FrancophonIA/ELRC3.0 huggingface dataset:
English: The 2-year PFS rate estimates for the high-risk CLL/SLL population were 78.8% [95% CI (67.3, 86.7)] and 15.5% [95% CI (8.1, 25.2)] in the IMBRUVICA+obinutuzumab and chlorambucil+obinutuzumab arms, respectively.
Maltese: L-istimi tar-rati ta' PFS ta' sentejn għall-popolazzzjoni ta' CLL/SLL b'riskju għoli kienu 78.8% [95% CI (67.3, 86.7)] u 15.
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Janssen-Cilag B.V.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON 420 MG TABLET
Maltese: KARTUNA GĦALL-PILLOLA TA' 420 MG
English: • Waldenström's macroglobulinaemia (WM), a type of cancer affecting white blood cells called lymphocytes.
Maltese: • Makroglobulinemija ta' Waldenström (WM), tip ta' kanċer li jaffettwa ċ-ċelluli bojod tad-demm imsejħa limfoċiti.
English: In patients who develop atrial fibrillation on therapy with IMBRUVICA a thorough assessment of the risk for thromboembolic disease should be undertaken.
Maltese: F'pazjenti li żviluppaw fibrillazzjoni talatriju waqt li kienu fuq terapija b'IMBRUVICA għandha ssir stima fil-fond tar-riskju ta' mard tromboemboliku.
English: There are no data in patients with severe renal impairment or patients on dialysis (see section 5.2).
Maltese: Ma hemm l-ebda data f'pazjenti b'indeboliment qawwi tal-kliewi jew pazjenti fuq id-dijalisi (ara sezzjoni 5.2).
English: • temporary episode of neurologic dysfunction caused by loss of blood flow, stroke.
Maltese: • episodju temporanju ta' disfunzjoni newroloġika kkawżata minn telf ta' fluss tad-demm, puplesija.
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging Pack size EU/1/12/763/001 Ecansya
Maltese: Il-pakkett li jmiss malprodott
English: 1 bottle + 1 oral syringe 10 ml
Maltese: 1 flixkun + 1 siringa tal-ħalq 10 ml
English: Packaging Content Package size
Maltese: Daqs tal-pakkett
English: Strength Pharmaceutical Form
Maltese: Numru ta' l-EU Isem inventat Qawwa Għamla farmaċewtika
English: This overview was last updated in 07-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 07-2018.
English: A cycle lasts 3 weeks.
Maltese: Ċiklu jdum 3 ġimgħat.
English: Further information on Ceplene can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Ceplene
Maltese: Informazzjoni oħra dwar Ceplene
English: Ceplene received a marketing authorisation valid throughout the EU on 7 October 2008.
Maltese: Ceplene rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE fis-7 ta' Ottubru 2008.
English: Ceplene and interleukin-2 are given for 10 cycles.
Maltese: Ceplene u interleukin-2 jingħataw għal 10 ċikli.
English: AML is rare, and Ceplene was designated an ‘orphan medicine' (a medicine used in rare diseases) on 11 April 2005.
Maltese: AML hija rari, u Ceplene ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fil11 ta' April 2005.
English: Ceplene contains the active substance histamine dihydrochloride.
Maltese: Ceplene fih is-sustanza attiva histamine dihydrochloride.
English: Why has Ceplene been approved?
Maltese: Għaliex Ceplene ġie approvat?
English: The active substance in Ceplene, histamine dihydrochloride, is an immune modulator.
Maltese: Is-sustanza attiva f'Ceplene, histamine dihydrochloride, hija modulatur immuni.
English: What information is still awaited for Ceplene?
Maltese: Liema informazzjoni għadha mistennija għal Ceplene?
English: The effectiveness of Ceplene has been studied in one main study involving 320 adults with AML who were in remission following leukaemia treatment.
Maltese: L-effikaċja ta' Ceplene ġiet studjata fi studju ewlieni wieħed li involva 320 adult b'AML li kienu f'remissjoni wara kura għal-lewkimja.
English: Ceplene is a medicine used in combination with interleukin-2 (a cancer medicine) as maintenance treatment in adults with acute myeloid leukaemia (AML), a type of cancer affecting the white blood cells.
Maltese: Ceplene huwa mediċina li tintuża flimkien ma' interleukin-2 (mediċina tal-kanċer) bħala kura ta' manteniment f'adulti b'lewkimja mijelojde akuta (AML), tip ta' kanċer li jaffettwa ċ-ċelloli bojod taddemm.
