FrancophonIA/ELRC3.0 huggingface dataset:
English: Flushed, dry skin; feeling sleepy or tired; dry mouth, fruity (acetone) breath; urinating more often, feeling thirsty; losing your appetite, feeling or being sick (nausea or vomiting).
Estonian: punetav kuiv nahk, unisus või väsimus, suukuivus, puuvilja (atsetooni) lõhn hingeõhus, sagenenud urineerimine, janu, isutus, iiveldus või oksendamine.
English: Ryzodeg 100 units/mL solution for injection in cartridge EU/1/12/806/007
Estonian: Ryzodeg 100 ühikut/ml süstelahus kolbampullis EU/1/12/806/007
English: Can be stored in a refrigerator (2°C - 8°C).
Estonian: Võib hoida külmkapis (2 °C...8 °C).
English: Use only clear, colourless solution Single patient use only
Estonian: Kasutada ainult selget värvitut lahust.
English: Solution for injection (FlexTouch) Multipack: 10 (2 packs of 5) 3 mL pre-filled pens
Estonian: Süstelahus pen-süstlis (FlexTouch) Mitmikpakend: 10 (2 x 5) 3 ml pen-süstlit.
English: Ratio: 0.29 [0.13;0.65]
Estonian: Suhe: 0,29 [0,13; 0,65]
English: The rapid absorption characteristics of the well-established insulin aspart are maintained by Ryzodeg.
Estonian: Ryzodeg'is on säilunud aspart-insuliini põhjalikult tõestatud kiire imendumise omadus.
English: Ryzodeg can be used in adolescents and children from the age of 2 years with diabetes mellitus.
Estonian: Ryzodeg'i võib kasutada noorukitel ja lastel alates 2 aasta vanusest.
English: Ratio: 0.91 [0.76;1.09]
Estonian: Suhe: 0,91 [0,76; 1,09]
English: Ratio: 0.27 [0.18;0.41]
Estonian: Suhe: 0,27 [0,18; 0,41]
English: Glycerol, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections
Estonian: Glütserool, metakresool, fenool, naatriumkloriid, tsinkatsetaat, vesinikkloriidhape ja naatriumhüdroksiid (pH reguleerimiseks) ning süstevesi.
English: Ryzodeg is presented as a clear and colourless solution for injection in a cartridge (300 units per 3 mL).
Estonian: Ryzodeg on selge ja värvitu süstelahus kolbampullis (300 ühikut 3 ml kohta).
English: Table 2 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given twice daily
Estonian: Tabel 2 Tulemused kahest 26-nädalasest II tüüpi diabeedi uuringust, kus Ryzodeg'i manustati kaks korda päevas.
English: Ryzodeg o.d.or b.i.d demonstrated similar glycaemic control (HbA1c) compared to IGlar o.d. plus IAsp 13 times daily after 38 weeks (the estimated mean reductions are -1.17% vs -1.26%).
Estonian: puhul glükeemiline kontroll (HbA1c) sarnane võrreldes IGlar o.d. pluss IAsp 1…3 korda ööpäevas manustamisel (hinnanguline keskmine vähenemine oli -1,17% vs -1,26%).
English: The half-life after subcutaneous administration of Ryzodeg is determined by the rate of absorption from the subcutaneous tissue.
Estonian: Ryzodeg'i subkutaansele manustamisele järgneva lõpliku poolväärtusaja määrab ära nahaaluskoest imendumise kiirus.
English: Difference: 0.05 [-0.10;0.20]
Estonian: Erinevus: 0,05 [-0,10; 0,20]
English: Get help from a person with good eyesight who is trained to use the pen.
Estonian: Küsige abi isikult, kellel on hea nägemine ja keda on FlexTouch pen-süstli kasutamise alal koolitatud.
English: )1 Insulin users
Estonian: Insuliini kasutajad
English: Ratio: 0.63 [0.49;0.81]
Estonian: Suhe: 0,63 [0,49; 0,81]
English: Table 1 Result from two 26-weeks' trials in type 2 diabetes mellitus with Ryzodeg given once daily
Estonian: Tabel 1 Tulemused kahest 26-nädalasest II tüüpi diabeedi uuringust, kus Ryzodeg'i manustati üks kord päevas
English: Keep the cartridges in the outer carton in order to protect from light.
