FrancophonIA/ELRC3.0 huggingface dataset:
English: Blood Test for Liver Function
Slovenian: Preiskave krvi za oceno delovanja jeter
English: In the patients with Child-Pugh class B liver impairment, the mean (95% CI) steady-state AUC of bosentan was 360 (212613) ng⋅h/mL, i.e., 4.7 times higher, and the mean (95% CI) AUC of the active metabolite Ro 48-5033 was 106 (58.4-192) ng⋅h/mL, i.e., 12.4 times higher than in the patients with normal liver function (bosentan: mean [95% CI] AUC: 76.1 [9.07-638] ng⋅h/mL; Ro 48-5033: mean [95% CI] AUC 8.57 [1.28-57.2] ng⋅h/ml).
Slovenian: (95-% IZ) AUCτ v stanju dinamičnega ravnovesja za bosentan 360 (212-613) ng·h/ml, tj., 4,7-krat višji, povprečni (95-% IZ) AUCτ aktivnega presnovka Ro 48-5033 pa je bil 106 (58,4-192) ng·h/ml,
English: Cartons contain 56 film-coated tablets (STAYVEER 125 mg film-coated tablets).
Slovenian: Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo STAYVEER 125 mg filmsko obložene tablete).
English: Inside your pack of STAYVEER tablets you will find a Patient Alert Card which you should read carefully.
Slovenian: Znotraj škatle s tabletami STAYVEER je Opozorilna kartica za bolnika.
English: Pulmonary arterial hypertension
Slovenian: • Pljučne arterijske hipertenzije (PAH).
English: What STAYVEER looks like and contents of the pack
Slovenian: Izgled zdravila STAYVEER in vsebina pakiranja
English: Concomitant use of STAYVEER and cyclosporine A is contraindicated (see sections 4.3 and 4.5).
Slovenian: Sočasna uporaba zdravila STAYVEER in ciklosporina A je kontraindicirana (glejte poglavji 4.3 in
English: Each tablet contains 62.5 mg of bosentan (as monohydrate).
Slovenian: Ena tableta vsebuje 62,5 mg bosentana (v obliki monohidrata).
English: Safety and tolerability of bosentan was investigated in an exploratory, uncontrolled 12-week study in 11 patients with pulmonary hypertension secondary to severe COPD (stage III of GOLD classification).
Slovenian: Varnost in prenašanje bosentana so raziskali v raziskovalni, nekontrolirani 12-tedenski študiji z 11
English: Kaplan-Meier estimates of survival were 90% and 85% at 3 and 4 years after the start of treatment, respectively.
Slovenian: Ocena preživetja po metodi Kaplan-Meier je bila 90 % 3 leta in
English: Each tablet contains 125 mg of bosentan (as monohydrate).
Slovenian: Ena tableta vsebuje 125 mg bosentana (v obliki monohidrata).
English: After oral administration, the systemic exposure is proportional to dose up to 500 mg. At higher oral doses, Cmax and AUC increase less than proportionally to the dose.
Slovenian: Pri višjih peroralnih odmerkih se Cmax in AUCτ povečujeta manj kot bi bilo sorazmerno odmerku.
English: Very common (may affect more than one in 10 people):
Slovenian: Zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • glavobol
English: Bosentan
Slovenian: Dojenje
English: • Thrombocytopenia (low number of blood platelets)
Slovenian: • trombocitopenija (nizko število trombocitov)
English: Liver cirrhosis, liver failure1
Slovenian: redki ciroza jeter, jetrna odpoved1
English: Twenty-six patients continued to receive bosentan in the 24-week open-label extension phase (AC-052-409) of the BREATHE-5 study (mean duration of treatment = 24.4 ± 2.0 weeks) and, in general, efficacy was maintained.
Slovenian: V fazi odprtega podaljška je šestindvajset bolnikov še naprej prejemalo bosentan v nadaljnjem 24-tedenskem obdobju zdravljenja (AC-052-409) študije
English: No dose proportionality was observed, as steady-state bosentan plasma concentrations and AUCs were similar at oral doses of 2 and 4 mg/kg (AUCτ: 3,577 ng·h/mL and 3,371 ng·h/mL for 2 mg/kg twice daily and 4 mg/kg twice daily, respectively).
