FrancophonIA/ELRC3.0 huggingface dataset:
English: Vectra Felis is available as a spot-on solution in an applicator and can be obtained without a prescription.
Slovenian: Zdravilo Vectra Felis je na voljo v obliki raztopine za kožni nanos v aplikatorju in se lahko izda brez recepta.
English: The content of one full Vectra Felis applicator is applied directly to the cat's skin, after parting its fur, at the base of the cat's head.
Slovenian: Vsebina enega polnega aplikatorja zdravila Vectra Felis se nanese neposredno na mačkino kožo med razmaknjeno dlako na zatilju njene glave.
English: After a single treatment, Vectra Felis prevents fleas for one month and blocks the flea life cycle so preventing infestation in the cat's environment for three months.
Slovenian: Zdravilo Vectra Felis po enkratnem nanosu še en mesec preprečuje infestacijo z bolhami in zavira njihov življenjski cikel, s čimer tri mesece zavira pojavljanje bolh v okolju mačke.
English: How does Vectra Felis work?
Slovenian: Kako zdravilo Vectra Felis deluje?
English: How is Vectra Felis used?
Slovenian: Kako se zdravilo Vectra Felis uporablja?
English: 0.5 milligram Al3+
Slovenian: 0,5 miligrama Al3+
English: * adsorbed on aluminium phosphate
Slovenian: * adsorbiran na aluminijev fosfat
English: 1 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
Slovenian: 1 konjugiran na nosilno beljakovino D (pridobljena iz netipiziranega Haemophilus influenzae)
English: --1 1 dose (0.5 ml) contains: Pneumococcal polysaccharide serotype 1* 1
Slovenian: --1 1 odmerek (0,5 ml) vsebuje: Pnevmokokni polisaharid serotip 1* 1
English: Pneumococcal polysaccharide serotype 18C* 2
Slovenian: Pnevmokokni polisaharid serotip 18C* 2
English: 2 conjugated to tetanus toxoid carrier protein
Slovenian: 2 konjugiran na nosilno beljakovino tetanusnega toksoida
English: Pneumococcal polysaccharide serotype 9V* 1
Slovenian: Pnevmokokni polisaharid serotip 9V* 1
English: Pneumococcal polysaccharide serotype 6B* 1
Slovenian: Pnevmokokni polisaharid serotip 6B* 1
English: 1 pre-filled syringe + 1 needle
Slovenian: 1 napolnjena injekijska brizga + 1 igla
English: 3 conjugated to diphtheria toxoid carrier protein
Slovenian: 3 konjugiran na nosilno beljakovino davičnega toksoida
English: 10 pre-filled syringes + 10 needles
Slovenian: 10 napolnjenih injekcijskih brizg + 10 igel
English: Strength Pharmaceutical form
Slovenian: Izmišljeno ime jakost farmacevtska oblika pot uporabe ovojnina vsebina velikost pakiranja
English: Outcome of a procedure under Article 30 of Directive 2001/83/EC
Slovenian: Rezultat postopka v skladu s členom 30 Direktive 2001/83/ES
English: The European Commission issued a decision on 13 July 2010.
Slovenian: Evropska komisija je odločbo izdala 13. julija 2010.
English: • essential hypertension;
Slovenian: • esencialno hipertenzijo;
English: Dr Alar Irs (Estonia)
Slovenian: dr. Alar Irs (Estonija)
English: Dr Pieter de Graeff (The Netherlands)
Slovenian: dr. Pieter de Graeff (Nizozemska)
English: Why was Atacand reviewed?
Slovenian: Zakaj je bilo zdravilo Atacand pregledano?
English: The companies that market these medicines are AstraZeneca and Takeda.
Slovenian: Družbi, ki ta zdravila tržita, sta AstraZeneca in Takeda.
English: Atacand is authorised in the EU via national procedures.
Slovenian: Zdravilo Atacand je v EU odobreno z nacionalnimi postopki.
English: The European Medicines Agency has completed a review of Atacand and associated names.
Slovenian: Evropska agencija za zdravila je zaključila pregled zdravila Atacand in povezana imena.
English: There were little differences among Member States in the special warnings section.
Slovenian: Pri posebnih opozorilih so bile med državami članicami majhne razlike.
English: Atacand is also available in the EU under other trade names: Amias, Blopress, Kenzen, Parapres, Racanda and Ratacand.
