FrancophonIA/ELRC3.0 huggingface dataset:
English: By blocking two enzymes called ‘DNA gyrase' and ‘topoisomerase IV', pradofloxacin stops the bacteria from growing and multiplying.
Maltese: Billi jimblokka żewġ enzimi msejħin ‘DNA gyrase' u ‘topoisomerase IV', pradofloxacin iwaqqaf lill-batterji milli jikbru u jimmultiplikaw.
English: What is the risk associated with Veraflox?
Maltese: X'inhu r-riskju assoċjat ma' Veraflox?
English: The most common side effects in dogs and cats are mild transient gastro-intestinal disturbances including vomiting, although these have only been observed rarely.
Maltese: L-aktar effetti sekondarji komuni fil-klieb u l-qtates huma disturbi gastro-intestinali ħfief għal żmien qasir, inkluż ir-rimettar, għalkemm dawn ġew osservati biss f'każijiet rari.
English: The studies showed that Veraflox was at least as effective as the comparator medicines in all indications.
Maltese: L-istudji urew li Veraflox kien għallinqas effikaċi daqs il-mediċini komparaturi fl-indikazzjonijiet kollha.
English: This document is a summary of the European Public Assessment Report.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Ewropew ta' Valutazzjoni Pubblika (EPAR).
English: Pradofloxacin works by blocking some of the enzymes that are important in allowing bacteria to make copies of their DNA.
Maltese: Pradofloxacin jaħdem billi jimblokka xi wħud mill-enzimi li huma importanti f'li jippermettu lill-batterji jagħmlu kopji tad-DNA tagħhom.
English: More information on the benefit-risk balance can be found in the Scientific Discussion part of this EPAR.
Maltese: Aktar informazzjoni dwar il-bilanċ bejn il-benefiċċjuriskju jista' jinstab fid-Diskussjoni Xjentifika ta' dan l-EPAR.
English: People who are hypersensitive (allergic) to quinolone antibiotics should avoid any contact with Veraflox.
Maltese: Nies li huma sensittivi żżejjed (allerġiċi) għal antibijotiċi li fihom quinolone għandhom jevitaw kwalunkwe kuntatt ma' Veraflox.
English: In case of contact, rinse immediately with plenty of water.
Maltese: Għal aktar informazzjoni, ara l-fuljett ta' tagħrif.
English: The full EPAR for Viramune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ dwar Viramune jista' jinstab fuq is-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Viramune immediate-release has been studied in five studies involving a total of 1,956 adults.
Maltese: Viramune b'rilaxx immedjat ġie eżaminat f'ħames studji li involvew total ta' 1,956 adult.
English: EPAR summary for the public nevirapine
Maltese: Sommarju tal-EPAR għall-pubbliku nevirapine
English: The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Is-sustanza attiva f'Viramune, nevirapina, hija inibitur mhux nukleosidiku tat-transkrittażi inversa (non-nucleoside reverse transcriptase inhibitor, NNRTI).
English: This summary was last updated in 09- 2011.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 09-2011.
English: Viramune is a medicine that contains the active substance nevirapine.
Maltese: Viramune huwa mediċina li fiha s-sustanza attiva nevirapina.
English: It is available as immediaterelease (200 mg) and prolonged-release tablets (50, 100 and 400 mg) and as an oral suspension (50 mg/5 ml).
Maltese: Huwa disponibbli bħala pilloli b'rilaxx immedjat (200 mg) u bħala pilloli b'rilaxx fit-tul (50, 100 u 400 mg) u bħala sospensjoni orali (50 mg/5 ml).
English: Similar results were seen in HIV-1-infected children.
Maltese: Riżultati analogi ġew osservati fi tfal infettati mill-HIV-1.
English: This is a summary of the European public assessment report (EPAR) for Viramune.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Viramune.
English: Viramune has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions.
Maltese: Viramune ġie assoċjat ukoll ma' effetti sekondarji gravi fosthom is-sindromu ta' Stevens-Johnson u nekroliżi epidermika tossika (reazzjonijiet allerġiċi perikolużi għall-ħajja li jolqtu l-ġilda u l-membrani mukużi), epatite gravi u insuffiċjenza epatika, u reazzjonijiet allerġiċi gravi.
