FrancophonIA/ELRC3.0 huggingface dataset:
English: Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants.
Maltese: Ladarba jkun ġie dokumentat ħin prothrombin stabbli, il-ħinijiet prothrombin jistgħu jiġu mmonitorjati fl-intervalli normalment irrakkomandati għal pazjenti fuq antikoagulanti coumarin.
English: Breastfeeding
Maltese: Treddigħ
English: Liver effects
Maltese: EFFETTI
English: Very rare: affect less than 1 user in 10,000:
Maltese: Rari ħafna: jaffettwa inqas minn utent 1 f'kull 10,000:
English: MA (EU) Number
Maltese: Numru ta' l-EU Numru tal-MA
English: (Invented) name Strength Pharmaceutical Form
Maltese: Għamla farmaċewtika
English: EMEA Number
Maltese: Numru ta'l-EU
English: Packaging
Maltese: kunjett wieħed
English: 1 pre-filled syringe with automatic needle guard (blistered)
Maltese: siringa mimlija għal-lest waħda (mhux fil-folja)
English: 1 pre-filled syringe (blistered)
Maltese: Mnejn jingħata Il-pakkett
English: Strength Pharmaceutical Form Route of Administration
Maltese: Numru ta' l-EU Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Co. Tipperary
Maltese: Tipperary
English: United Kingdom Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
Maltese: Id-Danimarka Vale Pharmaceuticals Limited 1b Gurtnafleur Business Park Gurtnafleur, Clonmel
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, applicant in the Member States
Maltese: Lista tal-ismijiet, għamliet farmaċewtiċi, qawwiet tal-prodotti mediċinali, mnejn jingħata, applikant fl-Istati Membri
English: (see section 4.3)
Maltese: (ara sezzjoni 4.3).
English: • AIDS/HIV (protease inhibitors)
Maltese: • AIDS/HIV (inibituri ta' protease)
English: The dose is 0.25 mg/kg.
Maltese: Id-doża hija 0.25 mg/kg.
English: [Oral suspension/syrup]
Maltese: [Suspensjoni orali/mistura]
English: • allergy (e.g., mequitazine, mizolastine)
Maltese: • allerġiji (eż., mequitazine, mizolastine)
English: • psychoses (e.g., haloperidol, pimozide, sertindole)
Maltese: • l-psikożi (eż., haloperidol, pimozide, sertindole)
English: • gastro-intestinal disorders (e.g., cisapride, dolasetron, prucalopride)
Maltese: • disturbi gastrointestinali (eż., cisapride, dolasetron, prucalopride)
English: • depression (e.g., citalopram, escitalopram)
Maltese: • id-dipressjoni (eż., citalopram, escitalopram)
English: [Effervescent granules 10 mg]
Maltese: [Granijiet li jfexfxu 10 mg]
English: o certain antipsychotics (e.g., haloperidol, pimozide, sertindole) o certain antidepressants (e.g., citalopram, escitalopram) o certain antibiotics (e.g. , erythromycin, levofloxacin, moxifloxacin, spiramycin) o certain antifungal agents (e.g., pentamidine) o certain antimalarial agents (in particular halofantrine, lumefantrine) o certain gastro-intestinal medicines (e.g., cisapride, dolasetron, prucalopride) o certain antihistaminics (e.g., mequitazine, mizolastine) o certain medicines used in cancer (e.g., toremifene, vandetanib, vincamine) o certain other medicines (e.g., bepridil, diphemanil, methadone) (see section 4.3).
