FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains 124 mg (5.4 mmol) of sodium per 1 g of sodium phenylbutyrate.
Maltese: Din il-mediċina fiha 124 mg (5.4 mmol) ta' sodju għal kull 1 g ta' sodium phenylbutyrate.
English: Each gram of sodium phenylbutyrate contains 124 mg (5.4 mmol) of sodium and 768 mg of sucrose.
Maltese: Kull gramma ta' sodium phenylbutyrate, fiha 124 mg (5.4 mmol) ta' sodju u 768 mg ta' sukrosju.
English: Very common side effects (may affect more than 1 in 10 people): irregular menstrual periods and stopping of menstrual periods in fertile women.
Maltese: Effetti sekondarji komuni ħafna (jistgħu jaffetwaw aktar minn persuna 1 minn kull 10): mestrwazzjoni irregolari u l-waqfien tal-mestrwazzjoni f'nisa fertili.
English: The mean time to peak concentration was 3.55 and 3.23 hours, respectively, and the mean peak concentration was 45.3 and 62.8 μg/ml, respectively.
Maltese: Il-perijodu medju biex tintlaħaq il-konċentrazzjoni massima kien ta' 3.55 u 3.23 sigħat, rispettivament, u l-konċentrazzjoni massima medja kienet ta' 45.3 u 62.8 μg/ml,
English: Common rash, abnormal skin odor
Maltese: Komuni raxx, riħa abnormali fil-ġilda
English: PHEBURANE 483 mg/g {For carton only}
Maltese: PHEBURANE 483 mg/g {Għall-kartuna biss}
English: Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Maltese: transaminażi, bilirubina, aċidu uriku, klorur, fosfat u sodju fid-demm.
English: • disorientation,
Maltese: • diżorjentament,
English: 172 rue de Charonne
Maltese: Lucane Pharma 172 rue de Charonne 75011 Pariġi
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, various alimentary tract and metabolism products, ATC code: A16AX03.
Maltese: Prodotti oħra tal-passaġġ alimentari u tal-metaboliżmu, prodotti varji tal-apparat alimentari u tal-metaboliżmu, Kodiċi ATC:
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Maltese: • 450 - 600 mg/kg/kuljum fi trabi tat-twelid, trabi u tfal li jiżnu anqas minn 20 kg
English: Common side effects (may affect more than 1 in 100 people): changes in number of blood cells (red cells, white cells and platelets), changes in the amount of bicarbonate in the blood, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances), stomach ache, vomiting, nausea, constipation, abnormal skin odor, rash, abnormal kidney function, weight gain, altered laboratory test values.
Maltese: Effetti sekondarji komuni (jistgħu jaffetwaw aktar minn persuna 1 minn kull 100): tibdil fin-numru ta' ċelloli tad-demm (ċelloli ħomor, ċelloli bojod u plejtlits), tibdil fl-ammont ta' bikarbonat fiddemm, aptit imnaqqas, dipressjoni, irritabilità, uġigħ ta' ras, ħass ħażin, żamma ta' fluwidu (nefħa), tibdil fit-togħma (disturbi fit-togħma) uġigħ ta' żaqq, rimettar, dardir, stitikezza, riħa abnormali filġilda, raxx, funzjoni abnormali tal-kliewi, żieda fil-piż, valuri mibdula tat-testijiet tal-laboratorju.
English: This medicine contains 768 mg of sucrose per 1 g of sodium phenylbutyrate.
Maltese: Din il-mediċina fiha 768 mg ta' sukrosju għal kull 1 g ta' sodium phenylbutyrate.
English: Arginine supplementation is required for patients diagnosed with deficiency of argininosuccinate synthetase at a dose of 0.4 - 0.7 g/kg/day or 8.8 - 15.4 g/m2/day.
Maltese: L-għoti supplimentari ta' arginine hu meħtieġ għall-pazjenti li fuqhom kien djanjostikat nuqqas ta' argininosuccinate synthetase b'doża ta' 0.4-0.7 g/kg/kuljum jew 8.8 - 15.4 g/m2/kuljum.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: PHEBURANE 483 mg/g granules
Maltese: PHEBURANE 483 mg/g granuli.
English: FrostPharma AB Tlf: +45 808 20 101 info@frostpharma.com
Maltese: Tlf: +45 808 20 101 info@frostpharma.com
English: Pheburane is contra-indicated during pregnancy (see section 4.3).
