qanastek/EMEA-V3 huggingface dataset:
Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
9 dożi ripetuti sa 40 mg ta ’ vardenafil mogħtija mill- ħalq, m’ għamlu l- ebda bidla klinikament relevanti fl- ECG ta ’ rġiel voluntiera b' saħħithom.
A single dose, double blind, crossover, randomised trial in 59 healthy males compared the effects on the QT interval of vardenafil (10 mg and 80 mg), sildenafil (50 mg and 400 mg) and placebo.
Fi prova randomised, double- blind, crossover, b’ doża waħda f’ 59 raġel b’ saħħtu, ġie mqabbel l- effett ta ’ vardenafil (10 mg u 80 mg), sildenafil (50 mg u 400 mg) u plaċebo fuq l- intervall QT.
Moxifloxacin (400 mg) was included as an active internal control.
Ġie inkluż moxifloxacin (400 mg) bħala kontroll attiv intern.
Effects on the QT interval were measured one hour post dose (average Tmax for vardenafil).
Effetti fuq l- intervall QT ġew imkejjla siegħa wara li ngħatat id- doża (Tmax medja ta ’ vardenafil).
The primary objective of this study was to rule out a greater than 10 msec effect (i. e. to demonstrate lack of effect) of a single 80 mg oral dose of vardenafil on QTc interval compared to placebo, as measured by the change in Fridericia's correction formula (QTcF=QT/ RR1/ 3) from baseline at the 1 hour post-dose time point.
Il- mira prinċipali ta ’ dan l- istudju kienet biex jiġi aċċertat li m’ hemmx effett akbar minn 10 msec fuq l- intervall QTc (i. e. biex jintwera nuqqas ta ’ dan l - effett) ta ’ doża waħda ta ’ 80 mg ta ’ vardenafil mogħtija mill- ħalq, meta mqabbla mal- plaċebo, kif imkejjel mill- bidla fil- formola ta ’ korrezzjoni ta ’ Fridericia (QTcF=QT/ RR1/ 3) mill- linja bażi siegħa wara li ngħatat id- doża.
The vardenafil results showed an increase in QTc (Fridericia) of 8 msec (90% CI:
Ir- riżultati ta ’ vardenafil urew żjieda f’ QTc (Fridericia) ta ’ 8 msec (90% CI:
6-9) and 10 msec (90% CI:
6 - 9) u ta ’ 10 msec (90% CI:
8-11) at 10 and 80 mg doses compared to placebo and an increase in QTci of 4 msec (90% CI:
8- 11) b’ dożi ta ’ 10 mg u 80 mg meta mqabbla mal- plaċebo u żjieda fil- QTci ta ’ 4 msec (90% CI:
3-6) and 6 msec (90% CI:
3- 6) u ta ’ 6 msec (90% CI:
4-7) at 10 and 80 mg doses compared to placebo, at one hour postdose.
4- 7) b’ dożi ta ’ 10 mg u 80 mg meta mqabbla mal - plaċebo, wara siegħa li ngħatat id- doża.
At Tmax, only the mean change in QTcF for vardenafil 80 mg was out of the study established limit (mean 10 msec, 90% CI (8-11)).
F’ Tmax, il- bidla medja f’ QTcF għal 80 mg vardenafil biss kienet barra mill- limitu stabbilit ta ’ l- istudju (medja 10 msec, 90% CI (8- 11)).
When using the individual correction formulae, none of the values were out of the limit.
Meta ġiet użata il - formola għall- korrezzjoni individwali, l- ebda wieħed mill- valuri ma kien barra mill- limitu ta ’ l- istudju.
In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.
Fi studju separat ta ’ wara t- tqegħid fuq is- suq f ’ 44 volontiera b’ saħħithom, dożi individwali ta ’ 10mg varadenafil jew ta ’ 50mg sildenafil ġew mogħtija flimkien ma ’ 400mg gatifloxacin, mediċina b’ effett QT komparabbli.
The actual clinical impact of these QT changes is unknown.
Kemm vardenafil kif ukoll sildenafil urew żieda fl- effett Fredericia QTc ta ’ 4 msec (vardenafil) u 5 msec (sildenafil) meta mqabbla ma ’ kull waħda mill- mediċini mogħtija waħidha.
9 Further information on clinical trials
Aktar informazzjoni dwar provi kliniċi
Over 1630 patients have been treated with Levitra for six months or longer.
Fi provi kliniċi, vardenafil, ingħata lil aktar minn 3750 raġel bi problemi fl- erezzjoni tal- pene (ED), b’ etajiet li varjaw bejn 18 u 89 sena, li ħafna minnhom kellhom aktar minn marda waħda fl- istess waqt. ’ L fuq minn 1630 pażjent kienu kkurati b’ Levitra għal sitt xhur jew aktar.
Of these, over 730 have been treated for one year or longer.
Minn dawn, ’ l fuq minn 730 kienu kkurati għal sena jew aktar.
The following patient groups were represented: elderly (22%), patients with hypertension (35%), diabetes mellitus (29%), ischaemic heart disease and other cardiovascular diseases (7%), chronic pulmonary disease (5%), hyperlipidaemia (22%), depression (5%), radical prostatectomy (9%).
Il- gruppi ta 'pazjenti li ġejjin kienu rappreżentati: anzjani (22%), pazjenti bi pressjoni għolja (35%), pazjenti li għandhom dijabete mellitus (29%), mard iskemiku tal- qalb u mard kardjovaskulari ieħor (7%), mard kroniku tal- pulmun (5%), iperlipidimja (22%), depressjoni (5%), tneħħija radikali tal - prostata (9%).
The following groups were not well represented in clinical trials: elderly (> 75 years, 2.4%), and patients with certain cardiovascular conditions (see section 4.3).
4%), u pazjenti b' ċerti tipi ta ’ mard kardjovaskulari (ara sezzjoni 4. 3).
No clinical trials in CNS diseases (except spinal cord injury), patients with severe renal or hepatic impairment, pelvic surgery (except nerve-sparing prostatectomy) or trauma or radiotherapy and hypoactive sexual desire or penile anatomic deformities have been performed.