Maltese: Il-prodotti mediċinali li jtawlu l-intervall QTc o antiarritmiċi tal-klassi IA (eż., disopyramide, hydroquinidine, quinidine) o antiarritmiċi tal-klassi III (eż., amiodarone, dofetilide, dronedarone, ibutilide, sotalol) o ċertu antipsikotiċi (eż., haloperidol, pimozide, sertindole) o ċertu antidipressanti (eż., citalopram, escitalopram) o ċertu antibijotiċi (eż., erythromycin, levofloxacin, moxifloxacin, spiramycin) o ċertu sustanzi antifungali (eż., pentamidine) o ċertu sustanzi ta' kontra l-malarja (b'mod partikolari halofantrine, lumefantrine) o ċertu mediċini gastrointestinali (eż., cisapride, dolasetron, prucalopride) o ċertu antiistaminiċi (eż., mequitazine, mizolastine) o ċertu mediċini li jintużaw għall-kanċer (eż., toremifene, vandetanib, vincamine)
English: Section 5.1 Pharmacodynamic properties
Maltese: .1 Propjetajiet farmakodinamiċi
English: Section 4.1 Therapeutic indications
Maltese: Sezzjoni 4.3 Kontraindikazzjonijiet
English: 10 ml (of 1 mg/ml oral suspension) up to three times per day with a maximum dose of 30 ml per day.
Maltese: 10 ml (ta' suspensjoni orali ta' 1 mg/ml) sa tliet darbiet kuljum b'doża massima ta' 30 ml kuljum.
English: The unbound fraction is increased by 25 %, and the terminal elimination half-life is prolonged from 15 to 23 hours.
Maltese: Il-porzjon mhux marbut jiżdied b'25%, u l-half-life terminali ta' tneħħija minn 15-il siegħa titwal għal 23 siegħa.
English: • heart problems or high blood pressure (e.g., amiodarone, dronedarone, quinidine, disopyramide,
Maltese: • problemi tal-qalb jew pressjoni għolja (eż., amiodarone, dronedarone, quinidine, disopyramide,
English: Section 4 Possible side effects
Maltese: Effetti sekondarji possibbli
English: Potent CYP3A4 inhibitors (regardless of their QT prolonging effects), i.e : o protease inhibitors o systemic azole antifungals o some macrolides (erythromycin, clarithromycin and telithromycin) (see section 4.3).
Maltese: Inibituri qawwija ta' CYP3A4 (irrispettivament mill-effetti tagħhom fuq kemm itawlu l-intervall QT), i.e.: o inibituri tal-protease o azole antifungali sistemiċi o xi macrolides (erythromycin ,clarithromycin, telithromycin) (ara sezzjoni 4.3).
English: However, two previous drug-drug interaction studies showed some evidence of QTc prolongation when domperidone was administered as monotherapy (10 mg 4 times a day).The largest time-matched mean difference of QTcF between domperidone and placebo was 5.4 msec (95 % CI: -1.7 to 12.4) and 7.5 msec (95 % CI: 0.6 to 14.4), respectively.
Maltese: L-akbar medja fid-differenza tal-QTcF, mqabbla għall-ħin, bejn domperidone u l-plaċebo kienet 5.4 msek (95% CI: -1.7 sa 12.4) u 7.5 msek (95% CI: 0.6 sa 14.4), rispettivament.
English: Do not take more than 30 mg per day.
Maltese: Tiħux aktar minn 30mg kuljum.
English: In subjects with moderate hepatic impairment (Pugh score 7 to 9, Child-Pugh rating B), the AUC and Cmax of domperidone is 2.9- and 1.5- fold higher, respectively, than in healthy subjects.
Maltese: F'individwi b'indeboliment moderat tal-fwied (punteġġ ta' Pugh minn 7 sa 9, klassifika B ta' Child-Pugh), l-AUC u s-Cmax ta' domperidone huma 2.9 u 1.5 drabi ogħla, rispettivament, minn f'individwi f'saħħithom.
English: Electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia) or bradycardia are known to be conditions increasing the proarrythmic risk.
Maltese: Disturbi fl-elettroliti (ipokalimja, iperkalimja, ipomagnesimja) jew bradikardija huma magħrufa li huma kondizzjonijiet li jżidu r-riskju ta' aggravament tal-arritmiji.
