FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE MEDICINAL PRODUCT Zinnat and associated names (see Annex I) 125 mg film-coated tablets Zinnat and associated names (see Annex I) 250 mg film-coated tablets Zinnat and associated names (see Annex I) 500 mg film-coated tablets [See Annex I - To be completed nationally] Cefuroxime
Maltese: Zinnat u ismijiet assoċjati (ara Anness I) 125 mg pilloli miksijn b'rita Zinnat u ismijiet assoċjati (ara Anness I) 250 mg pilloli miksijin b'rita Zinnat u ismijiet assoċjati (ara Anness I) 500 mg pilloli miksijin b'rita [Ara Anness I -biex timtela mill-pajjiż partikolari]
English: Renal impairment
Maltese: Doża rrakomanadata
English: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Finland, Ireland, Italy, Luxembourg, Malta, Poland, Slovakia, Slovenia, Spain, United Kingdom - Zinnat
Maltese: L-Awstrija , il-Belġju, il-Bulgarija, Ir-Repubblika Ċeka , Ċipru, il-Finlandja, l-Irlanda, l-Italja, ilLussemburgu, Malta, il-Polonja, is-Slovakkja, Slovenja, Spanja, ir-Renju Unit - Zinnat Greece - Zinadol
English: Cefuroxime axetil breakpoints
Maltese: Breakpoints ta' cefuroxime axetil
English: What you need to know before you take Zinnat Don't take Zinnat:
Maltese: Zinnat jista' jintuża wkoll:
English: standard individual dose given every 24 hours
Maltese: doża individwali standard tingħata kull 24 siegħa
English: 125 mg, 250 mg, 500 mg film-coated tablets Film-coated tablet (tablet) [To be completed nationally]
Maltese: 125 mg, 250 mg, 500 mg pilloli miksijin b'rita Pillola miksija b'rita (pillola) [Biex timtela mill-pajjiż partikolari]
English: Zinnat can affect the results of a test for blood sugar levels, or a blood screen called the Coombs test.
Maltese: Zinnat jista' jaffettwa r-riżultati ta' test għal-livelli ta' zokkor fid-demm, jew eżami tad-demm imsejjaħ it-test ta' Coombs.
English: Austria, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom - Zinnat
Maltese: L-Awstrija , il-Bulgarija, Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, Franza, il-Ġermanja, lUngerija, l-Islanda, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, Malta, l-Olanda, il-Polonja, ir-Rumanija, is-Slovakkja, Slovenja, Spanja, l-Isvezja, ir-Renju Unit - Zinnat
English: • Acute streptococcal tonsillitis and pharyngitis.
Maltese: • Tonsillite u farinġite akuti ikkawżati minn streptokokki.
English: Patients should be reassured that this is a common and usually self-limiting consequence of antibiotic treatment of Lyme disease (see section 4.8).
Maltese: Wieħed għandu jserraħ moħħ il-pazjenti li din hija konsegwenza komuni u li s-soltu tgħaddi waħedha ta' kura bl-antibijotiċi tal-marda ta' Lyme (ara sezzjoni 4.8).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients [To be completed nationally] 6.2 Incompatibilities [To be completed nationally] 6.3 Shelf life [To be completed nationally] 6.4 Special precautions for storage [To be completed nationally]
Maltese: 6.1 Lista ta' eċċipjenti [Biex timtela mill-pajjiż partikolari]
English: standard individual dose given every 48 hours
Maltese: doża individwali standard tingħata kull 48 siegħa
English: Contains 12.2 g of sucrose per unit dose
Maltese: 500 mg granijiet għal suspensjoni orali Fihom 12.2 g ta' sucrose f'kull doża
English: You must look out for certain symptoms, such as allergic reactions, fungal infections (such as candida) and severe diahorrea (pseudomembranous colitis) while you are taking Zinnat.
Maltese: Inti għandek toqgħod attent għal ċerti sintomi, bħal reazzjonijiet allerġiċi, infezzjonijiet bil-fungu (bħal candida) u dijarea qawwija (kolite psewdomembranuża) waqt li inti tkun qed tieħu Zinnat.
