FrancophonIA/ELRC3.0 huggingface dataset:
English: This helps the patients to recover from the operation but also leaves enough time for the cartilage cells to implant themselves and for the knee to heal.
Estonian: See aitab patsientidel taastuda operatsioonist ja ühtlasi jätab piisavalt aega, et kõhrerakud saaksid kohale kinnituda ja põlveliiges saaks paraneda.
English: Based on the assessment performed by the CAT, the CHMP decided that ChondroCelect's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Komitee hinnangu alusel otsustas inimravimite komitee, et ChondroCelecti kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas anda ravimi müügiloa.
English: ChondroCelect was compared with microfracture (a type of surgery used to treat defects in cartilage) in one main study involving 118 adult patients with symptoms caused by defects in their knee cartilage.
Estonian: ChondroCelecti võrreldi mikrofraktuurimeetodiga (kõhrekahjustuste teatud ravimeetod) ühes põhiuuringus, kus osales 118 täiskasvanut, kellel olid põlveliigese kõhrekahjustuste sümptomid.
English: This is a type of medicine containing cells or tissues that have been manipulated so that they can be used to repair, regenerate or replace tissue.
Estonian: Koetehnoloogiatoode sisaldab rakke või kudesid, mida on töödeldud nii, et neid saab kasutada koe parandamiseks, regenereerimiseks või asendamiseks.
English: ChondroCelect must be administered by a qualified surgeon in a hospital.
Estonian: ChondroCelecti peab manustama haiglas pädev kirurg.
English: For more information about treatment with ChondroCelect, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ChondroCelectiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It must also not be used in patients with advanced osteoarthritis of the knee (a disease causing swelling and pain in the knee) and those with the femoral growth plate (the end part of the thighbone) that is not fully closed.
Estonian: Seda ei tohi kasutada ka patsiendid, kellel on põlve kaugelearenenud osteoartriit (teatud haigus, mis tekitab põlve turset ja valu), ning patsiendid, kelle reieluu kasvuplaadid ei ole veel täielikult luustunud.
English: In addition, the company that makes ChondroCelect will ensure that all surgeons and other healthcare professionals involved in the handling or use of ChondroCelect receive training materials on how to use the product.
Estonian: Lisaks tagab ChondroCelecti tootja, et kirurgid ja teised tervishoiutöötajad, kes käsitsevad või kasutavad ChondroCelecti, saavad ravimi kohta teabematerjali.
English: This is a summary of the European public assessment report (EPAR) for ChondroCelect.
Estonian: See on ravimi ChondroCelect Euroopa avaliku hindamisaruande kokkuvõte.
English: ChondroCelect must not be used in people who are hypersensitive (allergic) to any of the other ingredients or to bovine serum (cow's blood).
Estonian: ChondroCelecti ei tohi kasutada patsiendid, kes on selle ravimi mis tahes muu koostisaine või veise vereseerumi suhtes ülitundlikud (allergilised).
English: The most common side effects with ChondroCelect (seen in more than 1 patient in 10) are arthralgia (joint pain), cartilage hypertrophy (overgrowth), joint crepitation (unusual crackling sounds) and swelling of the joint.
Estonian: ChondroCelecti kõige sagedamad kõrvalnähud (esinenud enam kui 1 patsiendil 10st) on liigesevalu, kõhrkoe vohamine, liigese krigisemine ja liigese turse.
English: The active substance in ChondroCelect is the patient's own cartilage cells.
Estonian: ChondroCelecti toimeaine on patsiendi enda kõhrerakud.
English: Patients treated with ChondroCelect should follow specific rehabilitation programme, including physiotherapy.
Estonian: ChondroCelectiga ravitud patsiendid osalevad spetsiaalses taastusravi programmis, mis sisaldab ka füsioteraapiat.
English: The cartilage cells are then grown and expanded in the laboratory to provide enough cells to make up a suspension of cells that can be used to treat the cartilage defect.
