FrancophonIA/ELRC3.0 huggingface dataset:
English: In vitro studies indicate that the likelihood for interactions with nusinersen due to competition for plasma protein binding, or competition with or inhibition of transporters is low.
Maltese: Studji in vitro jindikaw li l-probabbiltà għal interazzjonijiet ma' nusinersen minħabba kompetizzjoni għat-twaħħil mal-proteini tal-plażma, jew ilkompetizzjoni ma', jew l-inibizzjoni tat-trasportaturi, hi baxxa.
English: CS7 is a phase 2, randomized, double-blind, sham-procedure study in symptomatic patients diagnosed with infantileonset SMA (≤6 months) or later-onset SMA (>6 months) and 2 or 3 copies of SMN2 (Part 1), followed by a long-term open label extension phase (Part 2).
Maltese: CS7 hu studju ta' fażi 2, li fih il-parteċipanti ntgħażlu b'mod każwali, double-blind, ikkontrollat bi plaċebo, f'pazjenti sintomatiċi ddijanjostikati b'SMA li bdiet meta kienu trabi (≤6 xhur) jew SMA li bdiet aktar tard (>6 xhur) u 2 jew 3 kopji ta' SMN2 (Parti 1), segwit minn fażi ta' estensjoni fit-tul open-label (Parti 2).
English: How Spinraza is given
Maltese: Spinraza Kontroll
English: • Headache
Maltese: • Rimettar
English: How to store Spinraza
Maltese: Kif jingħata Spinraza
English: Four patients met the criteria for permanent ventilation and five patients died during the study.
Maltese: Erba' pazjenti ssodisfaw il-kriterja għal ventilazzjoni permanenti, u ħames pazjenti mietu matul l-istudju.
English: The use of ultrasound or other imaging techniques to assist with intrathecal administration of Spinraza, can be considered at the physician's discretion.
Maltese: L-użu ta' ultrasound jew tekniki oħra ta' immaġni biex jassistu fl-għoti ġot-teka ta' Spinraza, jistgħu jiġu kkunsidrati fid-diskrezzjoni tat-tabib.
English: 19.7% (95% CI: 10.9, p=0.0811
Maltese: 19.7% (95% CI: 10.
English: Thrombocytopenia and coagulation abnormalities, including acute severe thrombocytopenia, have been observed after administration of other subcutaneously or intravenously administered antisense oligonucleotides.
Maltese: Il-paragun ta' kisba ta' milestone tal-moviment fost il-pazjenti b'SMA sintomatika li bdiet fit-tfulija u SMA presintomatika, qed jintwera f'Figura 3.
English: Among patients older than the WHO defined window for expected age of achievement (95th percentile), 17 of 22 (77%) had achieved walking alone.
Maltese: Fost il-pazjenti li kellhom aktar żmien mill-intervall definit mill-WHO għall-età mistennija tal-kisba tal-milestone (95th percentile), 17 minn 22 (77%) kienu laħqu punt li fih kienu jimxu waħidhom.
English: The median age of onset of clinical signs and symptoms of SMA was 6.5 weeks and 8 weeks for Spinraza treated versus sham-control patients respectively, with 99% of patients having 2 copies of the SMN2 gene and therefore deemed most likely to develop Type I SMA.
Maltese: L-età medjana tal-bidu tas-sinjali u s-sintomi kliniċi ta' SMA kienet 6.5 ġimgħat u 8 ġimgħat għal pazjenti kkurati bi Spinraza kontra pazjenti tal-kontroll ikkurati bi plaċebo, rispettivament, b'99% talpazjenti li kellhom 2 kopji tal-ġene SMN2, u għalhekk li kienu kkunsidrati l-aktar probabbli li jiżviluppa
English: The safety assessment of Spinraza was based on two Phase 3 clinical studies in infants (CS3B) and children (CS4) with SMA, together with one Phase 2 study in infants and children with SMA (CS7) and open-label studies including pre-symptomatic infants (CS5) genetically diagnosed with SMA and infants and children with SMA.
