FrancophonIA/ELRC3.0 huggingface dataset:
English: DuoResp Spiromax can be prescribed for asthma in two different ways.
Maltese: DuoResp Spiromax jista' jiġi ordnat għall-ażma b'żewġ modi differenti.
English: DuoResp Spiromax is indicated for use in adults 18 years of age and older only.
Maltese: DuoResp Spiromax huwa indikat għall-użu f'persuni adulti minn 18-il sena 'l fuq biss.
English: DuoResp Spiromax pharmacokinetic profile
Maltese: Profil farmakokinetiku ta' DuoResp Spiromax
English: • Oxytocin which is given to pregnant women to induce labour.
Maltese: • Oxytocin li jingħata lil nisa tqal biex jinduċi l-ħlas.
English: DuoResp Spiromax contains formoterol and budesonide, which have different modes of action and show additive effects in terms of reduction of asthma exacerbations.
Maltese: DuoResp Spiromax fih formoterol u budesonide, li għandhom modi ta' azzjoni differenti u juru effetti addittivi f'termini tat-tnaqqis fit-taħrix tal-ażma.
English: DuoResp Spiromax maintenance therapy
Maltese: Tużax DuoResp Spiromax biex tittratta dawn is-sintomi tal-ażma.
English: DuoResp Spiromax 320 micrograms/9 micrograms inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Maltese: DuoResp Spiromax 320 mikrogramma/9 mikrogrammi, trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: DuoResp Spiromax maintenance therapy: DuoResp Spiromax is taken as regular maintenance treatment with a separate rapid-acting bronchodilator reliever inhaler.
Maltese: DuoResp Spiromax jittieħed bħala kura regolari ta' manteniment ma' bronkodilatur separat li jaħdem malajr bħala inalatur ta' solliev.
English: How to store DuoResp Spiromax 6.
Maltese: L-użu profilattiku ta' DuoResp Spiromax, eż.
English: For DuoResp Spiromax there are two treatment approaches:
Maltese: Għal DuoResp Spiromax hemm żewġ approċċi differenti ta' kura:
English: DuoResp Spiromax 160 micrograms / 4.5 micrograms inhalation powder
Maltese: DuoResp Spiromax 160 mikrogramma/4.5 mikrogrammi trab li jittieħed man-nifs.
English: DuoResp Spiromax 320 micrograms/9 micrograms should be used as maintenance therapy only.
Maltese: DuoResp Spiromax 320 mikrogramma/9.0 mikrogrammi għandu jintuża bħala terapija ta' manteniment biss.
English: (A) Using DuoResp Spiromax and a separate ‘reliever inhaler'
Maltese: (A) Użu ta' DuoResp Spiromax u inalatur ta' solljiev separat
English: DuoResp Spiromax 160 mcg/4.5 mcg inhalation powder budesonide/formoterol fumarate dihydrate Inhalation use.
Maltese: DuoResp Spiromax 160 μg/4.5 μg trab li jittieħed man-nifs budesonide/formoterol fumarate dihydrate
English: Pregnancyand breast-feeding
Maltese: U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Some medicines may increase the effects of DuoResp Spiromax and your doctor may wish to monitor you carefully if you are taking these medicines (including some medicines for HIV: ritonavir, cobicistat).
Maltese: Xi mediċini jistgħu jżidu l-effetti ta' DuoResp Spiromax u t-tabib tiegħek għandu mnejn ikun irid jimmonitorjak b'attenzjoni jekk tkun qed tieħu dawn il-mediċini (inklużi xi mediċini għall-HIV:
English: EU/1/08/481/004 100 mg sachet EU/1/08/481/005 500 mg sachet
Maltese: EU/1/08/481/004 100 mg qartas EU/1/08/481/005 500 mg qartas
English: BH4 deficiency
Maltese: Defiċjenza BH4
English: For instructions for use, see section 4.2.
Maltese: Għal istruzzjonijiet għall-użu, ara sezzjoni 4.2.
