FrancophonIA/ELRC3.0 huggingface dataset:
English: This supports the conclusion that in patients with known allergies and with immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) the risk of hypersensitivity reactions is enhanced.
Maltese: Dan jappoġġja l-konklużjoni li f'pazjenti b'allerġiji magħrufa u b'kundizzjonijiet immuni jew infjammatorji (eż. lupus erythematosus sistemiku, artrite rewmatika) ir-riskju ta' reazzjonijiet ta' sensittività eċċessiva jiżdied.
English: Only two MAH studies have been conducted with low molecular weight iron (III)-hydroxide dextran complex.
Maltese: Saru biss żewġ studji mill-MAH bil-kumpless ta' iron (III)-hydroxide dextran b'piż molekulari baxx.
English: Only 1 patient experienced an aggravation of symptoms at the sodium ferric gluconate re-introduction: minor skin reaction at infusion site then hypotension, syncope, nausea and vomiting at the 2nd administration.
Maltese: Pazjent 1 biss esperjenza aggravar tas-sintomi meta l-glukonat ferriku tas-sodju reġa' ġie introdott: reazzjoni minuri tal-ġilda fis-sit talinfużjoni u mbagħad pressjoni baxxa, sinkope, dardir u rimettar fit-tieni għotja.
English: When classifying all cases that were not reported as immune reactions, according to CTCAE approximately 20% were classified as grade III.
Maltese: Meta l-każijiet kollha li ma ġewx irrapportati bħala reazzjonijiet immuni ġew ikklassifikati, skont isCTCAE madwar 20% kienu kklassifikati bħala tal-grad III.
English: The vast majority of these concerned patients in chronic kidney disease (CKD) and treatment in patients undergoing chronic haemodialysis (HD).
Maltese: Il-maġġoranza kbira ta' dawn kienu jittrattaw pazjenti b'mard kroniku tal-kliewi (CKD) u kura fuq pazjenti li għaddejjin minn emodijalisi kronika (HD).
English: For reports classified as grade III, the most commonly reported term was “anaphylactic shock” and the outcome of these cases was either recovered, not recovered (1 case only) or unknown (8 cases).
Maltese: Għar-rapporti kklassifikati bħala tal-grad III, l-aktar terminu rrapportat b'mod komuni kien “xokk anafilattiku” u l-eżitu ta' dawn il-każijiet kien jew irkuprat, mhux rkuprat (każ 1 biss) jew mhux magħruf (8 każijiet).
English: The MAHs were requested by the CHMP to provide a detailed analysis classified according to Ring and Messmer for the purpose of the review of the risk of allergic reactions.
Maltese: Il-MAHs intalbu mis-CHMP sabiex jipprovdu analiżi dettaljata kklassifikata skont Ring u Messmer għallfini tar-reviżjoni tar-riskju ta' reazzjonijiet allerġiċi.
English: For ferric carboxymaltose as well as iron sucrose in animal studies in guinea pigs that had been administered immune serum containing iron-dextran antibodies, a clear skin reaction after the administration of dextran was observed (positive control).
Maltese: Għal ferric carboxymaltose kif ukoll għal iron sucrose fi studji fuq l-annimali fuq il-fniek tal-indi li kienu ngħataw serum immuni li kien fih antikorpi ta' iron-dextran, ġiet osservata reazzjoni ċara tal-ġilda wara l-għoti ta' dextran (kontroll pożittiv).
English: This risk was particularly of concern with low molecular-weight iron-dextran (LMWID) containing products, particularly in pregnant women for whom uterine hypertonia was observed.
Maltese: Dan ir-riskju kienu ta' tħassib partikulari bi prodotti li fihom iron-dextran b'piż molekulari baxx (LMWID), b'mod partikulari f'nisa tqal li fuqhom kienet osservata ipertonija tal-utru.
English: Over 8,000 patients have been included/treated across all arms in these clinical trials, of whom almost half (N=4,048) received iron sucrose either as the test product or as the reference (comparator) therapy.
Maltese: Aktar minn 8,000 pazjent ġew inklużi/rċevew kura fil-fergħat kollha f'dawn il-provi kliniċi, li minnhom madwar nofs (N=4,048) irċevew iron sucrose jew bħala lprodott tat-test jew bħala t-terapija ta' referenza (komparatur).
