FrancophonIA/ELRC3.0 huggingface dataset:
English: As the procedure concerns a range of products, the assessment has been limited to specific parts of the authorisations in accordance with Article 35(2) of Directive 2001/82/EC, as amended.
Maltese: Peress li l-proċedura tikkonċerna firxa ta' prodotti, ilvalutazzjoni ġiet limitata għall-partijiet speċifiċi ta' l-awtorizzazzjonijiet f'konformità ma' lArtikolu 35(2) tad-Direttiva 2001/82/KE, kif emendata.
English: The following indications have been justified:
Maltese: L-indikazzjonijiet li ġejjin ġew iġġustifikati:
English: On 27 November 2007, Ireland presented to the EMEA a referral under Article 35 of Directive 2001/82/EC, as amended, concerning all oral soluble powders containing sodium salicylate which are indicated for calves and pigs.
Maltese: Fis-27 ta' Novembru, l-Irlanda ppreżentat lill-EMEA referenza skond l-Artikolu 35 tad-Direttiva 2001/82/KE, kif emendat, dwar it-trabijiet orali kollha li jiddewbu li fihom is-saliċilat tas-sodju li huma indikati għall-għoġiela u l-ħnieżer.
English: The referral procedure started on 11 December 2007 and after adoption of a list of questions, the clock was stopped on 15 January 2008.
Maltese: Il-proċedura ta' referenza bdiet fil-11 ta' Diċembru 2007 u wara l-adozzjoni ta' lista ta' mistoqsijiet, twaqqfet fil-15 ta' Jannar 2008.
English: Sodium salicylate
Maltese: Saliċilat tas-sodju (Sodium salicylate)
English: Powder for oral solution
Maltese: Trab għal soluzzjoni orali
English: NA-Salicylaat, 100%, powder for solution for oral administration and NA-Salicylaat, 80% WSP
Maltese: NA-Salicylaat, 100%, trab għal soluzzjoni orali u NA-Salicylaat, 80% WSP
English: The clock was stopped again on 14 May 2008 and restarted on 6 June when responses to the outstanding issues where received.
Maltese: Il-proċedura reġgħet twaqqfet fl-14 ta' Mejju 2008 u reġgħet bdiet fis-6 ta' Ġunju meta waslu tweġibiet għall-kwistjonijiet pendenti.
English: The MAHs are requested to provide from the dossier submitted for each country of the EEA where the products are authorised: a) the Part I Summary of the dossier including SPCs, expert reports and the full composition of the products; b) if applicable, Part IV of the application dossier; c) an Assessment of the Periodic Safety Update Reports (PSURs) in relation to target animal safety and possible lack of efficacy.
Maltese: Il-MAHs huma mitlubin li jipprovdu mid-dossier sottomess għal kull pajjiz taż-ŻEE fejn ilprodotti huma awtorizzati: a) is-Sommarju ta' Parti I tad-dossier inkluż l-SPC, rapporti ta' l-esperti u l-kompożizzjoni sħiħa tal-prodotti; b) il-Parti IV tad-dossier ta' l-applikazzjoni, jekk applikabbli; c) Valutazzjoni tar-Rapporti Perjodiċi ta' Aġġornament tas-Sigurtà (PSURs) fir-rigward tassigurtà ta' l-annimali fil-mira u n-nuqqas fl-effikaċja possibbli.
English: Oral explanations were provided on 15 July 2008 and the CVMP Opinion was adopted on 16 July 2008.
Maltese: Ingħataw spjegazzjonijiet orali fil-15 ta' Lulju 2008 u l-Opinjoni tas-CVMP kienet adottata fis-16 ta' Lulju
English: Pigs
Maltese: Ħnieżer
English: Do not use in piglets of less than 4 weeks of age.
Maltese: Tużax fi driefeġ ta' età inqas minn 4 ġimgħat.
English: The dosage required for calves is however 40 mg/kg bodyweight.
Maltese: Fl-għoġiela, id-doża mogħtija għandha tiġi emendata sabiex taqra 40 mg/kg darba kuljum.
