FrancophonIA/ELRC3.0 huggingface dataset:
English: Increased blood alkaline phosphatase, transaminases, bilirubin, uric acid, chloride, phosphate and sodium.
Maltese: Żieda fl-alkaline phosphatase, transaminases, bilirubina, uric acid, chloride, phosphate u sodium fid-demm.
English: Common: Decreased blood potassium, albumin, total protein and phosphate.
Maltese: Tnaqqis fil-potassium, albumina, proteina totali u phosphate fid-demm.
English: Common: Metabolic acidosis, alkalosis, decreased appetite
Maltese: Komuni: Aċidożi metabolika, alkalosi, nuqqas t'aptit
English: The elimination half-life was estimated to be 0.8 hours.
Maltese: Il-half-life ta' l-eliminazzjoni hi 0.8 siegħa.
English: The volume of distribution of phenylbutyrate is 0.2 l/kg.
Maltese: Il-volum ta' distribuzzjoni ta' phenylbutyrate hu ta' 0.2 l/kg.
English: The elimination half-life was estimated to be 1.2 and 2.4 hours, respectively.
Maltese: Il-half-life ta' l-eliminazzjoni hi 1.2 u 2.4 siegħat, rispettivament.
English: The elimination half-life was estimated to be 1.3 and 2.4 hours, respectively.
Maltese: Il-half-life ta' l-eliminazzjoni hi 1.3 u 2.4 siegħat, rispettivament.
English: AMMONAPS 940 mg/g granules
Maltese: Ammonaps 940 mg/g granuli
English: AMMONAPS contains sodium
Maltese: AMMONAPS fih sodium
English: Very common: Amenorrhoea, irregular menstruation
Maltese: Komuni ħafna: Amenorrea, mestrwazzjoni irregolari
English: Frequency is 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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenza hi definita bħala komuni ħafna (≥1/10), komuni (≥1/100 sa <1/10) u mhux komuni (≥1/1,000 sa <1/100)), rari (≥1/10,000 sa <1/1,000), rari ħafna (<1/10,000), mhux magħruf (ma tistax tiġi stmata mit-tagħrif disponibbli).
English: Date of first authorisation: 08/12/1999 Date of latest renewal: 08/12/2009
Maltese: Data tal-aħħar tiġdid: 08/12/2009
English: Ammonaps 500 mg [outer packaging only]
Maltese: Ammonaps 500 mg [ippakkjar ta' barra biss]
English: Granules.
Maltese: valproate.
English: Plasma glutamine should be maintained at levels less than 1,000 µmol/l.
Maltese: Glutamine tal-plażma għandha tinżamm f'livelli ta' anqas minn 1,000 µmol/l.
English: Each AMMONAPS tablet contains 62 mg of sodium.
Maltese: Kull pillola ta' AMMONAPS fiha 62 mg ta' sodium.
English: - The active substance is sodium phenylbutyrate.
Maltese: - Is-sustanza attiva hi 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: argininosuccinate synthetase b'doża ta' 0.4 - 0.7 g/kg/kuljum or 8.8 - 15.4 g/m2/kuljum.
English: A probable case of toxic reaction to AMMONAPS (450 mg/kg/d) was reported in an 18-year old anorectic female patient who developed a metabolic encephalopathy associated with lactic acidosis, severe hypokalaemia, pancytopaenia, peripheral neuropathy, and pancreatitis.
Maltese: Każ probabbli ta' reazzjoni tossika għal AMMONAPS (450 mg/kg/kuljum) kien irrappurtat f'pazjenta anorettika ta' 18-il sena li żviluppat enċefalopatija metabolika assoċjata ma' aċidożi lattika, ipokalemija severa, panċitopenja, newropatija periferali, u pankreatite.
English: Each bottle contains 266 g or 532 g of granules.
Maltese: 266 g jew 532 g ta' granuli.