English: Tablets, Effervescent granules, Suppositories
Maltese: Pilloli, Granuli li jfexfxu, suppositorji
English: • malaria (in particular halofantrine)
Maltese: • l-malarja (b'mod partikolari halofantrine)
English: • bacterial infections, specifically erythromycin, clarithromycin, telithromycin, moxifloxacin,
Maltese: • infezzjonijiet bil-batterji, b'mod speċifiku erythromycin, clarithromycin, telithromycin,
English: Not known: ventricular arrhythmias, QTc prolongation, Torsade de Pointes, sudden cardiac death (see section 4.4)
Maltese: Arritmiji ventrikolari, QTc mtawwal, Torsade de Pointes, mewt zoptu ġejja mill-qalb, (ara sezzjoni 4.4)
English: ▼This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: In in vitro experiments on isolated cells transfected with hERG and on isolated guinea pig myocytes, exposure ratios ranged between 26 - 47-fold, based on IC50 values inhibiting currents through IKr ion channels in comparison to the free plasma concentrations in humans after administration of the maximum daily dose of 10 mg administered 3 times a day.
Maltese: F'esperimenti in vitro fuq ċelluli iżolati transfettati b'hERG, proporzjonijiet ta' esponimenti kienu fuq firxa bejn 26 u 47 darba aktar, abbażi ta' valuri IC50 li jinibixxu kurrenti mill-kanali IKr tal-jonji meta mqabbla mal-konċentrazzjonijiet ħielsa fil-plażma tal-bniedem wara l-għoti tal-ogħla doża ta' kuljum ta' 10 mg mogħtija tliet darbiet kuljum.
English: • fungal infections such as azole anti-fungals, specifically oral ketoconazole, fluconazole or voriconazole
Maltese: • infezzjonijiet bil-fungu, b'mod speċifiku ketoconazole, fluconazole jew voriconazole, mill-ħalq
English: Electrophysiological in vitro and in vivo studies indicate an overall moderate risk of domperidone to prolong the QTc interval in humans.
Maltese: Studji elettrofiżjoloġiċi in vitro u in vivo jindikaw riskju globali moderat li domperidone jtawwal l-intervall QTc fil-bniedem.
English: [Effervescent granules 5 mg]
Maltese: [Granijiet li jfexfxu 5 mg] [Granijiet li jfexfxu 5 mg]
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Maltese: L-informazzjoni tal-prodott sussegwentement tista' tiġi aġġornata mill-awtoritajiet kompetenti tal-Istat Membru, b'koperazzjoni mal-Istat Membru ta' Riferenza, kif xieraq, skont il-proċeduri mniżżlin f'Kapitlu 4 tat-Titolu III tad-Direttiva 2001/83/KE.
English: The Cmax and AUC values of domperidone increased proportionally with dose in the 10 mg to 20 mg dose range.
Maltese: Il-valuri tas-Cmax u l-AUC ta' domperidone żdiedu fi proporzjon mad-doża fuq firxa ta'dożi minn 10 mg sa 20 mg.
English: Adults and adolescents 12 years of age and older with a body weight of 35 kg or more Tablets 10 mg [Instructions for use must be included]
Maltese: Adulti u adolexxenti minn 12-il sena 'l fuq b'piż tal-ġisem ta' 35 kg jew aktar Pilloli 10mg [Istruzzjonijiet għal użu għandhom jiġu inklużi]
English: In subjects with severe renal insufficiency (creatinine clearance<30 ml/min/1.73m2) the elimination half-life of domperidone was increased from 7.4 to 20.8 hours, but plasma drug levels were lower than in healthy volunteers.
Maltese: F'individwi b'insuffiċjenza qawwija tal-kliewi (tneħħija tal-kreatinina < 30 ml/min/1.73 m2) il-half-life ta' tneħħija ta domperidone żdiedet minn 7.4 sa 20.
English: pentamidine (these are antibiotics)
Maltese: moxifloxacin, pentamidine (dawn huma antibijotiċi)
English: This study found a maximal difference of QTc between domperidone and placebo in LS-means in the change from baseline of 3.4 msec for 20 mg domperidone administered 4 times a day on Day 4.
