FrancophonIA/ELRC3.0 huggingface dataset:
English: PAES: In order to further confirm the efficacy of olaparib as maintenance treatment after the first-line platinum-containing chemotherapy in patients with BRCA mutated high grade serous ovarian cancer, the MAH should submit the updated PFS2, updated OS and final OS results of the study D0818C00001 (SOLO1), a phase III randomised double-blind placebo-controlled multicentre study.
Maltese: Sabiex tiġi kkonfermata aktar l-effikaċja ta' olaparib bħala kura ta' mantenient wara l-kimoterapija tal-ewwel linja li fiha l-platinu f'pazjenti b'kanċer tal-ovarji seruż ta' grad għoli b'mutazzjoni BRCA, l-MAH għandu jissottometti r-riżultati tal-PFS2 aġġornata, OS u OS finali aġġornati tal-istudju D0818C00001 (SOLO1), studju ta' fażi
English: An exposure-response relationship between olaparib and decreases in haemoglobin has been demonstrated.
Maltese: Intweriet relazzjoni bejn l-esponiment u r-rispons bejn olaparib u tnaqqis flemoglobina.
English: All patients had evidence of gBRCA1/2m at baseline.
Maltese: Il-pazjenti kollha kellhom evidenza ta' gBRCA1/2m fil-linja bażi.
English: Probability of progression free survival
Maltese: Probabbiltà ta' sopravivenza ming ħajr progressjoni
English: There are no data in patients with severe hepatic impairment (Child-Pugh classification C).
Maltese: M'hemm l-ebda data f'pazjenti b'indeboliment tal-fwied sever (Klassifikazzjoni Child-Pugh C).
English: In vitro, data also show that olaparib is not a substrate for OATP1B1, OATP1B3, OCT1, BCRP or MRP2 and is not an inhibitor of OATP1B3, OAT1 or MRP2.
Maltese: In vitro, id-data turi wkoll li olaparib mhuwiex substrat għal OATP1B1, OATP1B3, OCT1, BCRP jew MRP2 u mhuwiex inibitur ta' OATP1B3, OAT1 jew MRP2..
English: Patients with BRCA1/2 mutations were identified either from germline testing in blood via a local test or by central testing at Myriad or from testing a tumour sample using a local test. Large rearrangements in the BRCA1/2 genes were detected in 4.7% (14/295) of the randomised patients.
Maltese: Ġew identifikati arranġamenti mill-ġdid kbar fil-ġeni BRCA1/2 f'4.7 % (14/295) tal-pazjenti randomizzati.
English: In animal studies, no effect on conception was observed but there are adverse effects on embryofoetal survival (see section 5.3).
Maltese: Fi studji f'annimali, ma ġie osservat ebda effett fuq ilkonċentrazzjoni iżda hemm effetti avversi fuq is-sopravivenza embrijofetali (ara sezzjoni 5.3).
English: PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed (PSR) non-germline BRCA mutated high grade ovarian cancer in the maintenance setting and investigate predictive biomarkers within this patient group, the MAH should submit the results of study D0816C00020 (OPINION), a phase IIIb single-arm, open-label, multicentre study of maintenance therapy in PSR non-germline BRCA mutated ovarian cancer patients who are in complete or partial response following platinum based chemotherapy.
Maltese: Sabiex tiġi ddefinita aktar l-effiċjenza ta' olaparib f'pazjenti b'kanċer fl-ovarji ta' grad għoli b'mutazzjoni BRCA mhux germline rikadut sensittiv għall-platinum (PSR) fl-ambjent ta' manteniment u sabiex jiġu investigati l-bijomarkaturi ta' tbassir fi ħdan dan il-grupp ta' pazjenti, il-MAH għandu jissottometti r-riżultati tal-istudju D0816C00020 (OPINJONI), studju b'aktar minn ċentru wieħed, bit-tikketta mikxufa, ta' fergħa waħda, ta' fażi IIIb ta' terapija ta' manteniment f'pazjenti b'kanċer fl-ovarji b'mutazzjoni BRCA mhux germlina
English: Majority of the material was excreted as metabolites.
Maltese: Il-maġġoranza tal-materjal ġiet eliminata bħala metaboliti.
English: The recommended dose of Lynparza is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg.
Maltese: Inti se tintalab tieħu 200 mg (2 x 100 mg pilloli) darbtejn kuljum - total ta' 4 pilloli kuljum.
