FrancophonIA/ELRC3.0 huggingface dataset:
English: No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of nitroglycerin in a study in 18 healthy male subjects.
Slovenian: V študiji, v kateri je 18 zdravih moških jemalo vardenafil (10 mg) v različnih časovnih presledkih (1 do 24 ur) pred odmerkom nitroglicerina, vardenafil ni zvečal učinka nitroglicerina (0,4 mg sublingvalno) na znižanje krvnega tlaka.
English: Talk to your doctor or pharmacist before taking Levitra.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Levitra se posvetujte z zdravnikom ali farmacevtom.
English: EU/1/03/248/013 1 tablet EU/1/03/248/014 2 tablets EU/1/03/248/015 4 tablets EU/1/03/248/016 8 tablets
Slovenian: EU/1/03/248/013 1 tableta EU/1/03/248/014 2 tableti EU/1/03/248/015 4 tablete EU/1/03/248/016 8 tablet
English: Levitra 10 mg orodispersible tablets should not be taken as starting dose in patients treated with alpha-blockers (see section 4.4).
Slovenian: Bolniki, ki se zdravijo z zaviralci adrenergičnih receptorjev alfa, ne smejo uporabiti zdravila Levitra 10 mg orodisperzibilne tablete kot začetni odmerek (glejte poglavje 4.4).
English: With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.4).
Slovenian: Kadar pa je predpisano sočasno zdravljenje z drugimi zaviralci receptorjev alfa in vardenafilom, se od zaužitja enega zdravila do zaužitja drugega priporoča časovni presledek (glejte poglavje 4.4).
English: In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half-life of approximately 4 hours.
Slovenian: Eden od glavnih presnovkov (M1) v krvnem obtoku pri ljudeh nastane med deetilacijo vardenafila in se še naprej presnavlja.
English: Haematuria
Slovenian: - omedlevica
English: Levitra might make some people feel dizzy or affect their vision.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Pri nekaterih ljudeh lahko zdravilo Levitra povzroči vrtoglavico ali motnje vida.
English: Levitra 10 mg film-coated tablets vardenafil
Slovenian: Levitra 10 mg filmsko obložene tablete vardenafil
English: Each tablet contains 5 mg vardenafil (as hydrochloride).
Slovenian: Ena tableta vsebuje 5 mg vardenafila v obliki vardenafilijevega klorida.
English: Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.
Slovenian: Za delovanje vardenafila je potrebno spolno vzburjenje.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aspartam (E951)
English: Each tablet contains 20 mg vardenafil (as hydrochloride).
Slovenian: Ena tableta vsebuje 20 mg vardenafila v obliki vardenafilijevega klorida.
English: EU/1/03/248/009 2 tablets EU/1/03/248/010 4 tablets EU/1/03/248/011 8 tablets EU/1/03/248/012 12 tablets EU/1/03/248/023 20 tablets
Slovenian: EU/1/03/248/009 2 tableti EU/1/03/248/010 4 tablete EU/1/03/248/011 8 tablet EU/1/03/248/012 12 tablet EU/1/03/248/023 20 tablet
English: Suomi/Finland
Slovenian: Suomi/Finland Bayer Oy
English: EU/1/03/248/005 2 tablets EU/1/03/248/006 4 tablets EU/1/03/248/007 8 tablets EU/1/03/248/008 12 tablets EU/1/03/248/022 20 tablets
Slovenian: EU/1/03/248/005 2 tableti EU/1/03/248/006 4 tablete EU/1/03/248/007 8 tablet EU/1/03/248/008 12 tablet EU/1/03/248/022 20 tablet
English: Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
Slovenian: Enkratna peroralna odmerka 10 mg in 80 mg vardenafila podaljšata dobo QT povprečno za 8 oz. 10 msec. Enkratni odmerek 10 mg vardenafila uporabljen sočasno s 400 mg gatifloksacina, učinkovino, ki ima podoben učinek na QT dobo, se doba QT podaljša za 4 msec v primerjavi s posamezno učinkovino.
