FrancophonIA/ELRC3.0 huggingface dataset:
English: • Do not use this medicine after the expiry date which is stated on the label and carton.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq it-tikketta u l-kartuna.
English: Shingrix elicited higher gE-specific immune responses (humoral and CMI) at 1 month post-dose 2 when compared to pre-vaccination levels.
Maltese: Shingrix ħareġ rispons immuni speċifiku għal gE ogħla (umorali u CMI) wara xahar wara d doża 2 meta mqabbel ma' livelli ta' qabel it-tilqim.
English: The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jwettaq l-attivitajiet u linterventi meħtieġa ta' farmakoviġilanza dettaljati fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal
English: Shingrix can be given if you have already been vaccinated with a live attenuated herpes zoster vaccine.
Maltese: Shingrix jista' jingħata jekk diġà ġejt imlaqqam b'vaċċin attenwat ħaj ta' herpes zoster.
English: This facilitates the recruitment and activation of antigen presenting cells carrying gE-derived antigens in the draining lymph node, which in turn leads to the generation of gE-specific CD4+ T cells and antibodies.
Maltese: Dan jiffaċilita r-reklutaġġ u l-attivazzjoni ta' ċelluli li jippreżentaw antiġen li jkunu qed iġorru antiġens derivati minn gE fil-limfonodu drenanti li mbagħad iwassal għall-ġenerazzjoni ta' ċelluli CD4+ T speċifiċi għal gE u antikorpi.
English: In subjects with at least one confirmed HZ episode, Shingrix significantly reduced the maximum average pain score versus placebo over the entire HZ episode (mean = 3.9 vs. 5.5, P-value = 0.049 and mean = 4.5 vs. 5.6, P-value = 0.043, in subjects ≥ 50 years (ZOE-50) and ≥ 70 years (ZOE-50 and
Maltese: Shingrix naqqas b'mod sinifikanti l-inċidenza ta' HZ meta mqabbel mal-plaċebo f'individwi li kellom ≥ 50 sena (6 vs. 210 każijiet f'ZOE-50) u f'individwi li kellhom ≥ 70 sena (25 vs. 284 każijiet flanaliżi miġbura ta' ZOE-50 u ZOE-70).
English: Very common myalgia Uncommon arthralgia
Maltese: Mhux komuni artralġja
English: NAME OF THE MEDICINAL PRODUCT Shingrix powder and suspension for suspension for injection Herpes zoster vaccine (recombinant, adjuvanted)
Maltese: Vaċċin ta' herpes zoster (rikombinanti, adjuvantati)
English: Very common injection site reactions (such as pain, redness, swelling), fatigue, chills, fever
Maltese: Komuni ħafna reazzjonijiet fis-sit tal-injezzjoni (bħal uġigħ, ħmura, nefħa), għeja, sirdat, deni
English: • allergic reactions including rash, hives (urticaria), swelling of the face, tongue or throat which may cause difficulty in swallowing or breathing (angioedema)
Maltese: • reazzjonijiet allerġiċi inkluż raxx, ħorriqija (urtikarja), nefħa tal-wiċċ, ilsien jew gerżuma li tista' tikkawża diffikultà biex il-persuna tibla' jew tieħu nifs (anġjoedema)
English: Most of these reactions were not long-lasting (median duration of 2 to 3 days).
Maltese: Ħafna minn dawn ir-reazzjonijiet ma damux (durata medja ta' 2 sa 3 ijiem).
English: The burden-of-illness (BOI) score incorporates the incidence of HZ with the severity and duration of acute and chronic HZ-related pain over a 6 month period following rash onset.
Maltese: Il-punteġġ tal-piż tal-marda (BOI, burden-of-illness) jinkorpora l-inċidenza tal-HZ bis-severità u ddurata ta' uġigħ relatat mal-HZ akut u kroniku fuq perjodu ta' 6 xhur wara bidu ta' raxx.
English: vs. 210 cases in ZOE-50) and in subjects ≥ 70 years (25 vs. 284 cases in the pooled analysis of ZOE50 and ZOE-70).
Maltese: 043, f'individwi li kellhom ≥ 50 sena (ZOE-50) u ≥ 70 sena (ZOE-50 u ZOE-70 miġbura), rispettivament).
