FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (may affect up to 1 in 10,000 people) thrombocytopenia, neutropenia (blood disorders) diabetes mellitus motor weakness (most often reported in the setting of symptomatic hyperlacetatemia or lactic acidosis syndrome) liver failure
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna 1 minn kull 10,000) tromboċitopenija, newtropenija (disturbi fid-demm) dijabete mellitus dgħjufija fil-moviment (il-biċċa l-kbira rrappurtata fi sfond ta' iperlaketatemija sintomatika jew sindrome ta' aċidożi lattika) insuffiċjenza tal-fwied
English: Each hard capsule contains 40.42 mg of lactose monohydrate.
Maltese: 42 mg ta' lactose monohydrate.
English: Immune reactivation syndrome: in HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.
Maltese: Sindromu ta' reattivitazzjoni immunitarja: f'pazjenti infettati bl-HIV b'nuqqas gravi ta' immunità fiżżmien ta' meta tingħata t-terapija ta' kombinazzjoni antiretrovirali (CART), jista' jkun hemm reazzjoni ta' infjammazzjoni mill-patoġeni opportunisti li ma jkunu wrew l-ebda sintomu jew residwi u jikkawżaw kundizzjonijiet kliniċi serji, jew aggravar tas-sintomi.
English: When reconstituted with 202 ml of water, produces 210 ml of a colorless to slightly pink, hazy solution.
Maltese: Meta rikostitwit b'202 ml t'ilma, jipproduċi 210 ml ta' soluzzjoni bla kulur għal kemmxejn roża, mdardra.
English: Antiretroviral prophylaxis, the same medications as given to the mother, was given to the new-born infant within 36 hours of delivery and continued for 6 weeks.
Maltese: Profilassi antiretrovirali, l-istess mediċina li ngħatat lill-omm, ingħatat lit-tarbija tat-twelid mhux aktar tard minn 36 siegħa wara t-twelid u tkompliet għal 6 ġimgħat.
English: Study AI455-096 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily),
Maltese: Studju AI455-096 kien studju ta' 48 ġimgħa, b'kampjun magħżul kif jinzerta, double blind fejn Zerit (40 mg darbtejn kuljum) flimkien ma' lamivudine (150 mg darbtejn kuljum) kif ukoll efavirenz
English: (range 63 to 962 cells/mm
Maltese: (ammont ivarja bejn 63 u 962 ċelloli/mm3) u livell medju ta' plażma HIV-1
English: 15 mg twice daily
Maltese: 15 mg kull 24 siegħa
English: From birth* to 13 days old
Maltese: Minn età tat-twelid* sa 13-il ġurnata
English: zidovudine, used to treat HIV infection doxorubicin, used to treat cancer ribavirin, used to treat hepatitis C infection.
Maltese: Huwa importanti li jiġu rrappurtati effetti sekondarji suspettati wara l-awtorizzazzjoni tal-prodott mediċinali.
English: 20 mg twice daily
Maltese: 20 mg darbtejn kuljum20 mg kull 24 siegħa
English: Relevant grade 3-4 laboratory abnormalities in the 91 stavudine treated infants were low neutrophils in 7%, low hemoglobin in 1%, ALT increase in 1% and no lipase abnormality.
Maltese: Testijiet fil-laboratorju grad 3-4 li għandhom x'jaqsmu ma' dan fil-91 trabi li ngħataw stavudine wrew livell baxx ta' newtrofili fid-demm f'7%, livell baxx ta' emoglobina f'1%, livell ogħla ta' l-ALT f'1% u l-ebda tibdil fil-livell tal-lipase.
English: Adolescents, children and infants: the recommended oral dosage is
Maltese: Popolazzjoni pedjatrika Adoloxxenti, tfal u trabi: id-doża orali rrakkomandata hija
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/005
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/005
English: This product contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216) that may cause allergic reactions (possibly delayed).
Maltese: Dan il-prodott fih methylhydroxybenzoate (E218) u propylhydroxybenzoate (E216) li jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jdumu biex joħorġu).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/004
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/004
English: Treatment naive pregnant women were enrolled into the study at gestation week 34-36 and given antiretroviral treatment until delivery.