English: Having considered the grounds for referral and the responses provided by the Marketing Authorisation Holder and Applicant the CVMP concludes that:
Maltese: Wara li kkunsidra r-raġunijiet għar-referenza u t-tweġibiet ipprovduti mid-Detentur u l-Applikant ta' lAwtorizzazzjoni għat-Tqegħid fis-Suq, is-CVMP ikkonkluda li:
English: Pivotal documents, including the SPC, should be presented in English.
Maltese: Dokumenti bażi, inkluż l-SPC, għandhom jiġu ppreżentati bl-Ingliż.
English: 4.9 Amounts to be administered and administration route In calves, the dose administered should be amended to read 40 mg/kg once daily.
Maltese: .9 Doża rakkomandata u l-metodu ta' kif jingħata Fl-għoġiela, id-doża mogħtija għandha tiġi emendata sabiex taqra 40 mg/kg darba kuljum.
English: Given this outcome together with published data on the pharmacokinetics of sodium salicylate in calves and significant variation in individual pig concentrations post treatment2, the MAHs should justify that therapeutic concentrations are established and maintained following oral use of the drug through water medication and submit all available data that could substantiate the posology and dosage regimen of sodium salicylate when given orally to calves and pigs, together with a thorough discussion of the these data.
Maltese: B'dan ir-riżultat flimkien ma' dejta ppubblikata fuq il-farmakokinetika tas-saliċilat tas-sodju fl-għoġiela u l-varjazzjoni sinifikanti f'konċentrazzjonijiet individwali wara t-trattament2 fil-ħnieżer, il-MAHs għandhom jiġġustifikaw li l-konċentrazzjonijiet terapewtiċi huma stabbiliti u miżmumin wara l-użu orali tal-mediċina permezz ta' medikazzjoni bl-ilma u għandhom jippreżentaw id-dejta disponibbli
English: ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: ANNESS III EMENDI TAS-SOMMARJU TAL-KARATTERISTIĊI
English: NA-SALICYLAAT, 100%, powder for solution for oral administration
Maltese: NA-Salicylaat, 100%, trab għal soluzzjoni orali
English: It was recommended that Solacyl 100% powder for oral solution for calves and pigs should follow the outcome of the Community Referral according to Article 35(2) for sodium salicylate-containing oral soluble powders.
Maltese: Kien irrakkomandat li Solacyl 100% trab għal soluzzjoni għall-għoġiela u l-ħnieżer għandu jsegwi r-riżultat tar-referenza tal-Komunità skond lArtikolu 35(2) għat-trabijiet orali li jiddewbu li fihom is-saliċilat.
English: Pigs: For the treatment of inflammation in combination with concurrent antibiotic therapy.
Maltese: Għat-trattament ta' infjammazzjoni f'kombinazzjoni ma' terapija antibijotika mogħtija flistess ħin.
English: Ireland considered that there was a potentially serious risk to animal health by providing for the authorisation of a potentially ineffective medicine for mass use by farmers, especially when there are several authorised NSAIDs available for individual animal use.
Maltese: L-Irlanda kkunsidrat li kien hemm riskju potenzjalment serju għas-saħħa ta' l-annimali jekk tingħata lawtorizzazzjoni għal mediċina potenzjalment ineffikaċi għall-użu tal-massa mill-bdiewa, speċjalment meta hemm diversi
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER / APPLICANT
Maltese: TAL-PRODOTT MEDIĊINALI, SPEĊI TA' L-ANNIMALI, MNEJN JINGĦATA, U D-DETENTUR/APPLIKANT TA' LAWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ
English: NA-Salicylaat, 100%, powder for solution for oral administration 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Maltese: .2 Indikazzjonijiet għall-użu tal-prodott li jispeċifikaw l-ispeċi li fuqhom se jintuża l-prodott Għoġiela: trattament ta' appoġġ għal deni f'mard respiratorju akut, f'kombinazzjoni ma' terapija (eż.: antinfettiva) adegwata jekk meħtieġa.
English: Member State / Marketing Authorisation Number
Maltese: Stat Membru / Numru ta' lAwtorizzazzjoni għall-Kummerċ
English: Dopharma also described the history of the product since 1987, the year of its first authorisation in the Netherlands.
Maltese: Dopharma ddeskriviet ukoll l-istorja tal-prodott mill-1987, is-sena ta' l-ewwel awtorizzazzjoni tiegħu fl-Olanda.
