FrancophonIA/ELRC3.0 huggingface dataset:
English: In the table below, adverse reactions reported in all clinical studies and in the worldwide post-marketing experience for which a reasonable causal relationship exists are listed by MedDRA system organ class and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from available data).
Maltese: Fit-tabella ta' hawn taħt, ir-reazzjonijiet avversi rrappurtati fl-istudji kliniċi kollha u fl-esperjenza mid-dinja kollha ta' wara t-tqegħid fis-suq u li għalihom teżisti relazzjoni kawżali raġonevoli huma elenkati skont is-sistema tal-klassifika tal-organi tal-ġisem fid-database MedDRA u l-frekwenza: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100); rari (≥ 1/10,000 sa < 1/1,000); rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In healthy male subjects of the target age range (n = 16, mean age 55 ± 8 years) after once-a-day oral administration of 8 mg immediately after breakfast for 7 days, the following pharmacokinetic parameters were obtained: Cmax 87 ± 51 ng/mL (sd), tmax 2.5 hours (range 1.0-3.0), AUC 433 ± 286 ng • h/mL.
Maltese: F'irġiel b'saħħithom fil-medda ta' etajiet fil-mira (n = 16, età medja 55 ± 8 snin) wara l-għoti mill-ħalq ta' 8 mg darba kuljum immedjatament wara l-kolazzjon għal 7t ijiem, kienu miksuba l-parametri farmakokinetiċi li ġejjin: Cmax 87 ± 51 ng/mL (SD), tmax 2.5 sigħat (medda 1.0-3.0), AUC 433 ± 286 ng • h/mL.
English: The incidence of orthostatic hypotension in placebo-controlled clinical studies was 1.2% with silodosin and 1.0% with placebo.
Maltese: L-inċidenza ta' pressjoni ortostatika baxxa fl-istudji kliniċi kkontrollati bil-plaċebo kienet 1.2% b'silodosin u 1.0% bil-plaċebo.
English: Substances that inhibit (such as ketoconazole, itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Maltese: Sustanzi li jimpedixxu (bħal ketoconazole, itraconazole, ritonavir jew cyclosporine) jew jinduċu (bħal rifampicin, barbiturates, carbamazepine, phenytoin) dawn l-enzimi u trasportaturi jistgħu jaffettwaw il-konċentrazzjonijiet fil-plażma ta' silodosin u l-metabolit attiv tiegħu.
English: • medicines for epilepsy or rifampicin (a medicine to treat tubercolosis), since the effect of Silodyx may be reduced.
Maltese: • mediċini kontra l-epilessija jew rifampicin (mediċina għall-kura tat-tuberkulożi), billi jista' jitnaqqas l-effett ta' Silodyx.
English: Silodosin undergoes extensive metabolism through glucuronidation (UGT2B7), alcohol and aldehyde dehydrogenase and oxidative pathways, mainly CYP3A4.
Maltese: Silodosin jiġi mmetabolizzat b'mod estensiv permezz ta' glukoronidazzjoni (UGT2B7), alkoħol u aldehyde dehydrogenase u mogħdijiet ossidattivi, b'mod prinċipali CYP3A4.
English: In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (n = 5), iż-żieda fl-esponiment kienet ta' 2.2 darbiet għall-Cmax u 3.7 darbiet għall-AUC.
English: Silodyx belongs to a group of medicines called alpha1A-adrenoreceptor blockers.
Maltese: Silodyx jappartieni għal grupp ta' mediċini msejħa imblokkaturi tal-adrenoriċettur alpha1A.
English: EU/1/09/607/001 EU/1/09/607/002 EU/1/09/607/003 EU/1/09/607/004 EU/1/09/607/005 EU/1/09/607/006 EU/1/09/607/007
Maltese: EU/1/09/607/005 EU/1/09/607/006 EU/1/09/607/007 EU/1/09/607/008 EU/1/09/607/009 EU/1/09/607/010
English: Skin rash1, Pruritus1
Maltese: Raxx talġilda1
English: Other medicines and Silodyx
Maltese: Mediċini oħra u Silodyx
English: Tamsulosin
Maltese: Silodosin Tamsulosin
English: In a Phase IV clinical trial performed in Europe, with a mean baseline IPSS total score of 18.9 points, 77.1% were responders to silodosin (as assessed by a change from baseline in the IPSS total score of at least 25%).
