FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects and restrictions with Betaferon, see the package leaflet.
Estonian: Betaferoni kohta teatatud kõrvalnähtude ja piirangute täielik loetelu on pakendi infolehel.
English: • who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
Estonian: • patsiendid, kellel on sekundaarne progresseeruv hulgiskleroos (hulgiskleroosi vorm, mis tekib pärast relapseeruvat-remiteeruvat hulgiskleroosi), kui neil on aktiivne haigus.
English: Betaferon is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Estonian: Betaferoni turustatakse pulbri ja lahustina, millest valmistatakse lahus, mis sisaldab 250 µg annust.
English: In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses.
Estonian: Mõlemas uuringus vähendas Betaferon kliiniliste relapside arvu (30%).
English: Betaferon was also studied in 487 patients with a single demyelinating event, who received either Betaferon or placebo for two years.
Estonian: Betaferoni uuriti ka 487 üheainsa demüelinisatsioonisepisoodiga patsiendil, kes said kahe aasta vältel Betaferoni või platseebot.
English: Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, compared with 45% of those who received placebo.
Estonian: Betaferon vähendas kliiniliselt määratletud hulgiskleroosi tekke riski: hulgiskleroos tekkis 28%-l Betaferoni saanud patsientidest ja 45%-l platseebot saanutest.
English: Betaferon can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Estonian: Betaferon on retseptiravim ja ravi peab alustama hulgiskleroosi ravis kogenud arst.
English: What benefits of Betaferon have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Betaferoni kasulikkus?
English: How is Betaferon used?
Estonian: Kuidas Betaferoni kasutatakse?
English: The active substance in Betaferon is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Estonian: Betaferoni toimeaine on looduslike interferoonide rühma kuuluv valk beeta-1b-interferoon, mis tekib organismis, et aidata sel võidelda viiruste ja muude haigustekitajatega.
English: Betaferon is a medicine used to treat adults who have multiple sclerosis (MS).
Estonian: Betaferon on ravim, mida kasutatakse hulgiskleroosi raviks täiskasvanutel.
English: Betaferon was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where it was compared with placebo (a dummy treatment).
Estonian: Betaferoni uuriti kahe aasta jooksul 338 relapseeruva-remiteeruva hulgiskleroosiga patsiendil, kes suutsid kõndida kõrvalise abita, ning ravimit võrreldi platseeboga (näiv ravim).
English: Patients can inject Betaferon themselves once they have been trained.
Estonian: Pärast asjakohase väljaõppe saamist tohivad patsiendid süstida endale Betaferoni ise.
English: Betaferon is used when the patient is considered to be at high risk of developing MS. Before using Betaferon, doctors need to exclude other causes for the symptoms;
Estonian: Enne Betaferoni kasutamist peab arst välistama muud sümptomite põhjused;
English: Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Estonian: Betaferoni võrreldi platseeboga ka 1657 patsiendil kahes uuringus, milles osalesid sekundaarse progressiivse hulgiskleroosiga kõndimisvõimelised patsiendid.
English: An overview of Betaferon and why it is authorised in the EU
Estonian: Ülevaade ravimist Betaferon ja ELis müügiloa väljastamise põhjendus
English: Betaferon contains the active substance interferon beta-1b.
Estonian: Betaferoni toimeaine on beeta-1b-interferoon.
English: Betaferon treatment should be stopped in patients whose condition does not improve.
Estonian: Kui patsiendi seisund ei parane, tuleb ravi Betaferoniga lõpetada.
English: How does Betaferon work?
Estonian: Kuidas Betaferon toimib?
English: It is given by injection under the skin.
Estonian: Betaferoni manustatakse nahaaluse süstina.
English: ATC Code: A16AX06
Estonian: ATC-kood: A16AX06
English: • Always take this medicine exactly as your doctor has told you.
Estonian: Võtke seda ravimit alati täpselt nii, nagu arst on teile rääkinud.
English: Prins Bernhardplein 200 1097JB Amsterdam Netherlands
Estonian: Prins Bernhardplein 200 1097JB Amsterdam Holland
English: You should swallow the whole capsule with a glass of water.
