qanastek/EMEA-V3 huggingface dataset:
Ask you pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bżonn.
What Revasc contains
X’ fih Revasc
The active substance is desirudin (15mg/ 0.5ml powder).
Is- sustanza attiva hi desirudin (15 mg/ 0. 5 ml trab).
The other ingredients in the powder are magnesium chloride and sodium hydroxide.
L- ingredjenti l- oħrajn fit- trab huma magnesium chloride u sodium hydroxide.
In the solvent the ingredients are mannitol and water.
Is- solvent fl- ingredjenti huma mannitol u ilma.
Important information about some of the ingredients of Revasc
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Revasc
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i. e. essentially ‘ sodium- free’.
Dan il- prodott mediċinali fih anqas minn 1 mmol ta ’ sodium (23 mg) f’ kull 0. 5 ml, i. e. hu essenzjalment ‘ ħieles mis- sodium ’.
What Revasc looks like and contents of the pack
Id- dehra ta ’ Revasc u d- daqs tal- pakkett
Revasc consists of a vial containing a white powder and an ampoule containing clear, colourless solvent for solution for injection.
Revasc jikkonsisti f’ kunjett li fih trab abjad trab u ampulla li fiha solvent ċar u bla kulur għal soluzzjoni għall- injezzjoni.
1 vial and 1 ampoule in one package 2 vials and 2 ampoules in one package 10 vials and 10 ampoules in one package
1 kunjett u 1 ampulla f’ pakkett wieħed 2 kunjetti u 2 ampulli f’ pakkett wieħed 10 kunjetti u 10 ampulli f’ pakkett wieħed
The marketing authorisation holder is:
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Canyon Pharmaceuticals Limited 20-22 Bedford Row London WC1R 4JS United Kingdom.
Canyon Pharmaceuticals Limited 20- 22 Bedford Row London WC1R 4JS Renju Unit
The manufacturer is:
Il- manifattur hu:
This leaflet was last approved on.
Dan il- fuljett kien approvat l- aħħar f ’
What is Revatio?
X’ inhu Revatio?
Revatio is a medicine that contains the active substance sildenafil.
Revatio hija mediċina li fiha s- sustanza attiva sildenafil.
It is available as round, white tablets (20 mg).
Hija disponibbli bħala pilloli bojod tondi ta ’ 20 mg.
What is Revatio used for?
Għalxiex jintuża Revatio?
Revatio is used to treat adults with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Revatio jintuża għall- kura ta ’ pazjenti adulti b’ ipertensjoni ta ’ klassi III fl- arterji pulmonari biex tiġi mtejba l- kapaċità għall- eżerċizzju (il- kapaċità ta ’ eżerċizzju fiżiku).
PAH is abnormally high blood pressure in the arteries of the lungs.
L- ipertensjoni ta ’ l- arterji pulmonari hija pressjoni għolja b’ mod anormali fl- arterji tal- pulmun.
The ‘ class ’ reflects the seriousness of the disease: ‘ class III ’ involves marked limitation of physical activity.
Il - ‘ klassi ’ tirrifletti l- gravità tal - marda: ‘ klassi III ’ tinvolvi limitazzjoni viżibbli ta ’ l- attività fiżika..
Revatio has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.
Revatio ġie muri li huwa effettiv fl- ipertensjoni pulmonari primarja (ebda kawża oħra) u l- ipertensjoni pulmonari bla kawża identifikabbli u b’ PAH ikkawżata minn mard tal- connective tissue.
Because the number of patients with PAH is low, the disease is considered ‘ rare’, and Revatio was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 12 December 2003.
Billi n- numru ta ’ pazjenti b’ ipertensjoni pulmonari primarja huwa baxx, il- marda hija kkunsidrata ‘ rari ’, u Revatio ġie ikkategorizzata bħala ‘ mediċina orfni ’ (mediċina użata f’ mard rari) fit- 12 ta ’ Diċembru 2003.
How is Revatio used?
Kif jintuża Revatio?
Revatio treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.
Il- kura b’ Revatio għandha tinbeda u tiġi sorveljata biss minn tabib li għandu esperjenza fil- kura ta ’ l - ipertensjoni ta ’ l- arterji pulmonari (PAH).
The recommended dose is 20 mg three times a day.
Id- doża rakkomandata hija ta ’ 20 mg tliet darbiet kuljum.
The tablets should be taken about six to eight hours apart, with or without food.
Il- pilloli għandhom jittieħdu bejn sitta u tmien sigħat ’ il bogħod minn xulxin ma ’ l- ikel jew waħedhom.
The same dose is used in patients with kidney or liver problems, and should only be lowered if the patient does not tolerate the normal dose.
L- istess doża tintuża f’ pazjenti bi problemi tal- kliewi jew tal- fwied, u għandha titnaqqas biss jekk il- pazjent ma jittollerax id- dożaġġ normali.
Revatio can be used with epoprostenol (another medicine used in PAH).
Revatio jista ’ jintuża ma ’ epoprostenol (mediċina oħra użata fl- ipertensjoni ta ’ l- arterji pulmonari (PAH)).
How does Revatio work?
Kif jaħdem Revatio?
PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs.
Il- PAH (l- ipertensjoni ta ’ l- arterji pulmonari) hija marda ta ’ indeboliment fejn hemm restrizzjoni qawwija (tidjiq) tal- vini u l- arterji tal- pulmuni.
It causes high blood pressure in the pulmonary artery (the vessel taking blood from the heart to the lungs).
Din tikkawża pressjoni għolja ħafna tad- demm (fl - arterji li jieħdu d- demm min- naħa tal- lemin tal- qalb għall- pulmuni).
This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult.
Din il- pressjoni tnaqqas l- ammont ta ’ ossiġnu li jista ’ jmur fil- pulmuni, li jwassal sabiex l- attività fiżika ssir diffiċli.
The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘ phosphodiesterase type 5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme.