English: BH4 is a cofactor for nitric oxide synthetase.
Maltese: BH4 huwa ko-fattur għan-nitric oxide synthetase.
English: Volume of dissolution (ml)
Maltese: Volum ta' dissoluzzjoni (ml)
English: Gastritis, oesophagitis
Maltese: Gastrite, esofaġite
English: • A medicine cup with graduation markings at 20, 40, 60 and 80 ml
Maltese: • Tazza tal-mediċina b'marki tal-gradwazzjoni f'livelli ta' 20, 40, 60 u 80 ml
English: Tabulated list of adverse reactions
Maltese: Lista tabulata ta' reazzjonijet avversi
English: In vitro, sapropterin did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4/5, nor induce CYP1A2, 2B6, or 3A4/5.
Maltese: In vitro, sapropterin ma kienx inibitur ta' CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 jew CYP3A4/5, lanqas ma kien induttur ta' CYP1A2, 2B6, jew 3A4/5.
English: - The active substance is sapropterin dihydrochloride.
Maltese: - Is-sustanza attiva hi sapropterin dihydrochloride.
English: Polyethylene terephthalate, aluminum, polyethylene laminate sachet, heat sealed on four sides.
Maltese: Polyethylene terephthalate, aluminju, polyethylene laminate sachet, issiġillat bis-sħana fuq erba' naħat.
English: Potassium content
Maltese: Kontenut ta' potassium
English: Total dose (mg/day)
Maltese: Doża totali (mg/jum)
English: Sapropterin dihydrochloride is primarily metabolised in the liver to dihydrobiopterin and biopterin.
Maltese: Sapropterin dihydrochloride fil-fwied huwa primarjament immetabolizzat għal dihydrobiopterin u biopterin.
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-ġestjoni tar-Riskju (RMP)
English: Kuvan contains potassium citrate (E332)
Maltese: Kuvan fih potassium citrate (E332)
English: Hypophenylalaninaemia Nervous system disorders Very common:
Maltese: Hypophenylalaninemia Disturbi fis-sistema nervuża Komuni ħafna:
English: (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin), phosphodiesterase type 5 (PDE-5) inhibitors and minoxidil.
Maltese: isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin, minoxidil).
English: (ml)*
Maltese: NUMRU(I)
English: Dosing for BH4 deficiency
Maltese: Dożaġġ għal defiċjenza BH4
English: Each bottle contains 30, 120 or 240 tablets.
Maltese: Kull flixkun fih 30, 120 jew 240 pillola.
English: A calculated dose of 451 mg to 499 mg should be rounded up to 500 mg corresponding to 5 tablets.
Maltese: Doża kkalkulata ta' 451 mg sa 499 mg għandha tiġi korretta l-fuq sa 500 mg, li hija ekwivalenti għal 5 pilloli.
English: Date of first authorisation: 02 December 2008 Date of latest renewal: 02 December 2013
Maltese: Data tal-aħħar tiġdid: 02 ta' Diċembru 2013
English: - The other ingredients are mannitol (E421), calcium hydrogen phosphate anhydrous, crospovidone type A, ascorbic acid (E300), sodium stearyl fumarate, and riboflavin (E101).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), calcium hydrogen phosphate anhydrous, crospovidone tip A, ascorbic acid (E300), sodium stearyl fumarate, u riboflavin (E101).
English: Sapropterin is a synthetic version of the naturally occurring 6R-BH4, which is a cofactor of the hydroxylases for phenylalanine, tyrosine and tryptophan.
Maltese: Sapropterin hija verzjoni sintetika ta' 6R-BH4 maħdum b'mod naturali, li huwa ko-fattur talhydroxylases għal phenylalanine, tyrosine u tryptophan.
English: Kuvan contains the active substance sapropterin which is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4).
Maltese: Kuvan fih is-sustanza attiva sapropterin li hija kopja sintetika ta' sustanza prodotta mill-ġisem magħrufa bħala tetrahydrobiopterin (BH4).
