FrancophonIA/ELRC3.0 huggingface dataset:
English: Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
Croatian: prsišta i sredoprsja dispneja, disfonija, rinoreja, stezanje u grlu, bronhospazam, kašalj, laringealni/faringealni edem, faringitis, rinitis, kihanje
English: Rare (may affect up to 1 in 1000 people)
Croatian: Rijetko (mogu se javiti kod do 1 na 1000 osoba)
English: June 2018
Croatian: Završno izvješće o ispitivanju: lipanj 2018
English: Children and adolescents Optimark is not recommended in children who are below the age of two years.
Croatian: Ne preporučuje se primjena Optimarka kod djece mlađe od dvije godine.
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates.
Croatian: Zbog toga se Optimark ne smije davati bolesnicima kod kojih je transplantirana jetra, odnosno bolesnicima koji će biti podvrgnuti transplantaciji jetre te kod novorođenčadi.
English: 20 ml of the solution contain 28.75 mg sodium.
Croatian: 20 ml otopine sadrži 28,75 mg natrija.
English: The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide.
Croatian: Sljedeće nuspojave gadoversetamida zabilježene su u kliničkim istraživanjima i tijekom primjene kontrastnog sredstva nakon stavljanja na tržište.
English: It is unknown whether gadoversetamide is excreted in human milk.
Croatian: Nije poznato izlučuje li se gadoversetamid u majčino mlijeko u ljudi.
English: Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth
Croatian: Poremećaji probavnog sustava mučnina, proljev pojačana sekrecija sline, bolovi u abdomenu, konstipacija, suha usta povraćanje
English: Most of the adverse reactions were of mild to moderate intensity and transient in nature.
Croatian: Većina nuspojava je blaga do umjerena po svom intenzitetu i prolazna.
English: Pre-filled syringe Solution for injection in pre-filled syringe.
Croatian: Otopina za injekciju u napunjenoj štrcaljki.
English: The agent should be administered as a bolus peripheral intravenous injection.
Croatian: Pripravak treba primijeniti intravenskom injekcijom u obliku bolusa u perifernu venu.
English: Prior to using the syringe, twist off grey tip cap and discard.
Croatian: Prije uporabe štrcaljke, odvijte sivi zatvarač vrha štrcaljke i uklonite ga.
English: Each 30 ml syringe contains 9927 mg gadoversetamide.
Croatian: Jedna napunjena štrcaljka od 30 ml sadrži 9927 mg gadoversetamida.
English: Limited data with other gadolinium contrast agents suggests that for the exclusion of additional cranial metastases in a patient with a known solitary resectable metastasis, an MR exam with the injection of the dose of 300 micromol/kg body weight of Optimark may lead to higher diagnostic confidence.
Croatian: Ograničeni podaci dobiveni iz primjene drugih gadolinijskih kontrastnih sredstava upućuju da bi za isključivanje dodatnih kranijalnih metastaza u bolesnika s dokazanom operabilnom solitarnom metastazom, dijagnostički pouzdaniji mogao biti MR pregled uz injiciranje Optimarka u dozi od 300
English: Discard any remaining solution after first use.
Croatian: Otopinu koja preostane nakon prve primjene treba baciti.
English: ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin
Croatian: Pretrage poremećen kalcij u povišenje ALT-a, poremećeni nalazi u urinu, poremećeni nalazi elektrolita u urinu, albumin u urinu, povišeni CPK, sniženje produženje QT intervala na elektrokardiogramu
English: In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark.
Croatian: Kod primjene Optimarka u bolesnika s početnim oštećenjem funkcije bubrega nastala je akutna ozljeda bubrega koja je zahtijevala dijalizu.
English: Pre-filled syringes:
Croatian: Napunjene štrcaljke:
English: To enable immediate action in emergencies, the necessary medicinal products (e.g. epinephrine/ adrenaline, theophylline, antihistamines, corticosteroids and atropines), endotracheal tube and ventilator must be immediately available.
Croatian: epinefrin/adrenalin, teofilin, antihistaminici, kortikosteroidi i atropin), endotrahealni tubus i balon za ventilaciju moraju biti neposredno dostupni.
