FrancophonIA/ELRC3.0 huggingface dataset:
English: The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Estonian: Täiskasvanutega saadud tulemused lisasid täiendavat tõendusmaterjali selle kohta, et ImmunoGam kaitseb B-hepatiidi viiruse eest.
English: This means that it supplies the antibodies the body needs to fight the virus rather than stimulating the body to produce its own.
Estonian: ImmunoGam annab nn passiivset kaitset, mis tähendab, et see varustab organismi antikehadega, mida on vaja viiruse vastu võitlemiseks, selle asemel et stimuleerida organismi neid ise tootma.
English: The main measure of effectiveness was the number of people who remained free of hepatitis B infection.
Estonian: Efektiivsuse põhinäitaja oli nende patsientide arv, kes ei nakatunud B-hepatiidi viirusesse.
English: Side effects with ImmunoGam are not common.
Estonian: ImmunoGami kasutamisel esineb kõrvalnähte harva.
English: ImmunoGam human hepatitis B immunoglobulin
Estonian: B-hepatiidi humaanimmunoglobuliin
English: The full EPAR for ImmunoGam can be found here.
Estonian: Euroopa avaliku hindamisaruande täistekst ImmunoGami kohta on siin.
English: What benefit has ImmunoGam shown during the studies?
Estonian: Milles seisneb uuringute põhjal ImmunoGami kasulikkus?
English: All those who received ImmunoGam were also given a hepatitis B vaccine.
Estonian: Kõiki ImmunoGami saanud patsiente vaktsineeriti ka B-hepatiidi viiruse vastu.
English: ImmunoGam is used to provide protection against the hepatitis B virus.
Estonian: ImmunoGami kasutatakse kaitseks B-hepatiidi viiruse eest.
English: ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
Estonian: ImmunoGam on süstelahus, mis sisaldab toimeainena B-hepatiidi humaanimmunoglobuliini.
English: How does ImmunoGam work?
Estonian: Kuidas ImmunoGam toimib?
English: What is ImmunoGam used for?
Estonian: Milleks ImmunoGami kasutatakse?
English: For more information about treatment with ImmunoGam, read the Package Leaflet (also part of the EPAR).
Estonian: Ravi üksikasjalik teave on pakendi infolehel, mis on samuti Euroopa avaliku hindamisaruande osa.
English: ImmunoGam was effective at protecting against hepatitis B virus infection.
Estonian: ImmunoGam osutus efektiivseks kaitsevahendiks B-hepatiidi viiruse vastu.
English: How has ImmunoGam been studied?
Estonian: Kuidas ImmunoGami uuriti?
English: It is highly recommended that all those receiving ImmunoGam should also be given a hepatitis B vaccine.
Estonian: Tungivalt soovituslik on vaktsineerida ImmunoGami saavaid isikuid B-hepatiidi viiruse vastu.
English: The medicine can only be obtained with a prescription.
Estonian: ImmunoGam on retseptiravim.
English: When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.
Estonian: Nahaprobleemide korral võib tõmmist kasutada vanematel kui 12-aastastel kuni kaks nädalat; kui sümptomid püsivad kauem, tuleks pidada nõu pädeva tervishoiutöötajaga.
English: Dittany of Crete herb EMA/HMPC/441263/2013
Estonian: Kreeta pune ürt EMA/HMPC/441263/2013
English: At the time of the HMPC assessment, no side effects had been reported with these medicines.
Estonian: Ajal, mil taimsete ravimite komitee hindamise tegi, ei olnud teateid nende ravimite kõrvaltoimete kohta.
English: The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their ‘traditional use' in these conditions.
Estonian: Taimsete ravimite komitee järeldused kreeta pune ürti sisaldavate ravimite kasutamise kohta köha, mao-, soolestiku- ja nahaprobleemide korral põhinevad nende traditsioonilisel kasutamisel selliste seisundite korral.
English: EMA/HMPC/441263/2013
Estonian: EMA/HMPC/441263/2013 Taimsete ravimite komitee (HMPC)
English: Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material.
Estonian: Taimsed valmistised saadakse korjatud materjali peenestades (väikesteks tükkideks lõigates).
