FrancophonIA/ELRC3.0 huggingface dataset:
English: If not, your child may not be fully protected against the diseases.
Estonian: Vastasel korral ei pruugi kaitse
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Estonian: Difteeria (D), teetanuse (T), läkaköha (atsellulaarne, komponent) (Pa), hepatiit B (rDNA) (HBV), poliomüeliidi (inaktiveeritud) (IPV) vaktsiin (adsorbeeritud)
English: In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus, hepatitis B and polio vaccines.
Estonian: Sellistel juhtudel tuleb läkaköhavaktsiin ära jätta ning jätkata vaktsinatsioone vaid difteeria-teetanuse, hepatiit B ja
English: • fits - this may be when they have a fever These side effects have happened very rarely with other vaccines against whooping cough.
Estonian: hetked, mil ta kaotab teadvuse või esinevad hämardumise episoodid krambid - need võivad tekkida siis, kui tal on palavik Need kõrvaltoimed on esinenud väga harva teiste läkaköha vaktsiinide kasutamisel.
English: • This vaccine has been prescribed for your child. Do not pass it on to others.
Estonian: • Ravim on välja kirjutatud teie lapsele.
English: • Infanrix Penta will be given as an injection into a muscle.
Estonian: • Infanrix Penta't süstitakse lihasesse
English: Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Estonian: Infanrix Penta, süstesuspensioon Difteeria (D), teetanuse (T), läkaköha (atsellulaarne, komponent) (Pa), hepatiit B (rDNA) (HBV), poliomüeliidi (inaktiveeritud) (IPV) vaktsiin (adsorbeeritud)
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Estonian: A. BIOLOOGILIS(T)E TOIMEAINE(TE) TOOTJA(D) JA TOOTMISLOA HOIDJA(D), KES VASTUTAB RAVIMIPARTII VABASTAMISE EEST
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Estonian: Väga harv (need võivad esineda kuni 1 korral 10 000 vaktsiiniannuse kohta)
English: Protective antibodies against hepatitis B have been shown to persist for at least 3.5 years in more than 90% of children administered four doses of a combined vaccine containing the same HBs antigen as Infanrix Penta.
Estonian: On tõestatud, et rohkem kui 90%-l lastest, kellele manustatakse neli kombineeritud vaktsiini annust, mis sisaldab sama HB antigeeni kui Infanrix Penta, püsivad hepatiit B vastu kaitsvad antikehad vähemalt 3,5 aastat.
English: • If additional injections (boosters) are necessary, the doctor will tell you.
Estonian: • Arst ütleb teile, kui on vajalik vaktsiini lisaannuste (boosteri) manustamine.
English: Percentage of subjects with antibody titres ≥ assay cut-off one month after booster vaccination
Estonian: Osalejate protsent, kelle antikeha tiiter üks kuu pärast Infanrix Penta revaktsinatsiooni ≥ kui
English: The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliomyelitis (DTPa-HBV-IPV) suspension should be inspected visually for any foreign particulate matter and/or variation of physical aspect.
Estonian: Difteeria, teetanuse, atsellulaarset läkaköha-, hepatiit B ja inaktiveeritud poliomüeliidi (DTPa-HBV-IPV) komponenti sisaldavat suspensiooni tuleb enne segamist visuaalselt kontrollida; võõrosakeste esinemisel või ebatavalise välimuse korral tuleb preparaat hävitada.
English: Read all of this leaflet carefully before your child receives this vaccine.
Estonian: Enne lapse vaktsineerimist lugege hoolikalt infolehte.
English: GlaxoSmithKline d.o.o.
Estonian: Slovenija GlaxoSmithKline d.o.o.
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Estonian: Väga sage (need võivad esineda enam kui ühel korral 10 vaktsiiniannuse kohta)
English: The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
Estonian: Siiski võib immunosupressiooniga haigetel osutuda immunoloogiline vastus vaktsineerimisele ebaefektiivseks.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity, repeated dose toxicity and compatibility of ingredients.
