FrancophonIA/ELRC3.0 huggingface dataset:
English: diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
Slovenian: driska, navzea, bruhanje, bolezni ustne sluznice (npr. aftozni stomatitis, razjede v ustih), bolečine v trebuhu, kolitis, vključno z mikroskopskim kolitisom, kot je na primer limfocitni kolitis ali kolagenski kolitis
English: Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin.
Slovenian: Ena filmsko obložena tableta vsebuje 152 mg laktoze (v obliki monohidrata) in 0,12 mg sojinega lecitina.
English: What Leflunomide medac looks like and contents of the pack
Slovenian: Izgled zdravila Leflunomid medac in vsebina pakiranja
English: Study US301 randomised 482 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 182), methotrexate 7.5 mg/week increasing to 15 mg/week (n = 182), or placebo (n = 118).
Slovenian: V študiji US301 so 482 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 182), metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 182) ali placebo (n = 118).
English: Study MN301 randomised 358 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 133), sulphasalazine 2 g/day (n = 133), or placebo (n = 92).
Slovenian: V študiji MN301 so 358 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 133), sulfasalazin 2 g/dan (n = 133) ali placebo (n = 92).
English: • anxiety,
Slovenian: • tesnobnost,
English: • colitis,
Slovenian: • kolitis,
English: Leflunomide medac 15 mg film-coated tablets are white to almost white and round with a diameter of about 7 mm. One side of the tablet is debossed with “15”.
Slovenian: Leflunomid medac 15 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 7 mm. Na eni strani tablete je odtisnjena številka "15".
English: <Leflunomide medac 10 mg:> 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Slovenian: <Leflunomid medac 10 mg:> 30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson syndrome), peanut or soya or to any of the other ingredients of this medicine (listed in section 6),
Slovenian: kot je Stevens-Johnsonov sindrom), zemeljske oreščke ali sojo ali katerokoli sestavino tega zdravila (navedeno v poglavju 6),
English: It is not recommended to drink alcohol during treatment with Leflunomide medac.
Slovenian: Med zdravljenjem z zdravilom Leflunomid medac ni priporočljivo pitje alkohola.
English: • if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
Slovenian: • če ste kdaj doživeli alergijsko reakcijo na leflunomid (zlasti resno kožno reakcijo, ki jo pogosto spremljajo povišana telesna temperatura, bolečine v sklepih, rdeči madeži na koži ali mehurji,
English: White to almost white, round film-coated tablet with a diameter of 8 mm and a break-mark on one side of the tablet.
Slovenian: Bela do skoraj bela, okrogla filmsko obložena tableta s premerom 8 mm in zarezo za prelom na eni strani tablete.
English: Ireland medac GmbH Tel: +49 4103 8006-0
Slovenian: Slovenija medac GmbH Tel: +49 4103 8006-0
English: severe increase in blood pressure
Slovenian: izrazito zvišanje krvnega tlaka
English: The efficacy of leflunomide was confirmed in this study, but no incremental overall benefit was observed in the studied population with the use of a loading dose regimen.
Slovenian: V raziskovani populaciji z uporabo sheme z začetnim odmerkom v celoti niso ugotovili dodatne koristi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BOTTLE PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PLASTENKA
English: • tiredness (asthenia),
Slovenian: • utrujenost (astenija),
English: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
Slovenian: huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni Bolezni kože in podkožja
English: Cases of peripheral neuropathy have been reported in patients receiving Leflunomide medac.
Slovenian: Pri bolnikih, ki so jemali zdravilo Leflunomid medac, so poročali o primerih periferne nevropatije.
English: Leflunomide medac 20 mg film-coated tablets are white to almost white and round with a diameter of about 8 mm and a break-mark on one side of the tablet.
Slovenian: Leflunomid medac 20 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 8 mm ter zarezo za prelom na eni strani.
English: The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide medac.
Slovenian: Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid medac je treba upoštevati dolg razpolovni čas leflunomida.
English: • a decrease in the levels of potassium in the blood,
Slovenian: • zmanjšanje koncentracije kalija v krvi,
English: • In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
Slovenian: • Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
English: Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets leflunomide
Slovenian: Leflunomid medac 10 mg filmsko obložene tablete Leflunomid medac 15 mg filmsko obložene tablete Leflunomid medac 20 mg filmsko obložene tablete leflunomid
English: In this trial, the loading dose and maintenance dose of leflunomide was based on three weight categories: < 20 kg, 20 - 40 kg, and > 40 kg. After 16 weeks treatment, the difference in response rates was statistically significant in favour of methotrexate for the JRA Definition of Improvement (DOI) ≥ 30 % (p = 0.02).
