qanastek/EMEA-V3 huggingface dataset:
Sexual stimulation is still needed to produce an erection.
Xorta jibqa ’ l- bżonn ta ’ stimulazzjoni sesswali biex tiġi prodotta l- erezzjoni.
How has Levitra been studied?
Kif ġiet studjata Levitra?
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).
Levitra ġiet studjata f’ erba ’ studji ewlenin bis- sehem ta ’ 2, 431 pazjent ta ’ bejn 20 u 83 sena, fejn tqabbel mal- plaċebo (trattament finta).
One study was carried out in diabetic men and another in post-prostatectomy patients (men who have had their prostate gland removed).
Studju minnhom sar fi rġiel dijabetiċi u ieħor f’ pazjenti li tkun saritilhom prostatektomija (tneħħitilhom il- prostata).
The main measure of effectiveness was the ability to get and maintain an erection.
Il- mezz ewlieni tal- kejl ta ’ l- effikaċja kienet il - kapaċità li jilħqu u jżommu erezzjoni.
This was recorded in two questionnaires completed at home.
Dan ġie reġistrat f’ żewġ kwestjonarji li mtlew id- dar.
What benefit has Levitra shown during the studies?
X’ inhu l- benefiċċju ta ’ Levitra li ntwera f’ dawn l- istudji?
Levitra was significantly more effective than placebo for all measures in all studies.
Levitra kienet ferm iktar effikaċi mill- plaċebo fil- kejl kollu fl- istudji kollha.
What is the risk associated with Levitra?
X’ inhu r- riskju assoċjat ma ’ Levitra?
The most common side effects (seen in more than 1 patient in 10) are headache and flushing.
L- iktar effetti sekondarji komuni (li dehru f’ iktar minn pazjent 1 minn kull 10) huma l- uġigħ ta ’ ras u l- ħmura fil- wiċċ.
For the full list of all side effects reported with Levitra, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Levitra, ara l- Fuljett ta ’ Tagħrif.
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).
Levitra m’ għandhiex tintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal vardenafil jew għal xi sustanza oħra tiegħu, u minn persuni li ma jkunux rakkomandati li jieħdu sehem f’ attività sesswali (eż. rġiel b’ mard tal- qalb sever bħall- anġina instabbli jew falliment tal- qalb sever).
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).
Lanqas ma għandha tintuża minn pazjenti li xi darba kellhom telf tal- vista minħabba problema fil- fluss tad - demm lejn in- nervitura fl- għajn (newropatija ottika iskemika anterjuri mhux arteritika jew NAION).
Levitra should not be taken with nitrates (medicines used to treat angina).
Levitra ma għandhiex tittieħed man- nitrati (mediċini użati fit- trattament ta ’ l- anġina).
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.
Billi Levitra ma ġietx studjata f’ pazjenti b’ mard sever tal- fwied jew tal- kliewi, pazjenti li jkollhom problemi bil - pressjoni tad- demm, jew li tkun tathom puplesija jew attakk tal- qalb fl- aħħar sitt xhur, dawn il - pazjenti m’ għandhomx jużawha.
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).
Levitra ma għandhiex tintuża ma ’ xi mediċini, bħal ketoconazole u itraconazole (biex jittrattaw infezzjonijiet minn fungi) fi rġiel ta '' l fuq minn 75 sena, jew ritonavir jew indinavir (biex jittrattaw infezzjoni ta ’ l- HIV).
Why has Levitra been approved?
Għaliex ġiet approvata Levitra?
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.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Levitra użata għat- trattament ta ’ rġiel b' disfunzjoni erettili huma ikbar mir- riskji tiegħu.
The Committee recommended that Levitra be given marketing authorisation.
Il- Kumitat irrakkomanda li Levitra tingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Levitra:
Tagħrif ieħor dwar Levitra:
The European Commission granted a marketing authorisation valid throughout the European Union for Levitra to Bayer AG on 6 March 2003.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida fl- Unjoni Ewropea kollha għal Levitra lil Bayer AG fis- 6 ta ’ Marzu 2003.
The full EPAR for Levitra is available here.
L- EPAR sħiħ għal Levitra huwa disponibbli minn hawn.
Levitra 5 mg film-coated tablets
Levitra 5 mg, Pilloli miksija b’ rita.
For a full list of excipients, see section 6.1.
Kull pillola fiha 5 mg ta ’ vardenafil (bħala hydrochloride trihydrate).
Orange round tablets marked with the BAYER-cross on one side and “ 5 ” on the other side.
Pillola tonda, oranġjo immarkata b' salib tal- BAYER fuq naħa waħda u '5' fuq in- naħa l- oħra.
4.1 Therapeutic indications
1 Indikazzjonijiet terapewtiċi
Treatment of erectile dysfunction in adult men.
Kura għal problema ta ’ l- erezzjoni tal- pene fl- irġiel adulti.
Erectile dysfunction is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
Problema ta ’ l- erezzjoni tal- pene hija l - inabbiltà biex tintlaħaq jew tinżamm erezzjoni tal- pene suffiċjenti biex l- att sesswali iseħħ b’ mod sodisfaċenti.
In order for Levitra to be effective, sexual stimulation is required.
Biex Levitra ikun effettiv, hija meħtieġa stimulazzjoni sesswali.
Levitra is not indicated for use by women.
Levitra mhux indikat għal użu minn nisa.
