FrancophonIA/ELRC3.0 huggingface dataset:
English: PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties
Maltese: .1 Proprjetajiet farmakodinamiċi Kategorija farmakoterapewtika:
English: No dose adjustment is necessary in patients with mild to moderate renal impairment or hepatic impairment (see section 5.2).
Maltese: Mhux meħtieġ aġġustament fid-doża f'pazjenti b'indeboliment renali ħafif sa moderat jew indeboliment epatiku (ara sezzjoni 5.2).
English: Long-term study (Study 3)
Maltese: Studju fit-tul (Studju 3)
English: ATC code: Not yet assigned.
Maltese: Kodiċi ATC:
English: Assuming the model-derived estimated bioavailability of 66% (±SD of 26%) holds for the patient population, central clearance for a typical patient was 0.09 L/day (23.4% CV) following subcutaneous administration of 225 mg, 675 mg and 900 mg of fremanezumab.
Maltese: Jekk wieħed jassumi li l-bijodisponibilità stmata li ġejja minn mudell ta' 66% (± SD ta' 26%) tapplika għall-popolazzjoni ta' pazjenti, it-tneħħija ċentrali għal pazjent tipiku kienet ta' 0.09 L/jum (23.4% CV) wara għotja taħt il-ġilda ta' 225 mg, 675 mg u 900 mg ta' fremanezumab.
English: The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-dentatur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u l interventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2
English: Pain, induration and erythema were typically observed immediately after injection while pruritus and rash appeared within a median of 24 and 48 hours, respectively.
Maltese: Uġigħ, ebusija u eritema tipikament kienu osservati immedjatament wara l-injezzjoni, waqt li ħakk u raxx dehru fi żmien medjan ta' 24 u 48 siegħa,
English: EU/1/19/1358/001 1 pre-filled syringe EU/1/19/1358/002 3 pre-filled syringes
Maltese: EU/1/19/1358/001 siringa waħda mimlija għal-lest EU/1/19/1358/002 3 siringi mimlija għal-lest
English: The efficacy of fremanezumab was evaluated in episodic migraine in a randomised, multicentre, 12-week, placebo-controlled, double-blind study (Study 1).
Maltese: L-effikaċja ta' fremanezumab kienet evalwata fl-emigranja episodika fi studju fejn il-pazjenti ntgħażlu b'mod każwali, multiċentriku, li dam 12-il-ġimgħa, ikkontrollat bil-plaċebo u double-blind (Studju 1).
English: 50% Responder Rate MMD
Maltese: Rata ta' Rispons ta' MMD
English: Other medicines and AJOVY
Maltese: Mediċini oħra u AJOVY
English: EU/1/19/1358/003 1 pre-filled pen EU/1/19/1358/004 3 pre-filled pens
Maltese: EU/1/19/1358/003 pinna waħda mimlija għal-lest EU/1/19/1358/004 3 pinen mimlija għal-lest
English: Solution for injection (injection)
Maltese: prodotti antikonvulżivi).
English: Approximately 52% of the patients in the study had acute headache medication overuse.
Maltese: Madwar 52% tal-pazjenti fl-istudju kellhom użu żejjed ta' medikazzjoni għall-uġigħ ta' ras akut.
English: Solution for injection 1 pre-filled pen of 1.5 mL solution 3 pre-filled pens of 1.5 mL solution
Maltese: Kull pinna mimlija għal-lest fiha soluzzjoni ta' 1.5 mL.
English: Solution for injection 1 pre-filled syringe of 1.5 mL solution 3 pre-filled syringes of 1.5 mL solution
Maltese: Kull siringa mimlija għal-lest fiha soluzzjoni ta' 1.5 mL.
English: AJOVY Quarterly
Maltese: Siringa AJOVY
English: Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.
Maltese: IgG uman huwa magħruf li jiġi eliminat fil-ħalib tas-sider matul l-ewwel jiem wara t-twelid, li jonqos għal konċentrazzjonijiet baxxi ftit wara; konsegwentement, riskju gћal trabi li jkunu qed jiġu mredda' mhux eskluż matul dan il-perjodu qasir.