English: Common: Abdominal pain, vomiting, nausea, constipation, dysgeusia Uncommon: Pancreatitis, peptic ulcer, rectal haemorrhage, gastritis
Maltese: Komuni: Uġigħ ta' żaqq, rimettar, nawsja, konstipazzjoni, indeboliment fis-sens tat-togħma Mhux komuni: Pankreatite, ulċera peptika, emorraġija tar-rektum, gastrite
English: Therapeutic monitoring: Plasma levels of ammonia, arginine, essential amino acids (especially branched chain amino acids), carnitine and serum proteins should be maintained within normal limits.
Maltese: Il-livelli fil-plażma ta' ammonia, arginine, l-amino aċidi essenzjali (speċjalment branched chain amino acids), carnitine u proteini tas-serum għandhom jinżammu fillimiti normali.
English: EU/1/99/120/001 250 tablets EU/1/99/120/002 500 tablets
Maltese: EU/1/99/120/001 250 pillola EU/1/99/120/002 500 pillola
English: Evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
Maltese: Evalwazzjoni ta' studji sperimentali fuq l-annimali wrew tossiċità riproduttiva, i.e. effetti fuq l-iżvilupp ta' l-embriju jew il-fetu.
English: EU/1/99/120/001 (250 tablets) EU/1/99/120/002 (500 tablets)
Maltese: EU/1/99/120/001 (250 pillola) EU/1/99/120/002 (500 pillola)
English: Affects 1 to 10 users in 1,000
Maltese: Taffettwa minn 1 sa 10 utenti minn kull 1,000
English: Pharmacotherapeutic group: various alimentary tract and metabolism products, ATC code: A16A X03.
Maltese: Kategorija farmakoterapewtika: prodotti varji tal-apparat alimentari u tal-metaboliżmu, Kodiċi ATC:
English: In clinical trials with AMMONAPS, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to AMMONAPS.
Maltese: F'eżamijiet kliniċi b'AMMONAPS, 56 % tal-pazjenti esperjenzaw ta' l-anqas effett avvers wieħed u 78 % ta' dawn is-sintomi avversi ma kienux ikkunsidrati li huma marbuta ma' AMMONAPS.
English: AMMONAPS granules contain 124 mg (5.4 mmol) of sodium per gram of sodium phenylbutyrate, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Maltese: Il-granuli AMMONAPS jinkludu 124 mg (5.4 mmol) ta' sodium kull gramma ta' sodium phenylbutyrate, korrispondenti għal 2.5 g (108 mmol) ta' sodium kull 20 g ta' sodium phenylbutyrate, li hi l-għola doża ta' kuljum.
English: AMMONAPS tablets are off-white, oval and embossed with “UCY 500”.
Maltese: Il-pilloli huma ta' kulur off-wajt, ovali u bit-tinqix “UCY 500”.
English: Affects 1 to 10 users in 10,000
Maltese: Taffettwa minn 1 sa 10 utenti minn kull 10,000
English: AMMONAPS 500 mg tablets sodium phenylbutyrate
Maltese: AMMONAPS 500 mg pilloli sodium phenylbutyrate
English: • 450 - 600 mg/kg/day in children weighing less than 20 kg
Maltese: • 450 - 600 mg/kg/kuljum fi tfal li jiżnu anqas minn 20 kg
English: Three dosing spoons are provided which dispense 1.2 g, 3.3 g or 9.7 g of sodium phenylbutyrate.
Maltese: Huma pprovduti tliet kuċċarini tad-dożaġġ, li jferrgħu 1.2 g, 3.3 g jew 9.7 g ta' sodium phenylbutyrate.
English: Each AMMONAPS tablet contains 62 mg (2.7 mmol) of sodium, corresponding to 2.5 g (108 mmol) of sodium per 20 g of sodium phenylbutyrate, which is the maximum daily dose.
Maltese: Kull pillola AMMONAPS fiha 62 mg (2.7 mmol) ta' sodium, korrispondenti għal 2.5 g (108 mmol) ta' sodium kull 20 g ta' sodium phenylbutyrate, li hi l-għola doża ta' kuljum.