English: • The usual recommended dose is 8 capsules (400 mg) taken by mouth twice a day (a total of 16 capsules each day).
Maltese: • Id-doża rakkomandata tas-soltu hija ta' 8 kapsuli (400 mg) li jittieħdu mill-ħalq darbtejn kuljum (total ta' 16-il kapsula kuljum).
English: PAES: In order to further confirm the efficacy of olaparib in patients with platinum sensitive relapsed BRCA mutated high grade serous ovarian cancer, the MAH should submit the results of study D0816C00002, a phase III randomised double-blind placebo-controlled multicentre study.
Maltese: Sabiex tiġi kkonfermata aktar l-effiċjenza ta' olaparib f'pazjenti b'kanċer flovarji b'seru ta' grad għoli b'mutazzjoni BRCA, rikaduti, sensittivi għall-platinu, ilMAH għandu jissottometti r-riżultati tal-istudju D0816C00002, studju multiċentriku, ikkontrollat bi plaċebo, double blind, randomizzat tal-fażi
English: N Number of events/number of randomised patients; bd Twice daily; OS Overall survival; PFS Progression-free survival; CI Confidence interval; DCO Data cut off; TSST Time from randomisation to start of second subsequent therapy or death.
Maltese: Intervall ta' kunfidenza; DOR Durata ta' rispons; DCO Cut off tad-dejta; HR Proporzjon ta' periklu;
English: It is not known whether Lynparza passes into semen.
Maltese: Mhux magħruf jekk Lynparza jgħaddix fis-semen.
English: Platinum free interval was > 12 months in 60% and 6-12 months in 40% of the patients.
Maltese: L-intervall ħieles mill-platinum kien >12-il xahar f'60% u 6-12-il xahar f'40% tal-pazjenti.
English: Among the patients entering the trial with measurable disease (target lesions at baseline), an objective response rate of 41% was achieved in the Lynparza arm versus 17% on placebo.
Maltese: Fost il-pazjenti li daħlu għall-prova b'marda li tista' titkejjel (leżjonijiet fil-mira fil-linja bażi), inkisbet rata ta' rispons oġġettiv ta' 41% fil-fergħa ta' Lynparza kontra 17% fuq il-plaċebo.
English: Effect of olaparib on other medicinal products
Maltese: Effett ta' olaparib fuq prodotti mediċinali oħra
English: It is not known whether Lynparza may affect the effectiveness of some hormonal contraceptives.
Maltese: Mhuwiex magħruf jekk Lynparza jistax jaffettwa l-effikaċja ta' xi kontraċettivi ormonali.
English: Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 300 mg twice daily.
Maltese: Studji mhux kliniċi fil-firien urew li olaparib jikkawża effetti avversi fuq is-sopravivenza embrijofetali u jinduċi malformazzjonijiet fetali maġġuri f'esponimenti inqas minn dawk mistennija bid-doża tal-bniedem rakkomandata ta' 300 mg darbtejn kuljum.
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 100 mg (one 100 mg tablet) taken twice daily (equivalent to a total daily dose of 200 mg).
Maltese: Jekk ikun meħtieġ tnaqqis ulterjuri fid-doża, allura huwa rakkomandat tnaqqis għal 100 mg darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 200 mg).
English: The majority of the metabolism was attributable to oxidation reactions with a number of the components produced undergoing subsequent glucuronide or sulfate conjugation.
Maltese: Il-maġġoranza tal-metaboliżmu kien attribwibbli għal reazzjonijiet ta' ossidazzjoni b'numru mill-komponenti prodotti li jgħaddu minn konjugazzjoni sussegwenti ta' glucuronide jew sulfat.
English: The recommended dose of Lynparza is 400 mg (eight capsules) taken twice daily, equivalent to a total daily dose of 800 mg.
Maltese: Id-doża rrakkomandata ta' Lynparza hija 400 mg (tmien kapsuli) li jittieħdu darbtejn kuljum, ekwivalenti għal doża totali ta' kuljum ta 800 mg.
English: Before Lynparza treatment is initiated for first-line maintenance treatment of high-grade epithelial ovarian cancer (EOC), fallopian tube cancer (FTC) or primary peritoneal cancer (PPC), patients must have confirmation of deleterious or suspected deleterious germline and/or somatic mutations in the breast cancer susceptibility genes (BRCA) 1 or 2 using a validated test.
