FrancophonIA/ELRC3.0 huggingface dataset:
English: System Organ Class Preferred Term
Maltese: Terminu Ppreferut
English: Pregnancy, contraception and breast-feeding
Maltese: Ipoalbuminimja, ipokalimja
English: Multi-centre prospective non-interventional registry in patients with urea cycle disorders on treatment with glycerol phenylbutyrate to characterise patients` demographics, and to document long-term safety and clinical outcomes
Maltese: Reġistru b'aktar minn ċentru wieħed prospettiv u mingħajr intervent f'pazjenti b'disturbi fiċ-ċiklu tal-urea dwar trattament b'glycerol phenylbutyrate biex jiġu kkaratterizzati d-demografiċi tal-pazjenti, u biex jiġu dokumentati riżultati kliniċi u dwar is-sigurtà fit-tul
English: RAVICTI should not be used during pregnancy and in women of childbearing potential not using contraception unless the clinical condition of the woman requires treatment with glycerol phenylbutyrate, see section 4.6.
Maltese: RAVICTI m'għandux jintuża waqt it-tqala u fin-nisa li jista' jkollhom it-tfal li mhumiex jużaw kontraċettivi ħlief meta jkun hemm bżonn speċifiku tat-trattament b'glycerol phenylbutyrate, minћabba l-kundizzjoni klinika tal-mara, ara sezzjoni 4.6.
English: Kuvan sapropterin dihydrochloride
Maltese: Kuvan sapropterin diidrokloridu
English: The full EPAR for Kuvan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The active substance in Kuvan, sapropterin dihydrochloride, is a synthetic copy of BH4.
Maltese: Is-sustanza attiva f'Kuvan, is-sapropterin diidrokloridu, hija kopja sintetika ta' BH4.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Kuvan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Kuvan jista' jinstab fuq is-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designations.
English: Why is Kuvan approved?
Maltese: Għaliex ġie approvat Kuvan?
English: Kuvan contains the active substance sapropterin dihydrochloride.
Maltese: Kuvan fih is-sustanza attiva sapropterin diidrokloridu.
English: This is a summary of the European public assessment report (EPAR) for Kuvan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Kuvan.
English: Studies with Kuvan involved adults and children of all ages.
Maltese: L-istudji b'Kovan involvew adulti u tfal ta' kull età.
English: Kuvan is a medicine that is used to treat high blood levels of phenylalanine in adults and children of all ages with the genetic disorders phenylketonuria (PKU) or tetrahydrobiopterin (BH4) deficiency.
Maltese: Kuvan huwa mediċina li tintuża fil-kura tal-livelli għoljin fid-demm ta' fenilalanina fl-adulti u fit-tfal ta' kull età b'disturbi ġenetiċi fenilketonurja (PKU) jew defiċjenza tetraidrobiopterin (BH4).
English: The high levels of phenylalanine in the blood are due to a problem with the breakdown of phenylalanine through the enzyme ‘phenylalanine hydroxylase'.
Maltese: Il-livelli għolja ta' fenilalanina fid-demm huma minħabba problema bit-tibdil ta' fenilalanina permezz tal-enzima ‘fenilalanina idrossilasi'.
English: Kuvan is available as soluble tablets (100 mg) or as powder (100 or 500 mg), to be dissolved in water and drunk.
Maltese: Kuvan jiġi bħala pilloli solubbli (100 mg) jew bħala trab (100 jew 500 mg), li jinħallu fl-ilma u jinxtarbu.
English: Kuvan was more effective than placebo at reducing blood phenylalanine levels in patients with PKU, achieving a reduction of 236 micromoles per litre after 6 weeks compared with an increase of 3 micromoles per litre seen with placebo.
Maltese: Kuvan kien iktar effettiv mill-plaċebo fit-tnaqqis tal-livelli ta' fenilalanina fid-demm f'pazjenti li jbatu mill-PKU, billi kiseb tnaqqis ta' 236 mikromolu għal kull litru wara 6 ġimgħat meta mqabbel ma' żieda ta' 3 mikromoli għal kull litru bil-plaċebo.
English: The dose is then adjusted depending on blood levels of amino acids including phenylalanine.