English: This improves the effectiveness of interleukin-2, a medicine that stimulates the immune system to attack cancerous cells.
Maltese: Din ittejjeb l-effikaċja ta' interleukin-2, mediċina li tistimula s-sistema immuni biex tattakka ċelloli kanċerużi.
English: As for all medicines, data on the use of Ceplene are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Ceplene hija ssorveljata kontinwament.
English: Each Ceplene injection must be given slowly over five to 15 minutes, in a different site from the interleukin-2 injection, and preferably in the thigh or abdomen (belly).
Maltese: Kull injezzjoni ta' Ceplene għandha tingħata bil-mod għal ħames sa 15-il minuta, f'sit differenti mill-injezzjoni ta' interleukin-2, u preferibbilment fil-koxxa jew fl-addome (fiż-żaqq).
English: It must also not be used in patients who have received a bone marrow transplant from a donor, or who are taking steroids (medicines used to reduce or prevent inflammation) given systemically (given by mouth or by injection), clonidine (used to reduce high blood pressure) or histamine H2 blockers (used to treat stomach ulcers, indigestion or heartburn).
Maltese: Dan m'għandux jintuża wkoll f'pazjenti li rċivew trapjant tal-mudullun minn donatur, li qegħdin jiedħu sterojdi (mediċini li jintużaw biex inaqqsu jew jipprevjenu infjammazzjoni) mogħtija sistemikament (mogħtija mill-ħalq jew permezz ta' injezzjoni), clonidine (jintuża biex inaqqas pressjoni tad-demm għolja) jew imblokkaturi ta' istamina H2 (jintużaw biex jikkuraw ulċeri fl-istonku, indiġestjoni jew ħruq ta' stonku).
English: What are the risks associated with Ceplene?
Maltese: X'inhuma r-riskji assoċjati ma' Ceplene?
English: For patients who were into their first remission the combination of Ceplene and interleukin-2 was more effective than no treatment in increasing the time until AML came back or the patient died from any cause: the average time without disease increased from 291 days with no treatment to 450 days after treatment with Ceplene and interleukin-2.
Maltese: Għal pazjenti li kienu fl-ewwel remissjoni tagħhom, il-kombinazzjoni ta' Ceplene u interleukin-2 kienet aktar effettiva milli l-ebda kura biex jiżdied iż-żmien sakemm irritornat l-AML jew sakemm il-pazjent miet minn xi kawża: iż-żmien medju mingħajr il-marda żdied minn 291 jum bl-ebda kura għal 450 jum wara kura b'Ceplene u interleukin-2.
English: The most common side effects with Ceplene (seen in more than 1 patient in 10) are flushing (reddening), headache, tiredness, fever and inflammation or redness at the injection site.
Maltese: L-effetti sekondarji l-aktar komuni b'Ceplene (li dehru f'aktar minn 1 minn kull 10) huma vampati (ħmura), uġigħ ta' ras, għeja, deni u infjammazzjoni jew ħmura fis-sit tal-injezzjoni.
English: When Ceplene is given with interleukin-2, it helps the immune system to kill the leukaemia cells that may remain in the body during remission.
Maltese: Meta Ceplene jingħata ma' interleukin-2, dan jgħin lis-sistema immuni biex toqtol liċ-ċelloli tal-lewkimja li jistgħu jibqgħu fil-ġisem waqt irremissjoni.
English: The recommended dose of Ceplene is one injection twice a day, one to three minutes after an interleukin-2 injection.
Maltese: Id-doża rakkomandata ta' Ceplene hija injezzjoni waħda darbtejn kuljum, minuta sa tliet minuti wara injezzjoni ta' interleukin-2.
English: Ceplene has been authorised under ‘exceptional circumstances'.
Maltese: Ceplene ġie awtorizzat taħt ‘ċirkustanzi ta' eċċezzjoni'.
English: How is Ceplene used?
Maltese: Kif jaħdem Ceplene?
English: For the full list of side effects of Ceplene, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Ceplene, ara l-fuljett ta' tagħrif.
English: This means that it changes the activity of the immune system (the body's natural defences).
Maltese: Dan ifisser li din tibdel l-attività tas-sistema immuni (id-difiżi naturali tal-ġisem).
English: How does Ceplene work?
Maltese: Kif jintuża Ceplene?
