FrancophonIA/ELRC3.0 huggingface dataset:
English: In the three studies of Rivastigmine Hexal in patients with Alzheimer's dementia, patients taking doses of Rivastigmine Hexal between 6 and 9 mg per day had an average increase in cognitive symptoms of 0.2 points from a baseline of 22.9 points at the start of the study, where a lower score indicates better performance.
Maltese: Hexal fuq pazjenti bid-dimenzja ta' Alzheimer, il-pazjenti li ħadu dożi ta' Rivastigmine Hexal ta' bejn 6 u 9 mg kuljum kellhom żieda medja fis-sintomi konjittivi ta' 0.2 punti, mill-valur inizjali ta' 22.9 punti fil-bidu tal-istudju.
English: Rivastigmine Hexal was more effective than placebo at controlling symptoms.
Maltese: Hexal kien aktar effikaċi mill-plaċebo fil-kontroll tas-sintomi.
English: This was compared with an increase of 2.6 points from 22.5 in the patients taking placebo.
Maltese: Dan tqabbel ma' żieda ta' 2.6 punti rreġistrata fil-pazjenti ttrattati bi plaċebo millvalur inizjali ta' 22.5.
English: In patients with Alzheimer's dementia or dementia due to Parkinson's disease, certain nerve cells die in the brain, resulting in low levels of the neurotransmitter acetylcholine (a chemical that allows nerve cells to communicate with each other).
Maltese: Fil-pazjenti b'dimenzja tat-tip Alzheimer jew b'dimenzja kkaġunata mill-marda ta' Parkinson ċerti ċelluli nervużi tal-moħħ imutu, u dan jikkawża livelli baxxi tan-newrotrasmettitur aċetilkolina (sustanza kimika li tippermetti ċ-ċelluli nervużi jikkomunikaw ma' xulxin).
English: Rivastigmine Hexal was also studied in 541 patients with dementia due to Parkinson's disease.
Maltese: Hexal ġie studjat ukoll f'541 pazjent b'dimenzja kkaġunata mill-marda ta' Parkinson.
English: The patients with dementia due to Parkinson's disease taking Rivastigmine Hexal capsules showed an improvement in cognitive symptoms of 2.1 points, compared with a worsening of 0.7 points in those taking placebo, from a baseline of around 24 points.
Maltese: Il-pazjenti b'dimenzja kkaġunata mill-marda ta' Parkinson li ġew ittrattati bil-kapsuli ta' Rivastigmine Hexal urew titjib fis-sintomi konjittivi ta' 2.1 punti apparagun mat-taħżin ta' 0.7 punti rreġistrat filpazjenti li ngħataw plaċebo, minn valur inizjali ta' madwar 24 punt.
English: Rivastigmine Hexal is also used to treat mild to moderately severe dementia in patients with Parkinson's disease.
Maltese: Hexal jintuża wkoll għat-trattament tad-dimenzja minn ħafifa għal moderatament gravi f'pazjenti bil-Parkinson.
English: The CHMP concluded that Rivastigmine Hexal has a modest effectiveness in treating the symptoms of Alzheimer's dementia, although this does reflect an important benefit in some patients.
Maltese: Is-CHMP ikkonkluda li Rivastigmine Hexal għandu effikaċja moderata fit-trattament tas-sintomi taddimenzja ta' Alzheimer, għad illi dan tassew jirrappreżenta benefiċċju importanti għal uħud millpazjenti.
English: The main measures of effectiveness were the change in symptoms in two main areas: cognitive (the ability to think, learn and remember) and global (a combination of several areas including general function, cognitive symptoms, behaviour and the ability to carry out everyday activities).
Maltese: Il-kejl ewlieni tal-effikaċja kien il-bidla fis-sintomi f'żewġ oqsma prinċipali: konjittiv (kapaċità li taħseb, titgħallem u tiftakar) u globali (taħlita ta' bosta oqsma fosthom il-funzjonament ġenerali, is-sintomi konjittivi, l-imġiba u l-kapaċità li jingħamlu l-attivitajiet ta' kuljum).