Is- sustanza attiva f’ Revatio, sildenafil, tappartjeni għal kategorija ta ’ mediċini msejħa ‘ inibituri phosphodiesterase ta ’ tip 5 ’ (PDE5) li jfisser li jimblokka l- enzima PDE5.
This enzyme is found in the blood vessels of the lungs.
Din l- enzima tinstab fil- vini u l- arterji tal- pulmun.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Meta tiġi imblokkata, is- sustanza ‘ cyclic gaunine monophosphate ’ (cGMP) ma 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. tkunx tista ’ titkisser allura tibqa ’ fil- vini u l- arterji fejn tikkawża r- rilassament u t- twessigħ tagħhom (vażolidazzjoni).
How has Revatio been studied?
Kif ġie studjat Revatio?
Three doses of Revatio (20, 40 and 80 mg) have been compared with placebo (a dummy treatment) in 277 patients.
Tliet dożi ta ’ Revatio (20, 40, u 80 mg) ġew imqabbla ma ’ plaċebo (kura finta) f’ 277 pazjent.
One study also compared the effects of adding Revatio or placebo to epoprostenol in 267 patients.
Studju ieħor qabbel ukoll l- effetti taż- żjieda ta ’ Revatio jew plaċebo ma ’ epoprostenol f’ 267 pazjent.
In this study, the dose of Revatio started at 20 mg three times a day, and was increased to 40 mg and then to 80 mg at weeks 4 and 8.
F’ dan l - istudju, d- doża ta ’ Revatio bdiet b’ 20 mg tliet darbiet kuljum, u ġiet miżjuda għal 40 mg u mbagħad għal 80 mg fir- 4 u t- 8 ġimgħa.
In all studies, the main measure of effectiveness was the distance patients could walk in six minutes.
F’ dawn l- istudji kollha, il- kejl prinċipali ta ’ l- effikaċja kienet id - distanza li l- pazjenti setgħu jimxu f’ sitt minuti.
This measures the patients’ exercise capacity.
Dan ikejjel il- kapaċità ta ’ eżerċizzju tal- pazjent.
What benefit has Revatio shown during the studies?
X’ benefiċċju wera Revatio matul l- istudji?
Patients could walk significantly further after treatment with Revatio.
Il- pazjenti setgħu jimxu konsiderevolment aktar fit- tul wara l- kura b’ Revatio.
Before treatment, the average walking distance was 345 metres, which increased by 45 to 50 metres after 12 weeks of treatment.
Qabel il- kura d- distanza medja tal- mixi kienet 345 metru, li żdiedet b’ 45 sa 50 metru wara 12- il ġimgħa ta ’ kura.
This is not a large increase but it is a significant improvement.
Din mhix żieda kbira iżda huwa titjib sinifikanti.
As the three doses of Revatio had similar effects, the lowest dose (20 mg) was chosen for use in patients.
Billi t- tliet dożi ta ’ Revatio kellhom l- istess effett ġiet magħżula l- iċken doża (20 mg) sabiex tintuża għal pazjenti.
Revatio was more effective than placebo when it was added to epoprostenol, with walking distances increasing by 30.1 and 4.1 metres, respectively, after 16 weeks of treatment.
Revatio kien aktar effettiv mill- plaċebo meta ġie miżjud ma ’ epoprostenol, bid- distanzi tal- mixi jiżdiedu bi 30. 1 u 4. 1 metri, rispettivament, wara 16- il ġimgħa ta ’ kura.
What is the risk associated with Revatio?
X’ inhu r- riskju assoċjat ma ’ Revatio?
The most common side effects with Revatio (seen in more than 1 patient in 10) are headache, flushing, dyspepsia (indigestion), diarrhoea and limb pain.
L- aktar effetti sekondarji komuni b’ Revatio (jidhru f’ aktar minn 1 minn kull 10 pazjenti) huma wġigħ ta ’ ras, fwawar, dispepsja (indiġestjoni), dijarea u wġigħ fil- membri (dirgħajn u riġlejn).
For the full list of all side effects reported with Revatio, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha rrapportati b’ Revatio, ara l- Fuljett ta ’ Tagħrif.
Revatio should not be used in people who may be hypersensitive (allergic) to sildenafil or any of the other ingredients.
Revatio m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal sildenafil jew għal xi sustanzi oħra.
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 called non-arteritic anterior ischemic optic neuropathy (NAION).
M’ għandux jittieħed ukoll minn pazjenti li xi darba kellhom telf tal- vista minħabba problema bil- fluss tal- demm għan- nerv ta ’ ġo l- għajn imsejjaħ NAION jew non- arteritic anterior ischemic optic neuropathy.
Revatio should not be taken with nitrates (a group of medicines used to treat angina), with ketoconazole or itraconazole (anti-fungal medicines), or with ritonavir (used to treat HIV infection).
Revatio m’ għandux jittieħed man- nitrati (grupp ta ’ mediċini użati għall - kura ta ’ l- anġina) ma ’ ketoconazole jew itraconazole (mediċini anti- fungali) jew ma ’ ritonavir (użat għal- kura ta ’ l- AIDS).
Because Revatio has not been studied in patients with severe liver disease or severe hypotension (very low blood pressure), or who have recently had a stroke or myocardial infarction (heart attack), these patients should not take it.
Minħabba li Revatio ma ġiex studjat f’ pazjenti b’ mard tal- fwied serju jew pressjoni baxxa severa (pressjoni tad- demm baxxa ħafna), jew li riċentement tathom puplesija jew tagħhom infart mijokardijaku (attakk tal- qalb), dawn il- pazjenti m’ għandhomx jużawh.
Why has Revatio been approved?
Għaliex ġie approvat Revatio?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Revatio provides an alternative treatment option for PAH.
Il- Kumitat dwar Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li Revatio jipprovdi għażla ta ’ kura alternattiva għal PAH (ipertensjoni pulmonari).
