natgillin/translations-raw huggingface dataset:
This is a procedure where one Member State (the ‘reference Member State', in this instance the United Kingdom) assesses a veterinary medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Spain).
See on menetlus, kus üks liikmesriik (viiteliikmesriik, praegusel juhul Ühendkuningriik) hindab veterinaarravimit, et otsustada, kas anda ravimi müügiluba, mis kehtib selles riigis ja teistes liikmesriikides (asjaomased liikmesriigid, praegusel juhul Austria, Belgia, Bulgaaria, Eesti, Hispaania, Iirimaa, Itaalia, Kreeka, Küpros, Leedu, Luksemburg, Läti, Madalmaad, Malta, Poola, Portugal, Prantsusmaa, Rumeenia, Saksamaa, Slovakkia, Sloveenia, Taani, Tšehhi Vabariik ja Ungari).
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 October 2015
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22.
Huvepharma NV submitted a marketing authorisation application for Gutal to the United Kingdom via the decentralised procedure.
Huvepharma NV esitas Ühendkuningriigile Gutali müügiloa taotluse detsentraliseeritud menetluse kaudu.
The product is indicated for the prevention of post-weaning diarrhoea in piglets.
Ravim on näidustatud võõrutusjärgse kõhulahtisuse ennetamiseks põrsastel.
Gutal is a generic veterinary medicinal product based on a reference product, ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff, which is authorised in the United Kingdom.
Gutal on geneeriline veterinaarravim, mille võrdlusravim on Ühendkuningriigis heaks kiidetud ZincoTec Zinc Oxide 100% Premix for Medicated Feeding Stuff.
On 6 May 2015, the European Medicines Agency (the Agency) completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the veterinary medicinal product Gutal 1000 g/kg premix for medicated feeding stuff for piglets.
6. mail 2015 lõpetas Euroopa Ravimiamet (EMA) vahekohtumenetluse, mis algatati pärast seda, kui Euroopa Liidu liikmesriigid ei jõudnud kokkuleppele põrsaste ravimsööda eelsegu Gutal 1000 g/kg müügiloa heakskiitmises.
Thus the CVMP concluded that the concerns expressed by France and the Netherlands should not prevent the granting of marketing authorisations and recommended marketing authorisation be granted in the concerned Member States.
Seega järeldas veterinaarravimite komitee, et Madalmaade ja Prantsusmaa nimetatud probleemid ei saa takistada müügilubade andmist, ning soovitas anda asjaomastes liikmesriikides ravimi müügiloa.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that a risk to the environment has been identified due to accumulation of zinc, but that there is some uncertainty associated with the scale of this risk.
Praegu olemasolevate andmete hindamise ja veterinaarravimite komitees toimunud teadusliku arutelu põhjal järeldas komitee, et on tuvastatud tsingi kogunemisest põhjustatud keskkonnarisk, kuid riski suurus ei ole täielikult teada.
However, the Member States were not able to reach an agreement and the Veterinary Medicines Directorate of the United Kingdom referred the matter to the CVMP for arbitration on 30 September
Liikmesriigid ei jõudnud kokkuleppele, mistõttu tegi Ühendkuningriigi veterinaarravimite direktoraat 30. septembril 2014 veterinaarravimite komiteele vahekohtumenetluse alustamise esildise.
The grounds for the referral were concerns raised by France and The Netherlands that the marketing authorisation of Gutal may present a potential serious risk to the environment and that the risk mitigation measures proposed to control the risk are inadequate to control or prevent continuous zinc accumulation and, in addition, they are not feasible to implement in all pig farms.
Esildise alus on Madalmaade ja Prantsusmaa tõstatatud probleemid, et Gutali müügiluba võib põhjustada suurt keskkonnariski ja kavandatavad riskivähendusmeetmed on ebapiisavad, et ohjata või ennetada pidevat tsingi kogunemist, ning lisaks ei ole neid asjakohane rakendada kõigis seakasvatusettevõtetes.
Therefore, the Committee recommended several risk mitigation measures to be included in the product information, which are anticipated to reduce the accumulation of zinc in the environment.
Seetõttu soovitas komitee lisada ravimiteabesse mitu riskivähendusmeedet, mis eeldatavasti vähendavad tsingi kogunemist keskkonda.
The CVMP also recommended that the product information for Gutal be amended.
Veterinaarravimite komitee soovitas ka muuta Gutali ravimiteavet.
The active substance of Gutal is zinc oxide.
Gutali toimeaine on tsinkoksiid.