Maltese: Qabel tinbeda kura b'Lynparza għall-kura ta' manteniment tal-ewwel linja ta' kanċer tal-ovarji epiteljali ta' grad għoli (EOC), kanċer tat-tubu fallopjan (FTC) jew kanċer peritoneali primarju (PPC), il-pazjenti għandu jkollhom konferma ta' mutazzjonijiet tal-linja ġerminali jew somatiċi deleterużi jew suspettati deleterużi fil-ġeni ta' suxxetibbiltà ta' kanċer tas-sider (BRCA) 1 jew 2 permezz ta' test validat.
English: Pregnancy
Maltese: sussegwenti.
English: Platinum free interval was > 12 months in 60% and >6-12 months in 40% of the patients.
Maltese: L-intervall ħieles mill-platinum kien >12-il xahar f'60 % u >6-12-il xahar f'40 % tal-pazjenti.
English: In clinical studies with Lynparza the incidence of CTCAE grade ≥ 2 shifts (elevations) from baseline in blood creatinine was approximately 10%.
Maltese: Fl-istudji kliniċi b'Lynparza l-inċidenza ta' bidliet (elevazzjonijiet) ta' CTCAE grad ≥2 mil-linja bażi fil-kreatinina fid-demm kienet madwar 10 %.
English: The median follow-up time in censored patients was 25.3 months for olaparib versus 26.3 months for comparator.
Maltese: Iż-żmien ta' segwitu medjan f'pazjenti ċċensurati kien 25.3 xhur għal olaparib kontra 26.3 xhur għall-komparatur.
English: Following oral administration of olaparib via the capsule formulation, absorption is rapid with peak plasma concentrations typically achieved between 1 to 3 hours after dosing.
Maltese: Wara għoti orali ta' olaparib permezz ta' formulazzjoni ta' kapsula, l-assorbiment huwa rapidu blogħla konċentrazzjonijiet fil-plażma li ġeneralment jintlaħqu bejn 1 sa 3 sigħat wara d-dożaġġ.
English: Data demonstrating clinical validation of tumour BRCA1/2 tests in breast cancer are not currently available.
Maltese: Attwalment, data li turi l-validazzjoni klinika ta' testijiet tat-tumur BRCA1/2 f'kanċer tas-sider mhijiex disponibbli.
English: No significant interaction was observed with anastrozole or letrozole whereas tamoxifen decreased exposure to olaparib by 27%.
Maltese: Ma ġiet osservata l-ebda interazzjoni sinifikanti b'anastrozole jew letrozole waqt li tamoxifen naqqas l-espożizzjoni għal olaparib b'27 %.
English: Other
Maltese: Nieqes
English: Other side effects include:
Maltese: Numru ta' avvenimenti:
English: Median time (months) (95% CI)
Maltese: Żmien medjan (xhur) (95% CI)
English: The recommended dose reduction is to 250 mg (one 150 mg tablet and one 100 mg tablet) twice daily (equivalent to a total daily dose of 500 mg).
Maltese: It-tnaqqis fid-doża rakkomandat huwa għal 250 mg (pillola waħda ta' 150 mg u pillola waħda ta' 100 g) darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 500 mg).
English: However, no dose adjustment is required on the basis of ethnicity (see section 5.2).
Maltese: Madankollu, ma huwa meħtieġ ebda aġġustament fid-doża abbażi tal-etniċità (ara sezzjoni 5.2).
English: Breast cancer
Maltese: tuberculosis)
English: C-olaparib to female patients, unchanged olaparib accounted for the majority of the circulating radioactivity in plasma (70%) and was the major component found in both urine and faeces (15% and 6% of the dose, respectively).
Maltese: C-olaparib lil pazjenti nisa, olaparib mhux mibdul ammonta għall-maġġoranza tar-radjuattività li tiċċirkola fil-plażma (70 %) u kien il-komponent ewlieni misjub kemm fl-awrina kif ukoll fl-awrina u l-ippurgar (15% u u 6% tad-doża, rispettivament).
English: • The doses of Lynparza tablets and capsules are not the same.
Maltese: • Id-dożi ta' Lynparza pilloli u kapsuli mhumiex l-istess.
English: Median age was 59 years in both arms.
Maltese: L-età medjana kienet 59 sena fiż-żewġ fergħat.
English: Lynparza dose adjustment is recommended for patients with moderate renal impairment (see section 4.2).
Maltese: Huwa rrakkomandat aġġustament fid-doża ta' Lynparza għal pazjenti b'indeboliment tal-kliewi moderat (ara sezzjoni 4.2).
