FrancophonIA/ELRC3.0 huggingface dataset:
English: After discussions, on 31 October 2012 the scope of the review was extended from post-surgery pain relief in children to pain relief in children.
Croatian: Nakon razmatranja, dana 31. listopada 2012. godine predmet pregleda proširen je s ublažavanja boli nakon kirurškog zahvata u djece na ublažavanje boli u djece.
English: As codeine-containing medicines are all authorised nationally, the PRAC recommendations were sent to the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh), which adopted a final position.
Croatian: Svi lijekovi koji sadrže kodein odobreni su nacionalno, preporuke PRAC dostavljene su Koordinacijskoj grupi za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh), koja je usvojila konačno mišljenje.
English: Codeine is an opioid that is authorised as a painkiller in adults and children.
Croatian: Kodein je opioid, koji je odobren za upotrebu kao analgetik u odraslih i djece.
English: • Codeine is not recommended for use in children in whom respiratory function might be compromised as this may worsen the symptoms of morphine toxicity.
Croatian: • Kodein se ne preporuča za uporabu u djece, u koje postoji sumnja na ugroženost funkcije disanja, s obzirom da to može pogoršati simptome toksičnosti morfina.
English: Codeine is marketed as a singleingredient medicine or in combination with other substances such as aspirin or paracetamol.
Croatian: Kodein je stavljen u promet kao lijek s jednim sastojkom ili u kombinaciji s drugim tvarima, poput aspirina ili paracatemola.
English: These recommendations follow a review of available safety and efficacy data on codeine when used for pain relief in children, including pharmacokinetic data, clinical studies, post-marketing data in Europe and other published literature:
Croatian: Ove preporuke proizlaze na temelju pregleda dostupnih podataka o sigurnosti i djelotvornosti u vezi uporabe kodeina u djece, uključujući i farmakokinetičke podatke, klinička ispitivanja, podatke prikupljene nakon stavljanja lijeka u promet u Europi i u drugu objavljenu literaturu:
English: • The product information of these medicines should carry a warning that children with conditions associated with breathing problems should not use codeine.
Croatian: • informacije o lijeku ovih lijekova moraju sadržavati upozorenje da djeca sa stanjima povezanima s disanjem ne smiju uzimati kodein.
English: The product information for codeine should also include general information for healthcare professionals, patients and carers on the risk of morphine side effects with codeine, and how to recognise their symptoms.
Croatian: Informacije o lijeku za kodein trebaju sadržavati opće informacije za zdravstvene djelatnike, bolesnike i pružatelje skrbi u vezi s rizikom od nuspojava morfina s kodeinom i prepoznavanjem simptoma.
English: • Parents and caregivers who notice any of the following symptoms in a patient given codeine should stop giving the medicine and seek medical attention immediately: slow or shallow breathing, confusion, sleepiness, small pupils, feeling or being sick, constipation and lack of appetite.
Croatian: • Roditelji i pružatelji skrbi, koji uoče bilo koji od niže navedenih simptoma u bolesnika koji uzimaju kodein, moraju prestati davati lijek i odmah potražiti liječničku pomoć: usporeno ili plitko disanje, smetenost, pospanost, male zjenice, osjećaj slabosti ili slabost, zatvor i manjak apetita.
English: As the PRAC recommendation was endorsed by consensus by the CMDh, it will now be implemented directly by all Member States, according to an agreed timetable.
Croatian: S obzirom da je CMDh konsenzusom potvrdio preporuku PRAC, sve države članice sada će izravno primijeniti preporuku u skladu s dogovorenim rasporedom.
English: Nevertheless, it is considered that codeine still has a place in the treatment of acute pain in the paediatric population and given the concerns about its risks, it should only be used in line with the updated indication, contraindications, warnings and other changes to the product information described above.
Croatian: No, ipak se smatra da se kodein može primjenjivati u liječenju akutne boli u pedijatrijske populacije, te se, s obzirom na nuspojave, treba primjenjivati u skladu s ažuriranim indikacijama, kontraindikacijama, upozorenjima i ostalim promjenama u informacijama u proizvodu koje su prethodno opisane.