English: In the 3% of cases where sodium ferric gluconate was re-administered, the patients experienced the same type of ADRs, mainly allergic reactions without aggravation of the symptoms.
Maltese: Fit-3% talkażijiet fejn il-glukonat ferriku tas-sodju reġa' ngħata, il-pazjenti esperjenzaw l-istess tip ta' ADRs, prinċipalment reazzjonijiet allerġiċi mingħajr aggravar tas-sintomi.
English: All cases within this SOC have been classified according to the Ring and Messmer classification.
Maltese: Il-każijiet kollha f'din l-SOC ġew ikklassifikati skond il-klassifika ta' Ring u Messmer.
English: Six cases (4%) were classified as grade IV (2 reported anaphylactic shock leading to a fatal outcome and 4 anaphylactic shock leading to cardiac arrest (all patients made full recovery).
Maltese: Sitt każijiet (4%) kienu kklassifikati bħala tal-grad IV (2 irrapportaw xokk anafilattiku li wassal għal eżitu fatali u 4 każijiet ta' xokk anafilattiku li wassal għal arrest kardijaku (ilpazjenti kollha rkupraw kompletament).
English: Two ADRs have been included in the analysis of allergic reactions according to the Ring and Messmer classification from the analysed or completed studies.
Maltese: Żewġ ADRs kienu inklużi fl-analiżi ta' reazzjonijiet allerġiċi skont il-klassifika ta' Ring u Messmer mill-istudji analizzati jew li tlestew.
English: One of these cases was an anaphylactoid reaction, and another was a probable serious allergic reaction.
Maltese: Wieħed minn dawn il-każijiet kien reazzjoni anafilattojde, u ieħor kien probabbli reazzjoni allerġika serja.
English: So the CHMP conclusions are applicable to all the iron complexes assessed in this referral.
Maltese: Ilħames pazjenti kollha irkupraw kompletament.
English: According to the Ring and Messmer classification, three cases were classified as grade II anaphylactoid reactions and one case as grade III.
Maltese: Skont il-klassifika ta' Ring u Messmer, tliet każijiet kienu kklassifikati bħala reazzjonijiet anafilattojdi tal-grad II u każ wieħed bħala tal-grad III.
English: The Committee reviewed all available data from pre-clinical, clinical studies, published literature, postmarketing experience on the safety of intravenous iron containing medicinal products with regards to hypersensitivity reactions.
Maltese: Il-Kumitat irreveda d-dejta kollha disponibbli minn studji pre-kliniċi, kliniċi, minn riċensjoni, lesperjenza ta' wara tqegħid fis-suq dwar is-sigurtà ta' prodotti mediċinali li fihom il-ħadid li jingħataw ġol-vini fir-rigward ta' reazzjonijiet ta' sensittività eċċessiva.
English: In iron deficiency anaemia there were three publications with no anaphylactoid reactions reported.
Maltese: Fl-anemija minħabba defiċjenza tal-ħadid kien hemm tliet pubblikazzjonijiet li ma rrapportaw l-ebda reazzjoni anafilattojde.
English: Further, a test-dose might give the prescriber a feeling of false assurance that an allergic reaction is unlikely to happen.
Maltese: Barra minn hekk, doża tat-test tista' tagħti lil min jippreskrivi sensazzjoni ta' assigurazzjoni falza li m'hemmx il-probabbiltà li sseħħ reazzjoni allerġika.
English: The CHMP endorsed a Direct healthcare professional communication (DHPC), to communicate the outcome of the present review and to communicate to the healthcare professionals the updated method of administration for these products in an environment where trained staff and facilities for resuscitation exist and to highlight the risk of the hypersensitivity reactions.
Maltese: Is-CHMP approva Komunikazzjoni diretta lill-professjonisti tal-kura tas-saħħa (DHPC), biex jiġi kkomunikat ir-riżultat tar-reviżjoni attwali u biex jiġi kkomunikat lill-professjonisti tal-kura tas-saħħa lmetodu aġġornat ta' kif dawn il-prodotti għandhom jingħataw f'ambjent b'persunal imħarreġ u b'faċilitajiet għal risuxxitazzjoni u biex jiġi enfasizzat ir-riskju tar-reazzjonijiet ta' sensittività eċċessiva.
