FrancophonIA/ELRC3.0 huggingface dataset:
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 Flebogamma DIF.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: Flebogamma DIF must not be used in people who are allergic to normal human immunoglobulin or any of the other ingredients, or in patients who are allergic to other types of immunoglobulin, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Estonian: Ravimit Flebogamma DIF ei tohi kasutada patsiendid, kes on inimese normaalse immunoglobuliini või ravimi teiste koostisosade suhtes allergilised, või patsiendid, kes on allergilised muude immunoglobuliinide suhtes, eriti kui neil on immunoglobuliin-A (IgA) vaegus ning neil esinevad IgAvastased antikehad.
English: Flebogamma DIF is also used to treat certain immune system disorders:
Estonian: Ravimit Flebogamma DIF kasutatakse ka immuunsüsteemi teatud häirete raviks:
English: According to current guidelines, medicines that have been shown to be effective in patients with PID and in patients with ITP can also be approved for use in the treatment of all types of primary immunodeficiency, as well as low antibody levels due to blood cancers and AIDS in children.
Estonian: Vastavalt kehtivatele suunistele võib ravimid, mille efektiivsus primaarse immuunpuudulikkuse sündroomiga ja idiopaatilise trombotsütopeenilise purpuriga (ITP) patsientidel on tõestatud, heaks kiita kõigi primaarse immuunpuudulikkuse tüüpide raviks, samuti vere pahaloomulistest kasvajatest tingitud antikehade vaeguse korral ning AIDS-iga lastel.
English: Side effects such as chills, headache, dizziness, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain may occasionally occur with Flebogamma DIF.
Estonian: Ravimi Flebogamma DIF harvemad kõrvalnähud on külmatunne, peavalu, peapööritus, palavik, oksendamine, allergilised reaktsioonid, iiveldus, artralgia (liigesevalu), madal vererõhk ja mõõdukas alaseljavalu.
English: The second study looked at using Flebogamma DIF in 20 patients with ITP.
Estonian: Teises uuringus vaadeldi ravimi Flebogamma DIF kasutamist 20 patsiendil, kellel oli idiopaatiline trombotsütopeeniline purpur.
English: It contains immunoglobulin G (IgG), which is a type of antibody.
Estonian: See sisaldab antikeha IgG (immunoglobuliin G).
English: Flebogamma DIF is made like Flebogamma, another medicine containing human normal immunoglobulin, with some additional steps in the purification of the product from human plasma.
Estonian: Ravimit Flebogamma DIF toodetakse samamoodi nagu ravimit Flebogamma, mis on samuti inimese normaalset immunoglobuliini sisaldav ravim, kuid ravimi Flebogamma DIF korral on toote puhastamisel inimplasmast rakendatud veel mõnda lisaetappi.
English: • Idiopathic thrombocytopenic purpura (ITP), a condition where people do not have enough platelets in the blood;
Estonian: • idiopaatiline trombotsütopeeniline purpur (ITP) - seisund, mille korral ei ole veres piisavalt trombotsüüte (vereliistakuid);
English: Previously known as Flebogammadif
Estonian: Varasem nimetus Flebogammadif.
English: Flebogamma DIF is a solution for infusion (drip into a vein).
Estonian: Flebogamma DIF on infusioonilahus (veeni tilgutatav lahus).
English: • Primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies).
Estonian: • primaarsed immuunpuudulikkuse sündroomid (kaasasündinud seisundid, kus ei teki piisavalt antikehi);
English: human normal immunoglobulin
Estonian: inimese normaalne immunoglobuliin
English: The active substance in Flebogamma DIF, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood).
Estonian: Ravimi Flebogamma DIF toimeaine - inimese normaalne immunoglobuliin - on inimese vereplasmast (teatud verekomponendist) eraldatud ülipuhastatud valk.
English: Other information about Flebogamma DIF
Estonian: Muu teave ravimi Flebogamma DIF kohta
English: They can also be approved for the treatment of patients with Guillain-Barré syndrome, patients with Kawasaki disease and patients undergoing haematopoietic stem cell transplantation, without the need for specific studies in these diseases.