English: No formal clinical drug interaction studies have been performed with AJOVY.
Maltese: Ma twettaq l-ebda studju kliniku formali dwar interazzjonijiet tal-mediċina b'AJOVY.
English: CELLTRION Inc.
Maltese: Inc.
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -1.8 days (95% CI: -2.95, -0.55) and between fremanezumab 225 mg monthly and placebo -2.0 days (95% CI: -3.21, -0.86).
Maltese: F'pazjenti fuq prodott mediċinali konkomitanti ieħor għall-prevenzjoni tal-emigranja, id-differenza fittrattament għat-tnaqqis ta' jiem ta' emigranja kull xahar (MMD, monthly migraine days) osservata bejn fremanezumab 675 mg kull tliet xhur u plaċebo kienet ta' -1.8 ijiem (CI ta' 95%: -2.95, -0.55) u bejn fremanezumab 225 mg kull xahar u plaċebo -2.0 jiem (CI ta' 95%: -3.21, -0.86).
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly migraine days (MMD) observed between fremanezumab 675 mg quarterly and placebo was -2.3 days (95% CI: -3.64, -1.00) and between fremanezumab 225 mg monthly and placebo -2.4 days (95% CI: -3.61, -1.13).
Maltese: F'pazjenti li kienu użaw topiramate qabel, id-differenza fit-trattament għat-tnaqqis ta' jiem ta' emigranja kull xahar (MMD, monthly migraine days) osservata bejn fremanezumab 675 mg kull tliet xhur u plaċebo kienet ta' -2.3 ijiem (CI ta' 95%: -3.64, -1.00) u bejn fremanezumab 225 mg kull xahar u plaċebo -2.4 ijiem (CI ta' 95%: -3.61, -1.13).
English: Mean changea (95% CI) Baseline (SD) P-value (vs. placebo)a p=0.0023
Maltese: Valur p (kontra plaċebo)a p=0.0023
English: e) Inspect your AJOVY pre-filled syringe.
Maltese: d) Applika pressjoni fuq is-sit tal-injezzjoni.
English: AJOVY is a medicine containing the active substance fremanezumab, a monoclonal antibody, a type of protein that recognises and attaches to a specific target in the body.
Maltese: AJOVY huwa mediċina li fiha s-sustanza attiva fremanezumab, antikorp monoklonali, tip ta' proteina li tagħraf u tintrabat ma' mira speċifika fil-ġisem.
English: In patients on one other concomitant, migraine preventive medicinal product, the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -2.66, 0.03) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.27, -0.67).
Maltese: F'pazjenti fuq prodott mediċinali konkomitanti ieħor għall-prevenzjoni tal-emigranja, id-differenza fittrattament għat-tnaqqis ta' jiem ta' wġigħ ta' ras kull xahar (MHD, monthly headache days) ta' severità mill-inqas moderata osservata bejn fremanezumab 675 mg kull tliet xhur u plaċebo kienet ta'1.3 ijiem (CI ta'95%: -2.66, 0.03) u bejn fremanezumab 225 mg kull xahar b'doża tal-bidu ta' 675 mg u plaċebo -2.0 jiem (CI ta' 95%: -3.27, -0.67).
English: No data on exposure-efficacy relationship in subjects with body weight >132 kg is available.
Maltese: M'hemmx data disponibbli dwar ir-relazzjoni tal-effikaċja mal-esponiment f'individwi b'piż tal-ġisem ta' >132 kg.
English: The observed treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity between fremanezumab 675 mg quarterly and placebo in these patients was -2.2 days (95% CI: -3.14, -1.22) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.7 days (95% CI: -3.71, -1.78).
