natgillin/translations-raw huggingface dataset:
The phase II trial, study YU203, randomised 402 subjects with active rheumatoid arthritis to placebo (n = 102), leflunomide 5 mg (n = 95), 10 mg (n = 101) or 25 mg/day (n = 104).
faze, raziskave YU203, so 402 preiskovanca z aktivnim revmatoidnim artritisom randomizirano razvrstili na placebo (n = 102), leflunomid 5 mg (n = 95), 10 mg (n = 101) ali 25 mg/dan (n = 104).
• increased hair loss,
• zvečano izpadanje las,
• severe liver injury such as liver failure or necrosis which may be fatal,
• resne poškodbe jeter, kot sta odpoved jeter ali nekroza, ki sta lahko usodni,
• headache, dizziness,
• glavobol, omotica,
For other substrates of BCRP (e.g. methotrexate, topotecan, sulfasalazine, daunorubicin, doxorubicin) and the OATP family especially HMG-CoA reductase inhibitors (e.g. simvastatin, atorvastatin, pravastatin, methotrexate, nateglinide, repaglinide, rifampicin) concomitant administration should also be undertaken with caution.
Previdnost je potrebna tudi v primeru sočasne uporabe drugih substratov BCRP (npr. metotreksata, topotekana, sulfasalazina, daunorubicina, doksorubicina) in družine OATP, zlasti zaviralcev HMG-CoA-reduktaze (npr. simvastatina, atorvastatina, pravastatina, metotreksata, nateglinida, repaglinida, rifampicina).
Each film-coated tablet contains 114 mg of lactose (as monohydrate) and 0.09 mg of soya lecithin.
Ena filmsko obložena tableta vsebuje 114 mg laktoze (v obliki monohidrata) in 0,09 mg sojinega lecitina.
Leflunomide medac 10 mg film-coated tablets are white to almost white and round with a diameter of about 6 mm.
Leflunomid medac 10 mg filmsko obložene tablete so bele do skoraj bele barve in okrogle oblike s premerom približno 6 mm.
• severe increase in blood pressure,
• resno zvišanje krvnega tlaka,
White to almost white, round film-coated tablet with a diameter of about 6 mm.
Bela do skoraj bela, okrogla filmsko obložena tableta s premerom približno 6 mm.
Each film-coated tablet contains 76 mg of lactose (as monohydrate) and 0.06 mg of soya lecithin.
Ena filmsko obložena tableta vsebuje 76 mg laktoze (v obliki monohidrata) in 0,06 mg sojinega lecitina.
INFORMATION IN BRAILLE Leflunomide medac 10 mg
PODATKI V BRAILLOVI PISAVI Leflunomid medac 10 mg
Leflunomide medac contains lactose.
Zdravilo Leflunomid medac vsebuje laktozo.
pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes < 2 G/l), eosinophilia
pancitopenija (verjetno zaradi antiproliferacijskega mehanizma), levkopenija
interstitial lung disease (including interstitial pneumonitis), which may be fatal Not known: pulmonary hypertension
intersticijska bolezen pljuč (vključno z intersticijsko pljučnico), ki je lahko usodna.
• abnormal skin sensations like tingling (paraesthesia),
• nenormalne kožne zaznave, npr. mravljinčenje (parestezije),
with continuation of both drugs and 3 after discontinuation of leflunomide.
Tudi pri teh je izginilo, pri 2 ob nadaljevanju uporabe obeh zdravil in pri 3 po opustitvi leflunomida.
• For psoriatic arthritis: 20 mg Leflunomide medac once daily.
• za zdravljenje aktivnega psoriatičnega artritisa: 20 mg zdravila Leflunomide medac enkrat na dan.
Do not take Leflunomide medac
Ne jemljite zdravila Leflunomid medac
Study MN302 randomised 999 subjects with active rheumatoid arthritis to leflunomide 20 mg/day (n = 501) or methotrexate at 7.5 mg/week increasing to 15 mg/week (n = 498).
V študiji MN302 so 999 preiskovancev z aktivnim revmatoidnim artritisom randomizirano razvrstili na leflunomid 20 mg/dan (n = 501) ali metotreksat 7,5 mg/teden z zvečanjem na 15 mg/teden (n = 498).
• inflammation of the pancreas (pancreatitis),
• vnetje trebušne slinavke (pankreatitis),
• The active substance is leflunomide.