Estonian: Rakke kasvatatakse ja paljundatakse laboritingimustes, saades küllaldaselt rakke, et nendest saaks teha rakususpensiooni, millega ravida kõhrekahjustust.
English: After one year, when scans were performed and samples of cartilage were examined, patients who were treated with ChondroCelect showed better structural repair of their cartilage than patients treated with microfracture.
Estonian: Üks aasta pärast ravi leiti tomograafia ja kõhrebiopsia abil, et ChondroCelectiga ravitud patsientidel oli kõhre struktuur paranenud paremini kui mikrofraktuurmeetodiga ravitud patsientidel.
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 ChondroCelect.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: This means that they are cells taken from the patient, grown outside the body and can be used for implantation into the patient's cartilage.
Estonian: See tähendab, et rakud on võetud patsiendilt, kasvatatud laboritingimustes ja siiratakse patsiendi kõhrkoesse.
English: The KOOS was measured by patients rating the severity of their symptoms.
Estonian: KOOS-skaalal hindasid patsiendid sümptomite raskust.
English: The materials for other healthcare professionals will include information on how to handle the collected biopsy and prepare ChondroCelect for implantation, and how to follow patients up and plan the recommended physiotherapy.
Estonian: Teistele tervishoiutöötajatele suunatud õppematerjal sisaldab teavet selle kohta, kuidas käsitseda biopsial võetud rakke ja ChondroCelect ette valmistada siirdamiseks, samuti kuidas jälgida patsiente ja kuidas koostada patsiendile soovitatava füsioteraapia plaan.
English: The company is also performing an observational study to obtain more information about the safety and effectiveness of ChondroCelect.
Estonian: ChondroCelecti tootja teeb ravimi efektiivsuse ja ohutuse kohta rohkema teabe saamiseks veel uuringuid.
English: The training materials for surgeons will include information on how to collect the cartilage biopsy from patients, perform the operation and follow patients up.
Estonian: Kirurgidele suunatud õppematerjal sisaldab teavet selle kohta, kuidas võtta patsiendilt biopsia abil kõhrerakke, kuidas toimub rakkude siirdamise operatsioon ja kuidas patsiente jälgida.
English: Because ChondroCelect is an advanced therapy medicine, it was assessed by the Committee for Advanced Therapies (CAT).
Estonian: Et ChondroCelect on uudne ravim, hindas seda uudsete ravimeetodite komitee.
English: These cells are ‘characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins'.
Estonian: Toimeaine nimetuse järgi on need rakud „ex vivo kasvatatud elusrakud: kirjeldatud omadustega spetsiifilisi markervalke ekspresseerivad autoloogsed kondrotsüüdid”.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for ChondroCelect, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi omaduste kokkuvõttesse ja pakendi infolehele ChondroCelecti ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: ChondroCelect is a suspension for implantation that contains cartilage cells.
Estonian: ChondroCelect on siirdesuspensioon, mis sisaldab kondrotsüüte (kõhrerakke).
English: Why has ChondroCelect been approved?
Estonian: Miks ChondroCelect heaks kiideti?
English: For the full list of all side effects reported with ChondroCelect, see the package leaflet.
Estonian: ChondroCelecti kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: During surgery on the knee, the suspension is placed into the defect in the patient's cartilage.
Estonian: Põlveliigese operatsioonil paigaldatakse suspensioon patsiendi kõhrekahjustuse kohta.
English: What is ChondroCelect?
Estonian: Mis on ChondroCelect?
English: ChondroCelect characterised viable autologous cartilage cells expanded ex vivo expressing specific marker proteins
Estonian: ChondroCelect ex vivo kasvatatud elusrakud: kirjeldatud omadustega spetsiifilisi markervalke ekspresseerivad autoloogsed kondrotsüüdid
English: There was no clear evidence of a difference in the change of KOOS in patients treated with ChondroCelect and those treated with microfracture.
Estonian: KOOS-skaala punktisumma muutuse suhtes puudus ChondroCelectiga ja mikrofraktuurmeetodiga ravitud patsientide vahel selge erinevus.
