FrancophonIA/ELRC3.0 huggingface dataset:
English: The majority of the efficacy data submitted during the current procedure had already been assessed during the previous paediatric worksharing procedure under Article 45 of Regulation (EC) No 1901/2006, and the new data did not add relevant new elements to the previous assessment.
Slovenian: Večino podatkov o učinkovitosti, predloženih med tem postopkom, so že ocenili med prejšnjim pediatričnim postopkom delitve dela v skladu s členom 45 Uredbe (ES) št. 1901/2006, novi podatki pa niso dali pomembnih novih informacij, ki bi vplivale na navedeno oceno.
English: • Inclusion of specific warnings and precautions, mainly regarding the extrapyramidal adverse events.
Slovenian: • posebna opozorila in previdnostne ukrepe, predvsem v zvezi z ekstrapiramidnimi neželenimi dogodki.
English: For this indication and population, it is considered particularly important that oral formulations are available.
Slovenian: Za to indikacijo in populacijo je zlasti pomembno, da so na voljo pripravki za peroralno uporabo.
English: The exception is the treatment of established post-operative nausea and vomiting, which had already been recommended to be maintained in a previous worksharing procedure under Article 45 of Regulation (EC) No 1901/2006.
Slovenian: Izjema je indikacija zdravljenje nastale slabosti in bruhanja po operaciji, za katero so že v prejšnjem postopku delitve dela v skladu s členom 45 Uredbe (ES) št. 1901/2006 priporočili, da se ohrani.
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.
Slovenian: Po zaključku postopka v skladu s členom 45 Uredbe (ES) št. 1901/2006 je Odbor za dovoljenja za promet z zdravilom francoskega nacionalnega pristojnega organa pripravil nacionalno oceno razmerja med tveganji in koristmi metoklopramida pri otrocih in se oktobra 2011 odločil, da bo kontraindikacijo za vse pripravke razširil na vse otroke, mlajše od 18 let.
English: Therefore use of metoclopramide should be reserved for situations where alternative treatments have not been effective or cannot be administered.
Slovenian: Zato je treba uporabo metoklopramida omejiti na primere, ko druge možnosti zdravljenja niso učinkovite ali pa jih ni mogoče uporabiti.
English: For the majority of the indications, there is clinical data evaluating the efficacy of the posology of 10 mg three times a day.
Slovenian: Za večino indikacij obstajajo klinični podatki o učinkovitosti odmerjanja 10 mg trikrat na dan.
English: The published epidemiological studies conducted in different countries on the safety of metoclopramide use during pregnancy consistently showed the absence of association between exposure during pregnancy and risk of major congenital malformations.
Slovenian: Objavljene epidemiološke študije o varnosti uporabe metoklopramida med nosečnostjo, ki so bile opravljene v različnih državah, dosledno kažejo, da ne obstaja povezava med izpostavljenostjo med nosečnostjo in tveganjem za večje kongenitalne malformacije.
English: • The Committee considered the totality of the data submitted in support of the efficacy and safety of metoclopramide.
Slovenian: • odbor je pregledal vse predložene podatke, ki naj bi dokazovali učinkovitost in varnost metoklopramida;
English: However, there are no known unique differences in the mechanism of RINV when compared to CINV, and therefore it could be appropriate to extrapolate data from CINV to RINV.
Slovenian: Vendar pa med mehanizmoma RINV in CINV ni nobenih znanih značilnih razlik, zato bi lahko bila primerna ekstrapolacija podatkov o CINV na RINV.
English: In the absence of such data, no specific recommendation can be issued for lower levels of hepatic impairment.
Slovenian: Zaradi odsotnosti teh podatkov ni mogoče izdati posebnih priporočil za nižje stopnje okvare jeter.
English: Established renal failure is defined as ClCr < 15 ml/min, therefore this cut-off should be included in any dosing recommendations.
Slovenian: Končna odpoved ledvic je opredeljena z očistkom kreatinina < 15 ml/min, zato mora biti ta mejna vrednost vključena v vsa priporočila za odmerjanje.
English: However, it also took into consideration the recommendations of 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.
Slovenian: Vendar pa je upošteval tudi priporočila iz priročnika British National Formulary for children (BNFc), ki je bil potrjen na podlagi novih dokazov, smernic za najboljšo prakso in nasvetov, ki jih je dala mreža kliničnih strokovnjakov.
