FrancophonIA/ELRC3.0 huggingface dataset:
English: Long-term (at least 5-10 years) use of oestrogen-only HRT products has been associated with a slightly increased risk of ovarian cancer (see section 4.8).
Slovenian: Dolgotrajna uporaba (vsaj 5-10 let) samo estrogenskega zdravljenja je povezana z rahlo zvečanim tveganjem za raka jajčnikov (glejte poglavje 4.8).
English: With use of X, the increased risk of ovarian cancer is similar to other types of HRT.
Slovenian: Pri uporabi zdravila X je zvečano tveganje za raka jajčnikov podobno tveganju, povezanemu z uporabo drugih vrst HNZ.
English: The use of oestrogen-only HRT has been associated with a slightly increased risk of ovarian cancer.
Slovenian: Uporaba samo estrogenskega HNZ zdravljenjem je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
English: In the Million Women Study For women aged 50 to 54 years taking 5 years of HRT, this resultsed in about 1 extra case per 2,5000 users.
Slovenian: V študiji Million Women Study Pri ženskah, starih od 50 do 54 let, ki uporabljajo HNZ pet let, to povzroča je to povzročilo približno en dodaten primer na 2 5000 uporabnic.
English: For women aged 50 to 54 years taking 5 years of HRT, this results in about 1 extra case per 2000 users.
Slovenian: Pri ženskah, starih od 50 do 54 let, je 5-letna uporaba HNZ povzročila približno en dodaten primer na 2 000 uporabnic.
English: Cleanse surgical instruments, or gloves and adjacent tissues, if necessary.
Slovenian: Po potrebi očistite kirurške instrumente, ali rokavice in sosednja tkiva.
English: Some other studies, including the Women's Health Initiative (WHI) trial, suggest that the longterm use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Slovenian: Nekatere druge študije, vključno s preskušanjem Women's Health Initiative (WHI), kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
English: In the Million Women Study 5 years of HRT resulted in 1 extra case per 2500 users.
Slovenian: V študiji Million Women Study je 5-letna uporaba HNZ povzročila en dodatni primer na 2 500 uporabnic.
English: The use of oestrogen-only or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of ovarian cancer.
Slovenian: Uporaba HNZ, ki vsebuje samo estrogen ali kombinacijo estrogena in progestagena, je bila povezana z rahlo zvečanim tveganjem za raka jajčnikov.
English: Some other studies, including the WHI trial, suggest that use of combined HRTs may be associated with a similar or slightly smaller risk (see Section 4.8).
Slovenian: Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je uporaba kombiniranih HNZ lahko povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
English: In women aged 50 to 54 who are not taking HRT, about 2 women in 2000 will be diagnosed with ovarian cancer over a 5-year period.
Slovenian: Pri ženskah, starih od 50 do 54 let, ki ne uporabljajo HNZ, bodo v 5-letnem obdobju diagnosticirali raka jajčnikov pri približno dveh ženskah od 2 000.
English: Bowel obstruction and pain following abdominal surgeries can also occur.
Slovenian: Prav tako lahko pride do zapore črevesa in bolečin v trebuhu.
English: Some other studies, including the WHI trial, suggest that the long-term use of combined HRTs may confer be associated with a similar, or slightly smaller risk (see Section 4.8).
Slovenian: Nekatere druge študije, vključno s preskušanjem WHI, kažejo, da je dolgotrajna uporaba kombiniranih HNZ lahko pomeni povezana s podobnim ali rahlo manjšim tveganjem (glejte poglavje 4.8).
English: A slightly increased risk of ovarian cancer has been reported in women taking HRT for at least 5 to 10 years.
Slovenian: Pri ženskah, ki uporabljajo HNZ vsaj 5 do 10 let, so poročali o rahlo zvečanem tveganju za raka jajčnikov.
English: For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21000 users (i.e. up to about 1 extra case).
Slovenian: Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh izmed 2 1000 uporabnic (tj. do približno en primer več).
English: For women who have been taking HRT for 5 years, there will be between 2 and about 3 cases per 21,000 users (i.e. about up to 1 extra case).
Slovenian: Pri ženskah, ki uporabljajo HNZ pet let, bodo raka jajčnikov odkrili pri približno med 2 in treh zmed 2 1000 uporabnic (tj. do približno en primer več).