Maltese: Dan l-istudju sab differenza massima ta' QTc bejn domperidone u l-plaċebo fil-medji LS fil-bidla mill-linja bażi ta' 3.4 msec għal 20 mg ta' domperidone mogħtija erba' darbiet kuljum fil-Jum 4.
English: Suppositories 30 mg [Instructions for use must be included]
Maltese: Suppositorji 30mg [Istruzzjonijiet dwar l-użu għandhom jiġu inklużi]
English: Before taking this medicine contact your doctor if you: - suffer from liver problems (liver function impairment or failure) (see “Do not take this medicinal product”) - suffer from kidney problems (kidney function impairment or failure).
Maltese: Qabel tieħu din il-mediċina kkuntattja lit-tabib tiegħek jekk inti: - tbati minn problemi fil-fwied (indeboliment fil-funzjoni jew insuffiċjenza tal-fwied) (ara “Tiħux dan il-prodott mediċinali”) - tbati minn problemi fil-kliewi (indeboliment fil-funzjoni jew insuffiċjenza tal-kliewi).
English: Hepatic Impairment <X> is contraindicated in moderate or severe hepatic impairment (see section 4.3).
Maltese: <X>huwa kontraindikat f'indeboliment moderat jew qawwi tal-fwied (ara sezzjoni 4.3).
English: Effervescent granules 5 mg [Instructions for use must be included]
Maltese: Granuli li jfexfxu 5 mg [Istruzzjonijiet dwar l-użu għandhom jiġu inklużi]
English: Effervescent granules 10 mg [Instructions for use must be included]
Maltese: Granuli li jfexfxu 10 mg [Istruzzjonijiet dwar l-użu għandhom jiġu inklużi]
English: Adults, and adolescents (12 years of age and older and weighing 35 kg or more) [Tablets (Film-coated, Coated, Scored coated, Effervescent, Chewable), Orodispersible tablets, capsules]
Maltese: Adulti, u adolexxenti (minn 12-il sena 'l fuq u li jiżnu 35 kg jew aktar) Pilloli (Miksija b'rita, Miksija, Miksija f'ferq, Li jfexfxu, Li tomgħod), Pilloli li jinħallu fil-ħalq, kapsuli] Pillola waħda ta' 10 mg sa tliet darbiet kuljum b'doża massima ta' 30 mg kuljum.
English: Concomitant use of the following substances is not recommended Moderate CYP3A4 inhibitors i.e. diltiazem, verapamil and some macrolides.
Maltese: L-użu flimkien mas-sustanzi li ġejjin mhuwiex irrakkomandat Inibituri moderati ta' CYP3A4 i.e., diltiazem, verapamil u xi macrolides.
English: Domperidone is contraindicated in patients with known existing prolongation of cardiac conduction intervals, particularly QTc, in patients with significant electrolyte disturbances (hypokalaemia, hyperkalaemia, hypomagnesaemia), or bradycardia, or in patients with underlying cardiac diseases such as congestive heart failure due to increased risk of ventricular arrhythmia (see section 4.3.).
Maltese: Domperidone huwa kontraindikat f'pazjenti magħrufa li diġà għandhom intervalli mtawla tat-trasmissjoni tal-qalb, b'mod partikolari l-QTc, f'pazjenti b'disturbi sinifikanti tal-elettroliti (ipokalimja, iperkalimja, ipomagnesimja), jew bradikardija, jew f'pazjenti li għandhom mard kardijaku bħal mard konġestiv tal-qalb, minħabba żieda fir-riskju ta' arritmija ventrikolari (ara sezzjoni 4.3).
English: In accordance with ICH-E14 guidelines, a thorough QT study was performed.
Maltese: F'konformità mal-linji gwida ICH-E14, sar studju QT fil-fond.
English: This should be given up to three times per day with a maximum dose of 0.75 mg/kg per day.
Maltese: Din għandha tingħata sa tliet darbiet kuljum b'doża massima ta' 0.75mg/kg kuljum.