English: Rivastigmine Hexal is used for the treatment of patients with mild to moderately severe Alzheimer's dementia, a progressive brain disorder that gradually affects memory, intellectual ability and behaviour.
Maltese: Hexal jintuża fil-kura ta' pazjenti li jbatu bid-dimenzja ta' Alzheimer minn ħafifa għal moderatament gravi, diżordni progressiva tal-moħħ li bil-mod il-mod taffettwa l-memorja, l-abbiltà intellettwali u l-imġiba.
English: What is Rivastigmine Hexal?
Maltese: X'inhu Rivastigmine Hexal?
English: The Committee initially concluded that for the treatment of dementia due to Parkinson's disease, Rivastigmine Hexal's benefits did not outweigh its risks.
Maltese: Għall-ewwel il-Kumitat kien ikkonkluda li fit-trattament tad-dimenzja kkaġunata mill-marda ta' Parkinson, il-benefiċċji ta' Rivastigmine Hexal ma kinux ogħla mir-riskji tiegħu.
English: This authorisation was based on the authorisation granted to Exelon in 1998 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija lil Exelon fl-1998 (‘kunsens infurmat').
English: Why has Rivastigmine Hexal been approved?
Maltese: Għaliex ġie approvat Rivastigmine Hexal?
English: How does Rivastigmine Hexal work?
Maltese: Għal xiex jintuża Rivastigmine Hexal?
English: In patients who tolerate this dose, it can be increased in 1.5-mg steps no more frequently than every two weeks, to a regular dose of 3 to 6 mg twice a day.
Maltese: F'pazjenti li jittolleraw din iddoża, din tista' tiżdied b'1.5 mg kull darba, iżda bejn żieda u oħra għandu jitħalla intervalli ta' mhux iqsar minn ħmistax, sakemm tintlaħaq doża regolari ta' 3-6 mg darbtejn kuljum.
English: By blocking these enzymes, Rivastigmine Hexal allows levels of acetylcholine to be increased in the brain, helping to reduce the symptoms of Alzheimer's dementia and dementia due to Parkinson's disease.
Maltese: It-trattament b'Rivastigmine Hexal għandu jinbeda u jiġi mmonitorjat minn tabib li għandu lesperjenza fid-dijanjożi u fit-trattament tal-marda ta' Alzheimer jew fid-dimenzja f'pazjenti bil-marda ta' Parkinson.
English: Overall, the most common side effects include nausea (feeling sick, seen in 38 patients in 100) and vomiting (seen in 23 patients in 100), particularly during the phase when the dose of Rivastigmine Hexal is being increased.
Maltese: Kollox ma' kollox, l-effetti sekondarji l-aktar komuni jinkludu nawżja (dardir, li dehru fi 38 pazjent minn 100) u remettar (li dehru fi 23 pazjent minn 100),
English: Other information about Rivastigmine Hexal
Maltese: Aktar tagħrif dwar Rivastigmine Hexal
English: For the full list of all side effects reported with Rivastigmine Hexal, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati bl-użu ta' Rivastigmine Hexal, ara l-fuljett ta' tagħrif.
English: EMA/802043/2015 EMEA/H/C/003788
Maltese: EMA/635333/2015 EMA/H/C/003788
English: Ciambra is a ‘generic medicine'.
Maltese: Ciambra huwa ‘mediċina ġenerika'.
English: The full EPAR and risk management plan summary for Ciambra 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 Ciambra
Maltese: Informazzjoni oħra dwar Ciambra
English: Ciambra contains the active substance pemetrexed.
Maltese: Ciambra fih is-sustanza attiva pemetrexed.
English: This is a summary of the European public assessment report (EPAR) for Ciambra.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Ciambra.
English: The company provided data from the published literature on pemetrexed.
Maltese: Il-kumpanija pprovdiet dejta minn dokumentazzjoni ppubblikata dwar pemetrexed.
English: In the body, pemetrexed is converted into an active form that blocks the activity of the enzymes that are involved in producing ‘nucleotides' (the building blocks of DNA and RNA, the genetic material of cells).
