FrancophonIA/ELRC3.0 huggingface dataset:
English: - To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the concentrate (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Estonian: - 4 mg zoledroonhapet sisaldava infusioonilahuse valmistamiseks lahjendage kontsentraat (5 ml) 100 ml kaltsiumi või muid bivalentseid katioone mittesisaldava infusioonilahusega.
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: You must not be given Zoledronic acid Mylan: - if you are breast-feeding.
Estonian: Teile ei tohi manustada Zoledronic acid Mylan'i: - kui toidate last rinnaga.
English: How Zoledronic acid Mylan is given - Zoledronic acid Mylan 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 Mylan'i manustatakse Zoledronic acid Mylan manustatakse veeninfusiooni teel, mis peab kestma vähemalt 15 minutit ja seda tuleb manustada üksiku intravenoosse lahusena eraldi infusioonisüsteemi kaudu.
English: - Zoledronic acid Mylan must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Estonian: Zoledronic acid Mylan'i võivad manustada ainult bisfosfonaatide intravenoosse, st veeni kaudu, manustamise koolituse läbinud tervishoiutöötajad.
English: After dilution: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Estonian: Pärast lahjendamist: ravimi kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud 48 tunni jooksul temperatuuril 2°C…8°C ja kuni 25°C pärast lahjendamist 9 mg/ml (0,9%) naatriumkloriidi süstelahusega või 5% glükoosi lahusega (minimaalne kontsentratsioon: 3 mg/100 ml; maksimaalne kontsentratsioon: 4 mg/100 ml).
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Mylan and will check your response to treatment at regular intervals.
Estonian: Enne Zoledronic acid Mylan-ravi alustamist teeb arst vereanalüüsid ja kontrollib regulaarsete intervallide järel teie ravivastust.
English: The active substance in Zoledronic acid Mylan is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Estonian: Zoledronic acid Mylan'i toimeaine on zoledroonhape, mis kuulub bisfosfonaatideks nimetatud ravimite rühma.
English: Blurred vision, scleritis and orbital inflammation
Estonian: Hägune nägemine, skleriit ja orbita põletik harv:
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C-8°C and at 25°C after dilution in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution (minimal concentration: 3 mg/100 ml; maximal concentration: 4 mg/100 ml).
Estonian: Ravimi kasutusaegne keemilisfüüsikaline stabiilsus on tõestatud 48 tunni jooksul temperatuuril 2°C...8°C ja kuni 25°C pärast lahjendamist 100 ml 9 mg/ml (0,9%) naatriumkloriidi süstelahusega või 5% glükoosi lahusega (minimaalne kontsentratsioon: 3 mg/100 ml; maksimaalne kontsentratsioon: 4 mg/100 ml).
English: In Phase I dose finding studies in patients with mild to moderate tumour-induced hypercalcaemia (TIH), effective doses tested were in the range of approximately 1.2-2.5 mg.
Estonian: I faasi uuringutes sobiva annuse leidmiseks tuumorist tingitud kerge ja mõõduka hüperkaltseemiaga patsientidel osutus ravim efektiivseks annustevahemikus 1,2...2,5 mg.
English: Hypertension, hypotension, atrial fibrillation, hypotension leading to syncope or circulatory collapse
Estonian: Hüpertensioon, hüpotensioon, kodade virvendusarütmia, sünkoopi või vereringe seiskumist põhjustav hüpotensioon harv:
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Mylan.
Estonian: Teie arst võib soovitada teil enne Zoledronic acid Mylan'ga ravi alustamist käia hambakontrollis.
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 zoledroonhappe'st tingitud neerukahjustusega seotud kõrvalnähtude (kõrvaltoimete) sagedus järgmine: hulgimüeloom (3,2%), eesnäärmevähk (3,1%), rinnavähk (4,3%), kopsu- ja teised soliidtuumorid (3,2%).
English: - Since no data are available on the compatibility of Zoledronic acid Mylan with other intravenously administered substances, Zoledronic acid Mylan must not be mixed with other medicinal products/substances and should always be given through a separate infusion line.
Estonian: - Andmeid Zoledronic acid Mylan'i sobivusest manustamiseks koos teiste veenisiseselt manustatavate ainetega on ebapiisavalt, seetõttu ei tohi Zoledronic acid Mylan'i lahust segada teiste ravimite/ainetega ja selle manustamiseks tuleb kasutada eraldi infusioonisüsteemi.