English: Side effects reported with Ceplene are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Ceplene huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: • four cases of spontaneous abortion,
Maltese: • erba' każijiet ta' abort spontanju,
English: Benefit -risk balance
Maltese: Bilanċ tal-benefiċċju -riskju
English: 1 Parry 2000 & 2002; Kirsch-Volders 2002 2 Kirkland DJ Et al. 2001
Maltese: Kirsch-Volders 2002 2 Kirkland DJ Et al. 2001
English: Clinical Safety
Maltese: Sigurtà klinika
English: Pre-clinical studies
Maltese: Studji pre-kliniċi
English: • Teratogenicity is classified as an important identified risk.
Maltese: • It-teratoġeniċità hija kklassifikata bħala riskju importanti identifikat.
English: Carcinogenicity is an important potential risk.
Maltese: Il-karċinoġeniċità hija riskju potenzjali importanti.
English: Thiocolchicoside (TCC) is a semi-synthetic sulfurated colchicoside derivative with a muscle relaxant pharmacological activity.
Maltese: Thiocolchicoside (TCC) huwa derivattiv semi-sintetiku ta' sulfurated colchicoside b'attività farmakoloġika li tirrilassa l-muskoli.
English: • an in vitro micronucleus (MN) test in primary culture of human lymphocytes with the aglycone metabolite (SL59.0955), with centromere staining (Whitwell J., 2012);
Maltese: • test in vitro tal-mikronukleu (MN) f'kultura primarja ta' limfoċiti umani bil-metabolit aglikonu (SL59.0955), bi tlewwin taċ-ċentromeru (Whitwell J., 2012);
English: Genotoxicity data on aglycone metabolite SL59.0955 (M2)
Maltese: Dejta dwar il-ġenotossiċità dwar il-metabolit aglikonu SL59.0955 (M2)
English: However a follow-up study (in vivo micronucleus test) defined a no-effect level of 39.6 mg/kg.
Maltese: Madankollu studju ta' segwitu (test in vivo tal-mikronukleji) iddefinixxa livell bla ebda effett ta' 39.6 mg/kg.
English: The aneugenic effect was observed at LOEL corresponding to only 1.6 x human Cmax and 4.1 x AUC (8mg bid, Per Os (PO)).
Maltese: L-effett anewġeniku kien osservat f'LOEL li jikkorrispondi għal 1.6 x biss is-Cmax tal-bniedem u 4.1 x l-AUC (8mg darbtejn kuljum, mill-ħalq (PO)).
English: Postmarketing spontaneous cases were collected based on the reports recorded in two MAHs' global pharmacovigilance databases (cut-off dates of 15 February 2013 and 29 April 2013 respectively).
Maltese: Il-każijiet spontanji wara t-tqegħid fis-suq inġabru abbażi tar-rapporti reġistrati f'żewġ databases ta' farmakoviġilanza globali tal-MAHs (dati ta' skadenza 15 ta' Frar 2013 u 29 ta' April 2013 rispettivament).
English: It was concluded that M1 (SL18.0740) is devoid of mutagenic (gene mutations) and clastogenic (structural chromosome damage) potential, but is able to induce aneuploidy (numerical chromosome damage).
Maltese: Ġie konkluż li M1 (SL18.0740) m'għandux potenzjali mutaġeniku (mutazzjonijiet tal-ġeni) u klastoġeniku (ħsara strutturali fil-kromożomi), iżda huwa kapaċi jinduċi anewplojdija (ħsara numerika fil-kromożomi).
English: This was associated with M1 plasma AUC of 4073 ng.h/mL, which is more than 20 times higher than M1 exposure observed in human after a 8 mg bid oral dose of TCC (175 ng.h/mL at 30 min).
Maltese: Dan kien assoċjat ma' AUC ta' M1 fil-plasma ta' 4073 ng.h/mL, li huwa aktar minn 20 darba l-esponiment għal M1 osservat fil-bniedem wara doża orali ta' TCC ta' 8 mg darbtejn kuljum (175 ng.h/mL f'30 min).
English: The study protocol should be provided within the RMP.
Maltese: Il-protokoll tal-istudju għandu jiġi pprovdut flRMP.
English: On 21 February 2013, the CHMP started a referral procedure for TCC containing medicinal products.
Maltese: Fil-21 ta' Frar 2013, is-CHMP beda proċedura ta' riferiment għal prodotti mediċinali li fihom TCC.
English: In females, a positive response was observed at doses of 25, 50, 70 and 100 mg/kg/d based on group mean and individual data.
