FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with BindRen, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila BindRen, glejte navodilo za uporabo.
English: The most frequently reported side effects were nausea (feeling sick), dyspepsia (heartburn) and vomiting.
Slovenian: Drugi pogosto opaženi učinki so bili navzeja (slabost), dispepsija (zgaga) in bruhanje.
English: In the first study, an average dose of 11.5 g of BindRen reduced the blood phosphate level by 0.36 mmol/l on average after three months.
Slovenian: V prvi študiji je povprečni odmerek 11,5 g zdravila BindRen v povprečju znižal ravni fosfatov v krvi za 0,36 mmol/l po treh mesecih.
English: BindRen is used to control hyperphosphataemia (high blood phosphate levels) in adults with long-term kidney disease who are on dialysis (a blood clearance technique).
Slovenian: Zdravilo BindRen se uporablja za uravnavanje hiperfosfatemije (zvišane ravni fosfatov v krvi) pri odraslih bolnikih z dolgotrajnim obolenjem ledvic, ki so na dializi (tehniki čiščenja krvi).
English: Similarly in the second study, an average dose of 13.1 g of BindRen resulted in a reduction of the blood phosphate level by 0.50 mmol/l on average after three months.
Slovenian: Podobno je v drugi študiji povprečni odmerek 13,1 g zdravila BindRen v povprečju znižal ravni fosfatov v krvi za 0,50 mmol/l po treh mesecih.
English: Why has BindRen been approved?
Slovenian: Zakaj je bilo zdravilo BindRen odobreno?
English: The most serious reported side effects with BindRen were gastrointestinal haemorrhage (bleeding in the stomach and gut) and constipation.
Slovenian: Najresnejša neželena učinka, opažena pri uporabi zdravila BindRen, sta bila krvavenje v črevesju in trebuhu ter zaprtje.
English: It must not be used in people with bowel obstruction (a blockage in the gut).
Slovenian: Ne sme se uporabljati pri ljudeh, ki imajo zaporo črevesa.
English: How has BindRen been studied?
Slovenian: Kako je bilo zdravilo BindRen raziskano?
English: The active substance in BindRen, colestilan, is a phosphate binder.
Slovenian: Zdravilna učinkovina zdravila BindRen je fosfatni vezalec kolestilan.
English: What is BindRen used for?
Slovenian: Za kaj se zdravilo BindRen uporablja?
English: How is BindRen used?
Slovenian: Kako se zdravilo BindRen uporablja?
English: Patients should keep to their prescribed low phosphate diets.
Slovenian: Bolniki se morajo držati tudi diete, ki znižuje količino fosfatov v krvi.
English: What is BindRen?
Slovenian: Kaj je zdravilo BindRen?
English: How does BindRen work?
Slovenian: Kako zdravilo BindRen deluje?
English: Further information on Biktarvy can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Nadaljnje informacije o zdravilu Biktarvy so na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Side effects were similar to those of medicines of the same class.
Slovenian: Neželeni učinki so bili podobni kot pri drugih zdravilih iz istega razreda.
English: What measures are being taken to ensure the safe and effective use of Biktarvy?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Biktarvy?
English: The European Medicines Agency therefore decided that Biktarvy's benefits are greater than its risks and it can be authorised for use in the EU.
Slovenian: Evropska agencija za zdravila je zato zaključila, da so koristi zdravila Biktarvy večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
English: The benefits of Biktarvy in the treatment of HIV infection were investigated in four main studies.
Slovenian: Koristi zdravila Biktarvy pri zdravljenju okužbe z virusom HIV so raziskali v štirih glavnih študijah.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Biktarvy have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Biktarvy upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
English: Other information about Biktarvy
Slovenian: Druge informacije o zdravilu Biktarvy
English: What are the risks associated with Biktarvy?
Slovenian: Kakšna tveganja so povezana z zdravilom Biktarvy?
English: As for all medicines, data on the use of Biktarvy are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Biktarvy stalno spremljajo.
