FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to fertility, pregnancy and lactation, section 4.6 of the SmPC, information addressed to women of childbearing potential with regards to contraception in males and females was included.
Estonian: Ravimi omaduste kokkuvõtte lõiku 4.6 („Fertiilsus, rasedus ja imetamine“) lisati fertiilses eas naistele suunatud teave kontratseptsiooni kohta meestel ja naistel.
English: Increased within-patient variability in exposure may lead to greater variability in the dose-response relationship, i.e., leading to greater variability in patients' sensitivity to experience treatment
Estonian: Suurem varieeruvus samal patsiendil võib põhjustada annuse ja reaktsiooni seose suuremat varieeruvust, st suurendada eri tsüklites raviga kaasneva toksilise toime varieeruvust, ning võib mõnel patsiendil vähendada ravi üldist efektiivsust.
English: Vepesid and associated names was included in the list of products for summary of product characteristics (SmPC) harmonisation, drawn up by the CMDh, in accordance with Article 30(2) of Directive 2001/83/EC.
Estonian: Vepesid ja sarnased nimetused lisati direktiivi 2001/83/EÜ artikli 30 lõike 2 alusel inimravimite vastastikuse tunnustamise ja detsentraliseeritud menetluse koordineerimisrühma koostatud ravimi omaduste kokkuvõtete ühtlustamist vajavate ravimite loetellu.
English: - Non-Hodgkin's lymphoma
Estonian: - Mitte-Hodgkini lümfoom
English: - Recurrent or refractory testicular cancer
Estonian: - Taastunud või ravile raskesti alluv munandivähk
English: The CHMP recommended the variation to the terms of the marketing authorisations for which the product information is set out in Annex III for Vepesid and associated names (see Annex I).
Estonian: • komitee leppis kokku Vepesi ja sarnaste nimetuste ühtlustatud ravimiteabe, soovitas inimravimite komitee muuta Vepesi ja sarnaste nimetuste (vt I lisa) müügilubade tingimusi, millele vastav ravimi omaduste kokkuvõte on esitatud III lisas.
English: This summary was last updated in 01-2009.
Estonian: Kokkuvõtte viimane uuendus: 01-2009
English: It contains the active substance degarelix.
Estonian: See sisaldab toimeainet degareliksi.
English: The Committee recommended that Firmagon be given marketing authorisation
Estonian: Komitee soovitas anda Firmagonile müügiloa.
English: Which measures are being taken to ensure the safe use of Firmagon?
Estonian: Milliseid meetmed võetakse, et tagada Firmagoni kasutamise ohutus?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Firmagon to Ferring Pharmaceuticals A/S on 17 February 2009.
Estonian: Euroopa Komisjon andis Firmagoni müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, ettevõttele Ferring Pharmaceuticals A/S 17. veebruaril 2009.
English: This means that patients do not need to take other medicines to block testosterone at the start of treatment.
Estonian: See tähendab, et patsiendid ei pea ravi alguses testosterooni toime blokeerimiseks võtma teisi ravimeid.
English: Treatment starts with two 120-mg injections, followed by single 80-mg injections every month.
Estonian: Ravi alustatakse kahe 120 mg süstega, millele iga kuu järgnevad ühekordsed 80 mg süsted.
English: The company that makes Firmagon will make sure that educational materials are provided to all doctors in all Member States who will prescribe the medicine.
Estonian: Firmagoni valmistav ettevõte tagab, et kõigile seda ravimit määravatele arstidele edastatakse kõigis liikmesriikides teabematerjalid.
English: The most common side effects with Firmagon (seen in more than 1 patient in 10) are hot flushes and problems at the injection site such as pain and redness.
Estonian: Firmagoni kõige sagedamad kõrvalnähud (esinenud enam kui ühel patsiendil kümnest) on kuumahood ja süstekoha probleemid, nagu valu ja punetus.
English: However, because the main study looked at the medicine's effects on testosterone levels rather than the cancer or the patient's outcome directly, and because leuprorelin is only used for prostate cancer that is advanced, the Committee decided to restrict the use of Firmagon to advanced prostate cancer.