English: Recommended doses for Zinnat in renal impairment
Maltese: Dożi rrakkomandati għal Zinnat f'indeboliment tal-kliewi
English: 125 mg/5 mL, 250 mg/5 mL granules for oral suspension Shake the bottle before use.
Maltese: 125 mg/5 mL and 250 mg/5 mL granijiet għal suspensjoni orali Direzzjonijiet biex tħallat is-suspensjoni
English: 125 mg, 250 mg, 500 mg granules for oral suspension For step-by-step instructions on how to make up Zinnat sachets see Instructions for reconstitution at the end of this leaflet.
Maltese: 125 mg, 250 mg, 500 mg granijiet għal suspensjoni orali Għal istruzzjonijiet pass pass dwar kif tħallat il-qratas ta' Zinnat ara Istruzzjonijiet għarrikostituzzjoni fl-aħħar ta' dan il-fuljett.
English: • Acute bacterial sinusitis.
Maltese: • Sinożite akuta ikkawżata minn batterji.
English: Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment (see section 4.8).
Maltese: L-użu għal tul ta' żmien jista' jwassal ukoll għal tkabbir żejjed ta' mikroorganiżmi oħra mhux suxxettibbli (eż. enterococci u Clostridium difficile), li jista' jkun jeħtieġ it-twaqqif tal-kura (ara sezzjoni 4.8)
English: No special precaution is necessary in the elderly patients with normal renal function at dosages up to the normal maximum of 1 g per day.
Maltese: Ma hija meħtieġa l-ebda prekawzjoni speċjali f'pazjenti anzjani b'funzjoni normali tal-kliewi salogħla dożi normali ta' 1 g kuljum.
English: Some strains that produce beta-lactamases are susceptible or intermediate to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility.
Maltese: Xi razzez li jipproduċu beta-lactamases huma suxxettibbli jew intermedji għas-cephalosporins tat-tielet jew ir-raba' ġenerazzjoni b'dawn il-breakpoints u għandhom jiġu rrappurtati li nstabu, i.e. il-preżenza jew in-nuqqas ta' ESBL fih innifsu ma jinfluwenzax ilkategorizzazzjoni tas-suxxettibilità.
English: 3 Susceptibility of staphylococci to cephalosporins is inferred from the methicillin susceptibility except for ceftazidme and cefixime and ceftibuten, which do not have breakpoints and should not be used for staphylococcal infections.
Maltese: Kolite psewdomembranuża assoċjata ma' sustanzi antibatteriċi kienet irrappurtata bi kważi kull sustanża antibatterika, inkluż b'cefuroxime, u tista' tvarja minn ħafifa sa ta' periklu għall-ħajja filqawwa tagħha.
English: Cefuroxime axetil tablets and cefuroxime axetil granules for oral suspension are not bioequivalent and are not substitutable on a milligram-per-milligram basis (see section 5.2).
Maltese: Il-pilloli ta' cefuroxime axetil u l-granijiet ta' cefuroxime axetil għal suspensjoni orali mhumiex bijoekwivalenti u ma jistax wieħed jisostitwixxi lill-ieħor bl-istess ammont ta' milligrammi (ara sezzjoni 5.2).
English: Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered.
Maltese: Infezzjonijiet u infestazzjonijiet tkabbir żejjed ta' Candida tkabbir żejjed ta' Clostridium difficile
English: Cefuroxime axetil oral suspension was not bioequivalent to cefuroxime axetil tablets when tested in healthy adults and therefore is not substitutable on a milligramper-milligram basis (see section 4.2).The pharmacokinetics of cefuroxime is linear over the oral dosage range of 125 to 1000 mg. No accumulation of cefuroxime occurred following repeat oral doses of 250 to 500 mg.
Maltese: Is-supensjoni ta' cefuroxime axetil mill-ħalq ma kinitx ekwivalenti għall-pilloli ta' cefuroxime axetil meta ġiet ittestjata f'adulti f'saħħithom u għalhekk waħda ma tistax tissostitwixxi lill-oħra bl-istess ammont ta' milligrammi (ara sezzjoni 4.2).
