FrancophonIA/ELRC3.0 huggingface dataset:
English: • For both adults and children, metoclopramide should only be used for a maximum of 5 days.
Croatian: • I kod odraslih i kod djece metoklopramid se smije koristiti najviše do 5 dana.
English: • Recommended use in children is therefore now restricted to prevention of nausea and vomiting that occurs in the days after treatment with anticancer medicines, or to treat nausea and vomiting after surgery, and only when other treatments do not work or cannot be used.
Croatian: • Preporučena uporaba u djece je stoga sada ograničena na sprječavanje mučnine i povraćanja koji se događaju u danima nakon liječenja lijekovima protiv karcinoma ili za liječenje mučnine i povraćanja nakon kirurškog zahvata i to samo kada druge terapije ne djeluju ili se ne mogu koristiti.
English: The Agency's recommendations are based on a review of the benefit-risk of metoclopramide-containing products in all indications and populations.
Croatian: Preporuke Agencije temelje se na procjeni omjera koristi i rizika lijekova koji sadrže metoklopramid u svim indikacijama i populacijama.
English: • Given very rare reports of serious cardiovascular reactions associated with metoclopramide, particularly via the intravenous route, special care should be taken in populations likely to be at increased risk, including the elderly, patients with cardiac conduction disturbances, uncorrected electrolyte imbalance or bradycardia, and those taking other drugs known to prolong QT interval.
Croatian: • S obzirom da su izvješća o ozbiljnim kardiovaskularnim reakcijama povezanim s metoklopramidom vrlo rijetka, posebice kad se daje intravenski, potrebno je obratiti posebnu pozornost na populacije za koje je vjerojatno da su pod povećanim rizikom, uključujući starije osobe, bolesnike s poremećajima srčanog provođenja, neliječenom neravnotežom elektrolita ili bradikardijom i one koji uzimaju druge lijekove za koje se zna da produljuju QT interval.
English: • Metoclopramide is known to sometimes cause short-term side effects on the nervous system that result in unintentional movements such as twitches and nervous tics and these are commoner in children and young people, and at high doses.
Croatian: • Poznato je da metoklopramid ponekad uzrokuje kratkoročne nuspojave na živčanom sustavu koje rezultiraju u nenamjernim pokretima poput tikova i trzanja, a koje su češće u djece i mlađih osoba te pri visokim dozama.
English: Other nervous system side effects may occur when metoclopramide is used for prolonged periods and may occur more often in the elderly.
Croatian: Druge nuspojave na živčanom sustavu mogu se javiti kada se metoklopramid koristi tijekom duljih razdoblja i mogu se javiti češće u starijih.
English: Metoclopramide-containing medicines have been authorised separately in individual Member States of the EU, with differing licensed indications such as nausea and vomiting of various causes (for example after treatment with anticancer chemotherapy or radiotherapy, after surgery, or associated with migraine) and gastrointestinal motility disorders (conditions in which the normal passage of food through the gut is delayed).
Croatian: Lijekovi koji sadrže metoklopramid odobreni su zasebno u pojedinim državama članicama EU-a s različitim odobrenim indikacijama poput mučnine i povraćanja različitih uzroka (primjerice, nakon liječenja lijekovima protiv karcinoma ili terapije zračenjem, nakon kirurškog zahvata ili lijekova za migrenu) te poremećaja motiliteta probavnog sustava (stanja u kojima je odgođen normalan prolazak hrane kroz želudac).
English: • Cardiovascular reaction reports associated with metoclopramide appeared to be very rare, and mainly associated with intravenous formulations given to patients with underlying risks for cardiac disease; they included hypotension, shock, syncope, bradycardia or atrioventricular block, and cardiac arrest.
Croatian: • Izvješća o kardiovaskularnim reakcijama koje su povezane s metoklopramidom činila su se vrlo rijetka i uglavnom povezana s intravenskim formulacijama koje se daju bolesnicima s osnovnim rizicima od srčane bolesti; izvješća su obuhvaćala hipotenziju, šok, sinkopu, bradikardiju ili atrioventrikularni blok te srčani arest.
