natgillin/translations-raw huggingface dataset:
White to almost white, round film-coated tablet, debossed with “15” on one side with a diameter of about 7 mm.
Bijela do gotovo bijela, okrugla, filmom obložena tableta, s urezanom oznakom "15" na jednoj strani, promjera oko 7 mm.
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).
U studiji MN302 bilo je 999 randomiziranih bolesnika s aktivnim reumatoidnim artritisom koji su primali leflunomid 20 mg/dan (n = 501) ili metotreksat 7,5 mg/tjedan, s povećanjem doze na 15 mg/tjedan (n = 498).
Leflunomide 20 mg/day was significantly superior to placebo in reducing the symptoms of arthritis in patients with psoriatic arthritis: the PsARC (Psoriatic Arthritis treatment Response Criteria) responders were 59 % in the leflunomide group and 29.7 % in the placebo group by 6 months (p< 0.0001).
Psoriatic Arthritis treatment Response Criteria, PsARC) na liječenje odgovorilo 59 % bolesnika u skupini liječenoj flunomidom i 29,7 % bolesnika u skupini koja je primala placebo (p < 0,0001).
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.
Učinak na oralne kontraceptive (0,03 mg etinilestradiol i 0,15 mg levonorgestrel) Zabilježeno je povećanje prosječne Cmax i AUC0-24 (1,58 odnosno 1,54 puta) za etinilestradiol i povećanje prosječne Cmax i AUC0-24 (1,33 odnosno 1,41 puta) za levonorgestrel, nakon ponovljenih doza A771726.
increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin Uncommon: urticaria
pojačani gubitak kose, ekcem, osip (uključujući makulopapulozni osip), svrbež, suha koža
White to almost white, round film-coated tablet with a diameter of about 6 mm.
Bijela do gotovo bijela, okrugla, filmom obložena tableta, promjera otprilike 6 mm.
In the phase III trials, the ACR response rates for leflunomide 20 mg/day vs. placebo were 54.6 % vs. 28.6 % (study MN301), and 49.4 % vs. 26.3 % (study US301).
U studijama faze III terapijske stope prema ACR-u bile su 54,6 % za leflunomid 20 mg/dan u odnosu na 28,6 % za placebo (studija MN301), odnosno 49,4 % prema 26,3 % (studija US301).
<Leflunomide medac 10 mg:> 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
<Leflunomid medac 10 mg:> 30 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
Each film-coated tablet contains 152 mg of lactose (as monohydrate) and 0.12 mg of soya lecithin.
Jedna filmom obložena tableta sadrži 152 mg laktoze (u obliku hidrata) i 0,12 mg sojinog lecitina
It is not recommended to drink alcohol during treatment with Leflunomide medac.
Za vrijeme liječenja lijekom Leflunomid medac ne preporučuje se konzumacija alkohola.
White to almost white, round film-coated tablet with a diameter of 8 mm and a break-mark on one side of the tablet.
Bijela do gotovo bijela, okrugla filmom obložena tableta promjera 8 mm, s razdjelnom crtom na jednoj strani tablete.
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 filmom obložene tablete su bijele do gotovo bijele i okrugle filmom obložene tablete promjera otprilike 8 mm s razdjelnom crtom na jednoj strani tablete.
• mild increase in blood pressure,
• blagi porast krvnog tlaka,
• severe increase in blood pressure,
• jaki porast krvnog tlaka,
Uncommon: anaemia, mild thrombocytopenia (platelets < 100 G/l) Rare:
anemija, blaga trombocitopenija (trombociti < 100 g/l).
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 filmom obložene tablete Leflunomid medac 15 mg filmom obložene tablete Leflunomid medac 20 mg filmom obložene tablete leflunomid
The long half-life of leflunomide should be considered when contemplating administration of a live attenuated vaccine after stopping Leflunomide medac.
Kad se razmatra primjena živih atenuiranih cjepiva nakon prekida liječenja lijekom Leflunomide medac, potrebno je uzeti u obzir dugi poluvijek Leflunomida medac.
• a decrease in the levels of potassium in the blood,
• smanjenje koncentracije kalija u krvi,
Very rare side effects (may affect up to 1 in 10,000 people)
Vrlo rijetke nuspojave (mogu se javiti u do 1 na 10 000 ljudi):
How to take Leflunomide medac
Kako uzimati Leflunomid medac
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 filmom obložene tablete su bijele do gotovo bijele, okrugle, filmom obložene tablete, promjera otprilike 6 mm.