Estonian: Neelake kapslid alla tervelt koos klaasitäie veega.
English: The average half-life is 6-7 hours.
Estonian: Keskmine poolväärtusaeg on 6...7 h.
English: This leaflet was last revised in {MM/YYYY} Other sources of information
Estonian: Infoleht on viimati uuendatud {KK.AAAA} Muud teabeallikad
English: Weight loss has been reported in 55% of patients.
Estonian: Kehakaalu langust esines 55% patsientidest.
English: Quinto dè Stampi Rozzano (MI)
Estonian: Quinto dé Stampi Rozzano (MI)
English: Dose reduction may ameliorate the tremor, usually within days, but discontinuation of treatment may sometimes be required.
Estonian: Annuse vähendamine võib värinat tavaliselt paari päevaga leevendada, kuid mõnikord osutub vajalikuks ka ravi katkestamine.
English: Concomitant administration of food decreases the rate of absorption (Cmax was decreased by 36% and tmax delayed 2 hours), but has no statistically significant effect on the extent of absorption of miglustat (AUC decreased by 14%).
Estonian: Toidu samaaegsel manustamisel väheneb imendumise kiirus (Cmax langes 36% võrra ja tmax saavutati 2-tunnise viivitusega), kuid sellel puudub statistiliselt oluline mõju miglustaadi imendumisulatusele (AUC vähenes 14% võrra).
English: They may lower the amount of Miglustat Dipharma in your body.
Estonian: Need võivad Miglustat Dipharma taset teie kehas vähendada.
English: Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Dipharma.
Estonian: Teatage oma arstile, kui te võtate imiglütseraasi sisaldavaid ravimeid, mida kasutatakse mõnikord samal ajal Miglustat Dipharma'ga.
English: Hard capsule 84 capsules 84x1 capsules
Estonian: Kõvakapsel 84 kapslit 84x1 kapslit
English: Gastrointestinal events, mainly diarrhoea, have been observed in more than 80% of patients, either at the outset of treatment or intermittently during treatment (see section 4.8).
Estonian: Muutusi seedetraktis, peamiselt kõhulahtisust, on täheldatud üle 80% patsientidest kas ravi alguses või vahelduvalt ravi jooksul (vt lõik 4.8).
English: The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Miglustat Dipharma (see section 4 for further details).
Estonian: Testide abil saab arst otsustada, kas neid nähte põhjustavad teie haigus või teised olemasolevad seisundid või Miglustat Dipharma'i kõrvalmõjud (täiendavaid üksikasju vt lõik 4).
English: PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Estonian: PCTFE/PVC ja alumiiniumblisterpakendid, mis sisaldavad 12 (perforeeritud ühikannus) või 21 (perforeerimata) kapslit.
English: Eighteen patients then continued to receive miglustat under an optional extended treatment protocol.
Estonian: 18 patsienti jätkasid ravi miglustaadiga valikulise laiendatud raviprotokolli raames.
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil pärast „Kõlblik kuni/EXP“.
English: - The active substance is miglustat.
Estonian: - Toimeaine on miglustaat.
English: - The other ingredients are magnesium stearate, gelatine, titanium dioxide (E171), printing ink (consisting of black iron oxide (E172), propylene glycol (E1520) potassium hydroxide, shellac).
Estonian: - Teised koostisained on magneesiumstearaat, želatiin, titaandioksiid (E171), trükitint (sisaldab must raudoksiid (E172), propüleenglükool (E1520) kaaliumhüdroksiid, šellak).
English: Capsule content Magnesium stearate
Estonian: Kapsli sisu Magneesiumstearaat
English: If you take more capsules than you were told to, consult your doctor immediately.
Estonian: Kui võtate kapsleid rohkem kui ette nähtud, pöörduge kohe oma arsti poole.
English: Miglustat Dipharma can be taken with or without food.
Estonian: Miglustaati võib võtta koos toiduga või ilma.
English: The greatest prevalence was observed between 6 and 12 months.
Estonian: Kõige sagedamini täheldati kehakaalu langust 6 kuni 12 kuu möödudes.
