FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the EU for Olanzapine Neopharma on 14 November 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Olanzapine Neopharma fl-14 ta' Novembru 2007.
English: The CHMP concluded that, in accordance with EU requirements, Olanzapine Cipla has been shown to have comparable quality and to be bioequivalent to Zyprexa.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Olanzapine Cipla wera li għandu kwalità komparabbli u li huwa bijoekwivalenti ma' Zyprexa.
English: This means that Olanzapine Cipla is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zyprexa.
Maltese: Dan ifisser li Olanzapine Cipla huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Zyprexa.
English: This is a summary of the European public assessment report (EPAR) for Olanzapine Cipla.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Olanzapine Cipla.
English: Olanzapine Cipla is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Olanzapine Cipla jintuża wkoll fit-trattament ta' episodji moderati jew severi tal-manija (burdata tajba b'mod estrem) f'adulti.
English: The name of the medicine was changed to Olanzapine Cipla on 16 May 2013.
Maltese: L-isem tal-mediċina nbidel u sar Olanzapine Cipla fis16 ta' Mejju 2013.
English: Why has Olanzapine Cipla been approved?
Maltese: Għaliex ġiet approvata Olanzapine Cipla?
English: Schizophrenia is a mental illness that has a number of symptoms including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (mistaken beliefs).
Maltese: L-iskizofrenija hija marda mentali li għandha numru ta' sintomi, inkluż disturbi fil-ħsieb u fid-diskors, alluċinazzjonijiet (jiġifieri d-dehra u ssmigħ ta' affarijiet li jkunu immaġinarji), suspetti u delirji (thewdin żbaljat).
English: Because Olanzapine Cipla is a generic medicine, studies in patients have been limited to tests to demonstrate that it is bioequivalent to the reference medicine, Zyprexa.
Maltese: Billi Olanzapine Cipla huwa mediċina ġenerika, l-istudji fil-pazjenti ġew limitati għal testitjiet biex juru l-bijoekwivalenza tiegħu mal-mediċina ta' referenza, Zyprexa.
English: What is Olanzapine Cipla?
Maltese: Kif taħdem Olanzapine Cipla?
English: Other information about Olanzapine Cipla
Maltese: Tagħrif ieħor dwar Olanzapine Cipla
English: Olanzapine Cipla is a medicine that contains the active substance olanzapine.
Maltese: Olanzapine Cipla huwa mediċina li fiha s-sustanza attiva olanzapina.
English: Because Olanzapine Cipla is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine's.
Maltese: Minħabba li Olanzapine Cipla huwa mediċina ġenerika u bijoekwivalenti għall-mediċina ta' referenza, ilbenefiċċju u r-riskju tiegħu huma meqjusa li huma analogi għal dawk tal-mediċina ta' referenza.
English: Patients over 65 years of age and patients who have problems with their liver or kidneys may need a lower starting dose of 5 mg per day.
Maltese: Il-pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil-fwied jew fil-kliewi tagħhom jista' jkollhom bżonn ta' doża iktar baxxa fil-bidu ta' 5 mg kuljum.
English: It can also be used to prevent the recurrence of these episodes (when symptoms come back) in adults with bipolar disorder (a mental illness causing alternating periods of high mood and depression) who have responded to an initial course of treatment.
Maltese: Jista' jintuża wkoll biex jipprevjeni li sintomi ta' dawn l-episodji jerġgħu jitfaċċaw f'adulti b'disturbi bipolari (marda mentali li tikkawża perjodi jalternaw bejn burdata tajba ħafna u depressjoni) li jkunu rrispondew għal kors inizjali ta' kura.
English: Olanzapine Cipla 0F EMA/514077/2013
Maltese: L-EPAR sħiħ għal Olanzapine Cipla jinstab fis-sit elettroniku tal-Aġenzija:
English: Therefore, the CHMP's view was that, as for Zyprexa, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal f'Zyprexa, il-benefiċċji jegħlbu r-riskji identifikati.
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Maltese: Is-sommarju tal-karatteristiċi tal-prodott, tikkettar u fuljett ta' tagħrif validi huma l-verżjonijiet finali miksuba waqt il-proċedura tal-grupp ta' Koordinazzjoni.
English: The full EPAR for Ongentys can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Ongentys contains the active substance opicapone.
Maltese: Ongentys fih is-sustanza attiva opicapone.
English: Ongentys is available as capsules (25 mg and 50 mg) to be taken by mouth.
Maltese: Ongentys jiġi bħala kapsuli (25 mg u 50 mg) li għandhom jittieħdu mill-ħalq.
