FrancophonIA/ELRC3.0 huggingface dataset:
English: 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 administration (see section 4.4).
Estonian: Paget'i luutõvega patsientidel on soovitatav kasutada piisavas koguses kaltsiumi, mis vastab vähemalt 500 mg-le kaltsiumile kaks korda ööpäevas, vähemalt 10 päeva jooksul pärast zoledroonhappe ravi algust (vt lõik 4.4).
English: Each bag contains 100 ml of solution.
Estonian: Iga kott sisaldab 100 ml lahust.
English: Unusual fracture of the thigh bone particularly in patients on long-term treatment for osteoporosis may occur rarely.
Estonian: Harva esinevad (võivad tekkida kuni 1 inimesel 1000-st) Harva võib esineda reieluu ebaharilik murd, eriti pikaajalist osteoporoosi ravi saavatel patsientidel.
English: Women of childbearing potential Zoledronic acid is not recommended in women of childbearing potential.
Estonian: Rasestuda võivad naised Zoledroonhapet ei soovitata fertiilses eas naistele.
English: • Monitoring of serum creatinine should be considered in at-risk patients.
Estonian: • Vastava riskiga patsiendid tuleb kaaluda veres kreatiniinisisalduse jälgimise vajadust.
English: Zoledronic acid Teva Generics contains the active substance zoledronic acid.
Estonian: Zoledronic acid Teva Generics'i toimeaine on zoledroonhape.
English: Talk to your doctor before you are given Zoledronic acid Teva Generics: - if you are being treated with any other bisphosphonate medicine, since the combined effects of these medicines taken together with Zoledronic acid Teva Generics are unknown.
Estonian: Enne Zoledronic acid Teva Generics'i kasutamist pidage nõu oma arstiga: - kui te saate ravi mõne muu biofosfanaati sisaldava ravimiga, kuna selliste ravimite koostoime
English: Zoledronic acid Teva Generics contains sodium This medicine contains less than 1 mmol sodium (23 mg) per 100 ml, i.e. essentially “sodium-free.”
Estonian: Zoledronic acid Teva Generics sisaldab naatriumi Ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) 100 ml kohta, see tähendab põhimõtteliselt “naatriumivaba.”
English: Uncommon Conjunctivitis, eye pain Rare
Estonian: Konjunktiviit, silma valu
English: • Creatinine clearance should be calculated based on actual body weight using the Cockcroft-Gault formula before each zoledronic acid dose.
Estonian: • Enne iga zoledroonhappe annuse manustamist tuleb Cockcroft-Gault'i valemi järgi arvutada kreatiniini kliirens vastavalt patsiendi tegelikule kehakaalule.
English: Your doctor should do a blood test to check your kidney function before each dose of Zoledronic acid Teva Generics.
Estonian: Teie arst peab enne iga Zoledronic acid Teva Generics annuse manustamist tegema neerufunktsiooni kontrollimiseks vereanalüüsi.
English: Each bottle contains 100 ml of solution.
Estonian: Iga pudel sisaldab 100 ml lahust.
English: How to prepare and administer Zoledronic acid Teva Generics
Estonian: Kuidas ette valmistada ja manustada Zoledronic acid Teva Generics'it kottides
English: Approximately 42% of patients had a femoral neck BMD T-score below -2.5 and approximately 45% of the patients had a femoral neck BMD T-score above -2.5. zoledronic acid was administered once a year, until at least 211 patients in the study population had confirmed clinical fractures.
Estonian: Ligikaudu 42%-l patsientidest oli reieluukaela LMT T-skoor alla -2,5 ja umbes 45%-l patsientidest oli reieluukaela LMT T-skoor üle -2,5.
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 administration (see section 4.2).
Estonian: Lisaks on Paget'i tõvega haigetele oluline täiendav kaltsiumi manustamine (annuses, mis vastab vähemalt 500 mg kaltsiumile kaks korda ööpäevas), vähemalt 10 päeva jooksul pärast zoledroonhappe ravi algust (vt lõik 4.2).
English: 6.5 Nature and contents of container multilayer polyolefin/styrene-ethylene-butylene (SEB) bag with SFC polypropylene infusion port closed with rubber stopper and snap cap.
Estonian: Mitmekihline polüolefiin/stüreen-etüleen-butüleen (SEB) kott SFC propüleenist infusioonipordiga, mis on suletud kummikorgi ja äratõmmatava osaga.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 5 mg zoledronic acid (as monohydrate).
Estonian: KVALITATIIVNE JA KVANTITATIIVNE KOOSTIS Iga pudel sisaldab 5 mg zoledroonhapet (Acidum zoledronicum) (monohüdraadina).