English: Miglustat Dipharma has negligible influence on the ability to drive and use machines.
Estonian: Miglustat Dipharma mõjutab ebaoluliselt autojuhtimise ja masinate käsitsemise võimet.
English: You should not take Miglustat Dipharma if you are pregnant or thinking of becoming pregnant.
Estonian: Miglustat Dipharma't ei tohi võtta, kui olete rase või plaanite rasestuda.
English: There are no pharmacokinetic data available in patients with liver impairment or in the elderly (> 70 years).
Estonian: Farmakokineetilised andmed puuduvad maksakahjustusega patsientide ja eakate (> 70-aastased) kohta.
English: Contents of the pack and other information What Miglustat Dipharma contains
Estonian: Pakendi sisu ja muu teave Mida Miglustat Dipharma sisaldab
English: Data to support safety and efficacy of miglustat in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Estonian: Andmed miglustat efektiivsuse ja ohutuse kohta kasutamisel C-tüüpi Niemanni-Picki tõve raviks pärinevad perspektiivsest avatud kliinilisest uuringust ja retrospektiivsest küsitlusest.
English: The apparent volume of distribution of miglustat is 83 L. Miglustat does not bind to plasma proteins.
Estonian: Miglustaadi jaotusruumala on 83 l. Miglustaat ei seondu plasmavalkudega.
English: The benefit to the patient of treatment with miglustat should be evaluated on a regular basis (see section 4.4).
Estonian: Miglustat ravi kasulikkust patsiendile tuleb regulaarselt hinnata (vt lõik 4.4).
English: The kinetics of miglustat appears to be dose linear and time independent.
Estonian: Miglustaadi kineetika tundub olevat lineaarses suhtes annusega ja ajast sõltumatu.
English: If you have diarrhoea, your doctor may ask you to change your diet to reduce your lactose and carbohydrate intake such as sucrose (cane sugar), or not to take Miglustat Dipharma together with food, or to temporarily reduce your dose.
Estonian: Kui teil on kõhulahtisus, võib arst paluda teil muuta oma dieeti, et vähendada laktoosi ja süsivesikute, näiteks sahharoosi (roosuhkur) tarbimist, või mitte võtta Miglustat Dipharma't koos toiduga või ajutiselt vähendada Miglustat Dipharma annust.
English: Depression, insomnia, libido decreased
Estonian: Depressioon, unetus, libiido vähenemine
English: • if you suffer from liver disease
Estonian: • kui teil on mõni maksahaigus
English: Most patients get one or more of these side effects mentioned above, usually at the start of treatment or at intervals during treatment.
Estonian: Enamikul patsientidest ilmneb üks või mitu kõrvaltoimet tavaliselt ravi alguses või vahelduvate intervallidega ravi kestel.
English: Black iron oxide (E172) Potassium Hydroxide Shellac
Estonian: Must raudoksiid (E172) Kaaliumhüdroksiid Šellak
English: The neurological symptoms and thrombocytopenia could be due to the underlying disease.
Estonian: Neuroloogilised sümptomid ja trombotsütopeenia võivad olla põhjustatud ka olemasolevast haigusest.
English: At 12 months, there was a mean reduction in liver organ volume of 12.1% and a mean reduction in spleen volume of 19.0%.
Estonian: 12 kuu pärast võis täheldada maksa kogumahu vähenemist keskmiselt 12.1% ulatuses ja põrna kogumahu vähenemist keskmiselt 19,0% ulatuses.
English: Do not drive or use any tools or machines if you feel dizzy.
Estonian: Ärge juhtige autot ega käsitsege masinaid, kui teil on pearinglus.
English: Miglustat has been used in clinical trials at doses ten times higher than the recommended dose: this caused decreases in white blood cells and other side effects similar to those described in section 4.
Estonian: Miglustaati on kliinilistes uuringutes annustatud kümnekordsete soovitatavate annustena: see põhjustas valgete vereliblede hulga vähenemist ja teisi kõrvalnähte, mis sarnanesid lõigus 4 kirjeldatutega.