English: In the European Union (EU), codeinecontaining medicines have been approved via national procedures, and are available either on prescription or over the counter in the different Member States.
Croatian: U Europskoj uniji (EU), lijekovi koji sadrže kodein odobreni su za uporabu u sklopu nacionalnih postupaka, te se izdaju na recept ili bez recepta u različitim državama članicama.
English: The PRAC concluded that a number of risk minimisation measures are necessary to ensure that only children for whom the benefits are greater than the risks are given the medicine for pain relief.
Croatian: PRAC je zaključio da je potrebno provesti niz mjera za smanjivanje rizika kako bi se osiguralo da lijek za ublažavanje boli dobivaju samo djeca, u koje su koristi veće od rizika.
English: The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has endorsed by consensus a series of risk minimisation measures to address safety concerns with codeine-containing medicines when used for the management of pain in children.
Croatian: Koordinacijska grupa za postupak međusobnog priznavanja i decentralizirani postupak za humane lijekove (CMDh) potvrdila je konsenzusom niz mjera za smanjivanje rizika kako bi se riješila sigurnosna pitanja vezana uz lijekove, koji sadrže kodein, pri primjeni tih istih lijekova za upravljanje boli u djece.
English: • Mothers who are breastfeeding should not take codeine because codeine can pass to the baby through breast milk.
Croatian: • Majke koje doje ne smiju uzimati kodein jer se kodein može prenijeti na dijete putem majčinog mlijeka.
English: In addition, a published case report described a case of respiratory depression resulting in death in a breastfed infant whose codeine-using mother was a CYP2D6 ultra-rapid metaboliser.
Croatian: Nadalje, objavljen prikaz slučaja opisuje slučaj depresije disanja, koja je rezultirala smrću dojenčeta, čija je majka uzimala kodein i bila vrlo brzi metabolizator CYP2D6.
English: • Patients who are known to be ‘ultra-rapid metabolisers', which means that they are more at risk of serious side effects with codeine, should not use codeine as pain relief.
Croatian: • Bolesnici, za koje je poznato da su „vrlo brzi metabolizatori“, što znači da su izloženi većem riziku od ozbiljnih nuspojava izazvanih kodeinom, ne smiju uzimati kodein za ublažavanje boli.
English: Codeine is a widely used opioid medicine for pain relief.
Croatian: Kodein jest opioid široke primjene koji se upotrebljava za ublažavanje boli.
English: • Six cases (including 3 with a fatal outcome) of respiratory depression in children treated with codeine at recommended doses after undergoing tonsillectomy for obstructive sleep apnoea were reviewed.
Croatian: • Pregledano je šest slučajeva (uključujući 3 sa smrtnim ishodom) depresije disanja u djece liječene kodeinom u preporučenim dozama nakon podvrgavanja tonzilektomiji za opstruktivnu apneju u snu.
English: • Codeine is now contraindicated: in all paediatric patients (0-18 years of age) who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome and in patients of any age who are known to be CYP2D6 ultra-rapid metabolisers (up to approximately 10% of Caucasians are CYP2D6 ultra-rapid metabolisers, but prevalence differs according to racial and ethnic group), due to an increased risk of developing serious and life-threatening adverse reactions; and in women who are breastfeeding.
Croatian: • Kodein je sada kontraindiciran: za sve pedijatrijske bolesnike (0-18 godina), koji se podvrgavaju tonzilektomiji i/ili adenoidektomiji zbog sindroma opstruktivne apneje u snu u bolesnika bilo koje životne dobi, za koje je poznato da su vrlo brzi metabolizatori CYP2D6 (do otprilike 10% bijelaca je vrlo brzi metabolizatori CYP2D6, no učestalost se razlikuje ovisno o rasi i etničkoj grupi), zbog povećanog rizika od razvoja ozbiljnih nuspojava i nuspojava opasnih po život; te u žena koje doje.
English: Codeine should therefore not be used in people of any age who are known to be ultra-rapid metabolisers nor in breastfeeding mothers (because codeine can pass to the baby through breast milk).
Croatian: Stoga se kodein ne smije primjenjivati u ljudi bilo koje životne dobi, za koje je poznato da su vrlo brzi metabolizatori, te u dojilja (zato što se kodein može prenijeti na dijete majčinim mlijekom).
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as breathing difficulties.
Croatian: U ovih bolesnika, kodein je konvertiran u morfin u tijelu većom brzinom nego što je to uobičajeno, što rezultira višim razinama morfina u krvi, a to može uzrokovati toksične nuspojave poput poteškoća sa disanjem.
English: • Although morphine-induced side effects may occur at all ages, the current evidence suggests that children below 12 years are at special risk of life-threatening respiratory depression with codeine.
Croatian: • Iako nuspojave izazvane morfinom mogu nastupiti u svim životnim dobima, trenutni dokazi ukazuju da su djeca mlađa od 12 godina izložena posebnom riziku depresije disanja, koja je po život opasna i povezana s kodeinom.
English: • The available efficacy data on codeine for pain relief in children suggest that the analgesic effect of codeine on pain is not superior to that of other analgesics, such as non-steroidal anti-inflammatory drugs and non-opioid analgesics.
Croatian: • Dostupni podaci o djelotvornosti kodeina za ublažavanje boli u djece ukazuju da analgetički učinak kodeina na ublažavanje boli nije superioran u odnosu na isti učinak drugih analgetika, poput nesteoridnih protuupalnih lijekova i drugih neopioidnih analgetika.
English: The effect of codeine on pain is due to its conversion into morphine in the patient's body.
Croatian: Kodein djeluje na bol zbog njegove konverzije u morfin u tijelu bolesnika.
English: Some of the children who had suffered severe side effects had evidence of being ‘ultra-rapid metabolisers' of codeine.
Croatian: Pojedina djeca, kod koje su se manifestirale teške nuspojave, dokazano su bila „vrlo brzi metabolizatori“ kodeina.
English: Most of the cases occurred after surgical removal of the tonsils or adenoids for obstructive sleep apnoea (frequent interruption of breathing during sleep).
Croatian: Većina slučajeva nastupila je nakon kirurškog uklanjanja krajnika ili faringealnih tonzila zbog opstruktivne apneje u snu (čestih prekida disanja u snu).
English: The effect of codeine on pain is due to its conversion into morphine.
Croatian: Kodein djeluje na bol zbog konverzije u morfin.
English: • Codeine is now only indicated in patients older than 12 years of age for the treatment of acute moderate pain that cannot be relieved by other analgesics such as paracetamol or ibuprofen (alone).
Croatian: • Kodein je sada indiciran samo za bolesnike starije od 12 godina za liječenje akutne umjerene boli, koja se ne može ublažiti (samo) drugim analgeticima, poput paracetamola ili ibuprofena.
English: Some of the children were found to be CYP2D6 ultra-rapid metabolisers.
Croatian: Utvrđeno je da su pojedina djeca vrlo brzi metabolizatori CYP2D6.
English: • Codeine should not be used at all in children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea, as these patients are more susceptible to respiratory problems.
Croatian: • kodein se uopće ne smije primjenjivati u djece (mlađe od 18 godina), koja se podvrgavaju kirurškom zahvatu za uklanjanje krajnika ili faringealnih tonzila za liječenje opstruktivne apneje u snu, s obzirom da su ovi bolesnici skloniji poteškoćama s disanjem.
English: The children who had suffered severe side effects had evidence of being ‘CYP2D6 ultra-rapid metabolisers' of codeine.
Croatian: Djeca, kod koje su se manifestirale teške nuspojave, dokazano su bila „vrlo brzi metabolizatori CYP2D6“ kodeina.
English: • All children (aged below 18 years) who undergo surgery for the removal of the tonsils or adenoids to treat obstructive sleep apnoea (frequent interruption of breathing during sleep) should not be given codeine as they are more at risk of breathing problems.
Croatian: • Sva djeca (mlađa od 18 godina), koja se podvrgavaju operaciji uklanjanja krajnika ili faringealnih tonzila sa ciljem liječenja opstruktivne apneje u snu (čestog prekida disanja u snu), ne smiju uzimati kodein jer su izloženi većem riziku od poteškoća s disanjem.
English: Codeine is converted into morphine in the body by an enzyme called CYP2D6.
Croatian: Enzim naziva CYP2D6 konvertira kodein u morfin u tijelu.
English: • Because of a risk of breathing problems, the use of codeine medicines for pain relief in children has been restricted: these medicines are now only to be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen.
Croatian: • S obzirom na rizik od poteškoća s disanjem, primjena lijekova, koji sadrže kodein, za ublažavanje boli u djece ograničena je kako slijedi: ovi se lijekovi sada smiju primjenjivati samo za liječenje akutne (kratkoročne) umjerene boli u djece starije od 12 godina, te samo ako se bol ne može ublažiti drugim analgeticima, poput primjerice paracetamola ili ibuprofena.
English: In these patients, codeine is converted into morphine in the body at a faster rate than normal, resulting in high levels of morphine in the blood that can cause toxic effects such as respiratory depression.
Croatian: To rezultira većim razinama morfina u krvi, koje mogu uzrokovati toksične posljedice, poput primjerice depresije disanja.
English: • Codeine-containing medicines should only be used to treat acute (short lived) moderate pain in children above 12 years of age, and only if it cannot be relieved by other painkillers such as paracetamol or ibuprofen, because of the risk of respiratory depression associated with codeine use.
Croatian: • zbog rizika od depresije disanja povezane s uporabom kodeina, lijekovi koji sadrže kodein smiju se primjenjivati samo za liječenje akutne (kratkoročne) umjerene boli u djece starije od 12 godina, te samo ako se ista ne može ublažiti bilo kojim drugim analgetikom, poput paracetemola ili ibuprofena,
English: (See also section 4.6).
Croatian: (Također vidi odjeljak 4.6).
English: The reason for this longer half-life is unknown.
Croatian: Razlog tom duljem poluživotu nije poznat.
English: Tablets also contain the following ingredients
Croatian: Tablete također sadrže sljedeće sastojke:
English: Do not eat, drink, or smoke when handling the product.
Croatian: Nemojte jesti, piti niti pušiti dok rukujete proizvodom.
English: Wash hands after handling the product.
Croatian: Operite ruke nakon rukovanja proizvodom.
English: Dogs aged 12 months or more.
Croatian: Psi starosti 12 mjeseci ili više.
English: No drug interaction studies have been performed.
Croatian: Nisu provedene studije interakcija lijeka.
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY
Croatian: Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALIJA
English: Carton boxes containing one blister.
Croatian: Kartonske kutije koje sadržavaju jedan blister.
English: Date of last renewal: 12/08/2013.
Croatian: Datum posljednjeg produljenja odobrenja: 12/08/2013.
English: Advice for dog owner
Croatian: Savjet vlasniku psa
English: Particular attention should be paid to maintaining haemodynamic status.
Croatian: Posebnu pažnju treba posvetiti održavanju hemodinamskog statusa.
English: In rare cases these adverse reactions may be fatal.
Croatian: U rijetkim slučajevima te nuspojave mogu biti fatalne.
English: Adverse reactions could occur at any time point during this period.
Croatian: Nuspojave se mogu pojaviti u bilo kojem trenutku tijekom tog razdoblja.
English: Ask your veterinary surgeon how to dispose of medicines no longer required.
Croatian: Pitajte svojeg veterinara kako odlagati lijekove koji vam više nisu potrebni.
English: If your dog needs surgery, inform the surgeon that the dog is using Trocoxil.
Croatian: Ako je vašem psu potreban kirurški zahvat, obavijestite kirurga da pas uzima Trocoxil.
English: ATCvet code: QM01AH92.
Croatian: QM01AH92
English: The veterinary medicinal product does not require any special storage conditions.
Croatian: Ovaj veterinarsko-medicinski proizvod ne zahtijeva nikakve posebne uvjete čuvanja.
English: It therefore possesses analgesic and anti-inflammatory properties.
Croatian: Stoga posjeduje analgetička i protuupalna svojstva.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains:
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Svaka tableta za žvakanje sadržava:
English: MARKETING AUTHORISATION NUMBER(S) EU/2/08/084/001-005
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/08/084/001-005
English: Mavacoxib is 4-[5-(4-fluorophenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-benzenesulfonamide.
Croatian: Mavakoksib je 4-[5-(4-fluorofenil)-3-(trifluorometil)-1H-pirazol-1-il]-benzensulfonamid.
English: In laboratory studies with young adult dogs, mean elimination half-life values ranged from 13.8 to 19.3 days.
Croatian: U laboratorijskim studijama s mladim, odraslim psima srednje vrijednosti poluživota eliminacije bile su u rasponu od 13,8 do 19,3 dana.
English: Mavacoxib is well absorbed after oral administration; bioavailability was 87% in fed dogs and 46 % in fasted conditions and the recommended dose is based on administration with food.
Croatian: Mavakoksib se dobro apsorbira nakon oralne primjene, biološka raspoloživost iznosila je 87% u hranjenih pasa i 46% u uvjetima posta, a preporučena doza se temelji na primjeni s hranom.
English: Based on the results of canine whole blood assays, plasma concentrations producing 20% COX-1 inhibition and 80% COX-2 inhibition were 2.46 µg/mL and 1.28 µg/mL, respectively, so that the IC20COX-1:IC80COX-2 potency ratio is approximately 2:1, whilst the IC80COX-1:IC80COX-2 potency ratio is approximately 40:1.
Croatian: Na temelju rezultata analize kompletne krvi pasa, koncentracije u plazmi koje proizvode 20% inhibicije enzima COX-1 bile su 2,46 µg/mL, a one koje proizvode 80% inhibicije enzima COX-2 bile su 1,28 µg/mL, tako da je omjer potentnosti IC20COX-1:IC80COX-2 približno 2:1, dok je omjer potentnosti IC80COX-1:IC80COX-2 približno 40:1.
English: It is a diarylsubstituted pyrazole.
Croatian: To je diaril supstituirani pirazol.
English: Mavacoxib exhibits an extended plasma half life (up to > 80 days, see section 5.2) due to its low rate of elimination.
Croatian: Mavakoksib ima produljeni poluživot u plazmi (do > 80 dana, vidi odjeljak 5.2) zbog svoje niske stope eliminacije.
English: Trocoxil should not be used in dehydrated dogs.
Croatian: Trocoxil ne bi trebalo davati dehidriranim psima.
English: Similarly adverse reactions occurring at the use dose in the animal population principally involved the gastrointestinal system.
Croatian: Slično tomu, nuspojave koje se javljaju pri uporabnoj dozi u životinjskoj populaciji uglavnom su uključivale gastrointestinalni sustav.
English: Therapeutic concentrations in fed dogs are reached rapidly and peak concentrations are obtained in less than 24 hours after administering a dose.
Croatian: Terapeutske koncentracije u hranjenih pasa dosegnu se brzo, a najviše koncentracije dosegnu se za manje od 24 sata nakon primjene doze.
English: COX is a key enzyme in pathways of arachidonic acid metabolism.
Croatian: COX je ključni enzim u putovima metabolizma arahidonske kiseline.
English: Do not use in dogs less than 12 months of age and/or less than 5 kg body weight.
Croatian: Ne davati psima mlađima od 12 mjeseci i/ili lakšima od 5 kg.
English: Dogs should be carefully monitored if Trocoxil is administered simultaneously with an anticoagulant.
Croatian: Pse treba pažljivo nadzirati ako se Trocoxil primjenjuje istovremeno s antikoagulansom.
English: The treatment-free period should however, take into account the pharmacology of the medicinal products used previously.
Croatian: U razdoblju bez primjene lijekova treba uzeti u obzir farmakološka svojstva prethodno korištenih medicinskih proizvoda.
English: Population pharmacokinetic data derived from studies in dogs with a predominantly older population with heavier dogs as compared to the experimental studies (mean 9 years of age) showed that the mean elimination half-life was 39 days with a small sub-population (<5%) having an elimination half-life of more than 80 days and correspondingly an increased exposure was recorded in these individuals.
Croatian: Populacijski farmakokinetički podaci dobiveni iz studija na psima starije populacije težih pasa u usporedbi s eksperimentalnim studijama (prosječene starosti od 9 godina) pokazali su da je srednji poluživot eliminacije bio 39 dana, a poluživot eliminacije male podpopulacije (< 5%) bio je dulji od 80 dana pa je prema tome u tih jedinki zabilježena povišena izloženost.
English: There are two isoforms of COX, COX-1, and COX-2.
Croatian: COX ima dvije izoforme, COX-1 i COX-2.
English: Do not use in cases of heart insufficiency.
Croatian: Ne davati u slučajevima srčane insuficijencije.
English: Mavacoxib possessed a longer elimination half-life in clientowned animals.
Croatian: Mavakoksib je imao dulji poluživot eliminacije u životinja koje su bile u vlasništvu klijenata.
English: Medicines should not be disposed of via wastewater or household waste.
Croatian: Lijekovi se ne smiju bacati u otvorene vode ili kućni otpad.
English: These IC concentrations may be compared with mean trough concentrations of mavacoxib in plasma in clinical subjects of 0.52 and 1.11 µg/mL, respectively, after the first and fifth doses.
Croatian: Te IC koncentracije mogu se usporediti sa srednjim minimalnim koncentracijama mavakoksiba u plazmi u kliničkih ispitanika od 0,52 odnosno 1,11 µg/mL, nakon prve te nakon pete doze.
English: Pre-treatment with other anti-inflammatory substances may result in additional or increased adverse effects.
Croatian: Prethodno liječenje drugim protuupalnim sredstvima može uzrokovati dodatne ili pojačane nuspojave.
English: A maximum treatment administration of 6.5 months continuous therapy is recommended so as to manage plasma levels of mavacoxib in animals which exhibit reduced elimination
Croatian: Maksimalna primjena lijeka od 6,5 mjeseci neprekidne terapije preporučuje se kako bi se održale razine mavakoksiba u plazmi u životinja koje imaju smanjenu eliminaciju.
English: Risks for interactions have to be accounted for throughout the effect period i.e. 1-2 months after administration of Trocoxil.
Croatian: Opasnost od interakcija treba uzeti u obzir tijekom čitavog razdoblja djelovanja odnosno 1-2 mjeseca nakon primjene Trocoxila.
English: The key aim of intervention is to maintain renal perfusion.
Croatian: Ključni je cilj intervencije održati bubrežnu perfuziju.
English: A treatment cycle should not exceed 7 consecutive doses (6.5 months).
Croatian: Terapijski ciklus ne bi trebao biti veći od 7 uzastopnih doza (6,5 mjeseci).
English: Manufacturer responsible for batch release: Pfizer Italia s.r.l.
Croatian: Proizvođač odgovoran za puštanje serije u promet: Pfizer Italia s.r.l.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after Exp.
Croatian: Ne koristite veterinarsko-medicinski proizvod poslije isteka roka valjanosti naznačenog na kutiji i blisteru, poslije “Exp”.
English: Mavacoxib is approximately 98% bound to plasma proteins.
Croatian: Mavakoksib je približno 98% vezan na bjelančevine u plazmi.
English: Its activity culminates in the synthesis of local hormones and inflammatory mediators, termed eicosanoids, which include several prostaglandins.
Croatian: Njegovo djelovanje kulminira u sintezi lokalnih hormona i upalnih posrednika, pod nazivom eikozanoidi, koji uključuju nekoliko prostaglandina.