FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, at the time of the withdrawal, the CHMP's view was that a benefit of Cerepro had not been sufficiently demonstrated and any benefits did not outweigh the identified risks.
Estonian: Seetõttu oli inimtervishoius kasutatavate ravimite komitee taotluse tagasivõtmise ajal arvamusel, et Cerepro kasulikkus ei ole küllaldaselt tõendatud ega ületa tuvastatud ohte.
English: QUESTIONS AND ANSWERS ON THE WITHDRAWAL OF THE MARKETING APPLICATION for CEREPRO
Estonian: TEAVE MÜÜGILOA TAGASIVÕTMISE KOHTA CEREPRO
English: The cells then start to produce the thymidine kinase enzyme.
Estonian: Seejärel hakkavad need rakud tootma ensüümi nimega tümidiinkinaas.
English: The CHMP had concerns that a benefit of Cerepro had not yet been shown.
Estonian: Inimtervishoius kasutatavate ravimite komitee arvas, et Cerepro kasulikkus ei ole veel tõendatud.
English: How is Cerepro expected to work?
Estonian: Milline on Cerepro eeldatav toime?
English: It is made up into a solution that is injected directly into the brain during surgery.
Estonian: Ravimist valmistatakse lahus, mis süstitakse operatsiooni ajal otse ajju.
English: When Cerepro is injected into the brain, the modified virus is taken up by the cells near the injection sites.
Estonian: Cerepro süstimisel ajju haaravad süstekoha läheduses olevad rakud muudetud viiruse endasse.
English: Active substance: adenovirus-mediated Herpes simplex virus-thymidine kinase gene
Estonian: Toimeaine: adenoviirusega vahendatav Herpex simplex viiruse tümidiinkinaasi geen
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had given a negative opinion and did not recommend a marketing authorisation for Cerepro for the treatment of patients with operable high-grade glioma.
Estonian: Tuginedes andmete analüüsile ja ettevõtte vastusele, mille ta oli saatnud inimtervishoius kasutatavate ravimite komitee küsimustikule, oli komitee andnud Cereprole taotluse tagasivõtmise ajal negatiivse
English: The effects of Cerepro were first tested in experimental models before being studied in humans.
Estonian: Enne uuringuid inimestel kontrolliti Cerepro toimet muude katsetega.
English: What was Cerepro expected to be used for?
Estonian: Milleks kavatseti Cereprod kasutada?
English: Cerepro is a medicine containing a gene (a Herpes simplex virus thymidine kinase gene) carried by an adenovirus.
Estonian: Cerepro on ravim, mis sisaldab adenoviiruse poolt kantavat geeni (Herpes simplex viiruse tümidiinkinaasi geeni).
English: Cerepro was to be used in combination with ganciclovir sodium to treat high-grade glioma in patients who are eligible for surgery.
Estonian: Cereprod kavatseti kasutada koos naatriumgantsükloviiriga, et ravida patsiente, kelle raskekujulist glioomi on võimalik opereerida.
English: Cerepro contains the gene for the enzyme ‘thymidine kinase' from the herpes virus.
Estonian: Cerepro sisaldab herpesviiruse ensüümi tümidiinkinaasi geeni.
English: Nivestim (filgrastim)
Estonian: Nivestim (filgrastiim)
English: Nivestim received a marketing authorisation valid throughout the EU on 8 June 2010.
Estonian: Nivestim on saanud müügiloa, mis kehtib kogu ELis, 8. juunil 2010.
English: What measures are being taken to ensure the safe and effective use of Nivestim?
Estonian: Mis meetmed võetakse, et tagada Nivestimi ohutu ja efektiivne kasutamine?
English: Further information on Nivestim can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/nivestim.
Estonian: Lisateave Nivestimi kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/nivestim.
English: What is Nivestim and what is it used for?
Estonian: Mis on Nivestim ja milleks seda kasutatakse?
English: This means that Nivestim is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Estonian: See tähendab, et Nivestim on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
English: Why is Nivestim approved?
Estonian: Miks Nivestim heaks kiideti?
English: As for all medicines, data on the use of Nivestim are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse Nivestimi kasutamise kohta pidevat järelevalvet.
English: What are the risks associated with Nivestim?
Estonian: Mis riskid Nivestimiga kaasnevad?
English: Other information about Nivestim
Estonian: Muu teave Nivestimi kohta
English: Other side effects may be seen in more than 1 in 10 patients, depending on the condition that Nivestim is being used for.
Estonian: Muud kõrvalnähud võivad esineda enam kui 1 patsiendil 10st olenevalt haigusseisundist, mille ravimiseks Nivestimi kasutatakse.