English: What Shingrix looks like and contents of the pack
Maltese: Kif jidher Shingrix u l-kontenut tal-pakkett
English: Adults aged 50-69 years may experience more side effects compared to adults aged ≥ 70 years.
Maltese: L-adulti li għandhom 50-69 sena jistgħu jesperjenzaw aktar effetti sekondarji meta mqabbla mal-adulti ta' età ≥ 70 sena.
English: N Number of evaluable subjects at the specified time point Q1; Q3 First and third quartiles *** The gE-specific CD4[2+] data in the ≥70 years of age group were generated in ZOE-50 because CD4+ T
Maltese: *** Id-dejta ta' CD4[2+] speċifiku għal gE fil-grupp ta' età ta' ≥70 sena ġiet iġġenerata f'ZOE-50 minħabba li l-attività taċ-ċellula CD4+ T ma ġietx ivvalutata f'ZOE-70
English: After reconstitution:
Maltese: o Trab:
English: Shingrix is presented as a vial with a brown flip-off cap containing the powder (antigen) and a vial with a blue-green flip-off cap containing the suspension (adjuvant).
Maltese: Shingrix jiġi ppreżentat bħala kunjett b'tapp tat-tip flip-off kannella li jkun fih it-trab (antiġen) u kunjett b'tapp tat-tip flip-off blu jagħti fl-aħdar li jkun fih is-sospensjoni (adjuvant).
English: • Official batch release
Maltese: • It-trab huwa abjad.
English: How to store Shingrix
Maltese: L-effikaċja ta' Shingrix
English: • The other ingredients are:
Maltese: TA' EĊĊIPJENTI Eċċipjenti:
English: The adverse reactions of fever and shivering were more frequent when PPV23 vaccine is coadministered with Shingrix.
Maltese: Ir-reazzjonijiet avversi ta' deni u tertir kienu aktar frekwenti meta l-vaċċin ta' PPV23 ngħata fl-istess ħin ma' Shingrix.
English: 1 Injection set = injection syringe + 2 injection needles + cleansing swab.
Maltese: 1 Sett ta' l-injezzjoni = siringa tal-injezzjoni + 2 labar tal-injezzjoni + garża biex tnaddaf.
English: Blister (PVC/PVdC/Alu) 100 x 1 capsules (unit dose)
Maltese: 100 x 1 kapsula (doża waħda)
English: Blister (PVC/PVdC/Alu) 50 x 1 tablets
Maltese: 50 x 1 pillola (doża waħda)
English: (unit dose)
Maltese: Isem (ivvintat)
English: Further information on Feraccru 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: This overview was last updated in 03-2018.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar fi: 03-2018.
English: Feraccru received a marketing authorisation valid throughout the EU on 18 February 2016.
Maltese: Feraccru rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU fit-18 ta' Frar 2016.
English: Feraccru is available as capsules (30 mg).
Maltese: Feraccru jiġi bħala kapsuli (30 mg).
English: Severe side effects include abdominal pain, constipation and diarrhoea.
Maltese: Effetti sekondarji severi jinkludu uġigħ addominali, stitikezza u dijarea.
English: Other information about Feraccru
Maltese: Informazzjoni oħra dwar Feraccru
English: Feraccru contains the active substance ferric maltol.
Maltese: Feraccru fih is-sustanza attiva ferric maltol.
English: The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity.
Maltese: L-effetti sekondarji l-aktar komuni b'Feraccru (li jistgħu jaffetwaw sa persuna 1 minn kull 10) huma sintomi li jaffetwaw l-imsaren bħal uġigħ addominali (ta' żaqq), gass, stitikezza, skumdità u nefħa addominali, u dijarea; dawn l-effetti sekondarji huma normalment ta' intensità ħafifa għal waħda moderata.
English: Feraccru is effective at increasing haemoglobin levels in patients with iron deficiency and anaemia, (defined as haemoglobin levels lower than 12 g/dl for women and 13 g/dl for men).