English: This means a daily maximum of three capsules (300 mg).
Estonian: Seega on ööpäevane maksimaalne annus kolm kapslit (300 mg).
English: Detailed information on this medicinal prodcut is available on the website of the European Medicines Agency http://www.ema.europa.eu
Estonian: Täpne teave selle ravimpreparaadi kohta on Euroopa Ravimiameti kodulehel http://www.ema.europa.eu.
English: Data in severe renal impairment are limited to two patients with creatinine clearance in the range 18 - 29 ml/min and cannot be extrapolated below this range.
Estonian: Raske neerukahjustuse kohta piirduvad andmed kahe patsiendiga, kelle kreatiniini kliirens jäi vahemikku 18...29 ml/min ja neid andmeid ei saa laiendada sellest tasemest allapoole jäävatele vahemikele.
English: Among the 41 patients enrolled in the trial 14 patients were treated with miglustat for more than 3 years.
Estonian: Uuringusse võetud 41 patsiendist 14 said ravi miglustat üle 3 aasta.
English: They could be signs of peripheral neuropathy, due to side effects of Miglustat Dipharma or they could be due to existing conditions.
Estonian: Need võivad olla Miglustat Dipharma kõrvaltoimetest tuleneva perifeerse neuropaatia nähud või olla põhjustatud olemasolevatest seisunditest.
English: Miglustat Dipharma should not be taken during breast-feeding.
Estonian: Miglustat Dipharma'i ei tohi võtta rinnaga toitmise ajal.
English: Since some patients have had tingling or numbness in the hands and feet, or a decrease in body weight, while taking Miglustat Dipharma, your doctor will perform the following tests before treatment and during treatment with Miglustat Dipharma:
Estonian: Mõnel patsiendil on Miglustat Dipharma võtmise ajal esinenud käte ja jalgade surisemist ja tuimust või kehakaalu langust, seetõttu teeb arst enne ravi algust ja ravi ajal Miglustat Dipharma'ga järgmised uuringud:
English: The survey included a case series of 66 patients treated with miglustat outside of the clinical trial for a mean duration of 1.5 years.
Estonian: Küsitlus hõlmas 66 patsienti, keda raviti miglustat väljaspool kliinilist uuringut keskmiselt 1,5 aastat.
English: In some patients there were reductions in platelet count and increases in chitotriosidase activity indicating that miglustat monotherapy may not maintain the same control of disease activity in all patients.
Estonian: Osal patsientidest täheldati ka vereliistakute arvu vähenemist ja chitotriosidaasi aktiivsuse suurenemist, mis viitab sellele, et ainuüksi miglustaadi ravi ei pruugi kõigi patsientide puhul haigust kontrolli all hoida.
English: A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent.
Estonian: NOEL) ei õnnestunud määrata ja toime ei olnud annusest sõltuv.
English: After 3 years of continuous miglustat treatment, mean reductions in liver and spleen organ volume were 17.5% and 29.6%, respectively.
Estonian: Pärast 3-aastast katkematut ravi miglustaadiga oli maksa ja põrna maht vähenenud keskmiselt vastavalt 17,5 ja 29,6 protsenti.
English: Overall the data show that treatment with miglustat can reduce the progression of clinically relevant neurological symptoms in patients with Niemann-Pick type C disease.
Estonian: Andmed näitavad kokkuvõttes, et ravi Miglustat võib vähendada C-tüüpi Niemanni-Picki tõvega patsientidel kliiniliselt asjakohaste neuroloogiliste sümptomite progresseerumist.
English: The capsules are presented in PCTFE/PVC and Aluminium blister, ain pack size of 84 capsules in non-perforated blisters and 84x1 capsules in perforated unit dose blisters.
Estonian: Kapslid on PCTFE/PVC ja alumiiniumblisterpakendites, pakendis on 84 kapslit perforeerimata blistrites ja 84x1 kapslit üksikannuseline blister.
English: Do not stop taking Miglustat Dipharma without talking to your doctor.
Estonian: Ärge katkestage Miglustat Dipharma võtmist ilma arstiga nõu pidamata.
