FrancophonIA/ELRC3.0 huggingface dataset:
English: Following the evaluation of the data presented by the marketing authorisation holder, it was considered that there was insufficient information to identify the underlying mechanism for anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle, or potential factors that may contribute to such events.
Estonian: Pärast müügiloa hoidja esitatud andmete hindamist leiti, et veistele süsteemulsiooni HIPRABOVIS PNEUMOS manustamise järel esinenud anafülaktilist tüüpi kõrvalnähtude põhjuste või selliste kõrvalnähtude võimalike soodustavate tegurite tuvastamiseks ei ole piisavalt teavet.
English: In the absence of an identified underlying cause for the adverse events observed at the time, the changes proposed to the summary of product characteristics (SPC) and product literature were, on the whole, not considered sufficient to minimise the risk of anaphylactic-type events following administration of HIPRABOVIS PNEUMOS Emulsion for injection for cattle under authorised conditions of use.
Estonian: Et täheldatud kõrvalnähtude põhjus ei olnud sel ajal teada, ei peetud ravimi omaduste kokkuvõtte ja ravimiteabe muutmise ettepanekuid pärast veiste süsteemulsiooni HIPRABOVIS PNEUMOS ettenähtud näidustustel manustamist esinevate anafülaktilist tüüpi kõrvalnähtude riski vähendamiseks üldiselt piisavaks.
English: The Committee considered the measures proposed by the marketing authorisation holder to mitigate the risk of anaphylactic-type events following use of the product.
Estonian: Komitee arutas müügiloa hoidja kavandatud meetmeid vaktsiini kasutamise järel esinevate anafülaktilist tüüpi kõrvalnähtude riski vähendamiseks.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF HIPRABOVIS PNEUMOS EMULSION FOR INJECTION FOR CATTLE AND ASSOCIATED NAMES
Estonian: VEISTE SÜSTEEMULSIOONI HIPRABOVIS PNEUMOS JA SARNASTE NIMETUSTE TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE
English: • anaphylactic-type adverse events, some of which were fatal, reported after the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle indicates an association with the product;
Estonian: • pärast veiste süsteemulsiooni HIPRABOVIS PNEUMOS kasutamist esinenud ning mõnel juhul surmavad anafülaktilist tüüpi kõrvalnähud võisid olla seotud vaktsiiniga;
English: The vaccine is expected to benefit herd health and welfare by reducing the clinical signs and lung lesions caused by Mannheimia haemolytica serotype A1 and Histophilus somni in cattle.
Estonian: Eeldatavasti parandab see karja tervist ja heaolu, vähendades veistel Mannheimia haemolytica serotüübi A1 ja Histophilus somni põhjustatud kliinilisi nähte ja kopsukahjustusi, kuigi veiste hingamisteede haiguste vastu vaktsineerimine on kasulik nii loomatervishoiu, loomade heaolu kui ka majandusliku kasu tõttu, ei ole veiste süsteemulsioon HIPRABOVIS PNEUMOS veiste vältimatu vaktsiin.
English: There are valid alternative therapeutic and management tools available on the EU market to control the diseases caused by Mannheimia haemolytica and Histophilus somni.
Estonian: Euroopa Liidus turustatakse Mannheimia haemolytica ja Histophilus somni põhjustatud haiguste tõrjeks ka muid efektiivseid ravimeid ja vahendeid.
English: These reports raised concern over a potential association with the use of HIPRABOVIS PNEUMOS Emulsion for injection for cattle.
Estonian: Selliste kõrvalnähtude sagenemine on tekitanud kahtluse, et see võib olla seotud veiste süsteemulsiooni HIPRABOVIS PNEUMOS kasutamisega.
English: Fortekor Plus is given twice daily approximately one hour before feeding.
Estonian: Ravimit Fortekor Plus antakse kaks korda ööpäevas ligikaudu 1 tund enne söötmist.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Fortekor Plus on 8 September 2015.
