natgillin/translations-raw huggingface dataset:
decreased appetite, feeling anxious, sleep disorder, drowsy feeling, burning sensation, a sensation of movement or spinning, ringing in the ears, eyelid redness, eye pain, vision blurred, bloodshot eyes, awareness of the heartbeat, irregular heartbeats, extra heartbeats, low blood pressure, shortness of breath, hoarseness, runny nose, throat constriction, mouth watering, abdominal pain, constipation, dry mouth, hives, cold sweat, redness, higher blood level of a substance (creatinine) usually eliminated by the kidneys, blood in urine, face swollen, weakness and similar symptoms like fatigue and general feeling of being unwell, fever, swelling in limbs, chill, pain, cold feeling in extremities, liver enzyme increased, urine analysis abnormal, mineral values in urine increased, protein in urine, heart and muscle enzyme increased, decreased haemoglobin, feeling confused and disoriented, shaking, convulsion, pink eye, fast heart beat, high blood pressure, tightening of the airways, swollen throat or voice box, raw throat, cough, itchy nose, sneezing, sweating
povišena koncentracija u krvi tvari (kreatinin) koja se izlučuje bubrezima, krv u urinu, otečenost lica, slabost i slični simptomi poput umora i općenito lošeg osjećanja, vrućica, otečenost udova, zimica, bol, osjećaj hladnoće u udovima, povišenje jetrenih enzima, poremećeni nalazi analize mokraće, povišene vrijednosti minerala u mokraći, proteini u mokraći, povišeni srčani i mišićni enzimi, sniženje hemoglobina, osjećaj smetenosti i dezorijentacije, tresavica, konvulzije, ružičasta boja očiju, ubrzani otkucaji srca, visoki krvni tlak, suženje dišnih puteva, otečenost grla ili grkljana, suhoća grla, kašalj, svrbež nosa, kihanje,
Prior to administration of Optimark, all patients should be screened for renal dysfunction by obtaining laboratory tests.
Prije primjene Optimarka, potrebno je kod svih bolesnika laboratorijskim testovima isključiti bubrežnu disfunkciju.
10 ml vials and 15 ml vials contain less than 1 mmol sodium; i.e. they are essentially ‘sodium free‘.
Bočice sa 10 ml i 15 ml sadrže manje od 1 mmol natrija; tj. zanemarive količine natrija.
Inspect the syringe for signs of leakage.
Provjerite da iz štrcaljke ne curi otopina.
Do not use this medicine after the expiry date which is stated on the carton and on the syringe label after EXP.
Ovaj lijek ne smije se upotrijebiti nakon isteka roka valjanosti navedenog na pakiranju i naljepnici štrcaljke iza „Rok valjanosti“.
OTHER SPECIAL WARNING(S), IF NECESSARY Contrast medium for magnetic resonance imaging For recording: stick the peel-off tracking label onto the patient record.
DRUGO(A) POSEBNO(A) UPOZORENJE(A), AKO JE POTREBNO Kontrastno sredstvo za snimanje magnetskom rezonancijom
Rhinorrhoea, Throat tightness, Laryngeal/pharyngeal oedema, Pharyngitis, Rhinitis, Sneezing
prsišta i sredoprsja dispneja, disfonija, rinoreja, stezanje u grlu, bronhospazam, kašalj, laringealni/faringealni edem, faringitis, rinitis, kihanje
Rare (may affect up to 1 in 1000 people)
Rijetko (mogu se javiti kod do 1 na 1000 osoba)
June 2018
Završno izvješće o ispitivanju: lipanj 2018
Children and adolescents Optimark is not recommended in children who are below the age of two years.
Ne preporučuje se primjena Optimarka kod djece mlađe od dvije godine.
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates.
Zbog toga se Optimark ne smije davati bolesnicima kod kojih je transplantirana jetra, odnosno bolesnicima koji će biti podvrgnuti transplantaciji jetre te kod novorođenčadi.
20 ml of the solution contain 28.75 mg sodium.
20 ml otopine sadrži 28,75 mg natrija.