English: • Empty the contents of the sachet(s) into 120 ml to 240 ml of water.
Maltese: • Żvojta l-kontenut tal-qartas/qratas f'120 ml sa 240 ml ta' ilma.
English: Kuvan is used to treat hyperphenylalaninaemia (HPA) or phenylketonuria (PKU) in patients of all ages.
Maltese: Kuvan huwa użat biex jikkura l-hyperphenylalaninaemia (HPA) jew phenylketonuria (PKU) f'pazjenti ta' kull età.
English: Caution is recommended during concomitant use of Kuvan with all medicinal products that cause vasodilation, including those administered topically, by affecting nitric oxide (NO) metabolism or action including classical NO donors (e.g. glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP), molsidomin), phosphodiesterase type 5 (PDE-5) inhibitors and minoxidil.
Maltese: Kawtela hija rrakkomandata waqt l-użu ta' Kuvan fl-istess ħin ma' prodotti mediċinali kollha li jikkawżaw vażodilatazzjoni, inklużi dawk għal użu topikali, li jikkawżaw metaboliżmu tal-ossidu nitriku (NO), li jinkludu d-donaturi klassiċi NO (bħal glyceryl trinitrate (GTN), isosorbide dinitrate (ISDN), sodium nitroprusside (SNP) u molsidomin), inibituri phosphodiesterase tat-tip 5 (PDE-5) u minoxidil.
English: Calcium hydrogen phosphate, anhydrous Crospovidone type A Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
Maltese: Ascorbic acid (E300) Sodium stearyl fumarate Riboflavin (E101)
English: Dosing for PKU
Maltese: Dożaġġ għal PKU
English: The following definitions apply to the frequency terminology used hereafter: 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 available data).
Maltese: Id-definizzjonijiet li ġejjin japplikaw għat-terminolġija ta' frekwenza li tintuża minn hawn 'il quddiem: 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), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli)
English: - The other ingredients are mannitol (E421), potassium citrate (E332), sucralose (E955), ascorbic acid (E300).
Maltese: - Is-sustanzi l-oħra huma mannitol (E421), potassium citrate (E332), sucralose (E955), ascorbic acid (E300).
English: For patients with baseline blood phenylalanine levels ≥600 µmol/l, 41.9% (13/31) of those treated with sapropterin and 13.2% (5/38) of those treated with placebo had blood phenylalanine levels < 600 µmol/l at the end of the 6-week study period (p=0.012).
Maltese: Għall-pazjenti bil-livelli ta'phenylalanine fid-demm fil-linja bażi ta' ≥ 600 µmol/l, 41.9% (13/31) ta' dawk ikkurati b'sapropterin u 13.2% (5/38) ta' dawk ikkurati bil-plaċebo kellhom livelli ta' phenylalanine fid-demm <600 µmol/l fit-tmiem tal-perijodu ta' studju ta' 6 ġimgħat (p=0.012).
English: Approximately 35% of the 579 patients aged 4 years and over who received treatment with sapropterin dihydrochloride (5 to 20 mg/kg/day) in the clinical trials for Kuvan experienced adverse reactions.
Maltese: Approssimattivament 35% minn 579 pazjent li kellhom 4 snin jew iżjed li rċevew kura b'sapropterin dihydrochloride (5 sa 20 mg/kg/kuljum) fi provi kliniċi ta' Kuvan, esperjenzaw effetti mhux mixtieqa.
English: A shortening of the QT interval (-8.32 msec) was observed in a study with a single supratherapeutic dose of 100 mg/kg (5 times the maximum recommended dose); this should be taken into consideration in managing patients who have a pre-existing shortened QT interval (e.g. patients with familial short QT syndrome).
Maltese: Tqassir tal-intervall QT (-8.32 msec) kien osservat fi studju b'doża supraterapewtika waħda ta' 100 mg/kg (5 darbiet id-doża massima rakkomandata); dan għandu jiġi kkunsidrat fil-każ ta' pazjenti li għandhom intervall QT mqassar li jkun jeżisti minn qabel (eż. pazjenti li għandhom sindromu ta' QT qasir familjali).