Estonian: Farmakoloogilise ohutuse, spetsiifilise toksilisuse, kroonilise toksilisuse ja sobimatuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: Results obtained in the clinical studies for each of the components are summarised in the tables below: Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination months N= 55
Estonian: Osalejate protsent, kelle antikehade tiiter oli üks kuu pärast esmast Infanrix Penta vaktsinatsiooni ≥ kui uuringu lõpetamisel kuud N= 55
English: Infanrix Penta is for deep intramuscular injection, preferably at alternating sites for subsequent
Estonian: Infanrix Penta't tuleb manustada sügava intramuskulaarse süstena, vahetades igal järgneval
English: If any of the above apply to your child (or you are not sure), talk to your doctor or pharmacist before
Estonian: Kui midagi ülaltoodust käib teie lapse kohta (või te ei ole päris kindel), rääkige sellest oma arsti või apteekriga, enne kui teie lapsele tehakse Infanrix Penta't.
English: Uncommon (these may occur in up to 1 in 100 doses of the vaccine)
Estonian: Aeg-ajalt (need võivad esineda kuni 1 korral 100 vaktsiiniannuse kohta)
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml) 20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
Estonian: 50 x 1 annus (0,5 ml) 1 eeltäidetud süstal + 1 nõela 1 annus (0,5 ml) 10 eeltäidetud süstalt + 10 nõela 10 x 1 annus (0,5 ml) 20 eeltäidetud süstalt + 20 nõela 20 x 1 annus (0,5 ml) 50 eeltäidetud süstalt + 50 nõela
English: Infanrix Penta, Suspension for injection
Estonian: Infanrix Penta - süstesuspensioon
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or polio
Estonian: Ülitundlikkus pärast difteeria-, teetanuse-, läkaköha-, hepatiit B või poliovaktsiini eelnevat
English: Thrombocytopenia has been reported with hepatitis B vaccine.
Estonian: Hepatiit B vaktsiini kasutamisel on kirjeldatud trombotsütopeeniat.
English: • a sudden drop in blood pressure and loss of consciousness.
Estonian: Allergilise reaktsiooni lööve, mis võib olla sügelev või villidega äkiline vererõhu langus ja teadvuse kadu
English: 6.6 Special precautions for disposal and other handling Upon storage, a white deposit and clear supernatant may be observed.
Estonian: Suspensiooni säilitamisel võib tekkida valge sade ja läbipaistev hõljum.
English: HHOW TO STORE INFANRIX PENTA
Estonian: 5 Kuidas Infanrix Penta't säilitada
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2000
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE
English: Κύπρος
Estonian: • köha
English: Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code J07CA12
Estonian: 5.1 Farmakodünaamilised omadused Farmakoterapeutiline grupp: Bakteriaalsed ja viirusvaktsiinid, nende kombinatsioonid,
English: As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Estonian: Nagu teistegi süstitavate vaktsiinide puhul, tuleb patsienti pärast vaktsineerimist mõnda aega jälgida ning vajalikud esmaabivahendid harvaesineva anafülaktilise reaktsiooni puhuks käepärast hoida.
English: Booster vaccination:
Estonian: • Hepatiit B vaktsiini kasutamise kogemus:
English: BEFORE YOUR CHILD RECEIVES INFANRIX PENTA
Estonian: KUIDAS Infanrix Penta'T SÄILITADA
English: Name and address of the manufacturer responsible for batch release
Estonian: Ravimipartii vabastamise eest vastutava tootja nimi ja aadress GlaxoSmithKline Biologicals s.a.
English: What Infanrix Penta is and what it is used for 2.
Estonian: 1. Mis ravim on Infanrix Penta ja milleks seda kasutatakse 2. Mida on vaja teada enne Infanrix Penta manustamist teie lapsele 3.
