FrancophonIA/ELRC3.0 huggingface dataset:
English: The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown (see also section 4.4).
Maltese: Il-kombinazzjoni ta' Erbitux ma' kimoterapija li fiha oxaliplatin hija kontraindikata għal pazjenti b'kanċer metastatiku tal-kolon u tar-rektum (mCRC - metastatic colorectal cancer) mutanti RAS jew għal dawk li l-istat ta' RAS mCRC mhux magħruf (ara wkoll sezzjoni 4.4).
English: • CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
Maltese: Dan l-istudju randomised f'pazjenti b'kanċer metastatiku tal-kolon u tar-rektum li kienu rċivew kumbinazzjoni inizjali ta' kura b'oxaliplatin flimkien ma' fluoropyrimidine għal mard metastatiku qabbel il-kumbinazzjoni ta' cetuximab u irinotecan (648 pazjenti) b'irinotecan waħdu (650 pazjent).
English: (95% CI) p-value BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Maltese: (95% CI) valur p BSC = l-aħjar kura ta' appoġġ, CI = intervall tal-kunfidenza, ORR = rata ta' rispons oġġettiv (pazjenti b'rispons sħiħ jew b'rispons parzjali), OS = żmien totali ta' sopravivenza, PFS = żmien ta' sopravivenza mingħajr progressjoni
English: The combination of cetuximab with irinotecan compared to cetuximab alone reduced the overall risk of disease progression by 46% and significantly increased objective response rate.
Maltese: Il-kumbinazzjoni ta' cetuximab ma' irinotecan meta mqabbla ma' cetuximab waħdu, naqqset irriskju totali tal-progressjoni tal-marda b'46% u żiedet b'mod sinifikanti r-rata ta' rispons oġġettiv.
English: Infusion-related, including anaphylactic, reactions
Maltese: Reazzjonijiet marbuta mal-infużjoni, inkluż dawk anafilattiċi
English: Intravenous use.
Maltese: IgE preformati.
English: Set and control the rate as explained in section 4.2.
Maltese: Issettja u ikkontrolla r-rata kif spjegat f'sezzjoni 4.2.
English: Cetuximab as a single agent or in combination with chemotherapy was investigated in 5 randomised controlled clinical studies and several supportive studies.
Maltese: Cetuximab bħala mediċina waħidha jew flimkien mal-kimoterapija kien investigat f'5 studji kliniċi kkontrollati u randomised, u diversi studji ta' appoġġ.
English: Cetuximab
Maltese: Il-Ġermanja
English: • haemoglobin < 9 g/dL
Maltese: • ħass ħażin
English: With respect to the KRAS status, tumour samples were only available from 23% of the patients (300 of 1298).
Maltese: Fir-rigward tal-istat ta' KRAS, kampjuni tat-tumur kienu disponibbli biss minn 23% tal-pazjenti (300 minn 1,298).
English: In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia may be increased, and thus may lead to a higher rate of infectious complications such as febrile neutropenia, pneumonia and sepsis compared to platinum-based chemotherapy alone (see section 4.4).
Maltese: Flimkien ma' kimoterapija bbażata fuq il-platinum, il-frekwenza ta' lewkopenja severa jew ta' newtropenja severa tista' tiżdied, u għaldaqstant tista' twassal għal rata ogħla ta' kumplikazzjonijiet infettivi sussegwenti bħal newtropenja bid-deni, pnewmonja jew b'xi mikrobu ieħor meta mqabbel ma' kimoterapija bbażata fuq il-platinum waħidha (ara sezzjoni 4.4).
English: Animal data revealed no evidence of teratogenicity.
Maltese: Informazzjoni dwar l-annimali ma żvelat l-ebda evidenza ta' teratoġeniċità.
English: How to store Erbitux
Maltese: X'inhu Erbitux
English: EGFR is involved in foetal development.
Maltese: EGFR hu involut fl-iżvilupp tal-fetu.
English: For the subsequent weekly doses, the recommended infusion period is 60 minutes.
Maltese: Għad-dożi sussegwenti ta' kull ġimgħa, il-perijodu rrakkomandat tal-infużjoni hu ta' 60 minuta.
English: The RAS mutant population comprises these 65 patients together with 113 patients with KRAS exon 2 mutant tumours treated before study enrolment was restricted to patients with KRAS exon 2 wild-type mCRC.