English: Further information on the risks associated with dittany of Crete herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave kreeta pune ürti sisaldava ravimiga kaasnevate riskide, sh selle ohutu kasutamise ettevaatusabinõude kohta, on ravimtaime monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Estonian: Komitee kaalus ka avaldatud katseuuringuid ja aruandeid, mis toetavad kreeta pune ürdi kasutamise vastuvõetavust heakskiidetud näidustustel.
English: Herbal teas containing dittany of Crete should only be used in adults and should not be used for longer than a week for cough, or for longer than two weeks for stomach and gut problems, without seeking advice from a qualified healthcare practitioner.
Estonian: Kreeta pune ürti sisaldavat taimeteed tohivad kasutada ainult täiskasvanud ja seda ei tohiks kasutada pädeva tervishoiutöötajaga nõu pidamata kauem kui nädal aega köha korral või kauem kui kaks nädalat mao- ja soolestikuprobleemide korral.
English: The HMPC concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems.
Estonian: Taimsete ravimite komitee jõudis järeldusele, et lähtudes taime pikaajalisest kasutamisest, võib kreeta pune ürti kasutada taimeteena külmetusega kaasneva köha ning mao ja soolestiku kergete vaevuste, nagu täiskõhutunne või seedeprobleemid, leevendamiseks.
English: Further information on the HMPC assessment of dittany of Crete herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Estonian: Lisateave kreeta pune ürti sisaldava ravimi hinnangu kohta, sh komitee kokkuvõtte detailne kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Estonian: Oma hinnangus võttis taimsete ravimite komitee arvesse ka kreeta pune ürdi hästi dokumenteeritud ja pikaajalist kasutamist nimetatud seisundite korral.
English: Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.
Estonian: Taimseid ravimeid turustatakse tavaliselt peenestatud taimse materjalina, mida kasutatakse taimeteede valmistamiseks või millele lisatakse vett nahale kantava vedeliku (tõmmise) saamiseks.
English: Any applications for the licensing of medicines containing dittany of Crete herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Estonian: Kreeta pune ürti sisaldava ravimi müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimse ravimi müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslike järelduste kokkuvõtet.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dittany of Crete.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad kreeta pune ürti sisaldavate taimsete ravimite müügilubade taotlusi.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dittany of Crete herb.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb kreeta pune ürdi meditsiinilisi kasutusviise.
English: Other information about dittany of Crete herb medicines
Estonian: Muu teave kreeta pune ürti sisaldava ravimi kohta
English: The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.
Estonian: Tõmmist võib kasutada ka kergemate nahapõletike ja verevalumite korral nahale asetatava sideme immutamiseks.
English: What evidence supports the use of dittany of Crete herb medicines?
Estonian: Millised tõendid toetavad kreeta pune ürti sisaldava ravimi kasutamist?
English: What is dittany of Crete herb?
Estonian: Mis on kreeta pune ürt?
English: Dittany of Crete herb is the common name for the flowering above-ground (aerial) parts of Origanum dictamnus L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Estonian: Kreeta pune ürt on taime Origanum Dictamnus L. maapealsete õitsvate osade tavanimetus.
English: For practical information about using dittany of Crete medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Estonian: Kui vajate kreeta pune ürti sisaldava ravimi kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: For more information about treatment with dittany of Crete herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate lisateavet kreeta pune ürti sisaldava ravimi kasutamise kohta, lugege palun pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: What are the risks associated with dittany of Crete herb medicines?
Estonian: Mis riskid kaasnevad kreeta pune ürti sisaldava ravimiga?
English: This summary is not intended to provide practical advice on how to use medicines containing dittany of Crete herb.
Estonian: Kokkuvõttes ei anta kreeta pune ürti sisaldava ravimi kasutamise kohta praktilisi nõuandeid.
English: How are dittany of Crete herb medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus kreeta pune ürti sisaldavale ravimile müügiluba?
English: Information on the use and licensing of dittany of Crete herb medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab teavet kreeta pune ürti sisaldava ravimi kasutamise ja müügiloa kohta riiklikult ravimiametilt.
