FrancophonIA/ELRC3.0 huggingface dataset:
English: Oxalic acid dihydrate 39.4 mg (equivalent to 28.1 mg of oxalic acid) Colourless, clear to slightly turbid dispersion.
Maltese: 39.4 mg ta' diidrat tal-aċidu ossaliku (ekwivalenti għal 28.1 mg ta' aċidu ossaliku) Dispersjoni mingħajr kulur, ċara għal kemmxejn imdardra.
English: CLINICAL PARTICULARS 4.1 Target species Honey bees (Apis mellifera)
Maltese: KLINIKU 4.1 Speċi li fuqhom ser jintuża l-prodott
English: This did not affect long-term development of colonies.
Maltese: Dan m'affettwax l iżvilupp fit-tul tal-kolonji.
English: When possible, rotate the use of this veterinary medicinal product with another approved varroacide with a different mode of action to decrease the potential for Varroa mites to develop resistance.
Maltese: Meta possibbli, biddel l-użu ta' dan il prodott mediċinali għall-użu veterinarju ma' varroaċida approvata oħra b'tip ta' azzjoni differenti sabiex tnaqqas il-potenzjal tad-dud varroażi li jiżviluppaw reżistenza.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this product.
Maltese: L-addittivi elenkati f'sezzjoni 6.1 tal-Karatteristiċi tal-Prodott fil Qosor huma jew sustanzi ammissibbli li għalihom m'hemmx bżonn ta' limiti massimi ta' residwi kif indikat fit-tabella numru 1 tal-anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 jew huma kkunsidrati li ma jaqgħux fi ħdan l-iskop tar-Regolament (KE) Nru 470/2009 meta użati bħal f'dan il-prodott mediċinali veterinarju.
English: Oxalic acid dihydrate 35.0 g (equivalent to 25.0 g of oxalic acid)
Maltese: 35.0 g ta' Accidu ossaliku diidrat (ekwivalenti għal 25.0
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion oxalic acid dihydrate
Maltese: VETERINARJU It-trab u s-soluzzjoni Oxybee għal dispersjoni tad-doqqajs ta' 39.4 mg/ml. diidrat tal-aċidu ossaliku
English: No entry Antiinfectious agent
Maltese: Klassifikazzjo ni terapewtika
English: All colonies in the same apiary should be treated simultaneously to avoid re-infestations.
Maltese: Il-kolonji kollha fl-istess ġarra għandhom jiġu kkurati b'mod simultanju sabiex jiġu evitati infestazzjonijiet mill-ġdid.
English: Do not mix with any other veterinary medicinal product.
Maltese: Tħallatx ma' ebda prodott mediċinali veterinarju ieħor.
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid)
Maltese: 17.5 g ta' diidrat tal-aċidu ossaliku (ekwivalenti għal 12.5 g ta' aċidu ossaliku)
English: 750 g oxalic acid dihydrate solution to achieve 888 ml bee-hive dispersion.
Maltese: Soluzzjoni ta' 750 g ta' diidrat tal-aċidu ossaliku biex tinkiseb dispersjoni ta' 888 ml ta' doqqajs.
English: One sachet of 125 g of powder contains:
Maltese: Qartas wieħed ta' 125 g trab fih:
English: Pack sizes:
Maltese: Prekawzjonijiet oħra:
English: The major contributor to the acaricidal effects is the low pH of the dispersion, as opposed to the volume of dispersion administered.
Maltese: L-akbar kontributur għall-effetti akariċidali huwa l-pH baxx tad-dispersjoni, għall-kuntrarju tal-volum tad-dispersjoni amministrata.
English: Solution:
Maltese: Qartas:
English: In clinical trials, increased bee mortality was very commonly observed.
Maltese: Fi provi kliniċi, mortalità akbar tan-naħal ġiet osservata b'mod komuni ħafna.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Maltese: VETERINARJU It-trab u s-soluzzjoni Oxybee għal dispersjoni tad-doqqajs ta' 39.4 mg/ml għan-naħal tal-għasel.
English: All colonies in the same apiary should be treated simultaneously to avoid re-infestation.
Maltese: Il-kolonji kollha fl-istess ġarra għandhom jiġu kkurati b'mod simultanju sabiex tiġi evitata l infestazzjoni mill-ġdid.
English: One bottle of 750 g solution contains:
Maltese: Flixkun wieħed ta' soluzzjoni ta' 750 g fih: Sustanza Attiva:
English: The outside temperature during treatment with Oxybee should be at least 3 °C.
