natgillin/translations-raw huggingface dataset:
Four or five days after the Elonva injection, depending on how the ovaries have responded, treatment is started with a GnRH antagonist, which prevents the ovaries from releasing their eggs too early.
4-5 päeva pärast Elonva manustamist, sõltuvalt sellest, kuidas munasarjad on ravimile reageerinud, alustatakse ravi GnRH-antagonistiga, mis takistab munarakkude liiga varast vabanemist munasarjadest.
In three main studies involving 3,292 women who needed to have ovarian stimulation, Elonva treatment has been shown to be as effective as treatment with follitropin beta (an FSH medicine also used to stimulate the ovaries).
Kolmes põhiuuringus, milles osales 3292 munasarjade stimuleerimist vajavat naist, tõendati, et ravi Elonvaga oli sama efektiivne kui ravi beetafollitropiiniga (samuti munasarjade stimuleerimise FSH-ravim).
The main measure of effectiveness for these studies was the average number of eggs collected from each woman after treatment.
Efektiivsuse põhinäitaja oli mõlemas uuringus igalt naiselt pärast ravi kogutud munarakkude keskmine arv.
Elonva can only be obtained with a prescription and treatment should be started under the supervision of a doctor experienced in treating fertility problems.
Elonva on retseptiravim ning ravi tohib alustada ainult viljakusprobleemide ravis kogenud arsti järelevalve all.
FSH stimulates the production of eggs in the ovaries.
FSH stimuleerib munarakkude teket munasarjades.
It is given once as a single injection under the skin in a dose of 100 or 150 micrograms, depending on age and body weight.
Elonvat manustatakse ühekordse subkuntaanse süstina annuses 100 või 150 µg, olenevalt patsiendi vanusest ja kehamassist.
It must also not be used in women with abnormal (not menstrual) bleeding from the vagina without a known cause, fibroids or malformations of the womb that would prevent pregnancy, primary ovarian failure, enlarged ovaries or ovaries with cysts, or in women with risk factors for OHSS such as polycystic ovarian syndrome.
Hüpofüüs ehk ajuripats on ajupõhimikul asuv nääre, mis toodab FSH-d. Elonvat ei tohi kasutada ka naised, kellel on teadmata põhjusega ebanormaalne vaginaalne veritsus (v.a menstruaalne), emaka fibroidid või malformatsioonid, mis võivad takistada rasestumist, primaarne munasarjapuudulikkus, suurenenud või tsüstilised munasarjad, või naised, kellel on munasarjade hüperstimulatsiooni sündroomi risk, nt polütsüstiliste munasarjade sündroom.
Elonva is a hormonal medicine used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
Elonva on hormoonravim, mida kasutatakse viljakusravi saavatel naistel, et stimuleerida korraga mitme munaraku küpsemist munasarjades.
Finally, as soon as three eggs are close to maturation, a single injection of a hormone called human chorionic gonadotropin (hCG) is given to release the mature eggs.
Kui kolm munarakku on peaaegu küpsed, manustatakse ühekordne annus hormooni inimese kooriongonadotropiini (hCG), mis vabastab küpsed munarakud munasarjadest.
As a result, a single dose of the medicine can be given to stimulate egg production for seven days, instead of daily injections that would be required with other FSH medicines.
Selle tulemusena saab Elonvat munarakkude tekke stimuleerimiseks manustada ühe annusena 7 päeva kohta, erinevalt muudest FSH-d sisaldavatest ravimitest, mida tuleb süstida iga päev.
How does Elonva work?
Kuidas Elonva toimib?
The most common side effects with Elonva (which may affect up to 1 in 10 people) are headache, nausea (feeling sick), tiredness, pelvic pain and discomfort, breast tenderness and ovarian hyperstimulation syndrome (OHSS).
Elonva kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on peavalu, iiveldus, väsimus, valu ja ebamugavustunne vaagnapiirkonnas, rindade tundlikkus ning munasarjade hüperstimulatsiooni sündroom.
Elonva contains the active substance corifollitropin alfa.
Elonva sisaldab toimeainena alfakorifollitropiini.
The study in women over 60 kg had an additional main effectiveness measure which was the number of women with a successful early pregnancy.