Estonian: Hoida kolbampulli välispakendis valguse eest kaitstult.
English: Method of administration Subcutaneous use only.
Estonian: Ainult subkutaanseks kasutamiseks.
English: Difference: -0.05 [-0.18;0.08]
Estonian: Erinevus: -0,05 [-0,18; 0,08]
English: The frequency, type and severity of adverse reactions in the paediatric population do not indicate differences to the experience in the general diabetes population with the exception of a signal of higher occurrence of severe hypoglycaemia compared to a basalbolus regimen in the paediatric population, particularly in children 2 to 5 years old (see section 4.2, 4.4 and 5.1).
Estonian: Erandiks on signaal lastel raske hüpoglükeemia sagedasemast esinemusest võrreldes basaal-boolus raviskeemiga, eriti 2-kuni 5-aastaste laste vanuserühmas (vt lõigud 4.2, 4.4 ja 5.1).
English: Pen label
Estonian: Etikett
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) contained in a multidose disposable pre-filled pen made of polypropylene.
Estonian: 3 ml lahust kolvi (halobutüül) ja lamineeritud kummilehega (halobutüül/polüisopreen) kolbampullis (I tüüpi klaas), mis asub mitmeannuselises polüpropüleenist ühekordses pen-süstlis.
English: • If you want to change your usual diet, check with your doctor, pharmacist or nurse first as a change in diet may alter your need for insulin.
Estonian: • Kui soovite muuta tavapärast dieeti, pidage esmalt nõu oma arsti, apteekri või meditsiiniõega,
English: Ryzodeg 100 units/mL solution for injection in cartridge Before first use:
Estonian: Ryzodeg 100 ühikut/ml süstelahus kolbampullis Enne esmakordset kasutust:
English: Package leaflet: Information for the patient Ryzodeg 100 units/mL solution for injection in pre-filled pen
Estonian: Pakendi infoleht: teave patsiendile Ryzodeg 100 ühikut/ml süstelahus kolbampullis
English: There is no clinical experience with Ryzodeg during breast-feeding.
Estonian: Ryzodeg'i kasutamise kohta imetamise ajal puudub kliiniline kogemus.
English: Table 3 Result of a 26-weeks' trial in type 1 diabetes mellitus with Ryzodeg given once daily
Estonian: Tabel 3 26-nädalase I tüüpi diabeedi uuringu tulemus, kus Ryzodeg'i manustati üks kord ööpäevas
English: Ryzodeg 100 units/mL solution for injection in cartridge One cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Estonian: Ryzodeg 100 ühikut/ml süstelahus kolbampullis Üks kolbampull sisaldab 300 ühikut degludek-insuliini/aspart-insuliini 3 ml lahuses.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Ryzodeg 100 units/mL solution for injection in cartridge
Estonian: Ryzodeg 100 ühikut/ml süstelahus pen-süstlis Ryzodeg 100 ühikut/ml süstelahus kolbampullis
English: Fatty tissue under the skin may shrink (lipoatrophy) or get thicker (lipohypertrophy).
Estonian: Nahaalune rasvkude võib kahaneda (lipoatroofia) või pakseneda (lipohüpertroofia).
English: PC:
Estonian: s.c.
English: Injection site reactions (including injection site haematoma, pain, haemorrhage, erythema, nodules, swelling, discolouration, pruritus, warmth and injection site mass) occurred in patients treated with Ryzodeg.
Estonian: Ryzodeg'iga ravitud patsientidel esinesid süstekoha reaktsioonid (k.a verevalum süstekohal, valu, verejooks, erüteem, noodulid, turse, värvi muutus, kihelus, soojustunne ja süstekoha massi muutus).
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart FlexTouch
Estonian: Ryzodeg 100 ühikut/ml süstelahus 70% insulinum degludecum / 30% insulinum aspartum FlexTouch
English: Ryzodeg 100 units/mL solution for injection in cartridge 3 mL solution in a cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/polyisoprene) in a carton.
Estonian: 3 ml lahust kolvi (halobutüül) ja lamineeritud kummilehega (halobutüül/polüisopreen) kolbampullis (I tüüpi klaas), pakitud karpi.
English: Each cartridge contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Estonian: Üks kolbampull sisaldab 300 ühikut degludek-insuliini/aspart-insuliini 3 ml lahuses.
