FrancophonIA/ELRC3.0 huggingface dataset:
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Estonian: Lisa I Ravimi nimetuste nimekiri, ravimvorm, ravimpreparaadi tugevus, manustamisviis, müügiloa hoidjad liikmesriikides
English: County Mayo IRELAND
Estonian: County Mayo Irland
English: Sweden Baxter Medical AB Box 63
Estonian: Baxter AB Box 63
English: 11 g/l amino acids and 1,25 mmol/l Ca.
Estonian: 11 g/l Aminohapped and 1,25 mmol/l Ca.
English: Box 270 Valimotie 15A 00381 Helsinki,
Estonian: Box 270 Valimotie 15A 00381 Helsinski Finland
English: Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis
Estonian: Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis
English: Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A-1020 Wien, Austria
Estonian: Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
English: Baxter SPA piazzale dell' industria 2000144-roma Italy
Estonian: Piazzale dell'Industria 20 00144 Roma Italy
English: Poland Baxter Polska SP. z o.o.
Estonian: Baxter Polska SP. z.o.o.
English: Pouet de Camilo 2 Ribarroja del Turia (Valencia)
Estonian: Ribarroja del Turia (Valencia)
English: Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark
Estonian: Baxter A/S Gydevang 43 3450 Allerød Denmark
English: Netherlands Baxter B.V., Kobaltweg 49, 3542
Estonian: Holland Baxter B.V Kobaltweg 49
English: IP24 3SE United Kingdom
Estonian: Thetford IP24 3SE United Kingdom
English: 7,5 % 75 g / 1000 ml
Estonian: 7,5 % 75 9 I 1000 ml
English: w/v
Estonian: Extraneal w/v
English: Romania BAXTER HEALTHCARE S.A.
Estonian: Baxter Healthcare S.A.
English: Irland
Estonian: Iirimaa
English: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeist of
Estonian: Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
English: Germany Baxter Deutschland GmbH
Estonian: Saksamaa Baxter Deutschland GmbH Edisonstr.
English: Belgium Baxter SA Bld R Branquart 80 7860 Lessines Belgium
Estonian: Luksemburg Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgium
English: Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal
Estonian: Edificio 10 Sintra Business Park,
English: Norfolk IP24 3SE
Estonian: IP24 3SE
English: Bd René Branquart 80, B-7860 Lessines Belgium
Estonian: Boulevard R. Branquart 80 7680 Lessines Belgium
English: Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas
Estonian: Prantsusmaa Baxter S.A.S Avenue louis Pasteur 78310 ZA de Coigneres 78310 Maurepas France
English: 4 to 1,1% acides aminés
Estonian: 4 to 1,1% Aminohapped
English: 78310 Maurepas France
Estonian: 2710-089 Sintra Portugal
English: Sweden Baxter Healthare SA Moneen Road
Estonian: Baxter Healthare SA Moneen Road Castlebar
English: Ljubljana,
Estonian: Norfolk,
English: D-85716
Estonian: D-85716 Unterschleißheim Germany
English: 11,205 g / l 5.38 g / l 0.184 g / l
Estonian: 11.205 g/l 5.38 g/l 0.184 g/l 0.0508 g/l 4.48 g/l
English: Romania BAXTER HEALTHCARE Ltd.,
Estonian: Rumeenia Baxter Healthcare Ltd Caxton Way,
English: Bulgaria BAXTER d.o.o.,Zelezna cesta 18, 1000
Estonian: Bulgaaria BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia
English: Dianeal PD1 Glucose 1.36% w/v
Estonian: Dianeal PDl Glucose 1.36% w/v
English: Dianeal PD1 Glucose 2.27% w/v
Estonian: Dianeal PDl Glucose 2.27% w/v
English: Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Estonian: Rumeenia Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland
English: 13.60 g/l glucose anhydrate
Estonian: 13.60 g/l Veevaba glükoos
English: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Baxter Healthcare Ltd.,
Estonian: Baxter Healthcare Ltd Caxton Way,
English: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
English: Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,
Estonian: Thetford, Norfolk, IP24 3SE
English: Moneen Road,
Estonian: Zona Industrial da Abrunheira,
English: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Estonian: Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
English: Dianeal PD1 Glucose 3.86% w/v
Estonian: Dianeal PDl Glucose 3.86% w/v
