FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not heat Sevelamer carbonate Winthrop powder (e.g. microwave) or add to hot foods or liquids.
Estonian: Ärge kuumutage Sevelamer carbonate Winthrop pulbrit (nt mikrolaineahjus) või lisage soojale toidule või vedelikule.
English: Sevelamer carbonate Winthrop 800 mg film-coated tablets sevelamer carbonate
Estonian: Sevelamer carbonate Winthrop 800 mg õhukese polümeerikattega tabletid sevelameri carbonas
English: Serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Estonian: Seerumi fosforisisaldust tuleb jälgida ja sevelameerkarbonaadi annust tiitrida, suurendades annust 0,8 g võrra kolm korda ööpäevas (2,4 g/ööpäevas) iga 2...4 nädala järel kuni soovitud fosforisisalduse saavutamiseni vereseerumis koos järgneva regulaarse kontrolliga.
English: Each sachet contains 2.4 g of sevelamer carbonate.
Estonian: Üks kotike sisaldab 2,4 g sevelameerkarbonaati.
English: • if you have undergone major surgery on your stomach or bowel.
Estonian: • teil on olnud suuremahuline mao- või sooleoperatsioon.
English: If a dose of 0.4 g is to be administered, please use the dedicated 0.8 g powder presentation with dosing spoon.
Estonian: Kui tuleb manustada annus 0,4 g, kasutage selleks ettenähtud 0,8 g pulbriga mõõtelusikaga pakendit.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Estonian: Farmakoloogilise ohutuse, korduvannuse toksilisuse ja genotoksilisuse tavapärased mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: EU/1/14/952/005 90 sachets EU/1/14/952/006 90 sachets (with a dosing spoon)
Estonian: EU/1/14/952/005 90 kotikest EU/1/14/952/006 90 kotikest (koos mõõtelusikaga)
English: How to take Sevelamer carbonate Winthrop
Estonian: Kuidas Sevelamer carbonate Winthrop'it võtta
English: Package leaflet: Information for the user Sevelamer carbonate Winthrop 0.8 g powder for oral suspension sevelamer carbonate
Estonian: Pakendi infoleht: teave kasutajale Sevelamer carbonate Winthrop 0,8 g suukaudse suspensiooni pulber sevelameerkarbonaat (sevelameri carbonas)
English: The powder should be dispersed in 60 ml of water per sachet prior to administration.
Estonian: Pulber tuleb enne manustamist lahustada 60 ml vees kotikese kohta.
English: (Instructions for presentation WITHOUT dosing spoon)
Estonian: (Juhised MÕÕTELUSIKATA pakendi jaoks)
English: Sevelamer carbonate Winthrop powder for oral suspension is a pale yellow powder supplied in a foil sachet with a heat seal.
Estonian: Sevelamer carbonate Winthrop suukaudse suspensiooni pulber on kuumsuletud fooliumkotikeses väljastatav kahvatukollane pulber.
English: Pruritus, Rash
Estonian: Sügelus, lööve
English: The 0.4 g dose of Sevelamer carbonate Winthrop powder must be measured using the dosing spoon provided in the carton.
Estonian: Sevelamer carbonate Winthrop'i 0,4 g annus tuleb mõõta pakendis oleva mõõtelusika abil..
English: Sevelamer carbonate Winthrop 2.4 g powder for oral suspension sevelamer carbonate
Estonian: Sevelamer carbonate Winthrop 2,4 g suukaudse suspensiooni pulber sevelameri carbonas
English: Hepatic impairment No studies have been performed in patients with hepatic impairment.
Estonian: Maksakahjustusega patsientidel ei ole uuringuid läbi viidud.
English: Package leaflet: Information for the user Sevelamer carbonate Winthrop 2.4 g powder for oral suspension sevelamer carbonate
Estonian: Pakendi infoleht: teave kasutajale Sevelamer carbonate Winthrop 2,4 g suukaudse suspensiooni pulber
English: Sevelamer carbonate Winthrop 0.8 g powder for oral suspension sevelamer carbonate
Estonian: Sevelamer carbonate Winthrop 0,8 g suukaudse suspensiooni pulber sevelameri carbonas
English: Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus ≥ 1.78 mmol/l.