English: In about 80% of the cases, the outcome of pregnancy was unknown.
Maltese: F'madwar 80% tal-każijiet, l-eżitu tat-tqala ma kienx magħruf.
English: No dose response or relationship to method of administration (undiluted bolus injection versus diluted infusion) was observed for hypersensitivity events.
Maltese: Ma kien osservat l-ebda rispons għad-doża jew relazzjoni mal-metodu ta' kif ingħata (injezzjoni bolus mhux dilwita kontra infużjoni dilwita) għall-avvenimenti ta' sensittività eċċessiva.
English: 19 March 2018 EMA/176752/2018
Maltese: EMA/219991/2018
English: Xofigo was authorised in the European Union in November 2013.
Maltese: Xofigo ġie awtorizzat fl-Unjoni Ewropea f'Novembru 2013.
English: Fractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%).
Maltese: Il-ksur seħħ ukoll b'mod aktar frekwenti bil-kombinazzjoni ta' Xofigo milli bil-kombinazzjoni tal-plaċebo (26 % kontra 8.1 %).
English: More information on Xofigo is available.
Maltese: Hija disponibbli aktar informazzjoni dwar Xofigo.
English: In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone.
Maltese: F'dan listudju, s'issa mietu 34.7 % tal-pazjenti kkurati b'Xofigo, Zytiga u prednisone/prednisolone, meta mqabbel ma' 28.2 % tal-pazjenti mogħtija l-plaċebo, Zytiga u prednisone/prednisolone.
English: On 8 March 2018, the European Medicines Agency (EMA) recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga (abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.
Maltese: Fit-8 ta' Marzu 2018, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat il-kontraindikazzjoni talużu tal-mediċina ta' kontra l-kanċer tal-prostata Xofigo (radium-223 dichloride) ma' Zytiga (abiraterone acetate) u prednisone/prednisolone, minħabba riskju miżjud ta' mewt u ksur ta' għadam b'din il-kombinazzjoni.
English: • Xofigo must not be used with the anti-androgen Zytiga (abiraterone acetate) and prednisone/prednisolone because of possible increased risk of fractures and mortality.
Maltese: • Xofigo m'għandux jintuża mal-antiandroġenu Zytiga (abiraterone acetate) u prednisone/prednisolone minħabba riskju miżjud possibbli ta' ksur u mortalità.
English: EMA will communicate further at the conclusion of the review.
Maltese: L-EMA ser tikkomunika aktar meta tiġi konkluża r-reviżjoni.
English: Xofigo is used to treat men with cancer of the prostate (a gland of the male reproductive system).
Maltese: Xofigo jintuża biex jikkura rġiel bil-kanċer tal-prostata (glandola tas-sistema riproduttiva maskili).
English: EMA's Pharmacovigilance Risk Assessment Committee (PRAC) had reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients.
Maltese: Il-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC) tal-EMA kien irreveda d-dejta preliminari minn studju kliniku li għadu għaddej f'pazjenti b'kanċer tal-prostata metastatiku.
English: The review of Xofigo has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Xofigo nbdiet fuq talba tal-Kummissjoni Ewropea, skont L-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: The final stage of the review procedure is the adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Maltese: L-istadju finali tal-proċedura ta' reviżjoni huwa l-adozzjoni mill-Kummissjoni Ewropea ta' deċiżjoni legalment vinkolanti applikabbli fl-Istati Membri kollha tal-UE.
English: It is authorised for use when medical or surgical castration (stopping the production of male hormones in the body using medicines or surgery) does not work, and when the cancer has spread to the bones and is causing symptoms such as pain but is not known to have spread to other internal organs.
Maltese: Dan huwa awtorizzat għall-użu meta kastrazzjoni medika jew kirurġika (il-waqfien tal-produzzjoni talormoni maskili fil-ġisem permezz ta' mediċini jew kirurġija) ma taħdimx, u meta l-kanċer ikun infirex għall-għadam u jkun qiegħed jikkawża sintomi bħal uġigħ iżda mhux magħruf li jkun infirex lejn organi interni oħra.