English: Anhydrous glucose 38.6 g/L, sodium chloride 5.67 g/L, sodium lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Estonian: Veevaba glükoos 38.6 g/L, Naatriumkloriid 5.67 g/L, Naatrium(S)-laktaat 3.92 g/L, Kaltsiumkloriid 0,257 g/L, Magneesiumkloriid 0,152 g/L
English: Anhydrous glucose 13.6 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Estonian: Veevaba glükoos 13.6 g/L, Naatriumkloriid 5.67 g/L, Naatrium(S)-laktaat 3.92 g/L, Kaltsiumkloriid 0,257 g/L, Magneesiumkloriid 0,152 g/L
English: Anhydrous glucose 22.7 g/L, sodium chloride 5.67 g/L, sodium-L(+) lactate 3.92 g/L, calcium chloride dihydrate 0.257 g/L, magnesium chloride hexahydrate 0.152 g/L
Estonian: Veevaba glükoos 22.7 g/L, Naatriumkloriid 5.67 g/L, Naatrium(S)-laktaat 3.92 g/L, Kaltsiumkloriid 0,257 g/L, Magneesiumkloriid 0,152 g/L
English: 22,7g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Estonian: Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
English: Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK
Estonian: Thetford, Norfolk, IP24 3SE, United Kingdom
English: 38,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Estonian: Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
English: 13,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Estonian: Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
English: Dianeal PD4 med glucos 22,7 mg/ml
Estonian: Dianeal PD4 Glucose 22,7 mg/ml
English: Dianeal PD1 Glucose 2.27%w/v 22.7mg/ml
Estonian: Dianeal PD1 Glucose 2.27% (22,7 mg/ml).
English: Aptivus tipranavir
Estonian: Aptivus tipranaviir
English: The full EPAR for Aptivus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Aptivuse 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 Aptivus is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Aptivuse võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Aptivus?
Estonian: Mis meetmed võetakse, et tagada Aptivuse ohutu ja efektiivne kasutamine?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Estonian: Euroopa Komisjon andis Aptivuse müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. oktoobril
English: Each dose of Aptivus must be taken with ritonavir and food.
Estonian: Iga Aptivuse annus tuleb võtta koos ritonaviiri ja toiduga.
English: Aptivus does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Estonian: Aptivus ei ravi HIV-nakkust ega AIDSi välja, kuid võib edasi lükata immuunsüsteemi kahjustumise ning AIDSiga seostatavate nakkuste ja haiguste tekke.
English: It is available as capsules (250 mg) and as an oral solution.
Estonian: Seda turustatakse kapslitena (250 mg) ja suukaudse lahusena.
English: The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.
Estonian: Uuringus vaadeldi Aptivuse ohutust ja efektiivsust ning ravimi sisaldust patsientide veres.
English: • medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
Estonian: • ravimid, mis lagunevad organismis samal viisil nagu Aptivus või ritonaviir ning mille suur sisaldus veres on kahjulik.
English: The Committee recommended that Aptivus be given marketing authorisation.
Estonian: Komitee soovitas anda Aptivuse müügiloa.
English: Other information about Aptivus:
Estonian: Muu teave Aptivuse kohta
English: In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Estonian: Soovituslik annus vähemalt 12-aastastele patsientidele on 500 mg (kaks kapslit) kaks korda ööpäevas.
English: Aptivus has also been studied in one study involving 63 children aged between two and 12 years, and 52 adolescents aged between 12 and 18 years, almost all of whom had taken HIV treatments in the past.
Estonian: Aptivust uuriti ka ühes uuringus, milles osales 63 last vanuses 2-12 aastat ja 52 noorukit vanuses 1218 aastat, kellest peaaegu kõik olid varem saanud HIV-ravimeid.
English: The CHMP noted that the studies supported the use of Aptivus capsules in adults.
Estonian: Inimravimite komitee märkis, et uuringud toetasid Aptivuse kapslite kasutamist täiskasvanutel.
English: Aptivus should only be used in patients who have no other treatment options.
Estonian: Aptivust tohib kasutada ainult patsientidel, kellel muud ravi kasutada ei saa.
English: Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Estonian: Ravi Aptivusega peab alustama HIV-1-nakkuse ravis kogenud arst.