Slovenian: Po 16 tednih zdravljenja je bila razlika v deležu odziva statistično značilna v prid metotreksata po opredelitvi izboljšanja (DOI - Definition of Improvement) za JRA ≥ 30 % (p = 0,02).
English: Suomi/Finland medac GmbH sivuliike suomessa Puh/Tel: +358 10 420 4000
Slovenian: Suomi/Finland medac GmbH sivuliike suomessa Puh/Tel: +358 10 420 4000 Leflunomide@medac.eu
English: There was an increase in mean ethinylestradiol Cmax and AUC0-24 (1.58- and 1.54-fold, respectively) and levonorgestrel Cmax and AUC0-24 (1.33- and 1.41-fold, respectively) following repeated doses of A771726.
Slovenian: Vpliv na peroralne kontraceptive (0,03 mg etinilestradiola in 0,15 mg levonorgestrela) Po ponavljajočih se odmerkih A771726 se je povprečna Cmax etinilestradiola povečala za 1,58-krat in njegova povprečna AUC0-24 za 1,54-krat); povprečna Cmax levonorgestrela se je povečala za 1,33-krat in povprečna AUC0-24 za 1,41-krat).
English: However, a 25 % decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Slovenian: Toda med sočasno uporabo A771726 in varfarina se je največja vrednost internacionalnega normaliziranega razmerja (INR) v primerjavi z uporabo samega varfarina zmanjšala za 25 %.
English: Leflunomide medac contains soya lecithin.
Slovenian: Zdravilo Leflunomid medac vsebuje sojin lecitin.
English: One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta zdravila Leflunomid medac 20 mg filmsko obložene tablete vsebuje 20 mg leflunomida.
English: How to take Leflunomide medac
Slovenian: Kako jemati zdravilo Leflunomid medac
English: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme Not known: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
Slovenian: kožni eritematozni lupus, postulozna psoriaza ali njeno poslabšanje, neželena reakcija z eozinofilijo in sistemskimi simptomi (sindrom DRESS)
English: If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: White to almost white, round film-coated tablet, debossed with “15” on one side with a diameter of about 7 mm.
Slovenian: Bela do skoraj bela, okrogla filmsko obložena tableta s premerom približno 7 mm, na eni strani tablete je odtisnjena številka "15".
English: EU/1/10/637/005 (20 mg, 15 tablets) EU/1/10/637/006 (20 mg, 30 tablets) EU/1/10/637/007 (20 mg, 60 tablets) EU/1/10/637/009 (20 mg, 100 tablets)
Slovenian: EU/1/10/637/005 (20 mg, 15 filmsko obloženih tablet) EU/1/10/637/006 (20 mg, 30 filmsko obloženih tablet) EU/1/10/637/007 (20 mg, 60 filmsko obloženih tablet) EU/1/10/637/009 (20 mg, 100 filmsko obloženih tablet)
English: • For rheumatoid arthritis: 10 to 20 mg Leflunomide medac once daily, depending on the severity of the disease.
Slovenian: • za zdravljenje revmatoidnega artritisa: 10 do 20 mg zdravila Leflunomid medac enkrat na dan,
English: Do not take Leflunomide medac if you are, or think you may be pregnant.
Slovenian: Ne jemljite zdravila Leflunomid medac, če ste ali mislite, da ste noseči.
English: Leflunomide medac 20 mg film-coated tablets: Pack sizes of 15, 30, 60 or 100 film-coated tablets per bottle are available.
Slovenian: Zdravilo Leflunomid medac 20 mg filmsko obložene tablete: na voljo so pakiranja s 15, 30, 60 ali 100 filmsko obloženimi tabletami na plastenko.
English: • mild increase in blood pressure,
Slovenian: • blago zvišanje krvnega tlaka,
English: One tablet of Leflunomide medac 15 mg film-coated tablets contains 15 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta zdravila Leflunomid medac 15 mg filmsko obložene tablete vsebuje 15 mg leflunomida.
