FrancophonIA/ELRC3.0 huggingface dataset:
English: - Severe allergic reaction: shortness of breath, swelling mainly of the face and throat.
Estonian: − Tõsine allergiline reaktsioon: hingeldus, peamiselt näo ja kurgu paistetus.
English: From a microbiological point of view, the solution for infusion should be used immediately after dilution.
Estonian: Mikrobioloogilise puhtuse tagamiseks tuleb infusioonilahus kasutada koheselt pärast lahjendamist.
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Estonian: MÜÜGILOA MUUD TINGIMUSED JA NÕUDED Perioodilised ohutusaruanded
English: - Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Estonian: − Pidage nõu oma arstiga, kui teil on kõrvavalu, eritis kõrvast ja/või kõrvapõletik.
English: - Anti-angiogenic medicines (used to treat cancer), since the combination of these with zoledronic acid has been associated with an increased risk of osteonecrosis of the jaw (ONJ).
Estonian: − Antiangiogeenseid ravimeid (kasutatakse vähi ravimiseks), kuna nende kombinatsiooni zoledroonhappega on seostatud suurenenud lõualuu osteonekroosi (LON) tekke riskiga.
English: The study treatment period was 12 months preceded by a 4- to 9-week screening period during which vitamin D and elemental calcium supplements were taken for at least 2 weeks.
Estonian: Uuringu raviperiood kestis 12 kuud, millele järgnes 4-9 nädalane skriiningperiood, mille jooksul võtsid patsiendid vähemalt 2 nädalat D-vitamiini ja kaltsiumilisandit.
English: - Osteonecrosis has also very rarely been seen occurring with other bones than the jaw, especially the hip or thigh.
Estonian: − Osteonekroosi on täheldatud väga harva ka mujal kui lõualuus, eriti puusas või reies.
English: Your doctor, pharmacist or nurse knows how to store Zoledronic acid Actavis properly.
Estonian: Teie raviarst, apteeker ja meditsiiniõde teavad kuidas Zoledronic acid Actavis't õigesti säilitada.
English: An extension study was conducted in order to examine the long-term general and renal safety of once yearly or twice yearly zoledronic acid over the 12-month extension treatment period in children who had completed one year of treatment with either zoledronic acid or pamidronate in the core study.
Estonian: Viidi läbi jätku-uuring, et hinnata zoledroonhappe üks kord ja kaks korda aastas manustamise pikaajalist üldist ja renaalset ohutust 12-kuulise jätkuravi perioodi jooksul lastel, kes olid põhiuuringu raames saanud ühe aasta vältel ravi zoledroonhappe või pamidronaadiga.
English: • Hypersensitivity to the active substance, to other bisphosphonates or to any of the excipients listed in section 6.1
Estonian: • Ülitundlikkus toimeaine, teiste bisfosfonaatide või lõigus 6.1 loetletud mis tahes abiainete suhtes.
English: Zoledronic acid 8 mg (N=90) 55.6% (p=0.021)* 83.3% (p=0.010)* 86.7% (p=0.015)* Pamidronate 90 mg (N=99) *p-values compared to pamidronate.
Estonian: 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: - Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Estonian: − Harva võib esineda reieluu ebaharilik murd, eriti pikaajalist osteoporoosi ravi saavatel patsientidel.
English: Zoledronic acid Actavis is not recommended for use in adolescents and children below the age of 18 years.
Estonian: Zoledronic acid Actavis't ei ole soovitatav kasutada alla 18-aastastel lastel ja noorukitel.
English: There have been very rare cases of drowsiness and sleepiness with the use of zoledronic acid.
Estonian: Väga harvadel juhtudel zoledroonhappe kasutamisel esinenud uimasust ja unisust.
English: EXP Shelf life after dilution: See leaflet.
Estonian: EXP Kõlblikkusaeg pärast lahjendamist: vt pakendiinfolehte.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Estonian: Müügiloa hoidja peab nõutavad ravimiohutuse toiminguid ja sekkumismeetmed läbi viima vastavalt müügiloa taotluse moodulis 1.8.2 kokkulepitud riskijuhtimiskavale ja mis tahes järgmistele ajakohastatud riskijuhtimiskavadele.