English: Film-coated tablets 56 film-coated tablets
Maltese: Mhux komuni Żieda fil-kreatinina fid-demm
English: Clinical studies of olaparib in combination with other anticancer medicinal products, including DNA damaging agents, indicate a potentiation and prolongation of myelosuppressive toxicity.
Maltese: Studji kliniċi ta' olaparib flimkien ma' prodotti mediċinali oħra kontra l-kanċer, inkluż aġenti li jagħmlu ħsara lid-DNA, jindikaw potenzjalizzazzjoni u titwil tat-tossiċità majelosoppressiva.
English: A small number of patients treated with Lynparza reported inflammation of the lungs (pneumonitis).
Maltese: Numru żgħir ta' pazjenti kkurati b'Lynparza b'infjammazzjoni rrapportata tal-pulmuni (pulmonite).
English: The majority of reports were in germline breast cancer susceptibility gene 1 or 2 (gBRCA1/2) mutation carriers.
Maltese: Il-maġġoranza tarrapporti kienu fi trasportaturi ta' mutazzjoni ta' ġene suxxettibbli għal kanċer tas-sider 1 jew 2 fil-linja ġerminali (gBRCA1/2).
English: If a strong CYP3A inhibitor must be co-administered, the recommended Lynparza dose reduction is to 150 mg taken twice daily (equivalent to a total daily dose of 300 mg).
Maltese: Jekk inibitur CYP3A qawwi għandu jingħata flimkien, it-tnaqqis taddoża ta' Lynparza rakkomandat huwa ta' 150 mg meħuda darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 300 mg).
English: PAES: In order to further define the efficacy of olaparib in patients with platinum sensitive relapsed somatic BRCA mutated high grade serous ovarian cancer, the MAH should conduct and submit the results of a phase IV, open label, single arm, nonrandomised, multicentre study in patients with relapsed platinum sensitive ovarian cancer who are in complete or partial response following platinum based chemotherapy and who carry loss of function germline or somatic BRCA mutation(s).
Maltese: IV f'pazjenti b'kanċer flovarji, sensittivi għall-platinu, rikaduti li jkollhom rispons sħiħ jew parzjali wara kimoterapija bbażata fuq il-platinu u li għandhom telf ta' funzjoni tal-linja ġerminali jew mutazzjoni(jiet) BRCA somatiċi.
English: Uncommon Decreased appetite
Maltese: Komuni ħafna
English: • rash or itchy rash on swollen, reddened skin (dermatitis)
Maltese: • raxx jew raxx bil-ħakk fuq ġilda minfuħa, ħamra (dermatite)
English: bd Twice daily; NR Not reached; CI Confidence interval; PFS Progression-free survival; PFS2 Time to second progression or death; OS Overall survival; TFST Time from randomisation to first subsequent anti-cancer therapy or death.
Maltese: PFS soprovivenza mingħajr progressjoni; CI Intervall ta' fiduċja; DCO Data ta' limitu; TSST Żmien mirrandomizzazzjoni sal-bidu tat-tieni terapija sussegwenti jew mewt.
English: Lynparza 100 mg tablets are yellow to dark yellow, oval, bi-convex, film-coated tablets, marked with “OP100” on one side and plain on the other.
Maltese: Lynparza 100 mg pilloli huma pilloli miksijin b'rita sofor għal sofor skuri, ovali, bikonvessi, immarkati b'“OP100” fuq naħa waħda u b'xejn fuq in-naħa l-oħra.
English: Renal impairment
Maltese: Il-pazjenti kollha
English: Nonclinical studies in rats have shown that olaparib causes adverse effects on embryofoetal survival and induces major foetal malformations at exposures below those expected at the recommended human dose of 400 mg twice daily.
Maltese: Studji mhux kliniċi fil-firien urew li olaparib jikkawża effetti negattivi fuq issopravivenza embrijofetali u jikkaġuna malformazzjonijiet fetali maġġuri f'espożizzjonijiet taħt dawk mistennija fid-doża tal-bnedmin irrakkomandata ta' 400 mg darbtejn kuljum.
English: In population based PK analyses, patient age, bodyweight or race (including White and Japanese patients) were not significant covariates.
Maltese: F'analiżijiet PK ibbażati fuq il-popolazzjoni, l-età tal-pazjent, il-piż jew ir-razza (inkluż pazjenti Bojod u Ġappuniżi) ma kinux kovarjati sinifikanti.
