valjasti črvi:
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for large cats Outer carton, pack size of 2 (or 4) pipettes 
PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za velike mačke Škatla z 2 (ali 4) merilnima kapalkama
PACKAGE LEAFLET Profender 15 mg/3 mg modified-release Tablets for Small Dogs Profender 50 mg/10 mg modified-release Tablets for Medium Dogs Profender 150 mg/30 mg modified-release Tablets for Large Dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 15 mg/3 mg tablete s prirejenim sproščanjem za majhne pse Profender 50 mg/10 mg tablete s prirejenim sproščanjem za srednje velike pse Profender 150 mg/30 mg tablete s prirejenim sproščanjem za velike pse
Transient muscular tremors, incoordination and depression were occasionally observed when the veterinary product was administered at overdoses of up to 5 times the recommended dose. 
Pri zaužitju 5-kratnega terapevtskega odmerka se je občasno pojavilo prehodno mišično drgetanje, nekoordiniranost gibov in potrtost.
STATEMENT OF ACTIVE SUBSTANCES 
6.1 Seznam pomožnih snovi
21.4 mg/ml emodepside, 85.8 mg/ml praziquantel 
KOLIČINA UČINKOVIN(E) 21,4 mg/ml emodepsida, 85,8 mg/ml prazikvantela.
2 tablets 4 tablets 
VELIKOST PAKIRANJA 4 tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for small cats Outer carton, pack size of 2 (or 4) pipettes 
PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za majhne mačke Škatla z 2 (ali 4) merilnimi kapalkami
The following pack sizes are available: Profender 15 mg/3 mg tablets for small dogs - 2 tablets 
Profender 15 mg/3 mg tablete za majhne pse - 2 tableti
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Profender spot-on solution for medium cats Outer carton, pack size of 2 (or 4) pipettes 
PODATKI NA ZUNANJI OVOJNINI Profender, kožni nanos, raztopina za srednje velike mačke Škatla z 2 (ali 4) merilnimi kapalkami
Profender 30 mg/7.5 mg spot-on solution for small cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 30 mg/ 7.5 mg kožni nanos, raztopina za majhne mačke
Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. 
Pri nanosu desetkratnega terapevtskega odmerka odraslim mačkam ter petkratnega terapevtskega odmerka mačjim mladičem, se je občasno pojavilo slinjenje, bruhanje ter nevrološki znaki npr. drget.
EU/2/05/054/018 2 tablets EU/2/05/054/019 4 tablets 
EU/2/05/054/019 za 4 tablete
EXP {month/year} Shelf life after first opening the immediate container: 3 months 
Rok uporabnosti po prvem odpiranju vsebnika je…….
EU/2/05/054/008 12 pipettes EU/2/05/054/009 20 pipettes EU/2/05/054/010 40 pipettes 
EU/2/05/054/009 20 merilnih kapalk EU/2/05/054/010 40 merilnih kapalk
Bottle label 
Mlečna kislina
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for small cats blister 
Profender, kožni nanos, raztopina za majhne mačke Pretisni omot
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for medium cats blister 
Profender, kožni nanos, raztopina za srednje velike mačke Etiketa na merilni kapalki
Profender 60 mg/15 mg spot-on solution for medium cats 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 60 mg/ 15 mg kožni nanos, raztopina za srednje velike mačke
Profender spot-on solution for medium cats (>2.5-5 kg) 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender za mačke (> 2,5 - 5 kg)
Renal excretion of metabolites predominates. 
Glavni metaboliti so monohidroksicikloheksilni derivati prazikvantela.
Salivation, vomiting and trembling were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. 
Pri nanosu desetkratnega terpevtskega odmerka odraslim mačkam ter petkratnega terapevtskega odmerka mačjim mladičem, se je občasno pojavilo slinjenje, bruhanje ter nevrološki znaki npr. drget.
Lot: {number} 
ŠTEVILKA SERIJE Lot: {številka}
0.35 ml, 0.70 ml and 1.12 ml per pipette Blister packs containing 2, 4, 12, 20, or 40 unit dose pipettes; 0.70 ml pipette only: additional blister pack containing 80 pipettes 
Merilne kapalke z 0,35 ml, 0,70 ml in 1,12 ml raztopine za kožni nanos.
Pack sizes: Profender 15 mg / 3 mg modified-release Tablets for Small Dogs 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI Profender 15 mg/3 mg tablete s prirejenim sproščanjem za majhne pse
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Profender spot-on solution for large cats blister 
Profender, kožni nanos, raztopina za velike mačke Pretisni omot
Use within 60 days after first opening. 
Uporabite v roku 60 dni po prvem odprtju.
The optimal duration of treatment is unknown. 
Optimalno trajanje zdravljenja ni znano.
• Look out for infections. 
• Bodite pozorni na okužbe.
• swelling of the face, lips, tongue or throat. 
• oteklost obraza, ustnic, jezika ali grla
However, severe exacerbations, including fatalities, have been reported. 
Vendar pa so poročali tudi o hudih poslabšanjih, vključno s smrtnimi primeri.
The clinical implications of this are unknown. 