Estonian: Nendele tingimustele vastava ravimi võib eriuuringuid läbi viimata heaks kiita ka Guillaini-Barré sündroomi ja Kawasaki tõvega patsientide raviks ning nende patsientide raviks, kellele siiratakse vereloome tüvirakke.
English: Flebogamma DIF works by restoring abnormally low IgG levels to their normal range in the blood.
Estonian: Flebogamma DIF suurendab vere IgG-sisalduse ebanormaalselt väikeselt väärtuselt normaalsele.
English: What is Flebogamma DIF?
Estonian: Mis on Flebogamma DIF?
English: What is the risk associated with Flebogamma DIF?
Estonian: Mis riskid ravimiga Flebogamma DIF kaasnevad?
English: Why has Flebogamma DIF been approved?
Estonian: Miks ravim Flebogamma DIF heaks kiideti?
English: How does Flebogamma DIF work?
Estonian: Kuidas Flebogamma DIF toimib?
English: How has Flebogamma DIF been studied?
Estonian: Kuidas ravimit Flebogamma DIF uuriti?
English: How is Flebogamma DIF used?
Estonian: Kuidas ravimit Flebogamma DIF kasutatakse?
English: What benefit has Flebogamma DIF shown during the studies?
Estonian: Milles seisneb uuringute põhjal ravimi Flebogamma DIF kasulikkus?
English: What is Flebogamma DIF used for?
Estonian: Milleks ravimit Flebogamma DIF kasutatakse?
English: You may need to use both hands.
Estonian: Teil võib vaja minna mõlemat kätt.
English: The results have been negative.
Estonian: Tulemused on olnud negatiivsed.
English: This is unlikely to happen again.
Estonian: See tõenäoliselt ei kordu.
English: The activity against other standards is not known.
Estonian: Aktiivsus teiste standardite suhtes ei ole teada.
English: Not to be sold separately.
Estonian: Ei tohi müüa eraldi.
English: 10 seconds.
Estonian: 10 sekundit.
English: Date of first authorisation: 13 March 1997 Date of latest renewal: 13 March 2007
Estonian: Müügiloa esmase väljastamise kuupäev: 13. märts 1997 Müügiloa viimase uuendamise kuupäev: 13. märts 2007
English: Sensitivity to light.
Estonian: Tundlik valgusele.
English: Although the list of possible side effects can seem worrying, it's possible that you may not have any of them.
Estonian: Kuigi võimalike kõrvaltoimete loetelu võib murettekitav tunduda, on võimalik, et teil ei teki ühtki neist.
English: Call a doctor immediately.
Estonian: Pöörduge kohe arsti poole.
English: These can include:
Estonian: Nende hulka võivad kuuluda:
English: Alternative assay techniques are not sufficiently sensitive.
Estonian: Alternatiivsed meetodid ei ole aga piisavalt tundlikud.
English: At the present time, it is not known for how long patients should be treated.
Estonian: Käesoleval ajal ei ole teada, kui kaua peaks ravi kestma.
English: Keep a note of where you have injected each week.
Estonian: Tehke märkmeid selle kohta, kuhu te igal nädalal süstinud olete.
English: You may also wish to make a note of these details in case you are asked for this information in the future.
Estonian: Teil on otstarbekas need andmed ka enda jaoks üles märkida juhuks, kui teilt neid tulevikus küsitakse.
English: MS also tends to flare up from time to time: this is called a relapse.
Estonian: SM kaldub ka aeg-ajalt ägenema: seda nimetatakse retsidiiviks.
English: In any case, treatment should only be considered for patients classified at high risk.
Estonian: Igal juhul tuleb ravi kaaluda vaid kõrge riskiga patsientidel.
English: These interferons have overlapping but clearly distinguishable biological activities.
Estonian: Nimetatud interferoonidel on kattuvad, kuid selgelt eristatavad bioloogilised toimed.
English: 5 Disposal
Estonian: 5 Hävitamine
English: The window will now appear yellow when the full dose has been delivered.
Estonian: Aken peab olema nüüd kollane, kui kogu annus on süstitud.
