FrancophonIA/ELRC3.0 huggingface dataset:
English: A review of safety data of patients enrolled in all clinical studies does not indicate that mild renal impairment (n = 487) poses an additional safety risk during silodosin therapy (such as an increase in dizziness or orthostatic hypotension) as compared to patients with normal renal function (n = 955).
Maltese: Valutazzjoni tal-informazzjoni dwar is-sigurtà tal-pazjenti rreġistrati fl-istudji kliniċi kollha ma tindikax li indeboliment ħafif tal-kliewi (n = 487) joħloq riskju addizzjonali tas-sigurtà waqt kura b'silodosin (bħal żieda fl-isturdament jew fil-pressjoni baxxa ortostatika) meta mqabbel ma' pazjenti b'funzjoni tal-kliewi normali (n = 955).
English: 1 - adverse reactions from spontaneous reporting in the worldwide post-marketing experience (frequencies calculated from events reported in Phase I-IV clinical trials and non-interventional studies).
Maltese: 1 - reazzjonijiet avversi minn rappurtaġġ spontanju mid-dinja kollha mill-esperjenza ta' wara t-tqegħid fis-suq (frekwenzi kkalkulati minn avvenimenti rrappurtati fi provi kliniċi ta' fażi
English: INFORMATION IN BRAILLE silodosin recordati 8 mg
Maltese: silodosin recordati 8 mg
English: In subjects with severe renal impairment (n = 5) increase of exposure was 2.2-fold for Cmax and 3.7-fold for AUC.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi (n = 5), iż-żieda fl-esponiment kienet ta' 2.2 darbiet għall-Cmax u
English: B e lgië/Belgique/Belgien Recordati Ireland Ltd.
Maltese: België/Belgique/Belgien
English: • medicines which lower blood pressure (in particular, medicines called alpha1-blockers, such as prazosin or doxazosin) as there may be the potential risk that the effect of these medicines is increased whilst taking Silodosin Recordati.
Maltese: • mediċini li jbaxxu l-pressjoni tad-demm (b'mod partikolari, mediċini msejħa imblokkaturi alpha1, bħal prazosin jew doxazosin) billi jista' jkun hemm ir-riskju li l-effett ta' dawn il-mediċini jiżdied waqt li tkun qed tieħu Silodosin Recordati.
English: Slove nija
Maltese: U L-UŻU
English: Antihypertensives
Maltese: Palpitazzjonijiet
English: Steady state levels of digoxin, a substrate of P-glycoprotein, were not significantly affected by co-administration with silodosin 8 mg once daily.
Maltese: Il-livelli fissi ta' digoxin, substrat tal-glikoproteina P, ma ġewx affettwati b'mod sinifikattiv mill-għoti simultanju ma' silodosin 8 mg darba kuljum.
English: NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 4 mg hard capsules silodosin
Maltese: Silodosin Recordati 4 mg kapsuli ibsin silodosin
English: Substances that inhibit (such as ketoconazole, itraconazole, ritonavir or cyclosporine) or induce (such as rifampicin, barbiturates, carbamazepine, phenytoin) these enzymes and transporters may affect the plasma concentrations of silodosin and its active metabolite.
Maltese: Sustanzi li jimpedixxu (bħal ketoconazole, itraconazole, ritonavir jew cyclosporine) jew jinduċu (bħal rifampicin, barbiturates,
English: How to take Silodosin Recordati
Maltese: X'inhu Silodosin Recordati
English: When silodosin was co-administered with a CYP3A4 inhibitor of moderate potency such as diltiazem, an increase in silodosin AUC of approximately 30% was observed, but Cmax and half-life were not affected.
Maltese: Meta silodosin ingħata fl-istess ħin ma' inibitur CYP3A4 ta' qawwa moderata bħal diltiazem, ġiet osservata żieda ta' madwar 30% fl-AUC ta' silodosin, iżda is-Cmax u l-half-life ma kinux affettwati.
English: The pharmacokinetics of silodosin and its main metabolites have been evaluated in adult male subjects with and without BPH after single and multiple administrations with doses ranging from 0.1 mg to 48 mg per day.
Maltese: Il-farmakokinetika ta' silodosin u tal-metaboliti prinċipali tiegħu ġew evalwati f'irġiel bi jew mingħajr BPH wara li ngħataw darba u aktar minn darba dożi li jvarjaw minn 0.1 mg għal 48 mg kuljum.