English: If an appropriate measuring device is used as recommended, there will be no need to count drops.
Slovenian: Ob uporabi primernega odmernega pripomočka v skladu s priporočili ne bo potrebe po štetju kapljic.
English: For this particular indication in the paediatric population, both the parenteral and the oral pharmaceutical forms may be appropriate.
Slovenian: Za to indikacijo pri pediatrični populaciji sta primerni parenteralna in peroralna farmacevtska oblika.
English: Data on the dosing seems to indicate that individual doses of metoclopramide higher than 10mg do not result in increased efficacy.
Slovenian: Podatki o odmerjanju kažejo, da posamezni odmerki metoklopramida, ki so večji od 10 mg, ne izboljšajo njegove učinkovitosti.
English: Metoclopramide is a substituted benzamide used for its prokinetic and antiemetic properties.
Slovenian: Metoklopramid je substituiran benzamid, ki se uporablja zaradi svojih prokinetičnih in antiemetičnih lastnosti.
English: However the safety data seems to indicate that methaemoglobinaemia occurs almost exclusively in children, and that children are also at higher risk of serious neurological adverse reactions.
Slovenian: Vendar pa podatki o varnosti kažejo, da se metemoglobinemija pojavlja skoraj izključno pri otrocih in da pri njih obstaja tudi večje tveganje za resne nevrološke neželene učinke.
English: There appears to be no pharmacokinetic data on multiple-dosing, nor is there comparative data for different levels of hepatic impairment.
Slovenian: Kot kaže, ni na voljo nobenih farmakokinetičnih podatkov o večkratnem odmerjanju ali primerjalnih podatkov za različne stopnje okvare jeter.
English: While in some cases higher doses may be currently authorised, with the exception of acute CINV the existing data does not clearly indicate that higher doses result in increased efficacy.
Slovenian: Čeprav so trenutno v nekaterih primerih odobreni večji odmerki, obstoječi podatki razen za akutno CINV ne kažejo, da bi bili večji odmerki zagotovo učinkovitejši.
English: It is also noted that there are other well-established agents available for this indication, including proton pump inhibitors and H2 receptor antagonists, for which a positive benefit-risk balance has been clearly demonstrated for acute and chronic use.
Slovenian: Prav tako je bilo ugotovljeno, da so za to indikacijo na voljo druge dobro uveljavljene učinkovine, vključno z zaviralci protonske črpalke in antagonisti receptorjev H2, za katere je bilo jasno dokazano pozitivno razmerje med tveganji in koristmi pri akutnem in kroničnem zdravljenju.
English: Considering the recommendation for posology to be defined as 10mg three times a day and the fact that this pharmaceutical form does not allow for adjustment of dose, the Committee considered that the benefit-risk balance of the suppositories dosed at 20mg is negative.
Slovenian: Ob upoštevanju priporočila za odobritev odmerjanja 10 mg trikrat na dan in dejstva, da ta farmacevtska oblika ne omogoča prilagajanja odmerka, je odbor menil, da je razmerje med tveganji in koristmi svečk v odmerku 20 mg negativno.
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.
Slovenian: Čeprav je težko ugotoviti, kakšna je absolutna učinkovitost metoklopramida v teh posameznih okoliščinah, če jih upoštevamo skupaj, podatki kažejo, da ima učinek na slabost in bruhanje z različno etiologijo.
English: For the indications gastrointestinal motility disorders including gastroparesis and gastroesophageal reflux disease and dyspepsia, the Committee noted that these are essentially chronic conditions for which long term use is often required.
Slovenian: Pri indikacijah motnje gibljivosti prebavil, vključno z gastroparezo, in gastroezofagealna refluksna bolezen in dispepsija je odbor upošteval, da gre pravzaprav za kronične bolezni, ki pogosto zahtevajo dolgoročno zdravljenje.
English: However, the risk of serious neurological adverse reactions is increased.
Slovenian: Na drugi strani pa povečajo tveganje za resne nevrološke neželene učinke.
English: It is available in a variety of pharmaceutical forms (e.g. tablet, prolonged-release tablet, oral solution, suppository, solution for injection).
Slovenian: Na voljo je v več različnih farmacevtskih oblikah (npr. v obliki tablete, tablete s podaljšanim sproščanjem, peroralne raztopine, svečke in raztopine za injiciranje).