Maltese: Pheburane huwa kontra-indikat waqt it-treddigħ (ara sezzjoni 4.3).
English: In late-onset deficiency patients, including females heterozygous for ornithine transcarbamylase deficiency, who recovered from hyperammonaemic encephalopathy and were then treated chronically with dietary protein restriction and sodium phenylbutyrate, the survival rate was 98 %.
Maltese: F'pazjenti fejn il-marda ħarġet tard, inklużi eterożigi femminili għal nuqqas ta' ornithine transcarbamylase, li rkupraw minn enċefalopatija iperammonemika u kienu kkurati b'mod kroniku b'restrizzjoni tal-proteini fid-dieta u sodium phenylbutyrate, ir-rata ta' għajxien kienet ta' 98%.
English: Plasma and urine concentrations of phenylbutyrate and its metabolites have been obtained from fasting normal adults who received a single dose of 5 g of sodium phenylbutyrate and from patients with urea cycle disorders, haemoglobinopathies and cirrhosis receiving single and repeated oral doses up to 20 g/day (uncontrolled studies).
Maltese: Il-konċentrazzjonijiet fil-plażma u tal-awrina ta' phenylbutyrate u l-metaboliti tiegħu nkisbu minn adulti normali sajmin li ngħataw doża waħda ta' 5 g ta' sodium phenylbutyrate u minn pazjenti bi problemi fiċ-ċiklu tal-urea, emoglobinopatijiet u cirrhosis li ngħataw doża waħda u dożi orali ripetuti sa 20 g/kuljum (studji mhux kontrollati).
English: Citrulline or arginine supplementation is required for patients diagnosed with neonatal-onset form of carbamyl phosphate synthetase or ornithine transcarbamylase deficiency at a dose of 0.17 g/kg/day or 3.8 g/m2/day.
Maltese: L-għoti supplimentari ta' ċitrullina jew arginine huma meħtieġa għall-pazjenti li fuqhom kien djanjostikat nuqqas mat-twelid / mill-ewwel ta' carbamyl synthetase tal-fosfat jew ornithine transcarbamylase b'doża ta' 0.17 g/kg/kuljum jew 3.8 g/m2/kuljum.
English: Uncommon aplastic anaemia, ecchymosis
Maltese: Mhux komuni anemija aplastika, ekkimożi
English: Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-fruttożju, malassorbiment ta' glucose-galactose jew insuffiċjenza ta' sucrase-isomaltase ma għandhomx jieħdu dan il-prodott mediċinali.
English: A calibrated dosing spoon is provided which dispenses up to 3g of sodium phenylbutyrate by graduation of 250 mg.
Maltese: Hija pprovduta kuċċarina kkalibarata tad-dożaġġ li tagħti sa 3g ta' sodium phenylbutyrate b'gradwazzjoni ta' 250 mg.
English: Package leaflet: Information for the patient PHEBURANE 483 mg/g granules
Maltese: Informazzjoni għall-pazjent PHEBURANE 483 mg/g granuli
English: Available pharmacodynamic/toxicological data in animals have shown excretion of sodium phenylbutyrate/metabolites in milk (see section 5.3).
Maltese: Treddigħ Dejta farmakodinamika/tossikoloġika disponibbli fl-annimali wriet l-eliminazzjoni ta' sodium phenylbutyrate /metaboliti fil-ħalib (ara sezzjoni 5.3).
English: FrostPharma AB Tel: +46 775 86 80 02 info@medicalneed.com
Maltese: Tel: +46 775 86 80 02 info@medicalneed.com
English: • PHEBURANE is not recommended for the management of acute hyperammonaemia, which is a medical emergency.
Maltese: • PHEBURANE mhux rakkomandat għall-immaniġġjar ta' iperammonemija akuta, li hi emerġenza medika.
English: • sleepiness, tiredness, light-headedness and less frequently confusion,
Maltese: • ngħas, għeja, sturdament, u b'mod inqas frekwenti, konfużjoni,
English: Therapeutic monitoring
Maltese: Osservazzjoni terapewtika
English: FrostPharma AB Tel: +46 775 86 80 02 info@frostpharma.com
Maltese: Tel: +46 775 86 80 02 info@frostpharma.com
English: Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Maltese: Madwar 80 - 100% tal-prodott mediċinali jitneħħa mill-kliewi f'24 siegħa bħala prodott konjugat, phenylacetylglutamine.
