FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with severe hepatic impairment were excluded from clinical studies.
Maltese: Pazjenti b'indeboliment sever tal-fwied ġew esklużi mill-istudji kliniċi.
English: In very rare cases, intestinal obstruction and ileus/subileus have been observed in patients during treatment with BindRen.
Maltese: F'każijiet rari ħafna, ostruzzjoni intestinali u ileus/subileus ġew osservati f'pazjenti matul il-kura b'BindRen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS - FILM-COATED TABLETS
Maltese: - ostruzzjoni fil-marrara - problemi severi fil-fwied
English: It is available as turquoise capsules (120 mg).
Maltese: Huwa disponibbli bħala kapsuli turkważ (120 mg).
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) XENICAL EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) XENICAL Sommarju tal-EPAR għall-pubbliku
English: Xenical is a medicine containing the active substance orlistat.
Maltese: Xenical huwa mediċina li fiha s-sustanza attiva orlistat.
English: The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite.
Maltese: Is-sustanza attiva fi Xenical, orlistat, hija mediċina kontra l-obeżità, li ma tolqotx l-aptit.
English: The most common side effects with Xenical (seen in more than 1 patient in 10) are influenza (flu), hypoglycaemia (low blood sugar levels), headache, upper respiratory infection (colds), oily spotting from the rectum, abdominal (tummy) pain or discomfort, flatus (gas) with discharge, faecal urgency (urgent need to open the bowels), fatty or oily stools, flatulence (gas), liquid stools, oily evacuation (faeces) and increased defecation.
Maltese: L-effetti sekondarji l-aktar komuni bi Xenical (li dehru f'aktar minn pazjent 1 minn kull 10) huma linfluwenza, ipogliċemija (livelli baxxi ta' zokkor fid-demm), uġigħ ta' ras, infezzjoni fil-parti ta' fuq ta' l-apparat respiratorju (irjiħat), qtar żejtni mir-rektum, uġigħ jew skonfort addominali (ta' żaqq), flatulenza (gass) flimkien ma' ħruġ ta' feċi, urġenza biex jitbattlu l-imsaren, feċi li jidhru xaħmin jew żejtnin, flatulenza (gass), feċi maħlula, evakwazzjoni (feċi) żejtnija u żieda fl-ammont ta' feċi.
English: The marketing authorisation was renewed on 29 July 2003 and on 29 July 2008.
Maltese: L-awtorizzazzjoni għat-tqegħid fissuq ġiet mġedda fid-29 ta' Lulju 2003 u fid-29 ta' Lulju 2008.
English: Orlistat blocks gastrointestinal lipases (enzymes that digest fat).
Maltese: Orlistat jimblokka l-lipażi gastrointestinali (enzimi li jimmetabolizzaw ix-xaħam).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Xenical to Roche Registration Limited on 29 July 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Xenical lil Roche Registration Limited fid-29 ta' Lulju 1998.
English: What is Xenical?
Maltese: X'inhu Xenical?
English: Why has Xenical been approved?
Maltese: Għaliex ġie approvat Xenical?
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Xenical's benefits are greater than its risks in conjunction with a mildly hypocalorific diet for the treatment of obese patients with a BMI greater or equal to 30 kg/m2, or overweight patients (BMI ≥ 28 kg/m2) with associated risk factors.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Xenical huma ogħla mir-riskji tiegħu flimkien ma' dieta moderatament ipokalorika għat-trattament ta' pazjenti bil-problema tal-obeżità b'BMI ogħla minn jew ugwali għal 30 kg/m2, jew ta' pazjenti b'piż eċċessiv (BMI ≥ 28 kg/m2) b'fatturi ta' riskju assoċjati.
English: What is the risk associated with Xenical?
Maltese: X'inhuma r-riskji assoċjati ma' Xenical?
English: The proportion of patients losing 10% or more of their body weight was 20% in the patients taking this dose of Xenical and 8% in those taking placebo.
Maltese: Il-perċentwal ta' pazjenti li tilfu 10% jew aktar tal-piż talġisem tagħhom kien 20% fil-pazjenti ttrattati b'din id-doża ta' Xenical u 8% f'dawk ittrattati bilplaċebo.