Estonian: Kuid kuna põhiuuringus vaadeldi ravimi toimeid testosterooni tasemele ja mitte pahaloomulisele kasvajale või patsiendi tulemusele otseselt ning kuna leuproreliini kasutatakse ainult kaugelearenenud eesnäärmevähi korral, otsustas komitee piirata Firmagoni kasutamist ainult kaugelearenenud eesnäärmevähiga.
English: When injected, Firmagon forms a gel under the skin that releases the active substance slowly over a few weeks.
Estonian: Süstituna moodustab Firmagon naha alla geeli, millest toimeaine vabaneb aeglaselt mõne nädala jooksul.
English: Why has Firmagon been approved?
Estonian: Miks Firmagon heaks kiideti?
English: What is the risk associated with Firmagon?
Estonian: Mis riskid Firmagoniga kaasnevad?
English: The materials will include information on Firmagon's safety and remind doctors how to administer the medicine.
Estonian: Need materjalid sisaldavad teavet Firmagoni ohutuse kohta ja nendes tuletatakse arstidele meelde, kuidas ravimit manustada.
English: Doctors should monitor the effectiveness of Firmagon treatment by looking at blood levels of testosterone and prostate-specific antigen (PSA).
Estonian: Arstid peavad jälgima Firmagoni ravi tõhusust, jälgides testosterooni ja prostataspetsiifilise antigeeni (PSA) taset veres.
English: By blocking these processes, Firmagon reduces the amount of testosterone in the body and slows down the growth of the cancer cells.
Estonian: Neid protsesse blokeerides vähendab Firmagon organismi testosterooni hulka ja aeglustab pahaloomulise kasvaja rakkude kasvu.
English: The main measure of effectiveness was the number of patients whose testosterone levels were below those seen in men whose testes were producing no testosterone, over the first year of treatment.
Estonian: Tõhususe peamine näitaja oli nende patsientide arv, kellel esimese raviaasta jooksul oli testosterooni tase madalam kui neil meestel, kelle munandid testosterooni ei tootnud.
English: Firmagon should not be used in people who may be hypersensitive (allergic) to degarelix or any of the other ingredients.
Estonian: Firmagoni ei tohi kasutada patsiendid, kes võivad olla degareliksi või selle ravimi mis tahes muu koostisaine suhtes ülitundlikud (allergilised).
English: Testosterone can make prostate cancer cells grow.
Estonian: Testosteroon võib põhjustada eesnäärmevähi rakkude kasvu.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) FIRMAGON EPAR summary for the public
Estonian: EUROOPA AVALIK HINDAMISARUANNE FIRMAGON Kokkuvõte üldsusele
English: What is Firmagon?
Estonian: Mis on Firmagon?
English: Similar results were seen in patients receiving Firmagon at the higher dose of 160 mg once a month.
Estonian: Sarnased tulemused saadi patsientidel, kellele Firmagoni manustati kõrgemas annuses - 160 mg üks kord kuus.
English: Firmagon must not be injected into a vein or a muscle.
Estonian: Firmagoni ei tohi süstida veeni ega lihasesse.
English: Other information about Firmagon:
Estonian: Muu teave Firmagoni kohta
English: During the first year, 97% of the patients receiving Firmagon at the approved dose of 80 mg once a month dose had testosterone levels below the required level.
Estonian: Esimese aasta jooksul saavutas 97% Firmagoni saanud meestest üks kord kuus manustatava 80 mg heaks kiidetud annusega nõutavast tasemest madalama testosteroonitaseme.
English: The active substance in Firmagon, degarelix, is a gonadotrophin-releasing hormone antagonist, which means that it blocks the effects of a natural hormone called gonadotrophin-releasing hormone (GnRH).
Estonian: Firmagoni toimeaine degareliks on gonadotropiini vabastajahormooni antagonist, mis tähendab, et see ravim blokeerib gonadotropiini vabastajahormooniks (GnRH) nimetatava kehaomase hormooni toimeid.
English: Firmagon was as effective as leuprorelin at reducing testosterone levels.
Estonian: Firmagon oli testosterooni taseme vähendamisel sama tõhus kui leuproreliin.
English: Firmagon can be used if the cancer is ‘hormone-dependent', which means that it responds to treatments that reduce the levels of the hormone testosterone.