English: EU/1/14/912/001 EU/1/14/912/002 EU/1/14/912/003
Estonian: EU/1/14/912/004 EU/1/14/912/005
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: Zoledroonhape toimel vähenes oluliselt keskmine piiratud aktiivsuse ja seljavalu tõttu voodirežiimil veedetud päevade arv, vastavalt 17,9 päeva ja 11,3 päeva võrra platseeboga võrreldes.
English: In the subpopulation of patients receiving glucocorticoids for more than 3 months prior to randomisation, zoledronic acid increased lumbar spine BMD by 4.06% versus 2.71% for risedronate (mean difference: 1.36%; p<0.001).
Estonian: Patsientide alarühmas, kes said glükokortikoide enne randomiseerimist rohkem kui 3 kuud, suurenes lülisamba nimmeosa LMT zoledroonhappe toimel 4,06% ja risedronaadi toimel 2,71% (keskmine erinevus: 1,36%; p<0,001).
English: Renal failure requiring dialysis or with a fatal outcome has rarely occurred in patients with underlying renal impairment or with any of the risk factors described above.
Estonian: Harvadel juhtudel on olemasoleva neerufunktsiooni halvenemise või ülalkirjeldatud riskiteguritega patsientidel täheldatud dialüüsravi nõudnud või surmaga lõppenud neerupuudulikkust.
English: Nausea, vomiting, diarrhoea Uncommon Dyspepsia, abdominal pain upper, abdominal pain, gastroesophageal reflux disease, constipation, dry mouth, oesophagitis, toothache, gastritis#
Estonian: Düspepsia, ülakõhuvalu, kõhuvalu, gastroösofageaalne reflukshaigus, kõhukinnisus, suukuivus, ösofagiit, hambavalu, gastriit#
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/004
Estonian: MÜÜGILOA NUMBER(NUMBRID) EU/1/14/912/004
English: Osteonecrosis of the jaw has been reported in patients treated with zoledronic acid.
Estonian: Zoledroonhappega ravitud patsientidel on teatatud lõualuu osteonekroosi juhtudest.
English: If you experience any of the above side effects, you should contact your doctor immediately.
Estonian: Kui teil tekib ükskõik milline nendest kõrvaltoimetest, rääkige sellest oma arstile.
English: Any clinical fracture (1) Clinical vertebral fracture
Estonian: Igasugune kliiniline luumurd (1) Kliiniline lülimurd (2)
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: Treatment of osteoporosis
Estonian: Osteoporoosi ravi
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/912/001
Estonian: MÜÜGILOA NUMBER (NUMBRID) EU/1/14/912/001
English: Other products containing zoledronic acid as active substances are available for oncology indications.
Estonian: Onkoloogilisteks näidustusteks on saadaval teisi toimeainena zoledroonhapet sisaldavaid ravimeid.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml; i.e. essentially “sodiumfree.”
Estonian: See ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) 100 ml kohta, see tähendab põhimõtteliselt “naatriumivaba”.
English: Uveitis, episcleritis, iritis
Estonian: Lööve, hüperhidroos, kihelus, erüteem
English: The pack sizes of 5 and 10 are only available as multipacks comprising of 5 or 10 packs, each containing 1 bottle.
Estonian: Zoledronic acid Teva Generics on saadaval nii üksikpakendites, mis sisaldavad 1, 5 või 10 pudelit ja ka hulgipakendis, milles on viiene või kümnene pakend, igas neis üks pudel.
English: - Zoledronic acid Teva Generics 5 mg solution for infusion is ready for use.
Estonian: - Zoledronic acid Teva Generics 5 mg kasutamisvalmis infusioonilahus.
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 korda üle ea-spetsiifilise ülemise normi piiri) nais- ja meessoost patsientidel vanuses üle 30 aasta.
English: Solution for infusion multipack: 5 bags x 100 ml multipack: 10 bags x 100 ml
Estonian: hulgipakend: 10 kotti x 100ml
English: LIST OF EXCIPIENTS Excipients: Mannitol, sodium citrate and water for injections.
Estonian: ABIAINED Abiained: mannitool, naatriumtsitraat ja süstevesi.
English: Relative risk reduction in fracture incidence % (CI)
Estonian: Luumurdude esinemissageduse suhtelise riski vähenemine % (CI)
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 (Acidum zoledronicum) (monohüdraadina).
English: How to store Zoledronic acid Teva Generics
Estonian: Kuidas Zoledronic acid Teva Generics'it kasutada
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 100 ml vial, i.e. essentially “sodium free”.