English: This summary was last updated in 06-2008.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 07-2008.
English: Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients.
Maltese: Xenical ġie studjat f'seba' studji prinċipali li involvew 3,000 pazjent b'piż żejjed jew bil-problema talobeżità.
English: Xenical is used together with dieting for the treatment of obese (very overweight) patients with a body mass index (BMI) greater than or equal to 30 kg per square metre, or overweight patients (BMI greater than or equal to 28 kg/m2) who are at risk of illness because of their weight.
Maltese: Xenical jintuża flimkien ma' dieta għat-trattament ta' pazjenti bil-problema tal-obeżità (piż eċċessiv ħafna) b'indiċi ta' massa tal-ġisem (BMI) ogħla minn jew ugwali għal 30 kg/m², jew ta' pazjenti b'piż eċċessiv (BMI ogħla minn jew ugwali għal 28 kg/m²) li għandhom riskju li jimirdu minħabba l-piż tagħhom.
English: Other information about Xenical:
Maltese: Aktar tagħrif dwar Xenical:
English: When the results from all seven shorter studies were taken together, patients taking 120 mg Xenical three times a day had an average fall of 6.1 kg in body weight after a year, compared with 2.6 kg in those taking placebo.
Maltese: Meta rriżultati mis-seba' studji iqsar tqiesu flimkien, il-pazjenti ttrattati bi Xenical f'dożi ta' 120 mg, tliet darbiet kuljum, wara sena, kellhom tnaqqis medju tal-piż ta' 6.1 kg tal-piż tal-ġisem, meta mqabbel ma' 2.6 kg tal-pazjenti ttrattati bil-plaċebo.
English: How has Xenical been studied?
Maltese: Kif ġie studjat Xenical?
English: For the full description of all side effects reported with Xenical, see the Package Leaflet.
Maltese: Għal deskrizzjoni sħiħa tal-effetti sekondarji rrappurtati bi Xenical, ara l-Fuljett ta' Tagħrif.
English: At the end of the four-year study, 21% of the patients treated with Xenical had lost more than 10% of their body weight, compared with 10% of the patients who received placebo.
Maltese: Fit-tmiem tal-istudju ta' erba' snin, 21% tal-pazjenti ttrattati bi Xenical tilfu aktar minn 10% tal-piż tal-ġisem tagħhom, meta mqabbel ma' 10% tal-pazjenti ttrattati bil-plaċebo.
English: The effects of Xenical were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Xenical ġew l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fuq il-bniedem.
English: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue France
Maltese: Elanco France S.A.S 26 Rue de la Chapelle 68330 Huningue Franza
English: 10 μg/kg 50 μg/kg 10 μg/kg 2 μg/kg
Maltese: 10 μg/kg 2 μg/kg
English: ATC vet code: QA16QA06
Maltese: QA16QA06
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Maltese: - komuni ħafna (aktar minn wieħed f'10 annimali ttrattati li juru effetti mhux mixtieqa) - komuni (aktar minn wieħed iżda inqas minn 10 annimali f'100 annimal ittrattat) - mhux komuni (aktar minn wieħed iżda inqas minn10 annimali f'1,000 annimal ittrattat) - rari (aktar minn wieħed iżda inqas minn10 annimali f'10,000 annimal ittrattat) - rari ħafna (inqas minn annimal wieħed f'10,000 annimal ittrattat, inklużi rapporti iżolati).
English: Anti-infectious agent/antibiotic
Maltese: Sustanza antiinfettiva/antibijo tika
English: *The polypropylene components are coloured with sunset yellow E110
Maltese: *Il-komponenti tal-polypropylene huma kkuluriti b'sunset yellow E110
English: Date of last renewal: 06/12/2017
Maltese: Data tal-ewwel awtorizzazzjoni: 28/01/2013 Data tal-aħħar tiġdid: 06/12/2017
English: Monensin is a member of the pharmacotherapeutic group of polyether ionophores, specifically the carboxylic subgroup.
Maltese: Monensin hu membru tal-grupp farmakoterapewtiku ta' polyether ionophores, speċifikament issottogrupp carboxylic.
