FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Zarzio, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G CSF).
Estonian: Zarzio toimeaine filgrastiim on väga sarnane inimvalguga, mida nimetatakse granülotsüütide kolooniat stimuleerivaks faktoriks (G-CSF).
English: For more information about treatment with Zarzio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Zarzioga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Zarzio can also be used in people who are about to donate blood stem cells for transplant, to help release these cells from the bone marrow.
Estonian: Lisaks võib Zarziot kasutada patsientidel, kes hakkavad loovutama siirdamiseks vere tüvirakke, et aidata nendel rakkudel luuüdist vabaneda.
English: This is a summary of the European public assessment report (EPAR) for Zarzio.
Estonian: See on ravimi Zarzio Euroopa avaliku hindamisaruande kokkuvõte.
English: The most common side effect with Zarzio (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Estonian: Zarzio kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on luu-lihaskonna valu.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zarzio, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Zarzio ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: What is Zarzio?
Estonian: Mis on Zarzio?
English: For more information on biosimilar medicines, see the question-and-answer document here.
Estonian: Lisateave bioloogiliselt sarnaste ravimite kohta on teabedokumendis siin..
English: The CHMP decided that, in accordance with EU requirements, Zarzio has been shown to have a comparable quality, safety and efficacy profile to Neupogen.
Estonian: Inimravimite komitee otsustas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zarzio võrdväärne kvaliteet ning ohutus- ja efektiivsusprofiil ravimiga Neupogen.
English: 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 Zarzio.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Why has Zarzio been approved?
Estonian: Miks Zarzio heaks kiideti?
English: This was considered sufficient to demonstrate that the benefits of Zarzio are comparable to those of the reference medicine.
Estonian: Seda peeti piisavaks, et näidata Zarzio ja selle võrdlusravimi kasulikkuse võrreldavust.
English: Zarzio was studied to show that it is comparable to the reference medicine, Neupogen.
Estonian: Zarziot uuriti, et näidata selle võrreldavust võrdlusravimiga Neupogen.
English: Zarzio is used to stimulate the production of white blood cells in the following situations:
Estonian: Zarziot kasutatakse leukotsüütide (vere valgeliblede) tekke stimuleerimiseks järgmistel näidustustel:
English: What is the risk associated with Zarzio?
Estonian: Mis riskid Zarzioga kaasnevad?
English: Zarzio and Neupogen brought about similar increases in blood neutrophil counts in healthy volunteers over the course of the studies.
Estonian: Uuringutes suurendasid Zarzio ja Neupogen neutrofiilide sisaldust tervete vabatahtlike veres sarnasel määral.
English: This means that Zarzio is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘reference medicine').
Estonian: (võrdlusravimiga), millel juba on Euroopa Liidus müügiluba ning mis sisaldab sama toimeainet.
English: Zarzio is a solution for injection or infusion (drip into a vein) in a pre-filled syringe.
Estonian: Zarzio on süstelahus või infusioonilahus (veeni tilgutatav lahus) eeltäidetud süstlas.
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Zarzio kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: How does Zarzio work?
Estonian: Kuidas Zarzio toimib?
English: Zarzio is a ‘biosimilar' medicine.
Estonian: Zarzio on bioloogiliselt sarnane ravim.
English: The reference medicine for Zarzio is Neupogen.
Estonian: Zarzio võrdlusravim on Neupogen.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Zarzio is being used for.
Estonian: Olenevalt Zarzio kasutamise näidustusest võivad ka muud kõrvalnähud esineda enam kui 1 patsiendil 10st.
English: What benefit has Zarzio shown during the studies?
Estonian: Milles seisneb uuringute põhjal Zarzio kasulikkus?
English: How is Zarzio used?
Estonian: Kuidas Zarziot kasutatakse?
English: What is Zarzio used for?
Estonian: Milleks Zarziot kasutatakse?
English: Zarzio is given by injection under the skin or infusion into a vein.
Estonian: Zarziot manustatakse nahaaluse süstina või veeniinfusioonina.