• Zdravilna učinkovina je leflunomid.
diarrhoea, nausea, vomiting, oral mucosal disorders (e.g. aphthous stomatitis, mouth ulceration), abdominal pain, colitis including microscopic colitis such as lymphocytic colitis, collagenous colitis
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
Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin.
Ena filmsko obložena tableta vsebuje 152 mg laktoze (v obliki monohidrata) in 0,12 mg sojinega lecitina.
What Leflunomide medac looks like and contents of the pack
Izgled zdravila Leflunomid medac in vsebina pakiranja
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).
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).
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).
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).
• anxiety,
• tesnobnost,
• colitis,
• kolitis,
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”.
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".
<Leflunomide medac 10 mg:> 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
<Leflunomid medac 10 mg:> 30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
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),
kot je Stevens-Johnsonov sindrom), zemeljske oreščke ali sojo ali katerokoli sestavino tega zdravila (navedeno v poglavju 6),
It is not recommended to drink alcohol during treatment with Leflunomide medac.
Med zdravljenjem z zdravilom Leflunomid medac ni priporočljivo pitje alkohola.
• if you have ever had an allergic reaction to leflunomide (especially a serious skin reaction,
• 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,
White to almost white, round film-coated tablet with a diameter of 8 mm and a break-mark on one side of the tablet.
Bela do skoraj bela, okrogla filmsko obložena tableta s premerom 8 mm in zarezo za prelom na eni strani tablete.
Ireland medac GmbH Tel: +49 4103 8006-0
Slovenija medac GmbH Tel: +49 4103 8006-0
severe increase in blood pressure
izrazito zvišanje krvnega tlaka
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.
V raziskovani populaciji z uporabo sheme z začetnim odmerkom v celoti niso ugotovili dodatne koristi.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING/BOTTLE PACK
PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA /PLASTENKA
• tiredness (asthenia),
• utrujenost (astenija),
severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal
huda okvara jeter, npr. odpoved jeter in akutna jetrna nekroza, ki sta lahko usodni Bolezni kože in podkožja
Cases of peripheral neuropathy have been reported in patients receiving Leflunomide medac.
Pri bolnikih, ki so jemali zdravilo Leflunomid medac, so poročali o primerih periferne nevropatije.
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.
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.
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide medac.
Pri odločanju za uporabo živega oslabljenega cepiva po koncu zdravljenja z zdravilom Leflunomid medac je treba upoštevati dolg razpolovni čas leflunomida.
• a decrease in the levels of potassium in the blood,
• zmanjšanje koncentracije kalija v krvi,
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
• Pri psoriatičnem artritisu: zdravljenje z leflunomidom se začne z začetnim odmerkom 100 mg enkrat na dan 3 dni.
Leflunomide medac 10 mg film-coated tablets Leflunomide medac 15 mg film-coated tablets Leflunomide medac 20 mg film-coated tablets leflunomide
Leflunomid medac 10 mg filmsko obložene tablete Leflunomid medac 15 mg filmsko obložene tablete Leflunomid medac 20 mg filmsko obložene tablete leflunomid
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).
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).
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.
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).
However, a 25 % decrease in peak international normalised ratio (INR) was observed when A771726 was co-administered with warfarin as compared with warfarin alone.
Toda med sočasno uporabo A771726 in varfarina se je največja vrednost internacionalnega normaliziranega razmerja (INR) v primerjavi z uporabo samega varfarina zmanjšala za 25 %.
Leflunomide medac contains soya lecithin.
Zdravilo Leflunomid medac vsebuje sojin lecitin.
One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 mg of leflunomide.
Ena filmsko obložena tableta zdravila Leflunomid medac 20 mg filmsko obložene tablete vsebuje 20 mg leflunomida.
How to take Leflunomide medac
Kako jemati zdravilo Leflunomid medac
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)
kožni eritematozni lupus, postulozna psoriaza ali njeno poslabšanje, neželena reakcija z eozinofilijo in sistemskimi simptomi (sindrom DRESS)
If you get any side effects talk to your doctor, pharmacist or nurse.
Če opazite kateri koli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
White to almost white, round film-coated tablet, debossed with “15” on one side with a diameter of about 7 mm.
Bela do skoraj bela, okrogla filmsko obložena tableta s premerom približno 7 mm, na eni strani tablete je odtisnjena številka "15".