Maltese: Għall-evalwazzjoni tal-istat ta' RAS, ġew determinati mutazzjonijiet oħrajn minbarra dawk fuq exon 2 tal-ġene KRAS mill-kampjuni kollha tat-tumur evalwabbli fil-popolazzjoni KRAS exon 2 wild-type.
English: Since Erbitux is only compatible with sterile sodium chloride 9 mg/mL (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products.
Maltese: Minħabba li Erbitux hu kompatibbli biss ma' soluzzjoni għall-injezzjoni sterili ta' sodium chloride 9 mg/mL (0.9%), m'għandux jitħallat ma' prodotti mediċinali oħrajn li jingħataw minn ġol-vina.
English: An integrated analysis across all clinical studies showed that the pharmacokinetic characteristics of cetuximab are not influenced by race, age, gender, renal or hepatic status.
Maltese: Analiżi integrata li tħaddan l-istudji kliniċi kollha uriet li l-karatteristiċi farmakokinetiċi ta' cetuximab mhumiex influwenzati mir-razza, l-età, is-sess, jew l-istat tal-kliewi jew tal-fwied.
English: NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion
Maltese: Erbitux 5 mg/mL soluzzjoni għall-infużjoni
English: Erbitux may cause infusion-related side effects.
Maltese: Erbitux jista' jikkawża effetti sekondarji marbuta ma' l-infużjoni.
English: Limited observations in animals are indicative of a placental transfer of cetuximab, and other IgG1 antibodies have been found to cross the placental barrier.
Maltese: Osservazzjonijiet limitati fl-annimali jindikaw trasferiment millplaċenta ta' cetuximab, u antikorpi
English: Treatment in the cetuximab arm consisted of up to 6 cycles of platinum-based chemotherapy in combination with cetuximab followed by cetuximab as maintenance therapy until disease progression.
Maltese: Id-determinazzjoni tal-livelli tal-elektroliti fis-serum hi rrakkomandata qabel, u perjodikament, matul il-kura b'cetuximab.
English: The first dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 5 mg/min.
Maltese: L-ewwel doża (400 mg/m² ta' erja tas-superfiċje tal-ġisem) hi infuża fuq perijodu ta' madwar sagħtejn b'rata ta' infużjoni ta' mhux aktar minn 5 mg/min.
English: Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4).
Maltese: Pazjenti li kellhom funzjoni adegwata tal-kliewi u tal-fwied biss kienu investigati s'issa (ara sezzjoni 4.4).
English: An increased frequency of severe and sometimes fatal cardiovascular events and treatment emergent deaths has been observed in the treatment of non-small cell lung cancer, squamous cell carcinoma of the head and neck and colorectal carcinoma.
Maltese: Żieda fil-frekwenza ta' avvenimenti kardjovaskulari severi u xi kultant fatali, u mwiet li jiżviluppaw mill-kura kienu osservati fil-kura ta' kanċer tal-pulmun ta' ċelluli mhux żgħar, karċinoma taċ-ċelluli skwamużi tar-ras u tal-għonq u karċinoma tal-kolon u tar-rektum.
English: Each vial of 20 mL contains 100 mg cetuximab.
Maltese: Kull kunjett ta' 20 mL fih 100 mg ta' cetuximab.
English: CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Maltese: CI = intervall tal-kunfidenza, FOLFIRI = irinotecan flimkien ma' 5-FU/FA infużjonali, ORR = rata ta' rispons oġġettiv (pazjenti b'rispons sħiħ jew b'rispons parzjali), OS = żmien totali ta' sopravivenza, PFS = żmien ta' sopravivenza mingħajr progressjoni
English: In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR.
Maltese: Informazzjoni ddettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
Maltese: Il-proporzjon ta' pazjenti b'tumuri wild-type ġene KRAS mill-popolazzjoni ta' pazjenti li setgħu jkunu evalwati għallistat tal-ġene KRAS kien ta' 63%.
English: • For administration with infusion pump or gravity drip (undiluted): Calculate the required volume of Erbitux.
Maltese: • Biex tagħti l-infużjoni bil-pompa jew bi gravity drip (mhux dilwit): Ikkalkula l-volum meħtieġ ta' Erbitux.