Maltese: Id-doża hija aġġustata skont il-livelli taddemm tal-amino aċidi inkluż il-fenilalanina.
English: It is important that patients continue with a diet low in phenylalanine and protein when taking Kuvan, and intake of phenylalanine and protein must be monitored and adjusted to make sure that blood phenylalanine levels and nutritional balance are controlled.
Maltese: Huwa importanti li lpazjenti jkomplu b'dieta baxxa fil-fenilalanina u l-proteini meta jieħdu Kuvan, u l-konsum talfenilalanina u l-proteini għandu jkun sorveljat u aġġustat biex ikun assigurat li l-livelli ta' fenilalanina fid-demm u l-bilanċ nutrizzjonali huma kkontrollati.
English: When Kuvan plus diet restriction was compared with diet restriction alone, the average daily phenylalanine intake that was tolerated after 26 weeks was 81 mg/kg in the Kuvan group and 50 mg/kg in the group on diet restriction alone.
Maltese: Barra minn hekk Kuvan ippermetta lill-pazjenti li jbatu bilPKU li ma kinux fuq restrizzjoni dietetarja biex iżidu l-konsum ta' kuljum ta' fenilalanina bi 17.5 mg għal kull kg tal-piż korporju wara 10 ġimgħat meta mqabbel ma' 3.3 mg/kg bil-plaċebo. Meta Kuvan flimkien mar-restrizzjoni dietetarja tqabbel ma' restrizzjoni dietetarja waħidha, Il-konsum medju ta' kuljum ta' fenilalanina li kien tollerat wara 26 ġimgħa kien ta' 81 mg/kg fil-grupp ta' Kuvan u 50 mg/kg fil-grupp tar-restrizzjoni dietetarja biss.
English: Because the number of patients with conditions leading to high phenylalanine levels is low, the conditions are considered ‘rare', and Kuvan was designated an ‘orphan medicine' (a medicine used in rare diseases) on 8 June 2004.
Maltese: Minħabba li n-numru ta' pazjenti bil-kondizzjonijiet li jwasslu għal-livelli għolja ta' fenilalanina huwa wieħed baxx, il-kondizzjonijiet huma kkunsidrati bħala ‘rari', u Kuvan ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fit-8 ta' Ġunju 2004.
English: What are the risks associated with Kuvan?
Maltese: X'inhuma r-riskji assoċjati ma' Kuvan?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Kuvan on 2 December 2008.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Kuvan valida fl-Unjoni Ewropea kollha fit-2 ta' Diċembru 2008.
English: Patients with these disorders cannot process the amino acid phenylalanine from dietary protein, and as a result the amino acid builds up in the blood to abnormally high levels, causing problems in the nervous system.
Maltese: Il-pazjenti b'dawn id-disturbi ma jistgħux jipproċessaw l-amino aċidu fenilalanina mill-proteina alimentari, u minħabba f'hekk l-amino aċidu jinbena fid-demm biex jassorbi livelli għolja b'mod anormali, u jikkawża problemi fis-sistema nervuża.
English: The most common side effects with Kuvan (seen in more than 1 patient in 10) are headache and rhinorrhoea (runny nose).
Maltese: L-effetti sekondarji l-aktar komuni b'Kuvan (li dehur f'iktar minn pazjent 1 minn kull 10) huma wġigħ ta' ras u rionorrea (flissjoni).
English: A satisfactory response is defined as a reduction in blood phenylalanine levels of at least 30% or to a level determined by the doctor.
Maltese: Rispons sodisfaċenti huwa definit bħala tnaqqis fil-livelli ta' fenilalanina fid-demm ta' mill-inqas 30% jew għal livell determinat mit-tabib.
English: In PKU, it works by enhancing the activity of the defective enzyme, while in BH4 deficiency it replaces the missing cofactor.
Maltese: F'PKU, din taħdem billi ssaħħaħ l-attività tal-enzima difettuża, filwaqt li fid-defiċjenza BH4 tissostitwixxi l-kofattur nieqes.
English: How is Kuvan used?
Maltese: Kif jaħdem Kuvan?
English: For the treatment of BH4 deficiency, which is a very rare condition, the company presented results of three studies from the published literature in which some patients were treated with sapropterin for an average of 15.5 months.