English: • The benefit/risk balance of the product was shown to be positive, however in young animals, the summary of Product Characteristics should state that the product is not to be used in neonates or very young calves of less than 2 weeks of age nor in piglets of less than 4 weeks of age
Maltese: • Il-bilanċ ta' riskju/benefiċċju tal-prodott intwera li huwa pożittiv, madankollu f'annimali ta' età żgħira, is-Sommarju tal-Karatteristiċi tal-Prodott għandu jiddikjara li l-prodott la għandu jintuża fi frieħ li jkunu għadhom kif twieldu jew f'għoġiela ta' età żgħar ħafna ta' età inqas minn ġimagħtejn u lanqas fi driefeġ iżgħar minn 4 ġimgħat.
English: SOLACYL 100 %, powder for oral solution for calves and pigs 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Maltese: Chevita Ges m.b.H. ippreżentat il-partijiet tad-dossier mitlubin kollha (Parti I u Parti IV) kif ukoll studju tal-kalkolu tad-doża, li ma kienx inkluż fil-Parti IV tad-dossier ta' l-applikazzjoni.
English: 4.2 Indications for use, specifying the target species Calves: supportive treatment of pyrexia in acute respiratory disease, in combination with appropriate (e.g. anti-infective) therapy if necessary.
Maltese: Għoġiela: trattament ta' appoġġ għal deni f'mard respiratorju akut, f'kombinazzjoni ma' terapija (ngħidu aħna anti-infettiva) addattata jekk meħtieġa.
English: Consequently, the same conclusions on efficacy and safety apply to both products.
Maltese: Konsegwentement, l-istess konklużjonijiet dwar l-effikaċja u s-sigurtà japplikaw għaż-żewġ prodotti.
English: Ireland believed that the use of such a medicine for mass medication could mask the clinical signs of a developing infectious disease which could spread to other animals and thereby pose both an animal health and public health risk.
Maltese: L-Irlanda qieset li l-użu ta' mediċina bħal din għall-medikazzjoni tal-massa tista' taħbi sinjali kliniċi ta' marda infettiva li tkun qiegħda tiżviluppa li tista' tinfirex għall-annimali oħrajn u b'hekk tpoġġi f'riskju kemm is-saħħa ta' lannimal kif ukoll is-saħħa pubblika.
English: - the active substance is miglustat.
Maltese: - is-sustanza attiva hi miglustat.
English: Capsule Size: 4 (14.3 mm x 5.3 mm)
Maltese: Daqs tal-kapsula: 4 (14.3 mm x 5.3 mm)
English: Adult
Maltese: Adulti
English: Piramal Critical Care B.V. Rouboslaan 32 (ground floor) 2252 TR, Voorschoten The Netherlands
Maltese: Piramal Critical Care B.V. Rouboslaan 32 (ground floor) 2252 TR, Voorschoten L-Olanda
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 22 March 2017
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 22 Marzu, 2017
English: NN: {number}
Maltese: {numru}
English: Capsule shell gelatin purified water titanium dioxide (E171)
Maltese: Qoxra tal-kapsula gelatin ilma purifikat titanium dioxide (E171)
English: Small mean reductions in haemoglobin [-0.95 g/dL (95% CI: -1.38, -0.53)] and platelet count [-44.1 × 109/L (95% CI: -57.6, -30.7)] were observed between baseline and end of study.
Maltese: [-0.95 g/dL (95% CI: -1.38, -0.53)] u l-għadd tal-plejtlits [-44.1 × 109/L (95% CI: -57.6, -30.7)]
English: • measurement of vitamin B12 levels
Maltese: • kejl tal-livelli tal-vitamina B12.
English: Printing ink shellac glaze iron oxide black (E172) propylene glycol concentrated ammonia solution
Maltese: Shellac glaze iron oxide iswed (E172) propylene glycol concentrated ammonia solution
English: Pack size: 84 x 1 capsules.
Maltese: Daqs tal-pakkett: 84 x 1 kapsula.
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC: {number}
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM PC: {numru}
English: In vitro, glucosylceramide synthase is inhibited by miglustat with an IC50 of 20-37 µM.
Maltese: In vitro, glucosylceramide synthase huwa inibit minn miglustat b'IC50 ta' 20-37 µM.
