FrancophonIA/ELRC3.0 huggingface dataset:
English: • in patients with severe renal impairment (GFR <30ml/min/1.73m2) and/or acute kidney injury,
Estonian: • tõsise neerukahjustusega patsientidel (päsmakeste filtratsioonikiirus (GFR) <30 ml/min/1,73 m2)
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).
Estonian: Optimark on vastunäidustatud tõsise neerukahjustusega patsientidel (päsmakeste filtratsioonikiirus (GFR) <30 ml/min/1,73 m2) ja/või ägeda neeruvigastusega patsientidel, kellel on siirdatud maks või kellele siirdatakse maksa (vt lõik 4.3).
English: Each 15 ml vial contains 4963.5 mg gadoversetamide.
Estonian: Iga 15 ml viaal sisaldab 4963,5 mg gadoversetamiidi.
English: If solids remain, the vial must be discarded.
Estonian: Tahkete osakeste olemasolul tuleb viaal hävitada.
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
Estonian: VÄLISPAKENDILPEAVAD OLEMA JÄRGMISED ANDMED Tekst 10 ml, 15 ml, 20 ml ja 30 ml süstlite välispakendile
English: Insertion of a flexible in-dwelling venous catheter is recommended.
Estonian: Soovitatav on elastse püsiveenikateetri paigaldus.
English: There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of Optimark and some gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73 m²) and/or acute kidney injury.
Estonian: Optimark'i ja mõnede gadoliiniumi sisaldavate kontrastainete kasutamisel raske ägeda või kroonilise neerukahjustusega ja/või ägeda neeruvigastusega patsientidel (GFR <30 ml/min/1,73 m2) on esinenud nefrogeenset süsteemset fibroosi (NSF).
English: Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10 millimol.
Estonian: Iga 20 ml viaal sisaldab 6618 mg gadoversetamiidi, mis on ekvivalentne 10 millimooliga.
English: Optimark contains sodium
Estonian: Optimark'i sisaldab naatriumi
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide.
Estonian: Iga 15 ml süstel sisaldab 4963,5 mg gadoversetamiidi.
English: Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Estonian: Iga 15 ml viaal sisaldab 4963,5 mg gadoversetamiidi, mis on ekvivalentne 7,5 millimooliga.
English: Effect of Gender:
Estonian: Soolised erinevused
English: Hypoaesthesia, Paraesthesia, Parosmia
Estonian: Ärevus, unehäired, segasus ja
English: Nervous System Disorders
Estonian: Närvisüsteemi häired Peavalud, düsgeusia
English: Frequency Common (may affect up to 1 in 10 people)
Estonian: Esinemis-sagedus Võimalikud kõrvaltoimed Sage (võib mõjutada kuni ühte inimsest10st)
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.
Estonian: Optimark on vastunäidustatud tõsise neerukahjustusega patsientidel (päsmakeste filtratsioonikiirus (GFR) <30 ml/min/1,73 m2) ja/või ägeda neeruvigastusega patsientidel, kellel on siirdatud maks või kellele siirdatakse maksa.
English: Central nervous system disorders
Estonian: Kesknärvisüsteemi häired
English: What Optimark looks like and contents of the pack Optimark syringes contain a clear, colourless to pale yellow solution.
Estonian: Optimark'i süstlid sisaldavad läbipaistvat, värvitut kuni kahvatukollast lahust.
English: What Optimark looks like and contents of the pack Optimark vials contain a clear, colourless to pale yellow solution.
Estonian: Optimark'i viaalid sisaldavad läbipaistvat, värvitut kuni kahvatukollast lahust.
English: Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5 millimol.
Estonian: Iga 10 ml viaal sisaldab 3309 mg gadoversetamiidi, mis on ekvivalentne 5 millimooliga.
English: 1 x 15 ml 10 x 15 ml
Estonian: 1 x 15 ml
English: SPECIAL STORAGE CONDITIONS Keep the vial in the outer carton in order to protect from light.
Estonian: SÄILITAMISE ERITINGIMUSED Hoida viaali välispakendis, valguse eest kaitstult.
English: Keep the syringe in the outer carton in order to protect from light.
Estonian: Hoidke süstleid välispakendis, valguse eest kaitstult.
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).
Estonian: Mõõduka neerukahjustuse korral (GFR 30-59 ml/min/1,73 m2) võib Optimark'i kasutada ainult pärast kasu- ja riskiprofiili hoolikat kaalumist ja annuses kuni 100 mikromooli/kg kehakaalu kohta (vt lõik 4.4).
English: Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to 7.5 millimol.
