FrancophonIA/ELRC3.0 huggingface dataset:
English: • Limited immunogenicity data obtained three weeks after administration of a single dose of 0.25 ml or 0.5 ml to healthy children aged 10-17 years.
Estonian: • piiratud immunogeensuse andmed, mis on saadud kolm nädalat pärast (ühe 0,25 ml või 0,5 ml annuse manustamist tervetele lastele vanuses 10…17-aastat.
English: 3seroconversion factor (i.e. ratio of the post-vaccination GMT and the pre-vaccination GMT)
Estonian: 3 serokonversiooni faktor: vaktsineerimisjärgse ja vaktsineerimiseelse geomeetrilise keskmise tiitri
English: - two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber).
Estonian: - kahte pakendit, mis sisaldavad 25 (butüülkummist) korgiga viaali (I tüüpi klaas) 2,5 ml emulsiooniga (10 x 0,25 ml annust).
English: AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 * haemagglutinin
Estonian: Adjuvant AS03 sisaldab skvaleeni, DL-α-tokoferooli ja polüsorbaat 80.
English: Store in the original package in order to protect from light
Estonian: Mitte hoida sügavkülmas Hoida originaalpakendis valguse eest kaitstult
English: • Dizziness
Estonian: • Hingeldus
English: STATEMENT OF ACTIVE SUBSTANCE(S) Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
Estonian: Sisu: Adjuvant AS03 sisaldab skvaleeni (10,69 milligrammi), DL-α-tokoferooli (11,86 milligrammi) ja polüsorbaat 80 (4,86 milligrammi).
English: History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde and sodium deoxycholate) of this vaccine.
Estonian: Anamneesis anafülaktiline (eluohtlik) reaktsioon vaktsiini ükskõik millise koostisosa või jääkide (muna- ja kanavalk, ovalbumiin, formaldehüüd ja naatriumdeoksükolaat) suhtes.
English: Immunogenicity data obtained at three weeks after administration of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in clinical studies suggest that a single dose may be sufficient.
Estonian: Kliiniliste uuringute immunogeensuse andmed, mis on saadud kolm nädalat pärast AS03 sisaldava vaktsiini manustamist, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erinevat tootmisprotsessi kasutades, viitavad, et üksikannus võib olla piisav.
English: In this protection experiment, the ferrets (six ferrets/group) were immunized intramuscularly with vaccine candidate containing three different doses of H5N1 antigen (7.5, 3.8 and 1.9 µg of HA antigen) adjuvanted with the standard dose or half dose of AS03.
Estonian: Igas protektsiooni eksperimendis manustati kuuest tuhkrust koosnevale grupile lihasesiseselt AS03 adjuveeritud vaktsiini kandidaati, mis sisaldas kolme erinevat annust H5N1 antigeeni (7,5, 3,8 ja 1,9 µg HA antigeeni).
English: Total enrolled subjects N=120 [95% CI]
Estonian: Isikute koguarv N=120 [95% CI]
English: • Very limited safety and immunogenicity data obtained three weeks after a single administration of half the adult dose (i.e. 0.25 ml) to healthy children aged 3-9 years.
Estonian: • väga piiratud ohutuse ja immunogeensuse andmed, mis on saadud kolm nädalat pärast täiskasvanu annusest poole (st 0,25 ml) ühekordset manustamist tervetele lastele vanuses 3…9 aastat
English: In a clinical study that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received a single half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process, the frequency of the following adverse reactions was as shown in the table:
Estonian: Kliinilises uuringus hinnati reaktogeensust 3…5 ja 6…9-aastastel lastel, kes said ühekordselt pool täiskasvanu annust (st 0,25 ml) AS03 sisaldavat vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga, kõrvaltoimete esinemissagedus on toodud allolevas tabelis:
English: Seroconversion rate2
Estonian: Serokonversiooni määr2
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intramuscular use
Estonian: MANUSTAMISVIIS JA -TEE Intramuskulaarne
English: You should not receive Arepanrix:
Estonian: Mida on vaja teada enne Arepanrix'i kasutamist Ärge kasutage Arepanrix'i:
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Adjuvant emulsion for Arepanrix
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE Arepanrix adjuvandi süsteemulsioon i.m.