English: There was more consistent evidence of comparability with 5-HT3 antagonists when used for delayed CINV.
Croatian: Postojali su dosljedniji dokazi usporedivosti s antagonistima 5-HT3 kad su se koristili kod povraćanja izazvanog kemoterapijom.
English: Such oral liquids have been associated with overdose in children.
Croatian: Takve tekuće oralne formulacije povezane su s predoziranjem u djece.
English: French medicines regulatory agency highlighted that despite various risk minimisation measures implemented over the years, side effects had continued to be reported.
Croatian: U 2011. godini procjenom se koju je provela Francuska agencija za lijekove na djeci na državnoj razini istaknulo da se unatoč različitim mjerama smanjenja rizika koje su usvojene tijekom godina nuspojave nastavljaju prijavljivati.
English: • In adults, metoclopramide remains indicated for prevention of post-operative nausea and vomiting (PONV), radiotherapy-induced nausea and vomiting and delayed (but not acute) chemotherapyinduced nausea and vomiting, and for symptomatic treatment of nausea and vomiting including that associated with acute migraine (where it may also be used to improve absorption of oral analgesics).
Croatian: • Kod odraslih bolesnika metoklopramid ostaje indiciran za sprječavanje mučnine i povraćanja nakon kirurškog zahvata te odgođenih (ali ne akutnih) mučnina i povraćanja izazvanih kemoterapijom te za simptomatsko liječenje mučnine i povraćanja, uključujući i one povezane s akutnom migrenom (gdje se također može koristiti za poboljšavanje apsorpcije oralnih analgetika).
English: This followed a review by the EU Member States of metoclopramide-containing medicines in children, under Article 45 of the Paediatric Regulation 1901/2006, which in 2010 identified the risk of neurological side effects and recommended a number of risk minimisation measures.
Croatian: Pedijatrijske uredbe br. 1901/2006 kojom se u 2010. identificirao rizik od neuroloških nuspojava i preporučile brojne mjere smanjenja rizika.
English: • Metoclopramide is used to prevent or treat nausea and vomiting (feeling or being sick), including nausea and vomiting that may result from anticancer medicines or radiation treatment, surgery, or an attack of migraine.
Croatian: • Metoklopramid se koristi za sprječavanje ili liječenje mučnine i povraćanja, uključujući mučninu i povraćanje koji mogu nastati od lijekova protiv karcinoma ili zračenja, kirurškog zahvata ili napadaja migrene.
English: • In children, metoclopramide is only licensed as a second-line option for prevention of delayed chemotherapy-induced nausea and vomiting and treatment of established PONV.
Croatian: • Kod djece je metoklopramid odobren samo kao druga linija liječenja za sprječavanje odgođenih mučnina i povraćanja izazvanih kemoterapijom te za liječenje dijagnosticirane mučnine i povraćanja nakon kirurškog zahvata.
English: the Committee recommended use for the prevention and treatment of nausea and vomiting such as that associated with chemotherapy, radiotherapy, surgery and in the management of migraine.
Croatian: Povjerenstvo preporučilo uporabu za sprječavanje i liječenje mučnine i povraćanja poput onih povezanih s
English: It is typically transmitted through bites of infected animals.
Croatian: Najčešće se prenosi putem ugriza zaraženih životinja.
English: In the future, if the animals are exposed to these infections the immune system will be able to respond more quickly.
Croatian: Ubuduće ako se životinje izlože ovim infekcijama, imunosni sustav će brže stvarati protutijela.
English: The vaccine is given to puppies from eight to nine weeks of age as an injection, under the skin, and repeated once the puppies reach twelve weeks of age.
Croatian: Cjepivo se primjenjuje u štenadi u dobi od osam do devet tjedana u obliku supkutane injekcije i ponavlja se nakon što štenad dosegne starost od dvanaest tjedana.
English: The field study showed that after vaccination with Versican Plus Pi/L4R the percentage of dogs with protective levels of antibodies for parainfluenza virus ranged from 73 to 97%, for leptospira 59 to 96% and for rabies virus 86 to 100%.