4.2 Posology and method of administration
2 Pożoloġija u metodu ta ’ kif għandu jingħata
Use in adult men
Użu f’ irġiel adulti
The recommended dose is 10 mg taken as needed approximately 25 to 60 minutes before sexual activity.
Id- doża rakkomandata hija 10 mg, meħuda skond il- bżonn madwar 25 sa 60 minuta qabel l- att sesswali.
Based on efficacy and tolerability the dose may be increased to 20 mg or decreased to 5 mg.
Skond kemm tkun effettiva u tollerata mill- pazjent, id- doża tista ’ tiġi miżjuda għal 20 mg jew imnaqqsa għal 5 mg.
The maximum recommended dose is 20 mg.
Id- doża massima rakkomandata hija ta ’ 20 mg.
The maximum recommended dosing frequency is once per day.
Il- frekwenza massima ta ’ dożaġġ rakkomandata hija darba kuljum.
Levitra can be taken with or without food.
Levitra jista ’ jittieħed ma ’ l- ikel jew mingħajr ikel.
Use in elderly men
Jekk jittieħed ma ’ ikla li jkun fiha ħafna xaħmijiet, l- effett jista ’ jdum aktar biex jidher (ara sezzjoni 5. 2).
Dosage adjustments are not required in elderly patients.
Tibdil fid- dożaġġ mhux meħtieġ f’ pazjenti anzjani.
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).
Madankollu, żjieda sa doża massima ta ’ 20 mg għandha tiġi kkunsidrata b’ attenzjoni skond it- tolleranza ta ’ l- individwu (ara sezzjonijiet 4. 4 u 4. 8).
Use in children and adolescents
Użu fi tfal u adoloxxenti
Levitra is not indicated for individuals below 18 years of age.
Levitra mhux indikat għall- persuni taħt l- età ta ’ 18- il sena.
There is no relevant indication for use of Levitra in children.
Ma hemm l- ebda indikazzjoni rilevanti għall- użu ta ’ Levitra fit- tfal.
Use in patients with hepatic impairment
Użu f' pazjenti b’ indeboliment tal- fwied.
A starting dose of 5 mg should be considered in patients with mild and moderate hepatic impairment (Child-Pugh A-B).
F’ pazjenti b’ indeboliment ħafif jew moderat tal- fwied (Child- Pugh A- B), għandha tiġi kkunsidrata doża tal- bidu ta ’ 5 mg.
Based on tolerability and efficacy, the dose may subsequently be increased.
Skond kemm tkun tollerata u effettiva, id- doża tista ’ sussegwentement tiġi miżjuda.
The maximum dose recommended in patients with moderate hepatic impairment (Child-Pugh B) is 10 mg (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).
2 Use in patients with renal impairment
2 Użu f' pazjenti b’ indeboliment renali
No dosage adjustment is required in patients with mild to moderate renal impairment.
Tibdil fid- dożaġġ mhux neċessarju f’ pazjenti b’ indeboliment renali ħafif għal moderat.
In patients with severe renal impairment (creatinine clearance < 30 ml/ min), a starting dose of 5 mg should be considered.
F’ pazjenti b’ indeboliment renali sever (tneħħija tal- krejatinina < 30 ml/ min), għandha tiġi kkunsidrata doża tal- bidu ta ’ 5 mg.
Based on tolerability and efficacy the dose may be increased to 10 mg and 20 mg.
Skond kemm tkun ittollerata u effettiva, id- doża tista ’ tiġi miżjuda għal 10 mg u 20 mg.
Use in patients using other medicinal products
Użu f' pazjenti li qed jużaw mediċini oħra
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 bħal erythromycin jew clarithromycin, id- doża ta ’ vardenafil m' għandhiex tkun aktar minn 5 mg (ara sezzjoni 4. 5).
4.3 Contraindications
3 Kontra- indikazzjonijiet
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).
L- għoti ta ’ vardenafil flimkien ma ’ nitrates jew donaturi ta ’ nitric oxide (bħal amyl nitrate) f’ kull forma hija kontra- indikata (ara sezzjoni 4. 5 u 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).
Levitra huwa kontra- indikat f’ pazjenti li għandhom telf tal- vista f’ għajn waħda minħabba newropatija ottika anterjuri iskemika mhux arteritika (NAION), kemm jekk dan l- episodju kien konness ma ’ espożizzjoni minn qabel għal inibitur ta ’ PDE5 kif ukoll jekk le (ara sezzjoni 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]).
Sustanzi għall- kura tal- problema ta ’ l- erezzjoni tal- pene ġeneralment m' għandhomx jintużaw f’ irġiel li għalihom attività sesswali mhix irrakkomandata (eżempju, pazjenti b' disturbi kardjovaskulari severi, bħal anġina instabbli, jew insuffiċjenza kardijaka severa [New York Heart Association III jew IV])
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:
Is- sigurtà ta ’ vardenafil ma ġietx studjata fis- sottogruppi ta ’ pazjenti li ġejjin u għalhekk l- użu tiegħu huwa kontra- indikat sakemm ikun disponibbli aktar tagħrif:
- severe hepatic impairment (Child-Pugh C),
- indeboliment sever tal- fwied (Child- Pugh C),
- end stage renal disease requiring dialysis,
- marda tal- kliewi ta ’ l- aħħar stadju li teħtieġ dijalisi,
- 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),
- unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.
- anġina mhix stabbli, fejn hu magħruf li jkun hemm mard ereditarju ta ’ deġenerazzjoni tar- retina
Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.
