FrancophonIA/ELRC3.0 huggingface dataset:
English: In the absence of an established benefit, and taking into account the safety profile of metoclopramide, the Committee considered that the benefit-risk balance of metoclopramide in this indication is negative.
Croatian: Uslijed izostanka utvrđene koristi, i uzimajući u obzir sigurnosni profil metoklopramida, Povjerenstvo smatra da je omjer koristi i rizika metoklopramida u ovoj indikaciji negativan.
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).
Croatian: Iako postoje određeni podaci koji su indikativni za djelotvornost, u slučaju indikacije akutnog CINV-a potrebna je intravenozna primjena velikih doza metoklopramida, što donosi velike rizike, i to ne samo neuroloških nego i kardiovaskularnih nuspojava (uključujući i srčani zastoj).
English: • In view of the available data the Committee also concluded that the benefit-risk balance of metoclopramide-containing products:
Croatian: • S obzirom na dostupne podatke Povjerenstvo je također zaključilo da je omjer koristi i rizika lijekova koji sadrže metoklopramid:
English: The studies assessed seem to indicate that metoclopramide reduces gastric transit time, but this did not translate into a clinically meaningful outcome (time taken to complete the examination).
Croatian: Čini se da procijenjena ispitivanja ukazuju da metoklopramid skraćuje vrijeme prolaska kroz želudac, no to nije reflektirano u klinički smisleni ishod (vrijeme potrebno da se završi pregled).
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.
Croatian: S obzirom na naknadni CINV, Povjerenstvo je suglasno s prethodnim pregledom da su podaci vrlo skromni te da potvrđuju inferiornost metoklopramida u odnosu na antagoniste receptora 5-HT3.
English: Therefore, for these indications the Committee considered the benefitrisk balance to be positive.
Croatian: Stoga, u slučaju ovih indikacija Povjerenstvo smatra da je omjer koristi i rizika pozitivan.
English: Therefore the Committee considered that it is an important risk minimisation measure to restrict the maximum concentration of oral liquid formulations to 1 mg/ml, to ensure that clear instructions are given in the product information on posology for paediatric patients and that these oral liquid formulations are supplied with an appropriate measuring device such as a graduated oral syringe.
Croatian: Stoga Povjerenstvo smatra da je ograničavanje maksimalne koncentracije oralnih tekućih formulacija na 1 mg/ml važna mjera smanjivanja rizika kako bi se osiguralo da se u informacijama o lijeku navedu jasne upute za doziranje u pedijatrijskih bolesnika te da se ove oralne tekuće formulacije primjenjuju pomoću odgovarajućih mjernih proizvoda, poput graduirane oralne šprice.
English: It is possible that there is unintended misuse of the high concentration oral liquid formulations, leading to the inadvertent administration of doses higher than intended.
Croatian: Moguće je da postoji nehotična zlouporaba oralnih tekućih formulacija velike koncentracije što uzrokuje nehotičnu primjenu doza većih nego što je namjeravano.
English: For the indication adjuvant to surgical and radiological procedures, very limited efficacy data exists, and the existing data is not consistent.
Croatian: U slučaju indikacije adjuvans za kirurške i radiološke zahvate, postoje vrlo ograničeni podaci o djelotvornosti, te postojeći podaci nisu konzistentni.
English: There is sufficient evidence of efficacy of metoclopramide in the treatment of post-operative nausea and vomiting in the paediatric population.
Croatian: Postoji dovoljno dokaza djelotvornosti metoklopramida u liječenju mučnine i povraćanja nakon kirurškog zahvata u pedijatrijske populacije.
English: The data presented in support of the effect of metoclopramide in post-operative nausea and vomiting indicates that it has similar efficacy to other active substances authorised in this indication.
Croatian: Podaci dostavljeni u prilog djelotvornosti metoklopramida u slučaju postoperativne mučnine i povraćanja ukazuju da metoklopramid ima sličnu djelotvornost kao druge djelatne tvari odobrene u ovoj indikaciji.
English: Metoclopramide has long been associated with a risk of serious neurological adverse reactions such as acute extrapyramidal symptoms and irreversible tardive dyskinesia.