Üle 60 kg kaaluvate naiste uuringus kasutati ka teist efektiivsuse põhinäitajat - rasestunud naiste arv.
What benefits of Elonva have been shown in studies?
Milles seisneb uuringute põhjal Elonva kasulikkus?
OHSS occurs when the ovaries over-respond to treatment, causing abdominal swelling and pain, nausea and diarrhoea.
Munasarjade hüperstimulatsiooni sündroom tekib, kui munasarjad reageerivad ravile liiga tugevasti, mis põhjustab turset ja valu kõhupiirkonnas, iiveldust ja kõhulahtisust.
It is used together with a gonadotrophin-releasing hormone (GnRH) antagonist (another type of medicine used in fertility treatments).
Elonvat kasutatakse koos gonadotropiini vabastava hormooni (GnRH) antagonistiga (samuti viljakusravim).
Around 39% of those who received Elonva became pregnant compared with 38% of those treated with follitropin beta.
Elonvat saanud naistest rasestus ligikaudu 39% ja beetafollitropiini saanutest 38%.
For the full list of side effects of Elonva, see the package leaflet.
Elonva kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
How is Elonva used?
Kuidas Elonvat kasutatakse?
One of the studies involved women weighing 60 kg or less who received a 100-microgram dose of Elonva, and a second study involved women weighing above 60 kg who received a 150-microgram dose.
Ühes uuringus osalesid kuni 60 kg kaaluvad naised, kellele manustati Elonvat annuses 100 µg, teises üle 60 kg kaaluvad naised, kellele manustati Elonvat annuses 150 µg.
The active substance in Elonva, corifollitropin alfa, is similar to follicle stimulating hormone (FSH), a natural hormone in the body.
Elonva toimeaine alfakorifollitropiin sarnaneb organismis looduslikult tekkivale folliikuleid stimuleerivale hormoonile (FSH).
Seven days after the Elonva injection, if further ovarian stimulation is needed, injections of another medicine similar to Elonva, but suitable for daily injection, may be given.
Kui on vaja täiendavat munasarjade stimuleerimist, tohib 7 päeva pärast Elonva manustamist süstida teist ravimit, mille toime sarnaneb Elonva toimega, kuid mida võib manustada iga päev.
In corifollitropin alfa, a peptide (a short chain of amino acids) is attached to the FSH to prolong its activity in the body.
Alfakorifollitropiin erineb FSH-st selle poolest, et alfakorifollitropiinile on toime pikendamiseks organismis lisatud teatud peptiid (lühike aminohapete ahel).
In the second study in women weighing above 60 kg, the average number of eggs collected from each woman was 13.8 in those treated with Elonva compared with 12.6 in those treated with follitropin beta.
Teises, üle 60 kg kaaluvate naiste uuringus oli igalt naiselt pärast ravi kogutud munarakkude keskmine arv Elonva uuringurühmas 13,8 ja beetafollitropiini uuringurühmas 12,6.
An overview of Elonva and why it is authorised in the EU
Ülevaade ravimist Elonva ja ELis müügiloa väljastamise põhjendus
In the first study in women weighing 60 kg or less, the number of eggs collected from each woman was 13.3 for those treated with Elonva and 10.6 for those treated with follitropin beta.
Esimeses, kuni 60 kg kaaluvate naiste uuringus oli igalt naiselt pärast ravi kogutud munarakkude keskmine arv Elonva uuringurühmas 13,3 ja beetafollitropiini uuringurühmas 10,6.
The third study involved women in the age range 35 to 42 years weighing 50 kg or more who were given a 150-microgram dose of Elonva; the main measure of effectiveness in this study was the number of women with a successful early pregnancy, and 24 and 27% of women treated with Elonva and follitropin beta respectively became pregnant.
Efektiivsuse põhinäitaja oli selles uuringus rasestunud naiste arv: Elonva või follitropiiniga ravitud naistest rasestus vastavalt 24% ja 27%.
Elonva must not be used in patients with tumours of the ovary, breast, womb, pituitary (a gland located at the base of the brain that produces FSH) or hypothalamus (a region of the brain).
Elonvat ei tohi kasutada patsiendid, kellel on munasarja-, rinna-, emaka-, hüpofüüsi- või hüpotalamusekasvaja.
Elonva is available as a solution for injection.
Elonvat turustatakse süstelahusena.