English: Very common side effects: irregular menstrual periods and cessation of menstrual periods.
Maltese: Effetti sekondarji komuni ħafna: mestrwazzjoni irregolari u l-waqfien tal-mestrwazzjoni.
English: Nitrogen is a building block of proteins, because of this there is a build up of nitrogen in the body after eating protein.
Maltese: In-nitrogen huwa blokka li tinbena mill-proteini u minħabba dan ikun hemm akkumulazzjoni ta' nitrogen fil-ġisem wara li jittieħdu l-proteini.
English: How to store AMMONAPS Contents of the pack and other information
Maltese: Kontenut tal-pakkett u informazzjoni oħra
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'restirizzjoni tal-proteini fid-dieta u sodium phenylbutyrate, ir-rata ta' għajxien kienet ta' 98%.
English: One large spoon of AMMONAPS granules contains 1200 mg of sodium.
Maltese: Kuċċarina kbira ta' granijiet AMMONAPS fiha 1200 mg ta' sodium.
English: Common side effects: changes in number of blood cells (red cells, white cells and platelets), reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), changes in taste (taste disturbances),pain in the abdomen, vomiting, nausea, constipation, skin odour, rash, abnormal kidney function, weight gain, altered laboratory test values.
Maltese: Effetti sekondarji komuni: tibdil fin-numru ta' ċelloli ħomor tad-demm (ċelloli ħomor, ċelloli bojod u plejtlets), aptit imnaqqas, dipressjoni, irritabilità, uġigħ ta' ras, ħass ħażin, żamma ta' fluwidu (nefħa), disturbi fit-togħma, uġigħ ta' żaqq, rimettar, dardir, stitikezza, riħa fil-ġilda, raxx, funzjoni anormali tal-kliewi, żieda fil-piżvaluri mibdula tat-testijiet tal-laboratorju.
English: Sodium phenylbutyrate is a pro-drug and is rapidly metabolised to phenylacetate.
Maltese: Sodium phenylbutyrate hu pro-drug li jiġi metabolizzat malajr għal phenylacetate.
English: EU/1/99/120/003 (266 g granules) EU/1/99/120/004 (532 g granules)
Maltese: EU/1/99/120/003 (266 g granijiet) EU/1/99/120/004 (532 g granijiet)
English: - The other ingredients are microcrystalline cellulose, magnesium stearate and colloidal anhydrous silica.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose, magnesium stearate u colloidal anhydrous silica.
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 ta' l-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 ta' l-urea, emoglobinopatijiet u cirrhosis li ngħataw doża waħda u dożi orali ripetuti sa 20 g/kuljum (studji mhux kontrollati).
English: The majority of the patients who were tested had an IQ in the average to low average/borderline mentally retarded range.
Maltese: Il maġġoranza tal-pazjenti li kienu eżaminati kellhom livell ta' IQ bejn medju u medju baxx/borderline mentally retarded range.
English: EU/1/99/120/003 266 g granules EU/1/99/120/004 532 g granules
Maltese: EU/1/99/120/004 532 g granuli
English: One large blue spoon of AMMONAPS granules contains 1200 mg of sodium.
Maltese: Kuċċarina kbira blu ta' granuli ta' AMMONAPS fiha 1200 mg ta' sodium.
English: This will give the following doses: small measure 1.2 g, medium measure 3.3 g and large measure 9.7 g of sodium phenylbutyrate.
Maltese: Dan se jagħti d-dożi segwenti: miżura żgħira 1.2 g, miżura ta' daqs medju 3.3 mg u miżura kbira ta' 9.7 g ta' sodium phenylbutyrate.
English: One medium sized spoon of AMMONAPS granules contains 408 mg of sodium.
Maltese: Kuċċarina medja ta' granijiet AMMONAPS fiha 408 mg ta' sodium.
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.
Maltese: Espożizzjoni qabel it-twelid ta' frieħ tal-firien għal phenylacetate (il-metabolitu attiv ta' phenylbutyrate) ipproduċa feriti fiċ-ċelloli kortikali piramidali, l-ispina dendritika kienet itwal u irqaq min-normal u mnaqqsa fl-ammont.