Estonian: Euroopa Komisjon andis Fortekor Plusi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 8. septembril 2015.
English: The full EPAR for Fortekor Plus can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Fortekor Plusi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use.
Estonian: Selles selgitatakse, kuidas amet hindas veterinaarravimit, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
English: When the production of angiotensin II is lowered, the blood vessels relax and widen.
Estonian: Kui angiotensiin II tootmine väheneb, siis veresooned lõõgastuvad ja laienevad.
English: What is Fortekor Plus and what is it used for?
Estonian: Mis on Fortekor Plus ja milleks seda kasutatakse?
English: The dose is adjusted according to bodyweight.
Estonian: Annust kohandatakse vastavalt kehakaalule.
English: Congestive heart failure is a condition where the heart cannot pump enough blood around the body.
Estonian: Kongestiivne südamepuudulikkus on seisund, mille korral süda ei suuda pumbata organismi piisavalt verd.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) decided that Fortekor Plus' benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Fortekor Plusi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: The most common side effects with pimobendan (which may affect more than 1 in 10,000 dogs) are an increase in heart rate and vomiting.
Estonian: Pimobendaani kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 koeral 10 000st) on südame löögisageduse suurenemine ja oksendamine.
English: Fortekor Plus is a veterinary medicine used to treat congestive heart failure in dogs.
Estonian: Fortekor Plus on veterinaarravim, mida kasutatakse kongestiivse südamepuudulikkuse raviks koertel.
English: Other information about Fortekor Plus
Estonian: Muu teave Fortekor Plusi kohta
English: Why is Fortekor Plus approved?
Estonian: Miks Fortekor Plus heaks kiideti?
English: It is not intended to provide practical advice on how to use Fortekor Plus.
Estonian: Hindamisaruandes ei anta Fortekor Plusi kasutamise praktilisi nõuandeid.
English: It also must not be given to dogs with low blood pressure, low blood volume, low blood sodium levels or acute (short-term) kidney failure.
Estonian: Samuti ei tohi seda anda koertele, kellel on madal vererõhk, vähene naatriumisisaldus veres või äge (lühiajaline) neerupuudulikkus.
English: Fortekor Plus is available as tablets (pimobendan 1.25 mg/benazepril hydrochloride 2.5 mg and pimobendan 5 mg/benazepril hydrochloride 10 mg) and can only be obtained with a prescription.
Estonian: Ravimit Fortekor Plus turustatakse tablettidena (pimobendaan 1,25 mg / benasepriilvesinikkloriid 2,5 mg ja pimobendaan 5 mg / benasepriilvesinikkloriid 10 mg) ja see on retseptiravim.
English: What are the risks associated with Fortekor Plus?
Estonian: Mis riskid Fortekor Plusiga kaasnevad?
English: The most common side effects with benazepril are short-lived episodes of vomiting, incoordination or signs of tiredness.
Estonian: Benasepriili kõige sagedasemad kõrvalnähud on mööduv oksendamine, koordinatsioonihäired või väsimusnähud.
English: Pregnant women should take special care to avoid accidentally swallowing Fortekor Plus because angiotensin converting enzyme (ACE) inhibitors have been found to affect the unborn child during pregnancy.
Estonian: Rasedad naised peavad eriti hoolikalt vältima ravimi Fortekor Plus juhuslikku neelamist, sest on leitud, et angiotensiini konverteeriva ensüümi (ACE) inhibiitorid mõjutavad inimloodet raseduse ajal.
English: Pimobendan is an inotropic (heart stimulant) substance which increases the strength of the contraction of heart muscle and opens up blood vessels carrying blood to and from the heart, which reduces the work of the heart.
Estonian: Pimobendaan on inotroopne aine (südamestimulant), mis muudab südamelihase kokkutõmbe tugevamaks ning laiendab südamesse verd toovaid ja südamest verd viivaid veresooni, mis vähendab südame koormust.
