FrancophonIA/ELRC3.0 huggingface dataset:
English: The efficacy of one infusion of 5 mg zoledronic acid versus daily doses of 30 mg risedronate for 2 months was demonstrated in two 6-month comparative trials.
Estonian: Kahes 6-kuulises võrdlevas uuringus demonstreeriti 5 mg zoledroonhappe ühekordse infusiooni efektiivsust võrrelduna 30 mg risedronaadi ööpäevase annusega 2 kuu jooksul.
English: oesophagitis, toothache, gastritis#
Estonian: hambavalu, gastriit
English: In the HORIZON - Pivotal Fracture Trial [PFT] (see section 5.1), 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 and placebo, respectively.
Estonian: HORIZON'is - Olulise tähtsusega luumurru uuring [Pivotal Fracture Trial (PFT)] (vt lõik 5.1) oli keskmine kodade fibrillatsiooni esinemine zoledroonhapet ja platseebot saavatel patsientidel vastavalt 2,5% (96 3862-st) ja 1,9% (75 3852-st).
English: For information on the infusion of Zoledronic acid Teva Pharma, see section 6.6.
Estonian: Zoledronic acid Teva Pharma infusiooni kohta vt informatsiooni lõigus 6.6.
English: - if you have had some or all of the parathyroid glands in your neck surgically removed.
Estonian: - kui teil on kirurgiliselt eemaldatud kogu kõrvalkilpnääre või osa sellest (paikneb kaelas).
English: Teva Pharmaceuticals Ireland, L-Irlanda Tel: +353 51 321740
Estonian: Teva Pharmaceuticals Ireland Tel: +353 51 321 740
English: The chance of experiencing these side effects decreases with subsequent doses of Zoledronic acid Teva Pharma.
Estonian: Kõrvaltoimete tõenäosus väheneb järgnevate Zoledronic acid Teva Pharma annuste manustamisel.
English: In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following Zoledronic acid Teva Pharma administration (see section 4.2).
Estonian: Lisaks on Pageti tõvega haigetele oluline täiendav kaltsiumi manustamine (annuses, mis vastab vähemalt 500 mg kaltsiumile kaks korda päevas), vähemalt 10 päeva jooksul pärast Zoledronic acid Teva Pharma manustamist (vt. lõik 4.2).
English: • Need to calculate creatinine clearance based on actual body weight using the Cockcroft-Gault formula before each treatment with Zoledronic acid Teva Pharma
Estonian: • Vajadus arvutada Cockcroft-Gault'i valemi järgi vereseerumi kreatiniinisisaldus vastavalt patsiendi tegelikult kehakaalule enne igat Zoledronic acid Teva Pharma'ga ravi alustamist
English: Nausea, vomiting, diarrhoea
Estonian: Iiveldus, oksendamine, kõhulahtisus
English: - After opening the bottle, the product should be used immediately in order to avoid microbial contamination.
Estonian: - Mikrobioloogilise saastatuse vältimiseks tuleb ravim kohe ära kasutada.
English: There was no progressive reduction of bone turnover markers with repeated annual dosing.
Estonian: Luukoe ringluse progresseeruvat vähenemist korduval üks kord aastas manustamisel ei täheldatud.
English: Solution for infusion.
Estonian: RAVIMVORM Infusioonilahus.
English: In the HORIZON-RFT study zoledronic acid treatment significantly increased BMD at the total hip and femoral neck relative to treatment with placebo at all timepoints.
Estonian: HORIZON-RFT uuringus suurendas Zoledroonhappe-ravi oluliselt kogu reieluu proksimaalse osa ja reieluukaela LMT-d võrreldes platseeboga kõikidel ajahetkedel.
English: A dental examination with preventive dentistry and an individual benefit-risk assessment is recommended prior to treatment with Zoledronic acid Teva Pharma in patients with concomitant risk factors.
Estonian: Kaasuvate riskifaktoritega patsienditel on soovitatav enne Zoledronic acid Teva Pharma-ravi alustamist teha hammaste läbivaatus koos ennetava hambaraviga ning individuaalne kasu-riski hindamine.