Estonian: Iga 15 ml süstel sisaldab 4963,5 mg gadoversetamiidi, mis on ekvivalentne 7,5 millimooliga.
English: Keep the vial in the outer carton in order to protect from light.
Estonian: Hoidke viaale välispakendis, valguse eest kaitstult.
English: Prior to using the syringe, twist off grey tip cap and discard.
Estonian: Enne süstli kasutamist tuleb hall otsakork süstli küljest lahti keerata ja ära visata.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Estonian: TOIMEAINE(TE) SISALDUS 1 ml sisaldab 330,9 mg gadoversetamiidi, mis on ekvivalentne 500 mikromooliga.
English: NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in pre-filled syringe Optimark 500 micromol/ml solution for injection in vial
Estonian: RAVIMPREPARAADI NIMETUS Optimark 500 mikromooli/ml süstelahus süstelis Optimark 500 mikromooli/ml süstelahus viaalis
English: Solution for injection in vial 10 ml (1, 10 vials)
Estonian: Süstelahus viaalis 10 ml (1, 10 viaali) 15 ml (1, 10 viaali) 20 ml (1, 10 viaali)
English: PHARMACEUTICAL FORM AND CONTENTS Solution for injection in vial 15 ml
Estonian: RAVIMVORM JA PAKENDI SUURUS Süstelahus viaalis
English: Each 20 ml vial contains 6618 mg gadoversetamide.
Estonian: Iga 20 ml viaal sisaldab 6618 mg gadoversetamiidi1
English: Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5 millimol.
Estonian: Iga 10 ml süstel sisaldab 3309 mg gadoversetamiidi, mis on ekvivalentne 5 millimooliga.
English: 1 x 20 ml 10 x 20 ml
Estonian: 10 x 20 ml
English: Uncommon (may affect up to 1 in 100 people)
Estonian: Aeg-ajalt (võib mõjutada kuni ühte inimest 100st)
English: 1 x 30 ml 10 x 30 ml
Estonian: 10 x 30 ml
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Text for the outer packaging of 10 ml, 15 ml and 20 ml vials
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Tekst 10 ml, 15 ml ja 20 ml viaalide välispakendile
English: Feeling hot
Estonian: Väga harv
English: Pre-filled syringe
Estonian: Viaal Süstelahus viaalis.
English: 1 x 10 ml 10 x 10 ml
Estonian: 1 x 10 ml
English: Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Estonian: Optimark 500 mikromooli/ml süstelahus viaalis Gadoversetamiid
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml vial
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL
English: 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Estonian: 1 ml sisaldab 330,9 mg gadoversetamiidi, mis on ekvivalentne 500 mikromooliga.
English: Serum iron and zinc
Estonian: Raua- ja tsingisisaldus seerumis
English: 1 x 10 ml 10 x 10 ml 1 x 15 ml 10 x 15 ml 1 x 20 ml 10 x 20 ml
Estonian: Süstelahus süstlis 10 ml (1, 10 süstelit) 15 ml (1, 10 süstelit) 20 ml (1, 10 süstelit) 30 ml (1, 10 süstelit)
English: Rare (may affect up to 1 in 1000 people)
Estonian: Harv (võib mõjutada kuni ühte inimest 1000st)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml, 20 ml and 30 ml pre-filled syringes
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Tekst 15 ml, 20 ml ja 30 ml süstelite sisepakendile
English: Palpitations, AV block first Tachycardia, Arrhythmia
Estonian: Palpitatsioonid, 1. astme AVblokaad, ekstrasüstolid, tahhükardia,
English: Vial 1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Estonian: Viaal 1 ml sisaldab 330,9 mg gadoversetamiidi, mis on ekvivalentne 500 mikromooliga.
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.
Estonian: Äratõmmatav märgendsilt süstlil tuleb gadoliiniumkontrastaine kasutamise täpseks registreerimiseks kleepida patsiendi haigusloole.
English: Optimark must not be administered with an autoinjector to children of 2 to 11 years.
Estonian: Lastele vanuses 2…11 ei ole lubatud Optimark'i manustamine autoinjektoriga.
English: NAME OF THE MEDICINAL PRODUCT Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Estonian: RAVIMPREPARAADI NIMETUS Optimark 500 mikromooli/ml süstelahus viaalis Gadoversetamiid
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.
Estonian: Mõõduka neerukahjustuse korral (GFR 30-59 ml/min/1,73 m2) võib Optimark'i kasutada ainult pärast kasu- ja riskiprofiili hoolikat kaalumist ja annuses kuni 100 mikromooli/kg kehakaalu kohta.
English: The peel-off tracking label on the vials should be stuck onto the patients record to enable accurate recording of the gadolinium contrast agent used.
