FrancophonIA/ELRC3.0 huggingface dataset:
English: There is no significant difference in the pharmacokinetics of benazeprilat when benazepril (as hydrochloride) is administered to fed or fasted dogs.
Estonian: Benaseprilaadi farmakokineetikas ei ole olulisi erinevusi, kui benasepriili (vesinikkloriidina) manustada täis või tühja kõhuga koertele.
English: Kidney function and serum potassium levels should be evaluated before initiating the treatment with benazepril and spironolactone, especially in dogs which may suffer hypoadrenocorticism, hyperkalaemia or hyponatraemia.
Estonian: Enne ravi alustamist benasepriili ja spironolaktooniga tuleb hinnata neerufunktsiooni ja seerumi kaaliumisisaldust, eriti nendel koertel, kellel võib esineda hüpoadrenokortitsism, hüperkaleemia või hüponatreemia.
English: A slight increase in aldosterone blood levels may be observed in animals on treatment.
Estonian: Ravi saavatel koertel võib täheldada kerget aldosteroonisisalduse suurenemist veres.
English: In the kidney, spironolactone inhibits the aldosterone-induced sodium retention leading to increase in sodium, and subsequently water excretion, and potassium retention.
Estonian: Neerudes inhibeerib spironolaktoon aldosteroonist tingitud naatriumipeetust, tuues kaasa naatriumi ja seejärel vee eritumise ning kaaliumipeetuse.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the bottle.
Estonian: Ärge kasutage veterinaarravimit pärast kõlblikkusaega, mis on märgitud pudelil.Kõlblikkusaeg pärast pudeli esmast avamist: 6 kuud.
English: After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly and decline quickly as the drug is partially metabolized by liver enzymes to benazeprilat.
Estonian: Pärast benasepriilvesinikkloriidi suukaudset manustamist saavutatakse benasepriili maksimaalne sisaldus kiiresti ja sisaldus ka väheneb kiiresti, sest ravim osaliselt metaboliseeritakse maksaensüümide poolt benaseprilaadiks.
English: Symptomatic treatment, e.g., fluid therapy, should also be provided.
Estonian: Tuleb tagada sümptomaatiline ravi, nt anda loomale vedelikku.
English: Shelf-life after first opening the bottle: 6 months.
Estonian: Müügipakendis veterinaarravimi kõlblikkusaeg: 2 aastat Kõlblikkusaeg pärast pudeli esmast avamist: 6 kuud.
English: People with known hypersensitivity to spironolactone or benazepril should avoid contact with the product.
Estonian: Inimesed, kes on benasepriili või spironolaktooni suhtes ülitundlikud, peavad kokkupuudet veterinaarravimiga vältima.
English: The concomitant use of NSAIDs with this veterinary medicinal product may reduce its antihypertensive effect, its natriuretic effect and increase the level of serum potassium.
Estonian: Selle veterinaarravimi koosmanustamine MSPVA-dega võib põhjsutada antihüpertensiivse ja natriureetilise toime vähenemist ning suurendada seerumi kaaliumisisaldust.
English: Benazepril hydrochloride is a prodrug hydrolysed in vivo into its active metabolite, benazeprilat.
Estonian: Benasepriilvesinikkloriid on eelravim, mis in vivo hüdrolüüsitakse aktiivseks metaboliidiks, benaseprilaadiks.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Estonian: ERINÕUDED ETTEVAATUSABINÕUDE OSAS KASUTAMATA JÄÄNUD PREPARAADI VÕI JÄÄTMETE, KUI NEID TEKIB, HÄVITAMISEL
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Estonian: MÜÜGILOA HOIDJA NING, KUI NEED EI KATTU, RAVIMPARTII VABASTAMISE EEST VASTUTAVA TOOTMISLOA HOIDJA NIMI JA AADRESS
English: Interaction with other medicinal products and other forms of interactionFurosemide has been used together with this combination of benazepril (hydrochloride) and spironolactone in dogs with heart failure without any clinical evidence of adverse interactions.