Maltese: Feraccru huwa effettiv biex iżid il-livelli tal-emoglobina f'pazjenti b'defiċjenza tal-ħadid u anemija, (definiti bħala livelli tal-emoglobina aktar baxxi minn 12 g/dl għan-nisa u 13 g/dl għall-irġiel).
English: As for all medicines, data on the use of Feraccru are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Feraccru hija ssorveljata kontinwament.
English: In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.
Maltese: Barra minn hekk, madwar 65% tal-pazjenti li kienu qed jieħdu Feraccru kisbu livelli normali tal-emoglobina meta mqabbla mal-10 % ta' dawk fuq il-plaċebo.
English: What are the risks associated with Feraccru?
Maltese: X'inhuma r-riskji assoċjati ma' Feraccru?
English: In a study of 128 patients, those taking Feraccru for 12 weeks had their haemoglobin levels increase on average from 11.0 to 13.2 g/dl whereas in patients taking placebo (a dummy treatment)
Maltese: Fi studju ta' 128 pazjent, dawk li kienu qed jieħdu Feraccru għal 12-il ġimgħa kellhom żieda fil-livelli tagħhom tal-emoglobina bħala medja minn 11.0 sa 13.2 g/dl filwaqt li f'pazjenti li kienu qed jieħdu lplaċebo (kura finta), il-livelli tal-emoglobina baqgħu madwar 11.1 g/dl.
English: The active substance in Feraccru, ferric maltol, is an iron-containing compound.
Maltese: Is-sustanza attiva f'Feraccru, ferric maltol, hija kompost li fih il-ħadid.
English: What measures are being taken to ensure the safe and effective use of Feraccru?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Feraccru?
English: Feraccru has been shown to be effective in increasing haemoglobin levels in patients with iron deficiency anaemia.
Maltese: Feraccru ntwera li huwa effettiv fiż-żieda tal-livelli tal-emoglobina f'pazjenti b'anemija tad-defiċjenza tal-ħadid.
English: The safety profile of Feraccru is considered acceptable, with side effects that are mostly mild to moderate in intensity and in line with those of other iron preparations.
Maltese: Il-profil tas-sigurtà ta' Feraccru huwa kkunsidrat aċċettabbli, b'effetti sekondarji li huma l-aktar ħfief għal moderati fl-intensità u konformi ma' dawk ta' preparazzjonijiet oħra tal-ħadid.
English: This helps correct reduced production of haemoglobin (the oxygen-carrying pigment in red blood cells), anaemia (low levels of red blood cells) and any symptoms of the condition.
Maltese: Dan jgħin biex jikkoreġi produzzjoni mnaqqsa tal-emoglobina (il-pigment li jġorr l-ossiġenu fiċ-ċelluli ħomor taddemm), anemija (livelli baxxi ta' ċelluli ħomor tad-demm) u kwalunkwe sintomu tal-kundizzjoni.
English: Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.
Maltese: Feraccru huwa mediċina li fiha l-ħadid, li tintuża biex tikkura defiċjenza tal-ħadid (nuqqas ta' ħadid) fladulti.
English: For the full list of side effects of Feraccru, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji ta' Feraccru, ara l-fuljett ta' tagħrif.
English: Data on how the medicine is absorbed in the body show that Feraccru can also have an effect on patients with iron deficiency who have not already developed anaemia.
Maltese: Dejta dwar kif il-mediċina tiġi assorbita fil-ġisem turi li Feraccru jista' jkollu wkoll effett fuq pazjenti b'defiċjenza tal-ħadid li għadhom ma żviluppawx anemija.
English: For [indication*]
Maltese: Għall-[indikazzjoni*]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni dwar il-prodott tista' tiġi aġġornata sussegwentement mill-awtoritajiet kompetenti talIstat Membru, b'kollaborazzjoni mal-Istat Membru ta' referenza, kif xieraq, skont il-proċeduri stabbiliti fil-Kapitolu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING 7.
Maltese: Ż-ŻGĦAR EWLENIN 7.
English: Symptoms of overdose are e.g. sore throat, fever, mouth ulcers, diarrhoea, vomiting, skin rashes, bleeding or unusual weakness.