English: Other information about Ongentys
Maltese: Informazzjoni oħra dwar Ongentys
English: This is a summary of the European public assessment report (EPAR) for Ongentys.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Ongentys.
English: After 14-15 weeks, off periods were shortened by 117 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 96 minutes (about 1 and a half hour) in patients taking the comparator medicine entacapone and 56 minutes (less than 1 hour) in patients taking placebo.
Maltese: Wara 14-15-il ġimgħa, il-perjodi "off" tqassru b'117-il minuta (kważi sagħtejn) f'pazjenti li kienu qegħdin jieħdu Ongentys 50 mg, meta mqabbel ma' 96 minuta (madwar siegħa u nofs) f'pazjenti li kienu qed jieħdu l-mediċina komparatur entacapone u 56 minuta (inqas minn 1 siegħa) f'pazjenti li kienu qed jieħdu plaċebo.
English: Ongentys is used as an add-on to levodopa / DOPA decarboxylase inhibitors (DDCI) (other medicines for Parkinson's disease) in patients who are having fluctuations in the control of their condition.
Maltese: Ongentys jintuża bħala addizzjoni għal levodopa / inibituri ta' DOPA decarboxylase (DDCI - DOPA decarboxylase inhibitors) (mediċini oħrajn għall-marda tal-Parkinson) f'pazjenti li jkun qed ikollhom flutwazzjonijiet fil-kontroll tal-kundizzjoni tagħhom.
English: • patients with a history of neuroleptic malignant syndrome (a nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres);
Maltese: • pazjenti bi storja ta' sindrome newrolettiku malinn (disturb perikoluż fis-sistema nervuża li normalment ikun ikkawżat minn mediċini antipsikotiċi) jew rabdomijoliżi (tkissir tal-fibri muskolari);
English: Opicapone blocks an enzyme that is involved in the breakdown of levodopa in the body called catechol-O-methyl transferase (COMT).
Maltese: Opicapone jimblokka l-enzima li hija involuta fit-tkissir ta' levodopa fil-ġisem imsejħa catechol-O-methyl transferase (COMT).
English: Why is Ongentys approved?
Maltese: Għaliex ġie approvat Ongentys?
English: What are the risks associated with Ongentys?
Maltese: X'inhuma r-riskji assoċjati ma' Ongentys?
English: Regarding its safety, Ongentys was considered to be comparable to other medicines of the same class.
Maltese: Fir-rigward tas-sigurtà tiegħu, Ongentys tqies li huwa komparabbli għal mediċini oħrajn talistess klassi.
English: After 14-15 weeks, off periods were shortened by 119 minutes (almost 2 hours) in patients taking Ongentys 50 mg, compared with 64 minutes in patients taking placebo.
Maltese: Wara 14-15-il ġimgħa, il-perjodi "off" tqassru b'119-il minuta (kważi sagħtejn) f'pazjenti li kienu qegħdin jieħdu Ongentys 50 mg, meta mqabbel ma' 64 minuta f'pazjenti li kienu qed jieħdu plaċebo.
English: In the first study, 600 patients with fluctuations were given Ongentys, entacapone (another medicine for Parkinson's disease) or placebo (a dummy treatment), in addition to their current levodopa / DDCI combination.
Maltese: Fl-ewwel studju, 600 pazjent bi flutwazzjonijiet ingħataw Ongentys, entacapone (mediċina oħra għall-marda talParkinson) jew plaċebo (kura finta), apparti l-kombinazzjoni attwali tagħhom levodopa / DDCI.
English: The benefits of Ongentys in Parkinson's disease were investigated in two main studies.
Maltese: Il-benefiċċji ta' Ongentys fil-marda tal-Parkinson ġew investigati f'żewġ studji prinċipali.
English: • patients with tumours of the adrenal glands (small glands located on top of the kidneys) such as pheochromocytoma and paraganglioma;
Maltese: • pazjenti b'tumuri tal-glandoli adrenali (glandoli żgħar li jinsabu fuq il-kliewi) bħal feokromoċitoma u paraganglijoma;
English: The most common side effects with Ongentys are disorders of the nervous system (brain and spinal cord).
Maltese: L-aktar effetti sekondarji komuni b'Ongentys huma disturbi fis-sistema nervuża (moħħ u korda spinali).
English: In the second study, which also looked at the reduction in off periods, Ongentys was compared with placebo in 427 patients who were taking a levodopa / DDCI combination.
Maltese: Fit-tieni studju, li ħares ukoll lejn it-tnaqqis fil-perjodi "off", Ongentys tqabbel ma' plaċebo f'427 pazjent li kienu qed jieħdu kombinazzjoni ta' levodopa / DDCI.
English: The patients then lose their ability to control their movements reliably.