English: Pharmacotherapeutic group: Other alimentary tract and metabolism products, Various alimentary tract and metabolism products, ATC code: A16AX07
Maltese: Prodotti oħrajn tal-passaġġ alimentari u prodotti tal-metaboliżmu, prodotti relattivi għas-sistema alimentarja u l-metaboliżmu, Kodiċi ATC:
English: A higher intestinal concentration of Kuvan is needed to inhibit BCRP than P-gp, as inhibitory potency in intestine for BCRP (IC50=267 µM) is lower than P-gp (IC50=158 µM).
Maltese: Konċentrazzjoni intestinali ogħla ta' Kuvan hija meħtieġa biex tinibixxi BCRP firrigward ta' P-gp, billi l-potenza inibitorja fil-musrana għal BCRP (IC50=267 µM) hija aktar baxxa minn P-gp (IC50=158 µM).
English: The baseline blood phenylalanine levels for the Kuvan-treated group and the placebo group were similar, with mean ± SD baseline blood phenylalanine levels of 843 ± 300 μmol/l and 888 ± 323 μmol/l, respectively.
Maltese: Il-linja bażi tal-livelli ta' phenylalanine fid-demm tal-grupp ikkurat b'Kuvan u l-grupp tal-plaċebo kienu simili, bil-medja ± SD mill-livelli ta' phenylalanine fid-demm kienet ta' 843 ± 300 μmol/l u 888 ± 323 μmol/l, rispettivament.
English: Volume of solution to be administered (ml)*
Maltese: Volum ta' soluzzjoni li jrid jingħata (ml)*
English: This medicine contains potassium citrate (E332).
Maltese: Din il-mediċina fiha potassium citrate (E332).
English: Sustained or recurrent dysfunction in the phenylalanine-tyrosine-dihydroxy-L-phenylalanine (DOPA) metabolic pathway can result in deficient body protein and neurotransmitter synthesis.
Maltese: Disfunzjoni fit-tul u li tirrepeti ruħha fir-rotta metabolika tal-phenylalanine-tyrosine-dihydroxyL-phenylalanine (DOPA), tista' tirriżulta f'defiċjenza ta' proteini fil-ġisem u fis-sintesi ta' sustanzi newrotrasmittorji.
English: ≤10 ml or 20 ml syringe for administration of volumes of >10 ml)
Maltese: ≤10 ml jew siringa ta' 20 ml għall-għoti ta' volumi ta' >10 ml)
English: Cases of convulsion, exacerbation of convulsion, increased excitability and irritability have been observed during co-administration of levodopa and sapropterin in BH4-deficient patients (see section 4.5).
Maltese: Każijiet ta' konvulżjonijiet, aggravament ta' konvulżjoni, żieda fl-eċċitabilità u ta' irritabilità ġew osservati matul l-għoti flimkien ta' levodopa u sapropterin f'pazjenti b'defiċjenza ta' BH4 (ara sezzjoni 4.5).
English: For the sapropterin treatment group, the mean ± SD total dietary phenylalanine tolerance was 38.4 ± 21.6 mg/kg/day during treatment with sapropterin dihydrochloride 20 mg/kg/day compared to 15.7 ± 7.2 mg/kg/day before treatment.
Maltese: Għall-grupp ikkurat b'sapropterin, il-medja± SD tat-tolleranza totali ta' phenylanine fid-dieta kienet 38.4 ± 21.6 mg/kg/kuljum waqt il-kura b'sapropterin dihydrochloride ta' 20 mg/kg/kuljum komparat ma 15.7 ± 7.2 mg/kg/kuljum qabel il-kura.
English: In a separate 10-week, placebo-controlled study, 45 PKU patients with blood phenylalanine levels controlled on a stable phenylalanine-restricted diet (blood phenylalanine ≤480 μmol/l on enrolment) were randomised 3:1 to treatment with sapropterin dihydrochloride 20 mg/kg/day (n=33) or placebo (n=12).
