FrancophonIA/ELRC3.0 huggingface dataset:
English: People diagnosed with lipoprotein lipase deficiency are advised to be careful with their diet, both before and after Glybera therapy; they should not drink alcohol.
Estonian: Inimestel, kelle on diagnoositud lipoproteiinlipaasi puudus, soovitatakse nii enne kui ka pärast ravi Glyberaga järgida hoolikalt oma dieeti; keelatud on alkoholi tarvitamine.
English: In clinical trials with Glybera, antibodies against the adeno-associated virus (AAV) protein shell were present prior to treatment, in 18 out of 27 subjects; anti-AAV antibodies appeared or increased after Glybera administration, in all of the subjects.
Estonian: Glybera kliinilistes uuringutes esinesid 18 patsiendil 27-st antikehad adenoassotsieeritud viiruse (AAV) valgukesta vastu ja kõikidel isikutel tekkisid pärast Glybera manustamist anti-adenoassotsieeritud viiruse antikehad või suurenes nende sisaldus.
English: Therefore, use of barrier contraception methods for at least 12 months following Glybera administration is recommended.
Estonian: Seetõttu on soovitatav kasutada rasestumisvastast barjäärimeetodit vähemalt 12 kuud pärast Glybera manustamist.
English: High levels of vector DNA were observed up to 12 months after dosing in the target tissue for Glybera, injected leg muscle, but not in non-injected muscle.
Estonian: Vektor-DNA suur sisaldus oli tuvastatav kuni 12 kuud pärast Glybera manustamist sihtmärkkoesse (süstitud jalalihas), kuid mitte süstimata lihases.
English: Pre-clinical studies with doses ten times the recommended dose (1 x 1013 gc/kg) did not lead to any general systemic untoward signs or symptoms.
Estonian: Soovituslikust annusest 10 korda suuremate annuste (1 × 1013 gk/kg) manustamine prekliinilistes uuringutes ei toonud kaasa mingeid üldisi ebasoovitavaid sümptomeid.
English: Lipoprotein lipase is a key ‘first step' enzyme in the metabolism of lipoproteins following fat intake with diet.
Estonian: Lipoproteiinlipaas on esimese astme ensüüm toiduga manustatud rasva lipoproteiinide metabolismis.
English: Elevations in serum creatine kinase activity
Estonian: Seerumi kreatiinkinaasi aktiivsuse tõus
English: The MAH shall set up a disease registry to collect information on the epidemiology of the disease and the demographics, safety and effectiveness outcomes of patients with familial LPLD treated with Glybera.
Estonian: Müügiloa hoidja peab looma haiguse registri, et koguda haiguse kohta epidemioloogilist ja demograafilist teavet ning Glyberaga ravitud perekondliku LPLD-ga patsientide ohutuse ja efektiivsuse tulemusi.
English: Your doctor will weigh up the benefits to you against the risks to your baby of taking Glybera whilst you are pregnant.
Estonian: Teie arst kaalub raseduse ajal Glybera kasutamise kasulikkust teile ja riski teie lapsele.
English: Glybera therapy must be prescribed by and administered under the supervision of a physician with expertise in treating LPLD patients and in gene therapy administration, in full consultation with the patient.
Estonian: Ravi Glyberaga võib määrata ja manustada ainult sellise arsti järelevalve all, kellel on kogemusi LPLD-ga patsientide ravis ja geeniteraapias kasutatavate ravimite manustamisega, ning patsiendi täieliku koostöö korral.
English: o information on the signs and symptoms of a reduction/loss of efficacy o the use of the events diary and what should be recorded
Estonian: o teave efektiivsuse vähenemise/kadumise sümptomite kohta,
English: In addition, patients, who have been treated with Glybera in a clinical trial shall be enrolled in the registry at the end of the trial.
Estonian: Lisaks tuleb kõik kliinilistes uuringutes Glyberaga ravitud patsiendid uuringu lõpus registrisse kanda.
English: Alipogene tiparvovec contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector.
Estonian: Alipogeentiparvovek sisaldab vektoris inimese lipoproteiinlipaasi (LPL) geenivarianti LPLS447X.
English: Glybera contains sodium and potassium.
Estonian: Glybera sisaldab naatriumi ja kaaliumi.
