FrancophonIA/ELRC3.0 huggingface dataset:
English: One dose (1 ml) contains: Porcine circovirus type 2 ORF2 protein Carbomer
Estonian: Üks doos (1 ml) sisaldab: sigade tsirkoviiruse tüüp 2 ORF2 valku karbomeeri
English: Boehringer Ingelheim Vetmedica GmbH GERMANY
Estonian: Boehringer Ingelheim Vetmedica GmbH SAKSAMAA
English: Ingelvac MycoFLEX may be not authorised to use in certain Member States.
Estonian: Ingelvac MycoFLEXil ei pruugi olla teatavates liikmesriikides kasutamiseks müügiluba.
English: Carbomer Sodium chloride Water for injections
Estonian: Karbomeer Naatriumkloriid Süstevesi
English: 10 ml (10 doses) 50 ml (50 doses) 100 ml (100 doses) 250 ml (250 doses) 12 x 10 ml (12 x 10 doses) 12 x 50 ml (12 x 50 doses) 12 x 100 ml (12 x 100 doses) 12 x 250 ml (12 x 250 doses)
Estonian: 10 ml (10 doosi) 50 ml (50 doosi) 100 ml (100 doosi) 250 ml (250 doosi) 12 x 10 ml (10 doosi) 12 x 50 ml (50 doosi) 12 x 100 ml (100 doosi) 12 x 250 ml (250 doosi)
English: If needed, gently press the vaccine bottle of Ingelvac CircoFLEX to facilitate the transfer.
Estonian: Vajaduse korral vajutage ülekande hõlbustamiseks ettevaatlikult Ingelvac CircoFLEXi vaktsiinipudelile.
English: For the full list of excipients, see section 6.1.
Estonian: 1 mg Abiainete täielik loetelu on esitatud lõigus 6.1.
English: Shelf life after first opening the immediate packaging: use immediately.
Estonian: Kõlblikkusaeg pärast vahetu pakendi esmast avamist: koheseks kasutamiseks.
English: 10 ml (10 doses) 50 ml (50 doses)
Estonian: 10 ml (10 doosi) 50 ml (50 doosi)
English: Interactions with other medicinal products and other forms of interaction Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Estonian: Koostoimed teiste ravimitega ja muud koostoimed Kättesaadavad ohutuse ja efektiivsuse andmed näitavad, et seda vaktsiini võib segada Boehringer Ingelheimi Ingelvac MycoFLEXiga ja manustada sama süstekoha kaudu.
English: In addition, vaccination has been shown to reduce PCV2 nasal shedding, viral load in blood and lymphoid tissues, and duration of viraemia.
Estonian: Lisaks sellele on tõendatud, et vaktsineerimine vähendab PCV2 viiruse eritumist nina kaudu, viiruse hulka veres ja lümfikudedes ning vireemia kestust.
English: For active immunisation of pigs from the age of 2 weeks against porcine circovirus type 2 (PCV2) to reduce mortality, clinical signs - including weight loss - and lesions in lymphoid tissues associated with PCV2 related disease (PCVD).
Estonian: Sigade aktiivseks immuniseerimiseks alates 2 nädala vanusest sigade tsirkoviiruse tüüp 2 (PCV2) vastu PCV2-ga seotud haigustest põhjustatud suremuse, kliiniliste nähtude - sealhulgas kaalu alanemise - ja lümfikoe kahjustuste vähendamiseks.
English: Ingelvac CircoFLEX suspension for injection for pigs
Estonian: Ingelvac CircoFLEX süstesuspensioon sigadele
English: INDICATIONS
Estonian: NÄIDUSTUSED
English: Pharmacotherapeutic group: Immunologicals for Suidae, inactivated viral vaccines for pigs ATCvet code: QI09AA07
Estonian: Farmakoterapeutiline rühm: Immunoloogilised ained sigalastele (Suidae), inaktiveeritud viirusvaktsiinid sigadele
English: - After the transfer of the full content of Ingelvac CircoFLEX, disconnect and discard transfer needle and empty vaccine bottle of Ingelvac CircoFLEX.