L- użu ta ’ vardenafil flimkien ma ’ l- inibituri qawwija ta ’ CYP3A4, ketoconazole u itraconazole (il - forma li tittieħed mill- ħalq) huwa kontra- indikat f’ irġiel li għandhom ’ l fuq minn 75 sena.
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).
L- użu ta ’ vardenafil flimkien ma ’ inibituri tal- protease ta ’ l- HIV bħal ritanovir u indinavir huwa kontra- indikat, minħabba li huma inibituri qawwija ħafna ta ’ CYP3A4 (ara sezzjoni 4. 5).
4.4 Special warnings and precautions for use
4 Twissijiet speċjali u prekawzjonijiet għall- użu
A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Qabel tiġi kkunsidrata kura famakoloġika, għandu jitqies it- tagħrif tal- passat mediku u jsir eżami fiżiku tal- pazjent biex b’ hekk issir dijanjosi tal- problema ta ’ l- erezzjoni tal- pene u jinkixfu kawżi oħra li jistgħu iwasslu għal din il- problema.
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).
Qabel tinbeda xi tip ta ’ kura għal problema ta ’ l- erezzjoni tal- pene, it- tobba għandhom iqiesu il - kundizzjoni kardjovaskulari tal- pazjenti tagħhom peress li hemm ċertu riskju fuq il- qalb marbut ma ’ l - attività sesswali (ara sezzjoni 4. 3).
Vardenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see section 5.1).
Vardenafil għandu effetti vażodilatorji, u jirriżulta fi tnaqqis ħafif u temporanju fil- pressjoni tad- demm (ara sezzjoni 5. 1).
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 -
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
3 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.
3 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).
The safety and efficacy of combinations of vardenafil with other treatments for erectile dysfunction have not been studied.
Għadhom ma sarux studji dwar is- sigurtà u l- effikaċja ta ’ vardenafil mogħti flimkien ma ’ forom oħra ta ’ kura għall- problema ta ’ l- erezzjoni tal- pene.
Therefore the use of such combinations is not recommended.
Għaldaqstant, l- użu ta ’ taħlitiet bħal dawn mhux irrakkomandat.
The concomitant use of alpha-blockers and vardenafil may lead to symptomatic hypotension in some patients because both are vasodilators.
L- użu ta ’ alfa- blokers flimkien ma ’ vardenafil jista jwassal għal pressjoni baxxa sintomatika f’ uħud mill- pazjenti minħabba li t- tnejn huma vażodilataturi.
Concomitant treatment with vardenafil should only be initiated if the patient has been stabilised on his alpha-blocker therapy.
Kura flimkien ma ’ vardenafil għandha tinbeda biss jekk il- pazjent ġie stabilizzat fuq il- kura tiegħu ta ’ alfa- blokers.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg.
F’ dawk il- pazjenti li huma stabbli fuq kura ta ’ alfa- blockers, vardenafil għandu jinbeda bl- inqas doża rrakkomandata ta ’ 5mg.
Vardenafil may be administered at any time with tamsulosin.
Vardenafil jista ’ jingħata f’ kwalunkwe ħin ma ’ tamsulosin.
With other alpha blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.5).
Meta vardenafil jingħata flimkien ma ’ alfa- blockers oħra, għandu jiġi kkunsidrat perjodu ta ’ separazzjoni bejn id- dożi (ara sezzjoni 4. 5).
In those patients already taking an optimized dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose.
F’ dawk il - pazjenti li diġa ’ qed jieħdu doża ottimizzata ta ’ vardenafil, kura b’ alfa- blockers għandha tinbeda bl - inqas doża.
Stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure in patients taking vardenafil.
Żjieda ftit, ftit fid- doża ta ’ alfa- blockers tista ’ tiġi assoċjata ma ’ tnaqqis akbar fil- pressjoni tad- demm f’ pazjenti li qed jieħdu vardenafil.
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).
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).
Jista ’ jkun hemm bżonn tibdil fid- doża ta ’ vardenafil meta jingħata flimkien ma ’ inibituri moderati ta ’ CYP 3A4 bħal ma huma erythromycin u clarithromycin (ara sezzjoni 4. 5 u sezzjoni 4. 2).
Concomitant intake of grapefruit juice is expected to increase the plasma concentrations of vardenafil.
It- teħid fl- istess waqt ta ’ meraq tal- grejpfrut huwa mistenni li jżid il- konċentrazzjonijiet ta 'vardenafil fil- plażma.
The combination should be avoided (see section 4.5).
Din it- taħlita għandha tiġi evitata (ara sezzjoni 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.
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.
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.
U doża waħda mill- ħalq ta ’ 10 mg vardenafil mogħtija flimkien ma ’ 400 mg gatifloxacin, mediċina b ’ effett QT komparabbli, wriet effett QTc addizzjonali ta ’ 4 msec meta mqabbel mal- effett ta ’ kull waħda minn dawn il- mediċini individwalment.
The clinical impact of these QT changes is unknown (see section 5.1).
L- impatt kliniku ta ’ dan it - tibdil fil- QT mhux magħruf (ara sezzjoni 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.
Ir- relevanza klinika ta ’ din is- sejba mhix magħrufa u ma tistax tiġi ġeneralizzata għall- kull pazjent taħt kull ċirkostanza, għaliex tiddependi fuq il- fatturi ta ’ riskju individwali u suxxettibilitajiet li jistgħu jkunu preżenti f’ kull ħin, f’ kwalunkwe pazjent.
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).