Croatian: Metoklopramid je dugo povezivan s rizikom od ozbiljnih neuroloških nuspojava poput akutnih ekstrapiramidalnih simptoma i ireverzibilne tardivne diskinezije.
English: Very limited data exists in support of the efficacy of metoclopramide in this indication, and the existing data is not consistent.
Croatian: Postoje vrlo ograničeni podaci koji podupiru djelotvornost metoklopramida u ovoj indikaciji, te postojeći podaci nisu konzistentni.
English: While endorsing the conclusions of the previous assessment, the CHMP also took note of the fact that, in particular for the treatment of delayed CINV which can be quite a debilitating condition, there are limited alternative treatments available for the paediatric population.
Croatian: Iako je potvrdio zaključke prethodnog pregleda, CHMP je također uočio činjenicu da za pedijatrijsku populaciju postoje ograničena alternativna liječenja, posebice za liječenje naknadnog CINV-a, koji može biti poprilično iscrpljujuće stanje.
English: • Gastroesophageal reflux disease (GORD) and dyspepsia
Croatian: • bolest gastroezofagealnog refluksa (GORD) i dispepsija
English: • Gastrointestinal motility disorders including gastroparesis
Croatian: • poremećaji gastrointestinalnog motiliteta, uključujući gastroparezu
English: According to the BNFc, in patients at low risk of emesis, pre-treatment with metoclopramide continued for up to 24 hours after chemotherapy is often effective.
Croatian: Sukladno BNFc-u, u bolesnika s malim rizikom od emezisa, najčešće je učinkovita prethodna terapija metoklopramidom koja se nastavlja do 24 sata nakon kemoterapije.
English: o Is not favourable for ‘gastrointestinal motility disorders, including gastroparesis'
Croatian: o nepovoljan za „poremećaje gastrointestinalnog motiliteta, uključujući gastroparezu”,
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.
Croatian: Podaci dostavljeni u vezi s prevencijom naknadnog CINV-a odnose se uglavnom na bolesnike koji zaprimaju umjerenu emetogenu kemoterapiju primjenom oralnog metoklopramida u dozama od 10-20 mg tri ili četiri puta na dan.
English: The majority of cases of accidental overdose occurred in children and involve the use of high concentration oral liquid formulations.
Croatian: Većina slučajeva slučajnog predoziranja nastupila je u djece, te je uključivala oralne formulacije velikih doza.
English: Adjuvant to surgical and radiological procedures
Croatian: Adjuvans za kirurške i radiološke postupke
English: The MAH disagreed with the CHMP recommendation for revocation of oral liquid formulations with concentration higher than 1 mg/ml.
Croatian: Nositelj odobrenja nije bio suglasan s preporukom CHMP-a za ukidanje oralnih tekućih formulacija s koncentracijom većom od 1 mg/ml.
English: Post marketing data is suggestive of unintended misuse of these formulations (oral drops, oral solution, syrup), approved under a range of concentrations and with a range of administration devices potentially leading to the inadvertent administration of doses higher than intended.
Croatian: Podaci nakon stavljanja lijeka u promet govore o nehotičnoj zlouporabi ovih formulacija (oralnih kapi, oralne otopine, sirupa) odobrenih u cijelom nizu koncentracija i uz cijeli niz lijekova za primjenu, što može potencijalno uzrokovati nehotičnu primjenu doza koje su više nego što je to predviđeno.
English: • Adjuvant to surgical and radiological procedures
Croatian: • adjuvans za kirurške i radiološke postupke
English: The studies assessed seem to indicate that metoclopramide reduces gastric transit time, but this did not affect the time taken to complete the examination.
Croatian: Čini se da procijenjena ispitivanja indiciraju da metoklopramid skraćuje vrijeme prolaska kroz želudac, no to nije utjecalo na vrijeme potrebno da bi se završio pregled.
English: Nausea and vomiting of other origins
Croatian: Mučnina i povraćanje drugog porijekla
English: For this indication and population, it is considered particularly important that oral formulations are available.
Croatian: Dostupnost oralnih formulacija smatra se posebnom važnom za ovu indikaciju i populaciju.
English: However, a few cases of extrapyramidal reactions in newborns exposed to metoclopramide before delivery have been identified.