The following adverse reactions have been reported from clinical trials and from post-marketing use of gadoversetamide.
Sljedeće nuspojave gadoversetamida zabilježene su u kliničkim istraživanjima i tijekom primjene kontrastnog sredstva nakon stavljanja na tržište.
It is unknown whether gadoversetamide is excreted in human milk.
Nije poznato izlučuje li se gadoversetamid u majčino mlijeko u ljudi.
Salivary hypersecretion,, Abdominal pain, Constipation, Dry mouth
Poremećaji probavnog sustava mučnina, proljev pojačana sekrecija sline, bolovi u abdomenu, konstipacija, suha usta povraćanje
Most of the adverse reactions were of mild to moderate intensity and transient in nature.
Većina nuspojava je blaga do umjerena po svom intenzitetu i prolazna.
Pre-filled syringe Solution for injection in pre-filled syringe.
Otopina za injekciju u napunjenoj štrcaljki.
The agent should be administered as a bolus peripheral intravenous injection.
Pripravak treba primijeniti intravenskom injekcijom u obliku bolusa u perifernu venu.
Prior to using the syringe, twist off grey tip cap and discard.
Prije uporabe štrcaljke, odvijte sivi zatvarač vrha štrcaljke i uklonite ga.
Each 30 ml syringe contains 9927 mg gadoversetamide.
Jedna napunjena štrcaljka od 30 ml sadrži 9927 mg gadoversetamida.
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.
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
Discard any remaining solution after first use.
Otopinu koja preostane nakon prve primjene treba baciti.
ALT increased, Urine analysis abnormal, Urine electrolytes abnormal, albumin in urine, CPK Increased, Haemoglobin
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
In patients with baseline renal impairment, acute kidney injury requiring dialysis has occurred with the use of Optimark.
Kod primjene Optimarka u bolesnika s početnim oštećenjem funkcije bubrega nastala je akutna ozljeda bubrega koja je zahtijevala dijalizu.
Pre-filled syringes:
Napunjene štrcaljke:
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.
epinefrin/adrenalin, teofilin, antihistaminici, kortikosteroidi i atropin), endotrahealni tubus i balon za ventilaciju moraju biti neposredno dostupni.
• Hypersensitivity to gadoversetamide or to other gadolinium containing products or to any of the excipients.
Kontraindikacije: • Preosjetljivost na gadoversetamid, na druge pripravke koji sadrže gadolinij ili neku od pomoćnih tvari.
Solution for injection in vial 10 ml (1, 10 vials)
Otopina za injekciju u bočici 10 ml (1, 10 bočica)
Vial 20 ml of the solution contain 28.75 mg sodium.
Napunjena štrcaljka 20 ml otopine sadrži 28,75 mg natrija.
Up to 1 in 100 people may be affected.
Ova pojava se javlja kod do 1 na 100 osoba koje prime lijek.
• 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).
Optimarka u bolesnika s ovim stanjima povezana je s bolešću koja se naziva nefrogena sistemska fibroza (NSF).
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).
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
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml vial
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Tekst na unutarnjem pakiranju napunjene štrcaljke od 10 ml
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.
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.
Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15 millimol.
Jedna napunjena štrcaljka od 30 ml sadrži 9927 mg gadoversetamida što odgovara 15 milimola.
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.
Srednja vrijednost klirensa plazme gadoversetamida u zdravih ispitanika (111,0 ± 14,1 ml/min/1,73m²
Therefore, Optimark must not be used in patients who have had or are undergoing liver transplantation and in neonates (see section 4.3).
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
Intravenous use.
U venu.
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING
OSTALI UVJETI I ZAHTJEVI ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU
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.
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.
Cases of nephrogenic systemic fibrosis (NSF) have been reported with Optimark (see section 4.4).
Prilikom primjene Optimarka zabilježeni su slučajevi nefrogene sistemske fibroze (NSF) (vidjeti dio
Sodium hydroxide and/or hydrochloric acid for pH adjustment Water for injections
6.1 Popis pomoćnih tvari versetamid kalcijev hidroksid kalcijev klorid dihidrat natrijev hidroksid i/ili kloridna kiselina za podešavanje pH voda za injekcije
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).