Maltese: Sintomi ta' doża eċċessiva huma pereżempju uġigħ fil-griżmejn, deni, ulċeri fil-ħalq, dijarea, rimettar, raxxijiet fuq il-ġilda, fsada jew dgħjufija mhux normali.
English: If you think you have taken more than the prescribed dose, consult a physician immediately.
Maltese: Jekk taħseb li ħadt aktar mid-doża ordnata, ikkonsulta tabib immedjatament.
English: Overdose could lead to serious adverse effects and may be fatal.
Maltese: Doża eċċessiva tista' twassal għal effetti avversi serji u tista' tkun fatali.
English: • All parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease) {This section should include the following wording:} Important warning about the dosage of <product name> (methotrexate) In the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis, etc.)>, <product name> (methotrexate) must only be used once a week.
Maltese: • Il-prodotti mediċinali kollha li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ kura darba fil-ġimgħa (eż. mard rewmatoloġiku/dermatoloġiku jew il-marda ta' Crohn): {Kwalunkwe referenza għall-qsim tad-doża għal indikazzjonijiet li jeħtieġu kura darba fil-ġimgħa għandha titneħħa mill-fuljett ta' tagħrif.}
English: (include weekday of intake in full)
Maltese: (inkludi b'mod sħiħ il-jum tal-ġimgħa għall-użu)
English: • Parenteral formulations of methotrexate-containing products with at least one indication requiring treatment once a week (e.g. rheumatologic/dermatological diseases or Crohn's disease)
Maltese: • Il-formulazzjonijiet parenterali ta' prodotti li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ kura darba fil-ġimgħa (eż. mard rewmatoloġiku/dermatoloġiku jew il-marda ta' Crohn)
English: Amendments to relevant sections of the product information
Maltese: Emendi għas-sezzjonijiet rilevanti tal-informazzjoni dwar il-prodott
English: [Using] too much of <product name> (methotrexate) may be fatal.
Maltese: [Jekk tuża] ammont kbir wisq ta' <isem ilprodott> (methotrexate), dan jista' jkun fatali.
English: The warning should read as follows:}
Maltese: It-twissija għandha taqra kif ġej:}
English: For [indication*] Use only once a week on ………………………………………………………………(include weekday of use in full) *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis, psoriasis, where applicable.
Maltese: Għall-[indikazzjoni*] uża darba fil-ġimgħa biss *Fejn applikabbli l-MAHs għandhom idaħħlu [indikazzjoni] f'termini raggruppati, eż. kolite, artrite, psorjasi.
English: • Parenteral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week and oncologic indication:
Maltese: • Formulazzjonijiet parentali ta' prodotti mediċinali li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ kura darba fil-ġimgħa u indikazzjoni onkoloġika:
English: OTHER SPECIAL WARNING(S), IF NECESSARY A framed warning should be placed at the front of the outer package in a clearly visible place, e.g. after the information on the name and the active substance; the letters should be of appropriate size; the respective wording and frame should be in red colour on a white background, but ensuring that it contrasts with the rest of the packaging.
Maltese: Fil-parti ta' quddiem tal-pakkett ta' barra, f'post li wieħed jista' jarah b'mod ċar għandha titpoġġa twissija fi kwadru, eż. wara l-informazzjoni dwar l-isem u s-sustanza attiva; l-ittri għandhom ikunu ta' daqs xieraq; il-formulazzjoni tal-kliem rispettiva u l-kwadru għandhom ikunu ta' kulur aħmar fuq sfond abjad, iżda filwaqt li jiġi żgurat li dawn huma f'kuntrast mal-bqija tal-pakkett.
English: Methotrexate should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
Maltese: Methotrexate għandu jingħata biss b'riċetta minn tobba b'għarfien espert fl-użu ta' methotrexate u fehim sħiħ tar-riskji ta' terapija b'methotrexate.
English: For [indication*] take/use [depending on formulation] only once a week *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Maltese: Għall-[indikazzjoni*] ħu/uża [skont il-formulazzjoni] darba fil-ġimgħa biss *Fejn applikabbli l-MAHs għandhom idaħħlu [indikazzjoni] f'termini raggruppati, eż. kolite, artrite, psorjasi.