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 harv:
English: - Treatment of adult patients with tumour-induced hypercalcaemia (TIH).
Estonian: Tuumorist indutseeritud hüperkaltseemia (TIH) täiskasvanud patsientidel.
English: Dyspnoea, cough, bronchoconstriction
Estonian: Düspnoe, köha, bronhokonstriktsioon harv:
English: Fever, flu-like syndrome (including fatigue, rigors, malaise and flushing)
Estonian: Palavik, gripitaoline sündroom (sh väsimus, lihasjäikus, halb enesetunne ja õhetus)
English: The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks.
Estonian: Soovitatav annus luustikuga seotud tüsistuste vältimiseks luukude haarava kaugelearenenud pahaloomulise kasvajaga patsientidele on 4 mg zoledroonhapet iga 3...4 nädala järel.
English: Thrombocytopenia, leukopenia
Estonian: Trombotsütopeenia, leukopeenia harv:
English: How much Zoledronic acid Mylan is given - The usual single dose given is 4 mg zoledronic acid.
Estonian: Milline on tavaline Zoledronic acid Mylan'i annus Tavaline ühekordne annus on 4 mg zoledroonhapet.
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: Zoledroonhape't ei soovitata kasutada raske neerukahjustusega patsientidel, kellel kreatiniini kliirens on < 30 ml/min.
English: Rare (may affect up to 1 in 1,000 people): - Slow heart beat.
Estonian: Harv (võivad esineda kuni 1 inimesel 1000-st): - Aeglane südametegevus.
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,
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 zoledroonhappega ravitud patsientidel, peamiselt vähihaigetel, on teatatud lõualuu osteonekroosi tekkest (vt lõik 4.4).
English: Caution is advised when zoledronic acid is administered with medicinal products known to cause hypocalcaemia, as they may have a synergistic effect resulting in severe hypocalcaemia (see section 4.5).
Estonian: Mõnedel juhtudel võib hüpokaltseemia olla eluohtlik (vt lõik 4.8) Ettevaatust nõuab Zoledronic acid Mylan manustamine koos teadaolevalt hüpokaleemiat põhjustavate ravimitega, sest sünergistliku toime tagajärjel võib tekkida tõsine hüpokaleemia (vt lõik 4.5).
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 raskusega neerukahjustusega luumetastaasidega patsientidele kreatiniini kliirensiga 30...60 ml/min on ravi alustamiseks soovitatavad järgmised zoledroonhappe annused (vt lõik 4.4):
English: Zoledronic acid Mylan 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 Mylan'i 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: Diarrhoea, constipation, abdominal pain, dyspepsia, stomatitis, dry mouth
Estonian: Kõhulahtisus, kõhukinnisus, kõhuvalu, düspepsia, stomatiit, suukuivus
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
Estonian: Ravimit võib säilitada kuni 24 tundi temperatuuril 2°C…8°C, välja arvatud juhul, kui lahjendamine on toimunud kontrollitud ja valideeritud aseptilistest tingimustes.
English: How to prepare and administer Zoledronic acid Mylan
Estonian: Kuidas valmistada ja manustada Zoledronic acid Mylan'i
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: Radiation therapy to bone zoledronic acid 4 mg
Estonian: Radioteraapia luustikule zoledroonhape 4 mg
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Mylan: - if you have or have had a kidney problem.
Estonian: Enne Zoledronic acid Mylan'i kasutamist pidage nõu oma arstiga: - teil on olnud või on neeruhaigus.
English: PHARMACEUTICAL FORM AND CONTENTS Concentrate for solution for infusion 1 vial of 5 ml.
Estonian: RAVIMVORM JA PAKENDI SUURUS Infusioonilahuse kontsentraat 1 viaal 5 ml.
English: Pam 90 mg zoledronic acid 4 mg
Estonian: Pamidro-na at 90 mg zoledroonhape 4 mg
English: What you need to know before you are given Zoledronic acid Mylan
Estonian: Mida on vaja teada enne Zoledronic acid Mylan'i manustamist
English: - Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Estonian: - Uuringutest polüolefiinkottidega (eeltäidetud 9 mg/ml (0,9%) naatriumkloriidi süstelahusega või 5% glükoosi lahusega) ei ilmnenud sobimatust Zoledronic acid Mylan'iga.
English: Rare (may affect up to 1 in 1,000 people): - As a consequence of low calcium values: irregular heart beat (cardiac arrhythmia; secondary to hypocalcaemia).
