FrancophonIA/ELRC3.0 huggingface dataset:
English: Strontium ranelate, the active substance in Protelos/Osseor, is expected to stimulate formation of new cartilage and reduce bone breakdown.
Estonian: Eeldatavasti soodustab Protelose/Osseori toimeaine strontsiumranelaat uue kõhre teket ja vähendab luukoe lagunemist.
English: This causes pain and
Estonian: Seetõttu tekitab liigese liikumine valu ja liiges muutub jäigaks.
English: What is happening with Protelos/Osseor for the treatment of osteoporosis?
Estonian: Kuidas mõjutab müügiloa taotluse tagasivõtmine Protelose/Osseori kasutamist osteoporoosi raviks?
English: In osteoarthritis, the cartilage, a smooth layer that lines the joints and helps them to move easily, is gradually lost, and the bone underneath becomes damaged and exposed.
Estonian: Osteoartriidi korral laguneb ajapikku liigeseid kattev sile kõhrekiht, mis hõlbustab nende liikumist.
English: What was Protelos/Osseor expected to be used for?
Estonian: Milleks kavatseti Protelost/Osseori kasutada?
English: How is Protelos/Osseor expected to work?
Estonian: Milline on Protelose/Osseori eeldatav toime?
English: Invented Strength Pharmaceutical Form Route of Administration
Estonian: Tugevus Ravimvorm Manustamistee Pakendi iseloomustus
English: Packaging name
Estonian: Nimi
English: Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection Powder and solvent for prolonged release suspension for injection
Estonian: EU/1/08/479/002 Zypadhera 300 mg Toimeainet prolongeeritult vabastav pulber ja lahusti süstesuspensiooniks
English: Content (concentration)
Estonian: Pulber: viaal
English: MA (EU) number (Invented) name Strength
Estonian: (Väljamõeldu d) nimetus
English: Intralesional use vial (glass)
Estonian: Süstesuspensioon Intralesionaalne viaal (klaasist)
English: 5 million cells/ml Suspension for injection
Estonian: 5 miljonit rakku/ml
English: Pharmaceutica l Form
Estonian: Tugevus Ravimvorm Manustamistee Sisepakendi iseloomustus
English: The European Commission granted a marketing authorisation valid throughout the European Union for Gardasil on 20 September 2006.
Estonian: Euroopa Komisjon andis Gardasili müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 20. septembril 2006.
English: What measures are being taken to ensure the safe and effective use of Gardasil?
Estonian: Mis meetmed võetakse, et tagada Gardasili ohutu ja efektiivne kasutamine?
English: The full EPAR for Gardasil can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Gardasili 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 Gardasil is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Gardasili võimalikult ohutu kasutamine.
English: Gardasil is given according to official recommendations.
Estonian: Gardasili määratakse vastavalt ametlikele soovitustele.
English: The women were followed up for around three years after the third dose of the vaccine.
Estonian: Naisi jälgiti ligikaudu kolme aasta jooksul pärast vaktsiini kolmanda annuse manustamist.
English: There are more than 100 types of papillomavirus, some of which are associated with genital cancers.
Estonian: Papilloomiviirusi on üle 100 tüübi, millest mõnda seostatakse suguelundite vähkidega.
English: Gardasil is a vaccine.
Estonian: Gardasil on vaktsiin.
English: • genital warts.
Estonian: • kondüloomid.
English: These virus-like particles are not capable of causing infection.
Estonian: Need viirusesarnased osakesed ei suuda tekitada nakkust.
English: There were no cases of anal cancer in the study but it is expected that protection against precancerous anal lesions will translate into protection against the cancer.
Estonian: Pärakuvähi juhtumeid ei esinenud, kuid eeldatakse, et pärakupiirkonna vähieelsete kahjustuste kaitse on vähivastane kaitse.
English: Vaccination should be postponed in patients who are ill with a high fever.
Estonian: Kõrges palavikus patsientide vaktsineerimine tuleb edasi lükata.
English: The CHMP decided that Gardasil's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Gardasili kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda vaktsiini müügiloa.
English: This document is a summary of the European public assessment report (EPAR) for Gardasil.
Estonian: See on vaktsiini Gardasil Euroopa avaliku hindamisaruande kokkuvõte.
English: • cervical and anal cancers;
Estonian: • emakakaela- ja pärakuvähk;
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium) to stimulate a better response.
Estonian: Vaktsiin sisaldab parema ravivastuse saamiseks ka adjuvanti (alumiiniumiühendit).