English: ChondroCelect was more effective than microfracture at healing the defects in the cartilage.
Estonian: ChondroCelect oli kõhrekahjustuste ravimisel mikrofraktuurimeetodist efektiivsem.
English: ChondroCelect was also as effective as microfracture at improving symptoms.
Estonian: Sümptomite leevendamisel oli ChondroCelect sama efektiivne kui mikrofraktuurmeetod.
English: First, a biopsy (a small sample) is taken from the patient's cartilage in the knee.
Estonian: Kõigepealt võetakse biopsia teel patsiendi põlveliigesest veidi kõhrerakke.
English: It is used when there is a single defect in the cartilage of the femoral condyle (the bottom end of the thighbone) that is causing symptoms.
Estonian: Ravimit kasutatakse juhul, kui kahjustuse sümptomeid tekitab üksainus defekt, mis asub põlveliigese femoraalkondüülil (reieluupõndal ehk reieluu põlvepoolsel otsal).
English: ChondroCelect is used in adults to repair damage to the cartilage in the knee.
Estonian: ChondroCelecti kasutatakse täiskasvanud patsientide põlveliigese kahjustunud kõhrkoe raviks.
English: How is ChondroCelect used?
Estonian: Kuidas ChondroCelecti kasutatakse?
English: What benefit has ChondroCelect shown during the studies?
Estonian: Milles seisneb uuringute põhjal ChondroCelecti kasulikkus?
English: ChondoCelect is a type of advanced therapy medicine called a ‘tissue engineered product'.
Estonian: ChondoCelect on koetehnoloogiatoodete hulka kuuluv uudne ravim.
English: What is the risk associated with ChondroCelect?
Estonian: Mis riskid ChondroCelectiga kaasnevad?
English: What is ChondroCelect used for?
Estonian: Milleks ChondroCelecti kasutatakse?
English: How has ChondroCelect been studied?
Estonian: Kuidas ChondroCelecti uuriti?
English: How does ChondroCelect work?
Estonian: Kuidas ChondroCelect toimib?
English: A biological membrane is then used as a seal to keep the cells in place while the cartilage repairs.
Estonian: Kõhrerakkude paigalhoidmiseks kinnitatakse kahjustuskohale bioloogiline membraan.
English: WHAT [NEURONTIN AND ASSOCIATED NAMES] IS AND WHAT IT IS USED FOR
Estonian: KUIDAS [NEURONTIN JA SARNASED NIMETUSED] VÕTTA
English: All divergent opinions have been resolved.
Estonian: Kõik lahkarvamused on lahendatud.
English: No significant issues were identified during the procedure.
Estonian: Olulisi probleeme menetluse käigus esile ei tuvastatud.
English: Use in elderly patients (over 65 years of age)
Estonian: Kasutamine eakatel patsientidel (üle 65-aastased)
English: • Ringing in the ears
Estonian: • helin kõrvus
English: Adults and adolescents:
Estonian: Täiskasvanud ja noorukid:
English: The significance of these findings is unknown, but they have been associated with delayed development.
Estonian: Nende leidude olulisus ei ole teada, kuid neid on seostatud arengupeetusega.
English: − This medicine has been prescribed for you.
Estonian: - Ravim on välja kirjutatud teile.
English: Epilepsy typically requires long-term therapy.
Estonian: Epilepsia nõuab tavaliselt pikaajalist ravi.
English: Your doctor will usually build up your dose gradually.
Estonian: Teie arst suurendab teie annust tavaliselt järk-järgult.
English: Pharmacokinetic parameters are given in Table 3.
Estonian: Farmakokineetilised parameetrid on toodud tabelis 3.
English: T1/2 = Elimination half-life
Estonian: T1/2 = eliminatsiooni poolväärtusaeg
English: You should not drive, operate complex machinery or engage in other potentially hazardous activities until you know whether this medication affects your ability to perform these activities.
Estonian: Te ei tohi juhtida autot, töötada keerukate masinatega ega tegeleda teiste potentsiaalselt ohtlike tegevustega, kui te ei tea, kas see ravim mõjutab teie võimet neid teostada.
