FrancophonIA/ELRC3.0 huggingface dataset:
English: However, because human immunoglobulins are excreted in milk, women must not breast-feed for at least five months after the last Trudexa treatment.
Estonian: Rinnaga toitmine ei ole lubatud vähemalt viie kuu jooksul pärast viimast Trudexa-ravi, kuna inimese immuunglobuliinid erituvad rinnapiima.
English: Rare lymphoma, solid organ tumours (including breast, ovarian, testicular), squamous cell carcinoma of the skin
Estonian: Aeg-ajalt Harv nahapapilloom lümfoom, tahked organite tuumorid (sh rinna-, munasarja-, munandi-), naha lamerakk-kartsinoom
English: Evoltra clofarabine
Estonian: Evoltra klofarabiin
English: The European Commission granted a marketing authorisation valid throughout the European Union for Evoltra on 29 May 2006.
Estonian: Euroopa Komisjon andis Evoltra müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 29. mail 2006.
English: This means that, because the disease is rare, it has not been possible to obtain complete information about Evoltra.
Estonian: See tähendab, et kuna see haigus esineb harva, ei olnud Evoltra kohta võimalik saada täielikku teavet.
English: The treatment should be repeated every two to six weeks.
Estonian: Ravikuuri tuleb korrata iga 2-6 nädala järel.
English: A risk management plan has been developed to ensure that Evoltra is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Evoltra võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Evoltra?
Estonian: Mis meetmed võetakse, et tagada Evoltra ohutu ja efektiivne kasutamine?
English: The study did not compare Evoltra with any other treatments.
Estonian: Uuringus ei võrreldud Evoltrat ühegi teise ravimiga.
English: Other information about Evoltra
Estonian: Muu teave Evoltra kohta
English: The average age of the treated patients was 12 years.
Estonian: Ravitavate patsientide keskmine vanus oli 12 aastat.
English: All of the patients had previously received at least two other types of treatment but were not eligible for any other treatment.
Estonian: Kõik patsiendid olid eelnevalt saanud vähemalt kaht muud liiki ravi ning muud ravivõimalused puudusid.
English: This is a complex procedure where the patient receives stem cells from a matched donor to help restore the bone marrow.
Estonian: See on keeruline protseduur, mille käigus siiratakse patsiendile tüvirakke sobivalt doonorilt, et aidata taastada luuüdi.
English: Overall, the patients in the study survived for an average of 66 weeks.
Estonian: Üldiselt oli uuringus osalenud patsientide keskmine elulemus 66 nädalat.
English: The recommended dose is 52 mg per square metre of body surface area (calculated using the patient's height and weight).
Estonian: Soovitatav annus on 52 mg kehapindala ruutmeetri kohta (arvutatakse patsiendi pikkuse ja kehamassi järgi).
English: The most common side effects with Evoltra (seen in more than 1 patient in 10) were febrile neutropenia (low white blood cell counts with fever), anxiety, headache, flushing (reddening of the face), vomiting, diarrhoea, nausea (feeling sick), palmar-plantar erythrodysaesthesia syndrome (rash and numbness on the palms and soles), pruritus (itching), pyrexia (fever), mucosal inflammation (inflammation of the moist body surfaces, such as the lining of the mouth) and fatigue (tiredness).
Estonian: Evoltra kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on febriilne neutropeenia (palavik ja valgeliblede vähesus), ärevus, peavalu, õhetus, oksendamine, kõhulahtisus, iiveldus, palmaar-plantaarne erütrodüsesteesia (käe- ja jalalabade lööve ja tuimus), kihelus, püreksia (palavik), limaskestapõletik ja väsimus.
English: Evoltra has been authorised under ‘exceptional circumstances'.
Estonian: Evoltra on heaks kiidetud erandkorras.
English: It is given by infusion lasting two hours every day for five days.
Estonian: Ravimit manustatakse infusioonina kahe tunni vältel kokku viiel järjestikusel päeval.
English: In the main study, 20% of the patients went into remission (12 out of 61).
Estonian: Põhiuuringus leevendusid haigusnähud 20%-l patsientidest (12 patsiendil 61st).
English: This stops the cells making new DNA and RNA, and slows down the growth of tumour cells.
Estonian: See peatab uue DNA ja RNA tekke rakkudes ning aeglustab vähirakkude kasvu.
English: Most patients who respond to treatment do so after one or two treatment cycles.
Estonian: Enamikul patsientidest, kellel tekib ravivastus, tekib see pärast üht või kaht ravitsüklit.