Prodotti mediċinali li jistgħu jtawwlu l- interval QTc, inkluż vardenafil, aħjar jiġu evitati f’ pazjenti b’ fatturi ta ’ riskju relevanti, per eżempju, ipokalimja; żjieda konġenitali tal- QT; l- għoti flimkien ta ’ prodotti mediċinali kontra l- arritmija fi Klassi 1ª (eż. quinidine, procainamide), jew fi Klassi III (eż. amiodarone, sotalol).
Visual defects and cases of non-arteritic ischemic optic neuropathy (NAION) have been reported in connection with the intake of Levitra and other PDE5 inhibitors.
Difetti fil- vista u każijiet ta ’ newropatija ottika iskemika mhux arterika (NAION) ġew irrappurtati f’ konnessjoni ma ’ l- użu ta ’ Levitra u inibituri ta ’ PDE5 oħra.
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).
Il- pazjent għandu jiġi mgħarraf li f’ każ ta ’ difett fil- vista li jseħħ f’ daqqa waħda, hu għandu jieqaf jieħu Levitra u jkellem lit- tabib minnufih (ara sezzjoni 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).
It- tolleranza għad- doża massima ta ’ 20 mg tista ’ tkun inqas f’ pazjenti anzjani (età ta ’ ≥ 65) (ara sezzjonijiet 4. 2 u 4. 8).
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.
Fil- bnedmin, vardenafil
In humans, vardenafil had no effect on bleeding time alone or in combination with acetylsalicyclic acid (see section 4.5).
4 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).
There is no safety information available on the administration of vardenafil to patients with bleeding disorders or active peptic ulceration.
M' hemm l- ebda informazzjoni dwar is- sigurtà ta ’ vardenafil f' pazjenti li jsofru b’ mard tal- fsada jew li għandhom ulċera peptika attiva.
Therefore vardenafil should be administered to these patients only after careful benefit-risk assessment.
Għalhekk f’ dawn il- pazjenti vardenafil għandu jintuża biss wara stima b’ attenzjoni tal- benefiċċji u tar- riskji involuti.
Effects of other medicinal products on vardenafil
Effetti ta 'mediċini oħra fuq vardenafil
In vitro studies:
Studji in vitro:
Vardenafil is metabolised predominantly by hepatic enzymes via cytochrome P450 (CYP) isoform 3A4, with some contribution from CYP3A5 and CYP2C isoforms.
Vardenafil fil- biċċa l- kbira huwa metabolizzat mill- enżimi tal- fwied li jużaw ċitokromju P450 (CYP) iżoform 3A4, bi ftit kontribuzzjoni mill- iżoformi CYP3A5 u CYP2C.
Therefore, inhibitors of these isoenzymes may reduce vardenafil clearance.
Għalhekk inibituri ta ’ dawn l - iżoenżimi jistgħu inaqqsu t- tneħħija ta ’ vardenafil.
In vivo studies:
Studji 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.
Meta vardenafil (10 mg) ingħata flimkien ma ’ indinavir (800 mg tlett darbiet kuljum), inibitur ta ’ HIV protease, u inibitur qawwi ta ’ CYP3A4, l- AUC ta ’ vardenafil żdiedet b’ 16- il darba u Cmax ta ’ vardenafil żdiedet b’ 7 darbiet.
At 24 hours, the plasma levels of vardenafil had fallen to approximately 4% of the maximum vardenafil plasma level (Cmax).
Wara 24 siegħa, il- livell ta ’ vardenafil fil- plażma kien naqas għal madwar 4% ta 'l- ogħla livell fil- plażma li kien intlaħaq (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.
Meta vardenafil (5 mg) ingħata flimkien ma ’ ritanovir (600 mg darbtejn kuljum), Cmax ta ’ vardenafil żdiedet bi 13- il darba u l- AUC0- 24 ta ’ vardenafil żdiedet b’ 49 darba.
The interaction is a consequence of blocking hepatic metabolism of Levitra by ritonavir, a highly potent CYP3A4 inhibitor, which also inhibits CYP2C9.
L- interazzjoni hija konsegwenza ta ’ l- impediment tal- metaboliżmu ta ’ Levitra fil- fwied minn ritanovir, impeditur ta ’ CYP3A4 qawwi ħafna, li jimpedixxi wkoll CYP2C9.
Ritonavir significantly prolonged the half-life of Levitra to 25.7 hours (see section 4.3).
Ritanovir itawwal b’ mod sinifikanti il- half- life ta ’ Levitra għal 25. 7 siegħa (ara sezzjoni 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).
Meta vardenafil (5 mg) ingħata flimkien ma ’ ketoconazole (200 mg) li hu inibitur qawwi ta ’ CYP3A4, l- AUC ta ’ vardenafil żdiedet b’ 10 darbiet, waqt li Cmax żdiedet b’ 4 darbiet (ara sezzjoni 4. 4).
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.
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.
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).
L- użu ta ’ vardenafil flimkien ma ’ inibituri qawwija ta ’ CYP3A4 bħal itraconazole u ketoconazole (għall- użu orali) għandu jiġi evitat (ara sezzjoni 4. 3 u 4. 4).
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).
Co-administration of erythromycin (500 mg three times a day), a CYP3A4 inhibitor, with vardenafil (5 mg) resulted in a 4-fold increase in vardenafil AUC and a 3-fold increase in Cmax.
Meta vardenafil (5 mg) ingħata flimkien ma ’ erythromycin (500 mg tlett darbiet kuljum), inibitur ta ’ CYP3A4, l- AUC ta ’ vardenafil żdiedet b’ 4 darbiet, waqt li Cmax żdiedet bi 3 darbiet.