Maltese: Għalhekk il-pazjenti jitilfu lħila li jikkontrollaw il-movimenti tagħhom b'mod affidabbli.
English: • patients taking medicines known as non-selective monoamine oxidase (MAO) inhibitors except when used to treat Parkinson's disease.
Maltese: • pazjenti li jieħdu mediċini magħrufin bħala inibituri ta' monoamine oxidase mhux selettivi (MAO
English: Ongentys is a medicine used to treat adults with Parkinson's disease, a progressive brain disorder that causes shaking and muscle stiffness, and slows movement.
Maltese: Ongentys huwa mediċina li tintuża biex tikkura adulti bil-marda ta' Parkinson, disturb progressiv filmoħħ li jikkawża rogħda u ebusija tal-muskoli, u jdewwem il-moviment.
English: Ongentys was shown to be more effective than placebo and at least as effective as the comparator entacapone in reducing off periods in patients with Parkinson's disease taking levodopa combination medicines.
Maltese: Ongentys intwera li huwa aktar effettiv minn plaċebo u għallinqas effettiv daqs il-komparatur entacapone fittnaqqis tal-perjodi "off" f'pazjenti bil-marda tal-Parkinson li jieħdu mediċini ta' kombinazzjoni ta' levodopa.
English: The recommended dose is 50 mg, taken once a day at bedtime, at least one hour before or after levodopa combination medicines.
Maltese: Id-doża rrakkomandata hija 50 mg, li tittieħed darba kuljum fil-ħin tal-irqad, għallinqas siegħa qabel jew wara mediċini ta' kombinazzjoni ta' levodopa.
English: The active substance in Ongentys, opicapone, works to restore the levels of dopamine in the parts of the brain that control movement and coordination.
Maltese: Is-sustanza attiva f'Ongentys, opicapone, taħdem billi ġġib lura l-livelli ta' dopamina fil-partijiet tal-moħħ li jikkontrollaw il-moviment u lkoordinazzjoni.
English: How is Ongentys used?
Maltese: Kif jintuża Ongentys?
English: What measures are being taken to ensure the safe and effective use of Ongentys?
Maltese: X'miżuri qed jitteħdu biex jassiguraw l-użu sigur u effikaċi ta' Ongentys?
English: Among these, dyskinesia (difficulty controlling movement) may affect around 2 in 10 people.
Maltese: Fost dawn, diskinesja (diffikultà fil-kontroll tal-moviment) tista' taffettwa madwar 2 persuni minn kull 10).
English: As a result, levodopa remains active for longer.
Maltese: Minħabba dan, levodopa tibqa' attiva għal iżjed żmien.
English: Both studies were extended for one additional year and confirmed the benefits of Ongentys when used long-term.
Maltese: Iż-żewġ studji ġew estiżi għal sena addizzjonali u kkonfermaw il-benefiċċji ta' Ongentys meta użat fittul.
English: 036 80 Martin Slovak Republic
Maltese: 036 80 Martin Is-Slovakkja
English: Teva Pharma Belgium N.V./S.A./AG
Maltese: Teva Pharma Belgium N.V./S.A./AG Tél/Tel:
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Maltese: Il-medja tal-bijodisponibilità orali assoluta ta' hi ta' 41% (medda 25-63%).
English: In vivo studies
Maltese: Studji in vivo
English: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany
Maltese: ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm
English: The maximum recommended dose is 100 mg.
Maltese: Id-doża massima rrakkomandata hi ta' 100 mg.
English: - The other ingredients are: microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, calcium hydrogen phosphate anhydrous, talc, macrogol 6000, titanium dioxide, iron oxide red.
Maltese: - Is-sustanzi l-oħra huma: microcrystalline cellulose, hypromellose, croscarmellose sodium, magnesium stearate, calcium hydrogen phosphate anhydrous, talc, macrogol 6000, titanium dioxide, iron oxide red.
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Maltese: Nicorandil hu ibridu ta' attivatur tal-kanali tal-potassium u nitrate.
English: Date of latest renewal: 9 September 2014.
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Diċembru, 2009 Date tal-aħħar tiġdid: 9 ta' Settembru 2014.
English: HBM Pharma s.r.o.
Maltese: HBM Pharma s.r.o Sklabinská 30
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 µM).
Maltese: Sildenafil hu inibitur dgħajjef ta' ċitokrom P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 (1C50 > 150 μM).
English: Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP.
Maltese: Sildenafil hu inibitur potenti u selettiv ta' cGMP specific phosphodiesterase type 5 (PDE5) fil-corpus cavernosum, fejn PDE5 hu responsabbli għad-degradazzjoni ta' cGMP.