English: There should always be at least one month between the first and the second doses, and at least three months between the second and the third, and all doses should be given within a year.
Estonian: Esimese ja teise annuse vahele tuleb alati jätta vähemalt 1 kuu ning teise ja kolmanda annuse vahele vähemalt 3 kuud ning kõik annused tuleb manustada 1 aasta jooksul.
English: When a patient is given the vaccine, the immune system makes antibodies against the L1 proteins.
Estonian: Vaktsiini manustamisel patsiendile tekitab immuunsüsteem L1-valkude vastaseid antikehi.
English: For the full list of all restrictions, see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: • precancerous lesions (growths) in the cervix, vulva or vagina and anus;
Estonian: • vähieelsed kahjustused (väärarengud) emakakaela, häbeme- või tupe- ja pärakupiirkonnas;
English: HPV types 16 and 18 cause approximately 70% of cervical cancers and between 75 and 80% of anal cancers.
Estonian: Papilloomiviiruse 16. ja 18. tüüp põhjustavad ligikaudu 70% emakakaelavähi juhtudest ning 75-80% pärakuvähi juhtudest.
English: For more information about treatment with Gardasil, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Gardasiliga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Why has Gardasil been approved?
Estonian: Miks Gardasil heaks kiideti?
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Gardasil, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Kava alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Gardasili ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Gardasil human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed)
Estonian: Gardasil inimese papilloomiviiruse vaktsiin [6., 11, 16. ja 18. tüüp] (rekombinantne, adsorbeeritud)
English: What is Gardasil?
Estonian: Mis on Gardasil?
English: These same three doses can also be used in individuals aged nine to thirteen years.
Estonian: Kolme annust tohib samamoodi manustada ka 9-13-aastastele patsientidele.
English: In studies, the most common side effects with Gardasil (seen in more than 1 patient in 10) were headache and reactions at the site of the injection (redness, pain and swelling).
Estonian: Uuringutes olid Gardasili kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) peavalu ning süstekoha reaktsioonid (punetus, valu, turse).
English: It is available in vials or prefilled syringes.
Estonian: Seda turustatakse viaalides või eeltäidetud süstaldes.
English: The studies also showed that Gardasil provided some protection against lesions in the cervix linked to other cancer-causing types of HPV, including type 31.
Estonian: Samuti näitasid uuringud, et Gardasil kaitseb teatud määral emakakaela kahjustuste eest, mis on seotud muude vähkitekitavate papilloomiviiruse tüüpidega, sealhulgas 31. tüübiga.
English: The vaccine is given as an injection into a muscle, preferably in the shoulder or the thigh.
Estonian: Vaktsiin süstitakse lihasesse, soovitatavalt õla- või reielihasesse.
English: Patients who show signs of an allergy after a dose of Gardasil should not receive further doses of the vaccine.
Estonian: Kui patsiendil tekivad pärast Gardasili annuse saamist allergianähud, ei tohi talle järgmisi vaktsiiniannuseid manustada.
English: Gardasil is used in males and females from the age of nine years to protect against the following conditions caused by specific types of human papillomavirus (HPV):
Estonian: Gardasili kasutatakse vähemalt 9-aastastel meestel ja naistel, et kaitsta neid järgmiste haiguste eest, mida põhjustavad inimese papilloomiviiruse teatud tüübid:
English: What is the risk associated with Gardasil?
Estonian: Mis riskid Gardasiliga kaasnevad?
English: Gardasil contains the purified L1 proteins for HPV types 6, 11, 16 and 18, which are produced by a method known as ‘recombinant DNA technology': they are made by yeast cells into which a gene (DNA) has been introduced that makes them able to produce the L1 proteins.
Estonian: Gardasil sisaldab inimese papilloomiviiruse 6., 11., 16. ja 18. tüübi puhastatud L1-valke, mida valmistatakse rekombinant-DNAtehnika abil: neid toodavad pärmirakud, millesse on viidud L1-valkude teket võimaldav geen (DNA).
English: Human papillomaviruses are viruses that cause warts and abnormal tissue growth.
Estonian: Inimese papilloomiviirused on viirused, mis põhjustavad tüükaid ja kudede väärarengut.
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 Gardasil.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas vaktsiini ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas vaktsiini kasutada.
English: The studies looked at how many women developed genital lesions or warts that were due to HPV infection.
Estonian: Uuringutes vaadeldi, mitmel naisel tekkisid papilloomiviiruse nakkusest tingitud suguelundite kahjustused või kondüloomid.
