FrancophonIA/ELRC3.0 huggingface dataset:
English: After dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Estonian: Pärast lahjendamist: Keemiline ja füüsikaline stabiilsus on näidatud 24 tunni vältel temperatuuridel 2°C...8°C ja 25°C pärast lahjendamist 100 ml-s 0,9% naatriukloriidi lahuses või 100 ml-s 5% glükoosilahuses.
English: - To prepare an infusion solution containing 4 mg Zoledronic acid Actavis, further dilute the Zoledronic acid Actavis concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
Estonian: − 4 mg Zoledronic acid Actavis'e infusioonilahuse saamiseks tuleb Zoledronic acid Actavis'e kontsentraat (5,0 ml) lahjendada edasi 100 ml kaltsiumi või muid bivalentseid katioone mittesisaldava infusioonilahusega.
English: - For storage conditions of Zoledronic acid Actavis after dilution, see “Shelf life after dilution”
Estonian: − Zoledronic acid Actavis'e säilitamistingimusei pärast lahjendamist vt „Säilivus pärast lahjendamist“.
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 bisfosfonaatide-ravi alustamist teha asjakohane hammaste läbivaatus koos ennetava hambaraviga ning individuaalne kasu-riski hindamine.
English: What Zoledronic acid Actavis is and what it is used for
Estonian: Mis ravim on Zoledronic acid Actavis ja milleks seda kasutatakse
English: 10 x 5 ml vials
Estonian: 4 x 5 ml viaals 10 x 5 ml viaals
English: 82.6% (p=0.005)* 88.4% (p=0.002)*
Estonian: 10. päev Zoledroonhape 4 mg (n=86) 45,3% (p=0,104) 82,6% (p=0,005)* 88,4% (p=0,002)*
English: If you are given more Zoledronic acid Actavis than you should be
Estonian: Kui teile manustatakse Zoledronic acid Actavis't rohkem kui ette nähtud
English: Proportion of patients with SREs p-value
Estonian: Patsientide arv 561 Patsientide hulk LSTdega (%) p-väärtus
English: Asthenia, peripheral oedema, injection site reactions (including pain, irritation, swelling, induration), chest pain, weight increase, anaphylactic reaction/shock, urticaria Arthritis and joint swelling as a symptom of acute phase reaction
Estonian: asteenia, perifeersed tursed, reaktsioonid süstekohal (sh valu, nahaärritus, turse, induratsioon), valu rindkeres, kehakaalu suurenemine, anafülaktiline reaktsioon/šokk, urtikaaria artriit ja liigeste turse akuutse faasi reaktsiooni sümptomina
English: - Cancer, co-morbid conditions (e.g. anaemia, coagulopathies, infection), smoking.
Estonian: (parenteraalse manustamise korral on risk suurem) ja bisfosfonaadi kumulatiivne annus - Kasvaja, co-morbid conditions (e.g. anaemia, coagulopathies, infection), suitsetamine.
English: Patients must be maintained well hydrated prior to and following administration of Zoledronic acid Actavis.
Estonian: Patsiendid peavad enne ja pärast Zoledronic acid Actavis'e manustamist olema hästi hüdreeritud.
English: Zoledronic acid Actavis contains sodium
Estonian: Zoledronic acid Actavis sisaldab naatriumi
English: Nausea, vomiting, decreased appetite
Estonian: iiveldus, oksendamine, vähenenud söögiisu aeg-ajalt:
English: It is especially important that you tell your doctor if you are also taking: - Aminoglycosides (medicines used to treat severe infections), calcitonin (a type of medicine used to treat post-menopausal osteoporosis and hypercalcaemia), loop diuretics (a type of medicine to treat high blood pressure or oedema) or other calcium-lowering medicines, since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Estonian: − Aminoglükosiide (ravimid, mida kasutatakse raskete infektsioonide korral), kaltsitoniini (ravim, mida kasutatakse postmenopausaalse osteoporoosi ja hüperkaltseemia ravis), lingudiureetikume (ravim, mida kasutatakse kõrge vererõhu ja tursete ravis) ja teisi kaltsiumisisaldust vähendavaid ravimeid, kuna nende kasutamisel koos bisfosfonaatidega võib kaltsiumisisaldus veres langeda liiga madalale.
English: Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals.
Estonian: Enne Zoledronic acid Actavis-ravi alustamist teeb arst vereanalüüsid ja kontrollib regulaarsete intervallide järel teie ravivastust.
