FrancophonIA/ELRC3.0 huggingface dataset:
English: • Pain in the mouth, teeth and/or jaw, swelling or non-healing sores inside the mouth or jaw, discharge, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Estonian: Valu suus, hammastes ja/või lõualuus, paistetus või mitteparanevad villid suuõõnes või lõuapiirkonnas, tuimus või raskustunne lõualuus või hamba loksuma hakkamine.
English: • Severe bone, joint and/or muscle pain, occasionally incapacitating.
Estonian: Tugev luu-, liiges- ja/või lihasvalu, mõnikord teovõimetuks tegev.
English: Patients who are undergoing chemotherapy and/or radiotherapy, who are taking steroids, who are undergoing dental surgery, who do not receive routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent bone disorders) may have higher risk of developing osteonecrosis of the jaw.
Estonian: Kõrgem lõualuu osteonekroosi tekkerisk on patsientidel, kellel on käimas keemiaravi ja/või kiiritusravi, kes kasutavad kortikosteroide, kellele tehakse kirurgilist hambaravi, kes ei hoolitse regulaarselt hammast eest, kellel on igemehaigus, kes on suitsetajad või kes on varem saanud ravi bisfosfonaatidega (kasutatakse luuhaiguste raviks või ennetamiseks).
English: • Studies with several types of infusion lines made from polyvinylchloride, polyethylene and polypropylene showed no incompatibility with Zoledronic Acid Accord.
Estonian: Erinevat tüüpi infusioonisüsteemidega - polüvinüülkloriidist, polüetüleenist ja polüpropüleenist läbi viidud uuringutes ei ilmnenud sobimatust Zoledronic acid Accordiga.
English: Based on the review of both clinical trial and post-marketing cases, there is sufficient evidence to support an association between zoledronic acid therapy, the reported event of hypocalcaemia, and the secondary development of cardiac arrhythmia.
Estonian: Nii kliinilistes uuringutes kui turuletulekujärgselt kirjeldatud juhtude põhjal on piisavalt tõendeid, mis toetavad seost zoledroonhapperavi, kirjeldatud hüpokaltseemia ja sekundaarselt tekkinud südame arütmiate vahel.
English: Baseline creatinine clearance (ml/min) Zoledronic acid recommended dose* 4.0 mg zoledronic acid 3.5 mg* zoledronic acid 3.3 mg* zoledronic acid 3.0 mg* zoledronic acid * Doses have been calculated assuming target AUC of 0.66 (mg-hr/l) (CLcr = 75 ml/min).
Estonian: Zoledroonhappe soovitatav annus* 4,0 mg zoledroonhapet 3,5 mg* zoledroonhapet 3,3 mg* zoledroonhapet 3,0 mg* zoledroonhapet *annused on arvestatud lähtuvalt soovitavast AUC väärtusest 0,66 (mg•h/l) (CLcr = 75 ml/min).
English: • The other ingredients are: mannitol, sodium citrate, water for injections.
Estonian: Teised koostisosad on: mannitool, naatriumtsitraat, süstevesi.
English: You must not be given Zoledronic Acid Accord if you are breast-feeding.
Estonian: Te ei tohi kasutada Zoledronic acid Accordi: kui toidate last rinnaga.
English: When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Estonian: Hulgimüeloomi või soliidtuumori luumetastaasidega patsientide ravi alustamisel zoledroonhappega tuleb määrata seerumi kreatiniinisisaldus ja kreatiniinikliirens (CLcr).
English: • Zoledronic Acid Accord must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Estonian: Zoledronic acid Accordi võivad manustada ainult bisfosfonaatide intravenoosse, s.t veeni kaudu, manustamise koolituse läbinud tervishoiutöötajad.
English: In patients with mild to moderate renal impairment, reduced zoledronic acid doses are recommended (see section “Posology” above and section 4.4).
Estonian: Kerge või mõõduka neerukahjustusega patsientidele on soovitatav manustada madalamaid zoledroonhappe annuseid (vt alalõik „Annustamine“ ülal ja lõiku 4.4).
English: Zoledronic Acid Accord contains the same active substance as found in Aclasta (zoledronic acid).
Estonian: Zoledronic acid Accord sisaldab sama toimeainet, mis Aclasta (zoledroonhapet).
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Accord and will check your response to treatment at regular intervals.
Estonian: Enne Zoledronic acid Accordiga -ravi alustamist teeb arst vereanalüüsid ja kontrollib regulaarsete intervallide järel teie ravivastust.