English: Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Estonian: Sarnaseid kõrvalnähte esines ka lastel ja noorukeil, kuigi oksendamist, löövet ja palavikku esines neil sagedamini kui täiskasvanuil.
English: Although the Committee had some concerns over how the study in children and adolescents was designed, the Committee noted that its results supported the use of the capsules in adolescents and the oral solution in children between the ages of two and 12 years.
Estonian: Kuigi komitee väljendas ettevaatlikkust laste ja noorukite uuringu ülesehituse suhtes, märkis komitee, et uuringu tulemused toetasid kapslite kasutamist noorukitel ja suukaudse lahuse kasutamist 2-12aastastel lastel.
English: In the two adult studies taken together, 34% of the patients taking Aptivus (251 out of 746) responded to treatment, compared with 16% of the patients taking the comparator protease inhibitors (113 out of 737).
Estonian: Mõlemas täiskasvanute uuringus kokku esines ravivastus 34%-l (251 patsienti 746st) Aptivust võtnud patsientidest ja 16%-l võrdlusravimina proteaasiinhibiitoreid võtnud patsientidest (113 patsienti 737st).
English: It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
Estonian: See aeglustab tipranaviiri lagunemist, suurendades tipranaviiri sisaldust veres.
English: Aptivus is a medicine that contains the active substance tipranavir.
Estonian: Aptivus on ravim, mis sisaldab toimeainena tipranaviiri.
English: However, the available information does not support the use of the oral solution in patients aged 12 years or above.
Estonian: Samas ei toetanud olemasolev teave suukaudse lahuse kasutamist vähemalt 12-aastastel patsientidel.
English: Both studies compared the effects of Aptivus with those of another protease inhibitor that was chosen on the basis of the patient's previous treatments and predicted response.
Estonian: Mõlemas uuringus võrreldi Aptivuse toimet teise proteaasiinhibiitori toimega, mis oli valitud vastavalt patsiendi eelnevale ravile ning eeldatavale ravivastusele.
English: For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Aptivusega toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This was compared with an average of zero days in those taking the comparator, meaning that most of the patients taking the comparator did not respond to their treatment at all.
Estonian: Võrdlusravimiga oli see ajavahemik keskmiselt null päeva, mis tähendab, et võrdlusravimile ei reageerinud patsientide enamik üldse.
English: This allows a lower dose of tipranavir to be used for the same antiviral effect.
Estonian: Sel põhjusel on sama viirusevastase toime saavutamiseks võimalik kasutada väiksemat tipranaviiri annust.
English: Doctors should only prescribe Aptivus once they have looked at the HIV-medicines that the patient has taken before and the likelihood that the virus will respond to the medicine.
Estonian: Arst võib Aptivuse määrata ainult pärast seda, kui ta on üle vaadanud patsiendi poolt varem kasutatud HIV-ravimid ning on tõenäoline, et viirus sellele ravimile reageerib.
English: All of the patients started treatment with the oral solution, but adolescents taking the full adult dose could switch to the capsules after four weeks.
Estonian: Kõigi patsientide ravi alustati suukaudse lahusega, kuid täiskasvanute täisannust saanud noorukid hakkasid nelja nädala järel võtma kapsleid.
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 Aptivus.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Children aged between two and 12 years should use the oral solution.
Estonian: 2-12-aastastele lastele tuleb anda suukaudset lahust.
English: However, it concluded that the medicine should only be considered for use as ‘last line' therapy, when no other protease inhibitors are predicted to work.
Estonian: Komitee järeldas siiski, et ravimi kasutamist tuleb kaaluda üksnes viimase võimalusena, kui arvatakse, et mitte ükski teine proteaasiinhibiitor enam ei mõju.
English: What is the risk associated with Aptivus?
Estonian: Mis riskid Aptivusega kaasnevad?
English: In all three studies, the patients also took ritonavir and a combination of other HIV-medicines that were chosen as they had the best chances of reducing the levels of HIV in their blood.
Estonian: Kõigis kolmes uuringus said patsiendid ka ritonaviiri ja muude HIV-ravimite kombinatsiooni, mis valiti, et võimalikult palju vähendada HIV-sisaldust veres.
English: On average, it took 113 days for treatment to stop working in adults taking Aptivus.