English: In the anesthetized guinea pig model following slow intravenous infusions, there were no effects on QTc at total plasma concentrations of 45.4 ng/mL, which are 3-fold higher than the total plasma levels at in humans at maximum daily dose (10 mg administered 3 times a day).
Maltese: Fil-mudell ta' fenek tal-Indi illupjat wara infużjonijiet bil-mod fil-vina, ma kien hemm lebda effetti fuq il-QTc b'konċentrazzjonijiet totali fil-plażma ta' 45.4 ng/ml, li huma 3 darbiet aktar għolja mil-livelli totali fil-plażma tal-bnedmin bl-ogħla doża ta' kuljum (10 mg mogħtija tliet darbiet kuljum).
English: In the presence of inhibition of the metabolism via CYP3A4 free plasma concentrations of domperidone can rise up to 3-fold.
Maltese: Fil-preżenza ta' inibizzjoni tal-metaboliżmu permezz ta' CYP3A4, il-konċentrazzjonijiet ta' domperidone ħieles fil-plażma jistgħu jogħlew sa 3 darbiet aktar.
English: Section 4.6 Fertility, pregnancy and lactation
Maltese: Sezzjoni 4.9 Doża eċċessiva
English: An ECG monitoring could be undertaken, because of the possibility of a heart problem called prolonged QT interval.
Maltese: Jista' jsir monitoraġġ bl-ECG, minħabba l-possibbiltà ta' problema tal-qalb imsejħa “intervall QT imtawwal”.
English: Safety margins in in vitro proarrhythmic models (isolated Langendorff perfused heart) exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 9- up to 45-fold.
Maltese: Il-marġni ta' sigurtà f'mudelli proarritmiċi in vitro (qalb iżolata u infuża skont Langendorff) qabżu l-konċentrazzjonijiet ħielsa fil-plażma tal-bniedem bl-ogħla doża ta' kuljum (10 mg mogħtija tliet darbiet kuljum) b'9 sa 45 darba aktar.
English: Domperidone is contraindicated in patients with moderate or severe hepatic impairment (see section 4.3).
Maltese: Domperidone huwa kontraindikat f'pazjenti b'indeboliment moderat jew qawwi tal-fwied (ara sezzjoni 4.3).
English: Domperidone has been associated with prolongation of the QT interval on the electrocardiogram.
Maltese: Domperidone ġie assoċjat ma' intervall ta' QT imtawwal fuq l-elettrokardjogramma.
English: The 2-sided 90 % CI (1.0 to 5.9 msec) did not exceed 10 msec. No clinically relevant QTc effects were observed in this study when domperidone was administered at up to 80 mg/day (i.e., more than twice the maximum recommended dosing).
Maltese: Ma kienu osservati l-ebda effetti ta' QTc rilevanti b'mod kliniku f'dan l-istudju meta domperidone ngħata f'doża sa 80 mg/kuljum (i.e., iżjed mid-doppju tal-massimu tad-doża rrakkomandata).
English: Section 5.2 Pharmacokinetic properties [This section should be amended to include the following wording]
Maltese: Sezzjoni 5.2 Tagħrif farmakokinetiku [Din is-sezzjoni għandha tiġi emendata biex tinkludi l-kliem testwali li ġej]
English: Epidemiological studies showed that domperidone was associated with an increased risk of serious ventricular arrhythmias or sudden cardiac death (see section 4.8).
Maltese: Studji epidemjoloġiċi wrew li domperidone ġie assoċjat ma' żieda fir-riskju ta' arritmiji serji tal-ventrikulu jew mewt zoptu ġejja mill-qalb (ara sezzjoni 4.8).
English: Subjects with mild hepatic impairment have a somewhat lower systemic exposure than healthy subjects based on Cmax and AUC, with no change in protein binding or terminal half-life.
Maltese: Individwi b'indeboliment ħafif tal-fwied għandhom esponiment sistemiku kemxejn inqas minn individwi f'saħħithom abbażi tas-Cmax u l-AUC, mingħajr l-ebda bidla fl-irbit mal-proteini jew il-half-life terminali.