English: For more information about using Nivestim, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Nivestimi kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Nivestim has a highly similar structure, purity and biological activity to Neupogen and is distributed in the body in the same way.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt ELi nõuetele bioloogiliselt sarnaste ravimite kohta on Nivestim struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane Neupogeniga ning Nivestim jaotub organismis samamoodi.
English: Side effects reported with Nivestim are carefully evaluated and any necessary action taken to protect patients.
Estonian: Nivestimi kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: In addition, a study in 279 female adult patients with breast cancer who were being treated with cancer medicines showed that Nivestim is comparable to the reference medicine, Neupogen.
Estonian: Lisaks näitas uuring 279 rinnavähiga täiskasvanud naispatsiendil, keda raviti vähiravimitega, et Nivestim on võrreldav võrdlusravimiga Neupogen.
English: Therefore, the Agency's view was that, as for Neupogen, the benefits of Nivestim are greater than its risks and it can be authorised or use in the EU.
Estonian: Seetõttu oli amet arvamusel, et nagu ka Neupogeni korral, ületab Nivestimi kasulikkus sellega kaasnevad riskid ja seda võib ELis kasutada.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Nivestim have been included in the summary of product characteristics and the package leaflet.
Estonian: Nivestimi ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The safety of Nivestim has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neupogen.
Estonian: Nivestimi ohutust on hinnatud ja kõigi uuringute põhjal peetakse ravimi kõrvalnähte võrreldavaks võrdlusravimi Neupogeni kõrvalnähtudega.
English: Nivestim 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 Nivestimi kasutada patsientidel, kes hakkavad loovutama siirdamiseks vere tüvirakke, et aidata neil rakkudel luuüdist vabaneda.
English: The active substance in Nivestim, filgrastim, is very similar to a human protein called granulocyte colony stimulating factor (G-CSF).
Estonian: Nivestimi toimeaine filgrastiim on väga sarnane inimvalguga, mida nimetatakse granülotsüütide kolooniat stimuleerivaks faktoriks (G-CSF).
English: How is Nivestim used?
Estonian: Kuidas Nivestimi kasutatakse?
English: The most common side effects with Nivestim (which may affect more than 1 in 10 people) are fever, musculoskeletal pain (pain in the muscles and bones), anaemia (low red blood cell counts), vomiting and nausea (feeling sick).
Estonian: Nivestimi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on palavik, luuja lihasevalu, aneemia (vere punaliblede vähesus), oksendamine ja iiveldus.
English: The way Nivestim is given, its dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Estonian: Nivestimi manustamisviis, annus ja ravi kestus sõltuvad näidustusest ning patsiendi kehamassist ja ravivastusest.
English: Because Nivestim is a biosimilar medicine the studies on effectiveness and safety of filgrastim carried out with Neupogen do not all need to be repeated for Nivestim.
Estonian: Et Nivestim on bioloogiliselt sarnane ravim, ei pea Neupogeniga tehtud filgrastiimi efektiivsus- ja ohutusuuringuid Nivestimiga kordama.
English: Filgrastim works in the same way as naturally produced G-CSF by encouraging the bone marrow to produce more white blood cells.
Estonian: Filgrastiim toimib samal viisil kui looduslikult tekkiv G-CSF, soodustades leukotsüütide teket luuüdis.
English: For the full list of side effects and restrictions with Nivestim, see the package leaflet.
Estonian: Nivestimi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: • to reduce the duration of neutropenia in patients undergoing treatment to destroy the bone marrow cells before a bone marrow transplant (such as in some patients with leukaemia) if they are at risk of long-term, severe neutropenia;
Estonian: • Neutropeenia kestuse vähendamine patsientidel, kes saavad ravi, millega hävitatakse luuüdirakud enne luuüdi siirdamist (näiteks mõnel leukeemiaga patsiendil), kui on pikaajalise raske neutropeenia risk.
English: The patients who received Nivestim had severe neutropenia for a similar length of time as the patients who received Neupogen.
Estonian: Nivestimi saanud patsientide raske neutropeenia kestus oli sarnane Neupogeni saanud patsientidega.
English: The medicine is available in pre-filled syringes and is given by injection under the skin or infusion (drip) into a vein.
Estonian: Ravimit turustatakse eeltäidetud süstaldes ja seda manustatakse nahaaluse süstina või veeniinfusioonina.
English: Studies have also shown that giving Nivestim produces similar levels of the active substance in the body to giving Neupogen.
Estonian: Uuringud on samuti näidanud, et Nivestim tekitab organismis samasuguse toimeainesisalduse kui Neupogen.
