FrancophonIA/ELRC3.0 huggingface dataset:
English: Following potential serious risks to public health raised regarding the evidence of bioequivalence for the higher 40 mg/5 ml strength, a referral under Article 29(4) of Directive 2001/83/EC was triggered, requesting the CHMP to give its opinion on whether Simvastatin is bioequivalent to the reference product.
Maltese: Wara r-riskji serji potenzjali li tqajmu għas-saħħa pubblika fir-rigward talevidenza tal-bijoekwivalenza għall-qawwa ogħa ta' 40 mg/5 ml, inbeda riferiment skont l-Artikolu 29(4) tad-Direttiva 2001/83/KE, li fih is-CHMP intalab jagħti l-opinjoni tiegħu dwar jekk Simvastatin huwiex bijoekwivalenti għall-prodott ta' referenza.
English: Overall summary of the scientific evaluation of Simvastatin Vale and associated names (see Annex I)
Maltese: III għal Simvastatin Vale u ismijiet assoċjati (ara Anness I).
English: In conclusion, the CHMP was of the opinion that the benefit-risk ratio of Simvastatin Vale and associated names is favourable.
Maltese: Bħala konklużjoni, is-CHMP kien talfehma li l-proporzjoni bejn il-benefiċċji u r-riskji ta' Simvastatin Vale u ismijiet assoċjati huwa favorevoli.
English: The CHMP also evaluated the in vitro dissolution data, noting that both products showed rapid and high dissolution levels at pH 7 and that solubility was therefore unlikely to be a limiting factor.
Maltese: Is-CHMP evalwa wkoll id-dejta ta' dissoluzzjoni in vitro, filwaqt li osserva li ż-żewġ prodotti wrew livelli ta' dissoluzzjoni mgħaġġla u għoljin f'pH 7 u li għalhekk, is-solubilità aktarx li ma kinitx ser tkun fattur ta' limitazzjoni.
English: The CHMP noted that the proposed formulations are largely identical qualitatively and quantitatively and are manufactured according to the same process.
Maltese: Is-CHMP osserva li l-formulazzjonijiet proposti huma sewwa sew identiċi f'livell kwalitattiv u kwantitattiv u huma mmanifatturati bl-istess proċess.
English: Finally, the CHMP considered the bioanalytical method used to be sufficiently validated and in line with the bioequivalence guideline.
Maltese: Fl-aħħar, is-CHMP qies li lmetodu bijoanalitiku użat huwa validat biżżejjed u konformi mal-linja gwida dwar il-bijoekwivalenza.
English: EU (MA) number Invented name
Maltese: Numru ta' l-UE Isem kummerċjali
English: Route of administration
Maltese: Mod ta' Amministra zzjoni
English: Uncommon: agitation, irritability
Maltese: Mhux komuni: agitazzjoni, irritabilità
English: Date of first authorisation: 15 February 2007 Date of latest renewal: 21 November 2016
Maltese: Data tal-ewwel awtorizzazzjoni: 15 Frar 2007 Data tal-aħħar tiġdid: 21 Novembru 2016
English: Uncommon: anorexia
Maltese: Mhux komuni: anoreksja
English: Children and Adult
Maltese: Tfal u Adulti
English: There is no evidence of development of tolerance.
Maltese: M'hemm l-ebda evidenza ta' żvilupp ta' tolleranza.
English: Uncommon: urinary incontinence
Maltese: Mhux komuni: inkontinenza urinarja Investigazzjonijiet
English: Frequencies are defined as: 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).
Maltese: Il-frekwenza ġiet evalwata permezz tal-kriterji li ġejjin: komuni ħafna (>1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1,000 sa <1/100), rari (>1/10,000 sa <1/1,000), rari ħafna (<1/10,000).
English: Betaine anhydrous was rapidly distributed into a relatively large volume (V/F = 1.3 l/kg).