English: Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Estonian: Väljaspool riiklikku vaktsineerimisprogrammi difteeria-, teetanuse-, läkaköha-, hepatiit B ning poliomüeliidivastane aktiivne immuniseerimine imikutel ja väikelastel.
English: The full EPAR for Memantine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst ravimi Memantine ratiopharm kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Memantine ratiopharm should be given once a day at the same time every day.
Estonian: Ravimit Memantine ratiopharm peab võtma üks kord ööpäevas, iga päev samal kellaajal.
English: The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine ratiopharm should be re-assessed on a regular basis.
Estonian: Ravimi taluvust ja annust tuleb hinnata 3 kuu jooksul alates ravi algusest, seejärel tuleb Memantine ratiopharmiga toimuva ravi jätkamist regulaarselt uuesti hinnata.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine ratiopharm by the patient.
Estonian: Ravi tohib alustada vaid juhul, kui on olemas hooldaja, kes jälgib regulaarselt, kuidas patsient ravimit Memantine ratiopharm kasutab.
English: To prevent side effects, the dose of Memantine ratiopharm is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Estonian: Kõrvalnähtude ennetamiseks suurendatakse ravimi Memantine ratiopharm annust esimese kolme ravinädala jooksul järk-järgult: esimesel nädalal on annus 5 mg, teisel nädalal 10 mg ning kolmandal nädalal 15 mg.
English: This summary was last updated in June 2013.
Estonian: Kokkuvõtte viimane uuendus: 06-2013.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine ratiopharm on 13 June 2013.
Estonian: Euroopa Komisjon andis ravimi Memantine ratiopharm müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 13. juunil 2013.
English: Memantine ratiopharm is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Estonian: Memantine ratiopharm on retseptiravim ja seda turustatakse 5 mg, 10 mg, 15 mg ja 20 mg tablettidena.
English: What measures are being taken to ensure the safe and effective use of Memantine ratiopharm?
Estonian: Mis meetmed võetakse, et tagada ravimi Memantine ratiopharm kasutamise efektiivsus ja ohutus?
English: The Committee recommended that Memantine ratiopharm be approved for use in the EU.
Estonian: Komitee soovitas ravimi Memantine ratiopharm kasutamise Euroopa Liidus heaks kiita.
English: This is a summary of the European public assessment report (EPAR) for Memantine ratiopharm.
Estonian: See on ravimi Memantine ratiopharm Euroopa avaliku hindamisaruande kokkuvõte.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati ravimi Memantine ratiopharm ohutusteave koos vastavate ettevaatusabinõudega tervishoiuspetsialistidele ja patsientidele.
English: This means that Memantine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Estonian: See tähendab, et Memantine ratiopharm on sarnane võrdlusravimiga Ebixa, millel juba on Euroopa Liidus müügiluba.
English: Because Memantine ratiopharm is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Estonian: Et Memantine ratiopharm on geneeriline ravim ja võrdlusravimiga bioekvivalentne, peetakse tema kasulikkust ja riske samadeks mis võrdlusravimil.
English: Other information about Memantine ratiopharm
Estonian: Muu teave ravimi Memantine ratiopharm kohta
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm has been shown to have comparable quality and to be bioequivalent to Ebixa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Memantine ratiopharm võrdväärne kvaliteet ja bioekvivalentsus ravimiga Ebixa.
English: What is Memantine ratiopharm and what is it used for?
Estonian: Mis on Memantin ratiopharm ja milleks seda kasutatakse?
English: For practical information about using Memantine ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Estonian: Kui vajate ravimi Memantine ratiopharm kasutamise praktilisi nõuandeid, lugege pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: EPAR summary for the public
Estonian: Kokkuvõte üldsusele memantiinvesinikkloriid
English: Memantine ratiopharm is a ‘generic medicine'.
Estonian: Memantine ratiopharm on geneeriline ravim.
English: For more information about treatment with Memantine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate Memantine ratiopharmiga toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: It is not intended to provide practical advice on how to use Memantine ratiopharm.