English: • Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
Croatian: Kontraindikacije: • Preosjetljivost na gadoversetamid, na druge pripravke koji sadrže gadolinij ili neku od pomoćnih tvari.
English: Solution for injection in vial 10 ml (1, 10 vials)
Croatian: Otopina za injekciju u bočici 10 ml (1, 10 bočica)
English: Vial 20 ml of the solution contain 28.75 mg sodium.
Croatian: Napunjena štrcaljka 20 ml otopine sadrži 28,75 mg natrija.
English: Up to 1 in 100 people may be affected.
Croatian: Ova pojava se javlja kod do 1 na 100 osoba koje prime lijek.
English: • if you are a patient who is about to have or has had a liver transplant as use of Optimark in patients with these conditions has been associated with a disease called nephrogenic systemic fibrosis (NSF).
Croatian: Optimarka u bolesnika s ovim stanjima povezana je s bolešću koja se naziva nefrogena sistemska fibroza (NSF).
English: The elimination half life in the 2 to 11 and 12 to 18 year age groups (1.4 ± 0.3 and 1.6± 0.3 h-1, respectively) is shorter than that observed in the two adult populations (1.9 ± 0.5 and 2.5± 0.5 h-1 in the 19 to 64 and ≥ 65 year of age groups, respectively).
Croatian: 0,3 h-1) kraće je od onog uočenog u dvije populacije odraslih (1,9 ± 0,5 i 2,5± 0,5 h-1 u skupini od 19
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Tekst na unutarnjem pakiranju napunjene štrcaljke od 10 ml
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period.
Croatian: Optimark je kontraindiciran kod bolesnika s teškim oštećenjem funkcije bubrega (GFR < 30 ml/min/1,73m²) i/ili akutnom ozljedom bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji će biti podvrgnuti transplantaciji jetre.
English: Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Croatian: Jedna napunjena štrcaljka od 30 ml sadrži 9927 mg gadoversetamida što odgovara 15 milimola.
English: The mean plasma clearance of gadoversetamide in healthy subjects (111.0 ± 14.1 ml/min/1.73m² BSA) is not significantly different from the mean renal clearance.
Croatian: Srednja vrijednost klirensa plazme gadoversetamida u zdravih ispitanika (111,0 ± 14,1 ml/min/1,73m²
English: Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
Croatian: Zbog toga se Optimark ne smije davati bolesnicima kod kojih je transplantirana jetra, odnosno bolesnicima koji će biti podvrgnuti transplantaciji jetre i novorođenčadi (vidjeti dio
English: Intravenous use.
Croatian: U venu.
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
Croatian: OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
English: The risk for development of NSF in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m²) is unknown; therefore Optimark should only be used after careful risk-benefit evaluation in patients with moderate renal impairment.
Croatian: Rizik od razvoja NSF-a kod bolesnika s umjerenim oštećenjem bubrega (GFR 30-59 ml/min/1,73m²) nije utvrđen, stoga Optimark kod takvih bolesnika treba primjenjivati samo nakon pažljive procjene odnosa koristi i rizika liječenja.
English: Cases of nephrogenic systemic fibrosis (NSF) have been reported with Optimark (see section 4.4).
Croatian: Prilikom primjene Optimarka zabilježeni su slučajevi nefrogene sistemske fibroze (NSF) (vidjeti dio
English: Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections
Croatian: 6.1 Popis pomoćnih tvari versetamid kalcijev hidroksid kalcijev klorid dihidrat natrijev hidroksid i/ili kloridna kiselina za podešavanje pH voda za injekcije
English: Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73m2) at a dose not exceeding 100 micromol/kg body weight (see section 4.4).
Croatian: Optimark treba primjenjivati kod bolesnika s umjerenim oštećenjem funkcije bubrega (GFR 30 - 59 ml/min/1,73 m²) tek nakon pažljive procjene odnosa koristi i rizika liječenja te u dozama koje ne prelaze 100 mikromola/kg tjelesne težine (vidjeti dio 4.4).