English: If there is any blood at the site, wipe it off.
Estonian: Kui selles kohas on verd, pühkige see ära.
English: On each left hand page you'll find useful tips and explanations on how to get the best from your medicine.
Estonian: Igal vasakpoolsel lehel leiate kasulikke nõuandeid ja selgitusi, kuidas ravimit kasutades parimaid tulemusi saavutada.
English: For example, 100 person-years could be observed in 100 patients who were on treatment for one year or in 200 patients who were on treatment for half a year.
Estonian: Näiteks 100 patsiendiaastast võib rääkida 100 patsiendi puhul, keda raviti ühe aasta vältel või 200 patsiendi puhul, keda raviti pool aastat.
English: The frequencies of adverse reactions are expressed in patient-years, according to the following categories:
Estonian: Kõrvaltoimete esinemissagedust väljendatakse patsiendiaastates vastavalt järgmistele kategooriatele:
English: This leaflet is changed from time to time.
Estonian: Käesolevas infolehes tehakse aeg-ajalt muudatusi.
English: An effect on MRI parameters was also seen.
Estonian: Lisaks ilmnes ka efekt MRT parameetritele.
English: It gives you an idea how likely you are to get similar side effects.
Estonian: See näitab, kui suure tõenäosusega teil võivad samasugused kõrvaltoimed tekkida.
English: Based on animal data (see section 5.3), there is a possibly increased risk for spontaneous abortion.
Estonian: Loomkatsete andmed (vt lõik 5.3) näitavad võimalikku iseenesliku abordi suurenenud riski.
English: Waste paper and used wipes can be put in an ordinary rubbish bin.
Estonian: Paberjäätmed ja kasutatud vatitupsud võib panna ka tavalisse prügikasti.
English: This is the safety lock.
Estonian: See on turvalukk.
English: - Depression or problems affecting your moods
Estonian: - Depressioon või teie meeleolu mõjutavad probleemid
English: 2The frequency of occurrence is higher at the beginning of treatment.
Estonian: 2 Esinemissagedus on kõrgem ravi alguses.
English: Experience with exposure during the second and third trimester is very limited.
Estonian: Andmed kokkupuudete kohta raseduse teise ja kolmanda trimestri ajal on väga piiratud.
English: Not for children
Estonian: Mitte kasutada lastel
English: Do not make changes unless your doctor tells you.
Estonian: Ärge tehke selles muudatusi, kui arst ei ole teile seda öelnud.
English: Part of a multi-pack.
Estonian: Osa suuremast pakist.
English: - The sealed plastic tray is damaged or opened.
Estonian: - Suletud plastalus on vigastatud või avatud.
English: Continue injecting on this new day every week.
Estonian: Jätkake süstimist iga nädal sel uuel päeval.
English: You can't pass it on to anyone else.
Estonian: Ärge andke seda kellelegi teisele.
English: Even if you have used Avonex before, some of the information may have changed.
Estonian: Isegi kui te olete Avonex'i varem kasutanud, võib teave olla osaliselt muutunud.
English: Mutagenesis: Limited but relevant mutagenesis tests have been carried out.
Estonian: Mutagenees: läbi on viidud olulised, ent piiratud arv mutageneesi teste.
English: Wash your hands thoroughly with soap and water and dry them.
Estonian: Peske käed põhjalikult seebi ja veega ning kuivatage.
English: Please check every time you get your prescription refilled to see if the leaflet has been updated.
Estonian: Palun kontrollige ravimi saamisel iga kord, kas infolehte on uuendatud.
English: These symptoms are usually present during the first few months of treatment.
Estonian: Nimetatud sümptomid esinevad tavaliselt ravi esimestel kuudel.
English: Tip: Place the pen down on the table before beginning step 2.
Estonian: Nõuanne: Asetage pen-süstel lauale enne, kui alustate sammuga 2.
English: Alternate the left and right thighs.
Estonian: Kasutage vaheldumisi paremat ja vasakut reit.
English: • Do not remove the needle cover.
Estonian: • Ärge eemaldage nõela katet.
