FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Maltese: Għalhekk dan l-SPC, tikketta u l-fuljett ta' tagħrif mhux neċessarjament jirrapreżentaw il-kontenut attwali.
English: Transdermal use metering pump (PP/LDPE);
Maltese: (PP/LDPE);
English: Content (concentration)
Maltese: Il-pakkett Kontenut (konċentrazzjoni)
English: 1 metering pump
Maltese: 1 pompa tal-kejl
English: 30 sachets
Maltese: 30 qartas pompa talkejl
English: Retrieved from http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Articl e_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
Maltese: Miġjub minn http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Paediatric_Regulation/Assessment_Reports/Articl e_45_work-sharing/Metoclopramid_Art.45_PdAR_Update.pdf
English: Delayed CINV
Maltese: CINV ittardjat
English: Acute CINV
Maltese: CINV akut
English: Suppositories
Maltese: Suppożitorji
English: Rapporteur's public paediatric assessment report for paediatric studies submitted in accordance with Article 45 of Regulation (EC) No. 1901/2006, as amended, on Primperan (and others) / Metoclopramide (DE/W/007/pdWS/001), (2010).
Maltese: Rapport pubbliku ta' valutazzjoni pedjatrika tar-Rapporteur ippreżentat skont l-Artikolu 45 tar-Regolament (KE) Nru 1901/2006, kif emendat, dwar Primperan (u oħrajn) / Metoclopramide (DE/W/007/pdWS/001), (2010).
English: − rectal formulations dosed at 20mg
Maltese: − formulazzjonijiet rettali b'doża ta' 20mg
English: − parenteral formulations with concentration higher than 5mg/ml
Maltese: − formulazzjonijiet parenterali b'konċentrazzjoni ogħla minn 5mg/ml
English: Benefit-risk balance
Maltese: Bilanċ tal-benefiċċju-riskju
English: However, for patients with moderate to severe impairment (ClCr 15-60 ml/min), a 50% reduction remains appropriate.
Maltese: Madankollu, għal pazjenti b'indeboliment moderat għal sever (ClCr 1560 ml/min), tnaqqis ta' 50% jibqa' adegwat.
English: • Gastroesophageal reflux disease (GORD) and dyspepsia
Maltese: • Mard tar-rifluss gastroesofagali (GORD) u dispepsja
English: It is available in a variety of pharmaceutical forms (e.g. tablet, prolonged-release tablet, oral solution, suppository, solution for injection).
Maltese: Huwa disponibbli f'varjetà ta' forom farmaċewtiċi (eż. pillola, pillola li terħi l-mediċina bil-mod, soluzzjoni orali, suppożitorji, soluzzjoni għal injezzjoni).
English: • Post-operative nausea and vomiting (PONV)
Maltese: • Dardir u rimettar wara operazzjoni (PONV)
English: Gastrointestinal motility disorders
Maltese: Disturbi ta' motilità gastrointestinali
English: In its July 2013 opinion, the CHMP recommended that for all indications in adults the single dose is 10 mg, up to three times daily.
Maltese: Fl-opinjoni tiegħu ta' Lulju 2013, is-CHMP irrakkomanda li għall-indikazzjonijiet kollha fl-adulti, id-doża unika hija ta' 10 mg, sa tliet darbiet kuljum.
English: Both the 50% and the 75% dose reductions recommended, respectively, in hepatic and renal impairment are easily achievable with the 1 mg/ml liquid formulations.
Maltese: Kemm it-tnaqqis rakkomandat ta' 50% u ta' 75% fid-doża, rispettivament, f'indeboliment epatiku u renali faċilment jintlaħqu bil-formulazzjonijiet likwidi ta' 1 mg/ml.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for metoclopramide-containing medicinal products.
Maltese: • Il-Kumitat ikkunsidra l-proċedura taħt l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom metoclopramide.
English: • The Committee considered that metoclopramide is associated with a risk of serious adverse events, including neurological adverse events such as extrapyramidal symptoms and irreversible tardive dyskinesia.
Maltese: • Il-Kumitat ikkunsidra li metoclopramide huwa assoċjat ma' riskju ta' avvenimenti avversi serji, inkluż avvenimenti avversi newroloġiċi bħal sintomi ekstrapiramidali u diskinesija tardiva irriversibbli.
English: There appears to be no pharmacokinetic data on multiple-dosing, nor is there comparative data for different levels of hepatic impairment.
