FrancophonIA/ELRC3.0 huggingface dataset:
English: Very rare (may affect up to 1 in 10,000 people): - Fainting due to low blood pressure.
Estonian: Väga harv (võivad esineda kuni 1 inimesel 10 000-st): - Madalast vererõhust tingitud minestus.
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: In clinical trials with zoledronic acid, patients with serum creatinine > 265 μmol/l or > 3.0 mg/dl were excluded.
Estonian: Zoledroonhappe kliinilistest uuringutest arvati välja patsiendid, kellel seerumi kreatiniinisisaldus oli >265 mikromol/l või >3,0 mg/dl.
English: What Zoledronic Acid Teva looks like and contents of the pack Zoledronic Acid Teva is supplied as a concentrate for solution for infusion.
Estonian: Kuidas Zoledronic acid Teva välja näeb ja pakendi sisu Zoledronic acid Teva't turustatakse infusioonilahuse kontsentraadina.
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 infusioonisüsteemi kaudu.
English: Clinical studies in tumour-induced hypercalcaemia (TIH) demonstrated that the effect of zoledronic acid is characterised by decreases in serum calcium and urinary calcium excretion.
Estonian: Kliiniliste uuringute tulemused tuumorist indutseeritud hüperkaltseemia (TIH) ravis Kliinilised uuringud tuumorist indutseeritud hüperkaltseemia (TIH) näidustusel on näidanud, et zoledroonhappe toimel väheneb seerumi kaltsiumisisaldus ja uriiniga erituva kaltsiumi hulk.
English: Table 1 Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Estonian: Kõrvaltoimed on toodud järgnevas tabelis vastavalt nende esinemissagedusele: väga sage (≥1/10), sage (≥1/100 kuni <1/10), aeg-ajalt (≥1/1000 kuni <1/100), harv (≥1/10 000 kuni <1/1000), väga harv (<1/10 000), teadmata (ei saa hinnata olemasolevate andmete alusel).
English: Median time to relapse (re-increase of albumin-corrected serum calcium ≥ 2.9 mmol/l) was 30 to 40 days for patients treated with zoledronic acid versus 17 days for those treated with pamidronate 90 mg (p-values: 0.001 for 4 mg and 0.007 for 8 mg zoledronic acid).
Estonian: Aja mediaan hüperkaltseemia taastekkeni (albumiinkorrigeeritud seerumi kaltsiumisisalduse tõus ≥2,9 mmol/l) oli zoledroonhappe grupis 30…40 päeva ja pamidronaadi 90 mg grupis 17 päeva (p-väärtused: 4 mg zoledroonhappe puhul 0,001 ja 8 mg zoledroonhappe puhul 0,007).
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Estonian: - Ülitundlikkus toimeaine, mõne bisfosfonaadi või lõigus 6.1 loetletud mis tahes abiainete suhtes.
English: How Zoledronic Acid Teva is given - Zoledronic Acid Teva 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: Kuidas Zoledronic acid Teva't manustatakse - Zoledronic acid Teva't manustatakse veeninfusiooni teel, mis peab kestma vähemalt 15 minutit ja peab manustama üksiku intravenoosse lahusena eraldi infusioonisüsteemi kaudu.
English: How to prepare and administer Zoledronic Acid Teva - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Zoledronic Acid Teva concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Estonian: Kuidas Zoledronic acid Teva't ette valmistada ja manustada - 4 mg zoledroonhapet sisaldava infusioonilahuse valmistamiseks lahjendage kontsentraat (5 ml) 100 ml kaltsiumi või muid bivalentseid katioone mittesisaldava infusioonilahusega.
English: The following are the important identified risks with zoledronic acid in the approved indications: Renal function impairment, osteonecrosis of the jaw, acute phase reaction, hypocalcaemia, atrial fibrillation, anaphylaxis, interstitial lung disease.
Estonian: Zoledroonhappe kasutamisel heakskiidetud näidustustel on kindlaks tehtud järgmised olulised riskid: neerufunktsiooni kahjustus, lõualuu osteonekroos, ägeda faasi reaktsioon, hüpokaltseemia, kodade virvendusarütmia, anafülaksia, interstitsiaalne kopsuhaigus.
English: Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility.
Estonian: Uuringud klaaspudelite ja samuti polüvinüülkloriidist, polüetüleenist ja polüpropüleenist valmistatud erinevat tüüpi infusioonikottide ja -süsteemidega (täidetud 0,9% naatriumkloriidi- või 5% glükoosilahusega) ei näidanud sobimatust.
English: The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months.
Estonian: Otsuse korral kasutada ravimit luumetastaasidega patsientidel luustikuga seotud tüsistuste ennetamiseks, tuleb arvestada, et ravitoime ilmneb 2...3 kuu pärast.