Maltese: Id differenza fit-trattament osservata għat-tnaqqis ta' jiem ta' wġigħ ta' ras kull xahar (MHD, monthly headache days) ta' severità mill-inqas moderata bejn fremanezumab 675 mg kull tliet xhur u plaċebo f'dawn il-pazjenti kienet ta' -2.2 jiem (CI ta' 95%: -3.14, -1.22) u bejn fremanezumab 225 mg kull xahar b'doża tal-bidu ta' 675 mg u plaċebo -2.7 ijiem (CI ta' 95% CI: -3.71, -1.78).
English: Patients with certain major cardiovascular diseases were excluded from clinical studies (see section 5.1).
Maltese: Pazjenti b'ċertu mard kardjovaskulari maġġuri kienu esklużi mill-istudji kliniċi (ara sezzjoni 5.1).
English: Injection site pain Injection site induration Injection site erythema
Maltese: Ir-rekwiżiti biex jiġu ppreżentati
English: In patients who had previously used topiramate the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -2.7 days (95% CI: -3.88, -1.51) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.9 days (95% CI: -4.10, -1.78).
Maltese: F'pazjenti li kienu użaw topiramate qabel, id-differenza fit-trattament għat-tnaqqis ta' jiem ta' wġigħ ta' ras kull xahar (MHD, monthly headache days) ta' severità mill-inqas moderata osservata bejn fremanezumab 675 mg kull tliet xhur u plaċebo kienet ta' -2.7 ijiem (CI ta' 95%: -3.88, -1.51) u bejn fremanezumab 225 mg kull xahar b'doża tal-bidu ta' 675 mg u plaċebo -2.9 ijiem (CI ta' 95%: -4.10,1.78).
English: Teл.
Maltese: sħana.
English: Figure 2: Mean Change from Baseline in the Monthly Average Number of Headache Days of At Least Moderate Severity for Study 2
Maltese: Figura 2: Bidla Medja mil-Linja Bażi fin-Numru Medju ta' Jiem ta' Wġigħ ta' Ras ta' Severità mill-Inqas Moderata Kull Xahar għal Studju 2
English: • Each AJOVY pre-filled pen contains 225 mg of fremanezumab.
Maltese: • Kull pinna mimlija għal-lest ta' AJOVY fiha 225 mg ta' fremanezumab.
English: If your dose is 675 mg, repeat steps 1 e) to 3 a) with the second and third pre-filled syringe to inject the full dose.
Maltese: Jekk id-doża tiegħek hija ta' 675 mg, irrepeti l-passi 1 e) sa 3 a) bit-tieni u t-tielet pinna mimlija għal-lest biex tinjetta d-doża sħiħa.
English: • Each AJOVY pre-filled syringe contains 225 mg of fremanezumab.
Maltese: • Kull siringa mimlija għal-lest ta' AJOVY fiha 225 mg ta' fremanezumab.
English: Major cardiovascular diseases
Maltese: EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: After single subcutaneous administrations of 225 mg and 675 mg fremanezumab, median time to maximum concentrations (tmax) in healthy subjects was 5 to 7 days.
Maltese: Assorbiment Wara għotja waħda taħt il-ġilda ta' 225 mg u 675 fremanezumab, il-ħin medjan għal konċentrazzjonijiet massimi (tmax) f'individwi f'saħħithom kien ta' 5 sa 7 ijiem.
English: A total of over 2,500 patients (more than 1,900 patient years) have been treated with AJOVY in registration studies.
Maltese: Sommarju tal-profil tas-sigurtà Total ta' iżjed minn 2,500 pazjent (aktar minn 1,900 sena ta' pazjent) ġew ittrattati b'AJOVY fl-istudji ta' reġistrazzjoni.
English: How to use AJOVY
Maltese: Pinna AJOVY
English: Both monthly and quarterly dosing regimens of fremanezumab demonstrated statistically significant and clinically meaningful improvement from baseline compared to placebo for key endpoints (see Table 3).
Maltese: dożaġġ ta' fremanezumab kull xahar u kif ukoll dak ta' kull tliet xhur urew titjib statistikament u klinikament sinifikanti mil-linja bażi meta mqabbla mal-plaċebo għall-punti finali ewlenin (ara Tabella 3).