Estonian: Koostoimed teiste ravimitega ja muud koostoimed Furosemiidi on südamepuudulikkusega koertel kasutatud koos benasepriili (vesinikkloriidina ) ja spironolaktooni kombinatsiooniga ilma kliiniliste viideteta kõrvaltoimetele.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Estonian: A. RAVIMPARTII VABASTAMISE EEST VASTUTAV(AD) TOOTJA(D)
English: There may be a dose related hypertrophy of the adrenal zona glomerulosa at high dose rates.In a field study conducted in dogs with chronic degenerative valvular disease 85.9% of dogs showed good compliance with treatment (≥ 90% of prescribed tablets successfully administered) over a three month period.
Estonian: Kroonilise degeneratiivse südameklapirikkega koerte väliuuringus näitas 85% koertest 3 kuu jooksul head ravisoostumust (≥ 90% väljakirjutatud tablettidest manustati edukalt).
English: After multiple oral doses of 0.25 mg benazepril hydrochloride per kg (with 2 mg spironolactone per kg) for 7 consecutive days, a peak benazeprilat concentration (Cmax of 52.4 ng/ml) is achieved with a Tmax of 1.4 h.
Estonian: 0,25 mg/kg benasepriilvesinikkloriidi (koos 2 mg/kg spironolaktooniga) mitme suukaudse annuse manustamise järel 7 järjestikusel päeval saavutatakse benaseprilaadi maksimaalne kontsentratsioon (Cmax 52,4 ng/ml) Tmax 1,4 tunniga.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box of 1 bottle of 30 tablets
Estonian: VÄLISPAKENDIL JA SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 30 tabletiga pudel pappkarbis
English: Furosemide has been used together with this combination of benazepril hydrochloride and spironolactone in dogs with heart failure without any clinical evidence of adverse interactions.
Estonian: Furosemiidi on südamepuudulikkusega koertel kasutatud koos benasepriilvesinikkloriidi ja spironolaktooni kombinatsiooniga ilma kliiniliste viideteta kõrvaltoimetele.
English: After coadministration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-lives (t½) were 7 hours and 6 hours for canrenone and 7-α-thiomethylspironolactone respectively.
Estonian: Pärast spironolaktooni (2 mg/kg kehamassi kohta) ja benasepriilvesinikkloriidi l (0,25 mg/kg kehamassi kohta) koosmanustamist on terminaalne plasma poolväärtusaeg (t½) 7 tundi kanrenoonile ja 6 tundi 7α-tiometüülspironolaktoonile.
English: After co-administration of spironolactone (2 mg/kg bw) and benazepril hydrochloride (0.25 mg/kg bw) the terminal plasma half-life of benazeprilat (t½) was 18 hours.
Estonian: Pärast spironolaktooni (2 mg/kg kehamassi kohta) ja benasepriilvesinikkloriidi (0,25 mg/kg kehamassi kohta) koosmanustamist on terminaalne benaseprilaadi plasma poolväärtusaeg (t½) 18 tundi.
English: The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section "Special precautions for use in animals").
Estonian: Selle veterinaarravimi koosmanustamine teiste kaaliumi säästvate ravimitega (nt beetablokaatorid, kaltsiumikanali blokaatorid, angiotensiini retseptori blokaatorid) võib potentsiaalselt viia hüperkaleemiani (vt lõik „Erihoiatused kasutamisel loomadel“).
English: Spironolactone
Estonian: Spironolaktoon
English: At steady state, mean Cmax of 324 μg/l and 66 μg/l are achieved for the primary metabolites, 7-α-thiomethyl-spironolactone and canrenone, 2 and 4 hours post-dosing, respectively.
Estonian: Püsikontsentratsioonil saavutatakse peamistele metaboliitidele 7-α-tiometüülspironolaktoonile ja kanrenoonile keskmine Cmax 324 μg/l ja 66 μg/l vastavalt 2 ning 4 tunni möödudes peale manustamist.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIISID JA -MEETOD
English: Bottle of 90 tablets
Estonian: Pudel 30 tabletiga Pudel 90 tabletiga
English: Chewable tablet.