English: In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
Maltese: Fil-prova randomised, it-titjib fiż-żmien totali ta' sopravivenza ma laħaqx sinifikat statistiku; madankollu, fil-kura follow-up, kważi 50% tal-pazjenti fil-parti tal-istudju b'cetuximab waħdu, irċivew kumbinazzjoni ta' cetuximab u irinotecan wara l-progressjoni ta' marda, li setgħet influwenzat iż-żmien totali ta' sopravivenza.
English: The main side effects of Erbitux are infusion-related side effects and side effects concerning the skin: Infusion-related side effects
Maltese: L-effetti sekondarji ewlenin ta' Erbitux huma effetti sekondarji marbuta ma' l-infużjoni u effetti sekondarji li jikkonċernaw l-ġilda:
English: • EMR 62 202-002: This randomised study in patients with recurrent and/or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
Maltese: Dan l-istudju randomised f'pazjenti b'kanċer taċ-ċelluli skwamużi fir-ras u fl-għonq, rikorrenti u/jew metastatiku, li ma kinux irċivew kimoterapija fil-passat għal din ilmarda, qabbel il-kumbinazzjoni ta' cetuximab u cisplatin jew carboplatin flimkien ma' 5fluorouracil infużjonali (222 pazjent) ma' l-istess kimoterapija waħidha (220 pazjent).
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Maltese: Pazjenti li jkollhom sinjali u sintomi li jissuġġerixxu keratite bħal: infjammazzjoni fl-għajnejn, dmugħ, sensittività għad-dawl, vista mċajpra, uġigħ fl-għajnejn u/jew għajnejn ħomor akuti jew li qed jaggravaw għandhom jintbagħtu għand speċjalista tal-oftalmoloġija minnufih.
English: Connect the infusion line to the syringe, set and control the rate as explained in section 4.2 and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Maltese: Waħħal il-linja tal-infużjoni mas-siringa, mas-sett u ikkontrolla r-rata tal-infużjoni kif spjegat f'sezzjoni 4.2 u ibda l-infużjoni wara li tagħmel priming tal-linja b'Erbitux jew b'soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%).
English: In combination with capecitabine and oxaliplatin (XELOX) the frequency of severe diarrhoea may be increased.
Maltese: Bit-teħid flimkien ma' capecitabine u oxaliplatin (XELOX) il-frekwenza ta' dijarea severa tista' tiżdied.
English: Content (concentration)
Maltese: Kontenut (Konċentra zzjoni)
English: MA (EU) number (Invented) name
Maltese: Numru tal-EU
English: 10 (2 x 5) pre-filled pens (multipack)
Maltese: 10 (2 x 5) pinen mimlijin għal-lest (pakkett multiplu)
English: 1 pre-filled pen + 7 NovoFine Plus needles
Maltese: Pinna 1 mimlija għal-lest + 7 labar NovoFine Plus
English: Phentermine as amphetamine-like substance has a well known drug abuse potential.
Maltese: Phentermine bħala sustanza simili għal amphetamine għandu potenzjal magħruf sew ta' abbuż talmediċina.
English: Treatment with Qsiva 7.5/46 mg and 15/92 mg for 28 and 56 weeks resulted in clinically relevant reductions of body weight, with a maximum effect after approx. 36-40 weeks of treatment.
Maltese: Il-kura bi Qsiva 7.5/46 mg u 15/92 mg għal 28 u 56 ġimgħa rriżultat fi tnaqqis klinikament rilevanti talpiż tal-ġisem, b'effett massimu wara madwar 36-40 ġimgħa ta' kura.
English: The CHMP considered the following:
Maltese: Is-CHMP ikkunsidra dan li ġej:
English: • Quality issues
Maltese: • Kwistjonijiet ta' kwalità
English: There was a dose-dependent increase in the incidence of depression (3.8% in the mid dose group vs. 7.7% in the highest dose group, with 3.4% in the placebo group), anxiety (4.8% vs. 7.9%, respectively, with 2.6% in the placebo group), insomnia (6.8% vs. 10.8%, respectively, with 5.7% in the placebo group), paraesthesia (11.8% vs. 17.3%, respectively, with 1.2% in the placebo group) and cognitive disorders (5.0% vs. 7.6%, respectively, with 1.5% in the placebo group; mainly attention disturbances, memory impairment and language disorders).