English: Growth should be monitored in paediatric and adolescent patients during treatment with Miglustat Dipharma; the benefit/risk balance should be re-assessed on an individual basis for continuation of therapy.
Estonian: Ravi ajal miglustat tuleb jälgida pediaatriliste ja noorukieas patsientide kasvu; ravi jätkamiseks tuleb ravi kasulikkuse/riski tasakaalu individuaalselt uuesti hinnata.
English: If you get a slight tremor, usually trembling hands, seek medical advice from your doctor as soon as possible.
Estonian: Kui esineb kergeid värinaid, tavaliselt kätevärin, teatage sellest oma arstile niipea kui võimalik.
English: • if you suffer from kidney disease
Estonian: • kui teil on mõni neeruhaigus
English: Some patients have had tingling or numbness in the hands and feet (seen commonly).
Estonian: Mõnel patsiendil on täheldatud käte ja jalgade surisemist või tuimust (esines sageli).
English: What Miglustat Dipharma is and what it is used for
Estonian: Mis ravim on Miglustat Dipharma ja milleks seda kasutatakse
English: Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance accounting for 70-80% of the dose.
Estonian: Miglustaat eritub põhiliselt renaalselt, uriiniga eritub muutumatul kujul 70...80% annusest.
English: Other medicines and Miglustat Dipharma
Estonian: Muud ravimid ja Miglustat Dipharma
English: Limited data suggest that co-administration of miglustat and enzyme replacement with imiglucerase in patients with type 1 Gaucher disease may result in decreased exposure to miglustat (approximate reductions of 22% in Cmax and 14% in AUC were observed in a small parallel-group study).
Estonian: Piiratud andmed viitavad sellele, et miglustaadi ja imiglütseraasiga ensüümasendusravi koosmanustamine I tüüpi Gaucher' tõvega patsientidele võib vähendada miglustaadi biosaadavust (väikesemahulises paralleelsete rühmadega uuringus täheldati umbes 22%-list maksimaalse plasmakontsentratsiooni (Cmax) langust ja 14%-list AUC vähenemist).
English: In clinical practice, miglustat-induced gastrointestinal events have been observed to respond to individualised diet modification (for example reduction of sucrose, lactose and other carbohydrate intake), to taking miglustat between meals, and/or to anti-diarrhoeal medicinal products such as loperamide.
Estonian: Kliinilises praktikas on leitud, et miglustaadi toimel tekkivad seedetrakti nähud reageerivad individuaalsetele dieedimuutustele (näiteks sahharoosi, laktoosi ja teiste süsivesikute tarbimise vähendamisele), miglustaadi võtmisele söögiaegade vahel ja/või kõhulahtisuse vastastele ravimitele nagu näiteks loperamiid.
English: What Miglustat Dipharma looks like and contents of the pack
Estonian: Kuidas Miglustat Dipharma välja näeb ja pakendi sisu
English: Miglustat Dipharma may be used only in the treatment of patients for whom enzyme replacement therapy is unsuitable (see sections 4.4 and 5.1).
Estonian: Miglustat Dipharma'i võib kasutada ainult patsientide raviks, kellele ensüümasendusravi ei sobi (vt lõigud 4.4 ja 5.1).
English: Miglustat Dipharma contains the active substance miglustat which belongs to a group of medicines that affect metabolism.
Estonian: Miglustat Dipharma sisaldab toimeainena miglustaati, mis kuulub ainevahetust mõjutavate ravimite rühma.
English: Your doctor will perform some tests before and during treatment with Miglustat Dipharma to assess this (see section 2).
Estonian: Arst teeb selle hindamiseks mõningaid analüüse enne ravi ja ravi ajal Miglustat Dipharma'ga (vt lõik 2).
English: • Miglustat Dipharma is also used to treat progressive neurological symptoms in NiemannPick type C disease in adults and in children.
Estonian: • Miglustat Dipharma't kasutatakse ka progresseeruvate neuroloogiliste sümptomite raviks C-tüüpi Niemanni-Picki tõve puhul täiskasvanutel ja lastel
English: Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at month 24.