English: Gastrointestinal disorders:
Slovenian: Bolezni prebavil:
English: Long term uUse of estrogen-only and or combined estrogen-progestogen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Slovenian: Dolgotrajna uUporaba samo estrogenskega in ali kombinacije estrogenskega in progestagenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
English: Long-term uUse of oestrogen-only and or combined oestrogen-progestagen HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Slovenian: Dolgotrajna uUporaba samo estrogenskega zdravljenjem in ali kombinacije estrogenskega in progestogenskega HNZ je povezana z rahlo zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
English: SmPC section 4.4: Special warnings and precautions for use Ovarian cancer
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki Rak jajčnikov
English: For example, in women aged 50 to 5469 who are not taking HRT, on average about 2 women in 21,000 will be diagnosed with ovarian cancer over a 5year period.
Slovenian: Na primer pri ženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju petih let v povprečju pri približno dveh ženskah izmed 21 000 odkrili raka jajčnikov.
English: For example, in Wwomen aged 50 to 5469 who are not taking HRT, on average about 2 women in 21000 will be diagnosed with ovarian cancer over a 5year period.
Slovenian: Na primer pri Žženskah, starih od 50 do 5469 let, ki ne uporabljajo HNZ, bodo v obdobju 5 let v povprečju pri približno dveh ženskah izmed 2 1000 odkrili raka jajčnikov.
English: Other adverse reactions have been reported in association with oestrogen and oestrogenprogestogen treatment:
Slovenian: Povzetek glavnih značilnosti zdravila, poglavje 4.8: Neželeni učinki V zvezi z zdravljenjem z estrogenom in kombinacijo estrogena in progestogena so poročali tudi o drugih neželenih učinkih:
English: Long-term uUse of oestrogen-only HRT has been associated with a slightly increased risk of having ovarian cancer diagnosed (see Section 4.4).
Slovenian: Dolgotrajna uUporaba HNZ s samo estrogenskim zdravljenjem estrogenskega HNZ je povezana z zvečanim tveganjem za diagnosticiranje raka jajčnikov (glejte poglavje 4.4).
English: It is important to note that failure to adequately clean adjacent tissues may cause adhesions.
Slovenian: Upoštevajte, da lahko do lepljenja pride, če nezadostno očistite sosednja tkiva.
English: Inactivated Rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ≥70% cELISA40* (*) ≥=70% of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Slovenian: --1 Inaktivirani virus hemoragične bolezni kuncev tipa 2 (RHDV2), sev V-1037 ≥70 % cELISA40* (*) ≥ 70 % cepljenih kuncev bo imelo titer protiteles cELISA 40 ali več.
English: Vial (glass) 0.5 ml (1 dose)
Slovenian: 0,5 ml
English: EU (MA) Number
Slovenian: EU (MA) številka Izmišljeno ime Jakost
English: 10 vials Zero days
Slovenian: (1 odmerek vialami
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Slovenian: Po navadi so takšne reakcije opažali v prvih nekaj tednih ali mesecih po začetku CART.
English: 50 to <200 200 to <350
Slovenian: od 50 do < 200 od 200 do < 350
English: Date of latest renewal: 21 September 2018
Slovenian: Datum zadnjega podaljšanja: 21. september 2018
English: Keep the bottle tightly closed.
Slovenian: Vsebnik shranjujte tesno zaprt.
English: → Read the information in Section 4 of this leaflet.
Slovenian: → Preberite informacije v poglavju 4 tega navodila.
English: CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Slovenian: Celice CD4 so vrsta belih krvnih celic, ki so pomembna pomoč telesu v boju proti okužbi.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 January 2014
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum prve odobritve: 20. januar 2014
English: To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.
Slovenian: Za obvladovanje okužbe s HIV in preprečevanje poslabšanja bolezni morate nadaljevati z jemanjem vseh vaših zdravil, razen če vam zdravnik ne naroči, da katerega prenehate jemati.
English: Extremadura 3, 09400 Aranda De Duero, Burgos, Spain OR
Slovenian: Extremadura 3, 09400 Aranda De Duero, Burgos, Španija ALI
English: 40 or greater
Slovenian: 40 ali več
English: The mechanism for the decrease is unknown.
Slovenian: Mehanizem tega zmanjšanja ni pojasnjen.
English: Please refer to section 4.5.
Slovenian: Prosimo glejte poglavje 4.5.
English: After the functional monotherapy phase, subjects had the opportunity to re-optimize their background regimen when possible.
Slovenian: Po fazi funkcionalne monoterapije so imele osebe možnost ponovne optimizacije njihove osnovne sheme, kadar je bilo to mogoče.
English: †Other clades included: Complex (43), F1 (32), A1 (18), BF (14), all others <10.