Estonian: Äratõmmatav märgendsilt viaalidel tuleb gadoliiniumkontrastaine kasutamise täpseks registreerimiseks kleepida patsiendi haigusloole.
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
Estonian: 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: Nasal congestion, Throat irritation
Estonian: Ninakinnisus, kurguärritus
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in vial Gadoversetamide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Optimark 500 mikromooli/ml süstelahus viaalis Gadoversetamiid
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Text for the immediate packaging of 15 ml and 20 ml vials
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED Tekst 15 ml ja 20 ml viaalide sisepakendile
English: Special Populations
Estonian: Kasutamine eakatel
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Optimark 500 micromol/ml solution for injection in pre-filled syringe Gadoversetamide
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Optimark 500 mikromooli/ml süstelahus süstelis Gadoversetamiid
English: Higher doses contain 1 mmol sodium or more, which should be taken into consideration for patients on a controlled sodium diet.
Estonian: Sellega tuleb arvestada kontrollitud naatriumisisaldusega dieedil olevatel patsientide puhul.
English: Common (may affect up to 1 in 10 people)
Estonian: Sage (võib mõjutada kuni ühte inimsest10st)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Text for the immediate packaging of the 10 ml pre-filled syringe
Estonian: Tekst 10 ml süstli vahetule sisepakendile
English: Non-clinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity.
Estonian: Reproduktiivse toksilisuse mittekliinilised tavauuringud ei ole näidanud kahjulikku toimet inimesele.
English: OTHER SPECIAL WARNING(S), IF NECESSARY Contrast medium for magnetic resonance imaging For recording: stick the peel-off tracking label onto the patient record.
Estonian: Registreerimiseks: kleepige äratõmmatav jälgimismärgis patsiendi haigusloosse.
English: Discard syringe and unused portion of the solution after use.
Estonian: Pärast kasutamist tuleb süstal ja kasutamata jäänud lahus hävitada.
English: AUTHORISATION
Estonian: Näidustused
English: Excipient(s) with known effect:
Estonian: Teadaolevat toimet omav abiaine:
English: Gastrointestinal Disorders
Estonian: Kontrastaine magnetresonantstomograafiaks
English: Alapis Romania SRL, Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025
Estonian: Alapis Romania SRL, Romania, Leordeni nr.13 Street, Bragadiru, IIfov County, 077025 Romania
English: List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, applicant(s) in the Member States
Estonian: Ravimite nimetuste, ravimvormide, tugevuste, manustamisviiside, taotlejate loetelu liikmesriikides
English: Levotiroxina Alapis
Estonian: Levotiroxina Alapis 100 microgram/ml
English: Continuous release means that monensin is released slowly from the device.
Estonian: Pidevalt vabastav tähendab, et monensiini vabastatakse vahendist aeglaselt.
English: This summary was last updated on 28 January 2013.
Estonian: Kokkuvõtte viimane uuendus: 28/01/2013.
English: Kexxtone monensin
Estonian: Kexxtone monensiin
English: The cumulative ketosis rate was 11.5% in the Kexxtone group compared with 25.6% in the placebo group.
Estonian: Ketoosi kumulatiivne esinemissagedus oli 11,5% Kexxtone rühmas võrreldes 25,6%-ga platseeborühmas.
English: It attaches to the surface of bacterial cells and interferes with the mechanism for transporting nutrients.
Estonian: See kinnitub bakterirakkude pinnale ja sekkub toitainete transportimise mehhanismi.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Kexxtone on 28 January 2013.
Estonian: Euroopa Komisjon andis Kexxtone müügiloa, mis kehtib kogu Euroopa Liidu territooriumil 28/01/2013.
English: Other information about Kexxtone:
Estonian: Muu teave Kexxtone kohta:
English: Kexxtone must not be used in animals weighing less than 300 kg.
Estonian: Kexxtonet ei tohi kasutada alla 300 kg kaaluvatel loomadel.
English: Dogs, horses, other equines or guinea fowl must not be allowed access to Kexxtone as consumption of intraruminal device contents can be fatal in these species.
Estonian: Koerad, hobused, muud hobuslased ja pärlkanad ei tohi Kexxtonega kokku puutuda, sest intraruminaalse ravivahendi sisu tarbimine võib olla neile liikidele surmav.
English: If damaged a new intraruminal device should be used.
Estonian: Kui vahend on kahjustatud, tuleb kasutada uut intraruminaalset ravivahendit.
English: Exposure to monensin may result in an allergic response in certain people.
Estonian: Kokkupuude monensiiniga võib mõnedel inimestel põhjustada allergilise reaktsiooni.