Maltese: IV li twettaq fl-Ewropa, bi skor totali tal-IPSS tal-linja bażi medju ta' 18.9 punti, 77.1% kellhom rispons għal silodosin (kif evalwat minn bidla mil-linja bażi fl-iskor totali tal-IPSS ta' mill-inqas 25%).
English: In a single-dose study, exposure to silodosin (unbound) in subjects with mild (n = 8) and moderate renal impairment (n = 8) resulted, on average, in an increase of Cmax (1.6-fold) and AUC (1.7-fold) relative to subjects with normal renal function (n = 8).
Maltese: Fi studju ta' doża waħda, l-esponiment għal silodosin (mhux imwaħħal) f'pazjenti b'indeboliment ħafif (n = 8) u moderat tal-kliewi (n = 8) rriżulta, bħala medja, f'żieda fil-Cmax (1.6 darbiet) u fl-AUC (1.7 darbiet) meta mqabbel ma' persuni b'funzjoni tal-kliewi normali (n = 8).
English: EU/1/09/607/008 EU/1/09/607/009 EU/1/09/607/010 EU/1/09/607/011 EU/1/09/607/012 EU/1/09/607/013 EU/1/09/607/014
Maltese: EU/1/09/607/011 EU/1/09/607/012 EU/1/09/607/013 EU/1/09/607/014
English: Allergic-type reactions including facial swelling, swollen tongue and pharyngeal oedema1
Maltese: Reazzjonijiet ta' tip allerġiku inklużi nefħa fil-wiċċ, nefħa flilsien, edema fil-farinġi1
English: This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull kapsula, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: The use of silodosin in patients with severe renal impairment (CLCR <30 ml/min) is not recommended (see sections 4.2 and 5.2).
Maltese: Mhux irrakkomandat l-użu ta' silodosin f'pazjenti b'indeboliment sever tal-kliewi (CLCR < 30 mL/min) (ara sezzjonijiet 4.2 u 5.2).
English: In a Phase II dose-finding, double-blind, placebo-controlled clinical study with silodosin 4 or 8 mg once daily, a greater improvement in American Urologic Association (AUA) symptom index score was observed with silodosin 8 mg (-6.8 ± 5.8, n = 90; p = 0.0018) and silodosin 4 mg (-5.7 ± 5.5, n = 88; p = 0.0355) as compared to placebo (-4.0 ± 5.5, n = 83).
Maltese: II b'silodosin 4 jew 8 mg darba kuljum, ġie osservat titjib akbar fil-punteġġ ta' indiċi tas-sintomi tal-Assoċjazzjoni Uroloġika Amerikana (AUA) b'silodosin 8 mg (-6.8 ± 5.8, n = 90;
English: The requirements for submission of marketing authorisation holder shall submit periodic safety update reports for this medicinal product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
Maltese: Fil-programm ta' studju kliniku, ħafna pazjenti kienu fuq kura simultanja kontra l-pressjoni għolja (l-aktar is-sustanzi li jaħdmu fuq is-sistema rennin-angiotensin, imblokkaturi beta, antagonisti tal-kalċju u dijuretiċi) mingħajr ma esperjenzaw żieda fl-inċidenza tal-pressjoni baxxa ortostatika.
English: Hypotension1
Maltese: Urtikarja1
English: Syncope Loss of consciousness1
Maltese: Eruzzjoni minħabba lmediċina1
English: No dose adjustment is required for patients with mild renal impairment (CLCR ≥ 50 to ≤ 80 mL/min).
Maltese: M'hemmx bżonn ta' aġġustament fid-doża għal pazjenti b'indeboliment ħafif tal-kliewi (CLCR ≥ 50 sa ≤ 80 mL/min).
English: If you have severe kidney problems, you should not take Silodyx.