Maltese: Nisa tqal li qatt ma ħadu kura ġew miktuba flistudju fil-ġimgħat 34-36 tat-tqala u ngħataw kura antiretrovirali sakemm ħelsu.
English: Study AI455-099 was a 48-week, randomised, double-blind study with Zerit (40 mg twice daily), in combination with lamivudine (150 mg twice daily) plus efavirenz (600 mg once daily), in 391 treatment-naive patients, with a median CD4 cell count of 272 cells/mm3
Maltese: Studju AI455-099 kien studju ta' 48 ġimgħa, b'kampjun magħżul kif jinzerta, double blind fejn Zerit (40 mg darbtejn kuljum) flimkien ma' lamivudine (150 mg darbtejn kuljum) kif ukoll efavirenz (600 mg darba kuljum), fi 391 pazjent li qatt ma kienu ħadu trattament qabel, b'għadd medju ta' ċelloli
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/006
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/006
English: Early symptoms (symptomatic hyperlactatemia) include benign digestive symptoms (nausea, vomiting and abdominal pain), non-specific malaise, loss of appetite, weight loss, respiratory symptoms (rapid and/or deep breathing) or neurological symptoms (including motor weakness).
Maltese: Sintomi tal-bidu (iperlaktejtimja sintomatika) jinkludu sintomi mhux malinji tad-diġestjoni (dardir, remettar u wġigħ ta' żaqq), mard mhux speċifiku, nuqqas ta' aptit, tnaqqis fil-piż, sintomi tan-nifs (nifs mgħaġġel u/jew fil-fond) jew tan-nervituri (jinkludu dgħufija talmuskoli motorjali).
English: Zerit dosage (according to creatinine clearance)
Maltese: Doża ta' Zerit (skont it-tneħħija ta' krejatinina)
English: Approximately 70% of the orally administered stavudine dose was excreted as an unchanged drug in urine.
Maltese: Madwar 70 % tad-doża orali ta' stavudine tneħħiet bħala mediċina mhux mibdula fl-awrina.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/009
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/009
English: Patients co-infected with hepatitis C and treated with alpha interferon and ribavirin may constitute a special risk.
Maltese: Pazjenti li għandhom ukoll infezzjoni blepatite C u qegħdin jieħdu alpha interferon u ribavirin għandhom l-akbar riskju.
English: The therapy should be initiated by a doctor experienced in the management of HIV infection (see also section 4.4).
Maltese: It-terapija għandha tibda tingħata minn tabib li għandu esperjenza fil-kura ta' infezzjoni bl-HIV (ara wkoll sezzjoni 4.4).
English: Zerit 30 mg hard capsules are supplied in blister packs of 56 hard capsules or bottles of 60 hard capsules.
Maltese: Zerit 30 mg kapsuli iebsin jiġu f'pakketti tal-folji b'56 kapsula iebsin jew fliexken b'60 kapsuli iebsin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/96/009/003
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/96/009/003
English: In addition, K65R has been reported in patients receiving stavudine/didanosine or stavudine/lamivudine, but not in patients receiving stavudine monotherapy.
Maltese: Flimkien ma' dan, K65R kienet irrappurtata f'pazjenti li kienu qed jingħataw stavudine/didanosine jew stavudine/lamivudine, iżda mhux f'pazjenti li kienu qed jirċievu kura bi stavudine mogħti waħdu.
English: However, clinically significant peripheral neuropathy is less frequent.
Maltese: Iżda n-newropatija periferali fuq skala klinikament sinifikanti hija inqas komuni.
English: Pregnancy
Maltese: PRIMARJU
English: NAME OF THE MEDICINAL PRODUCT Zerit 200 mg powder for oral solution
Maltese: Zerit 200 mg trab għal soluzzjoni orali
English: Zerit 200 mg powder for oral solution is supplied in a bottle containing 200 ml solution.
Maltese: Zerit 200 mg trab għal soluzzjoni orali jiġi fi flixkun li fih soluzzjoni ta' 200 ml.
English: Treatment with stavudine should be discontinued if there is symptomatic hyperlactatemia and metabolic/lactic acidosis, progressive hepatomegaly, or rapidly elevating aminotransferase levels.