English: This adverse drug reaction consists of a constellation of symptoms that includes fever, myalgia, headache, extremity pain, nausea, vomiting, diarrhoea arthralgia and arthritis with subsequent joint swelling.
Estonian: See kõrvaltoime koosneb sümptomite kombinatsioonist, mis hõlmab palavikku, müalgiat, peavalu, valu jäsemetes, iiveldust, oksendamist, kõhulahtisust, artralgiat ja artriiti, millele järgneb liigeste turse.
English: - 3.8 ml for 3.0 mg dose
Estonian: - 3,8 ml lahust 3,0 mg annuse valmistamiseks
English: Patients with TIH and evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zoledronic Acid Teva outweighs the possible risk.
Estonian: Tuumorist indutseeritud hüperkaltseemiaga patsientidel ja neerufunktsiooni halvenemise nähtudega patsientidel tuleb hinnata, kas Zoledronic acid Teva'st saadav kasu kaalub üles võimalikud riskid.
English: - If you are being treated to reduce the amount of calcium in your blood, you will normally only be given a single infusion of Zoledronic Acid Teva.
Estonian: - Kui teid ravitakse vere kaltsiumisisalduse vähendamiseks, manustatakse teile üldjuhul ainult üks
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: Caution is advised when Zoledronic Acid Teva is administered with anti-angiogenic medicinal products as an increase in the incidence of ONJ has been observed in patients treated concomitantly with these medicinal products.
Estonian: Zoledronic acid Teva manustamisel koos antiangiogeensete preparaatidega on soovitatav ettevaatus, kuna patsientidel, kes on saanud neid ravimeid samaaegselt on täheldatud LON esinemissageduse suurenemist.
English: Do not mix Zoledronic Acid Teva concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Estonian: Ärge lahjendage Zoledronic acid Teva kontsentraati kaltsiumi või muid bivalentseid katioone sisaldava lahusega, nt Ringeri laktaatlahusega.
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 kontrolliga 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: You should not be given Zoledronic Acid Teva: - if you are breast-feeding.
Estonian: Teile ei tohi manustada Zoledronic acid Teva't: - kui toidate last rinnaga.
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Estonian: palavik, gripitaoline sündroom (sh väsimus, külmavärinad, halb enesetunne ja õhetus)
English: When initiating treatment with Zoledronic Acid Teva 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 Zoledronic acid Teva'ga tuleb määrata seerumi kreatiniini sisaldus ja kreatiniini kliirens (CLcr).
English: The other ingredients are: mannitol, sodium citrate and water for injections.
Estonian: - Teised koostisosad on mannitool, naatriumtsitraat ja süstevesi.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud kotil pärast „Kõlblik kuni:“.
English: Patients being treated with Zoledronic acid Teva should not be treated with such medicinal products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Estonian: Zoledronic acid Teva'ga ravitavaid patsiente ei tohi samaaegselt ravida ühegi teise bisfosfonaadiga, kuna ravimite koostoimed ei ole teada.
English: - Sleepiness.
Estonian: - Unisus.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Teva and will check your response to treatment at regular intervals.
Estonian: Enne Zoledronic acid Teva ravi alustamist teeb arst vereanalüüsid ja kontrollib regulaarsete intervallide järel teie ravivastust.
English: (See Annex I: Summary of Product Characteristics, section 4.2)
Estonian: Piiratud tingimustel väljastatav retseptiravim (vt I lisa: Ravimi omaduste kokkuvõte, lõik 4.2).
English: - Low blood pressure.
Estonian: - Madal vererõhk - Valu rinnus.
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Estonian: Aeg-ajalt (võivad esineda kuni 1 inimesel 100-st): - Ülitundlikkusreaktsioonid.
English: Common (may affect up to 1 in 10 people): - Headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/or muscle ache.
Estonian: Sage (võivad esineda kuni 1 inimesel 10-st): - Peavalu ja gripitaoline sündroom (palavik, väsimus, nõrkus, uimasus, külmavärinad ning luu-,
English: Zoledronic Acid Teva 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: Zoledronic acid Teva't ei soovitata kasutada raske neerukahjustusega patsientidel, kellel kreatiniini kliirens on <30 ml/min.
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 ravimpreparaati ei tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja peab manustama üksiku intravenoosse lahusena eraldi infusioonisüsteemi kaudu.
English: Patients treated with Zoledronic Acid Teva should be given the package leaflet and the patient reminder card.
Estonian: Zoledronic acid Teva'ga ravi saavatele patsientidele tuleb anda pakendi infoleht ja patsiendi meeldetuletuskaart.