The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the marketing authorisation for Gutal can be granted provided that the recommended risk mitigation measures, which are anticipated to reduce the accumulation of zinc in the environment, are added to the product information.
EMA veterinaarravimite komitee järeldas, et Gutali müügiloa tohib anda tingimusel, et ravimiteabesse lisatakse soovitatud riskivähendusmeetmed, mis eeldatavasti vähendavad tsingi kogunemist keskkonda.
What is Gutal 1000 g/kg premix for medicated feeding stuff for piglets?
Mis on põrsaste ravimsööda eelsegu Gutal 1000 g/kg?
Why was Gutal 1000 g/kg premix for medicated feeding stuff for piglets reviewed?
Miks põrsaste ravimsööda eelsegu Gutal 1000 g/kg taotlus üle vaadati?
The European Commission granted a marketing authorisation valid throughout the European Union for Sancuso on 20 April 2012.
Euroopa Komisjon andis Sancuso müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. aprillil
The full EPAR for Sancuso can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Sancuso kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Sancuso
Muu teave Sancuso kohta
Each patch releases 3.1 mg of granisetron over 24 hours.
Igast plaastrist vabaneb 24 tunni jooksul 3,1 mg granisetrooni.
The transdermal patch should not be cut into pieces.
Transdermaalset plaastrit ei tohi tükeldada.
The benefit of Sancuso in the prevention of nausea and vomiting caused by chemotherapy was investigated in one main study involving a total of 641 patients.
Sancuso kasulikkust keemiaravist tingitud iivelduse ja oksendamise ennetamisel uuriti ühes põhiuuringus, kus osales kokku 641 patsienti.
Sancuso transdermal patch showed similar effects to granisetron given by mouth in the prevention of vomiting and nausea after chemotherapy: 60.2% of patients receiving the Sancuso transdermal patch (171 out of 284 patients) had their nausea and vomiting under control, compared with 64.8% of patients taking granisetron by mouth (193 out of 298 patients).
Sancuso transdermaalse plaastri toime keemiaravijärgse iivelduse ja oksendamise ennetamisel sarnanes suukaudse granisetrooni toimega: nende patsientide osakaal, kellel allus iiveldus ja oksendamine ravile, oli Sancuso transdermaalset plaastrit kasutanute seas 60,2% (171 patsienti 284st) ja suukaudset granisetrooni tarvitanud patsientide seas 64,8% (193 patsienti 298st).
EPAR summary for the public granisetron
Kokkuvõte üldsusele granisetroon
One transdermal patch is applied 24 to 48 hours before chemotherapy.
Üks transdermaalne plaaster asetatakse nahale 24-48 tundi enne keemiaravi algust.
The most common side effect with Sancuso (seen in between 1 and 10 patients in 100) is constipation.
Sancuso kõige sagedam kõrvalnäht (esinenud 1-10 patsiendil 100st) on kõhukinnisus.
Because Sancuso is a hybrid generic, the applicant presented comparative data on the reference medicine in addition to results from its own studies.
Et Sancuso on geneeriline hübriidravim, esitas taotleja peale enda korraldatud uuringute tulemuste ka võrdlusravimi võrdlevad andmed.
By blocking these receptors, Sancuso prevents the nausea and vomiting that often happen after certain types of chemotherapy.
Nende retseptorite blokeerimise abil ennetab Sancuso iiveldust ja oksendamist, mis sageli esinevad pärast keemiaravi.
The patch can remain on the skin for up to seven days depending on the duration of the chemotherapy, and it is removed a minimum of 24 hours after completing chemotherapy.
Plaaster võib jääda nahale kuni 7 päevaks sõltuvalt keemiaravi pikkusest ja see eemaldatakse, kui keemiaravi lõpust on möödunud vähemalt 24 tundi.
For more information about treatment with Sancuso, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Kui vajate Sancusoga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
This is a summary of the European public assessment report (EPAR) for Sancuso.
See on ravimi Sancuso Euroopa avaliku hindamisaruande kokkuvõte.
The majority of adverse reactions were mild or moderate in severity.
Enamik kõrvalnähte olid kerged kuni mõõdukad.
This means that it stops a chemical in the body called 5-hydroxytryptamine (5HT, also known as serotonin) from attaching to 5HT3 receptors in the gut.
See takistab organismi teatud keemilise aine 5hüdroksütrüptamiini (5HT ehk serotoniini) seondumist soolestiku 5HT3-retseptoritega.
Therefore, the CHMP decided that Sancuso's benefits are greater than its risks and recommended that it be given marketing authorisation.