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 Actavis.
Estonian: - Kui teid ravitakse vere kaltsiumisisalduse vähendamiseks, manustatakse teile üldjuhul ainult üks Zoledronic acid Actavis'e infusioon.
English: - Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration.
Estonian: − Arst soovitab enne iga ravi juua piisavalt vedelikku, vältimaks veetustumist.
English: What Zoledronic acid Actavis is and what it is used for What you need to know before you are given Zoledronic acid Actavis How Zoledronic acid Actavis is used Possible side effects
Estonian: Mis ravim on Zoledronic acid Actavis ja milleks seda kasutatakse Mida on vaja teada enne Zoledronic acid Actavis'e võtmist Kuidas Zoledronic acid Actavis't kasutada Võimalikud kõrvaltoimed
English: - Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys.
Estonian: − Talidomiidi (ravim, mida kasutatakse teatud liiki verevähi, mis kahjustab luid, raviks) või mõnda muud ravimit, mis võib kahjustada neerude tööd.
English: - For single use only.
Estonian: − Ainult ühekordseks kasutamiseks.
English: The results demonstrated that 4 mg zoledronic acid showed comparable efficacy to 90 mg pamidronate in the prevention of SREs.
Estonian: Uuringu tulemused näitasid, et 4 mg zoledroonhapet on sama efektiivne kui 90 mg pamidronaati LST ennetamisel.
English: Caution is indicated when Zoledronic acid Actavis is used with other potentially nephrotoxic medicinal products.
Estonian: Ettevaatust nõuab Zoledronic acid Actavis'e kasutamine koos teiste potentsiaalselt nefrotoksiliste ravimitega.
English: 5 ml concentrate in a plastic vial made of clear, colourless oleofinic polymer closed with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Estonian: 5 ml kontsentraadi plastikviaal on läbipaistev, värvitu oleofiinpolümeerist viaal, mis on suletud fluoropolümeerkattega bromobutüül kummikorgi ning alumiiniumkattega, millel on plastikust flip-off osa.
English: Intravenously administered zoledronic acid is eliminated by a triphasic process: rapid biphasic disappearance from the systemic circulation, with half-lives of t½ α 0.24 and t½β 1.87 hours, followed by a long elimination phase with a terminal elimination half-life of t½γ 146 hours.
Estonian: Veenisiseselt manustatud zoledroonhape elimineerub kolmefaasiliselt: kiire kahefaasiline süsteemne puhastumine, poolväärtusajad t½α 0,24 tundi ja t½β 1,87 tundi, millele järgneb pikk eliminatsioonifaas poolväärtusajaga t½γ 146 tundi.
English: - If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Zoledronic acid Actavis every three to four weeks.
Estonian: - Kui teid ravitakse luumetastaasidest põhjustatud luutüsistuste ennetamiseks, manustatakse teile üks Zoledronic acid Actavis't infusioon iga kolme kuni nelja nädala tagant.
English: In the clinical studies, zoledronic acid treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Estonian: Kliinilistes uuringutes jätkati ravi Zoledronic acid Actavis'ega alles siis, kui kreatiniini väärtus ei erinenud rohkem kui 10% algväärtusest (vt lõik 4.4).
English: Zoledronic acid Actavis can be given to people aged 65 years and over.
Estonian: Zoledronic acid Actavis't võivad kasutada ka 65-aastased ja vanemad patsiendid.
English: - Blurred vision, tearing of the eye, eye sensitivity to light.
Estonian: − Ähmane nägemine, kiskuv tunne silmas, silmade valgustundlikkus.
English: Figure 1: Mean changes from baseline in BPI scores.
Estonian: Joonis 1: BPI skoori keskmised muutused algväärtustest.
English: If a lower dose of Zoledronic acid Actavis is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Estonian: Kui vajalik on väiksem Zoledronic acid Actavis'e annus, võtke vastavalt vajalik kogus kontsentraati nagu kirjeldatud allpool ja seejärel lahjendage see 100 ml infusioonilahusega.