Maltese: Filġisem, pemetrexed jinbidel f'forma attiva li timblokka l-attività tal-enzimi li huma involuti filproduzzjoni ta' ‘nukleotidi' ( li fuqhom jinbnew DNA u RNA, il-materjal ġenetiku taċ-ċelloli).
English: Ciambra is a cancer medicine used to treat two types of lung cancer:
Maltese: Ciambra huwa mediċina kontra l-kanċer li tintuża biex tikkura żewġ tipi ta' kanċers tal-pulmun:
English: Why is Ciambra approved?
Maltese: Għaliex ġie approvat Ciambra?
English: • malignant pleural mesothelioma (a cancer of the lining of the lungs that is usually caused by exposure to asbestos), where it is used together with cisplatin in patients who have not received chemotherapy before and whose cancer cannot be removed by surgery;
Maltese: • mesoteljoma plewrika malinna (kanċer tar-rita tal-pulmun, normalment ikkawżat minn esponiment għall-ażbestos), fejn jintuża flimkien ma' ċisplatin f'pazjenti li ma ngħatawx kimoterapija qabel u li l-kanċer li għandhom ma jistax jitneħħa b'intervent kirurġiku;
English: This means that Ciambra is similar to a ‘reference medicine' already authorised in the European Union (EU) called Alimta.
Maltese: Dan ifisser li Ciambra huwa simili għall-‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Alimta.
English: Ciambra is available as a powder that is made up into a solution for infusion (drip) into a vein.
Maltese: Ciambra huwa disponibbli bħala trab li jsir soluzzjoni għal infużjoni (dripp) ġol-vina.
English: The active substance in Ciambra, pemetrexed, is a cytotoxic medicine (a medicine that kills cells that are dividing, such as cancer cells), which belongs to the group ‘antimetabolites'.
Maltese: Is-sustanza attiva f'Ciambra, pemetrexed, hija mediċina ċitotossika (mediċina li toqtol iċ-ċelloli li jkunu qegħdin jimmultiplikaw, bħaċ-ċelloli tal-kanċer), li jagħmlu parti mill-grupp tal-‘antimetaboliti'.
English: What are the benefits and risks of Ciambra?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Ciambra?
English: When Ciambra is given with cisplatin, an ‘anti-emetic' medicine (to prevent vomiting) and fluids (to prevent dehydration) should also be given before or after the cisplatin dose.
Maltese: Meta Ciambra jingħata ma' cisplatin, mediċina‘ antiemetika' (biex tipprevjeni r-rimettar) u fluwidi (biex jipprevjenu d-deidrazzjoni) għandha tingħata wkoll qabel jew wara d-doża ta' cisplatin.
English: How has Ciambra been studied?
Maltese: Kif ġie studjat Ciambra?
English: The Committee recommended that Ciambra be approved for use in the EU.
Maltese: Il-Kumitat irrakkomanda li Ciambra jkun approvat għall-użu fl-UE.
English: Because Ciambra is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Ciambra huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: To reduce side effects, patients should take a corticosteroid (a type of medicine that reduces inflammation) and folic acid (a type of vitamin), and receive injections of vitamin B12 during treatment with Ciambra.
Maltese: Biex jitnaqqsu l-effetti sekondarji, il-pazjenti għandhom jieħdu kortikosterojde (tip ta' mediċina li tnaqqas l-infjammazzjoni) u aċidu foliku (tip ta' vitamina), u għandhom jingħataw injezzjonijiet ta' vitamina
English: What measures are being taken to ensure the safe and effective use of Ciambra?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Ciambra?
English: A risk management plan has been developed to ensure that Ciambra is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Ciambra jintuża bl-aktar mod sigur possibbli.
English: No additional studies were needed as Ciambra is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Alimta.
Maltese: Ma kien jinħtieġ lebda studju addizzjonali peress li Ciambra huwa mediċina ġenerika mogħtija permezz ta' infużjoni u fih l-istess sustanza attiva bħal dik tal-mediċina ta' referenza, Alimta.
English: • advanced non-small-cell lung cancer of the kind known as ‘non-squamous', where it is used either in combination with cisplatin in previously untreated patients or on its own in patients who have previously received cancer treatment.