English: In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed.
Estonian: Kliinilistes uuringutes täheldati üksikpatsientidel mööduvat triglütseriidide sisalduse vähenemist kuni 12 nädalaks.
English: Once thawed, the medicinal product must be used immediately; if not used immediately, the vials should be stored in a refrigerator at 2ºC to 8ºC, and protected from light for a maximum of 8 hours.
Estonian: Pärast sulatamist tuleb ravimpreparaati kasutada kohe; kui seda ei kasutata kohe, tuleb viaale hoida külmkapis (2 ºC…8 ºC) kuni 8 tundi, valguse eest kaitstult.
English: Glybera is used to treat a specific inherited condition known as “lipoprotein lipase deficiency (LPLD)”.
Estonian: Glyberat kasutatakse konkreetse päriliku seisundi, lipoproteiinlipaasi puuduse (LPLD) raviks.
English: Glybera is authorised for single treatment only and should not be re-administered.
Estonian: Glybera on lubatud ainult ühekordseks raviks ja seda ei tohi korduvalt manustada.
English: No vector DNA could be detected in the foetuses after treatment of either the females or the males prior to mating.
Estonian: Vektor-DNA ei ole lootes tuvastatav, kui emas- või isaslooma raviti enne paaritamist.
English: In addition, half an hour prior to Glybera injection an intravenous bolus of 1mg/kg of methylprednisolone should be administered (see section 4.4).
Estonian: Lisaks tuleb pool tundi enne Glybera süsti manustada intravenoosse boolusena 1 mg/kg metüülprednisolooni (vt lõik 4.4).
English: Disodium phosphate
Estonian: Dinaatriumfosfaat
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 LPLS447X gc/kg bodyweight.
Estonian: Üks patsiendispetsiifiline pakend sisaldab piisavas koguses viaale, et annustada igale patsiendile 1 × 1012 LPLS447× gk/kg kehakaalu kohta.
English: From three days prior to and for 12 weeks following Glybera administration an immunosuppressive regimen should be administered: ciclosporin (3 mg/kg/day) and mycophenolate mofetil (2 x 1 g/day) is recommended.
Estonian: Alates 3 päeva enne ja kuni 12 nädalat pärast Glybera manustamist tuleb manustada immunosupressante: soovituslik on ööpäevas 3 mg/kg tsüklosporiini ja kaks korda ööpäevas 1 g mükofenolaatmofetiili.
English: Muscle biopsies obtained up to 52 weeks after administration of Glybera show an infiltrate of lymphocytes and macrophages.
Estonian: Kuni 52 nädala möödumisel Glybera manustamisest võetud lihaste biopsiates sisaldub lümfotsüütide ja makrofaagide infiltraate.
English: Side effects from your immunosuppressants
Estonian: Immunosupressantide kõrvaltoimed
English: • Guidance on the need for immunosuppressive administration prior to and after treatment
Estonian: • juhis immunosupressiivse ravimi manustamiseks enne ravi ja ravi järel;
English: In particular, tell your doctor if you are taking the following before you are given Glybera:
Estonian: Teatage oma arstile enne Glybera manustamist, kui te tarvitate:
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: BIOLOOGILISTE TOIMEAINE TOOTJA JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAV TOOTJA
English: Patient Alert Card
Estonian: Patsiendikaart
English: If you receive two doses in one injection site by mistake this might lead to more local reaction such as bruising or sensitivity.
Estonian: Kui teile manustatakse kaks annust kogemata samasse süstekohta, võib tekkida suurem paikne reaktsioon, nagu verevalum või tundlikkus.
English: If any of the above applies to you, or if you are unsure of any of the above, please talk to your doctor before you receive Glybera.
Estonian: Kui te ei ole kindel, kas midagi ülaltoodust kehtib teie kohta, pidage enne Glybera saamist nõu oma arstiga.
English: The patients in CT-AMT-010-01 have been followed for up to 5 years (n=6) post therapy administration, those in CT-AMT-011-01 for up to 5 years (n=13), and those in CT-AMT-011-02 for up to 1 year (n=3).
Estonian: Patsiente on uuringust CT-AMT-010-01 jälgitud 5 aastat pärast ravimi manustamist (n = 6), uuringust CT-AMT-011-01 5 aastat (n = 13) ja uuringust CT-AMT-011-02 üks aasta (n = 3).