English: Hypoaesthesia, Paraesthesia, Parosmia
Croatian: disgeuzija konvulzije, tremor, somnolencija,
English: Frequency Common (may affect up to 1 in 10 people)
Croatian: Često (mogu se javiti kod do 1 na 10 osoba)
English: Effect of Renal Impairment
Croatian: Učinci oštećenja bubrega
English: 1 x 30 ml: EU/1/07/398/013 10 x 30 ml EU/1/07/398/014
Croatian: 1 x 10 ml: EU/1/07/398/001
English: Effects of Age:
Croatian: ROK VALJANOSTI Rok valjanosti:
English: Ear and Labyrinth Disorders
Croatian: Poremećaji uha i labirinta tinitus, vrtoglavica
English: Caution should be exercised in elderly patients.
Croatian: Kod starijih bolesnika ovaj lijek treba primjenjivati s oprezom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml, 20 ml and 30 ml pre-filled syringes
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Tekst na vanjskom pakiranju napunjenih štrcaljki od 10 ml, 15 ml, 20 ml i 30 ml
English: Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Croatian: Nakon primjene Optimarka treba prekinuti dojenje na barem 24 sata.
English: The peel-off tracking label on the pre-filled syringes should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used.
Croatian: Nakon uporabe treba odlijepiti naljepnicu sa napunjene štrcaljke te je nalijepiti u karton bolesnika kako bi se mogla voditi točna evidencija o primijenjenom kontrastnom sredstvu koje sadrži gadolinij.
English: Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral,
Croatian: osjećaj hladnoće (uključujući hladne udove), reakcije na mjestu primjene zimica, bol, otok lica, astenična stanja uključujući asteniju, umor i malaksalost, vrućica, periferni edem, abnormalno osjećanje
English: Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Croatian: Jedna napunjena štrcaljka od 20 ml sadrži 6618 mg gadoversetamida što odgovara 10 milimola.
English: Immune System Disorders
Croatian: Poremećaji imunološkog sustava anafilaktička reakcija
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Croatian: Jedna napunjena štrcaljka od 15 ml sadrži 4963,5 mg gadoversetamida što odgovara 7,5 milimola.
English: Each 10 ml syringe contains 3309 mg gadoversetamide.
Croatian: Jedna napunjena štrcaljka od 10 ml sadrži 3309 mg gadoversetamida.
English: Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Croatian: Jedna bočica od 20 ml sadrži 6618 mg gadoversetamida što odgovara 10 milimola.
English: 30 ml (1, 10 syringes)
Croatian: 30 ml (1, 10 štrcaljki)
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
Croatian: UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
English: Optimark should only be used after careful risk/benefit evaluation in patients with moderate renal impairment (GFR 30-59 ml/min/1.73 m2) at a dose not exceeding 100 micromol/kg body weight.
Croatian: Optimark treba primjenjivati kod bolesnika s umjerenim oštećenjem funkcije bubrega (GFR 30 - 59 ml/min/1,73 m²) tek nakon pažljive procjene odnosa koristi i rizika liječenja te u dozama koje ne prelaze 100 mikromola/kg tjelesne težine.
English: Gastrointestinal Disorders
Croatian: Tablični prikaz nuspojava
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Tekst na vanjskom pakiranju bočica od 10 ml, 15 ml i 20 ml
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Croatian: Jedna napunjena štrcaljka od 15 ml sadrži 4963,5 mg gadoversetamida.
English: Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Croatian: Jedna bočica od 15 ml sadrži 4963,5 mg gadoversetamida što odgovara 7,5 milimola.
English: Each 20 ml syringe contains 6618 mg gadoversetamide.
Croatian: Jedna napunjena štrcaljka od 20 ml sadrži 6618 mg gadoversetamida.
English: 20 ml (1, 10 syringes)
Croatian: 20 ml (1, 10 štrcaljki)
English: 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Croatian: 1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
English: As the renal clearance of gadoversetamide may be impaired in the elderly, it is particularly important to screen patients aged 65 years and older for renal dysfunction.
Croatian: vrlo je bitno provjeriti je li kod bolesnika koji imaju 65 ili više godina prisutna bubrežna disfunkcija.
English: Dizziness,
Croatian: Nije primjenjivo.
English: What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Croatian: Optimark štrcaljke sadrže bistru, bezbojnu do blijedožutu otopinu.