Maltese: Betaine anidru kien distribwit rapidament għal ġo volum relattivament kbir (V/F = 1.3 l/kg).
English: Hypersensitivity to the active substance.
Maltese: 4.3 Kontra-indikazzjonijiet Sensittività eċċessiva għas-sustanza attiva.
English: Biotransformation Betaine anhydrous is a methyl group donor
Maltese: Betaine anidru huwa donatur tal-methyl group
English: Betaine anhydrous was shown to lower plasma homocysteine levels in the three types of homocystinuria, i.e. CBS deficiency; MTHFR deficiency and cbl defect.
Maltese: Betaine anidru kien muri li jbaxxi l-livelli ta' homocysteine fil-plażma fi tlett tipi ta' omoċistinurja, i.e. defiċjenza CBS; defiċjenza MTHFR u difett cbl.
English: (age between 21 to 49 years), after a single oral dose of betaine anhydrous (50 mg/kg), absorption was rapid (tmax = 0.9 ± 0.3 hours and a Cmax = 0.9 ± 0.2 mM).
Maltese: F'voluntieri adulti f'saħħithom (età ta' bejn 21 u 49 sena), wara doża waħdanija orali ta' betaine anidru (50 mg/kg), l-assorbiment kien rapidu (tmax = 0.9 ± 0.3 sigħat u Cmax = 0.9 ± 0.2 mM).
English: What Cystadane contains - The active substance is betaine anhydrous.
Maltese: X'fih Cystadane - Is-sustanza attiva hi betaine anidru.
English: Other uncommon side effects (may affect up to 1 in 100 people) may include decreased appetite (anorexia), agitation, irritability, hair loss, hives, skin odour abnormal, lack of control over passing urine (urinary incontinence).
Maltese: Effetti sekondarji mhux komuni oħra (jistgħu jaffettwaw sa persuna 1 f'100) jistgħu jinkludu tnaqqis fl-aptit (anoreksja) aġitazzjoni, irritabilità, telf ta' xagħar, ħorriqija, ir-riħa tal-ġilda mhix normali, nuqqas ta' kontroll meta tgħaddi l-awrina (inkontinenza awrinarja).
English: To minimise the risk of potential drug interactions, it is advisable to leave 30 minutes between the intake of betaine anhydrous and amino acids mixtures and/or medicinal products containing vigabatrin and GABA analogues (see section 4.5).
Maltese: Biex tnaqqas ir-riskju ta' interazzjonijiet potenzjali tal-mediċina, huwa rakkomandat li jitħallew 30 minuta bejn it-teħid ta' betaine anidru u taħlitiet ta' aċidi amminiċi u/jew prodotti mediċinali li fihom vigabatrin u analogi ta' GABA (ara sezzjoni 4.5).
English: In paediatric patients less than 10 years of age, the usual effective dose regimen is 100 mg/kg/day given in 2 doses daily; increasing the frequency above twice daily and/or the dose above 150 mg/kg/day does not improve the homocysteine-lowering effect.
Maltese: F'pazjenti tfal li għandhom anqas minn 10 snin t'età, ir-reġimen effettiv tas-soltu huwa ta' doża ta' 100 mg/kg/kuljum mogħti f'2 dożi kuljum; żjieda fil-frekwenza għal aktar minn darbtejn kuljum u/jew aktar minn 150 mg/kg/kuljum ma jtejjibx l-effett ta' tnaqqis fil-homocysteine.
English: Methionine is present in regular food protein (e.g. meat, fish, milk, cheese, eggs).
Maltese: Methionine huwa preżenti bħala proteina regolari ta' l-ikel (e.g. laħam, ħut, ħalib, ġobon, bajd).
English: Three measuring spoons (green, blue, pink) dispense 100mg, 150mg or 1g of betaine anhydrous.
Maltese: Tliet imgħaref tal-kejl (ħadra, blu, roża) jagħtu, 100mg, 150 mg jew 1 g ta' betaine anidru.