Slovenian: Zdravilo Atacand je na voljo v EU tudi pod drugimi imeni: Amias, Blopress, Kenzen, Parapres, Racanda in Ratacand.
English: The CHMP recommended that Atacand should be used to treat adult patients with:
Slovenian: CHMP je priporočil, da se zdravilo Atacand uporablja za zdravljenje odraslih bolnikov z:
English: Some Member States had not approved the 32 mg dose for treating hypertension and there were differences in how heart failure was defined.
Slovenian: Nekatere države članice niso odobrile odmerka 32 mg za zdravljenje hipertenzije, poleg tega so bila prisotna razhajanja glede opredelitve srčnega popuščanja.
English: This helps blood pressure to drop, which also makes it easier for the heart to pump out blood.
Slovenian: To pomaga znižati krvni tlak in omogoča, da srce laže črpa kri.
English: Atacand is a medicine used to treat essential hypertension (high blood pressure) in adults.
Slovenian: Atacand je zdravilo, ki se uporablja za zdravljenje esencialne hipertenzije (visokega krvnega tlaka) pri odraslih.
English: For heart failure, the starting dose is 4 mg once a day, which can also be increased at intervals of at least two weeks up to a maximum of 32 mg once daily.
Slovenian: Pri srčnem popuščanju je začetni odmerek 4 mg enkrat dnevno, ki ga je mogoče povečati v najmanj dvotedenskih intervalih na največ 32 mg enkrat dnevno.
English: The recommended starting dose for treating hypertension is 8 mg once a day, which can be increased to a maximum of 32 mg once a day, depending on how the patient's blood pressure responds.
Slovenian: Priporočeni začetni odmerek pri zdravljenju hipertenzije je 8 mg enkrat dnevno in ga je mogoče povečati na največ 32 mg enkrat dnevno, odvisno od odziva krvnega tlaka bolnika.
English: This has led to divergences among Member States in the way the medicine can be used, as seen in the differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Slovenian: To je v različnih državah članicah privedlo do razhajanj glede uporabe zdravila, kakor je razvidno iz povzetkov glavnih značilnosti zdravila, označevanja in navodil za uporabo v državah, v katerih je zdravilo v prometu.
English: It must also not be given to women in their second or third trimesters of pregnancy or to patients with severe liver impairment or cholestasis (problems with the elimination of bile).
Slovenian: Prav tako ga ni dovoljeno dajati ženskam v drugem ali tretjem trimesečju nosečnosti ali bolnikom s hudo okvaro jeter ali holestazo (težavami z izločanjem žolča).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Atacand in the European Union (EU).
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da je treba v Evropski uniji (EU) uskladiti podatke o predpisovanju zdravila Atacand.
English: The Committee recommend that Atacand must not be used in patients who are hypersensitive (allergic) to candesartan cilexetil or to any of the ingredients.
Slovenian: Odbor je priporočil, da se zdravilo Atacand ne sme uporabljati pri bolnikih, ki so preobčutljivi za (alergični na) kandesartan cileksetil ali katero koli drugo sestavino zdravila.
English: The Committee harmonised the warning on hyperkalaemia (high blood potassium levels) across all Member States' SmPCs.
Slovenian: Odbor je uskladil opozorilo glede hiperkalemije (visokih ravni kalija v krvi) v povzetkih glavnih značilnosti zdravil v vseh državah članicah.
English: On 16 July 2009, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Atacand in the EU.
Slovenian: Da bi Evropska komisija uskladila dovoljenja za promet z zdravilom Atacand v EU, je 16. julija 2009 zadevo napotila na CHMP.
English: The active substance in Atacand, candesartan cilexetil, is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a hormone in the body called angiotensin II.
Slovenian: Zdravilna učinkovina zdravila Atacand, kandesartan cileksetil, je „antagonist človeškega receptorja za angiotenzin II“, ki zavira delovanje hormona angiotenzin II v telesu.
English: By blocking the receptors to which angiotensin II normally attaches, candesartan cilexetil stops the hormone having an effect, allowing the blood vessels to widen.
Slovenian: Kandesartan cileksetil z zaviranjem receptorjev, na katere se angiotenzin II običajno veže, preprečuje učinek hormona in omogoča širjenje krvnih žil.