English: One case of overdose occurred in a 5-month old infant with an accidental single dose of 10 g (1370 mg/kg).
Maltese: Każ wieħed ta' doża eċċessiva seħħ f'tarbija ta' 5 xhur b'doża aċċidentali waħda ta' 10 g (1370 mg/kg).
English: When high doses of phenylacetate (190 - 474 mg/kg) were given subcutaneously to rat pups, decreased proliferation and increased loss of neurons were observed, as well as a reduction in CNS
Maltese: Meta dożi għolja ta' phenylacetate (190 - 474 mg/kg) ingħataw taħt il-ġilda lill-frieħ tal-firien, kien osservat tnaqqis ta' proliferazzjoni u żieda fit-telf ta' newroni, kif ukoll tnaqqis ta' majelin fis-CNS.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Maltese: DATA TA' REVIŻJONI TAT-TEST Informazzjoni dettaljata dwar dan il-prodott mediċinali tinsab fuq is-sit web tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu.
English: The usual total daily dose of sodium phenylbutyrate in clinical experience is:
Maltese: Id-doża totali ta' kuljum normali ta' sodium phenylbutyrate fl-esperjenza klinika hi:
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Maltese: Ilmaġġoranza tal-pazjenti li kienu eżaminati kellhom livell ta' IQ bejn medju u medju baxx/borderline mentally retarded range.
English: Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Maltese: Kien hemm riżultat negattiv f'2 studji fuq il-mutaġeniċità b'sodium phenylbutyrate, i.e. l-eżami Ames u l-eżami tal-mikronukleju.
English: Common abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Maltese: Mhux komuni pankreatite, ulċera peptika, emorraġija rettali,
English: • Lines on the spoon indicate the amount (in gram of sodium phenylbutyrate).
Maltese: • Linji fuq il-kuċċarina jindikaw l-ammont (fi gramma ta' sodium phenylbutyrate).
English: White to off-white granules.
Maltese: Granuli bojod għal offwajt.
English: PHEBURANE granules are white to off-white.
Maltese: Il-granuli PHEBURANE huma bojod għal offwajt.
English: Micronucleus test results indicate that sodium phenylbutyrate was considered not to have produced any clastogenic effect in rats treated at toxic or non-toxic dose levels (examined 24 and 48 hours after a single oral administration of 878 to 2800 mg/kg).
Maltese: Ir-riżultati tal-eżami tal-mikronukleju jindikaw li sodium phenylbutyrate ma kienx ikkunsidrat li jipproduċi l-ebda effett klastoġeniku fuq firien ikkurati b'livelli ta' doża tossika jew mhux tossika (eżaminati 24 u 48 siegħa wara doża orali waħda ta' 878 sa 2800 mg/kg).
English: • This medicinal product contains 124 mg sodium per gram, equivalent to 6.2% of the WHO recommended maximum daily intake for sodium.
Maltese: Dan il-prodott mediċinali fih 124 mg ta' sodju għal kull gramma, ekwivalenti għal 6.2% talkonsum massimu ta' kuljum rakkomandat mill-ODS għal sodju.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylacetate and phenylacetylglutamine were detected 30 and 60 minutes respectively after dosing.
Maltese: Wara doża waħda ta' 5 g ta' sodiumphenylbutyrate fil-forma ta' granuli, livelli li jitkejlu fil-plażma ta' phenylacetate u phenylacetylglutamine kienu osservati 30 u 60 minuta rispettivament wara lgħotja tad-doża.
English: B. PACKAGE LEAFLET
Maltese: MANIFATTUR(I) REPONSABBLI
English: • probenecid (for treatment of hyperuricaemia, high levels of uric acid in the blood, associated with gout)
Maltese: • probenecid (għall-kura ta' iperurikemja, livelli għoljin ta' aċidu uriku fid-demm, assoċjata ma' gotta)
English: FrostPharma AB Puh/Tel: +35 875 32 51 209 info@frostpharma.com
Maltese: +35 875 32 51 209 info@frostpharma.com
English: With haemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in newborns diagnosed after birth (but within the first month of life) increased to almost 80 % with most deaths occurring during an episode of acute hyperammonaemic encephalopathy.
