FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH clarified that the mean decrease in the severely affected group (systolic blood pressure > 180 mm Hg) was of -25.5 mm Hg (while it was of -18.3 mm Hg in the moderately affected group (systolic blood pressure between 160 mm Hg and 180 mm Hg).
Maltese: Il-MAH ikkjarifika li t-tnaqqis medju fil-grupp li kien affettwat ħafna (pressjoni sistolika tad-demm > 180 mm Hg) kien ta' -25.5 mm Hg (filwaqt li kien ta' -18.3 mm Hg fil-grupp li kien affettwat b'mod moderat (pressjoni sistolika tad-demm bejn 160 mm Hg u 180 mm Hg).
English: The MAH submitted data where 53 % (40 out of 76) of included cats had urea concentrations above the upper limit of the reference range.
Maltese: Il-MAH issottometta dejta fejn 53 % (40 minn 76) tal-qtates inklużi kellhom konċetrazzjonijiet ta' urea ogħla mil-limitu ta' fuq tal-medda ta' referenza.
English: There were no significant differences between risk categories III and IV for age, bodyweight, heart rate, and total thyroxine, urea and creatinine concentrations.
Maltese: Ma kien hemm l-ebda differenza sinifikanti bejn il-kategoriji tar-riskju III u IV għall-età, il-piż talġisem, ir-rata tat-taħbit tal-qalb, u l-konċentrazzjonijiet totali ta' thyroxine, urea, u kreatinina.
English: The proposed recommended therapeutic dose for this new indication is 0.125 mg ramipril/kg body weight once daily.
Maltese: Id-doża terapewtika rakkomandata proposta għal din l-indikazzjoni ġdida hija 0.125 mg ramipril/kg tal-piż tal-ġisem darba kuljum.
English: Depending on the response to therapy, it is possible to double the dose to 0.25 mg ramipril/kg body weight per day.
Maltese: Skont ir-reazzjoni għat-terapija, huwa possibbli li d-doża tiġi rduppjata għal 0.25 mg ramipril/kg tal-piż tal-ġisem darba kuljum.
English: the CVMP considered the referral made under Article 6(12) of Commission Regulation EC No 1084/2003, for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg, tablets for dogs and associated names (see Annex I), all the overall submitted data in writing and in the oral explanations,
Maltese: is-CVMP ikkunsidra r-referenza li saret skont l-Artikolu 6(12) tar-Regolament tal-Kummissjoni KE Nru 1084/2003, għal Vasotop P 0.625 mg, Vasotop P 1.25 mg u Vasotop P 2.5 mg, pilloli għall-klieb u ismijiet assoċjati (ara l-Anness I), id-dejta globali kollha sottomessa bil-miktub u lispjegazzjonijiet orali,
English: The other 12 cats had a >20 mm Hg decrease in systolic blood pressure at Day 63 (mean decrease of 36.6 mm Hg, range 20 mm Hg to 57.8 mm Hg) but were still above the normotensive limit of 160 mm Hg.
Maltese: It-12-il qattus l-oħra kellhom tnaqqis ta' >20 mm Hg fil-pressjoni sistolika tad-demm fil-Jum 63 (tnaqqis medju ta' 36.6 mm Hg, medda 20 mm Hg sa 57.8 mm Hg) iżda kienu għadhom 'il fuq mil-limitu normotensiv ta' 160 mm Hg.
English: Belgium Intervet International B.V. P.O.
Maltese: Il-Finlandja Intervet International B.V. P.O.
English: Norway
Maltese: Qawwa
English: • Untreated hypertension is associated with a significant risk of target organ damage.
Maltese: • Il-pressjoni għolja mhux trattata hija assoċjata ma' riskju sinjifikanti ta' ħsara fl-organi mmirati.
English: the CVMP concluded that the absence of a negative control group (placebo group) in the pivotal clinical field trial was considered unacceptable,
Maltese: is-CVMP ikkonkluda li n-nuqqas ta' grupp ta' kontroll negattiv (grupp ta' plaċebo) fil-prova klinika pivotali f'kundizzjonijiet reali kien ikkunsidrat mhux aċċettabbli,
English: Benefit/Risk assessment
Maltese: 2.7. Valutazzjoni tal-Benefiċċji/Riskji
English: Following the absence of agreement between the Reference Member State and one Concerned Member State (Belgium) at Day 90 of the CMD(v) procedure, the matter was referred to CVMP.