Certain vaccinations should not be given while taking Leflunomide medac, and for a certain amount of time after stopping treatment.
Za vrijeme uzimanja lijeka Leflunomid medac kao i određeno vrijeme nakon prekida liječenja ne smije se provoditi cijepljenje određenim cjepivima.
How to store Leflunomide medac
Kako čuvati Leflunomid medac
Infections and infestations
Infekcije i infestacije Rijetko:
A randomised study assessed the clinical efficacy response rate in DMARD-naïve patients (n = 121) with early RA, who received either 20 mg or 100 mg of leflunomide with matching placebo in two parallel groups during the initial three day double blind period.
Bolesnici su podijeljeni u dvije paralelne skupine i dobivali su ili 20 mg ili 100 mg leflunomida s odgovarajućim placebom tijekom prva tri dana dvostruko slijepog ispitivanja.
Marketing Authorisation Holder medac
Nositelj odobrenja za stavljanje gotovog lijeka u promet medac
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva Često:
Uncommon side effects (may affect up to 1 in 100 people)
Manje česte nuspojave (mogu se javiti u do 1 na 100 ljudi)
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 eritemski lupus, pustularna psorijaza ili pogoršanje psorijaze, reakcija na lijek s eozinofilijom i sistemskim simptomima (engl.
• taste disturbances,
• poremećaji osjeta okusa,
• In psoriatic arthritis: leflunomide therapy is started with a loading dose of 100 mg once daily for
• U bolesnika s psorijatičnim artritisom: liječenje leflunomidom započinje primjenom udarne doze od 100 mg jedanput na dan tijekom 3 dana.
Leflunomide medac contains lactose.
Leflunomid medac sadrži laktozu.
One tablet of Leflunomide medac 20 mg film-coated tablets contains 20 mg of leflunomide.
Jedna tableta lijeka Leflunomid medac 20 mg filmom obložene tablete sadrži 20 mg leflunomida.
Leflunomide medac contains lactose
Leflunomid medac sadrži laktozu
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 tableta) EU/1/10/637/006 (20 mg, 30 tableta) EU/1/10/637/007 (20 mg, 60 tableta) EU/1/10/637/009 (20 mg, 100 tableta)
Immune system disorders
Poremećaji imunološkog sustava Često:
Leflunomide medac contains soya lecithin.
Leflunomid medac sadrži sojin lecitin.
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.
Učinak na supstrate organskog anionskog transportera 3 (OAT 3) Zabilježeno je povećanje prosječne Cmax i AUC (1,43 odnosno 1,54 puta) za cefaklor, nakon ponovljenih doza A771726, što ukazuje da je A771726 inhibitor OAT3 in vivo.
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 tableta) EU/1/10/637/011 (15 mg, 60 tableta) EU/1/10/637/012 (15 mg, 90 tableta) EU/1/10/637/013 (15 mg, 100 tableta)
One tablet of Leflunomide medac 15 mg film-coated tablets contains 15 mg of leflunomide.
Jedna tableta lijeka Leflunomid medac 15 mg filmom obložene tablete sadrži 15 mg leflunomida.
Leflunomide medac 15 mg film-coated tablets: Pack sizes of 30, 60, 90 or 100 film-coated tablets per bottle are available.
Leflunomid medac 15 mg filmom obložene tablete: Dostupne su veličine pakovanja od 30, 60, 90 ili 100 filmom obloženih tableta u boci.
Leflunomide medac 20 mg film-coated tablets: Pack sizes of 15, 30, 60 or 100 film-coated tablets per bottle are available.
Leflunomid medac 20 mg filmom obložene tablete: Dostupne su veličine pakovanja od 15, 30, 60 ili 100 filmom obloženih tableta u boci.
Leflunomide medac 10 mg film-coated tablets: Pack sizes of 30, 60 or 100 film-coated tablets per bottle are available.
Leflunomid medac 10 mg filmom obložene tablete: Dostupne su veličine pakovanja od 30, 60 ili 100 filmom obloženih tableta u boci.
Hepatic impairment
ruptura tetive
One tablet of Leflunomide medac 10 mg film-coated tablets contains 10 mg of leflunomide.
Jedna tableta lijeka Leflunomid medac 10 mg filmom obložene tablete sadrži 10 mg leflunomida.