Ma sarux provi kliniċi dwar mard tas- sistema nervuża ċentrali (minbarra korriment fis- sinsla ta’ dahar), f' pazjenti b’ indeboliment renali jew epatiku sever, pazjenti li kienu operati fil- pelvi (minbarra tneħħija tal - prostata mingħajr ma jintmissu n- nervituri), korriment jew radjuterapija u nuqqas fix- xewqa sesswali jew deformazzjoni anatomika tal- pene.
Across the pivotal trials, treatment with vardenafil resulted in an improvement of erectile function compared to placebo.
Fil- provi pivitali kollha, kura b’ vardenafil irriżultat f’ titjib fil- funzjoni ta ’ l- erezzjoni tal- pene meta mqabbel mal- plaċebo.
In the small number of patients who attempted intercourse up to four to five hours after dosing the success rate for penetration and maintenance of erection was consistently greater than placebo.
F’ dawk il- ftit pazjenti li ppruvaw jagħmlu l- att sesswali minn erba ’ sa ħames sigħat wara li ħadu d- doża, r- rata ta ’ suċċess ta ’ penetrazzjoni u żamma ta ’ l- erezzjoni tal- pene kienet ferm akbar minn dawk tal- plaċebo.
In fixed dose studies in a broad population of men with erectile dysfunction, 68% (5 mg), 76% (10 mg) and 80% (20 mg) of patients experienced successful penetrations (SEP 2) compared to 49% on placebo over a three month study period.
Fi studji mifruxa fuq tliet xhur li saru bl- użu ta ’ doża fissa f’ popolazzjoni b’ firxa kbira ta ’ rġiel bil - problema ta ’ l- erezzjoni tal- pene, 68% (5 mg), 76% (10 mg) u 80% (20 mg) tal- pazjenti kellhom suċċess tal- penetrazzjoni (SEP2), meta mqabbel ma ’ 49% li kienu fuq plaċebo.
The ability to maintain the erection (SEP 3) in this broad ED population was given as 53% (5 mg), 63% (10 mg) and 65% (20 mg) compared to 29% on placebo.
Il- ħila li tinżamm erezzjoni (SEP3) f’ din il- popolazzjoni vasta b’ ED kienet ta ’ 53% (5 mg), 63% (10 mg) u 65% (20 mg) meta mqabbla ma ’ 29% li kienu fuq plaċebo.
In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
Tagħrif miġbur mill- provi ewlenin dwar l- effikaċja wera li l- proporzjon ta ’ pazjenti li kellhom suċċess fil- penetrazjoni b’ vardenafil kien hekk: problemi erettili ta ’ natura psikoġenika (77- 87%), problemi mħallta ta ’ erezzjoni (69- 83%), problemi erettili ta ’ natura organika (64- 75%), anzjani (52- 75%), mard iskemiku tal- qalb (70- 73%), iperlipidimja (62- 73%), mard kroniku tal- pulmun (74- 78%), depressjoni (59- 69%) u pazjenti li kienu qed jieħdu mediċini kontra il- pressjoni għolja fl- istess ħin (62- 73%).
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
10 Waqt prova klinika f’ pazjenti b’ dijabete mellitus, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil wasslu għal titjib sinifikattiv fil- punteġġ tal- funzjoni erettili, fil- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal- plaċebo.
The response rates for the ability to obtain and maintain an erection was 61% and 49% on 10 mg and 64% and 54% on 20 mg vardenafil compared to 36% and 23% on placebo for patients who completed three months treatment.
Għall- pazjenti li temmew tliet xhur ta ’ kura, r- rati ta ’ ħila biex tintlaħaq u tinżamm erezzjoni tal- pene kienu ta ’ 61% u 49% b’ 10 mg u 64% u 54% b’ 20 mg vardenafil, meta mqabbla ma ’ 36% u 23% bil- plaċebo.
In a clinical trial in post-prostatectomy patients, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
Waqt prova klinika f’ pazjenti wara li tneħħitilhom il- prostata, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil tejjbu b’ mod sinifikanti il- punteġġ tal- funzjoni erettili, l- ħila biex tintlaħaq u tinżamm erezzjoni tal - pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal - plaċebo.
The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.
Għall- pazjenti li temmew tliet xhur ta ’ kura, r- rati tal- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene kienu ta ’ 47% u 37% b’ 10 mg u 48% u 34% b’ 20 mg vardenafil, meta mqabbla ma ’ 22% u 10% bil- plaċebo.
In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo.
Fi prova klinika b’ doża flessibli f’ pazjenti b’ korriment fis- sinsla ta’ dahar, vardenafil tejjeb b’ mod sinifikattiv id- domain score tal- funzjoni erettili, l- ħila li tintlaħaq u tinżamm erezzjoni għal- tul ta ’ żmien biżżejjed sabiex jirnexxi l- att sesswali u l- ebgħusija tal- pene, meta mqabbel mal- plaċebo.
The number of patients who returned to a normal IIEF domain score (> 26) were 53% on vardenafil compared to 9% on placebo.
In - numru ta ’ pazjenti li reġgħa kellhom IIEF domain score normali (> 26) kienu 53% b’ vardenafil meta mqabbel ma ’ 9% bil- plaċebo.
The response rates for the ability to obtain and maintain an erection were 76% and 59% on vardenafil compared to 41% and 22% on placebo for patients who completed three months treatment which were clinically and statistically significant (p < 0.001).
Għall- pazjenti li temmew tliet xhur ta ’ kura li kienu klinikament u statistikament sinifikanti (p < 0. 001), ir- rati ta ’ rispons għall- ħila biex tintlaħaq u tinżamm erezzjoni kienu ta ’ 76% u 59% b’ vardenafil meta mqabbel ma ’ 41% u 22% bil- plaċebo.
The safety and efficacy of vardenafil was maintained in long term studies.
Vardenafil żamm l- effikaċja u s- sigurtà tiegħu fi studji li damu żmien twil.
Vardenafil is rapidly absorbed with maximum observed plasma concentrations reached in some men as early as 15 minutes after oral administration.
Vardenafil huwa assorbit malajr, tant li f’ xi rġiel, l- ogħla konċentrazzjonijiet fil- plażma jintlaħqu wara biss 15- il minuta li tingħata id- doża mill- ħalq.