Klinične posledice tega niso znane.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 September 2016 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 15. september 2016
These symptoms may indicate that your body's improved immune system is fighting infection. 
Ti simptomi lahko nakazujejo, da se izboljšani imunski sistem vašega telesa bojuje proti okužbi.
Response after addition of emtricitabine is excluded (total of 17 subjects across both studies). 
Odziv po dodajanju emtricitabina je izključen (skupaj 17 oseb v obeh študijah).
Study 174-0108 
Študija 174-0108
2 years Shelf-life after first opening is 60 days. 
2 leti Rok uporabnosti po prvem odprtju je 60 dni.
The tablets are suitable for: 
Tablete so primerne za:
Keep the tablet bottle with you so that you can easily describe what you have taken. 
S seboj imejte plastenko tablet, da boste lahko opisali, kaj ste zaužili.
Benefit has also been demonstrated based on histological responses in compensated patients. 
Korist je bila dokazana tudi na osnovi histoloških odzivov bolnikov s kompenzirano boleznijo.
• It is very important to tell your doctor if you are taking other medicines that may damage your kidneys. 
• Zelo pomembno je, da svojega zdravnika obvestite, če jemljete druga zdravila, ki bi lahko poškodovala vaše ledvice.
Then mix the powder with about 100 ml (half a glass) of water, orange juice or grape juice and drink immediately. 
Nato zmešajte prašek s približno 100 ml (pol kozarca) vode, pomarančnega ali grozdnega soka in nemudoma popijte.
• Adults: One tablet each day with food (for example, a meal or a snack). 
• odrasli: 1 tableta vsak dan s hrano (na primer ob obroku ali prigrizku).
Do not store above 30 °C. 
Shranjujte pri temperaturi do 30 °C.
However, the subject's HBsAg loss was ultimately confirmed at the subsequent visit. 
Izguba HBsAg je bila dokončno potrjena ob naslednjem obisku.
No studies on the effects on the ability to drive and use machines have been performed. 
Študije o vplivu na sposobnost vožnje in upravljanja strojev niso izvedli.
This is because the active substance in this medicine passes into human breast milk. 
To je zato, ker učinkovina tega zdravila prehaja v materino mleko.
• Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection. 
• Nemudoma obvestite zdravnika o vsakem novem ali nenavadnem simptomu potem, ko ste prenehali z zdravljenjem, še posebej o simptomih, ki jih povezujete z okužbo s hepatitisom B.
• At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached. 
• na zahtevo Evropske agencije za zdravila; • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil dosežen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
Tests may also show: • liver problems. 
Preiskave lahko kažejo tudi: • težave z jetri
These dose interval adjustments have not been confirmed in clinical studies. 
Te prilagoditve odmerkov niso bile potrjene s kliničnimi študijami.
• Recommended schedule for monitoring renal function considering the presence or absence of additional risk factors for renal impairment 
• priporočeni režim za nadzorovanje delovanja ledvic, upoštevajoč prisotnost ali odsotnost dodatnih dejavnikov tveganja za ledvično okvaro;
The HIV and HBV adolescent educational brochures should contain the following key messages: 
Izobraževalno gradivo o mladostnikih s HIV in HBV morata vsebovati naslednja ključna sporočila:
• increased creatinine in your blood, 
• povišan kreatinin v krvi
Tests may also show: • decreases in phosphate in the blood. 
Preiskave lahko kažejo tudi: • zmanjšanje količine fosfata v krvi
If you are an adult, your doctor may advise you to take the tablets less often. 
Če ste odrasla oseba, vam bo zdravnik morda svetoval, da jemljete tablete manj pogosto.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment. 
Tako boste zagotovili polno učinkovitost vašega zdravila in zmanjšali možnost razvoja odpornosti na zdravljenje.
If you have hepatitis B infection, your doctor will carefully consider the best treatment for you. 
Če ste okuženi s hepatitisom B, bo vaš zdravnik skrbno razmislil o najboljšem zdravljenju za vas.
Your doctor will carefully consider whether to treat you with combinations of tenofovir and didanosine 
Vaš zdravnik bo skrbno pretehtal, če vas bo zdravil s kombinacijami tenofovirja in didanozina.
If this is unavoidable, your doctor will monitor your kidney function once a week. 
Če je to neizogibno, bo zdravnik enkrat tedensko nadzoroval funkcijo vaših ledvic.
• deep, rapid breathing, 
• globoko, hitro dihanje
Staggered administration (12 hours apart) provided similar results. 
Pri razporejenem odmerjanju (na 12 ur) so bili rezultati podobni.
• If it is less than 12 hours after it is usually taken, take it as soon as you can, and then take your next dose at its regular time. 
• Če je minilo manj kot 12 ur od časa, ko ga običajno vzamete, ga vzemite čim prej in nato vzemite naslednji odmerek ob običajnem času.
Ethnicity Pharmacokinetics have not been specifically studied in different ethnic groups. 
Etnična pripadnost Farmakokinetike niso posebej preučevali pri različnih etničnih skupinah.
If Tenofovir disoproxil Zentiva has been prescribed for your child, please note that all the information in this leaflet is addressed to your child (in this case please read “your child” instead of “you”). 