English: Zinnat and associated names (see Annex I) 125 mg granules for oral suspension Zinnat and associated names (see Annex I) 250 mg granules for oral suspension Zinnat and associated names (see Annex I) 500 mg granules for oral suspension [See Annex I - To be completed nationally]
Maltese: Zinnat u ismijiet assoċjati (ara Anness I) 125 mg granijiet għal suspensjoni orali Zinnat u ismijiet assoċjati (ara Anness I) 250 mg granijiet għal suspensjoni orali Zinnat u ismijiet assoċjati (ara Anness I) 500 mg granijiet għal suspensjoni orali [Ara Anness I -biex timtela mill-pajjiż partikolari]
English: MA (EU) Number
Maltese: Numru tal-MA (EU)
English: 6 (3 x 2) prefilled pens (multipack)
Maltese: 6 (3 x 2) pinen mimlija għal-lest (Pakkett b'ħafna)
English: Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Maltese: Pakkett għallbidu 1 siringa mimlija għal-lest (63 µg)
English: Initiation pack: 1 pre-filled pen (63 µg) + 1 pre-filled pen (94 µg)
Maltese: Pakkett għallbidu 1 pinna mimlija għal-lest (63 µg)
English: 2 pre-filled pens
Maltese: 2 siringi għal-lest
English: 20 December 2013 EMA/13239/2014 Corr. 1
Maltese: 20 ta' Diċembru 2013 EMA/13239/2014
English: Contact our press officers Monika Benstetter or Martin Harvey
Maltese: Ikkuntattja lill-uffiċjali tagħna għall-istampa Monika Benstetter jew Martin Harvey
English: More about the procedure
Maltese: Corr. 1
English: • Extrapyramidal disorders constituted nearly half of all spontaneously reported adverse effects in a manufacturer database (1749 cases out of 4005, up to December 2011).
Maltese: • Id-disturbi ekstrapiramidali kienu jikkostitwixxu kważi nofs l-effetti avversi kollha rrappurtati b'mod spontanju f'database ta' manifattur (1749 każ minn 4005, sa Diċembru 2011).
English: There was more consistent evidence of comparability with 5-HT3 antagonists when used for delayed CINV.
Maltese: Kien hemm evidenza aktar konsistenti ta' komparabbiltà mal-antagonisti ta' 5-HT3 meta jintuża għal CINV ittardjat.
English: In adults,
Maltese: Tel.
English: The review of metoclopramide-containing medicines was initiated in December 2011 at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tal-mediċini li fihom metoclopramide nbdiet f'Diċembru 2011 fuq talba ta' Franza, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: This followed a review by the EU Member States of metoclopramide-containing medicines in children, under Article 45 of the Paediatric Regulation 1901/2006, which in 2010 identified the risk of neurological side effects and recommended a number of risk minimisation measures.
Maltese: Din segwiet reviżjoni mill-Istati Membri tal-UE, tal-mediċini li fihom metoclopramide, fit-tfal, skont l-Artikolu 45 tar-Regolament Pedjatriku 1901/2006, li fl-2010 identifikat ir-riskju ta' effetti sekondarji newroloġiċi u rrakkomandat numru ta' miżuri għallminimizzazzjoni tar-riskju.
English: In children the recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily.
Maltese: Fit-tfal, id-doża rakkomandata hija ta' 0.1 sa 0.15 mg għal kull kg tal-piż tal-ġisem, ripetuta sa tliet darbiet kuljum.
English: • For adults and children the maximum dose in 24 hours is 0.5 mg per kg body weight; in adults, the usual dose of conventional formulations (all routes) is 10 mg up to 3 times daily.
Maltese: • Għall-adulti u t-tfal, id-doża massima f'24 siegħa hija ta' 0.5 mg għal kull kg tal-piż tal-ġisem; fladulti, id-doża normali tal-formulazzjonijiet konvenzjonali (ir-rotot kollha) hija 10 mg sa 3 darbiet kuljum.
English: • Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.
Maltese: • Il-formulazzjonijiet għal ġol-vini b'konċentrazzjonijiet ogħla minn 5 mg/ml u s-suppożitorji li fihom 20 mg ukoll se jiġu rtirati.
English: This followed a re-examination, at the request of a marketing authorisation holder, of the opinion originally given by the Committee on 26 July 2013.