English: The highest non-lethal single intravenous dose was 10 mg/kg bodyweight in mice and 0.6 mg/kg in rats.
Estonian: Äge toksilisus Suurim mitteletaalne annus oli 10 mg/kg kehakaalu kohta hiirtel ja 0,6 mg/kg rottidel.
English: If you have pre-existing hypocalcaemia, it must be corrected before initiating the first dose of Zoledronic acid Actavis.
Estonian: Kui teil esineb varasemalt hüpokaltseemia, tuleb see korrigeerida enne esimese Zoledronic acid Actavis annusega alustamist.
English: - Other medicines that contain zoledronic acid which are used to treat osteoporosis and other noncancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Zoledronic acid Actavis are unknown.
Estonian: − Teisi ravimeid, mis sisaldab samuti zoledroonhapet ning mida kasutatakse osteoporoosi ja teiste mittekasvajaliste luuhaiguste raviks, või mis tahes teine bisfosfonaat, kuna nende ravimite koosmõju Zoledronic acid Actavis'ega ei ole teada.
English: Contents of the pack and other information What Zoledronic acid Actavis contains
Estonian: Pakendi sisu ja muu teave Mida Zoledronic acid Actavis sisaldab
English: In the clinical programme patients aged 1 to < 3 years received 0.025 mg/kg zoledronic acid (up to a maximum single dose of 0.35 mg) every 3 months and patients aged 3 to 17 years received 0.05 mg/kg zoledronic acid (up to a maximum single dose of 0.83 mg) every 3 months.
Estonian: Kliinilise programmi raames manustati 1-<3 aastastele patsientidele 0,025 mg/kg zoledroonhapet (maksimaalne üksikannus oli 0,35 mg) iga 3 kuu tagant ja 3-17 aastastele patsientidele 0,05 mg/kg zoledroonhapet (maksimaalne üksikannus oli 0,83 mg) iga 3 kuu tagant.
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 Actavis and inform your doctor about your dental treatment.
Estonian: kui teile tehakse hambaravi või on plaanis teha hambaoperatsioon, teavitage hambaarsti Zoledronic acid Actavis-ravist ning oma arsti hambaravist.
English: Adverse reactions, such as dizziness and somnolence, may have influence on the ability to drive or use machines, therefore caution should be exercised with the use of Zoledronic acid Actavis along with driving and operating of machinery.
Estonian: Kõrvaltoimed nagu pearinglus ja unisus võivad avaldada toimet autojuhtimise ja masinate käsitsemise võimele, seetõttu tuleks Zoledronic acid Actavis'e kasutamise ajal autojuhtimisel ja masinate käsitsemisel olla ettevaatlik.
English: Healthcare professionals are advised not to dispose of unused Zoledronic acid Actavis via the domestic sewage system.
Estonian: Tervishoiutöötajatel soovitatakse kasutamata Zoledronic acid Actavis'e lahust mitte kallata kanalisatsioonisüsteemi.
English: 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: 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: In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients that were given zoledronic acid as indicated in sections 4.1 and 4.2.
Estonian: Turuletulekujärgselt on teatatud luude, liigeste ja/või lihaste tugevatest ning ajuti kuni teovõimetuks tegevatest valudest zoledroonhapet lõikudes 4.1 ja 4.2 välja toodud näidustustel saanud patsientidel.
English: - Severe bone, joint and/or muscle pain, occasionally incapacitating.
Estonian: − Tugev luu-, liiges- ja/või lihasvalu, mõnikord teovõimetuks tegev.
English: All patients should be encouraged to maintain good oral hygiene, undergo routine dental check-ups, and immediately report any oral symptoms such as dental mobility, pain or swelling, or non-healing of sores or discharge during treatment with Zoledronic acid Actavis.