Maltese: L-evalwazzjoni tas-sigurtà ta' Spinraza ġiet ibbażata fuq żewġ studji kliniċi ta' Fażi 3 fi trabi (CS3B) u tfal (CS4) b'SMA, flimkien ma' studju wieħed ta' Fażi
English: Presence of nusinersen was also demonstrated in neurons and other cell types in the spinal cord and brain, and peripheral tissues such as skeletal muscle, liver, and kidney.
Maltese: Il-preżenza ta' nusinersen intweriet ukoll fin-newroni u f'tipi oħrajn ta' ċelluli fis-sinsla u fil-moħħ, u f'tessuti periferali bħal muskoli skeletali, fwied, u kliewi.
English: The median time to death or permanent ventilation was 50.9 weeks after initiation of Spinraza treatment in Study CS11.
Maltese: Iż-żmien medjan sal-mewt jew ventilazzjoni permanenti kien ta' 50.9 ġimgħat wara l-bidu tat-trattament bi Spinraza fi Studju CS11.
English: The population PK analysis suggests that race is unlikely to affect the PK of nusinersen.
Maltese: L-analiżi PK tal-popolazzjoni tissuġġerixxi li rrazza mhux mistennija li taffettwa l-PK ta' nusinersen.
English: Aseptic technique should be used when preparing and administering Spinraza; see instructions for use in section 6.6.
Maltese: Teknika asettika għandha tintuża meta tipprepara u tagħti Spinraza; ara l-istruzzjonijiet għall-użu f'sezzjoni 6.6.
English: CLINICAL PARTICULARS 4.1 Therapeutic indications
Maltese: Studju CS4 1,2
English: These effects were observed within several hours post-dose and generally resolved within 48 hours.
Maltese: Dawn l-effetti ġew osservati fi żmien diversi sigħat wara d-doża, u ġeneralment għaddew fi żmien 48 siegħa.
English: Post-authorisation efficacy study (PAES): In order to evaluate the long term efficacy and safety of nusinersen in pre-symptomatic patients with spinal muscular atrophy, the MAH should conduct and submit the results of the Phase 2, open-label study (NURTURE (SM201))
Maltese: B'mod li tkun evalwata leffikaċja u s-sigurtà fit-tul ta' nusinersen f'pazjenti sintomatiċi f'atrofija muskolari tas-sinsla, il-MAH għandha twettaq u tissottometti r-riżultati ta' studju open-label Fażi 2 (NURTURE (SM201))
English: Proportion with improvement in total motor milestone score Proportion with worsening in total motor milestone score p<0.0001
Maltese: Medja (+/- SE) tal-Punteġġ Totali tal-Motor Milestone
English: Following intrathecal administration trough plasma concentrations of nusinersen were relatively low compared to the trough CSF concentration.
Maltese: Wara l-għoti minn ġot-teka, il-konċentrazzjonijiet l-aktar baxxi ta' nusinersen fil-plażma kienu relattivament baxxi meta mqabbla mal-konċentrazzjoni minima fis-CSF.
English: The protocol-defined criteria for clinically manifested SMA included age-adjusted weight below the fifth WHO percentile, a decrease of 2 or more major weight growth curve percentiles, the placement of a percutaneous gastric tube, and/or the inability to achieve expected age-appropriate WHO milestones (sitting without support, standing with assistance, hands-and-knees crawling, walking with assistance, standing alone and walking alone).
Maltese: Il-kriterji definiti permezz talprotokoll għal SMA klinikament manifestata kienu jinkludu piż aġġustat għall-età taħt il-ħames WHO percentile, tnaqqis ta' 2 jew aktar percentiles maġġuri tal-kurva piż-tkabbir, it-tqegħid ta' tubu gastriku perkutaneju, u/jew l-inabbiltà biex jintlaħqu milestones tal-WHO mistennija li huma adattati għall-età
English: Prevention and treatment will be managed by routine clinical practice and no additional risk minimization measures or evaluations are required as part of the pharmacovigilance plan.
Maltese: Il-prevenzjoni u t-trattament ser jiġu mmaniġġjati permezz ta' prattika klinika regolari u mhuma meħtieġa l-ebda miżuri ta' minimizzazzjoni tar-riskju jew evalwazzjonijiet tar-riskju bħala parti mill-pjan ta' farmakoviġilanza.