Maltese: Wara n-nuqqas ta' qbil bejn l-Istat Membru ta' Referenza u Stat Membru Kkonċernat wieħed (ilBelġju) fil-Jum 90 tal-proċedura CMD(v), il-kwistjoni ġiet riferuta lis-CVMP.
English: The CVMP is of the opinion that there are ethical issues for veterinarians in allowing cats with significant hypertension to remain untreated, contrary to current-day best clinical practice (ACVIM Consensus Statement 2007).
Maltese: Is-CVMP huwa tal-opinjoni li hemm kwistjonijiet etiċi għal veterinarji jekk jippermettu li l-qtates bi pressjoni għolja b'mod sinjifikanti jibqgħu mingħajr trattament, u dan imur kontra l-aħjar prattika klinika tal-lum (Dikjarazzjoni tal-Kunsens tal-ACVIM 2007).
English: The CVMP considered that due to the low case numbers and lack of comparative statistics, the main findings from this study were more “proof of concept” than proof of definitive clinical efficacy.
Maltese: Is-CVMP ikkunsidra li minħabba l-għadd baxx ta' każijiet u n-nuqqas ta' statistiċi ta' tqabbil, issejbiet ewlenin minn dan l-istudju kienu aktar “prova tal-kunċett” milli prova ta' effikaċja klinika definittiva.
English: The CVMP considered that it is important to emphasise that it is known from the literature that no one agent currently available is 100 % effective in the treatment of feline hypertension, and success rates of about 50 % are considered the norm.
Maltese: Is-CVMP ikkunsidra li huwa importanti li wieħed jenfasizza li huwa magħruf mid-dokumentazzjoni li l-ebda sustanza waħda li hija disponibbli attwalment ma hija effikaċi 100 % fit-trattament tal-pressjoni għolja felina, u r-rati ta' suċċess ta' madwar 50 % huma kkunsidrati bħala n-norma.
English: In addition at Day 63, only 53 % of cats still exhibited at least one clinical sign.
Maltese: Barra minn hekk fil-Jum 63, 53 % tal-qtates biss kien għad għandhom mill-inqas sinjal kliniku wieħed.
English: • Even a short placebo treatment of 28 or 63 days could be associated with irreversible pathological changes to organs such as the eye (e.g. detached retina/blindness).
Maltese: • Anke trattament qasir bi plaċebo ta' 28 jew 63 jum jista' jiġi assoċjat ma bidliet patoloġiċi irriversibbli għall-organi bħall-għajn (pereżempju retina distakkata/l-għama).
English: The MAH provided data to show that of the 82 % of cats showing at least one clinical sign, 46 % had two clinical signs or more.
Maltese: Il-MAH ipprovda dejta biex juri li mit-82 % tal-qtates li kellhom mill-inqas sinjali kliniku wieħed, 46 % kellhom żewġ sinjali kliniċi jew aktar.
English: P. 157-162.
Maltese: 0.625; 1.25 or
English: From the 43 cats belonging to the severe group at Day 0, 26 cats in total (60.5 %) became normotensive or had a >20 mm Hg decrease in systolic blood pressure at Day 63.
Maltese: Mit-43 qattus li kienu fil-grupp sever fil-Jum 0, total ta' 26 qattus (60.5 %) saru bi pressjoni normali jew kellhom tnaqqis ta' >20 mm Hg fil-pressjoni sistolika tad-demm fil-Jum 63. Minn dawn is-26 qattus, 14-il qattus kienu normotensivi sal-Jum 63.
English: the CVMP concluded that it is not clear, if the recorded reduction in systolic blood pressure and clinical signs in hypertensive cats following treatment with Vasotop P was a true treatmentrelated effect,
Maltese: is-CVMP ikkonkluda li mhuwiex ċar, jekk it-tnaqqis irreġistrat fil-pressjoni sistolika tad-demm u fis-sinjali kliniċi fil-qtates bi pressjoni għolja wara t-trattament b'Vasotop P kienx effett reali relatat mat-trattament,
English: Whilst fully accepting the scientific validity of requiring control groups in clinical studies, the CVMP is of the opinion that a significant proportion of placebo-control cats suffering from moderate-tosevere hypertension (i.e. systolic blood pressure >180 mm Hg) would be at risk of developing target organ damage if left untreated over a potential period of 63 days.