Slovenian: Sorazmernosti odmerka niso opazili, saj so bile koncentracije bosentana v plazmi v stanju dinamičnega ravnovesja in AUCτ pri peroralnih odmerkih 2 in 4 mg/kg podobne (AUCτ:
English: In a randomised, double-blind, multi-centre, placebo-controlled study (AC-052-364 [EARLY]), 185 PAH patients in WHO functional class II (mean baseline 6-minute walk distance of 435 metres) received bosentan 62.5 mg twice daily for 4 weeks followed by 125 mg twice daily (n = 93), or placebo (n = 92) for 6 months.
Slovenian: funkcijskega razreda po SZO (srednja izhodiščna vrednost 435 metrov prehojenih v 6 minutah) prejemalo bosentan 62,5 mg dvakrat na dan 4 tedne in nato 125 mg dvakrat na teden (n = 93), ali placebo (n = 92) 6 mesecev.
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 125 mg film-coated tablets).
Slovenian: 56 ali 112 filmsko obloženih tablet (STAYVEER 125 mg filmsko obložene tablete).
English: STAYVEER 125 mg film-coated tablets bosentan
Slovenian: STAYVEER 125 mg filmsko obložene tablete bosentan
English: Bosentan is an inducer of the cytochrome P450 (CYP) isoenzymes CYP2C9 and CYP3A4.
Slovenian: Bosentan je induktor izoencimov CYP2C9 in CYP3A4 citokroma P450 (CYP).
English: If the aminotransferase levels return to pre-treatment values reintroducing STAYVEER according to the conditions described below should be considered.
Slovenian: je treba presoditi o ponovni uvedbi zdravljenja z zdravilom STAYVEER v skladu s spodaj opisanimi pogoji.
English: Therefore, hormonebased contraceptives alone, regardless of the route of administration (i.e., oral, injectable, transdermal or implantable forms), are not considered as reliable methods of contraception (see sections 4.4 and
Slovenian: Zato kontracepcija, ki temelji samo na hormonih, ni zanesljiv način kontracepcije, ne glede na način apliciranja (npr. peroralno, parenteralno,
English: Cartons contain 56 or 112 film coated tablets (STAYVEER 62.5 mg film-coated tablets).
Slovenian: 56 ali 112 filmsko obloženih tablet (STAYVEER 62,5 mg filmsko obložene tablete).
English: • flu-like syndrome (joint and muscle pain with fever)
Slovenian: • letargijo ali utrujenost (nenavadna utrujenost ali izčrpanost) • gripi podobni sindromi (bolečine sklepov in mišic z zvišano telesno temperaturo)
English: BREATHE-3 (AC-052-356)
Slovenian: in AC-052-356 (BREATHE-3).
English: In a randomised placebo-controlled study, conducted in PPHN patients (FUTURE-4), a total of 13 neonates were treated with the bosentan dispersible tablet formulation at a dose of 2 mg/kg twice daily (8 patients were on placebo).
Slovenian: 13 novorojenčkov zdravljenih z bosentanom v obliki disperzibilnih tablet v odmerku 2 mg/kg dvakrat dnevno (8 bolnikov je dobivalo placebo).
English: Treatment with STAYVEER should only be started and monitored by a doctor who has experience in the treatment of PAH or systemic sclerosis.
Slovenian: Zdravljenje z zdravilom STAYVEER mora uvesti in nadzirati zdravnik z izkušnjami v zdravljenju
English: > 3 and ≤ 5 × ULN The result should be confirmed by a second liver test; if confirmed, a decision should be made on an individual basis to continue STAYVEER, possibly at a reduced dose, or to stop STAYVEER administration (see section 4.2).