English: In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral load fell by 99% in the three-medicine group, compared with 96% in the two-medicine group after 40 to 52 weeks.
Maltese: F'151 pazjent ġdid għat-trattament (li qatt ma kienu sottoposti trattament għall-infezzjoni mill-HIV qabel), it-tagħbija virali waqgħet b'99% fil-grupp ittrattat bi tliet mediċini, meta mqabbel ma' 96% fil-grupp ittrattat b'żewġ mediċini wara 40 sa 52 ġimgħa.
English: The most common side effects with Viramune (seen in between 1 and 10 patients in 100) are rash, headache, nausea (feeling sick), fatigue, abdominal pain, diarrhoea, fever, hepatitis (inflammation of the liver) and signs of liver problems in the blood.
Maltese: L-effetti sekondarji l-aktar komuni b'Viramune (li jidhru f'bejn pazjent 1 u 10 minn 100) huma raxx, uġigħ ta' ras, nawżea (dardir), għejja, uġigħ addominali, dijarea, deni, epatite (infjammazzjoni talfwied) u sinjali ta' problemi epatiċi fid-demm.
English: It is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Maltese: Viramune huwa mediċina antivirali użata flimkien ma' mediċini antivirali oħra sabiex tittratta pazjenti infettati bil-virus tal-immunodefiċjenza umana tat-tip 1 (HIV-1), virus li jikkawża s-sindromu minn immunodefiċjenza akkwiżita (AIDS).
English: In 398 treatment-experienced adults (who had taken treatment for HIV infection before), Viramune in combination with zidovudine and lamivudine led to a 38% reduction in viral load after 48 weeks, compared with a 28% rise in those taking zidovudine and lamivudine without Viramune.
Maltese: Fi 398 adult li kienu diġà sottoposti għal trattament għallinfezzjoni mill-HIV qabel, Viramune, flimkien ma' zidovudina u lamivudina, wassal għal tnaqqis ta' 38% fit-tagħbija virali wara 48 ġimgħa, meta mqabbel ma' żieda ta' 28% f'dawk li ħadu zidovudina u lamivudina mingħajr Viramune.
English: Why has Viramune been approved?
Maltese: Għaliex ġie approvat Viramune?
English: The studies compared Viramune, taken in combination with zidovudine and didanosine (other antiviral medicines), with other antiviral medicines.
Maltese: L-istudji qabblu Viramune, meħud flimkien ma' zidovudina u didanosina (mediċini antivirali oħra), ma' mediċini antivirali oħra.
English: The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine) and that there was insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after Viramune treatment.
Maltese: Il-Kumitat innota li l-maġġoranza tal-esperjenza b'Viramune kienet f'kombinazzjoni mal-inibituri nukleosidiċi tat-transkrittażi inversa (nucleoside reverse transcriptase inhibitors - NRTIs, tip ta' mediċina antivirali) u li mhumiex disponibbli provi suffiċjenti għall-użu tat-trattament ta' kombinazzjoni li jinkludi inibitur tal-proteażi (tip ieħor ta' mediċina antivirali) wara t-trattament b'Viramune.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Viramune on 5 February 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Viramune fil-5 ta' Frar 1998.
English: Viramune is an antiviral medicine.
Maltese: Għandu jittieħed ma' tal-anqas żewġ mediċini antivirali oħra.
English: What is the risk associated with Viramune?
Maltese: X'inhu r-riskju assoċjat ma' Viramune?
English: Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or of dying.
Maltese: Fl-adulti ttrattati bi tliet mediċini ġew osservati wkoll żidiet akbar fl-għadd ta' ċelloli CD4, u riskju iktar baxx li lmarda tagħhom taggrava jew li jmutu.
English: What is Viramune?
Maltese: Kif jintuża Viramune?
English: CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV.
Maltese: Iċ-ċelloli T CD4 huma ċelloli tad-demm bojod li huma importanti fil-ġlieda kontra l-infezzjonijiet, imma li jinqatlu mill-HIV.
English: How has Viramune been studied?
Maltese: Kif ġie studjat Viramune?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Viramune's benefits are greater than its risks in combination with other antiviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Viramune huma akbar mir-riskji tiegħu bħala parti minn terapija ta' kombinazzjoni ma' prodotti mediċinali antivirali oħrajn għat-trattament ta' adulti, adoloxxenti, u tfal ta' kwalunkwe età infettati mill-HIV-1.