English: Excipients: Thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Estonian: Abiained: tiomersaal, naatriumkloriid, dinaatriumvesinikfosfaat, kaaliumdivesinikfosfaat, kaaliumkloriid, süstevesi
English: • Generalised skin reactions including facial swelling and urticaria (hives)
Estonian: • Generaliseerunud nahareaktsioonid, sh näoturse ja nõgestõbi
English: There are no safety and immunogenicity data available from clinical studies with Arepanrix or with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in children aged less than 6 months.
Estonian: Arepanrix'i või AS03 sisaldava vaktsiiniga, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga kliinilistest uuringutest puuduvad ohutuse ja immunogeensuse andmed alla 6 kuu vanuste laste kohta.
English: Excipients: Sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections
Estonian: Abiained: naatriumkloriid, dinaatriumvesinikfosfaat, kaaliumdivesinikfosfaat, kaaliumkloriid, süstevesi
English: Seronegative subjects prior to vaccination N=61 [95% CI]
Estonian: Seronegatiivsed isikud enne vaktsineerimist N=61 [95% CI]
English: Immune response to A/California/7/2009 (H1N1)v-like 6-11 months
Estonian: A/California/7/2009 (H1N1)v-sarnane immuunvastus 6…11 kuud
English: STATEMENT OF ACTIVE SUBSTANCE(S) After mixing, 1 dose (0.5 ml) contains:
Estonian: Pärast segamist sisaldab 1 annus (0,5 ml):
English: - abridged report for post dose 2 Waves 1 and 2 (immuno data, solicited and unsolicited symptoms, SAEs )
Estonian: - lühendatud raport 1 annuse ja 2 annuse järgselt (immunogeensuse andmed, väljendunud ja vähem väljendunud sümptomid, SAE)
English: Total enrolled subjects N=75 [95% CI]
Estonian: Isikute koguarv N=75 [95% CI]
English: After mixing, use the vaccine within 24 hours and do not store above 25°C.
Estonian: Pärast vaktsiini segamist: Pärast segamist tuleb vaktsiin säilitada temperatuuril kuni 25°C ja kasutada ära 24 tunni jooksul.
English: Drowsiness
Estonian: Uimasus
English: In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process:
Estonian: Lisaks kliinilistes uuringutes ilmnenud kõrvaltoimetele on AS03 sisaldava vaktsiini kohta, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga turustamisjärgselt teatatud järgmistest.kõrvaltoimetest:
English: • Shivering
Estonian: • Pearinglus
English: Uncommon: back pain, musculoskeletal stiffness, neck pain, muscle spasms, pain in extremity
Estonian: Aeg-ajalt: seljavalu, lihas-skeleti jäikus, kaelavalu, lihasspasmid, jäsemevalu
English: Reactogenicity was also evaluated in healthy adults aged 18-60 years who received a first 0.5 ml dose of either Arepanrix (H1N1) (N=167) or an AS03-containing vaccine containing HA from H1N1v manufactured using a different process (N=167).
Estonian: Teises kliinilises uuringus, kus reaktogeensust hinnati tervetel täiskasvanutel vanuses 18...60 aastat, kes said ühe annuse kas Arepanrix'i (H1N1) (N=167) või AS03 sisaldavat vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga (N=167), oli kõrvaltoimete esinemissagedus kahe grupi vahel sarnane.
English: Arepanrix suspension and emulsion for emulsion for injection Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Estonian: Arepanrix suspensioon ja emulsioon süsteemulsiooni valmistamiseks Pandeemiline gripiviiruse vaktsiin (H1N1) (inaktiveeritud purustatud viirus, adjuveeritud)
English: Prospective cohort: initiated 23 Oct 2009; First endpoints available in Feb
Estonian: Prospektiivne kohort uuring: alustatud 23.