Komitee on seetõttu arvamusel, et Sancuso kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
This was defined as having no vomiting or retching (strong involuntary contractions of the stomach with the urge to vomit), no more than mild nausea and no need to take other anti-emetic medicines for quick relief after receiving chemotherapy.
Seda määratleti oksendamise või öökimise (mao tugevad tahtmatud oksendamiseelsed kokkutõmbed) puudumise kuni kerge iiveldusena ja vajaduse puudumisena teiste antiemeetikumide järele, et saavutada pärast keemiaravi kiiret leevendust.
Sancuso must not be used in people who are hypersensitive (allergic) to granisetron, other 5HT3 antagonists or any of the other ingredients.
Sancusot ei tohi kasutada patsiendid, kes on granisetrooni, teiste 5HT3-antagonistide või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
This means that it is similar to a ‘reference medicine' containing the same active substance, but given in a different way.
See tähendab, et Sancuso on sarnane võrdlusravimiga, mis sisaldab sama toimeainet, aga mida manustatakse teistmoodi.
The active substance in Sancuso, granisetron, is a ‘5HT3 antagonist'.
Sancuso toimeaine granisetroon on 5HT3-antagonist.
The main measure of effectiveness was the number of patients who had their nausea and vomiting under control.
Efektiivsuse põhinäitaja oli nende patsientide arv, kellel ravim ennetas iiveldust ja oksendamist.
Sancuso is a ‘hybrid generic medicine'.
Sancuso on geneeriline hübriidravim.
The patch is applied to dry, clean, healthy skin on the outer part of the upper arm or if this is not possible, it may be applied to the abdomen.
Plaaster asetatakse õlavarre väliskülje kuivale puhtale tervele nahale või, kui see ei ole võimalik, siis kõhule.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sancuso.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
Sancuso is a medicine that contains the active substance granisetron.
Sancuso on ravim, mis sisaldab toimeainena granisetrooni.
What is Sancuso?
Mis on Sancuso?
Sancuso is only used in adults who would have difficulty swallowing medicines and when the chemotherapy lasts from three to five days.
Sancusot kasutatakse ainult neelamisraskustega täiskasvanutel ja kui keemiaravi kestab 3-5 päeva.
The study compared one Sancuso transdermal patch worn over seven days with granisetron taken by mouth once a day for the duration of the chemotherapy.
Uuringus võrreldi keemiaravi ajal 7 ööpäeva kantud Sancuso transdermaalset plaastrit suukaudse üks kord ööpäevas manustatava granisetrooniga.
The CHMP considered however that Sancuso would be of benefit for patients with difficulty swallowing, who might otherwise need to be given daily intravenous injections.
Komitee arvas siiski, et Sancuso on kasulik neelamisraskustega patsientidele, kellele vastasel korral tuleb manustada ravimit igapäevase veenisisese süstiga.
What is the risk associated with Sancuso?
Mis riskid Sancusoga kaasnevad?
Why has Sancuso been approved?
Miks Sancuso heaks kiideti?
For the full list of all side effects reported with Sancuso, see the package leaflet.
Sancuso kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
These patients were receiving chemotherapy which was a moderate or strong trigger of nausea and vomiting, lasting for several days.
Patsiendid said mitu päeva keemiaravi, mis põhjustas mõõdukalt või tugevalt iiveldust ja oksendamist.
While the reference medicine for Sancuso is Kytril taken by mouth, Sancuso is a patch applied to the skin.
Sancuso võrdlusravim Kytril on suukaudne ravim ja Sancuso on nahale asetatav plaaster.
The Committee considered that Sancuso transdermal patch showed a similar benefit to granisetron taken by mouth but that it may have a slower onset of action.
Inimravimite komitee leidis, et Sancuso transdermaalse plaastri kasulikkus on sama mis suukaudsel granisetroonil, kuid toime algus võib olla hilisem.
Sancuso is an ‘anti-emetic', a medicine that prevents nausea (feeling sick) and vomiting.
Sancuso on antiemeetikum (iiveldust ja oksendamist ennetav ravim).
How does Sancuso work?
Kuidas Sancuso toimib?
It is used to prevent nausea and vomiting caused by types of chemotherapy (medicines used to treat cancer) that are moderate or strong triggers of nausea and vomiting.
Ravimit kasutatakse iiveldust ja oksendamist mõõdukalt kuni tugevalt põhjustavast keemiaravist (vähi ravimiseks kasutatavad ravimid) põhjustatud iivelduse ja oksendamise ennetamiseks.
What benefit has Sancuso shown during the studies?