English: The onset time is ≤ 3 days post-zoledronic acid infusion, and the reaction is also referred to using the terms “flu-like” or “post-dose” symptoms.
Estonian: Sümptomid võivad tekkida maksimaalselt kolme päeva jooksul pärast zoledroonhappe infundeerimist ja reaktsiooni nimetatakse ka gripilaadseteks või annustamisjärgseteks sümptomiteks.
English: Patients treated with Zoledronic Acid Accord should be given the package leaflet and the patient reminder card. Posology
Estonian: Zoledronic acid Accord'iga ravi saavatele patsientidele tuleb anda pakendi infoleht ja patsiendi meeldetuletuskaart.
English: The active substance in Zoledronic Acid Accord is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Estonian: Zoledronic acid Accordi toimeaine on zoledroonhape, mis kuulub bisfosfonaatideks nimetatud ravimite rühma.
English: • if you have or have had pain, swelling or numbness of the jaw, a feeling of heaviness in the jaw or loosening of a tooth.
Estonian: teil on olnud või on lõualuu valu, turse või tuimus, raskustunne lõualuus või hammaste logisemine.
English: Zoledronic acid should only be resumed when serum creatinine returns to within 10% of baseline.
Estonian: Zoledroonhapperavi võib jätkata vaid siis, kui seerumi kreatiniinisisaldus ei erine rohkem kui 10% algväärtusest.
English: Instructions for preparing reduced doses of Zoledronic Acid Accord: Withdraw the appropriate volume of the liquid concentrate, as follows: o 4.4 ml for 3.5 mg dose o 4.1 ml for 3.3 mg dose o 3.8 ml for 3.0 mg dose
Estonian: Juhend vähendatud annusega Zoledronic acid Accordi lahuse valmistamiseks Võtke kontsentraadi vajalik kogus järgmiselt: 4,4 ml lahust 3,5 mg annuse valmistamiseks 4,1 ml lahust 3,3 mg annuse valmistamiseks
English: • Zoledronic Acid Accord is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Estonian: - Zoledronic acid Accordi manustatakse veeninfusiooni teel, mis peab kestma vähemalt 15 minutit ja peab manustama üksiku intravenoosse lahusena eraldi infusioonivooliku kaudu.
English: In one 3-year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Estonian: Ühes kolmeaastases randomiseeritud topeltpimedas kontrollitud uuringus, kus uuriti üks kord aastas manustatud 5 mg zoledroonhappe efektiivsust ja ohutust postmenopausaalse osteoporoosi (PMO) ravis võrreldes platseeboga, oli kodade virvendusarütmia üldine esinemissagedus 5 mg zoledroonhapet või platseebot saanud patsientide seas vastavalt 2,5% (96 patsiendil 3862-st) ja 1,9% (75 patsiendil 3852st).
English: Do not mix Zoledronic Acid Accord concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.
Estonian: Ärge lahjendage Zoledronic acid Accordi kontsentraati kaltsiumi või muid bivalentseid katioone sisaldava lahusega, nt Ringeri laktaatlahusega.
English: Zoledronic acid was teratogenic in the rat at subcutaneous doses  0.2 mg/kg.
Estonian: Zoledroonhape osutus teratogeenseks kasutatuna rottidel subkutaanselt annuses  0,2 mg/kg.
English: EXP Use immediately after dilution.
Estonian: Kasutada koheselt pärast lahjendamist.
English: Prior to administration, 5ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution).
Estonian: Enne manustamist tuleb ühest viaalist 5 ml kontsentraati või nõutavas koguses väljatõmmatud kontsentraati lahjendada 100 ml kaltsiumit mittesisaldava infusioonilahusega (0,9% naatriumkloriidi süstelahusega või 5% glükoosilahusega).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING FOLDING BOX
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KOKKUVOLDITAV KARP
English: • Interstitial lung disease (inflammation of the tissue around the air sacks of the lungs)
Estonian: Interstitsiaalne kopsuhaigus (kopsude õhumahutite ümber oleva koe põletik).
English: The renal clearance of zoledronic acid was correlated with creatinine clearance, renal clearance representing 75 ± 33% of the creatinine clearance, which showed a mean of 84 ± 29 ml/min (range 22 to 143 ml/min) in the 64 cancer patients studied.
Estonian: Zoledroonhappe renaalne kliirens oli sõltuvuses kreatiniini kliirensist, olles viimasest 75  33% ja oli 64 vähihaigega uuringus keskmiselt 84  29 ml/min (vahemikus 22…143 ml/min).