Maltese: Permezz ta' emodijaliżi, l-użu ta' rotot alternattivi għat-tneħħija mill-ġisem ta' nitroġenu mhuwiex meħtieġ, (sodium phenylbutyrate, sodium benzoate u sodium phenylacetate), restrizzjoni tal-proteini fid-dieta, u, f'ċertu każijiet, lgħoti supplimentari ta' amino aċidi essenzjali, ir-rata ta' sopravivenza fi trabi li jkunu għadhom kif jitwieldu dijanjostikati wara t-twelid (iżda fl-ewwel xahar tal-ħajja) żdiedet sa kważi 80% bil-parti lkbira tal-imwiet isseħħ matul episodju ta' enċefalopatija iperammonemika akuta.
English: Each gram of granules contains 483 mg of sodium phenylbutyrate.
Maltese: Kull gramma ta' granuli fiha 483 mg ta' sodium phenylbutyrate.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients sugar spheres (sucrose and maize starch), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.
Maltese: ethylcellulose N7, macrogol 1500, povidone K25.
English: Excretion
Maltese: gastrite
English: On a molar basis, phenylacetylglutamine is comparable to urea (each containing 2 moles of nitrogen) and therefore provides an alternate vehicle for waste nitrogen excretion.
Maltese: Fuq bażi molari, phenylacetylglutamine jista' jitqabbel mal-urea (it-tnejn fihom żewġ moles ta' nitrogen) u għalhekk jipprovdi metodu alternattiv għat-tneħħija mill-ġisem ta' nitrogen mhux meħtieġ.
English: Mechanism of action and pharmacodynamic effects Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi Sodium phenylbutyrate hu pro-drug li jiġi metabolizzat malajr għal phenylacetate.
English: This may be due to the lipophilicity of sodium phenylbutyrate and consequent differences in volume of distribution.
Maltese: Dan jista' jkun minħabba l-lipofiliċità ta' sodium phenylbutyrate u differenzi konsegwenti fil-volum ta' distribuzzjoni.
English: In clinical trials with sodium phenylbutyrate, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to sodium phenylbutyrate.
Maltese: F'eżamijiet kliniċi b'sodium phenylbutyrate, 56 % tal-pazjenti esperjenzaw tal-anqas effett avvers wieħed u 78 % ta' dawn is-sintomi avversi ma kienux ikkunsidrati li huma marbuta ma' sodium phenylbutyrate.
English: • Pregnancy.
Maltese: • tqila.
English: The patient developed diarrhea, irritability and metabolic acidosis with hypokalaemia.
Maltese: Il-pazjent żviluppa dijarrea, irritabiltà u aċidożi metabolika b'ipokalemja.
English: In the majority of patients with urea cycle disorders or haemoglobinopathies receiving various doses of phenylbutyrate (300 - 650 mg/kg/day up to 20 g/day) no plasma level of phenylacetate could be detected after overnight fasting.
Maltese: Fil-maġġoranza tal-pazjenti b'disturbi fiċ-ċiklu tal-urea jew b'emoglobinopatiji li kienu qed jirċievu diversi dożi ta' phenylbutyrate (300 - 650 mg/kg/kuljum sa 20 g/kuljum) ma seta' jkun osservat lebda livell ta' phenylacetate fil-plażma wara lejl li fih il-pazjent ma ħa xejn.
English: • This medicinal product contains 768 mg sucrose per gram.
Maltese: • Dan il-prodott mediċinali fih 768mg ta' sukrosju għal kull gramma..
English: Uncommon arrhythmia
Maltese: Mhux komuni arritmija
English: Common oedema
Maltese: Komuni edema
English: HDPE bottle, child-resistant closure with desiccant, containing 174 g of granules.
Maltese: Flixkun HDPE, li ma jistax jinfetaħ mit-tfal b'dessikant, li fih174 g ta' granuli.
English: • Serum potassium should be monitored during therapy since renal excretion of phenylacetylglutamine may induce a urinary loss of potassium.
Maltese: • Il-potassju fis-serum għandu jkun immonitorjat matul it-terapija minħabba li l-eskrezzjoni mill-kliewi ta' phenylacetylglutamine tista' tikkawża t-telf ta' potassju mill-urina.
English: • worsening of existing neurological conditions.
Maltese: • aggravament ta' kundizzjonijiet newroloġiċi eżistenti.