Maltese: It-trattament bl- stavudine għandu jitwaqqaf jekk ikun hemm iperlaktejtimja sintomatika u aċidożi metabolika/lattika, fwied imkabbar, jew il-livelli ta' aminotransferase jogħlew bil-għaġġla.
English: Dual energy x-ray absorptiometry (DEXA) scans demonstrated overall limb fat loss in stavudine treated patients compared to limb fat gain or no change in patients treated with other NRTIs (abacavir, tenofovir or zidovudine).
Maltese: Skans ta' dual energy x-ray absorptiometry (DEXA) urew telf globali ta' xaħam fir-riġlejn jew fid-dirgħajn f'pazjenti kkurati bi stavudine meta mqabbel ma' żieda fixxaħam fir-riġlejn jew fid-dirgħajn, jew l-ebda tibdil, f'pazjenti kkurati b'NRTIs oħrajn (abacavir, tenofovir jew zidovudine).
English: Patients with pre-existing liver dysfunction including chronic active hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice.
Maltese: Pazjenti li diġà għandhom mard tal-fwied li jinkludi l-epatite kronika attiva għandhom rata akbar ta' tibdil fil-funzjoni tal-fwied waqt it-terapija antiretrovirali kombinata u għandhom jiġu segwiti kif isir normalment.
English: Osteonecrosis: cases of osteonecrosis have been reported, particularly in patients with generally acknowledged risk factors, advanced HIV disease or long-term exposure to combination antiretroviral therapy (CART).
Maltese: Osteonecrosis: każijiet ta' osteonecrosis ġew irrapurtati, b'mod partikulari f'pazjenti b'fatturi ġeneralment magħrufin li huma ta' riskju, marda ta' l-HIV jew espożizzjoni fuq medda twila għatterapija ta' kombinazzjoni antiretrovirali (CART).
English: Use in children
Maltese: Doża ta' l-adulti
English: Stavudine therapy is associated with several severe adverse reactions, such as lactic acidosis, lipoatrophy and polyneuropathy, for which a potential underlying mechanism is mitochondrial toxicity.
Maltese: It-terapija bi stavudine hi assoċjata ma' diversi reazzjonijiet avversi severi, bħal aċidożi lattika, lipoatrofija u polinewropatija, li għalihom mekkaniżmu potenzjali diġà eżistenti hi tossiċità mitokondrijali.
English: No carcinogenicity was noted at doses of 400 mg/kg/day in mice and 600 mg/kg/day in rats, corresponding to exposures ~ 39 and 168 times the expected human exposure, respectively, suggesting an insignificant carcinogenic potential of stavudine in clinical therapy.
Maltese: Ma deher l-ebda effett kanċeroġeniku f'dożi ta 400 mg/kg/jum fil-ġrieden u 600 mg/kg/jum fil-firien, li jissarrfu f'espożizzjoni ta' bejn wieħed u ieħor 39 u 168-il-darba akbar mill-espożizzjoni fil-bniedem, rispettivament, u dan jissuġġerixxi li l-potenzjal kanċeroġeniku ta' stavudine huwa insinifikanti.
English: Similar effects have been observed with other nucleoside analogues.
Maltese: Effetti jixxiebħu ntwerew b'analogi oħra tan-nuklejosidi.
English: EMA/119828/2014 EMEA/H/C/002656
Maltese: EMEA/H/C/002656
English: The full EPAR and risk management plan summary for Vokanamet 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 Vokanamet
Maltese: Informazzjoni oħra dwar Vokanamet
English: Vokanamet canagliflozin / metformin
Maltese: Sommarju tal-EPAR għall-pubbliku canagliflozin / metformin
English: Vokanamet is available as tablets containing canagliflozin and metformin in various strengths (50/850 mg, 150/850 mg, 50/1000 mg and 150/1000 mg) and can only be obtained with a prescription.
Maltese: Vokanamet huwa disponibbli bħala pilloli li fihom canagliflozin u metformin f'diversi qawwiet (50/850 mg, 150/850 mg, 50/1000 mg u 150/1000 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: This is a summary of the European public assessment report (EPAR) for Vokanamet.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Vokanamet.