Maltese: Dan segwa rieżami, fuq talba ta' detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, tal-opinjoni oriġinarjament mogħtija mill-Kumitat fis-26 ta' Lulju 2013.
English: This included published studies and meta-analyses on the efficacy of metoclopramide and analyses of reports of suspected adverse reactions.
Maltese: Din kienet tinkludi studji ppubblikati u meta-analiżijiet dwar l-effikaċja ta' metoclopramide u analiżijiet tar-rapporti ta' reazzjonijiet avversi suspettati.
English: The CHMP recommendation was then sent to the European Commission, which adopted it with a final legally binding decision, valid throughout the European Union (EU), on 20 December 2013.
Maltese: Ir-rakkomandazzjoni tas-CHMP imbagħad intbagħtet lill-Kummissjoni Ewropea, li adottatha b'deċiżjoni finali vinkolanti, valida fl-Unjoni Ewropea (UE) kollha, fl-20 ta' Diċembru 2013.
English: • Cardiovascular reaction reports associated with metoclopramide appeared to be very rare, and mainly associated with intravenous formulations given to patients with underlying risks for cardiac disease; they included hypotension, shock, syncope, bradycardia or atrioventricular block, and cardiac arrest.
Maltese: • Ir-rapporti ta' reazzjonijiet kardjovaskulari assoċjati ma' metoclopramide dehru li kienu rari ħafna, u assoċjati prinċipalment ma' formulazzjonijiet għal ġol-vina mogħtija lil pazjenti b'riskji eżistenti għall-mard tal-qalb; dawn kienu jinkludu pressjoni baxxa, xokk, sinkope, bradikardija jew imblokk atrijoventrikulari, u arrest kardijaku.
English: Elderly patients seemed to be more at risk of potentially irreversible tardive dyskinesia after longer term treatment.
Maltese: Il-pazjenti anzjani dehru li huma aktar f'riskju ta' diskinesija tardiva potenzjalment irriversibbli wara kura aktar fil-tul.
English: • Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
Maltese: • Id-dożi għal ġol-vini għandhom jingħataw bħala bolus bil-mod fuq perjodu ta' mill-anqas 3 minuti sabiex jitnaqqas ir-riskju ta' effetti avversi.
English: Metoclopramide-containing medicines have been authorised separately in individual Member States of the EU, with differing licensed indications such as nausea and vomiting of various causes (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders (conditions in which the normal passage of food through the gut is delayed).
Maltese: Il-mediċini li fihom metoclopramide kienu awtorizzati separatament fi Stati Membri individwali tal-UE, b'indikazzjonijiet illiċenzjati li jvarjaw bħal dardir u rimettar minħabba diversi kawżi (pereżempju wara kimoterapija jew radjoterapija kontra l-kanċer, wara operazzjoni, jew b'rabta mal-emigranja) u disturbi fil-motilità gastrointestinali (kundizzjonijiet li fihom il-passaġġ normali tal-ikel minn ġol-imsaren jiġi ttardjat.
English: • In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapyinduced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).
Maltese: • Fl-adulti, metoclopramide jibqa' indikat għall-prevenzjoni ta' dardir u rimettar wara operazzjoni (PONV), dardir u rimettar ikkawżat mir-radjoterapija u dardir u rimettar ittardjat (iżda mhux akut) ikkawżat mill-kimoterapija, u għall-kura sintomatika ta' dardir u rimettar inkluż dak assoċjat ma' emigranja akuta (fejn jista' jintuża wkoll sabiex itejjeb l-assorbiment tal-analġesiċi orali).
English: In addition, the maximum recommended doses in adults and children should be restricted, and higher strength formulations, including oral liquids in strengths above 1 mg/ml, removed from the market.
Maltese: Barra minn hekk, id-dożi massimi rakkomandati fl-adulti u t-tfal għandhom jiġu limitati, u l-formulazzjonijiet aktar b'saħħithom, inklużi l-likwidi orali f'qawwiet ogħla minn 1 mg/ml, jitneħħew mis-suq.
English: • Data on the use of metoclopramide in acute chemotherapy-induced nausea and vomiting (CINV) were limited and suggested that metoclopramide was inferior to 5-HT3 antagonists and required high doses which are associated with a greatly increased risk of adverse effects.