Estonian: Hindamisaruandes ei anta ravimi Memantine ratiopharm kasutamise praktilisi nõuandeid.
English: Because Memantine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Estonian: Et Memantine ratiopharm on geneeriline ravim, piirdusid uuringud katsetega, milles näidati selle bioekvivalentsust võrdlusravimiga Ebixa.
English: Memantine ratiopharm is a medicine that contains the active substance memantine hydrochloride.
Estonian: Memantine ratiopharm on ravim, mis sisaldab toimeainena memantiinvesinikkloriidi.
English: Why is Memantine ratiopharm approved?
Estonian: Miks Memantine ratiopharm heaks kiideti?
English: Therefore, the CHMP's view was that, as for Ebixa, the benefit outweighs the identified risk.
Estonian: Seetõttu arvas inimravimite komitee, et nagu ka Ebixa korral, ületab ravimi Memantine ratiopharm kasulikkus sellega kaasnevad riskid.
English: The active substance in Memantine ratiopharm, memantine hydrochloride, is an antidementia medicine.
Estonian: Ravimi Memantine ratiopharm toimeaine memantiinvesinikkloriid on dementsuse ravim.
English: It is used to treat patients with moderate to severe Alzheimer's disease.
Estonian: Ravimit Memantine ratiopharm kasutatakse mõõduka või raske Alzheimeri tõvega patsientide raviks.
English: How has Memantine ratiopharm been studied?
Estonian: Kuidas ravimit Memantine ratiopharm uuriti?
English: How is Memantine ratiopharm used?
Estonian: Kuidas ravimit Memantine ratiopharm kasutatakse?
English: Treatment should be started and supervised by a doctor who has experience in the diagnosis and treatment of Alzheimer's disease.
Estonian: Ravi Memantine ratiopharmiga tohib alustada üksnes Alzheimeri tõvega patsientide diagnoosimises ja ravis kogenud arst ning see peab toimuma tema järelevalve all.
English: How does Memantine ratiopharm work?
Estonian: Kuidas Memantine ratiopharm toimib?
English: What are the benefits and risks of Memantine ratiopharm?
Estonian: Milles seisneb ravimi Memantine ratiopharm kasulikkus ja mis riskid ravimiga kaasnevad?
English: Repeated accidental self-injection may cause an allergic reaction to the medicine.
Estonian: Korduv juhuslik enesesüstimine võib põhjustada allergilist ravimireaktsiooni.
English: The full EPAR for Cytopoint can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Cytopointi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Cytopoint on 25 April 2017.
Estonian: Euroopa Komisjon andis Cytopointi müügiloa, mis kehtib kogu Euroopa Liidus, 25/04/2017.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Cytopoint's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Veterinaarravimite komitee järeldas, et Cytopointi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: Once the dog's skin becomes damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.
Estonian: Kui koera nahk on kraapimisest ja hõõrumisest kahjustunud, võivad tekkida täiendavad bakteriaalsed ja seeninfektsioonid.
English: The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.
Estonian: Cytopointi kõige sagedamad kõrvalnähud (võivad esineda kuni 1 loomal 1000st) on allergilised reaktsioonid, millega kaasnevad näo paistetus ja sügelev lööve.
English: What is Cytopoint and what is it used for?
Estonian: Mis on Cytopoint ja milleks seda kasutatakse?
English: It is not intended to provide practical advice on how to use Cytopoint.
Estonian: Hindamisaruandes ei anta Cytopointi kasutamise praktilisi nõuandeid.
English: Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs.
Estonian: Cytopoint on veterinaarravim, mida kasutatakse atoopilise dermatiidi ravimiseks koertel.
English: Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin.
Estonian: Cytopoint oli nahasügeluse ravis sama efektiivne kui tsüklosporiin: 28 päeva järel vähenes sügelusskoor (nahasügeluse mõõdik) Cytopointiga ravitud koertel 52% ja tsüklosporiiniga ravitud koertel 44%.