English: In view of the seriousness of the events reported, the PRAC took action by introducing a contraindication as a temporary measure to protect patients' safety while an in-depth review of the benefits and risks of Xofigo is ongoing.
Maltese: Fid-dawl tas-severità tal-avvenimenti rrappurtati, il-PRAC ħa azzjoni billi introduċa kontraindikazzjoni bħala miżura temporanja sabiex tiġi protetta s-sigurtà tal-pazjenti filwaqt li għadha għaddejja reviżjoni fil-fond tal-benefiċċji u tar-riskji ta' Xofigo.
English: Healthcare professionals in the EU must not use a combination of Xofigo with the anti-androgen Zytiga and prednisone/prednisolone, and should stop this combination in men currently treated with it and review the treatment for these patients.
Maltese: Il-professjonisti tal-kura tas-saħħa fl-UE m'għandhomx jużaw il-kombinazzjoni ta' Xofigo malantiandroġenu Zytiga u prednisone/prednisolone, u għandhom iwaqqfu din il-kombinazzjoni fl-irġiel li attwalment qegħdin jiġu kkurati biha u għandha tiġi reveduta l-kura għal dawn il-pazjenti.
English: This was sent to the European Commission (EC), which issued a provisional legally binding decision on 19 March
Maltese: Din intbagħtet lill-Kummissjoni Ewropea (KE), li ħarġet deċiżjoni vinkolanti legalment provviżorja fid19 ta' Marzu 2018.
English: The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy.
Maltese: L-istudju li għadu għaddej ta' Xofigo flimkien ma' Zytiga u prednisone/prednisolone inkluda pazjenti b'kanċer tal-prostata reżistenti għall-kastrazzjoni li nfirex prinċipalment għall-għadam, li m'għandhom l-ebda sintomu jew sintomi ħfief biss u li ma ġewx ikkurati bil-kimoterapija.
English: Ongoing clinical study shows increased risk of death and fractures with the combination
Maltese: Studju kliniku li għadu għaddej juri riskju miżjud ta' mewt u ksur ta' għadam bil-kombinazzjoni
English: Once the PRAC review is concluded, its recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion.
Maltese: Ladarba tiġi konkluża r-reviżjoni tal-PRAC, ir-rakkomandazzjonijiet tagħha ser jintbagħtu lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli għall-evalwazzjoni tal-mediċini għall-użu mill-bniedem, li ser jadotta opinjoni finali.
English: • The safety and efficacy of Xofigo in combination with second generation androgen receptor antagonists such as Xtandi (enzalutamide) have not been established.
Maltese: • Ser issir disponibbli aktar informazzjoni ladarba tintemm ir-reviżjoni li għadha għaddejja talevidenza.
English: These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete.
Maltese: Dawn huma miżuri temporanji sakemm tintemm ir-reviżjoni fil-fond li għadha għaddejja tal-benefiċċji u tar-riskji ta' Xofigo.
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Maltese: Ir-reviżjoni qiegħda ssir mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), ilKumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini għall-użu millbniedem, li ser jagħmel sett ta' rakkomandazzjonijiet.
English: Xofigo is currently authorised for use in men whose prostate cancer has spread to the bones and is causing symptoms.
Maltese: Xofigo attwalment huwa awtorizzat għall-użu f'irġiel li l-kanċer tal-prostata tagħhom infirex għallgħadam u li qiegħed jikkawża sintomi.
English: Titration pack: 12 tablets
Maltese: Pakkett ta' titrazzjoni: 12-il pillola
English: Immediate packaging Pack size
Maltese: Daqs tal-pakkett
English: 2 mg
Maltese: Mnejn għandu jingħata
English: Film-coated tablet blister (PA/alu/PVC/alu) blister (PA/alu/PVC/alu) blister (PA/alu/PVC/alu)
Maltese: Il-pakkett li jmiss malprodott
English: The reference member state (RMS) is France and 8 concerned member states (CMS) are involved: Austria, Germany, Hungary, the Netherlands, Poland, Romania, Spain and the United Kingdom.