English: Neutropenia is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Estonian: Neutropeenia on vähiravi sage kõrvalnäht ning võib suurendada patsientide vastuvõtlikkust infektsioonidele.
English: Nivestim can only be obtained with a prescription and treatment should be given in collaboration with a centre for cancer treatment.
Estonian: Nivestim on retseptiravim ja seda tohib kasutada üksnes vähiravikeskuse juhiste kohaselt.
English: How does Nivestim work?
Estonian: Kuidas Nivestim toimib?
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and to prevent febrile neutropenia (neutropenia with fever) in cancer patients (excluding patients with chronic myeloid leukaemia or with myelodysplastic syndromes).
Estonian: • Neutropeenia (neutrofiilide ehk teatud valgeliblede vähesus) kestuse vähendamine ja febriilse neutropeenia (palavikuga neutropeenia) ennetamine vähipatsientidel (v.a kroonilise müeloidleukeemia või müelodüsplastiliste sündroomidega patsiendid).
English: An overview of Nivestim and why it is authorised in the EU
Estonian: Ülevaade ravimist Nivestim ja ELis müügiloa väljastamise põhjendus
English: Laboratory studies comparing Nivestim with Neupogen have shown that the active substance in Nivestim is highly similar to that in Neupogen in terms of structure, purity and biological activity.
Estonian: Nivestimi võrreldi Neupogeniga laboriuuringutes, mis tõendasid, et Nivestimi toimeaine on struktuuri, puhtuse ja bioloogilise toime poolest väga sarnane Neupogeni toimeainega.
English: The reference medicine for Nivestim is Neupogen.
Estonian: Nivestimi võrdlusravim on Neupogen.
English: • to increase levels of neutrophils and reduce the risk of infections in patients with neutropenia who have a history of severe, repeated infections;
Estonian: • Neutrofiilide sisalduse suurendamine ja infektsiooniriski vähendamine neutropeeniaga patsientidel, kellel on esinenud raskeid ja korduvaid infektsioone (nakkusi).
English: All these data were considered sufficient to conclude that Nivestim will behave in the same way as Neupogen in terms of effectiveness and safety in its authorised uses.
Estonian: Nende piisavate andmete põhjal järeldati, et Nivestimi efektiivsus ja ohutus on heakskiidetud näidustustel võrreldavad Neupogeni efektiivsuse ja ohutusega.
English: What benefits of Nivestim have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Nivestimi kasulikkus?
English: Nivestim is a medicine that stimulates the production of white blood cells and is used:
Estonian: Nivestim on ravim, mis stimuleerib leukotsüütide (vere valgeliblede) teket ja mida kasutatakse järgmistel näidustustel.
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Estonian: • Püsiva neutropeenia ravi inimese immuunpuudulikkuse viiruse (HIV) kaugelearenenud nakkusega patsientidel bakteriaalsete infektsioonide riski vähendamiseks, kui muu ravi ei sobi.
English: Nivestim is a ‘biosimilar' medicine.
Estonian: Nivestim on bioloogiliselt sarnane ravim.
English: Nivestim contains the active substance filgrastim.
Estonian: Ravimi toimeaine on filgrastiim.
English: The pregnancy section has been revised in line with the relevant guideline[9].
Estonian: Raseduse jaotis toimetati vastavalt kehtivatele suunistele[9].
English: The first European approval was in NL on 29 May 1981.
Estonian: Euroopas kiideti toimeaine esimest korda heaks Madalmaades, 29. mail 1981.
English: The product was subsequently approved in AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI and UK.
Estonian: Hiljem on ravim heaks kiidetud järgmistes riikides: AT, BE, DE, DK, EE, ES, FI, HR, IE, IT, LU, NO, RO, SE, SI, UK.
English: Based on data on bioavailability[1][2], the recommended oral dose is 100 to 200 mg/m2/day on day 1-5 in a cycle of 21 or 28 days; or 200 mg/m2/day on three days (most often days 1-3 or day 1, 3, and 5) in a cycle of 21 or 28 days.
Estonian: Biosaadavuse andmete alusel[1][2] on soovitatav suukaudne annus 100…200 mg/m2 ööpäevas 21või 28-päevase tsükli 1.-5. päeval või 200 mg/m2 ööpäevas 21- või 28-päevase tsükli kolmel päeval (enamasti 1.-3. päeval või 1., 3. ja 5. päeval).
English: The safety and efficacy of Vepesid and associated names in children below 18 years of age have not been established.
Estonian: Vepesidi ja sarnaste nimetuste ohutus ja efektiivsus alla 18-aastastel lastel ei ole tõestatud.