Maltese: It-temperatura ta' barra matul il-kura b'Oxybee għandha tkun tal-anqas 3 °C.
English: One bottle of 375 g solution contains:
Maltese: Flixkun wieħed ta' soluzzjoni ta' 375 g fih: Sustanza Attiva:
English: Avoid disturbing the hives in the days following treatment.
Maltese: Evita li tiddisturba d-doqqajs fil-jiem ta' wara l-kura.
English: The final bee-hive dispersion is to be trickled onto the bees in the seams.
Maltese: Id-dispersjoni finali tad-doqqajs għandha titqattar għal fuq in-naħal fil-ħjut.
English: 1 bottle with 750 g oxalic acid dihydrate solution and two sachets (each containing 125 g) of sucrose powder to achieve 888 ml bee-hive dispersion after mixing with sucrose.
Maltese: Flixkun wieħed b'750 g ta' soluzzjoni ta' diidrat tal-aċidu ossaliku u żewġ qratas (b'125 g il-wieħed) ta' trab tas-sukrożju biex tinkiseb dispersjoni ta' 888 ml ta' doqqajs wara li jitħallat mas-sukrożju.
English: Open the sachet(s) of the sucrose powder with a pair of scissors.
Maltese: Aħsel idejk u l-ġilda esposta bis-sapun u ħafna ilma minnufih.
English: Place the bottle containing the oxalic acid dihydrate solution into warm (30 - 35 °C) water.
Maltese: Poġġi l-flixkun li fih is-soluzzjoni tad-diidrat tal-aċidu ossaliku f'ilma sħun (30 - 35 °C).
English: SPECIAL WARNING(S)
Maltese: PERJODU(I)
English: 1 bottle with 375 g oxalic acid dihydrate solution and one sachet (125 g) of sucrose powder, to achieve 444 ml bee-hive dispersion after mixing with sucrose.
Maltese: DAQS TAL-PAKKETT Flixkun wieħed b'375 g ta' soluzzjoni ta' diidrat tal-aċidu ossaliku u qartas wieħed (125 g) ta' trab tas sukrożju, biex tinkiseb dispersjoni ta' 444 ml ta' doqqajs wara li jitħallat mas-sukrożju.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Oxybee powder for bee-hive dispersion sucrose
Maltese: Il-prodott mediċinali għall-użu veterinarju għandu jintuża bħala kura fi ħdan programm Integrat tal
English: Oxybee must only be applied once in brood-free colonies.
Maltese: Oxybee għandu jiġi applikat darba biss f'kolonji mingħajr doqqajs.
English: Oxalic acid dihydrate is externally distributed on the bees through body contact and/or social food exchange (trophallaxis).
Maltese: Id-diidrat tal-aċidu ossaliku jiġi distribwit esternament fuq in-naħal permezz ta' kuntatt fuq il-ġisem u/jew l-iskambju soċjali tal-ikel (trophallaxis).
English: After overdosing, increased bee mortality was very commonly observed.
Maltese: Wara dożaġġ eċċessiv, mortalità akbar tan-naħal ġiet osservata b'mod komuni.
English: Marker residue
Maltese: Proprjetajiet ambjentali
English: Oxybee powder and solution for 39.4 mg/ml bee-hive dispersion for honey bees
Maltese: Trab u soluzzjoni Oxybee għal dispersjoni tad-doqqajs ta' 39.4 mg/ml għan-naħal tal-għasel
English: Oxalic acid dihydrate 17.5 g (equivalent to 12.5 g of oxalic acid) Clear and colourless solution.
Maltese: 17.5 g ta' diidrat tal-aċidu ossaliku (ekwivalenti għal 12.5 g ta' aċidu ossaliku) Soluzzjoni ċara u mingħajr kulur.
English: This veterinary medicinal product is highly acidic and could have irritating and corrosive effects on the skin, eyes and mucous membranes.
Maltese: Dan il-prodott mediċinali għall-użu veterinarju huwa aċiduż ħafna u jista' jkollu effetti ta' irritazzjoni u korrużivi fuq il-ġilda, l-għajnejn u l-membrana mukużi.
English: Oxalic acid
Maltese: g ta' aċidu ossaliku)
English: STATEMENT OF ACTIVE SUBSTANCES One bottle contains:
Maltese: 1 ml ta' dispersjoni mħallta tad-doqqajs fiha: Sustanza Attiva:
English: Seek medical advice immediately and show the package leaflet or the label to the physician.