English: 32.4 g (equivalent to 35.2 g monensin sodium)
Maltese: Monensin 32.4 g (ekwivalenti għal 35.2 g ta' monensin sodium).
English: Manufacturer responsible for batch release: Eli Lilly and Company Ltd Speke Operations
Maltese: Manifattur responsabbli għall-ħrug tal-lott: Eli Lilly and Company Ltd Speke Operations
English: Incompatibilities: Not applicable
Maltese: Inkompatibilitajiet:
English: They are the product of natural fermentation products produced by Streptomyces cinnamonensis.
Maltese: Huma l-prodott ta' prodotti ta' fermentazzjoni naturali magħmula minn Streptomyces cinnamonensis.
English: Marketing authorisation holder: Elanco GmbH
Maltese: DETENTUR TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ Elanco GmbH
English: STATEMENT OF ACTIVE SUBSTANCES 35.2 g monensin sodium (equivalent to 32.4 g monensin)
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA 35.2 g ta' monensin sodium (ekwivalenti għal 32.4 g ta' monensin)
English: DO NOT USE EXCESSIVE FORCE.
Maltese: TUŻAX FORZA EĊĊESSIVA.
English: Monensin is mainly active against Gram-positive bacteria.
Maltese: Monensin hu primarjament attiv kontra batterji Gram-pożittivi.
English: In very rare cases, oesophagus obstruction has been observed.
Maltese: F'każijiet rari ħafna, ostruzzjoni fl-esofagu ġiet osservata.
English: Monensin A Bovine 2 μg/kg
Maltese: Baqar 2 μg/kg 10 μg/kg
English: Subunit
Maltese: UŻATI
English: MM/YYYY
Maltese: NUMRU/I
English: Polypropylene* orifice cap.
Maltese: Għatu tal-polypropylene* tal-ftuħ.
English: Polypropylene* plunger.
Maltese: Planġer tal-polypropylene*.
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products: drugs for prevention and/or treatment of acetonemia.
Maltese: Prodotti oħra għall-passaġġ tal-ikel u tal-metaboliżmu: mediċini għallprevenzjoni u/jew it-trattament tal-aċetonemija.
English: Identification of animals for treatment should be at veterinary discretion.
Maltese: L-identifikazzjoni ta' annimali għall-kura għandha tkun fid-diskrezzjoni veterinarja.
English: The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of Monensin in Kexxtone in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 37/2010 as follows:
Maltese: Il-Kumitat għal Prodotti Mediċinali għall-Użu Veterinarju rrakomanda l-inkluzjoni ta' Monesin f'Kexxtone f'tabella numru 1 (Sustanzi ammissibbli) fl-Anness tar-Regolament tal-Kummissjoni (UE) Nru 37/2010 kif ġej:
English: In rare cases, digestive signs (e.g. diarrhoea, ruminant stomach disorder) have been observed.
Maltese: F'każijiet rari, sinjali diġestivi (eż. dijarea, disturb fl-istonku ta' annimali ruminanti) ġew osservati.
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 veterinary medicinal 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: Monensin binds to bacterial cell membranes and interferes with the maintenance of important ion gradients in the cell which are needed for the transport of nutrients and to generate proton-motive force.
Maltese: Monensin jeħel mal-membrani ta' ċelluli batteriċi u jinterferixxi mal-manteniment ta' gradients ta' joni importanti fiċ-ċellula li huma meħtieġa għat-trasport ta' nutrijenti u biex jiġġeneraw forza protonmotiva.
English: PACKAGE SIZE 1 intraruminal device 3 intraruminal devices 5 intraruminal devices
Maltese: Strument 1 li jerħi l-mediċina fil-kirxa ta' bhima li tixtarr 3 strumenti li jerħu l-mediċina fil-kirxa ta' bhima li tixtarr 5 strumenti li jerħu l-mediċina fil-kirxa ta' bhima li tixtarr
English: Muscle Fat
Maltese: Muskoli Grass Fwied Kliewi
English: Device
Maltese: Strument
English: Ingestion or oral exposure to monensin can be fatal in dogs, horses, other equines or guinea fowl.