English: The significance of these data in pregnant women is not known; therefore the use of AMMONAPS is contra-indicated during pregnancy (see section 4.3).
Maltese: Is-sinifikat ta' din l-informazzjoni għan-nisa tqal mhux magħruf; għalhekk AMMONAPS huwa kontra-indikat waqt it-tqala (ara sezzjoni 4.3).
English: PHARMACEUTICAL FORM
Maltese: FARMAĊEWTIKA
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 ta' l-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: 1 g of granules contains 940 mg of sodium phenylbutyrate
Maltese: 1 g ta' granijiet fihom 940 mg ta' sodium phenylbutyrate
English: AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.
Maltese: AMMONAPS mhux rakkomandat għall-immaniġġjar ta' iperammonemija akuta, li hi emerġenza medika.
English: Other medicines and AMMONAPS
Maltese: Mediċini oħra u AMMONAPS
English: Common: Anaemia, thrombocytopenia, leukopenia, leukocytosis, thrombocytosis Uncommon: Aplastic anaemia, ecchymosis
Maltese: Disturbi tad-demm u tas-sistema limfatika Komuni: Anemija, tromboċitopenja, lewkopenja, lewkoċitosi, tromboċitosi
English: How to store AMMONAPS
Maltese: X'fih AMMONAPS
English: The mean time to peak concentration is 3.74 and 3.43 hours, respectively, and the mean peak concentration is 48.5 and 68.5 µg/ml, respectively.
Maltese: Il-perjodu medju biex tintlaħaq il-konċentrazzjoni massima hu ta' 3.74 u 3.43 siegħat, rispettivament, u l-konċentrazzjoni massima medja hi ta' 48.5 and 68.5 µg/ml,
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 ma' l-akkumulazzjoni ta' phenylacetate, li wera newrotossiċità limitata mid-doża meta mogħti fil-vina f'dożi li jwasslu sa 400 mg/kg/kuljum.
English: - if you are breast-feeding.
Maltese: - tnaqqis fis-sens tas-smigħ,
English: One small spoon of AMMONAPS granules contains 149 mg of sodium.
Maltese: Kuċċarina żgħira bajda ta' granuli ta' AMMONAPS fiha 149 mg ta' sodium.
English: OUTER CARTON AND BOTTLE LABEL FOR TABLETS
Maltese: KARTUNA TA' BARRA U TIKKETTA TAL-FLIXKUN GĦALL-PILLOLI
English: Dosage
Maltese: Granijiet
English: BOURGOIN JALLIEU
Maltese: TAGĦRIF
English: The mean time to peak concentration is 3.55 and 3.23 hours, respectively, and the mean peak concentration is 45.3 and 62.8 µg/ml, respectively.
Maltese: Il-perjodu medju biex tintlaħaq il-konċentrazzjoni massima hu ta' 3.55 u 3.23 siegħat, rispettivament, u l-konċentrazzjoni massima medja hi ta' 45.3 and 62.8 µg/ml,
English: • 450 - 600 mg/kg/day in neonates, infants and children weighing less than 20 kg
Maltese: • 450 - 600 mg/kg/kuljum fi trabi li għadhom jitwieldu, trabi u tfal li jiżnu anqas minn 20 kg
English: Metabolism and nutrition disorders
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni:
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 ma' l-urea (it-tnejn fihom żewġ moles ta' nitrogen) u għalhekk jipprovdi metodu alternattiv għat-tneħħija mill-ġisem ta' nitrogen mhux meħtieġ.
English: It has not been determined if phenylacetate is secreted in human milk and therefore the use of AMMONAPS is contra-indicated during lactation (see section 4.3).
Maltese: Ma kienx stabbilit jekk-phenylacetate jitneħħa fil-ħalib ta' l-omm u għalhekk AMMONAPS huwa kontra indikat waqt it-treddiegħ (ara sezzjoni 4.3).