Maltese: 8%, rispettivament, b'5.7% fil-grupp tal-plaċebo), paresteżija (11.8% kontra 17.3%, rispettivament, b'1.2% fil-grupp tal-plaċebo) u disturbi konjittivi (5.0% kontra 7.6%, rispettivament, b'1.5% fil-grupp tal-plaċebo; l-aktar disturbi tal-attenzjoni, indeboliment tal-memorja u disturbi fil-lingwa).
English: The proposed RMP was assessed at the request of the CHMP by the Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: L-RMP propost kien evalwat fuq talba tas-CHMP mill-Kumitat dwar il-Valutazzjoni tar-Riskji talFarmakoviġilanza (PRAC).
English: In the 1 year cohort the frequency of cardiac disorders (mostly palpitations and increase in heart rate) was higher in the Qsiva groups (4.2% and 4.7% in the mid dose and high dose group, respectively) compared to placebo (1.8%).
Maltese: Fil-koorti ta' sena l-frekwenza ta' disturbi kardijaċi (l-aktar palpitazzjonijiet u żieda fir-rata tal-qalb) kienet ogħla fil-gruppi ta' Qsiva (4.2% u 4.7% fil-grupp tad-doża tan-nofs u tad-doża għolja, rispettivament) meta mqabbel mal-plaċebo (1.8%).
English: Teratogenic risk - CHMP agreed that the risk from the teratogenic potential of Qsiva might be mitigated through the implementation of appropriate risk minimisation measures, which include a Pregnancy Prevention Plan (PPP), the principles of which should be consistent with that agreed across the EU for isotretinoin in 2003.
Maltese: Riskju teratoġeniku - Is-CHMP qabel li r-riskju mill-potenzjal teratoġeniku ta' Qsiva jista' jitnaqqas permezz tal-implimentazzjoni ta' miżuri xierqa ta' tnaqqis tar-riskju, li jinkludu Pjan ta' Prevenzjoni tatTqala (Pregnancy Prevention Plan - PPP), li l-prinċipju tiegħu għandu jkun konsistenti ma' dak miftiehem fl-UE kollha għal isotretinoin fl-2003.
English: The currently available cardiovascular outcome data for Qsiva remains inconclusive;
Maltese: Id-dejta tal-eżiti kardjovaskolari attwalment disponibbli għal Qsiva għadha inkonklussiva;
English: Known adverse events with the use of phentermine are palpitations, tachycardia, elevation of blood pressure, psychosis, CNS and gastrointestinal effects and with the use of topiramate paraesthesia, changes in taste, ocular disorders, psychiatric and cognitive disorders.
Maltese: L-effetti ħżiena magħrufa bl-użu ta' phentermine huma palpitazzjonijiet, takikardija, tlugħ tal-pressjoni tad-demm, psikożi, effetti fuq is-CNS u gastrointestinali u bl-użu ta' topiramate paraesthesia, bidliet fittogħma, disturbi fl-għajnejn, disturbi psikjatriċi u konjittivi.
English: Due to the inhibitory effect of topiramate on renal carbonic anhydrase, reductions in serum bicarbonate below 21 mEq/L were seen in 2.1%, 6.4% and 12.8% in the placebo, mid and high dose groups, and therefore are of concern in the targeted population.
Maltese: Minħabba l-effett inibitorju ta' topiramate fuq l-anidrażi karbonika tal-kliewi, kien hemm tnaqqis filbikarbonat fis-serum taħt il-21 mEq/L fi 2.1%, 6.4% u 12.8% fil-gruppi tal-plaċebo, tad-doża tan-nofs u tad-doża għolja, u għalhekk huwa ta' tħassib fil-popolazzjoni mmirata.
English: Grounds for re-examination
Maltese: Raġunijiet għal rifjut
English: Cardiovascular safety - The CHMP had methodological concerns with regard to the quality of the data source (with dropout rates of about 40%, and lost to follow up rate above 10%) and the magnitude of the dose-dependent increase in heart rate (as heart rate measurement was not an end point in the Qsiva clinical program and no standardised methodology for accurate assessment was implemented).
