FrancophonIA/ELRC3.0 huggingface dataset:
English: Filgrastim is produced by a method known as ‘recombinant DNA technology': it is made by bacteria into which a gene (DNA) has been introduced, which makes them able to produce filgrastim.
Estonian: Filgrastiimi valmistatakse rekombinant-DNA-tehnika abil: seda toodavad bakterid, millele on lisatud filgrastiimi teket võimaldav geen (DNA).
English: For more information about treatment with Ratiograstim, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Ratiograstimiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: The Committee recommended that Ratiograstim be given marketing authorisation.
Estonian: Komitee soovitas anda Ratiograstimi 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 Ratiograstim.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information on biosimilar medicines, see the question-and-answer document here.
Estonian: Lisateave bioloogiliselt sarnaste ravimite kohta on teabedokumendis siin.
English: How it is given, the dose and the duration of treatment depend on why it is being used, the patient's body weight and the response to treatment.
Estonian: Manustamisviis, annus ja ravi kestus olenevad näidustusest, patsiendi kehakaalust ja ravivastusest.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ratiograstim, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Ratiograstimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The most common side effect with Ratiograstim (seen in more than 1 patient in 10) is musculoskeletal pain (pain in the muscles and bones).
Estonian: Ratiograstimi kõige sagedam kõrvalnäht (esinenud enam kui 1 patsiendil 10st) on luu-lihaskonna valu.
English: The CHMP decided that, in accordance with EU requirements, Ratiograstim 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 Ratiograstim võrdväärne kvaliteet ning ohutus- ja efektiivsusprofiil ravimiga Neupogen.
English: Treatment with Ratiograstim and Neupogen brought about similar reductions in duration of severe neutropenia.
Estonian: Ravi Ratiograstimiga ja ravi Neupogeniga vähendasid raske neutropeenia kestust sarnasel määral.
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 a risk of long-term, severe neutropenia;
Estonian: • neutropeenia kestuse vähendamiseks patsientidel, kes saavad ravi, millega hävitatakse luuüdi rakud enne luuüdi siirdamist (näiteks mõningatel leukeemiaga patsientidel), kui neil on pikaajalise raske neutropeenia oht;
English: Therefore, the effectiveness of Ratiograstim was shown to be equivalent to that of Neupogen.
Estonian: Seega tõestati, et Ratiograstimi efektiivsus on samaväärne Neupogeni efektiivsusega.
English: This is a summary of the European public assessment report (EPAR) for Ratiograstim.
Estonian: See on ravimi Ratiograstim Euroopa avaliku hindamisaruande kokkuvõte.
English: Ratiograstim is used to stimulate the production of white blood cells in the following situations:
Estonian: Ratiograstimit kasutatakse leukotsüütide (vere valgeliblede) tekke stimuleerimiseks järgmistel näidustustel:
English: Ratiograstim was studied to show that it is comparable to the reference medicine, Neupogen.
Estonian: Ratiograstimit uuriti, et näidata selle võrreldavust võrdlusravimiga 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 suurendamiseks ja infektsiooniriski vähendamiseks neutropeeniaga patsientidel, kellel on esinenud raskeid ja korduvaid infektsioone (nakkusi);
English: Ratiograstim is a solution for injection or for infusion (drip into a vein).
Estonian: Ratiograstim on süstelahus või infusioonilahus (veeni tilgutatav lahus).
English: For the full list of all side effects and restrictions, see the package leaflet.
Estonian: Ratiograstimi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: • to reduce the duration of neutropenia (low levels of neutrophils, a type of white blood cell) and the occurrence of febrile neutropenia (neutropenia with fever) in patients receiving chemotherapy (cancer treatment) that is cytotoxic (cell-killing);
Estonian: • neutropeenia (teatud valgeliblede neutrofiilide vähesus) kestuse ja febriilse neutropeenia (palavikuga neutropeenia) esinemissageduse vähendamiseks tsütotoksilist (rakke hävitavat) keemiaravi (vähiravi) saavatel patsientidel;
English: The replacement acts in same way as naturally produced G CSF by encouraging the bone marrow to produce more white blood cells.
Estonian: Tehislik G-CSF toimib samal viisil kui looduslikult tekkiv G-CSF, soodustades leukotsüütide teket luuüdis.