Estonian: Firmagoni võib kasutada juhul, kui kasvaja on hormoonsõltuv, mis tähendab seda, et kasvaja reageerib ravimeetoditele, mis vähendavad testosterooniks nimetatava hormooni taset.
English: ‘Advanced' means that the cancer has spread beyond the gland to some lymph nodes, but not to other organs.
Estonian: Kaugelearenenud tähendab seda, et pahaloomuline kasvaja on levinud mõningatesse lümfisõlmedesse väljaspool eesnääret, kuid mitte teistesse elunditesse.
English: The Committee also noted that treatment with Firmagon does not trigger the temporary sharp rise in testosterone levels seen with ‘GnRH agonists' (other medicines for prostate cancer that stimulate the production of GnRH).
Estonian: Komitee märkis ka, et ravi Firmagoniga ei vallanda ajutist äkilist GnRH agonistide (GnRH tootmist stimuleerivad eesnäärmevähi ravis kasutatavad ravimid) kasutamisel täheldatavat testosteroonitaseme tõusu.
English: This was compared with 96% of patients receiving leuprorelin.
Estonian: Leuproreliini kasutamisel saavutati sama tulemus 96% patsientidest.
English: Firmagon is used to treat patients with advanced prostate cancer.
Estonian: Firmagoni kasutatakse kaugelearenenud eesnäärmevähiga patsientide ravimiseks.
English: The Committee for Medicinal Products for Human Use (CHMP) noted that Firmagon was as effective as leuprorelin in the main study.
Estonian: Inimravimite komitee märkis, et Firmagon oli põhiuuringus sama tõhus kui leuproreliin.
English: For the full list of all side effects reported with Firmagon, see the Package Leaflet.
Estonian: Firmagoni kohta teatatud kõrvalnähtude täieliku loetelu leiate pakendi infolehelt.
English: Therefore, the CHMP decided that Firmagon's benefits are greater than its risks for the treatment of adult male patients with advanced hormone-dependent prostate cancer.
Estonian: Inimravimite komitee jõudis seega otsusele, et Firmagoni kasulikkus kaugelearenenud hormoonsõltuva eesnäärmevähiga täiskasvanud meeste ravis on suurem kui ravimiga kaasnevad riskid.
English: PSA is a protein that is produced by the prostate gland and is often found at high levels in men with prostate cancer.
Estonian: Prostataspetsiifiline antigeen on eesnäärme toodetav valk, mille tase on eesnäärmevähiga meestel sageli tõusnud.
English: How does Firmagon work?
Estonian: Kuidas Firmagon toimib?
English: Firmagon is a powder and solvent that are made up into a solution for injection.
Estonian: Firmagon on pulber ja lahusti, millest valmistatakse süstelahus.
English: GnRH normally stimulates the pituitary gland at the base of the brain to produce two hormones which cause the testes to produce testosterone.
Estonian: Tavaliselt stimuleerib gonadotropiini vabastajahormoon ajupõhimikul paiknevat ajuripatsit (hüpofüüsi) tootma kaht hormooni, mis kutsuvad munandites (testistes) esile testosterooni tootmise.
English: The full EPAR for Firmagon can be found here.
Estonian: Euroopa avaliku hindamisaruande täisteksti Firmagoni kohta leiate siit.
English: Firmagon is injected under the skin of the abdomen.
Estonian: Firmagoni süstitakse kõhunaha alla.
English: Two doses of Firmagon have been compared with leuprorelin in one main study involving 610 men with prostate cancer at all stages of the disease.
Estonian: Ühes põhiuuringus, milles osales 610 haiguse igasuguse staadiumiga eesnäärmevähiga meest, võrreldi Firmagoni kaht annust leuproreliiniga.
English: What benefit has Firmagon shown during the studies?
Estonian: Milles seisneb uuringute põhjal Firmagoni kasulikkus?
English: This is cancer that affects the prostate gland, the gland below the bladder in men that produces the liquid in the semen.
Estonian: See pahaloomuline kasvaja haarab eesnääret (prostatat) - meestel põie all paiknevat nääret, mis toodab seemnevedelikku.
English: What is Firmagon used for?