Croatian: No, u novorođenčadi je identificirano nekoliko slučajeva ekstrapiramidalnih reakcija na metoklopramid prije poroda.
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.
Croatian: Nositelj odobrenja je naveo u svojim razlozima da je u djece koncentracija od 4 mg/ml prevelika za oralne tekuće otopine, te da postoji rizik od prekomjernog doziranja u ovoj populaciji.
English: The Committee noted this proposal from the MAH, but it also took note of the fact that, even if not specifically approved for paediatric use, high concentration oral liquid formulations are associated with risks in this population.
Croatian: Povjerenstvo je razmotrilo ovaj prijedlog nositelja odobrenja, no također je i uvažilo činjenicu da su oralne tekuće formulacije velikih koncentracija povezane s rizicima u ovoj populaciji, čak i ako nisu izričito odobrene za pedijatrijsku primjenu.
English: For this reason, the Committee considered that the benefit-risk balance of metoclopramide in this indication is negative and recommended that it is deleted.
Croatian: Iz tog razloga, Povjerenstvo smatra da je omjer koristi i rizika metoklopramida u ovoj indikaciji negativan i preporuča njegovo brisanje.
English: The data presented is indicative of the efficacy of metoclopramide in acute migraine induced nausea and vomiting based on its anti-emetic properties.
Croatian: Dostavljeni podaci indikativni su za djelotvornost metoklopramida u mučnine i povraćanja izazvanih akutnom migrenom na temelju antiemetogenih svojstava.
English: • Nausea and vomiting associated with migraine
Croatian: • mučnina i povraćanje povezani s migrenom
English: In conclusion, the Committee considered that oral liquid formulations with concentration 1 mg/ml are suitable for all situations mentioned, and that the availability of higher concentrations carries a risk of overdose in the paediatric population that is unlikely to be resolved by the proposed changes to the product information.
Croatian: Zaključno, Povjerenstvo smatra da su oralne tekuće formulacije koncentracije 1 mg/ml primjerene za sve navedene situacije, te da dostupnost većih koncentracija nosi sa sobom rizik od predoziranja u pedijatrijske populacije.
English: Thus, for both treatment of established post-operative nausea and vomiting and prevention of delayed CINV in children, the use of metoclopramide should be reserved as a second line option.
Croatian: Iz tog razloga, primjena metoklopramida u liječenju utvrđenih postoperativnih mučnina i povraćanja i prevencija naknadnog CINV-a u djece mora biti isključivo rezervirana kao odabir za drugu liniju liječenja.
English: • Nausea and vomiting of other origins
Croatian: • mučnina i povraćanje drugog porijekla
English: − oral liquid formulations with concentration higher than 1mg/ml
Croatian: − oralne tekuće formulacije u koncentracijama većima od 1mg/ml,
English: Efficacy data
Croatian: Podaci o djelotvornosti
English: Post-operative nausea and vomiting
Croatian: Postoperativna mučnina i povraćanje
English: Oral liquid formulations shall be supplied with an appropriate measuring device such as a graduated oral syringe.
Croatian: Oralne tekuće formulacije treba primjenjivati odgovarajućim proizvodom za mjerenje, primjerice graduiranom oralnom špricom.
English: Both gastroesophageal reflux disease and dyspepsia may be chronic diseases, and therefore existing data cannot be considered sufficient to support the use in these indications.
Croatian: S obzirom da bolest gastroezofagealnog refluksa i dispepsija mogu biti kronične bolesti, ne može se smatrati da postojeći podaci podržavaju primjenu u ovoj indikaciji.
English: Therefore the Committee considered that the benefit-risk balance of metoclopramide in these indications is negative.
Croatian: Stoga Povjerenstvo smatra da je omjer koristi i rizika metoklopramida u ovim indikacijama negativan.
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.
Croatian: Stoga Povjerenstvo smatra da se omjer koristi i rizika metoklopramida u prevenciji naknadnog CINV-a u pedijatrijske populacije može smatrati pozitivnim na temelju dugotrajnog iskustva u primjeni i kliničke potrebe za mogućnostima liječenja.