English: 15 ml (1, 10 syringes)
Croatian: 15 ml (1, 10 štrcaljki)
English: Pre-filled syringe 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011 10 x 20 ml: EU/1/07/398/012
Croatian: Napunjena štrcaljka 1 x 10 ml: EU/1/07/398/007 10 x 10 ml: EU/1/07/398/008 1 x 15 ml: EU/1/07/398/009 10 x 15 ml: EU/1/07/398/010 1 x 20 ml: EU/1/07/398/011 10 x 20 ml: EU/1/07/398/012 1 x 30 ml: EU/1/07/398/013 10 x 30 ml EU/1/07/398/014
English: Calcium hydroxide
Croatian: mokraćnog sustava hematurija
English: How Optimark is given
Croatian: Kako primjenjivati Optimark
English: Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.
Croatian: Više doze sadrže 1 mmol natrija ili više.
English: Nervous System Disorders
Croatian: Poremećaji živčanog sustava glavobolja,
English: SPECIAL STORAGE CONDITIONS Keep the syringe in the outer carton in order to protect from light.
Croatian: Napunjena štrcaljka Štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: (See Annex I: Summary of Product Characteristics, section 4.2).
Croatian: Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
English: to <1/100)
Croatian: (≥1/1000 i <1/100)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki gadoversetamid i.v.primjena
English: Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Croatian: Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki gadoversetamid
English: Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Croatian: Jedna napunjena štrcaljka od 10 ml sadrži 3309 mg gadoversetamida što odgovara 5 milimola.
English: Versetamide
Croatian: Učestalost
English: 15 ml (1, 10 vials)
Croatian: 15 ml (1, 10 bočica)
English: 20 ml (1, 10 vials)
Croatian: 20 ml (1, 10 bočica)
English: Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Croatian: TVARI 1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
English: NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Croatian: NAZIV LIJEKA Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki
English: AUTHORISATION
Croatian: Primjena
English: Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Croatian: Napunjena štrcaljka 1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
English: Vial Solution for injection in vial.
Croatian: Bočica Otopina za injekciju u bočici.
English: Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Croatian: Jedna bočica od 10 ml sadrži 3309 mg gadoversetamida što odgovara 5 milimola.
English: Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Croatian: Optimark 500 mikromol/ml otopina za injekciju u bočici gadoversetamid
English: Optimark is contraindicated in patients with severe renal impairment (GFR < 30 ml/min/1.73m2) and/or acute renal injury and in patients who have had liver transplantation or in patients in the perioperative liver transplantation period (see section 4.3).
Croatian: ml/min/1,73m²) i/ili akutnom ozljedom bubrega, bolesnika kojima je transplantirana jetra i bolesnika koji će biti podvrgnuti transplantaciji jetre (vidjeti dio 4.3).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Tekst na unutarnjem pakiranju napunjenih štrcaljki od 15 ml, 20 ml i 30 ml
English: Vascular Disorders
Croatian: Prijavljivanje nuspojava
English: Urticaria, Cold sweat, Erythema, Hyperhidrosis
Croatian: Poremećaji kože i potkožnog tkiva pruritus, osip urtikarija, hladno znojenje,
English: You must not be given Optimark if
Croatian: Ako ste primijenite više Optimarka nego što ste trebali
English: OTHER SPECIAL WARNING(S), IF NECESSARY This sticky label should be stuck on patient records.
Croatian: Ovu naljepnicu je potrebno nalijepiti na karton bolesnika.
English: 6.3 Shelf-life
Croatian: 6.3 Rok valjanosti
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Tekst na unutarnjem pakiranju bočica od 15 ml i 20 ml
English: • in patients in the perioperative liver transplantation period and
Croatian: • kod bolesnika koji će biti podvrgnuti transplantaciji jetre i
English: Posology and method of administration
Croatian: OZNAČAVANJE I UPUTA O LIJEKU
English: For the re-examination procedure the PRAC confirmed its previous position.
Croatian: Za postupak ponovne procjene PRAC je potvrdio svoje prethodno stajalište.
English: More about the procedures
Croatian: Više o postupcima
English: While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
Croatian: Dok je ponovni pregled bio u tijeku, pojedine države članice odlučile su suspendirati ili ograničiti stavljanje u promet ili uporabu tih lijekova na svojim teritorijima.