English: • Look through the oval display window.
Estonian: • Vaadake läbi ovaalse displei akna.
English: You may not get the full dose if it leaks.
Estonian: Te ei pruugi saada täisannust, kui süstal lekib.
English: Tip: If you twist the needle cover to remove it, you may accidentally remove the needle as well.
Estonian: NB: Kui keerate nõela kaitsekatet selle eemaldamiseks, võite kogemata eemaldada ka nõela.
English: Pharmacotherapeutic Group: Interferons, ATC code: L03 AB07.
Estonian: Farmakoterapeutiline rühm: interferoonid, ATC-kood: L03 AB07.
English: If you have severe depression or thoughts about suicide, you must not use Avonex.
Estonian: Kui teil on raske depressioon või enesetapumõtted, ei tohi te Avonex'i kasutada.
English: If you inject more than you should
Estonian: Kui süstite rohkem kui ette nähtud
English: In MS, your body's defence system reacts against its own myelin - the ‘insulation' that surrounds nerve fibres.
Estonian: SM korral reageerib teie keha kaitsesüsteem keha enda müeliini - närvikiude ümbritseva „isolatsioonikihi“ vastu.
English: • Check the safety lock is released.
Estonian: • Veenduge, et turvalukk on vabastatud.
English: These symptoms are not really flu.
Estonian: Need sümptomid ei tähenda tegelikult, et teil on gripp.
English: No direct comparison with the dose currently recommended in adults is available.
Estonian: Otsene võrdlus hetkel täiskasvanutele soovitatud annusega puudub.
English: Disability progression was measured as an increase in the Expanded Disability Status Scale (EDSS) of 1.0 point, sustained for at least six months.
Estonian: Invaliidsuse süvenemist hinnati laiendatud invaliidsusseisundi skaala (EDSS) skoori suurenemisena 1,0 punkti võrra, mis püsis vähemalt kuus kuud.
English: Interferons are natural substances made in your body to help protect you from infections and diseases.
Estonian: Interferoonid on kehas moodustuvad looduslikud ained, mis aitavad teid kaitsta infektsioonide ja haiguste eest.
English: The needle must go all the way in.
Estonian: Nõel peab minema lõpuni sisse.
English: • Use your other hand, and with one quick motion pull up the injector shield (grooved area) over the needle until the needle is fully covered.
Estonian: • Kasutades teist kätt tõmmake ühe kiire liigutusega süstla kaitse (soonega ala) üle nõela, kuni nõel on täielikult kaetud.
English: No formal interaction studies have been performed in humans.
Estonian: Koostoimete uuringuid ei ole inimestel läbi viidud.
English: In some cases these symptoms are associated with flu-like symptoms.
Estonian: Mõningatel juhtudel on kõnealused sümptomid seotud gripilaadsete sümptomitega.
English: • Apply pressure to the injection site for a few seconds.
Estonian: • Avaldage mõne sekundi vältel süstekohale survet.
English: In order to obtain adequate efficacy, a dose of 30 micrograms once a week should be reached and maintained after the initial titration period.
Estonian: Piisava efektiivsuse saavutamiseks tuleb jõuda annuseni 30 mikrogrammi üks kord nädalas ja jääda sellele pärast esialgset tiitrimisperioodi pidama.
English: This makes the injection more comfortable than using straight from the refrigerator.
Estonian: See muudab süstimise mugavamaks, kui kasutades otse külmkapist võetuna.
English: Do not twist it.
Estonian: Ärge seda keerake.
English: It may be possible for your doctor to prescribe you a shorter and thinner needle, depending on your body type.
Estonian: Arst võib teile määrata lühema ja peenema nõela, olenevalt teie kehatüübist.
English: It is for a single use only.
Estonian: See on ette nähtud ainult ühekordseks kasutamiseks.
English: Talk to your doctor to see if this is appropriate for you.
Estonian: Pidage nõu oma arstiga, kas see võiks teie puhul olla vajalik.
English: The figures are based on how many people said they'd had them.
Estonian: Lisatud on, mitu inimest neist teatas.