English: : + 33 153 868 750 info@lucanepharma.com
Maltese: Τηλ: + 33 153 868 750 info@lucanepharma.com
English: You should take PHEBURANE by mouth.
Maltese: PHEBURANE fih sodju u sukrosju.
English: These symptoms are consistent with the accumulation of phenylacetate, which showed dose-limiting neurotoxicity when administered intravenously at doses up to 400 mg/kg/day.
Maltese: Dawn is-sintomi huma konsistenti mal-akkumulazzjoni ta' phenylacetate, li wera newrotossiċità limitata mid-doża meta mogħti fil-vina f'dożi li jwasslu sa 400 mg/kg/kuljum.
English: • are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6).
Maltese: • allerġika għal sodium phenylbutyrate jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6)
English: A calibrating measuring spoon which dispenses up to 3 g of sodium phenylbutyrate is provided with the medicine.
Maltese: Kuċċarina kkalibrata tal-kejl li tiddispensa sa 3 g ta' sodium phenylbutyrate hija pprovduta malmediċina.
English: CARTON AND BOTTLE LABEL
Maltese: PRIMARJU KARTUNA U TIKKETTA TAL-FLIXKUN
English: Prenatal exposure of rat pups to phenylacetate (the active metabolite of phenylbutyrate) produced lesions in cortical pyramidal cells; dendritic spines were longer and thinner than normal and reduced in number (see section 4.6).
Maltese: Espożizzjoni qabel it-twelid ta' frieħ tal-firien għal phenylacetate (il-metabolitu attiv ta' phenylbutyrate) ipproduċa leżjnijiet fiċ-ċelloli kortikali piramidali, l-ispina dendritika kienet itwal u irqaq min-normal u mnaqqsa fl-ammont.
English: In small children this can be 4 to 6 times per day.
Maltese: Fi tfal żgħar dan jista' jkun 4 sa 6 darbiet kuljum.
English: The disposition of phenylbutyrate and its metabolites has also been studied in cancer patients following intravenous infusion of sodium phenylbutyrate (up to 2 g/m²) or phenylacetate.
Maltese: Id-dispożizzjoni ta' phenylbutyrate u l-metaboliti tiegħu kienet studjata wkoll f'pazjenti b'kanċer wara infużjoni fil-vina ta' sodium phenylbutyrate (sa 2 g/m²) jew phenylacetate.
English: What PHEBURANE looks like and contents of the pack
Maltese: Id-dehra ta' PHEBURANE u l-kontenuti tal-pakkett
English: Repeated dosing with phenylacetate showed evidence of an induction of clearance.
Maltese: Dożaġġ ripetut b'phenylacetate wera evidenza ta' induzzjoni tat-tneħħija.
English: • changes in taste (taste disturbances),
Maltese: • tnaqqis fis-sens tas-smigħ,
English: PHEBURANE will not prevent the occurrence of an acute excess of ammonia in the blood, a condition which usually constitutes a medical emergency.
Maltese: PHEBURANE ma jevitax kompletament l-okkorrenza ta' eċċess akut ta' ammonia fid-demm, kundizzjoni li ġeneralment tikkostitwixxi emerġenza medika.
English: Fertility There is no evidence available on the effect of sodium phenylbutyrate on fertility.
Maltese: Ma hemm l-ebda evidenza disponibbli fuq l-effett ta' sodium phenylbutyrate fuq il-fertilità.
English: It is unknown whether sodium phenylbutyrate/metabolites are excreted in human milk.
Maltese: Mhux magħruf jekk sodium phenylbutyrate /metaboliti jiġux eliminati mill-ħalib tal-omm.
English: Eurocept International BV
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Eurocept International BV
English: There have been published reports of hyperammonaemia being induced by haloperidol and by valproate.
Maltese: Kienu ppubblikati rapporti li jsostnu li l-iperammonemja rriżultat kaġun ta' haloperidol u ta' valproate.
English: The maximum daily dose of this medicinal product is equivalent to 125% of the WHO recommended maximum daily intake for sodium.
Maltese: Id-doża massima ta' kuljum ta' dan il-prodott mediċinali hija ekwivalenti għal 125% talkonsum massimu ta' kuljum rakkomandat mill-ODS għal sodju.
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Maltese: Phenylbutyrate hu magħruf li jossida ruħu għal phenylacetate li jingħaqad b'mod enżimatiku ma' glutamine biex jifforma phenylacetylglutamine fil-fwied u l-kliewi.