English: If the second dose is given earlier than six months after the first dose, a third dose should always be given.
Estonian: Kui teine annus manustatakse varem kui 6 kuud pärast esimest annust, tuleb tingimata manustada kolmas annus.
English: In contrast, there was a total of 189 cases of external genital lesions out of almost 8,000 women in the placebo group.
Estonian: Seevastu esines platseeborühmas 189 naisel (ligi 8000st) välissuguelundite kahjustusi.
English: All papillomaviruses have a shell, or ‘capsid', that is made up of proteins called ‘L1 proteins'.
Estonian: Kõigil papilloomiviirustel on väliskest ehk kapsiid, mis koosneb L1-valkudest.
English: It is a suspension for injection that contains purified proteins for four types of the human papillomavirus (types 6, 11, 16 and 18).
Estonian: See on süstesuspensioon, mis sisaldab inimese papilloomiviiruse nelja tüübi (6., 11., 16. ja 18. tüüp) puhastatud valke.
English: HPV types 6 and 11 cause approximately 90% of genital warts.
Estonian: Inimese papilloomiviiruse 6. ja 11. tüüp põhjustavad ligikaudu 90% kondüloomide juhtudest.
English: The study testing Gardasil given as 2 doses in girls aged 9 to 13 showed that that the two doses given six months apart were no less effective than the three-dose vaccination: all subjects had developed sufficient amounts of antibodies against HPV one month after their last dose.
Estonian: Uuring, mille käigus anti 9-13-aastastele tüdrukutele Gardasili kaks annust, näitas, et kuuekuulise vahega manustatud vaktsiini kaks annust ei olnud kolmest annusest vähem efektiivsed: kõigil vaktsineeritutel tekkis 1 kuu jooksul pärast viimase annuse saamist piisaval hulgal papilloomiviiruse vastaseid antikehi.
English: Another study in around 800 girls and women compared the effect of two doses of Gardasil in girls aged nine to 13 years with the effect of three doses in girls and young women aged 16 to 24 years.
Estonian: Veel ühes ligikaudu 800 tüdruku ja naisega tehtud lisauuringus võrreldi kahes annuses manustatud Gardasili efektiivsust 9-13-aastastel tüdrukutel ja kolmes annuses manustatud Gardasili efektiivsust 16-24-aastastel tüdrukutel ja noortel naistel.
English: Other information about Gardasil:
Estonian: Muu teave Gardasili kohta
English: Three studies of Gardasil given as three doses looked at the ability of Gardasil to prevent infection with HPV types 6, 11, 16 and 18 and genital warts caused by these HPV types in almost 4,000 women aged between 24 and 45 years, and at the development of antibodies against these HPV types in around 1,700 girls and boys aged between nine and 15 years.
Estonian: Kolmes uuringus vaadeldi kolmes annuses manustatud Gardasili võimet hoida ära papilloomiviiruse 6., 11., 16. ja 18. tüübi nakkust ning nende papilloomiviiruste tüüpidest tingitud suguelundite kahjustusi ligi 4000 naisel vanuses 24-45 aastat, samuti vaadeldi nende papilloomiviiruse tüüpide vastaste antikehade teket ligi 1700 tüdrukul ja poisil vanuses 9-15 aastat.
English: In four main studies of Gardasil given as three dose, Gardasil was compared with placebo (a dummy vaccine) in almost 21,000 women aged between 16 and 26 years.
Estonian: Kolmeannuselise manustamisskeemiga Gardasili kohta viidi läbi neli põhiuuringut, milles Gardasili võrreldi platseeboga (näiv vaktsiin) ligi 21 000 naisel vanuses 16-26 aastat.
English: In addition, these studies confirmed the ability of Gardasil to protect against lesions and HPV infection in 24- to 45-year-old women.
Estonian: Uuringud kinnitasid ka Gardasili võimet kaitsta 24- kuni 45aastaseid naisi kahjustuste ja papilloomiviiruse nakkuse eest.
English: How does Gardasil work?
Estonian: Kuidas Gardasil toimib?
English: What benefit has Gardasil shown during the studies?
Estonian: Milles seisneb uuringute põhjal Gardasili kasulikkus?
English: After vaccination, the immune system is able to produce antibodies more quickly when it is exposed to the real viruses.
Estonian: Kui immuunsüsteem puutub viirusega hiljem uuesti kokku, tekivad organismis antikehad kiiremini.
English: The studies also showed that the vaccine stimulates the production of sufficient amounts of antibodies against HPV in girls and boys aged between nine and 15 years.