English: If you have severe kidney problems, you should not take Silodosin Recordati.
Maltese: Jekk għandek problemi severi tal-kliewi, m'għandekx tieħu Silodosin Recordati.
English: Over 800 patients with moderate to severe symptoms of BPH (International Prostate Symptom Score, IPSS, baseline value ≥ 13) received silodosin 8 mg once daily in two Phase III placebo-controlled clinical studies conducted in the United States and in one placebo- and active-controlled clinical study conducted in Europe.
Maltese: Iżjed minn 800 pazjent b'sintomi moderati għal severi ta' BPH (Skor Internazzjonali tas-Sintomi tal-Prostata (International Prostate Symptom Score, IPSS), valur tal-linja bażi ≥ 13) irċevew silodosin 8 mg darba kuljum f'żewġ studji kliniċi ta' Fażi
English: Tél/Tel: + 353 21 4379400
Maltese: Tel: + 353 21 4379400
English: Silodosin Recordati 4 mg hard capsules Yellow, opaque, hard gelatin capsule, size 3 (approximately 15.9 x 5.8 mm).
Maltese: Silodosin Recordati 4 mg huma kapsuli ibsin tal-ġelatina, sofor, opaki, daqs 3 (madwar 15.
English: NAME OF THE MEDICINAL PRODUCT Silodosin Recordati 8 mg hard capsules silodosin
Maltese: Silodosin Recordati 8 mg kapsuli ibsin silodosin
English: In male rats, decreased fertility was observed from exposures which were approximately twice the exposure at the maximum recommended human dose.
Maltese: Ġo firien irġiel, ġie osservat tnaqqis fil-fertilità minn esponimenti li kienu bejn wieħed u ieħor id-doppju tal-esponiment bid-doża massima rrakkomandata fil-bniedem.
English: In the clinical study program, many patients were on concomitant antihypertensive therapy (mostly agents acting on the renin-angiotensin system, beta-blockers, calcium antagonists and diuretics) without experiencing an increase in the incidence of orthostatic hypotension.
Maltese: (l-aktar is-sustanzi li jaħdmu fuq is-sistema rennin-angiotensin, imblokkaturi beta, antagonisti tal-kalċju u dijuretiċi) mingħajr ma esperjenzaw żieda fl-inċidenza tal-pressjoni baxxa ortostatika.
English: Orthostatic hypotension may occasionally lead to syncope (see section 4.4).
Maltese: Il-pressjoni ortostatika baxxa tista' kultant twassal għal sinkope (ara sezzjoni 4.4).
English: The incidence of orthostatic effects with silodosin is very low.
Maltese: L-inċidenza tal-effetti ortostatiċi b'silodosin hija baxxa ħafna.
English: Very rare side effects (may affect up to 1 in 10,000 people) • Other allergic reactions with swelling of the face or throat
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa persuna 1 f'kull 10,000 persuna)
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing silodosin in all subsets of the paediatric population in BPH (see section 4.2 for information on paediatric use).
Maltese: Billi tirrapporta l-effetti sekondarji tista' tgħin biex tiġi pprovduta aktar informazzjoni dwar is-sigurtà ta' din il-mediċina.
English: This effect disappears after discontinuation of silodosin (see section 4.8).
Maltese: Dan l-effett imur fi żmien ftit ġranet wara t-twaqqif ta' silodosin (ara sezzjoni 4.8).
English: • Abnormal ejaculation (less or no noticeable semen is released during sex, see section “Warnings and precautions”)
Maltese: • Ħruġ anormali tas-semen (inqas jew ebda semen osservabbli li joħroġ waqt is-sess, ara s-sezzjoni “Twissijiet u prekawzjonijiet”)
English: Abnormal liver function tests1
Maltese: Testijiet tal-fwied b'riżultat mhux normali1
English: Results from this study should be interpreted with caution, since enrolled patients had normal biochemistry values, indicating normal metabolic function, and they were classified as having moderate liver impairment based on ascites and hepatic encephalopathy.