Rare side effects (may affect up to 1 in 1,000 people)
Rijetke nuspojave (mogu se javiti u do 1 na 1000 ljudi):
• colitis,
• proljev,
After stopping treatment with leflunomide:
Postupak ispiranja („washout“) Nakon prekida uzimanja leflunomida treba primijeniti:
Common side effects (may affect up to 1 in 10 people)
Česte nuspojave (mogu se javiti u do 1 na 10 ljudi):
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.
Terapijski učinak obično počinje nakon 4 do 6 tjedana, a stanje se može poboljšavati sljedećih 4 do 6 mjeseci.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 15 mg of leflunomide.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna filmom obložena tableta sadrži 15 mg leflunomida.
Leflunomide medac 20 mg film-coated tablets leflunomide
Leflunomid medac 20 mg filmom obložene tablete leflunomid
• The active substance is leflunomide.
• Djelatna tvar je leflunomid.
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 tableta) EU/1/10/637/002 (10 mg, 60 tableta) EU/1/10/637/004 (10 mg, 100 tableta)
Each film-coated tablet contains 15 mg of leflunomide.
Jedna filmom obložena tableta sadrži 15 mg leflunomida.
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.
HDPE boca širokog grla volumena 40 ml s navojnim zatvaračem s ugrađenim spremnikom za sredstvo za sušenje (bijeli silika gel) koja sadrži 30, 60, 90 ili 100 filmom obloženih tableta po spremniku.
Leflunomide medac 15 mg film-coated tablets leflunomide
Leflunomid medac 15 mg filmom obložene tablete leflunomid
• tiredness (asthenia),
• umor (astenija),
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).
U ovom su se ispitivanju udarna doza i doza održavanja leflunomida zasnivale na 3 kategorije tjelesne težine: < 20 kg, 20 - 40 kg i > 40 kg.
Leflunomide medac 10 mg film-coated tablets leflunomide
Leflunomid medac 10 mg filmom obložene tablete leflunomid
Italia medac Pharma S.r.l.
Gidamed Medical Supplies Ltd.
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)
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/10/637/001 (10 mg, 30 tableta) EU/1/10/637/002 (10 mg, 60 tableta) EU/1/10/637/004 (10 mg, 100 tableta)
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.
HDPE boca širokog grla volumena 40 ml s navojnim zatvaračem s ugrađenim spremnikom za sredstvo za sušenje (bijeli silika gel) koja sadrži 30, 60 ili 100 filmom obloženih tableta po spremniku.
Each film-coated tablet contains 10 mg of leflunomide.
Jedna filmom obložena tableta sadrži 10 mg leflunomida.
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.
HDPE boca širokog grla volumena 40 ml s navojnim zatvaračem s ugrađenim spremnikom za sredstvo za sušenje (bijeli silika gel) koja sadrži 15, 30, 60 ili 100 filmom obloženih tableta po spremniku.
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 20 mg film-coated tablets
NAZIV LIJEKA Leflunomid medac 20 mg filmom obložene tablete
• 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.
Budući da se ne može isključiti izlučivanje lijeka Leflonomide medac u sjeme, tijekom terapije lijekom Leflunomidom medac treba primjenjivati učinkovitu kontracepciju.
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 10 mg film-coated tablets
NAZIV LIJEKA Leflunomid medac 10 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Leflunomide medac 15 mg film-coated tablets
NAZIV LIJEKA Leflunomid medac 15 mg filmom obložene tablete
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 filmom obložene tablete su bijele do gotovo bijele, okrugle, filmom obložene tablete, promjera otprilike 7 mm.
Sími: + 354 499 01 68 Leflunomide@medac.eu
Williams & Halls ehf. Sími: +354 499 01 68 Leflunomide@medac.eu
Common:
Nepoznato:
with continuation of both drugs and 3 after discontinuation of leflunomide.
Sve su se te vrijednosti smanjile u 2 bolesnika koji su nastavili istodobno uzimati oba lijeka i u 3 bolesnika koji su prekinuli uzimati leflunomid.
(pancytopenia),
• tjeskoba,
Tel: + 39 06 515912 1 Leflunomide@medac.eu
Italia medac Pharma S.r.l. Tel: +39 06 515912 1 Leflunomide@medac.eu
Tell your doctor if you think Vivanza is too strong or too weak.
Obavijestite svog liječnika ako mislite da je Vivanza prejaka ili preslaba.
Do not take Vivanza more than once a day.
Nemojte uzimati lijek Vivanza više od jedanput na dan.
What Vivanza is and what it is used for
Što je Vivanza i za što se koristi
Vivanza will only work when you are sexually stimulated.
Vivanza će djelovati samo kad ste seksualno stimulirani.
What Vivanza looks like and contents of the pack
Kako Vivanza izgleda i sadržaj pakiranja
Rare to <1/1,000)
Rijetko i < 1/1000)
These measures will helpprotect the environment.
Ove će mjere pomoći u očuvanju okoliša.
Other medicines and Vivanza
Drugi lijekovi i Vivanza
Vivanza might make some people feel dizzy or affect their vision.
Vivanza može kod nekih ljudi izazvati omaglicu i utjecati na njihov vid.
Taking these medicines with Vivanza could seriously affect your blood pressure.
Uzimanje ovih lijekova s lijekom Vivanza moglo bi ozbiljno utjecati na Vaš krvni tlak.
- Don't drink grapefruit juice when you use Vivanza.
- Nemojte piti sok od grejpa kad uzimate lijek Vivanza.
The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek suu skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svakim daljnjim ažuriranjima objavljenim na europskom internetskom portalu za lijekove.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Kao i svi lijekovi, ovaj lijek može uzrokovati nuspojave iako se one neće javiti svakoga.
If you take more Vivanza than you should, tell your doctor.
Ako uzmete više lijeka Vivanza nego što ste trebali, obratite se liječniku.
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).
Nuspojave su navedene po učestalosti prema MedDRA konvenciji: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
Date of first authorisation: 4 March 2003 Date of latest renewal: 4 March 2008
Datum posljednje obnove odobrenja: 4. ožujka 2008.
With sexual stimulation you may achieve an erection anywhere from 25 minutes up to four to five hours after taking Vivanza.
Uz seksualnu stimulaciju možete postići erekciju bilo kada između 25 minuta do četiri do pet sati nakon uzimanja Vivanza.
Stop taking Vivanza and contact your doctor immediately.
Prestanite uzimati lijek Vivanza i odmah se javite liječniku.
What Vivanza is and what it is used for What you need to know before you take Vivanza How to take Vivanza
Što je Vivanza i za što se koristi Što morate znati prije nego počnete uzimati lijek Vivanza Kako uzimati lijek Vivanza
Vivanza allows an erection to last long enough for you to satisfactorily complete sexual activity.
Vivanza omogućuje dovoljno dugo trajanje erekcije da možete na zadovoljavajući način dovršiti spolni odnos.
Vivanza can be taken with or without food.
Vivanza se može uzimati s hranom ili bez nje.
In order for Vivanza to be effective, sexual stimulation is required.
Da bi Vivanza djelovala, potrebna je seksualna stimulacija.
Signs of an allergic reaction include a rash, itching, swollen face or lips and shortness of breath.
Znakovi alergijske reakcije uključuju osip, svrbež, otok lica ili usana i nedostatak zraka.
There is no relevant indication for use of Vivanza orodispersible tablets in children and adolescents.
Nema relevantne indikacije za primjenu Vivanza raspadljivih tableta za usta u djece i adolescenata.
- Place the entire orodispersible tablet in the mouth, on the tongue, where it will dissolve in seconds, then swallow with saliva.
- Stavite cijelu raspadljivu tabletu u usta, na jezik, gdje će se otopini u roku od nekoliko sekundi, a zatim je progutajte zajedno sa slinom.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
Postupno povećanje doze alfa blokatora može biti povezano s dodatnim sniženjem krvnog tlaka u bolesnika koji uzimaju vardenafil.
- If you experience sudden decrease or loss of vision, stop taking Vivanza and contact your doctor immediately.
- ako osjetite iznenadno slabljenje ili gubitak vida, prestanite uzimati lijek Vivanza i odmah se javite liječniku.
Vivanza is not indicated for individuals below 18 years of age.
Vivanza nije indicirana za osobe mlađe od 18 godina.
- If you have ever had a condition involving loss of vision due to damage to the optic nerve from insufficient blood supply known as non-arteritic ischemic optic neuropathy (NAION).
- ako ste ikad imali stanje u kojem dolazi do gubitka vida zbog oštećenja vidnog živca uslijed nedovoljne opskrbe krvlju, poznatog kao nearteritička ishemijska optička neuropatija (NAION). - ako uzimate riocigvat.
Ritonavir significantly prolonged the half-life of vardenafil to 25.7 hours (see section 4.3).