English: • To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).
Estonian: • Luutüsistuste, nt luumurdude ennetamiseks luumetastaasidega (vähi levik algsest asukohast luudesse) täiskasvanud patsientidel.
English: - Since no data are available on the compatibility of zoledronic acid with other intravenously administered substances, zoledronic acid must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Estonian: - Andmeid zoledroonhappe sobivusest manustamiseks koos teiste veenisiseselt manustatavate ainetega on ebapiisavalt, seetõttu ei tohi zoledroonhappe lahust segada teiste ravimite/ainetega ja selle manustamiseks tuleb kasutada eraldi infusioonisüsteemi.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks viaal 5 ml kontsentraadiga sisaldab 4 mg zoledroonhapet.
English: After dilution, it is preferable to use the diluted medicine immediately.
Estonian: Pärast aseptilist lahjendamist tuleb ravim ära kasutada kohe.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic Acid Teva.
Estonian: Teie arst võib soovitada teil enne Zoledronic acid Teva'ga ravi alustamist käia hambakontrollis.
English: In a third phase III randomised, double-blind trial, 4 mg zoledronic acid or 90 mg pamidronate every 3 to 4 weeks were compared in patients with multiple myeloma or breast cancer with at least one bone lesion.
Estonian: Kolmandas, III faasi randomiseeritud, topeltpimedas kliinilises uuringus võrreldi 4 mg zoledroonhappe ja 90 mg pamidronaadi efektiivsust, manustatuna iga 3…4 nädala järel hulgimüeloomi või rinnavähiga, vähemalt ühe luukoldega patsientidel.
English: 45.3% (p=0.104) 82.6% (p=0.005)* 88.4% (p=0.002)*
Estonian: Zoledroonhape 4 mg (n=86) 45,3% (p=0,104) 82,6% (p=0,005)* 88,4% (p=0,002)* Zoledroonhape 8 mg (n=90) 55,6% (p=0,021)* 83,3% (p=0,010)* 86,7% (p=0,015)* Pamidronaat 90 mg (n=99) 33,3% * p-väärtused võrrelduna pamidronaadiga
English: - Urticaria.
Estonian: - Kehakaalutõus.
English: Patients must be assessed prior to administration of Zoledronic Acid Teva to ensure that they are adequately hydrated.
Estonian: Üldine Enne Zoledronic acid Teva manustamist tuleb jälgida, et patsient oleks piisavalt hüdreeritud.
English: Unopened Vial - Keep Zoledronic Acid Teva out of the reach and sight of children.
Estonian: Avamata viaal - Zoledronic acid Teva't tuleb hoida laste eest varjatud ja kättesaamatus kohas.
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, kuigi seda väiksema sagedusega.
English: - Difficulty in breathing with wheezing or coughing.
Estonian: Hingamisraskused koos vilistava hingamise ja köhaga.
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: - Zoledronic acid must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Estonian: - Zoledronic acid Teva't võivad manustada ainult bisfosfonaatide intravenoosse, s.t veeni kaudu, manustamise koolituse läbinud tervishoiutöötajad.
English: Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of zoledronic acid are recommended.
Estonian: Kerge kuni keskmise neerukahjustusega luumetastaasidega patsientidele soovitatakse manustada väiksemad zoledroonhappe annused.
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 aja mediaani esimese LST-ni >2 kuu võrra ning vähendas LST juhtude arvu patsiendi kohta aastas.
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 Teva dose is recommended (see also section 4.4):
Estonian: Kerge kuni keskmise raskusega neerukahjustusega luumetastaasidega patsientidele kreatiniini kliirensiga 30…60 ml/min on ravi alustamiseks soovitatavad järgmised Zoledronic acid Teva annused (vt lõik 4.4):
English: Very common:
Estonian: väga harv:
English: - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which zoledronic acid belongs), or any of the other ingredients of this medicine (listed in section 6).
Estonian: - kui olete zoledroonhappe, mõne bisfosfonaadi (ravimigrupp, millesse zoledroonhape kuulub)
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic Acid Teva is used in combination with thalidomide.
Estonian: Hulgimüeloomiga patsientidel võib samaaegne talidomiidi kasutamine koos Zoledronic acid Teva'ga suurendada neerufunktsiooni kahjustuse riski.
English: There were no statistically significant differences between the two zoledronic acid doses.
Estonian: Zoledroonhappe erinevate annustega ravitud gruppide vahel ei olnud statistiliselt olulisi erinevusi.
English: Median time to SRE (days)
Estonian: LSTni (päevad)
English: Zoledronic Acid Teva 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 Teva kontsentraati ei tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja seda tuleb manustada ühe intravenoosse lahusena eraldi infusioonisüsteemi kaudu.