Croatian: Terenskim je ispitivanjem dokazano da se nakon cijepljenja cjepivom Versican Plus Pi/L4R postotak pasa s zaštitnim razinama protutijela za parainfluenza virusa kretao od 73 do 97%, za leptospiru od 59 do 96%, te za bjesnoću od 86 do 100%.
English: In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Croatian: U slučaju nehotičnog samoinjektiranja, odmah potražite pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Versican Plus Pi/L4R exceed the risks for the approved indications and recommended that Versican Plus Pi/L4R be given a marketing authorisation.
Croatian: Odbor za veterinarsko-medicinske proizvode (CVMP) zaključio je da koristi lijeka Versican Plus Pi/L4R nadmašuju rizike za odobrene indikacije i preporučilo je izdavanje odobrenja za stavljanje u promet VMP-a Versican Plus Pi/L4R.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Versican Plus Pi/L4R on 31 July 2014.
Croatian: Europska komisija dodijelila je odobrenje za stavljanje u promet koje je na snazi na teritoriju Europske unije za proizvod Versican Plus Pi/L4R od 31. srpnja 2014.
English: This will help protect them against kennel cough, leptospirosis and rabies.
Croatian: Ovo pomaže pri njihovoj zaštiti od kašlja čopora, leptospiroze i bjesnoće.
English: The effectiveness of Versican Plus Pi/L4R was investigated in a field study involving 129 dogs.
Croatian: Djelotvornost cjepiva Versican Plus Pi/L4R ispitana je terenskim ispitivanjem koje je obuhvatilo 129 pasa.
English: When Versican Plus Pi/L4R is given to dogs the animals' immune system recognises the viruses and bacteria as ‘foreign' and makes antibodies against them.
Croatian: U slučaju kada se Versican Plus Pi/L4R primjenjuje u pasa, imunosni sustav životinje prepoznaje viruse i bakterije kao „strane” i proizvode protutijela protiv virusa.
English: The most common side effect (seen in more than 1 in 100 dogs) with Versican Plus Pi/L4R is a short lived swelling of up to 5 cm which may occur at the injection site after vaccination.
Croatian: Najčešće nuspojave (kod 1 od 100 pasa) lijeka Versican Plus Pi/L4R su kratkotrajno oticanje do 5 cm koje može nastupiti u mjestu injekcije nakon cjepiva.
English: • leptospirosis, a bacterial disease that may be transmitted via infected urine and result in bleeding, hepatitis (inflammation of the liver) and jaundice or nephritis (kidney inflammation);
Croatian: • leptospiroze, bakterijske bolesti koja se može prenijeti putem zaraženog urina, a rezultira krvarenjem, hepatitisom (upalom jetre) i žuticom ili nefritisom (upalom bubrega);
English: Versican Plus Pi/L4R is a veterinary vaccine that contains live attenuated (weakened) canine parainfluenza virus type 2, inactivated (killed) strains of Leptospira bacteria (Icterohaemorrhagiae, Canicola, Bratislava and Grippotyphosa) as well as rabies virus.
Croatian: Versican Plus Pi/L4 je veterinarsko cjepivo koje sadrži živi atenuirani (oslabljeni) virus pseće parainfluence tip 2, inaktivirane (ubijene) sojeve bakterije Leptospira (Icterohaemorrhagiae, Canicola, Bratislava i Grippotyphosa) kao i virus bjesnoće.
English: • rabies, a viral zoonotic (communicable to man) disease that affects the central nervous system (brain and spinal cord), leading to death.
Croatian: • bjesnoće, bolesti virusne zoonoze (koja se može prenijeti na ljude) koja zahvaća središnji živčani sustav (mozak i kralježničnu moždinu), što rezultira smrću.
English: Versican Plus Pi/L4R is used to protect dogs against:
Croatian: Versican Plus Pi/L4R se koristi za zaštitu pasa od:
English: Versican Plus Pi/L4R contains an adjuvant (aluminium hydroxide) to enhance the immune response.
Croatian: Versican Plus Pi/L4R sadrži adjuvans (aluminijev hidroksid) kako bi se pojačao imunosni odgovor.