The Committee decided that Revatio’ s benefits are greater than its risks for the treatment of PAH classified as WHO functional class III, to improve exercise capacity.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Revatio huma akbar mir- riskji tiegħu għal kura ta ’ PAH klassifikata bħala funzjonali fil- klassi III ta ’ l - WHO, sabiex tiġi mtejjba l- kapaċità ta ’ l- eżerċizzju.
The Committee recommended that Revatio be given marketing authorisation.
Il- Kumitat irrakkomanda li Revatio jingħata l - awtorizzazzjoni għat- tqegħid fis- suq.
Revatio was originally authorised under ‘ Exceptional Circumstances’, because, as the disease is rare, limited information was available at the time of approval.
Revatio kien oriġinarjament awtorizzat taħt ‘ Ċirkustanzi ta ’ Eċċezzjoni ’, billi, minħabba li l- marda hija rari, kien informazzjoni limitata fiż- żmien ta ’ l- approvazzjoni.
As the company had supplied the additional information requested, the ‘ Exceptional Circumstances ’ ended on 25 August 2008.
Billi l- kumpanija tat l - informazzjoni addizzjonali mitluba, iċ - ‘ Ċirkustanzi Eċċezzjonali ’ spiċċaw fil- 25 ta ’ Awwissu 2008.
Which measures are being taken to ensure the safe use of Revatio?
X’ miżuri qed jiġu meħuda sabiex ikun assigurat użu sigur ta ’ Revatio?
Before Revatio is launched in each Member State, the company that makes the medicine will send a letter to healthcare workers explaining that it must not be taken with nitrates.
Qabel ma ’ Revatio jiġi mniedi f’ kull Stat Membru, l- kumpanija li tagħmel il- mediċina ser tibgħat ittra lil ħaddiema tas- settur tas- saħħa fejn tispjega li ma għandhux jingħata ma nitrati.
Other information about Revatio:
Aktar tagħrif dwar Revatio:
The European Commission granted a marketing authorisation valid throughout the European Union for Revatio to Pfizer Limited on 28 October 2005.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Revatio lil Pfizer Limited fit- 28 ta ’ Ottubru 2005.
The summary of opinion of the Committee for Orphan Medicinal Products for Revatio is available here.
Is- sommarju ta ’ l- opinjoni tal- Kumitat dwar Prodotti Mediċinali Orfni għal Revatio jista ’ jiġi kkonsultat hawnhekk.
The full EPAR for Revatio can be found here.
L- EPAR sħiħ għal Revatio jista ’ jiġi kkonsultat hawnhekk.
This summary was last updated in 07-2008.
Dan is- sommarju kien aġġornat l- aħħar f’ 07- 2008.
EU-Number
Mnejn Numru ta ’ l- EU
Route of administration
jingħata
Blister (PVC/ Alu)
folja (PVC/ Alu)
90 Tablets
90 pillola
Revatio 20 mg film-coated tablets
Revatio 20 mg pilloli miksija b’ rita
Each film-coated tablet contains 20 mg of sildenafil (as citrate).
Kull pillola miksija b’ rita fiha 20 mg ta ’ sildenafil (bħala citrate).
Revatio tablets also contain lactose.
Il- pilloli Revatio fihom ukoll lactose.
For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara 6. 1.
White, round, biconvex film-coated tablets marked “ PFIZER” on one side and “ RVT 20” on the other.
Il- pilloli miksijin b’ rita huma bojod, tondi, ġejjin għat- tond miż- żewġ naħat immarkati “ PFIZER ” fuq naħa u “ RVT 20” fuq in- naħa l- oħra.
Treatment of patients with pulmonary arterial hypertension classified as WHO functional class III, to improve exercise capacity.
Trattament ta ’ pazjenti bi pressjoni għolja arterjali tal- pulmun ikklassifikata bħala Klassi Funzjonali III tal- WHO, biex itejjeb il- kapaċità għall- eżerċizzju.
Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.
Intweriet effikaċja fil- pressjoni għolja primarja tal- pulmun u fil- pressjoni għolja fil- pulmun assoċjata ma ’ mard tat- tessut konnettiv.
Revatio is intended for oral use.
Revatio huwa intenzjonat għal użu orali
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension.
Trattament għandu jinbeda biss u jiġi immonitorjat minn tabib b’ esperjenza fi trattament tal- pressjoni għolja arterjali tal- pulmun.
In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
F’ każ ta’ deterjorament kliniku minkejja trattament b’ Revatio, għandhom jiġu kkunsidrati terapiji alternattivi.
Use in adults (≥ 18 years):
Użu fl- adulti (≥ 18- il sena):
The recommended dose is 20 mg three times a day.
Id- doża rakkomandata hija ta ’ 20 mg tlett darbiet kuljum.
Tablets should be taken approximately 6 to 8 hours apart with or without food.
Il- pilloli għandhom jittieħdu bejn wieħed u ieħor minn 6 sa 8 sigħat il- bogħod minn xulxin ma ’ l- ikel jew mhux ma ’ l- ikel.
Use in the elderly (≥ 65 years):
Użu fl- anzjani (≥ 65 sena):
Dosage adjustments are not required in elderly patients.
Aġġustamenti fid- doża m’ humiex meħtieġa f” pazjenti anzjani.
Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients.
L- effikaċja klinika, imkejla b’ mixja ta ’ 6 minuti tista ’ tkun inqas f’ pazjenti anzjani.
Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/ min).
Użu f’ pazjenti b’ indeboliment fil- funzjoni renali Aġġustamenti inizjali fid- doża m’ humiex meħtieġa f’ pazjenti b’ indeboliment renali, inkluż indeboliment renali ta ’ natura gravi (tneħħija tal- krejatinina < 30 ml/ min).
A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated.
Aġġustament ta ’ tnaqqis fid- doża. għal 20 mg darbtejn kuljum għandu jiġi kkunsidrat wara valutazzjoni akkurata tar- riskju - benefiċċju imma biss jekk it- terapija ma tkunx ġiet ittollerata sew.
Initial dose adjustments are not required in patients with hepatic impairment (Child-Pugh class A and B).