Maltese: • kanċer tal-pulmun avvanzat mhux b'ċelloli żgħar tat-tip magħruf bħala 'mhux skwamuż', fejn jintuża jew flimkien ma' cisplatin f'pazjenti li qatt ma kienu ngħataw kura qabel jew waħdu f'pazjenti li diġà ngħataw kura għal kontra l-kanċer.
English: 3 vials
Maltese: 3 kunjetti
English: 400 mg Powder for concentrate for solution for infusion
Maltese: 400 mg Trab għal konċentrat għal soluzzjoni għallinfużjoni
English: EMA Number
Maltese: Numru tal-MA
English: The full EPAR for Movymia 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: Movymia contains the active substance teriparatide.
Maltese: Movymia fih is-sustanza attiva teriparatide.
English: • men who are at an increased risk of fractures;
Maltese: • irġiel li għandhom riskju akbar ta' ksur;
English: Movymia is a ‘biosimilar medicine'.
Maltese: Movymia huwa ‘mediċina bijosimili'.
English: This is a summary of the European public assessment report (EPAR) for Movymia.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Movymia.
English: Other information about Movymia
Maltese: Informazzjoni oħra dwar Movymia
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku teriparatide
English: The active substance in Movymia, teriparatide, is identical to part of the human parathyroid hormone.
Maltese: Is-sustanza attiva f'Movymia, it-teriparatide, hija identika għal parti mill-ormon tal-paratirojde uman.
English: Movymia is available as a solution for injection in cartridges (containing 600 micrograms of teriparatide) intended to be used with ServoPen Fix system.
Maltese: Movymia jiġi bħala soluzzjoni għall-injezzjoni fi skrataċ (li fihom 600 mikrogramma ta' teriparatide) maħsuba biex jintużaw mas-sistema ServoPen Fix.
English: The reference medicine for Movymia is Forsteo.
Maltese: Ilmediċina ta' referenza għal Movymia hija Forsteo.
English: Why is Movymia approved?
Maltese: Għaliex ġie approvat Movymia?
English: What are the risks associated with Movymia?
Maltese: X'inhuma r-riskji assoċjati ma' Movymia?
English: Laboratory studies comparing Movymia with Forsteo have shown that the active substance in Movymia is highly similar to that in Forsteo in terms of structure, purity and biological activity.
Maltese: Studji fil-laboratorju li qabblu Movymia ma' Forsteo wrew li s-sustanza attiva f'Movymia hija simili ħafna għal dik f'Forsteo f'termini ta' struttura, purità u attività bijoloġika.
English: Movymia must not be used in patients who have other bone diseases such as Paget's disease, bone cancer or bone metastases (cancer that has spread to the bone), patients who have had radiation therapy of the skeleton, or patients who have hypercalcaemia (high blood calcium levels), unexplained high levels of alkaline phosphatase (an enzyme) or severe kidney disease.
Maltese: Movymia ma għandux jintuża fuq pazjenti li jkollhom mard ieħor tal-għadam bħall-marda ta' Paget, kanċer tal-għadam jew metastażi tal-għadam (kanċer li jkun infirex għall-għadam), fuq pazjenti li kellhom terapija ta' radjazzjoni tal-iskeletru, jew fuq pazjenti b'iperkalċemija (livelli għoljin ta' kalċju fid-demm), b'livelli għoljin mingħajr raġuni ta' alkaline phosphatase (enzima), jew b'mard serju talkliewi.
English: The recommended dose is 20 micrograms of Movymia given once a day as an injection under the skin of the thigh or abdomen (belly).
Maltese: Id-doża rakkomandata hija ta' 20 mikrogramma ta' Movymia li tingħata darba kuljum bħala injezzjoni taħt il-ġilda fil-koxxa jew fl-addome (iż-żaqq).
English: Further, Movymia and Forsteo produced similar effects on calcium levels in the blood.
Maltese: Barra minn hekk, Movymia u Forsteo pproduċew effetti simili fuq il-livelli tal-kalċju fid-demm.
English: This means that Movymia is highly similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Movymia huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala l-‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: • men and women who are at an increased risk of fractures due to long-term treatment with glucocorticoids (a type of steroid).