Maltese: Jekk għandek problemi severi tal-kliewi, m'għandekx tieħu Silodyx.
English: There is no relevant use of Silodyx in the paediatric population for the indication of benign prostatic hyperplasia (BPH).
Maltese: M'hemm l-ebda użu rilevanti ta' Silodyx fil-popolazzjoni pedjatrika għall indikazzjoni ta' iperplasija beninna tal-prostata (benign prostatic hyperplasia, BPH).
English: The main metabolite in plasma, the glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four times higher than those of silodosin.
Maltese: Il-metabolit prinċipali fil-plażma, il-konjugat glucuronide ta' silodosin (KMD-3213G), li ntwera li huwa attiv in vitro, għandu half-life estiża (madwar 24 siegħa) u jilħaq konċentrazzjonijiet fil-plażma bejn wieħed u ieħor erba' darbiet ogħla minn dawk ta' silodosin.
English: • antifungal medicines (such as ketoconazole or itraconazole), medicines used for HIV-AIDS (such as ritonavir) or medicines used after transplants to prevent organ rejection (such as cyclosporin) because these medicines can increase the blood concentration of Silodyx.
Maltese: • mediċini antifungali (bħal ketoconazole jew itraconazole), mediċini użati għal infezzjoni tal-HIV/AIDS (bħal ritonavir) jew mediċini użati wara t-trapjanti biex jevitaw ir-rifjut tal-organi (bħal cyclosporin) billi dawn il-mediċini jistgħu jżidu l-konċentrazzjoni fid-demm ta' Silodyx.
English: Silodyx 4 mg hard capsules Silodyx 8 mg hard capsules
Maltese: Silodyx 4 mg kapsuli ibsin Silodyx 8 mg kapsuli ibsin
English: OTHER
Maltese: Recordati
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Maltese: II-III, double-blind ikkontrollati (b'931 pazjent ħadu silodosin 8 mg darba kuljum u 733 pazjent ħadu plaċebo) u f'żewġ studji open-label ta' Fażi ta' estensjoni fuq perijodu fit-tul.
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodyx.
Maltese: • mediċini li jbaxxu l-pressjoni tad-demm (b'mod partikolari, mediċini msejħa imblokkaturi alpha1, bħal prazosin jew doxazosin) billi jista' jkun hemm ir-riskju li l-effett ta' dawn il-mediċini jiżdied waqt li tkun qed tieħu Silodyx.
English: Each hard capsule contains 8 mg silodosin.
Maltese: Kull kapsula iebsa fiha 8 mg silodosin.
English: Silodyx 4 mg and 8 mg hard capsules
Maltese: Silodyx 4 mg u 8 mg kapsuli ibsin
English: Silodyx 8 mg hard capsules silodosin
Maltese: Silodyx 8 mg kapsuli ibsin silodosin
English: It is reversible within a few days upon discontinuation of treatment (see section 4.4).
Maltese: IFIS ġie rrappurtat waqt operazzjoni tal-katarretti (ara sezzjoni 4.4).
English: Silodyx 4 mg are yellow, opaque, hard gelatin capsules, size 3 (approximately 15.9 x 5.8 mm).
Maltese: Silodyx 4 mg huma kapsuli ibsin tal-ġelatina, sofor, opaki, daqs 3 (madwar 15.
English: Silodyx 4 mg hard capsules silodosin
Maltese: Silodyx 4 mg kapsuli ibsin silodosin
English: The most frequent adverse reactions reported with silodosin in placebo controlled clinical studies and during long-term use were ejaculatory disorders such as retrograde ejaculation and anejaculation (ejaculatory volume reduced or absent), with a frequency of 23%.
Maltese: L-iżjed reazzjonijiet avversi spissi rrappurtati b'silodosin fl-istudji kliniċi kkontrollati bil-plaċebo u fl-użu fit-tul kienu disturbi eġakulatorji bħal eġakulazzjoni retrograd u n-nuqqas ta' eġakulazzjoni (volum tal-eġakulazzjoni mnaqqas jew nieqes), bi frekwenza ta' 23%.
English: Silodyx does not treat prostate cancer.