English: It is mainly active against Gram-positive bacteria.
Estonian: Ravim toimib peamiselt grampositiivsete bakterite vastu.
English: This improves energy production in the cow's body and reduces the level of ketones in the blood.
Estonian: Nii paraneb lehma organismi energiatoodang ja väheneb ketoonide sisaldus veres.
English: The main measure of effectiveness was the cumulative rate of clinical ketosis in the cows over the 15 to 16 weeks after calving.
Estonian: Efektiivsuse põhinäitaja oli kliinilise ketoosi kumulatiivne esinemissagedus lehmadel 15-16 nädala jooksul pärast poegimist.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Kexxtone exceed the risks for the approved indication and recommended that Kexxtone be given a marketing authorisation.
Estonian: Veterinaarravimite komitee järeldas, et Kexxtone kasulikkus on heakskiidetud näidustusel suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: Kexxtone has been studied in one main study involving 1,312 commercial dairy cows.
Estonian: Kexxtonet uuriti ühes põhiuuringus, mis hõlmas 1312 lüpsilehma.
English: Accidental administration of more than one intraruminal device could result in side effects typical of monensin overdose, including decreased appetite, scouring (diarrhoea) and lethargy.
Estonian: Rohkem kui ühe intraruminaalse ravivahendi juhuslik manustamine võib põhjustada monensiini üleannustamise tüüpilisi sümptomeid, sealhulgas vähenenud söögiisu, kõhulahtisust ja letargiat.
English: People should not eat, drink or smoke while handling Kexxtone.
Estonian: Kexxtone käsitsemise ajal ei tohi süüa, juua ega suitsetada.
English: Kexxtone is a veterinary medicine that contains the active substance monensin.
Estonian: Kexxtone on veterinaarravim, mis sisaldab toimeainena monensiini.
English: If this occurs, the product should be re-administered if undamaged.
Estonian: Sellisel juhul tuleb vahend uuesti manustada, kui see on terve.
English: A single dose of Kexxtone was compared with a placebo (dummy treatment) given three to four weeks before the expected calving date.
Estonian: Kexxtone üksikannust võrreldi platseeboga (toimeaineta ravim), mida manustati kolm kuni neli nädalat enne oodatavat poegimiskuupäeva.
English: People who are known to be hypersensitive (allergic) to monensin or any of the ingredients should avoid contact with the product.
Estonian: Inimesed, kes on monensiini või ravimi mis tahes koostisaine suhtes teadaolevalt ülitundlikud (allergilised), peavad kokkupuudet selle veterinaarravimiga vältima.
English: Clinical ketosis was defined based on a minimum level of the substance ß-hydroxybutyrate in the blood in combination with one or more clinical signs of ketosis.
Estonian: Kliiniline ketoos määratleti ß-hüdroksübutüraadi minimaalse sisalduse alusel veres koos ühe või enama ketoosi kliinilise nähuga.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Estonian: Ravimi kasulikkuse ja riski suhe on käesoleva Euroopa avaliku hindamisaruande teadusliku arutelu kokkuvõttes.
English: Treated cattle should be held in a confined area for one hour after administration to observe for failure to swallow or regurgitation.
Estonian: Ravitud veiseid tuleb pärast ravimi manustamist hoida piiratud alal ühe tunni jooksul neelamisraskuste või regurgitatsiooni jälgimiseks.
English: It is available as a continuous-release intraruminal device (a device administered through the animal's mouth and placed within the rumen, or first stomach, of cattle).
Estonian: Seda turustatakse toimeainet pidevalt vabastava intraruminaalse ravivahendina (vahend, mis manustatakse loomale suu kaudu ja paigutatakse veise vatsa ehk esimesse makku).
English: Ketosis is a metabolic disturbance in which blood glucose levels are low and substances called ketones (such as acetoacetatic acid and β-hydroxybutyrate) accumulate in the blood.
Estonian: Ketoos on ainevahetushäire, mille korral vere glükoosisisaldus on väike ja ketoonideks nimetatavad ained (nagu atsetoäädikhape ja β-hüdroksübutüraat) kuhjuvad veres.
English: The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat or milk used for human consumption.
Estonian: Keeluaeg on alates ravimi manustamisest arvestatav aeg, mille jooksul ei tohi looma tappa ega tema liha või piima toiduks tarvitada.
English: Gloves should be removed and hands and exposed skin washed after handling the product.
Estonian: Pärast vahendi käsitsemist tuleb kindad eemaldada ja käed ning ravimiga kokkupuutunud nahk puhtaks pesta.