Milles seisneb uuringute põhjal Sancuso kasulikkus?
How is Sancuso used?
Kuidas Sancusot kasutatakse?
What is Sancuso used for?
Milleks Sancusot kasutatakse?
How has Sancuso been studied?
Kuidas Sancusot uuriti?
It is available as a transdermal patch (a patch that delivers a medicine across the skin).
Sancuso on transdermaalne plaaster (ravimi manustamiseks naha kaudu).
Patients will also receive a guide and a card that they should carry with them.
Patsiendid saavad samuti juhendi ja kaardi, mida nad peavad kaasas kandma.
What measures are being taken to ensure the safe and effective use of Zynteglo?
Mis meetmed võetakse, et tagada Zynteglo ohutu ja efektiivne kasutamine?
In addition, the company will ensure that the medicine is only provided from approved centres.
Lisaks tagab turustaja, et ravimit saab ainult tunnustatud keskustest.
Further information on the orphan designation can be found here: ema.europa.eu/en/medicines/human/orphan-designations/eu3121091.
Lisateave harvikravimiks nimetatud ravimi kohta on leitav: ema.europa.eu/en/medicines/human/orphandesignations/eu3121091.
However, measures are in place to monitor such events through a registry of patients and a long-term study to assess patients' long-term outcomes.
On võetud meetmeid, et jälgida selliseid sündmusi patsientide registri ning pikaajalise uuringu kaudu, milles hinnatakse patsientide pikaajalisi ravitulemusi.
Although information on the safety of the medicine is limited because of the small number of patients treated to date and the lack of long-term data, the European Medicines Agency decided that Zynteglo's benefits are greater than its risks and it can be authorised for use in the EU.
Kuigi ravimi ohutusteave on piiratud, sest seni on ravitud vähe patsiente ja puuduvad pikaajalised andmed, otsustas Euroopa Ravimiamet, et Zynteglo kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
Further information on Zynteglo can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/zynteglo.
Lisateave Zynteglo kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/zynteglo.
As for all medicines, data on the use of Zynteglo are continuously monitored.
Nagu kõigi ravimite puhul, teostatakse Zynteglo kasutamise kohta pidevat järelevalvet.
Other information about Zynteglo
Muu teave Zynteglo kohta
There is also a potential risk of bleeding since the medicine may cause a drop in platelets.
Samuti on olemas potentsiaalne verejooksurisk, sest ravim võib vähendada trombotsüütide sisaldust.
What is Zynteglo and what is it used for?
Mis on Zynteglo ja milleks seda kasutatakse?
The company will also provide data from a registry of patients treated with Zynteglo to study its longterm safety and effectiveness, as well as further data on the tests used in the manufacturing of the medicine to ensure its quality.
Turustaja esitab ka Zyntegloga ravitud patsientide registri andmed, et uurida selle pikaajalist ohutust ja efektiivsust, samuti täiendavad andmed testide kohta, mida kasutatakse ravimi tootmisel selle kvaliteedi tagamiseks.
For more information about using Zynteglo, see the package leaflet or contact your doctor or pharmacist.
Lisateavet Zynteglo kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
Regarding safety, because Zynteglo is produced using a virus, there could be a theoretical risk of cancer caused by unintended changes in the genetic material, although no such cases have been seen so far.
Et Zynteglot valmistatakse viiruse abil, võivad geneetilise materjali soovimatud muutused teoreetiliselt tekitada vähiriski, kuigi seni ei ole selliseid juhtumeid esinenud.
Doctors should consider whether patients can be given the required pre-treatments needed before Zynteglo.
Arst peab otsustama, kas patsiendile tohib teha enne Zynteglo manustamist nõutavat eelravi.
Side effects reported with Zynteglo are carefully evaluated and any necessary action taken to protect patients.
Zynteglo kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zynteglo have also been included in the summary of product characteristics and the package leaflet.
Zynteglo ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
Zynteglo is used in patients who do not completely lack beta-globin and who are eligible for stem cell transplantation but do not have a matching related donor.
Zynteglot kasutatakse patsientidel, kellel beetaglobiini geen ei puudu täielikult ja kes sobivad tüvirakkude transplantatsiooniks, kuid kellel ei ole koesobivat doonorit.
Since Zynteglo has been given conditional authorisation, the company that markets Zynteglo will provide results of ongoing studies to further assess the effectiveness and safety of the medicine.
Et Zynteglo on saanud müügiloa tingimusliku heakskiidu alusel, esitab Zynteglo turustaja toimuvate uuringute tulemused, et täiendavalt hinnata ravimi efektiivsust ja ohutust.