English: It must not be used in patients who have severe problems with their liver or signs of liver problems in the blood, or who are taking St John's wort (a herbal preparation used to treat depression).
Maltese: Ma għandux jintuża f'pazjenti bi problemi gravi fil-fwied jew sinjali ta' problemi epatiċi fid-demm jew li qegħdin jieħdu l-fexfiexa tar-raba' (St John's wort, preparazzjoni erbali użata għat-trattament tad-depressjoni).
English: The dose should then be increased to the standard dose of 200 mg twice a day using immediate release tablets or oral suspension or to the standard dose of 400mg once a day using the prolonged-release tablets are prescribed.
Maltese: Id-doża għandha mbagħad tiżdied għad-doża standard ta' 200 mg darbtejn kuljum permezz tal-pilloli b'rilaxx immedjat jew bis-sospensjoni orali jew għad-doża standard ta' 400 mg darba kuljum permezz tal-pilloli b'rilaxx fit-tul preskritti.
English: For children and adolescents, the starting dose is 150 mg per square metre of body surface area (calculated using the child's height and weight) or 4 mg/kg once a day for two weeks with Viramune oral suspension, after which the dose should be increased to a maintenance dose (calculated using the patient's body surface area or weight).
Maltese: Għat-tfal u l-adoloxxenti, id-doża tal-bidu hija ta' 150 mg għal kull metru kwadru tas-superfiċje talġisem (ikkalkulat permezz tat-tul u l-piż tat-tifel/tifla) jew ta' 4 mg/kg darba kuljum għal ġimagħtejn b'Viramune sospensjoni orali, u wara d-doża għandha tiżdied għal doża ta' manteniment (ikkalkulata permezz tas-superfiċje tal-ġisem jew tal-piż tal-pazjent).
English: Viramune, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines.
Maltese: Viramune, meta jittieħed flimkien ma' żewġ mediċini antivirali oħra, kien aktar effikaċi millkombinazzjonijiet ta' żewġ mediċini.
English: Viramune, taken alone or in combination with one or two other antiviral medicines, has also been studied in two studies including 478 children.
Maltese: Viramune, meħud waħdu jew flimkien ma' mediċina antivirali waħda oħra jew tnejn oħra, ġie eżaminat f'żewġ studji li inkludew 478 tifel u tifla.
English: Viramune does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Viramune ma jfejjaqx infezzjoni mill-HIV jew tal-AIDS, iżda jista' jittardja l-ħsara prodotta lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjat malAIDS.
English: How does Viramune work?
Maltese: Għal xiex jintuża Viramune?
English: For the full list of all side effects reported with Viramune, see the package leaflet.
Maltese: Għal-lista sħiħa ta' dawn l-effetti sekondarji kollha rrapportati b'Viramune, ara l-fuljett ta' tagħrif.
English: 4 mg/2 ml [up to 10] vials/ampoules
Maltese: 4 mg/2 ml [sa 10] kunjetti/ampulli
English: o For IM form:
Maltese: o Għall-forma IM:
English: o For the oral form 4 mg and 8 mg:
Maltese: o Għall-forma orali 4 mg u 8 mg:
English: SL59.0955 is also demethylated into didemethyl-thiocolchicine.
Maltese: SL59.0955 jiġi wkoll demetilat f'didemethyl-thiocolchicine.
English: The corresponding values of AUC are respectively 283 and 417 ng.h/mL.
Maltese: Il-valuri tal-AUC li jaqblu magħhom huma 283 u 417 ng.siegħa/mL rispettivament.
English: 4 mg [up to 30] hard capsules [up to 30] tablets
Maltese: 4 mg [sa 30] kapsula iebsa
English: For SL59.0955 these values are much lower: Cmax around 13 ng/mL and AUC ranging from 15.5 ng.h/mL (until 3h) to 39.7 ng.h/mL (until 24h).
Maltese: Għal SL59.0955 dawn il-valuri huma ħafna aktar baxxi: Cmax madwar 13 ng/mL u AUC fuq medda bejn 15.5 ng.siegħa/mL (sa 3 sigħat) sa 39.7 ng.siegħa/mL (sa 24 siegħa).