Użu f’ pazjenti b’ indeboliment fil- funzjoni epatika Aġġustamenti inizjali fid- doża m’ humiex meħtieġa f’ pazjenti b’ indeboliment epatiku (Child- Pugh klassi A u B).
A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit- risk assessment only if therapy is not well-tolerated.
Aġġustament ta ’ tnaqqis fid- doża għal 20 mg darbtejn kuljum għandu jiġi kkunsidrat wara valutazzjoni akkurata tar- riskju benefiċċju, iżda biss jekk it- terapija ma tkunx ġiet ittolerata sew.
Revatio is contraindicated in patients with severe hepatic impairment (Child-Pugh class C), (see section 4.3).
Revatio huwa kontra- indikat f’ pazjenti b’ indeboliment renali ta ’ natura gravi (Child- Pugh klassi C), (ara sezzjoni 4. 3).
2 Use in children and adolescents (< 18 years):
2 Użu fit- tfal ul - adolexxenti (< 18- il sena):
The safety and efficacy in children and adolescents have not been studied in large controlled clinical trials.
Is- sigurtà u l- effikaċja fit- tfal u l- adolexxenti ma ġietx studjata fi studji kliniċi kbar ikkontrollati.
Therefore, the use of sildenafil is not recommended in these patients.
Għalhekk, l- użu ta ’ sildenafil m’ huwiex rakkomandat f’ dawn il- pazjenti.
Discontinuation of treatment:
Twaqqif tat- trattament:
Limited data suggests that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension.
Tagħrif limitat jissuġġerixxi li t- twaqqif f’ daqqa ta ’ Revatio m’ huwiex assoċjat ma ’ aggravar rebound tal- pressjoni għolja arterjali tal- pulmun.
However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.
Madankollu, biex tiġi evitata l- okkorrenza li tista ’ sseħħ ta ’ deterjorament kliniku f’ daqqa waqt il- waqfien tat- trattament, għandu jiġi kkunsidrat tnaqqis bil- mod il- mod.
Intensified monitoring is recommended during the discontinuation period.
Huwa rrakomandat monitoraġġ intensiv waqt il- perijodu ta ’ twaqqif.
Use in patients using other medicines:
Użu f’ pazjenti li qed jieħdu mediċini oħra:
Co-administration of sildenafil and intravenous epoprostenol has been evaluated (see section 4.8 and 5.1).
L- użu fl- istess ħin ta ’ sildenafil ma ’ epoprostenol għal ġol- vini ġie evalwat (ara sezzjoni 4. 8 u 5. 1).
The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension (eg. bosentan, iloprost) has not been studied in controlled clinical trials.
L- effikaċja u s- sigurtà ta ’ sildenafil mogħti fl- istess ħin ma ’ trattamenti oħra għall- pressjoni għolja arterjali tal- pulmun (eż. bosentan, iloprost) ma ġietx studjata fi provi kliniċi kkontrollati.
Therefore, caution is recommended in case of co-administration.
Għalhekk, hija rakkomandata kawtela f’ kas ta ’ għoti fl- istess ħin.
The safety and efficacy of Revatio when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients.
Is- sigurtà u l- effikaċja ta ’ Revatio meta jingħata fl- istess ħin ma ’ inibituri oħra ta ’ PDE5 ma ġewx studjati f’ pazjenti bi pressjoni għolja arterjali tal- pulmun.
Consistent with its known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors (such as amyl nitrite) or nitrates in any form is therefore contraindicated.
Konsistenti ma ’ l- effetti magħrufa tiegħu fuq il- pathway nitric oxide / cyclic guanosine monophosphate (cGMP) (ara sezzjoni 5. 1), sildenafil intwera li jsaħħaħ l- effetti ipotensivi tan- nitrati, u l- ko- amministrazzjoni tiegħu ma ’ donaturi ta ’ nitric oxide (bħal amyl nitrite) jew nitrati f’ xi forma oħra hija għalhekk kontra- indikata.
Combination with potent CYP3A4 inhibitors (eg. ketoconazole, itraconazole, ritonavir) (see section 4.5).
Kumbinazzjoni ma ’ inibituri potenti ta ’ CYP3A4 (ez. ketoconazole, itraconazole, ritonavir) (ara sezzjoni 4. 5).
Revatio is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Revatio huwa kontra- indikat f’ dawk il- pazjenti li tilfu l- vista f’ għajn waħda minħabba newropatija anterjuri iskimika, mhux arterika ta ’ l- għajn (NAION), sew jekk dan l- episodju ġara wara espożizzjoni għal inibitur ta ’ PDE5 kif ukoll jekk le.
The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: severe hepatic impairment, recent history of stroke or myocardial infarction, severe hypotension (blood pressure < 90/ 50 mmHg) at initiation.
Is- sigurtà ta ’ sildenafil ma ġietx studjata f’ dawn is- sotto gruppi ta ’ pazjenti li ġejjin, u għalhekk l- użu tiegħu huwa kontra- indikat; indeboliment epatiku gravi, storja riċenti ta ’ puplesija jew infart mijokardijaku, pressjoni baxxa ħafna u severa fil- bidu (pressjoni ta ’ < 90/ 50 mmHg).
The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
L- effikaċja ta ’ Revatio ma ġietx stabbilita f’ pazjenti bi pressjoni għolja ta ’ natura gravi fl- arterji tal - pulmun (klassi funzjonali IV).
If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e. g. epoprostenol) should be considered (see section 4.2).
Jekk is- sitwazzjoni klinika tiddeterjora, it- terapiji li huma rrakkomandati fl- istat gravi tal- marda (eż. epoprostenol) għandhom jiġu kkunsidrati (ara sezzjoni 4. 2).
The benefit-risk balance of sildenafil has not been established in patients with class I functional classification of pulmonary arterial hypertension.
Il- bilanċ bejn ir- riskji u l- benefiċċji ma ġietx stabbilit f’ pazjenti bi pressjoni għolja arterjali tal- pulmun ta ’ klassi funzjonali I.