English: How has Zarzio been studied?
Estonian: Kuidas Zarziot uuriti?
English: The full EPAR for Temomedac can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Temomedaci kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Temomedac on 25 January 2010.
Estonian: Euroopa Komisjon andis Temomedaci müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. jaanuaril 2010.
English: The dose of Temomedac depends on body surface area (calculated using the patient's height and weight) and ranges from 75 to 200 mg per square metre, once a day.
Estonian: Temomedaci annus oleneb kehapindalast (arvutatakse patsiendi pikkuse ja kehamassi järgi) ning on 75-200 mg/m2 ööpäevas.
English: • adults with newly diagnosed glioblastoma multiforme (an aggressive type of brain tumour).
Estonian: • Täiskasvanud, kellel on äsja diagnoositud multiformne glioblastoom (agressiivse kuluga teatud ajukasvaja liik).
English: Temomedac capsules should be taken whole without food.
Estonian: Temomedaci kapsel tuleb neelata tervena ilma toiduta.
English: The dose and the number of doses depend on the type of tumour being treated, whether the patient has been treated before, whether Temomedac is being used alone or with other treatments, and how the patient responds to treatment.
Estonian: Annus ja annuste arv sõltuvad ravitava kasvaja liigist, varasemast ravist, sellest, kas Temomedaci kasutatakse ainsa raviviisina või koos muude raviviisidega, ja patsiendi ravivastusest.
English: The Committee recommended that Temomedac be given marketing authorisation.
Estonian: Komitee soovitas anda Temomedaci müügiloa.
English: 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 Temomedac.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Temomedac is a ‘generic medicine'.
Estonian: Temomedac on geneeriline ravim.
English: Temomedac temozolomide
Estonian: Temomedac temosolomiid
English: Therefore, the CHMP's view was that, as for Temodal, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Temodali korral, ületab Temomedaci kasulikkus sellega kaasnevad riskid.
English: Because Temomedac is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as the reference medicine.
Estonian: Et Temomedac on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Why has Temomedac been approved?
Estonian: Miks Temomedac heaks kiideti?
English: What is Temomedac?
Estonian: Mis on Temomedac?
English: Temomedac is used to treat malignant glioma (brain tumours) in the following groups of patients:
Estonian: Temomedaci kasutatakse pahaloomulise glioomi (teatud ajukasvaja) ravimiseks järgmistel patsiendirühmadel.
English: Temomedac is a cancer medicine that contains the active substance temozolomide.
Estonian: Temomedac on vähiravim, mis sisaldab toimeainena temosolomiidi.
English: This document is a summary of the European Public Assessment Report (EPAR) for Temomedac.
Estonian: See on ravimi Temomedac Euroopa avaliku hindamisaruande kokkuvõte.
English: This means that Temomedac is similar to a ‘reference medicine' already authorised in the European Union (EU) called Temodal.
Estonian: See tähendab, et Temomedac on sarnane võrdlusravimiga Temodal, millel juba on Euroopa Liidus müügiluba.
English: Patients may also need to take medicines to prevent vomiting before taking Temomedac.
Estonian: Enne Temomedaci võtmist võib olla vaja võtta oksendamist ennetavaid ravimeid.
English: Because Temomedac is a generic medicine, studies in people have been limited to tests to determine that it is bioequivalent to the reference medicine, Temodal.
Estonian: Et Temomedac on geneeriline ravim, piirdusid inimuuringud katsetega, milles näidati Temomedaci bioekvivalentsust võrdlusravimiga Temodal.
English: The CHMP concluded that, in accordance with EU requirements, Temomedac has been shown to have comparable quality and to be bioequivalent to Temodal.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Temomedac võrdväärne kvaliteet ja bioekvivalentsus ravimiga Temodal.
English: Treatment with Temomedac should be prescribed by a doctor with experience in the treatment of brain tumours.
Estonian: Ravi Temomedaciga tohib üksnes määrata ajukasvajate ravis kogenud arst.