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Maltese: Il-profil tas-sigurtà ta' sildenafil hu bbażat fuq 9,570 pazjent f'74 studji kliniċi kkontrollati bil-plaċebo double-blind.
English: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Strasse 3 89143 Blaubeuren Il-Ġermanja
English: resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan Cmax (125 mg b.i.d.
Maltese: 8% fl-AUC ta' bosentan u żieda ta' 42% fis-Cmax ta' bosentan (125mg b.i.d.).
English: Manufacturer Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren Germany
Maltese: Merckle GmbH Ludwig-Merckle-Straße 3 89143 Blaubeuren
English: Sildenafil is an oral therapy for erectile dysfunction.
Maltese: Sildenafil hu terapija orali għal disfunzjoni erettili.
English: Sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
Maltese: Sildenafil (100 mg) ma affettwax il-farmakokinetika fl-istat fiss tal-inibituri ta' HIV protease, saquinavir u ritonavir, it-tnejn li huma substrati CYP3A4.
English: (≥ 1/10,000 and
Maltese: Rari (≥ 1/10,000 u <1/1,000)
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Maltese: Il-metabolit N-desmethyl jiġi mmetabolizzat iżjed, b'half-life terminali ta' madwar 4 sigħat.
English: There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina.
Maltese: Hemm selettività ta' 10 darbiet aktar fuq PDE6 li hu involut fil-phototransduction pathway fir-retina.
English: In clinical trials sildenafil was administered to more than 8,000 patients aged 19-87.
Maltese: Fi provi kliniċi, sildenafil ingħata lil aktar minn 8,000 pazjent li kellhom 19-87 sena.
English: The following patient groups were represented: elderly (19.9%), patients with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%).
Maltese: Kienu rrappreżentati dawn il-gruppi ta' pazjenti li ġejjin: anzjani (19.9%), pazjenti bi pressjoni għolja (30.9%), pazjenti b'dijabete mellitus (20.3%), mard iskemiku tal-qalb (5.8%), iperlipidemija (19.8%), feriti fis-sinsla tad-dahar (0.6%), dipressjoni (5.2%), qtugħ transuretrali tal-prostata (3.7%),
English: Epistaxis, Sinus congestion
Maltese: Epistassi, Konġestjoni tassinus
English: In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, (an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19) at steady state (125 mg twice a day) with sildenafil at steady state (80 mg three times a day) resulted in 62.6% and 55.4% decrease in sildenafil AUC and Cmax, respectively.
Maltese: Fi studju ta' voluntiera rġiel b'saħħithom, amministrazzjoni ta' antagonist tal-endothelin, bosetan, (induttur ta' CYP3A4 [moderat], CYP2C9 u possibilment ta' CYP2C19) fi stat fiss (125 mg darbtejn kuljum) flimkien ma' sildenafil fi stat fiss (80 mg tlett darbiet kuljum) irriżulta fi tnaqqis ta' 62.6% u 55.4% fl-AUC u Cmax ta' sildenafil rispettivament.
English: In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Maltese: B'mod partikulari, sildenafil għandu selettività ta' aktar minn 4,000 darba aktar għal PDE5 fuq PDE3, is-cAMP-specific phosphodiesterase isoform involut fil-kontroll talkontrattilità kardijaka.
English: Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Maltese: Sildenafil (50 mg) ma żiedx l-effetti ipotensivi tal-alkoħol f'voluntiera b'saħħithom b'medja ta' logħla livelli ta' alkoħol fid-demm ta' 80 mg/dl.
English: ● Risk Management Plan (RMP) Not applicable.
Maltese: • Pjan tal-ġestjoni tar-riskju (RMP) Mhux applikabbli.
English: Hypoaesthesia oral
Maltese: Ipoaestesija orali
English: This metabolite has a phosphodiesterase selectivity profile similar to sildenafil and an in vitro potency for PDE5 approximately 50% that of the parent drug.
Maltese: Dan il-metabolit għandu profil ta' selettività ta' phosphodiesterase simili għal sildenafil u potenza in vitro għal PDE5 ta' madwar 50% tal-mediċina ewlenija.
English: EU/1/09/603/009 1 film-coated tablet EU/1/09/603/010 4 film-coated tablets EU/1/09/603/011 8 film-coated tablets EU/1/09/603/012 12 film-coated tablets EU/1/09/603/015 2 film-coated tablets EU/1/09/603/016 24 film-coated tablets EU/1/09/603/018 48 film-coated tablets
Maltese: EU/1/09/603/009 1 pillola miksija b'rita EU/1/09/603/010 4 pilloli miksija b'rita EU/1/09/603/011 8 pilloli miksija b'rita EU/1/09/603/012 12-il pillola miksija b'rita EU/1/09/603/015 2-il pillola miksija b'rita EU/1/09/603/016 24 pillola miksija b'rita EU/1/09/603/018 48 pillola miksija b'rita
English: Sildenafil had no effect on saquinavir pharmacokinetics (see section 4.2).