Maltese: Filwaqt li jaċċetta bis-sħiħ il-validità xjentifika tal-ħtieġa ta' gruppi ta' kontroll fl-istudji kliniċi, isCVMP huwa tal-opinjoni li proporzjon sinifikanti ta' qtates ta' kontroll bi plaċebo li jbatu minn pressjoni għolja moderata sa severa (jiġifieri pressjoni sistolika tad-demm >180 mm Hg) jistgħu jkunu fir-riskju li jiżviluppaw ħsara fl-organi fil-mira jekk jitħallew mingħajr trattament fuq perijodu potenzjali ta' 63 jum.
English: The Marketing Authorisation Holder (MAH) Intervet International B.V. submitted applications for Type II variation subject to Mutual Recognition Procedures (MRP) for Vasotop P 0.625 mg, Vasotop P 1.25 mg and Vasotop P 2.5 mg tablets for dogs in order to include a new indication for cats as follows:
Maltese: Intervet International B.V. issottometta applikazzjonijiet għall-varjazzjoni tat-Tip II skont il-Proċeduri ta' Rikonoxximent Reċiproku (Mutual Recognition Procedures - MRP) għall-pilloli Vasotop P 0.625 mg, Vasotop P 1.25 mg u Vasotop P 2.5 mg għall-klieb sabiex jinkludi indikazzjoni ġdida għall-qtates kif ġej:
English: J Vet Intern Med, 1998, 12.
Maltese: J Vet Intern Med, 1998, 12. P. 157-162.
English: Thus, the finding that 63 % of severely affected cats became normotensive or had a >20 mm Hg reduction in systolic blood pressure following treatment with Vasotop P is noted; whilst it is accepted that 12/26 cats did not become normotensive, a mean reduction of 37 mm Hg in systolic blood pressure in severely hypertensive cats has also been noted.
Maltese: Hg fil-pressjoni sistolika tad-demm wara t-trattament b'Vasotop P; filwaqt li huwa aċċettat li 12/26 qattus ma sarux normotensivi, tnaqqis medju ta' 37 mm Hg fil-pressjoni sistolika tad-demm filqtates ipertensivi ħafna ġie nnotat ukoll.
English: • Some recent studies report low median survival times for hypertension in cats - 4-7 months if untreated (Chetboul et al., 2003) and approximately 9 months even with treatment.
Maltese: • Xi studji reċenti jirrapportaw żminijiet medji baxxi ta' sopravivenza għall-pressjoni għolja filqtates - 4-7 xhur jekk ma tiġix trattata (Chetboul et al., 2003) u madwar 9 xhur anke bit trattament.
English: The CVMP noted that better responses were obtained for the relatively non-specific clinical signs noted (e.g. polyuria, polydipsia, lethargy etc.), whilst the poorest responses were obtained for the ocular lesions (blindness, vascular tortuosity and retinal detachment).
Maltese: Is-CVMP innota li nkisbu reazzjonijiet aħjar għas-sinjal kliniċi li huma relattivament mhux speċifiċi nnotati (pereżempju polyuria, polydipsia, letarġija eċċ.), filwaqt l-agħar reazzjonijiet inkisbu għalleżjonijiet okulari (l-għama, it-tgħawwiġ vaskulari u d-distakk retinali minn postha).
English: Almost 82 % of the included cats presented at least one clinical sign related to hypertension.
Maltese: Kważi 82 % tal-qtates inklużi kellhom mill-inqas sinjal kliniku wieħed relatat mal-pressjoni għolja.
English: Comments on whether it is possible to devise and conduct a trial with a placebo control where an escape therapy is identified at certain points in the study period The MAH submitted argumentation which covered the following grounds:
Maltese: Kummenti dwar jekk huwiex possibbli li titfassal u titwettaq prova b'kontroll bi plaċebo fejn tiġi identifikata terapija tal-ħarba f'ċerti punti fil-perijodu ta' studju Il-MAH issottometta argumentazzjoni li kopriet l-opinjonijiet li ġejjin:
English: The MAH submitted data where ramipril (active substance of Vasotop P) produced a marked decrease of systolic blood pressure in mildly to severely hypertensive cats.