English: The summary of opinion of the Committee for Orphan Medicinal Products for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
Estonian: Harvikravimite komitee arvamuse kokkuvõte Evoltra kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/Rare Disease Designations.
English: What information is still awaited for Evoltra?
Estonian: Mis teavet Evoltra kohta veel oodatakse?
English: It is used when the disease has not responded to or has come back (relapsed) after at least two other treatments, and when no other treatment is expected to work.
Estonian: Ravimit kasutatakse juhul, kui haigus ei ole allunud ravile või on taastunud pärast ravi vähemalt kahe muu ravimiga ning eeldatakse, et ükski teine ravi ei toimi.
English: The full EPAR for Evoltra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Evoltra kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Evoltra must not be given to patients with severe kidney or liver disease.
Estonian: Evoltrat ei tohi manustada raske neeru- või maksahaigusega patsientidele.
English: Stem cells are cells that can develop into different types of cell.
Estonian: Tüvirakud võivad areneda eri liiki rakkudeks.
English: For more information about treatment with Evoltra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Evoltraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Evoltra has been examined in one study of 61 patients below 21 years of age with ALL.
Estonian: Evoltrat uuriti ühes uuringus, milles osales 61 alla 21-aastast ägeda lümfoidleukeemiaga patsienti.
English: The Committee decided that Evoltra's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Inimravimite komitee otsustas, et Evoltra kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: After treatment with Evoltra, 10 patients were able to go on to have a stem cell transplant.
Estonian: Pärast ravi Evoltraga olid 10 patsienti seisundis, et talusid tüvirakkude siirdamist.
English: Because the number of patients with ALL is low, the disease is considered ‘rare', and Evoltra was designated an ‘orphan medicine' (a medicine used in rare diseases) on 5 February 2002.
Estonian: Et ägeda lümfoidleukeemiaga patsientide arv on väike ja see haigus esineb harva, nimetati Evoltra 5. veebruaril 2002 harvikravimiks.
English: Evoltra is a cancer medicine that contains the active substance clofarabine.
Estonian: Evoltra on vähiravim, mis sisaldab toimeainena klofarabiini.
English: This is a summary of the European public assessment report (EPAR) for Evoltra.
Estonian: See on ravimi Evoltra Euroopa avaliku hindamisaruande kokkuvõte.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Evoltra, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati Evoltra omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The main measure of effectiveness was the number of patients who went into ‘remission' (clearance of leukaemia from the bone marrow and complete or partial recovery of blood cell counts to normal levels).
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kellel tekkis remissioon (haigusnähud leevendusid, st luuüdis puudusid leukeemiarakud ning vererakkude normaalne sisaldus taastus osaliselt või täielikult).
English: Why has Evoltra been approved?
Estonian: Miks Evoltra heaks kiideti?
English: The company that makes Evoltra will set up a registry to monitor the medicine's side effects.
Estonian: Evoltra tootja koostab ravimi kõrvalnähtude jälgimise registri.
English: What is the risk associated with Evoltra?
Estonian: Mis riskid Evoltraga kaasnevad?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evoltra.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For the full list of all side effects reported with Evoltra, see the package leaflet.
Estonian: Evoltra kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: Clofarabine is an ‘analogue' of adenine, which is part of the fundamental genetic material of cells (DNA and RNA).
Estonian: Klofarabiin on rakkude geneetilise põhimaterjali (DNA ja RNA) koostisaine adeniini analoog.
English: The CHMP concluded that Evoltra treatment may provide a way of obtaining remission, and of facilitating a stem cell transplant.
Estonian: Inimravimite komitee otsustas, et ravi Evoltraga võib anda võimaluse haigusnähtude leevendumiseks ja soodustada tüvirakkude siirdamist.
English: This means that clofarabine takes the place of adenine in the body, and interferes with the enzymes involved in making genetic material, called ‘DNA polymerase' and ‘RNA reductase'.
Estonian: Selle tõttu asendab klofarabiin organismis adeniini ning häirib geenimaterjali tekkes osalevate ensüümide DNA-reduktaasi ja DNA-polümeraasi toimet.
English: Patients with ALL who have not responded to or who have relapsed after receiving at least two treatments have a very poor chance of survival.
Estonian: Ägeda lümfoidleukeemiaga patsientidel, kellel ei tekkinud ravivastust vähemalt kahe ravikuuri järel või kelle haigusnähud taastusid, on elulemus väga väike.
English: Breast-feeding should be stopped before, during and after treatment with Evoltra.