English: Renal toxicity has been observed after administration of other subcutaneously and intravenously administered antisense oligonucleotides.
Maltese: TWISSIJA SPEĊJALI LI L­PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Of these patients, stabilization or improvement in mean HFMSE (1.4; SD 4.02) and RULM (2.1; SD 2.56) scores were observed from baseline to Study Day 265 in Study CS11.
Maltese: (2.1; SD 2.56) ġew osservati mil-linja bażi sa Jum tal-Istudju 265 fi Studju CS11.
English: Of the 8 patients with later-onset SMA, 4 out of 5 patients (80%; 95% CI: 38, 96) in the Spinraza group and 2 out of 3 (67%; 95% CI: 21, 94) in the sham-control group met this definition of response.
Maltese: Nota 2: Mill-110 pazjenti fis-sett tal-effikaċja, 29 mietu (13 (18%) għal Spinraza, u 16 (43%) għallGrupp tal-Kontroll) u 3 waqqfu l-kura għal raġuni oħra li ma kinitx mewt (2 (3%) għal Spinraza u 1 (3%) għall-Grupp tal-Kontroll), u għalhekk ma ġewx inklużi f'din l-analiżi ta' ES.
English: Two events, angioedema and serum sickness, were considered serious and related.
Maltese: Żewġ avvenimenti, anġjoedema u mard tas-serum kienu kkunsidrati serji u relatati.
English: Proportion with any improvement Proportion with any worsening p<0.0001
Maltese: Proporzjon li kisbu titjib ta' 4 punti p<0.0001
English: These results are supported by 2 open label studies (study CS2 and study CS12).
Maltese: Dawn ir-riżultati huma appoġġjati minn 2 studji open-label (studju CS2 u studju CS12).
English: The extent of improvement in CHOP INTEND is shown in Figure 1 (change from baseline score for each subject).
Maltese: Il-limitu ta' titjib f'CHOP INTEND qed jintwera f'Figura 1 (bidla mill-punteġġ tal-linja bażi għal kull individwu).
English: Taking into account the PRAC Assessment Report on the PSUR(s) for nusinersen, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal nusinersen, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: Reporting of side effects If you or your child get any side effects, talk to your doctor or nurse.
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma twettaq l-ebda studju ta' interazzjoni.
English: Autopsy data from patients (n=3) show that nusinersen administered intrathecally is broadly distributed within the CNS achieving therapeutic levels in the target spinal cord tissues.
Maltese: Il-ħtieġa għallkontinwazzjoni tat-terapija għandha tiġi riveduta regolarment u tiġi kkunsidrata fuq bażi individwali skont il-preżentazzjoni klinika tal-pazjent u r-rispons għat-terapija.
English: Sedation may be required to administer Spinraza, as indicated by the clinical condition of the patient.
Maltese: Is-sedazzjoni tista' tkun meħtieġa biex jingħata Spinraza, kif indikat mill-kundizzjoni klinika talpazjent.
English: Spinraza is for intrathecal use by lumbar puncture.
Maltese: Spinraza ma ġiex studjat f'pazjenti b'indeboliment tal-kliewi.
English: Further information on Gefitinib Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Gefitinib Mylan tinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The active substance in Gefitinib Mylan, gefitinib, is a protein tyrosine kinase inhibitor.
Maltese: Is-sustanza attiva f'Gefitinib Mylan, il-gefitinib, hija inibitur tat-tirożina kinażi tal-proteina.
English: Gefitinib Mylan contains the active substance gefitinib and is a ‘generic medicine'.
Maltese: Gefitinib Mylan fih is-sustanza attiva gefitinib u huwa "mediċina ġenerika".
English: Other information about Gefitinib Mylan
Maltese: Informazzjoni oħra dwar Gefitinib Mylan
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Iressa, and do not need to be repeated for Gefitinib Mylan.
Maltese: Diġà saru studji fuq il-benefiċċji u r-riskji tas-sustanza attiva fl-użu awtorizzat tal-mediċina ta' referenza, Iressa, u m'hemmx għalfejn jiġu ripetuti għal Gefitinib Mylan.