Če je bilo zdravilo Dizoproksiltenofovirat Zentiva predpisano za vašega otroka, veljajo vsi podatki v tem navodilu za uporabo za vašega otroka (v tem primeru berite “vaš otrok” namesto “vi”).
Tenofovir is also active against HIV-1 subtypes A, C, D, E, F, G, and O and against HIVBaL in primary monocyte/macrophage cells. 
Tenofovir je prav tako aktiven proti podtipom HIV-1 A, C, D, E, F, G in O in proti HIVBaL v primarnih monocitih/makrofagih.
U Kabelovny 130 102 37 Prague 10 Czech Republic 
U Kabelovny 130 102 37 Prague 10 Češka
Other suitable formulations should be checked for their availability. 
Preveriti je potrebno razpoložljivost drugih primernih pripravkov.
In addition, 61% of patients had normal ALT at week 48. 
Poleg tega je 61% bolnikov imelo normalne koncentracije ALT v 48. tednu.
medicines which are no longer fully effective due to development of resistance, or have caused side effects. 
HIV, ki niso več polno učinkovita zaradi nastanka odpornosti ali so povzročala neželene učinke.
Each bottle contains a silica gel desiccant that must be kept in the bottle to help protect your tablets. 
Vsaka plastenka vsebuje silikagelsko sušilno sredstvo, ki mora ostati v plastenki zaradi zaščite vaših tablet.
The decision to treat paediatric patients (adolescents) should be based on careful consideration of individual patient needs and with reference to current paediatric treatment guidelines including the value of baseline histological information. 
Odločitev za zdravljenje pediatričnih bolnikov (mladostnikov) mora temeljiti na skrbnem upoštevanju individualnih potreb bolnika in upoštevati trenutne smernice za zdravljenje pediatričnih bolnikov, vključno z vrednostjo izhodiščnih histoloških podatkov.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) or rare (≥ 1/10,000 to < 1/1,000). 
Pogostnosti so definirane kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100) ali redki (≥ 1/10.000 do < 1/1.000).
No further K65R development was observed up to week 144. 
Do 144. tedna niso opazili nobenega nadaljnjega razvoja K65R.
Triple therapy with nucleosides/nucleotides 
Tritirno zdravljenje z nukleozidi/nukleotidi
Histology Histological response (%)b 
Histologija Histološki odziv (%)
Week 
Teden
Liver flares are especially serious, and sometimes fatal in patients with decompensated liver disease. 
Poslabšanja so posebno resna in včasih smrtno nevarna pri bolnikih z dekompenzirano jetrno boleznijo.
A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) indicate no malformations or foetal/neonatal toxicity associated with tenofovir disoproxil. 
Veliko število podatkov pri nosečnicah (več kot 1.000 izpostavljenih nosečnosti) ne kaže na malformacije ali feto/neonatalno toksičnost, povezane z dizoproksiltenofoviratom.
Moreover, the reversibility of renal toxicity cannot be fully ascertained. 
Poleg tega reverzibilnosti toksičnih učinkov na ledvice ni mogoče popolnoma ugotoviti.
Non-clinical safety pharmacology studies reveal no special hazard for humans. 
Predklinične študije farmakološke varnosti ne kažejo posebnega tveganja za človeka.
(using MDRD equation). 
na leto (z uporabo enačbe MDRD).
• adolescents aged 12 to less than 18 years. 
• mladostnike, stare 12 do manj kot 18 let.
k One patient in this group became HBsAg negative for the first time at the 240 week visit and was ongoing in the study at the time of the data cut-off. 
En bolnik v tej skupini je postal prvič negativen na HBsAg ob obisku v 240. tednu, kar je ostalo ves čas študije do trenutka prvega zbiranja podatkov.
You can also pass on HIV or HBV to others, so it is important to take precautions to avoid infecting other people. 
Virus HIV ali HBV lahko prenesete tudi na druge, zato je pomembno, da uporabljate zaščitne ukrepe, ki preprečujejo okužbo drugih oseb.
• If it is more than 12 hours since you should have taken it, forget about the missed dose. 
• Če je minilo več kot 12 ur, odkar naj bi vzeli zdravilo, pozabljenega odmerka ne vzemite.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child. 
• Če zanosite ali načrtujete zanositev, se posvetujte z zdravnikom o možnih koristih in tveganjih vašega protiretrovirusnega zdravljenja za vas in vašega otroka.
Renal and bone effects in adult population 
Učinki na ledvice in kosti pri odrasli populaciji
*Generally, once weekly dosing assuming three haemodialysis sessions per week, each of approximately 4 hours duration or after 12 hours cumulative haemodialysis. 
* Na splošno velja: 1 odmerek enkrat tedensko pri predpostavljenih treh hemodializah na teden, vsaka po približno 4 ure ali skupno 12 ur hemodialize.
• You must not take Tenofovir disoproxil Zentiva during pregnancy unless specifically discussed with your doctor. 
• Zdravila Dizoproksiltenofovirat Zentiva ne smete jemati med nosečnostjo, razen če ste se o tem posebej dogovorili s svojim zdravnikom.