English: The withdrawal period for Kexxtone for cattle is zero days for meat and milk.
Estonian: Kexxtone puhul on veiste liha ja piima keeluaeg null päeva.
English: What is Kexxtone?
Estonian: Mis on Kexxtone?
English: The person administering Kexxtone should wear gloves when handling the product, including when retrieving a regurgitated intraruminal device.
Estonian: Kexxtonet manustav inimene peab vahendi, sealhulgas suu kaudu väljutatud vahendi käsitsemisel kandma kindaid.
English: Monensin changes the population of microbes in the rumen resulting in an increase of the bacteria that produce propionate, a substance used to make glucose.
Estonian: Monensiin muudab vatsas mikroobide populatsiooni, mille tulemusena suureneb bakterite arv, mis toodavad propionaati.
English: Kexxtone is used to reduce the incidence of ketosis in dairy cows and heifers which are expected to develop ketosis in the period around calving.
Estonian: Kexxtonet kasutatakse ketoosi esinemissageduse vähendamiseks lüpsilehmadel ja mullikatel, kellel võib poegimisperioodil tekkida ketoos.
English: Why has Kexxtone been approved?
Estonian: Miks Kexxtone heaks kiideti?
English: A single intraruminal device is given to a dairy cow or heifer three to four weeks before the expected calving, using an appropriate administration tool.
Estonian: Üks intraruminaalne vahend paigaldatakse vastava manustamisvahendi abil lüpsilehmale või mullikale kolm kuni neli nädalat enne oodatavat poegimist.
English: What is the risk associated with Kexxtone?
Estonian: Mis riskid Kexxtonega kaasnevad?
English: How does Kexxtone work?
Estonian: Kuidas Kexxtone toimib?
English: The active substance in Kexxtone, monensin, is an antibiotic produced by natural fermentation.
Estonian: Kexxtone toimeaine monensiin on loodusliku käärimisprotsessi teel toodetud antibiootikum.
English: What is Kexxtone used for?
Estonian: Milleks Kexxtonet kasutatakse?
English: How has Kexxtone been studied?
Estonian: Kuidas Kexxtonet uuriti?
English: What benefit has Kexxtone shown during the studies?
Estonian: Milles seisneb uuringute põhjal Kexxtone kasulikkus?
English: Cattle should be re-checked for up to four days after dosing in case the intraruminal device has not been fully swallowed and has lodged in the oesophagus (the gullet or tube leading from the mouth to the rumen).
Estonian: Veiseid tuleb kuni nelja päeva jooksul pärast manustamist kontrollida intraruminaalse ravivahendi mittetäieliku allaneelamise ja söögitorus paiknemise suhtes.
English: References: 1.
Estonian: Viited 1.
English: 19 December 2013 EMA/809470/2013
Estonian: 19. detsember 2013 EMA/809470/2013
English: In accordance with EU legislation, this type of action required that an EU review procedure be carried out.
Estonian: Euroopa Liidu õigusaktide kohaselt vajab selline tegevus Euroopa Liidu läbivaatusmenetluse korraldamist.
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.
Estonian: Taasläbivaatamise ajal otsustas mõni liikmesriik peatada või piirata nende ravimite müüki või kasutamist oma territooriumil.
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.
Estonian: HESi infusioonilahuste läbivaatamine algas 29. novembril 2012 Saksamaa ravimiameti taotlusel vastavalt direktiivi 2001/83/EÜ artiklile 31.
English: Tel. +44 (0)20 7418 8427 E-mail: press@ema.europa.eu
Estonian: Tel +44 (0)20 7418 8427 E-post: press@ema.europa.eu
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.
Estonian: Läbivaatusmenetlus toimus paralleelselt riskihindamiskomitee 2013. aasta juuni soovituse taasläbivaatamisega ja mõlemad menetlused lõppesid 10. oktoobril 2013.
English: For the re-examination procedure the PRAC confirmed its previous position.
Estonian: Taasläbivaatamise menetluses kinnitas riskihindamiskomitee oma eelmist arvamust.
English: Consequently, on 27 June 2013, the UK triggered an EU review of HES solutions under Article 107i of Directive 2001/83/EC.
Estonian: Selle tõttu algatas Ühendkuningriik 27. juunil 2013 HESi lahuste läbivaatamise vastavalt direktiivi 2001/83/EÜ artiklile 107i.
English: More about the procedures
Estonian: Menetluse lisateave
English: An increased need for renal replacement therapy has been reported up to 90 days after HES administration.
Estonian: On teatatud renaalse asendusravi suurenenud vajadusest kuni 90 päeva jooksul pärast HESi manustamist.