Estonian: - Pärast Ingelvac CircoFLEXi kogu sisu ülekandmist lahutage ülekandenõel ja tühi Ingelvac
English: Vaccination devices should be used in accordance with the device instructions provided by the manufacturer.
Estonian: Manustamiseks tuleb kasutada vaktsineerimisvahendeid vastavalt vahendi tootja juhistele.
English: Porcine circovirus type 2 ORF2 protein: RP* 1.0-3.75 * Relative potency (ELISA test) by comparison with a reference vaccine.
Estonian: sigade tsirkoviiruse tüüp 2 ORF2 valku suhteline tugevus* 1,0-3,75 * Suhteline tugevus (ELISA testi põhjal), võrreldes referentsvaktsiiniga
English: Vaccines devices should be used in accordance with the device instructions provided by the manufacturer.
Estonian: Vaktsineerimisvahendeid tuleb kasutada vastavalt vahendi tootja juhendile.
English: Avoid multiple broaching.
Estonian: Vältige korduvat korgi läbistamist.
English: Pregnancy and lactation Can be used during pregnancy and lactation.
Estonian: Tiinus ja laktatsioon Lubatud kasutada tiinuse ja laktatsiooni ajal.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Boehringer Ingelheim's Ingelvac MycoFLEX and administered at one injection site.
Estonian: Olemasolevad ohutuse ja efektiivsuse andmed näitavad, et seda vaktsiini võib manustada kokku segatuna Boehringer Ingelheimi Ingelvac MycoFLEXiga ja samasse süstekohta.
English: 100 ml (100 doses) 250 ml (250 doses)
Estonian: 100 ml (100 doosi) 250 ml (100 doosi)
English: Avoid multiple vial broaching.
Estonian: Vältige viaali korduvat korgi läbistamist.
English: Can be used during pregnancy and lactation.
Estonian: Lubatud kasutada tiinuse ja laktatsiooni ajal.
English: Pack sizes of 1 or 12 high density polyethylene bottles of 10 ml, 50 ml, 100 ml or 250 ml.
Estonian: Pakendis on 1 või 12 kõrgtihedast polüetüleenist pudelit 10 ml, 50 ml, 100 ml või 250 ml.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND
Estonian: A. BIOLOOGILISE TOIMEAINE TOOTJA JA RAVIMIPARTII KASUTAMISEKS
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case-by-case basis.
Estonian: Seetõttu tuleb selle vaktsiini kasutamine otsustada igal erineval juhul eraldi.
English: Any unused mixture or waste material should be disposed according with local requirements.
Estonian: Kasutamata segu või jäätmematerjal tuleb hävitada vastavalt kohalikule seadusandlusele.
English: • Cannot be administered in pregnant or lactating pigs.
Estonian: mitte manustada tiinetele ega lakteerivatele sigadele.
English: Pack sizes of 1 or 12 bottles of 10 ml (10 doses), 50 ml (50 doses), 100 ml (100 doses) or 250 ml (250 doses).
Estonian: Pakendis on 1 või 12 pudelit, igas 10 ml (10 doosi), 50 ml (50 doosi), 100 ml (100 doosi) või 250 ml (250 doosi).
English: U.S.A.
Estonian: USA
English: Onset of immunity:
Estonian: Immuunsuse teke:
English: Single intramuscular (IM) injection of one dose (1 ml) to pigs, irrespective of body weight.
Estonian: Ühe doosi (1 ml) ühekordne intramuskulaarne manustamine sigadele olenemata nende kehamassist.
English: - Transfer the Ingelvac CircoFLEX vaccine into the vaccine bottle of Ingelvac MycoFLEX.
Estonian: - Kandke vaktsiin Ingelvac CircoFLEX Ingelvac MycoFLEXi vaktsiinipudelisse.
English: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY
Estonian: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein SAKSAMAA
English: Pre-sterilised transfer needles (CE certified) are commonly available via medical equipment suppliers.
Estonian: turustatakse üldjuhul meditsiiniseadmete tarnijate kaudu.