Maltese: Il-MAH issottometta dejta fejn ramipril (is-sustanza attiva ta' Vasotop P) ipproduċa tnaqqis ċar talpressjoni sistolika tad-demm fil-qtates bi pressjoni għolja b'mod moderat jew sever.
English: The MAH provided data on the Coefficient of Variation (CV) between the 5 individual measurements performed at the different study time points.
Maltese: ipprovda dejta dwar il-Koeffiċjent tal-Varjazzjoni (Coefficient of Variation - CV) bejn il-5 qisien individwali li twettqu fil-punti ta' żmien differenti tal-istudju.
English: Luxemburg Intervet International B.V. P.O.
Maltese: Intervet International B.V.
English: Three strengths of tablet are covered by the current application as follows; Vasotop P 0.625 mg tablet, Vasotop P 1.25 mg tablet and Vasotop P 2.5 mg tablet.
Maltese: Tliet qawwiet ta' pilloli huma koperti millapplikazzjoni attwali kif ġej; pillola ta' Vasotop P 0.625 mg, pillola ta' Vasotop P 1.25 mg u pillola ta' Vasotop P 2.5 mg.
English: The National Competent Authority of Belgium was concerned that it was not possible to conclude on the clinical efficacy of the product in reducing systemic hypertension in cats in the absence of a placebo control group in the pivotal field trials.
Maltese: L-Awtorità Kompetenti Nazzjonali tal-Belġju kienet imħassba li ma kienx possibbli li wieħed jikkonkludi fuq l-effikaċja klinika tal-prodott fit-tnaqqis tal-pressjoni għolja sistemika fil-qtates fin-nuqqas ta' grupp ta' kontroll bi plaċebo fil-provi pivotali f'kundizzjonijiet reali.
English: Sustained decreased systolic blood pressure was observed for up to 6 months and blood pressure was controlled over the 24-hour time interval between two successive administrations of Vasotop P in all cats.
Maltese: Pressjoni sistolika tad-demm mnaqqsa sostenuta ġiet osservata għal perijodu sa 6 xhur u l-pressjoni tad-demm kienet ikkontrollata fl-intervall ta' żmien ta' 24 siegħa bejn żewġ għotjiet suċċessivi ta' Vasotop P fil-qtates kollha.
English: Marketing Authorisation Holder
Maltese: TAL-PRODOTT MEDIĊINALI
English: When broken down further, 32 % of cats had one clinical sign only and the remaining 21 % of cats had two clinical signs or more.
Maltese: Meta mqassam aktar, 32 % tal-qtates kellhom sinjali kliniku wieħed biss u l-21 % tal-qtates li fadal kellhom żewġ sinjali kliniċi jew aktar.
English: Improvement in hypertension in the absence of a negative control group
Maltese: Titjib fil-pressjoni għolja fin-nuqqas ta' grupp ta' kontroll negattiv
English: As many of the clinical signs are non-specific, and are cardiovascular in nature, an escape therapy could be possible and more than adequate in addressing those signs.
Maltese: Peress li ħafna mis-sinjali kliniċi mhumiex speċifiċi, u għandhom natura kardjovaskulari, terapija tal-ħarba tista' tkun possibbli u aktar minn xierqa fl-indirizzar ta' dawk is-sinjali.
English: The CVMP considers that a notable decrease in blood pressure measurements was evident between pre-treatment and post-treatment values.
Maltese: Is-CVMP jikkunsidra li tnaqqis notevoli fil-kejl tal-pressjoni tad-demm kien evidenti bejn il-valuri ta' qabel it-trattament u ta' wara t-trattament.
English: Strength
Maltese: TAL
English: Clinical signs like retinal haemorrhage and even polyuria-polydipsia can be quite severe and are not expected to readily respond to a placebo effect.
Maltese: Is-sinjali kliniċi bħall-emorraġija retinali u anke polyuria-polydipsia jistgħu jkunu pjuttost severi u mhumiex mistennija li jirreaġixxu mill-ewwel għal effett ta' plaċebo.
English: Percentage of cats with different number of clinical signs and their response to the treatment
Maltese: 2.3. Perċentwal ta' qtates b'għadd differenti ta' sinjali kliniċi u r-reazzjoni tagħhom għattrattament
English: LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Maltese: VETERINARJU, SPEĊI TA' ANNIMAL, MNEJN JINGĦATA, APPLIKANT/DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ FLISTATI
English: In relation to the non-specific signs such as polyuria, polydipsia etc., the CVMP opinion is that it is plausible that a correlation exists between the improvement in blood pressure measurements and the resolution of such signs.