No studies have been performed in related forms of pulmonary arterial hypertension other than related to connective tissue disease and surgical repair.
Ma saru ebda studji fuq forom oħra relatati ta ’ pressjoni għolja arterjali fil - pulmun ħlief dawk relatati ma ’ mard tat- tessut konnettiv u ma ’ tiswija kirurġika.
The safety of sildenafil has not been studied in patients with known hereditary degenerative retinal disorders such as Retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore its use is not recommended.
Is- sigurtà ta ’ sildenafil ma ġietx studjata f’ pazjenti b’ mard magħruf diġenerattiv u ereditarju tar- retina bħal Retinitis pigmentosa (minoranza ta ’ dawn il- pazjenti għandhom mard ġenetiku ta ’ phosphodiesterases retinali) u għalhekk l- użu ta ’ dan il- prodott mediċinali m’ huwiex rakkomandat.
3 In general, any dose adjustment should be administered only after a careful benefit-risk assessment.
3 B’ mod ġenerali, kull aġġustament fid- doża għandu jiġi amministrat biss wara valutazzjoni attenta tar - riskju- benefiċċju.
A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co- administered to patients already receiving medium potency CYP3A4 inhibitors like erythromycin or saquinavir.
Għandu jiġi kkunsidrat aġġustament ta ’ tnaqqis fid- doża għal 20 mg darbtejn kuljum meta sildenafil jingħata flimkien ma ’ mediċini oħra lil pazjenti li diġà jkunu qed jirċievu inibituri ta ’ CYP3A4 ta ’ saħħa medja bħal erythromycin jew saquinavir.
A downward dose adjustment to 20 mg once daily is recommended in case of co- administration with CYP3A4 inhibitors of intermediate potency like clarithromycin, telithromycin and nefazodone.
Aġġustament ta ’ tnaqqis fid- doża għal 20 mg darba kuljum huwa rakkomandat f’ każ ta ’ għoti fl- istess ħin ma ’ inibituri ta ’ CYP3A4 ta ’ saħħa intermedja bħal clarithromycin, telithromycin u nefazodone.
Co-administration of potent CYP3A4 inhibitors (e. g. ketoconazole, itraconazole, ritonavir) with sildenafil for pulmonary arterial hypertension is contraindicated (see section 4.3).
L- għoti fl- istess ħin ta ’ inibituri qawwija ta ’ CYP3A4 (eż. ketoconazole, itraconazole, ritonavir) ma ’ sildenafil għall- pressjoni għolja arterjali fil- pulmun huwa kontra- indikat (ara sezzjoni 4. 3).
Dose adjustments of sildenafil may be required when co-administered with CYP3A4 inducers (see section 4.5).
Jista ’ jkun meħtieġ aġġustament fid- dożi ta ’ sildenafil meta dan jingħata flimkien ma ’ inibituri ta ’ CYP3A4 (ara sezzjoni 4. 5).
When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil’ s mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction (see section 4.4).
Meta jagħtu sildenafil, it- tobba għandhom jikkunsidraw b’ kawtela jekk il- pazjenti b’ ċerti kondizzjonijiet eżistenti jistgħux jiġu affettwati ħażin bl- effetti vażodilatatorji ħfief ghal moderati ta ’ sildenafil, per- eżempju pazjenti bi pressjoni baxxa, pazjenti b’ nuqqas ta ’ likwidi, pazjenti b’ imblukkar gravi tal- ventrikola tax- xellug jew bis- sistema awtonomika li ma tkunx qed taħdem sew (ara sezzjoni 4. 4).
Sildenafil potentiates the hypotensive effect of nitrates therefore concomitant use of Revatio with nitrates is contraindicated (see section 4.3).
Sildenafil iżied l- effett ta ’ tnaqqis fil- pressjoni minħabba n- nitrates, għalhekk l- użu ta ’ Revatio fl - istess ħin ma ’ nitrates huwa kontra- indikat (ara sezzjoni 4. 3).
In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil.
F’ esperjenza ta ’ wara tqegħid fis- suq ta ’ sildenafil għal disturbi fl- erezzjoni maskili, ġew rapportati każi kardjovaskulari serji marbuta ma ’ l- użu fl- istess waqt ta ’ sidenafil, fosthom infart mijokardijaku, anġina instabbli, mewt għal għarrieda tal- qalb, arritmja ventrikulari, emorraġija ċerebrovaskulari, attakk iskimiku transitorju, pressjoni għolja u pressjoni baxxa.
Most, but not all, of these patients had pre- existing cardiovascular risk factors.
Il- biċċa l- kbira ta ’ dawn l- pazjenti, iżda mhux kollha, kellhom fatturi ta ’ riskju kardjovaskulari minn qabel.
Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity.
Ħafna każi ġew rappurtati li ġraw matul jew ftit wara rapport sesswali u ftit ġew rappurtati li ġraw wara l- użu ta ’ REVATIO mingħajr attività sesswali.
It is not possible to determine whether these events are related directly to these factors or to other factors.
Mhux possibbli jiġi determinat jekk dawn il- każi humiex relatati direttament ma ’ dawn il- fatturi jew ma ’ fatturi oħra.
Sildenafil 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 who have conditions which may predispose them to priapism (such as sickle cell anaemia, multiple myeloma or leukaemia).
Sildenafil għandu jintuża b’ kawtela f’ pazjenti b’ deformazzjoni anatomika tal- pene (bħal angulazzjoni, fibrosi fil- korpus kavernożum jew il- marda ta 'Peyronie), jew f’ pazjenti li għandhom kundizzjonijiet li jagħmluhom predisposti għal prijapiżmu (bħal anemija tas- sickle cell, majeloma multipla jew lewkimja).
Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with the intake of sildenafil and other PDE5 inhibitors.
Difetti fil- vista u każijiet ta ’ newropatija anterjuri iskimika, mhux arterika ta ’ l- għajn ġew irrapportati b’ konnessjoni ma ’ kura b’ sildenafil u inibituri ta ’ PDE5 oħrajn.