English: Detailed instruction on how to use dittany of Crete medicines and who can use them can be found in the package leaflet that comes with the medicine.
Estonian: Ravimiga kaasnevas pakendi infolehes on üksikasjalikud juhised, kuidas kreeta pune ürti sisaldavaid ravimeid kasutada ja kellele need on ette nähtud.
English: Dittany of Crete herb
Estonian: Kreeta pune ürt
English: 2333 BE Leiden Netherlands
Estonian: 2333 BE Leiden Holland
English: Currently available data are described in section 4.8, 5.1, 5.2.
Estonian: Olemasolevad andmed on toodud lõikudes 4.8, 5.1, 5.2.
English: % Difference [95% CI]
Estonian: % erinevus [95% CI]
English: (frequency cannot be estimated from available data)
Estonian: (ei saa hinnata olemasolevate andmete alusel)
English: Neutropenia persisted for a median of 13 days.
Estonian: Neutropeenia püsis keskmiselt 13 päeva.
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Estonian: Müügiloa esmase väljastamise kuupäev: 25. aprill 2008 Müügiloa viimase uuendamise kuupäev: 19. veebruar 2018
English: Other medicines and Mycamine
Estonian: Muud ravimid ja Mycamine
English: Your doctor will determine how much Mycamine you will receive each day.
Estonian: Arst määrab kindlaks, kui palju Mycamine'i te iga päev saate.
English: Mycamine with food and drink
Estonian: Mycamine koos toidu ja joogiga
English: Insufficient evidence
Estonian: Ebapiisavad andmed
English: Other Candida spp.
Estonian: Teised Candida spp.
English: Standard infusion (added up to 100 ml)
Estonian: Tavaline infusioon (lisatud kuni 100 ml)
English: However, the difference was not significant and whether it translates into a relevant clinical difference is unknown.
Estonian: Kuid erinevus polnud oluline ning on teadmata kas see omab olulist kliinilist erinevust.
English: Possible allergic-like symptoms
Estonian: Võimalikud allergiataolised sümptomid
English: The clinical relevance of this finding is not known.
Estonian: Selle leiu kliiniline tähtsus on teadmata.
English: In case of overdose, general supportive measures and symptomatic treatment should be administered.
Estonian: Üleannustamise korral tuleb rakendada üldisi toetavaid abinõusid ja sümptomaatilist ravi.
English: The vial is for single use only.
Estonian: Viaal on ette nähtud ainult ühekordseks kasutamiseks.
English: Mycamine is indicated for:
Estonian: Mycamine on näidustatud:
English: Elimination and excretion
Estonian: Eliminatsioon ja eritumine
English: This means there is insufficient evidence to indicate whether the wild-type population of these pathogens can be considered susceptible to micafungin.
Estonian: See tähendab, et puudub piisav tõestus näitamaks, kas nende patogeenide metsikut tüüpi populatsiooni võib pidada tundlikuks mikafungiinile.
English: However some people may feel dizzy when taking this medicine and if this happens to you, do not drive or use any tools or machines.
Estonian: Siiski võivad mõned inimesed tunda selle ravimi kasutamise ajal pearinglust ja kui see juhtub teiega, ärge juhtige autot ega kasutage masinaid või mehhanisme.
English: These findings showed reversibility over a follow-up period of 18 months.
Estonian: Nende leidude osas esines 18-kuulise jälgimisperioodi jooksul taandumise tunnuseid.
English: Information from clinical studies
Estonian: Teave kliinilistest uuringutest
English: ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
Estonian: ¶ Kliinilist tõhusust täheldati (< 5 patsiendil) ka järgmiste Candida liikide korral: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua ja C. dubliniensis.
English: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Estonian: Tuginedes kliiniliste uuringute andmetele, esines üldiselt 32,2% patsientidest kõrvaltoimeid.
English: More rapid infusions may result in more frequent histamine mediated reactions.
Estonian: Kiirema infusiooni korral esinevad histamiini vahendatud reaktsioonid sagedamini.
English: Your doctor may decide to adjust the dose of these medicines.
Estonian: Teie arst võib otsustada nende ravimite annust muuta.