Estonian: Harv (võivad esineda kuni 1 inimesel 1000-st): - Madal kaltsiumisisaldus veres võib põhjustada: südame rütmihäired (südame arütmia,
English: LIST OF EXCIPIENTS It also contains sodium citrate, sodium hydroxide, hydrochloric acid and water for injections.
Estonian: ABIAINED Viaal sisaldab naatriumtsitraati, naatriumhüdroksiidi, vesinikkloriidhapet ja süstevett.
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Estonian: Pearinglus, paresteesia, düsgeusia, hüpoesteesia, hüperesteesia, treemor, unisus väga harv:
English: For instructions on the dilution of the medicinal product before administration, see section 6.6.
Estonian: Ravimpreparaadi manustamiskõlblikuks muutmise ja lahjendamise juhised vt lõik 6.6.
English: Table 3: Efficacy results (solid tumours other than breast or prostate cancer) Any SRE (+TIH)
Estonian: Tabel 4: Kliinilise uuringu tulemuste kokkuvõte (hulgimüeloomi ja rinnavähiga patsiendid) Kõik LST (+TIH)
English: Studies with polyolefin bags (prefilled with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid Mylan.
Estonian: Uuringutest polüolefiinkottidega (eeltäidetud 9 mg/ml (0,9%) naatriumkloriidi süstelahusega või 5% glükoosi lahusega) ei ilmnenud sobimatust Zoledronic acid Mylan'iga.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001-004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/786/001-004
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: 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 zoledroonhappega ravi alustamisel tuleb määrata seerumi kreatiniini sisaldus ja kreatiniini kliirens (CLcr).
English: Pruritus, rash (including erythematous and macular rash), increased sweating
Estonian: Kihelus, lööve (sh erütematoosne ja makulaarne lööve), suurenenud higistamine
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1 VIAL
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED 1 VIAALI SISALDAV KARP
English: In a third phase III randomised, double-blind trial, zoledronic acid 4 mg 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 kaugelearenenud hulgimüeloomi ja luumetastaasidega rinnavähiga patsientidel.
English: Zoledronic acid Mylan contains sodium.
Estonian: Zoledronic acid Mylan sisaldab naatriumi.
English: Nausea, vomiting, decreased appetite
Estonian: Iiveldus, oksendamine, söögiisu vähenemine aeg-ajalt:
English: Statistically significant differences are marked (*p< 0.05) for between treatment comparisons (4 mg zoledronic acid vs.
Estonian: Statistiliselt olulised muutused erinevate võrdlusravimite vahel (4 mg zoledroonhapet võrrelduna platseeboga) on tähistatud (*p< 0,05)
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 zoledroonhappega teha hammaste ülevaatus koos ennetava hambaraviga ning individuaalne kasu-riski hindamine.
English: Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Estonian: Väliskuulmekanali osteonekroos (bifosfonaatide klassiefekt) ja osteonekroos teistes kehapiirkondades, sealhulgas puusa ja reieluu osteonekroos
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: Blood creatinine and blood urea increased, hypocalcaemia
Estonian: Kreatiniini ja uurea sisalduse tõus veres, hüpokaltseemia aeg-ajalt:
English: - if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Zoledronic acid Mylan and inform your doctor about your dental treatment.
Estonian: - kui teile tehakse hambaravi või on plaanis teha hambaoperatsioon, teavitage hambaarsti
English: Zoledronic acid Mylan contains sodium
Estonian: Zoledronic acid Mylan sisaldab naatriumi
English: - Storage conditions of the diluted solution are described in the above paragraph (See “How to prepare and administer Zoledronic acid Mylan”).
Estonian: Zoledronic acid Mylan'i lahjendatud infusioonilahus tuleb pärast avamist bakteriaalse saastuse vältimiseks kohe ära kasutada (vt lõiku „Kuidas valmistada ja manustada Zoledronic acid Mylan'i“).
English: In view of the potential impact of zoledronic acid on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 μmol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 μmol/l or ≥ 3.0 mg/dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/min), the use of zoledronic acid is not recommended in patients with severe renal impairment.
Estonian: patsientidel ja  265 mikromol/l või  3,0 mg/dl luukude haarava kaugelearenenud pahaloomulise kasvajaga patsientidel) ja väheste farmakokineetiliste andmete olemasolu ravimi kasutamisel raske neerupuudulikkusega (kreatiniini kliirensi algväärtus < 30 ml/min) patsientidel, ei soovitata neil zoledroonhapet kasutada.