Maltese: Silodyx ma jikkurax il-kanċer tal-prostata.
English: Silodyx may cause complications during a cataract surgery (eye surgery because of cloudiness of the lens, see section “Warnings and precautions”).
Maltese: Silodyx jista' jikkawża kumplikazzjonijiet waqt operazzjoni tal-katarretti (operazzjoni fl-għajnejn minħabba lenti mtappna, ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: Each hard capsule contains 4 mg silodosin.
Maltese: Kull kapsula iebsa fiha 4 mg silodosin.
English: Silodyx is used in adult men to treat the urinary symptoms associated with benign enlargement of the prostate (prostatic hyperplasia), such as:
Maltese: Silodyx jintuża f'irġiel adulti sabiex jittratta sintomi urinarji assoċjati ma' tkabbir beninn tal-prostata (iperplasija tal-prostata), bħal:
English: Abnormal liver function tests1
Maltese: Testijiet talfwied b'riżultat mhux normali1
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kartuna u fuq il-folja wara EXP.
English: Obstructive symptoms
Maltese: IPSS Sintomi ostruttivi
English: In the active-controlled clinical study conducted in Europe, silodosin 8 mg once daily was shown to be non inferior to tamsulosin 0.4 mg once daily: the adjusted mean difference (95% CI) in the IPSS Total Score between treatments in the per-protocol population was 0.4 (-0.4 to 1.1).
Maltese: Fl-istudju kliniku kkontrollat bis-sustanza attiva li twettaq fl-Ewropa, silodosin 8 mg darba kuljum intwera li mhux inferjuri għal tamsulosin 0.4 mg darba kuljum: id-differenza medja aġġustata (95% CI) fl-Iskor Totali tal-IPSS bejn il-kura fil-popolazzjoni għal kull protokoll kienet ta' 0.4
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/PVDC/ALUMINIUM FOIL BLISTERS
Maltese: TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL-FOLJI JEW FUQ L-ISTRIXXI FOLJI TAL-PVC/PVDC/ALUMINJU
English: Silodyx 4 mg hard capsules
Maltese: Silodyx 4 mg kapsuli ibsin
English: For special patient populations, one capsule of Silodyx 4 mg daily is recommended (see below).
Maltese: Għal gruppi ta' pazjenti speċjali, hija rrakkomandata kapsula waħda ta' Silodyx 4 mg kuljum (ara taħt).
English: Silodyx 8 mg hard capsules
Maltese: Silodyx 8 mg kapsuli ibsin
English: The European Medicines Agency has waived the obligation to submit the results of studies with Silodyx in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: Orthostatic hypotension may occasionally lead to syncope (see section 4.4).
Maltese: L-effett huwa riversibbli wara ftit ġranet mit-twaqqif tal-kura (ara sezzjoni 4.4).
English: Intraoperative Floppy Iris Syndrome (IFIS) IFIS has been reported during cataract surgery (see section 4.4).
Maltese: Il-pressjoni ortostatika baxxa tista' kultant twassal għal sinkope (ara sezzjoni 4.4).
English: The observed effect was reversible.
Maltese: L-effett osservat kien riversibbli.
English: Exposure to silodosin and its main metabolites does not change significantly with age, even in subjects of age over 75 years.
Maltese: L-esponiment għal silodosin u l-metaboliti prinċipali tiegħu ma jinbidilx b'mod sinifikanti mal-età, anki f'pazjenti ta' aktar minn 75 sena.
English: Silodosin 8 mg and 24 mg daily had no statistically significant effect on ECG intervals or cardiac repolarisation relative to placebo.
Maltese: Silodosin 8 mg u 24 mg kuljum ma kellhom ebda effett statistikament sinifikanti fuq l-intervalli tal-ECG jew ir-ripolarizzazzjoni tal-qalb meta mqabbel mal-plaċebo.
English: Tecnimede Sociedade Técnico-Medicinal, S.A Tel: +351 21 041 41 00
Maltese: Tel: +351 21 041 41 00
English: Silodyx is selective for the receptors located in the prostate, bladder and urethra.