English: Pharmacovigilance system
Estonian: Ravimi ohutusseire süsteem:
English: Children aged 3-9 years
Estonian: Lapsed vanuses 3...9 aastat
English: In a clinical study that evaluated the reactogenicity in children 10 to 17 years of age who received two 0.5 ml doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process, there was no increase in reactogenicity after the second dose compared to the first dose.
Estonian: Ühes kliinilises uuringus hinnati reaktogeensust 10…17-aastastel lastel, kes said AS03 sisaldavat vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga kaks 0,5 ml annust (21 päevaste vahedega), pärast teist annust ei täheldatud reaktogeensuse tõusu, võrreldes esimese annusega.
English: Pharmacovigilance The Applicant/MAH commits to establish the mechanisms to promptly investigate issues affecting the benefit-risk balance of the vaccine.
Estonian: MH kohustub koheselt uurima ilmnevaid ohutuse ja efektiivsuse probleeme, mis mõjutavad vaktsiini kasuriski suhet.
English: • Being sick, stomach pain, acid indigestion
Estonian: • Haiglane enesetunne, kõhuvalu,
English: Immune response to A/California/7/2009 (H1N1)v-like 61-70 years
Estonian: A/California/7/2009 (H1N1)v-sarnane immuunvastus 61...70-aastased
English: The side effects listed below have occurred during post-marketing surveillance with a similar vaccine (H1N1).
Estonian: Järgmised kõrvaltoimed on ilmnenud sarnase vaktsiini (H1N1) turustamisjärgsel kasutamisel: Need kõrvaltoimed võivad tekkida ka Arepanrix'iga.
English: After mixing with adjuvant emulsion: 10 doses of 0.5 ml
Estonian: Pärast segamist: 10 0,5 ml annust
English: Total enrolled subjects N=60 [95% CI]
Estonian: Isikute koguarv N=60 [95% CI]
English: In a clinical study that evaluated the reactogenicity of the first 0.5 ml dose of an AS03-containing vaccine containing HA from H1N1v manufactured using a different process in healthy adults aged 1860 (N=120) and above 60 years (N=120) the frequency of adverse reactions was similar between age groups, except for redness (more common in subjects aged >60 years) and shivering and sweating (more common in subjects aged 18-60 years).
Estonian: Kliinilises uuringus hinnati AS03 sisaldava vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga esimese 0,5 ml annuse reaktogeensust tervetel täiskasvanutel vanuses 18…60 (N=120) ja üle 60-aastastel (N=120).
English: Immune response to A/California/7/2009 (H1N1)v-like 3-5 years
Estonian: A/California/7/2009 (H1N1)v-sarnane immuunvastus 3…5-aastased
English: Total enrolled subjects N=30 [95% CI]
Estonian: Isikute koguarv N=30 [95% CI]
English: Children aged 3 to 9 years
Estonian: Lapsed vanuses 3…9 aastat
English: Seronegative subjects prior to vaccination N=43 [95% CI]
Estonian: Seronegatiivsed isikud enne vaktsineerimist N=43 [95% CI]
English: OTHER SPECIAL WARNING(S), IF NECESSARY Suspension to be exclusively mixed with adjuvant emulsion before administration
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) Enne manustamist tuleb suspensioon segada adjuvantemulsiooniga
English: Post dose
Estonian: Pärast annust
English: Common: nausea, diarrhoea
Estonian: Sage: iiveldus, kõhulahtisus
English: Seronegative subjects prior to vaccination N=29 [95% CI]
Estonian: Seronegatiivsed isikud enne vaktsineerimist N=29 [95% CI]
English: Pain
Estonian: Turse
English: • Generally feeling unwell
Estonian: • Üldine halb ja haiglane enesetunne
English: Seronegative subjects prior to vaccination N=27 [95% CI]
Estonian: Seronegatiivsed isikud enne vaktsineerimist N=27 [95% CI]
English: - abridged report for post dose 1 Wave 1 immuno data, solicited and unsolicited symptoms, SAEs )
Estonian: - lühendatud raport 1. annuse järgselt, 1 laine(immunogeensuse andmed, väljenunud ja vähem väljendunud sümptomid, SAE )
English: Total enrolled subjects N=5 [95% CI]
Estonian: Isikute koguarv N=5 [95% CI]
English: • if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any ingredient contained in the vaccine, to thiomersal, to egg and chicken protein, ovalbumin, formaldehyde or to sodium deoxycholate.