Maltese: Jidher li ma hemm l-ebda informazzjoni farmakokinetika dwar dożi multipli, u lanqas hemm dejta komparattiva għal-livelli differenti ta' indeboliment epatiku.
English: In addition to the neurological risk, there is also a risk of occurrence of cardiovascular adverse events including rare but potentially serious reactions such as bradycardia, atrioventricular block, cardiac arrest, mainly reported with the formulations for intravenous use.
Maltese: Minbarra r-riskju newroloġiku, hemm ukoll riskju ta' okkorrenza ta' avvenimenti avversi kardjovaskulari li jinkludu reazzjonijiet rari iżda potenzjalment serji bħal bradikardija, imblokk atrijoventrikulari, arrest kardijaku, prinċipalment irrapportati bil-formulazzjonijiet għall-użu ġol-vini.
English: Metoclopramide is a substituted benzamide used for its prokinetic and antiemetic properties.
Maltese: Metoclopramide huwa benzamide sostitut li jintuża għall-karatteristiċi prokinetiċi u antiemetiċi tiegħu.
English: The CHMP endorsed a communication i.e. Dear Healthcare Professional Communication (DHPC), to rapidly communicate the outcome of the present review.
Maltese: Is-CHMP approva komunikazzjoni jiġifieri Għażiż Professjonista tal-Kura tas-Saħħa (DHPC), biex ikun hemm komunikazzjoni rapida tal-eżitu tar-reviżjoni attwali.
English: o Is not favourable for ‘gastroesophageal reflux disease and dyspepsia' o Is not favourable for oral liquid formulations with concentration higher than 1mg/ml o Is not favourable for parenteral formulations with concentration higher than 5mg/ml o Is not favourable for rectal formulations dosed at 20mg Therefore, in accordance with Article 116 of Directive 2001/83/EC, the CHMP recommends:
Maltese: o Mhuwiex favorevoli għal formulazzjonijiet likwidi li jingħataw mill-ħalq b'konċentrazzjoni ogħla minn 1mg/ml o Mhuwiex favorevoli għal formulazzjonijiet parenterali b'konċentrazzjoni ogħla minn 5mg/ml o Mhuwiex favorevoli għal formulazzjonijiet rettali b'doża ta' 20mg
English: When administered for moderately emetic chemotherapy, doses ranging from 30 to 60mg appear to be effective.
Maltese: Meta jingħata għal kimoterapija moderatament emetika, dożi b'firxa minn 30 sa 60mg jidhru li huma effettivi.
English: The CHMP considered that formulations with concentration 1mg/ml are suitable for those patients that may prefer an oral liquid formulation to a solid pharmaceutical form.
Maltese: Is-CHMP ikkunsidra li formulazzjonijiet b'konċentrazzjoni ta' 1mg/ml huma adattati għalldawk il-pazjenti li jistgħu jippreferu formulazzjoni likwida orali għal forma farmaċewtika solida.
English: The review by Lee et al. provides a complete overview of the evidence of efficacy in diabetic gastroparesis.
Maltese: Ir-reviżjoni minn Lee et al. tipprovdi ħarsa ġenerali kompluta tal-evidenza tal-effikaċja fil-gastroparesi dijabetika.
English: Of note, the review by Jantunen et al. describes the low metoclopramide doses used (20-80mg) as ‘inadequate' and concludes that this may not be an appropriate comparator for 5-HT3 receptor antagonists.
Maltese: Ta' min jinnota, ir-reviżjoni minn Jantunen et al. tiddeskrivi d-dożi baxxi ta' metoclopramide wżati (2080mg) bħala ‘inadegwati' u tikkonkludi li dan jista' ma jkunx komparatur adegwat għal antagonisti tarriċettur ta' 5-HT3.
English: Metoclopramide has long been included in the British National Formulary for children (BNFc), which has been validated against emerging evidence, best practice guidelines and advice from a network of clinical experts.
Maltese: Metoclopramide ilu li ġie inkluż fil-British National Formulary għal tfal (BNFc), li kien ivvalidat ma' evidenza emerġenti, linji gwida dwar l-aħjar prattika u parir minn netwerk ta' esperti kliniċi.
English: On the basis of such limited and inconsistent data, it is not possible to conclude positively on the efficacy of metoclopramide in this indication.
Maltese: Abbażi ta' din linformazzjoni limitata u inkonsistenti, mhuwiex possibbli li ssir konklużjoni pożittiva dwar l-effikaċja ta' metoclopramide f'din l-indikazzjoni.