English: However, hypoglycaemia may develop over sequential stages if a patient is dosed with more insulin than required:
Estonian: Insuliini spetsiifiline liigannus ei ole määratletav, ent hüpoglükeemia võib areneda järk-järgult, kui manustatakse patsiendi vajadustega võrreldes liiga palju insuliini.
English: Each pre-filled pen contains 300 units of insulin degludec/insulin aspart in 3 mL solution.
Estonian: Üks pen-süstel sisaldab 300 ühikut degludek-insuliini/aspart-insuliini 3 ml lahuses.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen Solution for injection (FlexTouch).
Estonian: Ryzodeg 100 ühikut/ml süstelahus pen-süstlis Süstelahus (FlexTouch).
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING INNER CARTON FOR MULTIPACK (100 units/mL pre-filled pen (FlexTouch))
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED MITMIKPAKENDI KARP (100 ühikut/ml pen-süstel (FlexTouch))
English: Not known Lipodystrophy General disorders and administration site conditions Common
Estonian: Üldised häired ja manustamiskoha reaktsioonid Sage
English: Ryzodeg 100 units/mL solution for injection 70% insulin degludec / 30% insulin aspart Penfill
Estonian: Ryzodeg 100 ühikut/ml süstelahus 70% insulinum degludecum / 30% insulinum aspartum Penfill
English: Both treatments improved glycaemic control with an estimated mean reduction with Ryzodeg (-1.23%) against IDeg plus IAsp (-1.42%) for the primary endpoint of change from baseline in HbA1c at 26 weeks.
Estonian: Esmane tulemusnäitaja - HbA1c muutuse hinnanguline keskmine vähenemine 26 nädala jooksul oli Ryzodeg'iga (-1,23%) ning IDeg'i ja IAsp'iga (-1,42%).
English: Steady state will occur after 2-3 days of dose administration.
Estonian: Tasakaaluseisund saabub pärast annuse 2…3-päevast manustamist.
English: Insulins and analogues for injection, intermediateor long-acting combined with fast-acting, ATC code: A10AD06.
Estonian: ATC-kood: A10AD06.
English: 1 mL solution contains 100 units insulin degludec/insulin aspart* in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Estonian: 1 ml lahust sisaldab 100 ühikut degludek-insuliini/aspart-insuliini* suhtes 70/30 (vastab 2,56 mg degludek-insuliinile ja 1,05 mg aspart-insuliinile).
English: in patients with type 2 diabetes mellitus.
Estonian: Pioglitasoon - suukaudne diabeediravim II tüüpi suhkurtõve raviks.
English: 1 Once-daily regimen + insulin aspart to cover mealtime insulin requirements 2 Once- or twice-daily regimen + insulin aspart to cover mealtime insulin requirements 3 Confirmed hypoglycaemia was defined as episodes confirmed by plasma glucose < 3.1 mmol/L or by the patient needing third party assistance.
Estonian: 1 Kord-ööpäevas-režiim + aspart-insuliin söögiaegse insuliinivajaduse katmiseks 2 Kord- või kaks-korda-ööpäevas-režiim + aspart-insuliin söögiaegse insuliinivajaduse katmiseks
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Estonian: II LISA A. BIOLOOGILISTE TOIMEAINETE TOOTJAD JA RAVIMIPARTII KASUTAMISEKS VABASTAMISE EEST VASTUTAVAD TOOTJAD B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED D. RAVIMPREPARAADI OHUTU JA EFEKTIIVSE KASUTAMISE TINGIMUSED JA PIIRANGUD
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen The pre-filled pen (FlexTouch) is designed to be used with NovoFine/NovoTwist injection needles up to a length of 8 mm.
Estonian: Pen-süstel (FlexTouch) on mõeldud kasutamiseks kuni 8 mm pikkuste NovoFine/NovoTwist süstlanõeltega.
English: Injection site reactions Uncommon Peripheral oedema
Estonian: Dosaator Annuse nupp
English: Each mL of solution contains 100 units insulin degludec/insulin aspart in the ratio 70/30 (equivalent to 2.56 mg insulin degludec and 1.05 mg insulin aspart).
Estonian: 1 ml lahust sisaldab 100 ühikut degludek-insuliini/aspart-insuliini suhtes 70/30 (vastavalt 2,56 mg degludek-insuliini ja 1,05 mg aspart-insuliini).