Maltese: Ir-riżultati minn dan l-istudju għandhom jiġu interpretati b'attenzjoni, minħabba li pazjenti rreġistrati kellhom valuri bijokimiċi normali, li jindikaw funzjoni metabolika normali, u dawn ġew ikklassifikati bħala li għandhom indeboliment moderat tal-fwied, fuq il-bażi ta' axxite u enċefalopatija tal-fwied.
English: This leaflet was last revised in {MM/YYYY}.
Maltese: , li jinkludu eġakulazzjoni retrograd Nuqqas ta'
English: Uncommon side effects (may affect up to 1 in 100 people)
Maltese: Effetti sekondarji mhux komuni (jistgħu jaffettwaw sa persuna 1 f'kull 100 persuni)
English: How to store Silodosin Recordati Contents of the pack and other information
Maltese: Kif jidher Silodosin Recordati u l-kontenut tal-pakkett
English: Silodosin Recordati 8 mg hard capsules Each hard capsule contains 8 mg silodosin.
Maltese: Silodosin Recordati 8 mg kapsuli ibsin Kull kapsula iebsa fiha 8 mg ta' silodosin.
English: M anufacture r
Maltese: • Ħalq xott
English: * p < 0.001 vs Placebo; ° p = 0.002 vs Placebo
Maltese: * p < 0.001 vs Plaċebo; ° p = 0.002 vs Plaċebo Fl-istudju kliniku kkontrollat bis-sustanza attiva li twettaq fl-Ewropa, silodosin 8 mg darba kuljum intwera li mhux inferjuri għal tamsulosin 0.4 mg darba kuljum: id-differenza medja aġġustata
English: Silodosin Recordati may reduce the amount of sperm, and so could temporarily affect your ability to father a child.
Maltese: Silofosin Recordati jista' jnaqqas l-ammont ta' sperma, u għalhekk jista' jaffettwa b'mod temporanju l-abilità tiegħek biex tnissel it-tfal.
English: In a single-dose study, the pharmacokinetics of silodosin was not altered in nine patients with moderate hepatic impairment (Child-Pugh scores 7 to 9), compared to nine healthy subjects.
Maltese: Fi studju ta' doża waħda, il-farmakokinetika ta' silodosin ma nbidlitx f'disa' pazjenti b'indeboliment moderat tal-fwied (skor Child-Pugh 7 sa 9), meta mqabbel ma' disa' voluntiera b'saħħithom.
English: The main metabolite in plasma, the glucuronide conjugate of silodosin (KMD-3213G), that has been shown to be active in vitro, has an extended half-life (approximately 24 hours) and reaches plasma concentrations approximately four times higher than those of silodosin.
Maltese: Il-metabolit prinċipali fil-plażma, il-konjugat glucuronide ta' silodosin (KMD-3213G), li ntwera li huwa attiv in vitro,
English: Recordati Industria Chimica e Farmaceutica S.p.A. Tel: + 39 02 487871
Maltese: Tel: + 39 02 487871
English: Common side effects (may affect up to 1 in 10 people)
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'kull 10 persuni)
English: Body clearance of silodosin was approximately 0.28 L/h/kg.
Maltese: L/siegħa/kg.
English: Do not break or chew the capsule, but swallow it whole, preferably with a glass of water.
Maltese: Tkissirx jew tomgħodx il-kapsula, iżda iblagħha sħiħa, preferibbilment ma' tazza ilma.
English: Hypotension1
Maltese: Operazzjon i
English: • Fainting/ Loss of consciousness
Maltese: • Ħass ħażin/Tintilef minn sensik
English: Silodosin Recordati is selective for the receptors located in the prostate, bladder and urethra.
Maltese: Silodosin Recordati huwa selettiv għar-riċetturi li jinsabu fil-prostata, fil-bużżieqa tal-awrina u fl-uretra.
English: During pre-operative assessment, eye surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with silodosin, in order to ensure that appropriate measures will be in place to manage IFIS during surgery.
Maltese: Waqt valutazzjoni ta' qabel l-operazzjoni, il-kirurgi tal-għajnejn u t-tim tagħhom għandhom jikkunsidraw jekk il-pazjenti ippjanati għal operazzjoni tal-katarretti jkunux qegħdin jew kinux ġew ittrattati b'silodosin, sabiex jiġi żgurat li jittieħdu l-miżuri xierqa biex ikunu jistgħu jittieħdu l-passi meħtieġa għall-IFIS waqt l-operazzjoni.