English: What are the benefits and risks of Gefitinib Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Gefitinib Mylan?
English: As for all medicines, data on the use of Gefitinib Mylan are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Gefitinib Mylan hija ssorveljata kontinwament.
English: How is Gefitinib Mylan used?
Maltese: Kif jaħdem Gefitinib Mylan?
English: Gefitinib Mylan is used to treat adults who have non-small cell lung cancer that is locally advanced or metastatic (when cancer cells have spread from the original site to other parts of the body).
Maltese: Gefitinib Mylan huwa mediċina ta' kontra l-kanċer użata biex tikkura adulti li għandhom kanċer talpulmun b'ċelloli mhux żgħar li jkun lokalment avvanzat jew metastatiku (meta ċ-ċelloli tal-kanċer ikunu nfirxu mis-sit oriġinali għal partijiet oħra tal-ġisem).
English: Gefitinib Mylan is available as 250 mg tablets to be taken by mouth.
Maltese: Gefitinib Mylan jiġi bħala kapsuli ta' 250 mg li għandhom jittieħdu mill-ħalq.
English: This means that it blocks specific enzymes known as tyrosine kinases.
Maltese: Dan ifisser li din timblokka enzimi speċifiċi magħrufa bħala tirosina kinażi.
English: Because Gefitinib Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Gefitinib Mylan hija mediċina ġenerika u hija bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tagħha jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: How has Gefitinib Mylan been studied?
Maltese: Kif ġie studjat Gefitinib Mylan?
English: The company also carried out a study that showed that it is ‘bioequivalent' to the reference medicine.
Maltese: Il-kumpanija wettqet ukoll studju li wera li hija "bijoekwivalenti" għall-mediċina ta' referenza.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Gefitinib Mylan has been shown to have comparable quality and to be bioequivalent to Iressa.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Gefitinib Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Iressa.
English: It is used in patients whose cancer cells have a mutation in the genes that make a protein called epidermal growth factor receptor (EGFR).
Maltese: Jintuża f'pazjenti li ċ-ċelloli tal-kanċer tagħhom ikollhom mutazzjoni fil-ġeni li jagħmlu proteina msejħa "epidermal growth factor receptor" (EGFR).
English: This means that Gefitinib Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the EU called Iressa.
Maltese: Dan ifisser li Gefitinib Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-UE imsejħa Iressa.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Gefitinib Mylan have been included in the summary of product characteristics and the package leaflet.
Maltese: Fis-sommarju tal-karatteristiċi tal-prodott u fil-fuljett ta' tagħrif ġew inklużi r-rakkomandazzjonijiet u lprekawzjonijiet li għandhom ikunu segwiti mill-professjonisti fil-qasam tal-kura tas-saħħa u millpazjenti għall-użu sigur u effettiv ta' Gefitinib Mylan.
English: * Equivalent to titre prior to inactivation (log10)
Maltese: (*) ekwivalenti għal titru qabel l-inattivazzjoni (log10)
English: Route of Administration
Maltese: Mod ta' Amministrazzj oni
English: Subcutaneous use Type I glass bottle with a chlorobutyl rubber stopper and aluminium cap
Maltese: Flixkun talpolypropylen ee bi stopper tal-lastku chlorobutyl u tapp talaluminju
English: EMEA Number Invented name
Maltese: Numru ta' l-UE Isem kummerċjali
English: Adopted at the 6-9 June 2016 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-6-9 ta' Ġunju 2016
English: Riociguat - Increased mortality and serious adverse events (SAEs) in patients with pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) in a single clinical trial (EPITT no 18681)
Maltese: Riociguat - Żieda fil-mortalità u avvenimenti avversi serji (SAEs) f'pazjenti bi pressjoni għolja pulmonari (PH) assoċjata ma' pulmonite interstizjali idjopatika (IIP) fi prova klinika unika (EPITT nru 18681)
English: Section 4.3 - Contraindications - Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) (see Section 5.1)
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet - Pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (PH-IIP) (ara Sezzjoni 5
English: A randomised, double blind, placebo-controlled phase II study (RISE-IIP) to evaluate the efficacy and safety of riociguat in patients with symptomatic pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) was terminated early.