English: Tinnitus
Slovenian: - tesnoba
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja eritem izpuščaj fotosenzitivna reakcija
English: - Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva.
Slovenian: Tableta se bo raztopila v nekaj sekundah, pogoltnite jo s slino.
English: In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
Slovenian: V kliničnem preskušanju pri bolnikih po prostatektomiji, v kateri so primerjali placebo z 10- in 20miligramskimi odmerki vardenafila, je vardenafil pomembno izboljšal erektilno funkcijo, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
English: Each tablet contains 10 mg vardenafil (as hydrochloride).
Slovenian: Ena tableta vsebuje 10 mg vardenafila v obliki vardenafilijevega klorida.
English: Contents of the pack and other information What Levitra contains
Slovenian: Shranjevanje zdravila Levitra Vsebina pakiranja in dodatne informacije
English: In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
Slovenian: V kliničnem preskušanju, v katerem so sodelovali bolniki s sladkorno boleznijo in v kateri so primerjali placebo z 10- in 20-miligramskimi odmerki vardenafila, se je zaradi uporabe vardenafila pomembno izboljšala erektilna funkcija, zmožnost doseganja in ohranjanja erekcije (omogočen je bil uspešen spolni odnos), ter otrdelost penisa.
English: EU/1/03/248/001 2 tablets EU/1/03/248/002 4 tablets EU/1/03/248/003 8 tablets EU/1/03/248/004 12 tablets EU/1/03/248/021 20 tablets
Slovenian: EU/1/03/248/002 4 tablete EU/1/03/248/003 8 tablet EU/1/03/248/004 12 tablet EU/1/03/248/021 20 tablet
English: With other alpha-blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5).
Slovenian: Pri sočasnem zdravljenju z vardenafilom in drugimi zaviralci adrenergičnih receptorjev alfa je potreben med zaužitjem enega in drugega zdravila časovni presledek (glejte poglavje 4.5).
English: Talk to a doctor without taking
Slovenian: Preden začnete jemati zdravilo
English: In patients with severe renal impairment (creatinine clearance <30 ml/min), a starting dose of 5 mg should be considered.
Slovenian: Začetni odmerek za bolnike s hudo ledvično okvaro (kreatininski očistek < 30 ml/min) je 5 mg. Glede na učinkovitost zdravila in dejstvo, kako ga bolnik prenaša, se ga lahko poveča na 10 mg in 20 mg.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora nosna kongestija dispneja sinusna kongestija epistaksa
English: Sudden death
Slovenian: Jetrna okvara
English: Levitra is not for use by women.
Slovenian: Nosečnost in dojenje Zdravilo Levitra ni namenjeno ženskam.
English: Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2).
Slovenian: Med sočasno uporabo zmernih zaviralcev CYP3A4 (npr. eritromicin in klaritromicin), je treba odmerek vardenafila po potrebi prilagoditi (glejte poglavji 4.5 in 4.2).
English: Vardenafil dose adjustment might be necessary if moderate CYP3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see section 4.2 and 4.5).
Slovenian: Med sočasno uporabo zmernih zaviralcev CYP3A4 (npr. eritromicin in klaritromicin), je treba odmerek vardenafila po potrebi prilagoditi (glejte poglavji 4.2 in 4.5).
English: Increase in gamma-glutamyl transferase
Slovenian: Jenapharm GmbH & Co.
English: Each orodispersible tablet contains 10 mg of vardenafil (as hydrochloride).
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena orodisperzibilna tableta vsebuje 10 mg vardenafila v obliki vardenafilijevega klorida.
English: Do you currently use or take contraceptives?
Slovenian: Ali trenutno uporabljate ali jemljete kontraceptive?