Estonian: • kui teil on tekkinud allergiline reaktsioon mõne vaktsiini koostisosa, näiteks nagu tiomersaali, muna- või kanavalgu, ovalbumiini, formaldehüüdi, gentamütsiinsulfaadi (antibiootikum) või naatriumdeoksükolaadi suhtes (vt lõik 6.
English: Total enrolled subjects N=40 [95% CI]
Estonian: Isikute koguarv N=40 [95% CI]
English: However, in another clinical study which evaluated reactogenicity in children 3 to 9 years who received two adult (i.e. 0.5 ml) doses (21 days apart) of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose.
Estonian: Kuid ühe kliinilises uuringus, kus hinnati 3…9-aastaste laste reaktogeensust pärast kahte täiskasvanu annuse (st 0,5 ml) AS03 sisaldava vaktsiini manustamist, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga saamist (21päevaste vahedega), täheldati süstekohareaktsioonide ja üldise sümptomaatika suurenenud esinemissagedust pärast teist annust võrreldes esimese annusega.
English: • Post-marketing surveillance
Estonian: • Müügiloa saamise järgsed andmed
English: Non-clinical data obtained with a version of Arepanrix containing 3.75 µg HA derived from A/Indonesia/05/2005 (H5N1) reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Estonian: Farmakoloogilise ohutuse, ägeda ja kroonilise toksilisuse, lokaalse taluvuse, emaslooma fertiilsuse, embrüo/loote ja postnataalse toksilisuse (kuni laktatsiooni perioodi lõpuni) konventsionaalsetes uuringutes, kus kasutati Arepanrix'i versiooni, mis sisaldab 3,75 µg HA tuletatud A/Indonesia/05/2005 (H5N1) tüvega mudelvaktsiini, saadud mittekliinilised andmed ei ole näidanud kahjulikku toimet inimesele.
English: In a clinical study in healthy children 6 months to 35 months of age (stratified in ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a first and a second half adult dose (i.e. 0.25 ml) were as follows:
Estonian: Ühes teises kliinilises uuringus hinnati immunogeensust 6...35 kuu vanustel tervetel lastel (stratifitseeritud vanusevahemikes 6 kuni 11, 12 kuni 23 ja 24…35 kuud), kellele manustati pool täiskasvanu annusest.
English: Gastrointestinal disorders
Estonian: Artralgia Müalgia Väsimus
English: Total enrolled subjects N=59 [95% CI]
Estonian: Isikute koguarv N=59 [95% CI]
English: Timelines described in the RMP
Estonian: Ajakava on kirjeldatud riskiohjamise plaanis
English: Split influenza virus, inactivated, containing antigen* equivalent to: A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms** per 0.5 ml dose *propagated in eggs ** expressed in microgram haemagglutinin
Estonian: Inaktiveeritud purustatud gripiviirus, mille antigeeni* sisaldus on ekvivalentne: 3,75 mikrogrammi** A/California/7/2009 (H1N1)v-sarnane viirus * kultiveeritud kanamunades ** hemaglutiniin
English: Two clinical studies evaluated the immunogenicity of a half (0.25 ml) dose and a full (0.5 ml) adult dose in healthy children 10 to 17 years of age.
Estonian: Ühes kliinilises uuringus hinnati terve täiskasvanute annuse immunogeensust tervetel lastel vanuses 10...17 aastat).
English: Pandemic influenza vaccine should be used in accordance with Official Guidance.
Estonian: Gripi profülaktika ametlikult välja kuulutatud pandeemia korral.
English: Gastro-intestinal symptoms and shivering were at a higher rate in the children 10-17 years of age.