Maltese: Fi studju separat ta' 10 ġimgħat ikkontrollat bil-plaċebo, 45 pazjenti bil-PKU b'livelli ta' phenylalanine fid-demm ikkontrollati abbażi ta' dieta stabbli ristretta għal phenylalanine (phenylalanine fid-demm ta' ≤ 480 μmol/l meta ġew irreġistrati) ġew magħżula mingħajr pjan definit jew ordni rranġata minn qabel fuq bażi 3:1 għal kura b'sapropterin dihydrochloride 20 mg/kg/kuljum (n=33) jew bil-plaċebo (n=12).
English: Hyperphenylalaninaemia (HPA) is diagnosed as an abnormal elevation in blood phenylalanine levels and is usually caused by autosomal recessive mutations in the genes encoding for phenylalanine hydroxylase enzyme (in the case of phenylketonuria, PKU) or for the enzymes involved in 6R-tetrahydrobiopterin (6R-BH4) biosynthesis or regeneration (in the case of BH4 deficiency).
Maltese: (HPA) ikun hemm żieda anormali fil-livelli ta' phenylalanine fid-demm li hija normalment ikkawżata b'mutazzjonijiet awtosomali reċessivi involuti fil-konverżjoni tal-ġeni għall-enżima phenylalanine hydroxylase (f'kaz ta' phenylketonuria, PKU) jew għall-enżimi nvoluti fil-bijosintesi 6R-tetrahydrobiopterin (6R-BH4) jew fir-riġenerazzjoni (f'każ ta' defiċjenza BH4).
English: Each sachet contains 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin).
Maltese: Kull qartas fih 500 mg ta' sapropterin dihydrochloride (ekwivalenti għal 384 mg ta' sapropterin).
English: Based on an in vitro study, there is potential for sapropterin dihydrochloride to inhibit p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) in the gut at the therapeutic doses.
Maltese: Ibbażat fuq studju in vitro, sapropterin dihydrochloride jista' jinibixxi l-p-glycoprotein (P-gp) u lproteina ta' reżistenza għall-kanċer tas-sider (BCRP, breast cancer resistance protein) fl-intestini fiddożi terapewtiċi.
English: The absorption of sapropterin is higher after a high-fat, high-calorie meal as compared to fasting, resulting, in average, in 40-85% higher maximum blood concentrations achieved 4 to 5 hours after administration.
Maltese: L-assorbiment ta' sapropterin huwa ogħla wara ikla b'kontenut għoli ta' xaħam u kaloriji imqabbel ma' stat ta' sawm, b'riżultat fil-medja ta' 40-85% konċentrazzjonijiet massimi fid-demm ottenuti minn 4 sa 5 siegħat wara li jittieħed.
English: The mean ± SD increase in dietary phenylalanine tolerance was 17.5 ± 13.3 mg/kg/day for the group treated with sapropterin dihydrochloride 20 mg/kg/day, compared to 3.3 ± 5.3 mg/kg/day for the placebo group (p=0.006).
Maltese: Iż-żieda medja ± SD fit-tolleranza ta' phenylalanine fid-dieta kienet 17.5 ± 13.3 mg/kg/kuljum fil-grupp ikkurat b'sapropetin dihydrochloride abbażi ta' 20 mg/kg/kuljum, imqabbla ma' 3.3 ± 5.3 mg/kg/kuljum għall-grupp tal-plaċebo (p=0.006).
English: The mean ± SD decrease from baseline in blood phenylalanine levels at the end of the 6 week study period was 236 ± 257 μmol/l for the sapropterin treated group (n=41) as compared to an increase of 2.9 ± 240 μmol/l for the placebo group (n=47) (p<0.001).