English: What is Biktarvy and what is it used for?
Slovenian: Kaj je zdravilo Biktarvy in za kaj se uporablja?
English: Why is Biktarvy authorised in the EU?
Slovenian: Zakaj je bilo zdravilo Biktarvy odobreno v EU?
English: Side effects reported with Biktarvy are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Biktarvy, se skrbno ovrednotijo in po potrebi se lahko sprejmejo ukrepi za zaščito bolnikov.
English: It is only used in patients where the virus has not developed resistance to a class of HIV medicines called integrase inhibitors, or to tenofovir or emtricitabine.
Slovenian: Uporablja se le pri bolnikih, pri katerih virus ni razvil odpornosti na razred zdravil za zdravljenje okužb z virusom HIV, imenovanih zaviralci integraze, ali na tenofovir ali emtricitabin.
English: An overview of Biktarvy and why it is authorised in the EU
Slovenian: Pregled zdravila Biktarvy in zakaj je odobreno v EU
English: Biktarvy contains three active substances which work in different ways against HIV:
Slovenian: Zdravilo Biktarvy vsebuje tri učinkovine, ki na različne načine delujejo proti virusu HIV:
English: Biktarvy was shown to be as effective as comparator antiviral medicines.
Slovenian: Zdravilo Biktarvy se je pokazalo za enako učinkovito kot primerjalna protivirusna zdravila.
English: What benefits of Biktarvy have been shown in studies?
Slovenian: Kakšne koristi zdravila Biktarvy so se pokazale v študijah?
English: It blocks an enzyme called integrase that is needed by the HIV virus to make new copies of itself in the body.
Slovenian: Zavira encim, imenovan integraza, ki ga virus HIV potrebuje za to, da se v telesu lahko razmnožuje;
English: Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)
Slovenian: Biktarvy (biktegravir/emtricitabin/alafenamidtenofovirat)
English: Biktarvy is an antiviral medicine used to treat adults infected with human immunodeficiency virus 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Biktarvy je protivirusno zdravilo za zdravljenje odraslih, ki so okuženi z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: Biktarvy does not cure HIV-1 infection or AIDS, but it can hold off damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Biktarvy ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter prepreči razvoj okužb in bolezni, povezanih z aidsom.
English: The most common side effects with Biktarvy (which may affect around 1 in 20 people) are headache, diarrhoea and nausea (feeling sick).
Slovenian: Najpogostejši neželeni učinki zdravila Biktarvy (ki se lahko pojavijo pri približno 1 bolniku od 20) so glavobol, driska in navzeja (slabost).
English: • Emtricitabine is another type of NRTI (a nucleoside reverse transcriptase inhibitor) and it works in the same way as tenofovir.
Slovenian: • Emtricitabin je druga vrsta NRTI (nukleotidnega zaviralca reverzne transkriptaze) in deluje enako kot tenofovir.
English: Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI), which means that it blocks the activity of reverse transcriptase, another enzyme of the virus that allows it to reproduce itself.
Slovenian: tenofovir je nukleotidni zaviralec reverzne transkriptaze (NRTI), kar pomeni, da zavira delovanje reverzne transkriptaze, drugega encima, ki virusu omogoča razmnoževanje.
English: Biktarvy must not be used together with rifampicin (an antibiotic) or with St. John's wort (a herbal medicine used for treating depression).
Slovenian: Zdravilo Biktarvy se ne sme uporabljati skupaj z rifampicinom (antibiotikom) ali šentjanževko (zdravilom rastlinskega izvora, namenjenim zdravljenju depresije).
English: Biktarvy can only be obtained with a prescription and treatment should be started by a doctor who has experience in the management of HIV infection.
Slovenian: Predpisovanje in izdaja zdravila Biktarvy je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Biktarvy is available as tablets, each containing 50 mg bictegravir, 200 mg emtricitabine, and 25 mg tenofovir alafenamide.