English: • Gastrointestinal motility disorders including gastroparesis
Maltese: • Disturbi ta' motilità gastrointestinali fosthom gastroparesi
English: Based on the risk of neurological and cardiovascular adverse events, as well as on the limited evidence of efficacy for all indications approved, the French Competent Authority triggered a referral under Article 31 of Directive 2001/83/EC and asked the CHMP to review the benefit-risk balance of metoclopramide-containing products in all populations, particularly in children and the elderly.
Maltese: Abbażi tar-riskju ta' avvenimenti avversi newroloġiċi u kardjovaskulari, kif ukoll abbażi tal-evidenza limitata ta' effikaċja għall-indikazzjonijiet kollha approvati, l-Awtorità Kompetenti Franċiża tat bidu għal riferiment skont l-Artikolu 31 tad-Direttiva 2001/83/KE u talbet lis-CHMP jirrevedi l-bilanċ talbenefiċċju-riskju ta' prodotti li fihom metoclopramide fil-popolazzjonijiet kollha, b'mod partikolari fittfal u l-anzjani.
English: It was noted by the Committee that a formulation of suppositories dosed at 20mg is currently approved in some Member States.
Maltese: Il-Kumitat innota li attwalment f'xi Stati Membri hemm approvata formulazzjoni ta' suppożitorji f'doża ta' 20mg.
English: For this indication, prophylaxis is usually initiated with a 5-HT3 receptor antagonist before chemotherapy and is followed by metoclopramide (usually oral) prescribed for a further 24-48 hours.
Maltese: Għal din l-indikazzjoni, il-profilassi normalment jinbeda b'antagonist tar-riċettur ta' 5-HT3 qabel il-kimoterapija u jiġi segwit minn metoclopramide (ġeneralment mill-ħalq) preskritt għal 24-48 siegħa addizzjonali.
English: • Contraindication in neonates;
Maltese: • Kontraindikazzjoni fit-trabi tat-twelid;
English: The available evidence in relation to CYP2D6 polymorphisms, when taken together with the data on interactions with CYP2D6 inhibitors, is suggestive that whilst CYP2D6 metabolism is not the main metabolic pathway for metoclopramide, the inhibition of this pathway due to polymorphisms or pharmacokinetic interactions with other drugs may potentially be clinically significant.
Maltese: L-evidenza disponibbli fir-rigward ta' polimorfiżmi ta' CYP2D6, meta tittieħed flimkien mad-dejta dwar interazzjonijiet ma' inibituri ta' CYP2D6, tissuġġerixxi li filwaqt li l-metaboliżmu ta' CYP2D6 mhuwiex ilpassaġġ metaboliku ewlieni għal metoclopramide, l-inibizzjoni ta' dan il-passaġġ minħabba polimorfiżmi jew interazzjonijiet farmakokinetiċi ma' mediċini oħra tista' potenzjalment tkun klinikament sinifikanti.
English: A paediatric worksharing procedure under Article 45 of Regulation (EC) No 1901/20061 to assess information from paediatric studies with metoclopramide has been concluded in 2010 with a recommendation that Member States should introduce the following changes to the product information:
Maltese: Proċedura ta' qsim tax-xogħol pedjatriku skont l-Artikolu 45 tar-Regolament (KE) Nru 1901/20061 biex tivvaluta informazzjoni minn studji pedjatriċi b'metoclopramide ġiet konkluża fl-2010 b'rakkomandazzjoni li l-Istati Membri għandhom jintroduċu t-tibdil li ġej lill-informazzjoni dwar ilprodott:
English: It possesses parasympathomimetic activity as well as being a dopamine-receptor (D2) antagonist with a direct effect on the chemoreceptor trigger zone.
Maltese: Għandu attività parasimpatomimetika u huwa wkoll antagonist tar-riċettur ta' dopamine (D2) b'effett dirett fuq iż-żona li tistimula l-kemoriċettur.
English: • The Committee noted that the available data do not support clinically significant efficacy for the indications which require long term use (‘gastrointestinal motility disorders including gastroparesis', ‘gastroesophageal reflux disease and dyspepsia') and for the indication ‘adjuvant to surgical and radiological procedures'.