English: Date of first authorisation: 24 June 2013 Date of latest renewal: 8 January 2018
Slovenian: Datum prve odobritve: 24. junij 2013 Datum zadnjega podaljšanja: 08. januar 2018
English: • primary (with no identified cause or familial);
Slovenian: • primarna (brez ugotovljenega vzroka ali družinska),
English: Efficacy has been shown in:
Slovenian: Učinkovitost je bila ugotovljena pri:
English: It is especially important to tell your doctor if you are taking:
Slovenian: Še posebej pomembno je, da obvestite zdravnika, če jemljete:
English: He recovered completely within 24 hours with blood pressure support.
Slovenian: V 24 urah si je ob podpori krvnemu tlaku povsem opomogel.
English: A clinically significant reduction of efficacy cannot be excluded.
Slovenian: Klinično pomembnega zmanjšanja učinkovitosti ne moremo izključiti.
English: The results did not indicate an additional benefit of bosentan in this population:
Slovenian: Rezultati ne kažejo na dodatno korist bosentana pri tej populaciji:
English: 4 These types of reactions can also be related to the underlying disease.
Slovenian: 4 Te vrste reakcij so lahko tudi posledica osnovne bolezni.
English: This patient recovered within the 60-day follow-up period.
Slovenian: Ta bolnik je v 60dnevnem obdobju spremljanja okreval.
English: Date of first monthly test: _________________________________
Slovenian: Datum prvega mesečnega testa: _________________________________
English: Animal models
Slovenian: Živalski modeli
English: The table below illustrates the pre-specified protocol analyses.
Slovenian: Spodnja preglednica kaže predspecificirane analize protokola.
English: Signs that your liver may not be working properly include:
Slovenian: Znaki, da morda jetra ne delujejo pravilno, vključujejo:
English: Appropriate monitoring of the HIV therapy is recommended.
Slovenian: Priporoča se ustrezno nadziranje zdravljenja HIV.
English: 6-Minute Walk Distance (m)
Slovenian: Razdalja, prehojena v 6 minutah (m)
English: The mechanism of this adverse effect is unclear.
Slovenian: Mehanizem tega neželenega učinka ni jasen.
English: The primary objective was to show that bosentan did not worsen hypoxaemia.
Slovenian: Primarni cilj je bil pokazati, da bosentan ni poslabšal hipoksemije.
English: Invasive haemodynamic parameters were assessed in the first study only.
Slovenian: Invazivne hemodinamske parametre so ocenjevali samo v prvi študiji.
English: There was no decrease to below 8 g/dL.
Slovenian: Znižanj pod vrednost 8 g/dl ni bilo.
English: It is important that you have these tests as ordered by your doctor.
Slovenian: Pomembno je, da opravljate te preiskave, ki jih naroči zdravnik.
English: Your name: __________________________________________________ Prescribing doctor: ________________________________________ If you have questions about STAYVEER ask your doctor.
Slovenian: Vaše ime: __________________________________________________ Zdravnik, ki je zdravilo predpisal: _______________________________ Če imate kakšna vprašanja o zdravilu STAYVEER, se posvetujte z zdravnikom.
English: > 8 × ULN
Slovenian: > 8  ZMN
English: The patient's response to treatment and need for continued therapy should be re-evaluated on a regular basis.
Slovenian: Odziv bolnika na zdravljenje in potrebo po nadaljnji terapiji moramo redno ponovno ocenjevati.
English: • if you are pregnant, or could get pregnant because you are not using reliable contraceptive methods.
Slovenian: • če ste noseči ali lahko zanosite, ker ne uporabljate zanesljivih kontracepcijskih metod.
English: Tests your doctor will do during treatment
Slovenian: Testi, ki jih bo vaš zdravnik opravil med zdravljenjem
English: The clinical benefit of the combination has not been demonstrated.
Slovenian: Klinične koristi kombinacije niso dokazali.
English: The mean treatment duration was 45 weeks.
Slovenian: Povprečno je zdravljenje trajalo 45 tednov.
English: Increasing the dose or the dosing frequency will likely not result in additional clinical benefit.
Slovenian: Povečanje odmerka ali pogostnosti odmerjanja verjetno ne bo imelo za posledico dodatnih kliničnih koristi.