English: It is likely that due to the multiple nature of therapy (dietary, pharmaceutical, supportive) in these patients, there may be an element of overestimation in the clinical effects of betaine anhydrous treatment.
Maltese: Huwa probabbli li minħabba n-natura multipla tat-terapija (taddieta, farmaċewtika u t'appoġġ) f'dawn il-pazjenti, jista' jkun hemm element ta' stima żejda fl-effetti kliniċi ta' trattament b' betaine anidru.
English: Cystadane 1 g oral powder Betaine anhydrous
Maltese: Cystadane 1 g trab għall-ħalq Betaine anidru
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, ATC code: A16AA06.
Maltese: Prodotti oħrajn għall-passaġġ alimentari u għall-metaboliżmu, Kodiċi ATC:
English: Based on in vitro data, betaine anhydrous might interact with amino acids mixtures and medicinal products containing vigabatrin and GABA analogues.
Maltese: Ibbażat fuq dejta in vitro, betaine anidru jista' jkollu effett ma' taħlitiet ta' aċidi amminiċi u prodotti mediċinali li fihom vigabatrin u analogi GABA.
English: Uncommon cases of severe cerebral oedema associated with hypermethioninemia were reported with betaine anhydrous therapy in patients with CBS deficiency (see section 4.8).
Maltese: Ġew irrapportati każijiet mhux komuni ta' edema ċerebrali serja assoċjata ma' ipermetjoninemija b'betaine anhydrous f'pazjenti b'defiċjenza ta' CBS (ara sezzjoni 4.8).
English: Cystadane 1 g oral powder
Maltese: Cystadane 1 g trab għall-ħalq
English: In CBS-deficient patients without dietary restriction of methionine, excessive accumulation of methionine has been observed.
Maltese: F'pazjenti b'nuqqas ta' CBS mingħajr restrizzjoni djetetika ta' methionine, akkumulazzjoni eċċessiva ta' methionine ġiet osservata.
English: 180 g of oral powder.
Maltese: 180 g ta' trab għall-ħalq.
English: The use of Cystadane together with other treatments such as vitamin B6, vitamin B12, folate and a specific diet aims to reduce the elevated homocysteine levels in your body.
Maltese: L-użu ta' Cystadane flimkien ma' mediċini oħra bħal vitamina B6, vitamina B12, folate u dieta speċifika għandha l-għan li tnaqqas il-livelli elevati ta' omoċisteina filġisem tiegħek.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallmediċini (EMEA) http://www.ema.europa.eu/.
English: BOTTLE LABEL
Maltese: KARTUNA TA' BARRA
English: Other medicines and Cystadane
Maltese: Mediċini oħra u Cystadane
English: Elevated homocysteine plasma levels are associated with cardiovascular events (such as thrombosis), osteoporosis, skeletal abnormalities, and optic lens dislocation.
Maltese: Livelli għoljin ta' homocysteine fil-plażma huma assoċjati ma' każijiet kardjovaskulari bħal trombożi, osteoporożi, anormalitajiet skeletali, u żlogaturi tal-lenti ottika.
English: Methionine level can be related to swelling in the brain (cerebral swelling), which may affect up to 1 in 100 people (frequency uncommon).
Maltese: Il-livell ta' methionine jista' jiġi marbut ma' nefħa fil-moħħ (nefħa ċerebrali), li jista' jaffettwa sa persuna 1 f'100 (frekwenza mhix komuni).
English: Symptoms of cerebral oedema include morning headaches with vomiting and/or visual changes High increases in plasma methionine levels in a range from 1,000 to 3,000 µM were noted in these patients.
Maltese: Sintomi ta' edema ċerebrali jinkludu uġigħat ta' ras filgħodu b'remettar u/jew bidliet viżwali Żjidiet għoljin fil-livelli tal-methionine fil-plażma fuq firxa minn 1,000 sa 3,000 µM kienu notati f'dawn il-pazjenti.