English: The multiple event analysis revealed a significant risk reduction of 16% in patients treated with 4 mg zoledronic acid in comparison with patients receiving pamidronate.
Estonian: Tulemuste analüüsil ilmnes 4 mg zoledroonhapet saanud patsientidel riski vähenemine 16% võrreldes pamidronaatravi saanud patsientidega.
English: - Shelf life after dilution: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C and at 25°C after dilution in 100 ml 0.9% w/v sodium chloride solution or 100 ml 5% w/v glucose.
Estonian: − Säilivus pärast lahjendamist: Keemiline ja füüsikaline stabiilsus on näidatud 24 tunni jooksul temperatuuridel 2°C...8°C ja 25°C pärast 100 ml-s 0,9% naatriukloriidi lahuses või 100-s 5% glükoosilahuses lahejndamist.
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 tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja peab manustama üksiku intravenoosse lahusena eraldi infusioonivooliku kaudu.
English: - Zoledronic acid Actavis must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein.
Estonian: − Zoledronic acid Actavis't võivad manustada ainult bisfosfonaatide intravenoosse, s.t veeni kaudu, manustamise koolituse läbinud tervishoiutöötajad.
English: - Difficulty in breathing with wheezing or coughing.
Estonian: − Hingamisraskused koos vilistava hingamise ja köhaga.
English: - The active substance is zoledronic acid.
Estonian: − Toimeaine on zoledroonhape.
English: Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card.
Estonian: Zoledronic acid Actavis`ega ravi saavatele patsientidele tuleb anda pakendi infoleht ja patsiendi meeldetuletuskaart.
English: - Sleepiness.
Estonian: − Unisus.
English: Do not mix Zoledronic acid Actavis concentrate with calcium-containing or other divalent cation containing solutions such as lactated Ringer's solution.
Estonian: Ärge lahjendage Zoledronic acid Actavis'e lahust kaltsiumi või muid bivalentseid katioone sisaldava lahusega, nt Ringeri laktaatlahusega.
English: - Urticaria.
Estonian: − Nõgestõbi.
English: Contains mannitol, sodium citrate and water for injections.
Estonian: Sisaldab mannitooli, naatriumtsitraati ja süstevett.
English: 1.0 mg/dl or 88 micromol/l.
Estonian: (>1,4 mg/dl või >124 µmol/l).
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: Table 4: Efficacy results (breast cancer and multiple myeloma patients)
Estonian: Tabel 4: Kliinilise uuringu tulemuste kokkuvõte (hulgimüeloomi ja rinnavähiga patsiendid)
English: What you need to know before you are given Zoledronic acid Actavis
Estonian: Mida on vaja teada enne Zoledronic acid Actavis'e kasutamist
English: Cardiac arrhythmias and neurologic adverse events (including convulsions, hypoaesthesia and tetany) have been reported secondary to cases of severe hypocalcaemia.
Estonian: Teatatud on ka südame arütmiatest ja neuroloogilistest kõrvaltoimetest (sh krambid, hüpoesteesiaa ja tetaania), mis tekkisid sekundaarselt ägedate hüpokaltseemia juhtude tagajärjel.
English: Concentrate for solution for infusion 1 x 5 ml vial
Estonian: Infusioonilahuse kontsentraat 1 x 5 ml viaal
English: Zoledronic acid Actavis 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 Actavis't ei soovitata kasutada raske neerupuudulikkusega patsientidel, kellel kreatiniinikliirens on <30 ml/min.
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 osteonekroosi (lõualuu) tekkest (vt lõik 4.4).
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion, further diluted in 100 ml (see section 6.6), should be given as a single intravenous infusion in no less than 15 minutes.
Estonian: 100 milliliitrini lahjendatud (vt lõik 6.6) Zoledronic acid Actavis 4 mg/5 ml infusioonilahuse kontsentraat tuleb manustada ühe intravenoosse infusioonina vähemalt 15 minuti kestel.
English: Patients must be assessed prior to administration of Zoledronic acid Actavis to ensure that they are adequately hydrated.
Estonian: Üldine Enne Zoledronic acid Actavis'e manustamist tuleb jälgida, et patsient oleks piisavalt hüdreeritud.