Slovenian: Ena tableta vsebuje 50 mg biktegravirja, 200 mg emtricitabina in 25 mg alafenamidtenofovirata.
English: • Bictegravir is a type of antiviral agent called an ‘integrase inhibitor'.
Slovenian: • biktegravir je vrsta protivirusne snovi, imenovane „zaviralec integraze“.
English: Two studies involved adults infected with HIV-1 who had not been treated previously, and looked at the numbers whose viral load (the amount of HIV-1 in the blood) was reduced to less than 50 copies per ml after 48 weeks of treatment.
Slovenian: V dve študiji so bili vključeni odrasli, ki so bili okuženi z virusom HIV-1 in prehodno še niso bili zdravljeni, pri čemer so proučevali, pri koliko bolnikih se je po 48 tednih zdravljenja virusna obremenitev (količina virusa HIV-1 v krvi) zmanjšala na manj kot 50 kopij na ml.
English: In the second study, the viral load went above the threshold in 2% (5 out of 290) of patients switched to Biktarvy, and in 2% (5 out of 287) of patients who stayed on their previous treatment (‘boosted' atazanavir or darunavir plus either emtricitabine/tenofovir or abacavir/lamivudine).
Slovenian: V drugi študiji se je virusna obremenitev povečala nad mejno vrednost pri 2 % (5 od 290) bolnikov, ki so prešli na zdravilo Biktarvy, in pri 2 % (5 od 287) bolnikov, ki so ostali pri predhodnem zdravljenju (okrepljeni atazanavir ali darunavir v kombinaciji z emtricitabinom/tenofovirjem ali abakavirjem/lamivudinom).
English: Overall, 92% of patients taking Biktarvy (290 out of 314) achieved viral load reduction, compared with 93% (293 out of 315) of patients who achieved it with the comparator.
Slovenian: Skupno je zmanjšanje virusne obremenitve doseglo 92 % (290 od 314) bolnikov, ki so prejemali zdravilo Biktarvy, in 93 % (293 od 315) bolnikov, ki so prejemali primerjalno zdravilo.
English: The second study compared Biktarvy with dolutegravir plus emtricitabine/tenofovir alafenamide in 645 patients: 89% (286 out of 320) of patients taking Biktarvy achieved satisfactory viral load reduction, compared with 93% (302 out of 325) of patients on the comparator.
Slovenian: V drugi študiji so zdravilo Biktarvy primerjali z dolutegravirjem v kombinaciji z emtricitabinom/alafenamidtenofoviratom pri 645 bolnikih: Zadovoljivo zmanjšanje virusne obremenitve je doseglo 89 % (286 od 320) bolnikov, ki so jemali zdravilo Biktarvy, in 93 % (302 od 325) bolnikov, ki so prejemali primerjalno zdravilo.
English: Two other studies involved previously treated patients in whom the viral load was already lower than 50 copies per ml, and looked at whether it increased above this level 48 weeks after patients were switched from their previous HIV treatment to Biktarvy.
Slovenian: V drugi dve študiji so bili vključeni bolniki, ki so bili predhodno zdravljeni in so imeli virusno obremenitev že nižjo od 50 kopij na mililiter, pri čemer so opazovali, ali se v 48 tednih po prehodu s predhodnega zdravila za zdravljenje okužbe z virusom HIV na zdravilo Biktarvy virusna obremenitev pri njih zviša nad to raven.
English: In the first study, Biktarvy was compared with another antiviral medicine containing abacavir, dolutegravir and lamivudine in 629 patients.
Slovenian: V prvi študiji so pri 629 bolnikih primerjali zdravilo Biktarvy z drugim protivirusnim zdravilom, ki vsebuje abakavir, dolutegravir in lamivudin.
English: In one study, the percentage of patients with viral load greater than or equal to 50 copies/ml was 1% (3 out of 282) of patients who switched to Biktarvy, compared with 0.5% (1 out of 281) of patients who stayed on their previous treatment (dolutegravir, abacavir, lamivudine).