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 ta' l-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 l ebda livell ta' phenylacetate fil-plażma wara lejl li fih il-pazjent ma ħa xejn.
English: HDPE bottles, with child resistant caps, containing 266 g or 532 g of granules.
Maltese: Fliexken HDPE, b'għotjin li ma jinfetħux mit-tfal, li fihom 266 g jew 532 g ta' granijiet.
English: One gram of AMMONAPS granules contains 940 mg of sodium phenylbutyrate.
Maltese: Gramma waħda ta' granuli ta' AMMONAPS fiha 940 mg ta' sodium phenylbutyrate.
English: Carcinogenicity and fertility studies have not been conducted with sodium phenylbutyrate.
Maltese: Ma sarux studji dwar ilkarċinoġeniċità u fertilità ta' sodium phenylbutyrate.
English: Their cognitive performance remained relatively stable during phenylbutyrate therapy.
Maltese: Ir-riżulati konjittivi tagħhom jibqgħu relattivament stabbli matul it-terapija permezz ta' phenylbutyrate.
English: After a single dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylacetate and phenylacetylglutamine are detected 30 and 60 minutes respectively after dosing.
Maltese: Wara doża waħda ta' 5 g ta' fenajlbutirajt ta' sodium fil-forma ta' granijiet , livelli li jitkejjlu fil plażma ta' phenylacetate u phenylacetylglutamine kienu osservati 30 u 60 minuta rispettivament wara l-għotja tad-doża.
English: HDPE bottles, with child resistant caps, containing 250 or 500 tablets.
Maltese: Fliexken HDPE, b'għotjien li ma jinfetħux mit-tfal, li fihom 250 jew 500 pillola.
English: Patients who have taken very high doses of AMMONAPS experienced: - sleepiness, tiredness, light-headedness and less frequently confusion, - headache, - changes in taste (taste disturbances), - decrease in hearing, - disorientation, - impaired memory, - worsening of existing neurological conditions.
Maltese: L-aktar effetti predominanti ta' newrotossiċità kienu ħedla, għejja, nuqqas ta' konċentrazzjoni. Manifestazzjonijiet inqas frekwenti kienu: konfużjoni, uġigħ ta' ras, disgewsja, ipakużi, nuqqas ta' orjentazzjoni, diffikultajiet fil-memorja u żjieda f'newroapatija eżistenti minn qabel.
English: 532 g granules
Maltese: 266 g granijiet 532 g granijiet
English: Each tablet contains 500 mg sodium phenylbutyrate.
Maltese: Kull pillola fiha 500 mg sodium phenylbutyrate.
English: AMMONAPS is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase or argininosuccinate synthetase.
Maltese: AMMONAPS hu intiż bħala terapija aġġuntiva fil-kura kronika ta' disturbi fiċ-ċiklu ta' l-urea, li jinvolvu nuqqas ta' carbamyl phosphate synthetase, ornithine transcarbamylase, jew argininosuccinate synthetase.
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 myelin.
Maltese: Meta dożi għolja ta' phenylacetate (190 - 474 mg/kg) ingħataw minn taħt il-ġilda fi frieħ tal-firien,
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: Where a patient requires administration by tube, it is possible to re-constitute AMMONAPS in water prior to use (solubility for sodium phenylbutyrate is up to 5 g in 10 ml water).
Maltese: Meta l-pazjent jeħtieġ għotja permezz ta' tubu, hu possibbli li AMMONAPS jitħallat ma' l-ilma qabel jintuża (is-solubilità ta' sodium phenylbutyrate tilħaq il-5g f'10 ml ta' ilma.).
English: The mean time to peak concentration is 1.35 hour and the mean peak concentration 218 µg/ml.
Maltese: Il-ħin medju biex tintlaħaq il-konċentrazzjoni massima hu ta' 1.35 siegħa u l konċentrazzjoni massima medja hi ta' 218 µg/ml.