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)
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)
• For rheumatoid arthritis: 10 to 20 mg Leflunomide medac once daily, depending on the severity of the disease.
• za zdravljenje revmatoidnega artritisa: 10 do 20 mg zdravila Leflunomid medac enkrat na dan,
Do not take Leflunomide medac if you are, or think you may be pregnant.
Ne jemljite zdravila Leflunomid medac, če ste ali mislite, da ste noseči.
Leflunomide medac 20 mg film-coated tablets: Pack sizes of 15, 30, 60 or 100 film-coated tablets per bottle are available.
Zdravilo Leflunomid medac 20 mg filmsko obložene tablete: na voljo so pakiranja s 15, 30, 60 ali 100 filmsko obloženimi tabletami na plastenko.
• mild increase in blood pressure,
• blago zvišanje krvnega tlaka,
One tablet of Leflunomide medac 15 mg film-coated tablets contains 15 mg of leflunomide.
Ena filmsko obložena tableta zdravila Leflunomid medac 15 mg filmsko obložene tablete vsebuje 15 mg leflunomida.
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.
Terapevtski učinek se ponavadi pojavi po 4 do 6 tednih in se lahko dodatno povečuje še do 4 do 6 mesecev.
If you are allergic to peanut or soya, do not use this medicine.
Ne uporabljajte tega zdravila, če ste alergijčni na zemeljske oreščke ali sojo.
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)
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)
One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg of leflunomide.
Ena filmsko obložena tableta zdravila Leflunomid medac 10 mg filmsko obložene tablete vsebuje 10 mg leflunomida.
Leflunomide medac 10 mg film-coated tablets: Pack sizes of 30, 60 or 100 film-coated tablets per bottle are available.
Zdravilo Leflunomid medac 10 mg filmsko obložene tablete: na voljo so pakiranja s 30, 60 ali 100 filmsko obloženimi tabletami na plastenko.
• If you get any side effects talk to your doctor, pharmacist or nurse.
• Če opazite katerikoli neželeni učinek, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
Leflunomide medac 15 mg film-coated tablets: Pack sizes of 30, 60, 90 or 100 film-coated tablets per bottle are available.
Zdravilo Leflunomid medac 15 mg filmsko obložene tablete: na voljo so pakiranja s 30, 60, 90 ali 100 filmsko obloženimi tabletami na plastenko,
Respiratory, thoracic and mediastinal disorders
Bolezni dihal, prsnega koša in mediastinalnega prostora Redki:
Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare:
9/l) anemija, blaga trombocitopenija (trombociti < 100 x 10
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.
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.
Each film-coated tablet contains 15 mg of leflunomide.
Ena filmsko obložena tableta vsebuje 15 mg leflunomida.
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:
Imetnik dovoljenja za promet bo poskrbel, da bodo vsi zdravniki, ki nameravajo predpisovati zdravilo
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)
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)
• 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.
Obstaja možnost, da se zdravilo Leflunomid medac izloča v semensko tekočino, zato mora bolnik med zdravljenjem z zdravilom Leflunomid medac uporabljati zanesljivo kontracepcijo.
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.
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.
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.
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.
Leflunomide medac 20 mg film-coated tablets leflunomide
Leflunomid medac 20 mg filmsko obložene tablete leflunomid
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.
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.
• nausea, vomiting,
• slabost s siljenjem na bruhanje, bruhanje,
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 20 mg film-coated tablets
IME ZDRAVILA Leflunomid medac 20 mg filmsko obložene tablete
Leflunomide medac 15 mg film-coated tablets leflunomide
Leflunomid medac 15 mg filmsko obložene tablete leflunomid
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 10 mg film-coated tablets
IME ZDRAVILA Leflunomid medac 10 mg filmsko obložene tablete
Leflunomide medac 10 mg film-coated tablets leflunomide
Leflunomid medac 10 mg filmsko obložene tablete leflunomid
Effect on BCRP (Breast Cancer Resistance Protein) and /or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3) substrates
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.
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)
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)
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 15 mg film-coated tablets
IME ZDRAVILA Leflunomid medac 15 mg filmsko obložene tablete
What Leflunomide medac contains
Kaj vsebuje zdravilo Leflunomid medac
How to store Leflunomide medac
Shranjevanje zdravila Leflunomid medac
The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) Uporaba nekaterih imunosupresivnih zdravil poveča nevarnost malignomov, zlasti limfoproliferativnih bolezni.