The effects of Zynteglo are expected to last for the patient's lifetime.
Zynteglo toime püsib eeldatavalt kogu patsiendi elu jooksul.
In these studies, out of the 14 patients who did not completely lack beta-globin and were given Zynteglo, 11 of them had sufficiently high levels of red blood cells so that they did not need blood transfusions for at least 1 year after treatment.
Nendes uuringutes oli 14st patsiendist, kellel beetaglobiin ei puudunud täielikult ja kellele manustati Zynteglot, 11 patsiendil piisavalt palju erütrotsüüte, nii et nad ei vajanud vereülekandeid vähemalt 1 aasta jooksul pärast ravi.
What information is still awaited for Zynteglo?
Mis teavet Zynteglo kohta veel oodatakse?
This means that the patients can avoid the excessive build-up of iron that occurs with regular transfusions and which itself requires treatment.
See tähendab, et patsiendid väldivad korrapäraste vereülekannetega kaasnevat raua liigladestumist, mis vajab omakorda ravi.
A small number of patients have been treated with Zynteglo to date, and the most serious side effect observed is thrombocytopenia (low blood levels of platelets, components that help the blood to clot).
Seni on Zyntegloga ravitud väike arv patsiente ning täheldatutest kõige raskem kõrvalnäht on trombotsütopeenia (trombotsüütide ehk vereliistakute, vere hüübimist soodustavate verekomponentide vähesus).
As a result, these patients have low red blood cell levels and need frequent blood transfusions.
Tulemusena on neil patsientidel erütrotsüütide vähesus ja nad vajavad sageli vereülekandeid.
When these modified cells are given back to the patient, they are transported in the bloodstream to the bone marrow where they start to make healthy red blood cells that produce beta-globin.
Pärast nende modifitseeritud rakkude samale patsiendile tagasi manustamist liiguvad need vereringega luuüdisse, kus hakkavad moodustama terveid, beetaglobiini tootvaid punaliblesid.
Zynteglo (autologous CD34+ cells encoding βA-T87Q-globin gene) EMA/205979/2019
Zynteglo (autoloogsed βA-T87Q-globiini geeni sisaldavad CD34+ rakud)
Beta thalassaemia is rare, and Zynteglo was designated an ‘orphan medicine' (a medicine used in rare diseases) on 24 January 2013.
Beetatalasseemia esineb harva ja Zynteglo nimetati 24. jaanuaril 2013 harvikravimiks.
Zynteglo is made individually for each patient out of stem cells collected from their blood, and must only be given to the patient for whom it is made.
Zynteglo valmistatakse igale patsiendile eraldi patsiendilt kogutud tüvirakkudest ning seda tohib manustada üksnes patsiendile, kelle jaoks see on tehtud.
Zynteglo has been given ‘conditional authorisation'.
Zynteglo on saanud müügiloa tingimusliku heakskiidu alusel.
The company that markets Zynteglo will provide educational materials for healthcare professionals expected to use the medicine with information on its safety, including the potential risks of cancer and bleeding, and how it should be given.
Zynteglo turustaja annab eeldatavalt ravimit määravatele tervishoiutöötajatele teabepakme ravimi ohutuse kohta, sh potentsiaalse vähiriski ja verejooksuriski kohta, ning selle kohta, kuidas ravimit manustada.
It is given as an infusion (drip) into a vein and the dose depends on the bodyweight of the patient.
Ravimit manustatakse veeniinfusioonina ja annus sõltub patsiendi kehamassist.
Transfusion-dependent beta thalassaemia is a severe condition for which treatment options are limited.
Vereülekannetest sõltuv beetatalasseemia on raske seisund, mille ravivõimalused on piiratud.
Zynteglo must not be used in pregnant or breastfeeding women, and in patients who have previously had gene therapy treatment (medicine that delivers genes).
Zynteglot ei tohi kasutada raseduse ega imetamise ajal ega patsiendid, keda on varem ravitud geeniteraapiaga (geeniravimitega).
What are the risks associated with Zynteglo?
Mis riskid Zyntegloga kaasnevad?
How does Zynteglo work?
Kuidas Zynteglo toimib?
People with this genetic condition cannot make enough beta-globin, a component of haemoglobin, the protein in red blood cells that carries oxygen around the body.
Selle geneetilise seisundiga inimestel ei teki piisavalt beetaglobiini, mis on üks hemoglobiini (erütrotsüütide ehk vere punaliblede valk, mis transpordib hapnikku kõikjale organismis) komponente.