Maltese: Inġestjoni jew esponiment orali għal monensin jistgħu jkunu fatali fil-klieb, żwiemel, ekwini oħrajn jew fargħuni.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/12/145/001-003
Maltese: FIS-SUQ EU/2/12/145/001-003
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Kexxtone 32.4g continuous-release intraruminal device for cattle monensin
Maltese: VETERINARJU Kexxtone 32.4 g strument li jerħi l-mediċina fil-kirxa ta' bhima li tixtarr għal baqar monensin
English: Risk factors may include a history of energy-deficiency-related diseases, high body condition score and parity.
Maltese: Il-fatturi ta' riskju jistgħu jinkludu storja ta' mard assoċjat ma' nuqqas ta' enerġija, kundizzjoni tal-ġisem għolja u parità.
English: The highest tolerated dose is typically between 1 mg and 2 mg monensin/kg bodyweight/day.
Maltese: L-ogħla doża ttollerata hi tipikament bejn 1 mg u 2 mg ta' monensin/kg ta' piż tal-ġisem/jum.
English: Kexxtone delivers an approximate average dose of 335 mg of monensin per day for approximately 95 days.
Maltese: Kexxtone iforni doża medja ta' madwar ta' 335 mg ta' monensin kuljum għal madwar 95 jum.
English: Metabolites and parent drug are excreted in the bile.
Maltese: Il-metaboliti u l-mediċina prinċipali jiġu eliminati fil-bila.
English: Do not use in animals weighing less than 300 kg bodyweight.
Maltese: Tużax f'annimali li jiżnu inqas minn 300 kg ta' piż tal-ġisem.
English: Intraruminal use
Maltese: IL-PROVVISTA
English: Intraruminal administration of monensin is followed by extensive first pass metabolism which results in low concentrations of monensin in the systemic circulation.
Maltese: L-għoti ta' monensin fil-kirxa ta' bhima li tixtarr hu segwit minn metaboliżmu first pass estensiv li jirriżulta f'konċentrazzjonijiet baxxi ta' monensin fiċ-ċirkolazzjoni sistemika.
English: Accidental administration of more than one intraruminal device could result in some adverse reactions which are typical of monensin overdose, including decreased appetite, scouring and lethargy.
Maltese: jirriżulta f'xi reazzjonijiet avversi li huma tipiċi ta' doża eċċessiva ta' monensin, li jinkludu nuqqas ta' aptit, dijarea u letarġija.
English: None
Maltese: IL
English: Each intraruminal device contains 12 subunits each containing 2.7 g monensin (equivalent to 2.9 g monensin sodium).
Maltese: Kull strument li jerħi l-mediċina fil-kirxa tal-bhima li tixtarr fih 12-il sottounità li kull waħda jkun fiha 2.7 g ta' monensin (ekwivalenti għal 2.9 g ta' monensin sodium).
English: Do not allow canine, horses, other equines or guinea fowl access to veterinary medicinal proeducts containing monensin.
Maltese: Tħallix klieb, żwiemel, ekwini oħrajn jew fargħuni jiksbu aċċess għal prodotti mediċinali veterinarji li jkun fihom monensin.
English: In the event of early regurgitation, identify the animal by matching the animal ID number with the number on the intraruminal device and re-administer an undamaged intraruminal device (See section
Maltese: Fil-każ ta' rigurġitazzjoni bikrija, identifika l-annimal billi tqabbel in-numru tal-ID tal-annimal man-numru fuq l-istrument li jerħi l-mediċina fil-kirxa ta' bhima li tixtarr u erġa' agħti strument li jerħi l-mediċina fil-kirxa tal-bhima li tixtarr li ma jkunx fih ħsara (Ara sezzjoni 4.5).
English: Gram-negative bacteria have complex outer cell membranes, resulting in inherent resistance to the action of ionophores.
Maltese: Batterji Gram-negattivi għandhom membrani ċellulari ta' barra kumplessi, li jirriżultaw f'reżistenza inerenti għall-azzjoni tal jonofori.