English: It comes in a clear plastic bottle.
Estonian: Ravim on saadaval 100 ml läbipaistvast plastist pudelis.
English: - Hypersensitivity to the active substance, to any bisphosphonates or to any of the excipients listed in section 6.1.
Estonian: - Ülitundlikkus toimeaine, mõne bisfosfonaadi või või lõigus 6.1 loetletud mis tahes abiaine(te)
English: In the subpopulation of patients that had received glucocorticoids for 3 months or less prior to randomisation, zoledronic acid increased lumbar spine BMD by 2.60% versus 0.64% for risedronate (mean difference: 1.96% ; p<0.001).
Estonian: Patsientide alarühmas, kes said glükokortikoide enne randomiseerimist 3 kuud või vähem, suurenes lülisamba nimmeosa LMT zoledroonhappe toimel 2,60% ja risedronaadi toimel 0,64% (keskmine erinevus: 1,96%, p<0,001).
English: • Patient educational material
Estonian: • Patsiendi infopakett
English: Zoledronic acid significantly reduced the mean days of limited activity and the days of bed rest due to back pain by 17.9 days and 11.3 days respectively compared to placebo and significantly reduced the mean days of limited activity and the days of bed rest due to fractures by 2.9 days and 0.5 days respectively compared to placebo (all p<0.01).
Estonian: Oluliselt vähenes ka keskmine piiratud aktiivsusega päevade ja luumurdude tõttu voodirežiimil veedetud päevade arv, vastavalt 2,9 päeva ja 0,5 päeva võrra platseeboga võrreldes (kõik p<0,01).
English: Your doctor may ask you to undergo a dental examination before you start treatment with Zoledronic acid Teva Pharma.
Estonian: Teie arst võib paluda teil enne Zoledronic acid Teva Pharma'ga ravi alustamist käia hambakontrollis.
English: Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to post-dose symptoms such as fever, vomiting and diarrhoea
Estonian: Gripisarnane haigus, külmavärinad, väsimus, asteenia, valu, halb enesetunne, infusioonikoha reaktsioon Perifeerne ödeem, janu, akuutse faasi reaktsioon, mittekardiaalne rindkerevalu Dehüdratsiooni teke sekundaarselt annustamisjärgsetele sümptomitele nagu palavik, oksendamine ja kõhulahtisus
English: Measurement of serum calcium before infusion of Zoledronic acid Teva Pharma is recommended for patients with Paget´s disease.
Estonian: Pageti tõvega haigetel on soovitav enne Zoledronic acid Teva Pharma infusiooni mõõta seerumi kaltsiumisisaldust.
English: Cyclic olefin polymer (COP) plastic bottle, fitted with a chlorobutyl/butyl rubber stopper and aluminium cap fitted with violet plastic flip off disc.
Estonian: Pudelil on klorobutüülkummist kork ja alumiiniumist kaas, millel on lilla äratõmmatav plastkate.
English: Zoledronic acid Teva Pharma is administered via a vented infusion line and given slowly at a constant infusion rate.
Estonian: Zoledronic acid Teva Pharma't manustatakse aeglaselt antud püsiva infusioonikiirusega ventileeritava infusioonisüsteemi kaudu.
English: • Zoledronic acid Teva Pharma should be used with caution when concomitantly used with other medicinal products that could impact renal function (see section 4.5).
Estonian: - Zoledronic acid Teva Pharma samaaegsel kasutamisel koos teiste ravimitega, mis võivad halvendada neerufunktsiooni, tuleb olla ettevaatlik (vt lõik 4.5).
English: C-reactive protein increased Uncommon Blood calcium decreased
Estonian: C-reaktiivse valgu tõus Hüpokaltseemia
English: Your doctor should do a blood test to check your kidney function (levels of creatinine) before each dose of Zoledronic acid Teva Pharma.