Ritonavir je značajno produljio poluvvijek vardenafila na 25,7 sati (vidjeti dio 4.3).
Due to the nitrate component, it has the potential to have serious interaction with vardenafil.
Zbog nitratne sastavnice, može ući u ozbiljne interakcije s vardenafilom.
Vivanza is not indicated for use by women.
Vivanza nije indicirana za primjenu u žena.
Vivanza orodispersible tablets are not indicated for individuals below 18 years of age.
Vivanza raspadljive tablete za usta nisu indicirane u osoba mlađih od 18 godina.
What you need to know before you take Vivanza Do not take Vivanza
Što morate znati prije nego počnete uzimati lijek Vivanza
The tablets are provided in blister packs containing 2, 4, 8, 12 or 20 tablets.
Tablete su dostupne u blister pakiranjima od 2, 4, 8, 12 ili 20 tableta.
Vivanza is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous phosphodiesterase 5 (PDE5) inhibitor exposure (see section 4.4).
Vivanza je kontraindicirana u bolesnika koji su izgubili vid na jedno oko zbog nearteritičke prednje ishemijske optičke neuropatije (NAION), bez obzira na to je li ta epizoda bila povezana s prethodnom izloženosti inhibitoru fosfodiesteraze tipa 5 (PDE5) (vidjeti dio 4.4).
Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect on vardenafil pharmacokinetics of the following concomitant medicinal products: acetylsalicylic acid, ACE-inhibitors, beta-blockers, weak CYP3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Premda nisu provedena zasebna ispitivanja interakcija sa svim lijekovima, analiza populacijske farmakokinetike pokazala je da istodobna primjena sljedećih lijekova ne utječe na farmakokinetiku vardenafila: acetilsalicilatna kiselina, ACE inhibitori, beta blokatori, slabi inhibitori CYP3A4, diuretici i lijekovi za liječenje šećerne bolesti (derivati sulfonilureje i metformin).
Vivanza is not intended for use by children or adolescents under 18.
Djeca i adolescenti Vivanza nije namijenjena za primjenu u djece i adolescenata mlađih od 18 godina.
There is no relevant indication for use of Vivanza in children.
Nema relevantne indikacije za primjenu lijeka Vivanza u djece.
There was no consistent difference in mean Cmax between orodispersible tablets and film-coated tablets.
Nije bilo dosljedne razlike u srednjoj vrijednosti Cmax između raspadljivih tableta za usta i filmom obloženih tableta.
Patients with left ventricular outflow obstruction, e.g. aortic stenosis and idiopathic hypertrophic subaortic stenosis, can be sensitive to the action of vasodilators including Type 5 phosphodiesterase inhibitors.
Bolesnici s opstruktivnim smetnjama izlaznog trakta lijeve klijetke, npr., aortalnom stenozom i idiopatskom hipertrofičnom subaortalnom stenozom, mogu biti osjetljivi na djelovanje vazodilatatora uključujući inhibitore fosfodiesteraze tipa 5.
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Vardenafil (10 mg) nije pojačao produljenje vremena krvarenja izazvano acetilsalicilnom kiselinom (2 x 81 mg).
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Vivanza and other PDE5 inhibitors.
Oslabljen vid i slučajevi nearteritičke ishemijske optičke neuropatije (NAION) zabilježeni su u vezi s uzimanjem lijeka Vivanza i drugih inhibitora PDE5.
He or she may suggest a switch to an alternative vardenafil formulation with a different dose, depending on how well it works for you.
Liječnik može predložiti da uzmete alternativni oblik vardenafila u drugačijoj dozi, ovisno o tome koliko Vam dobro djeluje.
Contains aspartame (E951) and sorbitol (E420).
POPIS POMOĆNIH TVARI Sadrži aspartam (E951) i sorbitol (E420).
Vardenafil is rapidly absorbed after administration of Vivanza 10 mg orodispersible tablets without water.
Vardenafil se brzo apsorbira nakon primjene Vivanza 10 mg raspadljivih tableta za usta bez vode.
The maximum dose for Vivanza orodispersible tablet is 10 mg/day.
Maksimalna doza Vivanza raspadljive tablete za usta je 10 mg dnevno.
Talk to your doctor or pharmacist before taking Vivanza.
Upozorenja i mjere opreza Obratite se svom liječniku ili ljekarniku prije nego uzmete lijek Vivanza.