Maltese: Silodyx huwa selettiv għar-riċetturi li jinsabu fil-prostata, fil-bużżieqa tal-awrina u fl-uretra.
English: Following oral administration of 14C-labelled silodosin, the recovery of radioactivity after 7 days was approximately 33.5% in urine and 54.9% in faeces.
Maltese: 33.5% fl-awrina u 54.9% fl-ippurgar.
English: • If you have severe liver problems, you should not take Silodyx, as it was not tested in this condition.
Maltese: • Jekk għandek problemi tal-kliewi, jekk jogħġbok staqsi lit-tabib tiegħek għal parir.
English: Silodosin was evaluated at doses of up to 48 mg/day in healthy male subjects.
Maltese: Silodosin ġie evalwat f'dożi sa 48 mg/ġurnata f'irġiel b'saħħithom.
English: 1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in Phase I-IV clinical trials and non-interventional studies).
Maltese: 1-reazzjonijiet avversi minn rappurtaġġ spontanju mid-dinja kollha mill-esperjenza ta' wara t-tqegħid fis-suq (frekwenzi kkalkulati minn avvenimenti rrappurtati fi provi kliniċi ta' Fażi
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, carcinogenic, mutagenic and teratogenic potential.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, riskju ta' kanċer, potenzjal mutaġeniku u teratoġeniku, ma juri l-ebda periklu speċjali għall-bnedmin.
English: If you have moderate kidney problems, your doctor will start Silodyx with caution and possibly with a lower dose (see section 3 “Dose”).
Maltese: Jekk għandek problemi moderati tal-kliewi, it-tabib tiegħek jibda Silodyx bil-galbu u jista' jkun li b'doża aktar baxxa (ara s-sezzjoni 3 “Doża”).
English: How to take Silodyx
Maltese: X'fih Silodyx
English: Silodosin
Maltese: Sturdament
English: Consequently, the concomitant use of other α-adrenoreceptor antagonists is not recommended.
Maltese: Għaldaqstant, mhux irrakkomandat l-użu konkomittanti ta' antagonisti oħrajn tal-adrenoriċettur-α.
English: 10 April 2013
Maltese: 10 ta' April 2013
English: What is Kantos Master?
Maltese: X'inhu Kantos Master?
English: Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler) EMA/21628/2013 rev.1
Maltese: Mistoqsijiet u tweġibiet dwar Kantos Master u ismijiet assoċjati (beklomethasonedipropionate / formoterol fumarate, inalatur) EMA/21628/2013 rev.1
English: Kantos Master is a medicine that contains two active substances: beclomethasone dipropionate, a corticosteroid (a medicine that reduces inflammation), and formoterol fumarate, a bronchodilator (a medicine that opens the airways, allowing easier breathing) with a long duration of action.
Maltese: Kantos Master huwa mediċina li fiha żewġ sustanzi attivi: beclomethasone dipropionate, kortikosterojdi (mediċina li tnaqqas l-infjammazzjoni), u formoterol fumarate, bronkodilatur (mediċina li tiftaħ ilpassaġġi tal-arja, li tippermetti t-teħid aktar faċli tan-nifs) b'azzjoni fit-tul.
English: The company that makes the medicine is Chiesi.
Maltese: Il-kumpanija li tipproduċil-mediċina hija Chiesi.
English: The Committee concluded that the benefits of Kantos Master outweigh its risks in the new use and the change to the marketing authorisation can be granted in Germany and the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovenia, Spain, Sweden and the United Kingdom.
Maltese: IlKumitat ikkonkluda li l-benefiċċji ta' Kantos Master jegħlbu r-riskji tiegħu fl-użu l-ġdid u t-tibdil talawtorizzazzjoni għat-tqegħid fis-suq jista' jingħata fil-Ġermanja u fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, ir-Rumanija, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit.
English: Why was Kantos Master reviewed?
Maltese: Għal xiex ġie rivedut Kantos Master?