English: Do not take Cystadane If you are allergic to betaine anhydrous.
Maltese: Tiħux Cystadane Jekk inti allerġiku għal betaine anidru.
English: Betaine anhydrous acts as a methyl group donor in the remethylation of homocysteine to methionine in patients with homocystinuria.
Maltese: Betaine anidru jaġġixxi bħala donatur tal-grupp methyl f'remethylation ta' homocysteine għal methionine f'pazjenti b'omoċistinurja.
English: Most of these patients were also receiving other treatments such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin) and folate with variable biochemical responses.
Maltese: B12 (cobalamin) u folate b'reazzjonijiet bijokemikali diversi.
English: Reported adverse reactions are listed below, by system organ class and by frequency.
Maltese: Reazzjonijiet avversi rapportati huma elenkati hawn isfel, skond is-sistema tal-klassifika ta' l-organi u l-frekwenza.
English: Each bottle contains 180 g of powder.
Maltese: Kull flixkun fih 180 g ta' trab.
English: Gastrointestinal disorders like diarrhoea, nausea, vomiting, stomach discomfort and inflammation of the tongue may occur uncommonly (may affect up to 1 in 100 people).
Maltese: Disturbi gastrointestinali bħal dijarea, tqalligħ, remettar, stonku mqalla' u infjammazzjoni tal-ilsien jistgħu jseħħu b'mod mhux komuni (li jistgħu jaffettwaw sa persuna 1 f'100).
English: Late detection of homocystinuria in symptomatic state is responsible for residual morbidity due to irreversible damage to connective tissue (ophtalmological, skeletal) that cannot be corrected by further therapy.
Maltese: Skoperta fit-tard ta' omoċistinurja fi stat sintomatiku hija responsabbli għal morbidità residwali minħabba ħsara rriversibbli lit-tessuti konnettivi (oftalmoloġiċi, skeletali) li ma jistgħux jiġu kkorreġuti b'aktar terapija.
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: In observational studies, clinical improvement (cardiovascular and neurodevelopmental) was reported by the treating physician in about 75% of patients taking betaine anhydrous.
Maltese: Fi studji t'osservazzjoni, titjib kliniku (kardjovaskulari u fi zvilupp newroloġiku) kienu irrapportati mit-tabib kuranti f'madwar 75% tal-pazjenti li kienu fuq betaine anidru.
English: This will give the following doses: small measure 100 mg, middle size measure 150 mg and large measure 1 g of betaine anhydrous.
Maltese: Dan jagħti d-dożi li ġejjin: kuċċarina żgħira 100 mg, kuċċarina tan-nofs 150 mg u kuċċarina kbira 1 g ta' betaine anidru.
English: Cystadane contains betaine anhydrous which is intended to be an adjunctive treatment of homocystinuria, an inherited (genetic) disease where the amino acid methionine cannot be broken down completely by the body.
Maltese: Cystadane fih betaine anidru li hu intiż biex ikun trattament aġġuntiv għall-omoċistinurja, marda (ġenetika) li tintiret fejn l-aċidu amminiku methionine ma jitkissirx kompletament mill-ġisem.
English: Betaine anhydrous has also been shown to increase plasma methionine and S-adenosyl methionine (SAM) levels in patients with MTHFR deficiency and cbl defects.
Maltese: Betaine anidru ntwera li jżid il-livelli ta' methionine u S-adenosyl methionine (SAM) fil-plażma f'pazjenti b'nuqqas ta' MTHFR u effetti ebl.
English: Uncommon: diarrhoea, glossitis, nausea, stomach discomfort, vomiting Skin and subcutaneous tissue disorders Uncommon: hair loss, hives, skin odour abnormal Renal and urinary disorders
Maltese: Mhux komuni: telf tax-xagħar, ħorriqija, riħa anormali tal-ġilda Disturbi fil-kliewi u fis-sistema urinarja:
English: The available clinical data do not allow correlating posology and clinical efficacy.