English: Pharmacotherapeutic groups: Other antiepileptics ATC code: N03AX12
Estonian: Farmakoterapeutiline grupp: Teised epilepsiavastased ained ATC-kood: N03AX12
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF NEURONTIN AND ASSOCIATED NAMES (see Annex I)
Estonian: NEURONTINi JA SEOTUD NIMETUSTE TEADUSLIKU HINDAMISE ÜLDKOKKUVÕTE (vt I lisa)
English: Cmax (µg/ml) tmax (hr) T1/2 (hr) AUC (0-8) µg•hr/ml) Ae% (%)
Estonian: Cmax (µg/ml) tmax (h) T1/2 (h) AUC (0…8) µg•h/ml) Ae% (%)
English: Dosing instructions for children under 12 years of age are provided under a separate sub-heading later in this section.
Estonian: Annustamisjuhised alla 12-aastastele lastele on toodud selles lõigus hiljem, erineva alapealkirja all.
English: This is especially true at the beginning of the treatment and after increase in dose.
Estonian: See kehtib eriti ravi alustamisel ja annuse suurendamisel.
English: The treatment is started with a low initial dose which is gradually increased over a period of approximately 3 days.
Estonian: Ravi alustatakse väikese algannusega, mida suurendatakse järk-järgult umbes 3 päeva jooksul.
English: Take along any capsules or tablets that are left, the container and the label so that the hospital can easily tell what medicine you have taken.
Estonian: Võtke kaasa kõik allesjäänud kapslid või tabletid, pakend ja etikett, nii et haigla saaks ruttu kindlaks teha, missugust ravimit olete võtnud.
English: NA = Not available
Estonian: NA = ei ole teada
English: • Difficulties with erection
Estonian: • raskused erektsiooni saavutamisel
English: Do not suddenly discontinue taking this medicine as this may lead to breakthrough seizure, which could have serious consequences for you and your baby.
Estonian: Ärge katkestage järsku selle ravimi võtmist, sest see võib põhjustada võõrutuskrampe, millel võivad teile ja teie lapsele olla tõsised tagajärjed.
English: Response (≥ 50% Improved) by Treatment and Age MITT* Population Age Category
Estonian: Ravile reageerimine (≥50% paranemine) ja vanus MITT* populatsioonis Vanusekategooria Platseebo
English: Your doctor will prescribe [Neurontin and associated names] for you to help treat your epilepsy when your current treatment is not fully controlling your condition.
Estonian: Teie arst kirjutab [Neurontin ja sarnased nimetused] teile epilepsia ravimiseks, kui teie praeguse raviga ei saa teie seisundit täielikult kontrollida.
English: Contact address:
Estonian: Kontaktaadress:
English: Gabapentin can be given with or without food and should be swallowed whole with sufficient fluidintake (e.g. a glass of water).
Estonian: Gabapentiini võib võtta koos toiduga või ilma ja see tuleb alla neelata tervelt koos piisava koguse vedelikuga (nt klaasi veega).
English: PHARMACEUTICAL FORM AND CONTENTS XX capsules or XX tablets [To be completed nationally]
Estonian: RAVIMVORM JA PAKENDI SUURUS XX kapslit või XX tabletti [Täidetakse riiklikult]
English: The dose to be given to your child will be decided by your doctor as it is calculated against your child's weight.
Estonian: Teie lapsele antava annuse määrab arst, see arvutatakse teie lapse kehamassi põhjal.
English: Elimination pharmacokinetics (pharmacokinetic parameters which do not include F such as CLr and T1/2), are best described by linear pharmacokinetics.
Estonian: Eliminatsiooni farmakokineetikat (farmakokineetilised parameetrid, mis ei hõlma F-i nagu ClR ja t1/2) saab kõige paremini kirjeldada lineaarse farmakokineetikana.