Maltese: Sildenafil ma kellu l-ebda effett fuq ilfarmakokinetika ta' saquinavir (ara sezzjoni 4.2).
English: In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Maltese: Fi studju RigiScan separat, sildenafil xorta kien għadu kapaċi jipproduċi erezzjoni b'rispons għal stimulazzjoni sesswali 4-5 sigħat wara d-doża.
English: radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
Maltese: prostatektomija radikali (3.3%).
English: 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.
Maltese: Fi tliet studji speċifiċi dwar l-interazzjonijiet bejn żewġ prodotti mediċinali, alpha blocker doxazocin (4 mg u 8 mg) u sildenafil (25 mg, 50 mg u 100 mg), ingħataw fl-istess ħin lil pazjenti bi tkabbir beninn tal-prostata (BPH), stabbilizzati fuq terapija b'doxazocin.
English: Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors (such as tolbutamide, warfarin, phenytoin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP450 metabolism (such as rifampicin, barbiturates).
Maltese: Għalkemm ma sarux studji speċifiċi dwar l-interazzjoni għal prodotti mediċinali kollha, analiżi farmakokinetika tal-popolazzjoni ma turi l-l-ebda effett ta' kura li tingħata fl-istess ħin fuq ilfarmakokinetika ta' sildenafil meta miġbura fi gruppi bħala inibituri ta' CYP2C9 (bħal tolbutamide, warfarin, phenytoin), inibituri ta' CYP2D6 (bħal selective serotonin reuptake inhibitors, antidipressanti triċikliċi), thiazide u dijuretiċi relatati, dijuretiċi loop u potassium-sparing, inibituri ta' l-enzima li tikkonverti l-angiotensin, channel blockers tal-calcium, antagonisti beta-adrenoreceptor jew inducers tal-metaboliżu CYP450 (bħal rifampicin, barbiturate).
English: Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%),
Maltese: Fil-provi kollha, il-proporzjon ta' pazjenti li rrappurtaw titjib b'sildenafil kienu kif ġej: disfunzjoni erettili psikoġenika (84%), disfunzjoni erettili mħallta (77%), disfunzjoni erettili organika (68%), anzjani (67%), dijabetiċi (59%), mard iskemiku tal-qalb (69%), pressjoni għolja (68%), TURP (61%), prostatektomija radikali (43%), feriti fis-sinsla tad-dahar (83%), dipressjoni (75%).
English: In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency [very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000)].
Maltese: Fit-tabella t'hawn taħt, ir-reazzjonijiet avversi kollha ta' importanza medika, li seħħew fil-provi kliniċi b'inċidenza li kienet iktar minn dik tal-plaċebo, huma mniżżla skont il-klassi tal-organi tas-sistema u lfrekwenzi [komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000)].
English: Cimetidine (800 mg), a cytochrome P450 inhibitor and non-specific CYP3A4 inhibitor, caused a 56% increase in plasma sildenafil concentrations when co-administered with sildenafil (50 mg) to healthy volunteers.
Maltese: Cimetidine (800 mg), inibitur ta' ċitokrom P450 u inibitur mhux speċifiku ta' CYP3A4, wassal għal żieda ta' 56% fil-konċentrazzjonijiet tal-plażma ta' sildenafil meta ngħata ma' sildenafil (50 mg) lil voluntiera b'saħħithom.
English: Sildenafil ratiopharm contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Sildenafil ratiopharm fih is-sustanza attiva sildenafil li jappartjeni għall-grupp ta' mediċini msejħa inibituri ta' phosphodiesterase ta' tip 5 (PDE5).
English: Pack sizes of 1, 2, 4, 8, 12, 24 or 48 film-coated tablets.
Maltese: Daqs tal-pakketti ta' 1, 2, 4, 8, 12, 24 jew 48 pilloli miksija b'rita.
English: Do NOT take Sildenafil ratiopharm if you are taking medicines that contain nitrates (e.g. glycerol trinitrate) or nitric oxide donors (e.g. amyl nitrite, also called “poppers”).
Maltese: TIĦUX Sildenafil ratiopharm jekk qed tieħu mediċini li fihom in-nitrati (eż. glycerol trinitrate) jew donaturi ta' nitric oxide (eż. amyl nitrite, imsejħa wkoll “poppers”).