English: A benefit was also observed in patients with BRCA1/2 wild-type/variants of uncertain significance (BRCA1/2 wt/VUS), although of a lesser magnitude.
Maltese: Ġie osservat ukoll benefiċċju f'pazjenti b'tip selvaġġ/varjanti ta' BRCA1/2 ta' sinifikat inċert (BRCA1/2 wt/VUS), għalkemm sa daqs inqas.
English: On multiple dosing there is no marked accumulation, with steady state exposures achieved within ~3 to 4 days.
Maltese: Fuq dożaġġ multiplu m'hemm bda akkumulazzjoni evidenti, b'espożizzjonijiet bi stat fiss milħuqa fi żmien ~3 sa 4 ijiem.
English: Blister(Alu/Alu)
Maltese: Folja (Alu/Alu)
English: 14 Capsules
Maltese: 14-il Kapsula
English: 100 mg Capsule, hard Oral use
Maltese: 100 mg Kapsula, iebsa
English: 200 mg Powder for concentrate for solution for infusion
Maltese: 200 mg Trab għal konċentrat għal soluzzjoni għallinfużjoni
English: Intravenous use vial (glass)
Maltese: Użu ġol-vina kunjett (ħġieġ) 10 ml
English: EMA/58674/2015 EMEA/H/C/002581
Maltese: EMEA/H/C/002581
English: The full EPAR for Spedra 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: Other information about Spedra
Maltese: Informazzjoni oħra dwar Spedra
English: The active ingredient in Spedra, avanafil, belongs to a group of medicines called phosphodiesterasetype-5 (PDE5) inhibitors.
Maltese: Is-sustanza attiva fi Spedra, l-avanafil, hi parti minn grupp ta' mediċini magħruf bħala inibituri talfosfodjesterażi tat-tip -5 (PDE5).
English: An additional study involving 440 adults with erectile dysfunction was also carried out, where Spedra was taken approximately 15 minutes before sexual activity.
Maltese: Sar studju ieħor li involva 440 adult li jbatu b'disfunzjoni erettili, fejn Spedra kien meħud daqs 15-il minuta qabel attività sesswali.
English: Why is Spedra approved?
Maltese: Għalxiex ġie approvat Spedra?
English: This is a summary of the European public assessment report (EPAR) for Spedra.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Spedra.
English: The percentage of successful attempts was about 28% with Spedra at a dose of 200 mg and about 25% with a dose of 100 mg, compared with 14% with placebo.
Maltese: Il-perċentwal ta' attentati b'suċċess kien madwar 28% bi Spedra f'doża ta' 200 mg u madwar 25% b'doża ta' 100 mg, meta mqabbla ma' 14% bil-plaċebo.
English: Spedra has been studied in three main studies involving over 3,400 men with erectile dysfunction.
Maltese: Spedra ġie studjat fi tlet studji ewlenin li involvew 'il fuq minn 3,400 raġel ibatu b'disfunzjoni erettili.
English: The medicine also produced about 20% more successful vaginal penetrations than placebo.
Maltese: Il-mediċina pproduċiet ukoll madwar 20 % aktar penetrazzjonijiet vaġinali b'suċċess mill-plaċebo.
English: What are the risks associated with Spedra?
Maltese: X'inhuma r-riskji assoċjati ma' Spedra?
English: Spedra is available as tablets (50, 100 and 200 mg) and can only be obtained with a prescription.
Maltese: Spedra jiġi f'pilloli ta' (50, 100u 200 mg) u jista jinkiseb biss b'riċetta ta' tabib.
English: The results of the first study showed that Spedra taken approximately 30 minutes before sexual activity at a dose of 100 or 200 mg increased the percentage of successful attempts at intercourse from about 13% before treatment to about 57%, whereas placebo only increased it to 27%.
Maltese: Ir-riżultati tal-ewwel studju wrew li Spedra meħud daqs 30 minuta qabel attività sesswali f'doża ta' 100 jew 200 mg żied il-perċentwal ta' attentati b'suċċess għal rapport sesswali minn madwar 13% qabel il-kura għal kważi 57%, filwaqt li l-plaċebo żiedu biss sa 27%.
English: Regarding its safety, side effects were similar to other medicines of its class.
Maltese: Rigward is-sigurtà, l-effetti sekondarji kienu simili għal mediċini oħra tal-istess klassi.
English: During normal sexual stimulation, cGMP is produced in the penis, where it causes the muscle in the spongy tissue of the penis (the corpora cavernosa) to relax.