Maltese: • irġiel u nisa li għandhom riskju akbar ta' ksur minħabba kura għal żmien twil bil-glukokortikojdi (tip ta' sterojdi).
English: A study in 54 healthy women has shown that the same doses of the two medicines given by injection under the skin produced similar levels of the active substance teriparatide in the body.
Maltese: Studju fuq 54 mara b'saħħithom wera li l-istess dożi taż-żewġ mediċini mogħtija permezz ta' injezzjoni taħt il-ġilda pproduċew livelli simili tas-sustanza attiva teriparatide fil-ġisem.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) considered evidence showing that Movymia has a highly similar structure, purity and biological activity to Forsteo and is distributed in the body in the same way.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) qies evidenza li turi li Movymia għandu struttura, purità u attività bijoloġika simili ħafna għal Forsteo u jiġi distribwit bl-istess mod filġisem.
English: Movymia is a medicine used for the treatment of osteoporosis (a disease that makes bones fragile) in:
Maltese: Movymia huwa mediċina li tintuża għall-kura tal-osteoporożi (marda li tagħmel l-għadam fraġli) filgruppi li ġejjin:
English: This was considered sufficient to conclude that Movymia will behave in the same way in terms of effectiveness and safety.
Maltese: Dan tqies bħala suffiċjenti biex jiġi konkluż li Movymia ser jaġixxi bl-istess mod f'termini ta' effikaċja u sigurtà.
English: Movymia teriparatide
Maltese: Kif jintuża Movymia?
English: In women, osteoporosis is more common after the menopause, when the levels of the female hormone oestrogen fall.
Maltese: Fin-nisa, l-osteoporożi hija aktar komuni wara l-menopawża, meta l-livelli tal-ormon tan-nisa, lestroġenu, jaqgħu.
English: CMDh position
Maltese: Il-pożizzjoni tas-CMDh
English: • The PRAC considered the procedure under Article 31 of Directive 2001/83/EC resulting from pharmacovigilance data for zolpidem-containing medicinal products;
Maltese: • Il-PRAC qies il-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE li tirriżulta mid-dejta talfarmakoviġilanza għal prodotti mediċinali li fihom zolpidem;
English: Finally and in view of further minimising the risks of impaired driving and somnambulism, a potential lowering of the recommended dose for adults was discussed by the PRAC.
Maltese: Finalment, u fid-dawl ta' minimizzazzjoni ulterjuri tar-riskji ta' sewqan imxekkel u sonnambuliżmu, ilPRAC iddiskuta tnaqqis potenzjali tad-doża rakkomandata għall-adulti.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 with regards to zolpidem-containing medicinal products, agrees with the recommendation therein as stated below:
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC tas-6 ta' Marzu 2014 fir-rigward ta' prodotti mediċinali li fihom zolpidem, jaqbel mar-rakkomandazzjoni tiegħu kif iddikjarat hawn taħt:
English: Discrepancies about drug-drug interactions information were observed in different product information of zolpidem containing products, notably on the interaction of zolpidem with CNS depressant.
Maltese: Ġew osservati diskrepanzi dwar interazzjonijiet bejn mediċini f'informazzjoni dwar il-prodott differenti ta' prodotti li fihom zolpidem, b'mod partikolari fl-interazzjoni ta' zolpidem ma' dipressanti tas-CNS.
English: In February 2013, the Pharmacovigilance Risk Assessment Committee (PRAC) discussed the results of the search in EudraVigilance (EV) of cases of impaired driving ability as well as road traffic accidents associated with zolpidem, performed by the Italian Competent Authority (AIFA).
Maltese: Fi Frar 2013, il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) iddiskuta r-riżultati tat-tiftixa f'EudraVigilance (EV) ta' każijiet ta' ħila mnaqqsa ta' sewqan kif ukoll ta' inċidenti tat-traffiku assoċjati ma' zolpidem, imwettqa mill-Awtorità Kompetenti Taljana (AIFA).
English: Following this, the PRAC requested the MAH of the reference medicinal product for zolpidem to submit a cumulative review of spontaneous cases, clinical studies and published literature of ‘impaired driving ability', ‘Road traffic accidents' and ‘Somnambulism' associated with zolpidem.