English: Each gram of granules contains 483 mg of sodium phenylbutyrate
Maltese: Kull gramma ta' granuli fiha 483 mg ta' sodium phenylbutyrate
English: Common renal tubular acidosis
Maltese: Komuni aċidożi tubulari tal-kliewi
English: Three cirrhotic patients (out of 6) who received repeated oral administration of sodium phenylbutyrate (20 g/day in three doses) showed sustained plasma levels of phenylacetate on the third day that were five times higher than those achieved after the first dose.
Maltese: Tliet pazjenti ċirrotiċi (minn 6) li rċevew għotja orali ta' sodium phenylbutyrate (20 g/kuljum fi tliet dożi) urew livelli sostenuti ta' phenylacetate fil-plażma fit-tielet ġurnata, li huma ta' ħames darbiet aktar minn dawk miksuba mill-ewwel doża.
English: Uncommon side effects (may affect more than 1 in 1,000 people): deficiency in red blood cells due to failure of the bone marrow, bruising, altered heart rhythm, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffetwaw aktar minn persuna 1 minn kull 1,000): nuqqas ta' ċelloli ħomor tad-demm minħabba falliment tal-mudullun, tbenġil, ritmu mibdul tat-taħbit tal-qalb, fsada mir-rektum, infjammazzjoni tal-istonku, ulċera fl-istonku, infjammazzjoni tal-frixa.
English: PHEBURANE is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Maltese: PHEBURANE hu ntiż bħala terapija aġġuntiva fil-kura kronika ta' disturbi fiċ-ċiklu tal-urea, li jinvolvu nuqqas ta' carbamyl phosphate synthetase, ornithine transcarbamylase, jew argininosuccinate synthetase.
English: FrostPharma AB Tlf: +47 815 03 175
Maltese: Österreich Lucane Pharma Tel: + 33 153 868 750
English: Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Maltese: Ma sarux studji dwar il-karċinoġeniċità u fertilità ta' sodium phenylbutyrate.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of granules, measurable plasma levels of phenylbutyrate were detected 15 minutes after dosing.
Maltese: Phenylbutyrate jiġi assorbit malajr waqt li tkun sajjem: wara doża waħda orali ta' 5 g ta' sodium phenylbutyrate, fil-forma ta' granuli, livelli li jitkejlu fil-plażma kienu osservati 15-il minuta wara l għotja tad-doża.
English: PHEBURANE contains the active substance sodium phenylbutyrate which is used to treat patients of all ages with urea cycle disorders.
Maltese: PHEBURANE fih is-sustanza attiva sodium phenylbutyrate li tintuża fil-kura ta' pazjenti ta' kull età bi problemi fiċ-ċiklu tal-urea.
English: • Breast-feeding.
Maltese: • Tqala • Treddigħ
English: These rare disorders are due to a deficiency of certain liver enzymes which are necessary to eliminate waste nitrogen in the form of ammonia.
Maltese: Dan il-mard huma minħabba nuqqas ta' ċerti enzimi tal-fwied li huma meħtieġa biex ineħħu nitrogen żejjed fil-forma ta' ammonia.
English: Studies with high intravenous doses of phenylacetate showed non-linear pharmacokinetics characterised by saturable metabolism to phenylacetylglutamine.
Maltese: Studji b'għotja ta'dożi għoljin fil-vina ta' phenylacetate urew farmokinetika mhux lineari kkaraterizzata minn metaboliżmu saturabbli għal phenylacetylglutamine.
English: • impaired memory,
Maltese: • indeboliment tal-memorja
English: Lucane Pharma Τηλ: + 33 153 868 750 info@lucanepharma.com
Maltese: Lucane Pharma Teл.: + 33 153 868 750 info@lucanepharma.com
English: Age, gender, race
Maltese: Età, sess tal-persuna, razza
English: Day 1 Days 2 to 7
Maltese: Jum 1 Jiem 2 sa 7
English: Days 16 to 21
Maltese: Jiem 16 sa 21
English: Days 23 to 28
Maltese: Jiem 23 sa 28
English: Day 8 Days 9 to 14
Maltese: Jum 8 Jiem 9 sa 14
English: Reproductive and embryo-foetal development
Maltese: Żvilupp riproduttiv u embrijufetali