Maltese: Studju randomizzat, double blind, ikkontrollat bi plaċebo tal-fażi II (RISE-IIP) sabiex jevalwa l-effikaċja u s-sigurtà ta' riociguat f'pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (PH-IIP) twaqqaf kmieni.
English: Patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
Maltese: Pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (PH-IIP)
English: Riociguat is therefore contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (see section 4.3).
Maltese: Għaldaqstant riociguat huwa kontroindikat f'pazjenti bi pressjoni għolja pulmonari assoċjata ma' pulmonite interstizjali idjopatika (ara sezzjoni 4.3).
English: The available data do not indicate a clinically significant benefit from riociguat treatment in these patients.
Maltese: Id-dejta disponibbli ma tindikax benefiċċju klinikament sinifikanti minn kura b'riociguat f'dawn ilpazjenti.
English: Interim results showed an increased risk of mortality and serious adverse events in subjects receiving riociguat compared to those receiving
Maltese: ta'avvenimenti avversi serji f'individwi li jirċievu riociguat meta mqabbla ma' dawk li jirċievu l-plaċebo.
English: The mean absolute oral bioavailability is 15%.
Maltese: Il-biodisponibiltà medja assoluta hija 15%.
English: Date of first authorisation: 6 March 2003 Date of latest renewal: 6 March 2008
Maltese: Data tal-aħħar tiġdid: 6 ta' Marzu 2008
English: 51368 Leverkusen Germany
Maltese: 51368 Leverkusen
English: Elderly (≥65 years old)
Maltese: Anzjani (età ≥65 sena)
English: Mannitol (E421) Silica colloidal hydrated.
Maltese: Mannitol (E421) Silica colloidal anidru.
English: Use in adult men
Maltese: Użu f'irġiel adulti
English: Bayer A/S Tlf: +45 45 23 50 00
Maltese: Danmark Bayer A/S Tlf: +45 45 23 50 00
English: - Erythromycin or clarithromycin, macrolide antibiotics.
Maltese: - Erythromycin jew clarithromycin, antibiotiċi macrolide.
English: България Байер България ЕООД
Maltese: Байер България ЕООД Tел.:
English: SC Bayer SRL.
Maltese: România SC Bayer SRL.
English: Magnesium stearate, aspartame (E951), peppermint flavour, mannitol (E421), sorbitol (E420), crospovidone and silica colloidal hydrated.
Maltese: Magnesium stearate, aspartame (E951), benna tal-pepermint, mannitol (E421), sorbitol (E420), crospovidone u colloidal silica anidru.
English: During sexual stimulation, nitric oxide is released.
Maltese: Waqt stimulazzjoni sesswali jinħeles nitric oxide.
English: Effect on QTc interval
Maltese: Effect fuq l-intervall QTc
English: Tablet core: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal anhydrous silica.
Maltese: Qalba tal-pillola: crospovidone, magnesium stearate, microcrystalline cellulose, colloidal silica anidru.
English: Allergic oedema and angioedema
Maltese: Edima allerġika u anġjoedima
English: Film coat: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide yellow (E172), ferric oxide red (E172).
Maltese: Rita tal-pillola: macrogol 400, hypromellose, titanium dioxide (E171), ferric oxide isfar (E172), ferric oxide aħmar (E172).
English: 7.96 mg sorbitol (E420), and 1.80 mg aspartame (E951) per orodispersible tablet.
Maltese: 7.96 mg sorbitol (E420), u 1.80 mg aspartame (E951) għal kull pillola li tinħall fil-ħalq.
English: Levitra contains vardenafil, a member of a class of medicines called phosphodiesterase type 5 inhibitors.
Maltese: Levitra fih vardenafil, membru ta' klassi ta' mediċini msejħa inibituri ta' phosphodiesterase tip 5.
English: Contains aspartame (E951) and sorbitol (E420).
Maltese: TA' EĊĊIPJENTI Fih aspartame (E951) u sorbitol (E420).
English: Visual defects
Maltese: Difetti fil-vista
English: Palpitation Tachycardia
Maltese: Palpitazzjonijiet Takikardija
English: Take a Levitra tablet about 25 to 60 minutes before sexual activity.