English: • canagliflozin works by blocking a protein in the kidneys called sodium glucose co-transporter 2
Maltese: • canagliflozin jaħdem billi jimblokka proteina fil-kliewi msejħa kotrasportatur tal-glukożju tas-sodju 2 (SGLT2).
English: Vokanamet contains two different active substances, which work in different ways:
Maltese: Vokanamet fih żewġ sustanzi attivi differenti, li jaħdmu b'modi differenti:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Vokanamet on 23 April 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Vokanamet fl-Unjoni Ewropea kollha fit-23 ta' April 2014.
English: Vokanamet is a diabetes medicine that contains the active substances canagliflozin and metformin.
Maltese: Vokanamet huwa mediċina tad-dijabete li fiha s-sustanza attiva canagliflozin u metformin.
English: In two studies evaluating canagliflozin as an add-on to metformin, the reductions in HbA1c levels after 26 weeks was 0.91 to 1.16 percentage points higher with canagliflozin than with placebo (a dummy treatment) when added to metformin and canagliflozin achieved similar reductions to two other diabetes medicines, glimepiride and sitagliptin, after 52 weeks of treatment.
Maltese: F'żewġ studji li vvalutaw canagliflozin bħala suppliment għal metformin, it-tnaqqis fil-livelli ta' HbA1c wara 26 ġimgħa kien ta' 0.91 sa 1.16-il punt perċentwali ogħla b'canagliflozin meta mqabbel ma' plaċebo (trattament finta) meta żdied ma' metformin u canagliflozin kiseb tnaqqis simili għal żewġ mediċini oħrajn tad-dijabete, glimepiride u sitagliptin, wara kura ta' 52 ġimgħa.
English: What are the risks associated with Vokanamet?
Maltese: X'inhuma r-riskji assoċjati ma' Vokanamet?
English: Vokanamet must not be used in:
Maltese: Vokanamet ma jistax jintuża f':
English: Adding canagliflozin to treatment was shown to be effective at reducing HbA1c compared with placebo by 0.65 to 0.73 points after 18 weeks in patients receiving insulin and by 0.74 to 0.83 points in patients receiving a sulphonylurea.
Maltese: Meta mqabbel mal-plaċebo, intwera li ż-żieda ta' canagliflozin mal-kura hija effettiva biex tnaqqas HbA1c b'0.65 sa 0.73 punt wara 18-il ġimgħa f'pazjenti li kienu qed jingħataw insulina u b'0.74 sa 0.83 punt f'pazjenti li kienu qed jirċievu sulfonilurea.
English: The most common side effects with Vokanamet (which may affect more than 1 in 10 people) are hypoglycaemia (low blood glucose levels) when used in combination with insulin or a sulphonylurea and vulvovaginal candidiasis (thrush, a fungal infection of the female genital area caused by Candida).
Maltese: L-effetti sekondarji l-aktar komuni b'Vokanamet (li jistgħu jaffettwaw iktar minn persuna f'għaxra) huma ipogliċemija (livelli baxxi ta' glukożju fid-demm) meta jintuża flimkien ma' insulina jew sulfonilurea u kandidjażi vulvovaġinali (thrush, infezzjoni fungali tal-parti ġenitali tan-nisa kkaġunata minn Candida).
English: • patients with diabetic ketoacidosis or pre-coma (dangerous complications of diabetes),
Maltese: • pazjenti b'ketoaċidożi dijabetika jew prekoma (kumplikazzjonijiet perikolużi tad-dijabete),
English: Why is Vokanamet approved?
Maltese: Għaliex ġie approvat Vokanamet?
English: The studies, involving over 5,000 adults with type 2 diabetes, studied canagliflozin at daily doses of 100 and 300 mg and looked mainly at how they reduced the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Maltese: L-istudji, li involvew iktar minn 5,000 adult b'dijabete tat-tip 2, studjaw canagliflozin f'dożi ta' 100 u 300 mg kuljum u primarjament ħarsu lejn kif naqqsu llivell ta' sustanza fid-demm imsejħa emoglobina glikosilata (HbA1c), li tagħti indikazzjoni ta' kemm hu kkontrollat sew il-glukożju fid-demm.