English: For example, for a child weighing 10 kg, the dose is 2.5 mg and this can be given three times per day to a maximum dose of 7.5 mg per day.
Maltese: Per eżempju, għal tifel/tifla li jiżen/tiżen 10 kg, id-doża hija 2.5 mg u din tista' tingħata tliet darbiet kuljum sa doża massima ta' 7.5 mg kuljum.
English: o anti-arrhythmics class III (e.g., amiodarone, dofetilide, dronedarone, ibutilide, sotalol)
Maltese: o ċertu mediċini oħra (eż., bepridil, diphemanil, methadone) (ara sezzjoni 4.3).
English: Renal Impairment
Maltese: Twissijiet u prekawzjonijiet
English: Treatment with domperidone should be stopped.
Maltese: Tieħux aktar minn tliet pilloli kuljum.
English: Section 4.8 Undesirable effects [This following wording should be reflected in this section] Cardiac disorders
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa [Il-kliem testwali li ġej għandu jiġi rifless f'din is-sezzjoni]
English: Concomitant use of the following substances requires caution in use Caution with bradycardia and hypokalaemia-inducing drugs, as well as with the following macrolides involved in QT-interval prolongation: azithromycin and roxithromycin (clarithromycin is contraindicated as it is a potent CYP3A4 inhibitor).
Maltese: L-użu flimkien mas-sustanzi li ġejjin jeħtieġ użu b'kawtela Għandu jkun hemm kawtela b'mediċini li jikkawżaw bradikardija u ipokalimja, kif ukoll bil-macrolides li ġejjin li huma implikati li jtawlu l-intervall QT: azithromycin u roxithromycin (clarithromycin huwa kontraindikat minħabba li huwa inibitur qawwi ta' CYP3A4).
English: Although domperidone's bioavailability is enhanced in normal subjects when taken after a meal, patients with gastro-intestinal complaints should take domperidone 15 - 30 minutes before a meal.
Maltese: Għalkemm il-bijodisponibbiltà ta' domperidone tiżdied f'individwi normali meta d-doża tittieħed wara l-ikel, pazjenti bi problemi gastrointestinali għandhom jieħdu domperidone minn 15-30 minuta qabel l-ikel.
English: [Orodispersible tablets]
Maltese: [Suppositorji]
English: In in vivo models the no effect levels for QTc prolongation in dogs and induction of arrhythmias in a rabbit model sensitized for torsade de pointes exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by more than 22-fold and 435-fold, respectively.
Maltese: F'mudelli in vivo, il-livelli sa fejn ma jkun hemm l-ebda effett fuq it-tul ta' QTc fil-klieb u l-ikkaġunar ta' arritmiji f'mudell ta' fenek sensitizzat għal torsade de points qabżu l-konċentrazzjonijiet ħielsa fil-plażma tal-bniedem bl-ogħla doża ta' kuljum (10 mg mogħtija tliet darbiet kuljum) b'aktar minn 22 darba u 435 darba aktar, rispettivament.
English: This risk may be more likely in those over 60 years old or taking doses higher than 30mg per day.
Maltese: Dan ir-riskju aktar għandu mnejn jiġri f'dawk li għandhom aktar minn 60 sena jew f'dawk li qed jieħdu dożi ta' iktar minn 30 mg kuljum.
English: Tell your doctor or pharmacist if you are taking drugs to treat infection (fungal infections or bacterial infection) and/or if you have heart problems or AIDS/HIV (see section other medicines and X).
Maltese: Għid lit-tabib jew lill-ispiżjar tiegħek jekk inti qed tieħu mediċini biex tikkura infezzjoni (infezzjoni bil-fungu jew bil-batterji) u/jew jekk inti għandek problemi tal-qalb jew AIDS/HIV (ara “Meta tieħu mediċini oħra u X”).
English: A 2- to 3-fold accumulation of domperidone AUC was observed with repeated four times daily (every 5 hr) dosing of domperidone for 4 days.