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).
Hypoaesthesia, Paraesthesia, Parosmia
disgeuzija konvulzije, tremor, somnolencija,
Frequency Common (may affect up to 1 in 10 people)
Često (mogu se javiti kod do 1 na 10 osoba)
Effect of Renal Impairment
Učinci oštećenja bubrega
1 x 30 ml: EU/1/07/398/013 10 x 30 ml EU/1/07/398/014
1 x 10 ml: EU/1/07/398/001
Effects of Age:
ROK VALJANOSTI Rok valjanosti:
Ear and Labyrinth Disorders
Poremećaji uha i labirinta tinitus, vrtoglavica
Caution should be exercised in elderly patients.
Kod starijih bolesnika ovaj lijek treba primjenjivati s oprezom.
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
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Tekst na vanjskom pakiranju napunjenih štrcaljki od 10 ml, 15 ml, 20 ml i 30 ml
Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark.
Nakon primjene Optimarka treba prekinuti dojenje na barem 24 sata.
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.
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.
Chills, Pain, Face oedema, Asthenic conditions including asthenia, fatigue, and malaise, Fever, Oedema peripheral,
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
Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10 millimol.
Jedna napunjena štrcaljka od 20 ml sadrži 6618 mg gadoversetamida što odgovara 10 milimola.
Immune System Disorders
Poremećaji imunološkog sustava anafilaktička reakcija
Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Jedna napunjena štrcaljka od 15 ml sadrži 4963,5 mg gadoversetamida što odgovara 7,5 milimola.
Each 10 ml syringe contains 3309 mg gadoversetamide.
Jedna napunjena štrcaljka od 10 ml sadrži 3309 mg gadoversetamida.
Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Jedna bočica od 20 ml sadrži 6618 mg gadoversetamida što odgovara 10 milimola.
30 ml (1, 10 syringes)
30 ml (1, 10 štrcaljki)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
UVJETI ILI OGRANIČENJA VEZANI UZ OPSKRBU I PRIMJENU
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.
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.
Gastrointestinal Disorders
Tablični prikaz nuspojava
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Tekst na vanjskom pakiranju bočica od 10 ml, 15 ml i 20 ml
Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Jedna napunjena štrcaljka od 15 ml sadrži 4963,5 mg gadoversetamida.
Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Jedna bočica od 15 ml sadrži 4963,5 mg gadoversetamida što odgovara 7,5 milimola.
Each 20 ml syringe contains 6618 mg gadoversetamide.
Jedna napunjena štrcaljka od 20 ml sadrži 6618 mg gadoversetamida.
20 ml (1, 10 syringes)
20 ml (1, 10 štrcaljki)
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
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.
vrlo je bitno provjeriti je li kod bolesnika koji imaju 65 ili više godina prisutna bubrežna disfunkcija.
Dizziness,
Nije primjenjivo.
What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Optimark štrcaljke sadrže bistru, bezbojnu do blijedožutu otopinu.
15 ml (1, 10 syringes)
15 ml (1, 10 štrcaljki)
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
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
Calcium hydroxide
mokraćnog sustava hematurija
How Optimark is given
Kako primjenjivati Optimark
Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.
Više doze sadrže 1 mmol natrija ili više.
Nervous System Disorders
Poremećaji živčanog sustava glavobolja,
SPECIAL STORAGE CONDITIONS Keep the syringe in the outer carton in order to protect from light.
Napunjena štrcaljka Štrcaljku čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
(See Annex I: Summary of Product Characteristics, section 4.2).
Lijek se izdaje na ograničeni recept (vidjeti Dodatak I: Sažetak opisa svojstava lijeka, dio 4.2).
to <1/100)
(≥1/1000 i <1/100)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki gadoversetamid i.v.primjena
Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki gadoversetamid
Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Jedna napunjena štrcaljka od 10 ml sadrži 3309 mg gadoversetamida što odgovara 5 milimola.