Estonian: Milleks Firmagoni kasutatakse?
English: Firmagon should be used with caution in patients who have severe kidney or liver problems.
Estonian: Raske neeru- või maksaprobleemidega patsientidel tuleb Firmagoni kasutada ettevaatusega.
English: How has Firmagon been studied?
Estonian: Kuidas Firmagoni uuriti?
English: The effects of Firmagon were first tested in experimental models before being studied in humans.
Estonian: Enne inimuuringuid kontrolliti Firmagoni toimet muude katsetega.
English: How is Firmagon used?
Estonian: Kuidas Firmagoni kasutatakse?
English: Rapamune (sirolimus)
Estonian: Rapamune (siroliimus)
English: Rapamune received a marketing authorisation valid throughout the EU on 14 March 2001.
Estonian: Rapamune on saanud müügiloa, mis kehtib kogu ELis, 14. märtsil 2001.
English: Further information on Rapamune can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Lisateave Rapamune kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: What measures are being taken to ensure the safe and effective use of Rapamune?
Estonian: Mis meetmed võetakse, et tagada Rapamune ohutu ja efektiivne kasutamine?
English: Prevention of rejection
Estonian: Äratõukereaktsiooni ennetamine
English: The most common side effects with Rapamune (which may affect more than 1 in 10 people) are infections, fever, slow wound healing, low counts of various blood cells, blood tests showing altered levels of various substances (including low potassium and phosphate; raised fats, cholesterol, glucose and markers for tissue breakdown and for liver and kidney function), diabetes, lymphocele (collection of lymph fluid usually in the lower belly), pain in various parts of the body, rapid heartbeat, raised blood pressure, problems affecting the gut, proteinuria (protein in the urine), menstrual disorders, oedema (swelling because of fluid build-up), rash and acne.
Estonian: Rapamune kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 10st) on infektsioonid, palavik, haavade aeglane paranemine, eri vererakkude vähesus, eri ainete sisalduse muutused vereanalüüsis (sh väike kaaliumi- ja fosfaadisisaldus, suurenenud rasva-, kolesterooli- ja glükoosisisaldus, kudede lagunemise ning maksa- ja neerufunktsiooni markerite tõus), diabeet, lümfotseele (lümfivedeliku kogunemine, tavaliselt alakõhus), valu eri kehaosades, südame löögisageduse kiirenemine, suurenenud vererõhk, seedetrakti häired, proteinuuria (valk uriinis), menstruatsioonihäired, ödeem (turse vedeliku kogunemise tõttu), lööve ja akne.
English: Other information about Rapamune
Estonian: Muu teave Rapamune kohta
English: What is Rapamune and what is it used for?
Estonian: Mis on Rapamune ja milleks seda kasutatakse?
English: As for all medicines, data on the use of Rapamune are continuously monitored.
Estonian: Nagu kõigi ravimite puhul, teostatakse Rapamune kasutamise kohta pidevat järelevalvet.
English: Rapamune is available as an oral solution (1 mg/ml) and tablets (0.5, 1 and 2 mg).
Estonian: Rapamunet turustatakse suukaudse lahusena (1 mg/ml) ja tablettidena (0,5, 1 ja 2 mg).
English: The Agency decided that Rapamune's benefits are greater than its risks and it can be authorised for use in the EU.
Estonian: Euroopa Ravimiamet otsustas, et Rapamune kasulikkus on suurem kui sellega kaasnevad riskid ja et ravimi kasutamise võib ELis heaks kiita.
English: For more information about using Rapamune, see the package leaflet or contact your doctor or pharmacist.
Estonian: Lisateavet Rapamune kasutamise kohta vt pakendi infolehest või konsulteeri oma arsti või apteekriga.
English: Rapamune can then be used for continuing treatment with corticosteroids, but only if ciclosporin treatment can be stopped.
Estonian: Seejärel võib Rapamunet koos kortikosteroididega kasutada jätkuraviks, kuid ainult juhul, kui ravi tsüklosporiiniga on võimalik lõpetada.
English: The main measure of effectiveness was a change of FEV1 (the maximum volume of air a person can breathe out in 1 second).