English: National Digital Pk, Citywest Business Campus, Dublin 24,
Estonian: National Digital Pk, Citywest Business Campus,
English: If you forget to take [Neurontin and associated names] If you forget to take a dose, take it as soon as you remember unless it is time for your next dose.
Estonian: Kui te unustate [Neurontin ja sarnased nimetused] võtta Kui unustate annuse võtta, võtke see niipea, kui see teile meenub, välja arvatud juhul, kui on aeg võtta järgmine annus.
English: Cmax = Maximum steady state plasma concentration tmax = Time for Cmax
Estonian: Cmax = maksimaalne stabiilse taseme plasmakontsentratsioon tmax = aeg Cmax -i saavutamiseni
English: Like all medicines, [Neurontin and associated names] can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka [Neurontin ja sarnased nimetused] põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: However, several amendments to the SPC were introduced.
Estonian: Ravimi omaduste kokkuvõttesse viidi siiski sisse mitu muudatust.
English: Children aged 6 years and above:
Estonian: Lapsed vanuses 6 aastat ja üle 6 aasta:
English: Risk related to epilepsy and antiepileptic medicinal products in general
Estonian: Epilepsia ja epilepsiavastaste ravimite kasutamisega seotud üldine risk
English: If you are taking any medicines containing morphine, please tell your doctor or pharmacist as morphine may increase the effect of [Neurontin and associated names].
Estonian: Kui te võtate ükskõik millist morfiini sisaldavat ravimit, rääkige sellest palun oma arstile või apteekrile, sest morfiin võib tugevdada [Neurontin ja sarnased nimetused] toimet.
English: *The modified intent to treat population was defined as all patients randomised to study medication who also had evaluable seizure diaries available for 28 days during both the baseline and double-blind phases.
Estonian: * Modifitseeritud ravikavatsusega-populatsioon defineeriti kui kõik patsiendid, kes randomiseeriti saama uuringuravimit ja kellel olid hindamist võimaldavad hoogude päevikud 28 päeva kohta nii algses kui ka topeltpimedas faasis.
English: [Neurontin and associated names] may interfere with some laboratory tests, if you require a urine test tell your doctor or hospital that you are taking [Neurontin and associated names].
Estonian: [Neurontin ja sarnased nimetused] võib mõjutada mõningate laboratoorsete analüüside tulemusi, kui teil on vaja teha uriinianalüüsi, rääkige oma arstile või haiglas, et võtate [Neurontin ja sarnased nimetused].
English: It is not possible to differentiate if the developmental delay is caused by genetic, social factors, maternal epilepsy or the antiepileptic therapy.
Estonian: Ei ole võimalik vahet teha, kas arengupeetust on põhjustanud geneetilised, sotsiaalsed tegurid, ema epilepsia või epilepsiavastased ravimid.
English: No significant issues relating to quality were identified and the pharmaceutical particulars of the product information were completed, except for the sections to be completed nationally.
Estonian: Olulisi kvaliteediprobleeme ei tuvastatud ning koostati tooteinfo farmatseutilised andmed, välja arvatud osad, mis koostatakse riigiti.
English: Where an adverse reaction was seen at different frequencies in clinical studies, it was assigned to the highest frequency reported.
Estonian: Kui kõrvaltoime esines kliinilistes uuringutes erinevate sagedustega, käsitleti seda suurima teadaoleva sagedusega.
English: Gabapentin 100 mg capsules can be used to follow dosing recommendations for patients with renal insufficiency.
Estonian: Gabapentiin 100 mg kapsleid saab kasutada järgmiste annustamissoovitustega neerupuudulikkusega patsientidel.
English: It is therefore recommended to verify such a positive dipstick test result by methods based on a different analytical principle such as the Biuret method, turbidimetric or dye-binding methods, or to use these alternative methods from the beginning.
Estonian: Seetõttu soovitatakse selliseid positiivseid ribatesti tulemusi kontrollida erinevate analüütiliste meetoditega (nagu biureeditest, turbidimeetria või värvusreaktsioonid) või kasutada neid juba kohe alternatiivsete meetoditena.
English: Epilepsy: [Neurontin and associated names] is used to treat various forms of epilepsy (seizures that are initially limited to certain parts of the brain, whether the seizure spreads to other parts of the brain or not).
Estonian: Epilepsia: [Neurontin ja sarnased nimetused] kasutatakse epilepsia mitmesuguste vormide ravis (krambihood, mis esialgu piirduvad aju teatud osadega, levides sealt teistesse ajuosadesse või mitte).
English: Although plasma gabapentin concentrations were generally between 2 µg/ml and 20 µg/ml in clinical studies, such concentrations were not predictive of safety or efficacy.
Estonian: Kuigi gabapentiini plasmakontsentratsioonid olid kliinilistes uuringutes üldiselt vahemikus 2...20 µg/ml, ei võimalda need kontsentratsioonid ennustada ohutust ja efektiivsust.
English: Absolute bioavailability of a 300 mg capsule is approximately 60%.
Estonian: Absoluutne biosaadavus 300 mg kapsli manustamisel on umbes 60%.
English: The precise mechanism of action of gabapentin is not known.
Estonian: Gabapentiini täpne toimemehhanism ei ole teada.
English: Reduced dosages are for patients with renal impairment (creatinine clearance < 79 ml/min).
Estonian: Neerukahjustusega patsientidel on annust vähendatud (kreatiniini kliirens <79 ml/min).
English: The data from this additional post-hoc analysis are summarised in the table below:
Estonian: Kokkuvõte selle uuringu andmete täiendavast post hoc analüüsist on toodud allpool tabelis.
English: If a patient requires dosing longer than 5 months for the treatment of peripheral neuropathic pain, the treating physician should assess the patient's clinical status and determine the need for additional therapy.
Estonian: Kui patsiendil on perifeerset neuropaatilist valu vaja ravida kauem kui 5 kuud, peab raviarst hindama patsiendi kliinilist seisundit ja kindlaks tegema täiendava ravi vajaduse.
English: Therefore, whenever possible and only under the advice of your doctor, you should try to take only one seizure medication during pregnancy.
Estonian: Seetõttu peate võimalusel ja ainult arsti juhiste kohaselt püüdma raseduse ajal võtta ainult ühte krambihoogude vastast ravimit.
English: This medicinal product is authorised in the Member States of the EEA under the following names: Austria
Estonian: See ravimpreparaat on saanud müügiloa Euroopa Majanduspiirkonna liikmesriikides järgmiste nimetustega:
English: It is therefore recommended that [Neurontin and associated names] is taken at the earliest two hours after taking an antacid.
Estonian: Seetõttu on soovitatav, et [Neurontin ja sarnased nimetused] ei võeta varem kui kaks tundi pärast antatsiidi võtmist.
English: Instruction for all areas of indication
Estonian: Manustamisjuhised kõikide näidustuste puhul
English: In patients with poor general health, i.e., low body weight, after organ transplantation etc., the dose should be titrated more slowly, either by using smaller dosage strengths or longer intervals between dosage increases.
Estonian: Nõrga tervisega patsientidel (väike kehakaal, pärast elundi siirdamist jne) tuleb annust kohandada aeglasemalt, kasutades kas väiksema tugevusega annuseid või pikemaid vaheaegu annuse suurendamiste vahel.
English: • Allergic reaction such as hives
Estonian: • allergilised reaktsioonid nagu nahalööve
English: Total Daily Dosea (mg/day)
Estonian: Kogu ööpäevane annusa (mg ööpäevas)
English: No systematic studies in patients 65 years or older have been conducted with gabapentin.
Estonian: Süstemaatilisi uuringuid 65-aastastel ja vanematel patsientidel ei ole gabapentiiniga läbi viidud.
English: Take as directed by the doctor.
Estonian: Võtta vastavalt arsti juhistele.
English: Coadministration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%.
Estonian: Gabapentiini manustamine koos alumiiniumi ja magneesiumi sisaldavate antatsiididega vähendab gabapentiini biosaadavust kuni 24%.