Estonian: Ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) 100 ml viaali kohta, see tähendab põhimõtteliselt „naatriumivaba“.
English: One bottle contains 5 mg zoledronic acid (as monohydrate).
Estonian: 1 pudel sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: Absolute reduction in fracture event rate % (CI)
Estonian: Luumurdude esinemissageduse absoluutne vähenemine % (CI)
English: Marketing Authorisation Holder
Estonian: MÜÜGILOA HOIDJA NIMI JA AADRESS
English: (see Annex I: Summary of Product Characteristics, section 4.2).
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD Piiratud tingimustel väljastatav retseptiravim (vt I lisa: Ravimi omaduste kokkuvõte, lõik 4.2).
English: - Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. - The unopened bottle does not require any special storage conditions.
Estonian: - Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud karbil või pudelil pärast„Kõlblik kuni:“ Kõlblikkusaeg viitab selle kuu viimasele päevale.
English: - Zoledronic acid Teva Generics 5 mg solution for infusion in bags is ready for use.
Estonian: - Zoledronic acid Teva Generics 5 mg kasutamisvalmis infusioonilahus kottides.
English: Clinical vertebral fracture
Estonian: Reieluu atüüpilised murrud
English: Each ml of solution contains 0.05 mg zoledronic acid (as monohydrate).
Estonian: Üks ml lahust sisaldab 0,05 mg zoledroonhapet (monohüdraadina).
English: Mutagenicity and carcinogenic potential
Estonian: Mutageenne ja kartsinogeenne toime
English: (CI)
Estonian: Κύπρος
English: Outcome
Estonian: Tulemusnäitaja
English: It comes in a polyolefin/styrene-ethylene-butylene (SEB) foil bag with a foil over pouch.
Estonian: Zoledronic acid Teva Generics on polüolefiin/stüreen-etüleen-butüleen (SEB) fooliumkotis koos ümbriskotiga.
English: Relative reduction in fracture incidence % (CI)
Estonian: Luumurdude esinemissageduse suhtelise vähenemise % (CI)
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, näiteks kõrge iga, teiste nefrotoksiliste ravimite samaaegne kasutamine, samaaegne ravi diureetikumidega või dehüdratsioon pärast Zoledronic acid Teva Generics'i manustamist (vt lõik 4.4 ja lõik 4.8 „Ravimiklassi kõrvaltoimed“), on harvadel juhtudel teatatud ka dialüüsravi nõudnud või surmaga lõppenud neerupuudulikkusest.
English: Each ml of the solution contains 0.05 mg zoledronic acid (as monohydrate).
Estonian: Üks milliliiter lahust sisaldab 0,05 mg zoledroonhapet (monohüdraadina).
English: One bag contains 5 mg zoledronic acid (as monohydrate).
Estonian: Üks kott sisaldab 5 mg zoledroonhapet (monohüdraadina).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BAG
Estonian: SISEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KOTT
English: Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction)
Estonian: Kaelavalu, lihas-skeleti jäikus, liigeste turse, lihasspasmid, õlavalu, lihas-skeleti rindkerevalu, lihas-skeletivalu, liigeste jäikus, artriit, lihasnõrkus
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (with blue box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARTONGPAKEND(„BLUE BOX“-IGA)
English: A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e.g. cancer, chemotherapy, anti-angiogenic medicinal products, corticosteroids, poor oral hygiene).
Estonian: Kaasnevate riskifaktoritega (nt kasvajad, kemoteraapia, antiangiogeensed ravimpreparaadid, kortikosteroidid, puudulik suuhügieen) patsientidel tuleb enne bisfosfonaatidega ravi alustamist teostada hammaste ülevaatus ja asjakohane preventiivne hambaravi.
English: Teva Pharma Belgium N.V.
Estonian: Nederland Teva Nederland B.V.
English: Myalgia, arthralgia, bone pain, back pain, pain in extremity
Estonian: Müalgia, artralgia, luuvalu, seljavalu, valu jäsemetes
English: Elevated bone turnover is a characteristic of Paget's disease of the bone.