However, 90% of the time, maximum plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Madankollu, f’ 90% tad- drabi, fi stat sajjem, l- ogħla konċentrazzjonijiet fil- plażma jintlaħqu minn 30 sa 120 minuta (medjan 60 minuta) wara li tingħata d - doża mill- ħalq.
The mean absolute oral bioavailability is 15%.
Il- biodisponibiltà medja assoluta hija 15%.
After oral dosing of vardenafil AUC and Cmax increase almost dose proportionally over the recommended dose range (5 – 20 mg).
Wara doża mill- ħalq, l- AUC u s- Cmax ta ’ vardenafil jiżdiedu kważi proporzjonalment mad- doża fil- firxa tad- doża rakkomandata (5 - 20 mg).
When vardenafil is taken with a high fat meal (containing 57% fat), the rate of absorption is reduced, with an increase in the median tmax of 1 hour and a mean reduction in Cmax of 20%.
Meta vardenafil jittieħed ma ’ ikla b’ kontenut għoli ta ’ xaħmijiet (57% xaħam), ir- rata ta ’ assorbiment tonqos, b’ konsegwenza li tmax medjana tiżdiet b’ siegħa u Cmax tonqos b’ medja ta ’ 20%.
Vardenafil AUC is not affected.
L- AUC ta ’ vardenafil ma tinbidilx.
After a meal containing 30% fat, the rate and extent of absorption of vardenafil (tmax, Cmax and AUC) are unchanged compared to administration under fasting conditions.
Wara ikla li jkun fiha 30% xaħmijiet, ir- rata u l- kwantità ta ’ assorbiment ta ’ vardenafil (tmax, Cmax u AUC) ma jinbidlux meta mqabbla ma ’ pazjenti sajma.
The mean steady state volume of distribution for vardenafil is 208 l, indicating distribution into the tissues.
Il- volum ta ’ distribuzzjoni medju fi stat stabbli huwa ta ’ 208 lt. li jindika distribuzzjoni fit- tessuti.
Vardenafil and its major circulating metabolite (M1) are highly bound to plasma proteins (approximately 95% for vardenafil or M1).
Vardenafil u l- metabolit prinċipali tiegħu li jkun fiċ- ċirkolazzjoni (M1), huma marbuta b’ mod qawwi mal- proteini tal- plażma (madwar 95% għal vardenafil jew M1).
For vardenafil as well as M1, protein binding is independent of total drug concentrations.
Kemm għal vardenafil, kif ukoll għal M1, it- twaħħil mal- proteini mhux dipendenti mill- konċentrazzjonijiet totali tal- mediċina.
Based on measurements of vardenafil in semen of healthy subjects 90 minutes after dosing, not more than 0.00012% of the administered dose may appear in the semen of patients.
Minn kejl li sar fuq il- kwantità ta ’ vardenafil fis- semen ta ’ voluntiera b’ saħħithom, 90 minuta wara li ngħataw id- doża, mhux aktar minn 0. 00012% tad- doża li tingħata tista ’ tidher fis- semen tal- pazjenti.
Vardenafil is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms.
Vardenafil huwa metabolizzat fil- parti l- kbira ġol- fwied permezz ta ’ l- iżoforma 3A4 taċ- ċitokromju P450 (CYP) b’ xi kontribuzzjoni mill- iżoformi CYP3A5 u CYP2C.
In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half life of approximately 4 hours.
Fil- bnedmin, il- metabolit prinċipali li jiċċirkola fid- demm (M1) jifforma minn desethylation ta ’ vardenafil u jkompli jiġi metabolizzat, b’ half life ta ’ eliminazzjoni mill- plażma ta ’ madwar 4 sigħat.
Parts of M1 are in the form of the glucuronide in systemic circulation.
11 Partijiet minn M1 jinsabu bħala glucuronide fiċ- ċirkolazzjoni sistemika.
Metabolite M1 shows a phosphodiesterase selectivity profile similar to vardenafil and an in vitro potency for phosphodiesterase type 5 of approximately 28% compared to vardenafil, resulting in an efficacy contribution of about 7%.
Il- metabolit (M1) għandu profil ta ’ selettività għal phosphodiesetrase li jixbaħ ħafna dak ta ’ vardenafil u qawwa in vitro għal phosphodiesetrase tip 5 ta ’ madwar 28% meta mqabbel ma ’ vardenafil, li jissarraf f’ madwar 7% tal - kontribut għall- effikaċja ’.
The total body clearance of vardenafil is 56 l/ h with a resultant terminal half life of approximately 4-5 hours.
It- tneħħija totali ta ’ vardenafil mill- ġisem hija ta ’ 56 l/ h li tirriżulta f’ half life terminali ta ’ madwar 4- 5 sigħat.
After oral administration, vardenafil is excreted as metabolites predominantly in the faeces (approximately 91-95% of the administered dose) and to a lesser extent in the urine (approximately 2-6% of the administered dose).
Wara għoti mill- ħalq, vardenafil jitneħħa l- aktar bħala metaboliti fl- ippurgar (madwar 91- 95% tad- doża li tingħata), u b’ mod anqas fl- urina (madwar 2- 6% tad- doża li tingħata).
Pharmacokinetics in special patient groups
Farmakokinetika fi gruppi speċjali ta ’ pazjenti
Elderly Hepatic clearance of vardenafil in healthy elderly volunteers (65 years and over) was reduced as compared to healthy younger volunteers (18 - 45 years).
Anzjani It- tneħħija mill- fwied ta ’ vardenafil f’ voluntiera anzjani b’ saħħithom (minn 65 sena ’ l fuq) kienet inqas meta mqabbla ma ’ voluntiera iżgħar b’ saħħithom (18- 45 sena).
On average elderly males had a 52% higher AUC, and a 34% higher Cmax than younger males (see section 4.2).
Irġiel anzjani kellhom AUC ogħla b’ medja ta ’ 52% u Cmax ogħla b’ 34% meta mqabbla ma ’ rġiel iżgħar (ara sezzjoni 4. 2).
Renal insufficiency In volunteers with mild to moderate renal impairment (creatinine clearance 30 – 80 ml/ min), the pharmacokinetics of vardenafil were similar to that of a normal renal function control group.