Maltese: Is-sigurtà kardjovaskolari - Is-CHMP kellu tħassib metodoloġiku rigward il-kwalità tas-sors tad-dejta (b'rati ta' madwar 40% ta' persuni li waqfu mill-istudju, u rata ta' aktar minn 10% ta' persuni li ma baqgħux jiġu segwiti) u l-kobor taż-żieda fir-rata tal-qalb skont id-doża (peress li l-kejl tar-rata tal-qalb ma kienx punt ta' tmiem fil-programm kliniku ta' Qsiva u ma ġiet implimentata l-ebda metodoloġija standardizzata għall-valutazzjoni eżatta).
English: Psychiatric safety -Depression, anxiety and cognitive impairment were more commonly reported in patients treated with Qsiva than placebo.
Maltese: Sigurtà psikjatrika - Id-depressjoni, l-ansjetà u l-indeboliment konjittiv kienu rrapportati aktar filpazjenti kkurati bi Qsiva milli bil-plaċebo.
English: Importantly, there were no increases in major depression diagnoses (by PHQ-9 questionaire), emergent antidepressant use, or suicidality (by C-SSRS questionaire) in the programme.
Maltese: Fuq kollox, ma kien hemm lebda żieda fid-dijanjosi ta' depressjoni maġġuri (permezz tal-kwestjonarju PHQ-9), ta' użu emerġenti ta' mediċini kontra d-depressjoni, jew ta' suwiċidju (permezz tal-kwestjonarju C-SSRS) fil-programm.
English: Grounds for refusal
Maltese: • Kwistjonijiet ta' effikaċja
English: Following the CHMP scientific conclusions adopted on 18 October 2012 that Qsiva was not approvable for the treatment of
Maltese: Wara l-konklużjonijiet xjentifiċi adottati mis-CHMP fit-18 ta' Ottubru 2012 li Qsiva ma setax ikun approvat għall-kura ta'
English: Qsiva is recommended for obese patients (BMI ≥ 35 kg/m2), or obese patients (BMI ≥
Maltese: Qsiva huwa rrakkomandat għall-pazjenti obeżi (BMI ≥ 35 kg/m2), jew pazjenti obeżi (BMI ≥ 30 kg/m2) b'komorbiditajiet marbuta mal-piż bħal iperpressjoni, dijabete tat-tip 2 jew dislipidemija.
English: The CHMP is of the opinion that pursuant to Article 12 of Regulation (EC) No 726/2004, the safety of the above mentioned medicinal product is not properly or sufficiently demonstrated.
Maltese: Is-CHMP huwa tal-fehma li skont l-Artikolu 12 tar-Regolament (KE) Nru 726/2004, is-sigurtà tal-prodott mediċinali msemmi hawn fuq ma ntwerietx biżżejjed jew kif xieraq.
English: The mean change from baseline to Week 108 in heart rate was also higher in the Qsiva groups (1.3 bpm and 1.7 bpm, respectively) than in the placebo group (0.4 bpm).
Maltese: Il-bidla medja mil-linja bażi sal-108 Ġimgħa fir-rata tal-qalb kienet ukoll ogħla fil-gruppi ta' Qsiva (1.3 bpm u 1.7 bpm, rispettivament) milli fil-grupp talplaċebo (0.4 bpm).
English: Teratogenic risk - Topiramate has been associated with an increased risk of teratogenesis; however, topiramate has been approved for 16 years and is currently in widespread use within the EU for migraine prophylaxis and epilepsy, which requires treatment at higher doses.
Maltese: Riskju teratoġeniku - Topiramate ġie assoċjat ma' żieda fir-riskju ta' teratoġenesi; madankollu, topiramate ilu approvat għal 16-il sena u attwalment jintuża madwar l-UE għall-profilassi tal-emikranja u l-epilessija, li teħtieġ kura f'dożi ogħla.
English: A meta-analysis of cardiovascular events showed the population studied to be at a low risk of cardiovascular events.
Maltese: Meta-analiżi tal-avvenimenti kardjovaskolari wriet li l-popolazzjoni studjata kienet f'riskju baxx ta' avvenimenti kardjovaskolari.
English: Furthermore, the applicant cited the example of topiramate as further evidence that this risk can be effectively mitigated by SmPC and RMP.
Maltese: Barra minn hekk, l-applikant ikkwota l-eżempju ta' topiramate bħala evidenza ulterjuri li dan ir-riskju jista' jitnaqqas b'mod effettiv permezz tal-SmPC u l-RMP.