English: 8 mg [up to 14] hard capsules [up to14] orodispersible tablets
Maltese: 8 mg [sa 14-il] kapsula iebsa [sa 14-il] pillola li tinħall fil-ħalq
English: Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955.
Maltese: Il-metabolit attiv b'mod farmakoloġiku SL18.0740 u l-metabolit inattiv SL59.0955.
English: No data are available for the inactive metabolite SL59.0955.
Maltese: M'hemm l-ebda dejta disponibbli għall-metabolit inattiv SL59.0955.
English: The pharmacologically active metabolite SL18.0740 is also observed at lower concentrations with a Cmax of 11.7 ng/mL occurring 5 h post dose and an AUC of 83 ng.h/mL.
Maltese: Il-metabolit attiv b'mod farmakoloġiku SL18.0740 huwa osservat ukoll f'konċentrazzjonijiet aktar baxxi b'Cmax ta' 11.7 ng/mL li jseħħu 5 sigħat wara d-doża u AUC ta' 83 ng.siegħa/mL.
English: Elimination - After IM administration the apparent t1/2 of thiocolchicoside is 1.5h and the plasma clearance 19.2 L/h.
Maltese: - Wara għoti ġol-muskoli t-t 1/2 apparenti ta' thiocolchicoside hija 1.5 sigħat u t-tneħħija mill-plażma hija 19.2
English: Biotransformation After oral administration, thiocolchicoside is first metabolized in the aglycon 3demethyltiocolchicine or SL59.0955.
Maltese: Wara għoti mill-ħalq, thiocolchicoside l-ewwel jiġi metabolizzat f'aglycon 3-demethyltiocolchicine jew SL59.0955.
English: The aglycon metabolite (3-demethylthiocolchicine-SL59.0955) formed mainly after oral administration induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo oral micronucleus test in rat bone marrow administred orally).
Maltese: Il-metabolit aglycon (3-demethylthiocolchicine-SL59.0955) induċa ħsara fil-kromosomi in vitro (test talmikronukleju fuq il-limfoċiti umani in vitro) u ħsara fil-kromosomi in vivo (test tal-mikronukleju orali filmudullun tal-għadam tal-ġurdien in vivo).
English: After oral administration of thiocolchicoside, the SL18.0740 metabolite is eliminated with an apparent t1/2 ranging from 3.2 to 7 hours and the metabolite SL59.0955 has a t1/2 averaging 0.8h.
Maltese: Wara għoti ta' thiocolchicoside mill-ħalq, il-metabolit SL18.0740 jiġi eliminat b't1/2 apparenti fuq medda minn 3.2 sa 7 sigħat u l-metabolit SL59.0955 għandu t1/2 b'medja ta' 0.8 sigħat.
English: After a single oral dose of 8 mg of thiocolchicoside the Cmax and AUC of SL18.0740 are about 60 ng/mL and 130 ng.h/mL respectively.
Maltese: Wara doża waħda ta' 8 mg ta' thiocolchicoside mill-ħalq is-Cmax u l-AUC ta' SL18.0740 jkunu madwar 60 ng/mL u 130 ng.siegħa/mL rispettivament.
English: Thiocolchicoside was well tolerated following oral administration for periods of up to 6 months in both the rat and the non-human primate when administered at repeated doses of less than or equal to 2 mg/kg/day in the rat and less or equal to 2.5 mg/kg/day in non-human primate, and by the intramuscular route in the primate at repeated doses up to 0.5 mg/kg/day for 4 weeks.
Maltese: Thiocolchicoside kien ittollerat tajjeb wara għoti mill-ħalq għal perjodi sa 6 xhur kemm fil-far kif ukoll filprimat mhux uman meta ngħata b'dożi ripetuti ta' inqas minn jew ta' 2 mg/kg/jum fil-far u inqas minn jew 2.5 mg/kg/jum fil-primat mhux uman, u permezz tar-rotta ġol-muskolu fil-primat b'dożi ripetuti sa 0.5 mg/kg/jum għal 4 ġimgħat.
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is a risk factor for impairment of human fertility (see section 5.3).