English: Phenylbutyrate is known to be oxidised to phenylacetate which is enzymatically conjugated with glutamine to form phenylacetylglutamine in the liver and kidney.
Maltese: glutamine biex jifforma phenylacetylglutamine fil-fwied u l-kliewi.
English: It is especially important to tell your doctor if you are taking medicines containing: - valproic acid (an antiepileptic drug), - haloperidol (used in certain psychotic disorders), - corticosteroids (cortisone-like medicines that are used to provide relief for inflamed areas of the body), - probenecid (for treatment of hyperuricemia associated with gout)
Maltese: B'mod speċjali hu importanti li tgħid lit-tabib tiegħek jekk qed tieħu mediċini oħra li fihom: valproic acid (mediċina anti-epilettika), haloperidol (użat f'ċerti disturbi psikotiċi), kortikosterojdi (mediċini simili għal cortisone li jintużaw sabiex jipprovdu serħan għal partijiet tal-ġisem infjammati), probenecid (għal kura ta' iperurikemja assoċjata ma' gotta)
English: - The other ingredients are calcium stearate and colloidal anhydrous silica.
Maltese: - Is-sustanzi l-oħra huma calcium stearate u colloidal anhydrous silica.
English: The patient developed diarrhoea, irritability and metabolic acidosis with hypokalaemia.
Maltese: Il-pazjent żviluppa dijarrea, irritabbiltà u aċidożi metabolika b'ipokalemja.
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: Sodium phenylbutyrate was negative in 2 mutagenicity tests, i.e. the Ames test and the micronucleus test.
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Kien hemm riżultat negattiv f'2 studji fuq il-mutaġeniċita b'sodium phenylbutyrate, i.e. l-eżami Ames u l-eżami tal-mikronukleju.
English: If you require laboratory tests, it is important to remind your doctor that you are taking AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
Maltese: AMMONAPS, għax is-sodium phenylbutyrate jista' jinfluwenza ċerti riżultati tat-testijiet tal laboratorju.
English: Approximately 80 - 100 % of the medicinal product is excreted by the kidneys within 24 hours as the conjugated product, phenylacetylglutamine.
Maltese: Eliminazzjoni Madwar 80 - 100% tal-prodott mediċinali jitneħħa mill-kliewi f'24 siegħa bħala prodott konjugat,
English: The use of AMMONAPS tablets is indicated for adults and children who are able to swallow tablets.
Maltese: AMMONAPS hu indikat għal adulti u tfal li huma kapaċi jibilgħu l-pilloli.
English: Each bottle contains 250 or 500 tablets.
Maltese: Kull flixkun fih 250 jew 500 pillola.
English: Each tablet of AMMONAPS contains 500 mg of sodium phenylbutyrate.
Maltese: Kull pillola AMMONAPS fiha 500 mg ta' sodium phenylbutyrate.
English: After a single oral dose of 5 g of sodium phenylbutyrate, in the form of tablets, measurable plasma levels of phenylbutyrate are detected 15 minutes after dosing.
Maltese: Assorbiment Phenylbutyrate jiġi assorbit malajr waqt li tkun sajjem: wara doża waħda orali ta' 5 g ta' sodium phenylbutyrate, fil-forma ta' pilloli, livelli li jitkejjlu fil-plażma kienu osservati 15-il minuta wara l għotja tad-doża.
English: Pregnancy.
Maltese: distribuzzjoni.
English: Breast-feeding.
Maltese: Treddiegħ.
English: To measure the dose:
Maltese: Osservazzjoni terapewtika:
English: Mix the measured dose with solid foods (such as mashed potatoes or apple sauce) or liquid foods (such as water, apple juice, orange juice or protein-free infant formulas) and take it immediately after mixing.
Maltese: Ħallat id-doża mkejla ma' ikel solidu (bħal patata mgħaffġa jew sauce tat-tuffieħ) jew ikel likiwdu (bħall-ilma, meraq tat-tuffieħ, meraq tal-larinġ jew ikel tat-trabi li ma jkunx fih proteini) u ħudu eżatt kif tħawwad.