Maltese: Ħu pillola Levitra madwar 25 sa 60 minuta qabel attività sesswali.
English: Bayer AS Tlf: +47-23 13 05 00
Maltese: Tlf: +47-23 13 05 00
English: Nicorandil is a hybrid of potassium channel opener and nitrate.
Maltese: Nicorandil huwa ibridu ta' sustanza li tiftaħ il-kanali tal-potassju u ta' nitrate.
English: (≥65 years old) (see sections 4.2 and 4.8).
Maltese: (ara sezzjonijiet 4.2 u 4.8).
English: Adverse reactions are listed according to the MedDRA frequency convention: 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) and not known (can not be estimated from available data).
Maltese: Ir-reazzjonijiet avversi huma mniżżla skont il-konvenzjoni tal-frekwenza MedDRA: 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) u mhux magħruf (ma tistax tittieħed stima mid-dejta disponibbli).
English: Vardenafil (10 mg) did not potentiate the increase in bleeding time caused by acetylsalicylic acid (2 x 81 mg).
Maltese: Vardenafil (10 mg) ma tawwalx il-ħin ta' fsada ikkawżata minn acetylsalicylic acid (2 x 81 mg).
English: Aspartame (E951) Peppermint flavour.
Maltese: Aspartame (E951) Benna tal-pepermint.
English: The co-administration of vardenafil with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated (see sections 4.5 and 5.1).
Maltese: L-għoti ta' vardenafil flimkien ma' nitrates jew donaturi ta' nitric oxide (bħal amyl nitrate) f'kull forma hija kontra-indikata (ara sezzjoni 4.5 u 5.1).
English: Concomitant use of alpha-blockers
Maltese: Użu flimkien ta' alfa-blockers
English: (≥1/100 to
Maltese: (≥1/100 sa
English: The elimination half-life of the metabolite M1 is between 3 to 5 hours, similar to parent drug.
Maltese: Il-half-life tal-eliminazzjoni tal-metabolit M1 hija minn 3 sa 5 sigħat, simili għall-mediċina oriġinali.
English: Levitra with food, drink and alcohol
Maltese: Levitra ma' ikel, xorb u alkoħol
English: (≥1/1,000 to
Maltese: (≥1/1,000 u
English: In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidaemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
Maltese: Tagħrif miġbur mill-provi ewlenin dwar l-effikaċja wera li l-proporzjon ta' pazjenti li kellhom suċċess fil-penetrazjoni b'vardenafil kien hekk: problemi erettili ta' natura psikoġenika (77-87%), problemi mħallta ta' erezzjoni (69-83%), problemi erettili ta' natura organika (64-75%), anzjani (52-75%), mard iskemiku tal-qalb (70-73%), iperlipidimja (62-73%), mard kroniku tal-pulmun (74-78%), depressjoni (59-69%) u pazjenti li kienu qed jieħdu mediċini kontra il-pressjoni għolja fl-istess ħin
English: Tinnitus Vertigo
Maltese: Żarżir filwidnejn Vertigo
English: PP/Aluminium foil blisters in cartons of 2, 4, 8, 12 and 20 tablets.
Maltese: Il-pilloli huma pprovduti f'pakketti b'folji li fihom 2, 4, 8, 12 jew 20 pillola.
English: The number of patients who returned to a normal IIEF domain score (>26) were 53% on vardenafil compared to 9% on placebo.
Maltese: Innumru ta' pazjenti li reġgħa kellhom IIEF domain score normali (>26) kienu 53% b'vardenafil meta mqabbel ma' 9% bil-plaċebo.
English: Bayer AB Tel: +46 (0)8 580 223 00
Maltese: Tel: +46 (0)8 580 223 00
English: - Medicine for the treatment of arrhythmias, such as quinidine, procainamide, amiodarone or sotalol.
Maltese: - Mediċina għall-kura ta' l-arritmija, bħal quinidine, procainamide, amiodarone jew sotalol.
English: Jenapharm GmbH & Co. KG Tel: +49 (0)3641-64 8888
Maltese: KG Tel: +49 (0)3641-64 8888