Maltese: Id-dejta klinika disponibbli ma tħallix korelazzjoni bejn il-pożoloġija u l-effikaċja klinika.
English: Uncommon: brain oedema*
Maltese: Mhux komuni: edema fil-moħħ*
English: Long-term carcinogenicity and reproductive toxicity studies have not been conducted on betaine anhydrous.
Maltese: Karċinoġeniċittà u studji riproduttivi tossiċi ma ġewx magħmula fuq betaine anidru.
English: With a slow elimination rate (mean half life = 14 h, mean total body clearance, CL/F, = 84 ml/h/kg),
Maltese: Eliminazzjoni B'rata t'eliminazzjoni bil-mod (half life medja = 14-il siegħa b'rata ta' tneħħija totali mill-ġisem medja, CL/F, = 84 ml/h/kg), tneħħija renali meqjusa negliġibbli (5% ta' l-eliminazzjoni totali mill ġisem), fuq preżunzjoni ta' bijodisponibbiltà ta' 100%.
English: After a repeated dose regimen of 100 mg/kg/day for 5 days, the absorption kinetics did not change.
Maltese: Wara programm ta' kura ripetuta ta' 100 mg/kg/jum għal 5 ijiem, il-kinetiċi ta' assorbiment ma nbiddlux.
English: • the small green spoon measures 100 mg of betaine anhydrous powder;
Maltese: • il-kuċċarina ż-żgħira hija miżura għal 100 mg ta' trab ta' betaine anidru;
English: During pregnancy, administering betaine anhydrous in addition to pyridoxine, folate, anticoagulant and diet under close monitoring of plasma homocysteine would be compatible with good maternal and foetal outcomes.
Maltese: Waqt it-tqala, l-għoti ta' betaine anidru flimkien ma' pyridoxine, folate, antikoagulant u dieta taħt sorveljanza stretta tal-homocysteine filplażma huwa kompatibbli ma' eżitu matern u fetali tajjjeb.
English: If you are treated with Cystadane and with an amino-acid mixture and if you need to take other medicines at the same time, leave 30 minutes between the intake (see “section “Other medicines and Cystadane”).
Maltese: Jekk qed tiġi trattat b'Cystadane u b'taħlita ta' aċidi amminiċi u jekk għandek bżonn tieħu mediċini oħra fl-istess żmien, ħalli 30 minuta bejn kull teħid (ara “Mediċini oħra u Cystadane”).
English: At high doses, a CNS depressant effect and irritation of the gastrointestinal tract was seen in rats.
Maltese: F'dożi għoljin, effett dipressanti tas-SNĊ u irritazzjoni tal-passaġġ gastrointestinali kienu murija filfirien.
English: Clinical efficacy and safety
Maltese: Effikaċja kimika u sigurtà
English: 5 How to store Cystadane Contents of the pack and other information
Maltese: Kif taħżen Cystadane Kontenut tal-pakkett u informazzjoni oħra
English: In order to reduce methionine levels, modification of diet as well as dose reduction of Cystadane or temporal interruption of Cystadane treatment should be considered.
Maltese: Sabiex jitnaqqsu l-livelli ta' methionine jeħtieġ li tiġi kkunsidrata kemm modifikazzjoni tad-dieta kif ukoll tnaqqis fid-doża ta' Cystadane jew interruzzjoni temporali tal-kura bi Cystadane.
English: Description of selected adverse reactions *Uncommon cases of severe cerebral oedema and hypermethioninemia were reported within 2 weeks to 6 months of starting betaine anhydrous therapy in patients with CBS deficiency, with complete recovery after treatment discontinuation.