Slovenian: V eni študiji je imel virusno obremenitev večjo ali enako 50 kopij/ml 1 % (3 od 282) bolnikov, ki so prešli na zdravilo Biktarvy, in 0,5 % (1 od 281) bolnikov, ki so ostali pri predhodnem zdravljenju (dolutegravir, abakavir, lamivudin).
English: For more information about using Biktarvy, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Priporočeni odmerek je ena tableta na dan. Za več informacij glede uporabe zdravila Biktarvy glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: How is Biktarvy used?
Slovenian: Kako se zdravilo Biktarvy uporablja?
English: How does Biktarvy work?
Slovenian: Kako zdravilo Biktarvy deluje?
English: Biktarvy contains the active substances bictegravir, emtricitabine and tenofovir alafenamide.
Slovenian: Zdravilo Biktarvy vsebuje učinkovine biktegravir, emtricitabin in alafenamidtenofovirat.
English: For the full list of side effects of Biktarvy, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Biktarvy, glejte navodilo za uporabo.
English: The recommended dose is one tablet a day.
Slovenian: Zdravilo Biktarvy je na voljo v obliki tablet.
English: When should emergency contraception be used?
Slovenian: Kdaj je treba uporabiti nujno kontracepcijo?
English: Ask your doctor or pharmacist for advice on alternative methods of emergency contraception.
Slovenian: Vprašajte svojega zdravnika ali farmacevta o alternativnih načinih nujne kontracepcije.
English: [The existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below]
Slovenian: [obstoječe informacije o zdravilu se spremenijo (vstavi, nadomesti ali izbriše se besedilo, kot je ustrezno) tako, da vsebujejo dogovorjeno besedilo, kot je navedeno spodaj]
English: You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.
Slovenian: Svetujemo vam, da se pogovorite z zdravstvenim delavcem, če ste zaskrbljeni zaradi kakršnih koli težav, povezanih z jemanjem nujne kontracepcije.
English: Pregnancy rate 0.9% 1.3% 1.4% 6.4% 5.7%
Slovenian: Interval zaupanja 0,92 - 3,26 0,70 - 1,35 0,21 - 1,24 0,24 - 3,39
English: - if you weigh 75 kg or more (see “What <invented name> <strength> tablet is and what it is used for” for further details)
Slovenian: - če tehtate 75 kg ali več (glejte “Kaj tablete zdravila <izmišljeno ime> <jakost> so in za kaj jih uporabljamo” za več podatkov)
English: There is limited and inconclusive data on the effect of high body weight/high BMI on the contraceptive efficacy.
Slovenian: Na voljo so le omejeni in nedokončni podatki o vplivu velike telesne mase/visokega ITM na učinkovitost kontraceptiva.
English: Therefore, <invented name> is still recommended for all women regardless of their weight or BMI.
Slovenian: Zdravilo <izmišljeno ime> se zato še vedno priporoča pri vseh ženskah ne glede na njihovo telesno maso ali ITM.
English: Pregnancy rate (95% CI) according to weight categories Weight (kg) N total N pregnancies
Slovenian: Delež nosečnosti (95 % IZ) po skupinah z določeno telesno maso Telesna masa (kg) Skupno število 349 Število nosečnosti
English: Table 2: Meta-analysis on studies of Creinin et al., 2006 and Glasier et al., 2010
Slovenian: Tabela 2: Metaanaliza študij, ki sta jih izvedla Creinin in sod., 2006 in Glasier in sod., 2010
English: In three WHO studies no trend for a reduced efficacy with increasing body weight/BMI was observed (Table 1), whereas in the two other studies (Creinin et al., 2006 and Glasier et al., 2010) a reduced contraceptive efficacy was observed with increasing body weight or BMI (Table 2).