English: Lactation has been included as a contraindication, since breastfeeding women could replace breastfeeding by dairy products to feed their child.
Estonian: Imetamine on lisatud vastunäidustusena, sest imetavad naised saavad asendada lapse toitmisel rinnapiima piimatoodetega.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product, the European Commission therefore notified the CHMP/European Medicines Agency on 14 October 2015 of a referral under Article 30 of Directive 2001/83/EC for Vepesid and associated names, in order to resolve divergences amongst the nationally authorised product information and thus harmonise the product information across the EU.
Estonian: Et liikmesriigid on vastu võtnud erinevaid eespool nimetatud ravimi müügilubade otsuseid, teatas Euroopa Komisjon Euroopa Ravimiameti inimravimite komiteele 14. oktoobril 2015 direktiivi 2001/83 EÜ artikli 30 kohasest esildisest Vepesidi ja sarnaste nimetuste kohta, et lahendada erinevused liikmesriikides heakskiidetud ravimiteabes ja seega ühtlustada ravimiteave kõikjal Euroopa Liidus.
English: In patients with renal impairment, the CHMP agreed not to recommend a dose reduction when creatinine clearance is > 50 mL/min as supported by available literature[3][4][5][6][7].
Estonian: Inimravimite komitee nõustus, et neerupuudulikkusega patsientidele ei saa soovitada annuse vähendamist, kui kreatiniini kliirens on >50 ml/min, mida toetab olemasolev kirjandus[3][4][5][6][7].
English: • The product information proposed by the Marketing Authorisation Holders has been assessed based on the documentation submitted and the scientific discussion within the Committee,
Estonian: • müügiloa hoidjate esitatud ravimiteabe hindamisel tugineti esitatud dokumentidele ja komitees toimunud teaduslikule arutelule,
English: The following special warnings and precautions for use have been harmonised in section 4.4 where they were already included in some or most of the national SmPCs: within-patient variability, myelosuppression, secondary leukaemia, hypersensitivity, injection site reaction, low serum albumin, impaired renal and hepatic function, tumour lysis syndrome and mutagenic potential.
Estonian: Järgmised erihoiatused ja ettevaatusabinõud on ühtlustatud lõigus 4.4, kus need sisaldusid juba enne mõnes riiklikus ravimi omaduste kokkuvõttes või enamikus neist: kokkupuute varieeruvus samal patsiendil, müelosuppressioon, sekundaarne leukeemia, ülitundlikkus, süstekoha reaktsioon, seerumi väike albumiinisisaldus, neeru- ja maksafunktsiooni puudulikkus, tuumorilüüsi sündroom ja mutageensuse potentsiaal.
English: Vepesid is available as 50mg and 100 mg capsules for oral use.
Estonian: Vepesidi turustatakse 50 mg ja 100 mg suukaudsete kapslitena.
English: The revised indications in section 4.1 of the Summary of Product Characteristics (SmPC) are:
Estonian: Muudetud näidustused ravimi omaduste kokkuvõtte lõigus 4.1 on järgmised:
English: • The Committee considered the divergences identified in the notification for Vepesid and associated names, as well as the remaining sections of the product information.
Estonian: • komitee arutas Vepesi ja sarnaste nimetuste kohta tehtud teatises tuvastatud erinevusi, samuti ravimiteabe ülejäänud lõike,
English: The data in literature for patients with CrCl less than 15 mL/min and on dialysis strongly suggest that further dose reduction is required in these patients as reviewed by Inoue et al. (2004)[8].
Estonian: Kirjandusandmetest patsientide kohta, kellel on kreatiniini kliirens <15 ml/min või kes saavad dialüüsi, võib järeldada, et nende annust on vaja veelgi vähendada, nagu kirjeldatakse ülevaates Inoue et al. (2004)[8].
English: With regards to lactation, etoposide is excreted in the milk (Medications and Mothers' Milk: Thomas W. Hale) and it has been included as a contraindication.
Estonian: Imetamise kohta lisati teave, et etoposiid eritub rinnapiima (vt Thomas W. Hale, Medications and Mothers' Milk), ja see on lisatud vastunäidustusena.
English: The CHMP as a consequence, concluded that the benefit-risk balance of Vepesid and associated names remains favourable, subject to the agreed changes to the product information.
Estonian: Seega järeldas inimravimite komitee, et Vepesi ja sarnaste nimetuste kasulikkuse ja riski tasakaal on endiselt soodne, kui ravimiteabes tehakse soovitatud muudatused.
English: In renal impairment (creatinine clearance (CrCl) 15-5 mL/min) a dose reduction of 25% is recommended.