English: It is also used to treat heart failure in adult patients with impaired left ventricular systolic function who are receiving treatment with ‘angiotensin converting enzyme (ACE) inhibitors' or who cannot be given ACE inhibitors.
Slovenian: Uporablja se tudi za zdravljenje srčnega popuščanja pri odraslih bolnikih z oslabljeno sistolično funkcijo levega prekata, ki prejemajo „zaviralce angiotenzijske konvertaze (zaviralce ACE)“ ali ki teh zaviralcev ne morejo prejemati.
English: • heart failure and impaired left ventricular systolic function as ‘add-on' therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Slovenian: • srčnim popuščanjem in oslabljeno sistolično funkcijo levega prekata kot dodatno zdravljenje poleg zaviralcev ACE ali kadar bolniki teh zaviralcev ne prenašajo.
English: Company responses provided on: 8 October 2009, 12 February 2010 Opinion date:
Slovenian: 8. oktobra 2009, 12. februarja 2010
English: What is Atacand?
Slovenian: Kaj je zdravilo Atacand?
English: Atacand was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Slovenian: Skupina za usklajevanje za postopek z medsebojnim priznavanjem in decentralizirani postopek za zdravila v humani medicini (CMD(h)) je ugotovila, da je za zdravilo Atacand potrebno usklajevanje.
English: Darunavir Krka may be given to adults or children from 3 years of age and weighing at least 15 kg.
Slovenian: Zdravilo Darunavir Krka se lahko daje odraslim ali otrokom, starejšim od treh let, ki tehtajo najmanj 15 kg.
English: The full EPAR for Darunavir Krka can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Darunavir Krka je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Darunavir Krka.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Darunavir Krka.
English: What measures are being taken to ensure the safe and effective use of Darunavir Krka?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Darunavir Krka?
English: As for every medicine, the company provided studies on the quality of Darunavir Krka.
Slovenian: Kot to velja za vsako zdravilo, je družba zagotovila študije o kakovosti zdravila Darunavir Krka.
English: Studies on the benefits and risks of the active substance in the approved use have already been carried out with the reference medicine, Prezista, and do not need to be repeated for Darunavir Krka.
Slovenian: Študije o koristih in tveganjih zdravilne učinkovine pri dovoljenih uporabah so že bile izvedene z referenčnim zdravilom Prezista, zato jih ni treba ponoviti za zdravilo Darunavir Krka.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Darunavir Krka has been shown to have comparable quality and to be bioequivalent to Prezista.
Slovenian: Evropska agencija za zdravila je zaključila, da je bilo v skladu z zahtevami EU dokazano, da ima zdravilo Darunavir Krka primerljivo raven kakovosti kot referenčno zdravilo Prezista ter da mu je biološko enakovredno.
English: Because Darunavir Krka is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Darunavir Krka generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What are the benefits and risks of Darunavir Krka?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Darunavir Krka?
English: This means that Darunavir Krka contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Prezista.
Slovenian: To pomeni, da vsebuje enako zdravilno učinkovino in ima enak način delovanja kot „referenčno zdravilo“ Prezista, ki je že odobreno v Evropski uniji (EU).
English: Darunavir Krka is an antiviral medicine used with other HIV medicines to treat patients with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Darunavir Krka je protivirusno zdravilo, ki se uporablja v kombinaciji z drugimi zdravili za zdravljenje okužbe z virusom HIV pri bolnikih, okuženih z virusom humane imunske pomanjkljivosti tipa 1 (HIV-1), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: For more information about treatment with Darunavir Krka, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Darunavir Krka preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Darunavir Krka have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in varnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Darunavir Krka upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: Darunavir Krka, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Slovenian: Zdravilo Darunavir Krka v kombinaciji z drugimi protivirusnimi zdravili zniža količino virusa HIV v krvi in jo vzdržuje na nizki ravni.
English: What is Darunavir Krka and what is it used for?
Slovenian: Kaj je zdravilo Darunavir Krka in za kaj se uporablja?
English: Darunavir Krka does not cure HIV infection or AIDS, but HIV treatment may hold off the damage to the immune system and the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Darunavir Krka ne zdravi okužbe z virusom HIV ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: For practical information about using Darunavir Krka, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Darunavir Krka naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: It is not intended to provide practical advice on how to use Darunavir Krka.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Other information about Darunavir Krka
Slovenian: Druge informacije o zdravilu Darunavir Krka
English: The active substance in Darunavir Krka, darunavir, is a protease inhibitor.