The patient should be advised that in case of sudden visual defect, he should stop taking Revatio and consult a physician immediately (see section 4.3).
Il- pazjent għandu jkun avżat li f’ każ li f’ daqqa waħda jiżviluppa difett fil- vista, dan għandu jieqaf jieħu Revatio u jkellem tabib immedjatament (ara sezzjoni 4. 3).
Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co- administration may lead to symptomatic hypotension in susceptible individuals (see section 4.5).
Hija rakkomandata kawtela meta sildenafil jingħata lil pazjenti li qed jieħdu xi alpha blocker minħabba li ko- amministrazzjoni tista ’ twassal għal pressjoni baxxa sintomatika f’ individwi suxxettibbli (ara sezzjoni 4. 5).
In order to minimize the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.
Biex jitnaqqas ir- riskju ta ’ pressjoni baxxa posturali, pazjenti għandhom ikunu emodinamikament stabbli fuq kura ta ’ alpha blockers qabel ma jinbeda t- trattament b’ sildenafil.
Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Barra minn hekk, tobba għandhom jgħarrfu lill- pazjenti tagħhom fuq il- passi li jridu jieħdu f’ każ li jkollhom sintomi ta ’ pressjoni baxxa posturali.
Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.
Studji bi plejtlits umani jindikaw li sildenafil isaħħaħ l- effett kontra l- aggregazzjoni ta ’ sodium nitroprusside in vitro.
There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.
M’ hemmx informazzjoni dwar is- sigurtà ta ’ l- amminstrazzjoni ta ’ sildenafil f’ pazjenti b’ mard ta ’ fsada (tnixxijja tad- demm) jew ulċera attiva fl- istonku.
Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment.
Għalhekk sildenafil għandu jiġi amministrat biss lil dawn il- pazjenti wara eżami bir- reqqa tal- benefiċċji u r- riskji.
In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
F’ pazjenti bi pressjoni għolja arterjali fil- pulmun, jista ’ jkun hemm potenzjal għal żieda fir- riskju ta ’ emorraġija meta sildenafil jinbeda f’ pazjenti li diġà qed jużaw antagonista għall- vitamina K, b’ mod partikolari f’ pazjenti bi pressjoni għolja arterjali fil- pulmun sekondarja għall- mard tat- tessut konnettiv.
No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease.
L- ebda dejta m’ hija disponibbli b’ sildenafil f’ pazjenti bi pressjoni għolja fil- pulmun assoċjata ma ’ pulmonary veno- occlusive disease.
However, cases of life threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients.
Għalhekk, jekk ikun
Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
4 hemm sinjali ta ’ edema fil- pulmun meta sildenafil jiġi amministrat lil pazjenti bi pressjoni għolja fil - pulmun, il- possibilta ta ’ mard assoċjat ta ’ imblukkar tal- vini għandu jiġi kkunsidrat.
4 Lactose monohydrate is present in the tablet film coat.
Lactose monohydrate huwa preżenti fil- kisja tal- pillola.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Din il- mediċina ma għandhiex tingħata lil pazjenti li għandhom problemi ereditarji ta ’ intolleranza għall- galactose, defiċjenza fil- Lapp lactase jew li għandhom problemi fl- assorbiment ta ’ glucose- galactose.
Effects of other medicinal products on sildenafil In vitro studies:
Effetti ta ’ prodotti mediċinali oħra fuq sildenafil Studji in vitro:
Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route).
Il- metaboliżmu ta ’ sildenafil iseħħ l- aktar permezz ta ’ l- iżoformi ta ’ ċitokromju P450 (CYP) 3A4 (rotta ewlenija) u 2C9 (rotta minuri).
Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.
Għalhekk, l- inibituri ta ’ dawn l- iżo- enzimi jistgħu jnaqqsu it - tneħħija ta ’ sildenafil.
Population pharmacokinetic analysis of pulmonary arterial hypertension clinical trial data indicated a reduction in sildenafil clearance and/ or an increase of oral bioavailability when co-administered with CYP3A4 substrates and the combination of CYP3A4 substrates and beta-blockers.
Analiżi tal- farmakokinetiċi tal- popolazzjoni minn tagħrif ta ’ prova klinika fuq il- pressjoni għolja arterjali fil- pulmun indikat tnaqqis fit- tneħħija ta ’ sildenafil u/ jew żieda fil- biodisponibilità orali meta jiġu ko- amministrati ma ’ substrat ta ’ CYP3A4 u meta jiġu kkumbinati substrati ta ’ CYP3A4 u beta - blockers.
These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension.
Dawn kienu l- uniċi fatturi b’ impatt ta ’ sinifikat statistiku fuq il- farmakokinetiċi ta ’ sildenafil f’ pazjenti bi pressjoni għolja arterjali fil- pulmun.
The exposure to sildenafil in patients on CYP3A4 substrates and CYP3A4 substrates plus beta-blockers was 43% and 66% higher, respectively, compared to patients not receiving these classes of medicines.
L- espożizzjoni għal sildenafil f’ pazjenti fuq substrati ta ’ CYP3A4 u substrati ta ’ CYP3A4 flimkien ma ’ beta- blockers kienet ta ’ 43% u 66% ogħla, rispettivament, meta mqabbla ma ’ pazjenti li ma kienux qegħdin jirċievu dawn il- klassijiet tal - mediċini.
Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day.
L- espożizzjoni għal sildenafil kienet 5- darbiet ogħla fuq doża ta ’ 80 mg tlett darbiet kuljum meta mqabbla ma ’ espożizzjoni ta ’ 20 mg tlett darbiet kuljum.
This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors (except more potent CYP3A4 inhibitors e. g. ketoconazole, itraconazole, ritonavir).