English: Fortekor Plus must not be given to dogs with hypertrophic cardiomyopathy (heart muscle disease where the walls of the heart thicken reducing blood output), clinical conditions where heart output cannot increase because of functional or anatomical reasons (e.g. narrowing of the aorta or pulmonary artery).
Estonian: Ravimit Fortekor Plus ei tohi anda koertele, kellel esineb hüpertroofiline kardiomüopaatia (südamelihase haigus, mille korral südameseinad paksenevad ja vähendavad südame väljutusmahtu), kliiniline seisund, mille korral südame väljutusmahtu ei ole võimalik parandada funktsionaalsetel või anatoomilistel põhjustel (nt aordi või kopsuarteri ahenemine).
English: Both pimobendan and benazepril are already authorised for dogs as separate medicines.
Estonian: Nii pimobendaan kui ka benasepriil on koertel eraldi ravimitena juba heaks kiidetud.
English: This allows the blood pressure to drop, reducing the load on the heart.
Estonian: See toob kaasa vererõhu languse, mis samuti vähendab südame koormust.
English: Benazeprilat is an ‘angiotensin converting enzyme (ACE) inhibitor'.
Estonian: Benaseprilaat on angiotensiini konverteeriva ensüümi (ACE) inhibiitor.
English: The main measure of effectiveness was the total score of exercise intolerance, demeanour, breathing effort, coughing and difficulty of breathing at night.
Estonian: Toimivuse põhinäitaja oli koormustaluvuse, käitumise, hingamise pingutatuse, köhimise ja öiste hingamisraskuste koguskoor.
English: For the full list of all restrictions and side effects reported with Fortekor Plus, see the package leaflet.
Estonian: Fortekor Plusi kohta teatatud piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Fortekor Plus, including the appropriate precautions to be followed by healthcare professionals and animal owners/keepers.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Fortekor Plusi ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
English: Fortekor Plus contains two active substances, pimobendan and benazepril hydrochloride.
Estonian: Fortekor Plus sisaldab kahte toimeainet, pimobendaani ja benasepriilvesinikkloriidi.
English: If the product is accidentally swallowed by a person, the advice of a doctor should be sought immediately and the package leaflet or label shown to the doctor.
Estonian: Juhusliku enesesüstimise korral tuleb pöörduda kohe arsti poole ja näidata talle pakendi infolehte või etiketti.
English: ACE inhibitors lower the production of angiotensin II, a powerful vasoconstrictor (a substance that narrows blood vessels).
Estonian: ACE-ihibiitorid vähendavad organismis angiotensiin II - tugevatoimelise vasokonstriktori (veresooni ahendav aine - tootmist.
English: How is Fortekor Plus used?
Estonian: Kuidas Fortekor Plusi kasutatakse?
English: It is only for use in dogs whose heart failure is already being controlled by the same doses of pimobendan and benazepril hydrochloride given as separate medicines.
Estonian: Seda kasutatakse üksnes koertel, kellel pimobendaani ja bensaepriilvesinikkloriidi samade annuste manustamine eraldi ravimitena on südamepuudulikkust juba kontrolli all hoidnud.
English: How does Fortekor Plus work?
Estonian: Kuidas Fortekor Plus toimib?
English: The study showed Fortekor Plus to be as effective as pimobendan and benazepril when given as separate treatments.
Estonian: Uuringust nähtus, et Fortekor Plus on sama efektiivne kui pimobendaan ja benasepriil eraldi ravimitena manustatuna.
English: For practical information about using Fortekor Plus, animal owners/keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Fortekor Plusi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: This is a summary of the European public assessment report (EPAR) for Fortekor Plus.
Estonian: See on ravimi Fortekor Plus Euroopa avaliku hindamisaruande kokkuvõte.
English: Pimobendan/benazepril hydrochloride
Estonian: Fortekor Plus pimobendaan/benasepriilvesinikkloriid
English: In a field study involving 67 dogs with congestive heart failure treatment with Fortekor Plus was compared to pimobendan and benazepril given as separate treatments.