Slovenian: Zdravilna učinkovina zdravila Darunavir Krka, darunavir, je zaviralec proteaze.
English: Darunavir Krka is a ‘generic medicine'.
Slovenian: Zdravilo Darunavir Krka je „generično zdravilo“.
English: The medicine is always taken with low-dose ritonavir and with other HIV medicines, and should be taken with food.
Slovenian: Zdravilo Darunavir Krka se vedno jemlje v kombinaciji z nizkimi odmerki ritonavirja in drugimi zdravili za zdravljenje okužbe s HIV, jemati pa ga je treba sočasno s hrano.
English: Darunavir Krka is available as tablets.
Slovenian: Zdravilo Darunavir Krka je na voljo v obliki tablet.
English: Darunavir Krka can only be obtained with a prescription and treatment should be started by a healthcare professional who has experience in the management of HIV.
Slovenian: Predpisovanje in izdaja zdravila Darunavir Krka je le na recept, zdravljenje z njim pa mora uvesti zdravnik specialist, ki ima izkušnje z zdravljenjem okužbe z virusom HIV.
English: Why is Darunavir Krka approved?
Slovenian: Zakaj je bilo zdravilo Darunavir Krka odobreno?
English: Darunavir Krka contains the active substance darunavir.
Slovenian: Zdravilo Darunavir Krka vsebuje zdravilno učinkovino darunavir.
English: How is Darunavir Krka used?
Slovenian: Kako se zdravilo Darunavir Krka uporablja?
English: Darunavir Krka is always given with ritonavir.
Slovenian: Zdravilo Darunavir Krka se vedno daje v kombinaciji z ritonavirjem.
English: How has Darunavir Krka been studied?
Slovenian: Kako je bilo zdravilo Darunavir Krka raziskano?
English: How does Darunavir Krka work?
Slovenian: Kako zdravilo Darunavir Krka deluje?
English: Elderly people (over 65 years)
Slovenian: Starejši ljudje (stari več kot 65 let)
English: This is because the safety and benefits of this medicine are not known in this population.
Slovenian: Razlog za to je, da varnost in koristi tega zdravila pri tej populaciji niso znane.
English: • Inability to achieve or maintain erection
Slovenian: • nezmožnost doseganja ali ohranjanja erekcije.
English: Not known (frequency cannot be estimated from the available data):
Slovenian: Pogostnost neznana (ni mogoče oceniti iz razpoložljivih podatkov):
English: • Reduced appetite
Slovenian: • zmanjšan apetit,
English: The mechanism of this effect has not been established.
Slovenian: Mehanizem tega učinka ni pojasnjen.
English: Other side effects may include:
Slovenian: Med drugimi neželenimi učinki so lahko:
English: Alcohol, barbiturates or narcotics
Slovenian: Alkohol,barbiturati ali narkotiki
English: Date of latest renewal: 27 August 2018
Slovenian: Datum prve odobritve: 16 Januar 2009 Datum zadnjega podaljšanja: 27 Avgust 2018
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve glede predložitve rednega posodobljenega poročila o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov EU (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitveh, objavljenih na evropskem spletnem portalu o zdravilih.
English: Animal studies are insufficient.
Slovenian: Ni dovolj študij na živalih.
English: Results of the neurocognitive assessments showed some improvements in most of the test scores, with no meaningful difference between the treatment groups.
Slovenian: Rezultati nevrokognitivnih ocen so pokazali nekaj izboljšanja pri večini rezultatov testov, vendar med skupinama zdravljenja ni bilo pomembnih razlik.
English: • Increased sensitivity of skin to the sun
Slovenian: • povečana občutljivost kože na sončno svetlobo,
English: One dosage unit contains no more than 100 micrograms of gluten.
Slovenian: Ena enota odmerka ne vsebuje več kot 100 mikrogramov glutena.
English: Currently available data are described in sections 4.8, 5.1, and 5.2.
Slovenian: Trenutno razpoložljivi podatki so opisani v poglavjih 4.8, 5.1 in 5.2.
English: • Sad mood (depression)
Slovenian: • žalostno razpoloženje (depresija),
English: • Sugar in the urine
Slovenian: • sladkor v urinu.
English: These combinations were efficacious and well tolerated.