Maltese: L-istat membru ta' referenza (SMR) huwa Franza u huma involuti 8 stati membri kkonċernati (SMK): l-Awstrija, ilĠermanja, l-Ungerija, il-Pajjiżi l-Baxxi, il-Polonja, ir-Rumanija, Spanja u r-Renju Unit.
English: 1 VICH GL6: Guideline on environmental impact assessment (EIAs) for veterinary medicinal products - Phase I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf order to assess the potential risk of Suifertil 4 mg/ml Oral Solution for Pigs to the environment.
Maltese: 1 VICH GL6: Linjagwida fuq il-valutazzjoni tal-impatt fuq l-ambjent (EIAs) għall-prodotti mediċinali veterinarji - Fażi I http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004394.pdf
English: Altrenogest is a synthetic steroidal hormone, an orally active (pro)gestagen.
Maltese: Altrenogest huwa ormon sterojd sintetiku, (pro)ġestaġen attiv oralment.
English: Altrenogest is a synthetic steroidal hormone, an orally active progestogen.
Maltese: Altrenogest huwa ormon sterojd sintetiku, proġestoġen attiv oralment.
English: The two studies with the most sensitive results display effects in amphibians and fish already at the lowest test concentration of 1.3 and 0.8 ng/l, respectively.
Maltese: Iż-żewġ studji bl-aktar riżultati sensittivi juru effetti fl-amfibji u l-ħut diġà fl-aktar konċentrazzjoni baxxa tat-test ta' 1.3 u 0.8 ng/l, rispettivament.
English: This is a generic application according to Art. 13(1) of Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Maltese: Din hija applikazzjoni ġenerika skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Regumate soluzzjoni żejtnija 4 mg/ml.
English: These scenarios led to a PECsurfacewater ranging from 0.641 ng/l (for a closed system with 80% metabolism) up to 8.98 ng/l (for an open system with 0% metabolism).
Maltese: Dawn ix-xenarji wasslu għal PECilma tal-wiċċ li kienet tvarja minn 0.641 ng/l (għal sistema magħluqa bi 80% metaboliżmu) sa 8.98 ng/l (għal sistema miftuħa b'0% metaboliżmu).
English: For DT50 soil a conservative approach of 10 days was used, based on reported half-lives of different hormones.
Maltese: Għad-DT50 ħamrija ntuża approċċ konservattiv ta' 10 ijiem, ibbażat fuq il-half-lives irrapportati ta' ormoni differenti.
English: Applicant
Maltese: Stat Membru Applikant
English: For the DT50 water the conservative approach of 1000 days was used.
Maltese: GħadDT50 ilma ntuża l-approċċ konservattiv ta' 1000 jum.
English: The application in question, submitted via the decentralised procedure, is a generic application according to Article 13(1) Directive 2001/82/EC, as amended, referring to the reference product Regumate oily solution 4 mg/ml.
Maltese: L-applikazzjoni inkwistjoni, ippreżentata permezz tal-proċedura diċentralizzata, hija applikazzjoni ġenerika skont l-Artikolu 13(1) tad-Direttiva 2001/82/KE, kif emendata, li tirreferi għall-prodott ta' referenza Regumate soluzzjoni żejtnija 4 mg/ml.
English: Germany expressed concerns regarding a potential serious risk for the environment as the active ingredient is a steroid hormone and data from publicly available literature show a high risk to aquatic organisms arising from other steroids with a similar molecular structure at environmental concentrations far below the trigger value in nanogram range.
Maltese: Il-Ġermanja esprimiet tħassib dwar riskju serju potenzjali għall-ambjent billi ssustanza attiva hija ormon sterojd u d-dejta minn letteratura pubblikament disponibbli turi riskju għoli għall-organiżmi akkwatiċi li jirriżulta minn sterojdi oħra bi struttura molekulari simili f'konċentrazzjonijiet ambjentali ferm aktar baxxi mill-valur li jiskatta l-azzjoni f'medda ta' nanogrammi.
English: The calculated values for altrenogest were 13.5 (in the case of 80% metabolism) and 2.7 (in the case of 0% metabolism) times lower than the total gestagen excretion by pigs.