Maltese: Għall-kura tad-defiċjenza BH4, li hija kondizzjoni rari ħafna, il-kumpanija ppreżentat ir-riżultati ta' tliet studji mid-dokumentazzjoni ppubblikata li fihom xi pazjenti ġew ikkurati bis-sapropterin għal medja ta' 15.5 xhur.
English: For the full list of all side effects and restrictions with Kuvan, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Kuvan, ara l-fuljett ta' tagħrif.
English: Kuvan is taken with a meal at the same time every day, preferably in the morning.
Maltese: Kuvan jittieħed ma' ikla fl-istess ħin kuljum, preferibbilment filgħodu.
English: Two other studies in 101 patients looked at how effective Kuvan was at allowing the patients to consume foods containing phenylalanine while keeping blood phenylalanine at target levels (i.e. phenylalanine tolerance).
Maltese: Żewġ studji oħra f'101 pazjenti ħarsu lejn kemm kien effettiv Kuvan biex ippermetta lill-pazjenti jikkunsmaw ikel li kien fih il-fenilalanina u fl-istess ħin iżommilhom ilfenilalanina fid-demm f'livelli mmirati.
English: In PKU treatment, a main study compared the reductions in blood phenylalanine in 88 patients treated with either Kuvan or placebo (a dummy treatment).
Maltese: Fil-kura tal-PKU, studju ewlieni qabbel it-tnaqqis tal-fenilalanina fid-demm fi 88 pazjent li kienu kkurati b'Kuvan jew plaċebo (kura finta).
English: Patients with PKU have defective versions of the enzyme, and patients with BH4 deficiency have low levels of BH4, a ‘cofactor' that this enzyme needs to work properly.
Maltese: Il-pazjenti b'PKU għandhom verżjonijiet difettużi tal-enzima, u lpazjenti bid-defiċjenza BH4 għandhom livelli baxxi ta' BH4, ‘kofattur' li din l-enzima għandha bżonn biex taħdem sew.
English: Further information on Yescarta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • diffuse large B-cell lymphoma (DLBCL);
Maltese: • linfoma diffuża taċ-ċelloli B kbar (DLBCL);
English: The blood cancers that Yescarta is used to treat are rare, and Yescarta was designated an ‘orphan medicine' (a medicine used in rare diseases) for DLBCL on 16 December 2014 and for PMBCL on 9 October 2015.
Maltese: Il-kanċers tad-demm li jikkura Yescarta huma rari, u Yescarta ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) għal DLBCL fis-16 ta' Diċembru 2014 u għal PMBCL fid9 ta' Ottubru 2015.
English: Other information about Yescarta
Maltese: Informazzjoni oħra dwar Yescarta
English: • primary mediastinal large B-cell lymphoma (PMBCL).
Maltese: • linfoma medjastinali primarja taċ-ċelloli B kbar (PMBCL).
English: Yescarta is a type of advanced therapy medicine called a ‘gene therapy product'.
Maltese: Yescarta huwa tip ta' mediċina terapewtika avvanzata msejħa “prodott ta' terapija tal-ġeni”.
English: The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder caused associated with headache, somnolence and mental confusion) and infections.
Maltese: L-effetti sekondarji serji l-aktar komuni huma s-sindrome ta' rilaxx ta' ċitokini (kundizzjoni potenzjalment ta' periklu għall-ħajja li tista' tikkawża deni, rimettar, qtugħ ta' nifs, uġigħ u pressjoni tad-demm baxxa), enċefalopatija (disturb talmoħħ assoċjat ma' uġigħ ta' ras, ngħas u konfużjoni mentali) u infezzjonijiet.
English: Of the patients who joined the study, 47% had a complete response (which means they had no signs of the cancer left) and 66% had at least a partial response after treatment with Yescarta.
Maltese: Mill-pazjenti li ngħaqdu fl-istudju, 47 % kellhom rispons sħiħ (li jfisser li ma kien fadlilhom l-ebda sinjal tal-kanċer) u 66 % kellhom tal-inqas rispons parzjali wara kura b'Yescarta.
English: Yescarta contains the active substance axicabtagene ciloleucel (consisting of genetically modified white blood cells).