English: Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study.
Estonian: Ravi efektiivsust defineeriti kui tõestatud, tõenäolise või kahtlustatava süsteemse seeninfektsiooni puudumist ning tõestatud või tõenäolise süsteemse seeninfektsiooni puudumist kuni uuringu lõpuni.
English: In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Estonian: Süsteemses vereringes seondub mikafungiin ulatuslikult plasmavalkudega (> 99%), peamiselt albumiiniga.
English: For reconstitution instructions see section 6.6.
Estonian: Lahustamise juhiseid vt lõik 6.6.
English: Your doctor has prescribed Mycamine for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2):
Estonian: Arst on teile Mycamine määranud järgmistel juhtudel, mil teisi sobivaid seenevastaseid ravimeid ei ole võimalik kasutada (vt lõik 2):
English: Experience with Mycamine in patients less than 2 years of age is limited.
Estonian: Mycamine'i kasutamise kogemus alla 2-aastastel lastel on piiratud.
English: Mycamine must be prepared and given to you by a doctor or another healthcare professional.
Estonian: Mycamine peab valmistama ja manustama arst või mõni muu tervishoiutöötaja.
English: All of the reconstituted concentrate should be withdrawn from each vial and returned into the infusion bottle/bag from which it was originally taken.
Estonian: Igast viaalist tuleb kogu lahustatud kontsentraat välja tõmmata ja süstida tagasi pudelisse/kotti, kust see algselt võeti.
English: The drug is rapidly distributed into tissues.
Estonian: Ravim jaotub kiiresti kudedesse.
English: As Mycamine is given intravenously (into a vein), no restrictions on food or drink are required.
Estonian: Kuna Mycamine'i manustatakse veenisiseselt (intravenoosselt), puuduvad toidu või joogi tarbimise piirangud.
English: This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Estonian: Seda ravimpreparaati ei tohi segada ega infundeerida koos teiste ravimitega, välja arvatud nendega, mis on loetletud lõigus 6.6.
English: Contents of the pack and other information What Mycamine contains
Estonian: Pakendi sisu ja muu teave Mida Mycamine sisaldab
English: Mycamine may cause the following other side effects:
Estonian: Mycamine võib põhjustada järgmisi kõrvaltoimeid:
English: Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Estonian: Samaväärsus tõestati täiskasvanud patsientidel ning sarnaseid tulemusi täheldati laste alapopulatsioonides (sealhulgas vastsündinutel ja enneaegsetel lastel).
English: Astellas Ireland Co., Ltd. Killorglin, County Kerry Ireland
Estonian: Astellas Ireland Co., Ltd. Killorglin, County Kerry Iirimaa
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.
Estonian: See ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, mis tähendab sisuliselt „naatriumivaba“.
English: The MAH should agree the final content, format and distribution modalities of the Prescriber checklist with the National Competent Authority in each Member State and ensure that the materials contain the key elements as described below.
Estonian: Müügiloa hoidja peab loetelu lõpliku sisu, formaadi ja levitamise suhtes iga liikmesriigi pädevate ametiasutustega kokku leppima ja kindlustama, et materjalid sisaldaksid alltoodud põhilisi elemente.
English: There is no evidence of systemic accumulation with repeated administration and steady-state is generally reached within 4 to 5 days.
Estonian: Puuduvad tõendid ravimi süsteemsest kuhjumisest korduval manustamisel ning püsikontsentratsioon saabub üldjuhul 4 kuni 5 päeva jooksul.
English: Exposure to these metabolites is low and metabolites do not contribute to the overall efficacy of micafungin.
Estonian: Nende metaboliitide ekspositsioon on madal ja metaboliidid ei osale mikafungiini üldises toimes.
English: ≤S (Susceptible)
Estonian: ≤S (tundlik)
English: Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Estonian: Palun informeerige oma arsti, kui teil tekivad nähud, mis võivad tekitada probleeme autojuhtimisel või masinatega töötamisel.
English: In the following table adverse reactions are listed by system organ class and MedDRA preferred term.
Estonian: Alljärgnevas tabelis on kõrvaltoimed loetletud organsüsteemide klassi ja MedDRA eelistatud termini järgi.