Maltese: Il-valuri kkalkulati għal altrenogest kienu 13.5 (fil-każ ta' 80% metaboliżmu) u 2.7 (fil-każ ta' 0% metaboliżmu) darbiet aktar baxxi mill-eskrezzjoni totali ta' ġestaġen mill-majjali.
English: List of the name, pharmaceutical form, strength of the veterinary medicinal product, animal species, route of administration, applicant in the Member States
Maltese: Lista tal-ismijiet, għamla farmaċewtika, qawwa tal-prodott mediċinali veterinarju, speċi ta' annimali, mnejn jingħata, applikant tal-awtorizzazzjoni għat-tqegħid fis-suq fl-istati membri
English: A class referral under Article 35 of Directive 2001/82/EC has been initiated in April 2013 for all veterinary medicinal products containing altrenogest to be administered orally to pigs and horses, the scope of which also includes Suifertil.
Maltese: F'April 2013 inbeda riferiment ta' kategorija skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li fihom altrenogest għall-għoti b'mod orali lill-majjali u liż-żwiemel, li lkamp ta' applikazzjoni tiegħu jinkludi wkoll lil Suifertil.
English: Application of the ‘however clause' or can the ERA stop at Phase I
Maltese: 2.1. Applikazzjoni tal-‘however clause' jew l-ERA tista' tieqaf f'Fażi I
English: Benefit-risk assessment
Maltese: Valutazzjoni benefiċċji/riskji
English: The applicant provided a Phase I ERA, in which PECsoil initial for the active ingredient was calculated to be 0.93 µg/kg for open systems and 0.36 µg/kg for closed systems, which is considered plausible and acceptable.
Maltese: L-applikant ipprovda ERA ta' Fażi I, li fiha l-PECħamrija inizjali għas-sustanza attiva kienet ikkalkulata 0.93 µg/kg għal sistemi miftuħa u 0.36 µg/kg għal sistemi magħluqa, li hija meqjusa bħala plawsibbli u aċċettabbli.
English: The environmental risk assessment will be reviewed within the Article 35 referral.
Maltese: Il-valutazzjoni tar-riskju ambjentali se tiġi riveduta fi ħdan ir-riferiment skont l-Artikolu 35.
English: The applicant used Quantitative structure-activity relationship models (QSAR models) to calculate excretion levels of altrenogest and compared them with the measured total gestagen excretion by pigs reported in public literature.
Maltese: L-applikant uża mudelli ta' Relazzjoni struttura-attività kwantitattiva (mudelli QSAR) biex jikkalkula llivelli ta' eskrezzjoni ta' altrenogest u qabbilhom mal-eskrezzjoni totali mkejla ta' ġestaġen mill-majjali fil-letteratura pubblika.
English: Studies in the published literature on effects of several hormones other than altrenogest on aquatic organisms indicate adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Maltese: L-istudji fil-letteratura ppubblikata dwar l-effetti ta' diversi ormoni għajr altrenogest fuq l-organiżmi akkwatiċi jindikaw effetti avversi b'konċentrazzjonijiet ferm aktar baxxi mill-valur ta' 100 µg/kg ta' ħamrija li jiskatta l-azzjoni.
English: The submitted published literature on effect studies for three other hormones, the gestagens levonorgestrel, drosperinone and progestrerone, is indicating adverse effects at concentrations far below the trigger value of 100 µg/kg soil.
Maltese: Il-letteratura ppubblikata li ġiet ippreżentata dwar l-istudji tal-effett għal tliet ormoni oħra, il-ġestaġens levonorgestrel, drosperinone u progestrerone, qed tindika effetti avversi b'konċentrazzjonijiet ferm aktar baxxi mill-valur ta' 100 µg/kg ta' ħamrija li jiskatta l-azzjoni.
English: Consequently, the applicant concluded that the ERA can stop at Phase I. Additionally, the applicant provided a scientific justification why the ‘however clause' of VICH GL6 should not be invoked.
Maltese: Barra minn hekk, l-applikant ipprovda ġustifikazzjoni xjentifika għaliex m'għandhiex tiġi invokata l-‘however clause' tal-GL6 tal-VICH.