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 Actavis 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 Zoledronic acid Actavis'e annused (vt lõik 4.4):
English: - Since no data are available on the compatibility of Zoledronic acid Actavis with other intravenously administered substances, Zoledronic acid Actavis must not be mixed with other medications/substances and should always be given through a separate infusion line.
Estonian: − Andmeid Zoledronic acid Actavis'e sobivusest manustamiseks koos teiste veenisiseselt manustatavate ainetega on ebapiisavalt, seetõttu ei tohi Zoledronic acid Actavis'e lahust segada teiste ravimite/ainetega ja selle manustamiseks tuleb kasutada eraldi infusioonisüsteemi.
English: Your doctor may recommend a dental examination before you start treatment with Zoledronic acid Actavis.
Estonian: Teie arst võib soovitada teil enne Zoledronic acid Actavis'ega ravi alustamist käia hambakontrollis.
English: Zoledronic acid Actavis 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 Actavis'e lahust ei tohi segada kaltsiumi või teisi bivalentseid katioone sisaldavate infusioonilahustega, nt Ringeri laktaatlahusega ja seda tuleb manustada ühe intravenoosse lahusena eraldi infusioonivooliku kaudu.
English: What Zoledronic acid Actavis looks like and contents of the pack
Estonian: Kuidas Zoledronic acid Actavis välja näeb ja pakendi sisu
English: Warnings and precautions Talk to your doctor before you are given Zoledronic acid Actavis:
Estonian: Hoiatused ja ettevaatusabinõud Enne Zoledronic acid Actavis'e kasutamist pidage nõu oma arstiga kui:
English: - The other ingredients are: mannitol, sodium citrate and water for injections.
Estonian: − Abiained on: mannitool, naatriumtsitraat ja süstevesi.
English: Muscle spasms, osteonecrosis of the jaw Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) and other anatomical sites including femur and hip
Estonian: spasmid, lõualuu osteonekroos väliskuulmekanali osteonekroos (bifosfonaatide klassiefekt) ja osteonekroos teistes kehapiirkondades, sealhulgas puusa ja reieluu osteonekroos
English: How often Zoledronic acid Actavis is given
Estonian: Kui tihti Zoledronic acid Actavis't manustatakse
English: Dyspnoea, cough, bronchoconstriction Interstitial lung disease
Estonian: Düspnoe, köha, bronhokonstriktsioon harv:
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 kaugelearenenud hulgimüeloomi ja luumetastaasidega rinnavähiga patsientidel.
English: Common (may affect up to 1 in 10 people): - Severe kidney impairment (will normally be determined by your doctor with certain specific blood tests).
Estonian: − Raske neerukahjustus (ülduhul teeb selle spetsiaalsete vereanalüüsidega kindlaks arst).
English: INFORMATION IN BRAILLE
Estonian: INFORMATSIOON BRAILLE' KIRJAS (PUNKTKIRJAS) 17.
English: Prevention of skeletal related events in patients with advanced malignancies involving bone: When initiating treatment with Zoledronic acid Actavis in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CLcr) should be determined.
Estonian: Multiipelmüeloomi või soliidtuumori luumetastaasidega patsientide ravi alustamisel tuleb määrata seerumi kreatiniinisisaldus ja kreatiniinikliirens (CLcr).
English: Zoledronic acid Actavis is contraindicated in breast-feeding women (see section 4.3).
Estonian: Rinnaga toitmise ajal on Zoledronic acid Actavis vastunäidustatud (vt lõik 4.3).
English: In multiple myeloma patients, the risk of renal dysfunction may be increased when Zoledronic acid Actavis is used in combination with thalidomide.
Estonian: Hulgimüeloomiga patsientidel võib samaaegne talidomiidi kasutamine koos Zoledronic acid Actavis'ega suurendada neerufunktsiooni kahjustuse riski.
English: Other sources of information
Estonian: Infoleht on viimati kooskõlastatud Muud teabeallikad
English: Dizziness, paraesthesia, dysgeusia, hypoaesthesia, hyperaesthesia, tremor, somnolence
Estonian: pearinglus, paresteesia, düsgeusia hüpoesteesia, hüperesteesia, treemor, unisus väga harv:
English: Blurred vision, scleritis and orbital inflammation Uveitis
Estonian: hägune nägemine, skleriit ja orbita põletik uveiit väga harv:
English: - Weight increase.
Estonian: − Ülitundlikkusreaktsioonid.