English: How does Temomedac work?
Estonian: Kuidas Temomedac toimib?
English: What are the benefits and risks of Temomedac?
Estonian: Milles seisneb Temomedaci kasulikkus ja mis riskid ravimiga kaasnevad?
English: The active substance in Temomedac, temozolomide, belongs to a group of cancer medicines called alkylating agents.
Estonian: Temomedaci toimeaine temosolomiid kuulub alküleerivateks aineteks nimetatavate vähiravimite rühma.
English: Temomedac is used first with radiotherapy and then on its own;
Estonian: Temomedaci kasutatakse esialgu koos kiiritusraviga ning seejärel ainsa raviviisina.
English: Temomedac is used on its own in these patients.
Estonian: Nendel patsientidel kasutatakse Temomedaci ainsa raviviisina.
English: Other information about Temomedac:
Estonian: Muu teave Temomedaci kohta
English: What is Temomedac used for?
Estonian: Milleks Temomedaci kasutatakse?
English: How is Temomedac used?
Estonian: Kuidas Temomedaci kasutatakse?
English: For more information about treatment with Temomedac, read the Package Leaflet (also part of the EPAR).
Estonian: Ravimi kasutamise üksikasjalik teave on pakendi infolehel, mis on samuti Euroopa avaliku hindamisaruande osa.
English: How has Temomedac been studied?
Estonian: Kuidas Temomedaci uuriti?
English: 1 vial + 1 filter needle
Estonian: 1 viaal + 1 filternõel
English: Solution for injection Intravitreal use pre-filled syringe
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: Packaging Package size unit dose blister (PVC/PVDC/alu)
Estonian: Ühikannuseline blisterpakend (PVC/PVDC/alu)
English: 100 x 1 tablet l t o r
Estonian: 100 x 1 tabletti l n a
English: It has no relevant use in patients under 18 years of age.
Estonian: Puudub vajadus pajulille kasutamiseks alla 18-aastastel patsientidel.
English: 2 February 2016 EMA/822538/2015
Estonian: veebruar 2016 EMA/822538/2015
English: Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., herba
Estonian: Epilobium angustifolium L. ja/või Epilobium parviflorum Schreb., herba
English: What is willow herb?
Estonian: Mis on pajulill?
English: Willow herb EMA/822538/2015
Estonian: Pajulilleürt EMA/822538/2015
English: Willow herb may be taken long term.
Estonian: Pajulille tohib kasutada pika aja vältel.
English: Willow herb should only be used after serious conditions have been excluded by a medical doctor.
Estonian: Pajulille tohib kasutada alles siis, kui arst on välistanud rasked haigusseisundid.
English: Further information on the risks associated with willow herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave pajulille sisaldavate ravimitega kaasnevate riskide, sh nende ohutu kasutamise ettevaatusabinõude kohta, on ravimtaime monograafias Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take willow herb medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Üksikasjalik teave, kuidas võtta pajulille sisaldavaid ravimeid ja kes neid tohib kasutada, on ravimi pakendi infolehel.
English: Willow herb can also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis võib esineda pajulille ka kombinatsioonis teiste taimsete ainetega.
English: Further information on the HMPC assessment of willow herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave pajulille sisaldavate ravimite hindamise kohta, sh komitee kokkuvõtte üksikasjalik kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The HMPC concluded that, on the basis of its long-standing use, willow herb can be used by patients with benign prostatic hyperplasia (BPH) for the relief of lower urinary tract symptoms such as difficulty starting urination or a frequent need to urinate.
Estonian: Taimsete ravimite komitee järeldas, et lähtudes pikaajalisest kasutamisest tohivad pajulille kasutada eesnäärme healoomulise hüperplaasiaga patsiendid kuseteede alaosa sümptomite, näiteks näiteks urineerimisraskuse või sageda urineerimisvajaduse leevendamiseks.
English: Any applications for the licensing of medicines containing willow herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Pajulille sisaldavate ravimite müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimsete ravimite müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslikke järeldusi.