Maltese: Fir-rigward tas-sinjali mhux speċifiċi bħall-polyuria, polydipsia eċċ., l-opinjoni tas-CVMP hija li huwa possibbli li teżisti korrelazzjoni bejn it-titjib fil-kejl tal-pressjoni tad-demm u l-waqfien ta' tali sinjali.
English: Efficacy of Vasotop P in the treatment of arterial hypertension in cats
Maltese: MG, PILLOLA GĦALL-KLIEB U L-QTATES
English: 20 October 2009
Maltese: 20 ta' Ottubru 2009
English: What is Luveniq?
Maltese: X'inhu Luveniq?
English: The patients were treated for at least 24 weeks.
Maltese: Il-pazjenti ġew ikkurati għal mill-inqas 24 siegħa.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Luveniq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Luveniq is a medicine that contains the active substance voclosporin.
Maltese: Luveniq huwa mediċina li fiha s-sustanza attiva voclosporin.
English: The evaluation had finished and the CHMP had given a negative opinion.
Maltese: L-evalwazzjoni kienet tlestiet u s-CHMP kien ta opinjoni negattiva.
English: Luveniq is an immunosuppressive agent, which means that it reduces the activity of the immune system.
Maltese: Luveniq huwa aġent immunosuppressiv, li tifsser li jnaqqas l-attività tas-sistema immuni.
English: It belongs to the class of calcineurin inhibitors.
Maltese: Jappartjeni għall-klassi ta' inibituri tal-calcineurin.
English: Withdrawal of the marketing authorisation application for Luveniq (voclosporin) EMA/CHMP/835463/2011
Maltese: EMA/CHMP/835463/2011
English: Luveniq was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 14 September 2007 for the treatment of chronic non-infectious uveitis.
Maltese: Luveniq kien ikklassifikat bħala ‘mediċina orfni' (mediċina li għandha tintuża f'mard rari) fl-14 ta' Settembru 2007 għall-kura ta' uveitis mhux infettuża kronika.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li tgħarraf lill-Aġenzija bl-irtirar tal-applikazzjoni tista' tinstab taħt il-buttuna ‘All documents'.
English: What was Luveniq expected to be used for?
Maltese: Għalxiex kien mistenni li jintuża Luveniq?
English: The application was supported by one main study involving 218 patients with non-infectious uveitis which compared Luveniq with placebo.
Maltese: Lapplikazzjoni kienet appoġġata minn studju prinċipali wieħed li involva lil 218-il pazjent b'uveitis mhux infettuża li qabbel Luveniq ma' plaċebo.
English: Withdrawal of the marketing authorisation application for Luveniq (voclosporin)
Maltese: L-irtirar tal-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fis-suq għal Luveniq (voclosporin)
English: On 13 October 2011, Lux Biosciences GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Luveniq, for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Maltese: Fit-13 ta' Ottubru 2011, Lux Biosciences GmbH għarraf uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li jirtira l-applikazzjoni tiegħu għallawtorizzazzjoni għat-tqegħid fis-suq għal Luveniq, għall-kura ta' uveitis mhux infettuża attiva kronika li tinvolvi s-segmenti intermedji jew posterjuri tal-għajn.
English: It was expected to decrease the inflammation seen in uveitis by blocking an enzyme called calcineurin which is involved in activating Tcells.
Maltese: Kien mistenni li jnaqqas l-infjammazzjoni li dehret f'uveitis billi jimblokka enzim imsejjaħ calcineurin li huwa involut fl-attivar taċ-ċelloli-T.
English: It is called ‘non-infectious' when it is caused by the body's own immune system (the body's natural defences) attacking the uvea.
Maltese: Tissejjaħ 'mhux infettuża' meta tkun ikkawżata mis-sistema immuni tal-ġisem stess (id-difiża naturali tal-ġisem) li tattakka l-uvea.
English: The effects of Luveniq were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Luveniq ġew l-ewwel ittestjati f'mudelli esperimentali qabel ma ġew studjati fil-bnedmin.
English: Luveniq was expected to be used to treat chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye. Uveitis is inflammation of the uvea (the middle layer of the eye) which can lead to loss of vision.