Maltese: Deskrizzjoni ta' reazzjonijiet avversi magħżula * Ġew irrapportati każijiet mhux komuni ta' edema ċerebrali serja u ipermetjoninemija fi żmien ġimagħtejn sa 6 xhur wara li nbdiet kura b'betaine anhydrous f'pazjenti b'defiċjenza ta' CBS, b'fejqan sħiħ wara t-twaqqif tal-kura..
English: Betaine anhydrous supplementation was shown to improve the metabolic abnormalities in the cerebrospinal fluid of patients with homocystinuria.
Maltese: L-għoti supplimentari ta' betaine anidru ġie osservat li tejjeb l-abnormalitajiet metaboliċi fil-fluwidu ċerebrospinali ta' pazjenti b'omoċistinurja.
English: The recommended dose in children and adults is 100mg/kg/day divided in 2 dosesper day.
Maltese: Id-doża rakkomandata fit-tfal u fl-adulti, hi ta' 100 mg/kg/kuljum maqsuma f'2 dożi kuljum.
English: • the middle size blue spoon measures 150 mg of betaine anhydrous powder ;
Maltese: • il-kuċċarina tan-nofs hija miżura għal 150 mg ta' trab ta' betaine anidru;
English: If you notice side effects like headaches, vomiting or a change in your vision and you are of the homocystinuria subtype called CBS (cystathionine beta-synthase deficiency), please contact your doctor immediately, they could be signs of a swelling in the brain (cerebral oedema).
Maltese: Jekk tinnota effetti sekondarji bħal uġigħ ta' ras, rimettar jew tibdil fil-vista tiegħek u inti tas-sottotip omoċistinurja msejħa CBS (defiċjenza ta' beta-synthase ta' cystathionine), jekk jogħġbok ikkuntattja lit-tabib tiegħek immedjatament, dawn jistgħu jkunu sinjali ta' nefħa fil-moħħ (edema ċerebrali).
English: Cystadane should be used as supplement to other therapies such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a specific diet.
Maltese: Cystadane għandu jintuża bħala suppliment għal terapiji oħra bħala vitamina B6 (pyridoxine), vitamina
English: After a repeated dose regiment of 100 mg/kg/day for 5 days, the distribution half life was prolonged significantly (up to 36 h), indicating saturable transport and redistribution processes.
Maltese: Wara programm ta' kura ripetuta ta' 100 mg/kg/jum għal 5 ijiem, il-half-life ta' distribuzzjoni ġiet mtawwla b'mod sinifikanti (sa 36 siegħa) li jindika proċessi ta' ġarr u firxa mill-ġdid issaturati.
English: However, the dose should be individually titrated according to plasma levels of homocysteine and methionine.
Maltese: Madankollu, iddoża għandha tiġi titrata individwalment skont il-livelli ta' homocysteine u methionine fil-plażma.
English: 1 g of powder contains 1 g of betaine anhydrous.
Maltese: 1 g ta' trab fih 1 g ta' betaine anidru.
English: As cerebral oedema has also been reported in patients with hypermethioninemia, secondary hypermethioninemia due to betaine anhydrous therapy has been postulated as a possible mechanism of action.
Maltese: Billi edema ċerebrali kienet ukoll irrapportata f'pazjenti b'ipermetjoninemija, ipermetjoninemija sekondarja minħabba terapija b'betaine anidru ġiet postulata bħala mekkaniżmu t'azzjoni possibbli.
English: It is not known whether betaine anhydrous is excreted in human milk (although its metabolic precursor, choline, occurs at high levels in human milk).
Maltese: Mhux magħruf jekk betaine anidru jiġix eliminat mal-ħalib uman (għalkemm il-prekursur metaboliku tiegħu, choline, jinsab f'livelli għoljin fil-ħalib uman).
English: Metabolism and nutrition disorders
Maltese: Disturbi marbuta mal-metaboliżmu u nnutrizzjon:
English: 180 g of oral powder and three measuring spoons.
Maltese: 180 g ta' trab għall-ħalq u tliet imgħaref tal-kejl.