English: The safety of silodosin has been evaluated in four Phase II-III double-blind controlled clinical studies (with 931 patients receiving silodosin 8 mg once daily and 733 patients receiving placebo) and in two long-term open-label extension phase studies.
Maltese: (b'931 pazjent ħadu silodosin 8 mg darba kuljum u 733 pazjent ħadu plaċebo) u f'żewġ studji open-label ta' fażi ta' estensjoni fuq perijodu fit-tul.
English: Ee sti
Maltese: U
English: Recordati Ireland Ltd. Τηλ: + + 353 21 4379400
Maltese: Τηλ: + + 353 21 4379400
English: Blockade of these α1A-adrenoreceptors causes smooth muscle in these tissues to relax, thus decreasing bladder outlet resistance, without affecting detrusor smooth muscle contractility.
Maltese: Silodosin jitneħħa prinċipalment bħala metaboliti, ammonti żgħar ħafna biss ta' mediċina mhux mibdula jiġu rkuprati fl-awrina.
English: • Symptoms of allergic reaction affecting the skin like rash, itching, hives and rash caused by a medicine
Maltese: • Sintomi ta' reazzjoni allerġika li jaffettwaw il-ġilda bħal raxx, ħakk, ħorriqija u raxx ikkawżat minn mediċina
English: Metabolism
Maltese: Metabolżmu
English: Uncommon: bradycardia
Maltese: Mhux komuni: bradikardija
English: Date of first authorisation: 24 January 2003 Date of renewal: 20 May 2008
Maltese: Data tal-ewwel awtorizzazzjoni: 24 ta' Jannar 2003 Data ta' tiġdid: 20 ta'mejju 2008
English: Fax: + 33 1 4900 1800
Maltese: Faks: + 33 1 4900 1800
English: • Uncommon: bradycardia (decreased frequency of the heart), diarrhoea, fever, increased transaminases, vomiting
Maltese: • Mhux komuni: bradikardija (tnaqqis fil-frekwenza tat-taħbit tal-qalb), dijarea, deni, żieda fit transaminases, rimettar
English: - Undesirable effects in organic acidaemia
Maltese: - Effetti mhux mixtieqa f'aċidemija organika
English: Take special care with Carbaglu:
Maltese: Tieħux Carbaglu:
English: Carbaglu showed no significant mutagenic activity in a battery of genotoxicity tests performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo (micronucleus test in rat).
Maltese: Carbaglu ma wera l-ebda attività mutaġenika sinifikanti f'sensiela ta' testijiet dwar il-genotossiċità mwettqa in vitro (Ames Test, analiżi tal-metafażi tal-limfoċiti fil-bniedem) u in vivo (eżami mikronuklejari fil-far).
English: - The other ingredients are microcrystalline cellulose, sodium laurilsulfate, hypromellose,
Maltese: - Sustanzi oħra jinkludu microcrystalline cellulose, sodium laurilsulfate, hypromellose,
English: Uncommon: increased transaminases
Maltese: Mhux komuni: transaminases ogħla
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), not known (cannot be estimated from the available data).
Maltese: Il-frekwenzi huma mfissra bħala: 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: Nutritional management Protein restriction and arginine supplementation may be indicated in case of low protein tolerance.
Maltese: Tista' tkun indikata restrizzjoni ta' proteini u teħid żejjed ta' arginine f'każ ta' tolleranza baxxa ta' proteini.
English: A proportion of carglumic acid is metabolised.
Maltese: Proporzjon ta' carglumic acid jiġi metabolizzat.
English: Metabolites are detectable in plasma with a peak at 36-48 hours and a very slow decline (half-life around 100 hours).
Maltese: Il-metaboliti huma intraċċati fil-plażma f'livelli massimi wara 36-48 siegħa u tnaqqis kajman ħafna (ħalf-life ta' madwar 100 siegħa).
English: • Not known: rash
Maltese: • Mhux magħruf: raxx
English: Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not induce any mortality or abnormal clinical signs in adult rats.
Maltese: Dożi orali waħdanien ta' carglumic acid sa 2800 mg/kg u 239 mg/kg fil-vina ma wassal għall-ebda mortalità jew sinjali klinikament anormali fuq firien adulti.