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.
Slovenian: Ker je v nekaterih primerih za preprečevanje akutne RINV odobrena uporaba visokih odmerkov (210 mg/kg/dan), študije pa so bile izvedene z odmerkom 10 mg trikrat na dan, učinkovitost tega odmerjanja ni vprašljiva.
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.
Slovenian: V okviru mnenja, ki ga je odbor CHMP sprejel julija 2013, je priporočil, naj za vse indikacije pri odraslih enkraten odmerek znaša 10 mg največ trikrat na dan.
English: There is no data submitted to support the efficacy of metoclopramide in the required treatment duration, but there is evidence that the above mentioned risks are increased with prolonged treatment.
Slovenian: Predloženi niso bili nobeni podatki, ki bi dokazovali učinkovitost metoklopramida pri potrebnem trajanju zdravljenja, obstajajo pa dokazi, da se z dolgotrajnim zdravljenjem povečajo zgoraj navedena tveganja.
English: It possesses parasympathomimetic activity as well as being a dopamine-receptor (D2) antagonist with a direct effect on the chemoreceptor trigger zone.
Slovenian: Deluje kot parasimpatomimetik, hkrati pa je tudi antagonist dopaminskih receptorjev (D2) z neposrednim učinkom na kemoreceptorske prožilne cone.
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.
Slovenian: Poleg tveganja za nevrološke neželene učinke obstaja tudi tveganje za pojav srčno-žilnih neželenih dogodkov, vključno z redkimi, vendar potencialno resnimi neželenimi učinki, kot so bradikardija, atrioventrikularni blok in zastoj srca, o katerih so večinoma poročali pri uporabi pripravkov za intravensko uporabo.
English: • The variation to the terms of the marketing authorisation for the remaining metoclopramidecontaining medicinal products referred to in Annex I, for which the relevant sections of the summary of product characteristics and package leaflet are set out in annex III of the CHMP opinion.
Slovenian: • spremembo pogojev dovoljenja za promet z zdravilom za druga zdravila, ki vsebujejo metoklopramid in so navedena v Prilogi I, skladno z besedili ustreznih poglavij povzetka glavnih značilnosti zdravila in navodila za uporabo, opredeljenimi v Prilogi III k mnenju odbora CHMP.
English: Although serious cardiovascular reactions have been reported with metoclopramide (mainly associated to the intravenous administration), no new significant signals have been identified.
Slovenian: Čeprav so pri uporabi metoklopramida poročali o resnih srčno-žilnih neželenih učinkih (ki so bili pretežno povezani z intravensko uporabo), niso bili ugotovljeni nobeni novi pomembni znaki.
English: This posology applies to all oral formulations and is not dependent on body weight.
Slovenian: To odmerjanje velja za vse pripravke za peroralno uporabo in ni odvisno od telesne mase.
English: In addition, due to its prokinetic properties, metoclopramide may also play a role when given orally in combination with analgesics.
Slovenian: Poleg tega bi metoklopramid zaradi svojih prokinetičnih lastnosti lahko imel pomembno vlogo tudi ob peroralni uporabi v kombinaciji z analgetiki.
English: • The Committee considered that the risk of serious neurological adverse events can be minimised by using lower doses of metoclopramide and limiting treatment duration.
Slovenian: • odbor je menil, da je tveganje za resne nevrološke neželene dogodke mogoče zmanjšati z uporabo manjših odmerkov metoklopramida in omejitvijo trajanja zdravljenja.
English: Annex II Scientific conclusions and grounds for revocation / variation to the terms of the Marketing Authorisations
Slovenian: Znanstveni zaključki in podlaga za razveljavitev/spremembo pogojev dovoljenj za promet z zdravilom
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'.
Slovenian: • odbor je upošteval, da razpoložljivi podatki ne podpirajo klinično pomembne učinkovitosti zdravila pri indikacijah, ki zahtevajo dolgoročno uporabo („motnje gibljivosti prebavil, vključno z gastroparezo“, „gastroezofagealna refluksna bolezen in dispepsija“), in pri indikaciji „dodatek pri kirurških in radioloških posegih“;
English: The risks are increased when using high doses or during longterm treatment, and in particular for extrapyramidal symptoms the risk is higher in children than in adults.