Slovenian: †Drugi podtipi so vključevali: kompleks (43), F1 (32), A1 (18), BF (14), vse druge < 10.
English: Children 6 to less than 12 years of age
Slovenian: Otroci v starosti od 6 do manj kot 12 let
English: • suicide attempt*
Slovenian: • poskus samomora*
English: As a result of that, it also increases the CD4 cell count in your blood.
Slovenian: Posledica tega je, da se poveča tudi število celic CD4 v krvi.
English: * particularly in patients who have had depression or mental health problems before
Slovenian: *zlasti pri bolnikih, ki so že imeli probleme z depresijo ali duševnim zdravjem
English: It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Slovenian: Priporočljivo je, da ženske, okužene z virusom HIV, pod nobenim pogojem ne dojijo svojih otrok, da bi se izognile prenosu virusa HIV.
English: Not everyone responds to treatment with Tivicay in the same way.
Slovenian: Na zdravljenje z zdravilom Tivicay se vsi ne odzivajo enako.
English: When Tivicay is taken twice a day, your doctor may advise you to take with food.
Slovenian: Kadar pa se zdravilo Tivicay jemlje dvakrat na dan, vam bo zdravnik morda svetoval, da ga vzemite med jedjo.
English: The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection.
Slovenian: Simptomi avtoimunih bolezni se lahko pojavijo mnogo mesecev po tem, ko ste začeli jemati zdravila za zdravljenje okužbe z virusom HIV.
English: Food increased the extent and slowed the rate of absorption of dolutegravir.
Slovenian: Hrana poveča obseg in upočasni hitrost absorpcije dolutegravirja.
English: ‡ Adjusted mean treatment difference was statistically significant (p<0.001)
Slovenian: ‡ Prilagojena srednja razlika v zdravljenju je bila statistično značilna (p < 0,001)
English: • if you are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).
Slovenian: • če ste alergični na dolutegravir ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Slovenian: • oteklino, včasih obraza ali ust (angioedem), ki povzroča oteženo dihanje
English: These changes are not considered to be clinically relevant since they do not reflect a change in glomerular filtration rate.
Slovenian: Te spremembe niso klinično pomembne, saj ne odražajo spremembe v hitrosti glomerulne filtracije.
English: → If you think any of these apply to you, tell your doctor.
Slovenian: → Če menite, da kar koli od navedenega velja za vas, povejte svojemu zdravniku.
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Slovenian: Nadaljnja obravnava mora biti v skladu s kliničnimi indikacijami oziroma priporočili nacionalnega centra za zastrupitve, če so na voljo.
English: OSS: combined genotypic and phenotypic resistance (Monogram Biosciences Net Assessment)
Slovenian: OSS: skupaj genotipska in fenotipska odpornost (ocena po Monogram Biosciences Net)
English: • suicidal thoughts*
Slovenian: • samomorilne misli*
English: Approximately one third of the patients were infected with an HIV non-B subtype; these characteristics were similar between treatment groups.
Slovenian: Približno ena tretjina bolnikov je bila okužena z ne-B podtipom HIV; te značilnosti so bile primerljive med zdravljenimi skupinami.
English: • rifampicin, to treat tuberculosis (TB) and other bacterial infections
Slovenian: • rifampicin, za zdravljenje tuberkuloze (TBC) in drugih bakterijskih okužb
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
Slovenian: Pogostnosti so opredeljene kot: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000), zelo redki (<1/10.000).
English: Gender Male Female Race White African-America/African Heritage/Other Age (years)
Slovenian: Spol moški ženske Rasa belci afroameričani/afriški staroselci/ostali Starost (leta)
English: Established and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in Table 2.
Slovenian: Ugotovljene in hipotetične interakcije z izbranimi protiretrovirusnimi in ne-protiretrovirusnimi zdravili so navedene v Preglednici 2.
English: Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level.
Slovenian: Zdravilo Tivicay ne ozdravi okužbe z virusom HIV, ampak zmanjša količino virusa v telesu in jo vzdržuje na nizki ravni.
English: Tivicay can be taken with or without food.
Slovenian: Zdravilo Tivicay se lahko vzame s hrano ali brez nje.
English: *particularly in patients with a pre-existing history of depression or psychiatric illness.
Slovenian: *zlasti pri bolnikih z že obstoječo anamnezo depresije ali psihiatrične bolezni
English: Total blood and plasma drug-related radioactivity concentration ratios averaged between 0.441 to 0.535, indicating minimal association of radioactivity with blood cellular components.