English: Other information about Cytopoint
Estonian: Muu teave Cytopointi kohta
English: Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens.
Estonian: Atoopiline dermatiit on nahapõletik, mida seostatakse allergiaga, sageli keskkonnateguritega, nagu tolmulestad ja õietolm.
English: Cytopoint starts to be effective within eight hours of injection and the effect lasts for up to 28 days.
Estonian: Cytopointi toime tekib 8 tunni jooksul alates süstimisest ja kestab kuni 28 päeva.
English: This is a summary of the European public assessment report (EPAR) for Cytopoint.
Estonian: See on ravimi Cytopoint Euroopa avaliku hindamisaruande kokkuvõte.
English: The dose to be used depends on the weight of the dog being treated.
Estonian: Kasutatav annus sõltub ravitava koera kehakaalust.
English: Why is Cytopoint approved?
Estonian: Miks Cytopoint heaks kiideti?
English: By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.
Estonian: Valku interleukiin-31 blokeerides vähendab lokivetmab nahasügelust ja -põletikku.
English: This summary was last updated in February 2017.
Estonian: Kokkuvõtte viimane uuendus: 02-2017.
English: What are the risks associated with Cytopoint?
Estonian: Mis riskid Cytopointiga kaasnevad?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Estonian: Ravimi omaduste kokkuvõttesse ja pakendi infolehele lisati Cytopointi ohutusteave, kus on ka tervishoiuspetsialistide ja loomaomanike või -pidajate võetavad meetmed.
English: Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs.
Estonian: Lokivetmab on monoklonaalne antikeha (teatud tüüpi valk), mis tunneb ära teatud valgu interleukiin-31 (millel on koerte atoopilise dermatiidi tekkes oluline osa) ja seondub sellega.
English: How does Cytopoint work?
Estonian: Kuidas Cytopoint toimib?
English: For practical information about using Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Estonian: Kui loomaomanikud või -pidajad vajavad Cytopointi kasutamise praktilisi nõuandeid, peavad nad lugema pakendi infolehte või pöörduma oma veterinaararsti või apteekri poole.
English: In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.
Estonian: Järeluuringus manustati 81 koerale Cytopointi veel kuue kuu jooksul ning nende sügelusskoor vähenes 14-le.
English: How is Cytopoint used?
Estonian: Kuidas Cytopointi kasutatakse?
English: Over the three months of the study pruritus score went down from a value of 74 at the start to 26 at the end in dogs given Cytopoint.
Estonian: Cytopointi saanud koertel vähenes kolme uuringukuu jooksul sügelusskoor lähteväärtuselt 74 lõppväärtusele 26.
English: Cytopoint is available as a solution for injection that is injected under the skin once a month.
Estonian: Cytopointi turustatakse kord kuus naha alla süstitava süstelahusena.
English: What benefits of Cytopoint have been shown in studies?
Estonian: Milles seisneb uuringute põhjal Cytopointi kasulikkus?
English: Cytopoint contains the active substance lokivetmab.
Estonian: Cytopoint sisaldab toimeainena lokivetmabi.
English: In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis.
Estonian: Atoopilise dermatiidiga koerte väliuuringus anti 142 koerale kolme kuu jooksul kord kuus Cytopointi
English: Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.
Estonian: Cytopointi kohta teatatud piirangute ja kõrvalnähtude täielik loetelu on pakendi infolehel.
English: The recommended dose of Fosavance is one tablet once a week.
Estonian: Fosavance soovitatav annus on üks tablett üks kord nädalas.
English: A risk management plan has been developed to ensure that Fosavance is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada Fosavance võimalikult ohutu kasutamine.
English: What measures are being taken to ensure the safe and effective use of Fosavance?
Estonian: Mis meetmed võetakse, et tagada Fosavance ohutu ja efektiivne kasutamine?
English: The full EPAR for Fosavance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Fosavance kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.
Estonian: Euroopa Komisjon andis Fosavance müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 24. augustil