English: infection, to reduce the risk of bacterial infections when other treatments are not appropriate.
Estonian: • püsiva neutropeenia raviks inimese immuunpuudulikkuse viiruse (HIV) kaugelearenenud infektsiooniga patsientidel bakteriaalsete infektsioonide riski vähendamiseks, kui muu ravi ei sobi.
English: What is Ratiograstim?
Estonian: Mis on Ratiograstim?
English: Ratiograstim is a ‘biosimilar' medicine.
Estonian: Ratiograstim on bioloogiliselt sarnane ravim.
English: It contains the active substance filgrastim.
Estonian: Ravimi toimeaine on filgrastiim.
English: The reference medicine for Ratiograstim is Neupogen.
Estonian: Ratiograstimi võrdlusravim on Neupogen.
English: Other side effects may be seen in more than 1 patient in 10, depending on the condition that Ratiograstim is being used for.
Estonian: Olenevalt Ratiograstimi kasutamise näidustusest võivad ka muud kõrvalnähud esineda enam kui 1 patsiendil 10st.
English: What is the risk associated with Ratiograstim?
Estonian: Mis riskid Ratiograstimiga kaasnevad?
English: Why has Ratiograstim been approved?
Estonian: Miks Ratiograstim heaks kiideti?
English: Ratiograstim is given by injection under the skin or infusion into a vein.
Estonian: Ratiograstimit manustatakse nahaaluse süstega või veeniinfusiooniga.
English: How has Ratiograstim been studied?
Estonian: Kuidas Ratiograstimit uuriti?
English: What is Ratiograstim used for?
Estonian: Milleks Ratiograstimit kasutatakse?
English: How is Ratiograstim used?
Estonian: Kuidas Ratiograstimit kasutatakse?
English: What benefit has Ratiograstim shown during the studies?
Estonian: Milles seisneb uuringute põhjal Ratiograstimi kasulikkus?
English: How does Ratiograstim work?
Estonian: Kuidas Ratiograstim toimib?
English: This summary was last updated in 05-2013.
Estonian: Kokkuvõtte viimane uuendus: 05-2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union for NutropinAq on on 16 February 2001.
Estonian: Euroopa Komisjon andis NutropinAqi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. veebruaril 2001.
English: In children, these side effects are seen in between 1 and 10 patients in 100.
Estonian: Lastel esinevad need kõrvalnähud 1-10 patsiendil 100st.
English: The full EPAR for NutropinAq can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst NutropinAqi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The deficiency can have started in adulthood or childhood, and needs to be confirmed by testing before treatment.
Estonian: See puudulikkus võib olla alguse saanud kas täiskasvanu- või lapseeas ja peab olema enne ravi alustamist uuringutega tõestatud.
English: The doctor calculates the dose for each patient individually depending on the patient's condition.
Estonian: Arst arvutab iga patsiendi annuse eraldi, olenevalt patsiendi seisundist.
English: The main measures in the studies in children were the speed of growth during the study and the height at the end of the study.
Estonian: Laste uuringute efektiivsuse põhinäitajad olid kasvukiirus uuringu ajal ja pikkus uuringu lõpus.
English: NutropinAq is used to treat the following groups of children:
Estonian: NutropinAqi kasutatakse laste järgmiste rühmade ravimiseks:
English: • children who fail to grow because of a lack of growth hormone;
Estonian: • lapsed, kellel on kasvuhormooni puudulikkuse tõttu tekkinud kasvupeetus;
English: Blood sugar levels will need to be checked during treatment, and treatment with insulin may sometimes need to be started or adjusted.
Estonian: Ravi ajal tuleb kontrollida vere glükoosisisaldust ning mõnikord võib olla vaja alustada või kohandada insuliinravi.
English: The CHMP concluded that NutropinAq's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee järeldas, et NutropinAqi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda müügiloa.
English: NutropinAq has been studied in children with growth failure caused by a lack of growth hormone (230 patients), Turner syndrome (117 patients) or kidney disease (195 patients).
Estonian: NutropinAqi uuriti kasvupeetusega lastel, kelle häire oli tingitud kasvuhormooni puudulikkusest (230 last), Turneri sündroomist (117 last) või neeruhaigusest (195 last).