Maltese: Yescarta fih is-sustanza attiva axicabtagene ciloleucel (li tikkonsisti minn ċelloli bojod tad-demm modifikati ġenetikament).
English: Serious side effects occur in more than 1 in 2 patients.
Maltese: Effetti sekondarji serji jseħħu f'aktar minn pazjent 1 minn kull 2.
English: As for all medicines, data on the use of Yescarta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Yescarta hija ssorveljata kontinwament.
English: These results were better than those from studies of patients receiving standard cancer treatments, where around 7% of patients had a complete response and around 26% had at least a partial response.
Maltese: Dawn ir-riżultati kienu aħjar minn dawk minn studji ta' pazjenti li rċevew kuri ta' kanċer standard, fejn madwar 7 % tal-pazjenti kellhom rispons sħiħ u madwar 26 % kellhom tal-inqas rispons parzjali.
English: It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before having Yescarta, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they are given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.
Maltese: Qabel ma jieħu Yescarta, il-pazjent għandu jirċievi kors qasir ta' kimoterapija sabiex ineħħi ċ-ċelloli bojod tad-demm eżistenti tiegħu, u eżatt qabel l-infużjoni jingħata paracetamol u mediċina antistamina sabiex jitnaqqas ir-riskju ta' reazzjonijiet għall-infużjoni.
English: Yescarta contains the patient's own T cells (a type of white blood cell) that have been modified genetically in the laboratory so that they make a protein called chimeric antigen receptor (CAR).
Maltese: Yescarta fih iċ-ċelloli T tal-pazjent stess (tip ta' ċellola bajda tad-demm) li ġew modifikati ġenetikament fil-laboratrju sabiex jagħmlu proteina msejħa riċettur tal-antiġen kimeriku (CAR). CAR jista' jeħel ma' proteina oħra msejħa CD19 fuq il-wiċċ taċ-ċelloli tal-kanċer.
English: A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).
Maltese: Mediċina msejħa tocilizumab u tagħmir tal-emerġenza għandhom ikunu disponibbli f'każ li l-pazjent ikollu effett sekondarju potenzjalment serju msejjaħ sindrome ta' rilaxx ta' ċitokini (ara s-sezzjoni dwar ir-riskji hawn taħt).
English: What are the risks associated with Yescarta?
Maltese: Kif jaħdem Yescarta?
English: For the full list of side effects and restrictions with Yescarta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet b'Yescarta, ara l-fuljett ta' tagħrif.
English: A main study of 111 patients with DLBCL and PMBCL that was not responding to previous treatment or had returned showed that Yescarta is effective at clearing the cancer in many patients.
Maltese: Studju ewlieni ta' 111-il pazjent b'DLBCL u PMBCL li ma kinitx qiegħda tirrispondi għal kura preċedenti jew li rritornat wera li Yescarta huwa effettiv biex ineħħi l-kanċer f'bosta pazjenti.
English: Yescarta is a medicine for treating two types of blood cancer:
Maltese: Yescarta huwa mediċina għall-kura ta' żewġ tipi ta' kanċer tad-demm:
English: How does Yescarta work?
Maltese: Kif jintuża Yescarta?
English: The company that markets Yescarta must ensure that hospitals where Yescarta is given have appropriate expertise, facilities and training.
Maltese: Aktar informazzjoni fuq Yescarta tinstab fis-sit elettroniku tal-Aġenzija:
English: The company must provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.
Maltese: Il-kumpanija għandha tipprovdi materjal edukattiv għall-professjonisti fil-qasam talkura tas-saħħa u għall-pazjenti dwar l-effetti sekondarji possibbli, speċjalment għas-sindrome ta' rilaxx ta' ċitokini.
English: Patients should be closely monitored for 10 days after treatment for side effects and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib għal 10 ijiem wara l-kura għall-effetti sekondarji u huma rakkomandati jibqgħu viċin sptar speċjalista għal tal-inqas 4 ġimgħat wara l-kura.