English: Hypomagnesaemia, hypokalaemia
Estonian: Hüpomagneseemia, hüpokaleemia harv:
English: Placebo zoledronic acid 4 mg
Estonian: Platseebo zoledroonhape 4 mg
English: Sodium citrate Sodium hydroxide Hydrochloric acid Water for injections
Estonian: Abiainete loetelu naatriumtsitraat naatriumhüdroksiid vesinikkloriidhape süstevesi
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 outweighs the possible risk.
Estonian: Tuumorist indutseeritud hüperkaltseemiaga patsientidel ja neil, kelle neerufunktsioon on kahjustunud, tuleb hinnata zoledroonhappega ravi võimaliku kasu ja riski vahekorda.
English: 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 kontsentraat või sellest võetud vajalik osa lahjendada 100 ml kaltsiumit mittesisaldava infusioonilahusega (9 mg/ml (0,9%) naatriumkloriidi süstelahus või 5% glükoosi lahus).
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 zoledroonhappega ravi alustamist tuleb hoolikalt jälgida hüperkaltseemiaga seotud standardseid ainevahetuse näitajaid, nagu kaltsiumi, fosfaatide ja magneesiumi sisaldus seerumis.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/786/001
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 registreeritud akuutse faasi reaktsiooni, mille sümptomitena võivad esineda luuvalu, palavik, väsimus, artralgia, müalgia, külmavärinad ja artriit, millele järgneb liigeste turse.
English: To avoid potential incompatibilities, Zoledronic acid Mylan concentrate is to be diluted with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% w/v glucose solution.
Estonian: Sobimatuse vältimiseks tuleb Zoledronic acid Mylan'i kontsentraati lahjendada 9 mg/ml (0,9%) naatriumkloriidi süstelahusega või 5%glükoosi lahusega.
English: How Zoledronic acid Mylan is used
Estonian: Kuidas Zoledronic acid Mylan'i kasutada
English: The hydration status of patients must be assessed prior to and following administration of Zoledronic acid Mylan to ensure that they are adequately hydrated.
Estonian: Enne ja pärast Zoledronic acid Mylan'i manustamist tuleb kontrollida, kas patsient on piisavalt hüdreeritud.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/786/004
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/786/004
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg zoledronic acid (as monohydrate).
Estonian: TOIMEAINE(TE) SISALDUS Üks viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
English: - History of dental disease, poor oral hygiene, periodontal disease, invasive dental procedures
Estonian: Hambahaigused, puudulik suuhügieen, periodondi haigused, invasiivsed hambaprotseduurid (nt hambaekstraktsioonid) ja halvasti sobivad hambaproteesid anamneesis.
English: - Keep Zoledronic acid Mylan out of the sight and reach of children.
Estonian: - Zoledronic acid Mylan tuleb hoida laste eest varjatud ja kättesaamatus kohas.
English: Multiple event analysis showed a 36% risk reduction in developing SREs in the zoledronic acid 4 mg group compared with placebo.
Estonian: tekkeriski vähenemist 36% 4 mg zoledroonhappe grupis võrrelduna platseeboga.
English: Other medicines and Zoledronic acid Mylan Tell your doctor if you are taking, have recently taken or might take any other medicines.
Estonian: Teatage oma arstile, kui te võtate või olete hiljuti võtnud või kavatsete võtta mis tahes muid ravimeid.
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 mikromol/l või > 4,5 mg/dl. Annuse kohaldamine ei ole vajalik TIH patsientidel seerumi kreatiniinisisaldusega < 400 mikromol/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 zoledroonhape't.
English: - Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone.
Estonian: Luukude haarava kaugelearenenud pahaloomulise kasvajaga täiskasvanud patsientidel luustikuga seotud tüsistuste (patoloogilised luumurrud, seljaaju kompressioon, luude kiiritusravi või operatsioon, tuumorist indutseeritud hüperkaltseemia) vältimine.
English: You should not be given Zoledronic acid Mylan if you are pregnant.
Estonian: Raseduse ajal ei tohi Zoledronic acid Mylan'i kasutada.
English: Very rare:
Estonian: Uveiit väga harv:
English: How to store Zoledronic acid Mylan
Estonian: Kuidas Zoledronic acid Mylan'i säilitada