Estonian: Kõiki patsiente tuleb julgustada korralikult jälgima suuhügieeni, käima regulaarselt hammaste kontrollis ja Zoledronic acid Actavis-ravi ajal koheselt teatama mis tahes suuõõnega seotud sümptomite tekkest, nagu hammaste liikumine, valu või turse või suuhaavandite halb paranemine või eritise teke.
English: Following initiation of therapy, serum creatinine should be measured prior to each dose of Zoledronic acid Actavis and treatment should be withheld if renal function has deteriorated.
Estonian: Pärast ravi alustamist tuleb seerumi kreatiniinisisaldust mõõta enne iga Zoledronic acid Actavis'e annuse manustamist ning kui neerupuudulikkus on süvenenud, tuleb ravi katkestada.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Estonian: See ravimpreparaat sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, st see on põhimõtteliselt „naatriumivaba“.
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: Table 6: Adverse reactions observed in paediatric patients with severe osteogenesis imperfecta1 Nervous system disorders
Estonian: Tabel 6: Raskekujulise osteogenesis imperfecta'ga lastel täheldatud kõrvaltoimed1
English: Other medicines and Zoledronic acid Actavis
Estonian: Teiste ravimid ja Zoledronic acid Actavis
English: Zoledronic acid Actavis should not be used during pregnancy.
Estonian: Zoledronic acid Actavis't ei tohi kasutada raseduse ajal.
English: - Sudden coldness with fainting, limpness or collapse.
Estonian: − Järsk külmatunne koos minestamise, jõuetuse või kollapsiga.
English: One vial contains 5 ml of solution.
Estonian: Üks viaal sisaldab 5 mg lahust.
English: How to store Zoledronic acid Actavis Contents of the pack and other information
Estonian: Kuidas Zoledronic acid Actavis't säilitada Pakendi sisu ja muu teave
English: Caution is advised when Zoledronic acid Actavis 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: Ettevaatust nõuab Zoledronic acid Actavis'e manustamine koos antiangiogeensete ravimitega, kuna patsientidel, kes on saanud neid ravimeid samaaegselt on täheldatud LON esinemissageduse suurenemist.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Estonian: Nagu kõik ravimid, võib ka Zoledronic acid Actavis põhjustada kõrvaltoimeid, kuigi kõigil neid ei teki.
English: Additionally, there have been sporadic reports of osteonecrosis of other sites, including the hip and femur, reported predominantly in adult cancer patients treated with zoledronic acid.
Estonian: Lisaks on teatatud osteonekroosi esinemisest paiguti teistes kehapiirkondades, sealhulgas puusa ja reieluu osteonekroosist, millest teatati peamiselt zoledroonhappe-ravi saavatel vähki põdevatel täiskasvanud patsientidel.
English: - Carefully follow all the other instructions given to you by your doctor, pharmacist or nurse.
Estonian: − Järgige hoolikalt ka kõiki teisi arstilt, apteekrilt või meditsiiniõelt saadud juhiseid.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially “sodium-free”.
Estonian: See ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, s.t on põhimõtteliselt „naatriumivaba“.
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 micromol/l or ≥ 4.5 mg/dl for patients with TIH and ≥ 265 micromol/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 Actavis is not recommended in patients with severe renal impairment.
Estonian: Arvestades kliiniliste ohutuse andmete puudumist zoledroonhappe kohta raske neerupuudulikkusega (kliinilistes uuringutes seerumi kreatiniinisisalduse algväärtus ≥400 µmol/l või ≥4,5 mg/dl TIH patsientidel ja ≥265 µmol/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 Zoledronic acid Actavis't kasutada.
English: Zoledronic acid Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates.
Estonian: Zoledronic acid Actavis't võivad patsientidele määrata ja manustada ainult intravenoosse bisfosfonaadi manustamises kogenud tervishoiutöötajad.
English: Table 2: Efficacy results (prostate cancer patients receiving hormonal therapy)
Estonian: Tabel 2: Kliinilise uuringu tulemuste kokkuvõte (hormoonravi saavad prostatavähi patsiendid)
English: Zoledronic acid Actavis is supplied as a clear and colourless concentrate for solution for infusion (sterile concentrate) in a plastic vial.