Maltese: Thiocolchicoside u l-metaboliti tiegħu jeżerċitaw attività anewġenika f'livelli ta' konċentrazzjoni differenti, li hija magħrufa bħala fattur ta' riskju għal indeboliment fil-fertilità tal-bniedem (ara sezzjoni 5.3).
English: Aneuploidy is a modification in the number of chromosomes and loss of heterozygosity, which is recognized as a risk factor for teratogenicity, embryotoxicity/ spontaneous abortion, impaired male fertility, when impacting germ cells and a potential risk factor for cancer when impacting somatic cells.
Maltese: Anewplojdi hija modifika fin-numru ta' kromosomi u telf ta' eterozigożità, li huwa rikonoxxut bħala fattur ta' riskju għal teratoġeniċità, tossiċità tal-embriju/abort spontanju, fertilità indebolita fl-irġiel meta taffettwa ċ-ċelluli germ u kanċer meta taffettwa ċ-ċelluli somatiċi.
English: The aneugenic effect of SL59.0955 was observed at concentrations in the in vitro test and at exposures in the in vivo test close to those observed in human plasma at therapeutic doses of 8 mg twice daily per os. Aneugenic effect in dividing cells may result in aneuploid cells.
Maltese: L-effett anewġeniku ta' SL59.0955 kien osservat f'konċentrazzjonijiet fit-test in vitro u f'esponimenti fit-test in vivo qrib dawk osservati fil-plażma umana bid-dożi terapewtiċi ta' 8 mg darbtejn kuljum mill-ħalq.
English: Absorption - After IM administration, thiocolchicoside Cmax occur in 30 min and .reach values of 113 ng/mL after a 4 mg dose and 175 ng/mL after a 8 mg dose.
Maltese: - Wara għoti ġol-muskolu, l-ogħla konċentrazzjonijiet ta' thiocolchicoside fil-plażma jseħħu fi 30 min u jilħqu valuri ta' 113 ng/mL wara doża ta' 4 mg u 175 ng/mL wara doża ta' 8 mg.
English: Pregnancy
Maltese: Eliminazzjoni
English: The aneugenic effect of SL18.0740 was observed at concentrations in the in vitro test and at AUC plasma exposures in the in vivo test higher (more than 10 fold based on AUC) than those observed in human plasma at therapeutic doses.
Maltese: Leffett anewġeniku ta' SL18.0740 kien osservat fit-test in vitro u fl-esponiment tal-AUC tal-plażma fit-test in vivo f'konċentazzjonijiet ogħla (aktar minn 10 darbiet abbażi tal-AUC) minn dawk osservati fil-plażma tal-bniedem b'dożi terapewtiċi.
English: Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification).
Maltese: Barra minn hekk, kienu osservati anormalitajiet żgħar (kustilji żejda, dewmien fl-ossifikazzjoni).
English: SL59.0955 is then glucuroconjugated into SL18.0740 which has equipotent pharmacological activity to thiocolchicoside and thus supports the pharmacological activity after oral administration of thiocolchicoside.
Maltese: SL59.0955 imbagħad jiġi glukurokonjugat f'SL18.0740 li għandu attività farmakoloġika ekwipotenti għal thiocolchicoside u b'hekk isostni l-attività farmakoloġika wara għoti ta' thiocolchicoside mill-ħalq.
English: After repeated administration, thiocolchicoside induced gastro-intestinal disorders (enteritis, emesis) by oral route and emesis by IM route.
Maltese: Wara għoti ripetut, thiocolchicoside induċa disturbi gastrointestinali (enterite, rimettar) mir-rotta tal-ħalq u rimettar mir-rotta ġol-muskolu.
English: In the rabbit, thiocolchicoside showed maternotoxicity starting from 24 mg/kg/day.
Maltese: Fil-fenek, thiocolchicoside wera tossiċità fl-omm li bdiet mid-doża ta' 24 mg/kg/jum.
English: In a fertility study performed in rats, no impairment of fertility was seen at doses up to 12 mg/kg/day, i.e. at dose levels inducing no clinical effect.
Maltese: Fi studju dwar il-fertilità li sar fil-firien, ma deher l-ebda indeboliment fil-fertilità b'dożi sa 12 mg/kg, i.e. b'livelli ta' doża li ma tinduċi l-ebda effett kliniku.
English: Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration.