English: Take only once a week on …………………………………………………….. (include weekday of intake in full) *[Indication] should be inserted by the MAHs in grouped terms, e.g. colitis, arthritis psoriasis, where applicable.
Maltese: …………………………………………………………(inkludi b'mod sħiħ il-jum tal-ġimgħa għall-użu) *Fejn applikabbli l-MAHs għandhom idaħħlu [indikazzjoni] f'termini raggruppati, eż. kolite, artrite, psorjasi.
English: • Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week:
Maltese: • Formulazzjonijiet orali ta' prodotti mediċinali li fihom methotrexate b'indikazzjonijiet li jeħtieġu kura darba fil-ġimgħa biss:
English: • Parenteral formulations of methotrexate-containing medicinal products only with indications requiring treatment once a week:
Maltese: • Formulazzjonijiet parentali ta' prodotti mediċinali li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ kura darba fil-ġimgħa:
English: Section 3: How to use <product name> {A boxed warning should be included in this section as follows:} Important warning about the dose of <product name> (methotrexate): Use <product name> only once a week for the treatment of <indication(s) requiring dosing once a week, e.g. rheumatoid arthritis, psoriasis etc.>.
Maltese: Fil-kura ta' <indikazzjoni(jiet) li jeħtieġu dożaġġ darba fil-ġimgħa, eż. artrite rewmatojde, psorjasi, eċċ.)>, <isem il-prodott> (methotrexate) għandu jintuża darba fil-ġimgħa biss.
English: On blisters the wording should be printed repeatedly in one or more (e.g. on multilingual packages) rows depending on readability.
Maltese: Fuq folji, il-formulazzjoni tal-kliem għandha tiġi stampata b'mod ripetut f'ringiela waħda jew aktar (eż. f'pakketti multilingwi) skont il-leġibbiltà.
English: • Oral formulations of methotrexate-containing medicinal products with at least one indication requiring treatment once a week: {This section should include the following wording:} THIS PATIENT CARD IS ONLY INTENDED FOR PATIENTS WHO USE A METHOTREXATECONTAINING MEDICINE FOR <INDICATIONS INSERTED BY THE MAHS IN GROUPED TERMS, E.G. COLITIS, ARTHRITIS, PSORIASIS, AS PER INDICATIONS LISTED IN PACKAGE LEAFLET>.
Maltese: {Din is-sezzjoni għandha tiġi emendata kif ġej (test ġdid sottolinjat, test imħassar ingassat):} Huma biss dawk it-tobba li għandhom esperjenza fil-karatteristiċi varji tal-prodott mediċinali u fil-mod ta' azzjoni tiegħu li għandhom jagħtu methotrexate b'riċetta.
English: • All oral formulations of methotrexate-containing medicinal products with at least one indication requiring once weekly dosing: {The following wording should be reflected:}
Maltese: • Formulazzjonijiet orali ta' prodotti mediċinali li fihom methotrexate b'tal-inqas indikazzjoni waħda li teħtieġ kura darba fil-ġimgħa:
English: Patient card text
Maltese: Sommarju tal-karatteristiċi tal-prodott
English: Tablet
Maltese: 14-il pillola
English: Oral use
Maltese: Għal użu orali
English: 17 January 2014 EMA/40615/2014
Maltese: EMA/40615/2014
English: Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Maltese: Ir-Repubblika Ċeka, Franza, il-Greċja, l-Ungerija, l-Italja, Malta, il-Portugall u Spanja.
English: Thiocolchicoside is authorised through national procedures in the Czech Republic, France, Greece, Hungary, Italy, Malta, Portugal and Spain.
Maltese: Thiocolchicoside huwa awtorizzat permezz ta' proċeduri nazzjonali fir-Repubblika Ċeka, Franza, ilGreċja, l-Ungerija, l-Italja, Malta, il-Portugall u Spanja.
English: Aneuploidy is an established risk factor for teratogenicity, embryotoxicity or spontaneous abortion, and impaired male fertility.
Maltese: L-anewplojdija hija fattur ta' riskju stabbilit għal teratoġeniċità, embrijotossiċità jew abort spontanju, u indeboliment fil-fertilità maskili.
English: When given intramuscularly, the maximum dose should be 4 mg every 12 hours, for up to 5 days.