Estonian: Paget'i luutõvele on iseloomulik luukoe kiirenenud ainevahetus.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bottles
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Generics 5 mg infusioonilahus pudelis
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
Estonian: B. HANKE- JA KASUTUSTINGIMUSED VÕI PIIRANGUD C. MÜÜGILOA MUUD TINGIMUSED JA NÕUDED D. RAVIMPREPARAADI OHUTU JA EFEKTIIVSE
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON FOR MULTIPACKS (with blue box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED HULGIPAKENDI VÄLINE KARP („BLUE BOX“-IGA)
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bags
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Generics 5 mg infusioonilahus kotis
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (without blue box)
Estonian: VÄLISPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED KARTONGPAKEND(„BLUE BOX“-ITA)
English: PARTICULARS TO APPEAR ON THE INTERMEDIATE PACKAGING OVERPOUCH (without blue box)
Estonian: VAHEPAKENDIL PEAVAD OLEMA JÄRGMISED ANDMED ÜMBRISKOTT („BLUE BOX“-ITA)
English: Nederland Teva Nederland B.V. Tel: +31 800 0228400
Estonian: Tel: +31 800 0228400
English: The clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.
Estonian: Igal konkreetsel juhul peab raviarst hindama võimalikku kasu/riski suhet ning lähtudes sellest kavandama edasise tegevuse.
English: You must not be given Zoledronic acid Teva Generics:
Estonian: Zoledronic acid Teva Generics ´iga on teadmata.
English: NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Generics 5 mg infusioonilahus pudelis Zoledroonhape (Acidum zoledronicum)
English: Ask your doctor, pharmacist or nurse for advice before taking this medicine.
Estonian: Enne selle ravimi kasutamist pidage nõu oma arsti, apteekri või meditsiiniõega.
English: METHOD AND ROUTE(S) OF ADMINISTRATION
Estonian: Platseeb o (%)
English: ANNEX II
Estonian: TOIMEAINE(TE) SISALDUS
English: - if you are breast-feeding.
Estonian: - kui te imetate last.
English: Zoledronic acid Teva Generics 5 mg solution for infusion in bags zoledronic acid
Estonian: RAVIMPREPARAADI NIMETUS Zoledronic acid Teva Generics 5 mg infusioonilahus Zoledroonhape (Acidum zoledronicum)
English: Bone turnover markers
Estonian: Mannitool Naatriumtsitraat Süstevesi
English: C-reactive protein increased Uncommon Blood calcium decreased
Estonian: C-reaktiivse valgu tõus
English: Zoledronic acid Teva Generics 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 Generics võib toimida kauem kui üks aasta.
English: It works in a number of different ways:
Estonian: See toimib mitmel viisil:
English: This may lead to very serious infection.
Estonian: See võib põhjustada väga tõsise infektsiooni.
English: • then at least every month after that.
Estonian: • edaspidi vähemalt kord kuus.
English: For all indications described below:
Estonian: Kõikide allpool kirjeldatud näidustuste puhul:
English: ATC code: L04AX04.
Estonian: ATC-kood: L04AX04.
English: • The patient has acknowledged the aforementioned conditions.
Estonian: • patsient on eelnimetatud tingimustega nõus.
English: • Verification that appropriate counselling has taken place
Estonian: • tõestus, et vastav nõustamine on toimunud;
English: Your doctor will ask you to have a blood test:
Estonian: Teie arst palub teil vereanalüüsi teha:
English: Developmental toxicity studies were previously conducted in rabbits.
Estonian: Arengutoksilisuse uuringud on eelnevalt läbi viidud küülikutel.
English: Take your next capsule at the usual time the next day.
Estonian: Võtke järgmine kapsel järgmisel päeval tavalisel ajal.
English: This medicine belongs to a group of medicines which affect how your immune system works.
Estonian: See ravim kuulub ravimite rühma, mis mõjutavad teie immuunsüsteemi toimimist.
English: This can damage the bones and kidneys.
Estonian: See võib kahjustada luid ja neere.
English: However, on some days you do not take any of the medicines.
Estonian: Mõnel päeval ei võeta ühtki ravimit.
English: Time to event
Estonian: Aeg sündmuseni
English: However, the signs and symptoms can be greatly reduced or disappear for a period of time.
Estonian: Selle nähte ja sümptomeid on siiski võimalik tunduvalt vähendada või need võivad teatavaks ajaks kaduda.
English: Your doctor should check whether you have ever had hepatitis B infection
Estonian: Teie arst peab kontrollima, kas te olete kunagi nakatunud B-hepatiiti;
English: An extended follow-up efficacy analysis was conducted with a median follow-up of 130.7 weeks.
Estonian: Tehti pikendatud jälgimisperioodi efektiivsuse analüüs, milles jälgimisperioodi mediaan oli 130,7 nädalat.
English: The median age was 73 in the 3 arms.
Estonian: Vanuse mediaan 3 rühmas oli 73 aastat.