Estonian: Neerupuudulikkuse puhul (kreatiniini kliirens 15…50 ml/min) on soovitatav annust 25% võrra vähendada.
English: Vepesid contains etoposide, a semi-synthetic derivative of podophyllotoxin which ruptures double strand DNA by means of an interaction with DNA-topoisomerase II, or by the formation of free radicals.
Estonian: Vepesid sisaldab etoposiidi, mis on podofüllotoksiini poolsünteetiline saadus, mis lagundab kaheahelalisi DNA struktuure DNA-topoisomeraas II toimel või vabade radikaalide moodustamise kaudu.
English: The coefficient of variation is around 30% for oral administration, versus 10% for intravenous administration (between-patient variability is similar after intravenous or oral administration, i.e. 30-40%).
Estonian: Variatsioonikordaja on suukaudsel manustamisel ligikaudu 30% ja intravenoossel manustamisel 10% (patsientidevaheline varieeruvus pärast intravenoosset ja suukaudset manustamist on sarnane, 30…40%).
English: The text on breastfeeding has been amended accordingly.
Estonian: Imetamise punkti on vastavalt parandatud.
English: As regards the posology, all 17 SmPCs state in section 4.2 that the oral dose of etoposide capsules is based on the recommended intravenous (IV) dose and mention the need to consider bioavailability when prescribing, since it varies from patient to patient.
Estonian: Kõigi (17) ravimi omaduste kokkuvõtte lõigus 4.2 („Annustamine ja manustamisviis“) märgitakse, et etoposiidi kapslite suukaudne annus põhineb soovitataval intravenoossel (IV) annusel, ning mainitakse biosaadavuse hindamise vajadust ravi määramisel, sest see on patsienditi erinev.
English: The available efficacy data for etoposide in the different indications are based for the most part on studies in which etoposide was used intravenously.
Estonian: Etoposiidi efektiivsuse andmed eri näidustustel põhinevad enamasti etoposiidi manustati intravenoosselt.
English: For this reason, the CHMP agreed to include additional information in section 4.2 and 4.4 to inform physicians about the potential disadvantages of oral versus intravenous administration of etoposide.
Estonian: Seepärast nõustus inimravimite komitee lisama lõikudesse 4.2 ja 4.4 lisateabe arstidele etoposiidi suukaudse manustamise võimalikest puudustest võrreldes intravenoossega.
English: It has been found that with oral administration, within-patient variability in exposure (i.e. between cycles) is notably larger than after intravenous administration.
Estonian: On leitud, et suukaudsel manustamisel on kokkupuute varieeruvus samal patsiendil (eri tsüklites) märgatavalt suurem kui pärast intravenoosset manustamist.
English: This is particularly relevant when patients are treated in the curative setting (e.g. for testicular cancer).
Estonian: See on eriti oluline aktiivravi korral (nt. munandivähi ravis).
English: The adult dosing section contains details on monotherapy, combination therapy, an alternative dosing schedule, and dosing adjustments for a low neutrophil count.
Estonian: Täiskasvanutele annustamise punktis on andmed monoteraapia, kombineeritud teraapia, alternatiivse annustusskeemi ja annuste kohandamise kohta neutrofiilide väikese sisalduse korral.
English: - Hodgkin's lymphoma
Estonian: - Hodgkini lümfoom
English: In particular, for the concomitant use of live vaccines, immunosuppression is a common side effect of etoposide listed as very common in the SmPC.
Estonian: Eelkõige esineb samaaegse elusvaktsiinide manustamisel sageli immunosuppressiooni ja see on märgitud ravimi omaduste kokkuvõttes etoposiidi väga sageda kõrvaltoimena.
English: - Acute myeloid leukaemia
Estonian: - Äge müeloidleukeemia
English: Appendix 3 (EMEA/CHMP/203927/2005).
Estonian: Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labellingAppendix 3 (EMEA/CHMP/203927/2005).
English: For this reason, it is critical that the advantages of the oral administration route are carefully weighed against the disadvantages of larger within-patient variability in exposure after oral administration, which should be evaluated on an individual basis.
Estonian: manustamise eeliste kaalutlemisel arvestatakse ka sama patsiendi kokkupuute suuremat varieeruvust pärast suukaudset manustamist, mida peab hindama individuaalselt.
English: In section 4.3 of the SmPC Contraindications, the inclusions of hypersensitivity and concomitant use of live vaccines have been agreed as these are in line with the SmPC guidelines.
Estonian: Ravimi omaduste kokkuvõtte lõiku 4.3 („Vastunäidustused“) on lisatud ülitundlikkus ja samaaegne elusvaktsiinide manustamine, kooskõlas ravimi omaduste kokkuvõtte suunistega.