English: These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
Estonian: Need andmed on ebapiisavad, et toetada manustamissoovitusi raske maksakahjustusega patsientidel.
English: - if you are allergic to micafungin, other echinocandins (Ecalta or Cancidas) or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui te olete allergiline mikafungiini, teiste ehhinokandiinide (Ecalta või Cancidas) või selle ravimi mis tahes koostisosa (loetletud lõigus 6) suhtes.
English: These data indicate that elimination of micafungin is primarily non-renal.
Estonian: Need andmed näitavad, et mikafungiini eliminatsioon on peamiselt mitterenaalne.
English: The powder will dissolve completely.
Estonian: Pulber lahustub täielikult.
English: Pack size: packs of 1 vial.
Estonian: Pakendi suurus: pakendis on 1 viaal.
English: If this happens, your doctor may decide to monitor your kidney function more closely.
Estonian: Sellistel juhtudel võib teie arst otsustada jälgida hoolikalt teie neerufunktsiooni.
English: The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination.
Estonian: Lahustatud kontsentraat ja lahjendatud infusioonilahus tuleb ära kasutada kohe, sest see ei sisalda ühtegi säilitusainet, mis väldiks lahuse saastumist bakteritega.
English: Mycamine should not be used during pregnancy unless clearly necessary.
Estonian: Mycamine'i ei tohi kasutada raseduse ajal kui see ei ole hädavajalik.
English: Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Estonian: Mõnel patsiendil (1,1%, 0,4% rasked juhud) katkestati ravi maksa kõrvaltoime tõttu.
English: ‡ Adjusted for neutropenic status; primary endpoint.
Estonian: ‡ Kohandatud neutropeenilise staatuse järgi; esmane tulemusnäitaja.
English: Prolongation of infusion time reducing the plasma concentration peak appeared to reduce these effects.
Estonian: Selgus, et infusiooniaja pikendamine, mille tulemusena vähenes maksimaalne plasmakontsentratsioon, vähendas neid toimeid.
English: Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Estonian: Teiste ravide foonil tekkinud infektsioonide põhjuseks olid Fusarium (vastavalt 1 ja 2 patsienti) ja Zygomycetes (vastavalt 1 ja 0 patsienti).
English: The rate of treatment success was statistically significantly higher for micafungin than fluconazole (1.6% versus 2.4% breakthrough infections).
Estonian: Ravi efektiivsuse määr oli mikafungiini puhul statistiliselt oluliselt suurem võrreldes flukonasooliga (1,6% versus 2,4% läbimurdeinfektsioonid).
English: Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
Estonian: Mycamine'i ei tohi segada ega infundeerida koos teiste ravimitega, välja arvatud nendega, mis on loetletud allpool.
English: There are currently insufficient data available for the use of micafungin in patients with severe hepatic impairment and its use is not recommended in these patients (see sections 4.4 and 5.2).
Estonian: Praegu puuduvad piisavad andmed mikafungiini kasutamise kohta raske maksakahjustusega patsientidel, mistõttu nendele patsientidele seda ei soovitata (vt lõigud 4.4 ja 5.2).
English: At the recommended therapeutic dosage of Mycamine, these ratios are achievable for the wild-type distribution of Candida spp.
Estonian: Mikafungiini soovitusliku terapeutilise annuse puhul on need väärtused saavutatavad metsikut tüüpi Candida spp leviku puhul.
English: As for all antimicrobial agents, cases of reduced susceptibility and resistance have been reported and cross-resistance with other echinocandins cannot be excluded.
Estonian: Nagu kõigi antimikroobsete ainete korral on teatatud vähenenud tundlikkuse ja resistentsuse juhtudest; välistada ei saa ka ristresistentsust teiste ehhinokandiinidega.
English: Pharmacotherapeutic group: Antimycotics for systemic use, other antimycotics for systemic use, ATC code: J02AX05
Estonian: Farmakoterapeutiline rühm: Seenevastased ained süsteemseks kasutamiseks, teised seenevastased ained süsteemseks kasutamiseks, ATC-kood: J02AX05