English: In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
Croatian: U skladu sa zakonodavstvom EU-a, ova vrsta akcije zahtijevala je provođenje postupka procjene EU-a.
English: * The CMDh is a medicines regulatory body representing the European Union (EU) Member States
Croatian: * CMDh je regulatorno tijelo za lijekove koje predstavlja države članice Europske unije (EU)
English: 19 December 2013 EMA/809470/2013
Croatian: 19. prosinca 2013. EMA/809470/2013
English: Information for healthcare professionals
Croatian: Informacije za zdravstvene djelatnike
English: • Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
Croatian: • Bolesnici koji imaju bilo kakva pitanja ili bojazni trebaju se obratiti svom liječniku, ljekarniku ili medicinskoj sestri.
English: HES will be available in restricted patient populations
Croatian: HES će biti dostupna za ograničenu populaciju bolesnika
English: Blood coagulation parameters should be monitored carefully in case of repeated administration.
Croatian: Parametre koagulacije krvi treba nadzirati pažljivo u slučaju ponovljene primjene.
English: The expected benefit of treatment should be carefully weighed against the uncertainties with regard to long-term safety, and other available treatment options should be considered.
Croatian: Očekivanu dobrobit od liječenja treba pažljivo usporediti s neizvjesnostima u pogledu dugoročne sigurnosti te je potrebno razmotriti druge dostupne mogućnosti liječenja.
English: A review of HES solutions for infusion was initiated on 29 November 2012 at the request of the German medicines agency, under Article 31 of Directive 2001/83/EC.
Croatian: Procjena otopina za infuziju HES-a započela je 29. studenog 2012. na zahtjev njemačke Agencije za lijekove u skladu s člankom 31. Direktive 2001/83/EK.
English: These recommendations are based on a review of all available safety and efficacy data, including recent data4,5,6, from clinical studies, meta-analyses and post-marketing experience.
Croatian: Te se preporuke temelje na procjeni svih dostupnih podataka o sigurnosti i djelotvornosti uključujući nedavne podatke4,5,6 iz kliničkih ispitivanja, meta analiza i iskustva nakon stavljanja lijeka u promet.
English: However, new evidence was considered in the parallel Article 107i procedure and this was the basis for the PRAC's final recommendation on the use of HES solutions.
Croatian: Međutim, novi dokaz razmatran je istovremeno u okviru postupka prema članku 107.i te je to bio temelj za konačnu preporuku PRAC-a o uporabi otopina HES-a.
English: This review procedure ran in parallel with the re-examination of the PRAC's June 2013 recommendation and both procedures were finalised on 10 October 2013.
Croatian: Postupak procjene provodio se istovremeno s ponovnim pregledom preporuke PRAC-a od lipnja 2013., a oba su postupka dovršena 10. listopada 2013.
English: Siegemund M. Firstly presented at European Society of Anaesthesiology conference 2012.
Croatian: Prvi puta prikazano na konferenciji Europskog udruženja za anesteziju 2012.
English: Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Croatian: Shodno tome, 27. lipnja 2013., UK je pokrenula procjenu EU-a o otopinama HES-a u skladu sa člankom 107.i Direktive 2001/83/EZ.
English: This review, which had been carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), concluded on 13 June 2013, but some of the marketing authorisation holders requested a re-examination.
Croatian: Procjena, koju je provelo Povjerenstvo za procjenu rizika u farmakovigilanciji (PRAC), zaključena je 13. lipnja 2013., ali neki od nositelja odobrenja za stavljanje lijeka u promet zahtijevali su ponovni pregled.
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-a, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima diljem EU-a.
English: There are two main types of medicines used for volume replacement: crystalloids and colloids.
Croatian: Postoje dvije glavne vrste lijekova koji se koriste za zamjenski volumen: kristaloidi i koloidi.
English: Annane D. et al. CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial.
Croatian: CRISTAL: Colloids Compared to Crystalloids in Fluid Resuscitation of Critically Ill Patients: A Multinational Randomised Controlled Trial.
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Croatian: Povećana potreba za bubrežnom nadomjesnom terapijom prijavljena je do 90 dana nakon primjene HES-a.