Din il- medda ta ’ konċentrazzjonijiet tkopri ż- żieda fl- espożizzjoni ta ’ sildenafil osservata fi studji imfasslin speċifikament fuq interazzjonijiet bejn il- mediċini fuq inibituri CYP3A4 (ħlief inibituri iktar qawwija ta ’ CYP3A4 eż. ketoconazole, itraconazole, ritonavir).
CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan.
Indutturi ta ’ CYP3A4 dehru li għandhom impatt sostanzjali fuq il- farmakokinetiċi ta ’ sildenafil f’ pazjenti bi pressjoni arterjali għolja fil- pulmun, u dan ġie kkonfermat fi studju in vivo ta ’ l - interazzjoni ma ’ l- induttur ta ’ CYP3A4 bosentan.
Co-administration of bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of CYP2C19) 125mg twice daily with sildenafil 80 mg three times a day (at steady state) concomitantly administered during 6 days in healthy volunteers resulted in a 63% decrease of sildenafil AUC.
L- għoti fl- istess ħin ta ’ bosentan (induttur moderat ta ’ CYP3A4, CYP2C9 u possibbilment ta ’ CYP2C19) 125 mg darbtejn kuljum ma ’ sildenafil 80 mg tlett darbiet kuljum (fi stat fiss) mogħtija flimkien għal 6 ijiem f’ voluntiera b’ saħħithom irriżulta fi tnaqqis ta ’ 63% fl- AUC ta ’ sildenafil.
Caution is recommended in case of co-administration.
Fil - każ ta ’ amministrazzjoni fl- istess ħin, hija rrakkomandata l- kawtela.
Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John’ s wort and rifamipicine.
L- effikaċja ta ’ sildenafil għandha tkun immonitorjata mill- qrib f’ pazjenti li qed jużaw indutturi qawwijin ta ’ CYP3A4 fl- istess ħin, bħal carbamazepine, phenytoin, phenobarbital, St John’ s wort u rifamipicine.
Co-administration of the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg twice daily) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil Cmax and a 1,000% (11-fold) increase in sildenafil plasma AUC.
Ko- amministrazzjoni ta ’ l- inibitur ta ’ HIV protease ritonavir, li huwa inibitur potenti ħafna tal- P450, fi stat fiss (500 mg darbtejn kuljum) ma ’ sildenafil (100 mg doża waħda) irriżultat f’ żieda ta ’ 300% (4 darbiet) fis- Cmax ta ’ sildenafil u żieda ta ’ 1000% (11- il darba) fl- AUC tal- plażma ta ’ sildenafil.
At 24 hours, the plasma levels of sildenafil were still approximately 200 ng/ ml, compared to approximately 5 ng/ ml when sildenafil was administered alone.
F’ 24 siegħa, l- livelli tal- plażma ta ’ sildenafil kienu għadhom bejn wieħed u ieħor 200 ng/ ml, imqabblin ma ’ bejn wieħed u ieħor 5 ng/ ml meta sildenafil ingħata waħdu.
This is consistent with ritonavir’ s marked effects on a broad range of P450 substrates.
Dan huwa konsistenti ma ’ l- effetti sinifikanti ta ’ ritonavir fuq varjeta wiesgħa ta ’ sustrati ta ’ P450.
Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients (see section 4.3).
Bażata fuq dawn ir- riżultati farmakokinetiċi il- ko- amministrazzjoni ta ’ sildenafil ma ’ ritonavir hija kontra- indikata f’ pazjenti bi pressjoni arterjali għolja fil- pulmun (ara sezzjoni 4. 3).
Co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg three times a day) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
Ko- amministrazzjoni ta ’ l- inibitur ta ’ HIV protease saquinavir, inibitur ta ’ CYP3A4, fi stat fiss (1200 mg tlett darbiet kuljum) ma ’ sildenafil (100 mg doża waħda) irriżultat f’ żieda ta ’ 140% fis- Cmax ta ’ sildenafil u żieda ta ’ 210% fl- AUC ta ’ sildenafil.
Sildenafil had no effect on saquinavir pharmacokinetics.
Sildenafil ma kellux effett fuq il- farmakokinteċi ta ’ saquinavir.
When a single 100 mg dose of sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg twice daily for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
5 Meta doża waħda ta ’ 100 mg sildenafil ġiet amministrata ma ’ erythromycin, inibitur ta ’ CYP3A4 speċifiku, fi stat fiss (500 mg darbtejn kuljum għal 5 jiem), kien hemm żieda ta ’ 182% fis- systemic exposure (AUC) ta ’ sildenafil.
In normal healthy male volunteers, there was no evidence of an effect of azithromycin (500 mg daily for 3 days) on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.
F’ voluntiera rġiel normali u b’ saħħithom, ma kienx hemm evidenza ta ’ xi effett ta ’ azithromycin (500 mg kuljum għal 3 jiem) fuq ir- rata ta ’ l- eliminazzjoni fissa ta ’ l- AUC, Cmax u tmax, jew il- half life ta ’ wara ta ’ sildenafil jew il- metabolu prinċipali tiegħu fiċ- ċirkolazzjoni.
Cimetidine (800 mg), a cytochrome P450 inhibitor and a non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Cimetidine (800 mg), inibitur ta ’ ċitokromju P450 u inibitur ta ’ CYP3A4 mhux speċifiku, wassal għal żieda ta ’ 56% fil- konċentrazzjonijiet tal- plażma ta ’ sildenafil meta ko- amministrat ma ’ sildenafil (50 mg) fuq voluntiera b’ saħħithom.
5 Potent CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir (see section 4.3).
Huwa mistenni li inibituri qawwijin ta ’ CYP3A4, bħal ketoconazole u itraconazole jagħtu effetti simili għal dawk ta ’ ritonavir (ara sezzjoni 4. 3).
CYP3A4 inhibitors of intermediate potency (e. g. clarithromycin, telithromycin and nefazodone) are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors of medium potency (e. g. saquinavir/ erythromycin), a seven-fold increase in exposure is assumed.