Estonian: Samuti näitasid uuringud, et vaktsiin stimuleerib 9-15-aastastel tüdrukutel ja poistel piisaval hulgal papilloomiviiruse vastaste antikehade teket.
English: For the full list of all side effects reported with Gardasil, see the package leaflet.
Estonian: Gardasili kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: For people aged nine to thirteen years, Gardasil can be given as two doses six months apart.
Estonian: 9-13-aastastele patsientidele manustatakse Gardasili kahe annusena, jättes nende vahele 6 kuud.
English: In the four studies in 21,000 women, out of the more than 8,000 women vaccinated with Gardasil who had never been infected by HPV types 6, 11, 16 or 18 before, one woman developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Estonian: 21 000 naisel läbi viidud neljas uuringus tekkis ühel enam kui 8000st Gardasiliga vaktsineeritud naisest, kes ei olnud varem papilloomiviiruse 6., 11., 16. ja 18. tüübiga nakatunud, arvatavasti papilloomiviiruse 16. või 18. tüübist tingitud vähieelne emakakaela kahjustus.
English: Finally, a main study in around 4,000 boys and men from 16 years of age compared the vaccine with placebo to test the vaccine's effect in preventing genital warts, precancerous anal lesions and anal cancer.
Estonian: Põhiuuringus, milles osales ligikaudu 4000 poissi ja meest vanuses 16-26 aastat, võrreldi vaktsiini platseeboga, et kontrollida vaktsiini toimet kondüloomide, pärakupiirkonna vähieelsete kahjustuste ja pärakuvähi korral.
English: The main measure of effectiveness was the development of antibodies against HPV types 6, 11, 16 and 18 one month after the last dose.
Estonian: Efektiivsuse põhinäitaja oli inimese papilloomiviiruse 6., 11., 16. ja 18. tüübi vastaste antikehade teke ühe kuu jooksul pärast viimase annuse manustamist.
English: In the study boys and men, there were 3 cases genital lesions among around 1,400 patients given the vaccines compared with 32 cases among around 1,400 given placebo.
Estonian: Poiste ja meeste uuringus esines suguelundite kahjustusi 3 patsiendil ligi 1400st, keda vaktsineeriti Gardasiliga ja 32 patsiendil ligi 1400st, keda vaktsineeriti platseeboga.
English: In the three studies on genital warts, 2 women out of almost 8,000 in the Gardasil group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Estonian: Kondüloomide kolmes uuringus esines Gardasiliga vaktsineeritud rühmas kahel naisel (ligi 8000st) kondüloome ning vähieelseid tupe ja häbeme kahjustusi ei esinenud.
English: The proteins are assembled in ‘virus-like particles' (structures that look like HPV, so that the body can recognise them easily).
Estonian: Valgud on koondatud viirusesarnasteks osakesteks, et organism tunneks need ära samamoodi kui inimese papilloomiviiruse.
English: For people aged fourteen or above, Gardasil is normally given according to a three-dose schedule with the second dose given two months after the first and the third given four months after the second.
Estonian: Vähemalt 14-aastastele patsientidele manustatakse tavaliselt Gardasili kolm annust, millest teine annus manustatakse 2 kuud pärast esimest ja kolmas annus manustatakse 4 kuud pärast teist annust.
English: A similar effect of Gardasil was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Estonian: Sarnane Gardasili toime ilmnes ka papilloomiviiruse 6. ja 11. tüübist tingitud emakakaela kahjustuste analüüsimisel.
English: With regard to precancerous anal lesions, there 5 cases in the vaccinated group (consisting of around 200 patients) compared with 24 cases in the placebo group (which also had around 200 patients).
Estonian: Pärakupiirkonna vähieelseid kahjustusi esines 5 patsiendil ligi 200st, keda vaktsineeriti Gardasiliga ja 24 patsiendil ligi 200st, keda vaktsineeriti platseeboga.
English: It is recommended that individuals who receive the first dose of Gardasil should complete the dosing regimen with Gardasil.
Estonian: Esimese annuse saanud isikutel on soovitatav viia kogu Gardasili vaktsineerimiskuur lõpule.
English: What is Gardasil used for?
Estonian: Milleks Gardasili kasutatakse?
English: How is Gardasil used?
Estonian: Kuidas Gardasili kasutatakse?
English: In contrast, 85 of the more than 8,000 women who received the placebo vaccine developed lesions that were due to these two HPV types.