English: The canine parainfluenza virus in Versican Plus Pi/L4R is alive but has been attenuated (weakened) so that it does not cause disease; it is combined with killed (inactivated) strains of Leptospira bacteria and rabies virus.
Croatian: Pseći parainfluenza virus u cjepivu Versican Plus Pi/L4 je živ, ali je atenuiran (oslabljen) tako da ne uzrokuje bolest; kombiniran je s ubijenim (inaktiviranim) sojevima bakterije Leptospira i virusa bjesnoće.
English: For revaccination a single dose of Versican Plus Pi/L4R is required annually.
Croatian: Za docjepljivanje potrebna je jedna doza cjepiva Versican Plus Pi/L4R godišnje.
English: Canine parainfluenza virus (live attenuated), canine leptospirosis and rabies (inactivated) vaccine
Croatian: Virus pseće parainfluence (živi atenuirani), cjepivo protiv pseće leptospiroze i bjesnoće (inaktivirano)
English: Versican Plus Pi/L4R is a vaccine.
Croatian: Versican Plus Pi/L4R je cjepivo.
English: Versican Plus Pi/L4R is available as a lyophilisate (freeze-dried pellet) with solvent for injection.
Croatian: Versican Plus Pi/L4 dostupan je kao liofilizat (smrzavanjem osušen pelet) s otapalom za injekciju.
English: Other information about Versican Plus Pi/L4R:
Croatian: Druge informacije o Versican Plus Pi/L4R:
English: What is the risk associated with Versican Plus Pi/L4R?
Croatian: Koji su rizici povezani s Versican Plus Pi/L4R?
English: Why has Versican Plus Pi/L4R been approved?
Croatian: Zašto je Versican Plus Pi/L4R odobren?
English: What is Versican Plus Pi/L4R?
Croatian: Što je Versican Plus Pi/L4R?
English: What benefit has Versican Plus Pi/L4R shown during the studies?
Croatian: Koje koristi Versican Plus Pi/L4R su utvrđene tijekom ispitivanja?
English: What is Versican Plus Pi/L4R used for?
Croatian: Za što se Versican Plus Pi/L4R koristi?
English: How has Versican Plus Pi/L4R been studied?
Croatian: Kako se Versican Plus Pi/L4R ispitivao?
English: How does Versican Plus Pi/L4R work?
Croatian: Na koji način Versican Plus Pi/L4R djeluje?
English: The valid product information is the final version achieved during the Coordination group procedure.
Croatian: Važeće informacije o lijeku završna su verzija usuglašena tijekom postupka Koordinacijske grupe
English: Annex I List of medicinal products and presentations
Croatian: Dodatak I Popis lijekova i prezentacija
English: These results confirm a similar Australian case series.2,3
Croatian: Ti rezultati potvrđuju sličnu seriju slučajeva u Australiji.2,3
English: The review of modified-release paracetamol was initiated on 30 June 2016 at the request of Sweden, under Article 31 of Directive 2001/83/EC.
Croatian: Ocjenjivanje lijekova s prilagođenim oslobađanjem paracetamola započeto je 30. lipnja 2016. na zahtjev Švedske u skladu s člankom 31. Direktive 2001/83/EZ.
English: It is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: Odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima širom EU-a.
English: The maximum plasma concentration may occur later, and high concentrations, in particular after large doses, may persist for several days.
Croatian: Najveća koncentracija u plazmi može nastupiti naknadno, a visoke koncentracije mogu potrajati nekoliko dana, posebno nakon visokih doza.
English: Paracetamol has been widely used for many years to relieve pain and fever in adults and children.
Croatian: Paracetamol je dugi niz godina u širokoj uporabi za ublažavanje boli i vrućice u odraslih osoba i djece.
English: They are available in Belgium, Denmark, Finland, Greece, Iceland, Luxembourg, the Netherlands, Portugal, Romania, and Sweden under various names including Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard and Pinex Retard.