Maltese: Meta jingħata ġol-muskoli, id-doża massima għandha tkun ta' 4 mg kull 12-il siegħa, sa 5 ijiem.
English: • The current findings do not apply to topical preparations of thiocolchicoside.
Maltese: • Is-sejbiet attwali ma japplikawx għall-preparazzjonijiet topiċi ta' thiocolchicoside.
English: The review of systemic thiocolchicoside-containing medicines was triggered on 15 February 2013 at the request of Italy, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni ta' mediċini li fihom thiocolchicoside sistemiku nbdiet fil-15 ta' Frar 2013 fuq talba talItalja, skont l-Artikolu 31 tad-Direttiva 2001/83/KE.
English: Preclinical studies indicated that the thiocolchicoside metabolite 3demethylthiocolchicine (M2, SL59.0955) may be associated with aneuploidy (abnormal chromosome number and loss of heterozygosity) in dividing cells, at levels of exposure not much greater than those achieved in the body with maximum recommended oral doses.
Maltese: Studji prekliniċi indikaw li lmetabolit ta' thiocolchicoside 3-demethylthiocolchicine (M2, SL59.0955) jista' jkun marbut ma' anewplojdija (għadd anormali ta' kromożomi u telf ta' eterożigożità) f'ċelloli li jkunu qegħdin jinqasmu, f'livelli ta' esponiment mhux ħafna ogħla minn dawk miksuba fil-ġisem bid-dożi orali massimi rakkomandati.
English: The review of thiocolchicoside was triggered by the Italian medicines regulatory agency, AIFA, following new experimental evidence which suggested that thiocolchicoside was broken down in the body into a metabolite called M2 or SL59.0955 that could damage dividing cells, resulting in aneuploidy (an abnormal number or arrangement of chromosomes).
Maltese: Ir-reviżjoni ta' thiocolchicoside nbdiet mill-aġenzija regolatorja tal-mediċini Taljana, AIFA, wara evidenza sperimentali ġdida li ssuġġeriet li fil-ġisem thiocolchicoside jitkisser f'metabolit magħruf bħala M2 jew SL59.0955 li jista' jagħmel ħsara liċ-ċelloli li jkunu qed jinqasmu, li jwassal għal anewplojdija (għadd jew arranġament anormali ta' kromożomi).
English: • The maximum recommended oral dose is 8 mg every 12 hours; treatment duration should be no more than 7 consecutive days.
Maltese: • Id-doża orali massima rakkomandata hija ta' 8 mg kull 12-il siegħa; it-tul tal-kura m'għandux ikun aktar minn 7 ijiem konsekuttivi.
English: • Systemic thiocolchicoside is recommended only as adjuvant treatment for acute muscle contractures in spinal pathology, for adults and adolescents from 16 years of age.
Maltese: • Thiocolchicoside sistemiku huwa rakkomandat biss bħala kura aġġuvanti għal kontrazzjonijiet muskolari akuti f'patoloġija tas-sinsla tad-dahar, għal adulti u adolexxenti minn 16-il sena 'l fuq.
English: Thiocolchicoside metabolites were not associated with mutagenicity (changes to genes) or clastogenicity (structural damage to chromosomes).
Maltese: Il-metaboliti ta' thiocolchicoside ma kinux marbuta ma' mutaġeniċità (tibdil lill-ġeni) jew klastoġeniċità (ħsara strutturali lill-kromożomi).
English: It is thought to act on receptors in the nervous system that are involved in the regulation of muscle function.
Maltese: Huwa maħsub li jaġixxi fuq riċetturi fis-sistema nervuża li huma nvoluti fir-regolazzjoni talfunzjoni tal-muskoli.
English: In theory, long-term exposure might increase the risk of cancer although there is currently no evidence of this.
Maltese: Fit-teorija, esponiment fit-tul jista' jżid ir-riskju ta' kanċer, għalkemm attwalment ma hemm l-ebda evidenza ta' dan.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally-binding decision, valid across the EU, on 17 January 2014.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li approvatha u ħarġet deċiżjoni finali legalment vinkolanti, valida fl-UE kollha, fis-17 ta' Jannar 2014.