Maltese: • Id-dejta dwar l-użu ta' metoclopramide fid-dardir u r-rimettar akut ikkawżat mill-kimoterapija (CINV) kienet limitata u kienet tissuġġerixxi li metoclopramide kien inferjuri għall-antagonisti ta' 5HT3 u kien jeħtieġ dożi għoljin li huma assoċjati ma' riskju miżjud ħafna ta' effetti sekondarji.
English: The original review of metoclopramide was carried out at the request of the French medicines regulatory agency (ANSM), following continued safety concerns over side effects and concerns over efficacy.
Maltese: Ir-reviżjoni oriġinali ta' metoclopramide saret fuq talba tal-aġenzija regolatorja Franċiża dwar ilmediċini (ANSM), wara tħassib kontinwu relatat mas-sigurtà dwar l-effetti sekondarji u tħassib dwar leffikaċja.
English: Metoclopramide is a medicine that acts as an antiemetic (a medicine used to relieve nausea and vomiting) by acting on the part of the brain that triggers the sensation of sickness.
Maltese: Metoclopramide huwa mediċina li taġixxi bħala antiemetiku (mediċina użata biex ittaffi d-dardir u rrimettar) billi taħdem fuq il-parti tal-moħħ li tipproduċi s-sensazzjoni ta' dardir.
English: • The recommended maximum dose of the medicine has been lowered in adults to a total of 30 mg a day, and some high dose products will be removed from the market as they will no longer be needed.
Maltese: • Id-doża massima rakkomandata tal-mediċina ġiet imnaqqsa fl-adulti għal total ta' 30 mg filġurnata, u xi prodotti ta' doża għolja se jitneħħew mis-suq billi mhux se jkunu aktar meħtieġa.
English: Although it had been suggested adult doses would be difficult to give accurately as a 1 mg/ml solution because of the large number of drops required, there should be no problem if the Committee's recommendation were followed that liquid dose forms be given by a measuring device such as a graduated oral syringe.
Maltese: Għalkemm ġie ssuġġerit li d-dożi tal-adulti jkunu diffiċli li jingħataw b'mod preċiż bħala 1 mg/ml ta' soluzzjoni minħabba n-numru kbir ta' taqtiriet meħtieġa, ma għandu jkun hemm l-ebda problema jekk jiġu segwiti r-rakkomandazzjonijiet tal-Kumitat li l-forom likwidi tad-doża jingħataw bi strument tal-kejl bħal siringa orali gradwata.
English: • There was no evidence of consistent benefit in gastroparesis, gastro-oesophageal reflux disease and dyspepsia, all of which are chronic conditions requiring prolonged treatment which puts patients at risk of chronic neurological side effects.
Maltese: • Ma kien hemm ebda evidenza ta' benefiċċju konsistenti fil-gastroparesi, il-mard ta' rifluss gastroesofagali u d-dispepsja, li kollha huma kundizzjonijiet kroniċi li jeħtieġu kura fit-tul li tpoġġi lillpazjenti f'riskju ta' effetti sekondarji newroloġiċi kroniċi.
English: The review confirmed the well-known risks of neurological effects such as short-term extrapyramidal disorders, a group of involuntary movement disorders that may include muscle spasms (often involving the head and neck) and tardive dyskinesia (uncontrollable movements such as grimacing and twitching).
Maltese: Ir-reviżjoni kkonfermat irriskji magħrufin sewwa ta' effetti newroloġiċi bħad-disturbi ekstrapiramidali għal żmien qasir, grupp ta' disturbi ta' moviment involontarju li jistgħu jinkludu spażmi fil-muskoli (li ħafna drabi jinvolvu r-ras u lgħonq) u diskinesija tardiva (movimenti inkontrollabbli bħal tkerrih u tkagħwiġ).
English: Metoclopramide-containing medicines have been authorised by national procedures in all the Member States of the EU and have been available for many years under different trade names.
Maltese: Il-mediċini li fihom metoclopramide ġew awtorizzati permezz ta' proċeduri nazzjonali fl-Istati Membri kollha tal-UE u ilhom disponibbli għal bosta snin taħt ismijiet kummerċjali differenti.
English: • For both adults and children, metoclopramide should only be used for a maximum of 5 days.