Estonian: Teie arst peab enne iga Zoledronic acid Teva Pharma annuse manustamist tegema neerufunktsiooni jälgimiseks (kreatiniini tase) vereanalüüsi.
English: Solution for infusion 100 ml
Estonian: 100 ml
English: Zoledronic acid Teva Pharma contains the active substance zoledronic acid.
Estonian: Zoledronic acid Teva Pharma toimeaine on zoledroonhape.
English: EU/1/12/772/004 multipack with 10 bags
Estonian: EU/1/12/772/004 hulgipakend 10 kotiga
English: After opening: Chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8°C and 25ºC.
Estonian: Pärast avamist: kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud 24 tunni jooksul temperatuuril 2...8°C ja kuni 25°C.
English: The recommended dose is a single intravenous infusion of 5 mg Zoledronic acid Teva Pharma.
Estonian: Soovitatav annus on üks 5 mg Zoledronic acid Teva Pharma intravenoosne infusioon.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bag contains 5 mg zoledronic acid (as monohydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks kott sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: • Key signs and symptoms of serious adverse events • When to seek attention from the health care provider
Estonian: • Tõsiste kõrvaltoimete põhilised tunnused ja sümptomid
English: You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Estonian: Kõrvaltoimetest võite ka ise teavitada riikliku teavitussüsteemi, mis on loetletud V lisas, kaudu.
English: Atrial fibrillation Uncommon Palpitations
Estonian: Kodade fibrillatsioon Palpitatsioon
English: It is supplied in packs sizes of 1, 5 and 10.
Estonian: Ravim on saadaval pakendites, mis sisaldavad kas 1, 5 või 10 pudelit.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Üks pudel sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: Ocular hyperaemia Uncommon Conjunctivitis, eye pain Uveitis, episcleritis, iritis Not known** Scleritis and parophthalmia
Estonian: Okulaarne hüpereemia Konjunktiviit, silma valu Uveiit, episkleriit, iriit Skleriit ja paroftalmia
English: Clinical efficacy in the treatment of Paget's disease of the bone Zoledronic acid was studied in male and female patients aged above 30 years with primarily mild to moderate Paget's disease of the bone (median serum alkaline phosphatase level 2.6-3.0 times the upper limit of the age-specific normal reference range at the time of study entry) confirmed by radiographic evidence.
Estonian: Zoledroonhapet uuriti radiograafilise uuringuga kinnitatud, mõõduka kuni keskmise Pageti luutõvega (seerumi alkaalse fosfataasi keskmine tase uuringu alguses 2,6…3,0 korda üle ea-spetsiifilise ülemise normi piiri) nais- ja meessoost patsientidel vanuses üle 30 aasta.
English: Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth,
Estonian: Düspepsia, ülakõhuvalu, kõhuvalu, gastroösofageaalne refluksihaigus, kõhukinnisus, suukuivus, ösofagiit,
English: At least one new vertebral fracture (0-3 year)
Estonian: Vähemalt üks uus lülimurd (0...1 aasta) Vähemalt üks uus lülimurd (0...2 aastat) Vähemalt üks uus lülimurd (0...3 aastat) ** p <0,0001
English: Pharmacodynamic effects
Estonian: FARMAKOLOOGILISED OMADUSED
English: Other products containing zoledronic acid as an active substance are available for oncology indications.
Estonian: Onkoloogilisteks näidustusteks on saadaval teisi toimeainena zoledroonhapet sisaldavaid ravimeid.
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Pharma.
Estonian: Teie arst peab enne iga Zoledronic acid Teva Pharma annuse manustamist tegema neerufunktsiooni kontrollimiseks vereanalüüsi.
English: ONJ has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis (see section 4.8).
Estonian: Osteoporoosi näidustusel Zoledronic acid Teva Pharma'ga (zoledroonhape) ravitud patsientidel on turuletulekujärgselt teatatud lõualuu osteonekroosist (vt lõik 4.8).