English: SN: {number}
Maltese: SN:
English: Rouboslaan 32 (ground floor) 2252 TR, Voorschoten
Maltese: 2252 TR, Voorschoten
English: - the other ingredients are sodium starch glycolate (type A), povidone (K-29/32), magnesium stearate, gelatin, purified water, titanium dioxide (E171), printing ink (shellac glaze, iron oxide black (E172), propylene glycol and concentrated ammonia solution)
Maltese: - is-sustanzi l-oħra huma sodium starch glycolate (tip A), povidone (K-29/32), magnesium stearate, gelatin, ilma purifikat, titanium dioxide (E171), linka tal-istampar (shellac glaze, iron oxide iswed (E172), propylene glycol u concentrated ammonia solution)
English: Body surface area (m2)
Maltese: Erja tas-superfiċje talġisem (m2)
English: Apparent oral clearance (CL/F) is 230 ± 39 ml/min.
Maltese: Ir-rata ta' tneħħija apparenti mill-ħalq (apparent oral clearance) (CL/F) hi ta' 230 ± 39 ml/min.
English: Gastrointestinal disturbances
Maltese: Disturbi gastrointestinali Komuni ħafna
English: The clinical trial included 29 adult and juvenile patients in a 12-month controlled period, followed by extension therapy for an average total duration of 3.9 years and up to 5.6 years.
Maltese: Il-prova klinika inkludiet 29 pazjent adult u minorenni f'perijodu ikkontrollat ta' 12-il xahar, segwit minn estensjoni tat-terapija għal medja ta' tul totali ta' 3.9 snin u sa 5.6 snin.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: Mediċini: http://www.ema.europa.eu.
English: Capsule content sodium starch glycolate (Type A) povidone (K-29/32) magnesium stearate
Maltese: FARMAĊEWTIKU 6.1 Lista ta' eċċipjenti Kontenut tal-kapsula sodium starch glycolate (Tip A) povidone (K-29/32)
English: Investigations Common
Maltese: Investigazzjonijiet Komuni
English: The most abundant metabolite in urine was miglustat glucuronide accounting for 5% of the dose.
Maltese: L-aktar metabolit abbundanti fl-awrina kien miglustat glucuronide li jammonta għal 5% taddoża.
English: INFORMATION IN BRAILLE Yargesa 100 mg
Maltese: Yargesa 100 mg
English: After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Maltese: Wara 3 snin ta' kura kontinwa b'miglustat, kien hemm tnaqqis medju fil-volum tal-organu tal-fwied u tal-milsa ta' 17.5% u 29.6%, rispettivament.
English: In patients included in the clinical trial, 40%-50% of patients had platelet counts below the lower limit of normal at baseline.
Maltese: Fil-pazjenti inklużi fil-prova klinika, 40%-50% tal-pazjenti kellhom għadd ta' plejtlits taħt l-inqas limitu tan-normal fil-linja bażi.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia, headache, dizziness
Maltese: Newropatija periferali, atassija, amneżija, parasteżija, ipoestesija, uġigħ ta' ras, sturdament
English: Depression, insomnia, libido decreased Nervous system disorders Very common
Maltese: Depressjoni, nuqqas ta' rqad, tnaqqis fil-libido Disturbi fis-sistema nervuża Komuni ħafna
English: Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Maltese: Reazzjonijiet avversi minn provi kliniċi u rappurtar spontanju li seħħew f'>1% tal-pazjenti, huma mniżżlin fit-tabella taħt skont is-sistema tal-klassifika tal-organi u skond il-frekwenza (komuni ħafna: ≥1/10, komuni: ≥1/100, <1/10, mhux komuni: ≥1/1,000 sa <1/100, rari:
English: NAME OF THE MARKETING AUTHORISATION HOLDER Piramal Critical Care B.V.
Maltese: Piramal Critical Care B.V.
English: Niemann-Pick type C disease
Maltese: Marda ta' Niemann-Pick ta' tip Ċ
English: Pack size of 84 capsules.
Maltese: Daqs tal-pakkett ta' 84 kapsula.
English: The capsules are presented in a PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil.
Maltese: Il-kapsuli huma ppreżentati f'folja tal-PVC u polychlorotrifluoroethylene (PCTFE) issiġillata bil-fojl tal-aluminju.