Maltese: Luveniq kien mistenni li jintuża sabiex jikkura uveitis mhux infettuża attiva kronika li tinvolvi ssegmenti intermedji jew posterjuri tal-għajn.
English: Luveniq also caused side effects which are known to occur with this type of immunosuppressive medicine, including hypertension (high blood pressure).
Maltese: Luveniq ikkawża wkoll effetti sekondarji li huma magħrufin li jseħħu ma' din it-tip ta' mediċina immunosuppressiva, inkluż pressjoni tad-demm għolja.
English: The main measure of effectiveness was how the inflammation of the eye improved after 16 weeks and 24 weeks of treatment, measured by looking at the change in the amount of vitreous haze (clouding of the vitreous humour, the clear gel between the lens and the retina of the eyeball).
Maltese: Il-kejl ewlieni tal-effikaċja kien kemm l-infjammazzjoni tal-għajn marret għall-aħjar wara 16-il ġimgħa u 24 ġimgħa ta' kura, imkejla meta wieħed iħares lejn il-bidla fl-ammont ta' tiċpir tal-vitreus (tiċpir talvitreus humour, il-ġel ċar bejn il-lenti u r-retina tal-ballun tal-għajn).
English: At the time of the negative opinion, the CHMP was not convinced that the benefits of Luveniq had been shown to outweigh the risks as a treatment for chronic non-infectious uveitis.
Maltese: Fiż-żmien tal-opinjoni negattiva, is-CHMP ma kienx konvint li l-benefiċċji ta' Luveniq intwerew li kienu akbar mir-riskji bħala kura għal uveitis mhux infettuża kronika.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had previously given a negative opinion in June 2011 recommending that the marketing authorisation be refused for Luveniq for the treatment of chronic active non-infectious uveitis involving the intermediate or posterior segments of the eye.
Maltese: Fuq il-bażi tar-reviżjoni tad-dejta, fiż-żmien tal-irtirar, is-CHMP kien ta opinjoni negattiva f'Ġunju 2011 li fiha rrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq tiġi rifjutata għal Luveniq għall-kura ta' uveitis mhux infettuża attiva kronika li tinvolvi s-segmenti intermedji jew posterjuri tal-għajn.
English: Only one main study supported the application and the results did not show in a robust way that Luveniq was more effective than placebo at reducing eye inflammation, while no difference was seen in the patients' eyesight compared with placebo.
Maltese: Studju prinċipali wieħed biss appoġġa l-applikazzjoni u r-riżultati ma wrewx b'mod robust li Luveniq kien aktar effettiv minn plaċebo fittnaqqis tal-infjammazzjoni tal-għajn, filwaqt li ma ġiet osservata l-ebda differenza fil-vista tal-pazjenti meta mqabbla ma' plaċebo.
English: The full EPAR for Rasilamlo 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: Amlodipine is a calcium channel blocker.
Maltese: L-amlodipina huwa imblokkatur tal-kanal tal-kalċju.
English: This is a summary of the European public assessment report (EPAR) for Rasilamlo.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rasilamlo.
English: Aliskiren is a renin inhibitor.
Maltese: L-aliskiren huwa inibitur tar-renina.
English: Rasilamlo aliskiren / amlodipine
Maltese: Sommarju tal-EPAR għall-pubbliku aliskiren / amlodipina
English: It is available as tablets (150 mg aliskiren and 5 mg amlodipine; 150 mg aliskiren and 10 mg amlodipine; 300 mg aliskiren and 5 mg amlodipine; 300 mg aliskiren and 10 mg amlodipine).
Maltese: Jiġi bħala pilloli (150 mg aliskiren u 5 mg amlodipina; 150 mg aliskiren u 10 mg amlodipina; 300 mg aliskiren u 5 mg amlodipina; 300 mg aliskiren u 10 mg amlodipina).
English: In the second study the falls in blood pressure were 11.0 mmHg and 9.0 mmHg with Rasilamlo 300/10 mg and 150/10mg, respectively, compared with 7.2mmHg with amlodipine 10 mg.
Maltese: Fit-tieni studju, it-tnaqqis fil-pressjoni tad-demm kien ta' 11.0 mmHg u 9.0 mmHg b'Rasilamlo 300/10 mg u 150/10mg, rispettivament, meta mqabbla ma' 7.2 mmHg bl-amlodipina 10 mg.