English: EXP {MM/YYYY} Use within 30 days after the first opening
Slovenian: EXP: {MM/LLLL} Uporabite v 30 dneh po prvem odprtju.
English: The majority of patients were diagnosed with idiopathic or heritable PAH (61%).
Slovenian: Večina bolnikov je bila diagnosticirana z idiopatsko ali podedovano PAH (61 %).
English: Your doctor will advise you on your dosing.
Slovenian: Vaš zdravnik vam bo svetoval vaš odmerek.
English: Less than 3% of an administered oral dose is recovered in urine.
Slovenian: Manj kot 3 % danega peroralnega odmerka se izloči v urinu.
English: The consequences of these findings regarding hepatotoxicity are unknown.
Slovenian: Posledice teh izsledkov glede hepatotoksičnosti niso znane.
English: However, full induction by bosentan might not have been reached and a further decrease of protease inhibitors cannot be excluded.
Slovenian: Vendar pa popolna indukcija z bosentanom morda ni bila dosežena, zato nadaljnjega zmanjševanja zaviralcev proteaze ni mogoče izključiti.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ali ste pred kratkim jemali katerokoli zdravilo, vključno z zdravili, ki ste jih dobili brez recepta.
English: In healthy subjects, the absolute bioavailability of bosentan is approximately 50% and is not affected by food.
Slovenian: Pri zdravih osebah je absolutna biološka uporabnost bosentana približno 50 % in ni odvisna od hrane.
English: This lowers the blood pressure and relieves the symptoms.
Slovenian: tem se zniža krvni tlak in lajšajo simptomi.
English: Blurred vision have also been reported at an unknown frequency (frequency cannot be estimated from the available data).
Slovenian: Poročali so tudi o zamegljenem vidu, z neznano pogostnostjo (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov).
English: The plasma concentrations of bosentan were also decreased by 29%.
Slovenian: Plazemske koncentracije bosentana so se tudi znižale za 29 %.
English: Based on these findings and preclinical data, it cannot be excluded that bosentan may have a detrimental effect on spermatogenesis in men.
Slovenian: Na podlagi teh ugotovitev in predkliničnih podatkov ni mogoče izključiti možnosti, da ima lahko bosentan škodljiv učinek na spermatogenezo pri moških.
English: If you suspect you may be pregnant, tell your doctor or gynaecologist.
Slovenian: Če sumite, da ste morda noseči, to povejte zdravniku ali ginekologu.
English: The maximum plasma concentrations are attained within 3-5 hours.
Slovenian: Maksimalne plazemske koncentracije dosega v 3-5 urah.
English: Patients could receive additional PAH treatment as required in the open-label extension.
Slovenian: Bolniki so lahko prejemali dodatno zdravljenje PAH, kot je bilo potrebno v odprtem podaljšku.
English: Bosentan is highly bound (> 98%) to plasma proteins, mainly albumin.
Slovenian: Bosentan se v veliki meri veže (> 98 %) na plazemske beljakovine, zlasti na albumine.
English: Important Safety Alerts for Patients taking STAYVEER (bosentan)
Slovenian: Pomembna varnostna opozorila za bolnike, ki jemljejo zdravilo STAYVEER (bosentan)
English: The film-coated tablets are to be swallowed with water.
Slovenian: Filmsko obložene tablete se zaužijejo z vodo.
English: The combination is not recommended.
Slovenian: Te kombinacije ne priporočamo.
English: ULN = upper limit of normal
Slovenian: ZMN = Zgornja meja normalnih vrednosti
English: If you forget to take STAYVEER, take a dose as soon as you remember, then continue to take your tablets at the usual times.
Slovenian: Če ste pozabili vzeti zdravilo STAYVEER, vzemite odmerek takoj, ko se spomnite, nato nadaljujte z jemanjem tablet ob običajnem času.
English: This combination should not be used.
Slovenian: Te kombinacije ne smemo uporabljati.
English: In both studies, treatment with bosentan resulted in significant increases in exercise capacity.