English: Assessment of each individual subject's risk profile prior to Glybera administration is advised.
Estonian: Soovitatav on enne Glybera manustamist hinnata iga patsiendi individuaalset riskiprofiili.
English: Diabetes mellitus is common in patients who have the most severe symptoms of LPLD.
Estonian: Patsientidel, kellel on kõige tõsisemad LPLD sümptomid, on suhkurdiabeet tavaline.
English: Patient Code number:
Estonian: Arsti telefon: Patsiendi kood:
English: INFORMATION IN BRAILLE Justification for not including Braille accepted.
Estonian: Põhjendus Braille' mittelisamiseks.
English: After administration of Glybera to the participants, the highest vector DNA concentrations were detected in the serum, with clearance by one to two logs per week.
Estonian: Glybera manustamise järel oli suurim vektor-DNA kontsentratsioon tuvastatav vereseerumis kliirensiga 1…2 logaritmi nädalas.
English: Store frozen at -25°C to -15°C.
Estonian: Hoida sügavkülmas (-25 °C…-15 °C).
English: • Use appropriate barrier contraception such as condoms to avoid becoming pregnant during treatment and for at least 12 months after treatment.
Estonian: • Kasutage rasestumisvastast barjäärimeetodit (nagu kondoomid) ravi ajal Glyberaga ja vähemalt 12 kuud pärast ravi.
English: Each patient-specific pack contains a sufficient amount of vials to dose each patient with 1 x 1012 gc/kg body weight.
Estonian: Üks patsiendispetsiifiline pakend sisaldab piisavas koguses viaale, et annustada igale patsiendile 1 × 1012 gk/kg kehakaalu kohta.
English: The treatment should be monitored by measuring neutralising antibodies and T-Cell response against AAV1 and LPLS447X and T-Cell response at baseline as well as 6 and 12 months after treatment.
Estonian: Ravi tuleb jälgida ja mõõta selle ajal neutraliseerivaid antikehasid ning T-rakulist vastust AAV1 vastu; enne ravi ning 6 ja 12 kuud pärast ravi tuleb mõõta LPLS447X ning T-rakulist vastust.
English: Examples of typical dose schedules based on the body weight of patients are shown in the table below:
Estonian: Patsiendi kehakaalul põhinevad tavalise annustamisplaani näited on toodud allolevas tabelis.
English: Eight days after administration, high levels of vector DNA sequence were detected in injected muscle and the draining lymph nodes.
Estonian: Kaheksa päeva pärast manustamist oli vektor-DNA järjestuse suur sisaldus tuvastatav süstitud lihases ja äravoolu lümfisõlmedes.
English: After the amount of Glybera to be administered has been calculated (see section 4.2) remove the correct number of single use vials from the freezer to thaw at room temperature (15oC to 25oC), approximately 30-45 minutes in advance of syringe filling.
Estonian: Pärast manustatava Glybera koguse arvutamist (vt lõik 4.2) võtke enne süstalde täitmist vajalik arv ühekordseks kasutamiseks mõeldud viaale sügavkülmast umbes 30…45 minutiks toatemperatuurile (15 °C…25 °C) sulama.
English: Number of 1 ml syringes (each filled) with 0.5 ml)
Estonian: 1 ml süstalde arv (igas 0,5 ml)
English: 1) on efficacy data such as biochemical markers as part of normal practice and frequency and severity of pancreatitis and 2) on safety including immunogenicity against Glybera and LPL.
Estonian: 1) efektiivsuse kohta, nagu biokeemilised markerid tavapärase praktika raames ja pankreatiidi esinemissagedus ja raskus;
English: Anti-platelet or other anti-coagulant medicinal products must not be used concomitantly with Glybera at the time of injection.
Estonian: Trombotsüütide agregatsiooni pärssivaid või teisi hüübimisvastaseid ravimeid ei tohi Glybera süstimise ajal kasutada.
English: The product contains less than 1 mmol (39 mg) potassium per administration of 27-60 injection sites ; i.e. essentially potassium-free.