English: White crystalline free flowing powder.
Maltese: Cystadane huwa trab kristallin abjad li faċilment jitħallat.
English: 1 g of oral powder contains 1 g of betaine anhydrous.
Maltese: 1 g ta' trab tal-ħalq fiha 1 g ta' betaine anidru.
English: Monitoring betaine plasma concentrations does not help to define the efficacy of treatment, since these concentrations do not directly correspond to the flux through the cytosolic betaine homocysteine methyl transferase pathway.
Maltese: Monitoraġġ ta' konċentrazzjonijiet ta' betaine fil-plażma ma jgħinx biex jiġu mfissra l-effikaċja tattrattament, billi dawn il-konċentrazzjonijiet ma jikkorrispondux direttament mal-fluss minn ġolmogħdija cytosolic betaine homocysteine methyl transferase.
English: The recommended total daily dose is 100 mg/kg/day given in 2 doses daily.
Maltese: Id-doża totali ta' kuljum rakkomandata hija ta' 100 mg/kg mogħtija f'2 dożi kuljum.
English: This demonstrates that differences in betaine anhydrous kinetics are most probably due to betaine anhydrous depletion in untreated homocystinuria and are only meaningful for the initial treatment.
Maltese: Dan juri li differenzi fil-kinetika ta' betaine anidru huma wisq probabbli dovuti għal tnaqqis ta' betaine anidru f'omoċistinurja mhux ittrattata u huma sinifikanti biss għat-trattament tal-bidu.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
Maltese: Id-dehra ta' Cystadane u d-daqs tal-pakkett
English: For specific recommendations, see section 4.4.
Maltese: Għar-rakkomandazzjonijiet speċifiċi, ara sezzjoni 4.4.
English: In general, adverse reactions seen with betaine anhydrous therapy appeared to be not serious and are mainly related to the gastrointestinal system.
Maltese: B'mod ġenerali, ir-reazzjonijiet avversi li dehru b'terapija b'betaine anidru dehru li ma kienux serji u huma prinċipalment marbuta mas-sistema gastrointestinali.
English: Complete recovery was seen after treatment discontinuation: - The plasma methionine concentrations should be kept below 1000 µM.
Maltese: - Il-konċentrazzjonijiet ta' methionine fil-plasma għandhom jinżammu taħt l-1000 µM.
English: - If any symptoms of cerebral oedema like morning headaches with vomiting and/or visual changes appear, plasma methionine level and compliance to the diet should be checked and treatment with Cystadane interrupted.
Maltese: - Jekk jidhru xi sintomi ta' edema ċerebrali bħal uġigħat ta' ras ta' filgħodu b'rimettar u/jew bidliet fil-vista, il-livell ta' methionine fil-plażma u l-osservanza tad-dieta għandhom jiġu kontrollati u trattament b' Cystadane għandu jiġi interrott.
English: Gastrointestinal disorders like diarrhoea, glossitis, nausea, stomach discomfort, vomiting and dental disorders may occur uncommonly.
Maltese: Disturbi gastrointestinali bħal dijarea, glossite, tqalligħ, stonku mqalla', remettar u disturbi marbuta mas-snien jistgħu jseħħu b'mod mhux komuni.
English: Medicinal product subject to medical prescription.
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK APPLIKABBLI
English: Medicinal product subject to restricted medical prescription (see annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal- Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: 4.6 Fertility, pregnancy and lactation
Maltese: 4.6 Tqala u Treddigħ
English: Recordati Rare Diseases Τηλ: +33 (0)1 47 73 64 58 Γαλλία
Maltese: Recordati Rare Diseases Τηλ: +33 (0)1 47 73 64 58
English: A standard battery of genotoxicity test reveals no specific hazard for humans.
Maltese: Batterija standard ta' testijiet ġenotossiċi ma wriet l-ebda periklu speċifiku għal bnedmin.