Maltese: • Kemm fl-adulti kif ukoll fit-tfal, metoclopramide għandu jintuża biss għal mhux aktar minn 5 ijiem.
English: • Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
Maltese: • Minħabba r-rapporti rari ħafna ta' reazzjonijiet kardjovaskulari serji assoċjati ma' metoclopramide, b'mod partikolari permezz ta' għoti fil-vini, għandha ssir attenzjoni speċjali fil-popolazzjonijiet li huma probabbli li jkunu f'riskju akbar, fosthom l-anzjani, pazjenti b'disturbi fil-konduzzjoni talqalb, żbilanċ mhux korrett tal-elettroliti jew bradikardija, u dawk li jkunu qegħdin jieħdu mediċini oħra li huma magħrufin li jtawlu l-intervall QT.
English: • In order to minimise the risks of neurological and other adverse reactions, metoclopramide is now only licensed for short-term use (up to 5 days).
Maltese: • Sabiex jiġu minimizzati r-riskji ta' reazzjonijiet avversi newroloġiċi u oħrajn, metoclopramide issa huwa liċenzjat biss għall-użu għal żmien qasir (sa 5 ijiem).
English: Extrapyramidal disorders were more likely to occur after several doses, although usually early in treatment, and were less likely at slower infusion rates when metoclopramide was given intravenously.
Maltese: Id-disturbi ekstrapiramidali kienu aktar probabbli li jseħħu wara diversi dożi, għalkemm ġeneralment kmieni fil-kura, u kienu anqas probabbli b'rati ta' infużjoni aktar bil-mod meta metoclopramide ngħata filvini.
English: It is authorised for a variety of indications, which differ between EU Member States and is available in different formulations including as an injection (to be given into a vein or muscle), as tablets and oral liquids to be taken by mouth and as suppositories.
Maltese: Huwa awtorizzat għal varjetà ta' indikazzjonijiet, li jvarjaw bejn l-Istati Membri tal-UE u huwa disponibbli f'formulazzjonijiet differenti fosthom bħala injezzjoni (li għandha tingħata ġo vina jew f'muskolu), bħala pilloli u likwidi orali li għandhom jittieħdu mill-ħalq u bħala suppożitorji.
English: the Committee recommended use for the prevention and treatment of nausea and vomiting such as that associated with chemotherapy, radiotherapy, surgery and in the management of migraine.
Maltese: Fl-adulti, il-Kumitat irrakkomanda l-użu għallprevenzjoni u l-kura ta' dardir u rimettar bħal dak assoċjat ma' kimoterapija, radjoterapija, kirurġija u fil-ġestjoni tal-emigranja.
English: • Metoclopramide is known to sometimes cause short-term side effects on the nervous system that result in unintentional movements such as twitches and nervous tics and these are commoner in children and young people, and at high doses.
Maltese: • Metoclopramide huwa magħruf li xi kultant jikkawża effetti sekondarji għal żmien qasir fuq issistema nervuża li jwasslu għal movimenti involontarji bħal tkagħwiġ u tikks nervużi u dawn huma aktar komuni fit-tfal u ż-żgħażagħ, u b'dożi għoljin.
English: • Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.
Maltese: • Il-pazjenti li fil-preżent qegħdin jieħdu metoclopramide regolari għandhom ikollhom il-kura tagħhom riveduta f'appuntament mediku ta' rutina (mhux urġenti).
English: Given the known risk of neurological and other adverse effects, particularly in children and young people, the Committee concluded that the indications for metoclopramide should be restricted to those involving short-term use, at a maximum dose of 0.5 mg per kg body weight daily, and where there is sufficient evidence of efficacy.
Maltese: Minħabba r-riskju magħruf ta' effetti avversi newroloġiċi u oħrajn, b'mod partikolari fit-tfal u żżgħażagħ, il-Kumitat ikkonkluda li l-indikazzjonijiet għal metoclopramide għandhom ikunu limitati għal dawk li jinvolvu użu għal żmien qasir, f'doża massima ta' 0.5 mg għal kull kg tal-piż tal-ġisem kull ġurnata, u fejn ikun hemm evidenza suffiċjenti tal-effikaċja.