English: Pregnancy, breast-feeding and contraception - information for women and men
Estonian: Rasedus, imetamine ja rasestumisvastased vahendid - teave naistele ja meestele
English: If dose increased (15 mg) a
Estonian: Kui annust on suurendatud (15 mg)a
English: Regular monitoring of visual ability is recommended.
Estonian: Soovitatav on nägemisvõimet regulaarselt jälgida.
English: • Depending on the day of the cycle, you will take one or more of the medicines.
Estonian: • Olenevalt tsükli päevast võtate üht või mitut ravimit.
English: • more than 12 hours have passed - do not take your capsule.
Estonian: • möödunud on rohkem kui 12 tundi - ärge kapslit sisse võtke.
English: Lenalidomide has an asymmetric carbon atom and can therefore exist as the optically active forms S(-) and R(+).
Estonian: Lenalidomiidil on asümmeetriline süsinikuaatom, mistõttu see võib esineda optiliselt aktiivsete S(-) ja R(+)-vormidena.
English: The results for the study, using a cut-off of 1 February 2016, are presented in Table 4
Estonian: Uuringu tulemused, andmete kogumise lõppkuupäevaga 1. veebruar 2016, on esitatud tabelis 4.
English: No overall difference in safety or efficacy was observed between these patients and younger patients, but greater pre-disposition of older individuals cannot be ruled out.
Estonian: Nende ja nooremate patsientide võrdlemisel erinevusi ohutuse või efektiivsuse osas ei täheldatud, kuid eakamate isikute suuremat soodumust ei saa välistada.
English: Therefore you must tell your doctor immediately if you experience:
Estonian: Seepärast peate te oma arsti otsekohe informeerima, kui teil tekivad:
English: Other sources of information
Estonian: Muud teabeallikad:
English: This is called a ‘response'.
Estonian: Seda nimetatakse ravivastuseks.
English: If you are able to become pregnant, your doctor will record with each prescription that the necessary measures have been taken and provide you with this confirmation.
Estonian: Kui te olete võimeline rasestuma, märgib teie arst ravimi igal väljakirjutamisel üles, et vajalikud meetmed on tarvitusele võetud ja annab teile selle kinnituse.
English: Details of the PPP including the set-up of national measures to assess the effectiveness of and compliance with the PPP should be agreed with the National Competent Authorities in each Member State and put in place prior to the marketing of the product.
Estonian: PPP üksikasjad, sh riiklike meetmete käivitumine PPP järgimise ja efektiivsuse hindamiseks, peavad olema kooskõlastatud iga liikmesriigi riikliku pädeva asutusega ning kohaldatud enne toote turustamist.
English: Children and adolescents Lenalidomide is not recommended for use in children and adolescents under 18 years.
Estonian: Lapsed ja noorukid Lenalidomiidi ei soovitata kasutada lastel ja noorukitel vanuses kuni 18 aastat.
English: Currently available pharmacokinetic data are described in section 5.2.
Estonian: Praeguseks teadaolevad farmakokineetilised andmed on esitatud lõigus 5.2.
English: Injury, Poisoning and Procedural Complications
Estonian: Vigastus, mürgistus ja protseduuri tüsistused
English: • less than 12 hours have passed - take your capsule immediately.
Estonian: • möödunud on vähem kui 12 tundi - võtke kapsel otsekohe sisse;
English: • Women who are pregnant.
Estonian: • Rasedad naised.
English: Though this risk is not yet fully characterized, it should be kept in mind when considering and using lenalidomide in this setting.
Estonian: Kuigi see risk ei ole veel täiesti selge, tuleb sellega arvestada, kasutades lenalidomiidi sellises olukorras või kaaludes kasutamist.
English: Safety advice for men
Estonian: Ohutusteave meestele
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Estonian: TEISED ERIHOIATUSED (VAJADUSEL) HOIATUS!
English: • Explanation of the risk of neuropathy with long term use
Estonian: • selgitus neuropaatia riski kohta ravimi pikaajalisel kasutamisel;
English: In particular, tell your doctor or nurse if you are taking any of the following medicines:
Estonian: Eelkõige öelge oma arstile või meditsiiniõele, kui te kasutate mõnda järgmist ravimit:
English: Effective measures to avoid pregnancy must be taken (see sections 4.4 and 4.6).
Estonian: Raseduse vältimiseks peab rakendama tõhusaid meetmeid (vt lõigud 4.4 ja 4.6).
English: In IFM 2005-02, the adverse reactions were from the maintenance treatment period only.
Estonian: Uuringu IFM 2005-02 kõrvaltoimed pärinesid ainult säilitusravi perioodist.