Although a specific interaction study has not been conducted, the co-administration of clarithromycin can be expected to result in similar effects on vardenafil AUC and Cmax.
Għalkemm studju speċifiku ta ’ l- interazzjoni għadu ma sarx, meta clarithromycin jingħata flimkien ma ’ vardenafil huwa mistenni li dan jirriżulta f’ effetti simili fuq l- AUC u Cmax ta ’ vardenafil.
When used in combination with a moderate CYP 3A4 inhibitor such as erythromycin or clarithromycin, vardenafil dose adjustment might be necessary (see sections 4.2 and 4.4).
Meta mogħti flimkien ma ’ inibitur moderat ta ’ CYP 3A4, bħal erythromycin jew clarithromycin, għandu mnejn ikun hemm bżonn aġġustament fid- doża ta ’ vardenafil (ara sezzjoni 4. 2 u sezzjoni 4. 4).
Cimetidine (400 mg twice daily), a non-specific cytochrome P450 inhibitor, had no effect on vardenafil AUC and Cmax when co-administered with vardenafil (20 mg) to healthy volunteers.
Cimetidine (400 mg darbtejn kuljum), inibitur mhux speċifiku ta ’ ċitokromju P450, ma kellu l- ebda effett fuq l- AUC u s - Cmax ta ’ vardenafil, meta ingħata flimkien ma ’ vardenafil (20 mg) lill- voluntiera b' saħħithom.
Grapefruit juice being a weak inhibitor of CYP3A4 gut wall metabolism, may give rise to modest increases in plasma levels of vardenafil (see section 4.4).
Meraq tal- grejpfrut huwa inibitur ħafif tal- metaboliżmu ta ’ CYP3A4 fl- imsaren, u b’ hekk jista ’ jżid bi ftit il- livelli ta ’ vardenafil fil- plażma (ara sezzjoni 4. 4).
The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with the H2-antagonist ranitidine (150 mg twice daily), digoxin, warfarin, glibenclamide, alcohol (mean maximum blood alcohol level of 73 mg/ dl) or single doses of antacid (magnesium hydroxide/ aluminium hydroxide).
Il- farmakokinetika ta 'vardenafil (20 mg) ma nbidlitx meta ingħata flimkien ma ’ l- antagonist ta ’ H2, ranitidine (150 mg darbtejn kuljum), digoxin, warfarin, glibenclamide, alkoħol (medja tal- livell massimu ta' alkoħol fid- demm ta '73 mg/ dl), jew doża waħda ta ’ antaċidi (magnesium hydroxide/ aluminium hydroxide).
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).
5 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).
5 Effects of vardenafil on other medicinal products
Effett ta 'vardenafil fuq mediċini oħra
There are no data on the interaction of vardenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
M' hemmx tagħrif dwar l- interazzjoni bejn vardenafil u inibituri mhux speċifiċi ta ’ phosphodiesetrase bħal theophylline jew dipyridamole.
No potentiation of the blood pressure lowering effect of sublingual nitroglycerin (0.4 mg) was observed when vardenafil (10 mg) was given at varying time intervals (1 h to 24 h) prior to the dose of nitroglycerin in a study in 18 healthy male subjects.
F' dan l- istudju vardenafil (10 mg) ingħata f' intervalli li jvarjaw (bejn 1 u 24 siegħa) qabel id- doża ta ’ nitroglicerin.
Vardenafil 20 mg potentiated the blood pressure lowering effect of sublingual nitroglycerin (0.4mg) taken 1 and 4 hours after vardenafil administration to healthy middle aged subjects.
Vardenafil 20mg qawwa l- effett li jbaxxi l- pressjoni ta ’ nitroglicerine (0. 4mg) mogħti taħt l- ilsien wara siegħa u 4 sigħat mill- għoti ta ’ vardenafil f’ pazjenti b’ saħħithom ta ’ mezz ’ età.
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.
However, there is no information on the possible potentiation of the hypotensive effects of nitrates by vardenafil in patients, and concomitant use is therefore contraindicated (see section 4.3).
Madankollu, għad m' hemmx tagħrif dwar jekk vardenafil jistax iqawwi l- effett ta ’ nitrates li jbaxxu l- pressjoni u għalhekk l- użu flimkien huwa kontra- indikat (ara sezzjoni 4. 3).
Nicorandil is a hybrid of potassium channel opener and nitrate.
Nicorandil huwa ibridu ta ’ sustanza li tiftaħ il- kanali tal- potassju u ta ’ nitrate.
Due to the nitrate component it has the potential to have serious interaction with vardenafil.
Minħabba li l - komponent ta ’ nitrate għandu l- potenzjal ta ’ effetti ta ’ interazzjoni serji ma ’ vardenafil.
Since alpha-blocker monotherapy can cause marked lowering of blood pressure, especially postural hypotension and syncope, interaction studies were conducted with vardenafil.
Minħabba li monoterapija b’ alfa- bloker tista tbaxxi sew il- pressjoni tad- demm, speċjalment pressjoni baxxa minħabba tibdil fil- pożizzjoni u sinkope, saru studji dwar l- interazzjoni b’ vardenafil.
In two interaction studies with healthy normotensive volunteers after forced titration of the alpha-blockers tamsulosin or terazosin to high doses, hypotension (in some cases symptomatic) was reported in a significant number of subjects after co-administration of vardenafil.