English: For instructions on the dilution of zoledronic acid before administration, see section 6.6.
Estonian: Zoledroonhappe lahjendamise juhised vt lõik 6.6.
English: • Low level of magnesium and potassium in the blood.
Estonian: Madal magneesiumi- ja kaaliumisisaldus veres.
English: • To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Accord concentrate (5ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Estonian: Zoledroonhappe 4 mg sisaldusega infusioonilahuse valmistamiseks lahjendage Zoledronic acid Accordi kontsentraati (5 ml) edasi 100 ml kaltsiumi või muid bivalentseid katioone mittesisaldava infusioonilahusega.
English: • High blood pressure, shortness of breath, dizziness, anxiety, sleep disturbances, taste disturbances, trembling, tingling or numbness of the hands or feet, diarrhoea constipation,
Estonian: Kõrge vererõhk, õhupuudus, pearinglus, ärevus, unehäired, maitsetundlikkuse häired, värinad, käte või jalgade surisemine või tuimus, kõhulahtisus, kõhukinnisus, kõhuvalu, suukuivus..
English: • Slow heart beat.
Estonian: Aeglane südametegevus.
English: What Zoledronic Acid Accord looks like and contents of the pack Zoledronic Acid Accord is supplied as a liquid concentrate in a vial.
Estonian: Kuidas Zoledronic acid Accord välja näeb ja pakendi sisu Zoledronic acid Accordi turustatakse viaalides, milles on pulber.
English: This medicinal product must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Estonian: Seda ravimit ei või segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja peab manustama üksiku intravenoosse lahusena eraldi infusioonivooliku kaudu.
English: * Includes vertebral and non-vertebral fractures ** Accounts for all skeletal events, the total number as well as time to each event during the trial NR-Not Reached
Estonian: * sh vertebraal- ja mittevertebraalmurrud ** Arvestades kõiki luustikuga seotud tüsistusi, nii koguarv kui ka aeg tüsistuse tekkeni uuringu jooksul
English: In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%).
Estonian: Nende uuringute ohutusandmete kokkuvõtvas analüüsis oli tõenäoliselt zoledroonhappest tingitud neerukahjustusega seotud kõrvalnähtude (kõrvaltoimete) sagedus järgmine: hulgimüeloom (3,2%), eesnäärmevähk (3,1%), rinnavähk (4,3%), kopsu- ja teised soliidtuumorid (3,2%).
English: • The solution containing zoledronic acid is given as a single 15-minute intravenous infusion in a separate infusion line.
Estonian: Zoledroonhappe lahus manustatakse ühekordse 15-minutilise veenisisese infusioonina eraldi infusioonivooliku kaudu.
English: • Flu-like symptoms including arthritis and joint swelling.
Estonian: Gripilaadsed sümptomid, sealhulgas artriit ja turse liigestes.
English: Patients must be assessed prior to administration of zoledronic acid to ensure that they are adequately hydrated.
Estonian: Enne zoledroonhappe manustamist tuleb jälgida, et patsient oleks piisavalt hüdreeritud.
English: • If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Zoledronic Acid Accord.
Estonian: - Kui teid ravitakse vere kaltsiumisisalduse vähendamiseks, manustatakse teile üldjuhul ainult üks
English: 4.2 Posology and method of administration Zoledronic Acid Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Estonian: Zoledronic acid Accordi võivad patsientidele määrata ja manustada ainult intravenoosse bisfosfonaadi manustamises kogenud tervishoiutöötajad.
English: Zoledronic acid has been associated with reports of renal dysfunction.
Estonian: Zoledroonhappe manustamise korral on teatatud neerufunktsiooni häiretest.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks 5 ml kontsentraadiga viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: N Proportion of patients with SREs p-value Median time to SRE (days)
Estonian: Patsientide arv Patsiente LSTdega (%) p-väärtus Keskmine aeg LSTni (päevad)
English: NR NR
Estonian: Partii nr:
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Estonian: Müügiloa hoidja ja tootja Müügiloa hoidja
English: • Urticaria.
Estonian: Kehakaalutõus.
English: Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Estonian: Tuumorist indutseeritud hüperkaltseemia (TIH) täiskasvanud patsientidel.
English: Zoledronic Acid Accord concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer's solution, and should be administered as a single intravenous solution in a separate infusion line.
Estonian: Zoledronic acid Accordi kontsentraati ei tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja seda tuleb manustada ühe intravenoosse lahusena eraldi infusioonivooliku kaudu.