Estonian: Lastel vanuses 10...17 aastat teatati gastrointestinaalsete sümptomite ja värinate suurenenud esinemissagedusest.
English: No data are available at present on reactogenicity after a second half adult (i.e. 0.25 ml) dose of an AS03-containing vaccine containing HA from H1N1 manufactured using a different process in children aged 3 to 9 years.
Estonian: Praeguseks ei ole 3…9-aastastel lastel AS03 sisaldava vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga teise poole täiskasvanu annuse (st 0,25 ml) järgse reaktogeensuse kohta veel andmed saadaval.
English: Seronegative subjects prior to vaccination N=23 [95% CI]
Estonian: Seronegatiivse d isikud enne vaktsineerimis t N=23 [95% CI]
English: - abridged report for post dose 3 (immuno & solicited and unsolicited symptoms, SAEs)
Estonian: - lühendatud raport 3 annuse järgselt (immunogeensuse andmed, väljendunud ja vähem väljendunud sümptomid, SAE)
English: The Applicant/MAH commits to provide abridged report for the following study performed in children Study Q-Pan H1N1-031 (9-17 yrs, Safety/ Immunogenicity) - abridged report for post dose 1 & post dose 2 (immuno & solicited and unsolicited symptoms, SAEs )
Estonian: Uuring Q-Pan H1N1-032 (2…5 kuused, Ohutus/ Immunogeensus) - lühendatud raport 1 annuse ja 2 annuse järgselt (immunogeensuse andmed, väljendunud ja vähem väljendunud sümptomid, SAE)
English: Very common: • Pain at the injection site
Estonian: Väga sage: valu süstekohas, väsimus
English: Immune response to A/California/7/2009 (H1N1)v-like D-Pan H1N1-007
Estonian: A/California/7/2009 (H1N1)v-sarnane immuunvastus
English: Redness
Estonian: Annustamine
English: Antigen suspension for injection 50 vials: suspension
Estonian: Antigeeni süstesuspensioon 50 viaali: suspensioon 2,5 ml/viaal.
English: PHARMACEUTICAL PARTICULARS
Estonian: RAVIMPREPARAADI NIMETUS
English: Ear and labyrinth disorders Uncommon: vertigo
Estonian: Kõrva ja labürindi kahjustused Aeg-ajalt: vertiigo
English: The other ingredients are: thiomersal, sodium chloride, disodium hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, water for injections What Arepanrix looks like and contents of the pack
Estonian: Abiained on: polüsorbaat 80, oktoksünool 10, tiomersaal, naatriumkloriid (NaCl), dinaatriumvesinikfosfaat, kaaliumdivesinikfosfaat, kaaliumkloriid, magneesiumkloriid, süstevesi.
English: There are no data with Arepanrix using the subcutaneous route.
Estonian: Puuduvad andmed kasutamise kohta subkutaanselt.
English: Clinical studies with an AS03-containing vaccine containing HA from H1N1v manufactured using a different process currently provide:
Estonian: AS03 sisaldava vaktsiini, mis sisaldab HA, mis on tuletatud H1N1v tüvest ja toodetud erineva tootmisprotsessiga kliinilistest uuringutest on käesoleval ajal saadaolevad andmed järgmised:
English: • Very limited safety and immunogenicity data obtained three weeks after administration of a single dose to healthy adults aged over 80 years.
Estonian: • väga piiratud ohutuse ja immunogeensuse andmed, mis on saadud kolm nädalat pärast ühe 0,25 ml või 0,5 ml annuse manustamist tervetele täiskasvanutele vanuses üle 80 aasta.
English: Seronegative subjects prior to vaccination N=3 [95% CI]
Estonian: Seronegatiivse d isikud enne vaktsineerimis t N=3 [95% CI]
English: Loss of appetite
Estonian: Isu puudus
English: NAME OF THE MEDICINAL PRODUCT Suspension for emulsion for injection for Arepanrix Pandemic influenza vaccine (H1N1) (split virion, inactivated, adjuvanted)
Estonian: Suspensioon Arepanrix'i süsteemulsiooni valmistamiseks Pandeemilise gripi vaktsiin (H1N1) (inaktiveeritud purustatud viirus, adjuveeritud) i.m.
