FrancophonIA/ELRC3.0 huggingface dataset:
English: What measures are being taken to ensure the safe and effective use of Pregabalin Mylan Pharma?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Pregabalin Mylan Pharma?
English: For more information about treatment with Pregabalin Mylan Pharma, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Pregabalin Mylan Pharma pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Pregabalin Mylan Pharma is a ‘generic medicine'.
Croatian: Pregabalin Mylan Pharma je „generički lijek”.
English: For practical information about using Pregabalin Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Pregabalin Mylan Pharma bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: The Committee recommended that Pregabalin Mylan Pharma be approved for use in the EU.
Croatian: Odbor je preporučio izdavanje odobrenja za stavljanje lijeka Pregabalin Mylan Pharma u promet u EU-u.
English: What are the benefits and risks of Pregabalin Mylan Pharma?
Croatian: Koje su koristi i rizici od lijeka Pregabalin Mylan Pharma?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Pregabalin Mylan Pharma on 25 June 2015.
Croatian: Europska komisija izdala je odobrenje za stavljanje lijeka Pregabalin Mylan Pharma u promet koje je na snazi na prostoru Europske unije od 25. lipnja 2015.
English: What is Pregabalin Mylan Pharma and what is it used for?
Croatian: Što je Pregabalin Mylan Pharma i za što se koristi?
English: Other information about Pregabalin Mylan Pharma
Croatian: Ostale informacije o lijeku Pregabalin Mylan Pharma
English: It is not intended to provide practical advice on how to use Pregabalin Mylan Pharma.
Croatian: Svrha sažetka nije davati praktične savjete o primjeni lijeka Pregabalin Mylan Pharma.
English: Why is Pregabalin Mylan Pharma approved?
Croatian: Zašto je Pregabalin Mylan Pharma odobren?
English: Pregabalin Mylan Pharma contains the active substance pregabalin.
Croatian: Pregabalin Mylan Pharma sadrži djelatnu tvar pregabalin.
English: How is Pregabalin Mylan Pharma used?
Croatian: Kako se Pregabalin Mylan Pharma koristi?
English: How does Pregabalin Mylan Pharma work?
Croatian: Kako djeluje Pregabalin Mylan Pharma?
English: How has Pregabalin Mylan Pharma been studied?
Croatian: Kako je Pregabalin Mylan Pharma ispitivan?
English: Initiation pack: 1 pre-filled syringe (63 µg) + 1 pre-filled syringe (94 µg)
Croatian: Pakiranje za početak liječenja: 1 napunjena štrcaljka (63 µg) + 1 napunjena štrcaljka (94 µg)
English: 6 (3 x 2) prefilled pens (multipack)
Croatian: 6 (3x2) napunjenih brizgalica (višestruko pakiranje)
English: Initiation pack: 1 pre-filled pen (63 µg) + 1 pre-filled pen (94 µg)
Croatian: Pakiranje za početak liječenja: 1 napunjena brizgalica (63 µg) + 1 napunjena brizgalica (94 µg)
English: 2 pre-filled pens
Croatian: 2 napunjene brizgalice
English: 20 December 2013 EMA/13239/2014 Corr. 1
Croatian: 20. prosinca 2013. EMA/13239/2014 Corr.
English: Patients who have any questions should discuss them with their doctor or pharmacist.
Croatian: Bolesnici koji imaju bilo kakva pitanja trebaju se obratiti svojim liječnicima ili ljekarnicima.
English: European Medicines Agency recommends changes to the use of metoclopramide
Croatian: Europska agencija za lijekove preporučuje promjene u uporabi metoklopramida
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.
Croatian: Procjena lijekova koji sadrže metoklopramid započela je u prosincu 2011. godine na zahtjev Francuske u skladu s člankom 31. Direktive 2001/83/EZ.
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).
Croatian: • Ekstrapiramidalni poremećaji sačinjavaju približno polovicu svih prijavljenih spontanih nuspojava u bazi podataka proizvođača (1 749 slučajeva od 4 005 do prosinca 2011.).
English: There have also been very rare cases of serious effects on the heart or circulation, particularly after injection.