English: 6.6 Special precautions for disposal and other handling
Maltese: TD = differenza fit-trattament (treatment difference)
English: Within each system organ class, ADRs are ranked by frequency, most frequent reactions first.
Maltese: F'kull klassi tas-sistemi u tal-organi, l-ADRs huma kklassifikati skont ilfrekwenza, bl-aktar reazzjonijiet frekwenti elenkati l-ewwel.
English: Biotransformation
Maltese: CELLTRION
English: Furthermore, concomitant use of acute migraine treatments (specifically analgesics, ergots, and triptans) and migraine preventive medicinal products during the clinical studies did not affect the pharmacokinetics of fremanezumab.
Maltese: Barra minn hekk, l-użu ta' trattamenti għall-emigranja akuta (speċifikament analġeżiċi, ergots u triptans) flimkien ma' prodotti mediċinali għall-prevenzjoni tal-emigranja waqt l-istudji kliniċi ma affettwax il-farmakokinetika ta' fremanezumab.
English: Fremanezumab was evaluated in chronic migraine in a randomised, multicentre, 12-week, placebocontrolled, double-blind study (Study 2).
Maltese: ikkontrollat bil-plaċebo, double-blind u fejn il-pazjenti ntgħażlu b'mod każwali (Studju 2).
English: In patients who had previously used onabotulinumtoxin A the treatment difference for the reduction of monthly headache days (MHD) of at least moderate severity observed between fremanezumab 675 mg quarterly and placebo was -1.3 days (95% CI: -3.01, -0.37) and between fremanezumab 225 mg monthly with 675 mg starting dose and placebo -2.0 days (95% CI: -3.84, -0.22).
Maltese: F'pazjenti li kienu użaw onabotulinumtoxin A minn qabel, id-differenza fit-trattament għattnaqqis ta' jiem ta' wġigħ ta' ras kull xahar (MHD, monthly headache days) ta' severità mill-inqas moderata osservata bejn fremanezumab 675 mg kull tliet xhur u plaċebo kienet ta' -1.3 ijiem (CI ta' 95%: -3.01, -0.37) u bejn fremanezumab 225 mg kull xahar b'doża tal-bidu ta' 675 mg u plaċebo2.
English: - Keep this leaflet.
Maltese: Għadu mhux assenjat.
English: Mean at baseline (monthly average number of headache days of at least moderate severity): Placebo: 13.3, AJOVY Quarterly: 13.2, AJOVY Monthly: 12.8.
Maltese: 13.3, AJOVY Kull Tliet Xhur: 13.2, AJOVY Kull Xahar:
English: CI = confidence interval; HIT-6 = Headache Impact Test; MAHMD = monthly acute headache medication days; MHD = monthly headache days of at least moderate severity; MMD = monthly migraine days; SD = standard deviation; TD = treatment difference a For all endpoints mean change and CIs are based on the ANCOVA model that included treatment, gender, region, and baseline preventive medication use (yes/no) as fixed effects and corresponding baseline value and years since onset of migraine as covariates.
Maltese: Għall-punti finali kollha, il-bidla medja u s-CIs huma bbażati fuq il-mudell ANCOVA li kien jinkludi trattament, sess tal-persuna, reġjun, u użu ta' medikazzjoni ta' prevenzjoni fil-linja bażi (iva/le) bħala effetti fissi, u valur li jikkorrispondi għall-linja bażi u snin minn meta bdiet l-emigranja bħala kovarjabbli.
English: EXP
Maltese: RMP.
English: Overall, 30% of the patients had previously used topiramate and 15% onabotulinumtoxin A. A total of 1,034 patients completed the 12-week double-blind treatment period.
Maltese: B'mod globali, 30% tal-pazjenti kienu użaw topiramate qabel u 15% kienu użaw onabotulinumtoxin A.
English: --1 Live recombinant turkey herpesvirus (strain HVT/ILT-138) expressing the glycoproteins gD and gI of infectious laryngotracheitis virus: 103.1 - 104.1 PFU*.