English: o Is not favourable for ‘prevention of acute chemotherapy induced nausea and vomiting'
Croatian: o nepovoljan za „prevenciju akutne mučnine i povraćanja izazvanih kemoterapijom”,
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:
Croatian: o nepovoljan za oralne tekuće formulacije u koncentracijama većima od 1mg/ml, o nepovoljan za parenteralne formulacije u koncentracijama većima od 5mg/ml, o nepovoljan za rektalne formulacije doziranja od 20 mg.
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.
Croatian: Većina podataka o djelotvornosti dostavljenih tijekom aktualnog postupka bila je već procijenjena u sklopu prethodnog pedijatrijskog postupka podjele posla prema članku 45.
English: Nausea and vomiting associated with migraine
Croatian: Mučnina i povraćanje povezani s migrenom
English: • In view of the available data the Committee concluded, subject to the amendments to the product information and implementation of the risk minimisation measures, that the benefitrisk balance of metoclopramide-containing products:
Croatian: • s obzirom na dostupne podatke Povjerenstvo je zaključilo, što podliježe izmjenama informacija o lijeku i primjeni mjera smanjivanja rizika, da je omjer koristi i rizika lijekova koji sadrže metoklopramid:
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.
Croatian: U slučaju oštećenja bubrega i funkcije jetre jednostavno se postiže preporučeno smanjenje doze od 50%, odnosno preporučeno smanjenje doze od 75% s tekućim formulacijama od 1 mg/ml.
English: For this particular indication in the paediatric population, both the parenteral and the oral pharmaceutical forms may be appropriate.
Croatian: Parenteralni i oralni farmaceutski oblici mogu biti primjereni za ovu posebnu indikaciju u pedijatrijskoj populaciji.
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.
Croatian: H2 receptora, za koje je jasno demonstriran pozitivan omjer koristi i rizika za akutnu i kroničnu primjenu.
English: Gastroesophageal reflux disease and dyspepsia
Croatian: Bolest gastroezofagealnog refluksa i dispepsije
English: o Is favourable in adults for ‘prevention of post-operative nausea and vomiting' (parenteral route only)
Croatian: o povoljan u odraslih bolesnika za „prevenciju postoperativnih mučnina i povraćanja” (samo parenteralni način primjene),
English: In this population, and based on the studies submitted, the clearance of metoclopramide has shown to be significantly impaired.
Croatian: Na temelju dostavljenih ispitivanja utvrđeno je da je čišćenje metoklopramida značajno narušeno u ovoj populaciji.
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)
Croatian: o povoljan u djece u dobi između 1 i 18 godina za „prevenciju postoperativnih mučnina i povraćanja” (samo parenteralni način primjene).
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.
Croatian: Zadržavanje ove indikacije već je preporučeno u prethodnom postupku podjele posla provedenom prema članku 45.
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.
Croatian: Na temelju dostavljenih podataka, čini se da je metoklopramid djelotvoran pri intravenoznoj primjeni u dozama u rasponu od 6 do 10 mg/kg/danu, ako se primjenjuje za izrazito emetogenu kemoterapiju.
English: o Is favourable in adults for ‘prevention of radiotherapy induced nausea and vomiting' (parenteral, oral and rectal routes)
Croatian: o povoljan u odraslih bolesnika za „prevenciju mučnine i povraćanja izazvanih kemoterapijom” (parenteralni, oralni i rektalni načini primjene),
English: Radiotherapy induced nausea and vomiting
Croatian: Mučnina i povraćanje izazvani radioterapijom
English: When administered for moderately emetic chemotherapy, doses ranging from 30 to 60mg appear to be effective.
Croatian: Rasponi doza od 30 do 60 mg čine se djelotvornima, ako se primjenjuje za umjerenu emetogenu terapiju.
English: o Is favourable in adults for ‘prevention of delayed chemotherapy induced nausea and vomiting' (oral and rectal routes)
Croatian: o povoljan u odraslih bolesnika za „prevenciju naknadne mučnine i povraćanja izazvanih kemoterapijom” (oralni i rektalni načini primjene),
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)
Croatian: o povoljan u djece u dobi između 1 i 18 godina za „prevenciju naknadne mučnine i povraćanja izazvanih kemoterapijom” (oralni i rektalni načini primjene),
English: Very limited high quality data exists in support of the efficacy of metoclopramide in the majority of the indications authorised in the European Union.