Croatian: Dostupni su u Belgiji, Danskoj, Finskoj, Grčkoj, Islandu, Luksemburgu, Nizozemskoj, Portugalu, Rumunjskoj i Švedskoj pod različitim nazivima, uključujući Alvedon 665 mg, Panadol Artro, Panadol Extend, Panadol Retard 8 hours, Panodil 665 mg, Paratabs Retard i Pinex Retard.
English: Following a request from companies involved in the review, the PRAC re-examined and confirmed its previous recommendation in December 2017.
Croatian: Nakon zaprimanja zahtjeva tvrtki obuhvaćenih ocjenjivanjem, PRAC je u prosincu 2017. ponovno razmotrio i potvrdio svoju prethodnu preporuku.
English: Although this should be determined at local level in consultation with local Poison Information Centres, the following general guidance may be helpful unless local guidelines have already been adapted or already recommend a more conservative approach:
Croatian: Iako bi to trebalo utvrditi na lokalnoj razini u savjetovanju s lokalnim centrima za kontrolu otrovanja, opće smjernice u nastavku mogle bi biti od pomoći, ako lokalne smjernice nisu već prilagođene ili ne preporučuju konzervativniji pristup:
English: These combination products are also being removed.
Croatian: Ti kombinirani lijekovi također se povlače s tržišta.
English: Recommendation endorsed due to the difficulty in managing overdose
Croatian: Usvojena preporuka zbog poteškoća u postupanju kod predoziranja
English: However, you will need to speak to your doctor or pharmacist about the best replacement if you need further treatment once your supply runs out.
Croatian: Međutim, morat ćete se savjetovati sa svojim liječnikom ili ljekarnikom u pogledu najbolje zamjene ako vam nakon što potrošite svoju zalihu lijeka i dalje bude potrebno liječenje.
English: CMDh noted the PRAC conclusion that practical measures to sufficiently reduce the risk to patients had not been identified.
Croatian: CMDh je primio na znanje zaključak PRAC-a da nisu utvrđene praktične mjere kojima bi se dostatno smanjio rizik za bolesnike.
English: − antidote should be dosed as recommended by the local Poison Information Centre.
Croatian: − doziranje antidota treba biti u skladu s preporukama lokalnog centra za kontrolu otrovanja.
English: Modified-release medicines containing paracetamol with the opioid painkiller tramadol are available under the names Diliban Retard or Doreta SR in Bulgaria, Czech Republic, Estonia, Hungary, Iceland, Latvia, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia and Spain, and these medicines are also covered by this review.
Croatian: Lijekovi koji sadrže paracetamol u kombinaciji s opioidnim analgetikom tramadolom dostupni su pod nazivima Diliban Retard ili Doreta SR u Bugarskoj, Češkoj Republici, Estoniji, Mađarskoj, Islandu, Latviji, Litvi, Poljskoj, Portugalu, Rumunjskoj, Slovačkoj, Sloveniji i Španjolskoj, i ti su lijekovi također obuhvaćeni ovim ocjenjivanjem.
English: • When used correctly and at the recommended doses, paracetamol is an effective and safe treatment for pain and fever.
Croatian: • Ako se primjenjuje na ispravan način i u preporučenim dozama, paracetamol je djelotvoran i siguran lijek za liječenje boli i vrućice.
English: The recommendation was made by the Agency's experts in medicines safety, the Pharmacovigilance Risk Assessment Committee (PRAC).
Croatian: Preporuku su iznijeli stručnjaci za sigurnost lijekova pri Agenciji, Odbor za procjenu rizika u području farmakovigilancije (PRAC).
English: Additional samples should be considered if serum paracetamol concentrations are not declining to low levels.
Croatian: Treba razmotriti uzimanje dodatnih uzoraka ako se koncentracije paracetamola u serumu ne spuštaju na nisku razinu.
English: The medicines will remain suspended unless the companies that hold the marketing authorisations can provide evidence of appropriate and practical EU-wide measures to help prevent overdose with these products and adequately reduce its risks.