Estonian: Sevelamer carbonate Winthrop on samuti näidustatud hüperfosfateemia ohjamiseks dialüüsi mittesaavatel kroonilise neeruhaigusega täiskasvanud patsientidel seerumi fosforisisaldusega ≥1,78 mmol/l.
English: Hyperparathyroidism
Estonian: Hüperparatüreoos
English: Keep the bottle container tightly closed in order to protect from moisture.
Estonian: Hoida pudel niiskuse eest kaitsmiseks tihedalt suletuna.
English: For adult patients, serum phosphorus levels must be monitored and the dose of sevelamer carbonate titrated by 0.8 g three times per day (2.4 g/day) increments every 2-4 weeks until an acceptable serum phosphorus level is reached, with regular monitoring thereafter.
Estonian: Täiskasvanutel peab jälgima seerumi fosforisisaldust ja tiitrima sevelameerkarbonaadi annust, suurendades annust 0,8 g võrra kolm korda ööpäevas (2,4 g/ööpäevas) iga 2...4 nädala järel kuni soovitud fosforisisalduse saavutamiseni vereseerumis koos järgneva regulaarse kontrolliga.
English: Sevelamer carbonate Winthrop is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus > 1.78 mmol/L.
Estonian: Sevelamer carbonate Winthrop on samuti näidustatud hüperfosfateemia ohjamiseks dialüüsi mittesaavatel kroonilise neeruhaigusega täiskasvanud patsientidel seerumi fosforisisaldusega >1,78 mmol/l.
English: Name and address of the manufacturers responsible for batch release
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutavate tootjate nimi ja aadress Genzyme Ireland Limited
English: In this case the 0.4 g dose of Sevelamer Carbonate Winthrop powder must be measured using the dosing spoon provided in the carton.
Estonian: Sellisel juhul tuleb Sevelamer carbonate Winthrop'i pulbri 0,4 g annus mõõta pakendis oleva mõõtelusika abil.
English: • develop low or high levels of calcium in your blood.
Estonian: • teie vere kaltsiumisisaldus langeda liiga madalale või tõusta liiga kõrgeks.
English: How to store Sevelamer carbonate Winthrop
Estonian: Kuidas Sevelamer carbonate Winthrop'it säilitada
English: The treatment should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal symptoms.
Estonian: Patsientidel, kellel tekib tõsine kõhukinnisus või muud tõsised seedetrakti sümptomid, tuleb uuesti hinnata ravi sevelameerkarbonaadiga.
English: Sachet of ethylene methacrylic acid copolymer, polyester, LDPE and aluminium foil laminate, with a heat seal.
Estonian: Etüleen-metakrüülhappe kopolümeerist, polüestrist, madaltihedast polüetüleenist (LDPE) ja alumiiniumfooliumlaminaadist kuumsuletud kotike.
English: They will base the dose on your serum phosphorus level.
Estonian: Annus määratakse vastavalt teie vereseerumi fosforisisaldusele.
English: Regular monitoring of serum phosphorus levels is always necessary during phosphate binder administration.
Estonian: Fosfaadisidujate manustamisel tuleb alati regulaarselt jälgida seerumi fosforisisaldust.
English: • The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by Sevelamer carbonate Winthrop.
Estonian: • Sevelamer carbonate Winthrop võib vähendada selliste ravimite nagu tsüklosporiin, mükofenolaatmofetiil ja takroliimus (immuunsüsteemi pärssimiseks kasutatavad ravimid) toimet.
English: • upper abdominal pain,
Estonian: • valu kõhu ülaosas,
English: Pack size:
Estonian: Kattekile:
English: Genzyme Ireland Ltd. IDA Industrial Park Old Kilmeaden Road Waterford
Estonian: Genzyme Ireland Ltd.