English: The recommended maintenance dose is leflunomide 20 mg once daily (see section 5.1) The therapeutic effect usually starts after 4 to 6 weeks and may further improve up to 4 to 6 months.
Slovenian: Terapevtski učinek se ponavadi pojavi po 4 do 6 tednih in se lahko dodatno povečuje še do 4 do 6 mesecev.
English: If you are allergic to peanut or soya, do not use this medicine.
Slovenian: Ne uporabljajte tega zdravila, če ste alergijčni na zemeljske oreščke ali sojo.
English: EU/1/10/637/010 (15 mg, 30 tablets) EU/1/10/637/011 (15 mg, 60 tablets) EU/1/10/637/012 (15 mg, 90 tablets) EU/1/10/637/013 (15 mg, 100 tablets)
Slovenian: EU/1/10/637/010 (15 mg, 30 filmsko obloženih tablet) EU/1/10/637/011 (15 mg, 60 filmsko obloženih tablet) EU/1/10/637/012 (15 mg, 90 filmsko obloženih tablet) EU/1/10/637/013 (15 mg, 100 filmsko obloženih tablet)
English: One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta zdravila Leflunomid medac 10 mg filmsko obložene tablete vsebuje 10 mg leflunomida.
English: Leflunomide medac 10 mg film-coated tablets: Pack sizes of 30, 60 or 100 film-coated tablets per bottle are available.
Slovenian: Zdravilo Leflunomid medac 10 mg filmsko obložene tablete: na voljo so pakiranja s 30, 60 ali 100 filmsko obloženimi tabletami na plastenko.
English: • If you get any side effects talk to your doctor, pharmacist or nurse.
Slovenian: • Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Leflunomide medac 15 mg film-coated tablets: Pack sizes of 30, 60, 90 or 100 film-coated tablets per bottle are available.
Slovenian: Zdravilo Leflunomid medac 15 mg filmsko obložene tablete: na voljo so pakiranja s 30, 60, 90 ali 100 filmsko obloženimi tabletami na plastenko,
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
English: Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare:
Slovenian: 9/l) anemija, blaga trombocitopenija (trombociti < 100 x 10
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 30, 60, 90 or 100 film-coated tablets per container.
Slovenian: 40-ml plastenka s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo (beli silikagel), ki vsebuje bodisi 30, 60, 90 ali 100 filmsko obloženih tablet na vsebnik.
English: Each film-coated tablet contains 15 mg of leflunomide.
Slovenian: Ena filmsko obložena tableta vsebuje 15 mg leflunomida.
English: The Marketing Authorisation Holder (MAH) shall ensure that all physicians who are expected to prescribe/use Leflunomide medac are provided with a physician educational pack containing the following:
Slovenian: Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo
English: MARKETING AUTHORISATION NUMBER(S) EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/10/637/001 (10 mg, 30 filmsko obloženih tablet) EU/1/10/637/002 (10 mg, 60 filmsko obloženih tablet) EU/1/10/637/004 (10 mg, 100 filmsko obloženih tablet)
English: • if you are male and wish to father a child. As it cannot be excluded that Leflunomide medac passes into semen, reliable contraception should be used during treatment with Leflunomide medac.
Slovenian: Obstaja možnost, da se zdravilo Leflunomid medac izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid medac uporabljati zanesljivo kontracepcijo.
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 15, 30, 60 or 100 film-coated tablets per container.
Slovenian: 40-ml plastenka s širokim vratom in navojno zaporko za integriranim vsebnikom za sušilno sredstvo (beli silikagel), ki vsebuje bodisi 15, 30, 60 ali 100 filmsko obloženih tablet na vsebnik.
English: 40 ml HDPE-wide-necked bottle, with screw cap with integrated desiccant container (white silica gel), containing either 30, 60 or 100 film-coated tablets per container.
Slovenian: 40-ml plastenka s širokim vratom in navojno zaporko z integriranim vsebnikom za sušilno sredstvo (beli silikagel), ki vsebuje bodisi 30, 60 ali 100 filmsko obloženih tablet na vsebnik.
English: Leflunomide medac 20 mg film-coated tablets leflunomide
Slovenian: Leflunomid medac 20 mg filmsko obložene tablete leflunomid
English: There was an increase in mean cefaclor Cmax and AUC (1.43- and 1.54-fold, respectively), following repeated doses of A771726, suggesting that A771726 is an inhibitor of OAT3 in vivo.