Estonian: Närimistablett.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Estonian: TOIMEAINE(TE) SISALDUS
English: The concomitant administration of this veterinary medicinal product with other potassium-sparing treatments (such as ß-blockers, calcium channels blockers, angiotensin receptor blockers) may potentially lead to hyperkalaemia (see section 4.5).
Estonian: Selle veterinaarravimi koosmanustamine teiste kaaliumi säästvate ravimitega (nt, beetablokaatorid, kaltsiumi kanali blokaatorid, angiotensiini retseptori blokaatorid) võib põhjustada hüperkaleemiat (vt punkt 4.5).
English: Daily overdoses to healthy dogs, that is, 6 times (1.5 mg/kg bw benazepril hydrochloride and 12 mg/kg bw spironolactone) and 10 times (2.5 mg/kg bw benazepril hydrochloride and 20 mg/kg bw spironolactone) the recommended dose, led to a slight dose related decrease in red cell mass.
Estonian: Igapäevased üleannused tervetel koertel, st kuuekordne (1,5 mg/kg kehamassi kohta benasepriilvesinikkloriidi ja 12 mg/kg kehamassi kohta spironolaktooni) ja kümnekordne (2,5 mg/kg kehamassi kohta benasepriilvesinikkloriidi ja 20 mg/kg kehamassi kohta spironolaktooni) soovituslik annus tõi kaasa vähese erütrotsüütide massi vähenemise.
English: Active substances:
Estonian: Toimeaine(d):
English: Cardalis 2.5 mg/20 mg tablets
Estonian: Cardalis 2,5 mg / 20 mg tabletid
English: Cardalis chewable tablets should be administered to the dog once a day at a dosage of 0.25 mg/kg bodyweight benazepril hydrochloride (HCl) and 2 mg/kg bodyweight (bw) spironolactone, according to the following dosage table.
Estonian: Cardalise närimistablette tuleb koerale manustada üks kord päevas, benasepriilvesinikkloriidi (HCl) 0,25 mg/kg kehamassi kohta ja spironolaktooni annuses 2 mg/kg kehamassi kohta alltoodud annustamistabeli järgi.
English: EXPIRY DATE
Estonian: EXP
English: After administration of up to 10 times the recommended dose (2.5 mg/kg bw benazepril hydrochloride, 20 mg/kg bw spironolactone) to healthy dogs, dose dependant adverse effects were noted (see section 4.6).
Estonian: Pärast kümnekordse soovitusliku annuse (2,5 mg/kg kehamassi kohta benasepriilvesinikkloriidi, 20 mg/kg kehamassi kohta spironolaktooni) manustamist tervetele koertele tuvastati annusest sõltuvad kõrvaltoimed (vt punkt 4.6).
English: Cardalis 5 mg/40 mg tablets
Estonian: Cardalis 5 mg / 40 mg tabletid
English: Cardalis 10 mg/80 mg tablets
Estonian: Cardalis 10 mg / 80 mg tabletid
English: The concomitant administration of this veterinary medicinal product with other anti-hypertensive agents (e.g. calcium channel blockers, β-blockers or diuretics), anaesthetics or sedatives may potentially lead to additive hypotensive effects.
Estonian: Selle veterinaarravimi koosmanustamine teiste antihüpertensiivsete ravimite (nt kaltsiumikanali blokaatorid, beetablokaatorid või diureetikumid), anesteetikumide või uinutitega võib potentsiaalselt viia vererõhu lisalanguseni.
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril with laboratory animals (rats) at maternally non-toxic doses.
Estonian: Katsetes benasepriiliga täheldati laboriloomadel (rottidel) embrüotoksilisi toimeid (loote kuseteede väärareng) emale mittetoksilistes annustes.
English: Do not use during pregnancy and lactation.Embryotoxic effects (foetal urinary tract malformation) were seen in trials of benazepril (as hydrochloride) with laboratory animals (rats) at maternally nontoxic doses.