English: Cases of osteonecrosis of the jaw have been reported, predominantly in cancer patients treated with medicinal products that inhibit bone resorption, such as zoledronic acid (see section 4.4).
Estonian: Luuresorbtsiooni inhibeerivate ravimitega, nagu zoledroonhape, ravitud patsientidel, peamiselt vähihaigetel, on teatatud lõualuu osteonekroosi tekkest (vt lõik 4.4).
English: A dental examination with appropriate preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with bisphosphonates in patients with concomitant risk factors.
Estonian: Kaasuvate riskifaktoritega patsienditel on soovitatav enne zoledroonhappe-ravi alustamist teha asjakohane hammaste läbivaatus koos ennetava hambaraviga ning individuaalne kasu-riski hindamine.
English: Blood and lymphatic system disorders
Estonian: Vere ja lümfisüsteemi häired sage:
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy) Any SRE (+TIH)
Estonian: Tabel 2: Kliinilise uuringu tulemuste kokkuvõte (hormoonravi saavad prostatavähi patsiendid)
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoasthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Estonian: Teatatud on ka südame arütmiatest ja neuroloogilistest kõrvaltoimetest (sh krambid, hüpoesteesia ja tetaania), mis tekkisid sekundaarselt ägedate hüpokaltseemia juhtude tagajärjel.
English: What Zoledronic Acid Accord contains
Estonian: Mida Zoledronic acid Accord sisaldab
English: In a second study including solid tumours other than breast or prostate cancer, zoledronic acid 4 mg significantly reduced the proportion of patients with an SRE, delayed the median time to first SRE by > 2 months, and reduced the skeletal morbidity rate.
Estonian: Teises uuringus patsientidel, kellel olid soliidtuumorid (v.a. prostata- ja rinnavähk), vähendas 4 mg zoledroonhappe kasutamine oluliselt LST'de arvu ja pikendas aega esimese LST-ni > 2 kuu võrra ning vähendas LST juhtude arvu patsiendi kohta aastas.
English: How Zoledronic Acid Accord is used 4.
Estonian: Kuidas Zoledronic acid Accordi kasutada 4.
English: • Since no data are available on the compatibility of Zoledronic Acid Accord with other intravenously administered substances, Zoledronic Acid Accord must not be mixed with other medications/substances and should always be given through a separate infusion line.
Estonian: Andmeid Zoledronic acid Accordi sobivusest manustamiseks koos teiste veenisiseselt manustatavate ainetega on ebapiisavalt, seetõttu ei tohi Zoledronic acid Accordi segada teiste ravimite/ainetega ja selle manustamiseks tuleb kasutada eraldi infusioonisüsteemi.
English: In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CLcr 30-60 ml/min, the following zoledronic acid dose is recommended (see also section 4.4):
Estonian: Kerge kuni keskmise neerupuudulikkusega luumetastaasidega patsientidele kreatiniinikliirensiga 30…60 ml/min on ravi alustamiseks soovitatavad järgmised zoledroonhappe annused (vt lõik 4.4):
English: • The active substance is zoledronic acid.
Estonian: Toimeaine on zoledroonhape.
English: Renal impairment TIH:
Estonian: Südame häired aeg-ajalt:
English: • Chest pain.
Estonian: Valu rinnus.
English: To avoid potential incompatibilities, Zoledronic Acid Accord concentrate is to be diluted with 0.9% w/v sodium chloride solution for Injection or 5% w/v glucose solution.
Estonian: Sobimatuse vältimiseks Zoledronic acid Accordi kontsentraat tuleb lahjendada 0,9% naatriumkloriidi süstelahusega või 5% glükoosilahusega.
English: How to prepare and administer Zoledronic Acid Accord
Estonian: Kuidas valmistada ja manustada Zoledronic acid Accordi?
English: Mean changes from baseline in BPI scores.
Estonian: BPI skoori keskmised muutused algväärtusest.
English: 5-ml plastic vial made of clear, cycloolefine copolymer with chlorobutyl rubber stopper and aluminium cap with flip-off component.
Estonian: Läbipaistvast tsükloolefiinkopolümeerist valmistatud 5 ml viaal klorobutüülkummist punnkorgi ja pealt äratõmmatava alumiiniumkorgiga.
English: The following properties have been demonstrated in preclinical studies: In-vivo: Inhibition of osteoclastic bone resorption, which alters the bone marrow microenvironment, making it less conducive to tumour cell growth, anti-angiogenic activity and anti-pain activity.