Maltese: Taqbiżx id-doża rakkomandata u tamministrax dan il-prodott mediċinali għall-użu veterinarju aktar minn darba.
English: The concomitant use of other acaricidal products should be avoided because increased toxicity to bees might occur.
Maltese: L-użu konkomitanti ta' prodotti akariċidali oħra għandu jiġi evitat għax jista' jkun hemm żieda fittossiċità tan-naħal.
English: The final bee-hive dispersion should be a colourless, clear to slightly turbid dispersion.
Maltese: Id-dispersjoni finali taddoqqajs għandha tkun dispersjoni mingħajr kulur, ċara għal kemxejn imdardra.
English: Oxybee has corrosive properties on corrosion-sensitive parts of beekeeping equipment.
Maltese: Oxybee għandu karatteristiċi korrużivi fuq partijiet sensittivi għall-korrużjoni tat-tagħmir għat-trobbija tan-naħal.
English: Powder for bee-hive dispersion (sachet):
Maltese: Parir dwar l-għoti korrett:
English: The veterinary medicinal product should be used as a treatment within an Integrated Varroa Management program with mite drop monitored regularly.
Maltese: Il-prodott mediċinali għall-użu veterinarju għandu jintuża bħala kura fi ħdan programm Integrat tal-Ġestjoni tal-Varroażi b'monitoraġġ regolari tat-tnaqqis fid-dud.
English: Labelling
Maltese: Tikkettar
English: Summary of Product Characteristics 4.4 Special warnings and precautions for use
Maltese: Sommarju tal-Karatteristiċi tal-Prodott 4.4
English: Drinking alcohol whilst taking {product name} may make you feel more sleepy or increase the risk of serious side effects such as shallow breathing with a risk of stopping breathing, and loss of consciousness.
Maltese: Jekk tixrob l-alkoħol waqt li tieħu {isem tal-prodott}, dan jista' jġiegħlek tħossok aktar imħeddel/imħeddla jew iżid ir-riskju ta' effetti sekondarji serji bħal teħid tan-nifs ħafif ħafna b'riskju li tieqaf tieħu n-nifs, u li tintilef minn sensik.
English: Applicable to all products except those containing a polymethacrylate-triethylcitrate coating as modified-release mechanism.
Maltese: Applikabbli għall-prodotti kollha ħlief dawk li fihom kisja ta' polimetakrilat-tritiċitrat bħala mekkaniżmu ta' rilaxx modifikat.
English: Package Leaflet Section 2 - Before you take {product name}
Maltese: Fuljett ta' Tagħrif Sezzjoni 2 - Qabel ma tieħu {isem tal-prodott}
English: Alcohol may enhance the pharmacodynamic effects of {product name}; concomitant use should be avoided.
Maltese: L-alkoħol jista' jtejjeb l-effetti farmakodinamiċi ta' {isem tal-prodott}; l-użu fl-istess ħin għandu jiġi evitat.
English: Note: These amendments to the SPC, Package Leaflet and Labelling are valid at the time of the Commission Decision.
Maltese: Nota: Dawn l-emendi għall-SPC, għall-Fuljett ta' Tagħrif u għat-Tikketta huma validi fil-ħin tad-Deċiżjoni tal-Kummissjoni.
English: For products having warnings regarding the interaction with alcohol, the existing wording in the SPC and package leaflet should be replaced by the wording below.
Maltese: Għall-prodotti li għandhom twissijiet rigward l-interazzjoni mal-alkoħol, il-formulazzjoni eżistenti fl-SPC u fil-fuljett ta' tagħrif għandha tiġi sostitwita bil-formulazzjoni ta' hawn taħt.
English: It is recommended not to drink alcohol while you're taking {product name}.
Maltese: Huwa rrakkomandat li ma tixrobx alkoħol waqt li tkun qed tieħu {isem tal-prodott}.
English: For products not having warnings regarding the interaction with alcohol in the currently approved SPC and package leaflet, the below wording should be added.
Maltese: Għall-prodotti li m'għandhomx twissijiet rigward l-interazzjoni mal-alkoħol fl-SPC u fil-fuljett ta' tagħrif attwalment approvati, għandha tiżdied il-formulazzjoni ta' hawn taħt.