English: Thus, the ultimate effect of monensin within the rumen is to shift the microbial population resulting in a decrease of the bacteria that produce acetate and butyrate and increasing the bacteria that produce propionate, the gluconeogenic precursor.
Maltese: Għalhekk, l-effett aħħari ta' monensin fil-kirxa hu li ċċaqlaq il-popolazzjoni mikrobjali li jirriżulta fi tnaqqis tal-batterji li jipproduċu acetate u butyrate u jżid il-batterji li jipproduċu propionate, il-prekursur glukoneoġeniku.
English: Aluminium foil bag containing 1, 3 or 5 intraruminal device(s).
Maltese: Borża ta' fojl tal-aluminju li jkun fiha 1, 3 jew 5 strument(i) li jerħu mediċina fil-kirxa ta' bhima li tixtarr.
English: In the peri-parturient dairy cow, the positive effects of monensin include reduced blood ketones, increased serum glucose and reduced incidence of ketosis.
Maltese: Fil-baqra tal-ħalib waqt it-twelid u ftit wara li twelled, l effetti pożittivi ta' monensin jinkludu tnaqqis fil-ketones tad-demm, żieda fil-glucose fis-serum u tnaqqis fl-inċidenza ta' ketożi.
English: SPECIAL STORAGE CONDITIONS Keep the foil tightly closed.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu qegħdin fis-suq.
English: EXPIRY DATE
Maltese: ANNESS 1
English: Liver Kidney Milk
Maltese: Dispożizzjonijiet oħrajn
English: PACKAGE LEAFLET: Kexxtone 32.4g continuous-release intraruminal device for cattle
Maltese: Kexxtone 32.4 g strument li kontinwament jerħi l-mediċina fil-kirxa ta' bhima li tixtarr għal baqar
English: A cylindrical orange polypropylene intraruminal device uniquely identified with a number, fitted with wings, consisting of a core which presents as a stack of 12 subunits.
Maltese: Strument ċilindriku oranġjo tal-polypropylene li jerħi l-mediċina fil-kirxa ta' bhima li tixtarr identifikat unikament b'numru, mgħammar bil-ġwienaħ, li jikkonsisti f'qalba li hi ppreżentata f'munzell ta' 12-il sottounità.
English: Signs of lodging may include bloat which may be followed by coughing, drooling, inappetence and unthriftiness.
Maltese: Sinjali ta' twaħħil jistgħu jinkludu nefħa segwita minn sogħla, tlegħib, nuqqas ta' aptit u nuqqas ta' tqanċiċ.
English: The site of action for intraruminal administered monensin is the gastrointestinal tract.
Maltese: Is-sit ta' azzjoni għal monensin mogħti fil-kirxa ta' bhima li tixtarr hu l-passaġġ gastrointestinali.
English: EMA/87139/2016 EMEA/H/C/002081
Maltese: EMA/100665/2016 EMA/H/C/002081
English: Kolbam is available as capsules (50 and 250 mg).
Maltese: Kolbam jiġi bħala kapsuli (50 u 250 mg).
English: This summary was last updated in 02-2016.
Maltese: Dan is-sommarju kien aġġornat l-aħħar f'02-2016.
English: This was consistent with clinical expectations and literature data.
Maltese: Dan kien konsistenti ma' aspettattivi kliniċi u data minn dokumentazzjoni.
English: Why is Kolbam approved?
Maltese: Għaliex ġie approvat Kolbam?
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Kolbam can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: ema.europa.eu/Find medicine/Human medicines/Rare disease designation
English: This is a summary of the European public assessment report (EPAR) for Kolbam.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kolbam.
English: Kolbam cholic acid
Maltese: Kolbam aċidu koliku
English: Kolbam is a medicine that contains the active substance cholic acid.
Maltese: Kolbam huwa mediċina li fiha s-sustanza attiva aċidu koliku.
English: Kolbam must not be used in combination with phenobarbital (a medicine for epilepsy).
Maltese: Kolbam ma għandux jintuża flimkien ma' phenobarbital (mediċina kontra l-epilessija).
English: Side effects with Kolbam are generally mild to moderate in severity and transitory.