English: Needles are not included Read the package leaflet before use.
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
English: Dose button with 3 lines
Estonian: 3 joonega süstenupp
English: Ryzodeg 100 units/mL solution for injection in cartridge 70% insulin degludec / 30% insulin aspart
Estonian: Ryzodeg 100 ühikut/ml süstelahus kolbampullis 70% insulinum degludecum / 30% insulinum aspartum
English: Ryzodeg 100 units/mL solution for injection in cartridge Solution for injection (Penfill).
Estonian: Ryzodeg 100 ühikut/ml süstelahus kolbampullis Süstelahus (Penfill).
English: Talk to your doctor, pharmacist or nurse before using Ryzodeg.
Estonian: Enne Ryzodeg'i kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega.
English: Ryzodeg 100 units/mL solution for injection in pre-filled pen 70% insulin degludec / 30% insulin aspart
Estonian: Ryzodeg 100 ühikut/ml süstelahus pen-süstlis 70% insulinum degludecum / 30% insulinum aspartum
English: Instructions on how to use Ryzodeg 100 units/mL solution for injection in pre-filled pen (FlexTouch)
Estonian: SÜSTLI ETIKETT (100 ühikut/ml pen-süstel (FlexTouch))
English: Vaccination should be postponed for people with a severe illness with fever.
Estonian: Vaktsineerimine tuleb edasi lükata patsientidel, kellel on palavikuga raske haigus.
English: The full EPAR for HBVaxPro can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Estonian: Euroopa avaliku hindamisaruande täistekst HBVaxPro kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This summary was last updated in 02-2011.
Estonian: Kokkuvõtte viimane uuendus: 04-2017.
English: This means that they are fixed onto aluminium compounds to help stimulate a better response.
Estonian: See tähendab, et nad on parema immuunvastuse tekitamiseks kinnitatud alumiiniumiühenditele.
English: HBVaxPro is available in two strengths (10 and 40 micrograms/ml).
Estonian: HBVaxProd turustatakse kahes tugevuses (10 ja 40 µg/ml).
English: Therefore, the Committee decided that HBVaxPro's benefits are greater than its risks and recommended that it be given marketing authorisation.
Estonian: Seetõttu otsustas inimravimite komitee, et HBVaxPro kasulikkus on suurem kui sellega kaasnevad riskid, ning soovitas anda vaktsiini müügiloa.
English: The surface antigens are also ‘adsorbed'.
Estonian: Pinnaantigeenid on ka adsorbeeritud.
English: The timing of injections depends on the patient's age, strength of the immune system, response to vaccination and likelihood of exposure to the hepatitis B virus.
Estonian: Süstimisajad sõltuvad patsiendi vanusest, immuunsüsteemi tugevusest, immuunvastusest vaktsineerimisele ja B-hepatiidi viirusega kokkupuute tõenäosusest.
English: This included the vaccines that contain the same active substance as HBVaxPro.
Estonian: Nende hulka kuulusid ka vaktsiinid, mis sisaldavad sama toimeainet kui HBVaxPro.
English: HBVaxPro hepatitis B vaccine (rDNA)
Estonian: B-hepatiidi vaktsiin (rDNA)
English: The European Commission granted a marketing authorisation valid throughout the European Union for HBVaxPro to Sanofi Pasteur MSD SNC on 27 April 2001.
Estonian: Euroopa Komisjon andis HBVaxPro müügiloa, mis kehtib kogu Euroopa Liidus, 27. aprillil 2001.
English: This helps to protect against infection with the hepatitis B virus.
Estonian: See aitab kaitsta B-hepatiidi viiruse nakkuse eest.
English: The most common side effects with HBVaxPro (seen in between 1 and 10 patients in 100) are reactions at the injection site, including temporary soreness, erythema (redness) and induration (hardening).
Estonian: HBVaxPro kõige sagedamad kõrvalnähud (esinenud 1-10 patsiendil 100st) on süstekoha reaktsioonid, sealhulgas ajutine valulikkus, erüteem (punetus) ja naha kõvenemine.
English: The CHMP concluded that the removal of thiomersal from vaccines did not reduce their effectiveness in protecting against hepatitis B virus infection, but reduced their risks.