F’ żewġ studji ta ’ interazzjoni fuq voluntiera b’ saħħithom u bi pressjoni normali, wara titrazzjoni bil - fors ta ’ dożi għolja ta ’ l- alfa- blockers tamsulosin jew terazosin, kienet irrappurtata pressjoni baxxa (xi kultanti sinptomatika) f’ numru sinifikattiv tas- suġġetti wara li ngħataw ukoll vardenafil.
Among subjects treated with terazosin, hypotension was observed more frequently when vardenafil and terazosin were given simultaneously than when the dosing was separated by a time interval of 6 hours.
Fost is - suġġetti kkurati b’ terazosin, pressjoni baxxa ġiet osservata aktar ta ’ spiss meta vardenafil u terazosin ingħataw fl- istess ħin milli meta ngħataw separatament b’ intervall ta ’ 6 sigħat.
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.
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.
Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours.
Ma ġietx osservata pressjoni baxxa meta l- għoti ta ’ vardenafil 5mg u terazosin kien separat b’ 6 sigħat.
Therefore, concomitant treatment should be initiated only if the patient is stable on his alpha blocker therapy.
Għalhekk, kura flimkien għandha tinbeda biss jekk il- pazjent huwa stabbli fuq il- kura tiegħu ta ’ alfa - blocker.
In those patients who are stable on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5mg.
F’ dawk il- pazjenti li huma stabbli fuq kura ta ’ alfa- blocker, vardenafil għandu jinbeda bl - inqas doża tal- bidu rakkomandata ta ’ 5mg.
Levitra may be administered at any time with tamsulosin.
Vivanza jista ’ jingħata f’ kwalunkwe ħin ma ’ tamsulosin.
With other alpha blockers a time separation of dosing should be considered when vardenafil is prescribed concomitantly (see section 4.4).
Meta vardenafil jingħata flimkien ma ’ alfa- blockers oħrajn, għandu jiġi kkunsidrat separazzjoni fil- ħin tad- dożaġġ (ara sezzjoni 4. 4).
No significant interactions were shown when warfarin (25 mg), which is metabolised by CYP2C9, or digoxin (0.375 mg) was co-administered with vardenafil (20 mg).
Ma kienx hemm interazzjonijiet sinifikanti meta vardenafil (20 mg) inghata flimkien ma ’ warfarin (25 mg), li jiġi metabolizzat minn CYP2C9, jew digoxin (0. 375 mg).
The relative bioavailability of glibenclamide (3.5 mg) was not affected when co-administered with vardenafil (20 mg).
5 mg) ma nbidlitx meta ngħata flimkien ma ’ vardenafil (20 mg).
In a specific study, where vardenafil (20 mg) was co-administered with slow release nifedipine (30 mg or 60 mg) in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 6 mmHg and supine diastolic blood pressure of 5 mmHg accompanied with an increase in heart rate of 4 bpm.
Fi studju speċifiku, fejn vardenafil (20 mg) ingħata flimkien ma ’ nifedipine li jintreħa bil- mod (30 mg jew 60 mg) lill - pażjenti li jsofru minn pressjoni għolja, f’ dawn il- pażjenti, il- pressjoni sistolika f’ pożizzjoni minduda naqset b’ 6 mmHg aktar u l- pressjoni dijastolika f’ pożizzjoni minduda naqset b '5 mmHg aktar, waqt li r- rata li tħabbat il- qalb żdiedet b' 4 bpm.
When vardenafil (20 mg) and alcohol (mean maximum blood alcohol level of 73 mg/ dl) were taken together, vardenafil did not potentiate the effects of alcohol on blood pressure and heart rate and the pharmacokinetics of vardenafil were not altered.
Meta vardenafil (20 mg) ingħata flimkien ma ’ xorb alkoħoliku (medja ta ’ livell massimu ta 'alkoħol fid- demm ta ’ 73 mg/ dl), vardenafil ma qawwiex l- effetti ta ’ l- alkoħol fuq il- pressjoni u r- rata li tħabbat il- qalb, u l- farmakokinetika ta' vardenafil ma nbidlitx.
Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
6 Vardenafil (10 mg) ma tawwalx il- ħin ta ’ fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
6 4.7 Effects on ability to drive and use machines
4. 6 Tqala u treddigħ
No studies on the effects on the ability to drive and use machines have been performed.
M’ hemmx studji ta ’ vardenafil f’ nisa tqal.
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.
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
Over 9,500 patients have received Levitra in clinical trials.
Fi provi kliniċi li saru, ’ l fuq minn 9500 pazjent ingħataw Levitra.
The adverse reactions were generally transient and mild to moderate in nature.
L- effetti avversi ġeneralment kienu temporanji u ħfief għal moderati fin- natura tagħhom.
The most commonly reported adverse drug reactions occurring in ≥ 10% of patients are headache and flushing.
L- aktar effetti avversi komuni li ġew irrapurtati, li seħħew f '≥10% tal- pazjenti kienu uġigħ ta' ras u fawra.