Slovenian: V obeh študijah je zdravljenje z bosentanom pripeljalo do pomembnega povečanja fizične zmogljivosti.
English: Warnings and precautions Tests your doctor will do before treatment
Slovenian: Opozorila in previdnostni ukrepi Preiskave, ki jih bo vaš zdravnik opravil pred zdravljenjem
English: These will be done every month for the first 4 months of treatment, then every 3 months after that, as patients taking STAYVEER may get anaemia.
Slovenian: Opravijo se vsak mesec v prvih 4 mesecih zdravljenja, nato pa vsake 3 mesece, saj lahko bolniki, ki jemljejo zdravilo STAYVEER, postanejo slabokrvni.
English: Please read the information under “Contraceptives” and “Other medicines and STAYVEER”
Slovenian: Preberite informacije v poglavju „Kontraceptivi“ in „Druga zdravila in zdravilo STAYVEER“,
English: This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Slovenian: To zmanjša količino kisika, ki lahko pride v kri v pljučih, zato je fizična aktivnost otežena.
English: No clinically relevant differences in adverse reactions were observed between the overall dataset and the approved indications.
Slovenian: Klinično pomembnih razlik v neželenih učinkih med vsemi podatki in odobrenimi indikacijami niso opazili.
English: There are no reliable data on the use of STAYVEER in pregnant women.
Slovenian: Na voljo ni zanesljivih podatkov o uporabi zdravila STAYVEER pri nosečnicah.
English: Bosentan does not penetrate into erythrocytes.
Slovenian: Bosentan ne prodre v eritrocite.
English: If you have the impression that the effect of STAYVEER is too strong or too weak, talk to your doctor in order to find out whether your dose needs to be changed.
Slovenian: Če menite, da je učinek zdravila STAYVEER premočan ali prešibak, se posvetujte z zdravnikom, da ugotovite, ali je treba spremeniti vaš odmerek.
English: In this study, the exposure to bosentan decreased with time in a manner consistent with the known auto-induction properties of bosentan.
Slovenian: V tej študiji se je izpostavljenost bosentanu manjšala s časom na način, ki se je ujemal z znanimi samoindukcijskimi lastnostmi bosentana.
English: Only one death occurred in each treatment group during the 6-month double-blind study period, therefore no conclusion can be drawn on survival.
Slovenian: vsaki skupini je v času 6-mesečnega obdobja dvojno slepe študije umrla po ena oseba, zato o preživetju ni mogoče sklepati.
English: Haemodynamics were measured in 17 patients.
Slovenian: Hemodinamske kazalce so merili pri 17 bolnikih.
English: 95% CL
Slovenian: 95-% MZ
English: In the event of late clinical deterioration despite treatment with STAYVEER (i.e., after several months of treatment), the treatment should be re-assessed.
Slovenian: V primeru kasnejšega poslabšanja kliničnega stanja kljub zdravljenju z zdravilom STAYVEER (tj. po nekaj mesecih zdravljenja) je treba zdravljenje ponovno oceniti.
English: • Anaemia (low blood value) which may affect up to 1 in 10 people.
Slovenian: • anemija (nizke krvne vrednosti), ki se lahko pojavi pri največ 1 od 10 bolnikov.
English: The mechanism for this interaction may be induction of P-glycoprotein.
Slovenian: Mehanizem tega medsebojnega delovanja je lahko indukcija P-glikoproteina.
English: For further information see sections 4.5 and 4.6.
Slovenian: Za več informacij glejte poglavji 4.5 in 4.6.
English: This card contains important information about STAYVEER.
Slovenian: Kartica vsebuje pomembne informacije o zdravilu STAYVEER.
English: Monitoring of aminotransferase levels should be continued at least every 2 weeks.
Slovenian: Spremljanje ravni aminotransferaz naj se nadaljuje vsaj na vsaka 2 tedna.
English: STAYVEER reduces the number of new finger and toe ulcers that appear.