English: Sevelamer carbonate Winthrop powder should not be heated (e.g. microwave) or added to heated foods or liquids.
Estonian: Ärge kuumutage Sevelamer carbonate Winthrop pulbrit (nt mikrolaineahjus) või lisage kuumale toidule või vedelikule.
English: Sevelamer carbonate Winthrop 2.4 g powder for oral suspension
Estonian: Sevelamer carbonate Winthrop 2,4 g suukaudse suspensiooni pulber
English: Hypothyroidism
Estonian: Sukraloos
English: Sevelamer carbonate Winthrop 0.8 g powder for oral suspension
Estonian: Sevelamer carbonate Winthrop 0,8 g suukaudse suspensiooni pulber
English: Use the provided dosing spoon for each 0.4 g dose of Sevelamer Carbonate Winthrop powder.
Estonian: Sevelamer carbonate Winthrop pulbri ühe 0,4 g annuse jaoks kasutage pakendis olevat mõõtelusikat.
English: o Hold the dosing spoon horizontally and pour the powder out of the sachet into the dosing spoon.
Estonian: • Hoidke mõõtelusikat püstiasendis ja valage kotikesest pulbrit mõõtelusikasse.
English: • nausea.
Estonian: • kõhupuhitus.
English: - Blockage in the intestine (signs include: severe bloating; abdominal pain, swelling or cramps; severe constipation) has been reported.
Estonian: − Teatatud on sooleummistuse juhtudest (nähud on muuhulgas tugev kõhupuhitus, kõhuvalu, paistetus või kõhukramp, tugev kõhukinnisus).
English: The treatment response during the 2-week FDP was not affected by BSA, in contrast however, no treatment response was observed in pediatric patients with qualifying phosphorus levels <7.0 mg/dL.
Estonian: Seevastu ei saavutatud siiski ravivastust lastel, kelle seerumi fosforisisaldus uuringusse kvalifitseerudes oli <7,0 mg/dl. Enamik teatatud kõrvaltoimetest olid gastrointestinaalsed.
English: • indigestion,
Estonian: • kõrvetised,
English: Total daily dose of sevelamer carbonate to be taken over 3 meals per day
Estonian: Sevelameerkarbonaadi ööpäevane koguannus võtmiseks 3 toidukorraga ööpäevas
English: It can be an early symptom of a blockage in your intestine.
Estonian: See võib olla sooleummistuse varajane sümptom.
English: If you get any of the following side effects, seek immediate medical attention: - Allergic reaction (signs including rash, hives, swelling, trouble breathing).
Estonian: − Allergiline reaktsioon (nähud on muuhulgas lööve, nõgestõbi, turse, hingamisraskused).
English: D.
Estonian: SN:
English: The standard dose is one tablet once a day.
Estonian: Standardannus on üks tablett üks kord ööpäevas.
English: The studies included 1,159 patients and lasted 26 and 18 weeks, respectively.
Estonian: Uuringutes osales 1159 patsienti ning uuringud kestsid vastavalt 26 ja 18 nädalat.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasagiline ratiopharm on 12 January 2015.
Estonian: Euroopa Komisjon andis Rasagiline ratiopharmi müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 12. jaanuaril 2015.
English: The full EPAR and risk management plan summary for Rasagiline ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ja riskijuhtimiskava kokkuvõte Rasagiline ratiopharmi 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 Rasagiline ratiopharm is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Rasagiline ratiopharmi võimalikult ohutu kasutamine.
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Rasagiline ratiopharm's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Rasagiline ratiopharmi kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: Rasagiline ratiopharm is available as tablets (1 mg).
Estonian: Rasagiline ratiopharmi turustatakse tablettidena (1 mg).
English: It must also not be used with pethidine (a painkiller).
Estonian: Samuti ei tohi seda kasutada koos petidiiniga (teatud valuvaigisti).
English: This medicine is the same as Azilect, which is already authorised in the European Union (EU).