English: Each cartridge contains 10 mg of the active substance somatropin.
Estonian: Üks kolbampull sisaldab 10 mg toimeainet somatropiini.
English: It promotes growth during childhood and adolescence, and also affects the way the body handles proteins, fat and carbohydrates.
Estonian: See soodustab lapse- ja noorukieas kasvu ning mõjutab ka valkude, rasvade ja süsivesikute ainevahetust organismis.
English: The dose may need to be adjusted over time, depending on the patient's response, age and body weight.
Estonian: Aja jooksul võib olla vaja annust muuta, olenevalt patsiendi ravivastusest, vanusest ja kehamassist.
English: Other information about NutropinAq
Estonian: Muu teave NutropinAqi kohta
English: Somatropin may interfere with the body's use of insulin.
Estonian: Somatropiin võib häirida organismi insuliinikasutust.
English: This is a summary of the European public assessment report (EPAR) for NutropinAq.
Estonian: See on ravimi NutropinAq Euroopa avaliku hindamisaruande kokkuvõte.
English: They should use a different injection site each day.
Estonian: Ravimit peab süstima iga päev eri kohta.
English: EPAR summary for the public somatropin
Estonian: Kokkuvõte üldsusele somatropiin
English: The active substance in NutropinAq, somatropin, is identical to human growth hormone.
Estonian: NutropinAqi toimeaine somatropiin on inimese kasvuhormooniga identne.
English: For more information about treatment with NutropinAq, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate NutropinAqiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Other side effects seen at this lower frequency are reactions at the injection site, headache, hypertonia (muscle tension), hypothyroidism (under-activity of the thyroid gland), impaired glucose tolerance, asthenia (weakness) and development of antibodies (proteins that are produced in response to NutropinAq).
Estonian: Muud kõrvalnähud, mida on esinenud selle väiksema sagedusega, on süstekoha reaktsioonid, peavalu, hüpertoonia (suurenenud lihaspinge), hüpotüreoidism (kilpnäärme vaegtalitlus), glükoositaluvuse halvenemine, asteenia (nõrkus) ning antikehade (NutropinAqile vastureaktsioonina tekkivate valkude) moodustumine.
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 NutropinAq.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: • girls from 2 years old who are short because of Turner syndrome (a rare genetic disorder affecting girls), confirmed by chromosome analysis (DNA testing);
Estonian: • vähemalt 2-aastased tüdrukud, kellel on Turneri sündroomi (harva esinev tüdrukute geneetiline häire) tõttu tekkinud kasvupeetus, kui sündroomi olemasolu on tõestatud DNA-analüüsiga;
English: NutropinAq has also been studied in 171 adults with growth hormone deficiency.
Estonian: Samuti uuriti NutropinAqi 171-l kasvuhormooni puudulikkusega täiskasvanul.
English: In adults, NutropinAq increased lean body mass and reduced total body fat.
Estonian: Täiskasvanutel suurendas NutropinAq keha lihasmassi ning vähendas rasvamassi.
English: NutropinAq must not be used for growth promotion in children with closed epiphyses (when the large bones have finished growing).
Estonian: NutropinAqi ei tohi kasutada kasvu soodustamiseks lastel, kellel on epifüüsid luustunud (toruluud on lõpetanud kasvamise).
English: For the full list of all side effects reported with NutropinAq, see the package leaflet.
Estonian: NutropinAqi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The medicine is given once a day by injection under the skin, using the injection pen specially designed for the NutropinAq cartridge.
Estonian: Ravimit manustatakse üks kord ööpäevas subkutaanse (nahaaluse) süstina, kasutades spetsiaalset NutropinAqi kolbampulli jaoks ette nähtud süstalt.
English: NutropinAq produced better growth in children than would have been expected without treatment.
Estonian: NutropinAq soodustas laste kasvu, võrreldes eeldatava kasvuga ilma ravita.
English: NutropinAq replaces the natural hormone.
Estonian: NutropinAq asendab kehaomast hormooni.
English: It is produced by a method known as ‘recombinant DNA technology': the hormone is made by bacteria into which a gene (DNA) has been introduced that makes them able to produce somatropin.