English: If you have a fever, drink plenty of water to keep you hydrated.
Estonian: Kui teil on palavik, jooge palju vett, et kehas oleks piisavalt vedelikku.
English: Sometimes you will need to remind other medical staff that you are being treated with Avonex.
Estonian: Mõnikord peate teistele meditsiinitöötajatele meelde tuletama, et teid ravitakse Avonex'iga.
English: Serious side effects: get medical help Serious allergic reactions
Estonian: Tõsised kõrvaltoimed: pöörduge arsti poole Tõsised allergilised reaktsioonid
English: Other medicines and AVONEX
Estonian: Muud ravimid ja AVONEX
English: However, the duration of exposure during the first trimester is uncertain, because data were collected when interferon beta use was contraindicated during pregnancy, and treatment likely interrupted when pregnancy was detected and/or confirmed.
Estonian: Kuid kokkupuute kestus raseduse esimesel trimestril ei ole selge, kuna andmete kogumise ajal oli beetainterferooni kasutamine raseduse ajal vastunäidustatud ning raseduse tuvastamisel ja/või kinnitamisel ravi tõenäoliselt katkestati.
English: • Dispose of rubbish properly.
Estonian: • Hävitage jäätmed nõuetekohaselt.
English: The intramuscular injection site should be varied each week (see section 5.3).
Estonian: Lihasesisese süste kohta tuleb igal nädalal muuta (vt lõik 5.3).
English: Cessation of therapy with AVONEX should be considered (see also sections 4.3 and 4.8).
Estonian: Kaaluda tuleks AVONEX'iga ravi katkestamist (vt ka lõigud 4.3 ja 4.8).
English: Elderly: Clinical studies did not include a sufficient number of patients aged 65 and over to determine whether they respond differently than younger patients.
Estonian: Eakad: Kliinilistes uuringutes pole osalenud piisav hulk 65-aastaseid ja vanemaid patsiente, et kogutud andmete põhjal otsustada, kas eakate ravivastus erineb noorematest.
English: Now pull off the plastic needle cover.
Estonian: Tõmmake nüüd nõela plastmassist kaitsekate ära.
English: It is important to continue using Avonex regularly.
Estonian: Tähtis on kasutada Avonex'i regulaarselt.
English: Once the pen is sealed there is no risk of injury.
Estonian: Kui pen-süstel on suletud, siis pole enam vigastamise ohtu.
English: Patients should be clinically evaluated after two years of treatment and longer-term treatment should be decided on an individual basis by the treating physician.
Estonian: Patsiente tuleb kliiniliselt hinnata kaks aastat kestnud ravi järel ja pikaaegse ravi otsus tehakse raviarsti poolt igal individuaalsel juhul eraldi.
English: Make sure the cap is intact and has not been opened.
Estonian: Kontrollige, kas kork on terve ja seda ei ole avatud.
English: Allow the skin to dry.
Estonian: Laske nahal kuivada.
English: No harmful effects on the breastfed newborn/infant are anticipated.
Estonian: Kahjulikku toimet rinnaga toidetavale vastsündinule/imikule ei eeldata.
English: The syringe will not empty.
Estonian: Süstal ei tühjene.
English: A small rectangular area will be visible next to the oval display window.
Estonian: Väike nelinurkne ala on nähtav ovaalse displei akna kõrval.
English: • Patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis (see section 5.1).
Estonian: • Patsientide raviks, kellel esineb aktiivse põletikulise protsessiga üksik demüeliniseeriv episood, kui see on piisavalt tõsine, et ravi intravenoossete kortikosteroididega on põhjendatud, kui alternatiivsed diagnoosid on välistatud ja kui patsiendil on suur risk kliiniliselt kindla sclerosis multiplex'i kujunemiseks (vt lõik 5.1).
English: You will hear a “click” indicating the injection process has begun.
Estonian: Te kuulete klõpsatust, mis näitab, et süstimisprotsess on alanud.
English: Prepare alcohol wipes and sticking plasters (not supplied) if you need them.
Estonian: Pange valmis alkoholiga niisutatud vatitupsud ja plaaster (ei ole pakendis kaasas), kui te neid vajate.
English: Treatment should be discontinued if the patient develops chronic progressive MS.
Estonian: Ravi tuleb katkestada juhul, kui patsiendil tekib krooniline progresseeruv SM.
English: However, based on the mode of clearance of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly.
Estonian: Kui aga arvestada, kuidas toimeaine organismist eritub, puudub teoreetiline põhjus eakatel annuseid muuta.
English: Tip: The needle cover will come off automatically during step 3, below.
Estonian: Nõuanne: Nõela kate eemaldub automaatselt sammu 3 ajal, vt allpool.
English: Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is:
Estonian: Müügiloa hoidja ja tootja Müügiloa hoidja on:
English: Doctors may prescribe a 25 mm, 25 gauge needle to patients for whom such a needle is appropriate to administer an intramuscular injection.
Estonian: Arstid võivad 25 mm 25G süstlanõela määrata patsientidele, kellele see on vajalik ja sobib ravimi lihasesiseseks manustamiseks.
English: Tip: Take care not to press the blue activation button too early.
Estonian: Nõuanne: Kandke hoolt selle eest, et te ei vajutaks sinist aktiveerimisnuppu liiga vara.
English: If it looks like it has been opened, do not use that Avonex Pen.
Estonian: Kui tundub, et seda on avatud, siis ärge seda Avonex Pen'i kasutage.
English: Tell your doctor if you are using, have recently used or might use any other medicines, especially those used to treat epilepsy or depression.
Estonian: Rääkige oma arstile, kui te võtate, olete hiljuti võtnud või kavatsete võtta teisi ravimeid, eriti epilepsia- või depressiooniravimeid.
English: Avonex is not to be used in children below the age of 12 years.
Estonian: Avonex'i ei tohi kasutada alla 12-aastastel lastel.
English: Interferons alpha and beta are classified as Type I interferons, and interferon gamma is a Type II interferon.
Estonian: Interferoonid alfa ja beeta klassifitseeritakse kui I tüübi interferoonid ja interferoon gamma kui II tüübi interferoon.
English: Local Tolerance: Intramuscular irritation has not been evaluated in animals following repeated administration to the same injection site.
Estonian: Lokaalne talutavus: loomadel ei ole hinnatud lihasesisest ärritust korduval manustamisel samasse süstekohta.
English: Your doctor, nurse or pharmacist should provide you with instructions on how to dispose of your used Avonex Pen, for example into a sharps bin.
Estonian: Teie arst, medõde või apteeker peaks andma teile juhised, kuidas hävitada kasutatud Avonex Pen, näiteks teravate esemete prügi hulka.
English: • Patients diagnosed with relapsing multiple sclerosis (MS).
Estonian: • Patsientide raviks, kellel on diagnoositud retsidiveeruv sclerosis multiplex (SM).
English: - Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Estonian: - Hetkel raske depressiooniga ja/või suitsiidikalduvusega patsiendid (vt lõigud 4.4 ja 4.8).
English: Tell your doctor you are using Avonex:
Estonian: Rääkige arstile, et te kasutate Avonex'i:
English: The use of various assays to detect serum antibodies to interferons limits the ability to compare antigenicity among different products.
Estonian: Erinevate seerumi interferoonivastaste antikehade määramismeetodite kasutamine piirab võimalust võrrelda erinevate toodete antigeensust.
English: If clinically needed, the use of Avonex may be considered during pregnancy.
Estonian: Kliinilise vajaduse korral võib kaaluda Avonex'i kasutamist raseduse ajal.
English: Press the plunger slowly until the syringe is empty.
Estonian: Suruge aeglaselt kolbi, kuni süstal on tühi.
English: Signs are:
Estonian: Nähud on:
English: Do not use any more Avonex until you have spoken to a doctor.
Estonian: Ärge kasutage Avonex'i enne, kui olete arstiga rääkinud.
English: These notes are a reminder.
Estonian: Järgmised märkused on mõeldud meeldetuletuseks.
English: More about depression.
Estonian: Lähemalt depressioonist.