Slovenian: Tveganja se povečajo ob uporabi visokih odmerkov ali dolgotrajnem zdravljenju, poleg tega pa je zlasti tveganje za ekstrapiramidne simptome večje pri otrocih kot pri odraslih;
English: The almost totality of the data relates to the intravenous administration of metoclopramide, and in the majority of the studies assessed, a 10 mg dose was used.
Slovenian: Skoraj vsi podatki se nanašajo na intravensko uporabo metoklopramida, poleg tega pa so v večini ocenjenih študij uporabili odmerek 10 mg.
English: Gastroparesis is often a chronic disorder, for which long term treatment is necessary, therefore existing data cannot be considered supportive of the use in this indication.
Slovenian: Gastropareza je pogosto kronična bolezen, pri kateri je potrebno dolgoročno zdravljenje, zato z obstoječimi podatki ni mogoče upravičiti uporabe pri tej indikaciji.
English: In its grounds for re-examination, the MAH also argued that in case of nausea drops are easier to swallow than tablets.
Slovenian: Pri utemeljitvi zahteve za ponoven pregled je imetnik dovoljenja za promet z zdravilom trdil tudi, da je v primeru slabosti kapljice lažje pogoltniti kot tablete.
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.
Slovenian: Na podlagi tako omejenih in nedoslednih podatkov ni mogoče podati nedvoumnih zaključkov o učinkovitosti metoklopramida pri tej indikaciji.
English: With regards to the delayed CINV, the Committee agreed with the previous assessment that the data is limited and shows that metoclopramide is inferior to 5-HT3 receptor antagonists.
Slovenian: V zvezi z zapoznelo CINV se je odbor strinjal s prejšnjo oceno, da so podatki omejeni in kažejo, da je metoklopramid slabši od antagonistov receptorjev 5-HT3.
English: Using a device such as a graduated oral syringe may even be more convenient than counting drops and it ensures accurate and reproducible dosing in any situation, including when doses are reduced due to renal or hepatic impairment.
Slovenian: Uporaba pripomočka, kot je graduirana brizga za peroralno dajanje, je lahko celo priročnejša od štetja kapljic, hkrati pa zagotavlja točno in ponovljivo odmerjanje v vseh okoliščinah, vključno kadar so odmerki manjši zaradi okvare ledvic ali jeter.
English: It also has serotonin-receptor (5-HT3) antagonist properties.
Slovenian: Prav tako deluje kot antagonist serotoninskih receptorjev (5-HT3).
English: • The Committee also noted that the data supporting the therapeutic indication ‘prevention of acute chemotherapy induced nausea and vomiting' is indicative of efficacy but requires the use of high doses.
Slovenian: • odbor je prav tako upošteval, da podatki v podporo terapevtski indikaciji „preprečevanje akutne slabosti in bruhanja zaradi kemoterapije“ kažejo na učinkovitost zdravila, vendar le pri uporabi visokih odmerkov;
English: The slow administration of intravenous doses as a slow bolus over at least 3 minutes lowers the risk of all dystonic reactions.
Slovenian: Počasna intravenska titracija odmerkov v obliki počasnega bolusa, ki traja najmanj 3 minute, zmanjša tveganje za distonične reakcije.
English: • Oral liquid formulations intended to be used in children must be supplied with an appropriate measuring device (e.g. graduated oral syringe) to ensure accurate measuring of the dose and avoid accidental overdosing.
Slovenian: • tekočim pripravkom za peroralno uporabo, namenjenim za uporabo pri otrocih, mora biti priložen ustrezen odmerni pripomoček (npr. graduirana brizga za peroralno dajanje), da se zagotovi natančno odmerjanje zdravila in prepreči nenamerno preveliko odmerjanje.
English: • Only the intravenous formulations remain approved for use in paediatric patients >1 year of age, and only for the indication ‘treatment of postoperative nausea and vomiting';
Slovenian: • za uporabo pri pediatričnih bolnikih, starejših od 1 leta, ostanejo odobreni samo intravenski pripravki, in sicer samo za indikacijo „zdravljenje slabosti in bruhanja po operaciji“;
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.
Slovenian: Razpoložljivi dokazi v zvezi s polimorfizmi CYP2D6 skupaj s podatki o medsebojnem delovanju z zaviralci CYP2D6 kažejo, da bi lahko bilo kljub dejstvu, da presnova s CYP2D6 ni glavna presnovna pot metoklopramida, zaviranje te presnovne poti zaradi polimorfizmov ali farmakokinetičnih interakcij z drugimi zdravili klinično pomembno.