English: Questions and answers on Kantos Master and associated names (beclomethasone dipropionate / formoterol fumarate, inhaler)
Maltese: Mistoqsijiet u tweġibiet dwar Kantos Master u ismijiet assoċjati (beklomethasone dipropionate / formoterol fumarate, inalatur)
English: Kantos Master is marketed in all EU Member States except Czech Republic, Ireland, Malta Portugal and Slovakia under the names Kantos, Formodual, Foster, Inuxair, Innovair and associated names.
Maltese: Kantos Master jitqiegħed fis-suq fl-Istati Membri kollha tal-UE ħlief għar-Repubblika Ċeka, l-Irlanda, Malta, il-Portugall u s-Slovakkja bl-ismijiet Kantos, Formodual, Foster, Inuxair, Innovair u ismijiet assoċjati.
English: Kantos Master is used as maintenance therapy in patients who have asthma.
Maltese: Kantos Master jintuża bħala terapija ta' manteniment f'pazjenti bl-ażżma.
English: On 13 December 2012, Germany referred the matter to the CHMP for arbitration.
Maltese: Fit-13 ta' Diċembru 2012 il-Ġermanja rriferiet il-kwistjoni lis-CHMP għal arbitraġġ.
English: The company wanted the authorisation to be recognised in the following Member States: Austria, Belgium, Bulgaria, Cyprus, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Latvia, Lithuania,
Maltese: Il-kumpanija riedet li l-awtorizzazzjoni tiġi rikonoxxuta fl-Istati Membri li ġejjin: l-Awstrija, il-Belġju, il-Bulgarija, Ċipru, id-Danimarka, l-Estonja, il-Finlandja, Franza, il-Greċja, l-Ungerija, l-Italja, il-Latvja, il-Litwanja, il-Lussemburgu, il-Pajjiżi l-Baxxi, in-Norveġja, il-Polonja, il-Portugall, ir-Rumanija, is-Slovakkja, is-Slovenja, Spanja, l-Isvezja u r-Renju Unit (l-‘Istati Membri kkonċernati').
English: On 17 January 2013, the European Medicines Agency completed an arbitration procedure for Kantos Master and associated names.
Maltese: Fis-17 ta' Jannar 2013, l-Aġenzija Ewropea għall-Mediċini temmet proċedura ta' arbitraġġ għal Kantos Master u ismijiet assoċjati.
English: The CHMP noted that MART was not compared with the standard of care according to current guidelines, but agreed that there was no evidence that patients in the comparison group had been undertreated, as patients in both groups had shown clinical benefit from their maintenance treatment.
Maltese: Is-CHMP innota li MART ma kienx tqabbel mal-istandard ta' kura skont il-linji gwida attwali, imma qabel li ma kien hemm lebda evidenza li l-pazjenti fil-grupp ta' tqabbil kienu rċevew inqas kura, peress li l-pazjenti fiż-żewġ gruppi kienu urew benefiċċju kliniku mill-kura ta' manteniment tagħhom.
English: Kantos Master is authorised under a mutual recognition procedure based on an initial authorisation granted by Germany.
Maltese: Kantos Master huwa awtorizzat taħt proċedura ta' rikonoxximent reċiproku abbażi ta' awtorizzazzjoni inizjali mogħtija mill-Ġermanja.
English: It also took note of relevant literature supporting the principle of using such a combination of corticosteroid and long-acting bronchodilator (beclometasone and formoterol) for MART.
Maltese: Innota wkoll ir-riċensjoni rilevanti li tappoġġa l-prinċipju li tintuża tali kombinazzjoni ta' kortikosterojdi u bronkodilatur li jaġixxi fit-tul (beclometasone u formoterol) bħala MART.
English: The application was for the use of Kantos Master for both maintenance therapy of asthma and for relief of symptoms when they arise instead of the use of a separate short-acting bronchodilator (maintenance and reliever therapy, or MART).
Maltese: Lapplikazzjoni kienet għall-użu ta' Kantos Master kemm bħala terapija ta' manteniment għall-ażżma u għas-solliev meta jiżviluppaw is-sintomi minflok l-użu ta' bronkodilatur separat li jaġixxi tul perjodu qasir (terapija ta' manteniment u ta' solliev, jew MART).