English: WITHDRAWAL PERIOD
Estonian: KEELUAEG
English: Single IM injection of 1 ml.
Estonian: Ühe doosi ühekordne i.m.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals
Estonian: Ettevaatusabinõud veterinaarravimit loomale manustavale isikule Ei rakendata.
English: • Use the same volumes of Ingelvac CircoFLEX and Ingelvac MycoFLEX.
Estonian: • kasutage Ingelvac CircoFLEXi ja Ingelvac MycoFLEXi samas mahus;
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 10 ml; 50 ml, 100 ml, 250 ml cardboard box
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 10 ml, 50 ml, 100 ml, 250 ml pappkarp
English: METHOD AND ROUTE OF ADMINISTRATION
Estonian: MANUSTAMISVIIS JA -TEE(D)
English: EXP {month/year} Once broached use immediately.
Estonian: Kõlblik kuni (EXP) {kuu/aasta} Pärast korgi läbistamist kasutada kohe.
English: Name and address of the manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Estonian: Ravimipartii vabastamise eest vastutava tootja nimi ja aadress Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: QUANTITY OF THE ACTIVE SUBSTANCE
Estonian: TOIMEAINE KOGUS
English: Marketing authorisation holder and manufacturer responsible for batch release Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Estonian: Müügiloa hoidja ja partii vabastamise eest vastutav tootja Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
English: PACKAGE LEAFLET: Ingelvac CircoFLEX suspension for injection for pigs
Estonian: PAKENDI INFOLEHT Ingelvac CircoFLEX süstesuspensioon sigadele
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE 100 ml, 250 ml bottle
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 100 ml, 250 ml pudel
English: - Connect the opposite end of the transfer needle to the vaccine bottle of Ingelvac CircoFLEX.
Estonian: - Ühendage ülekandenõela teine ots Ingelvac CircoFLEXi vaktsiinipudeliga.
English: Name and address of the manufacturer of the biological active substance Boehringer Ingelheim Animal Health USA Inc.
Estonian: Bioloogilise toimeaine tootja nimi ja aadress Boehringer Ingelheim Animal Health USA Inc. 2621 North Belt Highway, St. Joseph,
English: Incompatibilities
Estonian: Sobimatus
English: Single intramuscular injection of one dose (1 ml), irrespective of body weight.
Estonian: Ühe doosi (1 ml) ühekordne intramuskulaarne (i.m.)
English: Suspension for injection.
Estonian: Retseptiravim.
English: IM
Estonian: Siga
English: Suspension for injection
Estonian: TOIMEAINE SISALDUS
English: • Use a pre-sterilised transfer needle.
Estonian: • kasutage eelsteriliseeritud ülekandenõela; eelsteriliseeritud ülekandenõelu (EÜ sertifikaadiga)
English: Clear to slightly opalescent, colourless to yellowish suspension for injection.
Estonian: Selge või veidi veiklev värvitu või kollakas süstesuspensioon.
English: ROUTE OF ADMINISTRATION
Estonian: MANUSTAMISVIIS
English: To ensure correct mixing follow the steps as described below: Connect one end of the transfer needle to the vaccine bottle of Ingelvac MycoFLEX.
Estonian: Õige segunemise tagamiseks järgige allpool kirjeldatud samme:
English: What measures are being taken to ensure the safe and effective use of Fampyra?
Estonian: Mis meetmed võetakse, et tagada Fampyra ohutu ja efektiivne kasutamine?
English: Fampyra fampridine
Estonian: Fampyra fampridiin
English: The full EPAR for Fampyra can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Fampyra kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a conditional marketing authorisation valid throughout the European Union for Fampyra on 20 July 2011.
Estonian: Euroopa Komisjon andis Fampyra tingimusliku müügiloa, mis kehtib kogu Euroopa Liidus, 20. juulil 2011.
English: This summary was last updated in 07-2017
Estonian: Kokkuvõtte viimane uuendus: 07-2017.
English: Other information about Fampyra
Estonian: Muu teave Fampyra kohta
English: This was switched to a full marketing authorisation on 22 May 2017.