English: Therefore, the Committee considered that the available evidence does not support the assumption that oral liquid formulations have a faster onset of action than tablets.
Slovenian: Odbor je zato menil, da razpoložljivi podatki ne podpirajo domneve, da začnejo tekoči pripravki za peroralno uporabo delovati hitreje kot tablete.
English: Metoclopramide crosses the blood-brain barrier and is associated to extrapyramidal disorders and other serious neurological adverse events, which are of particular concern in children.
Slovenian: Metoklopramid prehaja skozi krvno-možgansko pregrado in je povezan z ekstrapiramidnimi motnjami ter drugimi resnimi nevrološkimi neželenimi dogodki, ki so posebno zaskrbljujoči pri otrocih.
English: As such, based on the data assessed, the relative efficacy must be assessed in comparison to the 5-HT3 receptor antagonists.
Slovenian: Zato je treba na podlagi ocenjenih podatkov oceniti relativno učinkovitost v primerjavi z antagonisti receptorjev 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.
Slovenian: Metoklopramid je že dolgo vključen v priročnik British National Formulary for children (BNFc), ki je bil potrjen na podlagi novih dokazov, smernic za najboljšo prakso in nasvetov, ki jih je dala mreža kliničnih strokovnjakov.
English: Combination products are also approved, but this procedure focused on the assessment of the monocomponent products.
Slovenian: Odobrena so tudi kombinirana zdravila, vendar so se v tem postopku ocenjevala samo enokomponentna zdravila.
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.
Slovenian: Ta terapevtska možnost bi lahko bila še posebno pomembna, ker je daljša uporaba antagonistov receptorjev 5-HT3 povezana z neželenima učinkoma zaprtjem in glavobolom, ki sta lahko huda in ju bolniki slabo prenašajo.
English: From the data assessed, it appears that the risk of acute dystonias is increased when using high doses, and is higher in children than in adults.
Slovenian: Ocenjeni podatki kažejo, da se tveganje za akutne distonije poveča pri uporabi visokih odmerkov in da je tveganje večje pri otrocih kot pri odraslih.
English: Given the limited therapeutic alternatives for the paediatric population in this setting, it may be acceptable that delayed CINV is retained as a second line option despite the lack of robust efficacy data.
Slovenian: Glede na omejene terapevtske možnosti za pediatrično populacijo v teh okoliščinah bi lahko bilo sprejemljivo, da bi se metoklopramid kljub pomanjkanju trdnih podatkov o učinkovitosti ohranil kot zdravilo druge izbire za zapoznelo CINV.
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.
Slovenian: Pri tem je pomembno dodati, da so Jantunen in drugi v pregledu navedli, da so bili uporabljeni nizki odmerki metoklopramida (20-80 mg) „neustrezni“, in zaključili, da morda niso primerni za primerjavo z antagonisti receptorjev 5-HT3.
English: Therefore the Committee considered that, based on long term experience of use and the clinical need for treatment options in the paediatric population, the benefit-risk balance of metoclopramide for the prevention of delayed CINV in the paediatric population can be considered positive.
Slovenian: Zato je odbor menil, da je zaradi dolgoletnih izkušenj z uporabo in klinične potrebe po možnostih zdravljenja pri pediatrični populaciji razmerje med tveganji in koristmi metoklopramida za preprečevanje zapoznele CINV pri pediatrični populaciji pozitivno.
English: • Chemotherapy or radiotherapy induced nausea and vomiting (CINV or RINV)
Slovenian: • slabost in bruhanje zaradi kemoterapije ali radioterapije (CINV ali RINV);
English: It is noted that the majority of cases involves the use of high concentration oral liquid formulations, which are currently approved under a number of different formulations (oral drops, oral solution, syrup) with very different concentrations and a range of administration devices.
Slovenian: Ugotovljeno je bilo, da je bila večina primerov povezana z uporabo močno koncentriranih tekočih pripravkov za peroralno uporabo, ki so trenutno odobreni v več različnih oblikah (peroralne kapljice, peroralna raztopina, sirup) z zelo različnimi koncentracijami in vrsto pripomočkov za aplikacijo.