English: Solution for infusion Multipack: 5 bottles of 100 ml Multipack: 10 bottles of 100 ml
Estonian: Hulgipakend: 5 pudelit, igas 100 ml
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Estonian: Üks pudel sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: How to store Zoledronic acid Teva Pharma
Estonian: Kuidas Zoledronic acid Teva Pharma't säilitada
English: Each bag contains 100 ml solution.
Estonian: Iga kott sisaldab 100 ml lahust.
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Estonian: Kaelavalu, lihas-skeleti jäikus, liigeste turse, lihasspasmid, õlavalu, lihas-skeleti rindkerevalu, lihas-skeletivalu, liigeste jäikus, artriit, lihasnõrkus
English: Excipients: Mannitol, sodium citrate and water for injections.
Estonian: Abiained: Mannitool, naatriumtsitraat ja süstevesi.
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles EU/1/12/772/005 1 bottle
Estonian: EU/1/12/772/001 hulgipakend 5 pudeliga EU/1/12/772/002 hulgipakend 10 pudeliga EU/1/12/772/005 1 pudel
English: It comes in a polyolefin/styreneethylene-butylene (SEB) foil bag with a foil over pouch.
Estonian: Ravim on saadaval mitmekihilises polüolefiin/stüreen-etüleen-butüleen (SEB) kilekotis, mis on omakorda välises kiletaskus.
English: Österreich ratiopharm Arzenimittel Vertriebs-GmbH
Estonian: Österreich ratiopharm Arzenimittel Vertriebs-GmbH Tel: +43 1 97007-0
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle label after EXP.
Estonian: - Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja pudelil pärast „Kõlblik kuni“.
English: Women of childbearing potential Zoledronic acid Teva Pharma is not recommended in women of childbearing potential.
Estonian: Fertiilses eas naised Zoledronic acid Teva Pharma't ei ole soovitatav kasutada fertiilses eas naistel.
English: Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8
Estonian: Neerufunktsiooni häire ja teiste riskitegurite olemasolul, nagu näiteks kõrge iga, teiste nefrotoksiliste ravimite samaaegne kasutamine, samaaegne ravi diureetikumidega või dehüdratsioon pärast manustamist (vt lõi 4.4 ja lõik 4.8 „Ravimiklassi kõrvaltoimed“), on harvadel juhtudel teatatud ka dialüüsravi nõudnud või surmaga lõppenud neerupuudulikkusest.
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Estonian: - Vastava riskiga patsientidel tuleb kaaluda veres kreatiniinisisalduse jälgimise vajadust.
English: Batch
Estonian: KOTT
English: proteinuria
Estonian: Süstevesi
English: Blood and lymphatic system disorders
Estonian: Vere ja lümfisüsteemihäired Aeg-ajalt
English: EU/1/12/772/001 multipack with 5 bottles EU/1/12/772/002 multipack with 10 bottles
Estonian: EU/1/12/772/001 hulgipakend 5 pudeliga EU/1/12/772/002 hulgipakend 10 pudeliga
English: - After opening the bag, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Estonian: - Pärast koti avamist: kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud 24 tunni jooksul temperatuuril 2...8°C ja kuni 25°C.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/772/001 multipack with 5 bottles
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/12/772/001 hulgipakend 5 pudeliga EU/1/12/772/002 hulgipakend 10 pudeliga
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF UNIT PACK (with blue box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED ÜKSIKPAKENDI KARP (KAASA ARVATUD "BLUE BOX")
English: Excipients
Estonian: Püreksia
English: What Zoledronic acid Teva Pharma looks like and contents of the pack Zoledronic acid Teva Pharma is a clear and colourless solution.
Estonian: Zoledronic acid Teva Pharma on selge ja värvitu lahus.
English: A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported in the post-marketing setting in patients receiving Zoledronic acid Teva Pharma for osteoporosis.
Estonian: Zoledronic acid Teva Pharma't (zoledroonhape) osteoporoosi raviks saanud patsientidel on turuletulekujärgselt teatatud kõrvaltoimest, mida nimetatakse lõualuu osteonekroosiks (lõualuu kahjustus).