Slovenian: STAYVEER zmanjšuje število novih razjed prstov na rokah in nogah, ki se pojavijo.
English: Do not use this medicine after the expiry date which is stated on the carton and on the blister after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatlici in pretisnem omotu poleg oznake „EXP“.
English: The safety profile of the combination was not different from the one expected with each component and the combination therapy was well tolerated in children and adults.
Slovenian: Varnostni profil kombinacije se ni razlikoval od profila, ki bi ga pričakovali za vsako posamezno zdravilo, kombinirano zdravljenje pa so dobro prenašali tako otroci kot odrasli.
English: If you are a woman of childbearing age read this page carefully
Slovenian: Ženske v rodni dobi naj skrbno preberejo to stran
English: If a clinically relevant decrease in haemoglobin concentration occurs, further evaluation and investigation should be undertaken to determine the cause and need for specific treatment.
Slovenian: Če pride do klinično pomembnega znižanja koncentracije hemoglobina, opravimo dodatna vrednotenja in preiskave, da ugotovimo vzrok in potrebo po specifičnem zdravljenju.
English: • One patient in the bosentan group had treatment failure (need for ECMO as per protocol definition), which was declared based on increasing Oxygenation Index values within 8 h after the first study drug dose.
Slovenian: • Pri enem bolniku v skupini z bosentanom zdravljenje ni bilo uspešno (potreba po ECMO po opredelitvi v protokolu), kar je bilo ugotovljeno na podlagi naraščajočih vrednosti oksigenacijskega indeksa v 8 urah po prvem odmerku študijskega zdravila.
English: Due to the potential for interactions related to the inducing effect of bosentan on CYP450 (see section 4.5), which could affect the efficacy of antiretroviral therapy, these patients should also be monitored carefully regarding their HIV infection.
Slovenian: Zaradi možnosti medsebojnega delovanja v povezavi z učinkom bosentana na indukcijo encima CYP450 (glejte poglavje 4.5), ki bi lahko vplivalo na učinkovitost protiretrovirusnega zdravljenja, moramo te bolnike skrbno spremljati tudi v smislu njihove okužbe s HIV.
English: Other medicines and STAYVEER
Slovenian: Druga zdravila in zdravilo STAYVEER
English: The advice of a hepatologist is recommended.
Slovenian: Priporočamo posvet s hepatologom.
English: Due to limited data in children below 2 years of age, pharmacokinetics remain not well characterised in this age category.
Slovenian: Zaradi pomanjkljivih podatkov pri otrocih, mlajših od 2 let, ostaja farmakokinetika pri tej starostni skupini slabše opredeljena.
English: Syncope1, 4
Slovenian: pogosti sinkopa1, 4
English: What STAYVEER is and what it is used for
Slovenian: Kaj je zdravilo STAYVEER in za kaj ga uporabljamo
English: Based on the investigated range of each variable, it is not expected that the pharmacokinetics of bosentan will be influenced by gender, body weight, race, or age in the adult population to any relevant extent.
Slovenian: Na podlagi raziskanega razpona za vsako spremenljivko ne pričakujemo, da bi na farmakokinetiko bosentana pomembno vplival spol, telesna masa, rasa ali starost odrasle populacije.
English: You are advised to stop breast-feeding if STAYVEER is prescribed for you, because it is not known whether this medicine passes into breast milk.
Slovenian: Svetujemo vam, da prenehate dojiti, če ste dobili predpisano zdravilo STAYVEER, saj ni znano, ali se to zdravilo izloča v mleko.
English: Re-introduction of treatment
Slovenian: Ponovna uvedba zdravljenja
English: Some improvements have also been shown in patients with class II PAH.
Slovenian: Nekatera izboljšanja so opazili tudi pri bolnikih s PAH II.
English: If there is any doubt about what contraceptive advice should be given to the individual patient, consultation with a gynaecologist is recommended.
Slovenian: V primeru dvoma v zvezi z načinom kontracepcije, ki se svetuje posamični bolnici, se priporoča posvetovanje z ginekologom.