Estonian: See ravim sisaldab 27 kuni 60 süstekoha kohta vähem kui 1 mmol (39 mg) kaaliumi, st põhimõtteliselt on see kaaliumivaba.
English: Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Estonian: Glybera on näidustatud täiskasvanud patsientidele, kellel on diagnoositud perekondlik lipoproteiinlipaasi puudus (LPLD) ja kellel esinevad hoolimata toidurasva piiramisest tõsised või korduvad pankreatiidihood.
English: From the triglyceride data the 1 x 1012 gc/kg dose appears the most optimal.
Estonian: Triglütseriidide tulemuste järgi näib olevat kõige optimaalsem annus 1 × 1012 gk/kg.
English: Thromboembolic events
Estonian: Trombemboolilised seisundid
English: Only clear and colourless solutions without visible particles should be used.
Estonian: Kasutada võib ainult selget värvitut lahust, milles ei ole nähtavaid osakesi.
English: Glybera will only be given to you if you show detectable levels of LPL protein in your blood.
Estonian: Teile manustatakse Glyberat ainult sellisel juhul, kui teie veres on LPL-valgu tuvastatav sisaldus.
English: One patient developed myoglobinuria in association with raised serum creatine kinase activity.
Estonian: Ühel patsiendil tekkis seoses seerumi kreatiinkinaasi aktiivsuse tõusuga müoglobinuuria.
English: Male patients, including vasectomised males, are advised to practise barrier contraception methods for at least 12 months following Glybera administration.
Estonian: Meespatsientidel, sh vasektoomia läbinud meestel, on soovitatav kasutada viljastamisvastast barjäärimeetodit vähemalt 12 kuud pärast Glybera manustamist.
English: Hair growth abnormal, Palmar-plantar erythrodysaesthesia syndrome, Rash
Estonian: Ebanormaalne karvakasv, palmoplantaarne erütrodüsesteesia sündroom, lööve
English: In addition methylprednisolone might be administered half an hour prior to the Glybera administration.
Estonian: Lisaks võidakse manustada pool tundi enne Glybera manustamist metüülprednisolooni.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (2 vial pack)
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL LÄBIPAISTVA SULETUD PLASTÜMBRISE ETIKETT (2 viaali pakis)
English: Glybera will be given to you in a single therapy administration session in a hospital.
Estonian: Glyberat manustatakse haiglas ühekordse ravimi manustamise sessiooni ajal.
English: At this time a series of injections (27 to 60 injections) into the muscles of both upper and lower legs will be given.
Estonian: Teile tehakse ülemistesse ja alumistesse jalalihastesse süstide seeria (27 kuni 60 süsti).
English: No interaction studies other than preclinical and clinical studies with mycophenolate mofetil and ciclosporin have been performed.
Estonian: Prekliinilisi ja kliinilisi koostoimete uuringuid muude ravimitega kui mükofenolaatmofetiil ja tsüklosporiin ei ole läbi viidud.
English: No dose adjustment of Glybera is necessary in the elderly population.
Estonian: Glybera annuse kohandamine eakatel ei ole vajalik.
English: Subjects also received a daily oral dose of 3 mg/kg/day cyclosporine and 2 g/day of mycophenolate mofetil starting three days before administration of alipogene tiparvovec through week 12.
Estonian: Patsiendid said ka suukaudselt ööpäevas 3 mg/kg tsüklosporiini ja 2 g mükofenolaatmofetiili, mille manustamist alustati 3 päeva enne alipogeentiparvoveki manustamist ja jätkati kuni 12. nädalani.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TRANSPARENT SEALED PLASTIC CASING LABEL (3 vial pack)
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA BLISTER- VÕI RIBAPAKENDIL LÄBIPAISTVA SULETUD PLASTÜMBRISE ETIKETT (3 viaali pakis)
English: Glybera is used to treat adult patients diagnosed with lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions.
Estonian: Glyberat kasutatakse täiskasvanud patsientide raviks, kellel on diagnoositud lipoproteiinlipaasi puudus (LPLD) ja kellel esinevad hoolimata toidurasva piiramisest rasked või korduvad pankreatiidihood.
English: In the event two doses are administered by mistake to the identical injection site this might lead to more local reaction such as bruising or sensitivity.