Slovenian: Celotno razmerje koncentracije z zdravilom povezane radioaktivnosti v krvi in plazmi je povprečno med 0,441 in 0,535; to kaže na minimalno povezanost radioaktivnosti s celičnimi elementi krvi.
English: HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles).
Slovenian: Okužba s HIV se prenaša s spolnim stikom z nekom, ki ima okužbo, ali z okuženo krvjo (na primer s souporabo injekcijskih igel).
English: Tivicay can also affect how some other medicines work.
Slovenian: Zdravilo Tivicay lahko vpliva tudi na delovanje drugih zdravil.
English: Raltegravir/elvitegravir was part of the current failing regimen in 98/183 patients (part of prior failing therapies in the others).
Slovenian: Raltegravir/elvitegravir je bil del trenutno neuspešne sheme pri 98/183 bolnikih (del predhodnih neuspešnih terapij pri ostalih).
English: Adolescents aged 12 and above
Slovenian: Mladostniki, stari 12 let in več
English: The R263K mutation was also selected in vitro (see above).
Slovenian: Mutacija R263K je bila izbrana tudi in vitro (glejte zgoraj).
English: If you are pregnant, if you become pregnant, or if you are planning to have a baby:
Slovenian: Nosečnost Če ste noseči, če zanosite ali načrtujete zanositev:
English: Week 24 (N=161)
Slovenian: 24. teden (N=161)
English: • difficulty breathing In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
Slovenian: • oteženo dihanje V redkih primerih, ko se imunski sistem okrepi, lahko ta napade tudi zdrava telesna tkiva (avtoimune bolezni).
English: Tivicay is always used in combination with other anti-retroviral medicines (combination therapy).
Slovenian: Zdravilo Tivicay se vedno uporablja v kombinaciji z drugimi protiretrovirusnimi zdravili (kombinirano zdravljenje).
English: Based on data from other CYP3A4 inhibitors, a marked increase is not expected.
Slovenian: Na podlagi podatkov o drugih zaviralcih CYP3A4 ni pričakovati opaznega povišanja.
English: Dolutegravir ↔ (Not studied)
Slovenian: nelfinavir dolutegravir ↔ (ni raziskano)
English: (cps/mL)
Slovenian: (kopij/ml)
English: • increase in the level of enzymes produced in the muscles (creatine phosphokinase).
Slovenian: • zvišane vrednosti encimov, ki nastajajo v mišicah (kreatin fosfokinaza)
English: Limited experience of single higher doses (up to 250 mg in healthy subjects) revealed no specific symptoms or signs, apart from those listed as adverse reactions.
Slovenian: Omejene izkušnje z enkratnim višjim odmerkom (do 250 mg pri zdravih osebah) niso razkrile nobenih specifičnih simptomov ali znakov, razen tistih, naštetih med neželenimi učinki.
English: Using strain NL432, mutations E92Q (FC 3) and G193E (also FC 3) were selected.
Slovenian: NL432 so bile izbrane mutacije E92Q (tudi FC 3) in G193E (FC 3).
English: Co-treatment with atazanavir increases the exposure of dolutegravir markedly, and should not be used in combination with this high dose, since safety with the resulting dolutegravir exposure has not been established.
Slovenian: Sočasno zdravljenje z atazanavirjem izrazito poveča izpostavljenost dolutegravirju in se ga v kombinaciji s tem visokim odmerkom ne sme uporabljati, ker varnost posledične izpostavljenosti dolutegravirju ni ugotovljena.
English: Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in vsebniku poleg oznake »EXP«.
English: Week 48 (N=160)
Slovenian: 48. teden (N=160)
English: Do not discontinue Tivicay without consulting your doctor, as this may harm you and your unborn child.
Slovenian: Brez posvetovanja z zdravnikom ne prenehajte jemati zdravilo Tivicay, ker to lahko škoduje vam in vašemu nerojenemu otroku.
English: Creatinine increases were comparable by various background regimens.
Slovenian: Zvišane vrednosti kreatinina so bile pri različnih osnovnih shemah primerljive.
English: There is no evidence that elderly patients require a different dose than younger adult patients (see section 5.2).
Slovenian: Ni dokazov, da bi starejši bolniki potrebovali drugačen odmerek kot mlajši odrasli bolniki (glejte poglavje 5.2).
English: • etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
Slovenian: • etravirin, efavirenz, fosamprenavir/ritonavir, nevirapin ali tipranavir/ritonavir, za zdravljenje okužb z virusom HIV
English: Because gastrointestinal (GI) intolerance is considered to be due to local active substance administration, mg/kg or mg/m2 metrics are appropriate determinates of safety cover for this toxicity.