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria
Estonian: asteenia, perifeersed tursed, reaktsioonid süstekohal (sh valu, nahaärritus, turse, induratsioon), valu rindkeres, kehakaalu suurenemine, anafülaktiline reaktsioon/šokk, urtikaaria artriit ja liigesete turse ägeda faasi reaktsiooni sümptomina
English: For instructions of the dilution of the medicinal product before administration, see section 6.6.
Estonian: Ravimpreparaadi manustamiskõlblikuks muutmise ja lahjendamise juhised vt lõik 6.6.
English: One vial contains 4 mg zoledronic acid, (as monohydrate).
Estonian: Üks viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: Placebo Δ Zoledronic acid 
Estonian: Platseebo Δ Zoledroonhape 
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: 1.0 mg/dl or 88 μmol/l.
Estonian: (>1,4 mg/dl või >124 mikromol/l).
English: - Low level of calcium in the blood.
Estonian: - Vere madal kaltsiumisisaldus.
English: − As a consequence of low calcium values: seizures, numbness and tetany (secondary to hypocalcaemia).
Estonian: − Madal kaltsiumisisaldus veres võib põhjustada: krampe, tuimust ja tetaaniat (sekundaarsena hüpokaltseemiast).
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 August 2012
Estonian: ESMASE MÜÜGILOA VÄLJASTAMISE/MÜÜGILOA UUENDAMISE KUUPÄEV
English: 0.5 mg/dl or 44 μmol/l; - For patients with an abnormal baseline creatinine (> 1.4 mg/dl or > 124 μmol/l), an increase of
Estonian: (<1,4 mg/dl või <124 mikromol/l); - kreatiniini sisalduse tõus 1,0 mg/dl või 88 mikromol/l võrra, kui algväärtus ei olnud normi piires
English: Zoledronic Acid Teva is contraindicated in breast-feeding women (see section 4.3).
Estonian: Rinnaga toitmise ajal on Zoledronic acid Teva vastunäidustatud (vt lõik 4.3).
English: What Zoledronic Acid Teva contains
Estonian: Zoledronic acid Teva sisaldab naatriumi
English: How to store Zoledronic Acid Teva
Estonian: Kuidas Zoledronic acid Teva't kasutada
English: Figure 1: Mean changes from baseline in BPI scores.
Estonian: BPI skoori keskmised muutused algväärtusest.
English: 6.6 Special precautions for disposal and other handling Prior to administration, 5 ml 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 (sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution).
Estonian: Enne manustamist tuleb viaalis olev 5 ml kontsentraati või sellest võetud vajalikku osa lahjendada 100 ml kaltsiumit mittesisaldava infusioonilahusega (naatriumkloriidi 9 mg/ml (0,9%) süstelahusega või 5% w/v glükoosilahusega).
English: Zoledronic Acid Teva treatment should be resumed at the same dose as that given prior to treatment interruption.
Estonian: Ravi Zoledronic acid Teva'ga tuleb jätkata sama annusega, mida kasutati enne ravi katkestamist.
English: To avoid potential incompatibilities, Zoledronic Acid Teva concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Estonian: Võimaliku sobimatuse vältimiseks tuleb Zoledronic acid Teva lahus lahjendada 0,9% naatriumkloriidi- või 5% w/v glükoosilahusega.
English: Within three days after zoledronic acid administration, an acute phase reaction has commonly been reported, with symptoms including bone pain, fever, fatigue, arthralgia, myalgia, rigors and arthritis with subsequent joint swelling; these symptoms usually resolve within a few days (see description of selected adverse reactions).
Estonian: Kolme päeva jooksul pärast zoledroonhappe manustamist on sageli teatatud ägeda faasi reaktsiooni, mille sümptomitena võivad esineda luuvalu, palavik, väsimus, artralgia, müalgia, külmavärinad ja artriit, millele järgneb liigeste turse.
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 μmol/l), an increase of
Estonian: Kliinilistes uuringutes määratleti neerufunktsiooni halvenemist järgmiselt: - kreatiniini sisalduse tõus 0,5 mg/dl või 44 mikromol/l võrra, kui algväärtus oli normi piires
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 ravi alustamist Zoledronic acid Teva'ga teha hammaste ülevaatus koos ennetava hambaraviga ning individuaalne kasu-riski hindamine.
English: BPI mean change from baseline
Estonian: BPI keskmine muutus algväärtusest
English: Acute renal failure, haematuria, proteinuria Acquired Fanconi syndrome
Estonian: äge neerupuudulikkus, hematuuria, proteinuuria harv: