natgillin/translations-raw huggingface dataset:
If not, change the needle and repeat the procedure no more than 6 times.
Odmerek lahko popravite z obračanjem izbirnika v eno ali drugo smer.
If a drop of insulin still does not appear, the device is defective and must not be used.
Nastaviti ne morete odmerka, ki bi bil večji od števila preostalih enot v injekcijskem vložku.
Setting the dose
Injiciranje insulina
• Always check that the push-button is fully depressed and the dose selector is set to zero • Dial the number of units required by turning the dose selector clockwise (picture C).
Za injiciranje uporabite postopek, ki vam ga je svetoval zdravnik. • Odmerek vbrizgajte tako, da potisni gumb pritisnete do konca (slika D).
The dose can be corrected by turning the dial either way.
Ko se bo izbirnik odmerka vračal na ničlo, boste slišali klike. • Po injiciranju mora igla ostati pod kožo vsaj 6 sekund, da je zanesljivo vbrizgan celotni odmerek. • Pazite, da med injiciranjem ne boste ovirali izbirnika odmerka, kajti zagotoviti je treba, da se ta med pritiskom na potisni gumb neovirano vrne na ničlo. • Iglo po vsakem injiciranju odstranite.
You cannot set a dose larger than the number of units remaining in the cartridge.
D
C
Odstranitev igle
Injecting the insulin
Pazljivo jo zavrzite.
• Insert the needle into your skin.
Za vsako injiciranje uporabite novo iglo.
Use the injection technique advised by your doctor • Deliver the dose by pressing the push-button fully down (picture D).
Po vsakem injiciranju morate iglo odstraniti in zavreči, Levemir pa shraniti brez nameščene igle.
You will hear clicks as the dose selector returns to zero • After the injection, the needle should remain under the skin for at least 6 seconds to ensure that the full dose has been delivered • Make sure not to block the dose selector while injecting, as the dose selector must be allowed to return to zero when you press the push-button • Discard the needle after each injection.
Obrabljeni peresnik Levemir InnoLet pazljivo zavrzite; pazite, da boste pred tem z njega odstranili iglo.
80 D
80 E
Removing the needle
Vzdrževanje
Dispose of your used Levemir InnoLet carefully without the needle attached.
Vaš Levemir InnoLet je izdelan za natančno in varno delovanje.
If it is dropped, damaged or crushed, there is a risk of leakage of insulin.
Če pade, se poškoduje ali z njim kam udarite, obstaja nevarnost za puščanje insulina.
As a precautionary measure, always carry a spare insulin delivery device in case your InnoLet is lost or damaged.
Iz previdnosti vedno nosite s seboj rezervni sistem za injiciranje insulina, če bi se zgodilo, da InnoLet izgubite ali se poškoduje.
Do not refill Levemir InnoLet.
Peresnika Levemir InnoLet se ne sme ponovno napolniti.
You can clean your Levemir InnoLet by wiping it with a medicinal swab.
Levemir InnoLet lahko očistite tako, da ga obrišete z medicinskim zložencem.
Do not soak it in surgical spirit or wash or lubricate it.
Ne namakajte ga v razredčenem alkoholu, ne umivajte ga in ne mažite.
This may damage the mechanism.
Z vsem tem lahko poškodujete mehanizem.
It is available as round, orange tablets (5, 10, or 20 mg).
Na voljo je v obliki okroglih tablet oranžne barve (5, 10 ali 20 mg).
Levitra is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get, or keep, a hard penis (erection) sufficient for satisfactory sexual activity.
Zdravilo Levitra se uporablja za zdravljenje erektilne disfunkcije (imenovane tudi impotenca) pri odraslih moških, kadar ti ne zmorejo doseči ali ohraniti takšne erekcije penisa, ki omogoča zadovoljivo spolno aktivnost.
The recommended dose of Levitra is 10 mg, taken with or without food, about 25 to 60 minutes before sexual activity.
Priporočeni odmerek zdravila Levitra je 10 mg, ki se vzame s hrano ali brez nje, približno 25 do 60 minut pred spolnim odnosom.
If Levitra is taken with a high fat meal, the onset of activity may be delayed.
Zdravilo Levitra lahko začne učinkovati pozneje, če se tableta zaužije s hrano, ki vsebuje veliko maščob.
The dose may be increased to a maximum of 20 mg or decreased to 5 mg depending on the effectiveness and side effects.
Odmerek zdravila se lahko glede na učinkovitost in dejstvo, kako ga bolnik prenaša, poveča na 20 mg ali zmanjša na 5 mg.
Patients with liver problems or severe kidney problems should start treatment on the 5 mg dose.
Bolniki z jetrnimi obolenji ali resnimi motnjami v delovanju ledvic naj začnejo zdravljenje s 5 mg odmerkom.
The maximum recommended dosing frequency is one tablet per day.
Zdravilo se lahko vzame enkrat na dan.
The active ingredient of Levitra, vardenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Zdravilna učinkovina zdravila Levitra, vardenafil, spada v skupino zdravil, imenovanih zaviralci fosfodiesteraze tipa 5 (PDE5).
It works by blocking the phosphodiesterase enzyme which normally breaks down a substance known as cyclic GMP (cGMP).
Deluje tako, da blokira encim fosfodiesterazo, ki običajno razgrajuje snov, znano kot ciklični gvanozin monofosfat (cGMP).
During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax, allowing the inflow of blood in the corpora that produces the erection.
Med normalnim spolnim vzburjenjem se cGMP tvori v penisu, kjer povzroča, da se gobasto tkivo penisa (corpora cavernosa) sprosti, kar omogoči večji dotok krvi v corpora, posledica česar je erekcija.
By blocking the break down of cGMP, Levitra restores erectile function.
Z zaviranjem razgradnje cGMP zdravilo Levitra ponovno vzpostavi erektilno funkcijo.
Levitra has been studied in four main studies including 2,431 patients aged 20 to 83 years, where it was compared with placebo (a dummy treatment).
Zdravilo Levitra so preučevali v štirih glavnih študijah, v katerih je sodelovalo 2. 431 bolnikov, starih od 20 do 83 let.
One study was carried out in diabetic men and another in post-prostatectomy patients (men who have had their prostate gland removed).
V eno študijo so bili vključeni moški s sladkorno boleznijo, v drugo pa bolniki po prostatektomiji (operativni odstranitvi prostate).
What benefit has Levitra shown during the studies?
Kakšne koristi je zdravilo Levitra izkazalo med raziskavami?
Levitra was significantly more effective than placebo for all measures in all studies.
Zdravilo Levitra je bilo znatno bolj učinkovito kot placebo v vseh študijah in ob vseh uporabljenih merilih.
The most common side effects (seen in more than 1 patient in 10) are headache and flushing.
Najpogostejša neželena učinka (opažena pri več kot 1 bolniku od 10) sta bila glavobol in rdečica.
For the full list of all side effects reported with Levitra, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Levitra, glejte Navodilo za uporabo.
Levitra should not be used in people who may be hypersensitive (allergic) to vardenafil or any of the other ingredients, and where sexual activity is inadvisable (e. g. men with severe heart disease such as unstable angina or severe heart failure).
Zdravila Levitra ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) vardenafil ali katerokoli drugo sestavino zdravila, ter osebe, katerim je spolna aktivnost odsvetovana (npr. moški s hudimi boleznimi srca, kot je nestabilna angina pektoris ali hudo srčno popuščanje).
It should also not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischemic optic neuropathy or NAION).
Zdravilo se odsvetuje tudi bolnikom, ki so kdaj koli imeli težave z vidom zaradi dotoka krvi v očesni živec (nearteritična anteriorna ishemična optična nevropatija ali NAION).
Levitra should not be taken with nitrates (medicines used to treat angina).
Zdravilo Levitra se ne sme jemati skupaj z nitrati (zdravili za zdravljenje angine pektoris).
Because Levitra has not been studied in patients with severe liver or kidney disease, patients who have problems with their blood pressure, or who have had a stroke or a heart attack within the last six months, they should not use it.
Zdravilo Levitra ni bilo raziskano pri bolnikih, ki imajo huda obolenja jeter ali ledvic, pri bolnikih, ki imajo težave s krvnim tlakom, in pri bolnikih, ki so v zadnjih šestih mesecih doživeli možgansko ali srčno kap, zato le- ti zdravila ne smejo jemati.
Levitra should not be taken with some medicines, such as ketoconazole and itraconazole (to treat fungal infections) in men over 75 years, or ritonavir or indinavir (to treat HIV infection).
Zdravilo Levitra se ne sme jemati skupaj z nekaterimi zdravili, kot sta ketokonazol in itrakonazol (za zdravljenje glivičnih okužb) pri moških, starejših od 75 let, ali ritonavir ali indinavir (za zdravljenje bolnikov, okuženih z virusom HIV).
The Committee for Medicinal Products for Human Use (CHMP) decided that Levitra’ s benefits are greater than its risks for the treatment of men with erectile dysfunction.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila Levitra pri zdravljenju moških z erektilno disfunkcijo večje od z njim povezanih tveganj.
The Committee recommended that Levitra be given marketing authorisation.
Odbor je zato priporočil, da se za zdravilo Levitra odobri dovoljenje za promet.
Other information about Levitra:
Druge informacije o zdravilu Levitra:
The European Commission granted a marketing authorisation valid throughout the European Union for Levitra to Bayer AG on 6 March 2003.
Evropska komisija je dovoljenje za promet z zdravilom Levitra, veljavno po vsej Evropski uniji, odobrila družbi Bayer AG dne 6. marca 2003.
The marketing authorisation was renewed on 6 March 2008.
Dovoljenje za promet z zdravilom je bilo podaljšano 6. marca 2008.
The full EPAR for Levitra is available here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Levitra je na voljo tukaj.
Levitra 5 mg film-coated tablets
Levitra 5 mg filmsko obložene tablete
Each tablet contains 5 mg of vardenafil (as hydrochloride trihydrate).
Ena tableta vsebuje 5 mg vardenafila v obliki vardenafilijevega klorida trihidrata.
Orange round tablets marked with the BAYER-cross on one side and “ 5 ” on the other side.
Okrogle tablete oranžne barve, na eni strani je oznaka BAYER, na drugi pa številka “ 5 ”.
Levitra can be taken with or without food.
Tablete Levitra se lahko jemlje s hrano ali brez nje.
The onset of activity may be delayed if taken with a high fat meal (see section 5.2).
Zdravilo začne učinkovati pozneje, če se tableto zaužije s hrano, ki vsebuje veliko maščob (glejte poglavje 5. 2).
Use in elderly men
Uporaba pri starejših moških
Dosage adjustments are not required in elderly patients.
Starejšim bolnikom odmerka ni treba prilagajati.
However, an increase to a maximum 20 mg dose should be carefully considered depending on the individual tolerability (see sections 4.4 and 4.8).
Pri povečanju odmerka na največji odmerek 20 mg je potrebna previdnost; pri tem je treba upoštevati dejstvo kako ga bolnik prenaša (glejte poglavji 4. 4 in 4. 8).
Levitra is not indicated for individuals below 18 years of age.
Uporaba zdravila Levitra ni indicirana pri mlajših od 18 let.
There is no relevant indication for use of Levitra in children.
Ustreznih indikacij za uporabo zdravila Levitra pri otrocih ni.
Use in patients with hepatic impairment
Uporaba pri bolnikih z jetrno okvaro
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B).
Začetni odmerek za bolnike z blago in zmerno jetrno okvaro (A, B po Child- Pughu) je 5 mg.
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3 and 5.2).
Največji priporočen odmerek za bolnike z zmerno jetrno okvaro (B po Child- Pughu) je 10 mg (glejte poglavji 4. 3 in 5. 2).
2 Use in patients with renal impairment
2 Uporaba pri bolnikih z ledvično okvaro
No dosage adjustment is required in patients with mild to moderate renal impairment.
Bolnikom z blago do zmerno ledvično okvaro odmerka ni treba prilagajati.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min), a starting dose of 5 mg should be considered.
Začetni odmerek za bolnike s hudo ledvično okvaro (kreatininski očistek < 30 ml/ min) je 5 mg.
When used in combination with the CYP 3A4 inhibitors such as erythromycin or clarithromycin, the dose of vardenafil should not exceed 5 mg (see section 4.5).
Največji odmerek vardenafila za bolnike, ki sočasno jemljejo zdravila, ki zavirajo delovanje CYP 3A4 (npr. eritromicin ali klaritromicin), je 5 mg (glejte poglavje 4. 5).
The coadministration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 5.1).
Sočasno jemanje vardenafila in nitratov ali donorjev dušikovega oksida (npr. amil nitrita) v katerikoli obliki je kontraindicirano (glejte poglavji 4. 5 in 5. 1).
Levitra 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 PDE5 inhibitor exposure (see section 4.4).
Zdravilo Levitra je kontraindicirano pri bolnikih, ki so izgubili vid na enem očesu zaradi nearteritične anteriorne ishemične optične nevropatije (NAION), tudi če ta dogodek ni bil povezan s predhodnim jemanjem zaviralcev PDE5 (glejte poglavje 4. 4).
Agents for the treatment of erectile dysfunction should generally not be used in men for whom sexual activity is inadvisable (e. g. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).
Moški, ki se jim spolna aktivnost odsvetuje (npr. s hudimi boleznimi srca in ožilja, kot sta nestabilna angina pektoris ali hudo srčno popuščanje (III. ali IV. razred po lestvici združenja za bolezni srca – New York Heart Association)), ne smejo jemati učinkovin za zdravljenje erektilne disfunkcije.
The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available:
Varnost vardenafila ni raziskana pri bolnikih,
- severe hepatic impairment (Child-Pugh C),
- ki imajo hude motnje pri delovanju jeter (C po Child- Pughu),
- end stage renal disease requiring dialysis,
- ki imajo končno ledvično odpoved, ki zahteva dializno zdravljenje,
- hypotension (blood pressure < 90/ 50 mmHg),
- ki imajo hipotenzijo (krvni tlak < 90/ 50 mmHg),
- recent history of stroke or myocardial infarction (within the last 6 months),
- ki so doživeli možgansko kap ali miokardni infarkt v zadnjih šestih mesecih,
- unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
- ki imajo nestabilno angino pektoris in znano dedno degenerativno bolezen mrežnice (retinitis
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.
Sočasna uporaba vardenafila in močnih zaviralcev CYP 3A4, kot sta ketokonazol in itrakonazol (za peroralno uporabo), je pri moških, starih več kot 75 let, kontraindicirana.
Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5).
Sočasna uporaba vardenafila in zaviralcev HIV- proteaze, kot sta ritonavir in indinavir, je kontraindicirana, ker sta zelo močna zaviralca CYP3A4 (glejte poglavje 4. 5).
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity (see section 4.3).
Pred začetkom kakršnegakoli zdravljenja erektilne disfunkcije mora zdravnik upoštevati kardiovaskularno stanje bolnika, saj obstaja v povezavi s spolno aktivnostjo določena nevarnost poslabšanja srčnih bolezni (glejte poglavje 4. 3).
Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Vardenafil deluje vazodilatacijsko in lahko blago in prehodno zniža krvni tlak (glejte poglavje 5. 1).
Agents for the treatment of erectile dysfunction should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’ s disease), or in patients
Bolniki z obstrukcijo iztisa levega prekata, npr. aortno stenozo in idiopatsko hipertrofično subaortno stenozo, so lahko občutljivi za delovanje vazodilatatorjev, tudi za zaviralce fosfodiesteraze tipa 5.
3 who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
3 Pri bolnikih z anatomsko deformacijo penisa (npr. angulacija (ukrivljenost), kavernozna fibroza ali Peyronijeva bolezen) ali pri bolnikih z boleznimi, zaradi katerih obstaja večja možnost pojava priapizma (npr. anemija srpastih celic, multipli mielom ali levkemija), je treba zdravila za erektilno disfunkcijo uporabljati previdno.
The safety and efficacy of combinations of vardenafil with other treatments for erectile dysfunction have not been studied.
Varnost in učinkovitost zdravljenja z vardenafilom v kombinaciji z drugimi zdravili za erektilno disfunkcijo nista raziskani.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg.
Za bolnike, ki se zdravijo z zaviralci adrenergičnih receptorjev alfa in katerih zdravstveno stanje je stabilno, je zdravljenje z vardenafilom priporočljivo začeti z najmanjšim začetnim odmerkom 5 mg.
Vardenafil may be administered at any time with tamsulosin.
Vardenafil se lahko s tamsulozinom uporablja kadarkoli.
With other alpha blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5).
Pri sočasnem zdravljenju z vardenafilom in drugimi zaviralci adrenergičnih receptorjev alfa je potreben med zaužitjem enega in drugega zdravila časovni presledek (glejte poglavje 4. 5).
Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole (oral form) should be avoided as very high plasma concentrations of vardenafil are reached if the medicinal products are combined (see sections 4.5 and 4.3).
Sočasni uporabi vardenafila in močnih zaviralcev CYP 3A4, kot sta ketokonazol in itrakonazol (za peroralno uporabo), se je treba izogibati, saj se pri kombiniranju zdravil plazemske koncentracije vardenafila zelo zvečajo (glejte poglavji 4. 5 in 4. 3).
Vardenafil dose adjustment might be necessary if moderate CYP 3A4 inhibitors such as erythromycin and clarithromycin, are given concomitantly (see sections 4.5 and 4.2).
Med sočasno uporabo zmernih zaviralcev CYP 3A4 (npr. eritromicin in klaritromicin), je treba odmerek vardanafila po potrebi prilagoditi (glejte poglavji 4. 5 in 4. 2).
Concomitant intake of grapefruit juice is expected to increase the plasma concentrations of vardenafil.
Če zdravilo zaužijemo skupaj z grenivkinim sokom, lahko pričakujemo zvečanje plazemske koncentracije vardenafila.
The combination should be avoided (see section 4.5).
Tej kombinaciji se je treba izogibati (glejte poglavje 4. 5).
Single oral doses of 10 mg and 80 mg of vardenafil have been shown to prolong the QTc interval by a mean of 8 msec and 10 msec, respectively.
10 msec.
And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either drug alone.
Enkratni odmerek 10 mg vardenafila uporabljen sočasno s 400 mg gatifloksacina, zdravilom, ki ima podoben učinek na QT dobo, se doba QT podaljša za 4 msec v primerjavi s posameznim zdravilom.
The clinical impact of these QT changes is unknown (see section 5.1).
Klinični pomen spremembe QT ni znan (glejte poglavje 5. 1).
The clinical relevance of this finding is unknown and cannot be generalised to all patients under all circumstances, as it will depend on the individual risk factors and susceptibilities that may be present at any time in any given patient.
Odvisna je od dejavnikov tveganja in posameznikove občutljivosti, ki se lahko pojavi kadarkoli in pri vsakem bolniku.
Medicinal products that may prolong QTc interval, including vardenafil, are best avoided in patients with relevant risk factors, for example, hypokalaemia; congenital QT prolongation; concomitant administration of antiarrhythmic medicinal products in Class 1ª (e. g. quinidine, procainamide), or Class III (e. g. amiodarone, sotalol).