List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the member states
Lisa I Ravimi nimetuste nimekiri, ravimvorm, ravimpreparaadi tugevus, manustamisviis, müügiloa hoidjad liikmesriikides
County Mayo IRELAND
County Mayo Irland
Sweden Baxter Medical AB Box 63
Baxter AB Box 63
11 g/l amino acids and 1,25 mmol/l Ca.
11 g/l Aminohapped and 1,25 mmol/l Ca.
Box 270 Valimotie 15A 00381 Helsinki,
Box 270 Valimotie 15A 00381 Helsinski Finland
Extraneal (Icodextrin 7.5%) Solution for peritoneal dialysis
Extraneal (lcodextrin 7.5%) Solution for peritoneal dialysis
Baxter Healthcare GmbH, Stella-KleinLöw-Weg 15, A-1020 Wien, Austria
Baxter Healthcare GmbH Stella-Klein-Löw-Weg 15, A-1020 Wien Austria
Baxter SPA piazzale dell' industria 2000144-roma Italy
Piazzale dell'Industria 20 00144 Roma Italy
Poland Baxter Polska SP. z o.o.
Baxter Polska SP. z.o.o.
Pouet de Camilo 2 Ribarroja del Turia (Valencia)
Ribarroja del Turia (Valencia)
Denmark Baxter A/S, Gydevang 43, DK-3450 Allerød, Denmark
Baxter A/S Gydevang 43 3450 Allerød Denmark
Netherlands Baxter B.V., Kobaltweg 49, 3542
Holland Baxter B.V Kobaltweg 49
IP24 3SE United Kingdom
Thetford IP24 3SE United Kingdom
7,5 % 75 g / 1000 ml
7,5 % 75 9 I 1000 ml
w/v
Extraneal w/v
Romania BAXTER HEALTHCARE S.A.
Baxter Healthcare S.A.
Irland
Iirimaa
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeist of
Nutrineal PD4 met 11 g/l aminozuren en Ca 1,25 mmol/l, peritoneaaldialysevloeis t of
Germany Baxter Deutschland GmbH
Saksamaa Baxter Deutschland GmbH Edisonstr.
Belgium Baxter SA Bld R Branquart 80 7860 Lessines Belgium
Luksemburg Baxter S.A. Bd René Branquart 80 B-7860 Lessines Belgium
Zona Industrial da Abrunheira - Edifício 10 - Sintra Business Park, 2710-089 Sintra Portugal
Edificio 10 Sintra Business Park,
Norfolk IP24 3SE
IP24 3SE
Bd René Branquart 80, B-7860 Lessines Belgium
Boulevard R. Branquart 80 7680 Lessines Belgium
Baxter SAS Avenue louis Pasteur ZA de Coignères Maurepas
Prantsusmaa Baxter S.A.S Avenue louis Pasteur 78310 ZA de Coigneres 78310 Maurepas France
4 to 1,1% acides aminés
4 to 1,1% Aminohapped
78310 Maurepas France
2710-089 Sintra Portugal
Sweden Baxter Healthare SA Moneen Road
Baxter Healthare SA Moneen Road Castlebar
Ljubljana,
Norfolk,
D-85716
D-85716 Unterschleißheim Germany
11,205 g / l 5.38 g / l 0.184 g / l
11.205 g/l 5.38 g/l 0.184 g/l 0.0508 g/l 4.48 g/l
Romania BAXTER HEALTHCARE Ltd.,
Rumeenia Baxter Healthcare Ltd Caxton Way,
Bulgaria BAXTER d.o.o.,Zelezna cesta 18, 1000
Bulgaaria BAXTER d.o.o.,Zelezna cesta 18, 1000 Ljubljana, Slovenia
Dianeal PD1 Glucose 1.36% w/v
Dianeal PDl Glucose 1.36% w/v
Dianeal PD1 Glucose 2.27% w/v
Dianeal PDl Glucose 2.27% w/v
Lithuania Baxter Healthcare S.A., Moneen Road, Castlebar County Mayo, Ireland
Rumeenia Baxter Healthcare SA, Moneen Road, Castlebar, Co. Mayo, Ireland
13.60 g/l glucose anhydrate
13.60 g/l Veevaba glükoos
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Dianeal PD1 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
Baxter Healthcare Ltd.,
Baxter Healthcare Ltd Caxton Way,
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Dianeal PD1 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Dianeal PD1 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeist of
Dianeal PD4 Glucose 1.36%/13,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeist of
Dianeal PD4 Glucose 2.27%/22,7 mg/ml, peritoneaaldialysevloeis t of
Caxton Way, Thetford, Norfolk, 1P24 3SE, Thetford,
Thetford, Norfolk, IP24 3SE
Moneen Road,
Zona Industrial da Abrunheira,
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeist of
Dianeal PD4 Glucose 3.86%/38,6 mg/ml, peritoneaaldialysevloeis t of