English: Relevant Sections of the Summary of Product Characteristics, Package Leaflet and labelling
Maltese: Taqsimiet Rilevanti tas-Sommarju tal-Karatteristiċi talProdott, il-Fuljett ta' Tagħrif u t-tikkettar
English: Pharmaceutical Form
Maltese: 10 pilloli
English: EMA/474480/2010 EMEA/H/C/000679
Maltese: EMEA/H/C/000679
English: The marketing authorisation holder is Pfizer Limited.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq huwa Pfizer Limited.
English: This summary was last updated in 08-2010.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 08-2010.
English: It is available as yellow-toorange, capsule-shaped tablets (100 mg).
Maltese: Huwa disponibbli f'pilloli f'forma ta' kapsuli sofor fl-oranġjo (100 mg).
English: Thelin is a medicine that contains the active substance sitaxentan sodium.
Maltese: Thelin huwa mediċina li fiha s-sustanza attiva sitaxentan sodium.
English: The ‘class' reflects the seriousness of the disease: ‘class III' involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: “it-III klassi” tinvolvi llimitazzjoni mmarkata tal-eżerċizzju fiżiku.
English: This document is a summary of the European public assessment report (EPAR) for Thelin.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: Three doses of Thelin (50, 100 and 300 mg) have been compared with placebo (a dummy treatment) in three main studies involving a total of 523 patients with PAH, most of whom had class II or III disease.
Maltese: Tqabblu tliet dożaġġi ta' Thelin (50, 100 u 300 mg) ma' plaċebo (trattament finta) fi studju ewlieni wieħed li involva 523 pazjent li jbatu bil-PAH, minnhom, il-biċċa l-kbira sofrew mill-marda tal-klassi II jew tal-klassi III.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Thelin is available here.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Thelin huwa disponibbli hawn.
English: This is the maximum dose.
Maltese: Din hija d-doża massima.
English: After 12 to 18 weeks, this distance had increased by 33 metres more in the patients taking 100 mg Thelin than in the patients taking placebo.
Maltese: Wara 12 sa 18 -il ġimgħa, ilpazjenti li jieħdu Thelin 100 mg żiedu din id-distanza b'33 metru meta mqabbla mal-pazjenti ttrattati bil-plaċebo.
English: Thelin must not be taken with ciclosporin A (a medicine used to treat psoriasis and rheumatoid arthritis, and to prevent rejection of liver and kidney transplants).
Maltese: Thelin ma għandux jiġi meħud ma' ciclosporin A (mediċina wżata biex tittratta l-psorijażi u l-artrite rewmatojde, u biex tipprevjeni li t-trapjanti tal-fwied u l-kliewi milli jiġu riġettati).
English: Thelin is used to treat adults (aged 18 years or over) with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity).
Maltese: Thelin jintuża għat-trattament ta' pazjenti adulti (ta' 18 -il sena jew aktar) li jbatu minn ipertensjoni arterjali fil-pulmun (PAH) sabiex itejjeb il-kapaċità tal-eżerċizzju fiżiku (il-kapaċità li bniedem jagħmel attività fiżika).
English: Because the number of patients with pulmonary arterial hypertension is low, the disease is considered ‘rare', and Thelin was designated an ‘orphan medicine' (a medicine used in rare diseases) on 21 October 2004.
Maltese: Minħabba li n-numru ta' pazjenti bi pressjoni għolja pulmonari primarja huwa wieħed baxx, il-marda hija kkunsidrata ‘rari', u Ventavis kien meqjus bħala ‘mediċina orfni' (mediċina wżata f'mard rari) fil-21 ta' Ottubru 2004.
English: In the patients with class III disease, this was around 46 metres.
Maltese: III, dan kien ta' madwar 46 metru.
English: What is the risk associated with Thelin?
Maltese: X'inhu r-riskju assoċjat ma' Thelin?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Thelin on 10 August 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Thelin fl-10 ta' Awwissu 2006.
English: What is Thelin?
Maltese: X'inhu Thelin?
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Maltese: PAH hija pressjoni tad-demm għolja mhux normali fl-arterji u fil-pulmuni.
English: Before treatment, the patients could walk around 366 metres in six minutes.
Maltese: Qabel ittrattament, il-pazjenti setgħu jimxu madwar 336 metru f'sitt minuti.
English: The CHMP concluded that Thelin had shown an effectiveness that was as expected for this class of medicines.
Maltese: Is-CHMP ikkonkluda li Thelin wera effikaċja li kienet mistennija għal din il-klassi ta' mediċini.
English: The active substance in Thelin, sitaxentan sodium, blocks the receptors for a hormone called endothelin-1 (ET-1), which causes blood vessels to constrict.