Slovenian: V treh študijah, ki jih je izvedla Svetovna zdravstvena organizacija, niso ugotovili nikakršnega premika v smeri zmanjšane učinkovitosti ob večanju telesne mase/ITM (Tabela 1), medtem ko so v dveh drugih študijah (Creinin in sod., 2006 in Glasier in sod., 2010) opazili zmanjšanje učinkovitosti kontracepcije z večanjem telesne mase oziroma ITM (Tabela 2).
English: In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
Slovenian: Za vse ženske velja, da je treba nujno kontracepcijo vzeti čim prej po nezaščitenem spolnem odnosu.
English: Both meta-analyses excluded intake later than 72 hours after unprotected intercourse (i.e. off-label use of levonorgestrel) and women who had further acts of unprotected intercourse.
Slovenian: Obe metaanalizi sta izključili vnos kontraceptiva pozneje kot 72 ur po nezaščitenem spolnem odnosu (tj. neodobrena uporaba levonorgestrela) in ženske, ki so nadaljevale z nezaščitenimi spolnimi odnosi.
English: There is some evidence that <invented name> may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.
Slovenian: Na voljo je nekaj dokazov, da se lahko učinkovitost zdravila <izmišljeno ime> manjša z večanjem telesne mase oziroma indeksa telesne mase (ITM), vendar so ti podatki omejeni in nedokončni.
English: Limited and inconclusive data suggest that there may be reduced efficacy of <invented name> with increasing body weight or body mass index (BMI) (see section 5.1).
Slovenian: Omejeni in nedokončni podatki kažejo, da se lahko učinkovitost zdravila <izmišljeno ime> manjša z večanjem telesne mase oziroma indeksa telesne mase (ITM) (glejte poglavje 5.1).
English: [The information below should be added in this section together with the two tables which follow]
Slovenian: [Spodaj navedene podatke, vključno z dvema spodaj navedenima razpredelnicama, je treba v to poglavje dodati]
English: Take special care with <invented name> <strength> tablet
Slovenian: Bodite posebno pozorni pri uporabi zdravila <izmišljeno ime> <jakost> tablete
English: B. Package leaflet
Slovenian: Priloga III
English: Table 1: Meta-analysis on three WHO studies (Von Hertzen et al., 1998 and 2002; Dada et al., 2010)
Slovenian: Tabela 1: Metaanaliza treh študij, ki jih je izvedla Svetovna zdravstvena organizacija (Von Hertzen in sod., 1998 in 2002; Dada in sod., 2010)
English: In all women, emergency contraception should be taken as soon as possible after unprotected intercourse, regardless of the woman's body weight or BMI.
Slovenian: Za vse ženske velja, da je treba nujno kontracepcijo vzeti čim prej po nezaščitenem spolnem odnosu, ne glede na telesno maso ali ITM ženske.
English: Studies suggest that <invented name> is less effective in women weighing 75 kg or more and not effective in women weighing more than 80 kg.
Slovenian: Študije nakazujejo, da je zdravilo <izmišljeno ime>manj učinkovito pri ženskah s telesno maso 75 kg ali več, pri ženskah s telesno maso več kot 80 kg pa neučinkovito.
English: [The information below should be deleted together with the table] In clinical trials, contraceptive efficacy was reduced in women weighing 75 kg or more and levonorgestrel was not effective in women who weighed more than 80 kg (see sections 4.2 and 4.4).
Slovenian: [Spodaj navedene podatke, vključno z razpredelnico, je treba izbrisati] V kliničnih preskušanjih je bila učinkovitost kontracepcije pri ženskah s telesno maso 75 kg ali več zmanjšana, pri ženskah s telesno maso več kot 80 kg pa levonorgestrel ni bil učinkovit (glejte poglavji 4.2 in 4.4).