Estonian: Enne ravi Evoltraga, ravi ajal ja pärast ravi tuleb lõpetada rinnaga toitmine.
English: Evoltra is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), which is a cancer of the lymphocytes (a type of white blood cell).
Estonian: Evoltrat kasutatakse ägeda lümfoblastilise leukeemia (ALL, vere valgeliblede vähi liik) raviks lastel ja kuni 21-aastastel täiskasvanutel.
English: What benefit has Evoltra shown during the studies?
Estonian: Milles seisneb uuringute põhjal Evoltra kasulikkus?
English: How does Evoltra work?
Estonian: Kuidas Evoltra toimib?
English: How is Evoltra used?
Estonian: Kuidas Evoltrat kasutatakse?
English: What is Evoltra used for?
Estonian: Milleks Evoltrat kasutatakse?
English: Evoltra treatment should be started and supervised by a doctor who has experience in the management of patients with acute leukaemias.
Estonian: Ravi Evoltraga tohib alustada üksnes ägeda leukeemiaga patsientide ravis kogenud arst ning ravi peab toimuma tema järelevalve all.
English: How has Evoltra been studied?
Estonian: Kuidas Evoltrat uuriti?
English: The medicine can only be obtained with a prescription.
Estonian: Evoltra on retseptiravim.
English: Sachet (PE/alu/PET)
Estonian: Suukaudne kotike (PE/alu/PET)
English: 30 sachets + 2 syringes + 1 mixing cup
Estonian: 30 kotikest + 2 süstalt + 1 segamistass
English: 100 mg Powder for Oral Suspension
Estonian: 100 mg Suukaudse suspensiooni pulber
English: Strength Pharmaceutical Form
Estonian: Ravimvorm Manustamist ee
English: Oral use
Estonian: Tugevu
English: MA EU Number (Invented) name
Estonian: Ravimi väljamõeld ud nimetus
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Estonian: Pakendi suurus viaal (klaas) 1 viaal
English: 1 See section 4.2; NA: Not available
Estonian: 1 Vt lõik 4.2; NA: ei ole kättesaadav
English: Phone: +46 8 697 20 00
Estonian: Telefon: +46 8 697 20 00
English: Previously untreated patients
Estonian: Eelnevalt ravi mittesaanud patsiendid
English: (pre- and post-operative)
Estonian: (pre- ja postoperatiivselt)
English: This would be checked by your doctor.
Estonian: Selle selgitab välja teie arst.
English: 144h 168h 192h 240 h 288 h
Estonian: 6 h 24 h 48 h 96 h 144 h 168 h 192 h 240 h 288 h
English: Other medicines and ALPROLIX
Estonian: Muud ravimid ja ALPROLIX
English: It is a vitamin-K dependent coagulation factor.
Estonian: See on K-vitamiinist sõltuv hüübimisfaktor.
English: The haemostatic response was rated as excellent or good in 100% of major surgeries.
Estonian: Hemostaatiline vastus loeti suurepäraseks või heaks 100% ulatuslike operatsioonide korral.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Estonian: Märkus: AVM ei ole võrreldav faktorite eri kontsentratsioonide ning erinevate kliiniliste uuringute vahel.
English: Adverse events were monitored for a total of 561 subject years.
Estonian: Kõrvaltoimeid jälgiti kokku 561 osaleja-aastat.
English: The safety and efficacy of ALPROLIX in previously untreated patients have not yet been established.
Estonian: ALPROLIX'i ohutus ja efektiivsus eelnevalt ravi mittesaanud patsientidel ei ole veel tõestatud.
English: Wash your hands before opening the pack.
Estonian: Enne pakendi avamist peske käed.
English: Patients were less than 12 years of age (15 were <6 years of age and 15 were 6 to <12 years of age).
Estonian: Patsiendid olid alla 12-aastased (15 olid < 6-aastased ja 15 vanusevahemikus 6...< 12 aastat).
English: The antibodies prevent the treatment from working properly.
Estonian: Antikehad takistavad ravi toimimist.
English: QR code to be included + http://www.alprolix-instructions.com
Estonian: Lisatakse QR-kood + http://www.alprolix-instructions.com
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Estonian: Seejärel konverteerib trombiin fibrinogeeni fibriiniks ja moodustub hüüve.
English: ALPROLIX is used to replace the missing or deficient factor IX.
Estonian: ALPROLIX'i kasutatakse puuduva või puuduliku IX faktori asendamiseks.
English: • if you are allergic to eftrenonacog alfa or any other ingredients of this medicine (listed in section 6).