Estonian: Efektiivsuse põhinäitaja oli FEV1 (suurim õhukogus, mida patsient suudab 1 sekundi jooksul välja hingata) muutus.
English: Two additional studies looked at Rapamune as continuing treatment for up to 5 years in 765 patients who were able to stop ciclosporin after 2 to 3 months.
Estonian: Kahes lisauuringus jätkas Rapamune-ravi kuni 5 aasta jooksul 765 patsienti, kes said 2 või 3 kuu möödudes tsüklosporiinravi lõpetada.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rapamune have been included in the summary of product characteristics and the package leaflet.
Estonian: Rapamune ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: Side effects reported with Rapamune are carefully evaluated and any necessary action taken to protect patients.
Estonian: Rapamune kõrvaltoimeid hinnatakse hoolikalt ja patsientide kaitseks rakendatakse vajalikke meetmeid.
English: It is used in adults who are at a low to moderate risk of rejection.
Estonian: Seda kasutatakse täiskasvanutel, kellel on väike kuni mõõdukas äratõukereaktsiooni risk.
English: To treat patients with S-LAM, the dose of Rapamune is 2 mg daily and after 10 to 20 days the doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Estonian: S-LAMiga patsientide ravis on Rapamune annus 2 mg ööpäevas ning 10-20 päeva pärast kohandab arst annust, et tagada patsiendi veres sobiv siroliimuse sisaldus.
English: It is recommended that Rapamune is used with ciclosporin and corticosteroids (other medicines to prevent organ rejection) for two to three months.
Estonian: Rapamunet on soovitatav kasutada koos tsüklosporiini ja kortikosteroididega (samuti elundite äratõukereaktsiooni ennetamise ravimid) kahe kuni kolme kuu jooksul.
English: The main measure of effectiveness was the number of treatment failures (rejection or loss of the new kidney, or death) after 6 months.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kelle ravi osutus 6 kuu möödudes ebaõnnestunuks (siiratud neeru äratõuge või kaotus, surm).
English: Patients allergic to peanut or soya must not take Rapamune oral solution because the solution contains soya oil.
Estonian: Maapähklite või soja suhtes allergilised patsiendid ei tohi kasutada Rapamune suukaudset lahust, sest see sisaldab sojaõli.
English: By blocking mTOR, Rapamune reduces the multiplication of these cells.
Estonian: mTORi blokeerides vähendab Rapamune nende rakkude paljunemist.
English: The doctor will adjust the dose to achieve appropriate levels of sirolimus in the patient's blood.
Estonian: Arst kohandab annust, et tagada patsiendi veres sobiv siroliimuse sisaldus.
English: What are the risks associated with Rapamune?
Estonian: Mis riskid Rapamunega kaasnevad?
English: To prevent organ rejection, the first dose is usually 6 mg given soon after the transplantation followed by 2 mg once a day.
Estonian: Elundi äratõukereaktsiooni ennetamiseks manustatakse tavaliselt algannus 6 mg peagi pärast siirdamist ning seejärel 2 mg üks kord ööpäevas.
English: The Agency noted that no medicinal product has been approved for the treatment of S-LAM and Rapamune's effect on lung function is considered important.
Estonian: Amet märkis, et SLAMi raviks ei ole heaks kiidetud ühtki ravimit, ning Rapamune toimet kopsufunktsioonile peetakse oluliseks.
English: Rapamune contains the active substance sirolimus.
Estonian: Rapamune sisaldab toimeainena siroliimust.
English: Rapamune is also used for treating patients with sporadic lymphangioleiomyomatosis (S-LAM) with moderate lung disease or worsening lung function.
Estonian: Rapamunet kasutatakse ka nende sporaadilise lümfangioleiomüomatoosiga (S-LAM) patsientide raviks, kellel on mõõduka raskusega kopsuhaigus või halvenev kopsufunktsioon.
English: In S-LAM, mTOR is overactive, causing excessive multiplication of cells that cause the disease.
Estonian: S-LAMiga isikutel on mTOR üliaktiivne, mistõttu hakkavad haigust põhjustavad rakud ülemääraselt paljunema.
English: How is Rapamune used?
Estonian: Kuidas Rapamunet kasutatakse?