Estonian: Inimravimite komitee järeldas, et tiomersaali väljajätmine vaktsiinidest ei vähendanud vaktsiinide efektiivsust B-hepatiidi viiruse eest kaitsmisel, kuid vähendas vaktsiinidega kaasnevaid riske.
English: A course of vaccination should include at least three injections of HBVaxPro.
Estonian: Vaktsineerimine peab koosnema vähemalt kolmest HBVaxPro süstist.
English: HBVaxPro should not be given to people who may be hypersensitive (allergic) to the active substance or any of the other ingredients including substances present at very low (trace) levels, such as formaldehyde and potassium thiocyanate, used in the manufacture of the vaccine.
Estonian: HBVaxProd ei tohi kasutada patsiendid, kes võivad olla vaktsiini toimeaine või mis tahes muu koostisaine, sh mikrokoguses sisalduvate ainete, näiteks vaktsiini tootmises kasutatavate formaldehüüdi ja kaaliumtiotsüanaadi suhtes ülitundlikud (allergilised).
English: When a person is given the vaccine, the immune system recognises the surface antigens as ‘foreign' and makes antibodies against them.
Estonian: Kui inimesele manustatakse vaktsiini, peab immuunsüsteem pinnaantigeene võõrasteks ja tekitab nende vastu antikehi.
English: This is a summary of the European public assessment report (EPAR) for HBVaxPro.
Estonian: See on vaktsiini HBVaxPro Euroopa avaliku hindamisaruande kokkuvõte.
English: The surface antigens in HBVaxPro are produced by a method known as ‘recombinant DNA technology': they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
Estonian: HBVaxPros sisalduvaid pinnaantigeene valmistatakse rekombinant-DNA-tehnika abil: neid toodab pärm, millele on lisatud nende proteiinide tootmist võimaldav geen (DNA).
English: Because the active substance used in HBVaxPro was already authorised for use in the EU, there have been no formal studies with HBVaxPro.
Estonian: Et HBVaxPros toimeainena sisalduval ainel on juba Euroopa Liidus kasutamiseks müügiluba, ei ole HBVaxProga eriuuringuid tehtud.
English: The results of the studies presented showed that the thiomersal-free vaccines produced protective levels of antibodies against hepatitis B virus to a similar extent to the vaccines that contained thiomersal at the end of the vaccination course.
Estonian: Esitatud uuringutulemuste järgi tekitasid tiomersaalita vaktsiinid vaktsineerimise lõpuks B-hepatiidi viiruse vastu kaitsval tasemel antikehi sarnasel määral kui tiomersaali sisaldavad vaktsiinid.
English: For more information about treatment with HBVaxPro, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate HBVaxProga toimuva vaktsineerimise kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: Other information about HBVaxPro
Estonian: Muu teave HBVaxPro kohta
English: The company provided information comparing other vaccines with and without thiomersal, including studies of a vaccine that contains the same active substance as HBVaxPro.
Estonian: Ettevõte esitas tiomersaaliga ja tiomersaalita vaktsiinide võrdlusteabe, sealhulgas uuringud vaktsiini kohta, mis sisaldab sama toimeainet kui HBVaxPro.
English: For the full list of all side effects reported with HBVaxPro, see the package leaflet.
Estonian: HBVaxPro kohta teatatud kõrvalnähtude täielik loetelu on pakendi infolehel.
English: HBVaxPro was specifically developed from a vaccine that was already in use in the European Union (EU), in order to produce a vaccine that does not contain the preservative thiomersal.
Estonian: HBVaxPro töötati spetsiaalselt välja Euroopa Liidus juba kasutusel olnud vaktsiinist, et toota säilitusaine tiomersaalita vaktsiini.
English: HBVaxPro is a vaccine.
Estonian: HBVaxPro on vaktsiin.
English: The higher strength (40 micrograms/ml) is used in patients who are undergoing or are about to undergo dialysis (a blood clearance technique).
Estonian: Väiksema tugevusega vaktsiini kasutatakse kõigil patsientidel, välja arvatud neil, kellele kavatsetakse teha või tehakse dialüüsi (teatud verepuhastusmeetod).
English: Why has HBVaxPro been approved?
Estonian: Miks HBVaxPro heaks kiideti?
English: HBVaxPro is used to vaccinate against hepatitis B in people who are at risk of exposure to the hepatitis B virus, as determined on the basis of official recommendations.