Immune system disorders
Bolezni imunskega sistema Pogosti:
• unusual tingling, weakness or pain in your hands or feet as these may indicate problems with your nerves (peripheral neuropathy).
• nenavadno mravljinčenje, slabost ali bolečina v rokah in nogah.
• tendon rupture,
• pretrganje tetive,
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of leflunomide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena filmsko obložena tableta vsebuje 10 mg leflunomida.
<Leflunomide medac 20 mg:> 15 film-coated tablets
<Leflunomid medac 20 mg:> 15 filmsko obloženih tablet 30 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
Do not take Vivanza more than once a day.
Ne vzemite zdravila Vivanza več kot enkrat na dan.
Date of first authorisation: 4 March 2003 Date of latest renewal: 4 March 2008
Datum prve odobritve: 04.03.2003 Datum zadnjega podaljšanja: 04.03.2008
What Vivanza is and what it is used for
Kaj je zdravilo Vivanza in za kaj ga uporabljamo
Other medicines and Vivanza
Druga zdravila in zdravilo Vivanza
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.
Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
If you feel dizzy, or if your vision is affected after taking Vivanza don't drive or operate any tools or machines.
Če imate po zaužitju zdravila Vivanza vrtoglavico ali se vam je vid poslabšal, ne vozite avtomobila in ne upravljajte z orodji ali stroji.
See section 2 “Vivanza 10 mg orodispersible tablets contain Aspartame and Sorbitol”.
Glejte poglavje 2 »Zdravilo Vivanza 10 mg orodisperzibilne tablete vsebuje aspartam in sorbitol.«
There is no relevant indication for use of Vivanza orodispersible tablets in children and adolescents.
Ustreznih indikacij za uporabo zdravila Vivanza orodisperzibilne tablete pri otrocih in mladostnikih ni.
Due to the nitrate component, it has the potential to have serious interaction with vardenafil.
Zaradi vsebnosti nitrata je možno resno medsebojno učinkovanje z vardenafilom.
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).
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).
What you need to know before you take Vivanza Do not take Vivanza
Kaj morate vedeti, preden boste vzeli zdravilo Vivanza
Vardenafil causes mild and transient decreases in blood pressure, which in the majority of the cases, do not translate into clinical effects.
Vardenafil povzroči blago in prehodno znižanje krvnega tlaka, ki v večini primerov nima kliničnih učinkov.
Vardenafil is rapidly absorbed after administration of Vivanza 10 mg orodispersible tablets without water.
Vardenafil se hitro absorbira po zaužitju zdravila Vivanza 10 mg orodisperzibilne tablete brez vode.
Vivanza orodispersible tablets are not indicated for individuals below 18 years of age.
Uporaba zdravila Vivanza orodisperzibilne tablete ni indicirana pri osebah, mlajših od 18 let.
What Vivanza is and what it is used for What you need to know before you take Vivanza How to take Vivanza
Kaj je zdravilo Vivanza in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Vivanza Kako jemati zdravilo Vivanza Možni neželeni učinki
Vivanza might make some people feel dizzy or affect their vision.
Pri nekaterih ljudeh lahko zdravilo Vivanza povzroči vrtoglavico ali motnje vida.
Stop taking Vivanza and contact your doctor immediately.
Takoj prenehajte jemati zdravilo Vivanza in se posvetujte z zdravnikom.
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.
Lahko vam škoduje , če imate fenilketonurijo, redko genetsko bolezen pri kateri pride do kopičenja fenilalanina, ker se ne more ustrezno odstranjevati iz telesa.
Vivanza is not indicated for use by women.
Uporaba zdravila Vivanza ni indicirana pri ženskah.
The safety and efficacy of vardenafil was maintained in long term studies.
V dolgoročnih študijah sta varnost in učinkovitost vardenafila ostali nespremenjeni.
If you are allergic to vardenafil or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Vivanza - če ste alergični na vardenafil ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Vivanza orodispersible tablets can be taken with or without food.
Zdravilo Vivanza orodisperzibilne tablete se lahko vzame z ali brez hrane.
What Vivanza looks like and contents of the pack
Izgled zdravila Vivanza in vsebina pakiranja