English: How is Vokanamet used?
Maltese: Kif jaħdem Vokanamet?
English: A risk management plan has been developed to ensure that Vokanamet is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Vokanamet jintuża bl-aktar mod sigur possibbli.
English: • Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Maltese: • Metformin jaħdem primarjament billi jinibixxi l-produzzjoni tal-glukożju u jnaqqas l-assorbiment tiegħu fl-imsaren.
English: • patients with a condition that could lead to body tissues being deprived of oxygen (e.g. heart or respiratory failure)
Maltese: (eż. insuffiċjenza kardijaka jew respiratorja)
English: Three further studies evaluated canagliflozin as an add-on to combined treatment with metformin and either a sulphonylurea or pioglitazone.
Maltese: Tliet studji oħrajn vvalutaw canagliflozin bħala suppliment għal kura kombinata ma' metformin u sulfonilurea jew pioglitazone.
English: Canagliflozin was also studied as an add-on treatment in patients who were taking insulin alone, or insulin in combination with other diabetes medicines including metformin and in patients who were taking a sulphonylurea.
Maltese: Canagliflozin ġie studjat ukoll bħala kura supplimentari f'pazjenti li kienu qed jieħdu insulina waħedha, jew insulina flimkien ma' mediċini oħrajn għad-dijabete inkluża metformin u f'pazjenti li kienu qed jieħdu sulfonilurea.
English: Added to metformin and pioglitazone, canagliflozin was also superior to placebo, leading to HbA1c reductions that were 0.62 and 0.76 points more than was seen by adding placebo.
Maltese: Flimkien ma' metformin u pioglitazone, canagliflozin kien ukoll superjuri għall-plaċebo, billi wassal għal tnaqqis f'HbA1c li kien 0.62 u 0.76 punt iktar milli dak li deher meta żdied il-plaċebo.
English: The CHMP also noted that giving the combination of canagliflozin and metformin as a single tablet could provide an additional treatment option for patients with type 2 diabetes, and may improve adherence to treatment.
Maltese: Is-CHMP osserva wkoll li l-għoti tat-taħlita ta' canagliflozin ma' metformin bħala pillola waħda jista' jipprovdi alternattiva addizzjonali għall-kura ta' pazjenti b'dijabete tat-tip 2, u jista' jtejjeb l-aderenza mal-kura.
English: Vokanamet can also be used to replace canagliflozin and metformin given separately.
Maltese: Vokanamet jista' jintuża wkoll biex jieħu post canagliflozin u metformin mogħtija b'mod separat.
English: Type-2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Maltese: Id-dijabete tat-tip 2 hija marda li fiha l-frixa ma tipproduċix biżżejjed insulina biex tikkontrolla l-livell ta' glukożju fid-demm jew meta l-ġisem ma jkunx kapaċi juża l-insulina b'mod effettiv.
English: It is used, together with diet and exercise, to control the blood glucose (sugar) levels in adults with type 2 diabetes whose disease is not satisfactorily controlled with metformin alone, or in combination with other diabetes medicines, including insulin, when these medicines together with metformin are not providing adequate control of the diabetes.
Maltese: Jintuża flimkien ma' dieta u eżerċizzju biex jikkontrolla l-livelli ta' glukożju (zokkor) fid-demm fl-adulti b'dijabete tat-tip 2 li l-marda tagħhom mhijiex ikkontrollata biżżejjed b'metformin waħdu, jew flimkien ma' mediċini oħrajn tad-dijabete, inkluża l-insulina, meta dawn il-mediċini kif ukoll metformin ma jikkontrollawx id-dijabete b'mod xieraq.
English: 19 November 2015
Maltese: 19 ta' Novembru 2015
English: EMA/324406/2015 Corr.1
Maltese: EMA/324406/2015
English: Ginkgo leaf
Maltese: Werqa tal-Ġinko
English: For further information, see the HMPC assessment report.