Estonian: Zoledronic acid Actavis't turustatakse läbipaistva värvitu infusioonilahuse kontsentraadina (steriilse kontsentraadina) plastikviaalides.
English: Zoledronic acid Actavis treatment should be resumed at the same dose as that given prior to treatment interruption.
Estonian: Zoledronic acid Actavis-ravi tuleks jätkata sama annusega, mida kasutati enne ravi katkestamist.
English: - Conjunctivitis.
Estonian: − Konjunktiviit.
English: The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing zoledronic acid in all subsets of the paediatric population in the treatment of tumour-induced hypercalcaemia and prevention of skeletal-related events in patients with advanced malignancies involving bone (see section 4.2 for information on paediatric use).
Estonian: Euroopa Ravimiamet ei kohusta esitama zoledroonhappega läbi viidud uuringute tulemusi laste kõikide alarühmade kohta, kes saavad ravi tuumorist indutseeritud hüperkaltseemia (TIH) korral ja luukude haarava kaugelearenenud pahaloomulise kasvajaga patsientidel luustikuga seotud tüsistuste vältimise korral (teave lastel kasutamise kohta: vt lõik 4.2).
English: Within three days after zoledronic acid administration, used as indicated in sections 4.1 and 4.2, 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; need sümptomid taanduvad tavaliselt mõne päeva jooksul (vt „Valitud kõrvaltoimete kirjeldus“).
English: - if you are breast-feeding.
Estonian: − kui te imetate rinnaga.
English: The active substance in Zoledronic acid Actavis is zoledronic acid, which belongs to a group of substances called bisphosphonates.
Estonian: Zoledronic acid Actavis'e toimeaine on zoledroonhape, mis kuulub bisfosfonaatideks nimetatud ravimite rühma.
English: 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: You should not be given Zoledronic acid Actavis:
Estonian: Teil ei tohi kasutada Zoledronic acid Actavis't:
English: - Low level of magnesium and potassium in the blood.
Estonian: − Madal magneesiumi- ja kaaliumisisaldus veres.
English: Day 10
Estonian: 4. päev
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: Keskmine aeg 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: 0,001 4 mg ja 0,007 8 mg kohta).
English: Zoledronic acid, used as indicated in sections 4.1 and 4.2, has been associated with reports of renal dysfunction.
Estonian: Zoledroonhappe manustamise korral vastavalt lõikudes 4.1 ja 4.2 näidustatule on teatatud neerufunktsiooni häiretest.
English: In clinical trials with zoledronic acid, patients with serum creatinine > 265 micromol/l or > 3.0 mg/dl were excluded.
Estonian: zoledroonhappe kliinilistest uuringutest arvati välja patsiendid, kellel seerumi kreatiniinisisaldus oli >265 µmol/l või >3,0 mg/dl.
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 zoledroonhappe ravi, kirjeldatud hüpokaltseemia ja sekundaarselt tekkinud südame arütmiate vahel.
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: Patients being treated with Zoledronic acid Actavis should not be treated with such products or any other bisphosphonate concomitantly, since the combined effects of these agents are unknown.
Estonian: Zoledronic acid Actavis'ega ravitavaid patsiente ei tohi samaaegselt selliste ravimitega ega ühegi teise bisfosfonaadiga ravida, kuna ravimite koostoimed ei ole teada.
English: 1Adverse events occurring with frequencies < 5% were medically assessed and it was shown that these cases are consistent with the well established safety profile of zoledronic acid as indicated in sections 4.1 and 4.2 (see section 4.8)
Estonian: Hüpofosfateemia 1 Kõrvaltoimed esinemissagedusega <5% olid meditsiiniliselt hinnatud ning näidatud, et need juhtumid on kooskõlas zoledroonhappe ohutusandmetega (vt lõik 4.8).
English: - Zoledronic acid Actavis 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 Actavis't manustatakse tilgana (veeninfusiooni teel), mis peab kestma vähemalt 15 minutit ja peab manustama üksiku intravenoosse lahusena eraldi infusioonivooliku kaudu.