Estonian: Tingimuslik müügiluba muudeti tavaliseks müügiloaks 22. mail 2017.
English: Fampyra is available as 10 mg tablets taken without food twice a day, 12 hours apart.
Estonian: Fampyrat turustatakse 10 mg tablettidena, mida manustatakse ilma toiduta kaks korda ööpäevas 12tunnise vahega.
English: What is Fampyra and what is it used for?
Estonian: Mis on Fampyra ja milleks seda kasutatakse?
English: After two to four weeks, patients are evaluated and those who have not shown an improvement should stop treatment.
Estonian: Patsientide seisundit hinnatakse iga 2-4 nädala järel ning kui paranemismärke ei ole, tuleb ravi lõpetada.
English: Treatment should also be stopped if a patient's walking ability worsens or if the patient does not report any benefit.
Estonian: Samuti tuleb ravi lõpetada juhul, kui patsiendi kõndimisvõime halveneb või kui patsient arvab, et ravist ei ole kasu.
English: With regard to the medicine's safety, serious side effects with Fampyra are rare.
Estonian: Mis puudutab Fampyra ohutust, esineb raskeid kõrvalnähte Fampyraga harva.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Fampyra have been included in the summary of product characteristics and the package leaflet.
Estonian: Fampyra ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: The patients were treated for 9 or 14 weeks, with their waking speed measured along a 25 feet (7.5 metres) footpath.
Estonian: Patsiendid said ravi 9 või 14 nädala kestel ja nende kõndimiskiirust mõõdeti 7,5-meetrisel vahemaal.
English: The side effects seen with Fampyra are mostly neurological (relating to the brain or nerves) and include seizures (fits), insomnia (difficulty sleeping), anxiety, problems with balance, dizziness, paraesthesia (unusual sensations like pins and needles), tremor, headache and asthenia (weakness).
Estonian: Fampyra puhul on täheldatud peamiselt neuroloogilisi kõrvalnähte (seotud aju või närvidega), näiteks krambihood, unetus, rahutus, tasakaaluhäired, peapööritus, paresteesia (vääraistingud, näiteks torkiv tunne nahal), treemor, peavalu ja asteenia (nõrkus).
English: The European Medicines Agency therefore concluded that the benefits of Fampyra outweigh its risks for patients with a walking disability and recommended that it be given marketing authorisation.
Estonian: Seepärast järeldas Euroopa Ravimiamet, et Fampyra kasulikkus on liikumispuudega patsientidel suurem kui sellega kaasnevad riskid, ning soovitas anda ravimi müügiloa.
English: The most common side effect reported in clinical studies, affecting around 12% of the patients, is urinary tract infection.
Estonian: Kõige sagedam kliinilistes uuringutes teatatud kõrvalnäht (esinenud ligikaudu 12%-l patsientidest) on kuseteede infektsioon.
English: Fampyra must not be used with other medicines that contain fampridine or medicines known as ‘inhibitors of organic cation transporter 2' such as cimetidine.
Estonian: Fampyrat ei tohi kasutada koos teiste fampridiini sisaldavate ravimitega või orgaanilise katioontransportsüsteemi 2 inhibiitoritega, näiteks tsimetidiiniga.
English: It is not intended to provide practical advice on how to use Fampyra.
Estonian: Hindamisaruandes ei anta Fampyra kasutamise praktilisi nõuandeid.
English: It must not be used in patients who have seizures or have ever had seizures or in patients with kidney problems.
Estonian: Seda ei tohi kasutada patsiendid, kellel on varem esinenud või esineb krambihooge, ega neeruprobleemidega patsiendid.
English: The studies with Fampyra showed that the medicine is likely to benefit approximately one third of patients with MS who have a walking disability, and that patients benefiting from the treatment can be identified at an early stage allowing treatment to be stopped in other patients.
Estonian: Fampyraga tehtud uuringutes näidati, et tõenäoliselt aitab Fampyra ligikaudu kolmandikku hulgiskleroosi patsientidest, kel on liikumispuue, ning ravist kasu saavad patsiendid saab tuvastada varajases etapis, mis võimaldab teiste patsientide ravi lõpetada.