Maltese: Dit is een vertaling van de samenvatting voor het publiek van het oorspronkelijke HMPC beoordelingsrapport dat in het engels is aangemaakt door het EMA secretariaat
English: This means that there are bibliographic data providing scientific evidence of their effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Maltese: Dan ifisser li hemm data biblijografika li tipprovdi evidenza xjentifika tal-effikaċja u s-sigurtà tagħhom meta jintużaw b'dan il-mod, li tkopri perjodu ta' mill-inqas 10 snin flUE.
English: Ginkgo leaf is the common name for the leaf of the plant Ginkgo biloba L. This summary covers ginkgo leaf medicines containing a specific herbal preparation made by powdering the dried leaf or as dry extract.
Maltese: L-estratt niexef jiġi ppreparat permezz ta' teknika biex jiġu estratti komposti minn materjal tal-pjanti billi jiddewbu fl-aċetun li mbagħad jiġi evaporat biex jinkiseb l-estratt niexef.
English: When used for minor circulation problems, gastrointestinal disorders (side effects affecting the gut), headaches and allergic reactions have been reported.
Maltese: Meta jintużaw għal problemi żgħar fiċ-ċirkolazzjoni, ġew irrapportati disturbi gastrointestinali (effetti sekondarji li jaffettwaw limsaren), uġigħ ta' ras u reazzjonijiet allerġiċi.
English: The exact way ginkgo leaf works in dementia is not fully understood but it is thought to protect brain cells from damage either directly or indirectly by regulating blood flow or by neutralising toxic forms of oxygen molecules (called oxygen free radicals).
Maltese: Il-mod eżatt ta' kif il-werqa tal-ġinko taħdem fid-dimensja mhux mifhum għal kollox iżda huwa maħsub li tipproteġi ċ-ċelloli tal-moħħ mill-ħsara direttament jew indirettament billi tirregola l-fluss tad-demm jew billi tinnewtralizza forom tossiċi tal-molekuli tal-ossiġenu (imsejħin radikali ħielsa talossiġinu).
English: What is ginkgo leaf?
Maltese: X'inhu l-weraq tal-ġinko?
English: The most relevant clinical trials performed in adults aged 50 years and above indicated that ginkgo leaf medicines containing the dry extract could have beneficial effects on cognitive function in mild dementia.
Maltese: L-iktar provi kliniċi rilevanti twettqu f'adulti li għandhom 50 sena 'l fuq u l-mediċini tal-werqa tal-ġinko li fihom l-estratt niexef indikat hawn fuq jista' jkollhom effetti ta' benefiċċju fuq il-funzjoni konjittiva f'dimensja ħafifa.
English: How are ginkgo leaf medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini tal-werqa tal-ġinko?
English: Further information on the risks associated with ginkgo leaf medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: Aktar informazzjoni dwar ir-riskji assoċjati mal-mediċini tal-werqa tal-ġinko, inkluż il-prekawzjonijiet xierqa għall-użu sigur tagħhom, tinsab fil-monografu taħt it-tab "Id-dokumenti kollha" fis-sit elettroniku tal-Aġenzija:
English: Further information on the HMPC assessment of ginkgo leaf medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC conclusions on the use of ginkgo leaf medicines to improve the age-related cognitive impairment and quality of life of adults with mild dementia are based on their ‘well-established use' in this indication.
Maltese: Il-konklużjonijiet tal-HMPC dwar l-użu tal-mediċini tal-werqa tal-ġinko biex jittejjeb indeboliment konjittiv relatat mal-età u l-kwalità ta' ħajja ta' adulti b'dimensja ħafifa huma abbażi tal-"użu stabbilit sew" tagħhom f'din l-indikazzjoni.
English: How does ginkgo leaf work as a medicine?
Maltese: Kif taħdem il-werqa tal-ġinko bħala mediċina?
English: This means that, although there is insufficient evidence from clinical trials, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
Maltese: Dan ifisser li, għalkemm m'hemmx biżżejjed evidenza minn provi kliniċi, l-effikaċja ta' dawn il-mediċini erbali hija plawsibbli u hemm evidenza li ilhom jintużaw b'dan il-mod b'mod sigur għal mill-inqas 30 sena (inkluż mill-inqas 15il sena fl-UE).