Estonian: See ravim on samane Azilectiga, millel juba on Euroopa Liidus müügiluba.
English: The most common side effect with Rasagiline ratiopharm (seen in more than 1 patient in 10) is headache.
Estonian: Rasagiline ratiopharmi kõige sagedam kõrvalnäht (võib esineda enam kui 1 patsiendil 10st) on peavalu.
English: What measures are being taken to ensure the safe and effective use of Rasagiline ratiopharm?
Estonian: Mis meetmed võetakse, et tagada Rasagiline ratiopharmi ohutu ja efektiivne kasutamine?
English: The company that makes Azilect has agreed that its scientific data can be used for Rasagiline ratiopharm (‘informed consent').
Estonian: Azilecti tootja on andnud nõusoleku, et tema teaduslikke andmeid võib kasutada ka Rasagiline ratiopharmi toetuseks (teabel põhinev nõusolek).
English: It blocks the enzyme monoamine oxidase type B, which breaks down the neurotransmitter dopamine in the brain.
Estonian: See blokeerib B-tüüpi ensüümi monoamiinoksüdaasi, mis lagundab ajus neurotransmitterit dopamiini.
English: What is Rasagiline ratiopharm and what is it used for?
Estonian: Mis on Rasagiline ratiopharm ja milleks seda kasutatakse?
English: In one of the studies, a 26-week treatment with Rasagiline ratiopharm resulted in an average fall of 0.13 points in UPDRS (a standard scale for assessing symptoms of Parkinson's disease) from a starting value of 24.69 compared with a rise of 4.07 points in the patients taking placebo from a starting value of 24.54.
Estonian: Ühes uuringus vähenes UPDRS (ühtne Parkinsoni tõve hindamisskaala) skaala punktisumma Rasagiline ratiopharmi 26 nädalat võtnud patsientidel algväärtuselt 24,69 keskmiselt 0,13 punkti võrra ja platseebot võtnud patsientidel tõusis sama näitaja algväärtuselt 24,57 keskmiselt 4,07 punkti.
English: Fluctuations happen when the effects of the medication wear off and symptoms reemerge.
Estonian: Seisundite vaheldumine tekib, kui ravimiannuse toime lõpeb ja sümptomid ilmuvad uuesti.
English: Rasagiline ratiopharm rasagiline
Estonian: Rasagiline ratiopharm rasagiliin
English: By increasing levels of dopamine in the parts of the brain that control movement and coordination, Rasagiline ratiopharm improves the signs and symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Estonian: Suurendades dopamiini sisaldust aju osades, mis juhivad liigutusi ja koordinatsiooni, vähendab Rasagiline ratiopharm Parkinsoni tõve nähte ja sümptomeid, näiteks lihasjäikust ja liigutuste aeglust.
English: This is a summary of the European public assessment report (EPAR) for Rasagiline ratiopharm.
Estonian: See on ravimi Rasagiline ratiopharm Euroopa avaliku hindamisaruande kokkuvõte.
English: A fall in the UPDRS score indicates an improvement in symptoms, while a rise indicates a worsening of symptoms.
Estonian: UPDRSi punktisumma vähenemine näitab, et sümptomid leevenevad, ja suurenemine, et sümptomid süvenevad.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Rasagiline ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Rasagiline ratiopharmi omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: Similar reductions in time spent in the ‘off' state were seen in patients taking entacapone.
Estonian: Sarnast liikumisraskustega seisundi kestuse lühenemist täheldati entakapooni võtnud patsientidel.
English: The active substance in Rasagiline ratiopharm, rasagiline, is a ‘monoamine oxidase B inhibitor'.
Estonian: Rasagiline ratiopharmi toimeaine rasagiliin on monoamiinoksüdaas-B inhibiitor.
English: In the two other studies, Rasagiline ratiopharm was given as ‘add-on' to patients with later stage disease who were already being treated with levodopa, and compared with placebo and another medicine entacapone (also used as add-ons).