Insuffiċjenza renali F’ voluntiera b’ indeboliment renali ħafif għal moderat (tneħħija tal- krejatinina 30- 80 ml/ min), il - farmakokinetika ta ’ vardenafil kienet simili għal dik tal- grupp ta ’ kontroll b’ funzjoni renali normali.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment.
F’ voluntiera b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min), l- AUC medja żdiedet b’ 21% u s- Cmax naqset b’ 34% meta mqabbla ma ’ voluntiera b’ funzjoni renali normali.
11 vardenafil exposure (AUC and Cmax) (see section 4.2).
Ma nstabet l - ebda korrelazzjoni statistikament sinifikanti bejn it- tneħħija tal- krejatinina u l- użu ta ’ vardenafil (AUC u Cmax) (ara sezzjoni 4. 2).
Vardenafil pharmacokinetics has not been studied in patients requiring dialysis (see section 4.3).
Il- farmakokinetika ta ’ vardenafil ma ġietx studjata f’ pazjenti li jinħtieġu d - dijalisi (ara sezzjoni 4. 3).
Hepatic insufficiency In patients with mild to moderate hepatic impairment (Child-Pugh A and B), the clearance of vardenafil was reduced in proportion to the degree of hepatic impairment.
Insuffiċjenza tal- fwied F’ pazjenti b’ indeboliment tal- fwied ħafif sa moderat (Child- Pugh A u B), it- tneħħija mill- ġisem ta ’ vardenafil naqset proporzjonalment ma ’ kemm il- fwied ma kienx qed jaħdem.
In patients with mild hepatic impairment (Child-Pugh A), the mean AUC and Cmax increased 17% and 22% respectively, compared to healthy control subjects.
F’ pazjenti li kellhom indeboliment tal- fwied ħafif (Child- Pugh A), l- AUC medja għoliet b’ 17% u s- Cmax għoliet b ’ 22% meta mqabbla ma ’ grupp ta ’ kontroll ta ’ rġiel b’ saħħithom.
In patients with moderate impairment (Child-Pugh B), the mean AUC and Cmax increased 160% and 133% respectively, compared to healthy control subjects (see section 4.2).
F’ pazjenti li kellhom indeboliment moderat tal- fwied (Child- Pugh B), l- AUC medja għoliet b’ 160% u s- Cmax għoliet b’ 133% meta mqabbla ma ’ grupp ta ’ kontroll ta ’ rġiel b’ saħħithom (ara sezzjoni 4. 3).
The pharmacokinetics of vardenafil in patients with severely impaired hepatic function (Child-Pugh C) has not been studied (see section 4.3).
Il- farmakokinetika ta ’ vardenafil ma ġietx studjata f’ pazjenti b’ indeboliment sever fil- funzjoni tal- fwied (Child- Pugh C) (ara sezzjoni 4. 3).
5.3 Preclinical safety data
3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Informazzjoni mhux klinika magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il- ġeni, riskju ta ’ kanċer, effett tossiku fuq is- sistema riproduttiva, ma turi l- ebda periklu speċjali għall- bnedmin.
6.1 List of excipients
1 Lista ta ’ sustanzi mhux attivi
Tablet core: crospovidone magnesium stearate microcrystalline cellulose silica, colloidal anhydrous
Il- qalba tal- pillola: crospovidone, magnesium stearate, microcrystalline cellulose, silica, colloidal anhydrous.
Film coat: macrogol 400 hypromellose titanium dioxide (E171) ferric oxide yellow (E172) ferric oxide red (E172)
12 Kisja b’ rita: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172)
6.2 Incompatibilities
2 Inkompatibilitajiet
6.3 Shelf life
3 Żmien kemm idum tajjeb il- prodott mediċinali
6.4 Special precautions for storage
4 Prekawzjonijiet speċjali għall- ħażna
This medicinal product does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ta ’ ħażna speċjali.
6.5 Nature and contents of container
5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
PP/ Aluminium foil blisters in cartons of 2, 4, 8 and 12 tablets.
Folja magħmula minn fojl ta ’ PP/ aluminju f’ kaxxi ta ’ 2, 4, 8 jew 12- il pillola.
6.6 Special precautions for disposal
6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema
Bayer AG, D-51368 Leverkusen, Germany
Bayer AG, D- 51368 Leverkusen, Il- Ġermanja.
6 March 2003
6 ta ’ Marzu 2003
6 March 2008
6 ta ’ Marzu 2008
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
Levitra 10 mg film-coated tablets
Levitra 10 mg, Pilloli miksija b’ rita.
Each tablet contains 10 mg of vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 10 mg ta ’ vardenafil (bħala hydrochloride trihydrate).
Orange round tablets marked with the BAYER-cross on one side and “ 10 ” on the other side.
Pillola tonda, oranġjo immarkata b' salib tal- BAYER fuq naħa waħda u '10' fuq in- naħa l- oħra.
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Problema ta ’ l- erezzjoni tal- penehija l - inabbiltà biex tintlaħaq jew tinżamm erezzjoni tal- pene suffiċjenti biex l- att sesswali iseħħ b’ mod sodisfaċenti.
(see sections 4.3 and 5.2).
L- għola doża rakkomandata f’ pazjenti b’ indeboliment tal- fwied moderat (Child- Pugh B) hija ta ’ 10 mg (ara sezzjonijiet 4. 3 u 5. 2).
14 Use in patients with renal impairment
14 Użu f' pazjenti b’ indeboliment renali.
- - -
15
severe hepatic impairment (Child-Pugh C), end stage renal disease requiring dialysis, hypotension (blood pressure < 90/ 50 mmHg),
pressjoni baxxa (pressjoni tad- demm < 90/ 50mmHg),
- recent history of stroke or myocardial infarction (within the last 6 months),
puplesija jew infart mijokardijaku reċenti (fl- aħħar 6 xhur),
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.
Pazjenti li ġħandhom imblukkar tal- ħruġ mill - ventrikulu tax- xellug, eż., stenożi ta ’ l- aorta, stenożi subaortika ipertrofika idjopatika, jistgħu jkunu sensittivi għall- azzjoni ta ’ vażodilataturi inklużi impedituri ta ’ phosphodiesterase tat- tip 5.