Estonian: Keskmiselt kulus ravitoime lakkamiseni Aptivust võtnud täiskasvanud patsientidel 113 päeva.
English: The main measures of effectiveness were the number of patients who responded to treatment, and how long it took before treatment stopped working, during the first 48 weeks of treatment.
Estonian: Efektiivsuse põhinäitaja oli ravivastusega patsientide arv ja ravitoime lakkamiseni kulunud aeg esimese 48 ravinädala jooksul.
English: Aptivus capsules have been studied in two main studies involving a total of 1,483 adults who had received many different HIV-medicines in the past, and were not responding to their current treatment combination including a protease inhibitor.
Estonian: Aptivuse kapsleid uuriti kahes põhiuuringus, milles osales 1483 täiskasvanud patsienti, kes olid varem kasutanud mitmesuguseid HIV-ravimeid, kuid kelle viirus ei allunud kasutatavale ravimikombinatsioonile, mis muu hulgas sisaldas ka proteaasiinhibiitorit.
English: For the full list of all side effects reported with Aptivus, see the package leaflet.
Estonian: Aptivuse kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Estonian: Koos teiste HIV-ravimitega manustatav Aptivus vähendab HIVi kogust veres ja hoiab selle sisalduse väikese.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Aptivus, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Aptivuse ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: In adults, the most common side effects when taking Aptivus with ritonavir (seen in more than 1 patient in 10) are diarrhoea and nausea (feeling sick).
Estonian: Koos ritonaviiriga võetud Aptivuse kõige sagedamad kõrvalnähud täiskasvanuil (esinenud enam kui 1 patsiendil 10st) on kõhulahtisus ja iiveldus.
English: Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Estonian: Aptivust kasutatakse koos väikses annuses ritonaviiriga (samuti HIV-ravim) või teiste HI-viiruseravimitega.
English: It blocks an enzyme called protease that is involved in the reproduction of HIV.
Estonian: See blokeerib HIV-nakkuse paljunemisel osaleva ensüümi proteaasi.
English: This document is a summary of the European public assessment report (EPAR) for Aptivus.
Estonian: See on ravimi Aptivus Euroopa avaliku hindamisaruande kokkuvõte.
English: The active substance in Aptivus, tipranavir, is a protease inhibitor.
Estonian: Aptivuse toimeaine tipranaviir on proteaasiinhibiitor.
English: A ‘response' was defined as a fall in the levels of HIV in the blood (viral load) by 90% or more that was maintained until the end of the 48 weeks.
Estonian: Ravivastus loeti tekkinuks, kui HIV-sisaldus veres (viiruskoormus) langes vähemalt 90% võrra ja püsis sellisena vähemalt 48-nädalase raviaja lõpuni.
English: Aptivus with ritonavir must not be used in patients with moderate or severe problems with their liver or who are taking any of the following medicines:
Estonian: Aptivust ei tohi kasutada mõõdukate või raskete maksaprobleemidega patsientidel või patsientidel, kes kasutavad mis tahes järgmist ravimit:
English: It is used in patients who have already been treated with other antiviral medicines for HIV infection, and in whom many other medicines in the same class as Aptivus (protease inhibitors) do not work.
Estonian: Aptivust kasutatakse patsientidel, keda HIV-infektsiooni tõttu on varem ravitud viiruseravimitega ning kellel teised Aptivusega samasse ravimirühma kuuluvad ravimid (proteaasiinhibiitorid) ei mõju.
English: Why has Aptivus been approved?
Estonian: Miks Aptivus heaks kiideti?
English: The Committee also decided that the benefits of Aptivus oral solution are greater than its risks for children from two to 12 years of age.
Estonian: Komitee otsustas ka, et Aptivuse suukaudse lahuse kasulikkus 2-12-aastastel lastel on suurem kui sellega kaasnevad riskid.
English: Aptivus capsules, taken in combination with ritonavir, were more effective than the comparator medicines in patients with few remaining options for successful HIV treatment.
Estonian: Aptivuse kapslid, mida kasutati koos ritonaviiriga patsientidel, kellel oli vähe võimalusi HIV-nakkuse edukaks raviks, olid võrdlusravimitest efektiivsemad.