Croatian: Obustava za te lijekove ostaje na snazi, osim ako tvrtke koje su nositelji odobrenja za stavljanje lijeka u promet mogu pružiti dokaze o odgovarajućim i praktičnim mjerama na razini EU-a koje bi pomogle u sprječavanju predoziranja tim lijekovima i dostatno smanjile rizike.
English: The dose of NAC may have to be increased and the optimal dosing has not been determined.
Croatian: Povećanje doze Nacetilcisteina može biti potrebno, a optimalno doziranje nije utvrđeno.
English: • You should seek medical advice quickly if you have taken, or think you may have taken, more than the recommended amount of any paracetamol-containing product.
Croatian: • Odmah potražite liječničku pomoć ako ste uzeli ili mislite da ste možda uzeli više od preporučene količine bilo kojeg lijeka koji sadrži paracetamol.
English: • If you are taking modified-release medicines, you can continue to do so.
Croatian: • Ako uzimate lijekove s prilagođenim oslobađanjem, možete nastaviti s njihovom primjenom.
English: The review was carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety of human medicines, which made recommendations in September 2017.
Croatian: Ocjenjivanje je proveo Odbor za procjenu rizika u području farmakovigilancije (PRAC), odbor odgovoran za ocjenu sigurnosti lijekova za humanu uporabu, koji je u rujnu 2017. donio niz preporuka.
English: • Patients should continue using paracetamol medicines in line with instructions in the package leaflets, particularly instructions on how much to take.
Croatian: • Bolesnici trebaju nastaviti primjenjivati lijekove koji sadrže paracetamol u skladu s uputama iz upute o lijeku, osobito uputama o količini lijeka koja se uzima.
English: The CMDh is a body representing EU Member States as well as Iceland, Liechtenstein and Norway.
Croatian: CMDh je tijelo koje zastupa države članice Europske unije (EU) te Island, Lihtenštajn i Norvešku.
English: Salmonson H, Sjöberg G, Brogren J The standard treatment protocol for paracetamol poisoning may be inadequate following overdose with modified release formulation: a pharmacokinetic and clinical analysis of 53 cases.
Croatian: Salmonson H., Sjöberg G., Brogren J., Protokol standardnog liječenja otrovanja paracetamolom možda nije primjeren nakon predoziranja formulacijom s prilagođenim oslobađanjem: farmakokinetička i klinička analiza 53 slučaja.
English: • Some modified-release medicines are available in combination with another painkiller, tramadol.
Croatian: • Neki od lijekova s prilagođenim oslobađanjem dostupni su u kombinaciji s drugim analgetikom, tramadolom.
English: Paracetamol-containing immediate-release products have been authorised in all EU Member States but are not included in EMA's review.
Croatian: Lijekovi koji sadrže paracetamol s trenutnim oslobađanjem odobreni su u svim državama članicama EU-a, no nisu obuhvaćeni ocjenom koju je provela EMA.
English: The Agency's recommendations are based on a review of available data including a retrospective pharmacokinetic and clinical analysis of 53 cases of acute overdose with modified-release paracetamol by the Swedish Poison Information Centre,1 which found that the standard treatment protocol utilising solely the Rumack-Matthew nomogram (or variations thereof) based on conventional paracetamol formulations may not be effective for overdoses with modified-release paracetamol formulations.
Croatian: Preporuke Agencije temelje se na pregledu dostupnih podataka, uključujući retrospektivnu farmakokinetičku i kliničku analizu 53 slučaja akutnog predoziranja lijekovima s prilagođenim oslobađanjem paracetamola koju je proveo švedski centar za kontrolu otrovanja1, kojim je utvrđeno da protokol standardnog liječenja, u kojem se koristi isključivo Rumack-Matthewov nomogram (ili njegove varijante) temeljen na konvencionalnim formulacijama paracetamola, možda neće biti djelotvoran pri predoziranju formulacijama s prilagođenim oslobađanjem paracetamola.
English: • Until modified-release products have been removed from the market, adaptations of the standard protocol for paracetamol overdose should be considered.
Croatian: • Do povlačenja lijekova s prilagođenim oslobađanjem s tržišta trebalo bi razmotriti prilagodbe standardnog protokola liječenja predoziranja paracetamolom.