Maltese: --1 Herpesvirus rikombinant ħaj (strejn HVT/ILT-138) jesprimi il- glycoproteini gD u gI tal- virus infettiv laryngotracheitis: 103.1 - 104.1
English: EU (MA) number Invented name
Maltese: EU (MA) numbru Isem ivvintat
English: Content Package size
Maltese: Daqs tal-pakkett
English: 10 % Oral powder
Maltese: 10% Trab orali
English: In vivo studies:
Maltese: Studji in vivo:
English: Date of first authorisation: 21 September 2009 Date of latest renewal: 16 May 2014
Maltese: Data tal-ewwel awtorizzazzjoni: 21 ta' Settembru 2009 Data tal-aħħar tiġdid: 16 ta' Mejju 2014
English: In vitro studies:
Maltese: Studji in vitro:
English: Use in adults:
Maltese: Użu fl-adulti:
English: Rare ( 1/10000 and
Maltese: Rari ( 1/10000 u <1/1000)
English: Nicorandil is a hybrid of potassium channel activator and nitrate.
Maltese: Nicorandil huwa ibridu ta' attivatur tal-kanali tal-potassju u nitrate.
English: The mean absolute oral bioavailability is 41% (range 25-63%).
Maltese: Il-medja assoluta ta' bijodisponibilità orali hija ta' 41 % (medda 25-63 %).
English: What Vizarsin contains - The active substance is sildenafil.
Maltese: X'fih Vizarsin - The active substance is sidenafil.
English: Vizarsin contains sorbitol.
Maltese: Vizarsin fih sorbitol.
English: Common ( 1/100 and
Maltese: Komuni ( 1/100 u
English: Vizarsin contains sorbitol (E420).
Maltese: Vizarsin fih sorbitol (E420).
English: Contains aspartame (E951) and peppermint oil (sorbitol (E420)).
Maltese: Fih aspartame (E951) u peppermint oil (sorbitol (E420)).
English: Peppermint oil (containing sorbitol (E420)) Crospovidone
Maltese: Peppermint oil (li fih sorbitol (E420)) Crospovidone
English: - If you are taking riociguat.
Maltese: - qed/a tieħu riociguat.
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-farmakokinetiċi fi stat stabbli tal-inibituri ta' HIV protease, saquinavir u ritonavir, it-tnejn li huma sustrati CYP3A4.
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 (125 mg b.i.d.).
English: Sildenafil is an oral therapy for erectile dysfunction.
Maltese: Sildenafil huwa terapija orali għal problema ta' impotenza.
English: The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h.
Maltese: Il-metabolit N-desmethyl jiġi metabolizzat iżjed, b'half-life terminali ta' madwar 4 h.
English: At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
Maltese: Bl-ogħla dożi rakkomandati, hemm selettività ta' 80-darba fuq PDE1, u aktar minn 700-darba fuq PDE2, 3, 4, 7, 8, 9,10 u 11.
English: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil.
Maltese: Ma nstabux effetti avversi fi studji riproduttivi f'firien u fniek wara amministrazzjoni orali ta' sildenafil.
English: The maximum recommended dose is 100 mg.
Maltese: Id-doża massima rrakkomandata hija 100 mg.
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 huwa impeditur potenti u silettiv ta' cGMP specific phosphodiesterase type 5 (PDE5) filcorpus cavernosum, fejn PDE5 huwa responsabbli għad-degradazzjoni ta' cGMP.
English: In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
Maltese: Fi provi kliniċi sildenafil ġie mogħti lil aktar minn 8000 pazjent bejn l-etajiet ta' 19-87 sena.
English: Film coating: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).
Maltese: lactose monohydrate, hypromellose (E464), titanium dioxide (E171), triacetin (E1518).
English: Uncommon ( 1/1000 and
Maltese: Mhux komuni ( 1/1000 u
English: Sildenafil is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 > 150 μM).
Maltese: Sildenafil huwa inibitur dgħajjef ta' ċitokromju P450 iżoformi 1A2, 2C9, 2C19, 2D6, 2E1 u 3A4 (1C50 > 150 µM).