English: Data to support safety and efficacy of Yargesa in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Maltese: Tagħrif li jsostni s-sigurtà u l-effikaċja ta' Yargesa fil-marda ta' Niemann-Pick ta' tip Ċ ġej minn prova klinika open-label prospettiva u minn servej retrospettiv.
English: The patients were switched to monotherapy with miglustat 100 mg t.i.d.
Maltese: Il-pazjenti inqalbu għal monoterapija b'miglustat 100 mg t.i.d.
English: Yargesa is indicated for the treatment of progressive neurological manifestations in adult patients and paediatric patients with Niemann-Pick type C disease (see sections 4.4, and 5.1).
Maltese: Yargesa huwa indikat għall-kura ta' manifestazzjonijiet newroloġiċi progressivi f'pazjenti adulti u pazjenti pedjatriċi li għandhom il-marda Niemann-Pick ta' tip Ċ (ara sezzjonijiet 4.4, u 5.1).
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Maltese: Avvenimenti gastro-intestinali, prinċipalment dijarea, kienu osservati f'aktar minn 80% tal-pazjenti, jew fil-bidu tal-kura jew b'mod intermittenti waqt il-kura (ara sezzjoni 4.8).
English: Each hard capsule contains 100 mg miglustat.
Maltese: Kull kapsula iebsa fiha 100 mg ta' miglustat.
English: Weight loss has been reported in 55% of patients using miglustat.
Maltese: Tnaqqis fil-piż kien irrappurtat f'55% tal-pazjenti li kienu qed jieħdu miglustat.
English: When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
Maltese: Meta mqabbel mar-riżultati wara 6 xhur, il-kontroll tal-marda baqa' ma nbidilx wara 18 u 24 xahar ta' monoterapija ta' miglustat (20 u 6 pazjent, rispettivament).
English: There was a mean increase of 22.2 × 109/l in platelet count, and a mean increase of 0.95 g/dl in haemoglobin concentration.
Maltese: Kien hemm żjieda medja ta' 22.2 × 109/l fl-għadd tal-plejtlets u żjieda medja ta' 0.95 g/dl fil-konċentrazzjoni tal-emoglobina.
English: The apparent volume of distribution of miglustat is 83 l. Miglustat does not bind to plasma proteins.
Maltese: Il-volum apparenti tad-distribuzzjoni ta' miglustat hu ta' 83 l. Miglustat ma jeħilx mal-proteini talplażma.
English: Adverse events observed included granulocytopenia, dizziness and paraesthesia.
Maltese: Avvenimenti avversi osservati kienu jinkludu granuloċitopenja, sturdament u parasteżija.
English: A mean increase in haemoglobin concentration of 0.26 g/dl and a mean platelet count increase of 8.29 × 109/l were observed.
Maltese: Żjieda medja filkonċentrazzjoni tal-emoglobina ta' 0.26 g/dl u żjieda medja fl-għadd tal-plejtlets ta' 8.29 × 109/l kienu osservati.
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Maltese: F'analiżi miġbura ta' tagħrif mhux ikkontrollat, punteġġi Z tad-densità tal-minerali fl-għadam fl-ispina lombari u flgħonq femorali żdiedu b'aktar minn 0.1 unità mil-linja bażi f'27 (57%) u 28 (65%) tal-pazjenti b'qisien lonġitudinali tad-densità tal-għadam.
English: The average half-life is 6-7 hours.
Maltese: Il-medja tal-half-life hi ta' 6-7 sigħat.
English: Following administration of a single dose of 100 mg 14C-miglustat to healthy volunteers, 83% of the radioactivity was recovered in urine and 12% in faeces.
Maltese: Wara għoti ta' doża waħda ta' 100 mg 14C-miglustat lill-voluntiera b'saħħithom, 83% tar-radjuattività kienet irkuprata fl-awrina u 12% fl-ippurgar.
English: In 11 clinical trials in different indications 247 patients were treated with miglustat at dosages of 50-200 mg t.i.d.
Maltese: Fi 11-il prova klinika dwar indikazzjonijiet differenti, 247 pazjent kienu kkurati b'Yargesa b'dożaġġ ta' 50-200 mg t.i.d. għal tul medju ta' 2.1 sena.
English: PVC and polychlorotrifluoroethylene (PCTFE) blister sealed with aluminium foil containing 21 capsules.