Maltese: • Il-Kumitat innota li d-dejta disponibbli ma tappoġġjax l-effikaċja klinikament sinifikanti għallindikazzjonijiet li jeħtieġu użu fit-tul (‘disturbi ta' motilità gastrointestinali fosthom gastroparesi', ‘mard tar-rifluss gastroesofagali u dispepsja') u għall-indikazzjoni ‘aġġuvant għal proċeduri kirurġiċi u radjoloġiċi.
English: For therapeutic indications such as delayed CINV, prevention of RINV, prevention of PONV and symptomatic treatment of nausea and vomiting including migraine induced nausea and vomiting, data is indicative of efficacy at low doses (10mg, three times daily) which minimise the risk of serious neurological adverse reactions.
Maltese: Għal indikazzjonijiet terapewtiċi bħal CINV ittardjat, prevenzjoni ta' RINV, prevenzjoni ta' PONV u kura sintomatika ta' dardir u rimettar fosthom dardir u rimettar minħabba emigranja, id-dejta hija indikattiva ta' effikaċja f'dożi baxxi (10mg, tliet darbiet kuljum) li jimminimizza r-riskju ta' reazzjonijiet avversi serji newroloġiċi.
English: In order to minimise the risk of overdose in children, the MAH proposed to add the statement ‘for adults' in the label of oral liquid formulations with concentration > 1 mg/ml, and a contraindication in the paediatric population.
Maltese: Sabiex jiġi minimizzat ir-riskju ta' doża eċċessiva fit-tfal, il-MAH ippropona li tiżdied id-dikjarazzjoni ‘għalladulti' fit-tikketta tal-formulazzjonijiet likwidi li jingħataw mill-ħalq b'konċentrazzjoni ta' > 1 mg/ml, u kontraindikazzjoni fil-popolazzjoni pedjatrika.
English: After finalisation of the procedure under Article 45 of Regulation (EC) No 1901/2006, the Marketing Authorisation Committee of the French Competent Authority performed a national assessment of the benefit-risk balance of metoclopramide in children and decided, in October 2011, to extend the contraindication to all children under 18 years old for all formulations.
Maltese: Wara li l-proċedura skont l-Artikolu 45 tar-Regolament (KE) Nru 1901/2006 kienet finalizzata, ilKumitat għall-Awtorizzazzjonijiet għat-Tqegħid fis-Suq tal-Awtorità Kompetenti Franċiża wettaq valutazzjoni nazzjonali tal-bilanċ tal-benefiċċju-riskju ta' metoclopramide fit-tfal u ddeċieda, f'Ottubru 2011, li jestendi l-kontraindikazzjoni għat-tfal kollha taħt it-18-il sena għall-formulazzjonijiet kollha.
English: Based on data from both the Jantunen meta-analysis and the randomised clinical studies assessed, metoclopramide administered intravenously or orally is consistently inferior to 5-HT3 receptor antagonists for prevention of acute CINV for highly or moderately emetogenic chemotherapy.
Maltese: Abbażi ta' dejta kemm mill-meta-analiżi ta' Jantunen u l-istudji kliniċi randomizzati vvalutati, metoclopramide li jingħata ġol-vina jew mill-ħalq huwa konsistentement inferjuri għall-antagonisti tarriċettur ta' 5-HT3 għall-prevenzjoni ta' CINV akut għal kimoterapija emetoġenika ħafna jew moderata.
English: As such, a dose reduction of 75% would be necessary.
Maltese: Għalhekk, tnaqqis ta' 75% fid-doża ikun meħtieġ.
English: o Is favourable in adults for ‘prevention of post-operative nausea and vomiting' (parenteral route only)
Maltese: o Huwa favorevoli fl-adulti għall-‘prevenzjoni ta' dardir u rimettar wara operazzjoni' (rotta parenterali biss)
English: Data on the use of metoclopramide in the prevention of RINV is limited.
Maltese: Dejta dwar l-użu ta' metoclopramide fil-prevenzjoni ta' RINV hija limitata.
English: • Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV)
Maltese: • Dardir u rimettar minħabba kimoterapija jew radjuterapija (CINV jew RINV)
English: It also has serotonin-receptor (5-HT3) antagonist properties.
Maltese: Għandu wkoll karatteristiċi bħala antagonista tar-riċettur tas-serotonin (5-HT3).
English: Much of the available data is derived from trials designed to investigate newer agents such as the 5-HT3 receptor antagonists, and therefore do not always allow for a definite conclusion of the effect of metoclopramide due to the absence of a comparison to placebo.