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: − Madal kaltsiumisisaldus veres võib põhjustada: südame rütmihäired (südame arütmia, sekundaarsena hüpokaltseemiast).
English: To avoid potential incompatibilities, Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Estonian: Võimaliku sobimatuse vältimiseks tuleb Zoledronic acid Actavis'e infusioonilahuse kontsentraati lahjendada 0,9% naatriumkloriidi- või 5% glükoosilahusega.
English: Uncommon (may affect up to 1 in 100 people): - 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, eritis, tuimus või raskustunne lõualuus või hamba loksuma hakkamine.
English: Package leaflet: Information for the user Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion zoledronic acid
Estonian: Pakendi infoleht: teave kasutajale Zoledronic acid Actavis 4 mg/5 ml infusioonilahuse kontsenrtaat zoledroonhape
English: If refrigerated, the solution must be allowed to reach room temperature before administration.
Estonian: Jahutatud lahuse temperatuuri peab enne manustamist võrdsustama toatemperatuuriga.
English: Zoledronic acid Actavis recommended dose*
Estonian: Zoledronic acid Actavis'e soovitatav annus*
English: Clear and colourless concentrate for solution for infusion.
Estonian: Selge värvitu infusioonilahuse kontsentraat.
English: Uncommon: Very rare:
Estonian: aeg-ajalt: väga harv:
English: Read all of this leaflet carefully before you are given this medicine because it contains important information for you.
Estonian: Enne ravimi Zoledronic acid Actavis kasutamist lugege hoolikalt infolehte, sest siin on teile vajalikku infot.
English: Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zoledronic acid Actavis therapy.
Estonian: Pärast Zoledronic acid Actavis'e ravi alustamist tuleb hoolikalt jälgida hüperkaltseemiaga seotud standardseid ainevahetuse näitajaid, nagu kaltsiumi, fosfaatide ja magneesiumi sisaldus seerumis.
English: - Low level of calcium in the blood.
Estonian: − Vere madal kaltsiumisisaldus.
English: How to store Zoledronic acid Actavis
Estonian: Kuidas säilitada Zoledronic acid Actavis't
English: - Skin reactions (redness and swelling) at the infusion site, rash, itching.
Estonian: − Nahareaktsioonid (punetus ja turse) infusioonikohas, lööve, sügelus.
English: Zoledronic acid Actavis 4 mg/5 ml sterile concentrate zoledronic acid
Estonian: Zoledronic acid Actavis 4 mg/5 ml infusioonilahuse kontsentraat Acidum zoledronicum
English: One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate).
Estonian: Üks 5 ml viaal sisaldab 4 mg zoledroonhapet (monohüdraadina).
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 kontsenrtaat tuleb lahjendada 100 ml steriilse 0,9% naatriumkloriidi- või 5% glükoosilahusega.
English: In the clinical trials, renal deterioration was defined as follows: - For patients with normal baseline serum creatinine (< 1.4 mg/dl or < 124 micromol/l), an increase of 0.5 mg/dl or 44 micromol/l; - For patients with abnormal baseline creatinine (> 1.4 mg/dl or > 124 micromol/l), an increase of
Estonian: Kliinilistes uuringutes määratleti neerufunktsiooni halvenemist järgmiselt: - kreatiniini sisalduse tõus 0,5 mg/dl või 44 µmol/l võrra, kui algväärtus oli normi piires
English: - If you get any side effects , talk to your doctor, pharmacist or nurse.
Estonian: − Kui teil tekib ükskõik milline kõrvaltoime, palun rääkige sellest oma arstile, meditsiiniõele või apteekrile.
English: - Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Estonian: − Zoledroonhappe manustamise korral postmenopausaalse osteoporoosi raviks on patsientidel täheldatud südame rütmihäireid (kodade virvendusarütmia).
English: No dose adjustment is necessary in TIH patients with serum creatinine < 400 micromol/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: - 4.1 ml for 3.3 mg dose
Estonian: - 4,1 ml lahust 3,3 mg annuse valmistamiseks
English: Other products containing zoledronic acid as active substances are available for osteoporosis indications and treatment of Paget´s disease of the bone.
Estonian: Osteoporoosi näidustustele ja Paget'i tõve raviks on saadaval ka teisi ravimeid, mille toimeaineks on zoledroonhape.
English: 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 (0.9% w/v sodium chloride solution or 5% w/v glucose solution).