Croatian: Prijavljeni su također i rijetki slučajevi ozbiljnih učinaka na srce ili cirkulaciju, posebice nakon injekcije.
English: Use is contraindicated in children under 1 year of age.
Croatian: Uporaba je kontraindicirana u djece mlađe od godine dana.
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.
Croatian: Lijekovi koji sadrže metoklopramid odobreni su nacionalnim postupcima u svim državama članicama EU-a i dostupni su mnogo godina pod različitim trgovačkim nazivima.
English: Changes aim mainly to reduce the risk of neurological side effects
Croatian: Glavni cilj promjena je smanjenje rizika od neuroloških nuspojava
English: A dosing table for use in children will be included in the product information.
Croatian: Tablica doziranja za uporabu u djece bit će uključena u informacije o lijeku.
English: It is given by injection, by mouth, or as suppositories.
Croatian: Daje se injekcijom, kroz usta ili supozitorijima.
English: There were also a significant number of reports of overdose in children, particularly with oral liquid formulations.
Croatian: Također je zabilježene značajan broj izvješća o predoziranju u djece, posebice s oralnim tekućim formulacijama.
English: It also stimulates the movement of the stomach and upper part of the bowel, speeding passage through the gut.
Croatian: Također stimulira pokrete trbuha i gornjeg dijela crijeva ubrzavajući prolazak kroz crijeva.
English: • Intravenous formulations with concentrations above 5 mg/ml and suppositories containing 20 mg will also be withdrawn.
Croatian: • Intravenske formulacije s koncentracijama iznad 5 mg/l i supozitoriji koji sadrže 20 mg također će se povući iz prodaje.
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.
Croatian: • Preporučena maksimalna doza lijeka snižena je u odraslih na ukupno 30 mg na dan a neki lijekovi s visokim dozama bit će povučeni s tržišta jer više neće biti potrebni.
English: The evidence indicated that these risks outweighed the benefits of metoclopramide in conditions requiring long-term treatment.
Croatian: Dokazi su upućivali da su ti rizici nadmašili koristi od metoklopramida u stanjima koja su zahtijevala dugoročno liječenje.
English: • Metoclopramide should no longer be used in children under 1 year old.
Croatian: • Metoklopramid se više ne smije koristiti kod djece mlađe od godine dana.
English: Following this assessment and the issuing of the CHMP's original opinion, one of the companies producing metoclopramide-containing medicines exercised its legal right to ask for a re-examination of the opinion, which was duly carried out.
Croatian: Nakon te procjene i izdavanja izvornog mišljenja CHMP-a, jedna od tvrtki koja proizvodi lijekove koji sadrže metoklopramid primijenila je svoje pravo da zatraži ponovnu procjenu mišljenja što je i učinjeno.
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.
Croatian: • Za odrasle i djecu maksimalna doza u 24 sata je 0,5 mg po kg tjelesne težine; u odraslih uobičajena doza standardnih formulacija (svi načini primjene) je 10 mg do 3 puta na dan.
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.
Croatian: S obzirom na poznati rizik od neuroloških i drugih nuspojava, posebice kod djece i mladih, Povjerenstvo je zaključilo da indikacije za metoklopramid treba ograničiti na one koje uključuju kratkoročnu uporabu pri maksimalnoj dozi od 0,5 mg po kg tjelesne težine na dan i tamo gdje postoji dovoljno dokaza o djelotvornosti.
English: In children the recommended dose is 0.1 to 0.15 mg per kg body weight, repeated up to three times daily.
Croatian: U djece je preporučena doza 0,1 do 0,15 mg po kg tjelesne težine, ponovljeno do tri puta na dan.
English: The reporting rate for these disorders was calculated to be 6 times higher in children than in adults, although it was not possible to accurately account for usage patterns in different age-groups.
Croatian: Izračunato je da je stupanj prijavljivanja ovih poremećaja 6 puta veći u djece nego u odraslih iako nije bilo moguće točno izračunati obrasce primjene lijeka u različitim dobnim skupinama.
English: • If you are taking metoclopramide (especially for long-term conditions) you will have your treatment reviewed by your doctor at your next scheduled appointment, and in some cases you may be recommended a different treatment.