Slovenian: se za vsakega posameznega bolnika odločite, ali boste z zdravljenjem z zdravilom STAYVEER nadaljevali, morebiti znižali odmerek ali dajanje zdravila STAYVEER prekinili (glejte poglavje 4.2).
English: • Pregnancy (see sections 4.4 and 4.6)
Slovenian: • sočasna uporaba ciklosporina A (glejte poglavje 4.5) • nosečnost (glejte poglavji 4.4 in 4.6)
English: Jul ______
Slovenian: Jan ______ Maj ______ Sep _____ Feb ______ Jun ______ Okt _____ Mar ______ Jul ______ Nov _____ Apr ______ Avg ______ Dec _____
English: However, long-term vital status was recorded for all 235 patients who were treated with bosentan in the two pivotal placebo-controlled studies (AC-052-351 and AC-052-352) and/or their two uncontrolled, open-label extensions.
Slovenian: Vendar so v dveh ključnih s placebom nadzorovanih študijah (AC-052-351 in AC-052
English: STAYVEER 62.5 mg film-coated tablets bosentan
Slovenian: STAYVEER 62,5 mg filmsko obložene tablete bosentan
English: Treatment with bosentan was associated with a reduction in the rate of clinical worsening, defined as a composite of symptomatic progression, hospitalisation for PAH and death, compared with placebo (proportional risk reduction 77%, 95% confidence interval [CI] 20-94%, p = 0.0114).
Slovenian: Zdravljenje z bosentanom so povezali z zmanjšanjem stopnje kliničnega poslabšanja, opredeljeno kot sklop simptomatičnega napredovanja, hospitalizacije zaradi PAH in smrti v primerjavi s placebom
English: You need to use a barrier form of birth control - like a condom, diaphragm or vaginal sponge - in addition to any of these kinds of hormonal birth control.
Slovenian: Poleg katerekoli oblike hormonske kontracepcije morate uporabiti pregradno metodo, kot so kondom, diafragma ali kontracepcijska spužva.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 • Moderate to severe hepatic impairment, i.e., Child-Pugh class B or C (see section 5.2)
Slovenian: • srednje do hudo okvarjeno delovanje jeter, tj. razred B ali C po Child-Pughu (glejte poglavje
English: • facilitate patients' awareness of the need for regular blood tests for liver function.
Slovenian: Namen opozorilne kartice za bolnika, ki je sestavni del pakiranja zdravila, je: • olajšati ozaveščanje bolnika o potrebi rednih krvnih preiskav zaradi preverjanja delovanja jeter.
English: Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II (see section 5.1).
Slovenian: Določena izboljšanja so se pokazala tudi pri bolnikih s pljučno arterijsko hipertenzijo II.
English: Pregelatinised starch Sodium starch glycolate (Type A) Povidone
Slovenian: Jedro tablete: koruzni škrob predgeliran škrob natrijev karboksimetilškrob (vrsta A) povidon glicerildibehenat magnezijev stearat
English: Please see also section 3.
Slovenian: (glejte tudi poglavje 4.4).
English: For the same reason, concomitant administration of both a potent CYP3A4 inhibitor (such as ketoconazole, itraconazole or ritonavir) and a CYP2C9 inhibitor (such as voriconazole) with STAYVEER is not recommended.
Slovenian: itrakonazolom ali ritonavirjem) in tudi zaviralcem CYP2C9 (denimo, vorikonazolom).
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Izhodiščna vrednost (IV);
English: Cartons contain 56 film-coated tablets (STAYVEER 62.5 mg film-coated tablets).
Slovenian: Škatle vsebujejo 56 filmsko obloženih tablet (zdravilo STAYVEER 62,5 mg filmsko obložene tablete).
English: Patients had primary pulmonary hypertension (10 patients) or PAH related to congenital heart diseases (9 patients) and were in WHO functional class II (n = 15, 79%) or class III (n = 4, 21%) at baseline.
Slovenian: (10 bolnikov) ali PAH, povezano s prirojenimi boleznimi srca (9 bolnikov) in so bili po klasifikaciji
English: Cardiac disorders
Slovenian: Chronic Heart Failure).