Estonian: In vivo: osteoklastilise luuresorptsiooni inhibeerimine, mille tulemusena muutub luuüdi mikrokeskkond tuumori rakkude kasvuks ebasoodsamaks; antiangiogeenne toime; valuvaigistav toime.
English: The rate of atrial fibrillation serious adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Estonian: Kodade virvendusarütmia tõsiste kõrvaltoimete esinemissagedus oli 5 mg zoledroonhapet või platseebot saanud patsientide seas vastavalt 1,3% (51 patsiendil 3862-st) ja 0,6% (22 patsiendil 3852st).
English: Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CLcr < 30 ml/min.
Estonian: Zoledroonhapet ei soovitata kasutada raske neerupuudulikkusega patsientidel, kellel kreatiniinikliirens on < 30 ml/min.
English: The withdrawn amount of concentrate must be further diluted in 100 ml of sterile 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Estonian: Vajaliku annuse valmistamiseks võetud kontsentraati tuleb edasi lahjendada 100 ml steriilse 0,9% naatriumkloriidi- või 5% glükoosilahusega.
English: (listed in section 6).
Estonian: • Imetamine (vt lõik 4.6).
English: What Zoledronic Acid Accord is and what it is used for
Estonian: 1. Mis ravim on Zoledronic acid Accord ja milleks seda kasutatakse
English: • Conjunctivitis.
Estonian: Konjunktiviit.
English: • Difficulty in breathing with wheezing or coughing.
Estonian: Hingamisraskused koos vilistava hingamise ja köhaga.
English: Zoledronic Acid Accord contains sodium
Estonian: Zoledronic acid Accord sisaldab naatriumi
English: • Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Estonian: Peavalu ja gripitaoline sündroom (palavik, väsimus, nõrkus, uimasus, külmavärinad ning luu-, liiges- ja/või lihasvalu).
English: What you need to know before you are given Zoledronic Acid Accord
Estonian: 2. Mida on vaja teada enne Zoledronic acid Accordi manustamist
English: • As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Estonian: Madal kaltsiumisisaldus veres võib põhjustada: südame rütmihäired (südame arütmia, sekundaarsena hüpokaltseemiast).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16.01.2014
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating zoledronic acid therapy.
Estonian: Pärast zoledroonhapperavi alustamist tuleb hoolikalt jälgida hüperkaltseemiaga seotud standardseid ainevahetuse näitajaid, nagu kaltsiumi, fosfaatide ja magneesiumi sisaldus seerumis.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Zoledronic Acid Accord 4 mg/5 ml sterile concentrate zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS JA MANUSTAMISTEE(D) Zoledronic acid Accord 4 mg/5 ml steriilne kontsentraat Zoledroonhape i.v.
English: Table 4: Efficacy results (breast cancer and multiple myeloma patients) Any SRE (+TIH)
Estonian: Tabel 4: Kliinilise uuringu tulemuste kokkuvõte (hulgimüeloomi ja rinnavähiga patsiendid)
English: you will be given one infusion of Zoledronic Acid Accord every three to four weeks.
Estonian: Kui tihti Zoledronic acid Accordi manustatakse - Kui teid ravitakse luumetastaasidest põhjustatud luutüsistuste ennetamiseks, manustatakse teile üks Zoledronic acid Accordi infusioon iga kolme kuni nelja nädala tagant.
English: Name and address of the manufacturer(s) responsible for batch release
Estonian: Ravimipartii kasutamiseks vabastamise eest vastutava(te) tootja(te) nimi ja aadress Accord Healthcare Limited
English: EU/1/13/834/002
Estonian: EU/1/13/834/002-4 viaal
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/l or < 4.5 mg/dl (see section 4.4).
Estonian: Kliinilistest uuringutest arvati välja patsiendid, kellel kreatiniinisisaldus seerumis oli > 400 µmol/l või > 4,5 mg/dl. Annuse kohaldamine ei ole vajalik TIH patsientidel seerumi kreatiniinisisaldusega < 400 µmol/l või < 4,5 mg/dl (vt lõik 4.4).
English: Increases in serum creatinine also occur in some patients with chronic administration of zoledronic acid at recommended doses for prevention of skeletal related events, although less frequently.
Estonian: Kreatiniini sisaldus seerumis võib tõusta patsiendil, kes on luustikuga seotud tüsistuste vältimiseks saanud pikemat aega soovitatud annuses zoledroonhapet.
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic Acid Accord to ensure that they are adequately hydrated.
Estonian: Enne ja pärast Zoledronic acid Accordi manustamist tuleb veenduda, et patsient on piisavalt hüdreeritud.