Inibituri ta ’ CYP3A4 ta ’ qawwa intermedja (eż. clarithromycin, telithromycin u nefazodone) huma mistennija li jkollhom effett medju, bejn dak ta ’ ritonavir u inibituri ta ’ CYP3A4 ta ’ saħħa medja (eż. saquinavir/ erythromycin), hija assunta żieda fl - espożizzjoni ta ’ seba ’ darbiet iktar.
Therefore dose adjustments are recommended when using CYP3A4 inhibitors of intermediate potency (see section 4.4).
Għalhekk huma rakkomandati aġġustamenti fid- doża meta jintużaw inibituri ta ’ CYP3A4 ta ’ saħħa intermedja (ara sezzjoni 4. 4).
The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone.
Analiżi tal- farmakokinetiċi tal- popolazzjoni f’ pazjenti bi pressjoni għolja arterjali tal- pulmun issuġġerixxiet li l- ko- amministrazzjoni ta ’ beta blockers f’ kumbinazzjoni ma ’ substrati ta ’ CYP3A4 tista ’ tirriżulta f’ żieda addiżjonali fl- espożizzjoni ta ’ sildenafil meta mqabbla ma ’ amministrazzjoni ta ’ substrati ta ’ CYP3A4 waħidhom.
Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil.
Il- meraq tal- grejpfrut huwa inibitur dgħajjef tal- metaboliżmu ta ’ CYP3A4 li jseħħ fis- superfiċje ta ’ ġewwa tal- musrana u jista ’ jwassal għal żidiet modesti fil- livelli tal- plażma ta ’ sildenafil.
Single doses of antacid (magnesium hydroxide/ aluminium hydroxide) did not affect the bioavailability of sildenafil.
Doża waħda ta ’ mediċina kontra l- aċidu fl- istonku (magnesium hydroxide / aluminium hydroxide) ma effettwatx il- bijodisponiblità ta ’ sildenafil
Co-administration of oral contraceptives (ethinyloestradiol 30 μ g and levonorgestrel 150 μ g) did not affect the pharmacokinetics of sildenafil.
L- għoti fl- istess ħin ta ’ kontraċettivi orali (ethinyloestradiol 30 μg u levonorgestrel 150 μg) m’ affettwax il- farmakokinetiċi ta ’ sildenafil.
Nicorandil is a hybrid of potassium channel activator and nitrate.
Nicorandil huwa ibridu ta ’ attivatur tal- potassium channels u nitrate.
Due to the nitrate component it has the potential to have serious interaction with sildenafil.
Minħabba il- komponent ta ’ nitrate, hemm potenzjal ta ’ interazzjoni serja ma ’ sildenafil.
Effects of sildenafil on other medicinal products In vitro studies:
Effetti ta ’ sildenafil fuq prodotti mediċinali oħra Studji n vitro:
Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μ M).
Sildenafil huwa inibitur dgħajjef ta ’ ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 (1C50 > 150 µM).
There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
M’ hemmx informazzjoni dwar l- interazzjoni bejn sildenafil u inibituri ta ’ phosphodiesterase mhux speċifiċi bħal theophylline jew dipyridamole.
No significant interactions were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9.
Ma ntwerewx interazzjonijiet sinifikanti meta sildenafil (50 mg) kien ko- amministrat ma ’ tolbutamide (250 mg) jew ma’ warfarin (40 mg), fejn it- tnejn li huma jiġu metabolizzati minn CYP2C9.
Sildenafil had no significant effect on atorvastatin exposure (AUC increased 11%), suggesting that sildenafil does not have a clinically relevant effect on CYP3A4.
Sildenafil ma kellu l- ebda effett sinifikanti fuq l- espożizzjoni għal atorvastatin (żieda fl- AUC ta ’ 11%), li jissuġġerixxi li sildenafil ma fihx effett klinikament relevanti fuq CYP3A4.
No interactions were observed between sildenafil (100 mg single dose) and acenocoumarol.
L- ebda interazzjonijiet ma ’ ġew osservati bejn sildenafil (doża waħda ta ’ 100 mg) u acenocoumarol.
Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg).
6 Sildenafil (50 mg) ma saħħaħx iż- żieda fil- ħin tal- fsada kaġunat mill- aċidu acetyl salicyclic (150 mg).
Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/ dl.
Sildenafil (50 mg) ma saħħaħx l- effetti ipotensivi ta ’ l- alkoħol f’ voluntiera b’ saħħithom b’ medja ta ’ l - ogħla livelli ta ’ alkoħol fid- demm ta ’ 80 mg/ dl.
In a study of healthy volunteers sildenafil at steady state (80 mg three times a day) resulted in a 50% increase in bosentan AUC (125 mg twice daily).
Fi studju fuq voluntiera f’ saħħithom sildenafil b’ ammont stabbli (80 mg tlett darbiet kuljum) irriżulta f’ żieda ta ’ 50% fl- AUC ta ’ bosentan (125 mg darbtejn kuljum).
Caution is recommended in case of co-administration.
Hija rrakkomandata kawtela f’ kas ta ’ għoti fl- istess ħin.
6 In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg.
Fi studju speċifiku fuq l- interazzjonijiet, fejn sildenafil (100 mg) ingħata ma ’ amoldipine f’ pazjenti bi pressjoni għolja, kien hemm tnaqqis addizzjonali fil- pressjoni supine systolic tad- demm ta ’ 8 mmHg.
The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
It- tnaqqis addizzjonali korrespondenti ma ’ pressjoni għolja supine diastolic kienet ta ’ 7 mmHg.
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers.
Dan it - tnaqqis addizzjonali fil- pressjoni tad- demm kien ta ’ daqs simili għal dak li deher meta sindenafil ġie amministrat waħdu lil volunteera f’ saħħithom.
In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
Fi tlett studji speċifiċi fuq interazzjonijiet bejn droga u droga, l- alpha blocker doxazosin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg, jew 100 mg) ġew amministrati fl- istess waqt, lil pazjenti bi iperplażja beninn tal- prostata (BPH) stabbilizzati b’ kura b’ doxazosin.