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
Sustanzi għall- kura tal- problema ta ’ l- erezzjoni tal- pene għandhom jintuzaw b' aktar attenzjoni f' pazjenti b' deformazzjoni anatomika tal- pene (bħal angulazzjoni, fibrożi fil- korpus kavernożum jew il- marda ta 'Peyronie), jew f’ pazjenti li jsofru minn mard li minħabba fih hemm probabilità akbar li jkollhom prijapiżmu (bħal anemija sickle cell, majeloma multipla jew lewkimja).
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.
16 Ġie muri li doża waħda mill- ħalq ta ’ 10 mg u 80 mg vardenafil itawwlu l- interval QTc b’ medja ta ’ 8 msec u 10 msec, rispettivament.
In vitro studies with human platelets indicate that vardenafil has no antiaggregatory effect on its own, but at high (super-therapeutic) concentrations vardenafil potentiates the antiaggregatory effect of the nitric oxide donor sodium nitroprusside.
Studji in- vitro bi plejtlits umani jindikaw li vardenafil waħdu ma jwaqqafx l- aggregazzjoni tagħhom, iżda livelli għoljin ta ’ vardenafil (livell ogħla mid- doża terapewtika) iqawwu l- effett kontra l - aggregazzjoni ta ’ sodium nitroprusside, li huwa donatur ta ’ nitric oxide.
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
Fil- bnedmin, vardenafil m’ għandu l- ebda effett fuq il- ħin ta ’ kemm idum ħiereġ id- demm (fsada) la waħdu, u lanqas meta mħallat ma ’ acetylsalicylic acid (ara sezzjoni 4. 5).
16 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
Although specific interaction studies have not been conducted, the concomitant use of other potent CYP3A4 inhibitors (such as itraconazole) can be expected to produce vardenafil plasma levels comparable to those produced by ketoconazole.
17 Għalkemm għadhom ma sarux studji specifiċi dwar l- effetti ta ’ mediċini oħra fuq vardenafil, l- użu fl - istess waqt ta ’ inibituri qawwija oħra ta ’ CYP3A4 (eżempju itraconazole) huma mistennija li jwasslu għal livelli ta ’ vardenafil fil- plażma bħal dawk li jintlaħqu b’ ketoconazole.
In men older than 75 years the concomitant use of vardenafil with itraconazole or ketoconazole is contraindicated (see section 4.3).
F’ irġiel akbar minn 75 sena, l- użu ta ’ vardenafil flimkien ma ’ itraconazole jew ketoconazole huwa kontra- indikat (ara sezzjoni 4. 3).
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 CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
Għalkemm ma sarux studji speċifiċi dwar l- interazzjoni għall- mediċini kollha, analiżi farmakokinetika tal- popolazzjoni ma wriet l- ebda effett fuq il- farmakokinetika ta 'vardenafil meta ngħata flimkien ma ’ dawn il- mediċini: acetylsalicylic acid, inibituri ACE, beta- blokers, inibituri ħfief ta' CYP 3A4, dijuretiċi, u prodotti mediċinali għall- kura tad- dijabete (sulfonylureas u metformin).
17 Effects of vardenafil on other medicinal products
Effett ta 'vardenafil fuq mediċini oħra
Based on the results of interaction studies conducted with vardenafil in patients with benign prostatic hyperplasia (BPH) on stable tamsulosin or terazosin therapy: • When vardenafil was given at doses of 5, 10 or 20 mg on a background of stable therapy with tamsulosin, there was no symptomatic reduction in blood pressure, although 3/ 21 tamsulosin treated subjects exhibited transient standing systolic blood pressures of less than 85 mmHg. • When vardenafil 5 mg was given simultaneously with terazosin 5 or 10 mg, one of 21 patients experienced symptomatic postural hypotension.
18 Ibbażat fuq riżultati ta ’ studji ta ’ interazzjoni li saru b’ vardenafil f’ pazjenti b’ iperplażja beninna tal - prostata (BPH) li huma stabbli fuq kura ta ’ tamsulosin jew terazosin: • Meta vardenafil ingħata f’ dożi ta ’ 5, 10 jew 20 mg f’ pazjenti li huma diġa ’ stabbli fuq terapija b’ tamsulosin, ma kien hemm l- ebda tnaqqis sintomatiku fil- pressjoni tad- demm, għalkemm 3/ 21 pazjent kkurat b’ tamsulosin kellhom pressjoni tad- demm sistolika temporanja bil- wieqfa ta ’ anqas minn 85 mmHg • Meta vardenafil 5mg ingħata flimkien ma ’ terazosin 5 jew 10mg, wieħed minn 21 pazjent kellu pressjoni baxxa sintomatika bil- wieqfa.
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Vardenafil (10 mg) ma tawwalx il- ħin ta ’ fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
Levitra is not indicated for use by women.
Levitra mhux indikat għall- użu minn nisa.
There are no studies of vardenafil in pregnant women.
M’ hemmx studji ta ’ vardenafil f’ nisa tqal.
18 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
As dizziness and abnormal vision have been reported in clinical trials with vardenafil, patients should be aware of how they react to Levitra, before driving or operating machinery.
Fi provi kliniċi dwar vardenafil kienu rrappurtati sturdament u problemi fil- vista, għalhekk il- pazjenti għandhom jaraw x’ reazzjoni jkollhom għal Levitra qabel isuqu jew iħaddmu xi magni.