English: What are the risks associated with Fampyra?
Estonian: Mis riskid Fampyraga kaasnevad?
English: The active substance in Fampyra, fampridine, is a potassium channel blocker.
Estonian: Fampyra toimeaine fampridiin on kaaliumikanali blokaator.
English: This is a summary of the European public assessment report (EPAR) for Fampyra.
Estonian: See on ravimi Fampyra Euroopa avaliku hindamisaruande kokkuvõte.
English: As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Estonian: Et ettevõte esitas vajaliku lisateabe, muudeti tingimuslik müügiluba tavaliseks müügiloaks.
English: Why is Fampyra approved?
Estonian: Miks Fampyra heaks kiideti?
English: A third study in 633 patients measured improvements in walking ability over 24 weeks using a rating scale known as the multiple sclerosis walking scale (MSWS), where patients rated how well they were able to do various activities such as walking, running or climbing stairs.
Estonian: Kolmandas uuringus hinnati 633 patsiendil kõndimisvõime paranemist 24 nädala jooksul, kasutades hulgiskleroosi kõndimisskaalat (MSWS): patsiendid hindasid toimetulekut eri tegevustega, nagu kõndimine, jooksmine või trepist ülesminek.
English: Fampyra is a medicine used to improve walking ability in adults with multiple sclerosis (MS) who have a walking disability.
Estonian: Fampyra on ravim, mida kasutatakse kõndimisvõime parandamiseks hulgiskleroosiga täiskasvanutel, kellel on liikumispuue.
English: It contains the active substance fampridine.
Estonian: Ravim sisaldab toimeainena fampridiini.
English: Two main studies in 540 patients with multiple sclerosis showed that Fampyra was more effective than placebo (a dummy treatment) at improving walking speed.
Estonian: Kahes põhiuuringus, milles osales 540 hulgiskleroosiga patsienti, osutus Fampyra kõndimiskiiruse parandamisel efektiivsemaks kui platseebo (näiv ravim).
English: Fampyra was originally given ‘conditional approval' because there was more evidence to come about the medicine.
Estonian: Fampyra müügiluba anti esialgu tingimuslikult, sest selle ravimi toetuseks oodati täiendavaid andmeid.
English: How is Fampyra used?
Estonian: Kuidas Fampyrat kasutatakse?
English: For practical information about using Fampyra, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate Fampyra kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does Fampyra work?
Estonian: Kuidas Fampyra toimib?
English: For more information about treatment with Fampyra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Fampyraga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: In MS, this transmission of electrical impulses is impaired when the protective sheaths around the nerves become damaged, which can lead to muscle weakness, muscle stiffness and difficulty walking.
Estonian: Hulgiskleroosi korral on elektriimpulsside saatmine närvide ümber oleva kaitsekihi kahjustumise tõttu häiritud ning see võib põhjustada lihasenõrkust, lihasejäikust ja kõndimisraskusi.
English: MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves.
Estonian: Hulgiskleroos on närvihaigus, mille korral hävitab põletik närve ümbritseva kaitsekesta.
English: This is believed to have the effect of allowing the electrical impulse to continue travelling along the nerves to stimulate the muscles, making it easier to walk.
Estonian: Eeldatavasti liigub elektriimpulss seega mööda närvi edasi ja stimuleerib lihaseid, võimaldades patsiendil paremini kõndida.
English: It acts on damaged nerves, where it prevents charged potassium particles from leaving the nerve cells.
Estonian: See toimib kahjustatud närvidele, takistades kaaliumiioonide väljumist närvirakkudest.
English: In one of the studies 35% of patients taking Fampyra had higher walking speed on at least three out of four occasions than their quickest speed before treatment compared with 8% of patients taking placebo .
Estonian: Ühes uuringus oli 35%-l Fampyrat saanud patsientidest kõndimiskiirus vähemalt kolmel korral neljast suurem kui suurim kõndimiskiirus enne ravi; platseeborühmas oli selliste patsientide osakaal 8%.