English: Tel.: +36 1 288 64 00
Estonian: Magyarország Teva Gyógyszergyár Zrt Tel.: +36 1 288 64 00
English: 6.6 Special precautions for disposal and other handling
Estonian: 6.6 Erihoiatused ravimpreparaadi hävitamiseks ja käsitlemiseks Ühekordseks kasutamiseks.
English: Solution for infusion 1 bag of 100 ml.
Estonian: 1 kott - 100 ml.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACK (with blue box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED HULGIPAKENDI VÄLISKARP (KAASA ARVATUD "BLUE BOX")
English: Skin and subcutaneous tissue disorders Uncommon Rash, hyperhidrosis, pruritus, erythema Musculoskeletal and connective tissue disorders
Estonian: Okulaarne hüpereemia Konjunktiviit, silmavalu Uveiit, episkleriit, iriit Skleriit ja paroftalmia
English: Paget's disease of the bone, osteoporosis in post-menopausal women at an increased risk of fracture, osteoporosis in men at increased risk of fracture and prevention of clinical fractures after a hip fracture in men and women (see section 4.2 for information on paediatric use).
Estonian: Osteoporoosi ravi - postmenopausis naistel - täiskasvanud meestel suurenenud riskiga luumurdude tekke korral, sh madalast asendist kukkumise tagajärjel tekkinud reieluu proksimaalse osa murru korral.
English: • Need for adequate calcium and vitamin D supplementation, appropriate physical activity, non
Estonian: • Patsiendi infopakett peaks olema arstile antud ja sisaldama järgmist olulist informatsiooni: o Vajalik on piisav kaltsiumi ja D-vitamiini tarbimine, piisav füüsiline aktiivsus, mittesuitsetamine ja tervislik toitumine o Tõsiste kõrvaltoimete põhilised tunnused ja sümptomid o Millal pöörduda arsti poole
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Pharma 5 mg infusioonilahus pudelis
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bottles zoledronic acid
Estonian: Zoledronic acid Teva Pharma 5 mg infusioonilahus pudelis Acidum zoledronicum
English: Zoledronic acid Teva Pharma 5 mg solution for infusion in bags zoledronic acid
Estonian: Zoledronic acid Teva Pharma 5 mg infusioonilahus kotis zoledroonhape
English: • Transient increase in serum creatinine may be greater in patients with underlying impaired renal
Estonian: - Olemasoleva neerufunktsiooni häirega patsientidel võib mööduv vere kreatiniinisisalduse tõus olla suurem.
English: How to prepare and administer Zoledronic acid Teva Pharma
Estonian: Kuidas Zoledronic acid Teva Pharma't ette valmistada ja manustada
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion in bags
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Pharma 5 mg infusioonilahus kotis
English: Adequate calcium and vitamin D intake are recommended in association with Zoledronic acid Teva Pharma administration.
Estonian: Zoledronic acid Teva Pharma-ravi ajal on soovitatav võtta piisavas koguses kaltsiumi ja D-vitamiini preparaate.
English: Absolute reduction in fracture event rate (CI)
Estonian: Luumurdude esinemissageduse absoluutse vähenemise % (CI)
English: Zoledronic acid Teva Pharma may work for longer than one year, and your doctor will let you know if you need to be treated again.
Estonian: Zoledronic acid Teva Pharma võib toimida kauem kui üks aasta.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Pharma 5 mg solution for infusion zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Pharma 5 mg infusioonilahus Acidum zoledronicum
English: Ask your doctor, pharmacist or nurse for advice before using this medicine.
Estonian: Enne selle ravimi kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja kotil pärast „Kõlblik kuni“.
English: - Do not use this medicine after the expiry date which is stated on the carton and bag after EXP. - Store below 30°C.
Estonian: - Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil ja pudeli sildil pärast „Kõlblik kuni:“.
English: Talk to your doctor if you have ear pain, discharge from the ear, and/or an ear infection.