Estonian: Esmalt tuleb viaalist vajalik kogus kontsentraati lahjendada 100 ml kaltsiumit mittesisaldava infusioonilahusega (0,9% naatriumkloriidi- või 5% glükoosilahusega).
English: - Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite.
Estonian: − Mao-seedetrakti häired, nt iiveldus, oksendamine ja isutus.
English: Zoledronic acid Actavis treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Estonian: Tuumorist indutseeritud hüperkaltseemiaga patsientidel ja neil, kelle neerufunktsioon on kahjustunud, tuleb hinnata ravi võimaliku kasu ja riski vahekorda.
English: Zoledronic acid Actavis 4 mg/5 ml concentrate for solution for infusion
Estonian: Zoledronic acid Actavis 4 mg/5 ml infusioonilahuse kontsentraat
English: - Concomitant therapies: chemotherapy, angiogenesis inhibitors (see section 4.5), radiotherapy to neck and head, corticosteroids.
Estonian: - Samaaaegne ravi: kemoteraapia, angiogeneesi inhibiitorid (vt lõik 4.5), pea- ja kaelapiirkonna kiiritusravi, kortikosteroidid - Anamneesis hambahaigused, puudulik suuhügieen, periodontaalhaigused, invasiivsed dentaalprotseduurid (nt hamba väljatõmbamine) ja halvasti sobivad proteesid
English: - Keep Zoledronic acid Actavis out of the sight and reach of children.
Estonian: − Zoledronic acid Actavis't tuleb hoida laste eest varjatud ja kättesaamatus kohas.
English: For storage conditions of Zoledronic acid Actavis after dilution, see section 6.3.
Estonian: Manustamiskõlblikuks lahjendatud ravimpreparaadi säilitamistingimusi vt lõik 6.3.
English: Instructions for preparing reduced doses of Zoledronic acid Actavis: Withdraw the appropriate volume of the liquid concentrate, as follows: 4.4 ml for 3.5 mg dose
Estonian: Juhend vähendatud annusega Zoledronic acid Actavis'e lahuse valmistamiseks: Võtke vajalik kogus kontsentraati järgnevalt:
English: How Zoledronic acid Actavis is used
Estonian: Kuidas Zoledronic acid Actavis't kasutada
English: Osteonecrosis of the jaw (ONJ) has been reported uncommonly in clinical trials and in the post-marketing setting in patients receiving zoledronic acid.
Estonian: Zoledroonhappega ravitud patsientidel on kliinilistes uuringutes ja turuletulekujärgselt teatatud lõualuu osteonekroosi (LON).
English: Zoledronic acid 4 mg was also studied in a double-blind, randomised, placebo-controlled trial in 228 patients with documented bone metastases from breast cancer to evaluate the effect of 4 mg zoledronic acid on the skeletal related event (SRE) rate ratio, calculated as the total number of SRE
Estonian: 4 mg zoledroonhappe toime hindamiseks luustikuga seotud tüsistuste (LST) suhte määrale, mille arvutamiseks LST (välja arvatud hüperkaltseemia ja täpsustatud varasem luumurd) koguarvu jagatuna riskiperioodiga, uuriti topeltpimedas, randomiseeritud platseebokontrolliga uuringus 228 patsienti, kelle rinnavähi metastaaside esinemine luukoes oli dokumenteeritud.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTONS FOR VIALS
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED VIAALI KARP
English: Uncommon (may affect up to 1 in 100 people): - Hypersensitivity reactions.
Estonian: Aeg-ajalt (võib mõjutada 1 kasutajat 100st):
English: In clinical studies, zoledronic acid, used as indicated in sections 4.1 and 4.2, has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Estonian: Kliinilistes uuringutes ei ilmnenud kliiniliselt olulisi koostoimeid zoledroonhappe kasutamisel samaaegselt teiste kasvajavastaste ravimite, diureetikumide, antibiootikumide ja valuvaigistitega.
English: Zoledronic acid Actavis should only be resumed when serum creatinine returns to within 10% of baseline.
Estonian: Ravi võib jätkata vaid siis, kui seerumi kreatiniinisisaldus ei erine rohkem kui 10% algväärtusest.
English: Hypocalcaemia has been reported in patients treated with zoledronic acid.
Estonian: Zoledronic acid Actavis'ega ravitud patsientidel on teatatud hüpokaltseemia juhtudest.