Very Common (≥ 1/ 10)
Klassifika tal -
Common (≥ 1/ 100 and < 1/ 10)
(≥1% / 100 u
Uncommon (≥ 1/ 1,000 and < 1/ 100)*
(≥0. 1/ 1, 000% u
Rare (≥ 1/ 10,000 and < 1/ 1,000)*
(≥10. 0/ 10, 0001
Not Known (can not be estimated from available data)
Magħruf (ma
Immune System Disorders
(≥1/ 100)
Hypersensitivity
< 1/ 10%)
Psychiatric Disorders
< 1% / 100) *
Anxiety
tistax
Nervous System Headache Disorders
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi fis - Sistema Immuni Disturbi Psikjatriċi
Dizziness
Uġigħ ta 'ras
Somnolence
Sturdament
Related Investigations
Disturbi fl - Għajnejn inkluż Investigazzjonijiet Relatati
Visual brightness) Chromatopsia Conjunctivitis Blurred vision
Produzzjoni tad - dmugħ tiżdied Problemi fil - vista (inkluż vista għad- dawl aktar qawwija) Chromatopsia Konġuntivite Vista mċajpra
Cardiac Disorders incl. related Investigations
Disturbi Kardijaċi inkluż Investigazzjonijiet Relatati
Tachycardia Palpitations
Takikardja Palpitazzjonijiet
Angina Pectoris Myocardial ischemia
Anġina Pectoris Iskemja mijokardijaka
Myocardial Infarction
Infart mijokardijaku
Vascular Flushing Disorders incl. related Investigations
Disturbi Vaskulari inkluz Investigazzjonijiet Relatati
Hypertension Hypotension Orthostatic Hypotension
Pressjoni Għolja Pressjoni Baxxa Ipotensjoni Ortostatika
Respiratory, Thoracic and Mediastinal Disorders
Disturbi Respiratorji, Toraċiċi u Medjastinali
Nasal Congestion
Imnieħer Miżdud
Dyspnoea Epistaxis
Qtugħ ta ’ nifs Epistassi
Laryngeal oedema
Edima fil- larinġi
Gastrointestinal Disorders incl. related Investigations
Disturbi Gastro - intestinali inkluż Investigazzjonijiet Relatati
19 System Organ Class
Sistema tal -
Skin and Subcutaneous Tissue Disorders
(≥1/ 100)
Photosensitivity reaction Face oedema Rash
< 1% / 100) *
Related Investigations
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi Muskolu - skeltrali u tal - Connective Tissue inkluz Investigazzjonijiet Relatati
Blood creatine phosphokinase increased Myalgia Back Pain
Żjieda fil - creatine phosphokinase tad- demm Mijalġja Uġigħ fid- dahar
Muscle Rigidity
Riġidità fil - muskoli
Reproductive System and Breast Disorders
Disturbi fis- sistema Riproduttiva u fis - Sider
Priapism Erections increased (prolonged or painful erections)
Priapiżmu Erezzjonijiet miżjuda (Erezzjonijiet li jdumu jew bl - uġigħ)
Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post marketing in temporal association with another medicinal product in this class.
Disturbi vaskulari: każijiet ta ’ mard kardjovaskulari serju li kienu jinkludu emorraġija ċerebrovaskulari, mewta f' daqqa ikkawżata minn problemi fil- qalb, attakk iskemiku temporanju, anġina mhux stabbli u arritmija ventrikulari, kienu rrappurtati wara li l- prodott mediċinali ħareġ għall- bejgħ, fl- istess perijodu ta ’ żmien ma ’ prodott mediċinali ieħor f’ din il- klassi.
Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
21 Vardenafil huwa terapija li tingħata mill- ħalq biex ittejjeb il- funzjoni ta ’ l- erezzjoni tal- pene f’ irġiel bi problema fil- funzjoni erettili.
20 Penile erection is a haemodynamic process.
L- erezzjoni tal- pene hija proċess emodinamiku.
The mean maximum decreases in supine systolic blood pressure following 20 mg and 40 mg vardenafil were – 6.9 mmHg under 20 mg and – 4.3 mmHg under 40 mg of vardeanfil, when compared to placebo.
3 mmHg meta ngħatat 40 mg ta 'vardenafil.
These effects are consistent with the vasodilatory effects of PDE5-inhibitors and are probably due to increased cGMP levels in vascular smooth muscle cells.
Dawn l- effetti huma konsistenti ma ’ l- effetti vażodilatatorji ta ’ l- inibituri ta ’ PDE5 u probabbilment dan iseħħ minħabba ż- żjieda fil- livelli ta ’ cGMP fiċ- ċelloli vaskulari tal- muskoli lixxi.
Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
Doża waħda u dożi ripetuti sa 40 mg ta ’ vardenafil mogħtija mill- ħalq, m’ għamlu l- ebda bidla klinikament relevanti fl- ECG ta ’ rġiel voluntiera b' saħħithom.
In a separate postmarketing study of 44 healthy volunteers, single doses of 10 mg vardenafil or 50 mg sildenafil were co-administered concomitantly with 400 mg gatifloxacin, a drug with comparable QT effect.
Fi studju separat ta ’ wara t- tqegħid fuq is- suq f ’ 44 volontiera b ’ saħħithom, dożi individwali ta ’ 10mg varadenafil jew ta ’ 50mg sildenafil ġew mogħtija flimkien ma ’ 400mg gatifloxacin, mediċina b ’ effett QT komparabbli.
Further information on clinical trials
22 Aktar informazzjoni dwar provi kliniċi
The following groups were not well represented in clinical trials: elderly (> 75 years, 2.4%), and patients with
Il- gruppi ta 'pazjenti li ġejjin ma kienux rappreżentati tajjeb fil- provi kliniċi: anzjani (> 75 sena, 2.
21 certain cardiovascular conditions (see section 4.3).
4%), u pazjenti b' ċerti tipi ta ’ mard kardjovaskulari (ara sezzjoni 4. 3).
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
Waqt prova klinika f’ pazjenti b’ dijabete mellitus, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil wasslu għal titjib sinifikattiv fil- punteġġ tal- funzjoni erettili, fil- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal- plaċebo.
The safety and efficacy of vardenafil was maintained in long term studies.
23 Vardenafil żamm l- effikaċja u s- sigurtà tiegħu fi studji li damu żmien twil.
22 Distribution
Distribuzzjoni
Parts of M1 are in the form of the glucuronide in systemic circulation.
Partijiet minn M1 jinsabu bħala glucuronide fiċ- ċirkolazzjoni sistemika.
In volunteers with severe renal impairment (creatinine clearance < 30 ml/ min) the mean AUC was increased by 21% and the mean Cmax decreased by 23%, compared to volunteers with no renal impairment.
F’ voluntiera b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min), l- AUC medja żdiedet
No statistically significant correlation was observed between creatinine clearance and vardenafil exposure (AUC and Cmax) (see section 4.2).
Ma nstabet l - ebda korrelazzjoni statistikament sinifikanti bejn it- tneħħija tal- krejatinina u l- użu ta ’ vardenafil (AUC u Cmax) (ara sezzjoni 4. 2).