Estonian: 67-l kongestiivse südamepuudulikkusega koeral tehtud uuringus võrreldi ravimiga Fortekor Plus toimuvat ravi eraldi manustatud pimobendaan- ja benasepriilraviga.
English: For more information about treatment with Fortekor Plus, read the package leaflet (also part of the EPAR) or contact your veterinarian or pharmacist.
Estonian: Kui vajate Fortekor Plusi kasutamise praktilisi nõuandeid, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma veterinaararsti või apteekri poole.
English: Benazepril is a prodrug, a substance that is converted to benazeprilat in the body.
Estonian: Benasepriil on eelravim, mis muudetakse organismis aktiivseks toimeaineks benaseprilaadiks.
English: What benefits of Fortekor Plus have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Fortekor Plusi kasulikkus?
English: People who are hypersensitive (allergic) to pimobendan or benazepril hydrochloride should avoid contact with Fortekor Plus.
Estonian: Kokkupuudet Fortekor Plusiga peavad vältima isikud, kes on pimobendaani või benasepriili suhtes ülitundlikud (allergilised).
English: 12 vials Meat and offal: 15 days (cattle), 5 days (pigs, horses)
Estonian: 12 viaalid Liha ja söödavad koed: 15 ööpäeva (veised), 5 ööpäeva (sead, hobused)
English: Target species
Estonian: A lisa
English: 16 December 2010 EMA/792246/2010 EMEA/H/C/000859
Estonian: 16. detsember 2010 EMA/792246/2010 EMEA/H/C/000859
English: The company withdrew before the European Commission had issued a decision on this opinion.
Estonian: Ettevõte võttis taotluse tagasi, enne kui Euroopa Komisjon tegi arvamuse kohta otsuse.
English: What was the recommendation of the CHMP at that time?
Estonian: Milline oli sel ajal inimravimite komitee soovitus ?
English: What is Emerflu?
Estonian: Mis on Emerflu?
English: The main measure of effectiveness was the level of antibodies against the flu virus in the blood at three different times: before vaccination, on the day of the second injection (day 21) and 21 days later (day 42).
Estonian: Efektiivsuse põhinäitaja oli gripiviiruse vastaste antikehade sisaldus veres kolmel erineval ajahetkel: enne vaktsineerimist, teise süsti päeval (21. päeval) ja 21 päeva pärast teist süsti (42. päeval).
English: What consequences does this withdrawal have for patients in clinical trials or compassionate use programmes?
Estonian: Kuidas mõjutab tagasivõtmine kliinilistes uuringutes või eriloaga kasutamise programmides osalevaid patsiente?
English: Emerflu contains a flu strain called ‘A/Vietnam/1194/2004 NIBRG 14' (H5N1).
Estonian: Emerflu sisaldab gripiviiruse tüve A/Vietnam/1194/2004 NIBRG 14 (H5N1).
English: This is expected to help to protect against the disease caused by the virus.
Estonian: See eeldatavasti kaitseb haiguse eest, mida viirus põhjustab.
English: The injections were given 21 days apart.
Estonian: Süstide vahele jäeti 21 päeva.
English: Emerflu is a vaccine.
Estonian: Emerflu on vaktsiin.
English: This is a special type of vaccine that is designed to help with the management of a pandemic.
Estonian: See on vaktsiini eriliik, mis on välja töötatud pandeemia ohjeldamiseks.
English: Therefore, the Committee was also concerned that the vaccine's immunogenicity was low, regardless of the strain of virus included, and that the vaccine might not be able to adequately prepare the immune system for future infections.
Estonian: Seetõttu leidis komitee, et hoolimata vaktsiinis sisalduvast viirusetüvest on vaktsiini immunogeensus väike ning et vaktsiin ei valmista immuunsüsteemi tulevasteks nakkusteks piisavalt ette.
English: On 1 December 2010, Sanofi Pasteur SA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Emerflu, for the prevention of ‘pandemic' flu.