English: Uncommon: Nervousness, hallucination
Maltese: Mhux komuni: nervożità, alluċinazzjoni
English: Date of latest renewal: 23 June 2007
Maltese: Data ta' l-aħħar tiġdid: 23 ta' Ġunju 2007
English: Very common: Anorexia
Maltese: Komuni ħafna: Anoreksja
English: Uncommon: Gastrointestinal ulcer
Maltese: Mhux komuni: Ulċera gastro-intestinali
English: Uncommon: Nephrotic syndrome
Maltese: Mhux komuni: Sindromu nefrotiku
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskolo-skeletali u tat-tessut konnettiv
English: What CYSTAGON contains - The active substance is cysteamine bitartrate (mercaptamine bitartrate).
Maltese: Is-sustanza attiva hi cysteamine bitartrate (mercaptamine bitartrate).
English: The plasma protein binding in patients at steady state is similar: 53.1 % ( 3.6) and 51.1 % ( 4.5) at 1.5 and 6 hours post-dose, respectively.
Maltese: L-ammont li jintrabat mal-proteini tad-demm f'pazjenti fi stat fiss hu simili: 53.1% ( 3.6) u 51.1 % ( 4.5) f'1.5 u 6 siegħat wara d-doża, rispettivament.
English: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800 Puteaux France
Maltese: Recordati Rare Diseases Immeuble “Le Wilson” 70, Avenue du Général de Gaulle F-92800
English: Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide,
Maltese: Il-kapsula tikkonsisti minn: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Il-qoxra tal-kapsula tikkonsisti minn: gelatin, titanium dioxide,
English: Frequencies are defined as: very common (≥ 1/10), common (≥1/100 to 1/10) and uncommon (≥1/1,000 to 1/100).
Maltese: Frekwenzi huma mfissra bħala: komuni ħafna (≥ 1/10), komuni (≥1/100 sa <1/10) u mhux komuni (≥1/1,000 sa <1/100).
English: Pharmacotherapeutic group: Alimentary tract and metabolism product, ATC code: A16AA04.
Maltese: Prodott ta' l-apparat alimentari u tal-metaboliżmu, Kodiċi ATC:
English: An overdose of cysteamine may cause progressive lethargy.
Maltese: Doża eċċessiva ta' cysteamine tista' tikkawża letarġija progressiva.
English: HDPE bottles of 100 and 500 hard capsules.
Maltese: Fliexken HDPE ta' 100 u 500 kapsuli iebsin.
English: Immune system disorders
Maltese: Disturbi marbuta mas-sistema immuni
English: In a pharmacokinetic study performed in 24 healthy volunteers for 24 hours, the mean estimate ( sd) for the terminal half-life of elimination was 4.8 ( 1.8) hours.
Maltese: Fi studju farmakokinetiku mwettaq fuq 24 voluntiera b'saħħithom għal 24 siegħa, l-istima medja ( sd) għall-half-life terminali ta' l-eliminazzjoni kienet ta' 4.8 ( 1.8) siegħat.
English: CYSTAGON is indicated for the treatment of proven nephropathic cystinosis.
Maltese: CYSTAGON hu indikat fit-trattament ta' ċistinożi nefropatika ppruvata.
English: black ink on hard capsules containing E172
Maltese: Il-linka sewda fuq kapsuli iebsa fiha E172.
English: In contrast to phosphocysteamine, CYSTAGON does not contain phosphate.
Maltese: F'kuntrast ma' phosphocysteamine, CYSTAGON ma fihx fosfat.
English: Cystine build up causes kidney damage and excretion of excess amounts of glucose, proteins and electrolytes.
Maltese: It-tiġmigħ jikkaġuna ħsara fil-kliewi u l-eliminazzjoni ta' ammonti eċċessivi ta' glukows, proteini u elettroliti.
English: In one clinical study, baseline white cell cystine levels were 3.73 (range 0.13 to 19.8) nmol hemicystine/mg protein and were maintained close to 1 nmol hemicystine/mg protein with a cysteamine dose range of 1.3 to 1.95 g/m2/day.
Maltese: Fi studju kliniku, il-livelli bażi ta' referenza ta' cystine fiċ-ċelloli bojod kienu ta' 3.73 (medda 0.13 sa 19.8) nmol hemicystine/mg ta' proteina u nżammu viċin il-1 nmol hemicystine/mg ta' proteina permezz ta' firxa fid-doża ta' cysteamine minn 1.3 sa 1.95 g/m2/jum.