Maltese: Is-sustanza attiva f'Thelin, sitaxentan sodium, tinibixxi ormon magħruf bħala endotelin-1 (ET-1) li jokkorri b'mod naturali u li jġiegħel l-arterji u l-vini tad-demm jidjiequ.
English: Why has Thelin been approved?
Maltese: Għaliex ġie approvat Thelin?
English: The company will also set up a system to monitor Thelin's side effects, suspected interactions with other medicines and the outcome of any pregnancies that may happen in women using the medicine.
Maltese: Il-kumpanija ser tistabbilixxi wkoll sistema ta' monitoraġġ għall-effetti sekondarji ta' Thelin, interazzjonijiet suspetti ma' mediċini oħra u l-eżitu ta' tqala li jseġġu f'nisa li jkunu qed jieħdu lmediċina.
English: For the full list of all side effects reported with Thelin, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrapportati b'Thelin, ara l-Fuljett ta' Tagħrif.
English: Thelin is used in patients with class III disease.
Maltese: Thelin jintuża fil-pazjenti bil-marda tal-klassi III.
English: What measures are being taken to ensure the safe use of Thelin?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi assigurat l-użu bla periklu ta' Thelin?
English: How has Thelin been studied?
Maltese: Kif ġie studjat Thelin?
English: It is taken as one tablet a day, preferably at the same time of the day.
Maltese: Tiġi meħuda bħala pillola waħda kuljum, preferibbilment fl-istess ħin tal-ġurnata.
English: Thelin was more effective than placebo at improving exercise capacity.
Maltese: Thelin irriżulta aktar effikaċi mill-plaċebo biex itejjeb il-kapaċità ta' eżerċizzju fiżiku.
English: Thelin has been shown to be effective in PAH with no identified cause and PAH caused by connective tissue disease.
Maltese: Thelin ma għandux jintuża f'nisa li huma tqal.
English: How does Thelin work?
Maltese: Għal xiex jintuża Thelin?
English: Other information about Thelin:
Maltese: Tagħrif ieħor dwar Thelin:
English: Divided dose*
Maltese: Doża diviża*
English: Germany e-mail: info@leadiantbiosciences.com
Maltese: Il-Ġermanja posta elettronika: info@leadiantbiosciences.com
English: Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)
Maltese: Qoxra tal-kapsula: ġelatina, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine
English: Colestipol and antacid medicinal products
Maltese: Colestipol u prodotti mediċinali antaċidi
English: Date of first authorisation: 10/04/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 10/04/2017
English: Packs size: 100 capsules
Maltese: Daqs tal-pakketti: 100 kapsula
English: Telephone: +49 (0)89 5506675 - 0 Fax: +49 (0) 89 55 066 75 25 e-mail: info@leadiantbiosciences.com
Maltese: +49 (0) 89 55 066 75 25 posta elettronika: info@leadiantbiosciences.com
English: Ciclosporin and sirolimus
Maltese: Ciclosporin u sirolimus
English: Limited safety data are available (see section 4.8).
Maltese: Dejta limitata dwar is-sigurtà hija disponibbli (ara sezzjoni 4.8).
English: The correct volumes should preferably be marked on the oral syringe.
Maltese: Il-volumi korretti għandhom preferibbilment jiġu mmarkati fis-siringa orali.
English: 100 hard capsules
Maltese: 100 kapsula iebsa
English: Pyramidal dysfunction improved or stabilised in 60% (10/15) and cerebellar dysfunction in 88.7% (12/14).
Maltese: Disfunzjoni piramidali tjiebet jew stabilizzat f'60% (10/15) u diżfunzjoni ċerebrali fi 88.7% (12/14).
English: Magnesium stearate Silica, colloidal anhydrous Water
Maltese: Magnesium stearate Silica, anidru kollojdali
English: • ciclosporin and sirolimus (medicines used to suppress the immune system)
Maltese: • ciclosporin u sirolimus (mediċini użati biex irażżnu s-sistema immuni)
English: Epilepsy resolved in 100% (3/3 patients) and polyneuropathy stabilised or improved in 100% (11/11).
Maltese: L-epilessija rriżolviet 100% (3/3 pazjenti) u l-polinewropatija stabilizzat jew tjiebet għal 100% (11/11).
English: Pharmacotherapeutic group: Alimentary tract and metabolism - Bile therapy - Bile acid preparations, ATC code: A05AA01
Maltese: Passaġġ alimentari u metaboliżmu - Terapija biljari - Taħlitiet ta' aċidu biljari, Kodiċi ATC: A05AA01
English: Reabsorption of chenodeoxycholic acid is variable (29 - 84%).