Croatian: Za većinu indikacija odobrenih u Europskoj uniji postoji vrlo ograničena količina visoko kvalitetnih podataka koji idu u prilog djelotvornosti metoklopramida.
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.
Croatian: • je Povjerenstvo zaključilo da je metoklopramid povezan s rizikom od ozbiljnih nuspojava, uključujući neurološke nuspojave poput ekstrapiramidalnih simptoma i ireverzibilne tardivne diskinezije, rizici se povećavaju prilikom primjene velikih doza ili tijekom dugotrajnog liječenja, a posebice za ekstrapiramidalne simptome te je rizik veći u djece nego u odraslih osoba,
English: In respect of dose adjustment for renal and hepatic impairment, while it is correct that oral liquid formulations offer advantage over solid pharmaceutical forms, higher concentrations (such as 4
Croatian: S obzirom na prilagođavanje doze za oštećenje bubrega i funkcije jetre, veće koncentracije (primjerice 4 mg/ml) nemaju dodatnih prednosti u odnosu na predloženu dozu od 1 mg/ml, iako je točno da oralne tekuće formulacije nude prednost u odnosu na krute farmaceutske oblike.
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.
Croatian: Nije moguće donijeti pozitivne zaključke o djelotvornosti metoklopramida u ovoj indikaciji na temelju tako ograničenih i nekonzistentnih podataka.
English: Chemotherapy induced nausea and vomiting
Croatian: Mučnina i povraćanje izazvani kemoterapijom
English: de la Industria 30
Croatian: Avda. de la Industria 30
English: 31 January 2020
Croatian: 31. siječnja 2020.
English: Such reactions may be allergic.
Croatian: Takve reakcije mogu biti alergijske.
English: Other subtypes were infrequently represented.
Croatian: Ostale podvrste nisu bile često zastupljene.
English: The majority of these events occurred in the first 4 cycles.
Croatian: Većina tih događaja nastupila je tijekom prva 4 ciklusa.
English: The pain can last from few days to up to 200 days.
Croatian: Bol može potrajati od nekoliko dana do 200 dana.
English: The safety and efficacy of olaratumab in children aged 0 to 18 years of age have not yet been established.
Croatian: Sigurnost i djelotvornost olaratumaba u djece u dobi od 0 do 18 godina nisu još ustanovljene.
English: The following information is intended for healthcare professionals only
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: This corresponds to a mean terminal half-life of approximately 11 days.
Croatian: To odgovara srednjoj vrijednosti terminalnog poluvijeka od približno 11 dana.
English: Your doctor will discuss these with you and will explain the risks and benefits of your treatment.
Croatian: Liječnik će o tome razgovarati s Vama i objasniti Vam rizike i koristi liječenja.
English: White blood cells are important for fighting infection.
Croatian: Bijele krvne stanice važne su za borbu protiv infekcija.
English: Below is a list of some typical symptoms associated with infusion reactions:
Croatian: U nastavku slijedi popis nekih tipičnih simptoma povezanih s reakcijama na infuziju:
English: What Lartruvo is and what it is used for
Croatian: Što je Lartruvo i za što se koristi
English: The median age was 58 years with 42 patients ≥ 65 years of age.
Croatian: Medijan dobi iznosio je 58 godina, a 42 bolesnika bila su u dobi od ≥ 65 godina.
English: 86.4 % of the patients were Caucasian.
Croatian: 86,4% bolesnika bili su bijelci.
English: Talk to your doctor or nurse immediately if the following applies to you (or you are not sure):
Croatian: Odmah se obratite svom liječniku ili medicinskoj sestri ako se sljedeće odnosi na Vas (ili niste sigurni):
English: No dose reductions other than those recommended for the general patient population are necessary.
Croatian: Nisu potrebna druga sniženja doze osim onih koja se preporučuju za opću populaciju bolesnika.
English: Lartruvo should not be given to patients under the age of 18 years because there is no information about how it works in this age group.
Croatian: Lartruvo se ne smije davati bolesnicima mlađima od 18 godina jer nema podataka o tome kako lijek djeluje u toj dobnoj skupini.
English: Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Croatian: Prije početka liječenja morate reći liječniku ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete.