FrancophonIA/ELRC3.0 huggingface dataset:
English: Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe.
Croatian: Polako povlačite klip kako biste izvukli otopinu kroz nastavak za bočicu natrag u štrcaljku.
English: Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: generaliziranu urtikariju, glavobolju, hipotenziju, letargiju, mučninu, nemir, tahikardiju) rijetko su opažene i mogu, u nekim slučajevima, napredovati do teške anafilaksije (uključujući šok).
English: The calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL.
Croatian: 1 međunarodna jedinica (IU) faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: Dose based on bodyweight may require adjustment in underweight and overweight patients.
Croatian: U pothranjenih bolesnika i bolesnika s prekomjernom tjelesnom težinom može biti potrebna prilagodba doze obzirom na tjelesnu težinu.
English: The solvent provided for preparation of the solution to inject, is a clear, colourless solution.
Croatian: Otapalo priloženo za pripremu otopine koja će se ubrizgati je bistra, bezbojna tekućina.
English: • The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein).
Croatian: - Djelatna tvar je efmoroktokog alfa (rekombinantni faktor zgrušavanja krvi VIII, Fc fuzijski protein).
English: Type of surgical procedure
Croatian: Stupanj krvarenja / vrsta kirurškog postupka
English: Protect product from direct sunlight.
Croatian: Zaštitite lijek od izravne sunčeve svjetlosti.
English: Following a washout period of at least 96 hours (4 days), the subjects received a single dose of 50 IU/kg of ELOCTA.
Croatian: (4 dana) ispitanici su primili jednu dozu od 50 IU/kg lijeka ELOCTA.
English: On-demand treatment
Croatian: Liječenje prema potrebi
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: 4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: AUC/Dose (IU*h/dL per IU/kg)
Croatian: Postupni oporavak (IU/dl po IU/kg) AUC/doza (IU*h/dl po IU/kg) t½ (h)
English: H) 1 Gauze pad
Croatian: H) 1 kompresu od gaze
English: Median annual factor consumption was 4700 IU/kg (min 3819, max 8230 IU/kg) in Study II and 4990 IU/kg (min 3856, max 9527) in Study III.
Croatian: 3819, maks. 8230 IU/kg) u Ispitivanju II i 4990 IU/kg (min.
English: Table 4: Pharmacokinetic parameters of ELOCTA using the chromogenic assay Pharmacokinetic parameters1
Croatian: Tablica 4: Farmakokinetički parametri lijeka ELOCTA određeni pomoću kromogenog testa Farmakokinetički parametri1
English: Pharmacokinetic parameters of ELOCTA were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 120 hours (5 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 72 hours (3 days) post-dose).
Croatian: (5 dana) poslije doziranja) i za djecu u ispitivanju II (farmakokinetički uzorci bili su prikupljeni prije doziranja, a potom u više vremenskih točaka u razdoblju od 72 sata (3 dana) poslije doziranja).
English: The reconstituted solution should be clear to slightly opalescent and colourless.
Croatian: Rekonstituirana otopina mora biti bistra do blago zamućena i bezbojna.
English: Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Croatian: t½= poluvijek eliminacije; CL = klirens; MRT = srednja vrijednost vremena zadržavanja; Vss = volumen distribucije u stanju dinamičke ravnoteže.
English: Once you have prepared ELOCTA it should be used right away.
Croatian: Lijek ELOCTA mora se primijeniti odmah nakon pripreme.
English: The prepared solution will be clear to slightly opalescent and colourless.
Croatian: Pripremljena otopina bit će bistra do blago zamućena i bezbojna.
English: Median annual factor consumption was 5572 IU/kg (min 3849, max 7035) in Study I and 4456 IU/kg (min 3563, max 8011) in Study III.
Croatian: Medijan godišnje potrošnje faktora bio je 5572 IU/kg (min. 3849, maks. 7035) u Ispitivanju
English: More extensive haemarthrosis, muscle bleeding or haematoma
Croatian: krvarenje u mišiće ili hematom
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: Prašak saharoza natrijev klorid L-histidin kalcijev klorid dihidrat polisorbat 20 natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: Signs of allergic reactions may include generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure.
Croatian: stezanje u prsima, otežano disanje ili nizak krvni tlak.
English: After preparation, the solution to inject is clear to slightly opalescent and colourless.
Croatian: Nakon pripreme otopina koja će se ubrizgati je bistra do blago zamućena i bezbojna.
English: Nervous system disorders
Croatian: Poremećaji živčanog sustava glavobolja omaglica disgeuzija manje često
English: Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Croatian: Prije primjene potrebno je vizualno pregledati rekonstituirani lijek na prisutnost čestica i promjenu boje.
English: ELOCTA 250 IU powder for injection ELOCTA 500 IU powder for injection ELOCTA 750 IU powder for injection ELOCTA 1000 IU powder for injection ELOCTA 1500 IU powder for injection ELOCTA 2000 IU powder for injection ELOCTA 3000 IU powder for injection ELOCTA 4000 IU powder for injection ELOCTA 5000 IU powder for injection ELOCTA 6000 IU powder for injection efmoroctocog alfa recombinant coagulation factor VIII IV
Croatian: ELOCTA 250 IU prašak za injekciju ELOCTA 500 IU prašak za injekciju ELOCTA 750 IU prašak za injekciju ELOCTA 1000 IU prašak za injekciju ELOCTA 1500 IU prašak za injekciju ELOCTA 2000 IU prašak za injekciju ELOCTA 3000 IU prašak za injekciju ELOCTA 4000 IU prašak za injekciju ELOCTA 5000 IU prašak za injekciju ELOCTA 6000 IU prašak za injekciju efmoroctocog alfa rekombinantni faktor zgrušavanja krvi VIII i.v.
English: Posology
Croatian: Ispitivanje
English: Respective median ABR was 3.59 (min 0, max 58.0) and 2.24 (min 0, max 17.2).
Croatian: 58,0) i 2,24 (min. 0; maks.
English: After reconstitution, each mL of solution for injection contains approximately 83 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 83 IU efmoroktokoga alfa.
English: ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa.
Croatian: ELOCTA 750 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 750 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Sodium chloride
Croatian: Izraženija hemartroza,
English: Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Croatian: 15. Odvojite štrcaljku od nastavka za bočicu nježnim povlačenjem i zakretanjem bočice u suprotnom smjeru od kazaljke na satu.
English: Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening.
Croatian: Štrcaljku s otapalom spojite s nastavkom za bočicu tako što ćete vrh štrcaljke uvesti u otvor nastavka.
English: Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Croatian: Čvrsto ga pritisnite prema dolje dok ne sjedne na mjesto na vrhu bočice, tako da šiljak nastavka probije čep bočice.
English: Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package.
Croatian: Nemojte odvajati nastavak od njegovog zaštitnog zatvarača.
English: Respective median ABR was 2.01 (min 0, max 27.2) and 1.59 (min 0, max 8.0).
Croatian: 27,2) i 1,59 (min. 0; maks.
English: After reconstitution, each mL of solution for injection contains approximately 1333 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1333 IU efmoroktokoga alfa.
English: ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU efmoroctocog alfa.
Croatian: ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Median annual factor consumption was 5146 IU/kg (min 3695, max 8474) in Study II and 5418 IU/kg (min 3435, max 9564) in Study III.
Croatian: 3695, maks. 8474) u Ispitivanju II i 5418 IU/kg
English: ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU efmoroctocog alfa.
Croatian: ELOCTA 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU efmoroktokoga alfa (efmoroctocog alfa).
English: After reconstitution, each mL of solution for injection contains approximately 333 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 333 IU efmoroktokoga alfa.
English: ELOCTA 6000 IU powder and solvent for solution for injection Each vial contains nominally 6000 IU efmoroctocog alfa.
Croatian: ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 6000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Table 6: Pharmacokinetic parameters of ELOCTA for paediatrics using the chromogenic assay Pharmacokinetic parameters1
Croatian: Tablica 6: Farmakokinetički parametri lijeka ELOCTA u pedijatrijskih ispitanika određeni pomoću kromogenog testa
English: The solution should appear clear to slightly opalescent and colourless.
Croatian: Otopina izgledom mora biti bistra do blago zamućena i bezbojna.
English: After reconstitution, each mL of solution for injection contains approximately 2000 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 2000 IU efmoroktokoga alfa.
English: ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa.
Croatian: ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1500 IU efmoroktokoga alfa (efmoroctocog alfa).
English: After reconstitution, each mL of solution for injection contains approximately 250 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 250 IU efmoroktokoga alfa.
English: ELOCTA 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU efmoroctocog alfa.
Croatian: ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 4000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: After reconstitution, each mL of solution for injection contains approximately 667 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 667 IU efmoroktokoga alfa.
English: ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU efmoroctocog alfa.
Croatian: ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 3000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Do not refrigerate the prepared solution.
Croatian: Pripremljenu otopinu ne držite u hladnjaku.
English: After reconstitution, each mL of solution for injection contains approximately 1667 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1667 IU efmoroktokoga alfa.
English: Respective median ABR was 1.92 (min 0, max 7.1) and 1.25 (min 0, max 9.5).
Croatian: 7,1) i 1,25 (min. 0; maks.
English: After reconstitution, each mL of solution for injection contains approximately 500 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 500 IU efmoroktokoga alfa.
English: ELOCTA 5000 IU powder and solvent for solution for injection Each vial contains nominally 5000 IU efmoroctocog alfa.
Croatian: ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 5000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Weekly prophylaxis: Median annual factor consumption was 3805 IU/kg (min 3353, max 6196) in Study I and 3510 IU/kg (min 2758, max 3984) in Study III.
Croatian: Tjedna profilaksa: Medijan godišnje potrošnje faktora bio je 3805 IU/kg (min.
English: After reconstitution, each mL of solution for injection contains approximately 167 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 167 IU efmoroktokoga alfa.
English: Treatment of bleeding: 2490 bleeding events were treated during Study I and III with a median dose of 43.8 IU/kg (min 13.0, max 172.8) to control each bleed.
Croatian: I i III liječeno je 2490 slučajeva krvarenja medijanom doze od
English: ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU efmoroctocog alfa.
Croatian: ELOCTA 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU efmoroktokoga alfa (efmoroctocog alfa).
English: After reconstitution, each mL of solution for injection contains approximately 1000 IU efmoroctocog alfa.
Croatian: Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1000 IU efmoroktokoga alfa.
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa recombinant coagulation factor VIII, Fc fusion protein
Croatian: ELOCTA 250 IU prašak i otapalo za otopinu za injekciju ELOCTA 500 IU prašak i otapalo za otopinu za injekciju ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju efmoroctocog alfa rekombinantni faktor zgrušavanja krvi VIII, Fc fuzijski protein
English: ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa.
Croatian: ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU efmoroktokoga alfa (efmoroctocog alfa).
English: Table 3: Pharmacokinetic parameters of ELOCTA using the one-stage clotting assay Pharmacokinetic parameters1
Croatian: Tablica 3: Farmakokinetički parametri lijeka ELOCTA određeni pomoću jednostupanjskog testa zgrušavanja krvi Farmakokinetički parametri
English: ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa (recombinant coagulation factor VIII)
Croatian: ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju efmoroktokog alfa (efmoroctocog alfa) (rekombinantni faktor zgrušavanja krvi VIII)
English: Respective median Annualized Bleed Rate (ABR) was 0.00 (min 0, max 10.5) and 1.18 (min 0, max 9.2).
Croatian: Odgovarajući medijani godišnje stope krvarenja bili su 2,01 (min. 0; maks.
English: Respective median Annualized Bleed Rate (ABR) was 1.60 (min 0, max 18.2) and 0.74 (min 0, max 15.6).
Croatian: Odgovarajući medijani godišnje stope krvarenja bili su 1,60 (min. 0; maks.
English: Respiratory, thoracic, and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja kašalj manje često
English: Individualised prophylaxis: Median annual factor consumption was 4212 IU/kg (min 2877, max 7943) in Study I and 4223 IU/kg (min 2668, max 8317) in Study III.
Croatian: Individualizirana profilaksa: Medijan godišnje potrošnje faktora bio je 4212 IU/kg (min.
English: ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection
Croatian: ELOCTA 250 IU prašak i otapalo za otopinu za injekciju ELOCTA 500 IU prašak i otapalo za otopinu za injekciju ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju
English: Haemorrhage
Croatian: ROK VALJANOSTI
English: On-demand treatment: Median annual factor consumption was 1039 IU/kg (min 280, max 3571) for 23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min 286, max 913) for 6 patients remaining on on-demand treatment for at least one year in Study III.
Croatian: Liječenje prema potrebi: Medijan godišnje potrošnje faktora bio je 1039 IU/kg (min.
English: Table 5: Pharmacokinetic parameters of ELOCTA for paediatrics using the one-stage clotting assay Pharmacokinetic parameters1
Croatian: Tablica 5: Farmakokinetički parametri lijeka ELOCTA u pedijatrijskih ispitanika određeni pomoću jednostupanjskog testa zgrušavanja krvi
English: Each pack contains: - powder in a type 1 glass vial with a chlorobutyl rubber stopper - 3 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper - a plunger rod - a sterile vial adapter for reconstitution - a sterile infusion set - two alcohol swabs - two plasters - one gauze pad.
Croatian: - 3 ml otapala u napunjenoj štrcaljki od stakla tipa 1 s čepom klipa od brombutilne gume - klip
English: Attach the syringe with the prepared ELOCTA solution to the end of the infusion set tubing by turning clockwise.
Croatian: ELOCTA na kraj cijevi kompleta za infuziju tako što ćete je zakrenuti u smjeru kazaljke na satu.
English: You should always use ELOCTA exactly as your doctor has told you, check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Uvijek primijenite lijek ELOCTA točno onako kako Vam je rekao liječnik.
English: Pack size
Croatian: 3 bočice
English: 28 June 2013 EMA/385716/2013
Croatian: 28. lipnja 2013. EMA/385716/2013
English: Contact our press officers Monika Benstetter or Martin Harvey
Croatian: Obratite se našim predstavnicima za tisak Monika Benstetter ili Martin Harvey
English: The review was initiated on 3 October 2012, at the request of the United Kingdom medicines agency under Article 31 of Directive 2001/83/EC.
Croatian: Pregled je započet dana 3. listopada 2012. godine, na zahtjev Agencije za lijekove Ujedinjenog Kraljevstva prema članku 31. Direktive 2001/83/EZ.
English: The CMDh agreed with the PRAC's conclusions and endorsed the following recommendations:
Croatian: CMDh suglasan je s zaključkom PRAC i potvrdio je sljedeće preporuke:
English: • Codeine should be used at the lowest effective dose for the shortest period of time.
Croatian: • Kodein treba uzimati u najmanjoj djelotvornoj dozi tijekom najkraćeg vremenskog razdoblja.
English: • If you or your child are being treated with codeine and have any questions or concerns about your treatment, speak to your doctor or pharmacist.
Croatian: • Ako se Vi ili Vaše dijete liječite kodeinom i imate bilo kakvih pitanja ili nejasnoća u vezi liječenja, obratite se svom liječniku ili ljekarniku.
English: The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
Croatian: CMDh, tijelo koje predstavlja države članice EU, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene putem nacionalnih postupaka diljem EU.
English: • The pharmacokinetic profile of codeine has been studied in adults but limited information is available in children.
Croatian: • Farmakokinetički profil kodeina ispitan je i u odraslih, no ograničene informacije dostupne su u djece.
English: It is also used in the treatment of coughs, although this use in not covered by the current review.
Croatian: Lijek se, također, primjenjuje za liječenje kašlja, iako ova primjena nije obuhvaćena aktualnim pregledom.
English: The risk of side effects with codeine may also apply to adults.
Croatian: Rizik od nuspojava s kodeinom može se primijeniti i na odrasle osobe.
English: As the CMDh position was adopted by consensus, it will be directly implemented by the Member States.
Croatian: S obzirom da je mišljenje CMDh usvojeno konsenzusom, bit će izravno primijenjeno od strane država članica.
English: This follows a review of these medicines by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which investigated reports of serious and fatal respiratory depression in children after taking codeine for pain relief.
Croatian: Iz navedenog proizlazi pregled ovih lijekova od strane Povjerenstva za ocjenu rizika na području farmakovigilancije (PRAC) pri EMA, koje je istražilo izvješća o ozbiljnoj i smrtonosnoj depresiji disanja u djece nakon uzimanja kodeina za ublažavanje boli.
English: The available data suggest that there is a reduced ability to metabolise codeine in younger children but that the enzyme system responsible for the metabolism of codeine can be considered to be fully matured by the age of 12.
Croatian: Dostupni podaci ukazuju da postoji smanjena sposobnost probavljanja kodeina u mlađe djece, no sustav enzima odgovoran za metabolizam kodeina može se smatrati potpuno zrelim u 12. godini života.
English: There also seems to be a particular risk in those paediatric patients who might already have compromised airways and who require pain relief following tonsillectomy and/or adenoidectomy.
Croatian: Čini se da postoji poseban rizik u pedijatrijskih bolesnika čiji su zračni putovi već ugroženi i koji zahtijevaju ublažavanje boli nakon tonzilektomije i/ili adenoidektomije.