Maltese: Fin-nisa, kien osservat rispons pożittiv f'dożi ta' 25, 50, 70 u 100 mg/kg/d abbażi ta' dejta tal-medja tal-grupp u dejta individwali.
English: Case review reports from 2004 up to 29 April 2013 from the second database reported 23 cases secondary to exposure during pregnancy and / or exposition in utero:
Maltese: Rapporti ta' reviżjoni ta' każijiet mill-2004 sad-29 ta' April 2013 mit-tieni database irrapportaw 23 każ sekondarji għal esponiment matul it-tqala u / jew esponiment fl-utru:
English: • an in vivo MN test in rat bone marrow following administration of aglycone metabolite (SL59.0955) by oral route in rats with centromere staining and with a full assessment of exposure to SL59.0955 and to 3-O-glucuronidated aglycone metabolite (SL18.0740) to better assess the threshold of exposure (Wase K., October 2012).
Maltese: • test in vivo tal-MN fil-mudullun tal-firien wara l-għoti tal-metabolit aglikonu (SL59.0955) mill-ħalq fil-firien bi tlewwin taċ-ċentromeru u b'valutazzjoni sħiħa tal-esponiment għal SL59.0955 u għallmetabolit aglikonu 3-O-glucuronidated (SL18.0740) biex jiġi vvalutat aħjar il-limitu ta' esponiment (Wase K., Ottubru 2012).
English: In addition, the CHMP was of the view that the package size should be restricted according to the new treatment-days scheme recommended (up to 30 tablets or capsules/4 mg pack, up to 14 tablets or capsules/8 mg pack and up to 10 vials/ampoules).
Maltese: Barra minn hekk, is-CHMP kien tal-fehma li d-daqsijiet tal-pakketti għandhom jiġu ristretti skont l-iskema l-ġdida ta' ġranet ta' kura rakkomandata (sa 30 pillola jew kapsula/pakkett ta' 4 mg, sa 14-il pillola jew kapsula/pakkett ta' 8 mg u sa 10 kunjetti/ampulli).
English: The CHMP also considered that the use of TCC should be avoided during puberty (12 to 16-18 years) due to potential risk on fertility.
Maltese: Is-CHMP ikkunsidra wkoll li l-użu ta' TCC għandu jiġi evitat waqt il-pubertà (12 sa 16-18-il sena) minħabba riskju potenzjali fuq il-fertilità.
English: In the in vivo MN test in rat bone marrow, after M2 oral administration once daily for two consecutive days at doses of 25, 50, 70, 100 or 150 mg/kg/d, the rats bone marrow micronucleus test was found negative in males.
Maltese: It-test in vivo tal-MN fil-mudullun tal-firien, wara l-għoti ta' M2 mill-ħalq darba kuljum għal jumejn konsekuttivi f'dożi ta' 25, 50, 70, 100 jew 150 mg/kg/d, it-test tal-mikronukleji fil-mudullun tal-firien instab li kien negattiv fl-irġiel.
English: No cases of cancer, congenital abnormalities, spontaneous abortion and impaired male fertility were retrieved from a review of clinical trials and literature.
Maltese: L-ebda każijiet ta' kanċer, anormalitajiet konġenitali, abort spontanju u indeboliment fil-fertilità maskili ma kienu rkuprati minn reviżjoni tal-provi kliniċi u l-letteratura.
English: The CHMP was therefore of the view that risk minimisation measures (RMMs) should be undertaken in order to address the risks of teratogenicity, embryo-toxicity/spontaneous abortions, impaired male fertility and cancer.
Maltese: Is-CHMP kien għalhekk tal-fehma li miżuri ta' minimizzazzjoni tar-riskju (RMMs) għandhom jittieħdu sabiex jiġu ndirizzati r-riskji ta' teratoġeniċità, tossiċità tal-embriju/aborti spontanji, indeboliment talfertilità maskili u kanċer.
English: • 20 cases due to exposure during the embryonic period, of which: o two cases of teratogenic effects (malformations) associated with exposure in early pregnancy (the first quarter is the period during which the risk is the greatest), o four cases resulting in discontinuation of the pregnancy (3 spontaneous abortions and one voluntary abortion not due to medical reason), o five cases with a favourable evolution (no effect on the new born), o nine cases with an unknown evolution of the pregnancy due to lack of documentation.