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Dopolnitev ustreznih poglavij v povzetkih glavnih značilnosti zdravil in navodilih za uporabo
English: BEFORE YOU USE <invented name> <strength> TABLET
Slovenian: KAJ MORATE VEDETI PREDEN BOSTE UPORABILI ZDRAVILO <izmišljeno ime> <jakost> tablete
English: For Levonorgestrel-containing emergency contraceptive medicinal products A. Summary of product characteristics
Slovenian: A. Povzetek glavnih značilnosti zdravila
English: [the phrase below should be deleted from this section] Special population: body weight 75 kg or more
Slovenian: [spodaj navedeni stavek je treba iz tega poglavja izbrisati]
English: - If you are more than 3 months pregnant.
Slovenian: - če ste noseči več kot 3 mesece.
English: Try to take the tablet at the same time each day.
Slovenian: Tableto vsak dan vzemite ob istem času.
English: Therefore, the combination should be administered with caution, especially in the elderly.
Slovenian: Zato je treba takšno kombinacijo uporabljati previdno, še posebno pri starejših.
English: - if you are taking digoxin.
Slovenian: - če jemljete digoksin.
English: Your doctor may need to change the dose of these other medicines or take other precautions.
Slovenian: Zdravnik vam bo morda moral spremeniti odmerek teh drugih zdravil ali upoštevati druge previdnostne ukrepe.
English: The mean duration of follow up was 4 years and 8 months.
Slovenian: Povprečno je spremljanje trajalo 4 let in 8 mesecev.
English: Thus it is important to regularly measure blood pressure to verify if it is within the normal range.
Slovenian: Zato je pomembno redno meriti krvni tlak in tako preverjati, da je v normalnih mejah.
English: Cumulative urinary excretion is < 1% of dose.
Slovenian: Kumulativno izločanje v urinu je < 1 % odmerka.
English: The small reduction in AUC is not expected to cause a reduction in the therapeutic efficacy.
Slovenian: Ni pričakovati, da bi majhno zmanjšanje AUC zmanjšalo terapevtsko učinkovitost.
English: The risk is increased in case of the above-mentioned treatment combinations.
Slovenian: Tveganje je večje v primeru kombinirane uporabe zgoraj omenjenih zdravil.
English: 250 tablets
Slovenian: 250 tablet
English: The patient should be closely monitored, and the treatment should be symptomatic and supportive.
Slovenian: Bolnika je treba natančno nadzirati; zdravljenje mora biti simptomatsko in podporno.
English: - Lithium containing medicines to treat some types of depression.
Slovenian: - Zdravila, ki vsebujejo litij za zdravljenje nekaterih vrst depresije.
English: The tablets should be swallowed with some water or other non-alcoholic drink.
Slovenian: Tablete morate pogoltniti z nekaj vode ali z brezalkoholno pijačo.
English: The occurrence of hyperkalaemia depends on associated risk factors.
Slovenian: Pojav hiperkaliemije je odvisen od spremljajočih dejavnikov tveganja.
English: The clinical relevance of this observation is not known.
Slovenian: Klinični pomen tega opažanja ni znan.
English: Some side effects can be serious and need immediate medical attention: You should see your doctor immediately if you experience any of the following symptoms:
Slovenian: Nekateri neželeni učinki so lahko resni in zahtevajo takojšnjo zdravstveno oskrbo: Nemudoma morate obiskati zdravnika, če se pojavi kateri od naslednjih simptomov:
English: If you accidentally take too many tablets ask your doctor what to do or contact your nearest hospital emergency department immediately.
Slovenian: Če pomotoma vzamete preveč tablet, vprašajte svojega zdravnika, kaj morate storiti, ali se nemudoma posvetujte z oddelkom za nujno pomoč najbližje bolnišnice.
English: Plasma concentrations were higher in females than in males, without relevant influence on efficacy.
Slovenian: Koncentracija v plazmi je bila pri ženskah večja kot pri moških, a brez pomembnega vpliva na učinkovitost.
English: Pharmacokinetic studies in patients with hepatic impairment showed an increase in absolute bioavailability up to nearly 100 %.
Slovenian: Farmakokinetične študije pri bolnikih z okvaro jeter so pokazale povečanje absolutne biološke uporabnosti do skoraj 100 %.