Maltese: Akkumulazzjoni ta' darbtejn sa tlett darbiet aktar fl-AUC ta' domperidone kienet osservata b'doża ta' domperidone ripetuta erba' darbiet kuljum (kull 5 sigħat) għal 4 ijiem.
English: Safety margins for prolongation of action potential duration in in vitro experiments on isolated cardiac tissues exceeded the free plasma concentrations in humans at maximum daily dose (10 mg administered 3 times a day) by 45-fold.
Maltese: Il-marġni ta' sigurtà għat-titwil tal-potenzjal ta' azzjoni f'esperimenti in vitro fuq tessuti iżolati mill-qalb qabżu l-konċentrazzjonijiet ħielsa fil-plażma tal-bniedem bl-ogħla doża ta' kuljum (10 mg mogħtija tliet darbiet kuljum) b'45 darba aktar.
English: The elimination half-life of domperidone is prolonged in severe renal impairment.
Maltese: Minħabba li f'indeboliment qawwi tal-kliewi l-half life ta' tneħħija ta' domperidone tieħu iktar fit-tul.
English: Occurrence of adverse effects, in particular cardiac effects cannot be excluded after exposure via breast milk.
Maltese: Każijiet ta' effetti avversi, b'mod partikolari effetti fuq il-qalb ma jistgħux jiġu esklużi wara esponiment mill-ħalib tas-sider.
English: Oral bioavailability is decreased by prior concomitant administration of cimetidine and sodium bicarbonate.
Maltese: Bijodisponibbiltà mill-ħalq tonqos jekk qabel jingħata cimetidine flimkien ma' sodium bicarbonate.
English: One sachet (containing 10 mg domperidone per sachet) up to three times per day with a maximum dose of 3 sachets per day.
Maltese: Qartas wieħed (li fih 10 mg domperidone f'kull qartas) sa tliet darbiet kuljum b'doża massima ta' 3 qratas kuljum.
English: A higher risk was observed in patients older than 60 years, patients taking daily doses greater than 30 mg, and patients concurrently taking QT-prolonging drugs or CYP3A4 inhibitors.
Maltese: Riskju akbar kien osservat f'pazjenti li kellhom aktar minn 60 sena, pazjenti li kienu qed jieħdu dożi aktar minn 30 mg kuljum, u pazjenti li fl-istess waqt kienu qed jieħdu mediċini li jtawlu l-intervall QT jew inibituri ta' CYP3A4.
English: This study included a placebo, an active comparator and a positive control and was conducted in healthy subjects with up to 80 mg per day 10 or 20 mg administered 4 times a day of domperidone.
Maltese: Dan l-istudju kien jinkludi plaċebo, kumparatur attiv u kontroll pożittiv u sar f'individwi f'saħħithom b'doża sa 80 mg kuljum mogħtija bħala 10 jew 20 mg ta' domperidone erba' darbiet kuljum.
English: • co-administration with potent CYP3A4 inhibitors (regardless of their QT prolonging effects) (see section 4.5)
Maltese: (irrispettivament mill-effetti tagħhom fuq kemm itawlu l-intervall QT) (ara sezzjoni 4.5)
English: [The paragraph below is to be implemented where the marketing authorisation currently includes relief of the symptoms of nausea and vomiting in children under 12 years of age and adolescents weighing less than 35 kg:]
Maltese: [Il-paragrafu t'hawn taħt irid jiġi implimentat fejn l-awtorizzazzjoni tat-tqegħid fis-suq attwalment tinkludi serħan mis-sintomi tad-dardir u remettar fi tfal li għadhom m'għalqux it-12-il sena u adolexxenti li jiżnu inqas minn 35 kg:]
English: Do not take {Product Name} if you are taking medicine to treat:
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni
English: London, 30 May 2008 Doc.
Maltese: Londra, 30 ta' Mejju 2008 Dok. Ref.
English: Ref. EMEA/279720/2008
Maltese: EMEA/330949/2008