English: What Carbaglu contains - The active substance is carglumic acid.
Maltese: X'fih Carbaglu - Is-sustanza attiva hi carglumic acid.
English: 6.1 List of excipients
Maltese: 2.1 Deskrizzjoni ġenerali
English: Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase.
Maltese: In vitro, instab li carglumic acid jattiva carbamoyl phosphate synthetase fil-fwied.
English: The usual dose: the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10kg, you should take 1g per day, or 5 tablets), For patients suffering from N-acetylglutamate synthase deficiency, in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight.
Maltese: Id-doża normali: id-doża inizjali ta' kuljum hi ġeneralment ta' 100 mg kull kilogramma ta' piż tal-ġisem, sa massimu ta' 250 mg kull kilogramma ta' piż tal-ġisem (pereżempju jekk inti tiżen 10 kg, għandek tieħu 1g kuljum jew 5 pilloli).
English: Carbaglu 200 mg dispesible tablets Carglumic acid
Maltese: Carbaglu 200 mg pilloli li jinfirxu Carglumic acid
English: Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3).
Maltese: It-treddigħ waqt l-użu ta' carglumic acid hu kontra-indikat (ara sezzjonijiet 4.6 u 5.3).
English: Not known: rash
Maltese: Mhux magħruf: raxx
English: Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05
Maltese: Aċidi aminiċi u derivati; Kodiċi ATC:
English: The initial daily dose should be 100 mg/kg, up to 250 mg/kg if necessary.
Maltese: Id-doża inizjali ta' kuljum għandha tkun ta' 100 mg/kg, sa 250 mg/kg jekk meħtieġ.
English: At that dose-level, in 12 volunteers given Carbaglu tablets, plasma concentration peaked at 2.6 µg/ml (median; range 1.8-4.8) after 3 hours (median; range 2-4).
Maltese: F'dik il-livell ta' doża, fi 12-il voluntiera mogħtija l-pilloli Carbaglu, il-konċentrazzjoni ta' plażma laħqet l-ogħla livell f'2.6 µg/ml (medjan; firxa 1.8-4.8) wara tliet sigħat (medjan; firxa 2-4).
English: Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle.
Maltese: Carglumic acid hu strutturalment analogu għal N-acetylglutamate, li hu attivatur, preżenti b'mod naturali, ta' carbamoyl phosphate synthetase, l-ewwel enżima fiċ-ċiklu ta' l-urea.
English: Other studies have been conducted in rats under different experimental conditions leading to increased ammonia availability (starvation, protein-free or high-protein diet).
Maltese: Studji oħra li saru fuq il-firien taħt kundizzjonijiet sperimentali differenti wasslu għal żjieda fiddisponibilità ta' l-ammonja (nuqqas ta' ikel, dieta mingħajr proteini jew b'ħafna proteini).
English: In one patient treated with carglumic acid, where the dose was increased up to 750 mg/kg/day, symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and restlessness.
Maltese: F'pazjent wieħed trattat b'carglumic acid, fejn id-doża żdiedet sa 750 mg/kg/kuljum, kien hemm sintomi ta' intossikazzjoni li jistgħu jiġu kkaraterizzati bħala reazzjoni simpatomimetika: takikardja, żjieda qawwija ta' għaraq, żjieda ta' tnixxija mill-bronki, żjieda fit-temperatura tal-ġisem u irrekwitezza.
English: Uncommon: diarrhoea, vomiting
Maltese: Mhux komuni: dijarea, remettar
English: Each tablet contains 200 mg of carglumic acid.
Maltese: Kull pillola fiha 200 mg ta' carglumic acid.
English: Safety pharmacology studies have shown that Carbaglu administered orally at doses of 250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous system and cardiovascular system.
Maltese: Studji dwar is-sigurtà farmakoloġika wrew li l-għotja ta' Carbaglu b'mod orali b'dożi ta' 250, 500, 1000 mg/kg ma kellha l-ebda effett statistikament sinifikanti fuq respirazzjoni, fuq is-sistema nervuża ċentrali u fuq is-sistema kardjovaskulari.
English: POSSIBLE SIDE EFFECTS
Maltese: X'EFFETTI
English: Carbaglu is presented in a plastic container of 5, 15 and 60 tablets which is closed with a child resistant cap.