Dianeal PD1 Glucose 3.86% w/v
Dianeal PDl Glucose 3.86% w/v
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
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
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
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
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
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
22,7g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Dianeal PD4 Glucose 22,7g+5,38g+4,48g+0,184g+0,051 g/l
Baxter Healthcare Limited, Caxton Way, Thetford, Norfolk IP24 3SE, UK
Thetford, Norfolk, IP24 3SE, United Kingdom
38,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Dianeal PD4 Glucose 38,6g+5,38g+4,48g+0,184g+0,051 g/l
13,6g+5,38g+4,48g+0,184g+0,051g/l Solution for peritoneal dialysis
Dianeal PD4 Glucose 13,6g+5,38g+4,48g+0,184g+0,051 g/l
Dianeal PD4 med glucos 22,7 mg/ml
Dianeal PD4 Glucose 22,7 mg/ml
Dianeal PD1 Glucose 2.27%w/v 22.7mg/ml
Dianeal PD1 Glucose 2.27% (22,7 mg/ml).
Aptivus tipranavir
Aptivus tipranaviir
The full EPAR for Aptivus can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Euroopa avaliku hindamisaruande täistekst Aptivuse kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
A risk management plan has been developed to ensure that Aptivus is used as safely as possible.
Töötati välja riskijuhtimiskava, et tagada Aptivuse võimalikult ohutu kasutamine.
What measures are being taken to ensure the safe and effective use of Aptivus?
Mis meetmed võetakse, et tagada Aptivuse ohutu ja efektiivne kasutamine?
The European Commission granted a marketing authorisation valid throughout the European Union for Aptivus on 25 October 2005.
Euroopa Komisjon andis Aptivuse müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 25. oktoobril
Each dose of Aptivus must be taken with ritonavir and food.
Iga Aptivuse annus tuleb võtta koos ritonaviiri ja toiduga.
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.
Aptivus ei ravi HIV-nakkust ega AIDSi välja, kuid võib edasi lükata immuunsüsteemi kahjustumise ning AIDSiga seostatavate nakkuste ja haiguste tekke.
It is available as capsules (250 mg) and as an oral solution.
Seda turustatakse kapslitena (250 mg) ja suukaudse lahusena.
The study looked at the safety and effectiveness of Aptivus, and at the levels of the medicine in the patients' blood.
Uuringus vaadeldi Aptivuse ohutust ja efektiivsust ning ravimi sisaldust patsientide veres.
• medicines that are broken down in the same way as Aptivus or ritonavir and are harmful at high levels in the blood.
• ravimid, mis lagunevad organismis samal viisil nagu Aptivus või ritonaviir ning mille suur sisaldus veres on kahjulik.
The Committee recommended that Aptivus be given marketing authorisation.
Komitee soovitas anda Aptivuse müügiloa.
Other information about Aptivus:
Muu teave Aptivuse kohta
In patients aged 12 years and above, the recommended dose of Aptivus is 500 mg (two capsules) twice a day.
Soovituslik annus vähemalt 12-aastastele patsientidele on 500 mg (kaks kapslit) kaks korda ööpäevas.
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.
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.
The CHMP noted that the studies supported the use of Aptivus capsules in adults.
Inimravimite komitee märkis, et uuringud toetasid Aptivuse kapslite kasutamist täiskasvanutel.
Aptivus should only be used in patients who have no other treatment options.
Aptivust tohib kasutada ainult patsientidel, kellel muud ravi kasutada ei saa.
Treatment with Aptivus should be started by a doctor who has experience in the treatment of HIV-1 infection.