23 5.3 Preclinical safety data
3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Film coat: macrogol 400 hypromellose titanium dioxide (E171) ferric oxide yellow (E172) ferric oxide red (E172)
Kisja b’ rita: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172)
Levitra 20 mg film-coated tablets
Levitra 20 mg, Pilloli miksija b’ rita.
Each tablet contains 20 mg of vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 20 mg ta ’ vardenafil (bħala hydrochloride trihydrate).
Orange round tablets marked with the BAYER-cross on one side and “ 20 ” on the other side.
Pillola tonda, oranġjo b' salib tal- BAYER fuq naħa u '20' fuq in- naħa l- oħra.
26 Use in patients with renal impairment
27 Użu f' pazjenti b’ indeboliment renali.
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).
Meta jingħata flimkien ma ’ inibituri tas- CYP3A4 erythromycin jew clarithromycin, id- doża ta ’ vardenafil m' għandhiex tkun aktar minn 5 mg (ara sezzjoni 4. 5).
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
28 ventrikulu tax- xellug, eż., stenożi ta ’ l- aorta, stenożi subaortika ipertrofika idjopatika, jistgħu jkunu sensittivi għall- azzjoni ta ’ vażodilataturi inklużi impedituri ta ’ phosphodiesterase tat- tip 5.
27 who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sustanzi għall- kura tal- problema ta ’ l- erezzjoni tal- pene għandhom jintuzaw b' aktar attenzjoni f' pazjenti b' deformazzjoni anatomika tal- pene (bħal angulazzjoni, fibrożi fil- korpus kavernożum jew il- marda ta 'Peyronie), jew f’ pazjenti li jsofru minn mard li minħabba fih hemm probabilità akbar li jkollhom prijapiżmu (bħal anemija sickle cell, majeloma multipla jew lewkimja).
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
29 m’ għandu l- ebda effett fuq il- ħin ta ’ kemm idum ħiereġ id- demm (fsada) la waħdu, u lanqas meta mħallat ma ’ acetylsalicylic acid (ara sezzjoni 4. 5).
28 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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 CYP 3A4 inhibitors, diuretics and medicinal products for the treatment of diabetes (sulfonylureas and metformin).
30 Għalkemm ma sarux studji speċifiċi dwar l- interazzjoni għall- mediċini kollha, analiżi farmakokinetika tal- popolazzjoni ma wriet l- ebda effett fuq il- farmakokinetika ta 'vardenafil meta ngħata flimkien ma ’ dawn il- mediċini: acetylsalicylic acid, inibituri ACE, beta- blokers, inibituri ħfief ta' CYP 3A4, dijuretiċi, u prodotti mediċinali għall- kura tad- dijabete (sulfonylureas u metformin).
29 Effects of vardenafil on other medicinal products
Effett ta 'vardenafil fuq mediċini oħra
No effect on blood pressure was observed when nitroglycerin was taken 24 hours after administration of a single dose of vardenafil 20 mg.
Ma kien osservat l- ebda effett fuq il - pressjoni tad- demm meta nitroglicerine ittieħed 24 siegħa wara l- għoti ta ’ doza waħda ta ’ 20mg vardenafil.
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
31 Vardenafil (10 mg) ma tawwalx il- ħin ta ’ fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
30 4.7 Effects on ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Very
Komuni Komuni
Not Known
Klassifika tal -
Class
Ħafna
Common (≥ 1/ 100 and (≥ 1/ 10) < 1/ 10)
(≥1% / 100 u
(≥ 1/ 1,000 and < 1/ 100)*
(≥0. 1/ 1, 000% u
(≥ 1/ 10,000 and < 1/ 1,000)*
(≥10. 0/ 10, 0001
(can not be estimated from available data)
Magħruf (ma
Nervous System Headache Dizziness Disorders
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi fis - Sistema Immuni Disturbi Psikjatriċi
Somnolence
Sensittività eċċessiva Ansjetà
Syncope Seizure Transient global amnesia
Disturbi fis - Sistema Nervuża
Eye Disorders incl.
Uġigħ ta 'ras
Related Investigations
Sturdament
Lacrimation increased Visual Disturbance (incl.
Disturbi fl - Għajnejn inkluż Investigazzjonijiet Relatati
Cardiac Disorders incl. related Investigations
32
Vascular Flushing Disorders incl. related Investigations
Mhux
Respiratory, Nasal Thoracic and Congestion Mediastinal Disorders
Ħafna
Dyspnoea Epistaxis
(≥1% / 100 u
Laryngeal oedema
(≥0. 1/ 1, 000% u
Nausea related Investigations
(≥10. 0/ 10, 0001
Abnormal liver function tests GGTP increased
Magħruf (ma
31
Organi
System Organ
(≥1/ 100)
Very
< 1/ 10%)
Common
< 1% / 100) *
Uncommon
% u
Rare
tistax
Not Known
Infart mijokardijaku
Class
Fawra
Common (≥ 1/ 100 and (≥ 1/ 10) < 1/ 10)
Disturbi Respiratorji, Toraċiċi u Medjastinali
(≥ 1/ 1,000 and < 1/ 100)*
Imnieħer Miżdud
(≥ 1/ 10,000 and < 1/ 1,000)*
Qtugħ ta ’ nifs Epistassi
(can not be estimated from available data)
Testijiet tal - funzjoni tal - fwied mhux normali Żjieda fil- GGTP
Skin and Subcutaneous Tissue Disorders
Disturbi fil- Ġilda u Tessuti ta ’ taħt il - ġilda
Related Investigations
Disturbi Muskolu - skeltrali u tal - Connective Tissue inkluz Investigazzjonijiet Relatati
Serious cardiovascular events, including cerebrovascular haemorrhage, sudden cardiac death, transient ischaemic attack, unstable angina and ventricular arrhythmia have been reported post marketing in temporal association with another medicinal product in this class.
33 ventrikulari, kienu rrappurtati wara li l- prodott mediċinali ħareġ għall- bejgħ, fl- istess perijodu ta ’ żmien ma ’ prodott mediċinali ieħor f’ din il- klassi.
Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction.
Vardenafil huwa terapija li tingħata mill- ħalq biex ittejjeb il- funzjoni ta ’ l- erezzjoni tal- pene f’ irġiel bi problema fil- funzjoni erettili.