Estonian: HBVaxProd kasutatakse ametlike soovituste kohaselt nende inimeste vaktsineerimiseks B-hepatiidi vastu, kellel on B-hepatiidi viirusega kokkupuute oht.
English: What is the risk associated with HBVaxPro?
Estonian: Mis riskid HBVaxProga kaasnevad?
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 HBVaxPro.
Estonian: Selles selgitatakse, kuidas amet hindas vaktsiini, et soovitada müügiloa andmist Euroopa Liidus ja kasutustingimusi.
English: The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the viruses.
Estonian: Kui inimene puutub nende viirustega hiljem uuesti kokku, tekivad organismis antikehad kiiremini.
English: How does HBVaxPro work?
Estonian: Kuidas HBVaxPro toimib?
English: HBVaxPro is a vaccine, which is available as a suspension for injection in vials and pre-filled syringes.
Estonian: HBVaxProd turustatakse süstelahusena viaalides või eeltäidetud süstaldes.
English: HBVaxPro contains small amounts of ‘surface antigens' (proteins from the surface) of the hepatitis B virus.
Estonian: HBVaxPro sisaldab väikeses koguses B-hepatiidi viiruse pinnaantigeene (pinnavalke).
English: What benefit has HBVaxPro shown during the studies?
Estonian: Milles seisneb uuringute põhjal HBVaxPro kasulikkus?
English: How is HBVaxPro used?
Estonian: Kuidas HBVaxProd kasutatakse?
English: What is HBVaxPro used for?
Estonian: Mis on HBVaxPro ja milleks seda kasutatakse?
English: What is HBVaxPro?
Estonian: HBVaxPro
English: It contains parts of the hepatitis B virus as the active substance.
Estonian: HBVaxPro sisaldab toimeainena B-hepatiidi viiruse osi.
English: The marketing authorisation is valid for an unlimited period.
Estonian: Piirangute täielik loetelu on pakendi infolehel.
English: HBVaxPro is usually given as an injection into the muscle of the thigh in babies and infants, and of the shoulder in children, adolescents and adults.
Estonian: HBVaxPro ohutu ja efektiivse kasutamise soovitused ja ettevaatusmeetmed tervishoiutöötajatele ja patsientidele on lisatud ravimi omaduste kokkuvõttesse ja pakendi infolehele.
English: 27 March 2015 EMA/149624/2015
Estonian: 27. märts 2015 EMA/149624/2015
English: For similar reasons, it was recommended that the treatment duration should be as short as possible.
Estonian: Sarnastel põhjustel soovitati, et ravi kestus peab olema võimalikult lühike.
English: This potential risk was confirmed by clinical and post-marketing data.
Estonian: Seda potentsiaalset riski kinnitasid kliinilised ja turustamisjärgsed andmed.
English: Hydroxyzine-containing medicines have been authorised by national procedures in 22 Member States of the EU (Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Malta, Netherlands, Poland, Portugal, Slovakia, Spain, Sweden and United Kingdom) plus Norway and Iceland.
Estonian: Hüdroksüsiini sisaldavad ravimid on riiklike menetluste kaudu heaks kiidetud Euroopa Liidu 22 liikmesriigis (Austria, Belgia, Bulgaaria, Hispaania, Iirimaa, Itaalia, Kreeka, Küpros, Luksemburg, Madalmaad, Malta, Poola, Portugal, Prantsusmaa, Rootsi, Saksamaa, Slovakkia, Soome, Taani, Tšehhi Vabariik, Ungari ja Ühendkuningriik) ning Norras ja Islandil.
English: These medicines are available under various trade names including Atarax.
Estonian: Neid turustatakse eri kaubanduslike nimede all, sh Atarax.
English: The data showed that the risk did not differ between indications.
Estonian: Andmete järgi ei olnud risk eri näidustuste puhul erinev.
English: A letter explaining the changes will be sent to healthcare professionals.
Estonian: Tervishoiutöötajatele saadetakse muudatusi selgitav kiri.
English: The review of hydroxyzine was initiated on 25 April 2014 at the request of Hungary, under Article 31 of Directive 2001/83/EC.
Estonian: 25. aprillil 2014 algatati Ungari taotlusel hüdroksüsiini sisaldavate ravimite direktiivi 2001/83/EÜ artikli 31 kohane hindamine.