Slovenian: Navedene kombinacije so bile učinkovite in so jih bolniki dobro prenašali.
English: The antihypertensive effect is largely manifested within 1 week and the maximum effect is generally seen within 4 weeks.
Slovenian: Antihipertenzivni učinek se večinoma pokaže v 1 tednu, največji učinek pa je večinoma mogoče opaziti v 4 tednih.
English: − Second and third trimesters of pregnancy (see section 4.6).
Slovenian: − drugo in tretje trimesečje nosečnosti (glejte poglavje 4.6);
English: The safety of Rasilez HCT has been evaluated in more than 3,900 patients, including over 700 treated for over 6 months, and 190 for over 1 year.
Slovenian: Varnost zdravila Rasilez HCT so ocenjevali pri več kot 3.900 bolnikih, med katerimi je bilo več kot 700 bolnikov zdravljenih več kot 6 mesecev, 190 pa več kot 1 leto.
English: There were no new or unexpected findings observed of relevance to human use.
Slovenian: Novih ali nepričakovanih rezultatov, ki bi bili pomembni za uporabo pri ljudeh, niso opažali.
English: A high inter-individual variability of mRNA expression levels was observed (up to 600-fold).
Slovenian: Opažali so veliko interindividualno variabilnost izražanja mRNA (do 600-kratno).
English: Your doctor will normally advise you to stop taking this medicine before you become pregnant and will advise you to take another medicine instead of this medicine.
Slovenian: Zdravnik vam bo praviloma svetoval, da prenehate z jemanjem tega zdravila, še preden zanosite, in vam bo svetoval jemanje drugega zdravila namesto tega zdravila.
English: Do not take a double dose (two tablets at once) to make up for a forgotten tablet.
Slovenian: Ne vzemite dvojnega odmerka (dveh tablet naenkrat), če ste pozabili vzeti prejšnji odmerek.
English: These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking this medicine.
Slovenian: To sta lahko simptoma povečanega tlaka v očesu in se lahko pojavita v nekaj urah do nekaj tednih jemanja tega zdravila.
English: The average differences between aliskiren and placebo for the low and mid dose groups were <0.2 mmHg.
Slovenian: Povprečne razlike med aliskirenom in placebom pri skupinah z nizkim in srednjim odmerkom so bile < 0,2 mmHg.
English: The frequency of adverse reactions listed below is defined using the following convention: 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) and not known (cannot be estimated from the available data).
Slovenian: Pogostnost spodaj naštetih neželenih učinkov je opredeljena po naslednjem dogovoru: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: During your treatment, your doctor may adjust your dose depending on your blood pressure response.
Slovenian: Med zdravljenjem vam zdravnik lahko spremeni odmerek glede na odziv vašega krvnega tlaka.
English: Mean duration of follow-up was 3.5 years.
Slovenian: Spremljanje bolnikov je trajalo povprečno 3,5 leta.
English: If you only remember the forgotten dose the next day, you should simply take the next tablet at the usual time.
Slovenian: Če se na pozabljeni odmerek spomnite šele naslednji dan, preprosto vzemite samo naslednji odmerek ob običajnem času.
English: Hydrochlorothiazide has been extensively prescribed for many years, frequently in higher doses than those contained in Rasilez HCT.
Slovenian: Hidroklortiazid intenzivno predpisujejo že mnogo let, pogosto v precej višjih odmerkih, kot je prisoten v zdravilu Rasilez HCT.
English: It should not be used in children from 2 to less than 6 years of age, and is not recommended for use in children and adolescents from 6 to less than 18 years of age.
Slovenian: Ne sme se uporabljati pri otrocih po dopolnjenem 2. letu in pred dopolnjenim 6. letom starosti, njegova uporaba pa ni priporočena niti pri otrocih in mladostnikih, ki so stari vsaj 6 in manj kot 18 let.
English: The blood pressure lowering effect is present within one week after beginning treatment.
Slovenian: Zdravilo začne zniževati krvni tlak v roku enega tedna od začetka zdravljenja.
English: The results of this study did not suggest that age, body weight or gender have any significant effect on aliskiren systemic exposure (see section 4.2).
Slovenian: Rezultati te študije so pokazali, da starost, telesna masa in spol nimajo pomembnega vpliva na obseg sistemske izpostavljenosti aliskirenu (glejte poglavje 4.2).