Estonian: Katsetes benasepriiliga (vesinikkloriidina) täheldati laboriloomadel (rottidel) embrüotoksilisi toimeid (loote kuseteede väärareng) emale mittetoksilistes annustes.
English: Reversible prostatic atrophy in entire male dogs treated with spironolactone was noted in a Target Animal Safety study at the recommended dose.
Estonian: Sihtloomadel läbiviidud uuringus täheldati soovitatava annuse korral spironolaktooniga ravitud kastreerimata isastel koertel pöörduvat eesnäärme atroofiat.
English: Cardboard box of 1 bottle of 90 tablets
Estonian: 90 tabletiga pudel pappkarbis
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs
Estonian: Cardalis 2,5 mg/ 20 mg närimistabletid koertele Cardalis 5 mg / 40 mg närimistabletid koertele Cardalis 10 mg / 80 mg närimistabletid koertele
English: Cardalis 2.5 mg/20 mg chewable tablets for dogs Cardalis 5 mg/40 mg chewable tablets for dogs Cardalis 10 mg/80 mg chewable tablets for dogs benazepril HCl/spironolactone
Estonian: Cardalis 2,5 mg / 20 mg närismistabletid koertele Cardalis 5 mg / 40 mg närimistabletid koertele Cardalis 10 mg / 80 mg närimistabletid koertele benazeprili HCl/spironolactonum
English: Benazepril hydrochloride (HCl)
Estonian: Koera kehamass (kg)
English: Benazeprilat is excreted via the biliary and the urinary route in dogs.
Estonian: Koertel eritub benaseprilaat sapi ja uriiniga.
English: Absorption
Estonian: Imendumine
English: Cardalis 10 mg/80 mg chewable tablets
Estonian: Cardalis 10 mg / 80 mg närimistabletid
English: After multiple oral doses of 2 mg spironolactone per kg (with 0.25 mg benazepril hydrochloride per kg) for 7 consecutive days, no accumulation is observed.
Estonian: Kumulatsiooni ei täheldatud peale mitme 2 mg/kg spironolaktooni (koos 0,25 mg/kg benasepriilvesinikkloriidiga) annuse suukaudset manustamist 7 järjestikusel päeval.
English: After administration of up to 10 times the recommended dose (2.5 mg/kg bw benazepril hydrochloride, 20 mg/kg spironolactone) to healthy dogs, dose dependent adverse effects were noted, see section "Adverse reactions".
Estonian: Üleannustamine (sümptomid, esmaabi, antidoodid)Pärast kümnekordse soovitusliku annuse (2,5 mg/kg kehamassi kohta benasepriilvesinikkloriidi, 20 mg/kg kehamassi kohta spironolaktooni) manustamist tervetele koertele tuvastati annusest sõltuvad kõrvaltoimed (vt lõik „Kõrvaltoimed“).
English: What measures are being taken to ensure the safe and effective use of Stelara?
Estonian: Mis meetmed võetakse, et tagada Stelara ohutu ja efektiivne kasutamine?
English: The full EPAR for Stelara can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Stelara kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Stelara on 16 January 2009.
Estonian: Euroopa Komisjon andis Stelara müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. jaanuaril
English: Other information about Stelara
Estonian: Muu teave Stelara kohta
English: The infusion lasts at least one hour and the dose depends on the patient's bodyweight.
Estonian: Infusioon kestab vähemalt 1 tund ja annus sõltub patsiendi kehamassist.
English: What is Stelara and what is it used for?
Estonian: Mis on Stelara ja milleks seda kasutatakse?
English: Why is Stelara approved?
Estonian: Miks Stelara heaks kiideti?
English: Stelara is a medicine used to treat the following diseases:
Estonian: Stelara on ravim, mida kasutatakse järgmiste haiguste raviks.
English: Stelara must not be used in patients who have an active infection that the doctor considers important.