Estonian: • kui olete alfaeftrenonakogi või selle ravimi mis tahes koostisosade (loetletud lõigus 6) suhtes allergiline.
English: ALPROLIX pack contains:
Estonian: ALPROLIX'i pakend sisaldab:
English: If you stop using ALPROLIX you may no longer be protected against bleeding or a current bleed may not stop.
Estonian: ALPROLIX'i kasutamise lõpetamisel ei pruugi te olla enam kaitstud veritsuse tekke eest või teie veritsus ei pruugi peatuda.
English: 1 In some patients and circumstances the dosing interval can be prolonged up to 48 hours (see section 5.2 for pharmacokinetic data).
Estonian: 1 Mõnel patsiendil ja mõnes olukorras võib annustamisintervalli pikendada kuni 48 tunnini (farmakokineetilised andmed vt lõik 5.2).
English: The median time on Study II+III was 2.88 years and median number of exposure days was 166.
Estonian: Uuringutes II + III osalemise mediaanaeg oli 2,88 aastat ja kokkupuutepäevade mediaanarv oli 166.
English: ALPROLIX has no influence on the ability to drive and use machines.
Estonian: ALPROLIX ei mõjuta autojuhtimise ja masinate käsitsemise võimet.
English: If the product is not used within 6 hours, it must be discarded.
Estonian: Kui ravimit ei kasutata 6 tunni möödumisel, tuleb see ära visata.
English: Elderly population There is limited experience in patients ≥ 65 years.
Estonian: Kogemused patsientidega vanuses ≥ 65 aastat on piiratud.
English: If you are on a controlled sodium diet, see section 2.
Estonian: Kui olete kontrollitud naatriumisisaldusega dieedil, vt lõik 2.
English: The procedure below describes the preparation and administration of ALPROLIX.
Estonian: Järgmised protseduurid kirjeldavad ALPROLIX'i ettevalmistamist ja manustamist.
English: Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Estonian: Allolev tabel 2 vastab MedDRA organsüsteemi klassifikatsioonile (organsüsteemi klassi ja eelistatava termini alusel).
English: Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Estonian: Seetõttu võib IX faktorit kasutada raseduse ja imetamise ajal vaid kindla näidustuse korral.
English: Contents of the pack and other information What ALPROLIX contains
Estonian: Pakendi sisu ja muu teave Mida ALPROLIX sisaldab
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor IX levels in your blood.
Estonian: Arst viib läbi asjakohased laboratoorsed analüüsid veendumaks, et teie veri sisaldab piisavalt IX faktorit.
English: For extent and age characterisation of the safety database in children see section 5.1.
Estonian: Laste ohutuse andmebaasi andmeid kestuse ja ealise kirjelduse kohta vt lõik 5.1.
English: You or somebody else may administer ALPROLIX after receiving adequate training.
Estonian: ALPROLIX'i võite manustate teie ise või keegi teine pärast asjakohast väljaõpet.
English: Study I
Estonian: Uuring I
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Estonian: Manustatava koguse ja manustamissageduse määramisel peab alati lähtuma iga individuaalse juhtumi kliinilisest efektiivsusest.
English: After this time, the prepared ALPROLIX should be discarded.
Estonian: Pärast seda tuleb ettevalmistatud ALPROLIX ära visata.
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Estonian: Olemasolevate kardiovaskulaarsete riskiteguritega patsientidel võib FIX asendusravi suurendada kardiovaskulaarset riski.
English: ALPROLIX can be used in children and adolescents of all ages.
Estonian: ALPROLIX'it võib kasutada igas vanuses lastel ja noorukitel.
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Estonian: Seetõttu tuleb patsiente, kellel tekivad allergilised reaktsioonid, hinnata inhibiitorite olemasolu suhtes.
English: The prepared product should be injected intravenously over several minutes.
Estonian: Ettevalmistatud ravimit tuleb süstida intravenoosselt mitme minuti jooksul.
English: Of the 35 major surgeries, 28 surgeries (80.0%) required a single pre-operative dose to maintain haemostasis during surgery.
Estonian: 35 ulatuslikust operatsioonist 28 puhul (80,0%) tuli manustada ühekordne preoperatiivne annus hemostaasi säilitamiseks kirurgilise operatsiooni ajal.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Estonian: Lapsed Loetletud hoiatused ja ettevaatusabinõud rakenduvad nii täiskasvanutele kui lastele.
English: The dose will depend on your individual needs for replacement factor IX therapy and on whether it is used for prevention or treatment of bleeding.