Estonian: Väga harva esinevad (võivad tekkida kuni 1 inimesel 10 000-st) Pidage nõu oma arstiga, kui teil on kõrvavalu, eritis kõrvast ja/või kõrvapõletik.
English: GENERAL CLASSIFICATION FOR SUPPLY
Estonian: RAVIMPREPARAADI NIMETUS
English: - After opening the bottle, chemical and physical in-use stability has been demonstrated for 24 hours at 2 to 8ºC and 25ºC.
Estonian: - See ravimpreparaat ei vaja säilitamisel eritingimusi - Pärast pudeli avamist: kasutusaegne keemilis-füüsikaline stabiilsus on tõestatud 24 tunni jooksul temperatuuril 2...8°C ja kuni 25°C.
English: The recommended dose is 210 mg given once a week for the first 3 weeks and then every 2 weeks.
Estonian: Soovitatav annus on 210 mg üks kord nädalas esimesel 3 nädalal ja seejärel iga 2 nädala tagant.
English: What measures are being taken to ensure the safe and effective use of Kyntheum?
Estonian: Mis meetmed võetakse, et tagada Kyntheumi ohutu ja efektiivne kasutamine?
English: Other information about Kyntheum
Estonian: Muu teave Kyntheumi kohta
English: The full EPAR for Kyntheum can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Estonian: Euroopa avaliku hindamisaruande täistekst Kyntheumi kohta on ameti veebilehel: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Medicines Agency therefore decided that Kyntheum's benefits are greater than its risks and recommended that it be approved for use in the EU.
Estonian: Seetõttu otsustas Euroopa Ravimiamet, et Kyntheumi kasulikkus on suurem kui sellega kaasnevad riskid, ja soovitas ravimi kasutamise Euroopa Liidus heaks kiita.
English: What is Kyntheum and what is it used for?
Estonian: Mis on Kyntheum ja milleks seda kasutatakse?
English: Why is Kyntheum approved?
Estonian: Miks Kyntheum heaks kiideti?
English: The most common side effects with Kyntheum (which may affect more than 1 in 100 people) are joint pain, headache, tiredness, diarrhoea and oropharyngeal pain (pain in the mouth and throat).
Estonian: Kyntheumi kõige sagedamad kõrvalnähud (võivad esineda enam kui 1 patsiendil 100st) on liigesevalu, peavalu, väsimus, kõhulahtisus ja orofarüngeaalne valu (suu- ja kurguvalu).
English: After training, patients may inject Kyntheum if their doctor considers it appropriate.
Estonian: Patsiendid tohivad pärast asjakohase väljaõppe saamist süstida Kyntheumi ise, kui arst peab seda kohaseks.
English: Kyntheum has been shown to be effective at treating plaque psoriasis in 3 main studies involving over 4,300 patients who required systemic treatment.
Estonian: Kyntheumi efektiivsust naastulise psoriaasi ravis tõendati kolmes põhiuuringus, milles osales enam kui 4300 süsteemset ravi vajanud patsienti.
English: This is a summary of the European public assessment report (EPAR) for Kyntheum.
Estonian: See on ravimi Kyntheum Euroopa avaliku hindamisaruande kokkuvõte.
English: Although there have been recent advances in the treatment of plaque psoriasis, there remains a need for new treatment options.
Estonian: Kuigi naastulise psoriaasi ravis on hiljuti tehtud edusamme, püsib endiselt vajadus uute raviviiside järele.
English: What are the risks associated with Kyntheum?
Estonian: Mis riskid Kyntheumiga kaasnevad?
English: The active substance in Kyntheum, brodalumab, is a monoclonal antibody, a protein designed to block the activity of certain substances called interleukins 17 (A, F and A/F), which are messengers in the body's immune system (the body's natural defences).
Estonian: Kyntheumi toimeaine brodalumab on monoklonaalne antikeha - valk, mis blokeerib organismi immuunsüsteemi (keha loomuliku kaitsesüsteemi) nn virgatsainete interleukiin 17A, 17F ja 17A/F aktiivsuse.