Maltese: It-tnaqqis tal-medja ± SD fil-livelli ta' phenylalanine fid-demm mill-linja bażi fi tmiem il-perijodu ta' studju ta' 6 ġimgħat kien ta' 236 ± 257 μmol/l għall-grupp ikkurat b'sapropterin (n=41) meta mqabbel mażżieda ta' 2.9 ± 240 μmol/l għall-grupp ikkurat bil-plaċebo (n=47) (p < 0.001).
English: Health disturbances
Maltese: Disturbi fis-saħħa
English: Population pharmacokinetics
Maltese: Farmakonkinetiċi tal-popolazzjoni
English: There was a significant difference in dietary phenylalanine tolerance in the sapropterin treatment group as compared to the placebo group.
Maltese: Kien hemm differenza sinifikanti fit-tolleranza ta' phenylalanine fid-dieta fil-grupp ta' kura b'sapropterin imqabbel mal-grupp tal-plaċebo.
English: Frequency, type and severity of adverse reactions in children were essentially similar to those in adults.
Maltese: Il-frekwenza, it-tip, u s-severità ta' reazzjonijiet avversi fit-tfal kienu essenzjalment simili għal dawk fl-adulti.
English: 56 paediatric PKU patients <4 years of age were randomised 1:1 to receive either 10 mg/kg/day Kuvan in conjunction with a phenylalanine-restricted diet (n=27), or just a phenylalanine-restricted diet (n=29) over a 26-week Study Period.
Maltese: 56 pazjent pedjatriku b'PKU li kellhom <4 snin, intgħażlu b'mod każwali fi proporzjon ta' 1:1 biex jirċievu jew 10 mg/kg/jum Kuvan flimkien ma' dieta ristretta ta' phenylalanine (n=27), jew dieta ristretta ta' phenylalanine biss (n=29) fuq il-Perjodu ta' Studju ta' 26 ġimgħa.
English: Date of revision of the text: MM/YYYY
Maltese: Data tar-reviżjoni tat-test:{XX/SSSS}
English: It was intended that all patients maintained blood phenylalanine levels within a range of 120-360 µmol/l (defined as ≥120 to <360 µmol/l) through monitored dietary intake during the 26-week Study Period.
Maltese: L-intenzjoni kienet li l-pazjenti kollha jżommu livelli ta' phenylalanine fid-demm f'medda ta' 120-360 µmol/l (definita bħala ≥120 sa <360 µmol/l) permezz ta' konsum dijetetiku mmonitorjat matul il-Perjodu ta' Studju ta' 26 ġimgħa.
English: Pharyngolaryngeal pain, nasal congestion, cough Gastrointestinal disorders Common:
Maltese: Uġigħ fil-grieżem, konġestjoni tal-imnieħer, sogħla Disturbi gastro-intestinali
English: In a further clinical trial, approximately 30% of the 27 children aged below 4 years who received treatment with sapropterin dihydrochloride (10 or 20 mg/kg/day) experienced adverse reactions.
Maltese: Fi prova klinika addizzjonali, madwar 30% mis-27 tifel/tifla li kellhom inqas minn 4 snin, li rċievew kura b'sapropterin dihydrochloride (10 jew 20 mg/kg/jum) kellhom reazzjonijiet avversi.
English: Dietary intake
Maltese: Konsum dijetetiku
English: The prescribed number of tablets for a 2, 5, 10 and 20 mg/kg/day dose should be placed in a cup (that shows the appropriate graduation markings at 20, 40, 60 and 80 ml) with the amount of water as depicted in Tables 1-4 and stirred until dissolved.
Maltese: In-numru preskritt ta' pilloli għal doża ta' 2, 5, 10 u 20 mg/kg/jum għandu jitpoġġa f'tazza (li turi l-marki adatti ta' gradwazzjoni f'livelli ta' 20, 40, 60 u 80 ml) bl-ammont ta' ilma kif muri f'Tabelli 1-4, u dawn għandhom jitħawwdu sakemm il-pilloli jinħallu.
English: In 88 subjects with poorly controlled PKU who had elevated blood phenylalanine levels at screening, sapropterin dihydrochloride 10 mg/kg/day significantly reduced blood phenylalanine levels as compared to placebo.