Estonian: 1. detsembril 2010 teatas Sanofi Pasteur SA ametlikult Euroopa Ravimiameti inimravimite komiteele oma soovist võtta tagasi vaktsiini Emerflu müügiloa taotlus.
English: Withdrawal of the marketing authorisation application for Emerflu [pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted)]
Estonian: Müügiloa taotluse tagasivõtmise teave: Emerflu (pandeemilise gripi vaktsiin (H5N1), inaktiveeritud purustatud viirus, adjuveeritud)
English: It was only intended for use once a flu pandemic had been officially declared.
Estonian: Seda kavatseti kasutada ainult pärast pandeemia ametlikku väljakuulutamist.
English: Instead, they can prepare a vaccine that contains a strain of flu virus specifically chosen because nobody has been exposed to it, and to which nobody is immune.
Estonian: Selle asemel saab ette valmistada vaktsiini, mis sisaldab spetsiaalselt valitud gripiviiruse tüve, millega ei ole kokku puutunud keegi ega ole selle suhtes immuunne.
English: The higher dose vaccine also contained the adjuvant.
Estonian: Vaktsiini suurem annus sisaldas adjuvanti.
English: It is a suspension for injection that contains parts of influenza (flu) viruses that have been inactivated (killed).
Estonian: See on süstesuspensioon, mis sisaldab inaktiveeritud (hävitatud) gripiviiruste osi.
English: According to criteria laid down by the CHMP, a mock-up vaccine needs to bring about protective levels of antibodies in at least 70% of people for it to be considered suitable.
Estonian: Inimravimite komitee kriteeriumide kohaselt võib imitatsioonvaktsiini pidada sobivaks, kui see tekitab antikehade kaitsva sisalduse vähemalt 70%-l inimestest.
English: The main study of Emerflu included 600 healthy adults and compared the ability of two doses of Emerflu, to trigger the production of antibodies (‘immunogenicity').
Estonian: Emerfluga läbi viidud põhiuuringus osales 600 tervet täiskasvanut ja selles võrreldi kahe Emerflu annuse võimet stimuleerida antikehade teket (immunogeensust).
English: The company informed the CHMP that, at the time of the withdrawal, there were no clinical trials being carried out with Emerflu.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmise ajal ei toimunud ühtegi Emerflu kliinilist uuringut.
English: Emerflu was expected to be used in adults to protect against ‘pandemic' flu.
Estonian: Emerflud kavatseti kasutada täiskasvanute kaitsmiseks pandeemilise gripi eest.
English: Because antibody production following Emerflu administration was below this level in the main studies (less than 40% in participants aged below 60 years), the CHMP was concerned that Emerflu was not suitable for use as a mock-up vaccine.
Estonian: Et põhiuuringutes tekitas Emerflu antikehi väiksemal arvul inimestest (alla 60-aastastel uuringus osalenutest vähem kui 40%-l), ei pidanud inimravimite komitee Emerflu kasutamist imitatsioonvaktsiinina sobivaks.
English: Hence, the CHMP recommended that Emerflu be refused marketing authorisation.
Estonian: Seetõttu soovitas inimravimite komitee keelduda müügiloa andmisest Emerflule.
English: Some of the participants in the studies of Emerflu went on to receive a third dose of the vaccine, containing either of the two flu virus strains, with or without the adjuvant.
Estonian: Mõned Emerflu uuringute patsiendid said ka kolmanda vaktsiiniannuse, mis sisaldas ühte kahest gripiviiruse tüvest koos adjuvandiga või ilma.
English: At that point in time, the CHMP was of the opinion that the benefits of Emerflu used for prophylaxis of influenza in an officially declared pandemic situation did not outweigh its risks.
Estonian: Inimravimite komitee leidis, et Emerflu kasulikkus ametlikult väljakuulutatud pandeemiaolukorras täiskasvanute gripiprofülaktikaks kasutamisel ei ole suurem kui sellega kaasnevad riskid.
English: In addition, 100 further people received Emerflu that contained a different strain of flu virus.