Versetamide
Učestalost
15 ml (1, 10 vials)
15 ml (1, 10 bočica)
20 ml (1, 10 vials)
20 ml (1, 10 bočica)
Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
TVARI 1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
NAZIV LIJEKA Optimark 500 mikromol/ml otopina za injekciju u napunjenoj štrcaljki
AUTHORISATION
Primjena
Pre-filled syringe 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Napunjena štrcaljka 1 ml sadrži 330,9 mg gadoversetamida, što odgovara 500 mikromola.
Vial Solution for injection in vial.
Bočica Otopina za injekciju u bočici.
Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Jedna bočica od 10 ml sadrži 3309 mg gadoversetamida što odgovara 5 milimola.
Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Optimark 500 mikromol/ml otopina za injekciju u bočici gadoversetamid
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).
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).
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Tekst na unutarnjem pakiranju napunjenih štrcaljki od 15 ml, 20 ml i 30 ml
Vascular Disorders
Prijavljivanje nuspojava
Urticaria, Cold sweat, Erythema, Hyperhidrosis
Poremećaji kože i potkožnog tkiva pruritus, osip urtikarija, hladno znojenje,
You must not be given Optimark if
Ako ste primijenite više Optimarka nego što ste trebali
OTHER SPECIAL WARNING(S), IF NECESSARY This sticky label should be stuck on patient records.
Ovu naljepnicu je potrebno nalijepiti na karton bolesnika.
6.3 Shelf-life
6.3 Rok valjanosti
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU Tekst na unutarnjem pakiranju bočica od 15 ml i 20 ml
• in patients in the perioperative liver transplantation period and
• kod bolesnika koji će biti podvrgnuti transplantaciji jetre i
Posology and method of administration
OZNAČAVANJE I UPUTA O LIJEKU
For the re-examination procedure the PRAC confirmed its previous position.
Za postupak ponovne procjene PRAC je potvrdio svoje prethodno stajalište.
More about the procedures
Više o postupcima
While the re-examination was ongoing, some Member States decided to suspend or limit the marketing or use of these medicines in their territories.
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.
In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
U skladu sa zakonodavstvom EU-a, ova vrsta akcije zahtijevala je provođenje postupka procjene EU-a.
* The CMDh is a medicines regulatory body representing the European Union (EU) Member States
* CMDh je regulatorno tijelo za lijekove koje predstavlja države članice Europske unije (EU)
19 December 2013 EMA/809470/2013
19. prosinca 2013. EMA/809470/2013
Information for healthcare professionals
Informacije za zdravstvene djelatnike
• Patients who have any questions or concerns should speak to the treating doctor, pharmacist or nurse.
• Bolesnici koji imaju bilo kakva pitanja ili bojazni trebaju se obratiti svom liječniku, ljekarniku ili medicinskoj sestri.
HES will be available in restricted patient populations
HES će biti dostupna za ograničenu populaciju bolesnika
Blood coagulation parameters should be monitored carefully in case of repeated administration.
Parametre koagulacije krvi treba nadzirati pažljivo u slučaju ponovljene primjene.
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.
Očekivanu dobrobit od liječenja treba pažljivo usporediti s neizvjesnostima u pogledu dugoročne sigurnosti te je potrebno razmotriti druge dostupne mogućnosti liječenja.
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.
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.
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.
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.
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.
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.
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.
Postupak procjene provodio se istovremeno s ponovnim pregledom preporuke PRAC-a od lipnja 2013., a oba su postupka dovršena 10. listopada 2013.
Siegemund M. Firstly presented at European Society of Anaesthesiology conference 2012.
Prvi puta prikazano na konferenciji Europskog udruženja za anesteziju 2012.
Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
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.
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.
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.
The CMDh, a body representing EU Member States, is responsible for ensuring harmonised safety standards for medicines authorised via national procedures across the EU.
CMDh, tijelo koje predstavlja države članice EU-a, odgovorno je za osiguravanje usklađenih sigurnosnih standarda za lijekove odobrene nacionalnim postupcima diljem EU-a.
There are two main types of medicines used for volume replacement: crystalloids and colloids.
Postoje dvije glavne vrste lijekova koji se koriste za zamjenski volumen: kristaloidi i koloidi.