English: Results from laboratory studies indicate that willow herb may have an effect on the growth of prostate cells as well as anti-inflammatory and pain-relieving activity.
Estonian: Laboriuuringutes on selgunud, et pajulillel võib olla toime eesnäärme rakkude kasvule ning põletikuvastane ja valuvaigistav toime.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing willow herb.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad pajulille sisaldavate taimsete ravimite müügilubade taotlusi.
English: The HMPC conclusions on the use of willow herb medicines for the relief of lower urinary tract symptoms related to BPH are based on their ‘traditional use' in this condition.
Estonian: Taimsete ravimite komitee järeldused pajulille sisaldavate ravimite kasutamise kohta eesnäärme healoomulise hüperplaasiga seotud alumiste kuseteede sümptomite leevendamiseks põhinevad nende traditsioonilisel kasutamisel selle seisundi korral.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of willow herb.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb pajulille meditsiinilisi kasutusviise.
English: Herbal medicines containing willow herb are usually available as herbal tea to be drunk.
Estonian: Pajulille sisaldavaid ravimeid turustatakse tavaliselt joodava taimeteena.
English: Other information about willow herb medicines
Estonian: Muu teave pajulille sisaldavate ravimite kohta
English: Willow herb
Estonian: Pajulilleürt
English: Information on the use and licensing of willow herb medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab pajulille sisaldavate ravimite kasutamise ja müügilubade teavet asjakohastelt riiklikelt ravimiametitelt.
English: This summary is not intended to provide practical advice on how to use medicines containing willow herb.
Estonian: Kokkuvõttes ei anta pajulille sisaldavate ravimite kasutamise praktilisi nõuandeid.
English: What are the risks associated with willow herb medicines?
Estonian: Mis riskid pajulille sisaldavate ravimitega kaasnevad?
English: For more information about treatment with willow herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate pajulille sisaldavate ravimitega toimuva ravi kohta lisateavet, lugege palun ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What evidence supports the use of willow herb medicines?
Estonian: Mis tõendid toetavad pajulille sisaldavate ravimite kasutamist?
English: For practical information about using willow herb medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate pajulille sisaldavate ravimite kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Willow herb is the common name for the aerial parts of the plant Epilobium angustifolium L. and/or Epilobium parviflorum Schreb., collected before or during flowering time.
Estonian: Pajulill on taimede Epilobium angustifolium L. (ahtalehine põdrakanep) ja/või Epilobium parviflorum Schreb.
English: What are the HMPC conclusions on its medicinal uses?
Estonian: Mis on taimsete ravimite komitee järeldused pajulille meditsiiniliste kasutusalade kohta?
English: The HMPC noted the lack of clinical studies with willow herb.
Estonian: Taimsete ravimite komitee märkis, et ei ole toimunud pajulille kliinilisi uuringuid.
English: Willow herb preparations are obtained by drying and comminuting (reducing into tiny pieces) the aerial parts of the plant.
Estonian: Pajulille valmistisi saadakse taime maapealse osa kuivatamisel ja peenestamisel.
English: How are willow herb medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus pajulille sisaldavate ravimite müügiluba?
English: BPH is a non-cancerous increase in size of the prostate gland which surrounds the urethra, the tube that carries urine from the bladder out of the body.
Estonian: Eesnääre ümbritseb kusitit ehk juha, mille kaudu väljub uriin kusepõiest.
English: However, firm conclusions could not be drawn and the HMPC conclusions on the use of willow herb are based on their long-standing use.
Estonian: Seetõttu põhineb taimsete ravimite komitee järeldus pajulille kasutamise kohta selle pikaajalisel kasutamisel.
English: 14 July 2017 EMA/463868/2017
Estonian: 14. juuli 2017. a. EMA/463868/2017
English: It is injected under the skin once a month.
Estonian: Seda süstitakse naha alla üks kord kuus.
English: The review of Zinbryta has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Estonian: Zinbryta teabe läbivaatamist alustati Euroopa Komisjoni nõudel määruse (EÜ) nr 726/2004 artikli 20 alusel.