Ravi Aptivusega peab alustama HIV-1-nakkuse ravis kogenud arst.
Similar side effects were seen in children and adolescents, although vomiting, rash and pyrexia (fever) were seen more commonly than in adults.
Sarnaseid kõrvalnähte esines ka lastel ja noorukeil, kuigi oksendamist, löövet ja palavikku esines neil sagedamini kui täiskasvanuil.
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.
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.
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).
Mõlemas täiskasvanute uuringus kokku esines ravivastus 34%-l (251 patsienti 746st) Aptivust võtnud patsientidest ja 16%-l võrdlusravimina proteaasiinhibiitoreid võtnud patsientidest (113 patsienti 737st).
It slows down the rate at which tipranavir is broken down, increasing the levels of tipranavir in the blood.
See aeglustab tipranaviiri lagunemist, suurendades tipranaviiri sisaldust veres.
Aptivus is a medicine that contains the active substance tipranavir.
Aptivus on ravim, mis sisaldab toimeainena tipranaviiri.
However, the available information does not support the use of the oral solution in patients aged 12 years or above.
Samas ei toetanud olemasolev teave suukaudse lahuse kasutamist vähemalt 12-aastastel patsientidel.
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.
Mõlemas uuringus võrreldi Aptivuse toimet teise proteaasiinhibiitori toimega, mis oli valitud vastavalt patsiendi eelnevale ravile ning eeldatavale ravivastusele.
For more information about treatment with Aptivus, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
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.
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.
Võrdlusravimiga oli see ajavahemik keskmiselt null päeva, mis tähendab, et võrdlusravimile ei reageerinud patsientide enamik üldse.
This allows a lower dose of tipranavir to be used for the same antiviral effect.
Sel põhjusel on sama viirusevastase toime saavutamiseks võimalik kasutada väiksemat tipranaviiri annust.
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.
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.
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.
Kõigi patsientide ravi alustati suukaudse lahusega, kuid täiskasvanute täisannust saanud noorukid hakkasid nelja nädala järel võtma kapsleid.
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.
Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
Children aged between two and 12 years should use the oral solution.
2-12-aastastele lastele tuleb anda suukaudset lahust.
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.
Komitee järeldas siiski, et ravimi kasutamist tuleb kaaluda üksnes viimase võimalusena, kui arvatakse, et mitte ükski teine proteaasiinhibiitor enam ei mõju.
What is the risk associated with Aptivus?
Mis riskid Aptivusega kaasnevad?
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.
Kõigis kolmes uuringus said patsiendid ka ritonaviiri ja muude HIV-ravimite kombinatsiooni, mis valiti, et võimalikult palju vähendada HIV-sisaldust veres.
On average, it took 113 days for treatment to stop working in adults taking Aptivus.
Keskmiselt kulus ravitoime lakkamiseni Aptivust võtnud täiskasvanud patsientidel 113 päeva.
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.
Efektiivsuse põhinäitaja oli ravivastusega patsientide arv ja ravitoime lakkamiseni kulunud aeg esimese 48 ravinädala jooksul.
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.
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.
For the full list of all side effects reported with Aptivus, see the package leaflet.
Aptivuse kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
Aptivus, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Koos teiste HIV-ravimitega manustatav Aptivus vähendab HIVi kogust veres ja hoiab selle sisalduse väikese.
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.
Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele Aptivuse ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
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).
Koos ritonaviiriga võetud Aptivuse kõige sagedamad kõrvalnähud täiskasvanuil (esinenud enam kui 1 patsiendil 10st) on kõhulahtisus ja iiveldus.
Aptivus is used in combination with low-dose ritonavir (another HIV-medicine) and other HIV-medicines.
Aptivust kasutatakse koos väikses annuses ritonaviiriga (samuti HIV-ravim) või teiste HI-viiruseravimitega.
It blocks an enzyme called protease that is involved in the reproduction of HIV.
See blokeerib HIV-nakkuse paljunemisel osaleva ensüümi proteaasi.
This document is a summary of the European public assessment report (EPAR) for Aptivus.
See on ravimi Aptivus Euroopa avaliku hindamisaruande kokkuvõte.
The active substance in Aptivus, tipranavir, is a protease inhibitor.
Aptivuse toimeaine tipranaviir on proteaasiinhibiitor.