Maltese: Fi 88 suġġett b'kontroll fqir tal-PKU li meta ġew eżaminati (screened) kellhom livelli għolja ta' phenylalanine fid-demm, 10 mg/kg/kuljum ta' sapropterin dihydrochloride naqqas b'mod sinifikanti l-livelli ta' phenylalanine fid-demm meta mqabbel mal-plaċebo.
English: Low blood phenylalanine and tyrosine levels
Maltese: Livell baxx ta' phenylalanine u tyrosine fid-demm
English: The results of this study demonstrated that daily dosing with 10 or 20 mg/kg/day of Kuvan in conjunction with a phenylalanine-restricted diet led to statistically significant improvements in dietary phenylalanine tolerance compared with dietary phenylalanine restriction alone while maintaining blood phenylalanine levels within the target range (≥120 to <360 µmol/l).
Maltese: Ir-riżultati ta' dan l-istudju wrew li dożaġġ ta' kuljum b'10 jew 20 mg/kg/jum ta' Kuvan flimkien ma' dieta ristretta ta' phenylalanine, wasslu għal titjib statistikament sinifikanti fit-tolleranza ta' phenylalanine fid-dieta meta mqabbla ma' restrizzjoni ta' phenylalanine tad-dieta waħidha, filwaqt li l-livelli ta' phenylalanine fid-demm inżammu fil-medda fil-mira (≥120 sa <360 µmol/l).
English: Each sachet contains 1.6 mmol (62.7 mg) potassium.
Maltese: Kull qartas fih 1.6 mmol (62.7 mg) ta' potassium.
English: Emesis has been observed in both the safety pharmacology and the repeated-dose toxicity studies.
Maltese: Rimettar ġie osservat kemm fil-farmakoloġija tas-sigurta' u kemm fi studji fuq tossiċita' wara dożi ripetuti.
English: Each sachet contains 0.3 mmol (12.6 mg) potassium.
Maltese: Kull qartas fih 0.3 mmol (12.6 mg) ta' potassium.
English: In non-clinical studies, sapropterin was primarily distributed to the kidneys, adrenal glands, and liver as assessed by levels of total and reduced biopterin concentrations.
Maltese: Fi studji mhux kliniċi, sapropterin kien primarjament distribwit fil-kliewi, fil-glandoli adrenali u filfwied, kif valutati mill-livelli totali u dawk ridotti tal-konċentrazzjonijiet ta' biopterin.
English: • Oral syringe (graduated in 1 ml divisions) (10 ml syringe for administration of volumes of
Maltese: • Siringa tal-ħalq (gradwata f'diviżjonijiet ta' 1 ml) (siringa ta' 10 ml għall-għoti ta' volumi ta'
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Children up to 20 kg body weight (use only 100 mg powder sachet(s)) The measuring devices required for dosing in children up to 20 kg body weight (i.e. cup with graduations at 20, 40, 60, 80 ml; 10 ml and 20 ml oral syringes with graduation at 1 ml divisions) are not included in the Kuvan pack.
Maltese: Tfal b'piż tal-ġisem sa 20 kg (uża biss qartas/qratas ta' 100 mg trab) L-apparat tal-kejl meħtieġ għad-dożaġġ fi tfal b'piż tal-ġisem ta' massimu ta' 20 kg (jiġifieri tazza bi gradwazzjonijiet f'20, 40, 60, 80 ml; siringi tal-ħalq ta' 10 ml u 20 ml bi gradwazzjoni f'diviżjonijiet ta' 1 ml) mhumiex inklużi fil-pakkett ta' Kuvan.
English: Not known side effects (frequency cannot be estimated from the available data) Gastritis (inflammation of the lining of the stomach), oesophagitis (inflammation of the lining of the gullet).
Maltese: Effetti sekondarji mhux magħrufa (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli) Gastrite (infjammazzjoni tal-kisi tal-istonku), esofaġite (infjammazzjoni tal-kisi tal-griżmejn).