Croatian: • Ako uzimate metoklopramid (posebice kod dugoročnih stanja), vaš će liječnik morati pregledati vaše stanje prilikom sljedeće dogovorene kontrole te u će u nekim slučajevima možda preporučiti i drugačiju terapiju.
English: This included published studies and meta-analyses on the efficacy of metoclopramide and analyses of reports of suspected adverse reactions.
Croatian: To je uključivalo objavljena ispitivanja i meta analize o djelotvornosti metoklopramida i analize izvješća o sumnjama na nuspojave.
English: ANSM asked the CHMP to review the benefits and risks of these medicines in all age groups and to recommend consistent indications across the EU.
Croatian: ANSM je zatražila od CHMP-a da procijeni dobrobiti i rizike tih lijekova u svim dobnim skupinama i da preporuči konzistentne indikacije diljem EU-a.
English: The product information has been amended appropriately, and prescribers sent further communication at a national level.
Croatian: Informacije o lijeku također su nadopunjene na odgovaraju i način i propisivači su poslali daljnju komunikaciju na nacionalnoj razini.
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).
Croatian: • Kako bi se smanjili rizici od neuroloških i drugih nuspojava, metoklopramid je sada odobren za kratkoročnu uporabu (do 5 dana).
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.
Croatian: Osim toga maksimalne preporučene doze u odraslih i djece treba ograničiti, a formulacije većih jačina uključujući oralne pripravke i jačine iznad 1 mg/ml povući s tržišta.
English: • In other longer lasting conditions, the benefits of this medicine do not outweigh the risks of side effects.
Croatian: • U drugim dugoročnim uvjetima koristi od ovog lijeka ne nadmašuju rizike od nuspojava.
English: The effects of metoclopramide on gut motility may be of benefit when given orally with analgesics in this acute setting.
Croatian: Učinci metoklopramida na motilitet crijeva mogu biti korisni kada se daju peroralno s analgeticima u ovom akutnom okruženju.
English: • Intravenous doses should be administered as a slow bolus over at least 3 minutes to reduce the risk of adverse effects.
Croatian: • Intravenske doze treba primjenjivati u obliku sporog bolusa tijekom najmanje 3 minute kako bi se smanjio od rizik od nuspojava.
English: Following the re-examination, the final CHMP recommendation was then sent to the European Commission, which adopted it with an EU-wide legally binding decision on 20 December 2013.
Croatian: Nakon ponovne procjene, konačna preporuka CHMP-a je potom poslana Europskoj komisiji koja ju je usvojila kao pravno obvezujuću širom EU-a 20. prosinca 2013.
English: • The evidence also indicated efficacy in nausea and vomiting associated with acute migraine, but seemed to indicate that doses above 10 mg do not result in increased efficacy.
Croatian: • Dokaz je također ukazao na djelotvornost lijeka kod mučnine i povraćanja povezanih s akutnom migrenom, ali čini se da doze iznad 10 mg ne utječu na povećanu djelotvornost.
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.
Croatian: Preporuka CHMP-a poslana je potom Europskoj komisiji koja ju je usvojila kao konačnu i pravno obvezujuću širom Europske unije (EU) 20. prosinca 2013.
English: The French medicines agency therefore asked the CHMP to carry out an assessment of the benefit-risk balance in all populations, especially in children and the elderly.
Croatian: Francuska agencija za lijekove stoga je zatražila da CHMP provede procjenu omjera dobrobiti i rizika u svim populacijama, posebice kod djece i odraslih.
English: Evidence to support a role as an adjunct in surgical and radiological procedures was also lacking.
Croatian: Dokaz koji bi podupro ulogu kao pomoćno sredstvo u kirurškim i radiološkim postupcima također je izostao.
English: On 24 October the European Medicines Agency's Committee on Medicinal Products for Human Use (CHMP) confirmed previously recommended changes to the use of metoclopramide-containing medicines in the European Union (EU), including restricting the dose and duration of use of these medicines to minimise the known risks of potentially serious neurological (brain and nerve) side effects.