Maltese: • 20 każ minħabba esponiment matul il-perjodu embrijoniku, li minnhom: o żewġ każijiet ta' effetti teratoġeniċi (malformazzjonijiet) assoċjati ma' esponiment fil-bidu tat-tqala (l-ewwel kwart huwa l-perjodu li fih ir-riskju huwa l-akbar), o erba' każijiet li wasslu għat-twaqqif tat-tqala (3 aborti spontanji u abort wieħed volontarju mhux minħabba raġuni medika), o ħames każijiet b'evoluzzjoni favorevoli (l-ebda effett fuq it-tarbija tat-twelid), o disa' każijiet li l-evoluzzjoni tat-tqala mhijiex magħrufa minħabba nuqqas ta' dokumentazzjoni.
English: • six cases of congenital abnormalities (i.e. one multiple malformations leading to abortion, one pulmonary hypoplasia, one cleft palate, one spina bifida, one Poland's syndrome, one patent ductus arteriosus),
Maltese: • sitt każijiet ta' anormalitajiet konġenitali (jiġifieri każ wieħed ta' bosta malformazzjonijiet li wasslu għal abort, każ wieħed ta' ipoplażja pulmonari, każ wieħed ta' palat mixquq, każ wieħed ta' spina bifida, każ wieħed tas-sindromu ta' Poland, każ wieħed ta' patent ductus arteriosus),
English: Continuous monitoring of any safety signal correlated with aneuploidy (i.e. teratogenicity, embryo-foetal toxicity / spontaneous abortion, impaired male fertility and cancer) and pregnancy reporting to collect structured data on accidental exposure to the drug should be performed.
Maltese: Għadu jsir monitoraġġ kontinwu ta' kwalunkwe sinjal ta' sigurtà korrelatat ma' anewplojdija (jiġifieri teratoġeniċità, tossiċità embriju-fetali / abort spontanju, indeboliment tal-fertilità maskili u kanċer) u rapportar dwar ittqala biex tinġabar dejta strutturata dwar esponiment aċċidentali għall-mediċina.
English: Since no relevant genetic toxicology studies were previously performed with the aglycone metabolite SL59.0955, complementary studies (chromosome damage assays) were performed in order to investigate the genotoxic profile of this metabolite and its ability to induce aneuploidy in nonclinical in vitro (up to 600 µg/mL) and in vivo (up to 150 mg/kg):
Maltese: Peress li ma saru l-ebda studji tossikoloġiċi ġenetiċi rilevanti preċedenti bil-metabolit aglikonu SL59.0955, saru studji komplimentari (analiżi tal-ħsara fil-kromożomi) biex jinvestigaw il-profil ġenotossiku ta' dan ilmetabolit u l-kapaċità tiegħu li jinduċi anewplojdija f'testijiet mhux kliniċi in vitro (sa 600 µg/mL) u in vivo (sa 150 mg/kg):
English: Genotoxicity data on TCC and its main circulating metabolite SL18.0740 (M1)
Maltese: Dejta dwar il-ġenotossiċità dwar TCC u l-metabolit ċirkolanti ewlieni tiegħu SL18.0740 (M1)
English: But no NOAEL for aneugenic effects was identified in rat females (LOEL = 25 mg/kg) and no clear dose related effect was observed because only slight difference in exposure (AUC0-24 and Cmax) with 3demethylthiocolchicine (SL59.0955) were observed between the different doses in males and females.
Maltese: Iżda ma kien identifikat l-ebda NOAEL għal effetti anewġeniċi fil-firien nisa (LOEL = 25 mg/kg) u ma kien osservat l-ebda effett ċar relatat mad-doża peress li kienet osservata biss differenza żgħira fl-esponiment (AUC0-24 u Cmax) b'3-demethylthiocolchicine (SL59.0955) bejn id-dożi differenti flirġiel u n-nisa.
English: Various genetic toxicology studies were conducted on TCC and on its major identified metabolite 3-O-glucuronidated aglycone (SL18.0740), which is the active metabolite.
Maltese: Saru bosta studji tossikoloġiċi ġenetiċi dwar TCC u fuq il-metabolit ewlieni identifikat tiegħu 3-O-glucuronidated aglycone (SL18.0740), li huwa l-metabolit attiv.
English: A significantly increased cancer risk would in general be dependent on long-term/chronic exposure/dosing with the aneugen.
Maltese: Ġeneralment żieda sinifikanti fir-riskju ta' kanċer tkun tiddependi minn esponiment/dożaġġ fit-tul/kroniku blanewġenu.
English: New studies were performed in 2011 and 2012 regarding the genotoxicity of the parent compound (TCC), its main circulating metabolite SL18.0740 and the aglycone metabolite SL59.0955.
Maltese: Fl-2011 u 2012 saru studji ġodda dwar ilġenotossiċità tal-kompost ġenitur (TCC), il-metabolit ċirkolanti ewlieni tiegħu SL18.0740 u l-metabolit aglikonu SL59.0955.
English: Clinical trials and post marketing spontaneous reports were submitted by the MAHs.
Maltese: Provi kliniċi u rapporti spontanji wara t-tqegħid fis-suq kienu ppreżentati mill-MAHs.
English: • one case of threat of premature delivery.
Maltese: • każ wieħed ta' theddida ta' ħlas prematur.
English: However, whether the exposure to M2 would be below a threshold of aneugenicity (including a sufficient safety margin) is unknown since M2 has not been analysed in the available clinical kinetic studies.
Maltese: Madankollu, mhuwiex magħruf jekk l-esponiment għal M2 ikunx taħt il-limitu ta' anewġeniċità (inkluż marġini biżżejjed tas-sigurtà) peress li M2 ma kienx analizzat fl-istudji kinetiċi kliniċi disponibbli.
English: • and 2 cases with unknown exposure period: o 1 case of teratogenic effects (malformations) associated with exposure in early pregnancy, o 1 case with an unknown evolution of the pregnancy due to lack of documentation.
Maltese: • u 2 każijiet li l-perjodu ta' esponiment ma kienx magħruf: o każ 1 ta' effetti teratoġeniċi (malformazzjonijiet) assoċjati ma' esponiment fil-bidu tattqala, o każ 1 li l-evoluzzjoni tat-tqala mhijiex magħrufa minħabba nuqqas ta' dokumentazzjoni.
English: After discontinuation of the above-mentioned phase I clinical trial with TCC, the genotoxic potential of the aglycone metabolite SL59.0955 (M2) was further investigated.
Maltese: Wara li l-prova klinika tal-fażi I b'TCC imsemmija hawn fuq twaqqfet, il-potenzjal ġenotossiku talmetabolit aglikonu SL59.0955 (M2) kompla jiġi investigat.
English: Aneuploidy (variation in the number of chromosomes and loss of heterozygosity) is recognised as a potential risk factor for cancer when impacting somatic cells, and teratogenicity, embryotoxicity/spontaneous abortions and impaired male fertility when impacting germ cells1.
Maltese: L-anewplojdija (varjazzjoni fl-għadd ta' kromożomi u telf ta' eterożigożità) hija rikonoxxuta bħala fattur ta' riskju potenzjali għall-kanċer meta taffettwa ċ-ċelloli somatiċi, u teratoġeniċità, tossiċità talembriju/aborti spontanji u indeboliment fil-fertilità maskili meta taffettwa ċ-ċelloli tal-mikrobi1.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for thiocolchicoside containing medicinal products for systemic use (see annex I).
Maltese: • Il-Kumitat qies il-proċedura taħt l-Artikolu 31 tad-Direttiva 2001/83/KE għal prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku (ara anness I).
English: The results obtained from one of the metabolites' studies (metabolite SL59.0955, M2) led to concerns: new data on the aneugenic effect of the M2 metabolite of TCC generated from the submitted preclinical studies indicated a signal of genotoxic potential
Maltese: Ir-riżultati miksuba minn wieħed mill-istudji tal-metaboliti (metabolit SL59.0955, M2) wasslu għal tħassib: dejta ġdida dwar l-effett anewġeniku tal-metabolit M2 ta' TCC iġġenerata mill-istudji prekliniċi ppreżentati indikat sinjal ta' potenzjal ġenotossiku
English: • The Committee considered all available data from pre-clinical, clinical studies, pharmacoepidemiological studies, published literature, post-marketing experience on the safety of thiocolchicoside containing medicinal products for systemic use with regards to its genotoxicity.
Maltese: • Il-Kumitat qies id-dejta kollha disponibbli minn studji pre-kliniċi u kliniċi, studji farmakoepidemjoloġiċi, il-letteratura ppubblikata, l-esperjenza ta' wara t-tqegħid fis-suq dwar issigurtà ta' prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku fir-rigward talġenotossiċità tiegħu.
English: Subsequent safety assessments focusing on genotoxic potential were issued in 20012 and 20033 .
Maltese: Valutazzjonijiet sussegwenti tassigurtà li ffokaw fuq il-potenzjal ġenotossiku kienu ppubblikati fl-20012 u fl-20033 .