English: Efficacy in adult patients with pulmonary arterial hypertension Two randomised, double-blind, multi-centre, placebo-controlled studies have been conducted in 32 (study AC-052-351) and 213 (study AC-052-352 [BREATHE-1]) adult patients with WHO functional class III-IV PAH (primary pulmonary hypertension or pulmonary hypertension secondary mainly to scleroderma).
Slovenian: 32 (študija AC-052-351) in 213 (študija AC-052-352 [BREATHE-1]) odraslih bolnikih s PAH III. do
English: Each film-coated tablet contains 62.5 mg bosentan (as monohydrate)
Slovenian: Ena filmsko obložena tableta vsebuje 62,5 mg bosentana v obliki bosentana monohidrata
English: STAYVEER has not been shown to have a beneficial effect on the healing of existing digital ulcers.
Slovenian: Ugodni učinki zdravila STAYVEER pri zdravljenju obstoječih razjed prstov niso bili ugotovljeni.
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora pogosti zamašenost nosu1
English: Each film-coated tablet contains 125 mg bosentan (as monohydrate)
Slovenian: Ena filmsko obložena tableta vsebuje 125 mg bosentana v obliki bosentana monohidrata
English: Breast-feeding is not recommended during treatment with STAYVEER.
Slovenian: V času jemanja zdravila STAYVEER se dojenje odsvetuje.
English: The benefit/risk balance of bosentan has not been established in patients with WHO class I functional status of PAH.
Slovenian: Pri bolnikih s PAH I. funkcijskega razreda po klasifikaciji Svetovne zdravstvene organizacije razmerja med koristjo in tveganjem za bosentan še niso ugotovili.
English: No specific study has been performed in patients with pulmonary hypertension and concomitant left ventricular dysfunction.
Slovenian: Bolniki s pljučno arterijsko hipertenzijo in sočasnim popuščanjem levega prekata Posebnih študij pri bolnikih s pljučno arterijsko hipertenzijo in sočasnim motenim delovanjem levega prekata niso opravili.
English: Always take this medicine exactly as your doctor has told you.
Slovenian: Pri jemanju tega zdravila vedno natančno upoštevajte navodila zdravnika ali farmacevta.
English: Package leaflet: Information for the user STAYVEER 62.5 mg film-coated tablets
Slovenian: Filmsko obložena tableta (filmsko obložene tablete): STAYVEER 62,5 mg filmsko obložene tablete
English: Abnormal liver function test (see section 4.4)
Slovenian: Zdravilo STAYVEER je kontraindicirano (glejte poglavje 4.3)
English: No formal conclusion can be drawn regarding the effects of bosentan on antiretroviral drug efficacy (see also section 4.4).
Slovenian: O učinkih bosentana na učinkovitost protiretrovirusnih zdravil ni bilo mogoče sklepati
English: A reduction in symptoms of PAH was observed with bosentan treatment.
Slovenian: Pri zdravljenju z bosentanom so poročali o manj pogostih simptomih PAH.
English: Bosentan film-coated tablets were evaluated in an open-label uncontrolled study in 19 paediatric patients with PAH aged 3 to 15 years.
Slovenian: 19 pediatričnih bolnikih s PAH, starih od 3 do 15 let.
English: Bosentan is eliminated by biliary excretion following metabolism in the liver by the cytochrome P450 isoenzymes, CYP2C9 and CYP3A4.
Slovenian: Bosentan se presnavlja v jetrih z izoencimi citokroma P450 (CYP2C9 in CYP3A4) in se nato izloči z žolčem.
English: In the post-marketing period there have been rare reports of pulmonary oedema in patients treated with STAYVEER who had a suspected diagnosis of pulmonary veno-occlusive disease.
Slovenian: pri katerih so sumili na pljučno venookluzivno bolezen, o pljučnem edemu poročali redko.
English: Hypotension1, 4
Slovenian: Žilne bolezni pogosti rdečica pogosti hipotenzija1, 4
English: Do not swallow the desiccant.
Slovenian: Ne zaužijte sušilnega sredstva.
English: • Nasal congestion
Slovenian: • zamašenost nosu
English: Liver test abnormalities
Slovenian: Nenormalne vrednosti preiskav jetrnega delovanja
English: Anaemia or haemoglobin decreases requiring red blood cell transfusion1
Slovenian: Bolezni krvi in limfatičnega sistema pogosti anemija, znižanje ravni hemoglobina (glejte poglavje neznana anemija ali znižanje ravni hemoglobina, zaradi katere je bila potrebna transfuzija eritrocitov1
English: Do not store above 30 °C
Slovenian: Ne zaužijte sušilnega sredstva
English: Do not swallow the desiccant
Slovenian: PRETISNI OMOTI IME ZDRAVILA
English: Biotransformation and elimination
Slovenian: Končni razpolovni čas izločanja
English: Oedema, fluid retention5
Slovenian: Splošne težave in spremembe na mestu aplikacije zelo pogosti edem2, zastajanje tekočine5
English: This is a summary of the European public assessment report (EPAR) for Pemetrexed Fresenius Kabi.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Pemetreksed Fresenius Kabi.
English: The medicine can only be obtained with a prescription and should only be given under the supervision of a doctor who is qualified in the use of chemotherapy.
Slovenian: Predpisovanje in izdaja zdravila je le na recept, daje pa se lahko samo pod nadzorom zdravnika, ki je usposobljen za uporabo kemoterapije.
English: The full EPAR for Pemetrexed Fresenius Kabi 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) in povzetek načrta obvladovanja tveganj za zdravilo Pemetreksed Fresenius Kabi sta na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Pemetrexed Fresenius Kabi has been shown to be comparable to Alimta.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji je zaključil, da je bilo v skladu z zahtevami EU dokazano, da je zdravilo Pemetreksed Fresenius Kabi primerljivo z zdravilom Alimta.
English: The Committee recommended that Pemetrexed Fresenius Kabi be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Pemetreksed Fresenius Kabi odobri za uporabo v EU.
English: The recommended dose is calculated using the patient's height and weight.
Slovenian: Priporočeni odmerek se izračuna na podlagi telesne višine in mase bolnika.
English: Because Pemetrexed Fresenius Kabi is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Pemetreksed Fresenius Kabi generično zdravilo, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Pemetrexed Fresenius Kabi?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Pemetreksed Fresenius Kabi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pemetrexed Fresenius Kabi have been included in the summary of product characteristics and the package leaflet.
Slovenian: Priporočila in previdnostnih ukrepov, ki jih morajo za varno in učinkovito uporabo zdravila Pemetreksed Fresenius Kabi upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo.
English: This means that Pemetrexed Fresenius Kabi is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Alimta.
English: Pemetrexed Fresenius Kabi is a cancer medicine used to treat two types of lung cancer:
Slovenian: Zdravilo Pemetreksed Fresenius Kabi je zdravilo za zdravljenje raka, ki se uporablja za zdravljenje dveh vrst pljučnega raka:
English: For more information about treatment with Pemetrexed Fresenius Kabi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Pemetreksed Fresenius Kabi preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: For practical information about using Pemetrexed Fresenius Kabi, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Pemetreksed Fresenius Kabi naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Pemetrexed Fresenius Kabi.
Slovenian: Da bi zmanjšali neželene učinke, morajo bolniki med zdravljenjem z zdravilom Pemetreksed Fresenius Kabi jemati kortikosteroid (vrsto zdravila, ki ublaži vnetje) in folno kislino (vrsto vitamina) ter prejemati injekcije vitamina B12.
English: What are the benefits and risks of Pemetrexed Fresenius Kabi?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Pemetreksed Fresenius Kabi?
English: When Pemetrexed Fresenius Kabi is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Slovenian: Kadar se zdravilo Pemetreksed Fresenius Kabi daje v kombinaciji s cisplatinom, je treba pred odmerkom cisplatina ali po njem bolniku dati tudi „antiemetično“ zdravilo (za preprečevanje bruhanja) in tekočino (za preprečevanje dehidracije).