Croatian: Dana 24. listopada Povjerenstvo za lijekove za primjenu kod ljudi Europske agencije za lijekove (CHMP) potvrdilo je prethodno preporučene promjene u uporabi lijekova koji sadrže metoklopramid u Europskoj uniji (EU), uključujući ograničavanje doze i trajanja uporabe tih lijekova kako bi se smanjili rizici od potencijalno ozbiljnih neuroloških nuspojava (na mozgu i živcima).
English: The risk of acute (short-term) neurological effects is higher in children, although tardive dyskinesia is reported more often in the elderly, and the risk is increased at high doses or with long-term treatment.
Croatian: Rizik od akutnih (kratkoročnih) neuroloških učinaka je veći u djece, iako se tardivna diskinezija bilježi češće u starijih, a rizik se povećava pri višim dozama ili kod dugoročnog liječenja.
English: Oral liquids containing more than 1 mg/ml will be withdrawn from the market, and oral doses of remaining formulations should be administered using an appropriately designed graduated oral syringe to ensure accuracy.
Croatian: Tekući pripravci koji sadrže više od 1 mg/ml bit će povučeni s tržišta, a oralne doze preostalih formulacija treba primjenjivati uporabom odgovarajući dizajnirane graduirane oralne štrcaljke kako bi se osigurala točnost.
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.
Croatian: Prvotna procjena metoklopramida provedena je na zahtjev Francuske agencije za lijekove (ANSM) nakon nastavka bojazni glede nuspojava i djelotvornosti.
English: During the re-examination the Committee confirmed its recommendation that metoclopramide should only be authorised for short-term use (up to 5 days), that it should not be used in children below 1 year of age and that in children over 1 year of age it should only be used as a second-choice treatment (after other treatments have been considered or tried) for the prevention of delayed nausea and vomiting after chemotherapy and for the treatment of post-operative nausea and vomiting.
Croatian: Tijekom ponovnog pregleda Povjerenstvo je potvrdilo svoju preporuku da metoklopramid treba odobriti samo za kratkoročnu uporabu (do 5 dana), da se ne smije koristiti u djece mlađe od godinu dana i da ga u djece starije od godinu dana treba koristiti samo kao drugu liniju liječenja (nakon razmatranja ili iskušavanja drugih terapija) za sprječavanje odgođene mučnine i povraćanja nakon kemoterapije i za liječenje mučnine i povraćanja nakon kirurškog zahvata.
English: • Oral liquid formulations have been particularly associated with overdose in children.
Croatian: • Tekuće oralne formulacije posebno su povezane s predoziranjem u djece.
English: There was also some evidence suggestive of a role in radiotherapy-induced nausea and vomiting, although again it seemed to be less effective than the 5-HT3 antagonists.
Croatian: Postojali su neki dokazi koji su ukazivali na ulogu lijeka kod mučnine i povraćanja izazvanih zračenjem iako se opet činilo da je manje djelotvoran od antagonista 5-HT3.
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.
Croatian: Metoklopramid je lijek koji djeluje kao antiemetik (lijek koji se koristi za olakšavanje mučnine i povraćanja) tako što djeluje na dio mozga koji potiče osjećaj mučnine.
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.
Croatian: Ekstrapiramidalni poremećaji najčešće su se pojavljivali nakon nekoliko doza obično rano u liječenju, ali bili su manje vjerojatni pri sporijim brzinama infuzije kad se metoklopramid davao intravenski.
English: • Patients who are currently taking regular metoclopramide should have their treatment reviewed at a routine (non-urgent) medical appointment.
Croatian: • Bolesnicima koji trenutačno uzimaju metoklopramid redovito treba procijeniti terapiju prilikom rutinske kontrole (koja nije hitna).
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.
Croatian: • Nema dokaza o dosljednoj koristi kod gastropareze, gastroezofagealne refluksne bolesti i dispepsije, a to su sve kronična stanja koja zahtijevaju produljeno liječenje što bolesnike stavlja pod rizik od kroničnih neruoloških nuspojava.
English: Therefore, it should no longer be used to treat conditions such as indigestion, heartburn and acid reflux, or chronic (long-term) disorders due to slow emptying of the stomach.
Croatian: Stoga se više ne smije koristiti za liječenje stanja poput loše probave, žgaravice i refluksa kiseline ili kroničnih (dugoročnih) poremećaja zbog sporog pražnjenja želuca.