Maltese: Ħafna mill-informazzjoni disponibbli ġejja minn provi ddisinjati biex jinvestigaw aġenti aktar ġodda bħall-antagonisti tar-riċettur ta' 5-HT3, u għalhekk mhux dejjem tippermetti konklużjoni definittiva dwar l-effett ta' metoclopramide minħabba n-nuqqas ta' tqabbil ma' plaċebo.
English: The data presented in relation to the prevention of delayed CINV is predominantly in patients receiving moderately emetogenic chemotherapy, using oral metoclopramide at doses of 10-20 mg three or four times a day.
Maltese: Id-dejta ppreżentata fir-rigward tal-prevenzjoni ta' CINV ittardjat hija prinċipalment fuq pazjenti li kienu qed jirċievu kimoterapija moderatament emetoġenika, bl-użu ta' metoclopramide li jingħata millħalq f'dożi ta' 10-20 mg tlieta jew erba' darbiet kuljum.
English: o Is favourable in adults for ‘prevention of radiotherapy induced nausea and vomiting' (parenteral, oral and rectal routes)
Maltese: o Huwa favorevoli fl-adulti għall-‘prevenzjoni ta' dardir u rimettar minħabba radjuterapija' (rotot parenterali, orali u rettali)
English: Overall summary of the scientific evaluation of metoclopramide-only containing medicinal products (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom metoclopramide biss (ara Anness I)
English: There is sufficient evidence of efficacy of metoclopramide in the treatment of post-operative nausea and vomiting in the paediatric population.
Maltese: Hemm biżżejjed evidenza tal-effikaċja ta' metoclopramide fil-kura ta' dardir u rimettar wara operazzjoni fil-popolazzjoni pedjatrika.
English: Metoclopramide can therefore be used during pregnancy, if clinically justified.
Maltese: Metoclopramide jista' għalhekk jintuża waqt it-tqala, jekk dan ikun klinikament iġġustifikat.
English: Gastroesophageal reflux disease and dyspepsia
Maltese: Dardir u rimettar assoċjati mal-emigranja
English: − oral liquid formulations with concentration higher than 1mg/ml
Maltese: − formulazzjonijiet likwidi li jingħataw mill-ħalq b'konċentrazzjoni ogħla minn 1mg/ml
English: Based on data submitted, when administered for highly emetic chemotherapy, metoclopramide appears to be effective by intravenous route at doses ranging from 6 to 10 mg/kg/day.
Maltese: Abbażi tad-dejta ppreżentata, meta jingħata għal kimoterapija emetika ħafna, metoclopramide jidher li huwa effettiv meta jingħata ġol-vina f'dożi b'firxa minn 6 sa 10 mg/kg/kuljum.
English: • Inclusion of specific warnings and precautions, mainly regarding the extrapyramidal adverse events.
Maltese: • L-inklużjoni ta' twissijiet u prekawzjonijiet speċifiċi, prinċipalment fir-rigward tal-avvenimenti avversi ekstrapiramidali.
English: While in some cases a high dose regimen (2-10mg/kg/day) is approved for prevention of acute RINV, studies have been conducted using 10 mg three times a day and the efficacy of this posology is not questioned.
Maltese: Filwaqt li f'ċerti każijiet, reġimen ta' doża għolja (2-10mg/kg/kuljum) huwa approvat għall-prevenzjoni ta' RINV akut, saru studji li użaw 10 mg tliet darbiet kuljum u l-effikaċja ta' din il-pożoloġija mhijiex ikkontestata.
English: The MAH considered in its grounds that for oral liquid solutions a concentration of 4 mg/ml is too high for children and that there is a risk of overdose in this population.
Maltese: Il-MAH ikkunsidra fir-raġunijiet tiegħu li għal soluzzjonijiet likwidi li jingħataw mill-ħalq konċentrazzjoni ta' 4 mg/ml hija għolja wisq għat-tfal u li hemm riskju ta' doża eċċessiva f'din il-popolazzjoni.
English: • Adjuvant to surgical and radiological procedures
Maltese: • Aġġuvant ma' proċeduri kirurġiċi u radjoloġiċi
English: o Is favourable in children between 1 and 18 years of age for ‘prevention of delayed chemotherapy induced nausea and vomiting, as second line option' (parenteral and oral routes)
Maltese: o Huwa favorevoli fit-tfal bejn sena u 18-il sena għall-‘prevenzjoni ta' dardir u rimettar ittardjat minħabba kimoterapija, bħala għażla tat-tieni linja' (rotot parenterali u orali)
English: Metoclopramide has long been associated with a risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia.
Maltese: Metoclopramide ilu assoċjat ma' riskju ta' reazzjonijiet avversi serji newroloġiċi bħal sintomi ekstrapiramidali akuti u diskinesija tardiva irriversibbli.
English: While it is difficult to conclude on absolute efficacy of metoclopramide in these individual settings, when taken together, the data are indicative of an effect on nausea and vomiting of different aetiologies.
Maltese: Filwaqt li huwa diffiċli li ssir konklużjoni dwar l-effikaċja assoluta ta' metoclopramide f'dawn is-sitwazzjonijiet individwali, meta tittieħed flimkien, id-dejta hija indikattiva ta' effett fuq dardir u rimettar ta' etjoloġiji differenti.
English: Metoclopramide has been authorised in the European Union since the 1960's and marketing authorisations currently exist in all Member States as well as in Norway and Iceland.
Maltese: Metoclopramide ilu awtorizzat fl-Unjoni Ewropea sa mis-sittinijiet u l-awtorizzazzjonijiet għat-tqegħid fis-suq attwalment jeżistu fl-Istati Membri kollha kif ukoll fin-Norveġja u l-Islanda.
English: This therapeutic alternative may be of particular relevance due to the association between prolonged use of 5-HT3 receptor antagonists and adverse effects of constipation and headache, which may be severe and poorly tolerated.
Maltese: Din l-alternattiva terapewtika tista' tkun ta' rilevanza partikolari minħabba l-assoċjazzjoni bejn l-użu fit-tul ta' antagonisti tar-riċettur ta' 5-HT3 u l-effetti avversi ta' stitikezza u uġigħ ta' ras, li jistgħu jkunu severi u mhux ittollerati sew.
English: o Is favourable in children between 1 and 18 years of age for ‘treatment of established post-operative nausea and vomiting, as second line option' (parenteral route only)
Maltese: o Huwa favorevoli fit-tfal bejn sena u 18-il sena għall-‘kura ta' dardir u rimettar stabbiliti wara operazzjoni, bħala għażla tat-tieni linja' (rotta parenterali biss)
English: • In view of the available data the Committee also concluded that the benefit-risk balance of metoclopramide-containing products:
Maltese: • Fid-dawl tad-dejta disponibbli l-Kumitat ikkonkluda wkoll li l-bilanċ tal-benefiċċju-riskju ta' prodotti li fihom metoclopramide:
English: For the majority of the indications, there is clinical data evaluating the efficacy of the posology of 10 mg three times a day.
Maltese: Għall-maġġoranza tal-indikazzjonijiet, hemm dejta klinika li tevalwa l-effikaċja tal-pożoloġija ta' 10 mg tliet darbiet kuljum.
English: For the indication acute CINV, while there is some data indicative of efficacy, it requires the intravenous use of high doses of metoclopramide which carry higher risks not only of neurological but also cardiovascular adverse reactions (including cardiac arrest).
Maltese: Għall-indikazzjoni CINV akut, filwaqt li hemm xi dejta indikattiva tal-effikaċja, jeħtieġ l-użu ta' dożi għoljin ta' metoclopramide ġol-vini li jġorr riskji ogħla mhux biss ta' reazzjonijiet avversi newroloġiċi iżda wkoll kardjovaskulari (inkluż arrest kardijaku).
English: Combination products are also approved, but this procedure focused on the assessment of the monocomponent products.
Maltese: Prodotti ta' kombinazzjoni huma wkoll approvati, iżda din ilproċedura ffokat fuq il-valutazzjoni tal-prodotti monokomponenti.
English: o Is favourable in adults for ‘prevention of delayed chemotherapy induced nausea and vomiting' (oral and rectal routes)
Maltese: o Huwa favorevoli fl-adulti għall-‘prevenzjoni ta' dardir u rimettar ittardjat minħabba kimoterapija' (rotot orali u rettali)
English: While metoclopramide was found to improve gastric emptying and relieve symptoms in diabetic and idiopathic gastroparesis in short term treatment when compared to placebo, no consistent benefit was observed in the long term.
Maltese: Filwaqt li metoclopramide nstab li jtejjeb it-tbattil gastriku u jtaffi s-sintomi f'gastroparesi dijabetiċi u idjopatiċi f'kura fuq żmien qasir meta mqabbel ma' plaċebo, ma kien osservat l-ebda benefiċċju konsistenti fit-tul.