Estonian: Annus sõltub teie individuaalsest IX faktori asendusravi vajadusest ja sellest, kas ravimit kasutatakse veritsuse ärahoidmiseks või raviks.
English: The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications.
Estonian: Neil juhtudel tuleb kaaluda ALPROLIX-ravi kasu võrreldes nimetatud tüsistuste riskiga.
English: The product should not be used beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
Estonian: Ravimit ei tohi kasutada pärast viaalile trükitud kõlblikkusaega või kuue kuu möödumisel pärast karbi külmkapist väljavõtmist, olenevalt sellest, kumb on varasem.
English: If a repeat dose is required to control the bleed, the prolonged half-life of ALPROLIX should be taken into account (see section 5.2).
Estonian: Kui veritsuse peatamiseks tuleb manustada korduvannus, peab arvestama ALPROLIX'i pikenenud poolväärtusajaga (vt lõik 5.2).
English: Chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C).
Estonian: Ravimi kasutusaegne keemilis- ja füüsikaline stabiilsus on tõendatud 6 tunni jooksul temperatuuril kuni 30°C.
English: Factor IX level required (%) (IU/dL)
Estonian: Nõutav IX faktori tase (%) (RÜ/dl)
English: The Fc fusion protein in ALPROLIX increases the length of time that the medicine works.
Estonian: ALPROLIX'is sisalduv Fc fusioonvalk pikendab ravimi toimimisaega.
English: Pharmacokinetic parameters1
Estonian: FK parameetrid1
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor IX activity of 30% to 60% (IU/dL).
Estonian: Süsti korrata iga 8...24 tunni järel, kuni haava piisava paranemiseni, seejärel ravida veel vähemalt 7 päeva jooksul, et säiliks IX faktori aktiivsus 30...60% (RÜ/dl).
English: Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Estonian: Lastel esinevate kõrvaltoimete sagedus, tüüp ja raskusaste on tõenäoliselt sarnane täiskasvanute omaga.
English: In patients with haemophilia B, factor IX is missing or not working properly.
Estonian: B-hemofiiliat põdevatel patsientidel on IX faktor puudu või ei toimi korralikult.
English: Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack, and allow to air dry.
Estonian: Puhastage viaali korki, kasutades selleks ühte pakis olevatest alkoholis niisutatud vatitupsudest (F), ja laske õhu käes kuivada.
English: Do not use if the product has expired.
Estonian: Ärge kasutage, kui ravimi kõlblikkusaeg on möödas.
English: <6 years
Estonian: < 6-aastased
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Estonian: IX faktor on üheahelaline glükovalk, mille molekulmass on ligikaudu 68 000 daltonit.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Estonian: Mõnel juhul on need reaktsioonid, progresseerunud raskekujuliseks anafülaksiaks ja esinenud ajaliselt lähedases seoses IX faktori inhibiitorite tekkega (vt ka lõik 4.4).
English: Excipient with known effect: 0.3 mmol (6.4 mg) sodium per vial.
Estonian: Teadaolevat toimet omav abiaine: 0,3 mmol (6,4 mg) naatriumi viaali kohta.
English: The Fc region of human immunoglobulin G1 binds with the neonatal Fc receptor.
Estonian: Inimese immuunglobuliini G1 Fc regioon seondub neonataalse Fc retseptoriga.
English: Your doctor will decide the dose of ALPROLIX (in International Units or “IU”) you will receive.
Estonian: Teie arst otsustab, millise ALPROLIX'i annuse (rahvusvahelistes ühikutes ehk RÜ) te saate.
English: If ALPROLIX has been stored in a refrigerator, allow the vial of ALPROLIX (A) and the syringe with solvent (B) to reach room temperature before use.
Estonian: Juhul kui ALPROLIX'it on hoitud külmkapis, tuleb ALPROLIX'i viaalil (A) ja süstlal lahusega (B) lasta enne kasutamist toatemperatuurini soojeneda.
English: Out of 123 subjects who completed Study I, 93 were enrolled in Study III (extension study) with median total follow-up time of 6.5 years.
Estonian: Uuringu I lõpetanud 123 uuritavast kaasati 93 uuringusse III (jätku-uuring), mille järelkontrolli mediaanaeg oli 6,5 aastat.
English: Post Marketing Experience
Estonian: Turuletulekujärgne kogemus
English: • 50 IU/kg once weekly, adjust dose based on individual response or
Estonian: • 50 RÜ/kg üks kord nädalas, annust tuleb kohandada vastavalt individuaalsele ravivastusele või