English: However, the CHMP concluded that although liquid dose forms had some benefits, such as easier adjustment of doses in patients with reduced kidney or liver function, the 1 mg/ml solution could be used in situations where a liquid dosage form was appropriate, and the Committee was not convinced the proposed restrictions would be sufficient to reduce the risk of error and overdose in children.
Croatian: Međutim, CHMP je zaključio da iako tekući dozirni oblici imaju određene koristi poput lakše prilagodbe doza u bolesnika sa smanjenom funkcijom bubrega ili jetre, otopina jačine 1 mg/ml smije se koristiti u situacijama kad je tekući dozirni oblik odgovarajući, a Povjerenstvo nije bilo uvjereno da će predložena ograničenja biti dostatna za smanjivanje rizika od pogreške i predoziranja u djece.
English: Elderly patients seemed to be more at risk of potentially irreversible tardive dyskinesia after longer term treatment.
Croatian: Čini se da su stariji pacijenti pod većim rizikom od potencijalno nepovratne diskinezije nakon duljeg razdoblja liječenja.
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.
Croatian: Iako je bilo predloženo da će doze za odrasle biti teške za točno doziranje u obliku otopine od 1 mg/ml jer je potreban veći broj kapi, ne bi trebalo biti problema ako se prate preporuke Povjerenstva da se tekući dozirni oblici daju s pomoću mjernog uređaja kao što je graduirana oralna štrcaljka.
English: In adults,
Croatian: Kod odraslih je bolesnika
English: It should no longer be used in chronic conditions such as gastroparesis, dyspepsia and gastro-oesophageal reflux disease, nor as an adjunct in surgical and radiological procedures.
Croatian: Više se ne smije koristiti u kroničnim stanjima poput gastropareze, dispepsije i gastroezofagealnog refluksa niti kao pomoćno sredstvo u kirurškim i radiološkim postupcima.
English: At the request of a manufacturer of higher strength oral solutions, the Committee reconsidered the evidence behind its view that oral solutions above 1 mg/ml should no longer be available, and the arguments and proposals to minimise the risk that were supplied by the company, specifically a restriction on the use of the higher strength solution in children.
Croatian: Na zahtjev proizvođača viših jačina oralnih otopina Povjerenstvo je ponovno razmotrilo dokaz koji podupire njegovo stajalište da oralne otopine jače od 1 mg/ml ne smiju više biti dostupne i argumente i prijedloge za smanjivanjem rizika koje je podastrla tvrtka, a posebice ograničenje uporabe otopina viših jačina u djece.
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.
Croatian: • Podaci o uporabi metoklopramida kod akutne mučnine i povraćanja izazvanih kemoterapijom (CINV) bili su ograničeni i ukazivali su na to da je metoklopramid bio inferioran antagonistima 5HT3 i zahtijevao visoke doze koje su bile povezane s uvelike povećanim rizikom od nuspojava.
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.
Croatian: Odobren je za niz indikacija koje se razlikuju između država članica EU-a te je dostupan u različitim formulacijama kao injekcija (koja se daje u venu ili mišić), u obliku tableta i oralnih tekućih pripravaka koji se uzimaju na usta te u obliku supozitorija.
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.
Croatian: Nakon toga uslijedila je ponovna procjena mišljenja koje je izvorno dalo Povjerenstvo 26. srpnja 2013. na zahtjev nositelja odobrenja za stavljanje lijeka u promet.
English: The evidence for intravenous metoclopramide in post-operative nausea and vomiting suggests it is as effective as other licensed treatments.
Croatian: Dokaz za uporabu intravenskog metoklopramida kod liječenja mučnine nakon kirurškog zahvata i povraćanja ukazuje da je djelotvoran kao i druge odobrene terapije.
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).
Croatian: Procjenom su potvrđeni dobro poznati rizici od neuroloških učinaka poput kratkoročnih ekstrapiramidalnih poremećaja, skupine nevoljnih poremećaja kretanja koji mogu uključivati mišićne spazme (često uključuju glavu i vrat) te tardivne diskinezije (nekontroliranih pokreta poput grimasiranja i trzanja).