English: In the second study the results were similar, with 43% of patients in the Fampyra group surpassing their previous best speed on three out of four occasions, compared with 9% in the placebo group.
Estonian: Teise uuringu tulemused olid sarnased: 43% Fampyrat saanud patsientidest ületas oma varasema suurima kõndimiskiiruse kolmel korral neljast; platseeborühmas saavutas sama tulemuse 9% patsientidest.
English: What benefits of Fampyra have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Fampyra kasulikkus?
English: For the full list of all side effects reported with Fampyra, see the package leaflet.
Estonian: Fampyra kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: For the body's muscles to contract, electrical impulses are transmitted along the nerves to the muscles.
Estonian: Lihaste kokkutõmbumiseks kanduvad lihastesse mööda närve elektriimpulsid.
English: In this study, 43% of patients taking Fampyra had at least an 8-point improvement in their MSWS score compared with 34% of those on placebo.
Estonian: Selles uuringus saavutasid vähemalt 8-punktilise MSWSskoori paranemise 43% Fampyrat saanud patsientidest ja 34% platseebot saanud patsientidest (8punktilist paranemist peetakse selle 100-punkti skaala puhul kliiniliselt oluliseks).
English: The medicine can only be obtained with a prescription, and should be prescribed by a doctor experienced in treating MS. For further information, see the package leaflet.
Estonian: Ravi peab välja kirjutama hulgiskleroosi ravis kogenud arst.
English: (*) equivalent to titre prior to inactivation (log10)
Estonian: (*) (*) samaväärne tiitrile enne inaktiveerimist (log10)
English: EU Number
Estonian: El number
English: Subcutaneous Type I glass bottle with butyl elastomere closure
Estonian: Tüüp I klaaspudel butüülelastomeer sulguriga
English: Strength
Estonian: Keeluajad
English: Packaging Content Package size Withdrawal period
Estonian: Ravimvorm Loomaliigid Manustamisviis Pakend Sisaldus Pakendi suurus
English: Invented Name
Estonian: Nimetus Tugevus
English: Note:
Estonian: Märkus.
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Estonian: Liikmesriikide pädevad asutused võivad hiljem uuendada ravimiteavet koostöös viiteliikmesriigiga (kui asjakohane) ja kooskõlas menetlusega, mis on sätestatud direktiivi 2001/83/EÜ III jaotise 4. peatükis.
English: The valid product information is the final version achieved during the Coordination group procedure.
Estonian: Kehtiv ravimiteave on lõplik versioon, milleni jõuti koordineerimisrühma menetluses.
English: This product information is the outcome of the referral procedure to which this Commission decision relates.
Estonian: See ravimiteave on komisjoni käesoleva otsusega seotud esildismenetluse tulemus.
English: Annex III Product information
Estonian: III lisa Ravimiteave
English: Product information
Estonian: Ravimiteave
English: The European Commission granted a marketing authorisation valid throughout the European Union for HyQvia on 16 May 2013.
Estonian: Euroopa Komisjon andis HyQvia müügiloa, mis kehtib kogu Euroopa Liidus, 16. mail 2013.
English: This summary was last updated in 07-2016.
Estonian: Kokkuvõtte viimane uuendus: 07-2016.
English: The study showed that HyQvia was able to reduce this number to 0.03 per year.
Estonian: Uuringus selgus, et HyQvia vähendas seda arvu 0,03 juhuni aastas.
English: What measures are being taken to ensure the safe and effective use of HyQvia?
Estonian: Mis meetmeid võetakse, et tagada HyQvia ohutu ja efektiivne kasutamine?
English: This study was extended to almost 4 years and confirmed the long-term benefits and safety of HyQvia.
Estonian: Uuringut pikendati ligikaudu 4 aastale ja see tõendas HyQvia pikaajalist kasulikkust ja ohutust.
English: What is HyQvia and what is it used for?
Estonian: Mis on HyQvia ja milleks seda kasutatakse?
English: The full EPAR for HyQvia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst HyQvia kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.