32 Penile erection is a haemodynamic process.
L- erezzjoni tal- pene hija proċess emodinamiku.
Single and multiple oral doses of vardenafil up to 40 mg produced no clinically relevant changes in the ECGs of normal male volunteers.
34 dożi ripetuti sa 40 mg ta ’ vardenafil mogħtija mill- ħalq, m’ għamlu l- ebda bidla klinikament relevanti fl- ECG ta ’ rġiel voluntiera b' saħħithom.
Further information on clinical trials
Aktar informazzjoni dwar provi kliniċi
33 certain cardiovascular conditions (see section 4.3).
4%), u pazjenti b' ċerti tipi ta ’ mard kardjovaskulari (ara sezzjoni 4. 3).
In a clinical trial in patients with diabetes mellitus, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo at vardenafil doses of 10 mg and 20 mg.
35 Waqt prova klinika f’ pazjenti b’ dijabete mellitus, dożi ta ’ 10 mg u 20 mg ta ’ vardenafil wasslu għal titjib sinifikattiv fil- punteġġ tal- funzjoni erettili, fil- ħila biex tintlaħaq u tinżamm erezzjoni tal- pene għal tul ta ’ ħin biżżejjed biex jirnexxi l- att sesswali u rigidita ’ tal- pene, meta mqabbla mal- plaċebo.
34 Distribution
Distribuzzjoni
In humans the one major circulating metabolite (M1) results from desethylation of vardenafil and is subject to further metabolism with a plasma elimination half life of approximately 4 hours.
36 Fil- bnedmin, il- metabolit prinċipali li jiċċirkola fid- demm (M1) jifforma minn desethylation ta ’ vardenafil u jkompli jiġi metabolizzat, b’ half life ta ’ eliminazzjoni mill- plażma ta ’ madwar 4 sigħat.
35 5.3 Preclinical safety data
3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- medicina
Film coat: macrogol 400 hypromellose titanium dioxide (E171) ferric oxide yellow (E172) ferric oxide red (E172)
37 Kisja b’ rita: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172)
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. LevitraLevitraLevitraLevitra
38 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Bayer HealthCare AG D-51368 Leverkusen Germany
Il- Ġermanja
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCTS
• KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
Levitra 5 mg film-coated tablets vardenafil
Levitra 5 mg, Pilloli miksija b’ rita vardenafil
Each tablet contains 5 mg vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 5 mg Vardenafil (bħala hydrochloride trihydrate).
2 film-coated tablets 4 film-coated tablets 8 film-coated tablets 12 film-coated tablets
2 pilloli miksija b’ rita 4 pilloli miksija b’ rita 8 pilloli miksija b’ rita 12- il pilloli miksija b’ rita
EXP
EXP {XX/ SSSS}
EU/ 1/ 03/ 248/ 001 2 Tablets EU/ 1/ 03/ 248/ 002 4 Tablets EU/ 1/ 03/ 248/ 003 8 Tablets EU/ 1/ 03/ 248/ 004 12 Tablets
EU/ 1/ 03/ 248/ 001 2 Pilloli EU/ 1/ 03/ 248/ 002 4 Pilloli EU/ 1/ 03/ 248/ 003 8 Pilloli EU/ 1/ 03/ 248/ 004 12- il Pillola
Lot
Lot {numru}
43 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Levitra 5 mg film-coated tablets vardenafil
Levitra 5 mg, pilloli miksija b’ rita vardenafil
Levitra 10 mg film-coated tablets vardenafil
Levitra 10 mg, Pilloli miksija b’ rita vardenafil
Each tablet contains 10 mg vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 10 mg Vardenafil (bħala hydrochloride trihydrate).
EU/ 1/ 03/ 248/ 005 2 Tablets EU/ 1/ 03/ 248/ 006 4 Tablets EU/ 1/ 03/ 248/ 007 8 Tablets EU/ 1/ 03/ 248/ 008 12 Tablets
EU/ 1/ 03/ 248/ 005 2 Pilloli EU/ 1/ 03/ 248/ 006 4 Pilloli EU/ 1/ 03/ 248/ 007 8 Pilloli EU/ 1/ 03/ 248/ 008 12- il Pillola
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Levitra 10 mg film-coated tablets vardenafil
Levitra 10 mg, pilloli miksija b’ rita vardenafil
Levitra 20 mg film-coated tablets vardenafil
Levitra 20 mg, Pilloli miksija b’ rita vardenafil
Each tablet contains 20 mg vardenafil (as hydrochloride trihydrate).
Kull pillola fiha 20 mg Vardenafil (bħala hydrochloride trihydrate).
EU/ 1/ 03/ 248/ 009 2 Tablets EU/ 1/ 03/ 248/ 010 4 Tablets EU/ 1/ 03/ 248/ 011 8 Tablets EU/ 1/ 03/ 248/ 012 12 Tablets
EU/ 1/ 03/ 248/ 009 2 Pilloli EU/ 1/ 03/ 248/ 010 4 Pilloli EU/ 1/ 03/ 248/ 011 8 Pilloli EU/ 1/ 03/ 248/ 012 12- il Pillola
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
Levitra 20 mg film-coated tablets vardenafil
Levitra 20 mg, pilloli miksija b’ rita vardenafil
Levitra 5 mg film-coated tablets Vardenafil
Levitra 5 mg pilloli miksija b’ rita Vardenafil
Read all of this leaflet carefully before you start using this medicine.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina
- If any of the side effects gets serious, or you notice any side effects not listed in this leaflet, please
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Levitra is and what it is used for 2.
X’ inhu Levitra u għalxiex jintuża 2.
Before you take Levitra 3.
Qabel ma tieħu Levitra 3.
How to take Levitra 4.
Kif għandek tieħu Levitra 4.
Possible side effects 5 How to store Levitra 6 Further information
Kif taħżen Levitra 6.
WHAT LEVITRA IS AND WHAT IT IS USED FOR
X’ INHU LEVITRA U GĦALXIEX JINTUŻA
Levitra belongs to a group of medicines which are used to treat difficulties in getting or keeping an erection (erectile dysfunction).
Levitra jagħmel parti minn grupp ta ’ mediċini użati fil- kura ta ’ diffikultajiet biex tintlaħaq jew biex tinżamm erezzjon (disfunzjoni erettili).