English: • Aching muscles, joint pain
Estonian: • Lihase-, liigesevalu
English: The emulsion presents as a whitish appearance.
Estonian: Kaasasolev emulsioon on valkja värvusega.
English: Full dose
Estonian: Kõrvaltoime
English: The full EPAR for Zoledronic acid Teva 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 Zoledronic acid Teva kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: A risk management plan has been developed to ensure that Zoledronic acid Teva is used as safely as possible.
Estonian: Töötati välja riskijuhtimiskava, et tagada ravimi Zoledronic acid Teva võimalikult ohutu kasutamine.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zoledronic acid Teva on 16 August 2012.
Estonian: Euroopa Komisjon andis ravimi Zoledronic acid Teva müügiloa, mis kehtib kogu Euroopa Liidu territooriumil, 16. augustil 2012.
English: It is available as a concentrate (4 mg/5 ml) to be used to make a solution for infusion (drip) into a vein, and as a solution for infusion (4 mg/100 ml).
Estonian: Seda turustatakse infusioonilahuse (veeni tilgutatava lahuse) kontsentraadina (4 mg/5 ml) ja infusioonilahusena (4 mg/100 ml).
English: What measures are being taken to ensure the safe and effective use of Zoledronic acid Teva?
Estonian: Mis meetmed võetakse, et tagada ravimi Zoledronic acid Teva ohutu ja efektiivne kasutamine?
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 Zoledronic acid Teva.
Estonian: Selles selgitatakse, kuidas inimravimite komitee hindas ravimit ja otsustas toetada müügiloa andmist; samuti esitatakse komitee soovitused, kuidas ravimit kasutada.
English: For more information about treatment with Zoledronic acid Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Estonian: Kui vajate ravimiga Zoledronic acid Teva toimuva ravi kohta lisateavet, lugege palun pakendi infolehte (mis on samuti Euroopa avaliku hindamisaruande osa) või pöörduge oma arsti või apteekri poole.
English: This includes fractures (breaks in the bone), spinal compression (when the spinal cord is compressed by the bone), bone disorders needing radiotherapy (treatment with radiation) or surgery, and hypercalcaemia (high levels of calcium in the blood).
Estonian: Luutüsistused on näiteks luumurrud, seljaaju kompressioon (seljaaju pitsumine luude vahel), kiiritusravi või kirurgilist sekkumist vajavaid luukahjustused ja hüperkaltseemia (vere liigne kaltsiumisisaldus).
English: No additional studies were needed as Zoledronic acid Teva is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Zometa.
Estonian: Lisauuringuid ei olnud vaja, sest Zoledronic acid Teva on infusioonina manustatav geneeriline ravim, mis sisaldab sama toimeainet kui võrdlusravim Zometa.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zoledronic acid Teva, including the appropriate precautions to be followed by healthcare professionals and patients.
Estonian: Selle alusel lisati ravimi Zoledronic acid Teva omaduste kokkuvõttesse ja pakendi infolehele ravimi ohutusteave, kus on ka tervishoiuspetsialistide ja patsientide võetavad meetmed.
English: The usual dose of Zoledronic acid Teva is one infusion of 4 mg over at least 15 minutes.
Estonian: Ravimi Zoledronic acid Teva tavaannus on 4 mg, mida manustatakse ühe infusioonina vähemalt 15 minuti jooksul.
English: The CHMP concluded that, in accordance with EU requirements, Zoledronic acid Teva has been shown to be comparable to Zometa.
Estonian: Inimravimite komitee järeldas, et vastavalt Euroopa Liidu nõuetele on tõendatud ravimi Zoledronic acid Teva võrreldavus ravimiga Zometa.
English: This means that Zoledronic acid Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zometa.
Estonian: See tähendab, et ravim Zoledronic acid Teva on sarnane võrdlusravimiga Zometa, millel juba on Euroopa Liidus müügiluba.