Estonian: Lisaks sellele said veel 100 inimest Emerflud, mis sisaldas erinevat viirustüve.
English: The vaccine also contains an ‘adjuvant' (a compound containing aluminium), which is expected to stimulate a better response.
Estonian: Vaktsiin sisaldab mõju tõhustamiseks ka adjuvanti (alumiiniumiühendit).
English: How was Emerflu expected to work?
Estonian: Milline oli Emerflu eeldatav toime?
English: The CHMP was concerned over the ability of Emerflu to trigger the production of enough antibodies against the flu virus.
Estonian: Inimravimite komitee ei olnud rahul Emerflu võimega stimuleerida gripiviiruse kaitseks vajaliku antikehade sisalduse teket.
English: Emerflu contains small amounts of haemagglutinins (proteins from the surface) of a virus called H5N1.
Estonian: Emerflu sisaldab vähesel hulgal viiruse H5N1 hemaglutiniine (viiruse pinnavalgud).
English: If a pandemic were to start, the virus strain in Emerflu would have been replaced by the strain causing the pandemic before the vaccine could have been used.
Estonian: Pandeemia puhkedes asendatakse enne vaktsiini kasutamist Emerflu viirusetüvi pandeemiat põhjustanud viiruse tüvega.
English: The effects of Emerflu were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Emerflu toimet muude katsetega.
English: The immune system is then able to produce antibodies more quickly when it is exposed to the virus again.
Estonian: Kui immuunsüsteem puutub viirusega kokku hiljem uuesti, tekivad organismis antikehad kiiremini.
English: The participants received two injections of Emerflu containing one of two different doses of haemagglutinin.
Estonian: Uuringus osalejad said kaks Emerflu süsti, mis sisaldasid ühte kahest hemaglutiniini annusest.
English: Emerflu was expected to work as a ‘mock-up' vaccine.
Estonian: Eeldati, et Emerflu toimib nagu imitatsioonvaktsiin.
English: What was Emerflu expected to be used for?
Estonian: Milleks kavatseti Emerflud kasutada?
English: Similar results were seen in the people who received Emerflu that contained a different strain of flu virus, and there were contradictory results in the studies looking at the effects of a third dose of Emerflu.
Estonian: Samalaadsed tulemused saadi ka inimestel, kes said erinevat gripiviiruse tüve sisaldavat Emerflud.
English: 2 x 5 pre-filled syringes without safety device
Estonian: 2 x 5 eeltäidetud süstalt ilma kaitseseadiseta
English: Filgrastim has been available in other medicines in the EU for a number of years.
Estonian: Filgrastiimi on Euroopa Liidus muudes ravimites turustatud aastaid.
English: Grasustek (pegfilgrastim)
Estonian: Grasustek (pegfilgrastiim)
English: Further information on Grasustek can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/grasustek.
Estonian: Lisateave Grasusteki kohta on ameti veebilehel: ema.europa.eu/medicines/human/EPAR/grasustek.
English: What measures are being taken to ensure the safe and effective use of Grasustek?
Estonian: Mis meetmed võetakse, et tagada Grasusteki ohutu ja efektiivne kasutamine?
English: What is Grasustek and what is it used for?
Estonian: Mis on Grasustek ja milleks seda kasutatakse?
English: This means that Grasustek is highly similar to another biological medicine (the ‘reference medicine') that is already authorised in the EU.
Estonian: See tähendab, et Grasustek on väga sarnane teise bioloogilise ravimiga (võrdlusravimiga), millel juba on ELis müügiluba.
English: Other information about Grasustek
Estonian: Muu teave Grasusteki kohta
English: Severe neutropenia lasted just over one-and-a-half days on average with both medicines.
Estonian: Keskmiselt kestis raske neutropeenia mõlema ravimiga veidi üle 1,5 päeva.
English: As for all medicines, data on the use of Grasustek are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Grasusteki kasutamise kohta pidevat järelevalvet.