Maltese: In-natura u tal-kontenitur u ta' dak li hemm ġo fih Folja ta' PVC u polychlorotrifluoroethylene (PCTFE) issiġillata b'fojl tal-aluminju li fiha 21 kapsula.
English: At steady state, the concentration of miglustat in cerebrospinal fluid of six type 3 Gaucher disease patients was 31.4-67.2% of that in plasma.
Maltese: Fi stat stabbli, ilkonċentrazzjoni ta' miglustat fil-fluwidu ċerebrospinali ta' sitt pazjenti bil-marda ta' Gaucher ta' tip 3 kienet 31.4-67.2% ta' dik fil-plażma.
English: Tabulated list of adverse reactions
Maltese: Lista ta' reazzjonijiet avversi f'tabella
English: Miglustat is an inhibitor of glucosylceramide synthase, the enzyme responsible for the first step in the synthesis of most glycolipids.
Maltese: Miglustat hu impeditur ta' glycosylceramide synthase, l-enzima responsabbli għall-ewwel pass tas-sintesi ta' ħafna mill-glycolipids.
English: Administration of miglustat to male and female CD1 mice by oral gavage at dose levels of 210, 420 and 840/500 mg/kg/day (dose reduction after half a year) for 2 years resulted in an increased incidence of inflammatory and hyperplastic lesions in the large intestine in both sexes.
Maltese: L-għotja ta' miglustat lill-ġrieden CD1 maskili u femminnili permezz ta' gavage orali f'livelli ta' doża ta' 210, 420 u 840/500 mg/kg/kuljum (tnaqqis fid-doża wara nofs sena) għal sentejn wasslet għal żjieda fl-inċidenza ta' leżjonijiet infjammati u iperplastiċi fil-musrana l-kbira fiż-żewġ sessi.
English: Diarrhoea, flatulence, abdominal pain
Maltese: Dijarea, gass, uġigħ addominali
English: Administration of miglustat to male and female Sprague-Dawley rats by oral gavage for 2 years at dose levels of 30, 60 and 180 mg/kg/day resulted in an increased incidence of testicular interstitial cell (Leydig cell) hyperplasia and adenomas in male rats at all dose levels.
Maltese: L-għoti ta' miglustat lill-firien Sprague-Dawley maskili u femminnili permezz ta' gavage orali għal sentejn f'livelli ta' doża ta' 30, 60 u 180 mg/kg/kuljum wassal għal żjieda fl-inċidenza ta' iperplasja taċ-ċellola interstizjali testikolari (ċellola Leydig) u adenomi fil-firien maskili fil-livelli ta' dożaġġ kollha.
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged drug accounting for 70-80% of the dose.
Maltese: Fil-biċċa l-kbira miglustat huwa eliminat permezz ta' eskrezzjoni renali, b'irkupru millawrina tal-mediċina mhux mibdula li jammonta għal 70-80% tad-doża.
English: This means a daily maximum of three capsules (300 mg).
Maltese: Dan ifisser massimu ta' tliet kapsuli kuljum (300 mg).
English: The most common serious adverse reaction reported with miglustat treatment in clinical studies was peripheral neuropathy (see section 4.4).
Maltese: L-aktar reazzjoni avversa komuni u serja rrappurtata b'kura ta' miglustat fi studji kliniċi kienet newropatija periferali (ara sezzjoni 4.4).
English: Dosage
Maltese: FOLJI
English: Dosage in type 1 Gaucher disease
Maltese: Marda ta' Gaucher ta' Tip 1
English: Tremor Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Maltese: Madwar 37% tal-pazjenti fil-provi kliniċi bil-marda ta' Gaucher ta' tip 1, u 58% tal-pazjenti fi prova klinika bil-marda ta' Niemann-Pick ta' tip Ċ irrappurtaw li qabdithom rogħda meta ħadu l-kura.
English: At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
Maltese: Wara 12-il xahar, kien hemm tnaqqis medju fil-volum talorganu tal-fwied ta' 12.1% u tnaqqis medju fil-volum tal-milsa ta' 19.0%.
English: Effects on spermatogenesis
Maltese: Effetti fuq spermatoġenesi
English: BATCH NUMBER
Maltese: Numru tal-Lott