Estonian: Kahes teises uuringus kasutati Rasagiline ratiopharmi lisaravimina hilisemas staadiumis haigusega patsientidele, kes juba võtsid levodopat, ning seda võrreldi platseebo ja entakapooniga, mida samuti kasutati lisaravimina.
English: It is not intended to provide practical advice on how to use Rasagiline ratiopharm.
Estonian: Hindamisaruandes ei anta Rasagiline ratiopharmi kasutamise praktilisi nõuandeid.
English: There should be at least 14 days between stopping treatment with Rasagiline ratiopharm and starting treatment with another monoamine-oxidase inhibitor or with pethidine.
Estonian: Pärast Rasagiline ratiopharmi ravi lõppu peab ootama vähemalt 14 päeva, enne kui tohib alustada ravi muu monoaminoksüdaasiinhibiitori või petidiiniga.
English: Rasagiline ratiopharm is a medicine used to treat adults with Parkinson's disease (a progressive brain disorder that causes shaking, slow movement and muscle stiffness).
Estonian: Rasagiline ratiopharm on ravim, mida kasutatakse Parkinsoni tõvega (progresseeruv ajuhäire, mis põhjustab värisemist, liigutuste aeglust ja lihasjäikust) täiskasvanute raviks.
English: Rasagiline ratiopharm has been shown in three studies, involving 1,563 patients, to be effective in both relieving the symptoms of Parkinson's disease and in reducing the time patients spend in their ‘off' periods.
Estonian: Kolmes 1563 patsiendiga uuringus tõestati, et Rasagiline ratiopharm on efektiivne nii Parkinsoni tõve sümptomite leevendamisel kui ka liikumisraskustega seisundiga perioodide lühendamises.
English: Why is Rasagiline ratiopharm approved?
Estonian: Miks Rasagiline ratiopharm heaks kiideti?
English: For practical information about using Rasagiline ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Rasagiline ratiopharmi kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: In both studies, patients taking Rasagiline ratiopharm spent an average of around one hour less in the ‘off' state than those taking placebo.
Estonian: Mõlemas uuringus olid Rasagiline ratiopharmi uuringurühma patsiendid keskmiselt ligikaudu ühe tunni võrra vähem liikumisraskustega seisundis kui platseeborühma patsiendid.
English: Rasagiline ratiopharm contains the active substance rasagiline.
Estonian: Rasagiline ratiopharm sisaldab toimeainet rasagiliini.
English: Other information about Rasagiline ratiopharm
Estonian: Muu teave Rasagiline ratiopharmi kohta
English: Rasagiline ratiopharm can be used either alone, or as an add-on to levodopa (another medicine used in Parkinson's disease) in patients who are having ‘fluctuations' towards the end of the period between levodopa doses.
Estonian: Rasagiline ratiopharmi tohib kasutada ainsa ravimina või lisaks levodopale (samuti Parkinsoni tõve ravim) patsientidel, kellel esineb levodopa annuste vahelise aja lõpus seisundite vaheldumist.
English: Patients with mild liver problems should use Rasagiline ratiopharm with caution and should stop treatment if their liver problems get worse.
Estonian: Rasagiline ratiopharmi kasutamisel kergete maksaprobleemidega patsientidel peab olema ettevaatlik ning maksaprobleemide süvenemisel tuleb ravi peatada.
English: For more information about treatment with Rasagiline ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Rasagiline ratiopharmiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: They are linked to a reduction in the effect of levodopa, when the patient experiences sudden switches between being ‘on' and able to move, and being ‘off' and having difficulty moving about.
Estonian: Seisundite vaheldumine on seotud levodopa toime vähenemisega, mil patsiendil hakkavad liikumisvõimega ja liikumisraskustega seisundid järsku vahelduma.
English: For the full list of all side effects and restrictions with Rasagiline ratiopharm, see the package leaflet.
Estonian: Rasagiline ratiopharmi kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: What are the risks associated with Rasagiline ratiopharm?