English: Children and adolescents Vizarsin should not be given to individuals under the age of 18.
Maltese: Tfal u adolexxenti Vizarsin m'għandux jingħata lil individwi taħt l-età ta' 18-il sena.
English: The safety profile of sildenafil is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies.
Maltese: Is-sigurtà ta' Vizarsin hija bbażata fuq 9570 pazjenti f'74 studju klinikubi plaċebo bħala kontroll u double-blind.
English: Stevens-Johnson Syndrome (SJS) Toxic Epidermal Necrolysis (TEN)
Maltese: Sindromu ta' StevensJohnson (SJS),
English: Vizarsin with food, drink and alcohol
Maltese: Vizarsin ma' ikel, xorb u alkoħol
English: Other medicines and Vizarsin
Maltese: Mediċini oħra u Vizarsin
English: Vizarsin are fragile.
Maltese: Vizarsin huwa fraġli.
English: 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.
Maltese: Ma kienx hemm interazzjonijiet sinifikanti meta sildenafil (50 mg) kien mogħti wkoll ma' tolbutamide (250 mg) jew warfarin (40 mg), li t-tnejn huma metabolizzati b'CYP2C9.
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 kien għadu kapaċi jipproduċi erezzjoni bi tweġiba għal stimulazzjoni sesswali 4-5 sigħat wara d-doża.
English: Vizarsin contains the active substance sildenafil which belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Maltese: Vizarsin fih is-sustanza attiva sildenafil li jagħmel ma' grupp ta' mediċinali msejħa inibituri ta' phosphodiesterase tip 5 (PDE5).
English: In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.
Maltese: F'dawn il-popolazjonijiet tal-istudji, kien osservat tnaqqis addizzjonali medju talpressjoni meta kienu mimdudin ta' 7/7 mmHg, 9/5 mmHg u 8/4 mmHg rispettivament u meta bilwieqfa tnaqqis addizzjonali medju ta' 6/6 mmHg, 11/4 mmHg u 4/5 mmHg.
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% flAUC u Cmax ta' sildenafil rispettivament.
English: - The other ingredients are hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951),
Maltese: - Is-sustanzi l-oħra huma: hydroxypropylcellulose (E463), mannitol (E421), aspartame (E951),
English: Vizarsin contains aspartame (E951) and sorbitol (E420) Aspartame is a source of phenylalanine which may be harmful for people with a disorder called phenylketonuria.
Maltese: Vizarsin fih aspartame (E951) u sorbitol (E420) Aspartame huwa sors ta' phenylalanine lii jista' jikkaġuna ħsara f'persuni li għandhom dosturb li jissejjaħ phenylketonuria.
English: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (E464), magnesium stearate (E572).
Maltese: Qalba tal-pillola: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate, croscarmellose sodium, hypromellose (E464), magnesium stearate (E572).
English: Sildenafil potentiates the hypotensive effect of nitrates (see section 4.3).
Maltese: Sildenafil iħarrax l-effett ipotensiv ta' nitrati (ara sezzjoni 4.3).
English: Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.
Maltese: L-ogħla konċentrazzjonijiet fil-plażma osservati intlaħqu fi żmien bejn 30 sa 120 minuta (medjan 60 minuta) ta' doża orali fi stat sajjem.
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 saħħaħx l-effetti ipotensivi tal-alkoħol f'voluntiera b'saħħithom b'medja tal-ogħla livelli ta' alkoħol fid-demm ta' 80 mg/dl.
English: Vizarsin contains lactose.
Maltese: Vizarsin fih lactose.
English: This is most likely to happen within 4 hours after taking Vizarsin.
Maltese: Dan ġeneralment iseħħ fi żmien 4 sigħat wara li tkun ħadt Vizarsin.
English: neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (containing sorbitol
Maltese: neohesperidin-dihydrochalcone (E959), spearmint oil, peppermint oil (li fih sorbitol (E420)),