Estonian: Ravimit ei tohi kasutada patsiendid, kellel on aktiivne infektsioon, mida arst peab oluliseks.
English: Most of these effects were considered mild and did not require treatment to be stopped.
Estonian: Enamikku kõrvalnähte peeti kergeteks ning ravi ei olnud vaja peatada.
English: The first injection is followed by a further injection four weeks later, and then an injection every 12 weeks.
Estonian: Esimesele süstele järgneb nelja nädala järel teine süst ja seejärel üks süst iga 12 nädala järel.
English: The most serious side effect reported with Stelara is serious hypersensitivity (allergic reaction).
Estonian: Stelara kohta teatatud kõige raskem kõrvalnäht on raske ülitundlikkus (allergiline reaktsioon).
English: The side effects of the medicine were considered tolerable and manageable.
Estonian: Ravimi kõrvalnähte peeti talutavateks ja hallatavateks.
English: EPAR summary for the public
Estonian: Kokkuvõte üldsusele ustekinumaab
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Stelara have also been included in the summary of product characteristics and the package leaflet.
Estonian: Stelara ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on samuti lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: However, patients in some studies had unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression which might be related to Stelara.
Estonian: Mõnes uuringus süvenesid patsientidel ootamatult südame- ja veresoonkonnahäired ning psühhiaatrilised probleemid (nt depressioon), mis võib olla seotud Stelaraga.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Stelara's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Inimravimite komitee otsustas, et Stelara kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: These cytokines are involved in inflammation and other processes that are important in psoriasis, psoriatic arthritis and Crohn's disease.
Estonian: Need tsütokiinid osalevad põletikus ja teistes protsessides, mis on olulised psoriaasi, psoriaatilise artriidi ja Crohni tõve korral.
English: What are the risks associated with Stelara?
Estonian: Mis riskid Stelaraga kaasnevad?
English: These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Estonian: Selles keskendutakse Stelara ohutusele, eriti tuberkuloosi, teiste infektsioonide ja pahaloomuliste kasvajate tekke riskile.
English: By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Estonian: Nende toimet blokeerides vähendab ustekinumaab immuunsüsteemi aktiivsust ja haigussümptomeid.
English: Patients then continue with Stelara given under the skin every 8 or 12 weeks depending on response to treatment.
Estonian: Seejärel jätkatakse patsiendile Stelara manustamist nahaaluse süstina iga 8 või 12 nädala tagant sõltuvalt ravivastusest.
English: The company subsequently provided the longer-term results of the studies (after 5 years of treatment), and the results of a study comparing Stelara with etanercept (another medicine for psoriasis).
Estonian: Ettevõte esitas seejärel uuringute pikaajalised tulemused (5-aastase ravi järel) ja Stelarat etanertseptiga (samuti psoriaasiravim) võrdleva uuringu tulemused.
English: In over half of these patients other treatments for psoriasis had failed or the patients could not receive them.
Estonian: Neist enam kui pooltel ei andnud muud psoriaasi raviviisid ravivastust või patsiendid ei saanud neid kasutada.
English: Eight weeks after the first infusion patients should receive 90 mg Stelara by injection under the skin.
Estonian: 8 nädalat pärast esimest infusiooni peab patsient saama 90 mg Stelarat nahaaluse süstina.
English: This is a summary of the European public assessment report (EPAR) for Stelara.
Estonian: See on ravimi Stelara Euroopa avaliku hindamisaruande kokkuvõte.
English: Stelara may be used alone or combined with methotrexate (a DMARD);
Estonian: Stelarat tohib kasutada ainuravimina või koos metotreksaadiga (samuti DMARD-ravim).
English: Stelara is available as a solution for injection (45 and 90 mg) in vials or prefilled syringes and as a concentrate (130 mg) to make a solution for infusion (drip) into a vein.
Estonian: Stelarat turustatakse süstelahusena (45 ja 90 mg) viaalis või eeltäidetud süstlas ja infusioonilahuse (veeni tilgutatava lahuse) valmistamise kontsentraadina (130 mg).