Za bolnike s pomembnimi dejavniki tveganja, na primer hipokaliemijo, prirojenim podaljšanjem dobe QT, za tiste, ki sočasno jemljejo antiaritmike razreda IA (npr. kinidin, prokainamid) ali razreda III (npr. amiodaron, sotalol), je najbolje, da se jemanju zdravil, ki podaljšajo dobo QT, tudi vardenafilu, izognejo.
The patient should be advised that in the case of sudden visual defect, he should stop taking Levitra and consult immediately a physician (see section 4.3).
Bolnika je treba opozoriti, da naj v primeru nenadne okvare vida preneha jemati zdravilo Levitra in o tem nemudoma obvesti svojega zdravnika (glejte poglavje 4. 3).
Tolerability of the maximum dose of 20 mg may be lower in elderly patients (≥ 65 years old) (see sections 4.2 and 4.8).
Starejši bolniki (≥ 65 let) lahko največji odmerek 20 mg slabše prenašajo (glejte poglavji 4. 2 in 4. 8).
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
Vardenafil pri človeku niti sam niti v kombinaciji z acetilsalicilno kislino ne vpliva na čas krvavitve (glejte poglavje 4. 5).
In vitro studies:
Študije in vitro
In vivo studies:
Študije in vivo
Co-administration of the HIV protease inhibitor indinavir (800 mg three times a day), a potent CYP3A4 inhibitor, with vardenafil (10 mg) resulted in a 16-fold increase in vardenafil AUC and a 7-fold increase in vardenafil Cmax.
Med sočasnim jemanjem zaviralca HIV- proteaze indinavirja (800 mg trikrat na dan), ki je močan zaviralec CYP3A4, in vardenafila (10 mg) je površina pod krivuljo plazemskih koncentracij vardenafila (AUC) 16- krat večja, največja koncentracija vardenafila (Cmax) pa je 7- krat večja.
At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Po 24 urah se plazemska raven vardenafila zniža na približno 4% največje plazemske vrednosti vardenafila (Cmax).
Co-administration of vardenafil with ritonavir (600 mg twice daily) resulted in a 13-fold increase in vardenafil Cmax and a 49-fold increase in vardenafil AUC0-24 when co-administered with vardenafil 5 mg.
Med sočasnim jemanjem vardenafila (5 mg) in ritonavira (600 mg dvakrat na dan) je največja koncentracija vardenafila (Cmax) 13- krat večja, površina pod krivuljo plazemskih koncentracij vardenafila (AUC0- 24) pa je 49- krat večja.
The interaction is a consequence of blocking hepatic metabolism of Levitra by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
Medsebojno delovanje je posledica ritonavirovega zaviranja presnove zdravila Levitra v jetrih.
Ritonavir significantly prolonged the half-life of Levitra to 25.7 hours (see section 4.3).
Ritonavir je zelo močan zaviralec CYP3A4, ki zavira tudi CYP2C9 in pomembno podaljša razpolovno dobo zdravila Levitra na 25, 7 ur (glejte poglavje 4. 3).
Co-administration of ketoconazole (200 mg), a potent CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 10-fold increase in vardenafil AUC and a 4-fold increase in vardenafil Cmax (see section 4.4).
Med sočasnim jemanjem ketokonazola (200 mg), ki je močan zaviralec CYP3A4, in vardenafila (5 mg) je bila vrednost AUC vardenafila 10- krat večja, Cmax pa 4- krat večja (glejte poglavje 4. 4).
Concomitant use of vardenafil with potent CYP 3A4 inhibitors such as itraconazole and ketoconazole (oral use) should be avoided (see sections 4.3 and 4.4).
Hkratni uporabi vardenafila in močnih zaviralcev CYP 3A4, npr. itrakonazola in ketokonazola (za peroralno uporabo), se je treba izogibati (glejte poglavji 4. 3 in 4. 4).