Estonian: Seda toodetakse rekombinant-DNAtehnika abil: somatropiini toodab bakter, millele on lisatud somatropiini teket võimaldav geen (DNA).
English: NutropinAq was compared with a placebo (a dummy treatment) or with a group of untreated patients, except in the studies of children with a lack of growth hormone where there was no comparison with any other group.
Estonian: NutropinAqi saanud patsiente võrreldi platseebot (näivat ravimit) saanud patsientidega või patsientidega, kes ei saanud üldse ravi, välja arvatud kasvuhormooni puudulikkusega laste uuringutes, kus ravitavate patsientide rühma ühegi teise rühmaga ei võrreldud.
English: NutropinAq must not be used in people who are hypersensitive (allergic) to somatropin or any of the other ingredients.
Estonian: NutropinAqi ei tohi kasutada patsiendid, kes on somatropiini või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: The patient or their carer can inject NutropinAq after training by a doctor or a nurse.
Estonian: Kui patsient või tema hooldaja on saanud arstilt või õelt asjakohase väljaõppe, tohivad nad süstida NutropinAqi ka ise.
English: What is NutropinAq?
Estonian: Mis on NutropinAq?
English: NutropinAq must not be used when the patient has an active tumour or a lifethreatening illness.
Estonian: NutropinAqi ei tohi kasutada aktiivse kasvajaga või eluohtliku haigusega patsientidel.
English: What is the risk associated with NutropinAq?
Estonian: Mis riskid NutropinAqiga kaasnevad?
English: NutropinAq is also used to treat adults with a deficiency (low levels) of growth hormone.
Estonian: NutropinAqi kasutatakse ka asendusravina kasvuhormooni puudulikkuse (vähesuse) raviks täiskasvanutel.
English: • children (before puberty) who fail to grow because of long-lasting kidney disease, up to the time when they receive a kidney transplant.
Estonian: • murdeeaeelsed lapsed, kellel on pikaajalise neerupuudulikkuse tõttu tekkinud kasvupeetus, kuni ajani, mil neile siiratakse uus neer.
English: Why has NutropinAq been approved?
Estonian: Miks NutropinAq heaks kiideti?
English: In adults, the most common side effects with NutropinAq (seen in more than 1 patient in 10) are myalgia (muscle pain), arthralgia (joint pain) and oedema (swelling).
Estonian: Täiskasvanuil on NutropinAqi kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) lihasevalu, liigesevalu ja turse.
English: The main measures in the adult study were lean body mass and the decrease in total body fat.
Estonian: Täiskasvanute uuringus olid efektiivsuse põhinäitajad keha lihasmassi suurenemine ja rasvamassi vähenemine.
English: NutropinAq treatment should be started and supervised by a doctor who has experience in the management of patients with growth disorders.
Estonian: Ravi NutropinAqiga tohib alustada üksnes kasvuhäiretega patsientide ravis kogenud arst ning ravi peab toimuma tema järelevalve all.
English: Growth hormone is a substance secreted by a gland located at the base of the brain called the pituitary gland.
Estonian: Kasvuhormoon on ajuripatsi (aju allosas asuv nääre) eritatav aine.
English: How has NutropinAq been studied?
Estonian: Kuidas NutropinAqi uuriti?
English: How is NutropinAq used?
Estonian: Kuidas NutropinAqi kasutatakse?
English: How does NutropinAq work?
Estonian: Kuidas NutropinAq toimib?
English: What benefit has NutropinAq shown during the studies?
Estonian: Milles seisneb uuringute põhjal NutropinAqi kasulikkus?
English: The most serious side effects reported were the development of neoplasms (tumours) and intracranial hypertension (increased pressure inside the skull).
Estonian: Kõige raskemad kõrvalnähud on kasvajate teke ja koljusisese rõhu tõus.
English: What is NutropinAq used for?
Estonian: Milleks NutropinAqi kasutatakse?
English: NutropinAq is a solution for injection in a cartridge.
Estonian: NutropinAq on kolbampullides turustatav süstelahus.
English: Strength Pharmaceutical Form Route of administration
Estonian: Tugevus Ravimvorm Manustamistee Pakeni iseloomustus
English: Invented name
Estonian: Ravimpreparaadi nimetus
English: Treatment should be for the shortest duration possible as long as benefits outweigh risks.