Estonian: Kui kaks annust manustatakse kogemata samasse süstekohta, võib tekkida suurem paikne reaktsioon, nagu verevalum või tundlikkus.
English: Glybera is administered as a one-time series of intramuscular injections in the legs.
Estonian: Glyberat manustatakse ühekordse intramuskulaarsete süstide seeriana jalgadesse.
English: There is limited experience in the use of Glybera in patients with renal or hepatic impairment.
Estonian: Glybera kasutamisest neeru- või maksakahjustusega patsientidel on kogemused piiratud.
English: Glybera is authorised for single treatment only.
Estonian: Glybera on lubatud ainult ühekordseks raviks.
English: If not stored in a refrigerator the medicinal product can be stored in syringes at not more than 25°C, and protected from light for a maximum of 8 hours.
Estonian: Kui ravimpreparaati ei hoita külmkapis, võib seda süstlas säilitada kuni 8 tundi temperatuuril kuni 25 °C, valguse eest kaitstult.
English: In CT-AMT-01102 faeces was also collected.
Estonian: Uuringus CT-AMT-011-02 koguti ka väljaheiteid.
English: This information is also provided in the Glybera Patient's Alert Card.
Estonian: See teave on toodud ka patsiendikaardil.
English: Posology The maximum total dose of Glybera for administration is 1 x 1012 gc/kg body weight.
Estonian: Annustamine Glybera maksimaalne koguannus manustamiseks on 1 × 1012 gk/kg kehakaalu kohta.
English: No dose adjustment of Glybera is required.
Estonian: Glybera annuse kohandamine ei ole vajalik.
English: Meibergdreef 61, 1105 BA Amsterdam, The Netherlands.
Estonian: Meibergdreef 61, 1105 BA Amsterdam, Holland
English: It is not known whether Glybera passes into breast milk.
Estonian: Ei ole teada, kas Glybera eritub rinnapiima.
English: Five eligible subjects were included in the study with all subjects receiving alipogene tiparvovec.
Estonian: Uuringusse kaasati viis sobivat patsienti, kes kõik said alipogeentiparvovekki.
English: Pharmacotherapeutic group: Lipid modifying agents, other lipid modifying agents, ATC code: C10AX10.
Estonian: Farmakoterapeutiline rühm: lipiidisisaldust muutvad ained, teised lipiidisisaldust muutvad ained, ATC-kood:
English: The aim of this open label, dose escalating study was to assess the safety profile and reduction of fasting plasma triglyceride (TG) levels after 12 weeks post Glybera administration in 14 LPLD patients.
Estonian: Avatud, annuse suurendamise uuringu eesmärk oli hinnata 14-l LPLD-ga patsiendil 12 nädalat pärast Glybera manustamist ohutusprofiili ja plasma triglütseriidide (TG) sisaldust tühja kõhuga.
English: Preparation of Glybera for administration
Estonian: Glybera valmistamine manustamiseks
English: Glybera is a clear to slightly opalescent, colourless solution for injection, supplied in a clear glass vial with a siliconised injection stopper and flip-off seal.
Estonian: Glybera on selge või veiklev värvitu süstelahus, mida tarnitakse silikooniga kaetud korgi ja eemaldatava kaanega läbipaistvas klaasviaalis.
English: This medicinal product has been authorised under ‘exceptional circumstances'.
Estonian: See ravimpreparaat on saanud müügiloa erandlikel asjaoludel.
English: After treatment with Glybera do not donate blood, organs, tissues and cells for transplantation to avoid spreading cells that contain your medicine.
Estonian: Pärast ravi Glyberaga ei tohi te annetada verd, siirdamiseks organeid, kudesid ega rakke.
English: Number of vials (1 mL) Number of 1ml syringes (each filled with 0.5ml)
Estonian: Viaalide arv (1 ml) 1 ml süstalde arv (igas 0,5 ml)
English: Glybera contains the human LPL gene variant LPL S447X in an adeno-associated virus serotype 1 (AAV1) vector intended to target the muscle.
Estonian: Toimemehhanism Glybera sisaldab inimese LPL-geenivarianti LPL S447X adenoassotsieeritud viiruse serotüüp 1 (AAV1)
English: After time, residual vector DNA levels remained high in the injected muscle and inguinal lymph nodes while decreasing steadily in the other organs.