Maltese: Ir-riassorbiment ta' chenodeoxycholic acid hu varjabbli (29 - 84%).
English: Dose calculation (Children 1-12yr, adolescents 12-18yr and adults) chenodeoxycholic acid 10 mg/mL suspension
Maltese: Kalkolazzjoni tad-doża (Tfal 1-12-il sena, adolexxenti 12-18-il sena u adulti) sospensjoni ta' chenodeoxycholix acid 10 mg/mL
English: Neurological disability scale scores (Rankin and EDSS) stabilised or improved by the clinical current visit in 84.6% and 76.9% of patients respectively.
Maltese: Punteġġi fl-iskala ta' diżabilità newroloġika (Rankin u EDSS) stabilizzaw jew marru għall-aħjar bil-viżita klinika attwali f'84.6% u 76.9% ta' pazjenti rispettivament.
English: DATE OF REVISION OF THE TEXT
Maltese: Protokollbilli
English: Paediatric population (1 month -18 years)
Maltese: Popolazzjoni pedjatrika (xahar -18-il sena)
English: The total daily dose = 10 kg x 15 mg/kg = 150 mg
Maltese: 10 kg x 15 mg/kg = 150 mg
English: Capsule contents: maize starch, magnesium stearate, silica colloidal anhydrous, water,
Maltese: Kontenut tal-kapsula: lamtu tal-qamħirrun, magnesium stearate, silika anidru u kollojdali, ilma.
English: Rankin and EDSS scores remained stable in 61.5% and 50% of patients respectively, however there was an overall worsening of the mean score from baseline.
Maltese: Il punteġġi ta' Rankin u EDSS baqgħu stabbli f'61.5% u 50% ta' pazjenti rispettivament, madanakollu kien hemm aggravar globali tal-punteġġ medji mil-linja bażi.
English: Adverse reactions are ranked according to system organ class, using the following convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥ 1/1,000 to <1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Ir-reazzjonijiet avversi huma gradati skont is-sistema ta' klassifika tal-organi permezz tal-konvenzjoni li ġejja: komuni ħafna (≥1/10), komuni (≥1/100 sa < 1/10), mhux komuni (≥1/1,000 sa < 1/100), rari
English: MedDRA System Organ Class Preferred term
Maltese: Sistema ta' klassifika tal-organi fid-database MedDRA
English: Reduced production of cholestanol: reduces serum cholestanol (action on HMG CoA reductase and CYP7A1).
Maltese: Produzzjoni mnaqqsa ta' kolestanol: inaqqas il-kolestanol fis-serum (azzjoni fuq HMG CoA reductase u CYP7A1
English: Deconjugation results in the free bile acid, oxidation in the 7-keto-lithocholic acid and lithocholic acid (3α-hydroxycholanic acid) is formed by elimination of the 7-hydroxy group.
Maltese: Id-dekonjugazzjoni tirriżulta fl-aċidu biljari liberu, ossidazzjoni fis-7-keto-lithocholic acid u lithocholic acid (3α-hydroxycholanic acid) huwa fformat bl-eliminazzjoni tal-grupp ta' 7-hydroxy.
English: The total daily dose = 3 kg x 5 mg/kg = 15 mg
Maltese: 3 kg x 5 mg/kg = 15 mg
English: Reduced production of cholesterol: reduces serum cholestanol (action on HMG CoA reductase).
Maltese: Produzzjoni mnaqqsa ta' kolesterol: inaqqas il-kolestanol fis-serum (azzjoni fuq HMG Co reductase).
English: In CTX, a defect in the CYP27A1 gene results in a deficient mitochondrial sterol 27-hydroxylase enzyme.
Maltese: CYP27A1 jirriżulta fin-nuqqas tal-enzima mitokondrijali sterol 27-hydroxylase.
English: - The active substance is chenodeoxycholic acid.
Maltese: - Is-sustanza attiva hi chenodeoxycholic acid.
English: Exogenous replacement with Chenodeoxycholic acid inhibits CYP7A1 (via nuclear receptor, FXR) and HMG CoA reductase, thus restoring the feedback inhibition.
Maltese: Sostituzzjoni eksoġenuża b'Chenodeoxycholic acid timpedixxi CYP7A1 (permezz tar-riċettatur nukleari, FXR) u HMG Co A reductase, b'hekk tiġi restawrata l-impediment ta' rispons.