The following adverse reactions have been reported:
Ġew irraportati l- effetti avversi li ġejjin:
System Organ Class
(≥1% / 100 u
Very Common (≥ 1/ 10)
(≥0. 1/ 1, 000% u
Common (≥ 1/ 100 and < 1/ 10)
(≥1/ 100)
Uncommon (≥ 1/ 1,000 and < 1/ 100)*
< 1/ 10%)
Rare (≥ 1/ 10,000 and < 1/ 1,000)*
< 1% / 100) *
Not Known (can not be estimated from the available data)
tistax
Immune System Disorders Psychiatric Disorders
tittieħed < 0. 1/ 1, 000%) * stima mid - data disponibbli) Disturbi fis - Sistema Immuni Disturbi Psikjatriċi
Hypersensitivit y Anxiety
Sensittività eċċessiva Ansjetà
Syncope Seizure Transient global amnesia
Sinkope Aċċessjoni Amnesija globali temporanja
Related Investigations
Disturbi fl - Għajnejn inkluż Investigazzjonijie t Relatati
Visual brightness) Chromatopsia Conjunctivitis Blurred Vision
Produzzjoni tad - dmugħ tiżdied Problemi fil - vista (inkluż vista għad- dawl aktar qawwija) Chromatopsia Konġuntivite Vista mċajpra
Intraocular pressure increased
Żjieda tal - Pressjoni ta ’ ġol- għajn
Non-arteritic-anterior ischemic optic neuropathy Visual defects
newropatija ottika anterjuri iskemika mhux arterika (NAION) Difetti fil- vista
Ear and labyrinth Disorders
Disturbi fil - widnejn u fis - sistema labirintika
Sudden deafness**
Telf tas- smigħ f ’ daqqa waħda **
Cardiac Disorders incl. related Investigations
7
Tachycardia Palpitations
Sistema tal -
Angina Pectoris Myocardial ischemia
Komuni Komuni
Myocardial Infarction
Mhux Komuni
Vascular Disorders incl. related Investigations
Rari
Flushing
Mhux
Hypertension Hypotension Orthostatic Hypotension
Klassifika tal -
Respiratory, Thoracic and Mediastinal Disorders
Ħafna
Nasal Congestion
(≥1% / 100 u
Dyspnoea Epistaxis
(≥0. 1/ 1, 000% u
Laryngeal oedema
(≥10. 0/ 10, 0001
7 System Organ Class
Magħruf (ma
Very Common (≥ 1/ 10)
Organi
Not Known (can not be estimated from the available data)
Disturbi Respiratorji, Toraċiċi u Medjastinali
Gastrointestinal Disorders incl. related Investigations
Disturbi Gastro - intestinali inkluż Investigazzjonijie t Relatati
Dyspepsia Nausea
Dispepsja Tqalligħ
Abnormal liver function tests GGTP increased
Testijiet tal - funzjoni tal - fwied mhux normali Żjieda fil- GGTP
Skin and Subcutaneous Tissue Disorders
Disturbi fil- Ġilda u Tessuti ta ’ taħt il- ġilda
Photosensitivit y reaction Face oedema Rash
Reazzjoni ta ’ sensittività għad- dawl Edima fil- wiċċ Raxx
Musculoskeletal and Connective Tissue Disorders incl.
Disturbi Muskolu- skeltrali u tal- Connective Tissue inkluz Investigazzjonijie t Relatati
Related Investigations Reproductive System and Breast Disorders
Żjieda fil - creatine phosphokinase tad- demm Mijalġja Uġigħ fid- dahar
Blood creatine Muscle phosphokinase Rigidity increased Myalgia Back Pain Priapism Erections increased (prolonged or painful erections)
Priapiżmu Erezzjonijiet miżjuda (Erezzjonijiet li jdumu jew bl - uġigħ)
*For adverse reactions reported in < 1% of patients, only those which warrant special attention, because of their possible association with serious disease states or of otherwise clinical relevance are listed. **Sudden deafness or loss of hearing has been reported in a small number of postmarketing and clinical trial cases with the use of all PDE5 inhibitors, including vardenafil.
* Minn dawk l- effetti mhux mixtieqa li deheru f '< 1% tal- pazjenti, ġew mnizzla biss dawk li jeħtieġu attenzjoni speċjali, minħabba li jistgħu jkunu assoċjati ma ’ mard serju jew ta ’ relevanza klinika. ** Ġie rrappurtat tnaqqis jew telf tas- smigħ f’ daqqa waħda f’ numru żgħir ta ’ każijiet fi provi ta ’ wara t- tqegħid fis- suq u fi provi kliniċi bl- użu ta ’ inibituri ta ’ PDE5, inkluż vardenafil.
At the 20mg dose, elderly (≥ 65 years old) patients had higher frequencies of headaches (16.2% versus 11.8%) and dizziness (3.7% versus 0.7%) than younger patients (< 65 years old).
B’ doża ta ’ 20mg, pazjenti anzjani (età ta ’ ≥ 65) kellhom frekwenzi ogħla ta ’ uġigħ ta ’ ras (16, 2% kontra 11, 8%) u sturdament (3, 7% kontra 0, 7%) minn pazjenti iżgħar (età ta ’ < 65).
Vascular Disorders:
Rapporti ta ’ wara t- tqegħid fis- suq ta ’ prodott mediċinali ieħor ta ’ din il- klassi:
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.
8 ventrikulari, kienu rrappurtati wara li l- prodott mediċinali ħareġ għall- bejgħ, fl- istess perijodu ta ’ żmien ma ’ prodott mediċinali ieħor f’ din il- klassi.
4.9 Overdose
9 Doża eċċessiva
In single dose volunteer studies, doses up to and including 80 mg per day were tolerated without exhibiting serious adverse reactions.
Fi studji kliniċi b’ voluntiera li ngħataw doża waħda, dożi sa u inkluż 80 mg kuljum kienu ttollerati mingħajr ma ħolqu reazzjonijiet avversi serji.