Slovenian: Vpliv na substrate prenašalca organskih anionov 3 (OAT3) Po večkratnih odmerkih A771726 so ugotovili povečanje povprečne Cmax cefaklorja za 1,43-krat in njegove povprečne AUC za 1,54-krat; to kaže, da A771726 in vivo zavira OAT3.
English: • nausea, vomiting,
Slovenian: • slabost s siljenjem na bruhanje, bruhanje,
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 20 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid medac 20 mg filmsko obložene tablete
English: Leflunomide medac 15 mg film-coated tablets leflunomide
Slovenian: Leflunomid medac 15 mg filmsko obložene tablete leflunomid
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 10 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid medac 10 mg filmsko obložene tablete
English: Leflunomide medac 10 mg film-coated tablets leflunomide
Slovenian: Leflunomid medac 10 mg filmsko obložene tablete leflunomid
English: Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
Slovenian: Vpliv na substrate proteina odpornosti pri raku dojk (BCRP- Breast Cancer Resistance Protein) in/ali transportne polipeptide organskih anionov B1 in B3 (OATP1B1/B3) Po večkratnih odmerkih A771726 se je povprečna Cmax rosuvastatina povečala za 2,65-krat in njegova povprečna AUC za 2,51-krat.
English: EU/1/10/637/001 (10 mg, 30 tablets) EU/1/10/637/002 (10 mg, 60 tablets) EU/1/10/637/004 (10 mg, 100 tablets)
Slovenian: EU/1/10/637/001 (10 mg, 30 filmsko obloženih tablet) EU/1/10/637/002 (10 mg, 60 filmsko obloženih tablet) EU/1/10/637/004 (10 mg, 100 filmsko obloženih tablet)
English: NAME OF THE MEDICINAL PRODUCT Leflunomide medac 15 mg film-coated tablets
Slovenian: IME ZDRAVILA Leflunomid medac 15 mg filmsko obložene tablete
English: What Leflunomide medac contains
Slovenian: Kaj vsebuje zdravilo Leflunomid medac
English: How to store Leflunomide medac
Slovenian: Shranjevanje zdravila Leflunomid medac
English: The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Slovenian: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Uporaba nekaterih imunosupresivnih zdravil poveča nevarnost malignomov, zlasti limfoproliferativnih bolezni.
English: Immune system disorders
Slovenian: Bolezni imunskega sistema Pogosti:
English: • unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
Slovenian: • nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
English: • tendon rupture,
Slovenian: • pretrganje tetive,
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of leflunomide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
English: <Leflunomide medac 20 mg:> 15 film-coated tablets
Slovenian: <Leflunomid medac 20 mg:> 15 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Do not take Vivanza more than once a day.
Slovenian: Ne vzemite zdravila Vivanza več kot enkrat na dan.
English: Date of first authorisation: 4 March 2003 Date of latest renewal: 4 March 2008
Slovenian: Datum prve odobritve: 04.03.2003 Datum zadnjega podaljšanja: 04.03.2008
English: What Vivanza is and what it is used for
Slovenian: Kaj je zdravilo Vivanza in za kaj ga uporabljamo
English: Other medicines and Vivanza
Slovenian: Druga zdravila in zdravilo Vivanza
English: Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription.
Slovenian: Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: Bayer A/S Tlf: +45 45 23 50 00
Slovenian: Danmark Bayer A/S Tlf: +45 45 23 50 00
English: If you feel dizzy, or if your vision is affected after taking Vivanza don't drive or operate any tools or machines.
Slovenian: Če imate po zaužitju zdravila Vivanza vrtoglavico ali se vam je vid poslabšal, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
English: See section 2 “Vivanza 10 mg orodispersible tablets contain Aspartame and Sorbitol”.
Slovenian: Glejte poglavje 2 »Zdravilo Vivanza 10 mg orodisperzibilne tablete vsebuje aspartam in sorbitol.«
English: There is no relevant indication for use of Vivanza orodispersible tablets in children and adolescents.
Slovenian: Ustreznih indikacij za uporabo zdravila Vivanza orodisperzibilne tablete pri otrocih in mladostnikih ni.
English: Due to the nitrate component, it has the potential to have serious interaction with vardenafil.
Slovenian: Zaradi vsebnosti nitrata je možno resno medsebojno učinkovanje z vardenafilom.
English: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and not known (can not be estimated from available data).