English: The longer-term results showed that with continuous treatment, the response to Stelara is maintained over 5 years.
Estonian: Pikaajalised tulemused näitasid, et pideva ravi korral püsis Stelara toime vähemalt 5 aastat.
English: Patients weighing over 100 kg should be given Stelara in 90-mg doses for psoriasis, and this should also be considered for psoriatic arthritis.
Estonian: Üle 100 kg kehamassiga patsientidele peab andma Stelarat psoriaasi korral 90 mg annusena; seda tohib kasutada ka psoriaatilise artriidi korral.
English: Stelara can only be obtained with a prescription and should be given under the supervision of a doctor who has experience in diagnosing and treating the diseases that Stelara is used for.
Estonian: Stelara on retseptiravim ning ravi sellega peab toimuma üksnes sellise arsti järelevalve all, kes on kogenud nende seisundite diagnoosimises ja ravis, mille jaoks Stelarat kasutatakse.
English: It is not intended to provide practical advice on how to use Stelara.
Estonian: Hindamisaruandes ei anta Stelara kasutamise praktilisi nõuandeid.
English: In Crohn's disease, treatment is started with Stelara concentrate.
Estonian: Crohni tõve korral alustatakse ravi Stelara kontsentraadiga.
English: Ustekinumab attaches to two cytokines (messenger molecules) in the immune system called interleukin 12 and interleukin 23.
Estonian: Ustekinumaab seondub immuunsüsteemi kahe virgatsaine tsütokiiniga (interleukiin-12 ja interleukiin-23).
English: For the full list of restrictions please see the package leaflet.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: The most common side effects with Stelara (seen in more than 5% of patients during clinical trials) are headache and nasopharyngitis (inflammation of the nose and throat).
Estonian: Stelara kõige sagedamad kõrvalnähud (esinesid kliinilistes uuringutes enam kui 5%-l patsientidest) on peavalu ja nasofarüngiit (nina-neelupõletik).
English: For adults the usual dose is 45 mg, whereas the dose in children depends on bodyweight.
Estonian: Täiskasvanute tavaline annus on 45 mg, laste annus oleneb kehamassist.
English: An additional study involved 110 children with moderate to severe plaque psoriasis aged between 12 and 18 years.
Estonian: Täiendavas uuringus osales 110 last vanuses 12-18 aastat, kellel oli mõõdukas kuni raske naastuline psoriaas.
English: The company that makes Stelara will also provide educational material for healthcare providers and patients.
Estonian: Stelara tootja varustab tervishoiutöötajad ja patsiendid teabematerjaliga.
English: Some of the patients from the two main studies went on to receive Stelara (injection under the skin) every 8 or 12 weeks, or placebo.
Estonian: Osa kahe põhiuuringu patsiente said veel iga 8 või 12 nädala järel Stelarat (nahaaluse süstina) või platseebot.
English: Therefore, the CHMP decided to restrict the use of the medicine in moderate to severe plaque psoriasis to patients aged 12 years and above in whom other treatments had failed or who could not receive them.
Estonian: Sel põhjusel otsustas inimravimite komitee piirata ravimi kasutamist mõõduka kuni raske naastulise psoriaasiga vähemalt 12-aastaste patsientidega, kellele teised raviviisid ei ole mõjunud või kes ei ole saanud neid kasutada.
English: A monoclonal antibody is a type of protein that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Estonian: Monoklonaalne antikeha on teatud valk, mis tunneb ära organismis leiduva teatud aine (antigeeni) ja seondub sellega.
English: In Crohn's disease, the effects of Stelara in reducing symptoms in patients in whom other treatments had failed or who could not receive them were considered important, also given the unmet medical need of these patients.
Estonian: Crohni tõve korral peeti Stelara sümptomeid vähendavat toimet oluliseks patsientidel, kellel teised raviviisid ei olnud mõjunud või kellele need ei sobinud, arvestades samuti nende patsientide rahuldamata ravivajadust.