English: In the study of children and adolescents, 31% of the adolescents taking the capsules (9 out of 29) and 50% of the children taking the oral solution (31 out of 62) had reached and maintained viral loads below 400 copies/ml after 48 weeks.
Estonian: Laste ja noorukite uuringus langes viiruskoormus alla 400 koopia/ml ja püsis sellisena 31%-l kapsleid võtnud noorukitest (9 patsienti 29st) ja 50%-l suukaudset lahust võtnud lastest (31 patsienti 62st).
English: Aptivus is used to treat patients aged two years and above who have human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Estonian: Seda kasutatakse omandatud immuunpuudulikkuse sündroomi (AIDS) põhjustava 1. tüüpi inimese immuunpuudulikkuse viiruse (HIV-1) nakkuse raviks vähemalt 2-aastastel patsientidel.
English: What is Aptivus?
Estonian: Mis on Aptivus?
English: Therefore, the CHMP decided that the benefits of Aptivus capsules are greater than their risks for the treatment of adults and adolescents 12 years of age or older.
Estonian: Seetõttu otsustas komitee, et Aptivuse kapslite kasulikkus täiskasvanutel ja vähemalt 12-aastastel noorukitel on suurem kui ravimiga kaasnevad riskid.
English: Aptivus with ritonavir must not be used with colchicine (a medicine used to treat gout) in patients with kidney or liver impairment.
Estonian: Koos ritonaviiriga võetud Aptivust ei tohi kasutada koos kolhitsiiniga (podagraravim) patsientidel, kellel on neeru- või maksakahjustus.
English: The dose of the oral solution depends on body surface area (calculated using the child's height and weight).
Estonian: (arvutatakse lapse pikkuse ja kaalu järgi).
English: What benefit has Aptivus shown during the studies?
Estonian: Milles seisneb uuringute põhjal Aptivuse kasulikkus?
English: How is Aptivus used?
Estonian: Kuidas Aptivust kasutatakse?
English: What is Aptivus used for?
Estonian: Milleks Aptivust kasutatakse?
English: How has Aptivus been studied?
Estonian: Kuidas Aptivust uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: Aptivus on retseptiravim.
English: How does Aptivus work?
Estonian: Kuidas Aptivus toimib?
English: EMA/CHMP/800910/2012 EMEA/H/C/002610
Estonian: 13. detsember 2012 EMA/130414/2013 EMEA/H/C/002610
English: What is Isomarv medium?
Estonian: Mis on Isomarv medium?
English: The application was a joint application from Marvel LifeSciences for Isomarv medium and two other medicines (Solumarv and Combimarv, also developed as biosimilar medicines).
Estonian: Ettevõtte Marvel LifeSciences esitas ühistaotluse ravimi Isomarv medium ja veel kahe teise ravimi kohta (Solumarv ja Combimarv, mis on samuti välja töötatud bioloogiliselt sarnaste ravimitena).
English: This means that it was intended to be similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU).
Estonian: See tähendab, et Isomarv medium pidi sarnanema bioloogilise võrdlusravimiga, millel juba on Euroopa Liidus müügiluba.
English: The insulin in Isomarv medium is produced by a method known as ‘recombinant DNA technology': it is made by bacteria that have received a gene (DNA) which makes the bacteria able to produce the insulin.
Estonian: Ravimis Isomarv medium sisalduvat insuliini valmistatakse rekombinant-DNA-tehnoloogia abil: insuliini toodab bakter, millele on lisatud selle teket võimaldav geen (DNA).
English: The company informed the CHMP that at the time of the withdrawal no patients were receiving Isomarv medium in clinical trials.
Estonian: Ettevõte teatas inimravimite komiteele, et taotluse tagasivõtmise ajal ei saanud ravimit Isomarv meedium kliinilistes uuringutes mitte ükski patsient.
English: Isomarv medium is a medicine that contains the active substance human insulin.
Estonian: Isomarv medium on ravim, mis sisaldab toimeainena iniminsuliini.
English: The initial concerns related mainly to the manufacture of the medicine and whether Isomarv medium was sufficiently similar to its reference medicine.
Estonian: Ettevaatlikkuse peamised põhjused olid seotud ravimi tootmisega, samuti kaheldi, kas Isomarv medium on võrdlusravimiga piisavalt sarnane.