Maltese: Wara, il-PRAC talab lill-MAH tal-prodott mediċinali ta' referenza għal zolpidem sabiex jissottometti analiżi kumulattiva ta' każijiet spontanji, studji kliniċi u tagħrif ippubblikat dwar ‘ħila mnaqqsa ta' sewqan', ‘Inċidenti tat-traffiku' u ‘Sonnambuliżmu' assoċjati ma' zolpidem.
English: The CMDh, having considered the PRAC recommendation dated 6 March 2014 pursuant to Article 107k(1) and (2) of Directive 2001/83/EC, reached a position on the variation of the marketing authorisations of zolpidem containing medicinal products for which the amendments to the product information are set out in annex III.
Maltese: Is-CMDh, wara li kkunsidra r-rakkomandazzjoni tal-PRAC datata s-6 ta' Marzu 2014 skont l-Artikolu 107k(1) u (2) tad-Direttiva 2001/83/KE, laħaq pożizzjoni dwar il-varjazzjoni tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti mediċinali li fihom zolpidem li għalihom l-emendi għat-tagħrif dwar ilprodott huma stabbiliti fl-Anness
English: • The PRAC considered that the above-mentioned risks of impaired driving ability and somnambulism could be mitigated by changes to the product information of zolpidem-containing medicines, in particular that zolpidem should be taken as a single intake immediately at bedtime and not exceed the recommended dose, without being re-administered during the same night, as well as highlighting the risks regarding impaired driving and somnambulism, warnings and precautions aimed at decreasing this risk and also the risks of co-administration with CNS depressants and alcohol, and/ or illicit drugs;
Maltese: • Il-PRAC qies li r-riskji msemmija hawn fuq ta' ħila mnaqqsa ta' sewqan u sonnambuliżmu jistgħu jittaffew b'tibdil fit-tagħrif dwar il-prodott ta' mediċini li fihom zolpidem, b'mod partikolari li zolpidem għandu jittieħed bħala teħid waħdieni minnufih f'ħin l-irqad u d-doża rakkomandata ma għandhiex tinqabeż, mingħajr ma jingħata mill-ġdid matul l-istess lejl, kif ukoll jiġu enfasizzati rriskji rigward sewqan imxekkel u sonnambuliżmu, twissijiet u prekawzjonijiet immirati lejn ittnaqqis ta' dan ir-riskju u kif ukoll riskji ta' koamministrazzjoni b'depressanti tas-CNS u alkoħol, u/jew drogi illeċiti;
English: However, on a population level, the randomised trials only showed convincing evidence of efficacy of the 10mg dose of zolpidem.
Maltese: Madankollu, fil-livell ta' popolazzjoni, il-provi kliniċi aleatorji wrew biss evidenza konvinċenti tal-effikaċja tad-doża ta' 10mg ta' zolpidem.
English: Grounds for the PRAC recommendation
Maltese: Konklużjonijiet xjentifiċi
English: Considering that the effect of zolpidem may last for at least 8 hours and in view of the above referred risk factors, the PRAC also recommended to include warnings indicating that the risk of impaired driving is increased if zolpidem is taken within less than 8 hours before performing activities that require mental alertness, if zolpidem is taken in a higher than the recommended dose, and/or coadministered with other CNS depressants, and/or alcohol or illicit drugs.
Maltese: Peress li l-effett ta' zolpidem jista' jdum tal-inqas 8 sigħat u fid-dawl tal-fatturi ta' riskju msemmijin hawn fuq, il-PRAC irrakkomanda wkoll li jiddaħħlu twissijiet li jindikaw li r-riskju ta' sewqan imxekkel jiżdied jekk zolpidem jittieħed inqas minn 8 sigħat qabel ma jitwettqu attivitajiet li jeħtieġu prontezza mentali, jekk zolpidem jittieħed f'doża ogħla minn dik rakkomandata, u/jew jiġi koamministrat ma' dipressanti tas-CNS oħrajn, u/jew alkoħol jew drogi illeċiti.