English: Pemetrexed Fresenius Kabi is a ‘generic medicine'.
Slovenian: Zdravilo Pemetreksed Fresenius Kabi je „generično zdravilo“.
English: The active substance in Pemetrexed Fresenius Kabi, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Slovenian: Zdravilna učinkovina zdravila Pemetreksed Fresenius Kabi, pemetreksed, je citotoksik (zdravilo, ki uničuje celice, ki se delijo, kot na primer rakave celice) iz skupine „antimetabolitov“.
English: Other information about Pemetrexed Fresenius Kabi
Slovenian: Druge informacije o zdravilu Pemetreksed Fresenius Kabi
English: What is Pemetrexed Fresenius Kabi and what is it used for?
Slovenian: Kaj je zdravilo Pemetreksed Fresenius Kabi in za kaj se uporablja?
English: Pemetrexed Fresenius Kabi is available as a powder that is made up into a solution for infusion (drip) into a vein.
Slovenian: Zdravilo Pemetreksed Fresenius Kabi je na voljo v obliki praška za pripravo raztopine za infundiranje (kapalne infuzije) v veno.
English: Pemetrexed Fresenius Kabi pemetrexed
Slovenian: Pemetreksed Fresenius Kabi pemetreksed
English: Why is Pemetrexed Fresenius Kabi approved?
Slovenian: Zakaj je bilo zdravilo Pemetreksed Fresenius Kabi odobreno?
English: Pemetrexed Fresenius Kabi contains the active substance pemetrexed.
Slovenian: Zdravilo Pemetreksed Fresenius Kabi vsebuje zdravilno učinkovino pemetreksed.
English: No additional studies were needed as Pemetrexed Fresenius Kabi is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Slovenian: Ker je zdravilo Pemetreksed Fresenius Kabi generično zdravilo, ki se daje z infundiranjem in vsebuje isto zdravilno učinkovino kot referenčno zdravilo Alimta, niso bile potrebne nobene dodatne študije.
English: How does Pemetrexed Fresenius Kabi work?
Slovenian: Kako zdravilo Pemetreksed Fresenius Kabi deluje?
English: How is Pemetrexed Fresenius Kabi used?
Slovenian: Kako se zdravilo Pemetreksed Fresenius Kabi uporablja?
English: How has Pemetrexed Fresenius Kabi been studied?
Slovenian: Kako je bilo zdravilo Pemetreksed Fresenius Kabi raziskano?
English: It is not intended to provide practical advice on how to use Pemetrexed Fresenius Kabi.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o njegovi uporabi.
English: Further information on Ebilfumin can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/ebilfumin.
Slovenian: Nadaljnje informacije za zdravilo Ebilfumin so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/ebilfumin.
English: Ebilfumin is available as capsules (30 mg, 45 mg, and 75 mg).
Slovenian: Zdravilo Ebilfumin je na voljo v obliki kapsul (30 mg, 45 mg in 75 mg).
English: For adults with a weakened immune system (the body's natural defences), it is given for 10 days.
Slovenian: Odraslim osebam z oslabljenim imunskim sistemom (naravnim obrambnim mehanizmom telesa) se zdravilo daje deset dni.
English: What measures are being taken to ensure the safe and effective use of Ebilfumin?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Ebilfumin?
English: Ebilfumin received a marketing authorisation valid throughout the EU on 22 May 2014.
Slovenian: Za zdravilo Ebilfumin je bilo 22. maja 2014 izdano dovoljenje za promet, veljavno po vsej EU.
English: Ebilfumin does not replace flu vaccination, and its use should be based on official recommendations.
Slovenian: Zdravilo Ebilfumin ne more nadomestiti cepljenja proti gripi, njegova uporaba pa naj temelji na uradnih priporočilih.
English: What are the benefits and risks of Ebilfumin?
Slovenian: Kakšne so koristi in tveganja zdravila Ebilfumin?