Slovenian: Gastrointestinalna intoleranca (GI) velja za posledico lokalne uporabe učinkovine, zato sta enoti mg/kg ali mg/m2 ustrezni determinanti varnostnega kritja za ta toksični učinek.
English: Dolutegravir is present in cerebrospinal fluid (CSF).
Slovenian: Dolutegravir je prisoten v cerebrospinalni tekočini (CSF - cerebrospinal fluid).
English: Lamivudine and dolutegravir
Slovenian: Lamivudin in dolutegravir
English: Over the preweaning treatment period, mean body weight gain was decreased in this group and the decrease persisted throughout the entire study for females during the postweaning period.
Slovenian: Med obdobjem uporabe zdravila pred odstavitvijo se je povprečno povečanje telesne mase v tej skupini zmanjšalo in zmanjšanje se je ohranilo med celotno študijo pri samicah med obdobjem po odstavitvi.
English: A clinically relevant phenotypic cut-off value (FC vs wild type virus) has not been determined; genotypic resistance was a better predictor for outcome.
Slovenian: Klinično pomembna fenotipska izhodiščna vrednost (FC proti virusu divjega tipa) ni bila določena; boljši napovedni dejavnik izida je bila genotipska odpornost.
English: At week 96, results were consistent with those seen at week 48.
Slovenian: Rezultati po 96 tednih so se skladali z rezultati po 48 tednih.
English: • if you are taking another medicine called dofetilide (to treat heart conditions).
Slovenian: • če jemljete drugo zdravilo, ki se imenuje dofetilid (za zdravljenje bolezni srca).
English: Your doctor will decide on the correct dose of Tivicay for you.
Slovenian: Zdravnik bo presodil o pravilnem odmerku zdravila Tivicay za vas.
English: Tivicay can be taken with or without food (see section 5.2).
Slovenian: Zdravilo Tivicay se lahko jemlje s hrano ali brez nje (glejte poglavje 5.2).
English: Your doctor may decide to adjust your dose or that you need extra check ups.
Slovenian: da vam prilagodi odmerek ali da potrebujete dodatne kontrolne preglede.
English: The effect of prolonged daily treatment with high doses of dolutegravir has been evaluated in repeat oral dose toxicity studies in rats (up to 26 weeks) and in monkeys (up to 38 weeks).
Slovenian: Vpliv dolgotrajnega vsakodnevnega zdravljenja z velikimi odmerki dolutegravirja so ocenili v študijah toksičnosti ponavljajočih se peroralnih odmerkov pri podganah (do 26 tednov) in opicah (do 38 tednov).
English: TIVICAY ~1 mg/kg Once Daily + OBR
Slovenian: TIVICAY ~1 mg/kg enkrat na dan + OBR
English: **see below under Description of selected adverse reactions.
Slovenian: ** glejte Opis izbranih neželenih učinkov spodaj Opis izbranih neželenih učinkov
English: Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Slovenian: Vsak simptom vnetja, ki se pojavi, je treba oceniti in uvesti zdravljenje, kadar je potrebno.
English: Some people taking medicines for HIV infection develop other conditions, which can be serious.
Slovenian: Pri nekaterih ljudeh, ki jemljejo zdravila za zdravljenje okužbe s HIV, se pojavijo druge zdravstvene težave, ki so lahko resne.
English: - This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Slovenian: - To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.
Slovenian: Zdravnik se lahko odloči, da pri vas opravi teste za pregled jeter, ledvic ali krvi in vam naroči, da prenehate z jemanjem zdravila Tivicay.
English: Bioequivalence has not been unequivocally shown for 1x50 mg tablet compared to 5x10 mg tablets.
Slovenian: Bioekvivalenca ni bila nedvoumno dokazana za 1x50 mg tablete v primerjavi z 5x10 mg tabletami.
English: The most commonly seen treatment emergent adverse reactions were nausea (13%), diarrhoea (18%) and headache (13%).
Slovenian: Najpogosteje opaženi neželeni učinki, povezani z zdravljenjem, so bili: navzea (13%), driska (18%) in glavobol (13%).
English: • increase in the level of liver enzymes
Slovenian: • zvišane vrednosti jetrnih encimov
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tivicay in paediatric patients aged 4 weeks to below 6 years with HIV infection (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Tivicay pri pediatrični populaciji bolnikov, starih od 4 tednov do manj kot 6 let, okuženih z virusom HIV (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).