Maltese: Carbaglu jiġi f'reċipjenti tal-pastik ta' 5, 15 u 60 pillola li jingħalaq b'għatu li ma jistax jinfetaħ mittfal.
English: Plasma levels of ammonia and amino acids should be maintained within normal limits.
Maltese: Il-livelli ta' ammonja u amino acids fil-plażma għandhom jinżammu fil-limiti normali.
English: EU/1/02/246/001 (15 dispersible tablets) EU/1/02/246/002 (60 dispersible tablets) EU/1/02/246/003 (5 dispersible tablets)
Maltese: EU/1/02/246/001 (15-il pillola li jinfirxu)
English: After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the urine and up to 60% in the faeces.
Maltese: Wara doża orali waħdanija ta' 100 mg/kg piż korporali, 9% tad-doża tiġi eliminata mingħajr bidla fl-awrina u sa 60% fl-ippurgar.
English: Carbaglu is indicated in treatment of
Maltese: Caraglu hu indikat għat-trattament ta'
English: 60 dispersible tablets
Maltese: 60 pillola li jinfirxu
English: After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is estimated to be absorbed.
Maltese: Wara doża orali waħdanija ta' 100 mg/kg piż korporali, madwar 30% ta' carglumic acid hi stmata li tista' tiġi assorbita.
English: - In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust the dose in order to maintain normal ammonia plasma levels.
Maltese: - Fuq pazjent b'iperammonemija moderata, agħti doża ta' prova ta' 100 sa 200 mg/kg/kuljum għal tliet ijiem b'għoti kostanti ta' proteini u kejjel b'mod ripetut il-konċentrazzjoni ta' ammonja fil plażma (siegħa qabel u siegħa wara ikla); biddel d-doża b'mod li żżomm il-livelli normali ta'ammonja fil-plażma.
English: The end product of carglumic acid metabolism is carbon dioxide, which is eliminated through the lungs.
Maltese: Il-prodott aħħari tal-metaboliżmu ta' carglumic acid hu d-dijossidu karboniku, li jiġi eliminate mill-pulmun.
English: The following side effects were reported as follows: very common (occurring in at least one in 10 patients), common (occurring in at least one in 100 patients), uncommon (occurring in at least one in1,000 patients), rare (occurring in at least one in 10,000 patients), very rare (occurring in at least one in 100,000 patients) and not known (frequency cannot be estimated from the available data).
Maltese: L-effetti sekondarji li ġejjin kienu rrapportati kif ġej: komuni ħafna (li jseħħu f'tal-anqas 10 pazjenti), komuni (li jseħħu f'tal-anqas 100 pazjent), mhux komuni (li jseħħu f'tal-anqas pazjent 1 f'kull 1,000 pazjent) rari (li jseħħu f'tal-anqas pazjent 1 f'kull 10,000), rari ħafna (li jseħħu f'tal-anqas pazjent 1 f'kull 100,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
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 ta' l-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu/.
English: The maternal systemic exposures after 500 and 2000 mg/kg/day were twenty five times and seventy times the expected human exposure.
Maltese: L-espożizzjonijiet sistematiċi materni wara 500 u 2000 mg/kg/kuljum kienu ħames darbiet u sebgħin darba l-espożizzjoni mistennija għal bniedem.
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 60 TABLETS
Maltese: KAXXA TAL-KARTUN TA' BARRA U TIKKETTA TAL-KONTENITUR TAL-PILLOLI X 60 PILLOLA
English: OUTER CARTON BOX AND TABLET CONTAINER LABEL X 5 TABLETS
Maltese: KAXXA TAL-KARTUN TA' BARRA U TIKKETTA TAL-KONTENITUR TAL-PILLOLI X 5 PILLOLI
English: • For N-acetylglutamate synthase deficiency:
Maltese: F'dan il-fuljett:
English: It should then be individually adjusted in order to maintain normal ammonia plasma levels (see section 4.4).
Maltese: Imbagħad għandha tiġi aġġustata individwalment sabiex jiġi mantenut livelli normali ta' ammonja fil-plażma (ara sezzjoni 4.4).
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA) http://www.ema.europa.eu/.
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq il-website ta' l-Aġenzija Ewropea dwar il-Mediċini (EMA) http://www.ema.europa.eu