Maltese: Il-profil ta' thiocolchicoside ġie evalwat in vitro, u in vivo wara għoti fil-vini u mill-ħalq.
English: Pregnancy, breast-feeding and fertility
Maltese: Użu fit-tfal u fl-adolexxenti
English: Thiocolchicoside itself did not induce gene mutation in bacteria (Ames test), in vitro chromosomal damage (chromosome aberration test in human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus in mouse bone marrow administered intraperitoneally).
Maltese: Thiocolchicoside nnifsu ma induċiex tibdil ġenetiku fil-batterji (test ta' Ames), ħsara fil-kromosomi in vitro (test ta' aberrazzjoni fil-kromosomi tal-limfoċiti umani) u ħsara fil-kromosomi in vivo (mikronukleju ta' ġol-peritonew fil-mudullun tal-għadam tal-ġurdien in vivo).
English: The major glucuro-conjugated metabolite SL18.0740 did not induce gene mutation in bacteria (Ames test); however it induced in vitro chromosomal damage (in vitro micronucleus test on human lymphocytes) and in vivo chromosomal damage (in vivo micronucleus test in mouse bone marrow administered orally).
Maltese: Il-metabolit glukurokonjugat prinċipali SL18.0740 ma induċiex tibdil ġenetiku fil-batterji (test ta' Ames); madankollu huwa induċa ħsara fil-kromosomi in vitro (test tal-mikronukleju fuq il-limfoċiti umani in vitro) u ħsara fil-kromosomi in vivo (test tal-mikronukleju orali fil-mudullun tal-għadam tal-ġurdien in vivo).
English: Contents of the pack and other information [the currently approved wording should be deleted and replaced by the following] 30 tablets/capsules for the 4mg dose and 14 tablets/capsules for the 8mg dose.
Maltese: Kontenut tal-pakkett u informazzjoni oħra [il-kliem approvat s'issa għandu jitneħħa u minfloku jitqiegħed dan li ġej] 30 pillola/kapsula għad-doża ta' 4 mg u 14-il pillola/kapsula għad-doża ta' 8 mg. 10 kunjetti / ampolli għad-doża ta '4 mg / 2 ml.
English: The presence of the aglycon metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been assessed, therefore its formation using this route of administration can not be excluded.
Maltese: Il-presenza talmetabolit aglycon (3-demethylthiocolchicine-SL59.0955) wara t-teħid minn ġol-muskoli qatt ma ġie evalwat, għalhekk il-formazzjoni tiegħu b'dan il-mod ta' teħid ma jistax jiġi eskluż.
English: o For intramuscular form:
Maltese: o Għall-forma minn ġol-muskoli:
English: Thiocolchicoside and its metabolites exert aneugenic activity at different concentration levels, which is recognised as a risk factor for impairment of human fertility.
Maltese: Thiocolchicoside u l-metaboliti tiegħu jeżerċitaw attività anewġenika f'livelli ta' konċentrazzjonijiet differenti, li huwa rikonoxxut bħala fattur ta' riskju għal indeboliment tal-fertilità fil-bniedem.
English: SL18.0740 and SL59.0955 are found in urine and feces while the didemethyl-thiocolchicine is only recovered in feces.
Maltese: SL18.0740 u SL59.0955 jinstabu fl-awrina u fl-ippurgar filwaqt li didemethyl-thiocolchicine jiġi rkuprat biss fl-ippurgar.
English: In the rat, an oral dose of 12 mg/kg/day of thiocolchicoside caused major malformations along with foetotoxicity (retarded growth, embryo death, impairment of sex distribution rate).
Maltese: Fil-far, doża orali ta' 12-il mg/kg /jum ta' thiocolchicoside ikkawżat formazzjonijiet difettużi kbar flimkien ma' tossiċità fil-fetu (baqgħu lura fl-iżvilupp fiżiku, mewt tal-embriju, indebolimnet fir-rata ta' distribuzzjoni tas-sess).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection
Maltese: Kartuna ta' barra għall-kapsuli, ibsin/pilloli/pilloli li jinħallu fil-ħalq u għas-soluzzjoni għallinjezzjoni
English: The dose without toxic effect was 3 mg/kg/day.
Maltese: Id-doża mingħajr effett tossiku kienet ta' 3 mg/kg/jum.