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi tal-ġilda u tat-tessut subkutaneji
English: - Uncommon: skin striae, skin lesion (little-hard lumps on elbows), joint laxity, leg pain, bone fracture, scoliosis (deviation of the vertebral column), bone deformity and fragility, hair discoloration, severe allergic reaction, somnolence, fits, nervousness, hallucination, decrease in white blood cells, gastrointestinal ulcer manifested by bleeding in the digestive tract and effect on the kidney manifested by swelling of the extremities and weight gain.
Maltese: - Mhux komuni: striji tal-ġilda, leżjonijiet fuq il-ġilda (ġundalli kemmxejn iebsin fuq ilminkbejn), laxkezza tal-ġogi, uġigħ fir-riġlejn, ksur ta' l-għadam, skoljosi (is-sinsla tad-dahar ma tibqax dritta), deformità u fraġilità ta' l-għadam, bdil fil-kulur tax-xagħar, reazzjoni allerġika severa, ħedla, attakki tal-qamar, nervożità, alluċinazzjoni, tnaqqis fl-għadd ta' ċelloli bojod taddemm, ulċeri gastrointestinali li jistgħu jġibu emorraġija fl-imsaren, u effett fuq il-kliewi li jimmanifesta ruħu b'nefħa ta' l-estremitajiet u b'żieda fil-piż.
English: Cases of nephrotic syndrome have been reported within 6 months of starting therapy with progressive recovery after treatment discontinuation.
Maltese: Każijiet ta' sindromu nefrotiku kienu rrapurtati sa 6 xhur mill-bidu ta' terapija b'fejqan progressiv wara t-twaqqif ta' trattament.
English: Consult the doctor for complete directions.
Maltese: Ikkonsulta mat-tabib tiegħek għal struzzjonijiet sħaħ.
English: The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients).
Maltese: L-effetti kollaterali li ġejjin ġew irrapportati kif ġej: komuni ħafna (li jseħħu f'ta' l-anqas wieħed minn kull 10 pazjenti), komuni (li jseħħu f'ta' l-anqas wieħed minn kull 100 pazjent), mhux komuni (li jseħħu f'ta' l-anqas wieħed minn kull 1,000 pazjent), rari (li jseħħu f'ta' l-anqas wieħed minn kull 10,000 pazjent), rari ħafna (li jseħħu f'ta' l-anqas wieħed minn kull 100,000 pazjent).
English: Γαλλία
Maltese: U L-UŻU
English: Metabolism and nutrition disorders
Maltese: Disturbi marbuta mal-metaboliżmu u nnutrizzjon
English: Cysteamine reacts with cystine to form the mixed disulfide of cysteamine and cysteine.
Maltese: Cysteamine tirreaġixxi ma' cystine biex tifforma disulfide ta' cysteamine u cysteine, u cysteine.
English: Studies in animals have shown reproductive toxicity, including teratogenesis (see section 5.3).
Maltese: Studji fuq annimali wrew tossiċità riproduttiva, inkluż teratoġenesi (ara sezzjoni 5.3). Ir-riskju potenzjali fin-nies, mhux magħruf.
English: In patients at steady state, these values are 1.4 ( 0.4) hours and 2.6 ( 0.9) µg/ml, respectively, after a dose ranging from 225 to 550 mg. Cysteamine bitartrate (CYSTAGON) is bioequivalent to cysteamine hydrochloride and phosphocysteamine.
Maltese: F'pazjenti fi stat fiss, dawn il-valuri huma ta' 1.4 ( 0.4) siegħat u 2.6 ( 0.9) µg/ml, rispettivament, wara doża li tvarja minn 225 sa 550 mg.
English: Common: Liver function tests abnormal
Maltese: Komuni: testijiet tal-funzjoni tal-fwied, anormali
English: Capsule content: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium Capsule shell: gelatin, titanium dioxide, black ink on hard capsules containing E172
Maltese: Il-kapsula tikkonsisti minn: microcrystalline cellulose, pregelatinized starch, magnesium stearate/sodium lauryl sulfate, colloidal silicon dioxide, croscarmellose sodium, Il-qoxra tal-kapsula tikkonsisti minn: gelatin, titanium dioxide,