Maltese: fil-pene tiġi prodotta s-cGMP u tikkawża r-rilassament fil-korpora kavernoża (muskolu fit-tessut talpene li qisu sponża).
English: The first study involved men from the general population, but because certain conditions associated with erectile dysfunction might affect response to treatment the second study looked mainly at men who had erectile dysfunction and diabetes, and the third was in men who had erectile dysfunction after surgery on the prostate gland.
Maltese: Lewwel studju involva rġiel mill-popolazzjoni ġenerali, iżda minħabba li ċerti kondizzjonijiet assoċjati mad-disfunzjoni erettili jistgħu jaffettwaw ir-rispons għall-kura t-tieni studju ffoka prinċipalment fuq irġiel li kellhom disfunzjoni erettili u d-dijabete, filwaqt li t-tielet studju kien fuq irġiel li kellhom disfunzjoni erettili wara intervent kirurġiku fuq il-glandola tal-prostata.
English: It must also not be used by patients who have severely reduced liver or kidney function, or who have had loss of vision because of a problem with blood flow to the nerve in the eye (non-arteritic anterior ischaemic optic neuropathy, NAION) that can be triggered by this class of medicines.
Maltese: Din il-mediċina ma għandhiex tintuża wkoll minn pazjenti li għandhom tnaqqis gravi fil-funzjoni tal-fwied jew tal-kliewi, jew li għandhom nuqqas ta' viżjoni minħabba problemi bil-fluss tad-demm għan-nerv fl-għajn (newropatija ottika anterjuri iskemika nonarteritika, (NAION) li tista' tiġi mibdija minn din il-klassi ta' mediċini.
English: The most common side effects with Spedra (which may affect up to 1 in 10 people) are headache, flushing (reddening of the skin) and nasal congestion; back pain has also been reported and may affect up to 1 in 100 people.
Maltese: L-effetti sekondarji l-aktar komuni bi Spedra (li jistgħu jaffettwaw sa 1 minn kull 10 min-nies) huma uġigħ ta' ras, ħmura fil-wiċċ (ħmura tal-ġilda) u konġestjoni nażali; l-uġigħ fid-dahar ġie rrapportat ukoll u jista' jaffettwa 1 minn kull 100 ruħ.
English: The recommended dose is 100 mg, taken approximately 15 to 30 minutes before sexual activity; patients should not take more than one dose a day.
Maltese: Id-doża rakkomadata hija ta' 100 mg, meħuda bejn 15 u 30 minuta qabel attività sesswali; il-pazjenti ma għandhomx jieħdu iktar minn doża waħda kuljum.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Spedra on 21 June 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Spedra valida fl-Unjoni Ewropea kollha fil-21 ta' Ġunju 2013.
English: This allows blood to flow into the corpora, producing the erection.
Maltese: Dan jippermetti l-fluss tad-demm jasal fil-korpora u jipproduċi l-erezzjoni.
English: The medicine must not be used by patients with certain serious heart or circulatory problems, including those who have had a heart attack, stroke, or serious arrhythmia (irregularity of the heart rhythm) in the last six months and those who have unstable angina (a severe type of chest pain), angina during sexual intercourse, heart failure, or high or low blood pressure.
Maltese: Il-mediċina ma għandhiex tittieħed minn pazjenti li jbatu minn ċertu mard tal-qalb serju jew problemi ċirkolatorji, fosthom dawk li kellhom attakk tal-qalb, puplesija, jew arritmija gravi (irregolarità fir-ritmu tal-qalb) f'dawn l-aħħar sitt xhur u dawk li għandhom anġina instabbli (tip ta' uġigħ gravi fis-sider), anġina waqt ir-rapport sesswali, insuffiċjenza kardijaka, jew pressjoni tad-demm għolja jew baxxa.
English: The Committee therefore considered that Spedra's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għaldaqstant ikkonsidra li l-benefiċċji ta' Spedra huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: A risk management plan has been developed to ensure that Spedra is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Spedra jintuża bl-aktar mod sigur possibbli.
English: In these studies, which lasted for 12 weeks, different doses of Spedra taken approximately 30 minutes before sexual activity were compared with placebo (a dummy tablet).
Maltese: F'dawn l-istudji, li damu għal 12-il ġimgħa, dożi differenti ta' Spedra meħuda daqs 30 minuta qabel attività sesswali ġew imqabbla ma' plaċebo (trattament finta).