Estonian: Neist 18 patsiendil olid maksa ja põrna mahu, hemoglobiinitaseme ja trombotsüütide arvu ravieelsed tasemed kehtestatud ravieesmärkide piires ja 16 patsiendil jäid 24 kuu möödudes kõik need näitajad kehtestatud ravieesmärkide piiresse.
English: Miglustat has been studied in indications where certain events reported as adverse reactions, such as neurological and neuropsychological symptoms/signs, cognitive dysfunction and thrombocytopenia could also be due to the underlying conditions.
Estonian: Miglustaadi efektiivsust on uuritud näidustustel, kus teatud kõrvaltoimetena teatatud nähud, näiteks neuroloogilised ja neuropsühholoogilised sümptomid ja nähud, kognitiivne funktsioonihäire ja trombotsütopeenia, võivad tuleneda ka patsiendi olemasolevatest haigustest.
English: Elderly There is no experience with the use of miglustat in patients over the age of 70.
Estonian: Eakad Miglustaadi kasutamise kohta üle 70 aasta vanustel patsientidel kogemused puuduvad.
English: In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
Estonian: Kontrollrühmata saadud andmete koondanalüüsis suurenesid luu mineraalse tiheduse Z-skoor lülisamba nimmepiirkonnas ja reieluukaela piirkonnas ravi algusega võrreldes rohkem kui 0,1 ühiku võrra 27 (57%) ja 28 (65%) patsiendil, kellel mõõdeti luutihedust kestevuuringuna.
English: The benefit of treatment with miglustat for neurological manifestations in patients with Niemann-Pick type C disease should be evaluated on a regular basis, e.g. every 6 months; continuation of therapy should be re-appraised after at least 1 year of treatment with miglustat.
Estonian: Miglustat ravi kasulikkust C-tüüpi Niemanni-Picki tõvega patsientide neuroloogiliste nähtude puhul tuleb regulaarselt hinnata, nt iga 6 kuu järel; ravi jätkamist tuleb uuesti hinnata pärast vähemalt 1aastast ravi miglustat.
English: Weight loss, decreased appetite
Estonian: Kehakaalu langus, söögiisu langus
English: In healthy subjects miglustat is rapidly absorbed.
Estonian: Tervetel uuringus osalejatel imendus miglustaat kiiresti.
English: 100 mg three times a day 100 mg twice a day
Estonian: Soovituslik annus 200 mg kolm korda ööpäevas 200 mg kaks korda ööpäevas 100 mg kolm korda ööpäevas 100 mg kaks korda ööpäevas 100 mg üks kord ööpäevas
English: Pharmacokinetic data were obtained in paediatric patients with type 3 Gaucher disease aged 3 to 15 years, and patients with Niemann-Pick type C disease aged 5-16 years.
Estonian: Farmakokineetilised andmed saadi III tüüpi Gaucher' tõvega 3...15-aastastelt pediaatriliste patsientide kohta ja C-tüüpi Niemanni-Picki tõvega 5-16-aastaste patsientide kohta.
English: He or she may reduce the dose of Miglustat Dipharma or recommend other medicines to help control side effects.
Estonian: Arst võib Miglustat Dipharma annust vähendada või soovitada kõrvaltoimete ärahoidmiseks kasutada teisi ravimeid.
English: Due to limited experience, miglustat should be used with caution in patients with renal or hepatic impairment.
Estonian: Piiratud kogemuse tõttu tuleb neeru- ja maksakahjustusega patsientidele manustada miglustaati ettevaatusega.
English: Peripheral neuropathy, ataxia, amnesia, paraesthesia, hypoaesthesia headache, dizziness
Estonian: Perifeerne neuropaatia, ataksia, amneesia, paresteesia, hüpesteesia, peavalu, pearinglus
English: The most common serious adverse reaction reported with miglustat treatment in clinical trials was peripheral neuropathy (see section 4.4).
Estonian: Kõige raskem miglustaadi raviga seotud kõrvaltoime kliinilistes uuringutes oli perifeerne neuropaatia (vt lõik 4.4).