Estonian: Ravi peaks olema võimalikult lühike, tingimusel, et kasulikkus on suurem kui riskid.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Duavive on 16 December 2014.
Estonian: Euroopa Komisjon andis Duavive müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. detsembril 2014.
English: Both active substances have been available in the European Union (EU) for a number of years.
Estonian: Mõlemat toimeainet on Euroopa Liidus aastaid turustatud.
English: What is Duavive and what is it used for?
Estonian: Mis on Duavive ja milleks seda kasutatakse?
English: What measures are being taken to ensure the safe and effective use of Duavive?
Estonian: Mis meetmed võetakse, et tagada Duavive ohutu ja efektiivne kasutamine?
English: The full EPAR and risk management plan summary for Duavive can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Duavive kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Duavive is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Duavive võimalikult ohutu kasutamine.
English: The recommended dose of Duavive is one tablet once a day.
Estonian: Duavive soovitatav annus on üks tablett üks kord ööpäevas.
English: Regarding safety, the long-term risk of endometrial hyperplasia has not been fully investigated and the CHMP recommended further studies to be carried out.
Estonian: Seoses ohutusega ei ole endomeetriumi hüperplaasia pikaajalist riski põhjalikult uuritud ja inimravimite komitee soovitas läbi viia lisauuringud.
English: Other information about Duavive
Estonian: Muu teave Duavive kohta
English: It must not be used in women who have had a stroke or heart attack.
Estonian: Seda ei tohi kasutada naised, kellel on olnud insult või südameinfarkt.
English: Why is Duavive approved?
Estonian: Miks Duavive heaks kiideti?
English: Because studies with the higher strength combination did not sufficiently show that this strength was more effective than the approved strength of Duavive, the company withdrew its application for the former.
Estonian: Kuna suurema tugevusega kombinatsiooni uuringud ei tõendanud piisavalt selle tugevuse suuremat efektiivsust võrreldes Duavive heakskiidetud tugevusega, võttis ettevõte oma taotluse esimese kohta tagasi.
English: It must also not be used in women who have, are likely to have or have had breast cancer or other cancers that are known to be oestrogen-dependent.
Estonian: Samuti ei tohi seda kasutada naised, kellel on, võib tekkida või on olnud rinnavähk või muu teadaolevalt östrogeensõltuv vähk.
English: What are the risks associated with Duavive?
Estonian: Mis riskid Duavivega kaasnevad?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Duavive's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Duavive kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: It is not intended to provide practical advice on how to use Duavive.
Estonian: Hindamisaruandes ei anta Duavive kasutamise praktilisi nõuandeid.
English: It is used in women who still have their uterus (womb) and who cannot be treated with progestogen-containing medicines (medicines derived from the hormone called progesterone).
Estonian: Seda kasutatakse naistel, kelle emakat ei ole eemaldatud ja keda ei saa ravida progestageene sisaldavate ravimitega (hormoon progesteroonist tuletatud ravimid).
English: An additional study also looked at the effects of Duavive on osteoporosis.
Estonian: Lisauuringus vaadeldi Duavive toimet ka osteoporoosile.
English: Because the observed treatment effects were smaller than what is seen with alternative treatments (progestogen-containing treatments) the CHMP therefore concluded that Duavive should be reserved for women who cannot take these alternative medicines.
Estonian: Et täheldatud ravitoime oli väiksem kui alternatiivse ravi (progestageeni sisaldavad ravimid) puhul, järeldas inimravimite komitee, et Duavivet tohivad kasutada ainult need naised, kes ei saa manustada alternatiivseid ravimeid.
English: It replaces the oestrogen hormones that are no longer produced naturally in women who have been through the menopause, thereby alleviating symptoms such as hot flushes.
Estonian: See asendab östrogeenhormoone, mida ei teki enam looduslikult menopausijärgses eas naistel, ja leevendab selle kaudu sümptomeid, nagu kuumahood.
English: How is Duavive used?
Estonian: Kuidas Duavivet kasutatakse?
English: The most common side effect with Duavive (which may affect more than 1 in 10 people) is abdominal pain (stomach ache).
Estonian: Duavive kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on kõhuvalu.