English: In the second study, treatment failed in 30% (68 out of 277) of the patients adding Rapamune, compared with 48% (62 out of 130) of those adding placebo.
Estonian: Teises uuringus ebaõnnestus ravi 30%-l patsientidest (68 patsienti 277st), kelle ravile lisati Rapamune, ning 48%-l patsientidest (62 patsienti 130st), kelle ravile lisati platseebo.
English: For the full list of side effects and restrictions of Rapamune, see the package leaflet.
Estonian: Rapamune kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: The active substance in Rapamune, sirolimus, is an immunosuppressant (a medicine that reduces the activity of the immune system).
Estonian: Rapamune toimeaine siroliimus on immuunsupressant ehk aine, mis pärsib immuunsüsteemi talitlust.
English: S-LAM is a rare lung disease that causes worsening symptoms such as shortage of breath and occurs mainly in women who are at an age when they can have children.
Estonian: S-LAM on harvaesinev kopsuhaigus, mis põhjustab süvenevaid sümptomeid (nagu hingeldus) ja mida esineb enamasti viljakas eas naistel.
English: Treatment of S-LAM
Estonian: Sporaadilise lümfangioleiomüomatoosi (S-LAMi) ravi
English: Rapamune was effective in helping the new kidney to survive, with an improvement in how well it worked and an improvement in blood pressure when ciclosporin treatment was stopped.
Estonian: Ravi Rapamunega aitas efektiivselt uuel neerul püsima jääda, parandades selle talitlust, samuti normaliseeris Rapamune vererõhku, kui tsüklosporiinravi lõpetati.
English: The European Medicines Agency considered that Rapamune is effective for the prevention of rejection of a transplanted kidney in patients at low to moderate risk of rejection.
Estonian: Euroopa Ravimiamet on arvamusel, et Rapamune on efektiivne siiratud neeru äratõukereaktsiooni ennetamisel patsientidel, kellel on väike või mõõdukas äratõukereaktsiooni risk.
English: Since mTOR is involved in the multiplication of activated T-lymphocytes (white blood cells that are responsible for attacking the transplanted organ), Rapamune reduces the number of these cells, reducing the risk of organ rejection.
Estonian: Et mTOR osaleb aktiveeritud T-lümfotsüütide (siiratud elundit ründavad valgelibled) paljunemises, vähendab Rapamune nende rakkude hulka ja seeläbi elundi äratõukereaktsiooni riski.
English: This complex then blocks another protein called ‘mammalian target of rapamycin' (mTOR).
Estonian: Kompleks blokeerib seejärel teise valgu, mTORi (imetajate rapamütsiinisihtvalk).
English: In the first study, treatment failed in 19% (53 out of 284) of the patients adding Rapamune after 6 months, compared with 32% (52 out of 161) of those adding azathioprine.
Estonian: Esimeses uuringus oli 6 kuu möödudes ravi ebaõnnestunud 19%-l patsientidest (53 patsienti 284st), kelle ravile lisati Rapamune, ja 32%-l patsientidest (52 patsienti 161st), kelle ravile lisati asatiopriin.
English: FEV1 improved by an average of 1 ml per month in patients treated with Rapamune compared with a worsening by 12 ml per month in patients receiving placebo.
Estonian: FEV1 paranes Rapamunega ravitud patsientidel keskmiselt 1 ml võrra kuus, kuid platseebot kasutanud patsientidel vähenes see 12 ml võrra kuus.
English: All patients were also treated with ciclosporin and corticosteroids and were at low to moderate risk of rejection.
Estonian: Kõiki patsiente raviti lisaks tsüklosporiini ja kortikosteroididega ning nende äratõukereaktsiooni risk oli väike või mõõdukas.
English: How does Rapamune work?
Estonian: Kuidas Rapamune toimib?
English: An overview of Rapamune and why it is authorised in the EU
Estonian: Ülevaade ravimist Rapamune ja ELis müügiloa väljastamise põhjendus
English: Rapamune treatment should be started by and remain under the guidance of a doctor who is a qualified specialist in transplantation.
Estonian: Ravi Rapamunega peab alustama ja jälgima eriväljaõppega elundisiirdamise spetsialist.