Slovenian: Neželeni učinki so razvrščeni po pogostnosti glede na klasifikacijo MedDRA: 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) in neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: What you need to know before you take Vivanza Do not take Vivanza
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Vivanza
English: Vardenafil causes mild and transient decreases in blood pressure, which in the majority of the cases, do not translate into clinical effects.
Slovenian: Vardenafil povzroči blago in prehodno znižanje krvnega tlaka, ki v večini primerov nima kliničnih učinkov.
English: Vardenafil is rapidly absorbed after administration of Vivanza 10 mg orodispersible tablets without water.
Slovenian: Vardenafil se hitro absorbira po zaužitju zdravila Vivanza 10 mg orodisperzibilne tablete brez vode.
English: Vivanza orodispersible tablets are not indicated for individuals below 18 years of age.
Slovenian: Uporaba zdravila Vivanza orodisperzibilne tablete ni indicirana pri osebah, mlajših od 18 let.
English: What Vivanza is and what it is used for What you need to know before you take Vivanza How to take Vivanza
Slovenian: Kaj je zdravilo Vivanza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Vivanza Kako jemati zdravilo Vivanza Možni neželeni učinki
English: Vivanza might make some people feel dizzy or affect their vision.
Slovenian: Pri nekaterih ljudeh lahko zdravilo Vivanza povzroči vrtoglavico ali motnje vida.
English: Stop taking Vivanza and contact your doctor immediately.
Slovenian: Takoj prenehajte jemati zdravilo Vivanza in se posvetujte z zdravnikom.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Slovenian: Lahko vam škoduje , če imate fenilketonurijo, redko genetsko bolezen pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
English: Vivanza is not indicated for use by women.
Slovenian: Uporaba zdravila Vivanza ni indicirana pri ženskah.
English: The safety and efficacy of vardenafil was maintained in long term studies.
Slovenian: V dolgoročnih študijah sta varnost in učinkovitost vardenafila ostali nespremenjeni.
English: If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Vivanza - če ste alergični na vardenafil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Vivanza orodispersible tablets can be taken with or without food.
Slovenian: Zdravilo Vivanza orodisperzibilne tablete se lahko vzame z ali brez hrane.
English: What Vivanza looks like and contents of the pack
Slovenian: Izgled zdravila Vivanza in vsebina pakiranja
English: Vardenafil AUC and Cmax in elderly patients (65 years or over) taking vardenafil orodispersible tablets were increased by 31 to 39% and 16 to 21%, respectively, in comparison to patients aged 45 years and below.
Slovenian: Pri starejših bolnikih (65 let in več), ki so jemali orodisperzibilne tablete, ki so vsebovale vardenafil, sta se AUC in Cmax vardenafila povečala od 31 do 39 % oziroma 16 do 21 %, v primerjavi z bolniki starimi 45 let in manj.
English: He or she may suggest a switch to an alternative vardenafil formulation with a different dose, depending on how well it works for you.
Slovenian: Lahko vam bo predlagal zamenjavo z drugo obliko ali jakostjo zdravila, ki vsebuje vardenafil, odvisno od tega kako zdravilo Vivanza učinkuje pri vas.
English: Vivanza is not intended for use by children or adolescents under 18.
Slovenian: Otroci in mladostniki Zdravilo Vivanza ni namenjeno otrokom ali mladostnikom, mlajšim od 18 let.
English: Bayer (logo)
Slovenian: Bayer [znak]
English: Vivanza 10 mg orodispersible tablets are taken as needed approximately 25 to 60 minutes before sexual activity.
Slovenian: Zdravilo Vivanza 10 mg orodisperzibilne tablete se vzame po potrebi približno 25 do 60 minut pred spolnim odnosom.
English: PDE5 inhibitors, such as Vivanza have been shown to increase the hypotensive effects of this medicine.
Slovenian: Zaviralci PDE5, kot je zdravilo Vivanza, dokazano povečujejo hipotenzivne učinke tega zdravila.
English: Elderly (≥65 years old)
Slovenian: Posebne skupine bolnikov Starostniki (≥ 65 let)
English: Sorbitol This medicine contains 7.96 mg sorbitol in each 10 mg orodispersible tablet.
Slovenian: Sorbitol To zdravilo vsebuje 7,96 mg sorbitola v vsaki 10-mg orodisperzibilni tableti.