Estonian: Aja möödudes jäi süstitud lihases ja kubeme lümfisõlmedes vektor-DNA jääksisaldus suureks, samas kui teistes organites see pidevalt vähenes.
English: Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA body system organ class and by frequency.
Estonian: Kõrvaltoimed on rühmitatud MedRA organsüsteemide ja esinemissageduse järgi.
English: Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Estonian: Kui raviarst peab vajalikuks, on soovitatav üleannustamise korral rakendada sümptomaatilist ja toetavat ravi.
English: Spinal or regional anaesthesia is advised prior to intramuscular administration, due to the number of injections required.
Estonian: Süstete arvu tõttu on enne intramuskulaarset süsti soovitatav teha spinaalne või regionaalne anesteesia.
English: Package leaflet: Information for the user Glybera 3 x 1012 genome copies /ml solution for injection
Estonian: Pakendi infoleht: teave kasutajale Glybera 3 × 1012 genoomi koopiat/ml süstelahus
English: Male patients must use condoms for at least 12 months after injection with Glybera.
Estonian: Meespatsiendid peavad vähemalt 12 kuud pärast Glybera süste kasutama kondoomi.
English: Clear, to slightly opalescent, colourless solution.
Estonian: Selge või kergelt hägune värvitu lahus.
English: No neutralising assay was used.
Estonian: Neutralisatsiooni teste ei kasutatud.
English: The clear to slightly opalescent and colourless solution must be free of visible particles.
Estonian: Selge või kergelt veiklev hägune värvitu lahus ei tohi sisaldada nähtavaid osakesi.
English: To ensure intramuscular injection, ultrasound or electrophysiological guidance of injections is advised.
Estonian: Intramuskulaarse süste tagamiseks on soovitatav kasutada ultraheli või elektrofüsioloogia suuniseid.
English: Product manufacturer and license holder: uniQure biopharma B.V.
Estonian: Ravimi tootja ja müügiloa hoidja: uniQure biopharma B.V.
English: Glybera is injected as a one-time series into the muscle of the lower extremities where it is taken up by myocytes.
Estonian: Glyberat süstitakse ühekordse seeriana alajäseme lihasesse, kus see võetakse lihasrakkudesse.
English: What Glybera is and what it is used for What you need to know before you are given Glybera
Estonian: Mis ravim on Glybera ja milleks seda kasutatakse Mida on vaja teada enne Glybera kasutamist Kuidas Glyberat kasutada Võimalikud kõrvaltoimed Kuidas Glyberat säilitada Pakendi sisu ja muu teave
English: Assessment of postprandial chylomicron metabolism in at least 12 patients before 12 months and 24 months after treatment with Glybera to be chosen in addition to the patients included in study CT-AMT.011.02; and eight healthy subjects in the second study.
Estonian: Lisaks uuringusse CT-AMT.011.02 kaasatud patsientidele tuleb hinnata söömisjärgse külomikroni metabolismi vähemalt 12 patsiendil ning 8 tervel isikul teises uuringus 12 kuud enne ja 24 kuud pärast ravi Glyberaga.
English: - You should present this card to your health care professionals (doctor, nurse) upon consultation or hospitalisation.
Estonian: - Esitage kaart tervishoiutöötajale (arstile, meditsiiniõele) visiidil arsti juurde või haiglasse jäämisel.
English: MedDRA System Organ Class Metabolism and nutrition disorders
Estonian: MedRA organsüsteemi klass
English: The final outer carton contains a variable number of casings according to the patient specific dose required.
Estonian: Lõplik välispakend sisaldab patsiendile vajalikule spetsiifilisele annusele vastavalt erineva arvu pakendeid.
English: Glybera should under no circumstances be administered intravascularly.
Estonian: Mitte ühelgi juhul ei tohi Glyberat manustada veresoonde.
English: This is an open-label study of alipogene tiparvovec at a fixed dose of 1x1012 gc/ kg body weight administered by a single series of intramuscular injections.
Estonian: Kliiniline uuring CT-AMT-011-02 See on avatud alipogeentiparvoveki fikseeritud annuse (1 × 1012 gk/kg kehakaalu kohta, mida masnustatakse ühekordse intramuskulaarsete süstide seeriana) uuring.