English: • Further information will also be provided once the review is concluded.
Estonian: • Lisateavet esitatakse ka pärast läbivaatamise lõppemist.
English: These were forwarded to the European Commission (EC), which on 14 July 2017 issued a provisional legally binding decision applicable in all EU Members States.
Estonian: Need edastati Euroopa Komisjonile, kes tegi 14. juulil 2017 õiguslikult siduva esialgse otsuse, mida kohaldatakse kõigis Euroopa Liidu liikmesriikides.
English: Healthcare professionals have been informed in writing about the provisional measures to be followed by doctors.
Estonian: Tervishoiutöötajaid on teavitatud kirjalikult esialgsetest meetmetest, mida arstid peavad võtma.
English: If you are being given Zinbryta and have any questions or concerns, speak to your doctor or pharmacist.
Estonian: Kui võtate Zinbrytat ja teil tekib küsimusi või kahtlusi, pöörduge oma arsti või apteekri poole.
English: The risk of liver damage with the medicine was already known at time of its approval in the EU, and several measures were in place to manage this risk, including the requirement to monitor liver function and provide educational materials to healthcare professionals and patients on the risk of liver damage.
Estonian: Ravimiga seotud maksakahjustuse risk oli Euroopa Liidus müügiloa andmise ajal juba teada ning selle riski juhtimiseks olid kehtestatud mitmesugused meetmed, sealhulgas nõue jälgida maksatalitlust ning anda tervishoiutöötajatele ja patsientidele teabematerjale maksakahjustuse riski kohta.
English: • Patients should be informed about the potential risk of serious liver problems and how to recognise them.
Estonian: • Patsiente tuleb teavitada võimalikust raskete maksaprobleemide riskist ja selgitada, kuidas maksaprobleeme ära tunda.
English: • If you are already being treated with this medicine, your doctor will check whether you should continue or switch to an alternative treatment.
Estonian: • Kui olete ravi Zinbrytaga juba alustanud, kontrollib teie arst, kas peate ravi jätkama või minema üle alternatiivsele ravile.
English: Zinbryta contains the active substance daclizumab and was authorised in the EU in July 2016.
Estonian: Zinbryta sisaldab toimeainena daklitsumaabi ja ravimi müügiluba ELis anti juulis 2016.
English: • While on treatment with this medicine, you should contact your doctor immediately if you develop any symptoms of liver problems, such as unexplained nausea (feeling sick), vomiting, abdominal pain, tiredness, loss of appetite, yellowing of the skin and eyes and dark urine.
Estonian: • Ravimi kasutamise ajal peate võtma oma arstiga viivitamata ühendust, kui teil tekib mõni maksaprobleemi sümptom, nagu ebaselge põhjusega iiveldus, oksendamine, kõhuvalu, väsimus, isutus, naha ja silmade kollasus ning tume uriin.
English: • Healthcare professionals should review promptly any patients who are currently taking Zinbryta to assess whether this medicine continues to be appropriate for them.
Estonian: • Tervishoiutöötajad peavad kiiresti läbi vaatama kõik Zinbrytat võtvad patsiendid, et hinnata, kas ravim on neile jätkuvalt sobilik.
English: In case of signs and symptoms suggestive of hepatic injury, the patient should be promptly referred to a hepatologist.
Estonian: Maksakahjustuste nähtude ja sümptomite esinemisel tuleb patsient otsekohe suunata hepatoloogi juurde.
English: These provisional measures have been taken, as a precaution, to ensure that Zinbryta continues to be used as safely as possible while a review of its liver safety is ongoing.
Estonian: Esialgsed meetmed on võetud ettevaatusabinõuna, et tagada Zinbryta võimalikult ohutu kasutamine ravimi maksaohutuse läbivaatamise ajal.
English: Relapsing means that the patient has flare-ups of the symptoms.
Estonian: Relapseeruv vorm tähendab, et patsiendil esineb sümptomite ägenemisi.