English: The supportive information on safety of phentermine from the literature provided by the applicant was considered by CHMP to be very limited due to factors such as only retrospective, cohort studies submitted, absence of a reliable control group, etc..
Maltese: L-informazzjoni ta' appoġġ mil-letteratura li pprovda l-applikant dwar is-sigurtà ta' phentermine kienet meqjusa limitata ħafna mis-CHMP minħabba fatturi bħal studji sottomessi retrospettivi u ta' koorti biss, in-nuqqas ta' grupp ta' kontroll affidabbli, eċċ..
English: The Applicant addressed the need for effective contraception and the risk of teratogenesis in the SmPC and the RMP, which included a detailed healthcare provider checklist as well as patient education card.
Maltese: L-Applikant indirizza l-ħtieġa ta' kontraċezzjoni effettiva u r-riskju ta' teratoġenesi fl-SmPC u l-RMP, li kien jinkludi lista ta' kontroll dettaljata għat-tobba kif ukoll skeda edukattiva għall-pazjenti.
English: Reported rates for most CNS-related side effects were similar between the mid-dose and placebo.
Maltese: Ir-rati rrapportati għall-parti l-kbira tal-effetti sekondarji marbuta mas-CNS kienu simili bejn id-doża tan-nofs u l-plaċebo.
English: Off-label use - The CHMP considers that Qsiva is expected to have a high probability of off-label use, particularly in patients with some nutritional disorders (e.g. bulimia, Binge Eating Disorder) as well as in psychiatric patients, paediatric populations, adults with high CV risk, and elderly patients.
Maltese: Użu differenti minn dak stabbilit fuq it-tikketta - Is-CHMP jikkunsidra li Qsiva huwa mistenni li jkollu probabbiltà għolja ta' użu differenti minn dak stabbilit fuq it-tikketta, b'mod partikolari f'pazjenti b'xi disturbi nutrizzjonali (eż. bulimja, Disturb ta' Ikel bla Rażan) kif ukoll f'pazjenti psikjatriċi, popolazzjonijiet pedjatriċi, adulti b'riskju KV għoli, u f'pazjenti anzjani.
English: The applicant provided with the grounds for re-examination revised Summary of Product Characteristics (SmPC) and risk management plan (RMP) proposals.
Maltese: L-applikant ipprovda proposti ta' Sommarju tal-Karatteristiċi talProdott (SmPC) rivedut u pjan ta' ġestjoni tar-riskji (RMP) mar-raġunijiet għall-eżaminazzjoni mill-ġdid.
English: The Applicant presented hazard ratios for major cardiovascular events in Qsiva-treated subjects.
Maltese: L-Applikant ippreżenta proporzjonijiet ta' periklu għal avvenimenti kardjovaskolari kbar fis-suġġetti kkurati bi Qsiva.
English: The overall quality of the medicinal product was considered acceptable by the CHMP.
Maltese: Il-kwalità globali tal-prodott mediċinali kienet ikkunsidrata aċċettabbli mis-CHMP.
English: In the view of the CHMP an unmet medical need in the treatment of patients with obesity is acknowledged.
Maltese: Fil-fehma tas-CHMP ħtieġa medika mhux issodisfata hija rikonoxxuta fil-kura tal-pazjenti obeżi.
English: The applicant emphasised that Qsiva is highly effective in achieving and maintaining weight loss in obese patients, of a magnitude greater than that of any other pharmacological treatment to date with expected improvement of cardiovascular, metabolic, and other outcomes, as well as demonstrated improvements in blood pressure, glycaemic control, lipids, quality of life, incidence of new onset type 2 diabetes and other outcomes.
Maltese: L-applikant saħaq li Qsiva huwa effettiv ħafna sabiex wieħed jikseb u jżomm it-tnaqqis fil-piż f'pazjenti obeżi, b'rata akbar minn dik ta' kwalunkwe kura farmakoloġika oħra disponibbli sal-ġurnata tal-lum b'titjib mistenni ta' eżiti kardjovaskolari, metaboliċi u oħrajn, kif ukoll wera titjib fil-pressjoni tad-demm, fil-kontroll gliċemiku, lipidi, kwalità ta' ħajja, inċidenza ta' bidu mill-ġdid ta' dijabete tat-tip 2 u eżiti oħrajn.