Estonian: Mis riskid Rasagiline ratiopharmiga kaasnevad?
English: For the full list of all side effects reported with Rasagiline ratiopharm, see the package leaflet.
Estonian: Rasagiline ratiopharmi kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: How does Rasagiline ratiopharm work?
Estonian: Kuidas Rasagiline ratiopharm toimib?
English: Rasagiline ratiopharm must not be used with other monoamine oxidase inhibitors including medicines and herbal preparations without prescription such as St John's wort (used to treat depression).
Estonian: Rasagiline ratiopharmi ei tohi kasutada koos teiste monoaminoksüdaasiinhibiitoreid sisaldavate ravimite ja taimsete käsimüügiravimitega, näiteks naistepunaga (teatud depressiooniravim).
English: It is not recommended for patients with moderate liver problems.
Estonian: Rasagiline ratiopharmi ei ole soovitatav kasutada ka mõõdukate maksaprobleemidega patsientidel.
English: What benefits of Rasagiline ratiopharm have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Rasagiline ratiopharmi kasulikkus?
English: Rasagiline ratiopharm must not be used in patients who have severe problems with their liver.
Estonian: Raske maksapuudulikkusega patsiendid ei tohi Rasagiline ratiopharmi kasutada.
English: How is Rasagiline ratiopharm used?
Estonian: Kuidas Rasagiline ratiopharmi kasutatakse?
English: Cortacare received a marketing authorisation valid throughout the EU on 27 August 2018.
Estonian: Cortacare müügiluba, mis kehtib kogu Euroopa Liidus, anti 27. augustil 2018.
English: Further information on Cortacare can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Lisateave Cortacare kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This reduces swelling, redness and itching.
Estonian: See vähendab turset, punetust ja sügelust.
English: Cortacare EMA/406528/2018
Estonian: EMA/406528/2018
English: Other information about Cortacare
Estonian: Muu teave Cortacare kohta
English: The European Medicines Agency concluded that, in accordance with EU requirements, Cortacare has been shown to be comparable to Cortavance.
Estonian: Euroopa Ravimiamet järeldas, et vastavalt ELi nõuetele on tõendatud Cortacare võrreldavus ravimiga Cortavance.
English: As for every medicine, the company provided studies on the quality of Cortacare.
Estonian: Nagu iga ravimi korral, esitas ettevõte Cortacare kvaliteedi uuringud.
English: Cortacare is sprayed onto the affected area of skin at a distance of about 10 cm once daily for a week.
Estonian: Cortacaret pihustatakse haigestunud nahapiirkonnale ligikaudu 10 cm kauguselt kord ööpäevas ühe nädala jooksul.
English: What is Cortacare and what is it used for?
Estonian: Mis on Cortacare ja milleks seda kasutatakse?
English: How has Cortacare been studied?
Estonian: Kuidas Cortacaret uuriti?
English: Cortacare (hydrocortisone aceponate)
Estonian: Cortacare (hüdrokortisoonatseponaat)
English: An overview of Cortacare and why it is authorised in the EU
Estonian: Ravimi Cortacare ülevaade ja Euroopa Liidus heakskiitmise põhjused
English: Therefore, the Agency's view was that, as for Cortavance, the benefit of Cortacare outweighs the identified risk and it can be authorised for use in the EU.
Estonian: Seetõttu on amet arvamusel, et nagu ka Cortavance korral, ületab Cortacare kasulikkus sellega kaasnevad riskid ja seda võib kasutada ELis.
English: Because Cortacare is a hybrid medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Cortacare on hübriidravim, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Studies on the benefits and risks of the active substance in the authorised use have already been carried out with the reference medicine, Cortavance, and do not need to be repeated for Cortacare.
Estonian: Võrdlusravimiga Cortavance on juba tehtud toimeaine heakskiidetud kasutamisviisi kasulikkuse ja riski uuringud ning neid ei ole vaja ravimiga Cortacare korrata.