Maltese: L-effetti sekondarji b'Kolbam huma ġeneralment ħfief għal moderati fis-severità u temporanji.
English: The most common side effects (which may affect up to 1 in 10 people) are peripheral neuropathy (nerve damage in the hands and feet), diarrhoea, nausea (feeling sick), acid reflux (stomach acid flowing up into the mouth), oesophagitis (inflammation of the food pipe), jaundice (yellowing of the skin and eyes), skin problems (lesions) and malaise (feeling unwell).
Maltese: L-effetti sekondarji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma newropatija periferali (ħsara fin-nervituri fl-idejn u fis-saqajn), dijarea, nawżja (tħossok imdardar), rifluss tal-aċidu (aċidu tal-istonku li jitla' fil-ħalq), esofaġite (infjamazzjoni tal-pajp tal-ikel), suffejra (sfurija tal-ġilda u tal-għajnejn), problemi tal-ġilda (leżjonijiet) u telqa (ma tħossokx tajjeb).
English: The CHMP concluded that Kolbam has beneficial effects in patients with deficiencies in the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; and cholesterol 7α-hydroxylase.
Maltese: Is-CHMP ikkonkluda li Kolbam għandu effetti ta' benefiċċju f'pazjenti b'nuqqasijiet fl-enzimi tal-fwied li ġejjin: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; u cholesterol 7-hydroxylase.
English: Kolbam was investigated in one main study involving 52 patients with inborn errors in primary bile acid synthesis, including 7 patients who lack either sterol 27-hydroxylase, 2-methylacyl-CoA racemase or cholesterol 7α-hydroxylase.
Maltese: Kolbam ġie investigat fi studju ewlieni wieħed li kien jinvolvi 52 pazjent b'difett konġenitu fis-sinteżi tal-aċidu biljari primarju, inkluż 7 pazjenti li ma għandhomx sterol 27-hydroxylase, 2-methylacyl-CoA racemase jew cholesterol 7-hydroxylase.
English: The maximum daily dose should not exceed 15 mg per kilogram body weight.
Maltese: Id-doża massima ma tistax taqbeż il-15 mg għal kull kilogramma tal-piż tal-ġisem.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kolbam on 20 November 2015.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Kolbam fl-20 ta' Novembru 2015.
English: Kolbam is authorised for the life-long treatment of adults and children from one month of age who cannot produce enough primary bile acids such as cholic acid due to certain genetic abnormalities that result in a lack of the following liver enzymes: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; or cholesterol 7α-hydroxylase.
Maltese: Kolbam huwa awtorizzat għall-kura tul il-ħajja ta' adulti u tfal minn età ta' xahar 'il fuq li ma jistgħux jipproduċu biżżejjed aċidi biljari primarji bħall-aċidu koliku minħabba ċerti anormalitajiet ġenetiċi li jirriżultaw fin-nuqqas ta' dawn l-enzimi tal-fwied li ġejjin: sterol 27-hydroxylase; 2-methylacyl-CoA racemase; jew cholesterol 7-hydroxylase.
English: The condition is known as ‘inborn errors in primary bile acid synthesis'.
Maltese: Il-kundizzjoni hija magħrufa bħala ‘difett konġenitu fis-sinteżi talaċidu biljari primarju'.
English: Because the number of patients with inborn errors in primary bile acid synthesis is low, the condition is considered ‘rare', and Kolbam was designated an ‘orphan medicine' (a medicine used in rare diseases) on 28 October 2009.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn difett konġenitu fis-sinteżi tal-aċidu biljari primarju huwa baxx, il-kundizzjoni hija kkunsidrata ‘rari', u Kolbam ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-28 ta' Ottubru 2009.
English: This is a ‘primary bile acid', which is a main component of the bile (a fluid produced by the liver that helps to digest fats).
Maltese: Dan huwa ‘aċidu biljari primarju', li huwa komponent importanti tal-bili (fluwidu prodott mill-fwied li jgħin sabiex ix-xaħam jiġi diġestit).
English: Other information about Kolbam
Maltese: Informazzjoni oħra dwar Kolbam
English: How does Kolbam work?
Maltese: Kif jintuża Kolbam?