When vardenafil was administered in higher doses and more frequently than the recommended dosing regimen (40 mg twice daily) cases of severe back pain have been reported.
Meta vardenafil intuża f’ doża akbar u aktar ta ’ spiss milli rakkomandat fid- dożimetrija (40 mg darbtejn kuljum), ġew irrapportati każijiet ta ’ uġigħ fid- dahar qawwi.
This was not associated with any muscle or neurological toxicity.
Dan ma kienx assoċjat ma ’ l - ebda tossiċità fil- muskoli jew newroloġika.
In cases of overdose, standard supportive measures should be adopted as required.
F’ każ li tingħata doża eċċessiva, il- miżuri ta ’ għajnuna li normalment jingħataw f’ dawn il- każijiet għandhom jintużaw skond il- bżonn.
Renal dialysis is not expected to accelerate clearance, as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.
Dijalisi tal- kliewi mhux mistennija li żżid it- tneħħija mill- ġisem, għax vardenafil huwa marbut b’ mod qawwi mal- proteini tal- plażma, u ftit li xejn joħroġ fl- awrina.
5.1 Pharmacodynamic properties
1 Tagħrif farmakodinamiku
Medicinal product used in erectile dysfunction, ATC code:
Prodott mediċinali li jintuża għall- kura tal- problema ta ’ l- erezzjoni tal- pene, Kodiċi ATC:
8 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.
In the natural setting, i. e. with sexual stimulation it restores impaired erectile function by increasing blood flow to the penis.
F’ ċirkustanzi naturali, i. e. bi stimulazzjoni sesswali jneħħi l- problema tal- funzjoni erettili billi jżid l- ammont ta ’ demm li jidħol fil- pene.
Penile erection is a haemodynamic process.
L- erezzjoni tal- pene hija proċess emodinamiku.
During sexual stimulation, nitric oxide is released.
Waqt stimulazzjoni sesswali jinħeles nitric oxide.
It activates the enzyme guanylate cyclase, resulting in an increased level of cyclic guanosine monophosphate (cGMP) in the corpus cavernosum.
Dan jattiva l- enżima guanylate cyclase u jirriżulta f’ żjieda fil- livell ta 'cyclic guanosine monophosphate (cGMP) fil- korpus kavernożum.
This in turn results in smooth muscle relaxation, allowing increased inflow of blood into the penis.
B' hekk, il- muskoli lixxi jirrilassaw u jżidu l- ammont ta ’ demm li jidħol ġol- pene.
The level of cGMP is regulated by the rate of synthesis via guanylate cyclase and by the rate of degradation via cGMP hydrolysing phosphodiesterases (PDEs).
Il- livell ta 'cGMP huwa regolat mir- rata ta' sintesi permezz ta ’ guanylate cyclase kif ukoll mir- rata ta 'degradazzjoni permezz ta ’ cGMP hydrolysing phosphodiesterases (PDEs).
Vardenafil is a potent and selective inhibitor of the cGMP specific phosphodiesterase type 5 (PDE5), the most prominent PDE in the human corpus cavernosum.
Vardenafil huwa inibitur qawwi u selettiv ta ’ phosphodiesetrase tip 5 (PDE5) li hu speċifiku għal cGMP u li hu l- aktar PDE komuni fil- korpus cavernosum uman.
Vardenafil potently enhances the effect of endogenous nitric oxide in the corpus cavernosum by inhibiting PDE5.
Vardenafil iżid b' mod qawwi l- effett ta 'nitric oxide fil- korpus cavernosum billi jimpedixxi lil PDE5.
When nitric oxide is released in response to sexual stimulation, inhibition of PDE5 by vardenafil results in increased corpus cavernosum levels of cGMP.
Meta jinħeles nitric oxide b' reazzjoni għal stimulazzjoni sesswali, l- impediment ta 'PDE5 minn vardenafil jirriżulta f’ żjieda fil- livelli ta' cGMP fil- korpus cavernosum.
Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.
Għalhekk stimulazzjoni sesswali hija neċessarja biex vardenafil jipproduċi effetti terapewtiċi ta ’ ġid.
In vitro studies have shown that vardenafil is more potent on PDE5 than on other known phosphodiesterases (> 15-fold relative to PDE6, > 130-fold relative to PDE1, > 300-fold relative to PDE11, and > 1000-fold relative to PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 and PDE10).
Studji in vitro urew li vardenafil għandu effett aktar qawwi fuq PDE5 milli fuq phosphodiesterases oħrajn (> 15- il darba meta mqabbel ma ’ PDE6, > 130 darba meta mqabbel ma ’ PDE1, > 300 darba meta mqabbel ma ’ PDE11, u > 1000 darba meta mqabbel ma ’ PDE2, PDE3, PDE4, PDE7, PDE8, PDE9 u PDE10).
In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing.
F' xi rġiel dan ġara wara biss 15- il minuta li ngħatat id- doża.
The overall response of these subjects to vardenafil became statistically significant, compared to placebo, 25 minutes after dosing.
Meta mqabbel mal- plaċebo, ir- reazzjoni għal vardenafil f' dawn il- pazjenti kienet statistikament sinifikattiva, 25 minuta wara li ngħatat id- doża.
Vardenafil causes mild and transient decreases in blood pressure which, in the majority of the cases, do not translate into clinical effects.
Vardenafil ibaxxi l- pressjoni b' mod ħafif u temporanju, li fil- biċċa l- kbira tal- każijiet, ma jikkawżawx effetti kliniċi.
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 vardenafil, 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.
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