Estonian: Seevastu tekkisid 85 platseebovaktsiini saanud naisel (enam kui 8000st) papilloomiviiruse 16. ja 18. tüübist tingitud kahjustused.
English: How has Gardasil been studied?
Estonian: Kuidas Gardasili uuriti?
English: Further information on Pegfilgrastim Mundipharma can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
Estonian: Lisateave Pegfilgrastim Mundipharma kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/pegfilgrastim-mundipharma.
English: This slows down the removal of filgrastim from the body, allowing the medicine to be given less often.
Estonian: See aeglustab filgrastiimi väljutamist organismist, võimaldades harvemat manustamist.
English: This means that Pegfilgrastim Mundipharma is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Estonian: See tähendab, et Pegfilgrastim Mundipharma on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
English: What measures are being taken to ensure the safe and effective use of Pegfilgrastim Mundipharma?
Estonian: Mis meetmed võetakse, et tagada Pegfilgrastim Mundipharma ohutu ja efektiivne kasutamine?
English: Side effects reported with Pegfilgrastim Mundipharma are carefully evaluated and any necessary action taken to protect patients.
Estonian: Pegfilgrastim Mundipharma kõrvalnähte hinnatakse hoolikalt ja patsientide kaitseks võetakse vajalikke meetmeid.
English: It is given specifically to reduce the duration of neutropenia and prevent febrile neutropenia (when neutropenia is accompanied by fever due to an infection).
Estonian: Ravimit kasutatakse eelkõige neutropeenia kestuse vähendamiseks ja febriilse neutropeenia (neutropeenia koos infektsiooni põhjustatud palavikuga) ennetamiseks.
English: Pegfilgrastim Mundipharma is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy.
Estonian: Ravimit Pegfilgrastim Mundipharma manustatakse annuses 6 mg ühekordse subkutaanse süstena vähemalt 24 tundi pärast iga keemiaravi tsükli lõppu.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pegfilgrastim Mundipharma has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Estonian: Euroopa Ravimiamet otsustas, et vastavalt ELi nõuetele bioloogiliselt sarnaste ravimite kohta sarnaneb Pegfilgrastim Mundipharma struktuuri, puhtuse ja bioloogilise toime poolest Neulastaga ning jaotub organismis samamoodi.
English: Therefore, the Agency's view was that, as for Neulasta, the benefits of Pegfilgrastim Mundipharma outweigh the identified risks and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Neulasta korral, ületab Pegfilgrastim Mundipharma kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: The safety of Pegfilgrastim Mundipharma 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 Neulasta.
Estonian: Pegfilgrastim Mundipharma ohutust on hinnatud ja kõigi uuringute põhjal peetakse ravimi kõrvalnähte võrreldavaks võrdlusravimi Neulasta kõrvalnähtudega.
English: For more information about using Pegfilgrastim Mundipharma, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet ravimi Pegfilgrastim Mundipharma kasutamise kohta saate pakendi infolehelt või küsige oma arstilt või apteekrilt.
English: What is Pegfilgrastim Mundipharma and what is it used for?
Estonian: Mis on Pegfilgrastim Mundipharma ja milleks seda kasutatakse?
English: Pegfilgrastim Mundipharma (pegfilgrastim)
Estonian: Pegfilgrastim Mundipharma (pegfilgrastiim)
English: The most common side effect with Pegfilgrastim Mundipharma (which may affect more than 1 in 10 people) is pain in the bones.
Estonian: Pegfilgrastim Mundipharma kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on luuvalu.
English: Filgrastim has been available in other medicines in the EU for a number of years.
Estonian: Pegfilgrastim Mundipharmat on Euroopa Liidus muude ravimite koostisosana turustatud aastaid.
English: The active substance in Pegfilgrastim Mundipharma, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Estonian: Pegfilgrastim Mundipharma toimeaine pegfilgrastiim on filgrastiimi vorm, mis on väga sarnane teatud inimvalguga - granulotsüütide kolooniaid stimuleeriva faktoriga (G-CSF).
English: Because Pegfilgrastim Mundipharma is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pegfilgrastim Mundipharma.
Estonian: Et Pegfilgrastim Mundipharma on bioloogiliselt sarnane ravim, ei pea Neulastaga tehtud pegfilgrastiimi efektiivsus- ja ohutusuuringuid Pegfilgrastim Mundipharmaga kordama.
English: As for all medicines, data on the use of Pegfilgrastim Mundipharma are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, tehakse ravimi Pegfilgrastim Mundipharma kasutamise kohta pidevat järelevalvet.